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NCT ID: NCT05731128 Recruiting - Colitis Ulcerative Clinical Trials

A Study to Investigate the Efficacy and Safety of Dupilumab Therapy Compared With Placebo in Participants Aged ≥18 Years With Moderately to Severely Active Ulcerative Colitis With an Eosinophilic Phenotype (LIBERTY-UC SUCCEED (Study in UC for Clinical Efficacy Evaluation of Dupilumab))

Start date: January 12, 2023
Phase: Phase 2
Study type: Interventional

The protocol of this Phase 2 clinical trial consists of a double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of dupilumab in participants with moderately to severely active Ulcerative Colitis (UC) with an eosinophilic phenotype. Screening period: 2 to up to 4 weeks Treatment period: 52-week investigational medicinal product (IMP) intervention (dupilumab or matching placebo) from Week 0 to Week 52 Open-label arm (optional): administration of open-label dupilumab therapy for study participants who qualify. Follow-up period: 12 weeks The maximum duration of study per participant is up to 68 weeks.

NCT ID: NCT05729711 Recruiting - Clinical trials for Bronchial Asthma (Only the Patients With Severe or Intractable Bronchial Asthma Which Could Not be Controlled With the Existing Therapy)

TEZSPIRE (Tezepelumab) Asthma Japan Post-Marketing Study (PMS)

Start date: April 4, 2023
Phase:
Study type: Observational

The purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of Tezspire. 1. Development of related AEs 2. Contributing factors possibly having an impact on the safety and effectiveness 3. Development of unexpected related AEs

NCT ID: NCT05729373 Recruiting - Clinical trials for Generalized Anxiety Disorder

A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder

Start date: March 8, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

A clinical study that will meaure how well SEP-363856 works and how safe it is in adults with Generalized Anixety Disorder. This study will be accepting both male and female subjects between the ages of 18 years and 65 years old. The study will be held in Approximately 50 global study centers and approximately 15 additional centers for a separate Japan population. Participation in the study can be up to approximately 12 weeks.

NCT ID: NCT05727176 Recruiting - Clinical trials for Advanced Cholangiocarcinoma

Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement

FOENIX-CCA4
Start date: May 12, 2023
Phase: Phase 2
Study type: Interventional

This is an open-label, multinational, randomized Phase 2 study confirming the clinical benefit of 20 mg futibatinib and evaluating the safety and efficacy of 16 mg futibatinib in previously treated CCA harboring FGFR2 gene fusions and other rearrangements.

NCT ID: NCT05723562 Recruiting - Neoplasms, Rectal Clinical Trials

A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer

AZUR-1
Start date: April 3, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate dostarlimab monotherapy in participants with locally advanced Mismatch-repair deficient (dMMR)/Microsatellite instability-high (MSI-H) rectal cancer who have received no prior treatment. Participants who achieve complete clinical response (cCR) following dostarlimab treatment will undergo non-operative management (NOM), including close surveillance for recurrent disease. The goal of the study is to determine if Dostarlimab therapy alone is an effective treatment that can allow participants to avoid chemotherapy, radiation, and surgery.

NCT ID: NCT05723198 Recruiting - Skin Diseases Clinical Trials

A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata

BRAVE-AA-PEDS
Start date: February 27, 2023
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to determine the efficacy and safety of baricitinib for the treatment of severe or very severe alopecia areata (hair loss) in children from 6 years to less than 18 years of age. The study is divided into 4 periods, a 5-week Screening period, a 36-week Double-Blind Treatment Period, an approximately 2-year Long-term Extension Period, and a 4-week Post-treatment Follow-up period.

NCT ID: NCT05717075 Recruiting - Decision Making Clinical Trials

Effects of Parents Included in Medical Round of Neonatal Intensive Care Unit

Start date: March 5, 2023
Phase: N/A
Study type: Interventional

The goal of this cross-over randomized controlled study is to evaluate the effects of medical rounds with parents. The main questions it aims to answer are: - How feasible the protocol of this study is to include parents in the medical round? - Does the Family Round promote the quality of family centered care in the NICU perceived by parents and healthcare staff? - Does the Family Round promote parent-infant bonding? - Does the Family Round reduce parents' anxiety? - Does the Family Round increase parents' satisfaction? - Does the Family Round improve staff's communication skills to integrate parents in the discussion of medical rounds? Participants will participate in the Family Round for two weeks, which is organized by healthcare staff following a protocol aiming to integrate parents into the discussion. They will be compared to the two-week period without the Family Round.

NCT ID: NCT05714839 Recruiting - Multiple Myeloma Clinical Trials

A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments

DREAMM-20
Start date: June 14, 2023
Phase: Phase 1
Study type: Interventional

The study consists of three parts - Part 1: The primary purpose of this part is to determine the safety, and recommended part 2 dose of belantamab (bela) in participants with relapsed or refractory multiple myeloma (RRMM). - Part 2: The primary purpose of this part is to determine safety, tolerability and percentage of adverse events (AEs) that happen to eyes in participants with RRMM treated with bela in combination with other treatments. - Part 3: The primary objective of this part is to assess the safety, tolerability and rate of ocular AEs in participants with transplant-ineligible newly diagnosed multiple myeloma (TI-NDMM) treated with either belantamab mafodotin (belamaf) or bela in combination with other treatments.

NCT ID: NCT05714202 Recruiting - Bladder Cancer Clinical Trials

A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)

SunRISe-3
Start date: March 23, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B).

NCT ID: NCT05712746 Recruiting - Heart Failure Clinical Trials

Samtasu Post-marketing General Drug Use-results Survey in Patients With Volume Overload in Heart Failure.

Start date: March 3, 2023
Phase:
Study type: Observational [Patient Registry]

To confirm the safety of tolvaptan sodium phosphate in patients with volume overload in heart failure.