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Safety clinical trials

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NCT ID: NCT03955666 Completed - Safety Clinical Trials

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects

PREVAIL1
Start date: August 7, 2019
Phase: Phase 1
Study type: Interventional

This Phase 1b study will evaluate the safety of PRV-3279 in healthy adult subjects

NCT ID: NCT03927625 Withdrawn - Safety Clinical Trials

Evaluation of Ascorbate-Meglumine Therapeutic for SRS

Start date: December 1, 2021
Phase: Phase 1
Study type: Interventional

Phase 1, Single-Center, Dose-Escalating, Open-Label, Safety Clinical Trial of Parenteral Ascorbate-Meglumine as a Novel Magnetic Resonance Imaging-guided Adjunctive Therapeutic for Stereotactic Radiosurgery (SRS).

NCT ID: NCT03927235 Recruiting - Safety Clinical Trials

The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Different Freezing Time in the Diffuse Parenchymal Lung Diseases

Start date: May 16, 2019
Phase: N/A
Study type: Interventional

Transbronchial cryobiopsy in different freezing time is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety.

NCT ID: NCT03908138 Recruiting - Multiple Myeloma Clinical Trials

RDD Versus VDD in Newly Diagnosed Patients With Multiple Myeloma

Start date: March 30, 2019
Phase: Phase 4
Study type: Interventional

Multiple myeloma (MM) is a common malignant hematology disease. The development of proteasome inhibitors (PIs) and immunomodulatory drugs (IMiDs) significantly improved the survival of MM patients. IMiDs have multiple effects in MM therapy. Except for direct cytotoxicity, IMiDs also play a variety of immune regulatory roles. Lenalidomide, a kind of IMiDs, was usually used in the therapy of relapsed/refractory MM. The efficacy and safety of RDD (lenalidomide, pegylated liposomal doxorubicin, dexamethasone) in newly diagnosed patients with MM still needs to be further validated.

NCT ID: NCT03832517 Terminated - Safety Clinical Trials

Single and Multiple Dose Escalation Trial of an Intravenous Antibiotic RC-01

Start date: April 14, 2019
Phase: Phase 1
Study type: Interventional

A Phase 1 study of the safety, tolerability and pharmacokinetics of a new antibiotic (RC-01). In Part 1 cohorts of healthy adults will participate in a single dose escalation study of increasing intravenous doses of RC-01. In Part 2 cohorts of healthy adults will participate in a multiple dose escalation study of increasing intravenous doses of RC-01 given either twice daily or three times daily.

NCT ID: NCT03830762 Completed - Clinical trials for Peripheral Neuropathy

Xanamemâ„¢ in Healthy Elderly Subjects

XanaHES
Start date: January 21, 2019
Phase: Phase 1
Study type: Interventional

Xanamemâ„¢ is being developed as a potential drug for Alzheimer's disease. This study drug has been designed to change the cortisol levels in the brain. Cortisol is a naturally occurring hormone in the body. It is believed that reducing the level of cortisol will be a benefit in the treatment of Alzheimer's disease. The XanaHES study is testing the safety and tolerability of Xanamem. It is planned to enrol approximately 84 participants, male and female aged from 50 to 75 who are in good health, in the study at 1 centre in Australia. The XanaHES Phase I study is a single-blind study. Subjects will be randomised to receive either 20mg once daily Xanamem or Placebo in cohort 1. Once all subjects have completed the study treatment of 12 weeks, a dose escalation committee will decide if a new cohort, cohort 2, with 30mg once daily vs placebo is started.

NCT ID: NCT03806465 Active, not recruiting - Safety Clinical Trials

Malaria Vaccine Pilot Evaluation

MVPE
Start date: February 25, 2019
Phase:
Study type: Observational

The RTS,S/AS01 malaria vaccine is being introduced sub-nationally in phased pilot introductions through the EPI programmes in Malawi Ghana and Kenya. Vaccine introduction is by the respective MoH in selected areas randomly assigned to receive the vaccine at the beginning of the pilots. In the context of this programmatic activity, the Malaria Vaccine Pilot Evaluation (MVPE) registered here as observational evaluations during early vaccine introduction, include a series of 3 household surveys, and sentinel hospital and community mortality surveillance, building on routine systems. These observational evaluations will measure: 1. The programmatic feasibility of delivering a 4 dose schedule; 2. Safety in routine use, with focus on cerebral malaria and meningitis; 3. The impact of the malaria vaccine in routine use on severe malaria and all-cause mortality

NCT ID: NCT03760302 Completed - Pain, Acute Clinical Trials

Analgesia in ÖAMTC Helicopter Emergency Service in Austria

Start date: December 1, 2018
Phase:
Study type: Observational

A sufficient analgesia in injured or sick people is the main goal of physicians treating a patient. In emergency medicine potent analgesia like ketamine or opioids are routinely used. It is unknown if there are any severe side effects or if the use is safe while in use in a Helicopter Emergency Service equipped with emergency physicians.

NCT ID: NCT03727750 Completed - Pharmacokinetics Clinical Trials

Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML

Start date: July 3, 2019
Phase: Phase 4
Study type: Interventional

This is a single-arm, open-label, Phase 4 study evaluating the effect of GO on the QTc, pharmacokinetics, safety, and immunogenicity of GO as a single-agent monotherapy in adult and pediatric patients with relapsed or refractory CD33-positive AML.

NCT ID: NCT03715114 Recruiting - Pharmacokinetics Clinical Trials

A Study to Assess the Safety and Pharmacokinetics of Oral Sodium Oligo-mannurarate (GV-971) in Healthy Chinese Subjects

Start date: October 15, 2018
Phase: Phase 1
Study type: Interventional

To evaluate the safety and pharmacokinetics of GV-971 capsules after oral a single or multiple doses of 900 mg, 1200 mg and 1500 mg in healthy subjects.