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NCT ID: NCT06046274 Withdrawn - Clinical trials for Advanced Endometrial Cancer

GEN1046 in Combination With Anticancer Agents for the Treatment of Advanced Endometrial Cancer

Start date: October 1, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical study is to learn about the bispecific antibody, acasunlimab (also known as GEN1046) in combination with the cancer drug pembrolizumab for treatment of participants with incurable endometrial cancer (cancer of the womb). The main questions the study aims to answer are: - How well acasunlimab in combination with pembrolizumab works against endometrial cancer - What are the potential side effects participants may experience when they are treated with acasunlimab in combination with pembrolizumab Participants will receive both acasunlimab and pembrolizumab. All participants will receive active drug; no one will receive placebo. participants will participate in 1 of 2 cohorts. A participant will receive study treatment up to a maximum of 24 months. The study duration (including screening, treatment, and follow-up) for each participant will be about 39 months.

NCT ID: NCT06045806 Recruiting - Multiple Myeloma Clinical Trials

A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

KarMMa-9
Start date: October 16, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).

NCT ID: NCT06045689 Recruiting - Clinical trials for Myelodysplastic Syndromes

A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants

MAXILUS
Start date: October 5, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of Luspatercept when administered at the maximum approved dose in low-risk Myelodysplastic Syndrome participants who require red blood cell transfusions.

NCT ID: NCT06045052 Completed - Fanconi Anemia Clinical Trials

Eltrombopag for Treatment of Fanconi Anemia

Start date: December 2, 2020
Phase: Phase 2
Study type: Interventional

An open-label, phase II study to assess the efficacy and safety of eltrombopag for the treatment of children and adolescents with Fanconi anemia.

NCT ID: NCT06044818 Recruiting - Clinical trials for Major Depressive Disorder (MDD)

Validation of Accexible as a Tool for Screening and Monitoring Depression.

Start date: January 22, 2024
Phase:
Study type: Observational

Major depressive disorder (MDD) is a chronic disease with a prevalence around 8-12% and is considered one of the most debilitating disease worldwide. A recent orientation is the analysis of language in relation to the description of images with a high and varied semantic and emotional content. It can be studied that changes in the description of an image check if these changes are associated with the evolution of a person with probable impairment both in memory and cognitive as well as emotional, psychiatric, behavioral and even in their interaction with environmental factors especially those associated with socialization and loneliness. The present study has the objective of validating Accexible as a tool for Screening and Monitoring Depression.

NCT ID: NCT06044623 Recruiting - Quality of Life Clinical Trials

Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase (CDK) 4/6-inhibitors in Older Breast Cancer Patients

IMPORTANT
Start date: March 4, 2024
Phase: Phase 3
Study type: Interventional

IMPORTANT study is a multicenter, open-label, prospective, randomized-controlled, non-inferiority trial with a pragmatic approach involving older patients (≥ 70 years old) with advanced hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer, not amenable for curative treatment and without prior therapy for advanced disease, who are suitable to receive CDK 4/6-inhibitors plus endocrine therapy as first line therapy. The study implements two approaches with high level of evidence, namely the use of comprehensive geriatric assessment (CGA) approach in treatment decision making and the use of CDK 4/6-inhibitors as the initial treatment of choice, to investigate whether a common clinical practice (starting dose reduction of CDK 4/6-inhibitors in older patients) with evidence of low certainty can be standardized using a more individualized-based approach. On the basis of baseline CGA assessment, patients will either receive full dose of CDK 4/6-inhibitors plus endocrine therapy (if patients are fit according to CGA) or be randomized to full dose vs. reduced initial dose of CDK 4/6-inhibitors (if vulnerable or frail according to CGA). The study hypothesis is that adjusting the dose according to vulnerability will allow patients to tolerate treatment better without jeopardizing the treatment efficacy. This project has received funding from the European Union's HORIZON 2022 research and innovation actions supporting the implementation of the Mission on Cancer under grant agreement No 101104589.

NCT ID: NCT06044337 Enrolling by invitation - Clinical trials for Subacute Cutaneous Lupus Erythematosus

A Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 (Litifilimab) in Adults With Active Subacute Cutaneous Lupus Erythematosus (CLE) and/or Chronic CLE With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy

AMETHYST LTE
Start date: October 3, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the long-term safety and tolerability BIIB059 (litifilimab) in participants who completed the parent study 230LE301 (NCT05531565) with active subacute CLE and/or chronic CLE with or without systemic manifestations and refractory and/or intolerant to antimalarial therapy. The secondary objectives of the study are to evaluate the long-term effect of litifilimab on disease activity and the effect of litifilimab in preventing disease damage in participants with active subacute CLE and/or chronic CLE with or without systemic manifestations and refractory and/or intolerant to antimalarials; to evaluate the long-term effect of litifilimab on preventing lupus flare in participants with CLE with systemic lupus erythematosus (SLE); to assess long-term use of oral corticosteroid (OCS) in participants receiving litifilimab treatment; to assess the impact of litifilimab on participant-reported health-related quality of life (HRQoL); to evaluate long-term effect of litifilimab on laboratory parameters; to evaluate the immunogenicity and pharmacokinetics (PK) of litifilimab.

NCT ID: NCT06044116 Active, not recruiting - Morbid Obesity Clinical Trials

Design and Validation of a Preoperative Calculator for "Textbook Outcome" After Bariatric Surgery (BARCINO)

BARCINO
Start date: January 1, 2022
Phase:
Study type: Observational

The present study aims to design, develop and validate a preoperative calculator for "Textbook Outcome" after bariatric surgery, in order to calculate the possibility of not achieving "Textbook outcome" based on the characteristics of the patient and the proposed surgical technique.

NCT ID: NCT06043245 Enrolling by invitation - Clinical trials for Diabetes Mellitus, Type 2

Diabetes Remission and Hypoabsorptive Bariatric Surgery

DIABAR-3
Start date: June 21, 2023
Phase: N/A
Study type: Interventional

Bariatric surgery is the most effective treatment to achieve type 2 Diabetes Mellitus (DM) remission in patients with severe obesity. However, there is little evidence of the effectiveness and pathophysiological mechanisms involved in metabolic improvement after hypoabsortive tecniques such as duodenal switch (DS), single anastomosis duodenal switch (SADI-S) or minigastric bypass (MGB). We have designed a randomized study to compare type 2 diabetes remission after the 3 bariatric procedures in patients with severe obesity (BMI > 45kg/m2) and to study the implication of gastrointestinal hormones, bile acids and gut microbiota in metabolic improvement in each procedure.

NCT ID: NCT06043206 Completed - Obesity Clinical Trials

Bariatric Surgery in Patients With Schizophrenia

SCHIZOBAR
Start date: October 1, 2022
Phase:
Study type: Observational

It is known that schizophrenia is associated with obesity in a significant number of patients and it implies a poor prognostic factor, with weight loss being important in this population. However, data about the prognosis of weight loss surgery in subjects with schizophrenia is scant. Hypothesis: Bariatric surgery in subjects with schizophrenia leads to an improvement in weight and cardiometabolic comorbidities similar to that of subjects without schizophrenia Main goal: To study the evolution after bariatric surgery in patients with obesity and schizophrenia Design: Multicenter retrospective case control study. Disease under study: Schizophrenia and Obesity Methodology: Retrospective observational study Study population and total number of subjects Cases: Patients with schizophrenia and obesity undergoing bariatric surgery. (number: all cases collected within the GOSEEN group). Controls: Patients without psychiatric pathology matched by age, sex, body mass index and type of surgery and in a 4:1 ratio to cases. Calendar. Expected duration of the study. 12 months ethical considerations Informed consent will be obtained from patients who are currently being followed up at the reference centers.