Clinical trials: Biologic
Healthy, Biological Availability
A Study to Assess the Relative Bioavailability of TMC207 Following Single-Dose Administrations of Two Pediatric Formulations in Healthy Adult Participants
The purpose of this study is to test the relative bioavailability (extent and rate to which a drug is taken up by the body) of TMC207 following the administration of two pediatric formulations of TMC207 taken with and without…
- Trial name
- NCT01803373
- Testing
- Treatment A (reference), Treatment B, Treatment C
- Where
- Netherlands
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Janssen Infectious Diseases BVBA
Thrombocythemia Essential
Prospective Study of Different Biological Tests (Multiplate, ROTEM) in a Cohort of Patients Followed for Essential Thrombocytemia (ET)
There is no prospective study published on the Essential Thrombocythemia and the correlation between this specific disease, its complications and the biological variations observed.
- Trial name
- THETE (NCT03212053)
- Testing
- biological tests of haemostasis at each consultation (Multiplate, ROTEM, VASP)
- Where
- France
- Volunteers
- 51 people
- Sponsor
- Hospices Civils de Lyon
Chemical Injury, Chemicals; Intoxication
The Medical Management in Patients Exposed to Weapons of Mass Destruction
Observation study measuring medical response in contaminated environment.
- Conditions
- Chemical Injury, Chemicals; Intoxication, Acute Respiratory Distress Syndrome, Distress Respiratory Syndrome
- Trial name
- CBRNEObs (NCT05026645)
- Testing
- Clinical interventions performed in acute settings (contaminated environment), Protection (clinician and patient), Decontamination (clinician and patient)
- Where
- 15 sites in United States, Canada and 4 more
- Volunteers
- 1,000 people
- Sponsor
- St. Justine's Hospital
Immune System and Related Disorders
Creation of a Prospective Cohort of Healthy and Sick Subjects and of a Collection of Associated Biological Resources, for the Study of the Immune System and of Its Genetic and Environmental Determinants.
CoSImmGEn is a protocol set up to respond to the current lack of healthy and sick population cohorts. Biological resources from these cohorts allow researchers to study the immune system and its genetic and environmental…
- Trial name
- CoSImmGEn (NCT03925272)
- Testing
- Collection of samples (blood, stool, etc.), Genetic determinants analysis, Sample obtained after surgery performed in the context of care
- Where
- 4 sites in France
- Volunteers
- 2,200 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Inflammation, Psoriasis
First Human Dose Study of Anti-IL-20 in Psoriasis: A Study of Safety, Tolerability and Early Signals of Biologic and Clinical Effects
This trial is conducted in the United States of America (USA). The aim of this clinical trial is evaluate the safety and tolerability of anti-IL-20 in patients with psoriasis and to determine the preliminary efficacy in an…
- Trial name
- NCT01261767
- Testing
- anti-IL-20
- Where
- 16 sites in United States
- Volunteers
- 55 people
- Sponsor
- Novo Nordisk A/S
Bronchopulmonary Dysplasia
Ascorbyl Peroxide Association With Bronchopulmonary Dysplasia
Urinary ascorbyl peroxide level in the first week of life will be a good predictor of Bronchopulmonary dysplasia (BPD) in preterm infants less than 33 weeks of gestation.
- Trial name
- NCT01439295
- Where
- Canada
- Volunteers
- 51 people
- Sponsor
- St. Justine's Hospital
Sepsis Syndrome, Systemic Inflammatory Response Syndrome
The Role of Myristic Acid in Serum for Early Diagnosis of Sepsis and Comparison With Selected Biomarkers of Sepsis
The aim of the study is to measure serum levels of myristic acid in septic patients and to compare them with myristic acid serum levels in patients with Systemic Inflammatory Response Syndrome of non infective etiology and in…
- Trial name
- NCT03314831
- Where
- Czechia
- Volunteers
- 282 people, healthy volunteers welcome
- Sponsor
- Charles University, Czech Republic
Atherosclerosis
Comparative Study of the Effect of Ezetimibe Versus Extended-Release Niacin on Atherosclerosis
Recent evidence on the use of statin therapy indicates the potential for ultra-low levels of low-density lipoprotein (LDL-C) to provide greater protection from recurrent coronary heart disease (CHD) events.
- Trial name
- NCT00397657
- Testing
- extended release niacin, ezetimibe
- Where
- 2 sites in United States
- Volunteers
- 400 people
- Sponsor
- Walter Reed Army Medical Center
Human Papillomavirus (HPV) Infection
Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (GSK580299) in Healthy Female Subjects 10-25 Years of Age.
Cervical cancer is the second most common cancer among women worldwide. Approximately 500 000 new cases are reported each year worldwide, from which 83% occur in developing countries.
- Trial name
- NCT00481767
- Testing
- Cervarix
- Where
- 2 sites in Senegal, Tanzania
- Volunteers
- 676 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Hepatitis A
Evaluation of the Long-term Hepatitis A and B Antibody Persistence in Healthy Adult Subjects, Primed 16 to 20 Years Earlier With GSK Biologicals' Combined Hepatitis A and B Vaccine, Twinrix® (SB208127) in Study HAB-084 (208127/084)
The purpose of this study is to assess the long-term persistence of immunity to hepatitis A and B in adults who were vaccinated 16-20 years earlier with the combined hepatitis A and hepatitis B vaccine, Twinrix.
- Trial name
- NCT02135666
- Testing
- Blood sampling
- Where
- Czechia
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
Generation of Biological Samples Positive to Salmeterol for Anti-Doping Control
Background: In terms of doping, there is controversy regarding the beneficial effects of β2-agonists like salmeterol on physical performance.
- Trial name
- SALM (NCT04195867)
- Testing
- Salmeterol Xinafoate
- Where
- Spain
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Parc de Salut Mar
Amyotrophic Lateral Sclerosis, ALS
Expanded Access Protocol of BHV-0223 for Patients With Amyotrophic Lateral Sclerosis (ALS)
This is an open label expanded access protocol for the treatment of up to approximately 250 adult patients with amyotrophic lateral sclerosis (ALS) who have difficulty swallowing oral riluzole tablets and may be able to derive…
- Conditions
- Amyotrophic Lateral Sclerosis, ALS, Lou Gehrig Disease, Lou Gehrig's Disease
- Trial name
- NCT03537807
- Testing
- Riluzole
- Sponsor
- Biohaven Pharmaceuticals, Inc.
Psoriasis
Analysis of Influence Factors on Osteopenia in Different Treatment of Psoriasis
This clinical study aims to evaluate and compare changes in bone mineral density (BMD) and bone metabolism markers in patients with moderate-to-severe psoriasis treated with either Secukinumab or Adalimumab.
- Trial name
- NCT07140666
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Chongli Yu
Coronary Artery Disease
Clopidogrel and Response Variability Investigation Study 2
To evaluate the role of the genetic variant 2C19*2 on the pharmacodynamic response as assessed by optical aggregometry and on the pharmacokinetic response as assessed by measuring active metabolites following an oral…
- Trial name
- CLOVIS2 (NCT00822666)
- Testing
- clopidogrel
- Where
- France
- Volunteers
- 109 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Breast Cancer Female
Mind Programme for Women With Breast Cancer (Nationwide Coverage)
The purpose of this research project is to optimize the Mind programme for women with breast cancer, taking into consideration the results from its pilot study, and to testits efficacy and cost-effectiveness through a 3-arm…
- Trial name
- MIND(n) (NCT06212414)
- Testing
- Mind Programme, Support Group
- Where
- Portugal
- Volunteers
- 153 people
- Sponsor
- University of Coimbra
Obesity, Childhood, Asthma in Children
Asthma and Obesity Diet Versus Exercise
Obesity is recognized as a pro-inflammatory condition associated with multiple chronic diseases, including asthma. The specific mechanisms linking asthma and obesity remain hypothetical.
- Conditions
- Obesity, Childhood, Asthma in Children, Inflammatory Response, Metabolic Syndrome
- Trial name
- NCT03644355
- Testing
- Lifestyle counseling
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Louisiana State University Health Sciences Center in New Orleans
Immune Thrombocytopenia, Autoimmune Hemolytic Anemia
Biological Bank for the Patients Followed in a Constitutive Reference Center for Autoimmune Cytopenia
The Internal Medicine Department of Haut-Lévêque Hospital (Pr E LAZARO, Pr JL PELLEGRIN, Pr JF VIALLARD) was accredited in 2017 by the Ministry of Health as a Constitutive Reference Center for Autoimmune Cytopenia.
- Conditions
- Immune Thrombocytopenia, Autoimmune Hemolytic Anemia, Autoimmune Neutropenia
- Trial name
- BIOCAI (NCT04005638)
- Testing
- blood sample, urine sample
- Where
- France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Bordeaux
Hepatitis B
LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers
To evaluate the persistence of anti-HBs antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine.
- Trial name
- NCT00240526
- Testing
- Engerix™ -B, Hepatitis B immunoglobulin (HBIg)
- Where
- Thailand
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Low-back Pain
Effectiveness of Pain Neuroscience Education Compared to a Conventional Education for Patients With Chronic Low Back Pain
The hypothesis is that pain biology education, combined with a rehabilitation program, reduces disability to 3 months, compared to conventional spinal physiology education.
- Trial name
- EVAL-PNE (NCT04179708)
- Testing
- Pain Neuroscience Education, Conventional education
- Where
- France
- Volunteers
- 88 people
- Sponsor
- University Hospital, Lille
Acellular Pertussis, Diphtheria
Post-marketing Surveillance to Assess the Safety of Infanrix-IPV Vaccine Among Infants and Children in Korea
The purpose of this study is to collect safety information following routine vaccination with Infanrix-IPV among infants and children in Korea.
- Conditions
- Acellular Pertussis, Diphtheria, Tetanus, Poliomyelitis
- Trial name
- NCT01568060
- Testing
- Infanrix-IPV data collection
- Where
- South Korea
- Volunteers
- 645 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline