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Safety clinical trials

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NCT ID: NCT04391036 Completed - Safety Clinical Trials

Randomized Cross-Over Study of Self-Insertion of Two Placebo Vaginal Film Formulations

FAME103B
Start date: July 14, 2020
Phase: N/A
Study type: Interventional

This is a double-blinded crossover study to evaluate whether Eudragit® content impacts the ability to self-insert placebo vaginal films. Thirty women will self-insert one high and and one low Eudragit® content film. The insertion order will be randomized in a 1:1 ratio. After inserting each film, participants will complete a survey reporting their perceptions and experience. The primary endpoint is successful insertion defined as all of the film inside the vagina upon visual assessment by a study clinician. Secondary outcomes include preference for the low level or high level Eudragit® formulation film with respect to insertion and participants' description of identified challenges.

NCT ID: NCT04338802 Not yet recruiting - COVID-19 Clinical Trials

Efficacy and Safety of Nintedanib in the Treatment of Pulmonary Fibrosis in Patients With Moderate to Severe COVID -19

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

This center intends to conduct a single-center, randomized, placebo-controlled study to evaluate the effectiveness and safety of Nintedanib ethanesulfonate soft capsule in the treatment of pulmonary fibrosis in patients with moderate to severe COVID-19.

NCT ID: NCT04319718 Completed - Pharmacokinetics Clinical Trials

Safety and Pharmacokinetics of Two Vaginal Film Formulations Containing the Integrase Inhibitor MK-2048

FAME103
Start date: August 19, 2020
Phase: Phase 1
Study type: Interventional

This is a proof of concept study to determine whether an extended release vaginal film can deliver drug for seven days. Two film formulations containing MK-2048 which differ by dissolution and spreadability attributes will be compared for safety and pharmacokinetic outcomes.

NCT ID: NCT04304976 Completed - Clinical trials for Spinal Cord Injuries

Clinical Trial ROBERT® - Project Active Training

Start date: November 27, 2019
Phase: N/A
Study type: Interventional

The overall purpose with this clinical trial is to, monitor and secure ROBERT®'s clinical performance and safety in a clinical environment in the regional hospital North Denmark, Neuro Unit North. The purpose of the study is to investigate if ROBERT® has the ability to 1. Perform guided active training. 2. Perform resistance based active training. And validate the safety of ROBERT® in a clinical environment.

NCT ID: NCT04099069 Not yet recruiting - Anesthesia Clinical Trials

The Impacts of the Different Anesthesia Methods on Patients of Transbronchial Cryobiopsy

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

to evaluate the difference between the tracheal intubation (TI) and rigid bronchoscopy (RB) under general anesthesia on patients with transbronchial cryobiopsy.

NCT ID: NCT04071379 Completed - Safety Clinical Trials

Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B

Start date: October 13, 2020
Phase: Phase 3
Study type: Interventional

Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B

NCT ID: NCT04069780 Recruiting - Safety Clinical Trials

Suprachoroidal Injection of Triamcinolone Acetonide for Management of Diabetic Macular Edema

SCI
Start date: March 13, 2019
Phase: N/A
Study type: Interventional

Intravitreal triamcinolone acetonide is a well-known method of treatment of diabetic macular edema, however, it has many side effects, most commonly causing cataract and glaucoma. Suprachoroidal route is an emerging route of delivery of intraocular drugs. This is to our knowledge the first prospective study to compare the effect of triamcinolone acetonide delivered via the intravitreal versus the suprachoroidal route in the treatment of diabetic macular edema as regards safety and efficacy.

NCT ID: NCT04014426 Completed - Healthy Volunteers Clinical Trials

Evaluation of Healthcare Workers Safety During Pressurized Intraperitoneal Aerosol Chemotherapy

PIPAC-Secure
Start date: January 2, 2018
Phase: N/A
Study type: Interventional

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a new treatment that applies chemotherapeutic drugs into the peritoneal cavity as an aerosol. It is used to treat patient with Peritoneal Carcinomatosis (PC). During this procedure, healthcare workers may be under risks of exposure to cytotoxic treatments. The purpose of this study is to evaluate the safety of the heathcare workers and the risk of operation room Oxaliplatin's contamination during a PIPAC.

NCT ID: NCT04013646 Recruiting - Stroke Clinical Trials

Combination Therapy of Umbilical Cord Blood and Erythropoietin for Stroke Paients

Start date: May 2, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This clinical trial is a clinical trial for the evaluation of the safety and efficacy of umbilical cord blood (UCB) therapy, UCB and erythropoietin (EPO) combination therapy in adult stroke patients.

NCT ID: NCT03969641 Completed - Safety Clinical Trials

Safety of RIV4 Versus IIV4 in Pregnant Women

Start date: September 5, 2019
Phase: Phase 4
Study type: Interventional

This is a prospective, randomized clinical trial. During the study, pregnant women will be randomized (1:1) to receive RIV4 or IIV4. Vaccines will be administered by licensed providers. Prior influenza vaccine history will be verified by medical record review when possible. Injection-site (local) and systemic reaction data will be assessed on vaccination day and during the 8 days following vaccination using either identical web-based or paper diaries, depending on study participant preference. Maternal serum samples will be collected for antibody titers relevant to Influenza at time points that include: prior to vaccination and ~29 days post vaccination. When feasible, maternal blood at delivery and cord blood serum will be analyzed for the same antibody titers. Pregnant women will be followed through delivery with comprehensive obstetric and neonatal outcomes obtained from medical record review for 90 days of life.