Clinical trials: Reactions Adverse
Cardiovascular Diseases, Statin Adverse Reaction
Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo
The purpose of this study is to determine if treatment with bempedoic acid (ETC-1002) versus placebo decreases the risk of cardiovascular events in participants who have or are at high risk for cardiovascular disease and are…
- Trial name
- CLEAR Outcomes (NCT02993406)
- Testing
- Bempedoic acid 180 mg tablet
- Where
- 1,319 sites in United States, Argentina and 30 more
- Volunteers
- 13,970 people
- Sponsor
- Esperion Therapeutics, Inc.
Adverse Effect of MRI on an Implanted Pacemaker Lead, Adverse Effect of MRI on an Implanted Pacemaker
Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead
The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI™ System in a patient population indicated for implant of a pacemaker within and outside of the MRI…
- Trial name
- NCT01576016
- Testing
- Accent MRI system (lead safety), Accent MRI system (with MRI scan)
- Where
- 70 sites in United States, Australia and 3 more
- Volunteers
- 950 people
- Sponsor
- Abbott Medical Devices
Adverse Drug Events, Adverse Drug Reactions
Pharmacogenetic Testing Among Home Health Patients
Patients meeting eligibility criteria will be randomized into two groups, one receiving pharmacogenetic testing and the other not receiving pharmacogenetic testing.
- Conditions
- Adverse Drug Events, Adverse Drug Reactions, Drug Interaction Potentiation, Drug Metabolism, Poor, CYP2D6-RELATED
- Trial name
- NCT02378220
- Testing
- Pharmacogenetic testing
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Genelex Corporation
Smallpox Vaccine Adverse Reaction
VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV
The purpose of this study is to vaccinate plasma donors with ACAM2000 smallpox vaccine for collection of plasma to be used in the manufacturing of Vaccinia Immune Globulin Intravenous (VIGIV).
- Trial name
- NCT01158157
- Testing
- ACAM2000
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Neoplasms, Medication Toxicity
Study of Orally-Administered AMXT 1501 Dicaprate in Normal Healthy Volunteers
This is a Phase 1 study, which will assess the safety, PK, and pharmacodynamics (PD) of orally-administered AMXT 1501 dicaprate in normal healthy male volunteers.
- Conditions
- Neoplasms, Medication Toxicity, Tolerance
- Trial name
- NCT03077477
- Testing
- AMXT 1501
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Aminex Therapeutics, Inc.
Carcinoid Syndrome, Carcinoid
Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
A Phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of paltusotine treatment vs placebo as well as the long-term safety of paltusotine in adults with carcinoid syndrome due to…
- Conditions
- Carcinoid Syndrome, Carcinoid, Carcinoid Tumor, Carcinoid Tumor of Ileum
- Trial name
- CAREFNDR (NCT07087054)
- Testing
- Paltusotine
- Where
- 72 sites in United States, Argentina and 12 more
- Volunteers
- 141 people
- Sponsor
- Crinetics Pharmaceuticals Inc.
Akathisia, Drug-Induced, Antipsychotic Agents
Study of Preladenant for the Treatment of Neuroleptic Induced Akathisia (Study P05145)
This study is designed to evaluate the effectiveness of preladenant in the prevention (Part 1) or treatment (Part 2) of antipsychotic induced akathisia in participants with acute psychosis using the Barnes Akathisia Scale.
- Conditions
- Akathisia, Drug-Induced, Antipsychotic Agents, Movement Disorders
- Trial name
- NCT00693472
- Testing
- Preladenant, Anticholinergic agents or propanolol, Haloperidol
- Volunteers
- 46 people
- Sponsor
- Merck Sharp & Dohme LLC
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
Vaccine Reaction, Vaccine Adverse Reaction
Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)
This is a phase 3, experimental, randomized, observer-blind, lot to lot consistency study. The primary objective of this study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses…
- Trial name
- NCT05482295
- Testing
- In-House Recombinant Hepatitis B (Bio Farma) vaccine, Registered Hepatitis B vaccine recombinant (Engerix-B)
- Volunteers
- 540 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Drug/Agent Toxicity by Tissue/Organ, Lymphoma
Dexamethasone Followed by Denileukin Diftitox in Treating Patients With Persistent or Recurrent T-Cell Lymphoma
RATIONALE: Denileukin diftitox may be able to deliver cancer-killing substances directly to T-cell lymphoma cells. Dexamethasone may decrease the side effects of denileukin diftitox.
- Trial name
- NCT00006345
- Testing
- denileukin diftitox, dexamethasone
- Where
- 11 sites in United States
- Sponsor
- Ligand Pharmaceuticals
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
Advanced Malignancy, Advanced Solid Cancers
ADCX-020 for the Treatment of Patients With Locally Advanced or Metastatic Cancers
The purpose of this first-in-human study is to explore the safety, pharmacokinetics and effects of the study drug ADCX-020 in patients with advanced and metastatic solid tumors.
- Conditions
- Advanced Malignancy, Advanced Solid Cancers, Metastatic Solid Tumors
- Trial name
- NCT07238075
- Testing
- ADCX-020
- Where
- 9 sites in Australia, Spain
- Volunteers
- 290 people
- Sponsor
- Adcytherix SAS
Vaccine Reaction, Vaccine Adverse Reaction
Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children
A Phase III, Observer-blind, randomized, active-controlled prospective intervention study
- Trial name
- NCT05546502
- Testing
- SARS-CoV-2 Protein Subunit Recombinant Vaccine, Active Comparator
- Where
- 10 sites in Indonesia
- Volunteers
- 1,050 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
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
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.
Adverse Drug Event, Effect of Drug
Research on Human Insulin rDNA Safety and Efficacy in Patients With Type 2 Diabetes Mellitus
Objective: To evaluate the safety and efficacy of Human Insulin rDNA (Insuget) in patients with Type II Diabetes Mellitus. Study Design: Open-label, prospective, observational, single arm, multi-center, post-marketing…
- Conditions
- Adverse Drug Event, Effect of Drug, Type 2 Diabetes Treated With Insulin
- Trial name
- RISE (NCT05161741)
- Testing
- Insulin
- Where
- Pakistan
- Volunteers
- 238 people
- Sponsor
- Getz Pharma
Relapsing-Remitting Multiple Sclerosis (RRMS)
Brimonidine Tartrate for the Treatment of Injection Related Erythema
The primary objective of this study is to evaluate the Injection Related Erythema (IRE) mitigation effect of a single administration of brimonidine tartrate in comparison with a vehicle gel (placebo).
- Trial name
- BRITE (NCT02568111)
- Testing
- peginterferon beta-1a, brimonidine tartrate, Vehicle Gel
- Sponsor
- Biogen
Acute Drug Induced Liver Injury
Efficacy and Safety of Polyene Phosphatidylcholine in Treatment of Patients With Acute Drug-induced Liver Injury
The purpose of this study is to explore the efficacy and the safety of polyene phosphatidylcholine Injection in patients with acute drug-induced liver injury after 2-4 weeks of treatment.
- Trial name
- NCT04595916
- Testing
- Polyene phosphatidylcholine injection 930 mg QD, Magnesium Isoglycyrrhizinate injection 200 mg QD
- Where
- 9 sites in China
- Volunteers
- 73 people
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
Adverse Drug Event, Drug Drug Interaction
Implementation of a Pharmacist-led Pharmacogenomic Clinical Service
Tabula Rasa HealthCare (TRHC), doing business as CareKinesis, is the first national pharmacy that provides science-based medication risk identification and mitigation technologies and services.
- Conditions
- Adverse Drug Event, Drug Drug Interaction, Pharmacogenomics, Elderly
- Trial name
- NCT04984538
- Testing
- Pharmacogenomic Testing
- Where
- United States
- Sponsor
- Tabula Rasa HealthCare
Acromegaly, Neuroendocrine Tumors
Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs)
This is a Phase II, open-label multicentre, randomised study to assess the PK, PD, efficacy, and safety of two dosing regimens of CAM2029 in adult patients with acromegaly or a functional, well-differentiated NET, with carcinoid…
- Trial name
- NCT02299089
- Testing
- octreotide FluidCrystal® injection depot
- Where
- 10 sites in France, Germany and 2 more
- Volunteers
- 12 people
- Sponsor
- Camurus AB