PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT00291226: Glycine vs Placebo for the Schizophrenia Prodrome
Official title: Glycine vs Placebo for the Schizophrenia Prodrome
Conditions: Schizophrenia Prodrome
Summary: Glycine is a natural amino acid neurotransmitter that acts as a co-agonist at NMDA receptors in brain. We hypothesize that symptoms of the schizophrenia prodrome will improve with glycine to a greater degree than with placebo.
Interventions:
description: Glycine 0.4 g/kg bid
name: Glycine
type: Drug
description: Placebo
name: Placebo
type: Drug
Study arms:
design_group_description: Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing > 100 kg were limited to a total daily dose of 80 g daily. Glycine was dispensed under IND 33,515 (DCJ).
design_group_title: Glycine
design_group_type: Experimental
design_group_description: Placebo was dispensed as a proprietary formulations developed by Glytech, Inc, consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech placebo formulation, consisting of proprietary pre-flavored sugar powders to be dissolved in 8 ounces of water.
design_group_title: Placebo Group
design_group_type: Placebo Comparator
Sponsor: Yale University
Collaborators: National Alliance for Research on Schizophrenia & Depression
GlyTech, Inc.
Drug name mappings:
name: 甘氨酸
lang: CN
name: Glycine
lang: EN
Clinical trial NCT00684554: Buprenorphine Maintenance Treatment of Opioid Dependence in Primary Care: A Randomized Clinical Trial
Official title: Buprenorphine Maintenance Treatment of Opioid Dependence in Primary Care: A Randomized Clinical Trial of At-Home Versus In-Office Buprenorphine Induction
Conditions: Opioid-Related Disorders
Heroin Dependence
Summary: The study will assess the effectiveness of at-home vs. in-office induction for patients entering buprenorphine maintenance at Associates in Internal Medicine (AIM) primary care clinic.
Interventions:
description: Dose is determined according to the participants' individual need.
name: Buprenorphine
other_name: Bup
type: Drug
Study arms:
design_group_description: Buprenorphine Unobserved at home induction
design_group_title: Unobserved-at home
design_group_type: Active Comparator
design_group_description: Buprenorphine Observed in office induction
design_group_title: Observed
design_group_type: Active Comparator
Sponsor: The New York State Psychiatric Institute
Collaborators: National Institute on Drug Abuse
Drug name mappings:
name: 盐酸丁丙诺啡
lang: CN
name: Buprenorphine Hydrochloride
lang: EN
name: ブプレノルフィン塩酸塩
lang: JP
Clinical trial NCT00004795: Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Mild to Moderate Systemic Lupus Erythematosus
Conditions: Systemic Lupus Erythematosus
Summary: OBJECTIVES: I. Evaluate the safety and efficacy of synthetic dehydroepiandrosterone (GL701) in women with prednisone-dependent systemic lupus erythematosus.
II. Describe the pharmacokinetics of GL701.
Interventions:
name: dehydroepiandrosterone
type: Drug
Study arms:
Sponsor: National Center for Research Resources
Collaborators: Northwestern University
Drug name mappings:
name: 普拉睾酮
lang: CN
name: Prasterone
lang: EN
Clinical trial NCT00152633: Effect of Losartan on Retinal Endothelial Function in Patients With Essential Hypertension
Official title: Effect of Losartan on Retinal Endothelial Function in Patients With Essential Hypertension
Conditions: Hypertension
Summary: Essential hypertension is commonly associated with impaired endothelial function. The retinal vasculature is morphologically and functionally related to the cerebral vessels because of the common origin from the internal carotid artery. A recent study in hypertensive patients demonstrated that endothelial function of the retinal vasculature is impaired in hypertensive patients and that it can be restored by treatment with an AT1-receptor antagonist. It is not clear whether this effect is due to blood pressure lowering or whether this is a blood pressure independent effect. The present randomized, double blind study with a cross over design addresses this issue by comparing the effects of losartan and metoprolol on retinal endothelial function in patients with essential hypertension.
Interventions:
name: Losartan
type: Drug
name: Metoprolol
type: Drug
description: Treatment with Losartan
name: Losartan
type: Drug
Study arms:
design_group_description: Treatment with Losartan.
design_group_title: Losartan
design_group_type: Active Comparator
design_group_description: Treatment with Metoprolol.
design_group_title: Betablocker
design_group_type: Active Comparator
Sponsor: Friedrich Alexander Universität Erlangen Nürnberg
Collaborators: Merck Sharp & Dohme Corp.
Drug name mappings:
name: 酒石酸美托洛尔
lang: CN
name: Metoprolol Tartrate
lang: EN
name: メトプロロール酒石酸塩
lang: JP
name: 氯沙坦钾
lang: CN
name: Losartan Potassium
lang: EN
name: ロサルタンカリウム
lang: JP
Clinical trial NCT05797831: Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer
Official title: A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy
Conditions: Endometrial Cancer
Summary: This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.
The study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.
Interventions:
description: Navtemadlin is an experimental MDM2 anticancer drug taken by mouth
name: Navtemadlin
other_name: KRT-232
type: Drug
description: Navtemadlin placebo is a placebo that is the same in appearance to navtemadlin drug taken by mouth
name: Navtemadlin Placebo
type: Drug
Study arms:
design_group_description: Navtemadlin administered orally at 180 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles.
design_group_title: Part 1 Arm 1
design_group_type: Experimental
design_group_description: Navtemadlin administered orally at 240 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles.
design_group_title: Part 1 Arm 2
design_group_type: Experimental
design_group_description: Observational control ("watch and wait") on a 28-day cycle.
design_group_title: Part 1 Arm 3
design_group_type: No Intervention
design_group_description: Navtemadlin administered orally at 180 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles.
design_group_title: Part 2 Arm A
design_group_type: Experimental
design_group_description: Navtemadlin administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles.
design_group_title: Part 2 Arm B
design_group_type: Experimental
design_group_description: Placebo administered orally at 180 mg once daily (QD) on Days 1-7 in a 28-day administration cycle.
design_group_title: Part 2 Arm C
design_group_type: Placebo Comparator
design_group_description: Placebo administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day administration cycle.
design_group_title: Part 2 Arm D
design_group_type: Placebo Comparator
Sponsor: Kartos Therapeutics, Inc.
Collaborators: The Gynecologic Oncology Group
The European Network for Gynaecological Oncological Trial groups (ENGOT)
Drug name mappings:
name: Navtemadlin
lang: EN
Clinical trial NCT00209833: Treatment of Adults Aged Up to 60 Years With De Novo Acute Myeloblastic Leukaemia,Secondary AML, or RAEB-T
Official title: Protocol for the Treatment of Adults Aged </= 60 Years With De Novo Acute Myeloblastic Leukaemia or Secondary AML or RAEB-T (AML 01/99 Trial)
Conditions: De Novo Akute Myeloid Leukemia (AML)
Secondary Acute Myeloid Leukemia (AML)
Refractory Anemia With Excess of Blasts in Transformation
Summary: This randomized phase II/III trial investigates the antileukemic activity and toxicity of the FLAG-Ida regimen as a second induction course in patients with acute myeloid leukaemia and bad response to the first induction cycle and/or with a high risk karyotype and compares the antileukemic activity and toxicity of high dose cytarabine/daunorubicin vs. autologous peripheral blood stem cell transplantation as late consolidation therapy in standard risk patients.
Interventions:
name: Cytarabine
type: Drug
name: Idarubicin
type: Drug
name: Etoposide
type: Drug
name: Fludarabine
type: Drug
name: G-CSF
type: Drug
name: Daunorubicine
type: Drug
Study arms:
Sponsor: Hannover Medical School
Collaborators: Universität Ulm
Humboldt-Universität zu Berlin
Hospital of the Johann Wolfgang Goethe University
Universitatsklinikum Augsburg
Universitätsklinikum Freiburg
Ghent University Hospital
Universitätsklinikum Hamburg-Eppendorf
Drug name mappings:
name: 依托泊苷
lang: CN
name: Etoposide
lang: EN
name: エトポシド
lang: JP
name: 磷酸氟达拉滨
lang: CN
name: Fludarabine Phosphate
lang: EN
name: フルダラビンリン酸エステル
lang: JP
name: Acetyladriamycin
lang: EN
name: 盐酸伊达比星
lang: CN
name: Idarubicin Hydrochloride
lang: EN
name: イダルビシン塩酸塩
lang: JP
name: 阿糖胞苷
lang: CN
name: Cytarabine
lang: EN
name: シタラビン
lang: JP
Clinical trial NCT02510469: Apatinib as Maintenance Therapy After Adjuvant Chemotherapy in Progressive Gastric Cancer With Positive Exfoliative Cancer Cells
Conditions: Gastric Cancer
Summary: The purpose of this study is to assess the efficacy and safety of apatinib as maintenance therapy after adjuvant chemotherapy in progressive gastric cancer patients with positive exfoliative cancer cells.
Interventions:
description: Apatinib Mesylate Tablets 500 mg qd p.o.
name: Apatinib
other_name: ATAN
type: Drug
Study arms:
design_group_description: Apatinib Mesylate Tablets 500 mg qd p.o. after XELOX Adjuvant Chemotherapy (Capectabine 1000mg/m2 po bid d1-14, oxaliplatin 130mg/m2 iv d1, q21d)
design_group_title: Apatinib Maintenance Therapy After Adjuvant Chemotherapy
design_group_type: Experimental
design_group_description: No Intervention After XELOX Adjuvant Chemotherapy (Capectabine 1000mg/m2 po bid d1-14, oxaliplatin 130mg/m2 iv d1, q21d)
design_group_title: Only Adjuvant Chemotherapy
design_group_type: No Intervention
Sponsor: Hebei Medical University
Collaborators: Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Drug name mappings:
name: 甲磺酸阿帕替尼
lang: CN
name: Apatinib Mesylate
lang: EN
Clinical trial NCT05033743: Suppressive Antibacterial Therapy With Once-Weekly Secnidazole Granules to Prevent Recurrent Bacterial Vaginosis; A Pilot Study
Official title: Suppressive Antibacterial Therapy With Once-Weekly Secnidazole Granules to Prevent Recurrent Bacterial Vaginosis; A Pilot Study
Conditions: Recurrent Bacterial Vaginosis
Summary: The purpose of this study is to test the effectiveness Secnidazole to treat recurrent BV. Secnidazole is approved for one-time use in acute BV. In this study, the drug will be used for recurrent BV, and given weekly for 18 weeks.
Interventions:
description: Once weekly 2g oral secnidazole for 18 weeks
name: Secnidazole 2 GM Oral Granules
type: Drug
Study arms:
design_group_description: Secnidazole treatment
design_group_title: Treatment Group
design_group_type: Experimental
Sponsor: Indiana University
Collaborators: Lupin Pharmaceuticals, Inc.
Drug name mappings:
name: 塞克硝唑
lang: CN
name: Secnidazole
lang: EN
Clinical trial NCT00273533: Ramipril in Rheumatoid Arthritis
Official title: Effects of Ramipril on Endothelial Function in Patients With Rheumatoid Arthritis
Conditions: Arthritis, Rheumatoid
Summary: The present study is designed to evaluate the hypothesis that the Angiotensin-Converting Enzyme (ACE) inhibitor Ramipril improves vascular function and reduces markers of low-grade chronic inflammation and oxidative stress in patients with Rheumatoid Arthritis.
Interventions:
name: Ramipril
type: Drug
Study arms:
Sponsor: University of Zurich
Collaborators: Sanofi
Drug name mappings:
name: 雷米普利
lang: CN
name: Ramipril
lang: EN
Clinical trial NCT04692766: Study to Evaluate the Efficacy and Safety of RPH-104 Treatment in Patients With Idiopathic Recurrent Pericarditis
Official title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of RPH-104 Treatment in Patients With Idiopathic Recurrent Pericarditis
Conditions: Pericarditis
Summary: The goal of this study was to evaluate the Efficacy and Safety of RPH-104 Treatment in patients in comparison to placebo with Idiopathic Recurrent Pericarditis
Interventions:
description: solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL transparent glass vial
name: RPH-104
type: Biological
description: Normal Saline (0.9% Sodium Chloride solution for Injection), 5 mL in a polypropylene ampoule, 10 ampoules per labeled package
name: Placebo
type: Drug
Study arms:
design_group_description: subjects will receive RPH-104 at a dose of 80 mg subcutaneously once every 2 weeks
design_group_title: RPH-104 80 mg
design_group_type: Experimental
design_group_description: subjects will receive placebo subcutaneously once every 2 weeks
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: R-Pharm International LLC
Collaborators: Data Management 365
Center of Pharmaceutical Analytics LLC
Drug name mappings:
name: Goflikicept
lang: EN
Clinical trial NCT00477607: Alpha-Lipoic Acid in Preventing Hearing Loss in Cancer Patients Undergoing Treatment With Cisplatin
Official title: Prevention of Cisplatin Ototoxicity With the Antioxidant Alpha-Lipoic Acid
Conditions: Ototoxicity
Unspecified Adult Solid Tumor
Summary: RATIONALE: Alpha-lipoic acid may prevent or lessen hearing loss caused by cisplatin.
PURPOSE: This randomized clinical trial is studying the effectiveness of alpha-lipoic acid in preventing hearing loss in cancer patients undergoing treatment with cisplatin.
Interventions:
description: Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.
name: alpha-lipoic acid
other_name: lipoic acid
type: Drug
description: otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.
name: Audiology
other_name: ototoxicity monitoring
type: Behavioral
description: Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.
name: laboratory biomarker analysis
other_name: MDA
type: Biological
description: Placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.
name: Placebo
type: Drug
Study arms:
design_group_description: Receiving alpha-lipoic acid during cisplatin treatment.
design_group_title: Arm 1
design_group_type: Experimental
design_group_description: Receiving placebo during cisplatin treatment
design_group_title: Arm 2
design_group_type: Placebo Comparator
Sponsor: US Department of Veterans Affairs (District of Columbia)
Collaborators: Oregon Health & Science University
Drug name mappings:
name: 硫辛酸
lang: CN
name: Lipoic acid
lang: EN
Clinical trial NCT06697301: Safety and Efficacy of EIK1001 in Combo With Pembro Versus Placebo and Pembro as First-Line Therapy in Patients With Advanced Melanoma.
Official title: A Multicenter, Randomized, Double-Blind, Active Comparator-Controlled, Adaptive Phase 2/3 Study to Evaluate the Safety and Efficacy of EIK1001 and Pembrolizumab Versus Placebo and Pembrolizumab as First-Line Therapy in Participants With Advanced Melanoma (TeLuRide-006)
Conditions: Advanced Melanoma
Summary: The study is for patients with advanced melanoma who are eligible for standard therapy with Pembrolizumab.
Interventions:
description: EIK1001 is a Toll-like receptor 7/8 (TLR 7/8) dual agonist.
name: EIK1001
type: Drug
description: Pembrolizumab is a PD-1 inhibitor.
name: Pembrolizumab (KEYTRUDA® )
type: Drug
Study arms:
design_group_description: Participants in this arm will receive Placebo and Standard of Care (Pembrolizumab).
design_group_title: Arm 1
design_group_type: Active Comparator
design_group_description: Participants in this arm will receive EIK1001 (selected dose 1) + Standard of Care (Pembrolizumab).
design_group_title: Arm 2
design_group_type: Experimental
design_group_description: Participants in this arm will receive EIK1001 (selected dose 2) + Standard of Care (Pembrolizumab).
design_group_title: Arm 3
design_group_type: Experimental
Sponsor: Eikon Therapeutics, Inc.
Collaborators: Merck Sharp & Dohme LLC
Drug name mappings:
name: Resiquimod Sulfate
lang: EN
name: 帕博利珠单抗
lang: CN
name: Pembrolizumab
lang: EN
name: ペムブロリズマブ（遺伝子組換え）
lang: JP
Clinical trial NCT02597478: Fentanyl Sublingual Spray for Exercise-Induced Breakthrough Dyspnea
Official title: A Preliminary Study of Prophylactic Fentanyl Sublingual Spray for Exercise-Induced Breakthrough Dyspnea
Conditions: Advanced Cancers
Summary: The goal of this clinical research study is to learn if fentanyl can help shortness of breath in cancer patients. Researchers also want to learn if the study drug can help to improve your physical function.
Interventions:
description: Low-dose Fentanyl Goup: 15-25% of the morphine equivalent daily dose (MEDD) sprayed into mouth and under tongue one hour after first Shuttle Walk Test.<br/>High-Dose Fentanyl Group: 35-45% of the morphine equivalent daily dose (MEDD) sprayed into mouth and under tongue one hour after first Shuttle Walk Test.
name: Fentanyl Sublingual Spray
other_name: FSS
Fentanyl SL Spray
type: Drug
description: Participants walk back and forth between 2 cones in an indoor hallway for up to 12 minutes. After one hour Fentanyl Spray delivered, then second walk test performed.
name: Shuttle Walk Test
type: Procedure
description: Questionnaire completed about any breathing problems or other symptoms participant may be having at baseline. End of study questionnaire asks which dose level of study drug participant thinks they received. Participant also completes a questionnaire about how study drug may have helped them and how satisfied they are with the study. It should take about 5 minutes to complete the questionnaire.
name: Questionnaires
other_name: Surveys
type: Behavioral
description: After each walk test, participant completes 4 tests of their mental abilities. It should take 15 minutes total to complete these tests.
name: Mental Ability Tests
type: Behavioral
description: Thirty days study visit participant called by study staff. This call should last about 10 minutes.
name: Phone Call
type: Behavioral
Study arms:
design_group_description: Questionnaires completed at baseline and at end of study visit. Participant performs Shuttle Walk Test before and after receiving low-dose Fentanyl sublingual spray. Four mental ability tests completed after each walk test. Low-dose Fentanyl sprayed into mouth and under tongue one hour after first Shuttle Walk Test.
design_group_title: Low-Dose Fentanyl Spray Group
design_group_type: Experimental
design_group_description: Questionnaires completed at baseline and at end of study visit. Participant performs Shuttle Walk Test before and after receiving high-dose Fentanyl sublingual spray. Four mental ability tests completed after each walk test. High-dose Fentanyl sprayed into mouth and under tongue one hour after first Shuttle Walk Test.
design_group_title: High-Dose Fentanyl Spray Group
design_group_type: Experimental
Sponsor: The University of Texas MD Anderson Cancer Center
Collaborators: INSYS Therapeutics, Inc.
Drug name mappings:
name: 芬太尼
lang: CN
name: Fentanyl
lang: EN
name: フェンタニル
lang: JP
Clinical trial NCT00970944: Effectiveness of Amantadine Hydrochloride for Treatment of Severe Traumatic Brain Injury (TBI)
Official title: A Multicenter Prospective Randomized Controlled Trial of the Effectiveness of Amantadine Hydrochloride in Promoting Recovery of Function Following Severe Traumatic Brain Injury
Conditions: Traumatic Brain Injury
Summary: This is a controlled trial of amantadine to improve level of function following severe traumatic brain injury.
The purpose of this study is:
1. To determine whether amantadine hydrochloride, given in a dose of 200-400 mg, improves functional recovery from the vegetative and minimally conscious states
2. To determine whether amantadine-related gains in function persist following drug discontinuation
3. To determine the safety profile of amantadine in patients with disorders of consciousness
Interventions:
description: 184 patients who remain in VS or MCS 4 - 16 weeks post-TBI will be randomized in a stratified fashion to 4 weeks of amantadine (200 - 400 mg/day) followed by a 2-week washout period. The Disability Rating Scale (DRS) will be the primary dependent variable with the Coma Recovery Scale-Revised (CRS-R) serving as a supplementary measure.
name: Amantadine Hydrochloride
other_name: Symmetrel
type: Drug
description: Placebo administered twice daily.
name: Placebo
type: Drug
Study arms:
design_group_description: 100mg BID administered for 2 weeks, then increased to 150mg BID in week 3 if change on primary outcome measure (ie Disability Rating Scale, DRS) was less than 2 points after week 2. If change in DRS score remained less than 2 points after week 3, dose was increased to 200mg BID in week 4.
design_group_title: Amantadine HCL
design_group_type: Experimental
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: The Community Hospital Group, Inc.
Collaborators: U.S. Department of Education
Drug name mappings:
name: 盐酸金刚烷胺
lang: CN
name: Amantadine Hydrochloride
lang: EN
name: アマンタジン塩酸塩
lang: JP