Clinical trials: Documentation
Cushing Syndrome
Observational Registry on Patients With Endogenous CS to Document Safety and Effectiveness of Ketoconazole.
This is a non-interventional, prospective, multinational, multicentre, observational study, in which data collected are those derived from routine clinical practice via an European registry on CS: ERCUSYN.
- Trial name
- KetoPASS (NCT04872920)
- Where
- 6 sites in Croatia, France and 2 more
- Volunteers
- 200 people
- Sponsor
- HRA Pharma
Pulmonary Disease, Chronic Obstructive
Symbicort in Chronic Obstruktive Pulmonary Disease
Under daily routine conditions and without any intervention by the sponsor regarding the selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non- medicinal therapy, dose, duration, etc.), routine…
- Trial name
- SYMBIOSE (NCT00612976)
- Volunteers
- 18,014 people
- Sponsor
- AstraZeneca
Inherited Epidermolysis Bullosa
Oleogel-S10 in Wound Healing of Inherited Epidermolysis Bullosa (BEB-10)
The purpose of this study was to compare intra-individually the reepithelialization of skin lesion(s) in inherited Epidermolysis bullosa (either 1 wound ≥10 cm2 and ≤200 cm2 in size divided in 2 equal halves or 2 comparable…
- Trial name
- NCT01294241
- Testing
- Oleogel-S10, Mepilex® soft silicone faced polyurethane foam dressing
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- Birken AG
Fibrodysplasia Ossificans Progressiva
A Study to Document and to Further Describe Long-term Safety and Effectiveness of Palovarotene in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
The participants in this registry study will have fibrodysplasia ossificans progressiva (FOP). FOP is an ultra-rare, severely disabling disease characterized by new bone formation in areas of the body where bone is not normally…
- Trial name
- FOPal (NCT06089616)
- Where
- 5 sites in United States, Canada
- Volunteers
- 100 people
- Sponsor
- Ipsen
Functional Constipation
Prucalopride in Pediatric Subjects With Functional Constipation
To evaluate the efficacy of prucalopride compared to placebo for the treatment of functional constipation in a paediatric population, aged ≥ 6 months to < 18 years.
- Trial name
- FC (NCT01330381)
- Testing
- prucalopride, PEG 4000
- Where
- Netherlands
- Volunteers
- 215 people
- Sponsor
- Shire
Stroke
An Ischaemic Stroke Observational Study
A non-interventional observational clinical study to document the clinical course of patients at 12 months or more following an ischaemic stroke
- Trial name
- NCT03333980
- Where
- 7 sites in United Kingdom
- Volunteers
- 39 people
- Sponsor
- ReNeuron Limited
Clinical Documentation, Artificial Intelligence
Ambient Audio-Visual Capture for Clinical Documentation and Assessment
AI-powered tools that automatically document clinical conversations are being adopted rapidly in outpatient settings but have not been evaluated in hospital wards.
- Conditions
- Clinical Documentation, Artificial Intelligence, Surgical Education, Medical Education
- Trial name
- BLACKFRAME-AV- (NCT07649772)
- Testing
- BlackFrame ambient audio-visual capture platform
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- BlackFrame.ai
Hemophilia B
IMMUNINE Pre-Treatment Study
The primary objective of this study is to prospectively document the exposure to IMMUNINE and to monitor FIX inhibitors over a period of approximately 20 to 50 exposure days while receiving prophylactic treatment in up to 50…
- Trial name
- NCT01128881
- Testing
- Factor IX Concentrate (purified, virus-inactivated)
- Where
- 18 sites in Argentina, Brazil and 8 more
- Volunteers
- 57 people
- Sponsor
- Baxalta now part of Shire
Progressive Familial Intrahepatic Cholestasis
A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in South Korea
This study will collect information from people with Progressive Familial Intrahepatic Cholestasis (PFIC) as they use odevixibat in their daily lives.
- Trial name
- NCT07185919
- Where
- 5 sites in South Korea
- Volunteers
- 10 people
- Sponsor
- Ipsen
Progressive Familial Intrahepatic Cholestasis
A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in China
This registry-based study will collect information from people with Progressive Familial Intrahepatic Cholestasis (PFIC) who take odevixibat (Bylvay) as part of routine clinical care in China.
- Trial name
- NCT07588880
- Where
- 6 sites in China
- Volunteers
- 20 people
- Sponsor
- Ipsen
Hemophilia A
Non-interventional Post-authorisation Study to Document the Immunogenicity, Safety, and Efficacy of NUWIQ
Prospective, multinational, non-interventional post-authorisation study to collect additional clinical data and to ensure consistency in the long-term between the outcome from pre-authorisation clinical studies (in 135 previously…
- Trial name
- NCT02962765
- Where
- 39 sites in United States, Argentina and 11 more
- Volunteers
- 80 people
- Sponsor
- Octapharma
Hemophilia A
A Prospective Study to Collect High-Quality Documentation of Bleeds, Health-Related Quality of Life (HRQoL), and Safety Outcomes in Patients With Hemophilia A Treated With Standard-of-Care Treatment
This non-interventional study will prospectively collect detailed, high-quality documentation of bleeds, HRQoL, and safety in patients with hemophilia A with or without FVIII inhibitors treated according to local routine clinical…
- Trial name
- NCT02476942
- Testing
- Bypassing Agents, FVIII Replacement
- Where
- 35 sites in United States, Australia and 10 more
- Volunteers
- 221 people
- Sponsor
- Hoffmann-La Roche
Constipation
A Study of Prucalopride For Functional Constipation in Children and Teenagers
Functional constipation is a condition when it is very hard to pass a stool that is not due to any other health problem or to medicines being taken. This condition is more common in children and teenagers.
- Trial name
- NCT04759833
- Testing
- Prucalopride
- Where
- 41 sites in United States
- Volunteers
- 175 people
- Sponsor
- Takeda
Asthma, Bronchiolitis
Documentation of Continuous Wheeze and Cough Dynamics in Pediatric ER SOB Patients
Phenotype characterization of shortness of breath of pediatric emergency room patients by objective wheeze and cough monitoring improves diagnostic and severity assessment accuracy and correlates with overall patient outcomes.
- Trial name
- NCT01414322
- Where
- Israel
- Volunteers
- 45 people
- Sponsor
- KarmelSonix Ltd.
Primary Immunodeficiencies (PID)
Retrospective, Observational Chart Review Study Conducted in Poland to Document the Management and Clinical Outcome of CUVITRU and HYQVIA in Pediatric Participants (< 18 Years) With Primary Immunodeficiency (PID)
The purpose of this observational, multi-center, retrospective cohort study is to assess treatment patterns of Cuvitru (SCIG) 20 percent (%) and HyQvia (fSCIG) in polish pediatric participants with PID.
- Trial name
- IG-TATRY (NCT04636502)
- Where
- 5 sites in Poland
- Volunteers
- 96 people
- Sponsor
- Shire
Multiple Sclerosis
An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical Practice
The primary objective of the study is to collect additional safety data including the incidence rate of seizure and other specific Adverse Events (AEs) of interest from participants taking Fampyra in routine clinical practice.
- Trial name
- LIBERATE (NCT01480063)
- Testing
- Fampridine
- Where
- 164 sites in Argentina, Canada and 11 more
- Volunteers
- 4,734 people
- Sponsor
- Biogen
SIADH, Non-SIADH Hyponatremia
Post-Authorisation Safety Study of Samsca (Tolvaptan) Used in Routine Medical Practice
A Drug Utilisation Survey is performed to monitor and document the drug utilisation patterns of Samsca in routine medical practice.
- Conditions
- SIADH, Non-SIADH Hyponatremia, Non-Hyponatremia
- Trial name
- NCT01228682
- Testing
- Tolvaptan
- Where
- 47 sites in Denmark, Germany and 5 more
- Volunteers
- 200 people
- Sponsor
- Otsuka Frankfurt Research Institute GmbH
Rheumatoid Arthritis
Efficacy and Safety Study of RoActemra (Tocilizumab) in Participants With Rheumatoid Arthritis
This is an open-label, non-interventional study to evaluate efficacy and safety in rheumatoid arthritis participants receiving tocilizumab as per the product label.
- Trial name
- NCT02721004
- Testing
- Tocilizumab
- Where
- Austria
- Volunteers
- 592 people
- Sponsor
- Hoffmann-La Roche
Pediatric Solid Tumors
A Study to Document Long-Term Safety and Continued Benefit of Irinotecan and Carboplatin or Irinotecan in Subjects With Refractory Solid Tumors (Rollover Study -001, -002)
The purpose of this study is to determine the long term safety of patients with refractory solid tumors who have experienced clinical benefit after at least 6 cycles of treatment in BMS Protocol CA124-001 or CA124-002.
- Trial name
- NCT00990912
- Testing
- Carboplatin, Irinotecan
- Volunteers
- 20 people
- Sponsor
- Bristol-Myers Squibb
Chronic Pain
A 15-day Study to Assess the Safety and Clinical Utility of Duragesic (Fentanyl Transdermal Patch) in the Treatment of Children With Continuous Pain Requiring Narcotic Pain Relief Therapy
The objective of this study is to assess the safety and clinical utility of Duragesic® 12.5 micrograms/hour (a transdermal patch delivering the narcotic pain-reliever fentanyl) in the treatment of children ages 2 to 12 with…
- Trial name
- NCT00271414
- Testing
- Duragesic® (fentanyl) Transdermal Therapeutic System (TTS)
- Volunteers
- 53 people
- Sponsor
- Janssen Pharmaceutica N.V., Belgium