[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Uruguay\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":548},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,42,71,96,130,155,185,213,238,260,298,322,353,383,410,437,467,491,520],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100506864","phase-3-evaluating-the-addition-of-adjuvant-chemotherapy-to-ovarian-function-suppression-plus-endocrine-therapy-in-premenopausal-patients-with-pn0-1-er-positiveher2-negative-breast-cancer-and-an-oncotype-recurrence-score-less-than-or-equal-to-25-100506864",false,"NCT05879926","Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive\u002FHER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25","A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive\u002FHER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET)","OFSET","Inclusion Criteria:\n\n* A patient cannot be considered eligible for this study unless ALL of the following conditions are met.\n\n  * The patient or a legally authorized representative must provide study-specific informed consent prior to pre-entry and, for patients treated in the U.S., authorization permitting release of personal health information.\n  * Female patients must be greater than or equal to 18 years of age.\n  * Patients must be premenopausal (evidence of functioning ovaries) at the time of pre-entry. For study purposes, premenopausal is defined as:\n  * Age 50 years or under with spontaneous menses within 12 months; or\n  * Age greater than 50-60 years with spontaneous menses within 12 months plus follicle-stimulating hormone (FSH) and estradiol levels in the premenopausal range; or\n  * Patients with amenorrhea due to IUD or prior uterine ablation must have FSH and estradiol levels in the premenopausal range; or\n  * Patients with prior hysterectomy must have FSH and estradiol levels in the premenopausal range.\n  * The patient must have an ECOG performance status of less than or equal to 2 (or Karnofsky greater than or equal to 60%).\n  * Patients may have ipsilateral or contralateral synchronous breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.\n  * Patients may have multicentric or multifocal breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.\n  * Patient may have undergone a total mastectomy, skin-sparing mastectomy, nipple-sparing mastectomy, or a lumpectomy.\n  * For patients who undergo a lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS (ductal carcinoma in situ) with no ink on tumor as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. Positive posterior margin is allowed if surgeon deems no further resection possible. (Patients with margins positive for LCIS (lobular carcinoma in situ) are eligible without additional resection.)\n  * For patients who undergo mastectomy, the margins must be free of residual gross tumor. (Patients with microscopic positive margins are eligible if post-mastectomy RT (radiation therapy) of the chest wall will be administered.)\n  * Patient must have undergone axillary staging with sentinel node biopsy (SNB), targeted axillary dissection (TAD), or axillary lymph node dissection (ALND).\n  * The following staging criteria must be met postoperatively according to AJCC 8th edition criteria:\n  * By pathologic evaluation, primary tumor must be pT1-3. (If N0, must be T1c or higher.)\n  * By pathologic evaluation, ipsilateral nodes must be pN0 or pN1 (pN1mi, pN1a, pN1b, pN1c).\n  * Patients with positive isolated tumor cells (ITCs) in axillary nodes will be considered N0 for eligibility purposes.\n  * Patients with micrometastatic nodal involvement (0.2-2 mm) will be considered N1.\n  * Oncotype DX RS (recurrence score) requirements\\*:\n  * If node-negative:\n  * Oncotype DX RS must be RS 21-25, or\n  * Oncotype DX RS must be 16-20 and disease must be high clinical risk, defined as: low histologic grade with primary tumor size greater than 3 cm, intermediate histologic grade with primary tumor size greater than 2 cm, or high histologic grade with primary tumor size greater than 1 cm.\n  * If 1-3 nodes involved:\n  * Oncotype DX RS must be less than 26.\n\n    \\* Patients with a \"Low Risk\" or \"MP1\" MammaPrint (a genomic test that analyzes the activity of certain genes in early-stage breast cancer) result must have eligibility assessed with an Oncotype DX RS at pre-entry (see Section 3.1). Blocks or unstained slides must be sent to the Genomic Health centralized laboratory for testing at no cost to these patients. If MammaPrint High Risk or MP2, these patients are not eligible.\n  * The tumor must be ER and\u002For PgR-positive (progesterone receptor) by current ASCO\u002FCAP guidelines based on local testing results. Patients with greater than or equal to 1% ER and\u002For PgR staining by IHC will be classified as positive.\n  * The tumor must be HER2-negative by current ASCO\u002FCAP (American Society of Clinical Oncology\u002FCollege of American Pathologists) guidelines based on local testing results.\n  * The interval between the last surgery for breast cancer (including re-excision of margins) and pre-entry must be no more than 16 weeks.\n  * Short course of endocrine therapy of less than 6 weeks duration before pre-entry is acceptable either as neoadjuvant or adjuvant therapy. An Oncotype DX RS must be performed on core biopsy specimen obtained prior to initiation of neoadjuvant endocrine therapy if received.\n  * Patients with a prior or concurrent non-breast malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. This would include prior cancers treated with curative intent.\n  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n  * Radiation therapy should be used according to standard guidelines; the intended radiation therapy should be declared prior to pre-entry.\n\nExclusion Criteria:\n\n* • Definitive clinical or radiologic evidence of metastatic disease.\n\n  * pT4 (pathological state) tumors, including inflammatory breast cancer.\n  * History of ipsilateral or contralateral invasive breast cancer. (Patients with synchronous and\u002For previous DCIS or LCIS are eligible.)\n  * If prior ipsilateral DCIS was treated with lumpectomy and XRT (ionizing radiation therapy), a mastectomy must have been performed for the current cancer.\n  * Life expectancy of less than 10 years due to co-morbid conditions in the opinion of the investigator.\n\nKnown results from most recent lab studies obtained as part of routine care prior to study entry showing ANY of the following values:\n\n* ANC (absolute neutrophil count) less than 1200\u002Fmm3;\n* Platelet count less than 100,000\u002Fmm3;\n* Hemoglobin less than 10 g\u002FdL;\n* Total bilirubin greater than ULN (upper limit of normal) for the lab or greater than 1.5 x ULN for patients who have a bilirubin elevation due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin;\n* AST(aspartate aminotransferase)(SGOT)\u002FALT (alanine transminase)(SGPT): greater than 3 × institutional ULN;\n* Renal function of GFR (glomular filtration rate) less than 30 mL\u002Fmin\u002F1.73m2.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n* Non-epithelial breast malignancies such as sarcoma or lymphoma.\n* Any treatment with radiation therapy, chemotherapy, or biotherapy administered for the currently diagnosed breast cancer prior to pre-entry. (Patients with prior ET of more than 6 weeks duration for treatment of this cancer are not eligible.) Prior tamoxifen given for breast cancer prevention is allowed. Prior AI or GnRH for fertility preservation is allowed.\n* Hormonally based contraceptive measures must be discontinued prior to pre-entry (including progestin\u002Fprogesterone IUDs).\n* Patients with evidence of chronic hepatitis B virus (HBV) infection are ineligible unless the HBV viral load is undetectable on suppressive therapy. Patients with a history of hepatitis C virus (HCV) infection are ineligible unless they have been treated and cured or have an undetectable HCV viral load if still on active therapy.\n* Pregnancy or lactation at the time of pre-entry. (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to pre-entry.)\n* Other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results.","FEMALE","18 Years","60 Years",{"count":21,"type":22},3960,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).",[28],"Breast Cancer","RECRUITING","2026-08-03",{"date":32,"type":33},"2026-08-04","ACTUAL",{"date":35,"type":33},"2023-10-18",{"date":37,"type":22},"2034-07",{"name":39,"class":40},"NRG Oncology","OTHER",1259,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100561650","phase-3-docetaxel-to-androgen-receptor-pathway-inhibitors-in-patients-with-metastatic-castration-sensitive-prostate-cancer-and-suboptimal-psa-response-100561650","NCT06592924","Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response","A Randomized Phase III Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response","TRIPLE-SWITCH","Inclusion Criteria:\n\n* Histologically\u002Fcytologically confirmed adenocarcinoma of the prostate or participants with a PSA \\>100 ng\u002Fml (100 ug\u002FL) and radiographic evidence of metastatic disease at diagnosis.\n* Metastatic disease by conventional imaging (bone scan or CT and\u002For MRI or PSMA-PET scan at the time of ADT initiation.\n* PSA of ≥ 2.0 ng\u002Fml (2.0 ug\u002FL) prior to commencement of ADT (this refers to patients who have histologically\u002Fcytologically confirmed adenocarcinoma of the prostate)\n* Patients will have recovered from any treatment-related toxicities prior to enrollment (unless ≤ grade 1, irreversible, or considered by investigator as not clinically significant).\n* Patients may enroll with persistent toxicities attributable to ADT, including hot flushes and fatigue, of any grade, provided these toxicities are clinically stable, not rapidly worsening, and not considered by the Investigator to pose a safety risk or impair the patient's ability to comply with study procedures. Such toxicities do not need to resolve to Grade ≤1 prior to study entry.\n* Receipt of ADT for mCSPC for at least 6 months and no greater than 12 months (+\u002F- 3 weeks) at time of enrollment.\n* Receipt of ARPI (e.g. abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for at least 4 months (+\u002F- 2 weeks) at time of enrollment\n* Patients may have had radiotherapy to prostatic bed and\u002For metastatic sites prior to enrollment. Potential trial participants should have recovered from radiotherapy-related toxicities prior to enrollment.\n* Serum testosterone \\\u003C1.7 nmol\u002FL or 50 ng\u002FdL.\n* PSA ≥ 0.2 ng\u002Fml (0.2 ug\u002FL) within 28 days of enrollment.\n* Candidate for docetaxel chemotherapy\n* ECOG Performance Status (PS) 0 to 2.\n* Adequate organ and marrow function measured within 28 days prior to enrollment.\n* Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrollment in the trial to document their willingness to participate.\n* Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.\n* In accordance with CCTG policy, protocol treatment is to begin within 10 working days of participant enrollment.\n* If the participant and the participant's partner are of childbearing potential, they must agree to use medically accepted methods of contraception\n* HIV-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* Participant access to all protocol therapies must be confirmed prior to enrollment\n\nExclusion Criteria:\n\n* Confirmed PSA progression, defined by an increase in PSA of 25% above the nadir since achieving castration on ADT, an absolute increase in PSA value of 2.0 ng\u002Fml (ug\u002FL) above nadir, and a subsequent increase in PSA of 25% further separated by 3 or more weeks.\n* Evidence of confirmed radiographic progression or clinical progression since start of ADT. Participants may be enrolled on the study if, in the opinion of the investigator, any new bone lesions on bone scan and CT represent flare or treatment effect.\n* Docetaxel criteria:\n\n  * Prior treatment with taxane chemotherapy\n  * Grade 2 or worse peripheral neuropathy\n  * Severe hypersensitivity to drugs formulated with polysorbate 80\n* Clinically significant cardiac disease including:\n\n  * History of unstable angina pectoris, symptomatic pericarditis, or myocardial infarction within 6 months prior to study entry.\n  * History of documented congestive heart failure (New York Heart Association functions classification III-IV).\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous.\n* Patients with a prior or concurrent malignancy whose natural history of treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Concurrent treatment with other anti-cancer systemic therapy other than ADT and ARPI.\n* Live attenuated vaccination administered within 30 days prior to enrollment\u002Frandomization.\n* For participants with a history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* High-grade neuroendocrine prostate cancer or small cell features (except if a participant has no histological diagnosis but a PSA \\>100 ng\u002Fml (\\>100 ug\u002FL) at diagnosis and radiographic evidence of metastatic disease)","MALE",{"count":52,"type":22},830,[25],"This study is being done to answer the following question: can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual combination of drugs?\n\nThis study would like to find out if this approach is better or worse than the usual approach for prostate cancer.\n\nThe usual approach for patients who are not in a study is hormone treatment with Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitor (ARPI).",[56],"Prostate Cancer (Adenocarcinoma)",[58,59],"PR26","Castration sensitive","2026-07-13",{"date":62,"type":33},"2026-07-14",{"date":64,"type":33},"2025-05-28",{"date":66,"type":22},"2031-04-15",{"name":68,"class":69},"Canadian Cancer Trials Group","NETWORK",395,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":95},"100475978","an-observational-pregnancy-safety-study-in-women-who-were-exposed-to-the-drug-nifurtimox-during-pregnancy-to-learn-about-the-risk-of-pregnancy-complications-and-about-the-mothers-and-babys-health-100475978","NCT05477953","An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother's and Baby's Health","Observational Pregnancy Safety Study of Women Exposed to Nifurtimox During Pregnancy to Describe the Risk of Pregnancy and Maternal Complications and Other Events of Interest on the Developing Fetus, Neonate, and Infant","Inclusion Criteria:\n\n* Females exposed to at least 1 dose of nifurtimox at any time during pregnancy (i.e., from the first day of the last menstrual period \u002F time of conception to pregnancy outcome).\n* Written informed consent (for adolescents under the age of majority, written informed assent by the pregnant minor (where applicable) and written informed consent by the parent\u002Flegal guardian).\n\nExclusion Criteria:\n\n* None",{"count":79,"type":22},50,"OBSERVATIONAL","This is an observational study in which data from women with Chagas disease who will take or have already taken nifurtimox during pregnancy and the impact on their babies are studied.\n\nChagas disease is an inflammatory, infectious disease caused by the parasite Trypanosoma cruzi. This parasite is mainly spread by insects called triatomine bug. If Chagas disease is left untreated, it can later cause e.g. serious heart and digestive problems.\n\nNifurtimox has been used for more than 50 years to treat Chagas disease in children and adults.\n\nIt is not recommended to be used during pregnancy as data from animal studies indicate that it may harm the baby. Currently, there are not enough data to know if this is also the case in humans.\n\nIn this study, researchers want to collect data on the safety of nifurtimox use in pregnant women. To do this, researchers will collect the following information:\n\n* Birth defects (abnormal and problematic structures or functions, a child is born with)\n* Pregnancy outcomes (like live birth, preterm birth, still birth\u002Fdeath of the unborn baby, miscarriage, or abortion)\n* Certain health problems of the child up to 12 months of age\n* Certain health problems of the women experienced during pregnancy The data will be collected from different sources including telephone calls with the women or their doctor, CRFs (case reprt forms) or from medical records The researchers will compare the proportion of children with birth defects, pregnancy outcomes or certain health problems of the child or the women during pregnancy with available data on these outcomes in the general population.\n\nThe study will run for approximately 10 years.",[83],"Chagas Disease","NOT_YET_RECRUITING","2026-07-02",{"date":87,"type":33},"2026-07-06",{"date":89,"type":22},"2026-12-31",{"date":91,"type":22},"2032-01-31",{"name":93,"class":94},"Bayer","INDUSTRY",12,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":105,"minAge":18,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":23,"phases":109,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":129},"100627249","blood-glucose-response-to-test-foods-containing-brewers-spent-grain-100627249","NCT07446179","Blood Glucose Response to Test Foods Containing Brewer's Spent Grain","Brewer's Spent Grain a Potential Ally for the Prevention of Type II Diabetes: Determination of Blood Glucose Absorption of New Foods","BSG-PPG","Inclusion Criteria:\n\n* Body mass index (BMI) between 18.5 and 30 kg\u002Fm².\n\nExclusion Criteria:\n\n* Pregnancy\n* Diabetes\n* Recent surgerys\n* Food allergies",true,"ALL","75 Years",{"count":108,"type":22},20,[110],"NA","The objective of this project is to determine the impact of incorporating brewers' spent grain into cookie formulations on postprandial blood glucose absorption levels following consumption. The methodology for assessing blood glucose response to cookies formulated with brewers' spent grain is described as follows.\n\nA total of 20 participants will be recruited from the Universidad Católica del Uruguay. Volunteers will be recruited through institutional email dissemination, with Dr. María Belén Gutiérrez serving as the research contact.\n\nEligible participants will be healthy adults without diagnosed diseases and not taking regular medication. Inclusion criteria will be: men and women aged 18 to 75 years and a body mass index (BMI) between 18.5 and 30 kg\u002Fm². Exclusion criteria will include: pregnancy, diabetes, special dietary regimens, recent surgeries, and hypersensitivity or allergy to any of the components of the tested foods.\n\nA physical assessment will be performed for each participant, including waist and hip circumferences, body weight, and height. Each participant will be assigned a volunteer identification code, and the data analyst will be blinded to the identity of the participants. Volunteers may withdraw from the study at any time without any consequences.\n\nParticipants will be studied on four separate occasions (one session per week). On two occasions they will receive 30 g of a commercial María cookie, and on the other two occasions 30 g of a reduced-sugar cookie containing 17% extruded brewers' spent grain. During the study period, participants will be asked to maintain their usual lifestyle.\n\nParticipants will attend the University Clinic in the morning after an 8-10 hour overnight fast. After a fasting blood sample is obtained, the corresponding treatment will be provided, and participants will have 15 minutes to consume it. Capillary blood samples will be collected at 15, 30, 45, 60, 90, and 120 minutes after the start of treatment consumption.\n\nBlood sampling will be performed via capillary puncture using a commercially available glucometer, with disposable lancets used for each measurement and safely discarded after each sample. Sample collection will be carried out by trained personnel from the Department of Health and Well-being of the Universidad Católica del Uruguay.\n\nDuring the testing period, participants will be allowed to drink up to 250 mL of water and must remain seated. For each participant and each treatment day, a data collection sheet will be used to record all measurements. After each experimental session, participants will receive a breakfast voucher.",[113],"Glycemic Responses",[115,116,117,118,119],"Glycemic response","brewers' spent grain","sustainability","type 2 diabetes","food science","2026-06-08",{"date":122,"type":33},"2026-06-11",{"date":124,"type":33},"2026-03-01",{"date":126,"type":22},"2026-12",{"name":128,"class":40},"Universidad Católica del Uruguay",1,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":105,"minAge":138,"maxAge":18,"enrollmentInfo":139,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":108},"100607839","altitude-and-outcomes-in-pediatric-ards-a-multicenter-study-100607839","NCT07193771","Altitude and Outcomes in Pediatric ARDS: A Multicenter Study","Evaluation of Altitude as an Independent Risk Factor for Mortality in Pediatric Acute Respiratory Distress Syndrome: Influence of Oxygenation, Ventilation, and Hospital Structure in a Multicenter Observational Study.","LARed-ALT","Inclusion Criteria:\n\n* Age between 1 month (corrected gestational age) and 18 years.\n* Admission to a pediatric intensive care unit (PICU) or facility where mechanically ventilated children are cared for.\n* Requirement of invasive mechanical ventilation.\n* Diagnosis of pediatric acute respiratory distress syndrome (PARDS) according to PALICC criteria, confirmed within 24 hours before or after endotracheal intubation.\n\nExclusion Criteria:\n\n* Patients with active perinatal lung disease (e.g., neonatal respiratory distress syndrome, pulmonary hemorrhage, persistent pulmonary hypertension of the newborn, early bronchopulmonary dysplasia, meconium aspiration).\n* Patients who have received extracorporeal membrane oxygenation (ECMO) prior to or within the first 24 hours of PARDS diagnosis.\n* Patients with pre-established limitation of therapeutic effort (LTE) orders or palliative care directives documented before the initiation of invasive mechanical ventilation.\n* Readmissions to the PICU during the study period (only the first episode per patient will be included).","1 Month",{"count":140,"type":22},1600,"This multicenter observational study will evaluate the association between geographic altitude, availability of critical care resources, and clinical outcomes in children with pediatric acute respiratory distress syndrome (PARDS). Data on demographics, physiology, and hospital structure will be collected from PICUs located at different altitudes worldwide. The study aims to identify gaps in PARDS management and provide recommendations adapted to diverse resource settings.",[143,144,145],"Respiratory Distress Syndrome, Pediatric","Altitude Hypoxia","High Altitude Effects","2026-05-29",{"date":148,"type":33},"2026-06-02",{"date":150,"type":33},"2025-11-01",{"date":152,"type":22},"2028-03",{"name":154,"class":40},"Latin American Pediatric Collaborative Network",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":17,"minAge":163,"maxAge":106,"enrollmentInfo":164,"targetDuration":4,"studyType":23,"phases":165,"briefSummary":166,"conditions":167,"keywords":171,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":181,"leadSponsor":183,"locationsCount":129},"100639304","invasive-evaluation-and-phenotype-guided-treatment-of-anoca-in-women-100639304","NCT07593157","Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women","Invasive Functional and Morphological Coronary Assessment Followed by Phenotype-Guided Multidisciplinary Treatment in Women With Angina and Non-Obstructive Coronary Arteries: A Prospective Single-Center Interventional Study","ANOCA-UY","Inclusion Criteria:\n\n* Female participants aged 35 to 75 years.\n* Symptoms compatible with stable angina or suspected myocardial ischemia.\n* Non-obstructive coronary arteries, defined as absence of angiographic stenosis greater than or equal to 50%.\n* Ability to undergo invasive coronary assessment and clinical follow-up.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Significant structural heart disease.\n* Severe left ventricular systolic dysfunction, defined as left ventricular ejection fraction \\\u003C40%.\n* Clinically relevant contraindication to adenosine or acetylcholine, including severe asthma, untreated high-grade atrioventricular block, or known hypersensitivity.\n* Active oncological disease or life expectancy less than 12 months.\n* Inability to complete the diagnostic or therapeutic study protocol.\n* Participation in another clinical study that could interfere with the present protocol.","35 Years",{"count":79,"type":22},[110],"This prospective single-center interventional study will include women with angina and non-obstructive coronary arteries. Participants will undergo a standardized invasive coronary assessment combining coronary physiology, acetylcholine provocation testing, and optical coherence tomography. The diagnostic protocol will identify functional and morphological mechanisms of angina, including microvascular dysfunction, epicardial vasospasm, microvascular spasm, endothelial dysfunction, functional epicardial disease, combined mechanisms, or normal coronary physiology.\n\nBased on the identified phenotype, participants will receive individualized multidisciplinary treatment, including targeted pharmacological therapy, adapted cardiovascular rehabilitation, and psycho-emotional support when indicated. Clinical follow-up will be performed at 1, 6, and 12 months to assess angina symptoms, quality of life, functional capacity, adherence to treatment, and cardiovascular events.",[168,169,170],"ANOCA - Angina With Non-obstructive Coronary Arteries","Coronary Microvascular Dysfunction (CMD)","Vasospastic Angina",[172,173,174,175,176],"Angina with non-obstructive coronary arteries","ANOCA","INOCA","Vasospastic angina","Coronary Microvascular Dysfunction","2026-05-15",{"date":179,"type":33},"2026-05-18",{"date":177,"type":22},{"date":182,"type":22},"2029-04-30",{"name":184,"class":40},"Hospital de Clínicas Dr. Manuel Quintela",{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":105,"minAge":18,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":23,"phases":195,"briefSummary":196,"conditions":197,"keywords":199,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":212},"100581770","effect-of-continuous-prolonged-prone-position-versus-intermittent-daily-prone-position-in-ards-100581770","NCT06854627","Effect of Continuous Prolonged Prone Position Versus Intermittent Daily Prone Position in ARDS","Effect of Continuous Prolonged Prone Position Versus Intermittent Daily Prone Position on Mortality in ARDS Patients: A Multicenter Randomized Controlled Trial","ePRONE","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Endotracheal intubation and mechanical ventilation for less than 72 hours\n* Moderate-severe ARDS defined as:\n\n  1. Within 1 week of a known clinical insult or new or worsening respiratory symptoms\n  2. Bilateral infiltrates not fully explained by effusions, lobar\u002Flung collapse, or nodules\n  3. Respiratory failure not fully explained by cardiac failure or fluid overload\n  4. PaO2\u002FFiO2 \\\u003C 150 mmHg in supine position\n* Prone positioning has been indicated by the attending physician, OR has already been initiated within the last 16 hours\n\nExclusion Criteria:\n\n* Contraindications for prone positioning such as intracranial pressure \\> 20 mmHg, massive hemoptysis, recent tracheal surgery or sternotomy or abdominal surgery with an open wound, recent facial trauma or facial surgery, unstable spine, femur, or pelvic fractures, or a single anterior chest tube with air leaks\n* Patient on extracorporeal membrane oxygenation (ECMO) before randomization\n* Chronic respiratory failure requiring oxygen therapy or non-invasive ventilation (NIV)\n* Known pregnancy\n* Anticipating withdrawal of life support or shift to palliative care",{"count":194,"type":22},780,[110],"Prone position (placing the patient on his abdomen) has been shown to be an effective intervention to decrease mortality in adults connected to mechanical ventilation for moderate to severe Acute Respiratory Distress Syndrome (ARDS). Patients may require one or more sessions of prone position. However, the optimal duration of prone sessions is unknown. The goal of this clinical trial is to learn if applying prone position in prolonged sessions (\\> 48 hours - prolonged prone position) is more effective than applying it in daily sessions (16 to 24 hours - intermittent prone position). The trial will also learn about the safety of prolonged prone position compared to intermittent prone position. The main questions it aims to answer are:\n\n* Does prolonged prone position increase survival compared to intermittent prone position in participants with moderate to severe ARDS ?\n* How does prolonged prone position compare to intermittent prone position in terms of medical problems associated to prone position ?\n\nResearchers will compare prolonged versus intermittent prone position to see which approach is better to treat moderate to severe ARDS.\n\nParticipants will:\n\n* Receive prone position either in prolonged (\\> 48 hours) or daily (16 to 24 hours) sessions during the first 7 days\n* Be followed for up to 90 days to assess their clinical evolution",[198],"Acute Respiratory Distress Syndrome",[200,201,202,203],"ACUTE RESPIRATORY DISTRESS SYNDROME","RESPIRATORY FAILURE","PRONE POSITION","MECHANICAL VENTILATION","2026-05-14",{"date":179,"type":33},{"date":207,"type":33},"2025-04-07",{"date":209,"type":22},"2028-01",{"name":211,"class":40},"Pontificia Universidad Catolica de Chile",38,{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":17,"minAge":220,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":23,"phases":223,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":237},"100511218","phase-4-nuwiq-dosing-and-outcomes-in-the-management-of-womengirls-with-haemophilia-a-needing-fviii-treatment-for-surgery-100511218","NCT05936580","Nuwiq Dosing and Outcomes In the ManagEment of Women\u002FGirls With Haemophilia A Needing FVIII Treatment for Surgery","Nuwiq Dosing and Outcomes In the ManagEment of Women\u002FGirls With Haemophilia A Needing FVIII Treatment for Surgery - an International, Open-label, Non-controlled Study (NuDIMENSION)","Inclusion Criteria:\n\n1. Women\u002Fgirls with haemophilia A (FVIII:C ≥1-\\\u003C40%) according to medical history. Additionally, women\u002Fgirls with documented FVIII activity levels between ≥ 40% and 50% may be included if there is a documented history of clinically significant bleeding episodes consistent with haemophilia A; and\u002For either documented prior treatment with FVIII concentrates or a clinical indication that FVIII treatment would have been appropriate (e.g., use of FVIII from a family member, or treatment with alternative haemostatic agents due to access limitations)\n2. At least 12 years of age\n3. Scheduled to undergo major surgery\\* requiring FVIII treatment, including elective and emergency procedures and caesarean section in pregnant women with haemophilia A\n4. Freely given written informed consent of the patient, or parent\u002Flegal representative where applicable, obtained in accordance with local regulations\n\nExclusion Criteria:\n\n1. Coagulation disorder other than haemophilia A\n2. Present or past FVIII inhibitor (≥0.6 Bethesda units \\[BU\\]\u002FmL)\n3. Severe liver or kidney disease (alanine aminotransferase \\[ALT\\] and\u002For aspartate aminotransferase \\[AST\\] levels \\>5 times the upper limit of normal; or creatinine \\>120 μmol\u002FL)\n4. Known hypersensitivity to Nuwiq's active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188)\n5. Pregnancy, except in participants with a planned caesarean section\n6. Already had surgery in this study\n7. Current participation in another interventional clinical trial\n8. Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit","12 Years",{"count":222,"type":22},28,[224],"PHASE4","Recombinant factor VIII for the prevention of bleeding in women\u002Fgirls with haemophilia A undergoing major surgery",[227],"Hemophilia A","2026-05-08",{"date":230,"type":33},"2026-05-12",{"date":232,"type":22},"2026-04",{"date":234,"type":22},"2027-02",{"name":236,"class":94},"Octapharma",16,{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":105,"minAge":18,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":259},"100429397","immune-checkpoint-inhibitor-toxicity-risk-prediction-in-solid-tumors-100429397","NCT04871542","Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors","Immune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational Study","Inclusion Criteria:\n\n* Participants must be planning to receive ICI-based therapy for a solid tumor malignancy. This therapy must be given according to Food and Drug Administration (FDA) label or National Comprehensive Cancer Network (NCCN) guidelines at Category 1 or 2A and not in the context of a clinical trial\n* Participants who have received prior ICI-based therapy must have completed ICI based therapy at least 180 days prior to registration\n* Participants must not have discontinued any prior ICI-based therapy (if applicable) because of irAE\n* Participants must not have received chemotherapy, biologic, or targeted-therapy within 21 days prior to registration\n* Participants must have recovered from side effects of prior therapy to the following standards per treating physician's discretion:\n\n  * =\\\u003C Grade 1 for any non-hematologic side effects (excluding neuropathy and alopecia); lab-related parameters of liver and renal function will be considered at the discretion of the treating physician)\n  * =\\\u003C Grade 2 for neuropathy and\u002For alopecia\n  * Grade 3 or less for any hematologic side effects\n* Participants must be planning to begin standard of care ICI-based therapy within 3 calendar days after registration\n* Participants must not be planning to receive ICI-based therapy in combination with chemotherapy or any other non-ICI therapy for treatment of their cancer\n* Participants must be at least 18 years of age\n* Participants must complete their history and physical examination within 28 days prior to registration\n* Participants who can complete the S2013 Feasibility Questionnaire in English or Spanish must participate at the scheduled assessments\n* Participants must be able to complete Patient-Reported Outcome (PRO) instruments in English, Spanish, or French and must be planning to complete PROs at all scheduled assessments\n* Participants must complete the pre-registration (baseline) PRO forms within 14 days prior to registration\n* Participants must be willing to participate in PRO data collection\n\n  * Note: Prior to registration, participants must decide on their method (paper or electronic) of completing their follow-up questionnaires. Participants who elect electronic (ePRO) completion must have an iPhone, Android phone, or tablet with cellular or WiFi connectivity in order to download the Patient Cloud mobile applications onto the device (personal device or a site provisioned device for multi-users)\n* Participants must be offered the opportunity to participate in the optional specimen banking\n* Note: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines",{"count":246,"type":22},2062,"This study examines how certain risk factors (such as age, gender, other medical conditions, and the type of immunotherapy used to treat the cancer) affect whether a patient with a malignant solid tumor will develop mild or serious side effects from the immunotherapy medications. Immunotherapy is the type of treatment that helps the body's immune system fight cancer. In the future, this information may help doctors make better decisions about cancer treatments.",[249],"Malignant Solid Neoplasm","2026-05-04",{"date":252,"type":33},"2026-05-05",{"date":254,"type":33},"2021-09-13",{"date":256,"type":22},"2028-03-14",{"name":258,"class":69},"SWOG Cancer Research Network",849,{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":270,"conditions":271,"keywords":277,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":297},"100598171","organ-dysfunction-score-for-obstetric-patients-100598171","NCT07068022","Organ Dysfunction Score for Obstetric Patients","Development and Validation of an Obstetric Organ Dysfunction Score to Predict Mortality in Intensive Care Unit: A Multicenter, Prospective, Cohort Study","SOFA-OBS","Inclusion Criteria:\n\nAll of the following=\n\n* Pregnant (at any gestational age) or post-partum patients (at ≤3 days postpartum)\n* ≥ 18 years old\n* Requiring admission to ICU for any reason\n* Staying in the ICU for ≥ 24h\n* Giving her consent to participate. Patients will be recruited consecutively until reaching the sample size.\n\nExclusion Criteria:\n\nAny of the following=\n\n* Patients \\\u003C18 years old\n* Non-pregnant patients\n* ≥ 4 days postpartum\n* Patients or surrogates not giving consent to participate\n* ICU-LOS \\\u003C 24 h",{"count":269,"type":22},130,"The goal of this observational study is to develop and evaluate an organ dysfunction score adapted to pregnancy and early puerperium (SOFA-OBS) that also incorporates a non-invasive tool to evaluate respiratory function (pulse oximeter).\n\nThe main question it aims to answer is: Does an organ dysfunction score adapted to pregnant and postpartum patients have a higher capacity to predict mortality than a non-adjusted organ dysfunction score? Participants: Patients requiring ICU (Intensive Care Units) admission, who are either pregnant or postpartum (up to 3 days after giving birth). The investigators aimed to include 130 participants.\n\nThe investigators will only collect participants' data and laboratory results that ICU doctor usually need for clinical practice. No additional interventions are required. Moreover, the investigators will evaluate if measuring participants' oxygenation through a non-invasive tool (pulse oximeter) is equally effective as measuring oxygenation by an arterial puncture.\n\nBackground: When managing severely ill patients in ICU, the investigators often use what it is called scores. Scores refer to a numerical value assigned to a patient's condition, which often predict outcome. The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assess severity of organ dysfunction (in liver, kidney, blood pressure, respiratory, neurologic and platelets). It also identifies patients with severe infections (sepsis) and patients with bad outcomes.\n\nPatients undergoing pregnancy or early postpartum develop physiological changes, such us a decrease in creatinine (a laboratory test measuring kidney function) and a decrease in blood pressure during the second trimester. These changes are not considered by the SOFA score. Actually, there is not an organ dysfunction score adapted to pregnant\u002Fpostpartum patients to be used in the ICU. Moreover, a blood sample taken by arterial puncture is required to evaluate respiratory function by the SOFA score, which is a painful procedure. Instead, the investigators could evaluate respiratory function using a pulse oximeter, which measures peripheral oxygen saturation without needing an arterial puncture.\n\nPotential benefits: A SOFA-OBS would hopefully become a more precise tool than general SOFA to evaluate organ dysfunction and to predict outcome among these patients. It would also help to detect sepsis earlier and treat it promptly, which might help reducing its mortality.",[272,273,274,275,276],"Pregnancy","Postpartum","Organ Dysfunction","Critical Care, Intensive Care","Sepsis",[278,272,273,279,280,281,282,283,284,285,276,286,287],"Sequential Organ Failure Assessment score","Critical care","Intensive Care Unit","Creatinine","Peripheral oxygen saturation","Hypotension","Maternal mortality","Mortality","Septic shock","Multicenter study","2026-04-22",{"date":290,"type":33},"2026-04-28",{"date":292,"type":33},"2025-10-06",{"date":294,"type":22},"2027-02-28",{"name":296,"class":40},"Daniela Vasquez",18,{"id":299,"slug":300,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":105,"minAge":18,"maxAge":306,"enrollmentInfo":307,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":321},"100531911","a-european-registry-and-sample-sharing-network-to-promote-the-diagnosis-and-management-of-light-chain-amyloidosis-eureka-100531911","NCT06205953","A EUropean REgistry and Sample Sharing networK to Promote the Diagnosis and Management of Light Chain Amyloidosis (EUREKA)","Bonding Molecular Genotyping and Phenotyping to Outcome Measures in AL Amyloidosis: A EUropean REgistry and Sample Sharing networK to Promote the Diagnosis and Management of Light Chain Amyloidosis (EUREKA)","EUREKA","Inclusion Criteria:\n\n* diagnosis of systemic AL amyloidosis;\n* treatment-naïve;\n* age ≥18 years;\n* ability to understand and willingness to sign an informed consent;\n* planned follow-up at participating center.\n\nExclusion Criteria:\n\n* non-AL amyloidosis;\n* previous treatment for AL amyloidosis.","99 Years",{"count":308,"type":22},400,"A prospective patients' registry collecting all new cases of AL amyloidosis evaluated at referral Centers from across Europe and a sample sharing network will be created to study mechanisms of the disease through the use of advanced molecular technologies and big data analysis tools.",[311],"AL Amyloidosis","2026-04-13",{"date":314,"type":33},"2026-04-16",{"date":316,"type":33},"2024-01-01",{"date":318,"type":22},"2026-06-01",{"name":320,"class":40},"Fondazione IRCCS Policlinico San Matteo di Pavia",6,{"id":323,"slug":324,"hasResults":11,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":11,"sex":17,"minAge":330,"maxAge":331,"enrollmentInfo":332,"targetDuration":4,"studyType":23,"phases":334,"briefSummary":335,"conditions":336,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":352},"100385147","tubectomy-with-delayed-oophorectomy-in-high-risk-women-to-assess-the-safety-of-prevention-100385147","NCT04294927","TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention","TUBectomy With Delayed Oophorectomy as Alternative for Risk-reducing Salpingo-oophorectomy in High Risk Women to Assess the Safety of Prevention: TUBA-WISP II Study.","TUBA-WISP-II","Inclusion Criteria:\n\n* Women with a class 5 (definitely pathogenic) BRCA1, BRCA2, RAD51C, RAD51D or BRIP1 germline mutation in one of the participating centers.\n* Age at inclusion;\n\n  * BRCA1: 25-40 years\n  * BRCA2: 25-45 years\n  * RAD51C, RAD51D, BRIP1: 25-50 years\n* Childbearing completed\n* Presence of at least one fallopian tube\n* Participants may have a personal history of non-ovarian malignancy\n* Informed consent must be obtained and documented according to national and local regulatory requirements and the local rules followed in the institution.\n\nExclusion Criteria:\n\n* Postmenopausal status (natural menopause or due to treatment)\n* Wish for second stage RRO within two years after RRS\n* Legally incapable\n* Prior bilateral salpingectomy\n* A personal history of ovarian, fallopian tube or peritoneal cancer\n* Current diagnosis or treatment for malignant disease","25 Years","50 Years",{"count":333,"type":22},3000,[110],"The aim of the project is to evaluate the risk-reducing salpingectomy with delayed oophorectomy as an alternative for risk-reducing salpingo-oophorectomy in high risk women with respect to ovarian cancer incidence.",[337,338,339,340,341,342],"BRCA1 Gene Mutation","BRCA2 Gene Mutation","RAD51C Gene Mutation","RAD51D Gene Mutation","BRIP1 Gene Mutation","Ovarian Cancer","2026-03-31",{"date":345,"type":33},"2026-04-06",{"date":347,"type":33},"2020-03-01",{"date":349,"type":22},"2040-02-17",{"name":351,"class":40},"University Medical Center Nijmegen",66,{"id":354,"slug":355,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":359,"eligibilityCriteria":360,"healthyVolunteers":11,"sex":105,"minAge":18,"maxAge":361,"enrollmentInfo":362,"targetDuration":4,"studyType":23,"phases":364,"briefSummary":365,"conditions":366,"keywords":369,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":381,"locationsCount":129},"100631858","group-based-acceptance-and-commitment-therapy-versus-active-control-in-university-students-with-emotional-symptoms-100631858","NCT07506148","Group-Based Acceptance and Commitment Therapy Versus Active Control in University Students With Emotional Symptoms","Efficacy of a Group-Based Acceptance and Commitment Therapy Protocol Compared to an Active Control in University Students With Emotional Symptoms: a Randomized Controlled Trial With an Ideographic Approach","ACT-EMA-RCT","Inclusion Criteria:\n\n* University students aged 18 to 28 years.\n* Score ≥8 on the PHQ-9.\n* Score ≥8 on the GAD-7.\n* Willingness to participate in a longitudinal study including pre-, post-, and follow-up assessments.\n* Willingness to complete daily and weekly ecological momentary assessments (EMA).\n* Provision of written informed consent.\n\nExclusion Criteria:\n\n* Suicide risk based on clinical indicators derived from PHQ-9 assessment.\n* Self-reported history of psychotic disorders.\n* Self-reported problematic substance use.\n* Failure to provide informed consent.","28 Years",{"count":363,"type":22},48,[110],"This study evaluates the efficacy of a group-based Acceptance and Commitment Therapy (ACT) protocol compared to a non-directive group therapy used as an active control condition in university students presenting moderate to moderate\u002Fhigh levels of emotional symptomatology.\n\nEmotional difficulties such as depressive and anxiety symptoms are highly prevalent among university students and may negatively affect academic performance, well-being, and long-term functioning. Acceptance and Commitment Therapy (ACT) is an evidence-based psychological intervention that aims to improve mental health by increasing psychological flexibility, the ability to act in accordance with personal values while remaining open to difficult internal experiences.\n\nParticipants will be randomly assigned to either (1) a structured ACT group intervention or (2) a non-directive supportive group intervention that controls for therapeutic attention and group support factors. The primary hypothesis is that participants receiving ACT will show greater reductions in emotional symptoms and greater improvements in psychological flexibility compared to the active control group.\n\nOutcomes will include depressive and anxiety symptoms, psychological flexibility, repetitive negative thinking, and meaning in life. The study uses a multimethod assessment strategy combining traditional self-report questionnaires administered at baseline, post-intervention, and follow-up; Ecological Momentary Assessment (EMA) with daily and weekly measures during the intervention period; and qualitative interviews to explore participants' experiences.",[367,368],"Depression","Anxiety",[370,371,372,373,374],"Acceptance and Commitment Therapy","psychological flexibility","repetitive negative thinking","ecological momentary assessment","university students","2026-03-27",{"date":377,"type":33},"2026-04-01",{"date":379,"type":33},"2026-03-20",{"date":126,"type":22},{"name":382,"class":40},"Mónica Larrosa Signorelli",{"id":384,"slug":385,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":105,"minAge":390,"maxAge":391,"enrollmentInfo":392,"targetDuration":394,"studyType":80,"phases":4,"briefSummary":395,"conditions":396,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":409},"100438858","stroke-thrombectomy-and-aneurysm-registry-100438858","NCT04994756","Stroke Thrombectomy and Aneurysm Registry","STAR","Inclusion Criteria:\n\n* Undergoing surgical intervention for central nervous system vascular lesion\n* Between 1 and 120 years of age\n\nExclusion Criteria:\n\n* No exclusion criteria","1 Year","120 Years",{"count":393,"type":22},40000,"90 Days","This international multi-center registry is used to collect existing information and outcomes for patients undergoing an operation for treatment of injuries to the brain including the blockage of blood flow to an area of the brain, an abnormal ballooning of an artery, abnormal tangling of blood vessels, abnormal formation of blood vessels, tearing of vein, and bleeding in the brain. This information is used to help predict outcomes that undergo an operation for treatment of the above-listed brain injuries. Additionally, the information is used to compare techniques and devices' effects on technical and clinical outcomes.",[397,398,399],"Stroke","Thromboses, Intracranial","Aneurysm, Brain","2025-12-18",{"date":402,"type":33},"2025-12-24",{"date":404,"type":33},"2019-09-17",{"date":406,"type":22},"2055-01-01",{"name":408,"class":40},"Medical University of South Carolina",63,{"id":411,"slug":412,"hasResults":11,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":4,"eligibilityCriteria":416,"healthyVolunteers":11,"sex":105,"minAge":18,"maxAge":4,"enrollmentInfo":417,"targetDuration":4,"studyType":23,"phases":419,"briefSummary":421,"conditions":422,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":436},"100442359","phase-2-testing-the-use-of-chemotherapy-after-surgery-for-high-risk-pancreatic-neuroendocrine-tumors-100442359","NCT05040360","Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors","Randomized Phase II Trial of Postoperative Adjuvant Capecitabine and Temozolomide Versus Observation in High-Risk Pancreatic Neuroendocrine Tumors","Inclusion Criteria:\n\n* Participants must have a histologic diagnosis of well-differentiated pancreatic neuroendocrine tumor (pNET) that was resected between 14 and 120 days prior to registration. Participants must have a scan within 90 days prior to registration without evidence of metastatic disease. Acceptable scans are multiphase computed tomography (CT) abdomen, magnetic resonance imaging (MRI) with intravenous (IV) contrast of the abdomen, or positron emission tomography (PET)-CT DOTATATE imaging if the DOTATATE PET-CT included IV iodine contrast for the CT portion of the exam\n* Resection must have been an R0 or R1 per treating investigator's assessment and\u002For pathology report\n* Ki-67 testing, which is considered part of standard of care in the pathology report, must have been performed between 14 and 90 days prior to registration and the result must be \\>= 3% and =\\\u003C 55%. Treating investigators are encouraged to contact the S2104 Study Chairs and\u002For the study pathology chair with questions. If more than one Ki-67 is reported (e.g., primary tumor versus lymph node or metastatic site), the highest one should be considered for the study eligibility criteria\n* Participants with localized resected pNETS must have a Zaidi score of \\>= 3 derived by the following factors and points:\n\n  * 1 point; symptomatic tumor defined as one of the following:\n\n    * Gastrointestinal bleed\n    * Jaundice\n    * Gastrointestinal obstruction\n    * Pain from primary tumor prior to surgical resection\n    * Pancreatitis\n  * 2 points; primary pancreas tumor size \\> 2 cm\n  * 1 point; Ki-67 3% to 20%\n  * 1 point; lymph node positivity = 1\n  * 6 points; Ki-67 21% to 55%\n* Participants may have received resection\u002Fablation of liver oligo-metastatic disease (up to 5 liver metastases) at the time of well-differentiated pNET resection\n* Participants must have recovered from effects of surgery as determined by the treating investigator\n* Participants must be \\>= 18 years old\n* Participants must have Zubrod performance status of 0-2\n* Participants must have a complete medical history and physical exam within 28 days prior to registration\n* Leukocytes \\>= 3 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Absolute neutrophil count \\>= 1.5 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Platelets \\>= 100 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Total bilirubin =\\\u003C institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\\\u003C 5 x institutional ULN (within 28 days prior to registration)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 3 x institutional ULN (within 28 days prior to registration)\n* Serum creatinine =\\\u003C 1.5 x institutional ULN (within 28 days prior to registration)\n* Calculated creatinine clearance \\>= 50 ml\u002Fmin (within 28 days prior to registration)\n* Participants must be able to swallow pills\n* Participants must be able to tolerate CT or magnetic resonance (MR) imaging including contrast agents as required for their treatment and the protocol\n* No other active malignancy or history of prior malignancy is allowed, except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for two years\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n\nExclusion Criteria:\n\n* Participants must not have unresected or unablated metastatic disease\n* Participants must not have clinically apparent central nervous system metastases or carcinomatous meningitis\n* Participants must not have received prior neoadjuvant therapy for treatment of pancreatic neuroendocrine tumor. Use of somatostatin analogs prior to surgery is permitted\n* Participants must not have received somatostatin analogs after surgery\n* Participants must not be planning to receive warfarin while on protocol treatment. Other anticoagulants are allowed\n* Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine\n* Participants must not have known absorption issues that would limit the ability to absorb study agents\n* Participants must not have had an arterial thromboembolic event, unstable angina, or myocardial infarction within 12 months prior to registration\n* Participants must not have active or uncontrolled infection\n* Participants must not have serious medical or psychiatric illness that could affect study participation in the judgement of the treating investigator\n* Participants must not be pregnant due to the possibility of harm to the fetus. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen",{"count":418,"type":22},141,[420],"PHASE2","This phase II trial studies the effect of capecitabine and temozolomide after surgery in treating patients with high-risk well-differentiated pancreatic neuroendocrine tumors. Chemotherapy drugs, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving capecitabine and temozolomide after surgery could prevent or delay the return of cancer in patients with high-risk well-differentiated pancreatic neuroendocrine tumors.",[423,424,425,426,427],"Metastatic Malignant Neoplasm in the Liver","Pancreatic Neuroendocrine Tumor","Stage I Pancreatic Neuroendocrine Tumor AJCC v8","Stage II Pancreatic Neuroendocrine Tumor AJCC v8","Stage III Pancreatic Neuroendocrine Tumor AJCC v8","2025-12-10",{"date":430,"type":33},"2025-12-15",{"date":432,"type":33},"2022-05-05",{"date":434,"type":22},"2027-03-31",{"name":258,"class":69},448,{"id":438,"slug":439,"hasResults":11,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":11,"sex":105,"minAge":18,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":23,"phases":447,"briefSummary":448,"conditions":449,"keywords":452,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":466},"100439315","chemoradiation-and-consolidation-chemotherapy-with-or-without-oxaliplatin-for-distal-rectal-cancer-and-watch-and-wait-100439315","NCT05000697","Chemoradiation and Consolidation Chemotherapy With or Without Oxaliplatin for Distal Rectal Cancer and Watch and Wait","Chemoradiation and Consolidation Chemotherapy With or Without Oxaliplatin for Distal Rectal Cancer and Watch and Wait. A Multi-center Prospective Randomized Controlled Trial. (CCHOWW)","CCHOWW","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. ECOG 0-2 or KPS≥70;\n3. Primary rectal adenocarcinoma (biopsy confirmed) within the reach of digital rectal examination (at least lower tip\u002Fborder) by the attending colorectal surgeon;\n4. Endoscopic documentation;\n5. Abdominal and chest CT scans showing no evidence of metastatic disease;\n6. High-resolution magnetic resonance images performed at either 1.5T or 3.0T system using a phased array surface coil with: sagittal T2 images including the anal verge and the sacrum; axial oblique T2 weighted images acquired in a plane perpendicular to the long axis of the rectal wall guided by the sagittal images; coronal images acquired in parallel to the anal canal plane. Small field of view (16-18cm), 3mm section thickness, increased matrix size and increased number of signal averages are required;\n7. Radiological defining criteria (centralized):\n\n   1. Lower edge of tumor at the level (max. 1cm distance) or below the anorectal ring defined at sagittal or coronal views;\n   2. mrT2, mrT3 (any subclassification)\n   3. mrN0-1 (≤3 radiologically positive lymph nodes)\n   4. mrEMVI: any status\n   5. mrMRF: any status\n\nExclusion Criteria:\n\n1. Pregnancy\n2. ECOG ≥3 or KPS\\\u003C70\n3. Unwilling to consent\n4. Metastatic disease (any kind; internal iliac and obturator nodes are considered local disease and not metastatic disease and therefore will not be considered as exclusion criteria)\n5. mrT4 or mrN2\n6. Previous pelvic irradiation\n7. Baseline neuropathy\n8. Receiving treatment of other anti-cancer drug or methods\n9. Presence of uncontrolled life threatening diseases",{"count":446,"type":22},216,[110],"Background: Neoadjuvant chemoradiation (nCRT) has been considered the preferred initial treatment strategy for distal rectal cancer. Advantages of this approach include improved local control after radical surgery but also the opportunity for organ preserving strategies (Watch and Wait - WW). Consolidation chemotherapy (cCT) regimens using fluoropyrimidine-based with or without oxaliplatin following nCRT have demonstrated to increase complete response and organ preservation rates among these patients. However, the benefit of adding oxaliplatin to cCt compared to fluoropyrimidine alone regimens in terms of primary tumor response remains unclear. Since oxaliplatin-treatment may be associated with considerable toxicity, it becomes imperative to understand the benefit of its incorporation into standard cCT regimens in terms of primary tumor response. The aim of the present trial is to compare the outcomes of 2 different cCT regimens following nCRT (fluoropyrimidine-alone versus fluoropyrimidine+oxaliplatin) for patients with distal rectal cancer.\n\nMethods: In this multi-centre study, patients with magnetic resonance-defined distal rectal tumors will be randomized on a 1:1 ratio to receive long-course chemoradiation (54Gy) followed by cCT with fluoropyrimidine alone versus fluoropyrimidine+oxaliplatin. Magnetic resonance (MR) will be analyzed centrally prior to patient inclusion and randomization. mrT2-3N0-1 tumor located no more than 1cm above the anorectal ring determined by sagittal views on MR will be eligible for the study. Tumor response will be assessed after 12 weeks from radiotherapy (RT) completion. Patients with clinical complete response (clinical, endoscopic and radiological) will be enrolled in an organ-preservation program (WW). The primary endpoint of this trial is decision to organ-preservation surveillance (WW) at 18 weeks from RT completion.\n\nDiscussion: Long-course nCRT with cCT is associated with improved complete response rates and may be a very attractive alternative to increase the chances for organ-preservation strategies. Fluoropyrimidine-based cCT with or without oxaliplatin has never been investigated in the setting of a randomized trial to compare clinical response rates and the possibility of organ-preservation. The outcomes of this study may significantly impact clinical practice of patients with distal rectal cancer interested in organ-preservation.",[450,451],"Rectal Cancer","Consolidation",[453,454,455,456],"Rectal cancer","Consolidation Chemotherapy","Complete Response","Watch and Wait","2024-11-25",{"date":459,"type":33},"2024-11-27",{"date":461,"type":33},"2021-07-14",{"date":463,"type":22},"2027-04",{"name":465,"class":40},"Hospital Alemão Oswaldo Cruz",24,{"id":468,"slug":469,"hasResults":11,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":473,"eligibilityCriteria":474,"healthyVolunteers":11,"sex":105,"minAge":18,"maxAge":475,"enrollmentInfo":476,"targetDuration":4,"studyType":23,"phases":478,"briefSummary":479,"conditions":480,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":129},"100543151","phase-3-comparative-study-of-two-recombinant-human-erythropoietin-products-in-chronic-kidney-disease-patients-100543151","NCT06352138","Comparative Study of Two Recombinant Human Erythropoietin Products in Chronic Kidney Disease Patients","Phase III, Multicentre, Double-blind, Randomised, Parallel, Equivalence Clinical Trial to Assess Efficacy, Safety of Megalabs® Recombinant i\u002Fv Human Erythropoietin Compared to Epogen® in Anaemia in Patients With Chronic Kidney Disease","ENCASE","Inclusion Criteria:\n\n* Stage V Chronic kidney disease undergoing hemodialysis\n\nExclusion Criteria:\n\n* Lack of consent to participate in the trial, other severe chronic disease, history of pure red cell aplasia, existence of anti erythropoietin antibodies","65 Years",{"count":477,"type":22},280,[25],"Phase III, multicentre, double-blind, randomised, parallel, equivalence clinical trial to determine the efficacy, safety and immunogenicity of Megalabs® recombinant human alfa epoetin for intravenous use, compared to Epogen®, in the treatment of anaemia in participants with chronic renal disease, dependent on haemodialysis",[481],"Anemia of Chronic Kidney Disease","2024-08-15",{"date":484,"type":33},"2024-08-19",{"date":486,"type":22},"2025-07",{"date":488,"type":22},"2027-03",{"name":490,"class":94},"Megalabs",{"id":492,"slug":493,"hasResults":11,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":497,"eligibilityCriteria":498,"healthyVolunteers":11,"sex":105,"minAge":18,"maxAge":499,"enrollmentInfo":500,"targetDuration":4,"studyType":23,"phases":502,"briefSummary":503,"conditions":504,"keywords":510,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":129},"100554225","morbidity-of-conventional-and-no-touch-saphenectomy-in-coronary-artery-bypass-grafting-100554225","NCT06496321","Morbidity of Conventional and No-touch Saphenectomy in Coronary Artery Bypass Grafting.","Morbidity of Conventional and No-touch Saphenectomy in Coronary Artery Bypass Grafting, a Randomized Non-inferiority Clinical Trial","TNT","Inclusion Criteria:\n\n* Patients undergoing coordination coronary revascularization surgery, in which it is necessary to use the internal saphenous vein as a conduit.\n\nExclusion Criteria:\n\n* Emergency surgeries.\n* Poor metabolic control (HbA1c \\> 6.5%).\n* Chronic venous insufficiency or chronic obstructive arteriopathy of the lower limbs.\n* Type II obesity (BMI\\>35).","70 Years",{"count":501,"type":22},52,[110],"A clinical research project will be carried out that will consist of a non-inferiority study. The objective is to compare the morbidity of two different surgical techniques for the extraction of the internal saphenous vein, intended to be used as a conduit in coronary bypass.",[505,506,507,508,509],"Saphenectomy","No Touch","Coronary Artery Disease","Cardiovascular Diseases","Wound Complication",[505,506,507],"2024-07-08",{"date":513,"type":33},"2024-07-11",{"date":515,"type":33},"2024-03-15",{"date":517,"type":22},"2025-12-31",{"name":519,"class":40},"Instituto Nacional de Cirugia Cardiaca, Uruguay",{"id":521,"slug":522,"hasResults":11,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":526,"eligibilityCriteria":527,"healthyVolunteers":11,"sex":105,"minAge":528,"maxAge":106,"enrollmentInfo":529,"targetDuration":4,"studyType":23,"phases":531,"briefSummary":532,"conditions":533,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":95},"100385501","urinary-proteomics-combined-with-home-blood-pressure-telemonitoring-for-health-care-reform-100385501","NCT04299529","Urinary Proteomics Combined With Home Blood Pressure Telemonitoring for Health Care Reform","Urinary Proteomics Combined With Home Blood Pressure Telemonitoring for Health Care Reform: a Randomised Controlled Trial","UPRIGHT-HTM","Inclusion Criteria:\n\n* Patients must have at least three additional guideline-defined risk factors, preferably including hypertension, type 2 diabetes mellitus (T2DM), or both;\n* Patients should be willing patients to engage for the duration of the study in home blood pressure telemonitoring (1 reading per day);\n* Patients must have an email address and internet access via smartphone, tablet, or laptop or desktop computer;\n* Patients should comply with the study protocol during the run-in phase.\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus;\n* Absence of a practicable echocardiographic window;\n* Previous or concurrent severe cardiovascular or non-cardiovascular disease;\n* Cancer within 5 years of enrolment;\n* Suspected substance abuse;\n* Psychiatric illness;\n* Use of nephrotoxic drugs;\n* Particpation in another clinical study.","55 Years",{"count":530,"type":22},1000,[110],"UPRIGHT-HTM will compare risk stratification, treatment efficiency and health economic outcomes of a diagnostic approach based on home blood pressure telemonitoring combined with urinary proteomic profiling with home blood pressure telemonitoring alone",[534,535,536,537,538],"Protein Deregulation","Blood Pressure","Health Care Utilization","Cost Effectiveness","Patient Empowerment","2020-03-05",{"date":541,"type":33},"2020-03-06",{"date":543,"type":22},"2020-04-01",{"date":545,"type":22},"2026-07-31",{"name":547,"class":40},"KU Leuven",""]