Clinical Trials Logo

Filter by:
NCT ID: NCT04063033 Completed - Heart Failure Clinical Trials

IV Iron in Acute Decompensated Heart Failure

Start date: September 1, 2019
Phase: Phase 4
Study type: Interventional

The study aims Compare the effect of addition of IV FERRLECITR (ferric gluconate) to standard therapy to standard therapy alone (without any IV iron treatment) in patients admitted with acute decompensated heart failure.

NCT ID: NCT04062838 Withdrawn - Rotator Cuff Tear Clinical Trials

Prolotherapy for the Treatment of Partial Rotator Cuff Tears

Start date: August 1, 2020
Phase: Phase 4
Study type: Interventional

This is a Prospective Pilot Single Arm study on prolotherapy for the treatment of patients with pain due to Partial Rotator Cuff (RC) Tears of the Shoulder. The aim of this trial is to study the effects of injected glucose on injured or degenerative RC tears of the shoulder. Glucose is not recognized by the FDA for this purpose but is used in 2 main concentrations: 50% solution to treat hypoglycemia and 5% solution for fluid replacement. In the prolotherapy group, 20% dextrose will be injected into 4 locations of the affected shoulder. In the active control group, patients will receive a single injection of methylprednisolone into the subacromial bursa and 3 saline injections overlying the tendons.

NCT ID: NCT04060979 Completed - Bronchiolitis Acute Clinical Trials

Evaluation of Two Doses of Nitric Oxide (NO) Given Intermittently Via Inhalation to Subjects With Bronchiolitis

Start date: November 6, 2019
Phase: Phase 2
Study type: Interventional

Prospective, Double-Blinded, Randomized, Multi-Center Study for Evaluation of Two Doses of Nitric Oxide (NO) Given Intermittently Via Inhalation to Subjects With Bronchiolitis The proposed study judiciously expands these observations for use of NO treatment in pediatric patients with bronchiolitis aged less than 12 months. The intermittent dosing strategy used in this study has been selected to minimize the potential for adverse effects. The inclusion of two doses in the proposed pilot study is intended to determine a dose response effect and select a dose that is optimally safe and effective. The primary endpoint evaluation of time to fit for discharge will provide an effective objective measurement for the treatment effectiveness compared to standard supportive treatment of bronchiolitis. Primary objective: • Assess whether Nitric Oxide (NO) administered intermittently in 2 concentrations (via inhalation for 40 minutes 4 times per day for up to 5 consecutive days) in addition to Standard Supportive Treatment (SST) shortens the recovery time of infants with bronchiolitis, compared to SST alone. Secondary objectives: - Time to achieve O2 saturation of ≥ 92 % sustained for at least 2 hours - Reduction in hospital Length of Stay (LOS) - Time to achieve mTal score of ≤ 5 Safety objectives: Characterize the safety of 2 doses of NO intermittent inhalation treatment therapy as measured by Adverse Events (AE) - number and percentage of subjects that experience AEs - and Serious Adverse Events (SAEs). A total of 90 subjects will be enrolled into the study and randomized in a 1:1:1 ratio to receive the study treatments. Treatment administration: Treatment blindness will be kept by designation of blinded and un-blinded team members.The blinded staff will be performing the study assessment procedures and the un-blinded team will be administering the actual treatment. Subjects' parents/legal guardian will be contacted for a follow up phone call at days 14+5 and 30+5 from the date of enrollment of the subject into the study.

NCT ID: NCT04059484 Active, not recruiting - Clinical trials for Breast Cancer Metastatic

Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer

AMEERA-3
Start date: October 22, 2019
Phase: Phase 2
Study type: Interventional

Primary Objective: To determine whether amcenestrant per overall survival (os) improves progression free survival (PFS) when compared with an endocrine monotherapy of the choice of the physician, in participants with metastatic or locally advanced breast cancer Secondary Objectives: - To compare the overall survival in the 2 treatment arms - To assess the objective response rate in the 2 treatment arms - To evaluate the disease control rate in the 2 treatment arms - To evaluate the clinical benefit rate in the 2 treatment arms - To evaluate the duration of response in the 2 treatment arms - To evaluate the PFS according to the estrogen receptor 1 gene (ESR1) mutation status in the 2 treatment arms - To evaluate the pharmacokinetics of amcenestrant as single agent - To evaluate health-related quality of life in the 2 treatment arms - To compare the overall safety profile in the 2 treatment arms

NCT ID: NCT04058353 Completed - Cystic Fibrosis Clinical Trials

A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)

Start date: August 28, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a gating or residual function mutation (F/G and F/RF genotypes).

NCT ID: NCT04056611 Terminated - Clinical trials for Respiratory Syncytial Virus Infections

Effects of JNJ-53718678 in Adult and Adolescent Participants Who Had a Hematopoietic Stem Cell Transplantation and Who Are Infected With Respiratory Syncytial Virus (RSV)

FREESIA
Start date: December 26, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effect of JNJ-53718678 on the development of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTIs) in adult hematopoietic stem cell transplant (HSCT) recipients with RSV upper RTI.

NCT ID: NCT04056442 Completed - Clinical trials for Steroid Dependent Crohn's Disease

A Phase 2a Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol as a Steroid-sparing Therapy in Steroid-dependent Crohn's Disease Patients

Start date: July 7, 2019
Phase: Phase 2
Study type: Interventional

Treatment will start with dose escalation in addition to Standard of Care (steroid therapy with or without additional therapies) . At the conclusion of the dose escalation segment of the study, if the 300 mg Cannabidiol dose level/placebo is deemed safe for two weeks with Standard of care dose of steroids, patients will continue receiving this 300 mg dose/placebo for an additional period of 3 months. Weekly tapering off of steroids will then commence and will be carried out . Three months after starting treatment with Cannabidiol an interim analysis to evaluate Cannabidiol's safety and efficacy will be carried out and treatment assignment group may be changed (according to response confirmation)

NCT ID: NCT04056247 Recruiting - Clinical trials for Stage IV Non-small Cell Lung Cancer

Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments

PROPHETIC
Start date: October 1, 2019
Phase:
Study type: Observational

This study will develop an algorithm of identifying patients with stage IV NSCLC and Melanoma who could benefit from cancer treatment they receive.

NCT ID: NCT04055558 Recruiting - Clinical trials for Childhood Leukemia and Lymphoma

Lymphoproliferative Disorders After Diagnosis of Childhood Acute Lymphoblastic Leukemia/Lymphoma

Start date: August 25, 2019
Phase:
Study type: Observational

Lymphoproliferative disorders (LPD) are a major cause of morbidity and mortality in immunodeficient patients. There have been isolated case reports of patients with childhood ALL who developed LPD after ALL diagnosis, without undergoing stem cell transplantation, but data regarding such cases are limited. We propose here an international collaboration, to form a comprehensive database of children who developed LPD after diagnosis of acute lymphoblastic leukemia/lymphoma

NCT ID: NCT04051892 Completed - Clinical trials for Reconstruction of the Breast Nipple and Areola Complex

Multicenter Study Evaluating the FixNip™ NRI Safety and Performance

Start date: October 6, 2020
Phase: N/A
Study type: Interventional

A prospective, Open Label, Single arm, Multicenter study Evaluating the FixNip™ NRI Safety and Performance in Female Patients Seeking Reconstructive Surgery of the Nipple.