Clinical trials: Drug Effect
Healthy Participants
A Study to Evaluate the Effect of the Potent Cytochrome P-450 3A4 (CYP3A4) Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-954 in Healthy Adult Participants
The purpose of this study is to evaluate the effect of the potent CYP3A4 inhibitor itraconazole on the single-dose PK of TAK-954.
- Trial name
- NCT03173170
- Testing
- TAK-954, Itraconazole
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Takeda
Peripheral Arterial Disease
Effectiveness of Intensive Lipid Modification Medication in Preventing the Progression of Peripheral Arterial Disease (The ELIMIT Study)
Peripheral arterial disease (PAD) occurs when arteries become narrowed or hardened because of a build-up of plaque or fat deposits.
- Trial name
- NCT00687076
- Testing
- Ezetimibe, Niaspan, Statin therapy
- Where
- United States
- Volunteers
- 102 people
- Sponsor
- Baylor College of Medicine
Stage IV Pancreatic Cancer
Assessing the Efficacy and Safety of IV Vitamin C in Combination With Standard Chemotherapy for Pancreatic Ca
The investigators recently completed a phase I study of intravenous ascorbic acid (IV AA) plus standard chemotherapy (gemcitabine and erlotinib) in patients with metastatic pancreatic cancer.
- Trial name
- NCT01555489
- Testing
- Ascorbic Acid
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Thomas Jefferson University
Asthma Chronic, Adherence, Medication
Pictograms to Facilitate Comprehension of Medical Indications
SIMAP is a triple-masked randomised trial aimed at assessing whether an automated system of pictograms associated to medical indications results in better comprehension and adherence of said indications.
- Conditions
- Asthma Chronic, Adherence, Medication, Primary Health Care
- Trial name
- SIMAP (NCT05609760)
- Testing
- SIMAP, Usual Care
- Where
- 4 sites in Chile
- Volunteers
- 22 people
- Sponsor
- Universidad de Concepcion
Sepsis
Effects of Code Sepsis Implementation on Emergency Department (ED) Sepsis Care
Sepsis is a life-threatening complication of infection that can be difficult to recognize and treat promptly. Timely administration of antibiotics for emergency department (ED) patients with sepsis is challenging.
- Trial name
- Code Sepsis (NCT04148989)
- Testing
- Code Sepsis protocol (full implementation)
- Where
- 3 sites in United States
- Volunteers
- 180,402 people
- Sponsor
- Intermountain Health Care, Inc.
Acute Liver Failure, Acute Liver Injury
Safety Study of Ornithine Phenylacetate to Treat Patients With Acute Liver Failure/Severe Acute Liver Injury
This Phase 2a clinical study is designed to provide data on OCR-002 in patients with acute liver failure/acute liver injury (ALF/ALI) in regard to: safety and tolerability; metabolism of the compound to glutamine and…
- Trial name
- STOP-ALF (NCT01548690)
- Testing
- Ornithine Phenylacetate
- Where
- 11 sites in United States
- Volunteers
- 47 people
- Sponsor
- William Lee
Schizophrenia
A Clinical Study to Investigate the Effect of an Investigational Drug as an Added Medication to an Antipsychotic, in Adults With Schizophrenia, as Measured Positron Emission Tomography (PET) Imaging
A clinical study to investigate the effect of an investigational drug as an added medication to an antipsychotic, in adults with schizophrenia, as measured positron emission tomography (PET) imaging .
- Trial name
- NCT04038957
- Testing
- SEP-363856
- Where
- United Kingdom
- Volunteers
- 22 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Pharmacogenetic Testing
Medication Optimization Using Pharmacogenetic Testing and the G-DIG to Reduce Polypharmacy in a Mental Health Population
Use of polypharmacy has significantly increased over the past two decades, which has unproven clinical benefit and is associate with an increased the risk of adverse side effects.
- Trial name
- MedOPT (NCT03468309)
- Testing
- Genecept Assay and G-DIG decision tool
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Seattle Institute for Biomedical and Clinical Research
Spinal Muscular Atrophy
A Drug-drug Interaction Study With Risdiplam Multiple Dose and Midazolam in Healthy Participants
This will be a Phase I, 2-part, open-label, non-randomized study to investigate the safety, tolerability, and pharmacokinetics (PK) of a multiple-dosing regimen of risdiplam (Part 1) and the effect of risdiplam on the PK of…
- Trial name
- NCT03988907
- Testing
- Risdiplam, Midazolam
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Brain Tumor, Central Nervous System Tumor
Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy
RATIONALE: Sodium thiosulfate may reduce or prevent hearing loss in young patients receiving cisplatin for cancer. It is not yet known whether sodium thiosulfate is more effective than no additional treatment in preventing…
- Conditions
- Brain Tumor, Central Nervous System Tumor, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor
- Trial name
- NCT00716976
- Testing
- sodium thiosulfate, examination
- Where
- 76 sites in United States, Australia and 1 more
- Volunteers
- 131 people
- Sponsor
- Children's Oncology Group
Rotator Cuff Tear Arthropathy
Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder Functional Outcomes
This will be a randomized controlled trial to determine if postoperative ibuprofen after arthroscopic rotator cuff repair impacts postoperative opiate medication use, Visual Analog Scale (VAS) pain scores, shoulder range of…
- Trial name
- NCT02588027
- Testing
- Ibuprofen
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- University of California, San Francisco
Pain
The Effect of Pretreatment With Intravenous Lidocaine for Intravenous Contrast:
Intravenous contrast media is commonly used for CT scans for improved image clarity in pediatric emergency medicine. Children who feel discomfort during the administration of IV contrast media may not remain still during the CT…
- Trial name
- NCT05143489
- Testing
- Preservative Free Lidocaine, Saline
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Antonios Likourezos
Obstructive Sleep Apnea
The Effect of Eszopiclone on the Arousal Threshold in Sleep Apnea Syndrome
The purpose of this study is to find out whether taking eszopiclone (Lunesta) changes the breathing effort required to briefly wake people with obstructive sleep apnea from sleep (respiratory arousal threshold).
- Trial name
- NCT01102270
- Testing
- Eszopiclone
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Brigham and Women's Hospital
Neonatal Abstinence Syndrome
Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain
The long term goals of our research are to establish the best pharmacological treatment for NAS and determine how pharmacologic treatment of NAS affects long-term developmental outcomes.
- Trial name
- No-POPPY (NCT03396588)
- Testing
- Clonidine, Morphine
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Henrietta Bada
Candidemia, Mycoses
Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis
The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by optional oral fluconazole).
- Conditions
- Candidemia, Mycoses, Fungal Infection, Invasive Candidiases
- Trial name
- ReSTORE (NCT03667690)
- Testing
- Rezafungin for Injection, Caspofungin, Fluconazole
- Where
- 132 sites in United States, Argentina and 16 more
- Volunteers
- 199 people
- Sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Bleeding
A Study in Participants With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants (Extension Study)
The purpose of this study was to evaluate the hemostatic efficacy of andexanet alfa (andexanet) in participants receiving a factor Xa (FXa) inhibitor (apixaban, rivaroxaban, edoxaban, enoxaparin) who were experiencing an acute…
- Trial name
- NCT02329327
- Testing
- Andexanet
- Where
- 87 sites in United States, Belgium and 7 more
- Volunteers
- 479 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Proctitis, Proctosigmoiditis
Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who…
- Trial name
- NCT01008423
- Testing
- Budesonide
- Where
- 62 sites in United States
- Volunteers
- 281 people
- Sponsor
- Bausch Health Americas, Inc.
Obstetric Pain, Postpartum Depression
Ketamine to Improve Recovery After Cesarean Delivery - Part 1
The objective of this study is evaluate the breastmilk transfer and pharmacokinetics (Part 1) and effectiveness (Part 2) of a post-cesarean delivery intravenous ketamine bolus-and-infusion strategy, as a preventive analgesic…
- Conditions
- Obstetric Pain, Postpartum Depression, Breastfeeding, Pain, Acute
- Trial name
- KINETIC (NCT04037085)
- Testing
- Ketamine
- Where
- 2 sites in United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Grace Lim, MD, MS
Healthy Male Adults
Bioequivalence Between Single Administration of ASC-01 (Aripiprazole/Sertraline Combination Drug) and Concomitant Single Administration of Aripiprazole and Sertraline, and Food Effect on Pharmacokinetics of ASC-01 in Healthy Male Adults
To investigate the bioequivalence of aripiprazole between administration of one ASC-01 tablet (aripiprazole 3 mg/sertraline 100 mg combination drug) and concomitant administration of one aripiprazole 3-mg tablet and two…
- Trial name
- NCT03342963
- Testing
- ASC-01, Aripiprazole and sertraline
- Where
- Japan
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Endometrial Carcinoma
Preoperative Olaparib Endometrial Carcinoma Study (POLEN)
The primary objective of this study is to identify, in human tumour samples, biomarker changes associated to short exposure to AZD2281 as potential predictors of activity in Endometrial Carcinoma (EC).
- Trial name
- Polen (NCT02506816)
- Testing
- Olaparib
- Where
- 10 sites in Spain
- Volunteers
- 36 people
- Sponsor
- MedSIR