Clinical trials: Drug Safety
Drug Resistant Epilepsy, Epilepsy, Drug Resistant
Safety of Using NaviFUS System in Patients With Drug Resistant Epilepsy
This study is to evaluate the safety and the intracranial electroencephalography (iEEG) changes of using NaviFUS System for the treatment of patients with drug resistant epilepsy.
- Conditions
- Drug Resistant Epilepsy, Epilepsy, Drug Resistant, Drug Refractory Epilepsy, Epilepsy, Drug Refractory
- Trial name
- NCT03860298
- Testing
- NaviFUS System
- Where
- Taiwan
- Volunteers
- 6 people
- Sponsor
- NaviFUS Corporation
Drug Safety
Colistin Plus Rifampicin in MDR P. Aeruginosa and A. Baumanii
In Siriraj Hospital, Colistin alone for treatment of MDR. A.baumanii or P.aeruginosa contributed to mortality 45%. In vitro studies revealed synergism of Rifampicin and Colistin. In this study, patients with documented MDR.
- Trial name
- NCT01297855
- Testing
- Colistin, Colistin plus Rifampicin
- Where
- Thailand
- Volunteers
- 130 people
- Sponsor
- Mahidol University
Parkinson Disease, Parkinson's Disease
A Long-Term Follow-up Study of the Severe Parkinson's Disease Patients Administered the IPS101A Gene Therapy Product.
The purpose of this study is to evaluate the long-term safety of IPS101A and to assess the durability of efficacy in subjects who received IPS101A.
- Trial name
- NCT07629115
- Where
- South Korea
- Volunteers
- 6 people
- Sponsor
- Innopeutics Corporation
Parkinson Disease, Early Parkinson's Disease
A Phase 3 Study With P2B001 in Subjects With Early Parkinson's
P2B001 is an investigational drug that comprised of low doses of two drugs, pramipexole and rasagiline, which are both approved drugs and routinely used in standard therapy for Parkinson's disease.
- Trial name
- NCT03329508
- Testing
- P2B001 0.6/0.75 mg, Rasagiline 0.75 mg, Pramipexole 0.6 mg
- Where
- 72 sites in United States, Canada and 2 more
- Volunteers
- 544 people
- Sponsor
- Pharma Two B Ltd.
Malaria
Comparison of Three Drug Combinations for Intermittent Treatment of Malaria in Children
Intermittent preventive treatment (IPT) offers a way of preventing malaria infection without compromising the development of malaria immunity or encouraging drug resistance.
- Trial name
- NCT00561899
- Testing
- SP, amodiaquine, piperaquine, dihdroartemisinin, intermittent preventive treatment, Du-Cotecxin
- Where
- The Gambia
- Volunteers
- 1,295 people, healthy volunteers welcome
- Sponsor
- London School of Hygiene and Tropical Medicine
AIDS Vaccines, HIV Infections
Phase 1 Safety Study of Two Experimental HIV Vaccines
This study will test whether two experimental HIV vaccines are safe and whether they cause any side effects in healthy adults. It will examine the body s immune response to the vaccines and monitor the social impact, if any, of…
- Conditions
- AIDS Vaccines, HIV Infections, HIV-1
- Trial name
- NCT00479999
- Testing
- VRC-HIVADV027-00-VP, VRC-HIVADV038-00-VP
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hepatic Impairment
A Clinical Trial of the Study Medicine (Called Fosmanogepix) in Participants With Varying Degrees of Hepatic Function.
The primary purpose of this open-label study is to characterize the plasma pharmacokinetics (PK) of manogepix (active moiety of fosmanogepix) in participants with varying degrees of hepatic function following administration of a…
- Trial name
- NCT05582187
- Testing
- Fosmanogepix
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
HIV Infections
A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of MN Recombinant Soluble gp120/HIV-1 (rsgp120/HIV-1) (Genentech) in Combination With QS21 Adjuvant and/or Alum in Healthy Adults
To extend the evaluation of safety and immunogenicity of MN recombinant soluble gp120/HIV-1 (MN rsgp120/HIV-1) in combination with QS21 with or without alum and on two different vaccination schedules.
- Trial name
- NCT00001052
- Testing
- Aluminum hydroxide, QS-21, rgp120/HIV-1MN
- Where
- 5 sites in United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Liposarcoma, Prostate Cancer
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
This is a Phase 1/2A, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060 administered as a single agent and in combination with endocrine therapy.
- Conditions
- Liposarcoma, Prostate Cancer, Advanced Breast Cancer, NSCLC (Non-small Cell Lung Cancer)
- Trial name
- CDK4i (NCT04557449)
- Testing
- PF-07220060, Letrozole, Fulvestrant
- Where
- 39 sites in United States, Argentina and 6 more
- Volunteers
- 430 people
- Sponsor
- Pfizer
Breast Cancer, Adherence, Medication
Adherence and Safety of Ribociclib Plus Aromatase Inhibitors in Patients With Early Stage, HR+ and HER2- Breast Cancer
Breast cancer is the most common malignancy in women, with HR+/HER2- early breast cancer accounting for approximately 70% of cases.
- Trial name
- riboADHERE (NCT07630948)
- Testing
- Adherence package consisting of additional education and adherence reminders
- Where
- Slovenia
- Volunteers
- 90 people
- Sponsor
- Institute of Oncology Ljubljana
Osteosarcoma, Pulmonary Metastasis
Safety and Feasibility of Intraoperative Visualization With Cytalux in Children
Pediatric subjects aged 6-17 with biopsy confirmed cancer and imaging findings suspicious for pulmonary metastatic disease scheduled to undergo pulmonary metastasectomy via and open or minimally invasive approach.
- Conditions
- Osteosarcoma, Pulmonary Metastasis, Fluorescence, Metastatic Sarcoma
- Trial name
- Cytalux (NCT06235125)
- Testing
- Cytalux
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Diabetes Mellitus
Efficacy and Safety of SYR-472 in Subjects With Type 2 Diabetes Mellitus
The purpose of this study is to determine the efficacy and safety of SYR-472, once daily (QD), in subjects with type 2 diabetes mellitus who have not achieved glycemic control with diet and exercise, or by taking metformin.
- Trial name
- NCT00760344
- Testing
- SYR-472, Sitagliptin
- Where
- 112 sites in United States, Mexico
- Volunteers
- 386 people
- Sponsor
- Takeda
Mood, Depression Disorders
Technology Exposure and Child Health: Wellness Impact and Social Effects: An Observational Product Registry Study
The goal of this study is to understand how children's mobile device usage (smartphones or tablets), including social media use and online games, are related to their mental wellness and mental health, as well as some aspects of…
- Conditions
- Mood, Depression Disorders, Anxiety Disorders, Sleep
- Trial name
- TECHWISE (NCT06664944)
- Where
- United States
- Volunteers
- 912 people, healthy volunteers welcome
- Sponsor
- Aura
Healthy
A Clinical Study to See How the Study Drug MT-4129 is Taken up by the Body in Healthy Volunteers
The purpose of this study is to investigate the safety and tolerability of ascending single and multiple oral doses of MT-4129 in healthy subjects.
- Trial name
- NCT02953132
- Testing
- MT-4129
- Where
- Netherlands
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Tanabe Pharma Corporation
Bacterial Infections
Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections
Adolescent subjects hospitalized for the treatment of bacterial infections will be given 1 gram of dalbavancin through their veins and levels of dalbavancin in blood and urine will be measured at different time points.
- Trial name
- NCT00678106
- Testing
- Dalbavancin
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Pfizer
Healthy Male Volunteers
Pharmacokinetic Drug Interaction Study in Healthy Male Subjects
A Randomized, Open Label, Drug-Drug interaction study to investigate effect of ketoconazole or rifampicin on the Pharmacokinetic characteristics and safety of LC15-0444 in Healthy Male Volunteers.
- Trial name
- NCT01426906
- Testing
- Ketoconazole, rifampicin
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Hypercholesterolemia, LDL Cholesterol
Safety, Pharmacokinetics and Pharmacodynamics of LGT209 in Healthy Volunteers With Elevated Cholesterol and in Hypercholesterolemic Patients Treated With Statins
This study is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of LGT209 in hypercholesterolemic patients taking common statin medications and in healthy volunteers.
- Trial name
- NCT01859455
- Testing
- LGT209 50 mg, LGT209 300 mg, Statins (atorvastatin or simvastatin)
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hepatic and Hepatobiliary Disorders
Essentiale® Paste in Patients With Gastrointestinal Symptoms in Acute or Chronic Liver Diseases
Primary Objective: To assess safety of Phosphatidylcholine paste 600 mg (ESSENTIALE® paste) oral 3 times a day for 12 weeks in patients with gastrointestinal symptoms in acute and chronic liver diseases.
- Trial name
- EPLID (NCT02517385)
- Testing
- Phosphatidylcholine
- Where
- Russia
- Volunteers
- 147 people
- Sponsor
- Sanofi
Moderate Hepatic Impairment, Severe Hepatic Impairment
A Study to Learn About the Study Medicine (Called Lorlatinib) in People With Liver Dysfunction
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Lorlatinib) in health participants.
- Conditions
- Moderate Hepatic Impairment, Severe Hepatic Impairment, Healthy Volunteers
- Trial name
- NCT05224609
- Testing
- Lorlatinib
- Where
- 3 sites in United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Pfizer
Platinum-resistant Ovarian Cancer
GB-5267 for the Treatment Platinum-Resistant Ovarian, Peritoneal, or Fallopian Tube Cancer
This phase 1 study evaluates the safety, efficacy, and biological activity of GB-5267 in patients with platinum-resistant ovarian cancer.
- Trial name
- NCT07489287
- Testing
- GB-5267 - IV only, GB-5267 -Combined IV and IP Infusion
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Roswell Park Cancer Institute