Clinical trials: Safety Issues
Safety Issues, Efficacy, Self
Lower Silesia Sinus Reducer Registry
Lower Silesia Sinus Reducer Registry is a , single-center, single-arm registry including patients with chronic disabling refractory angina pectoris (Canadian Cardiovascular Society [CCS] classes 2-4) despite maximally tolerated…
- Trial name
- LSSRR (NCT06288165)
- Testing
- Coronary Sinus Reducer Implantation
- Where
- 2 sites in Poland
- Volunteers
- 200 people
- Sponsor
- Miedziowe Centrum Zdrowia SA
Safety Issues, Post Operative Pain
Safety and Efficacy of Wide Awake Local Anesthesia no Tourniquet Technique (WALANT) in Ankle Removal of Implant Surgery
Safety and efficacy of wide awake local anesthesia no torniquet technique (WALANT) in ankle surgery. Studying risks and benefits from WALANT compared to general anesthesia .
- Conditions
- Safety Issues, Post Operative Pain, Local Anesthetic Complication
- Trial name
- NCT05864664
- Testing
- Wide awake local anaesthesia no tourniquet technique
- Where
- Kuwait
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ali Lari
Hospitalization
Safety Issues and SurvIval For Medical Outliers
Each Investigator will have to record data concerning 70 patients. In particular 40 patients "outliers" and 30 patients "control".
- Trial name
- SISIFO (NCT03651414)
- Testing
- Clinical data collection
- Where
- 32 sites in Italy
- Volunteers
- 2,056 people
- Sponsor
- Fadoi Foundation, Italy
Safety Issues
Evaluations of CDS Systems
Indications-based prescribing is a medication ordering system in which a clinician selects an indication, and then the electronic health record (EHR) suggests an appropriate medication regimen.
- Trial name
- NCT06330740
- Testing
- Clinical Decision Support
- Volunteers
- 2,000 people
- Sponsor
- New York Presbyterian Hospital
Safety Issues
Safety and PK Multi-dose Study of TAF/EVG Vaginal Insert
MATRIX-001 will examine the safety, PK, modeled PD, and acceptability of inserts containing the combination of TAF and EVG applied vaginally, daily for 3 days, then every other day for 14 days.
- Trial name
- NCT06087913
- Testing
- TAF/EVG vaginal insert
- Where
- 3 sites in United States, Kenya and 1 more
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Eastern Virginia Medical School
Intubation Complication, Intubation; Difficult or Failed
Prehospital Intubation of COVID-19 Patient With Personal Protective Equipment
The safety and efficacy of a laryngoscopy as a primary intubation tool in urgent endotracheal intubation of cardiac arrest patients with suspected/confirmed COVID-19 has not been well-described in the literature.
- Conditions
- Intubation Complication, Intubation; Difficult or Failed, Cardiac Arrest, Influenza
- Trial name
- NCT04365608
- Testing
- Direct laryngoscopy, Vie Scope laryngoscopy
- Where
- 2 sites in Poland
- Volunteers
- 90 people
- Sponsor
- Lazarski University
Rheumatic Disease, HIV Infections
COVID-19 CoronaVac in Patients With Autoimmune Rheumatic Diseases and HIV/AIDS
Patients with chronic rheumatic diseases (such as systemic lupus erythematosus [SLE], rheumatoid arthritis [RA], ankylosing spondylitis [AS], juvenile idiopathic arthritis [JIA], poly/dermatomyositis [PM/DM], systemic sclerosis…
- Conditions
- Rheumatic Disease, HIV Infections, AIDS, Safety Issues
- Trial name
- CoronavRheum (NCT04754698)
- Testing
- CoronaVac
- Where
- Brazil
- Volunteers
- 2,196 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo General Hospital
Patient Satisfaction, Drug Adherence
Tenofovir Alafenamide Switch Therapy in Chronic Hepatitis B
Chronic hepatitis B (CHB) patients may be unsatisfied to entecavir (ETV) therapy due to the inconvenience in drug taking, i.e., fasting for more than 2 hours and/or dose adjustment according to estimated glomerular filtration…
- Conditions
- Patient Satisfaction, Drug Adherence, Efficacy, Self, Safety Issues
- Trial name
- NCT05583006
- Testing
- tenofovir alafenamide (TAF)
- Where
- Taiwan
- Volunteers
- 60 people
- Sponsor
- Taichung Veterans General Hospital
Safety Issues, Effect of Drug
ADC189 Tablets on Influenza A Virus Infection/Influenza B Virus Infection
The goal of this Phase II/III study is to investigate the safty and efficacy of ADC189 tablets in adolescents and adults with influenza A virus infection/influenza B virus infection.
- Trial name
- ADC (NCT06342921)
- Testing
- 15 mg ADC189, 45 mg ADC189
- Where
- China
- Volunteers
- 749 people
- Sponsor
- Jiaxing AnDiCon Biotech Co.,Ltd
Safety Issues
Safety of Immediate Skin-to-Skin Contact After Vaginal Birth in Vigorous Late-Preterm Neonates
Late-preterm neonates are born between 34 and 36 weeks 7 days gestational age (GA). Neonates born less than 34 weeks GA are at increased risk for morbidity and directly admitted to the Neonatal Intensive Care Unit (NICU).
- Trial name
- NCT03585192
- Testing
- Skin Group, Warmer Group
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Type II Diabetes Mellitus, Efficacy, Self
Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in T2DM Patients - EASE Study
Study Objective To evaluate the safety and tolerability of Empagliflozin with or without metformin in patients with Type II Diabetes Mellitus in the Pakistani population.
- Conditions
- Type II Diabetes Mellitus, Efficacy, Self, Safety Issues
- Trial name
- EASE (NCT05164263)
- Testing
- Empagliflozin
- Where
- 6 sites in Afghanistan, Kenya and 3 more
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Getz Pharma
Safety Issues
Oral Remimazolam With and Without Alcohol in Healthy Female Subjects
A Phase 1 Study to Determine the Single-dose Pharmacodynamics, Pharmacokinetics, and Safety and Tolerability of Remimazolam Following Oral Administration With and Without Alcohol in Healthy Female Subjects
- Trial name
- NCT04113343
- Testing
- Remimazolam, Alcohol
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Paion UK Ltd.
Bioavailability, Safety Issues
Bioavailability Comparison Study of Two Types of Nimodipine Injections in Healthy Volunteers
A Randomized, Open-label, Single Dose, Two Formulation, Two Period, Double Cross Over Bioavailability Comparison Study of two types of Nimodipine Injections in Healthy Volunteers.
- Conditions
- Bioavailability, Safety Issues, Ischemic Cerebrovascular Disease
- Trial name
- NCT03794843
- Testing
- Nimodipine Injection, Nimodipine Injection (II)
- Where
- China
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Shenyang Dongxing Pharmaceutical Technology Co., Ltd.
Safety Issues, BPD - Bronchopulmonary Dysplasia
Autologous Cord Blood Cells for Prevention of BPD in Preterm
To study the effect of Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates
- Conditions
- Safety Issues, BPD - Bronchopulmonary Dysplasia, Neonatal Death
- Trial name
- NCT04311476
- Testing
- Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy, 0.9% Sodiun Chloride
- Where
- China
- Volunteers
- 62 people
- Sponsor
- yangjie
Safety Issues, Efficacy, Self
Lowdose Nivolumab in Combination With AVD as Front Line Therapy for Classic Hodgkin's Lymphoma
This study aims to prove the efficacy and safety of low dose nivolumab (40mg as the lowest available presentation) in combination with AVD (adriamycin,vinblastine sulfate and dacarbazine) as frontline treatment for classic…
- Trial name
- NCT05772624
- Testing
- low dose nivolumab in combination with AVD
- Where
- Mexico
- Volunteers
- 16 people
- Sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
Safety Issues
INTERCEPT Safety Evaluation on Whole Blood
The pathogen reduction system for whole blood using amustaline (S-303) and glutathione (GSH) hast a potential to decrease transfusion-transmitted infection.
- Trial name
- POINT1africa (NCT04020224)
- Testing
- Amustaline/GSH pathogen reduction technology, Standard of Care
- Sponsor
- Swiss Transfusion SRC
Iron-deficiency, Iron Toxicity
A Double Blind Randomised Placebo-controlled Trial to Assess the Role of Iron Repletion in Glucose Homeostasis.
In this study the investigators aim at addressing potential relationships between iron stores and glucose homeostasis. Iron (i.e.
- Conditions
- Iron-deficiency, Iron Toxicity, Glucose Metabolism Disorders (Including Diabetes Mellitus), Metabolic Side Effects of Drugs
- Trial name
- DIAFER (NCT03191201)
- Testing
- Ferric Carboxymaltose, 0.9% sodium chloride solution
- Where
- Switzerland
- Volunteers
- 32 people
- Sponsor
- Prof Gérard WAEBER
Safety Issues, Tolerance
Safety and Tolerability of 2 Dietary Supplement Beverages Designed to Maintain Healthy Blood Pressure.
This study is designed to evaluate the safety and tolerability of two distinct dietary supplement beverage formulations designed to maintain normal blood pressure.
- Trial name
- NCT06442293
- Testing
- Treatment 1, Treatment 2
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- USANA Health Sciences
Safety Issues, HPV Infection
BS-FU01 Follow-Up Study of FluBHPVE6E7 Study Subjects
This is a follow-up study for patients treated with FluBHPVE6E7 in previous interventional studies.
- Trial name
- NCT04528407
- Testing
- Observation without intervention
- Where
- Austria
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- BlueSky Immunotherapies GmbH
Safety Issues, Tolerability
Single Ascending Dose and Multiple Ascending Dose Study of AVR-48
This is a Phase 1 (healthy adult volunteers), 2-part, double-blind, randomized, placebo controlled trial to evaluate the safety and pharmacokinetic (PK) profiles of escalating single doses of AVR-48 versus placebo (SAD) and…
- Conditions
- Safety Issues, Tolerability, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT06847698
- Testing
- AVR-48
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- AyuVis Research, Inc.