PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT03380728: Ibogaine in the Treatment of Alcoholism: an Open-label Escalating-dose Trial
Official title: Tolerability and Efficacy of Ibogaine in the Treatment of Alcoholism: an Open-label Escalating-dose Trial
Conditions: Alcoholism
Summary: Approximately 5% of the world's adult population has some alcohol-related disorder, which in addition is associated with 3% of all deaths in the world. In Brazil, harmful use and dependence on alcohol reach about 10% of the population, with alcohol being one of the main factors of disease and mortality. Although the medications currently used have some efficacy, the adverse effects and relatively long time of treatment are factors that may reduce patients' motivation to continue taking the medication correctly. Therefore, it is necessary to conduct research with new drugs for the treatment of alcoholism. Ibogaine is an alkaloid present in the bush Tabernanthe iboga (iboga), a plant from Central Africa traditionally used in countries such as Gabon and Cameroon. Animal studies and case series suggest that one or a few doses of ibogaine significantly reduce withdrawal symptoms and the intensity of use of various drugs, including opioids, psychostimulants, and alcohol. However, there are no controlled clinical studies that have explored these effects. The aim of the present study is to evaluate the safety, tolerability and efficacy of increasing doses of ibogaine in 12 alcoholic patients. Each patient will be hospitalized for 20 days and receive 3 increasing doses of ibogaine. The first 3 patients will receive oral doses of 20 to 400 mg of ibogaine in an open-label design. If the 3 higher doses (240, 320 and 400 mg) are well tolerated, the next 9 volunteers will receive these doses or placebo randomly. The volunteers will also be evaluated 7, 14 and 21 days and 1, 3, 6 and 12 months after leaving the hospital to monitor the consumption of alcohol and other drugs.
Interventions:
description: The first 3 patients will receive oral doses of 20 to 400 mg of ibogaine in an open-label design. If the 3 higher doses (240, 320 and 400 mg) are well tolerated, the next 9 volunteers will receive these doses or placebo randomly in 3 different groups.
name: Ibogaine Hydrochloride
other_name: Placebo
type: Drug
Study arms:
design_group_description: Ibogaine Hydrochloride 240 mg on day 1, placebo on day 4, placebo on day 7
design_group_title: Ibogaine
design_group_type: Experimental
Sponsor: University of Sao Paulo
Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
Conselho Nacional de Desenvolvimento Cientifico e Tecnológico
Drug name mappings:
name: 伊博格碱
lang: CN
name: Ibogaine
lang: EN
Clinical trial NCT02784444: A Study to Evaluate the Safety, Tolerability & Efficacy of MSDC-0602K in Patients With NASH
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 12-Month, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of MSDC-0602K in Patients With NASH (EMMINENCE™)
Conditions: Non-alcoholic Fatty Liver Disease
Non-alcoholic Steatohepatitis
NASH - Nonalcoholic Steatohepatitis
Summary: This is a randomized, double-blinded study of three doses of MSDC-0602K or placebo given orally once daily to subjects with biopsy proven NASH with fibrosis and no cirrhosis.
Interventions:
description: MSDC-0602K capsules
name: MSDC-0602K
type: Drug
description: Placebo capsules
name: Placebo
type: Drug
Study arms:
design_group_description: MSDC-0602K Dose 1 capsule taken once daily for 360 days
design_group_title: MSDC-0602K Dose 1 capsules
design_group_type: Active Comparator
design_group_description: MSDC-0602K Dose 2 capsules taken once daily for 360 days
design_group_title: MSDC-0602K Dose 2 capsules
design_group_type: Active Comparator
design_group_description: MSDC-0602K Dose 3 capsules taken once daily for 360 days
design_group_title: MSDC-0602K Dose 3 capsules
design_group_type: Active Comparator
design_group_description: Matching Placebo capsule taken once daily for 360 days
design_group_title: Placebo capsules
design_group_type: Placebo Comparator
Sponsor: Cirius Therapeutics, Inc.
Collaborators: Chiltern International, Inc.
Drug name mappings:
name: MSDC-0602K
lang: EN
Clinical trial NCT06204237: Safety, Tolerability, and Biodistribution of [89Zr]Zr-DFO-APAC in Subjects With PAOD/CLI and Healthy Volunteers (Acronyms: 89Zr = Zirconium-89, DFO = Desferrioxamine, APAC = AntiPlatelet AntiCoagulant, PET/CT = Positron Emission Tomography/Computed Tomography)
Official title: Safety, Tolerability, and Biodistribution of [89Zr]Zr-DFO-APAC (Phase 0) in Subjects With Peripheral Arterial Occlusive Disease / Critical Limb Ischemia (PAOD/CLI) and Healthy Volunteers - an Open Label PET Study (Acronyms: 89Zr = Zirconium-89, DFO = Desferrioxamine, APAC = AntiPlatelet AntiCoagulant, PET/CT = Positron Emission Tomography/Computed Tomography)
Conditions: Peripheral Arterial Occlusive Disease
Critical Limb Ischemia
Summary: The goal of this Phase 0 clinical trial is to evaluate safety and biodistribution of [89Zr]Zr-DFO-APAC in patients with peripheral arterial occlusive disease / critical limb ischemia (PAOD/CLI) and healthy volunteers. The main questions it aims to answer are:
* What is the safety, tolerability and pharmacokinetic profile (PK: both systemic and local vascular injury site-specific PK) of [89Zr]Zr-DFO-APAC?
* What is the biodistribution and internal radiation dosimetry of the tracer dose of [89Zr]Zr-DFO-APAC?
* What is the binding and retention time of [89Zr]Zr-DFO-APAC to arteries and atherosclerotic or microvascular lesions? Participants will receive a dose of the [89Zr]Zr-DFO-APAC (IMP) and PET/CT imaging is performed on days 1, 3 and 7, and follow-up visit 7-14 days post IMP dosing.
Interventions:
description: All participants will receive a single i.v. injection of [89Zr]Zr-DFO-APAC 15 MBq (Megabecquerel).
name: [89Zr]Zr-DFO-APAC
type: Drug
description: The IMP administration will be followed by whole-body PET/CT scanning (day 1), and repeated PET/CT scans on days 3 and 7.
name: PET/CT scan
type: Radiation
Study arms:
design_group_title: [89Zr]Zr-DFO-APAC
design_group_type: Experimental
Sponsor: Aplagon Oy
Collaborators: Tracer Europe BV
Drug name mappings:
name: [89Zr]Zr-DFO-APAC
lang: EN
Clinical trial NCT07176923: CS-121 APOC3 Base Editing in FCS
Official title: A Clinical Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of CS-121, an In Vivo Base Editing Therapy Delivered by Lipid Nanoparticles Targeting APOC3, in Adults With Familial Chylomicronemia Syndrome
Conditions: Familial Chylomicronemia Syndrome (FCS)
Summary: This is an open-label, single-arm, dose-escalation Phase I clinical trial to evaluate the safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of CS-121, an in vivo base editing therapy delivered by lipid nanoparticles targeting APOC3, in adult participants (18-55 years) with familial chylomicronemia syndrome (FCS).
Interventions:
description: CS-121 is a in vivo base editing therapy formulated in lipid nanoparticles for targeted editing of the APOC3 gene in hepatocytes. In this study, participants receive a single intravenous infusion of CS-121 at escalating dose levels. The investigational product is designed to reduce ApoC3 protein expression and serum triglyceride levels in adults with familial chylomicronemia syndrome (FCS).
name: CS-121
type: Biological
Study arms:
design_group_description: Participants in this arm will receive a single low dose of CS-121.
design_group_title: Single Low Dose CS-121
design_group_type: Experimental
design_group_description: Participants in this arm will receive a single middle dose of CS-121.
design_group_title: Single Middle Dose CS-121
design_group_type: Experimental
design_group_description: Participants in this arm will receive a single high dose of CS-121.
design_group_title: Single High Dose CS-121
design_group_type: Experimental
design_group_description: Participants in this arm will receive a single lower dose 1 of CS-121.
design_group_title: Single Lower Dose 1 of CS-121
design_group_type: Experimental
design_group_description: Participants in this arm will receive a single lower dose 2 of CS-121.
design_group_title: Single Lower Dose 2 of CS-121
design_group_type: Experimental
Sponsor: CorrectSequence Therapeutics Co., Ltd.
Collaborators: Anhui Medical University No. 1 Affiliated Hospital
Drug name mappings:
name: CS-121
lang: EN
Clinical trial NCT07290205: Remimazolam NeuroImaging
Official title: Neuroimaging of Sedation With Remimazolam
Conditions: Anesthesia
Pain
Remimazolam
Summary: This is a single-arm functional MRI study that will determine the effects of remimazolam on cognition and brain activity and connectivity at rest, during noxious stimulation, and during a memory encoding task
Interventions:
description: Subjects in this group will receive an intravenous infusion of this drug, during a portion of the study.
name: Remimazolam
type: Drug
description: Experimental acute pain stimulus will be delivered using a nerve stimulator. These painful shocks will be paired with a fixed number of the experimental cues, in a pattern that appears random to participants.
name: Peripheral Nerve Stimulation
type: Device
Study arms:
design_group_description: Single-arm study. All subjects receive remimazolam and painful electric nerve stimulation, while being imaged with MRI, as described in the interventions.
design_group_title: Remimazolam+Pain
design_group_type: Experimental
Sponsor: University of Pittsburgh
Collaborators: National Institute of General Medical Sciences
Drug name mappings:
name: 甲苯磺酸瑞马唑仑
lang: CN
name: Remimazolam Tosylate
lang: EN
Clinical trial NCT03336372: Picato for the Treatment of Molluscum Contagiosum in Immunocompromised Patients
Official title: Picato for the Treatment of Molluscum Contagiosum in Immunocompromised Patients
Conditions: Molluscum Contagiosum
Summary: Patients at least 18 years of age will be enrolled in the study to assess the efficacy and tolerability of Picato gel in the treatment of molluscum contagiosum. Patients must have an immunocompromised condition due to taking immunosuppressive drugs or having an inherited disease affecting the immune system.
Interventions:
description: Picato 0.05% or 0.015% topical gel applied nightly for 3 consecutive nights
name: Picato
type: Drug
Study arms:
design_group_title: Picato topical gel
design_group_type: Experimental
Sponsor: Center For Clinical Studies Ltd. LLP
Collaborators: Leo Pharma, Inc.
Drug name mappings:
name: 巨大戟醇甲基丁烯酸酯
lang: CN
name: Ingenol Mebutate
lang: EN
Clinical trial NCT06216938: RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis
Official title: Phase I Pilot Study of RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis
Conditions: Melanoma
Summary: This early-phase study will examine Vusolimogene Oderparepvec, a genetically modified oncolytic viral strain of the herpes simplex type 1 (HSV-1) virus, with potential oncolytic, immunostimulating and antineoplastic activities. Upon administration, vusolimogene oderparepvec specifically targets, infects and replicates in tumor cells and does not infect healthy cells. This results in tumor cell lysis and the release of virus particles which infect and replicate within nearby tumor cells, resulting in tumor cel death. The immune system is activated by the released tumor-associated antigens (TAAs) from the tumor cells creating an anti-tumor immune response against the tumor cells, thereby further killing the tumor cells. The virus itself also elicits a tumor-specific systemic immune and cytotoxic T-lymphocyte (CTL) response, thereby killing nearby non-infected tumor cells.
Interventions:
description: Vusolimogene Oderparepvec is a genetically modified oncolytic viral strain of the herpes simplex type 1 (HSV-1) virus, with potential oncolytic, immunostimulating and antineoplastic activities.
name: Vusolimogene oderparepvec (RP1)
type: Biological
Study arms:
design_group_description: Patients will receive 3 doses of RP1 (1.0 mL/injection; 10e6 PFU/mL for the first dose, and 10e7 mL for the subsequent 2 doses). The drug will be injected into the skin at the tumor biopsy site at baseline (day 1), day 15, and day 21, 4-5 weeks prior to SOC WLE and SLNB. Definitive surgery will occur up to 28-35 (± 2 days) days from first injection, to avoid treatment delay.
design_group_title: Vusolimogene oderparepvec (RP1)
design_group_type: Experimental
Sponsor: University of Pittsburgh
Collaborators: Replimune, Inc.
Drug name mappings:
name: Vusolimogene oderparepvec
lang: EN
Clinical trial NCT05851378: Hyperpolarized Carbon-13 Alpha-ketoglutarate Imaging in IDH Mutant Glioma
Official title: Hyperpolarized Carbon-13 Alpha-ketoglutarate Metabolic Imaging in IDH Mutant Glioma
Conditions: Adult Gliomas, Mixed
Summary: This study will investigate the use of hyperpolarized (HP) carbon-13 (13C) alpha-ketoglutarate (aKG) (HP 13C-aKG) to characterize tumor burden in participants with isocitrate dehydrogenase (IDH) mutant glioma.
Interventions:
description: Given intravenously at time of imaging
name: Hyperpolarized Carbon 13 Alpha-ketoglutarate (HP C13-aKG)
other_name: Hyperpolarized C13-aKG
HP C13-aKG
type: Drug
description: Magnetic resonance imaging is a medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body
name: Magnetic Resonance Image (MRI)
other_name: MRI
MRI scan
type: Procedure
Study arms:
design_group_description: Cohort 1 will be comprised of 10 participants with Isocitrate dehydrogenase (IDH) mutant glioma who may or may not have received prior treatment for optimizing imaging protocol. Participants will be injected with 0.67ml/kg actual body weight of 100 millimolar (mM) of α-KG solution and have a single imaging scan.
design_group_title: Cohort 1: Hyperpolarized Carbon-13 Alpha-ketoglutarate (HP 13C-aKG)
design_group_type: Experimental
design_group_description: Cohort 2 will be comprised 30 participants with recurrent IDH mutant glioma before receiving surgical resection. Participants will be injected with 0.67ml/kg actual body weight of 100 millimolar (mM) of α-KG solution and have a single imaging scan.
design_group_title: Cohort 2: Hyperpolarized Carbon-13 Alpha-ketoglutarate (HP 13C-aKG)
design_group_type: Experimental
Sponsor: The University of California, San Francisco
Collaborators: National Cancer Institute
Drug name mappings:
name: Hyperpolarized Carbon 13 Alpha-ketoglutarate
lang: EN
Clinical trial NCT04630444: Riluzole Effects on Hippocampus Biomarkers
Official title: An Investigational Study of Riluzole Effects on Hippocampus Biomarkers
Conditions: Posttraumatic Stress Disorder
Summary: To examine the clinical efficacy of the anti-glutamatergic medication riluzole in posttraumatic stress disorder (PTSD), and its effect on hippocampus biomarkers that our laboratory previously has identified using MRS.
Interventions:
description: 30 PTSD patients with riluzole 100 mg daily (50 mg bid).
name: Riluzole
type: Drug
Study arms:
design_group_description: 30 PTSD patients receiving riluzole 100 mg daily (50 mg bid).
design_group_title: Intervention Group
design_group_type: Experimental
Sponsor: McLean Hospital, Inc.
Collaborators: Brain & Behavior Research Foundation
Drug name mappings:
name: 利鲁唑
lang: CN
name: Riluzole
lang: EN
name: リルゾール
lang: JP
Clinical trial NCT06692933: Effects of a Hemp Product on the Pharmacokinetics and Pharmacodynamics of Clopidogrel
Official title: Effects of a Hemp Product on the Pharmacokinetics and Pharmacodynamics of Clopidogrel
Conditions: Interaction
Summary: The goal of this clinical trial is to determine how two different doses of cannabidiol (CBD), given as a hemp product, change the blood concentrations of the drug clopidogrel in the body. Results will be used to help design future studies and to assist healthcare providers in informing their patients about the safe use of CBD.
Interventions:
description: Cannabidiol (30 mg) in the form of an orally administered hemp oil softgel
name: Cannabidiol in the form of hemp
other_name: CBD
type: Drug
description: 75 mg oral clopidogrel
name: Clopidogrel
other_name: Plavix
type: Drug
Study arms:
design_group_description: Participants will be administered a single oral dose (75 mg) of clopidogrel. Blood and urine will be collected for 24 hours.
design_group_title: Arm 1: clopidogrel alone
design_group_type: Experimental
design_group_description: Participants will self-administer a single low dose of hemp (30 mg CBD) as an oral softgel at home daily for 5 consecutive days. On day 6, participants will return to the research setting, where they will be administered a single low dose of hemp (30 mg CBD) and a single oral dose of clopidogrel (75 mg). Blood will be collected for 72 hours and urine will be collected for 24 hours.
design_group_title: Arm 2: chronic hemp (30 mg CBD) + clopidogrel
design_group_type: Experimental
design_group_description: Participants will repeat the Arm 2 procedures using a higher dose of hemp (240 mg CBD)
design_group_title: Arm 3: chronic hemp (240 mg CBD) + clopidogrel
design_group_type: Experimental
Sponsor: Washington State University
Collaborators: National Center For Complementary & Integrative Health
Office of Dietary Supplements
Drug name mappings:
name: 硫酸氢氯吡格雷
lang: CN
name: Clopidogrel Bisulfate
lang: EN
name: クロピドグレル硫酸塩
lang: JP
name: 大麻二酚
lang: CN
name: Cannabidiol
lang: EN
Clinical trial NCT04369560: Virtual Histology of the Bladder Wall for Bladder Cancer Staging
Official title: Virtual Histology of the Bladder Wall for Bladder Cancer Staging; A Novel Intravesical Contrast-Enhanced MRI for Bladder Cancer Staging
Conditions: Urinary Bladder Neoplasms
Summary: This is a phase Ib study of the safety and performance of a novel intravesical contrast-enhanced Magnetic Resonance Imaging protocol for determination of bladder cancer stage prior to transurethral resection of bladder tumor (21 subjects) or prior to radical cystectomy for muscle invasive disease (21 subjects). Subjects will undergo a single MRI study: a pre-contrast, single breath hold image followed by sterile placement of a temporary urethral catheter for instillation of a 50mL solution containing Gadobutrol (4 mM) plus ferumoxytol (5 mM) and then a second, post-contrast image. Images will be reviewed by two dedicated abdominal radiologists, who are blinded to the pathologic staging, for determination of tumor presence and depth of bladder wall penetration.
Interventions:
description: 60-cm wide bore 3T scanner (Siemens AG, Erlangen, Germany) with a 32-channel pelvic phased-array coil placed over the bladder.
name: Magnetic Resonance Imaging
type: Diagnostic Test
description: A paramagnetic macrocyclic gadolinium-based contrast agent administered intravenously for use in magnetic resonance imaging. Contrast-enhancement is a result of the neutral complex of gadolinium and dihydroxy-hydroxymethylpropyl- tetraazacyclododecane-triacetic acid (butrol).
name: Gadobutrol intravesical administration (4mM)
other_name: Image result for other names for Gadobutrol Gadavist
type: Drug
description: An iron preparation (Fe3O4) approved for intravenous treatment of anemia in the setting of renal failure, comprised of superparamagnetic iron oxide nanoparticles which are coated by a semi-synthetic carbohydrate shell in an isotonic, neutral pH solution.
name: Ferumoxytol intravesical administration (5 mM)
other_name: FERAHEME
type: Drug
Study arms:
design_group_description: Prior to planned surgical resection, subjects will undergo a single Magnetic Resonance Imaging study: a single breath-hold pre-contrast image followed by sterile placement of a temporary urethral catheter for instillation of a 50mL solution containing Gadobutrol (4 mM) plus ferumoxytol (5 mM) and a second, single breath hold post-contrast image.
design_group_title: Magnetic Resonance Imaging
design_group_type: Experimental
Sponsor: University of Pittsburgh
Collaborators: National Cancer Institute
Drug name mappings:
name: 非莫妥尔
lang: CN
name: Ferumoxytol
lang: EN
name: 钆布醇
lang: CN
name: Gadobutrol
lang: EN
name: ガドブトロール
lang: JP
Clinical trial NCT07067905: Clinical Evaluation of [68Ga]Ga-XT771 PET for Diagnosis in Patients With Glioblastoma and Clear Cell Renal Cell Carcinoma
Official title: Clinical Evaluation of [68Ga]Ga-XT771 PET for Diagnosis in Patients With Glioblastoma and Clear Cell Renal Cell Carcinoma
Conditions: Clear Cell Renal Cell Carcinoma and Glioblastoma
Summary: A prospective, open-label, phase 1 study. This clinical trial aims to evaluate the diagnostic value of 68Ga-XT771, a CAIX/CAXII protein-specific probe, in PET/CT imaging for patients with clear cell renal cell carcinoma and glioblastoma. Safety, tolerability, and biodistribution characteristics of 68Ga-XT771 will also be assessed.
Interventions:
description: 68Ga-XT771 is injected intravenously with a dose of 4-8 mCi
name: 68Ga-XT771
type: Drug
Study arms:
design_group_description: Experimental: 68Ga-XT771 Subjects with suspected or confirmed clear cell renal cell carcinoma will receive an intravenous injection of 68Ga-XT771followed by PET imaging. The subjects will also receive a 18F-FDG PET/CT or 68Ga-DPI-4552 scan within a four-week period.<br/>Pathologically confirmed glioblastoma subjects will receive intravenous administration of the CAIX/CAXII-targeted probe 68Ga-XT771, followed by PET imaging. Additionally, 11C-METHIONINE (11C-MET) PET scanning will be performed within a 4-week window<br/>Drug: 68Ga-XT771 68Ga-XT771 is injected intravenously with a dose of 4-8 mCi
design_group_title: Participant Group
design_group_type: Experimental
Sponsor: Chinese People's Liberation Army General Hospital
Collaborators: Sinotau Pharmaceutical Group
Drug name mappings:
name: 68Ga/64Cu-FAPI-XT117
lang: EN