PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT06716905: Safety, Tolerability, and Pharmacokinetics of ACT500 in Healthy Adult Participants
Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Dose Escalations of ACT500 (Formerly Known as NM6606) in Chinese Healthy Adult Participants
Conditions: Non-alcoholic Steatohepatitis
Summary: This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical study, divided into two parts. The first part is a single-dose escalation study (Part1,SAD study phase), and the second part is a multiple-dose escalation study (Part2,MAD study phase). It's aimed to evaluate the safety, tolerability, and pharmacokinetics (PK) of ACT500 in healthy adult participants, and to explore possible metabolites and biomarkers of ACT500.
Interventions:
description: Participants will receive a single ascending oral dose of ACT500 Tablets under fasting state on the first day in Part 1
name: ACT500 tablets
type: Drug
description: Participants will receive placebo matched to ACT500 Tablets.
name: Placebo
type: Drug
description: Participants will receive multiple ascending oral dose of ACT500 Tablets under fasting state once daily for 7 days in Part 2.
name: ACT500 tablets
type: Drug
description: Participants will receive placebo matched to ACT500 Tablets.
name: Placebo
type: Drug
Study arms:
design_group_title: Part 1:ACT500 Tablets
design_group_type: Experimental
design_group_title: Part 1: Placebo
design_group_type: Placebo Comparator
design_group_title: Part 2:ACT500 Tablets
design_group_type: Experimental
design_group_title: Part 2: Placebo
design_group_type: Placebo Comparator
Sponsor: Xiamen Amoytop Biotech Co. Ltd.
Collaborators: Zhongnan hospital of wuhan university
Drug name mappings:
name: NM-6606
lang: EN
Clinical trial NCT04673630: Study to Evaluate the Pharmacokinetics of Tezepelumab in Children With Asthma
Official title: A Phase I, Open-label Study to Evaluate the Pharmacokinetics of Tezepelumab in Children ≥ 5 to 11 Years of Age With Mild, Moderate, or Severe Asthma (TRAILHEAD)
Conditions: Asthma
Summary: This study will evaluate the pharmacokinetic (PK) profile of a single subcutaneous (SC) dose of tezepelumab in children aged ≥ 5 to 11 years with asthma.
Interventions:
description: Single dose subcutaneous injection
name: Tezepelumab
type: Biological
Study arms:
design_group_description: Tezepelumab subcutaneous injection
design_group_title: Tezepelumab
design_group_type: Experimental
Sponsor: AstraZeneca PLC
Collaborators: Amgen, Inc.
Drug name mappings:
name: 特泽利尤单抗
lang: CN
name: Tezepelumab
lang: EN
name: テゼペルマブ (遺伝子組換え)
lang: JP
Clinical trial NCT01076868: Incidence of Vivax Along the Thai Burma Border
Official title: Determining the Incidence of New Plasmodium Vivax Infections After Radical Treatment Following Vivax Malaria Along the Thai Burma Border
Conditions: Vivax Malaria
Summary: This is a continuous cohort study consisting of 200 participants (one third 6 months old to 5 years, one third 6 to 15 years old, one third ≥ 15 years old) i.e. a new patient will be recruited (from the same age group) for any patient who develops a Pv infection so that the cohort will always have 200 patients for 3 years. Each patient will be actively followed-up every 8 weeks until Plasmodium vivax infection occurs but the duration of follow up and the number of follow up visits for each patient will vary depending on when or if a vivax infection occurs and when the patient is recruited. Therefore, the minimum follow up period for each patient will be 6 months or time to vivax infection and the maximum will be 3 years if a patient does not get vivax infection and is recruited at the beginning of the study.
Interventions:
description: Primaquine x 14 days
name: Primaquine
other_name: primaquine 0.5 mg/kg/day
type: Drug
Study arms:
design_group_description: Primaquine 14 days
design_group_title: Primaquine
design_group_type: Experimental
Sponsor: University of Oxford
Collaborators: Mahidol University
Drug name mappings:
name: 磷酸伯氨喹
lang: CN
name: Primaquine Phosphate
lang: EN
name: プリマキンリン酸塩
lang: JP
Clinical trial NCT06732427: Clinical Study of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment
Official title: Efficacy and Safety of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment: a Multicenter-prospective, Randomized, Controlled Trial
Conditions: Efficacy and Safety
Summary: This is a study on the efficacy and safety of fospropofol disodium for injection in painless endoscopic diagnosis and treatment, project No.2024-YCRF-M1021, which will take more than 2 years to complete.
This is a multicenter, randomized, double-blind, controlled clinical study. Using a computer-generated randomized number table, the patients were divided into two groups: the group L (fospropofol disodium group) and the group B (propofol group). After determining the group of enrolled patients, the drug was administered by two fixed anesthesiologists By participating in this study, it is possible to make your anesthesia induction stable, stable intraoperative circulation, awake and safe and comfortable, to reduce the incidence of intraoperative hypoxemia, intraoperative awareness, cardiovascular and cerebrovascular malignant events (malignant arrhythmia, cardiac arrest), which is conducive to your rapid postoperative recovery and reduce hospitalization costs.
Interventions:
description: Group L received slow intravenous sufentanyl 0. 1 ug / kg +fospropofol Disodium for injection 8mg / kg (completed within 60 seconds)
name: fospropofol Disodium for injection
other_name: sulfentanyl
type: Drug
description: Group B received slow intravenous sufentanyl 0. 1 ug / kg +propofol 2mg / kg (completed within 60 seconds)
name: Propofol
other_name: sulfentanyl
type: Drug
Study arms:
design_group_description: Painless gastrointestinal endoscopy in group L was mainly performed using fospropofol Disodium for injection
design_group_title: Fospropofol Disodium
design_group_type: Experimental
design_group_description: Painless gastrointestinal endoscopy in group B was mainly performed using propofol
design_group_title: propofol
design_group_type: Active Comparator
Sponsor: Affiliated Hospital of Nantong University
Collaborators: Rugao People's Hospital
Drug name mappings:
name: 磷丙泊酚二钠
lang: CN
name: Fospropofol Disodium
lang: EN
Clinical trial NCT02252523: Dexmedetomidine-based Sedation in Neurocritical Care Patients
Official title: Feasibility of Dexmedetomidine-based Sedation in Neurocritical Care Patients : a Pilot Study
Conditions: Acute Brain Injuries
Summary: This will be an open, prospective pilot study with pharmacological analysis. This study is designed to assess the efficacity and safety of dexmedetomidine-based sedation in two subgroups of neurocritically ill patients requiring mechanical ventilation for more than 48 hours. Those with or at risk for intracranial hypertension requiring deep sedation and those requiring a light to moderate sedation for early neurological evaluation.
The main objective is to assess the feasability of dexmedetomidine infusion in terms of efficacy and safety (especially cardiovascular tolerance) in brain-injured patients admitted to intensive care unit and requiring sedation and mechanical ventilation for a predictable duration greater than or equal to 48 hours. Secondary objectives include the study of hemodynamic parameters evolution, dose-response relationship, blood (+/- cerebrospinal fluid) drug concentration, opioates and co-hypnotic consumption.
Interventions:
name: Dexmedetomidine
type: Drug
Study arms:
design_group_title: DEXMEDETOMIDINE
design_group_type: Experimental
Sponsor: Centre Hospitalier Universitaire de Clermont Ferrand
Collaborators: Orion Oyj
Drug name mappings:
name: 盐酸右美托咪定
lang: CN
name: Dexmedetomidine Hydrochloride
lang: EN
name: デクスメデトミジン塩酸塩
lang: JP
Clinical trial NCT05406479: Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy (Phase 2)
Official title: Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy: Phase 2 Study
Conditions: Leprosy
Summary: This study will evaluate a combination of bedaquiline and rifampicin as post exposure prophylaxis (PEP) for leprosy in Comoros. It will be a follow-up to the PEOPLE trial on PEP with rifampicin, which is ending in 2022. This new trial will be called the 'Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy' or 'BE-PEOPLE' trial. There will be two main study arms, a comparator arm based on the current WHO recommendation of providing a single dose of rifampicin (10 mg/kg) to close contacts of leprosy patients and an intervention arm in which this regimen will be reinforced with bedaquiline, 400 or 800 mg depending on weight, to be repeated once after four weeks for household contacts. The main study will be preceded by a phase 2 safety study.
Interventions:
description: Single dose of Bedaquiline
name: BE-PEP (Bedaquiline)
type: Drug
description: Single dose of Rifampicin
name: SDR-PEP
type: Drug
description: Single dose of Rifampicin
name: BE-PEP (Rifampicine)
type: Drug
Study arms:
design_group_description: Eligible participants will receive one dose of Bedaquiline plus Rifampicin
design_group_title: BE-PEP (Bedaquiline Post-Exposure Prophylaxis)
design_group_type: Experimental
design_group_description: Eligible participants will receive one dose of Rifampicin (WHO recommendation)
design_group_title: SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis)
design_group_type: Active Comparator
Sponsor: Instituut voor Tropische Geneeskunde
Collaborators: Damien Foundation
Drug name mappings:
name: 富马酸贝达喹啉
lang: CN
name: Bedaquiline Fumarate
lang: EN
name: ベダキリンフマル酸塩
lang: JP
Clinical trial NCT00452075: Erlotinib as First-line Treatment of Advanced Non-small Cell Lung Cancer (NSCLC) for Patients Unfit for Chemotherapy
Official title: A Phase II Study of Erlotinib and Predictive Markers as First-line Treatment of Advanced Non-small Cell Lung Cancer for Patients Unfit for Chemotherapy
Conditions: Non Small Cell Lung Cancer
Summary: A phase II study of Tarceva (Erlotinib) and predictive markers as first-line treatment of advanced non-small cell lung cancer for patients unfit for chemotherapy (NSCLC) Clinical Phase II Stage IIIB or IV non-small cell lung cancer (NSCLC) Primary end point: Disease control rate (= CR+PR and SD at 8 weeks /patients). Secondary end point: Safety (Serious Adverse Events, Adverse Events leading to premature withdrawal, unexpected TarcevaTM related AEs) .Correlation of EGFR expression rate (HER1) and FISH potentially predictive for response.
An open-label, non randomized, multicenter, clinical trial of TarcevaTM as single agent The sample size is 29 patients in 2 stages and based on Simon´s optimal 2 stage design. Stage 1 will accrue 10 patients, if less than 1 response is observed the study will stop; if more than 1 response is observed the accrual will continue up till 29 patients. A total of 29 patients would be entered and the treatment will be declared to have sufficient activity to deserve further attention if at least 5 patients obtain disease control.
Interventions:
description: 150mg daily
name: erlotinib
other_name: tarceva
type: Drug
Study arms:
design_group_description: erlotinib daily
design_group_title: arm 1 medicine
design_group_type: Experimental
Sponsor: Rigshospitalet
Collaborators: Hoffmann-La Roche, Inc.
Drug name mappings:
name: 盐酸厄洛替尼
lang: CN
name: Erlotinib Hydrochloride
lang: EN
name: エルロチニブ塩酸塩
lang: JP
Clinical trial NCT02695628: [18F]FMISO PET/CT After Transcatheter Arterial Embolization in Imaging Tumors in Patients With Liver Cancer
Official title: Assessment of Treatment-Induced Tissue Hypoxia After Transcatheter Arterial Embolization of Hepatocellular Carcinoma: A Feasibility Study With [18F]FMISO PET/CT
Conditions: Adult Liver Carcinoma
Liver Cirrhosis
Summary: This clinical trial studies how well 18F-fluoromisonidazole ([18F]FMISO) positron emission tomography (PET)/computed tomography (CT) works after transcatheter arterial embolization in imaging tumors in patients with liver cancer. Transcatheter arterial embolization blocks blood flow to tumor cells by inserting tiny foreign particles into an artery near the tumor. [18F]FMISO is a type of radioimaging agent that binds to large molecules in tumor cells that have a low level of oxygen, and the radiation given off by [18F]FMISO is picked up by a PET scan and this may help researchers learn whether changes occur in the tumors after treatment, which can help decide how well the treatment worked earlier than is currently possible
Interventions:
description: Undergo [18F] FMISO PET/CT
name: 18F-Fluoromisonidazole
other_name: 18F-MISO
18F-Misonidazole
FMISO
type: Drug
description: Undergo transcatheter arterial embolization
name: Arterial Embolization
other_name: TAE
Transarterial Embolization
type: Procedure
description: Undergo [18F] FMISO PET/CT
name: Computed Tomography
other_name: CAT
CAT Scan
CT
CT SCAN
Computerized Axial Tomography
Computerized Tomography
tomography
type: Diagnostic Test
description: Undergo [18F] FMISO PET/CT
name: Positron Emission Tomography
other_name: Medical Imaging, Positron Emission Tomography
PET
PET SCAN
Positron Emission Tomography Scan
Positron-Emission Tomography
proton magnetic resonance spectroscopic imaging
type: Diagnostic Test
Study arms:
design_group_description: Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole IV and undergo PET/CT scans 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment.
design_group_title: Diagnostic (18F-fluoromisonidazole, PET/CT, embolization)
design_group_type: Experimental
Sponsor: Stanford University
Collaborators: National Cancer Institute
Drug name mappings:
name: 18F-Fluoromisonidazole
lang: EN
Clinical trial NCT00616187: Atorvastatin in Relapsing-Remitting Multiple Sclerosis
Official title: Oral High-Dose Atorvastatin Treatment in Relapsing-Remitting Multiple Sclerosis
Conditions: Relapsing Remitting Multiple Sclerosis
Summary: A phase II open-label baseline-to-treatment trial was designed to evaluate the safety, tolerability and efficacy of orally administered atorvastatin in patients with relapsing-remitting multiple sclerosis (RRMS). Patients with at least one gadolinium-enhancing lesion (CEL) at screening by magnetic resonance imaging (MRI) were eligible for the study. Patients are screened and enrolled in the outpatient clinic of the Cecilie Vogt Clinic at the Charité - University Medicine Berlin. After a baseline period of 3 monthly MRI scans (months -2 to 0), patients followed a 9-month treatment period on 80 mg atorvastatin daily. The primary endpoint is the number of CEL in treatment months 6 to 9 compared to baseline. Secondary endpoints include other MRI-based parameters and changes in clinical scores and immune responses.
Interventions:
description: IFN-β-1a 22 µg s.c. 3 times weekly or IFN-β-1b s.c. every other day (3 months baseline) and add on oral daily 80 mg atorvastatin (9 months add on treatment)
name: interferon beta treatment to add-on atorvastatin treatment
type: Drug
description: no treatment(3 months baseline)and oral daily 80 mg atorvastatin (9 months add on treatment)
name: untreated to atorvastatin treatment
type: Drug
Study arms:
design_group_title: interferon
design_group_type: Active Comparator
design_group_title: untreated
design_group_type: Sham Comparator
Sponsor: Charité - Universitätsmedizin Berlin
Collaborators: Pfizer Inc.
Deutsche Forschungsgemeinschaft
German Federal Ministry Of Education And Research
Drug name mappings:
name: 干扰素β-1a(Biogen, Inc.)
lang: CN
name: Interferon Beta-1a (Biogen, Inc.)
lang: EN
name: インターフェロン ベータ-1a （遺伝子組換え）
lang: JP
name: 阿托伐他汀锶
lang: CN
name: Atorvastatin strontium
lang: EN
Clinical trial NCT00227721: Gemcitabine and Docetaxel in Treating Patients With Relapsed or Refractory Ovarian Epithelial or Peritoneal Cancer
Official title: Phase II Trial of Weekly Gemcitabine and Docetaxel Combination Therapy for Relapsed Ovarian or Peritoneal Cancer
Conditions: Ovarian Cancer
Peritoneal Cavity Cancer
Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with relapsed or refractory ovarian epithelial or peritoneal cancer.
Interventions:
description: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days
name: Docetaxel
other_name: Taxotere®
type: Drug
description: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days
name: Gemcitabine hydrochloride
other_name: Gemzar ®
type: Drug
Study arms:
design_group_description: Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle
design_group_title: Docetaxel & Gemcitabine hydrochloride
design_group_type: Experimental
Sponsor: Barbara Ann Karmanos Cancer Institute
Collaborators: National Cancer Institute
Drug name mappings:
name: 盐酸吉西他滨
lang: CN
name: Gemcitabine Hydrochloride
lang: EN
name: ゲムシタビン塩酸塩
lang: JP
name: 多西他赛
lang: CN
name: Docetaxel
lang: EN
name: ドセタキセル
lang: JP
Clinical trial NCT03762395: Anti Inflammatory Lipid Mediators in Asthma Lipid Anti-Inflammtory Mediators in Asthma
Official title: Anti Inflammatory Lipid Mediators in Asthma: A Double Blind Placebo Control Cross Over, Proof of Concept Study of CXA-10 to Reduce Bronchial Hyperresponsiveness in Obese Asthmatics; Lipid Anti-Inflammatory Mediators in Asthma to Reduce Hyperresponsiveness in Obese Asthmatics
Conditions: Asthma
Obesity
Summary: The main purpose of this Phase 2 double blind, placebo controlled crossover clinical study is to demonstrate the efficacy and safety of CXA-10 in obese adult asthmatics. Obesity induces a chronic systemic inflammatory state characterized by impaired adipokine signaling, pro-inflammatory cytokine responses, inflammatory cell activation and enhanced generation of oxidative inflammatory mediators. This impacts the lung, increasing the severity of asthma and its exacerbations. This research will evaluate how a synthetic nitro-fatty acid (CXA-10, 10-nitro-octadec-9-enoic acid) suppresses the systemic and airway inflammation that contributes to the obese asthmatic phenotype. Current data support the pleiotropic signaling actions of CXA-10 to induce adaptive signaling actions that beneficially modulate adipokine and cytokine expression and inhibit systemic and pulmonary inflammation. The investigators hypothesize that CXA-10 induced signaling responses will alleviate obesity-related airway hyperreactivity in obese adult asthmatics.
Interventions:
description: 6 weeks of treatment with 150 mg/day of orally administered CXA-10
name: CXA-10
other_name: 10-nitro-9(E)-octadec-9-enoic acid
type: Drug
description: 6 weeks of treatment with orally administered matching placebo (to 150 mg/day of CXA-10)
name: Matching Placebo
type: Drug
Study arms:
design_group_description: Administered orally, continuously, and daily for at least 6 weeks. Dispensed at Visit 1. Washout period of at least 4 weeks and then enter crossover phase of an additional 6 weeks. Drug will be dispensed at Visit 4.
design_group_title: CXA-10
design_group_type: Experimental
design_group_description: Administered orally, daily, and continuously for at least 6 weeks. Dispensed at Visit 1. Washout period of at least 4 weeks and then enter crossover phase of an additional 6 weeks. Placebo will be dispensed at Visit 4.
design_group_title: Matching Placebo
design_group_type: Placebo Comparator
Sponsor: University of Colorado Denver
Collaborators: National Heart, Lung & Blood Institute
National Institutes of Health
Drug name mappings:
name: 10-硝基油酸
lang: CN
name: 10-Nitrooleic acid
lang: EN
Clinical trial NCT00585507: Efficacy and Safety of 500mg of Fulvestrant
Official title: A Phase II Multi-Center Study to Evaluate the Efficacy and Safety of 500mg of Fulvestrant (Faslodex) as a First Line Hormonal Treatment in Postmenopausal Women With Hormone Receptor Positive Metastatic Breast Cancer
Conditions: Breast Cancer
Summary: Fulvestrant has proven effective in the treatment of hormone receptor positive metastatic breast cancer. The dose used in studies so far has been well tolerated and may be too low for optimal effectiveness. In this study, a higher dose will be used to see whether an improved outcome will result.
Interventions:
description: 500mg into the muscle on days 1, 15 and 29 and then every 28 days thereafter.
name: Fulvestrant
other_name: Faslodex
type: Drug
Study arms:
design_group_description: fulvestrant 500mg
design_group_title: single
design_group_type: Experimental
Sponsor: Beth Israel Deaconess Medical Center, Inc.
Collaborators: The Brigham & Women's Hospital, Inc.
The General Hospital Corp.
Dana-Farber Cancer Institute, Inc.
University of Colorado Denver
Lowell General Hospital
University of Maryland Greenebaum Cancer Center
Drug name mappings:
name: 氟维司群
lang: CN
name: Fulvestrant
lang: EN
name: フルベストラント
lang: JP
Clinical trial NCT01821560: Baclofen Effects in Cigarette Smokers
Official title: Baclofen Effects on Brain and Behavior in Cigarette Smokers
Conditions: Nicotine Dependence
Summary: The proposed project will utilize perfusion functional magnetic resonance imaging (fMRI), a functional candidate gene association approach (of dopaminergic addictions-targeted polymorphisms), and the dopamine-modulating and gamma-aminobutyric acid (GABA) B receptor agonist, baclofen, to examine the brain and behavioral responses in smokers to appetitive smoking reminders (cues that motivate continued smoking and relapse). These studies will provide a means to identify an appetitive cue-sensitive pharmacologic-responsive endophenotype. Once brain/behavioral/genetic endophenotypes can be determined prior to treatment, smoking cessation treatments can be structured to meet individual needs, which will significantly improve treatment outcome.
Interventions:
name: Baclofen
other_name: Beklo
Gablofen
Kemstro
Liofen
Lioresal
type: Drug
name: placebo
type: Drug
Study arms:
design_group_description: Placebo-treated subjects will follow the identical schedule as Baclofen subjects.
design_group_title: Sugar pill
design_group_type: Placebo Comparator
design_group_description: Baclofen will be dispensed in pill form. Baclofen will be prescribed at 20 mg 4 times per day. Each baclofen pill will be 10 mg. Thus, 2 pills will be taken at each scheduled dose for a total of 8 pills a day over a period of 8 weeks. In this way, the titration schedule, taper and potential dose reductions can be managed.
design_group_title: Baclofen
design_group_type: Active Comparator
Sponsor: University of Pennsylvania
Collaborators: National Institute on Drug Abuse
National Institutes of Health
Drug name mappings:
name: 巴氯芬
lang: CN
name: Baclofen
lang: EN
name: バクロフェン
lang: JP