Clinical trials: Reactions Adverse
Carcinoid Syndrome
Telotristat Etiprate for Carcinoid Syndrome Therapy
The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.
- Trial name
- TELECAST (NCT02063659)
- Testing
- Telotristat etiprate
- Where
- 50 sites in United States, Australia and 9 more
- Volunteers
- 76 people
- Sponsor
- Lexicon Pharmaceuticals
COVID, Drug Effect
Simulation of Risk of Adverse Drug Events Associated With the Initiation of Drugs Repurposed for the Treatment of COVID-19 in Adults With Polypharmacy Using Data From Large Medicare and Commercially Insured Populations
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 a health insurance…
- Conditions
- COVID, Drug Effect, Drug Interaction, Adverse Drug Event
- Trial name
- NCT04378881
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Tabula Rasa HealthCare
Cancer, Drug Induced Liver Injury
Remaxol® in Patients With Drug-induced Liver Injuries During Cancer Chemotherapy
Cancer has moved from the tenth place to the second one over the last 100 years, being inferior to only cardiovascular diseases in morbidity and mortality.
- Trial name
- NCT05789797
- Testing
- Remaxol
- Where
- 5 sites in Russia
- Volunteers
- 368 people
- Sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
Mucositis, Nephrotoxicity
Treatment of Radiation and Cisplatin Induced Toxicities with Tempol
A 10 week trial to assess the ability of Tempol to prevent and/or reduce toxicities associated with cisplatin and radiation treatment in head and neck cancer patients.
- Conditions
- Mucositis, Nephrotoxicity, Ototoxicity
- Trial name
- NCT03480971
- Testing
- Tempol
- Where
- 9 sites in United States
- Volunteers
- 120 people
- Sponsor
- Matrix Biomed, Inc.
Drug-Related Side Effects and Adverse Reactions, Iatrogenic Disorder
Association Between Genetic Variant Scores and DOACs (DARES2)
The study's objective is to evaluate the predictive accuracy of Cipherome's algorithm in predicting and preventing serious adverse drug reactions (ADRs) experienced by patients while on direct oral anti-coagulants (DOACs).
- Trial name
- NCT04597593
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Cipherome, Inc.
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.
Drug Toxicity
Phase I Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics of KD101 in Healthy Male Subjects
To Evaluate the safety and tolerability after KD101 single oral dosing in healthy male subjects To Evaluate the pharmacokinetic property after KD101 single oral dosing in healthy male subjects To Evaluate the effect of food on…
- Trial name
- NCT01979380
- Testing
- KD101
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Kwang Dong Pharmaceutical co., ltd.
Tumor Infiltrating Lymphocytes, Safety
A Study of GC101 TIL in Advanced Melanoma (BZ)
20 participants are expected to be enrolled for the Phase Ib clinical trial，this trail is expected to be finished in 20 months.
- Conditions
- Tumor Infiltrating Lymphocytes, Safety, Melanoma, Efficacy
- Trial name
- MIZAR-002 (NCT06120712)
- Testing
- GC101 TIL
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Shanghai Juncell Therapeutics
Atrial Fibrillation, Deep Vein Thrombosis
Association Between Genetic Variant Scores and Warfarin Effect
Study objective is to determine whether there is an association between genetic variant risk scores and clinical outcomes (percent time in therapeutic range, time to reach therapeutic international normalized ratio (INR), INR ≥…
- Conditions
- Atrial Fibrillation, Deep Vein Thrombosis, Intracardiac Thrombus, Pulmonary Embolism
- Trial name
- AWARE1 (NCT03894878)
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Cipherome, Inc.
Rabies Vaccine Adverse Reaction
A Clinical Trial of Freeze-dried Human Rabies Vaccine (MRC-5 Cells)
This trial is a randomized, blind, similar vaccine controlled, single center, non-inferiority design phase III clinical trial, with a study population of 10 to 60 years old, conducted in two stages.Phase 1 and Phase 2
- Trial name
- NCT06078423
- Testing
- Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 5-dose program, Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 4-dose program, Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 5-dose program
- Where
- China
- Volunteers
- 1,880 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Hepatitis C
Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio Therapy
An observational, postmarketing commitment following the marketing authorization for DCV Trio therapy in Japan
- Trial name
- NCT03071133
- Where
- Japan
- Volunteers
- 344 people
- Sponsor
- Bristol-Myers Squibb
Drug Related Side Effects and Adverse Reactions, Infusion Reactions
Retrospective Kinetic Safety Evaluation of an Intravenous Micellar Excipient Platform
Protocol PICO-RWE-001: The goal of this observational study is to evaluate the kinetic safety and tolerability of an investigational intravenous micellar delivery platform.
- Trial name
- NCT07609069
- Testing
- PIV-850 (850-picometer Dual-NCE Acidic Matrix), Legacy Heterogeneous Payload (Micellar Vehicle)
- Where
- United States
- Volunteers
- 625 people
- Sponsor
- PICO IV, Inc.
Carcinoid Syndrome
Real-world Evidence Study EvaLuating PAtient-Reported Outcomes With XERMELO
The primary objective of the study is to estimate the proportion of carcinoid syndrome (CS) patients who are satisfied with their overall symptom control, 6 months after initiating treatment with telotristat ethyl (XERMELO).
- Trial name
- RELAX (NCT03223428)
- Testing
- Xermelo
- Where
- United States
- Volunteers
- 223 people
- Sponsor
- TerSera Therapeutics LLC
Cardiotoxicity, Heart Failure
MyoStrain CMR for the Detection of Cardiotoxicity
The Prefect Pilot Study evaluates the use of the EC approved MyoStrain SENC CMR Imaging System to detect cardiotoxicity from drugs used to treat cancer (e.g. Breast Cancer and Lymphomas).
- Conditions
- Cardiotoxicity, Heart Failure, Chemotherapeutic Toxicity
- Trial name
- Prefect (NCT03543228)
- Testing
- MyoStrain
- Where
- Germany
- Volunteers
- 63 people
- Sponsor
- Myocardial Solutions
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
Drug-Induced Liver Injury, Cholestatic Liver Injury
A Randomized,Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Safety and Efficacy of MT2004 Capsule in DILI Subjects
The goal of this randomized, double-blind, placebo controlled, Multicenter Phase II clinical trial is to initially evaluate the Safety and Efficacy of MT2004 Capsule in Cholestatic and Mixed drug induced liver injury (DILI)…
- Conditions
- Drug-Induced Liver Injury, Cholestatic Liver Injury, Mixed Liver Injury
- Trial name
- NCT06019936
- Testing
- MT2004 Capsule
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Xi'An Aolitai Pharmaceutical Technology Co Ltd
Renal Cell Carcinoma, Kidney Cancer
A Study to Observe the Onset of Immune-related Adverse Reactions in Patients With Non-surgical or Renal Cell Carcinoma (RCC) That Has Spread
Patients with non-surgical or renal cell carcinoma that has spread who are starting treatment for the first time with Yervoy and Opdivo in the real world
- Trial name
- NCT03663946
- Testing
- Non-Interventional
- Where
- Japan
- Volunteers
- 81 people
- Sponsor
- Bristol-Myers Squibb
Drug/Agent Toxicity by Tissue/Organ, Pancreatic Cancer
Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells.
- Trial name
- NCT00024427
- Testing
- fluorouracil, gemcitabine hydrochloride, triacetyluridine
- Where
- 29 sites in United States, Canada
- Volunteers
- 250 people
- Sponsor
- Wellstat Therapeutics
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
Chronic Renal Failure
Pharmacodynamics and Non-Clinical Inferiority of Heparin Sodium (Cristália) Compared With the Product Liquemine (Roche) in Chronic Renal Failure
The primary objective of the study was to assess the safety in use of the drug Heparin Sodium, produced by Cristália Laboratory, compared drug Liquemine ®, manufactured by Roche Laboratory, and secondary purpose was to evaluate…
- Trial name
- heparin (NCT00828776)
- Testing
- Heparin sodic - Cristália, heparin - Liquemine (Roche)
- Where
- Brazil
- Volunteers
- 62 people
- Sponsor
- Azidus Brasil