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NCT ID: NCT04854512 Suspended - Clinical trials for Diabetes Mellitus, Type 2

Investigational Study of Delayed Release Metformin

DREAM-T2D
Start date: May 18, 2021
Phase: Phase 3
Study type: Interventional

In Phase 1 and 2 studies already conducted, Metformin DR, with its targeted delivery to the distal small intestine, has shown the potential to be a safe and effective way to improve glycemic control in patients with T2DM and CKD with less systemic metformin exposure. The primary purpose of this Phase 3 clinical study is to collect pivotal data confirming the safety and efficacy of Metformin DR in T2DM patients with varying renal function from normal up to CKD3B.

NCT ID: NCT04825535 Suspended - Clinical trials for Major Depressive Disorder

Non-Inferiority RCT Comparing Online and On-Site CBT in MDDi

Start date: April 2024
Phase: N/A
Study type: Interventional

In recent years, Cognitive Behavioral Therapy has been integrated with mindfulness meditation (CBT-M) following evidence for increased efficacy when modalities are combined. We will assess whether online group CBT-M plus standard psychiatric care is non-inferior in efficacy and more cost-effective than office-based, on-site group CBT-M (plus standard psychiatric care) per outcomes at post-intervention and at 6-month follow up in adults with major depressive disorder (MDD). This non-inferiority randomized controlled trial will employ both assessor-blinded and self-report outcome measures and will include a full economic evaluation.

NCT ID: NCT04814108 Suspended - Clinical trials for Uterine Serous Carcinoma

A Study of ZN-c3 in Women With Recurrent or Persistent Uterine Serous Carcinoma

Start date: July 28, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase 2 study to evaluate the clinical activity and safety of ZN-c3 (azenosertib) in adult women with recurrent or persistent uterine serous carcinoma (USC).

NCT ID: NCT04771416 Suspended - Clinical trials for Leukodystrophy, Globoid Cell

Study of Safety, Tolerability and Efficacy of PBKR03 in Pediatric Subjects With Early Infantile Krabbe Disease

GALax-C
Start date: February 24, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

PBKR03 is a gene therapy for Krabbe Disease (Globoid cell leukodystrophy) intended to deliver a functional copy of the GALC gene to the brain and peripheral tissues. This study will evaluate the safety, tolerability and efficacy of this treatment by first evaluating two different doses in two different age groups, then confirming the optimal dose to be used for confirmation of safety and efficacy.

NCT ID: NCT04740073 Suspended - Clinical trials for Total Knee Arthroplasty

How Muscle and Tendon Properties Contribute to Functional Change Prior to and Following Knee Replacement

Start date: February 2021
Phase:
Study type: Observational

It is unknown how progressive physiological change in muscle and tendon contributes to loss of functional ability in patients undergoing total knee replacement between referral to surgery, and during post-surgery recovery. This study will use ultrasound and neurophysiological measures to evaluate progressive alterations of tissue to understand functional decline in men and women prior to and following knee replacement surgery. A group of healthy controls not undergoing knee replacement will also be studied to contrast changes in the patient group to normal changes over time. It is hypothesized that from the point of referral to surgery, patients will exhibit reductions in muscle and tendon size (atrophy) and reflex excitability that will be greater in the surgical compared with non-surgical leg, and these changes will precede observable losses in functional measures and strength. Secondly, it is hypothesized that following total knee replacement, muscle and tendon size, reflex activity, strength and functional measures will increase to a level below the pre-surgery values.

NCT ID: NCT04738136 Suspended - Covid19 Clinical Trials

Safety, Tolerability and Efficacy Of S-1226 in Moderate Severity Covid-19 Bronchiolitis/Pneumonia

Start date: September 15, 2021
Phase: Phase 2
Study type: Interventional

This is a randomized, open-label, controlled, Phase II proof of concept study to evaluate the safety, tolerability and efficacy of S-1226 in which hospitalized subjects (n≤30) with moderate severity COVID-19 Bronchiolitis/Pneumonia will be enrolled. The safety and tolerability of S-1226 composed of PFOB with ascending doses of carbon dioxide (4%, 8%, and 12% CO2) administered twice daily will be assessed subjects in hospitalized subjects with moderate severity COVID-19 Bronchiolitis/Pneumonia.

NCT ID: NCT04684628 Suspended - Prostate Cancer Clinical Trials

68Ga-PSMA PET/CT in Prostate Cancer

Start date: December 9, 2020
Phase: Phase 3
Study type: Interventional

This is a single-center, multi-arm, open-label, phase III trial in up to 500 patients with biopsy-proven prostate cancer. Participants will receive regular standard of clinical care. The only study-specific procedures will the administration of 68Ga-PSMA-11 followed by a PET/CT (positron emission tomography/computed tomography) scan. Participants will be followed for two hours after the infusion for identification of any immediate adverse events (AE), and will be contacted by telephone after 7 to 14 days to enquire about any delayed AEs. PET/CT images, CT-alone images and bone scans will be read by separate readers who will not be blinded to all other clinical and imaging information. The standard of truth will be a consensus of the readers based on all available clinical, imaging, and histopathological information available for up to 6 months after the PET/CT scan.

NCT ID: NCT04559867 Suspended - Clinical trials for Biliary Tract Diseases

Fistulotomy as the Primary Cannulation Technique for All Patients Undergoing ERCP: A Randomized, Controlled Trial

Start date: September 10, 2020
Phase: N/A
Study type: Interventional

Participants in this study will be undergoing a procedure called an endoscopic retrograde cholangiopancreatography (ERCP). This procedure is most commonly performed to help treat conditions affecting specific areas of the digestive system called the pancreas and bile ducts. Patients will consent to allow the study physician to access these areas of the digestive system by either making a cut called a needle-knife fistulotomy or a sphincterotomy.

NCT ID: NCT04546399 Suspended - Down Syndrome Clinical Trials

A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Start date: December 4, 2020
Phase: Phase 2
Study type: Interventional

This phase II trial studies the effect of nivolumab in combination with blinatumomab compared to blinatumomab alone in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) that has come back (relapsed). Down syndrome patients with relapsed B-ALL are included in this study. Blinatumomab is an antibody, which is a protein that identifies and targets specific molecules in the body. Blinatumomab searches for and attaches itself to the cancer cell. Once attached, an immune response occurs which may kill the cancer cell. Nivolumab is a medicine that may boost a patient's immune system. Giving nivolumab in combination with blinatumomab may cause the cancer to stop growing for a period of time, and for some patients, it may lessen the symptoms, such as pain, that are caused by the cancer.

NCT ID: NCT04520412 Suspended - Alzheimer Disease Clinical Trials

A Study of Sodium Oligomannate (GV-971) in Participants With Mild to Moderate Alzheimer's Disease

GREEN MEMORY
Start date: October 27, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and efficacy of GV-971 in mild to moderate Alzheimer's disease.