Clinical trials: Safety Study
Typhoid Fever
Safety, Immunogenicity and Compatibility With DTP of a Typhoid Fever Vaccine in Infants
The purpose of this study is to evaluate the safety, immunogenicity, and compatibility of our Vi-rEPA conjugate administered to infants with their routine vaccinations.
- Trial name
- NCT00342628
- Testing
- Vi-rEPA conjugate vaccine for typhoid fever, Hib-TT, DTP
- Where
- Vietnam
- Volunteers
- 301 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Chronic Plaque Psoriasis
Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
This study will assess the safety and efficacy of ARQ-151 cream applied once a day for 24 weeks by subjects with chronic plaque psoriasis
- Trial name
- DERMIS-OLE (NCT04286607)
- Testing
- Topical roflumilast
- Where
- 85 sites in United States, Canada and 1 more
- Volunteers
- 337 people
- Sponsor
- Arcutis Biotherapeutics, Inc.
Congenital Heart Diseases
Ulinastatin Injection in in Pediatric Patients Undergoing Open Heart Surgery
1. Explore the efficacy of Ulinastatin use in improving post-operative pulmonary insufficiency and safety in pediatric patients undergoing scheduled CPB open heart surgery to treat Complex Congenital Heart Disease 2.
- Trial name
- NCT02527811
- Testing
- Ulinastatin
- Where
- 5 sites in China
- Volunteers
- 450 people
- Sponsor
- Techpool Bio-Pharma Co., Ltd.
Retinal Vein Occlusion
To Study the Effectiveness and Safety of Niacin and a Topical Steroid Eye Drop to Treat Retinal Vein Occlusions
The purpose of this study is to determine whether Niacin, a B vitamin, may act as a vasodilator to encourage earlier formation of collateral blood vessels that may serve to bypass the obstructed vein in the eye.
- Trial name
- NCT00493064
- Testing
- Nicotinic acid, Prednisolone acetate
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- Palo Alto Medical Foundation
Generalized Pustular Psoriasis
A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis
This is a study in adolescents and adults with Generalized Pustular Psoriasis (GPP). People between 12 and 75 years old can take part in the study.
- Trial name
- NCT04399837
- Testing
- Spesolimab
- Where
- 72 sites in United States, Argentina and 21 more
- Volunteers
- 123 people
- Sponsor
- Boehringer Ingelheim
Influenza
A Study to Evaluate the Efficacy and Safety of Intravenous Peramivir in Subjects With Uncomplicated Influenza.
This is a study to evaluate the efficacy and safety of a single dose of intravenous peramivir versus placebo in adolescents and adults with acute uncomplicated influenza.
- Trial name
- NCT01224795
- Testing
- Peramivir
- Where
- 96 sites in United States
- Sponsor
- BioCryst Pharmaceuticals
Diabetes Mellitus, Type 1, Closed-Loop
Safety Assessment of DBLUS System in Adolescent and Adult Patients With Type 1 Diabetes and Assessment of Its Clinical Efficacy (DIABELOOP SP8)
This clinical trial is a randomized trial including a 3-month single-arm part and a 6-month extension phase. Following randomization between the 1st group and 2nd group, a 2-week baseline period in open-loop for 148 adults and 30…
- Trial name
- DIABELOOP SP8 (NCT04190277)
- Testing
- Open-loop condition, Closed-loop condition
- Where
- 9 sites in France
- Volunteers
- 184 people
- Sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Bloody Diarrhea, STEC, Unspecified
Phase 2/3 Study to Evaluate PK, Safety & Efficacy of INM004 in STEC Positive Pediatric Patients for Prevention of HUS
The investigational medicinal product (IMP), INM004, proposes to neutralize the toxin in the bloodstream to prevent the interaction of the Stx with the specific receptor, by means of a polyclonal antibody to be administered upon…
- Conditions
- Bloody Diarrhea, STEC, Unspecified, Hemolytic-Uremic Syndrome, Pediatric Kidney Disease
- Trial name
- NCT04132375
- Testing
- INM004
- Where
- 7 sites in Argentina
- Volunteers
- 11 people
- Sponsor
- Inmunova S.A.
B Cell Leukemia, B Cell Lymphoma
A Feasibility and Safety Study of Universal Dual Specificity CD19 and CD20 or CD22 CAR-T Cell Immunotherapy for Relapsed or Refractory Leukemia and Lymphoma
CD19-directed CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory B-cell malignancies; however, a subset of patients relapse due to the loss of CD19 in tumor cells.
- Trial name
- NCT03398967
- Testing
- Universal Dual Specificity CD19 and CD20 or CD22 CAR-T Cells
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Chinese PLA General Hospital
Vascular Anomaly
Efficacy and Safety of Sirolimus to Vascular Anomalies
To evaluate the safety and efficacy of Sirolimus in complicated vascular anomalies in Chinese children
- Trial name
- NCT03583307
- Testing
- Sirolimus
- Where
- China
- Volunteers
- 126 people
- Sponsor
- West China Hospital
Schizophrenia
Adaptive Phase II Study to Evaluate the Safety & Efficacy of NaBen®
The purpose of this study is to determine if NaBen® is a safe and effective add-on treatment for schizophrenia in adolescents.
- Trial name
- NCT01908192
- Testing
- NaBen®
- Where
- 23 sites in United States, Taiwan
- Volunteers
- 60 people
- Sponsor
- SyneuRx International (Taiwan) Corp
Exocrine Pancreatic Insufficiency
Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb)
Protocol ALCT-0000497 is a multicenter safety, tolerability and fat absorption study that anticipates enrolling 35 male and female subjects (pediatric and adult) with cystic fibrosis.
- Trial name
- NCT02598128
- Testing
- RELiZORB
- Where
- 11 sites in United States
- Volunteers
- 34 people
- Sponsor
- Alcresta Therapeutics, Inc.
Schizophrenia, Schizoaffective Disorder
A Safety and Pharmacokinetic Study of ER OROS Paliperidone in Pediatric Patients With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder
The purposes of this study are to characterize the pharmacokinetics of paliperidone after single- and multiple-dose administration of paliperidone ER in children and adolescent patients (>= 10 to <= 17 years of age) with…
- Conditions
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders
- Trial name
- NCT00796081
- Testing
- ER OROS paliperidone, paliperidone ER
- Volunteers
- 25 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Severe Influenza
Evaluate the Safety and Efficacy of Xiyanping in Pediatric Participants With Severe Influenza-Like Symptoms
This is a multicenter, randomized, open Label, add-on study.
- Trial name
- NCT03947411
- Testing
- Oseltamivir Phosphate, Xiyanping injection+Oseltamivir Phosphate
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Acquired Immunodeficiency Syndrome, HIV Infection
Genetically Modified Lymphocytes to Treat HIV-Infected Identical Twins - Study Modifications
Certain patients enrolled in NIH protocol 94-I-0206 at the Clinical Center may be eligible to participate in one or more of the following new options: Donor/recipient extension phase - Both the recipient (HIV-infected twin) and…
- Trial name
- NCT00001409
- Testing
- Interleukin-2
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Acne Vulgaris, Acne
Study of NVN1000 Topical Gel and Topical Gel Vehicle in the Treatment of Moderate to Severe Acne Vulgaris
The primary objective of this study is to compare the tolerability, safety and efficacy of NVN1000 Topical Gel and Topical Gel Vehicle in the treatment of subjects with moderate to severe acne vulgaris.
- Trial name
- NCT01556698
- Testing
- NVN1000, Vehicle
- Where
- Dominican Republic
- Volunteers
- 70 people
- Sponsor
- Novan, Inc.
Alzheimer's Disease
An Observational Study of LEQEMBI in Routine Clinical Practice in Taiwan
The primary purpose of this study is to describe the incidence and severity of known adverse events, including amyloid-related imaging abnormalities (ARIA)-oedema/effusion (ARIA-E), ARIA-microhemorrhage and haemosiderin deposit…
- Trial name
- NCT07869264
- Testing
- No Intervention
- Where
- 12 sites in Taiwan
- Volunteers
- 100 people
- Sponsor
- Eisai Taiwan Inc.
Rett Syndrome, RTT
Efficacy and Safety of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome
To evaluate the efficacy of cannabidiol oral solution (GWP42003-P, CBD-OS) in reducing symptom severity when compared with placebo, in participants with Rett syndrome.
- Trial name
- ARCH (NCT03848832)
- Testing
- GWP42003-P
- Where
- 26 sites in United States, Italy and 2 more
- Volunteers
- 29 people
- Sponsor
- Jazz Pharmaceuticals
Bone Cancer, Articular Disease
18F-sodium Fluoride (NaF) PET to Replace Bone Scintigraphy: Safety and Efficacy Assessment
18F-sodium fluoride (18F-NaF) was already investigated numerous times in the last 40 years as a PET alternative to standard 99m-technetium-derived bone scintigraphy.
- Conditions
- Bone Cancer, Articular Disease, Infectious Disease
- Trial name
- NCT04842071
- Testing
- 18F-sodium fluoride
- Where
- 2 sites in Canada
- Volunteers
- 2,500 people
- Sponsor
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Pregnancy
Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
The goal of this study is to pilot and evaluate a telemedicine medical abortion service delivery that allows remote communication between the woman and provider and limits medically unnecessary in-person visits to health or…
- Trial name
- NCT05028387
- Testing
- medical abortion
- Where
- 4 sites in Ukraine, Uzbekistan
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Gynuity Health Projects
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