Clinical trials: Drug Toxicity
Drug Toxicity
Real World Asparaginase Therapy Toxicity
This research study is being done to learn more about the short term and long term side effects of treatment with asparaginase drugs, which are commonly used in acute lymphoblastic leukemia (ALL) or acute lymphoblastic lymphoma…
- Trial name
- NCT07008027
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- St. Jude Children's Research Hospital
Neuropathy, Cancer
Daily Hand-Held Vibration Therapy
The purpose of this pilot study is to determine the safety and feasibility of a daily 3-minute hand-held vibration therapy intervention to reduce the severity of CIPN in the hands.
- Conditions
- Neuropathy, Cancer, Chemotherapeutic Drug - Induced Nephropathy, Chemotherapeutic Toxicity
- Trial name
- NCT04207437
- Testing
- Vibration therapy
- Where
- 3 sites in United States
- Volunteers
- 16 people
- Sponsor
- Indiana University
Colorectal Cancer, Liver Metastases
SAMe in Prevention of Oxaliplatin-associated Liver Injury
This is an open-label, phase II study that may provide evidence that taking S-adenosylmethionine (SAMe) supplementation prevents oxaliplatin, a type of chemotherapy drug, associated liver toxicity in patients with resectable…
- Conditions
- Colorectal Cancer, Liver Metastases, Liver Metastasis Colon Cancer, Liver Injury
- Trial name
- NCT06258525
- Testing
- Standard of care oxaliplatin-based chemotherapy, S-adenosylmethionine (SAMe) supplement, Surgery
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Cedars-Sinai Medical Center
Cancer Survivors, Cardiotoxicity
In-Bedroom Renewed Air as Anti-inflammatory Adjuvant Therapy in Cancer Survivors
The BREATHS trial aims to investigate whether overnight in-bedroom air filtration reduces inflammation and cardiac biomarkers in adult survivors of cancer who are at high risk for cardiovascular complications.
- Conditions
- Cancer Survivors, Cardiotoxicity, Cardiovascular Toxicity Induced by Antitumoral Drugs
- Trial name
- BREATHS (NCT06778122)
- Testing
- High efficiency particulate air filtration system (nightly administration), High efficiency particulate air filtration system (nightly and daily administration)
- Where
- 3 sites in Spain
- Volunteers
- 10 people
- Sponsor
- University College, London
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
Melanoma Stage III, Melanoma Stage IV
Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis
The goal of this clinical trial is to compare the safety and effectiveness of infliximab compared to steroids for the treatment of immune checkpoint inhibitor-induced colitis (ICI colitis) in patients with stage III/IV skin…
- Conditions
- Melanoma Stage III, Melanoma Stage IV, Skin Cancer Stage III, Skin Cancer Stage IV
- Trial name
- NCT04305145
- Testing
- Infliximab, Methylprednisolone, Prednisone
- Where
- 2 sites in United States
- Volunteers
- 42 people
- Sponsor
- Massachusetts General Hospital
Kidney Cancer, Renal Cell Carcinoma Metastatic
TDM for Optimized Outcome in Patients With mRCC.
The purpose of this observational study is to assess the role of plasma concentration monitoring of treatment drugs for patients with metastatic renal cell carcinoma (mRCC) in terms of efficacy and side effects.
- Conditions
- Kidney Cancer, Renal Cell Carcinoma Metastatic, Drug Toxicity, Drug Side Effect
- Trial name
- NCT04659343
- Testing
- Measurement of concentration of active metabolite in cancer treatment.
- Where
- Denmark
- Volunteers
- 200 people
- Sponsor
- Niels Fristrup
Diarrhea, Drug/Agent Toxicity by Tissue/Organ
N2003-01: Irinotecan, Temozolomide, and Cefixime in Treating Young Patients With Recurrent or Resistant Neuroblastoma
RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die.
- Conditions
- Diarrhea, Drug/Agent Toxicity by Tissue/Organ, Neuroblastoma
- Trial name
- NCT00093353
- Testing
- cefixime, irinotecan hydrochloride, temozolomide
- Where
- 13 sites in United States
- Volunteers
- 30 people
- Sponsor
- New Approaches to Neuroblastoma Therapy Consortium
Breast Cancer, Drug-Related Side Effects and Adverse Reactions
Telenursing for the Early Detection and Management of Side Effects Associated With Cyclin-Dependent Kinase Inhibitors in Breast Cancer Patients
This study is a multicenter randomized controlled trial designed to evaluate the effectiveness of a structured telenursing intervention in patients with breast cancer receiving cyclin-dependent kinase (CDK) inhibitor therapy.
- Conditions
- Breast Cancer, Drug-Related Side Effects and Adverse Reactions, Chemotherapy Toxicity, Treatment Adherence
- Trial name
- NCT07524829
- Testing
- Structured Telenursing Follow-up, Standard Nursing Care
- Where
- Italy
- Volunteers
- 124 people
- Sponsor
- Azienda Sanitaria Locale di Asti
Drug Toxicity
Protective Effect of Nicotinamide Riboside Against Acetaminophen Toxicity
Over-the-counter drugs like acetaminophen (e.g., Tylenol®) can be detrimental. In space, astronauts who have pain and constant discomfort use acetaminophen extensively.
- Trial name
- NCT06214468
- Testing
- Acetaminophen and Nicotinamide Riboside, Acetaminophen
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- University of South Alabama
ALL, Childhood, Pediatric Cancer
Pharmacogenomic Association Study in Indian Children With Acute Lymphoblastic Leukemia
A five-year prospective observational cohort study. The study is focused on observing the relation between static germline variants and therapeutic response in Indian children with acute lymphoblastic leukemia (ALL).
- Conditions
- ALL, Childhood, Pediatric Cancer, Toxicity, Drug, Adverse Drug Event
- Trial name
- MPGx-INDALL (NCT05512169)
- Where
- 2 sites in India
- Volunteers
- 556 people
- Sponsor
- University of Geneva, Switzerland
Acetaminophen, Drug Overdose
Evaluation of the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose
This study is a randomized, placebo-controlled double-blinded clinical trial of patients presenting with acetaminophen poisoning who are at increased risk of developing liver injury.
- Conditions
- Acetaminophen, Drug Overdose, Acetaminophen Overdose, Acetaminophen Poisoning
- Trial name
- NCT05517668
- Testing
- Intravenous infusion of N-acetylcysteine, Intravenous infusion of Fomepizole (4-MP)
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Richard Dart, MD, PhD
Drug Mechanism, Metabolism Medication Toxicity
Pharmacology Space Kit (PSK) - Dried Blood Spot for Caffeine Pharmacokinetics Under Microgravity Conditions
The PSK study is preliminary to the study of drug metabolism in space flight conditions. The investigators propose to use simplified blood sampling methods that can be applied in microgravity.
- Conditions
- Drug Mechanism, Metabolism Medication Toxicity, Space Motion Sickness
- Trial name
- PSK (NCT06431984)
- Testing
- prick test
- Where
- France
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Beta-lactam Antibiotics, Therapeutic Drug Monitoring
The OPTIMAL TDM Study: Determining Optimal Beta-lactam Plasma Concentrations Through Therapeutic Drug Monitoring
Little is known of beta-lactam antibiotics' true therapeutic plasma concentration range. The aims of this study are to define evidence-based, safe and effective upper and lower limits of the plasma concentrations of imipenem…
- Conditions
- Beta-lactam Antibiotics, Therapeutic Drug Monitoring, Toxicity, Efficacy
- Trial name
- OPTIMAL TDM (NCT03790631)
- Testing
- The study is observational.
- Where
- Switzerland
- Volunteers
- 771 people
- Sponsor
- University of Geneva, Switzerland
Kidney Transplant; Complications, Toxicity
Effect of Tacrolimus Formulation on Neurological Side Effects in Older Kidney Transplant Recipients
Previous studies have shown that elderly patients experience higher trough levels of tacrolimus and are more sensitive to the effects of medications, they experience higher occurrence and severity of such medication related…
- Conditions
- Kidney Transplant; Complications, Toxicity, Drug Toxicity, Neurotoxicity
- Trial name
- NCT03461445
- Testing
- Envarsus, IR Tacrolimus
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- University of California, Davis
Multidisciplinary Consultation Program, Adherence to Oral Anticancer Treatment
Impact of a Multidisciplinary Consultation Program on Drug Adherence in First Oral Anticancer Treatment
Oncology management has changed dramatically over the last decade with the approval and rapid adoption of newly targeted oral oncology medications.
- Conditions
- Multidisciplinary Consultation Program, Adherence to Oral Anticancer Treatment, Drug Related Toxicity, Securing Medication Management
- Trial name
- IMPAM (NCT04797143)
- Testing
- multidisciplinary consultation program
- Where
- France
- Volunteers
- 300 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Melanoma Stage IV, Melanoma Stage III
Safe Stop Ipilimumab-nivolumab (IPI-NIVO) Trial
Safe Stop IPI-NIVO Trial: Early discontinuation of nivolumab upon achieving a (confirmed) complete or partial response in patients with irresectable stage III or metastatic melanoma treated with first-line ipilimumab-nivolumab
- Conditions
- Melanoma Stage IV, Melanoma Stage III, Immunotherapy, Toxicity, Drug
- Trial name
- NCT05652673
- Testing
- nivolumab
- Where
- Netherlands
- Volunteers
- 80 people
- Sponsor
- Erasmus Medical Center
Alcoholic Cirrhosis, Alcohol Abstinence
Safety & Efficacy of Baclofen for Alcohol Withdrawal in Chronic Liver Disease With Active Alcohol Consumption
This study examines the safety and effectiveness of baclofen as a treatment for alcohol withdrawal in patients with chronic liver disease who continue drinking.
- Conditions
- Alcoholic Cirrhosis, Alcohol Abstinence, Alcohol Withdrawal, Medication Toxicity
- Trial name
- BAWIC (NCT06840652)
- Testing
- Baclofen
- Where
- Spain
- Volunteers
- 120 people
- Sponsor
- Corporacion Parc Tauli
Methadone Toxicity, Methadone Overdose
Methadone Dose Monitoring With a Remote Medication Monitor
Proof of concept: Pilot Study A Pilot, proof of concept, observational study with a long-term goal to develop a minimally invasive wearable Remote Medication Monitor (RMM) that provides continuous, real-time data on methadone…
- Conditions
- Methadone Toxicity, Methadone Overdose, Pain, Chronic, Drug Metabolism, Poor, CYP2D6-Related
- Trial name
- NCT06837571
- Testing
- Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivo, Measurement of Methadone in the Interstitial Fluid before and after prescribed dose taken in vivo, ISF Extraction Device 2
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Cari Health Inc.
Methadone Toxicity, Methadone Overdose
Assessment of Methadone Dose Taken
Proof of concept: Pilot Study A Pilot, proof of concept, observational study with a long-term goal to develop a minimally invasive wearable Remote Medication Monitor (RMM) that provides continuous, real-time data on methadone…
- Conditions
- Methadone Toxicity, Methadone Overdose, Pain, Chronic, Drug Metabolism, Poor, CYP2D6-Related
- Trial name
- NCT05981573
- Testing
- Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivo, Measurement of Methadone in the Interstitial Fluid before and after prescribed dose taken in vivo, ISF Extraction Device 2
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Cari Health Inc.