Clinical trials: Toxicity, Drug
Smoking, Cigarette, Smoking, Tobacco
Examination of Low Wattage and High Wattage E-Cigarettes
The overall aim of the proposed study is to evaluate the effect of switching from conventional cigarettes to either a LWe or HWe on smoking behavior, product use patterns and continued use, as well as biomarkers of toxicant…
- Conditions
- Smoking, Cigarette, Smoking, Tobacco, Nicotine Dependence, Exposure to Toxic Agent
- Trial name
- SWITCH (NCT03113136)
- Testing
- Low wattage E cigarette device, High wattage E cigarette device, Usual brand cigarette
- Where
- United States
- Volunteers
- 372 people, healthy volunteers welcome
- Sponsor
- Ohio State University Comprehensive Cancer Center
Drug Toxicity Psychotropic Agents Psychostimulants
Efficacy and Safety Study of Ryanodex as Adjuvant Treatment in Subjects With Psychostimulant Drug-Induced Toxicity (PDIT)
Ryanodex is being investigated as a potential adjuvant treatment for people suffering from psychostimulant drug-induced toxicity (PDIT), a life-threatening medical condition that results mainly from the abuse of certain illicit…
- Trial name
- NCT03189433
- Testing
- Ryanodex (dantrolene sodium) for injectable suspension
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Eagle Pharmaceuticals, Inc.
Tobacco Use Disorder, Oral Nicotine Pouch Use
Switching to Potential Reduced Exposure Products in Adult Smokers
This study aims to assess the feasibility, acceptability, and the potential harm reduction of switching to potentially lower risk, oral nicotine pouches in adult smokers.
- Conditions
- Tobacco Use Disorder, Oral Nicotine Pouch Use, Smoking Behaviors, Harm Reduction
- Trial name
- ZYN (NCT04250727)
- Testing
- ZYN
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Yale University
Tobacco Use
Sugars in Cigarettes
The aim of this study is to investigate the impact of sugar levels in cigarette tobacco on cigarette abuse liability and appeal.
- Trial name
- NCT05308316
- Testing
- Cigarettes with added sucrose
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Masonic Cancer Center, University of Minnesota
Hepatitis C, Chronic
An Observational Study of the Safety of Direct-acting Antivirals in Patients With Hepatitis C
The investigators will assess whether patients with the Hepatitis C virus (HCV) who are prescribed direct-acting antiviral (DAA) medications experience higher rates of adverse events than patients with HCV who are untreated.
- Trial name
- NCT03423641
- Testing
- Direct Acting Antivirals
- Volunteers
- 33,808 people
- Sponsor
- Kaiser Permanente
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
Prostate Cancer
Study Evaluating Toxicity & Efficacy of Lenalidomide(Revlimid®)in Chemotherapy-Naïve AIPC Patients
This is a single institution, open label, phase II study in androgen-independent prostate cancer patients who are chemotherapy-naïve.
- Trial name
- NCT00654186
- Testing
- Revlimid
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Oncology Specialists, S.C.
Breast Cancer, Chemotherapeutic Agent Toxicity
Nicotine Patches in Reducing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine For Metastatic Breast Cancer
RATIONALE: Nicotine patches may reduce hand-foot syndrome in patients receiving capecitabine for metastatic breast cancer. It is not yet known which nicotine patch regimen may be more effective in reducing hand-foot syndrome.
- Conditions
- Breast Cancer, Chemotherapeutic Agent Toxicity, Palmar-plantar Erythrodysesthesia
- Trial name
- NCT00751101
- Testing
- Nicotine patch
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of California, San Francisco
Analgesia, Obstetrical, Coagulation Defect; Postpartum
IV Ketorolac on Platelet Function Post-Cesarean Delivery
Cesarean delivery has become the most common surgical procedure in the US. Non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to improve the quality of post-cesarean analgesia and markedly reduce opioid consumption.
- Conditions
- Analgesia, Obstetrical, Coagulation Defect; Postpartum, Nonsteroidals (NSAIDs)Toxicity, Postpartum Hemorrhage
- Trial name
- KetoPltAgg (NCT03805607)
- Testing
- Ketorolac Tromethamine 30 MG/ML
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
Cardiotoxicity, Risk Factor, Cardiovascular
Risk-Guided Cardioprotection With Carvedilol in Breast Cancer Patients Treated With Doxorubicin and/or Trastuzumab
Investigators will evaluate the safety, tolerability, and feasibility of a risk-guided cardioprotective treatment strategy with carvedilol, as compared to usual care, in breast cancer patients undergoing treatment with…
- Conditions
- Cardiotoxicity, Risk Factor, Cardiovascular, Toxicity Due to Chemotherapy, Breast Cancer
- Trial name
- CCTGuide Pilot (NCT04023110)
- Testing
- Carvedilol
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- Abramson Cancer Center at Penn Medicine
Drug Toxicity, Healthy
Aminotransferase Trends During Prolonged Acetaminophen Dosing
The objective of this study is to monitor liver function tests (blood levels of an indicator of liver function) of healthy people taking the maximum labeled daily dose of acetaminophen compared to people taking placebo for 16 to…
- Trial name
- NCT00743093
- Testing
- acetaminophen
- Where
- 2 sites in United States
- Volunteers
- 398 people, healthy volunteers welcome
- Sponsor
- Denver Health and Hospital Authority
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
Chemotherapeutic Agent Toxicity, Neuropathy
Glutathione in Preventing Peripheral Neuropathy Caused by Paclitaxel and Carboplatin in Patients With Ovarian Cancer, Fallopian Tube Cancer, and/or Primary Peritoneal Cancer
This randomized phase III trial is studying glutathione to see how well it works in preventing peripheral neuropathy caused by paclitaxel and carboplatin in patients with ovarian cancer, fallopian tube cancer, and/or primary…
- Conditions
- Chemotherapeutic Agent Toxicity, Neuropathy, Neurotoxicity Syndrome, Pain
- Trial name
- NCT02311907
- Testing
- Carboplatin, Glutathione, Laboratory Biomarker Analysis
- Where
- 390 sites in United States
- Volunteers
- 195 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Breast Cancer
An Integrated Consent Model Study to Compare Two Standard of Care Schedules for Monitoring Cardiac Function in Patients Receiving Trastuzumab for Early Stage Breast Cancer
Several large adjuvant trastuzumab trials have demonstrated improved overall survival in participants with early stage breast cancer, with a 33% decrease in risk of death.
- Trial name
- OTT 15-05 (NCT02696707)
- Testing
- LVEF 3 month, LVEF 4 month
- Where
- 4 sites in Canada
- Volunteers
- 200 people
- Sponsor
- Ottawa Hospital Research Institute
Melanoma
Lenalidomide (Revlimid) to Treat Advanced Ocular Melanoma
This study will test whether an experimental drug called Revlimid (lenalidomide) can reduce tumor size and prolong survival in patients with metastatic melanoma (melanoma that has spread beyond the original tumor site).
- Trial name
- NCT00109005
- Testing
- Revlimid
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- National Cancer Institute (NCI)
Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome
Study to Evaluate the Use of Palifermin to Treat Toxic Epidermal Necrolysis
To test the ability of palifermin (a recombinant human keratinocyte growth factor) to decrease mucocutaneous injury and to promote epithelial repair in Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome-Toxic Epidermal…
- Trial name
- NCT02037347
- Testing
- Palifermin
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Brett King
Breast Cancer, Colorectal Cancer
Celecoxib in Preventing Hand/Foot Syndrome Caused By Capecitabine With Metastatic Breast or Colorectal Cancer
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them…
- Conditions
- Breast Cancer, Colorectal Cancer, Pain
- Trial name
- NCT00305643
- Testing
- Capecitabine, Celecoxib, Radiation Therapy
- Where
- 14 sites in United States, Puerto Rico
- Volunteers
- 11 people
- Sponsor
- M.D. Anderson Cancer Center
Sepsis, Critical Illness
Optimizing Vancomycin Therapy in Children
The purpose of Opt Vanc is to evaluate the feasibility of Bayesian dose adaptation, based on a previously-developed population pharmacokinetic (PK) model and a single optimally timed PK sample, to predict vancomycin area under…
- Conditions
- Sepsis, Critical Illness, Infections, Drug Toxicity
- Trial name
- Opt Vanc (NCT05691309)
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Children's Hospital of Philadelphia
Ophthalmological Agent Toxicity, Bacterial Conjunctivitis
Study to Evaluate the Safety and Tolerability of PRO-231 Versus VIGAMOXI® on the Ocular Surface of Healthy Subjects
This is a phase I clinical study evaluating the safety and tolerability of PRO-231 ophthalmic solution through the incidence of unexpected adverse events, incidence of conjunctival hyperemia and chemosis, changes in Best…
- Trial name
- NCT06363292
- Testing
- PRO-231, VIGAMOXI®
- Where
- Mexico
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Laboratorios Sophia S.A de C.V.
Chemotherapeutic Agent Toxicity, Mucositis
Selenomethionine in Reducing Mucositis in Patients With Locally Advanced Head and Neck Cancer Who Are Receiving Cisplatin and Radiation Therapy
This randomized phase II trial is studying how well selenomethionine (SLM) works in reducing mucositis in patients with locally advanced head and neck cancer who are receiving cisplatin and radiation therapy.
- Conditions
- Chemotherapeutic Agent Toxicity, Mucositis, Radiation Toxicity, Stage III Squamous Cell Carcinoma of the Hypopharynx
- Trial name
- NCT01682031
- Testing
- selenomethionine, cisplatin, radiation therapy
- Where
- 2 sites in United States, New Zealand
- Volunteers
- 18 people
- Sponsor
- Roswell Park Cancer Institute