Clinical trials: High Risk Medications
Tuberculosis
Rifampicin at High Dose for Difficult-to-Treat Tuberculosis
The purpose of this study is to assess the safety of rifampicin given at a dose three times as the standard one, in persons with tuberculosis that belong to groups that have not been widely included in previous trials.
- Trial name
- RIAlta (NCT04768231)
- Testing
- Rifampin
- Where
- 5 sites in Netherlands, Paraguay and 2 more
- Volunteers
- 130 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Epilepsy
Precision Medicine in the Treatment of Epilepsy
Primary objectives: The purpose of this study is to identify single and composite biomarkers (from neuroimaging, electrophysiological, and non-imaging biological measures), clinical measures (from cognitive, psychometric, and…
- Trial name
- BDE (NCT05450822)
- Testing
- Levetiracetam, Levetiracetam Tablets, Lamotrigine tablet
- Where
- Denmark
- Volunteers
- 550 people, healthy volunteers welcome
- Sponsor
- Gitte Moos Knudsen
Senior High Cost Users (HCU)
Characterizing the Senior High Cost User (HCU) in Ontario
High cost users (HCUs) are a small group of patients who use a disproportionate amount of health care resources. This study is a retrospective population-based matched cohort analysis of newly incident senior High Cost Users…
- Trial name
- NCT02815930
- Testing
- HCU Status
- Volunteers
- 700,000 people
- Sponsor
- McMaster University
Birth Defects, Pregnancy Complications
UCB Antiepileptic Drugs (AED) Pregnancy Registry (Formerly the Keppra® Pregnancy Registry)
This is a prospective, observational, exposure-registration and follow-up study of women and their offspring exposed to Keppra® (levetiracetam) and Keppra XR® at the time of conception (i.e., any time from the first day of the…
- Conditions
- Birth Defects, Pregnancy Complications, Epilepsy, Seizures
- Trial name
- NCT00345475
- Where
- United States
- Volunteers
- 516 people
- Sponsor
- UCB Pharma
Bladder Cancer
Sequential Bacillus Calmette-Guérin (BCG) and Electromotive Mitomycin-C Versus Bacillus Calmette-Guérin (BCG) Alone for High Risk Superficial Bladder Cancer
Intravesical treatment for superficial bladder cancer has been used for the past 4-5 decades. Intravesical chemotherapy is beneficial in terms of recurrence and time to recurrence in grade 1-2 stage Ta tumours, usually…
- Trial name
- BCG/EMDA-MMC (NCT01442519)
- Testing
- bacillus Calmette-Guerin, electromotive mitomycin
- Where
- Italy
- Volunteers
- 212 people
- Sponsor
- University of Rome Tor Vergata
High Cardiovascular Risk, Hypertension
Zilebesiran as Add-on Therapy in Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications (KARDIA-3)
The purpose of this study is to evaluate the effect of zilebesiran as add-on therapy in patients with high cardiovascular risk and hypertension not adequately controlled by standard of care antihypertensive medications.
- Trial name
- KARDIA-3 (NCT06272487)
- Testing
- Zilebesiran
- Where
- 195 sites in United States, Australia and 4 more
- Volunteers
- 375 people
- Sponsor
- Alnylam Pharmaceuticals
Missing Teeth, Implants
Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication
Aim of the study is to examine the feasibility of dental implant insertion in patients receiving high, adjuvant and low dose > 4 years.
- Conditions
- Missing Teeth, Implants, Cancer, Osteoporosis
- Trial name
- NCT04741906
- Testing
- Dental implant surgery, Prosthetic treatment
- Where
- Denmark
- Volunteers
- 225 people
- Sponsor
- Copenhagen University Hospital at Herlev
Heart Failure, Atrial Fibrillation
Rhythm Control - Catheter Ablation With or Without Anti-arrhythmic Drug Control of Maintaining Sinus Rhythm Versus Rate Control With Medical Therapy and/or Atrio-ventricular Junction Ablation and Pacemaker Treatment for Atrial Fibrillation
Atrial fibrillation and heart failure are two common heart conditions that are associated with an increase in death and suffering. When both of these two conditions occur in a patient the patient's prognosis is poor.
- Trial name
- RAFT-AF (NCT01420393)
- Testing
- Rhythm control, Rate Control
- Where
- 21 sites in Brazil, Canada and 2 more
- Volunteers
- 411 people
- Sponsor
- Ottawa Heart Institute Research Corporation
Acute Coronary Syndrome
A Bioequivalence Study of SCH 530348 2.5 mg Tablets (P06558)
The purpose of this study is determine if SCH 530348 2.5 mg tablets containing a high percentage of drug as the free base are equivalent to tablets with the standard percentage when given to participants.
- Trial name
- NCT01358344
- Testing
- Pantoprazole, SCH 530348 (high percentage), SCH 530348 (standard percentage)
- Volunteers
- 173 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Tobacco Smoking, Alcohol-Related Disorders
Intervention to Increase Intention to Change Alcohol/Tobacco Use in Veterans With Chronic Disease
Many Veterans who have chronic conditions like cardiovascular disease or diabetes smoke or drink too much alcohol, which can worsen the condition.
- Trial name
- MINDSET (NCT07039175)
- Testing
- MINDSET, Usual Care
- Where
- United States
- Volunteers
- 270 people
- Sponsor
- VA Office of Research and Development
Osteosarcoma, Nephrotoxicity
Preventing Nephrotoxicity and Ototoxicity From Osteosarcoma Therapy
Osteosarcoma is the most common type of bone cancer in children, adolescents and young adults. Treatment with surgery and a combination of three conventional chemotherapy drugs can cure nearly two-thirds patients with…
- Conditions
- Osteosarcoma, Nephrotoxicity, Ototoxicity
- Trial name
- NCT01848457
- Testing
- Pantoprazole, High-dose methotrexate infusion duration
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Children's Hospital of Philadelphia
NREM Parasomnias, Sleepwalking
Acoustic Stimulation to Study and Modulate Sleepwalking and Related Arousal Disorders
Disorders of Arousal (DoA)-such as sleepwalking, sleep terrors, and confusional arousals-are common sleep problems that happen during deep, non-dreaming sleep.
- Conditions
- NREM Parasomnias, Sleepwalking, Sleep Terrors, Confusional Arousals
- Trial name
- DoA-CLAS (NCT07754838)
- Testing
- Closed-Loop/Open-Loop Acoustic Stimulation (CLAS)
- Where
- Switzerland
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Anna Castelnovo
Newly Diagnosed Glioblastoma
Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma
Proposed treatment of subjects with newly diagnosed glioblastoma with novel personalized drug regimens identified to be effective in vitro using cancer stem cells derived from their individual tumors, alongside standard of care…
- Trial name
- NCT05380349
- Testing
- combinations of up to 3 FDA approved drugs from a panel of compounds
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Swedish Medical Center
Plasma Cell Leukemia, Recurrent Multiple Myeloma
High Throughput Drug Sensitivity and Genomics Data in Developing Individualized Treatment in Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia
This pilot clinical trial studies whether using high throughput drug sensitivity and genomics data is feasible in developing individualized treatment in patients with multiple myeloma or plasma cell leukemia that has come back or…
- Conditions
- Plasma Cell Leukemia, Recurrent Multiple Myeloma, Refractory Multiple Myeloma
- Trial name
- NCT03389347
- Testing
- Biospecimen Collection, High Throughput Screening, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Washington
Coronary Artery Disease, Chronic Stable Angina
LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients
This study aims to demonstrate that the BioFreedom™ Ultra Drug Coated Stent (DCS) is non-inferior to the BioFreedom™ DCS, with respect to in-stent late lumen loss, and that it has safety characteristics similar to the BioFreedom™…
- Conditions
- Coronary Artery Disease, Chronic Stable Angina, Unstable Angina, Silent Ischemia
- Trial name
- NCT06657326
- Testing
- BioFreedom™ Ultra cobalt-chromium Biolimus A9™-coated stent, BioFreedom™ stainless steel Biolimus A9™-coated stent
- Where
- 6 sites in Malaysia
- Volunteers
- 444 people
- Sponsor
- Biosensors Europe SA
Tuberculosis, Pulmonary
Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3)
The purpose of this study is to investigate the effectiveness and safety of the regimen including high dose rifampicin for individualized duration (3 months after Culture Conversion) for the treatment of drug-sensitive pulmonary…
- Trial name
- Hi-DoRi-3 (NCT04485156)
- Testing
- High-dose rifampicin, Isoniazid, Pyrazinamide
- Where
- South Korea
- Volunteers
- 926 people
- Sponsor
- Seoul National University Hospital
Adverse Drug Events
Eliminating Risk of Preventable Adverse Drug Events at the Hospital-community Interface of Care
This initiative aims to decrease the risk of medication errors at the hospital-community interface as well as health system utilization following hospital discharge by implementing a pharmacist-led medication reconciliation in…
- Trial name
- CMR (NCT01164137)
- Testing
- Medication Reconciliation
- Where
- Canada
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- Westview Physician Collaborative
High Blood Pressure
Blood Pressure Treatment by the Corsano CardioWatch 287-2 Evaluation Study
Rationale: Wearables have the potential to monitor patients remotely. The Corsano CardioWatch 287-2 is such a medical device that can monitor long-term blood pressure.
- Trial name
- BPTreat (NCT06508619)
- Testing
- Corsano CardioWatch 287-2 non-invasive blood pressure (NIBP) monitoring
- Where
- Netherlands
- Volunteers
- 80 people
- Sponsor
- Corsano Health B.V.
Liver Tumour
Targeted Chemotherapy Using Focused Ultrasound for Liver Tumours
This proof of concept study proposes targeted delivery of a broad-spectrum cytotoxic agent (doxorubicin), via a specially formulated LTSL (ThermoDox®) activated by mild hyperthermia, by using focused ultrasound (FUS), to achieve…
- Trial name
- TARDOX (NCT02181075)
- Testing
- ThermoDox® (LTLD), Focused Ultrasound of Target Liver Tumour, Pre-LTLD Biopsy of Target Liver Tumour
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- University of Oxford
High Grade Serous Ovarian Cancer, Fallopian Tube Cancer
Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT)
UP-NEXT is a double-blind, randomized, placebo-controlled study of the antibody-drug conjugate (ADC) XMT-1536 (upifitamab rilsodotin) administered as an intravenous infusion once every four weeks in patients with recurrent…
- Conditions
- High Grade Serous Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- Trial name
- UP-NEXT (NCT05329545)
- Testing
- Upifitimab rilsodotin
- Where
- 30 sites in United States, Australia and 1 more
- Volunteers
- 20 people
- Sponsor
- Mersana Therapeutics