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NCT ID: NCT05175976 Completed - Safety Issues Clinical Trials

Patient Safety in the Operating Room: Helsinki Declaration Implementation in Ukraine

Start date: March 1, 2021
Phase:
Study type: Observational

Athe study to evaluate the implementation of the components of the Declaration of Helsinki in Ukrainian hospitals, as well as other safety measures during surgeries.

NCT ID: NCT05171855 Active, not recruiting - Clinical trials for Endocrine System Diseases

A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency

Start date: December 16, 2021
Phase: Phase 3
Study type: Interventional

This is a phase 3 open-label multicenter extension study designed to evaluate the long-term safety and efficacy of Lonapegsomatropin administered once-weekly. The study participants are adults (males and females) with confirmed growth hormone deficiency (GHD) having completed the treatment period in study TCH-306 (foresiGHt).

NCT ID: NCT05163314 Recruiting - Clinical trials for Dravet Syndrome (DS)

A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome

Start date: March 4, 2022
Phase: Phase 3
Study type: Interventional

The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of seizures in children and adults with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS). Participants will receive their standard anti-seizure therapy, plus tablets of soticlestat. There will be scheduled visits and follow-up phone calls throughout the study.

NCT ID: NCT05152147 Recruiting - Clinical trials for Esophageal Adenocarcinoma

A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers

HERIZON-GEA-01
Start date: December 2, 2021
Phase: Phase 3
Study type: Interventional

This study is being done to find out if zanidatamab, when given with chemotherapy plus or minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy. The patients in this study will have advanced human epidermal growth factor 2 (HER2)-positive stomach and esophageal cancers that are no longer treatable with surgery (unresectable) or chemoradiation, and/or have grown or spread to other parts of the body (metastatic).

NCT ID: NCT05138562 Recruiting - Endometriosis Clinical Trials

TUC3PII-01_TU2670 Phase IIa Clinical Study

Start date: August 19, 2021
Phase: Phase 2
Study type: Interventional

This Protocol for TU2670 is to investigate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of TU2670 in subjects with moderate to severe endometriosis-associated pain.

NCT ID: NCT05134441 Recruiting - Multiple Sclerosis Clinical Trials

Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis

ENSURE-1
Start date: November 18, 2021
Phase: Phase 3
Study type: Interventional

Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults with Relapsing Multiple Sclerosis (ENSURE-1)

NCT ID: NCT05126576 Suspended - COVID-19 Clinical Trials

Study to Evaluate the Effects of RO7496998 (AT-527) in Non-Hospitalized Adult and Adolescent Participants With Mild or Moderate COVID-19

MORNINGSKY
Start date: April 28, 2021
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, antiviral activity, and pharmacokinetics of study drug RO7496998 (AT-527) compared to placebo in non-hospitalized adult and adolescent participants with mild to moderate coronavirus disease 2019 (COVID-19) in the outpatient setting.

NCT ID: NCT05125549 Completed - Pharmacokinetics Clinical Trials

Fasted Bioequivalence Study of Clopidogrel Film-coated Tablets, 75 mg in 48 Healthy, Adult Male and Female Subjects.

Start date: July 12, 2018
Phase: Phase 1
Study type: Interventional

This study was designed to compare bioequivalence of the Test Product Clopidogrel bisulfate, film-coated tablets, 75 mg (JSC Farmak, Ukraine) and Reference Product Plavix® 75 mg film-coated tablets (Sanofi Winthrop Industrie, France) in healthy male and female volunteers under fasting conditions.

NCT ID: NCT05123703 Recruiting - Clinical trials for Relapsing-Remitting Multiple Sclerosis

A Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis

Operetta 2
Start date: February 4, 2022
Phase: Phase 3
Study type: Interventional

This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with relapsing-remitting multiple sclerosis aged between 10 and < 18 years over a duration of at least 96 weeks.

NCT ID: NCT05117788 Active, not recruiting - Clinical trials for Tuberculosis, Multidrug-Resistant

Bioneer IRONqPCR ™ RFIA Kit Kit Clinical Evaluation

Start date: February 23, 2022
Phase:
Study type: Observational

Evidence of the clinical diagnostic accuracy and operational characteristics of the Bioneer IRONqPCR ™ RFIA Kit is needed to comprehensively evaluate Bioneer RFIA validity and inform global and national policy decision-making. The rapid diagnosis and appropriate treatment of M/XDR-TB is essential to prevent significant morbidity, mortality and further transmission of disease. The FQ are key components of the new bedaquiline-containing 6-9 month regimen, and so it is necessary to rule-out resistance to these compounds prior to treating patients with the shorter regimen. Currently there are no WHO endorsed tests that can identify resistance to both first and second-line drugs in one reaction.