Clinical trials: Drug Reactions
Drug/Agent Toxicity by Tissue/Organ, Leukemia
05-001: Treatment of Acute Lymphoblastic Leukemia in Children
RATIONALE: L-asparaginase is an important component of treatment for childhood acute lymphoblastic leukemia, but is also associated with notable side-effects, including hypersensitivity, pancreatitis, and thrombosis.
- Trial name
- NCT00400946
- Testing
- asparaginase, cyclophosphamide, cytarabine
- Where
- 8 sites in United States, Canada
- Volunteers
- 800 people
- Sponsor
- Dana-Farber Cancer Institute
Cardiac Toxicity, Malignant Neoplasm
MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capacity Addendum
This trial studies how well magnetic resonance imaging (MRI) works in detecting heart damage in patients with cancer receiving chemotherapy.
- Conditions
- Cardiac Toxicity, Malignant Neoplasm, Breast Cancer
- Trial name
- NCT01719562
- Testing
- Magnetic resonance imaging, Physical Activity, Healthy Living
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- Wake Forest University Health Sciences
Carcinoid Syndrome
Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome
The purpose of the study is to evaluate the safety and tolerability of orally administered telotristat etiprate (LX1606) in participants with symptomatic carcinoid syndrome.
- Trial name
- NCT01104415
- Testing
- Telotristat etiprate
- Where
- 10 sites in Germany, United Kingdom
- Volunteers
- 15 people
- Sponsor
- Lexicon Pharmaceuticals
Quality of Life, Injection Site Reaction
Simultaneous mRNA COVID-19 and IIV4 Vaccination Study
This study is a prospective, randomized clinical trial. During this study, participants will be randomly assigned to receive quadrivalent inactivated influenza vaccine (IIV4) and mRNA COVID-19 vaccine either simultaneously or…
- Conditions
- Quality of Life, Injection Site Reaction, Adverse Drug Event, Systemic Reaction
- Trial name
- NCT05028361
- Testing
- mRNA COVID-19, IIV4
- Where
- 3 sites in United States
- Volunteers
- 348 people, healthy volunteers welcome
- Sponsor
- Duke University
Carcinoid Syndrome
Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms
The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.
- Trial name
- TELEPATH (NCT02026063)
- Testing
- Telotristat etiprate
- Where
- 43 sites in United States, Australia and 10 more
- Volunteers
- 124 people
- Sponsor
- Lexicon Pharmaceuticals
Asthma, Aspirin-Induced
Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)
The purpose of this phase 2 study is to assess the safety and efficacy of oral ifetroban for the treatment of aspirin-exacerbated respiratory disease (AERD).
- Trial name
- NCT03028350
- Testing
- Ifetroban Oral Capsule
- Where
- 16 sites in United States
- Volunteers
- 54 people
- Sponsor
- Cumberland Pharmaceuticals
Carcinoid Syndrome, Carcinoid
Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and exploratory dose response of paltusotine treatment in subjects with carcinoid syndrome.
- Conditions
- Carcinoid Syndrome, Carcinoid, Carcinoid Tumor, Carcinoid Tumor of Ileum
- Trial name
- NCT05361668
- Testing
- Randomized: 40 mg Paltusotine, Randomized: 80 mg Paltusotine
- Where
- 35 sites in United States, Argentina and 5 more
- Volunteers
- 36 people
- Sponsor
- Crinetics Pharmaceuticals 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
Drug Hypersensitivity
Evaluation of TNF-α Blockade Effect in Patients With Severe Cutaneous Adverse Drug Reactions
Severe skin adverse drug reactions can result in death. Toxic epidermal necrolysis (TEN) has the highest mortality (30-35%); Stevens-Johnson syndrome and transitional forms correspond to the same syndrome, but with less extensive…
- Trial name
- NCT01276314
- Testing
- anti- TNF-a, Prednisolone
- Where
- Taiwan
- Volunteers
- 135 people
- Sponsor
- Chang Gung Memorial Hospital
Venous Thromboembolism, Deep Venous Thrombosis
Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery
Plastic and reconstructive surgeons consistently create large, raw surfaces as part of their operative procedures. Thus, plastic \& reconstructive surgery patients are among those at highest risk for anticoagulant-associated…
- Conditions
- Venous Thromboembolism, Deep Venous Thrombosis, Pulmonary Embolus, Reconstructive Surgery
- Trial name
- NCT03212365
- Testing
- Fixed dose, Variable dose
- Where
- 2 sites in United States
- Volunteers
- 295 people
- Sponsor
- University of Utah
Recurrent Tonsillitis, Obstructive Sleep Apnea
Post-operative Pain Control After Pediatric Adenotonsillectomy
Adenotonsillectomy is one of the most common surgical procedures performed in the pediatric population in the United States. It is generally a well-tolerated procedure with post-operative bleeding risk ranging from 3-5% in…
- Conditions
- Recurrent Tonsillitis, Obstructive Sleep Apnea, Sleep Disordered Breathing, Adverse Reaction to Drug
- Trial name
- NCT02296840
- Testing
- Ibuprofen, Hydrocodone-Acetaminophen
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Emory University
Patient Readmission, Adverse Drug Event
Regional Data Exchange to Improve Care for Veterans After Non-VA Hospitalization
Among older VA patients who have Medicare coverage, 43% use both VA and non-VA (Medicare-covered) services. VA and non-VA providers are often uninformed about encounters, treatments and test results provided in the other system.
- Conditions
- Patient Readmission, Adverse Drug Event, Cost
- Trial name
- NCT02689076
- Testing
- HIE Notification, Care transitions intervention
- Where
- 2 sites in United States
- Volunteers
- 796 people
- Sponsor
- VA Office of Research and Development
Breast Cancer, Hormone Changes
Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as triptorelin, may protect normal ovarian cells from the side effects of…
- Conditions
- Breast Cancer, Hormone Changes, Drug Toxicity
- Trial name
- NCT00090844
- Testing
- triptorelin
- Where
- 9 sites in United States
- Volunteers
- 49 people
- Sponsor
- University of South Florida
HIV/AIDS, Antiviral Toxicity
Relative Mitochondrial Toxicity of Tenofovir Alafenamide (TAF) vs. Tenofovir Disoproxil Fumarate (TDF)
Increased comorbidities such as cardiovascular disease (CVD), are emerging problems in HIV infection but the mechanisms are unclear.
- Conditions
- HIV/AIDS, Antiviral Toxicity, Antiviral Drug Adverse Reaction, Mitochondrial Alteration
- Trial name
- UCLACAREMITO (NCT03251144)
- Testing
- Switch to E/C/FTC/TAF daily
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
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
Cardiotoxicity, Breast Cancer
PROactive Evaluation of Function to Avoid CardioToxicity
This study is intended to evaluate the ability of an intramyocardial strain analysis package with cardiac MRI to assist in the early detection and management of cardiotoxicity from therapeutics used to treat cancer.
- Conditions
- Cardiotoxicity, Breast Cancer, Lymphoma, Sarcoma
- Trial name
- PROACT (NCT03862131)
- Testing
- MyoStrain®
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Washington University School of Medicine
Cannabidiol, Drug Induced Liver Injury
Clinical Study to Evaluate Cannabidiol Liver Enzyme Elevations and Drug Interactions
Cannabidiol (CBD) is available as a prescription drug product for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex.
- Conditions
- Cannabidiol, Drug Induced Liver Injury, Drug Interaction
- Trial name
- NCT06192589
- Testing
- Cannabidiol, Citalopram, Morphine
- Where
- United States
- Volunteers
- 241 people, healthy volunteers welcome
- Sponsor
- Food and Drug Administration (FDA)
Aging, Benzodiazepine Sedative Adverse Reaction
Optimizing Electronic Health Record Prompts With Behavioral Economics to Improve Prescribing for Older Adults
Prescribing of potentially unsafe medications for older adults is extremely common; benzodiazepines and sedative hypnotics are, for example, key drug classes frequently implicated in adverse health consequences for vulnerable…
- Conditions
- Aging, Benzodiazepine Sedative Adverse Reaction, Anticholinergic Adverse Reaction, Adverse Drug Event
- Trial name
- NUDGE-EHR (NCT04284553)
- Testing
- Order Entry, Open Encounter, Follow-up booster Alert
- Where
- United States
- Volunteers
- 216 people
- Sponsor
- Brigham and Women's Hospital
Asthma, Aspirin-Induced, Aspirin Exacerbated Asthma
Therapeutic Control of Aspirin-Exacerbated Respiratory Disease (Aspirin)
The investigators are doing this research study to find out if giving a drug called prasugrel, which is used to prevent blood clots, can reduce reactions to aspirin in people with aspirin exacerbated respiratory disease (AERD)…
- Trial name
- Aspirin (NCT01597375)
- Testing
- Prasugrel Oral Tablet
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Elliot Israel, MD
Carcinoid Syndrome
TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)
The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the number of daily bowel movements (BMs) from baseline averaged over the 12-week…
- Trial name
- NCT01677910
- Testing
- Telotristat etiprate
- Where
- 75 sites in United States, Australia and 10 more
- Volunteers
- 135 people
- Sponsor
- Lexicon Pharmaceuticals