Clinical trials: Clinical Documentation
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, Relapsing-Remitting
A Trial for Evaluating Both Safety and Preliminary Efficacy of a Single Infusion of Stimulated Autologous CD4+T Cells in Patients With Relapsing- Remitting Multiple Sclerosis
The purpose of this study is to assess the safety and the preliminary efficacy of a single infusion of stimulated autologous CD4+ T cells in patients with Relapsing-Remitting Multiple Sclerosis.
- Trial name
- SCLEROLYM (NCT02427776)
- Testing
- Autologous CD4+T cells stimulated and expanded ex vivo by a MOG peptide modified by the introduction of a thioreductase motif into the flanking residues of the T cell epitope
- Where
- 3 sites in Belgium
- Volunteers
- 2 people
- Sponsor
- Imcyse SA
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
Stroke, Motor Activity
Observational Study of Ischaemic Stroke
The rationale for this study is to facilitate future Phase II/III clinical trials and improve outcome for patients suffering residual disability after an ischaemic stroke.
- Trial name
- OSIS (NCT01859572)
- Where
- United Kingdom
- Volunteers
- 110 people
- Sponsor
- ReNeuron Limited
Chronic Low-back Pain, Herniated Disc
LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant
The study is a post-market surveillance study of the Lumbar Implant for Stiffness Augmentation (LISA), a medical device, which is used to treat low-back pain that accompanies degenerative lesions of grades II, III, and IV…
- Conditions
- Chronic Low-back Pain, Herniated Disc, Degenerative Disc Disease, Lumbar Canal Stenosis
- Trial name
- LISA-PMCF (NCT04631133)
- Testing
- Lumbar Implant for Stiffness Augmentation (LISA)
- Where
- 5 sites in Denmark, France and 1 more
- Volunteers
- 136 people
- Sponsor
- BACKBONE
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
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
Post Stroke Arm Spasticity
Study to Document the Effectiveness of Dysport in Patients Suffering From Upper Limb Spasticity (ULS) After Stroke
The objective of this non-interventional study is to evaluate clinical effectiveness and cost effectiveness of Dysport within the reimbursement scheme called "drug programme" funded by Polish National Health Fund (NHF) for…
- Trial name
- PSAS REGISTRY (NCT02444494)
- Where
- 6 sites in Poland
- Volunteers
- 108 people
- Sponsor
- Ipsen
Psoriatic Arthritis
Safety and Effectiveness and Effect on Quality of Life and Work Productivity of Humira in Patients With Psoriatic Arthritis in Clinical Routine
Safety and effectiveness, quality of life and work productivity of Humira in patients with psoriatic arthritis in clinical routine.
- Trial name
- ELAN (NCT01078610)
- Testing
- adalimumab (Humira)
- Sponsor
- Abbott
Total Knee Arthroplasty, Knee Disease
Open Label Study to Collect Clinical Data to Document Clinical Performance and Safety in Total Knee Arthroplasty
The purpose of this study is to evaluate clinical performance and safety in total knee arthroplasty using HLS implants.
- Conditions
- Total Knee Arthroplasty, Knee Disease, Total Knee Replacement, Osteo Arthritis Knee
- Trial name
- NCT04727060
- Testing
- patient with knee arthroplasty
- Where
- France
- Volunteers
- 2,146 people
- Sponsor
- Corin
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
Ankylosing Spondylitis
Basic Documentation of Adalimumab (Humira) in Patients With Ankylosing Spondylitis (AS)
The research question explored in this study was whether the effectiveness and safety of adalimumab in participants with ankylosing spondylitis was maintained during long-term therapy in routine clinical practice in Germany.
- Trial name
- NCT01079182
- Volunteers
- 4,681 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
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
Prostate Cancer Metastatic
Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen
The purpose of this study is to allow patients similar to that evaluated in the TROPIC trial (NCT00417079), and Investigators access to cabazitaxel for the management of metastatic Hormone Refractory Prostate Cancer (mHRPC) in…
- Trial name
- NCT01254279
- Testing
- CABAZITAXEL
- Where
- 165 sites in Australia, Austria and 27 more
- Volunteers
- 984 people
- Sponsor
- Sanofi
Autoimmune Diseases
Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorber GLOBAFFIN® in Clinical Routine
Documentation of the safety and effectiveness profile of the CE-labelled immunoadsorber GLOBAFFIN® in clinical routine according to their intended use.
- Trial name
- SEPIAR (NCT04078698)
- Testing
- Immunoadsorber GLOBAFFIN®
- Where
- 3 sites in Germany
- Volunteers
- 34 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Multiple Sclerosis, Relapsing-Remitting
A Study Investigating the Utilization, Effectiveness and Quality of Life in Clinical Practice in Germany for Participants With Relapsing-remitting Multiple Sclerosis Treated With Ozanimod (Zeposia®)
The purpose of this study is to collect real-world data and to gain insights about long-term usage of ozanimod (Zeposia ®), its effect on well-defined outcome parameters comprising participant-relevant outcomes, as well as…
- Trial name
- OzEAN (NCT05335031)
- Testing
- Ozanimod
- Where
- Germany
- Volunteers
- 450 people
- Sponsor
- Bristol-Myers Squibb
Diabetes Mellitus
Insulin Glargine Benefits in Japanese Pts Outside of Japan (US or Brazil)
To estimate the efficacy of combination therapy with Lantus plus Amaryl in controlling blood glucose in Japanese patients with type 2 diabetes having failed OAD therapy, and document the ability to preserve the endocrine…
- Trial name
- NCT00642915
- Testing
- Lantus, Amaryl
- Where
- Brazil
- Volunteers
- 100 people
- Sponsor
- Sanofi
Localized, Primary Osteoarthritis, Post-traumatic Arthrosis of Other Joints, Shoulder Region
Clinical Outcomes in Shoulder Hemi-arthroplasty Using a PyC Spherical Interpositional Implant
The INSPYRE implant is a new range of shoulder hemi-arthroplasty device. It consists of a Pyrocarbon spherical interpositional implant and is indicated in primary surgery to relieve severe pain or significant disability caused by…
- Conditions
- Localized, Primary Osteoarthritis, Post-traumatic Arthrosis of Other Joints, Shoulder Region, Avascular Necrosis of the Head of Humerus
- Trial name
- NCT02424760
- Testing
- Shoulder hemi-arthroplasty
- Volunteers
- 67 people
- Sponsor
- Stryker Trauma and Extremities
Anemia
An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Anemic Patients With Chronic Kidney Disease (NORM)
This observational, prospective, multi-centre, single-arm study will evaluate the efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease previously on treatment with short-acting…
- Trial name
- NCT01417377
- Testing
- Mircera
- Where
- 6 sites in Pakistan
- Volunteers
- 22 people
- Sponsor
- Hoffmann-La Roche
Hyperlipidemia
Compliance With Treatment For Patients With Hyperlipidemia
It is a prospective observational study. Patients will be high risk patients (for developing cardiovascular events) that are treated with a statin.
- Trial name
- COLL (NCT00828945)
- Testing
- Lipid Self Test
- Where
- 17 sites in Sweden
- Volunteers
- 259 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.