Clinical trials: Adverse Reaction
Drug-Induced Liver Injury
Risk of Acute Liver Injury in Users of Antimicrobials
Moxifloxacin is a broad-spectrum antibacterial agent used to treat common community-acquired respiratory tract infections, complicated intra-abdominal infections, and pelvic inflammatory disease.
- Trial name
- NCT01434173
- Testing
- Moxifloxacin (Avelox, BAY12-8039), Amoxicillin, Amoxicillin plus clavulanic acid, Cefuroxime, Clarithromycin, Doxycycline, Levofloxacin, Telithromycin
- Where
- United States
- Volunteers
- 1,299,056 people
- Sponsor
- Bayer
Post Operative Hemorrhage, Transfusion Related Complication
Monitoring Noninvasively for Infusion and Transfusion Optimization
This is a multicenter, cluster randomized controlled trial to assess the effects of an optimized intraoperative fluid and blood management strategy on postoperative complications.
- Conditions
- Post Operative Hemorrhage, Transfusion Related Complication, Blood Transfusion Associated Adverse Reactions, Hypovolemia
- Trial name
- NCT04388722
- Testing
- Pulse CO-Oximeter Sensor
- Sponsor
- Masimo Corporation
Chemotherapy-Related Cognitive Impairment, Healthy
Telerehabilitation Cognitive Impairments Following Chemotherapy Usability Study
Develop a game-based upper-extremity motor and cognitive rehabilitation system using custom and adaptable virtual reality simulations.
- Trial name
- TCIFCU (NCT04839588)
- Testing
- Usability study
- Where
- 2 sites in United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Bright Cloud International Corp
Cardiotoxicity, Heart Failure
Novel On-body Evaluation of Cardiac Health for Oncology
The goal of this study is to develop a wearable sensor system that can estimate left ventricular ejection fraction (LVEF), which is a measurement of the heart's function.
- Trial name
- NOECHO (NCT07158450)
- Where
- 11 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Skribe Medical
Aspirin Exacerbated Respiratory Disease (AERD)
Trial to Determine the Safety of Oral Ifetroban in Patients With a History of Aspirin Exacerbated Respiratory Disease
The primary objective of the study is to determine the safety of oral ifetroban compared to placebo as measured by a > 20% decrease in FEV1 compared to baseline following a dose of Investigational Medicinal Product (IMP) (Study…
- Trial name
- NCT02216357
- Testing
- Ifetroban, Oral Capsule
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Cumberland Pharmaceuticals
Drug-induced Liver Injury
Rechallenge, Potential Drug Induced Liver Injury (Kaiser)
Drug re-administration or rechallenge should be avoided after drug-induced liver injury (DILI) to avoid recurrent and fatal injury. Rechallenge outcomes vary considerably by drug and patient subjects.
- Trial name
- NCT01584765
- Testing
- Prescription drugs with known hepatotoxicity
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Diagnostic Agent Adverse Reaction, Radiation Exposure
18F-LY3950321-01 Biodistribution and Safety Study
18F-LY3950321 (also known as 18F-MNI-1256) is a radiolabeled positron emission tomography (PET) tracer targeting granzyme B. The overall goal of this protocol is to evaluate the safety, tolerability, and radiation dosimetry of…
- Trial name
- NCT05775601
- Testing
- 18F-LY3950321, PET Scan
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Avid Radiopharmaceuticals
Drug Hypersensitivity
Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)
The objective of this study was to rule out a greater than 10% incidence of hypersensitivity to Vitrase following a single intradermal injection of 3 USP units Vitrase.
- Trial name
- NCT00198419
- Testing
- Vitrase
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Bausch & Lomb Incorporated
Anesthesia; Adverse Effect, Cardiac Arrhythmia
Effects of HSK3486 on Cardiac Repolarization in Health Subjects (TQT)
To assess the effects of a single IV bolus of HSK3486 single dose on cardiac repolarization (QTc interval of the electrocardiogram, and to evaluate the safety and tolerability of a single IV bolus of HSK3486 in healthy subjects
- Trial name
- NCT06795204
- Testing
- HSK3486, Moxifloxacin Hydrochloride
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Haisco-USA Pharmaceuticals, Inc.
Ototoxicity
SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity
The primary objective of this study is to determine the safety and efficacy of SPI-1005 treatment in CF patients with active pulmonary exacerbation that are receiving an IV course of tobramycin, determined by comparing hearing…
- Trial name
- NCT02819856
- Testing
- SPI-1005 Ebselen 200mg Capsule x1, SPI-1005 Ebselen 200mg Capsule x2, SPI-1005 Ebselen 200mg Capsule x3
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Sound Pharmaceuticals, Incorporated
Adverse Reaction to Contact Lens Solution
The Clinical and Subjective Performance of Three Different MPDS With Silicon Hydrogel Lenses
The purpose of the clinical investigation is to assess the clinical and subjective performance of three novel multipurpose disinfecting solutions (MPDS) in daily wear with two silicone hydrogel contact lenses (Lotrafilcon B and…
- Trial name
- NCT01665612
- Testing
- Contact lens care solution
- Where
- Finland
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Finnsusp Ltd.
Carcinoid Syndrome
Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy
The purpose of this study is to evaluate the safety and tolerability of telotristat etiprate (LX1606) versus a placebo control in participants with symptomatic carcinoid syndrome not managed by stable-dose long-acting octreotide…
- Trial name
- NCT00853047
- Testing
- Telotristat etiprate, Octreotide LAR Depot
- Where
- 9 sites in United States
- Volunteers
- 23 people
- Sponsor
- Lexicon Pharmaceuticals
HIV Infections
A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV
This study will evaluate the tolerability and acceptability of injection site reactions (ISRs) of two long-acting (LA) injectables.
- Trial name
- NCT06970223
- Testing
- Cabotegravir long-acting, Lenacapavir long-acting
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Carcinoid Tumors
Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors
Study evaluating SOM230 in patients with metastatic carcinoid tumors
- Trial name
- NCT00088595
- Testing
- Pasireotide (SOM230)
- Where
- 4 sites in United States
- Volunteers
- 45 people
- Sponsor
- Novartis Pharmaceuticals
Parkinson Disease, Dyskinesia, Medication-Induced
Efficacy, Safety and Pharmacokinetic Study of CPL500036 in Patients with Levodopa Induced Dyskinesia
The aim of the study is to determine potential anti-dyskinetic properties of CPL500036 (PDE10A inhibitor) in Parkinson disease patients suffering from levodopa Induced dyskinesia.
- Trial name
- NCT05297201
- Testing
- CPL500036 - low dose, CPL500036 - high dose
- Where
- 16 sites in Poland, Ukraine
- Volunteers
- 105 people
- Sponsor
- Celon Pharma SA
Lymphoma, T-cell, Peripheral, Lymphoma, T-cell, Cutaneous
A Study of Remitoro in Participants With Recurrent or Refractory Peripheral T Cell Lymphoma and Cutaneous T Cell Lymphoma (All Case Study)
The primary purpose of the study is to investigate the incidence of adverse drug reactions (ADRs) (ADR of special interest: capillary leak syndrome, infusion reaction, rhabdomyolysis, myelosuppression, infection, hepatic…
- Trial name
- NCT05137847
- Testing
- Remitoro
- Where
- 3 sites in Japan
- Volunteers
- 118 people
- Sponsor
- Eisai Inc.
Type 2 Diabetes Mellitus
Examination of Dermatologic Effects From Subcutaneous Injections of ISIS 113715
10 healthy volunteers will be enrolled to each receive two subcutaneous injections of ISIS 113715 in the abdomen on Study Day 1. Each subject will receive their two injections within a 5-minute period.
- Trial name
- NCT00365781
- Testing
- ISIS 113715
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Ionis Pharmaceuticals, Inc.
Lung Cancer, Head and Neck Cancer
SPI-1005 for Prevention and Treatment of Chemotherapy Induced Hearing Loss
Chemotherapy treatment with platinum based agents is well noted to cause ototoxicity. It is the objective of this study to determine the safety and efficacy of SPI-1005 at three dose levels when delivered orally twice daily for 3…
- Conditions
- Lung Cancer, Head and Neck Cancer, Hearing Loss, Ototoxicity
- Trial name
- NCT01451853
- Testing
- SPI-1005 Low Dose, SPI-1005 Middle Dose, SPI-1005 High Dose
- Where
- United States
- Sponsor
- Sound Pharmaceuticals, Incorporated
Injection Site Irritation, Injection Site Bruising
Comparison of Subcutaneous Injection of Normal Saline and Bacteriostatic Saline
This is a randomized, double-blind, single-center clinical trial comparing normal saline and bacteriostatic saline subcutaneous injection within a single subject.
- Conditions
- Injection Site Irritation, Injection Site Bruising, Injection Site Discomfort, Benzoic Acid Adverse Reaction
- Trial name
- NCT05109000
- Testing
- Sodium Chloride 0.9% Inj, Bacteriostatic Sodium Chloride 0.9 % INJECTION VIAL (ML)
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jeffrey Alan Klein, MD
COVID, Drug Effect
Simulation of Risk of Adverse Drug Events Associated With the Initiation of Drugs Repurposed for the Treatment of COVID-19 in Frail Elderly Adults With Polypharmacy
This retrospective study aims to perform a medication risk stratification using drug claims data and to simulate the impact of the addition of various repurposed drugs on the Medication Risk Score (MRS) in elderly people enrolled…
- Conditions
- COVID, Drug Effect, Drug Interaction, Adverse Drug Event
- Trial name
- NCT04339634
- Testing
- Simulation of Repurposed Drugs for COVID-19
- Where
- United States
- Volunteers
- 12,873 people
- Sponsor
- Tabula Rasa HealthCare