Clinical trials: Therapeutic Agent Toxicity
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.
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
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
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
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
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
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
Chemotherapeutic Agent Toxicity, Colorectal Cancer
Calcium Aluminosilicate Anti-Diarrheal in Treating and Preventing Diarrhea in Patients With Metastatic Colorectal Cancer Receiving Irinotecan
RATIONALE: Calcium aluminosilicate anti-diarrheal (CASAD) may help treat and prevent diarrhea caused by irinotecan. It is not yet known whether CASAD is more effective than a placebo in treating and preventing diarrhea in…
- Conditions
- Chemotherapeutic Agent Toxicity, Colorectal Cancer, Diarrhea
- Trial name
- NCT00748215
- Testing
- calcium aluminosilicate anti-diarrheal
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- M.D. Anderson Cancer Center
Drug Toxicity
MW151-101: First-in-human Study of MW151
MW01-2-151SRM (=MW151), a small molecule, is being developed for the treatment of cognitive disorders. The development program is based on nonclinical evidence that MW151 improves neurocognitive outcomes in animal models of…
- Trial name
- NCT04120233
- Testing
- MW151, 10mg, MW151, 20mg, MW151, 40mg
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Linda Van Eldik
Drug Toxicity
Regional Data Exchange to Improve Medication Safety
Medication reconciliation, a process by which a provider obtains and documents a thorough medication history with specific attention to comparing current and previous medication use, can prevent medication-related errors and…
- Trial name
- NCT01239121
- Testing
- HIE-Enhanced Medication Reconciliation, Optimal Medication Reconciliation without HIE
- Where
- United States
- Volunteers
- 402 people
- Sponsor
- VA Office of Research and Development
Small Cell Lung Cancer, Soft Tissue Sarcoma
Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors.
Tinostamustine (EDO-S101) is a first-in-class alkylating deacetylase inhibitor designed to improve drug access to deoxyribonucleic acid (DNA) strands, induce DNA damage and counteract its repair in cancer cells.
- Conditions
- Small Cell Lung Cancer, Soft Tissue Sarcoma, Triple-negative Breast Cancer, Ovarian Cancer
- Trial name
- EDO-S101 (NCT03345485)
- Testing
- Tinostamustine 60mg/m2 over 30min, Tinostamustine 80mg/m2 over 30min, Tinostamustine 100mg/m2 over 30min
- Where
- 13 sites in United States, Canada and 3 more
- Volunteers
- 71 people
- Sponsor
- Mundipharma Research Limited
Analgesia, Obstetrical, Postpartum Hemorrhage
Prospective Effect of Intravenous Ketorolac on Opioid Use, EBL and Complications Following Cesarean Delivery
In this randomized, double-blind control trial to evaluate the effect of ketorolac given at the time of cord clamp has on estimated blood loss and postcesarean pain control.
- Conditions
- Analgesia, Obstetrical, Postpartum Hemorrhage, Opioid Use, Nonsteroidals (NSAIDs)Toxicity
- Trial name
- NCT02509312
- Testing
- Ketorolac
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Brain and Central Nervous System Tumors, Drug/Agent Toxicity by Tissue/Organ
Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
- Conditions
- Brain and Central Nervous System Tumors, Drug/Agent Toxicity by Tissue/Organ, Lymphoma, Thrombocytopenia
- Trial name
- NCT00074165
- Testing
- Rituxan, Cyclophosphamide, Etoposide
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- OHSU Knight Cancer Institute
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
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
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
Limbal Stem Cell Deficiency
Limbal Stem Cell Deficiency (LSCD) Treatment With Cultivated Stem Cell (CALEC) Graft
The main aim of the study is to determine the safety and feasibility of a cultivated autologous limbal epithelial cell (CALEC) transplantation in the treatment of limbal stem cell deficiency.
- Trial name
- CALEC (NCT02592330)
- Testing
- Biopsy to collect limbal epithelial stem cells that will be cultivated into a graft, Cultivation of Limbal epithelial cells into a graft, CALEC Transplant
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Massachusetts Eye and Ear Infirmary
Chemotherapeutic Agent Toxicity, Cognitive/Functional Effects
Rituximab, Methotrexate, Vincristine Sulfate, Procarbazine Hydrochloride, and Cytarabine With or Without Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them.
- Conditions
- Chemotherapeutic Agent Toxicity, Cognitive/Functional Effects, Lymphoma, Neurotoxicity
- Trial name
- NCT01399372
- Testing
- Rituximab, Cytarabine, Methotrexate
- Where
- 45 sites in United States, Israel
- Volunteers
- 91 people
- Sponsor
- Radiation Therapy Oncology Group
Chemotherapeutic Agent Toxicity, Neurotoxicity
Electrical Stimulation Therapy Using the MC5-A Scrambler in Reducing Peripheral Neuropathy Caused by Chemotherapy
RATIONALE: Electronic stimulation using a MC5-A Scrambler may help relieve pain in patients who develop peripheral neuropathy while undergoing chemotherapy treatments for cancer.
- Conditions
- Chemotherapeutic Agent Toxicity, Neurotoxicity, Pain, Peripheral Neuropathy
- Trial name
- NCT00952848
- Testing
- questionnaire administration, Sensory Neuropathy Scale instrument, Quality of Life instrument
- Volunteers
- 18 people
- Sponsor
- Virginia Commonwealth University