PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT05706454: Phase 2/Phase 3 Study To Evaluate The Efficacy And Safety Of Ramatroban Along With The Standard Of Care In Subjects Hospitalized For COVID Pneumonia
Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multi- Centre, Adaptive Phase 2/Phase 3 Study To Evaluate The Efficacy And Safety Of Ramatroban Along With The Standard Of Care In Subjects Hospitalized For SARS-CoV-2 Infection
Conditions: COVID-19 Pneumonia
COVID-19 Respiratory Infection
Summary: Phase II/Phase III study to evaluate the safety and efficacy of Ramatroban 75 mg tablet against Placebo in subjects hospitalized for pneumonia due to SARS-CoV-2 infection.
Approximately 324 eligible subjects will be randomized in a 1:1 ratio to one of the two treatment groups.
Group I: Ramatroban 75 mg tablet + Standard of care; Group II: Placebo + Standard of care.
Phase 2
Primary Objective:
To evaluate the safety of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.
Secondary Objective:
To assess the efficacy of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.
Phase 3
Primary Objective:
To evaluate the efficacy of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.
Secondary Objective:
To evaluate the safety of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.
Long COVID [Follow-up Phase- Objectives- (Phase 2 & 3)]
To examine lipid mediators, specifically thromboxane A2, prostaglandin D2, F2-isoprostane and/or their metabolites in convalescent subjects after treatment.
To assess the efficacy of Ramatroban administered during the acute illness in preventing/mitigating subsequent development of long COVID / PASC
Interventions:
description: Route of Administration: Oral Dose: 75 mg; Frequency: Twice daily; Total duration of intervention: 28 days.<br/>Subjects will be evaluated over a study period of approximately 365 days.
name: Ramatroban
other_name: BAYu3405
IUPAC Name: 3-[(3R)-3-[(4-fluorophenyl)sulfonylamino]-1,2,3,4-tetrahydrocarbazol-9-yl]propanoic acid
type: Drug
description: Matching placebo will be administered orally twice a day
name: Placebo
type: Drug
Study arms:
design_group_title: Ramatroban 75 mg tablet
design_group_type: Experimental
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Kare Biosciences, Inc.
Collaborators: BioLink Life Sciences, Inc.
JSS Medical Research, Inc.
Open Philanthropy Project LLC
Biomedical Advanced Research & Development Authority (Barda)
Drug name mappings:
name: 雷马曲班
lang: CN
name: Ramatroban
lang: EN
name: ラマトロバン
lang: JP
Clinical trial NCT05398484: Psilocybin Therapy in Advanced Cancer
Official title: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Effects of Psilocybin-assisted Psychotherapy on Psychiatric and Existential Distress in Advanced Cancer
Conditions: Advanced Cancer
Summary: The purpose of this research is to study the safety and effects of single-dose psilocybin 25mg versus an active placebo (single dose niacin 100mg) in the treatment of anxiety, depression, and existential distress (i.e., loss of meaning and hope; fear of death) in advanced cancer (i.e., stage 3 or 4). Study medications will be administered in conjunction with brief psychotherapy that is designed to treat anxiety, depression and existential distress in advanced cancer.
Interventions:
description: One capsule containing 25mg of psilocybin will be administered with water orally. The appearance of psilocybin is Size 2 HPMC opaque.
name: Psilocybin 25 mgs
type: Drug
description: One capsule contains 100mg of niacin will be administered with water orally. The appearance of the active placebo is Size 2 HPMC opaque.
name: Niacin 100mg
type: Drug
description: The manualized psychotherapy platform will consist of 6 hours of preparatory psychotherapy (prior to the single medication session) and 8 hours of integration psychotherapy following the dosing session.
name: Psychotherapy
type: Behavioral
Study arms:
design_group_description: Advanced cancer participants will receive experimental medication, psilocybin (25mg). In addition to the pharmacologic intervention, participants will receive a manualized psychotherapy platform. The combination of interventions is referred to as psilocybin-assisted psychotherapy (PAP).
design_group_title: Participants receiving Study Drug
design_group_type: Experimental
design_group_description: Advanced cancer participants will receive active placebo - single dose of niacin (100mg). In addition to the placebo, participants will receive the same manualized psychotherapy platform as the experimental arm.
design_group_title: Participants receiving Placebo
design_group_type: Active Comparator
Sponsor: NYU Langone Health
Collaborators: National Cancer Institute
Drug name mappings:
name: 裸盖菇素
lang: CN
name: Psilocybin
lang: EN
Clinical trial NCT00222235: Adjunctive Treatment for Decreasing Symptoms of Schizophrenia
Official title: Cognitive and Negative Symptoms in Schizophrenia Trial (CONSIST)
Conditions: Schizophrenia
Schizoaffective Disorder
Summary: This study will determine the effectiveness of treatment with glycine or d-cycloserine in addition to a normal antipsychotic regimen in improving negative symptoms and cognitive impairments in patients with schizophrenia.
Interventions:
name: d-cycloserine
type: Drug
name: glycine
type: Drug
name: placebo
type: Drug
Study arms:
Sponsor: University of Maryland Baltimore
Collaborators: University of Maryland
University of California, Los Angeles
National Institute of Mental Health
Nathan S. Kline Institute for Psychiatric Research
Herzog Hospital
Drug name mappings:
name: 环丝氨酸
lang: CN
name: Cycloserine
lang: EN
name: サイクロセリン
lang: JP
name: 甘氨酸
lang: CN
name: Glycine
lang: EN
Clinical trial NCT00711503: Anti-Interleukin-1 in Diabetes Action
Official title: A Randomised Clinical Trial of the Effect of Interleukin-1 Receptor Antagonism on the Insulin Production in Patients With New Onset Type 1 Diabetes
Conditions: Type 1 Diabetes
Summary: A draw trial of the effect of Interleukin-1 Receptor Antagonist (anakinra, Kineret®) on the insulin production in patients with new onset Type 1 diabetes.
Kineret® is already being used in the treatment of patients suffering from rheumatoid arthritis and preclinical studies are now suggesting that it may also be useful for patients with Type 1 diabetes. The active substance in Kineret is interleukin-1 receptor antagonist, a blocker of an immune-signal molecule named interleukin-1.
The trial is a blinded randomised trial, in which the patient is allocated to receive the active drug (Kineret®) or placebo (saline). The hypothesis is that anti-IL-1 treatment as add-on therapy to conventional insulin therapy will preserve or enhance beta-cell function.
Interventions:
description: The patients are instructed to administer anti-IL-1 therapy in the form of recombinant human non-glycosylated interleukin-1 receptor antagonist (IL-1Ra, anakinra, Kineret®, Amgen, CA, USA) [13] at a dose of 100 mg once daily by subcutaneous injection
name: anakinra
other_name: Kineret
type: Drug
description: The patients are instructed to administer placebo (saline) once daily by subcutaneous injection
name: saline
type: Drug
Study arms:
design_group_description: The patients are instructed to administer placebo by subcutaneous injection
design_group_title: 2
design_group_type: Placebo Comparator
design_group_description: The patients are instructed to administer anti-IL-1 therapy in the form of recombinant human non-glycosylated interleukin-1 receptor antagonist (IL-1Ra, anakinra, Kineret®, Amgen, CA, USA) [13] at a dose of 100 mg once daily by subcutaneous injection
design_group_title: 1
design_group_type: Experimental
Sponsor: Steno Diabetes Center A/S
Collaborators: Juvenile Diabetes Research Foundation
Oeresund Diabetes Academy
Drug name mappings:
name: 安纳白介素
lang: CN
name: Anakinra (Amgen)
lang: EN
Clinical trial NCT07437287: Testing Mitazalimab in Combination With Standard Chemotherapy in Immunotherapy Resistant Advanced Biliary Tract Cancers
Official title: Countering Immunotherapy Resistance With Novel Combinations in Advanced Biliary Tract Cancers
Conditions: Biliary Tract Cancer (BTC)
Summary: The goal of this clinical trial is to etablish whether adding Mitazalimab to standard chemotherapy is more effective than standard chemotherapy alone in people with advanced bile duct cancer. It will also learn about the safety of Mitazalimab.
The main questions it aims to answer are:
* Does the addition of Mitazalimab enhance efficacy?
* What medical problems do participants have when taking Mitazalimab + mFOLFOX?
Participants will:
* Take drug mFOLFOX every two weeks until disease progression or mFOLFOX every two weeks plus mitazalimab in addition to mFOLFOX, with a first injection 7 days before the first mFOLFOX chemotherapy and then 3 days after the start of each mFOLFOX cycle.
* Visit the clinic once every 2 weeks for checkups and tests
* Have a radiological assessment every 8 weeks during treatment. After stopping treatment, participants will be monitored at the hospital every 8 weeks if no progression is observed, or every 12 weeks after disease progression.
Interventions:
description: oxaliplatin 85 mg/m² intravenous infusion (IV), folinic acid 400 mg/m² IV (or L-folinic acid 200 mg/m²), and fluorouracil (5-FU) 400 mg/m² IV bolus; followed by 5 FU 2400 mg/m² as a 46-hours continuous IV infusion:<br/>* every two week (14-day cycles) until disease progression on control arm<br/>* at D8 the first cycle and at D1 for subsequent cycles (14-day cycles) until disease progression on experimental arm
name: mFOLFOX regimen
other_name: Oxaliplatin, folinic acid and 5-FU
type: Drug
description: The first cycle of treatment (21-day cycle): Mitazalimab 900 µg/kg by intravenous infusion (IV) at D1 and D10 Subsequent cycles (14-day cycles): Mitazalimab 900 µg/kg by intravenous infusion (IV) at D3 of each cycle until disease progression
name: Mitazalimab
other_name: ADC-1013
JNJ-64457107
type: Drug
Study arms:
design_group_title: Mitazalimab + mFOLFOX
design_group_type: Experimental
design_group_title: mFOLFOX
design_group_type: Active Comparator
Sponsor: UNICANCER
Collaborators: Alligator Bioscience AB
Drug name mappings:
name: 亚叶酸钙
lang: CN
name: Leucovorin Calcium
lang: EN
name: ホリナートカルシウム
lang: JP
name: 奥沙利铂
lang: CN
name: Oxaliplatin
lang: EN
name: オキサリプラチン
lang: JP
name: 氟尿嘧啶
lang: CN
name: Fluorouracil
lang: EN
name: フルオロウラシル
lang: JP
name: 米佐利单抗
lang: CN
name: Mitazalimab
lang: EN
Clinical trial NCT03455218: Nitric Oxide Administration During Pediatric Cardiopulmonary Bypass Surgery to Prevent Platelet Activation
Official title: Nitric Oxide Administration During Pediatric Cardiopulmonary Bypass Surgery to Prevent Platelet activation-a Single Center Pilot Study
Conditions: Inflammation
Platelet Dysfunction
Summary: Open heart surgery requires the use of a cardiopulmonary bypass (CPB) circuit. As blood flows across the artificial surfaces of the CPB circuit, platelets are activated and consumed. This activation results in a profound inflammatory reaction and need for transfusion. This reaction is intensified in younger, smaller patients undergoing longer, more complex open heart surgery. Nitric oxide is naturally released by vascular endothelial surfaces and acts as a signaling molecule which prevents platelet activation. The investigators hypothesize that the addition of the nitric oxide to the sweep gas of the oxygenator during cardiopulmonary bypass surgery will replace this natural endothelial function and thus prevent platelet activation and consumption. The investigators plan to test this hypothesis with a pilot double blinded, randomized trial of 40 patients less than a year of age undergoing cardiac surgery requiring CPB.
Interventions:
description: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass
name: Nitric Oxide
other_name: INOmax
type: Drug
description: INOmax device connected to oxygenator, but no gas is delivered
name: Placebo
type: Drug
description: All patients will have the INOmax device connected to the oxygenator
name: INOmax
other_name: inhaled nitric oxide delivery device
type: Device
Study arms:
design_group_description: 20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time
design_group_title: Nitric Oxide
design_group_type: Experimental
design_group_description: INOmax device attached to the oxygenator, but no gas is delivered through the device
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Medical College of Wisconsin
Collaborators: Versiti, Inc.
Keenova Therapeutics Plc
Drug name mappings:
name: 一酸化窒素
lang: CN
name: Nitric oxide (inhaled)
lang: EN
Clinical trial NCT03321656: Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
Official title: Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
Conditions: End Stage Renal Disease
Summary: This will be a single center, prospective, open-label, randomized, controlled trial comparing Envarsus XR® to twice-daily tacrolimus. The targeted population will be patients with end stage renal disease listed for primary solitary kidney transplant. Transplant Surgery is not part of the study.
Interventions:
description: 0.1-0.2 mg/kg/day orally divided into two doses every 12 hours orally
name: Tacrolimus
type: Drug
description: 0.07-0.14 mg/kg/day every morning orally
name: Envarsus XR
type: Drug
Study arms:
design_group_description: 0.1 - 0.2 mg/kg/day in 2 divided doses every 12 hours orally
design_group_title: Tacrolimus
design_group_type: Active Comparator
design_group_description: 0.07-0.14 mg/kg/day every morning orally
design_group_title: Envarsus XR
design_group_type: Experimental
Sponsor: University of Kentucky
Collaborators: Veloxis Pharmaceuticals A/S
Drug name mappings:
name: 他克莫司
lang: CN
name: Tacrolimus
lang: EN
name: タクロリムス水和物
lang: JP
Clinical trial NCT02939898: Mapping the Endocrine Determinants of Ovarian Stimulation to Optimize Outcomes in Fresh Embryo Transfer Cycles
Official title: Reducing the Impact of Ovarian Stimulation - The RIOT Project Study RIOT-B: Mapping the Endocrine Determinants of Ovarian Stimulation to Optimize Outcomes in Fresh Embryo Transfer Cycles
Conditions: Infertility
Summary: The goal of this project is to identify autocrine, paracrine and endocrine factors which are associated with intercycle variation in cyclical follicle recruitment.
Patients will be monitored in a natural cycle, a stimulated cycle and a follow up. In the stimulated cycle patients will be randomized to co-treatment with aromatase inhibitor or placebo during ovarian stimulation.
Interventions:
description: Adjuvant therapy to recFSH during ovarian stimulation
name: Placebo
other_name: Lactose Monohydrate
type: Drug
description: Adjuvant therapy to recFSH during ovarian stimulation
name: Letrozole
other_name: Aromatase Inhibitor
type: Drug
Study arms:
design_group_description: 2 tablets of placebo are administered daily from stimulation start to day before hCG as adjunctive therapy to 150 International Units of recFSH
design_group_title: Lactose Monohydrate
design_group_type: Placebo Comparator
design_group_description: 2 tablets of 2,5 mg Letrozole are administered daily from stimulation start to day before hCG as adjunctive therapy to 150 International Units of recFSH
design_group_title: Letrozole
design_group_type: Active Comparator
Sponsor: Herlev Hospital
Collaborators: Rigshospitalet
Copenhagen University Hospital
Drug name mappings:
name: 来曲唑
lang: CN
name: Letrozole
lang: EN
name: レトロゾール
lang: JP
Clinical trial NCT03651206: Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib
Official title: An International Multicentric Randomized Phase II Evaluating Dostarlimab in Combination With Niraparib Versus Niraparib Alone Compared to Chemotherapy in the Treatment of Metastatic or Recurrent Endometrial or Ovarian Carcinosarcoma After at Least One Line of Chemotherapy
Conditions: Ovarian Carcinosarcoma
Endometrial Carcinosarcoma
Summary: Carcinosarcomas (CS) (malignant mixed Müllerian tumors) are highly aggressive and rare tumors with a worldwide annual incidence between 0.5-3.3 cases/100.000 women. Gynecological CS, i.e. ovarian CS (OCS) and uterine CS (UCS), have a 5-year overall survival (OS) < 10% and a poor prognosis. After initial treatment (surgery +/- adjuvant radiotherapies +/- chemotherapies (CT)), vast majority of patients relapsed and received diverse CT producing modest benefits, and nearly all patients will die. After first line CT including platinum salt, monotherapy (doxorubicin or paclitaxel) is frequently used for relapsed patients, but the response rate (RR) is <20%, progression-free survival (PFS) <4 months, and OS <1 year. In this unmet need situation, a better knowledge of these aggressive neoplasms is essential to propose new therapeutic options.
Interventions:
description: PARP Inhibitor
name: Niraparib
type: Drug
description: Combination of 2 drugs, a PARP Inhibitor and an Anti-PD-1
name: Niraparib + TSR-042 (Dostarlimab)
type: Combination Product
description: Chemotherapies given in standard of care
name: Chemotherapy Drugs
type: Drug
Study arms:
design_group_description: Niraparib, 200 mg or 300 mg, daily dose
design_group_title: Arm A - Niraparib
design_group_type: Experimental
design_group_description: Niraparib, 200 mg or 300 mg, daily dose<br/>TSR042, intravenous infusion on Day 1 of every 21-day cycle at 500 mg for the 4 first cycles, followed by 1,000 mg on Day 1 of every 42-day cycle thereafter
design_group_title: Arm B - Niraparib + TSR-042 (Dostarlimab)
design_group_type: Experimental
design_group_description: Chemotherapies (Standard of care)<br/>For Ovarian Cancer Patients Paclitaxel, 80 mg/m², Intravenous, Day 1, 8, 15 every 28 days Pegylated Liposomal Doxorubicin, 40 mg/m², Intravenous, every 28 days Topotecan, 4mg/m², Intravenous, Day 1, 8, 15 every 28 days<br/>For Endometrial Cancer Patients Doxorubicin, 60 mg/m², Intravenous, every 21 days Paclitaxel, 80 mg/m², Intravenous, Day 1, 8, 15 every 28 days Gemcitabine, 800 mg/m², Intravenous, Day 1, 8 every 21 days
design_group_title: Arm C - Chemotherapy drugs
design_group_type: Active Comparator
Sponsor: Arcagy-Gineco
Collaborators: Tesaro, Inc.
Drug name mappings:
name: 甲苯磺酸尼拉帕利
lang: CN
name: Niraparib Tosylate
lang: EN
name: ニラパリブトシル酸塩水和物
lang: JP
name: 多塔利单抗
lang: CN
name: Dostarlimab-gxly
lang: EN
Clinical trial NCT02003794: Randomized Controlled Study of the Effectiveness of IV Fluid Infusion in Patients With Acute Ischemic Stroke (IVIS)
Official title: Randomized Controlled Study of the Effectiveness of IV Fluid Infusion in Patients With Acute Ischemic Stroke (IVIS)
Conditions: Ischemic Stroke
Summary: To study the result of intravenous fluid in patients with acute ischemic stroke within 72 hours.
Interventions:
description: 0.9% NaCl solution intravenous infusion: 100 ml/hr for three days.
name: 0.9% NaCl solution
other_name: Normal saline
type: Drug
Study arms:
design_group_description: 0.9% NaCl solution infusion: 100 ml/hr for three days.
design_group_title: IV Fluid
design_group_type: Experimental
design_group_description: Not receive any intravenous fluid but can consume oral fluid normally for three days.
design_group_title: No IV Fluid
design_group_type: No Intervention
Sponsor: University of Chulalongkorn
Collaborators: National Research Council of Thailand
Drug name mappings:
name: 氯化钠
lang: CN
name: Sodium Chloride
lang: EN
name: 塩化ナトリウム
lang: JP
Clinical trial NCT06994195: A Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer(PANKU-GYN01)
Official title: A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer
Conditions: Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Summary: This trial is a registered, phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with platinum-resistant recurrent epithelial ovarian cancer.
Interventions:
description: Administration by intravenous infusion for a cycle of 3 weeks.
name: BL-B01D1
other_name: BMS-986507
iza-bren
izalontamab brengitecan
type: Drug
description: Administration by intravenous infusion for a cycle of 4 weeks.
name: Liposomal doxorubicin, Paclitaxel or Topotecan
type: Drug
Study arms:
design_group_description: Participants receive BL-B01D1 in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
design_group_title: BL-B01D1
design_group_type: Experimental
design_group_description: Participants receive Liposomal doxorubicin, Paclitaxel or Topotecan in the first cycle (4 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
design_group_title: Investigator's choice of chemotherapy
design_group_type: Active Comparator
Sponsor: Sichuan Baili Pharmaceuticals Co.,Ltd
Collaborators: Baili Bio Chengdu Pharmaceutical Co. Ltd.
Drug name mappings:
name: 伦康依隆妥单抗
lang: CN
name: Izalontamab Brengitecan
lang: EN
Clinical trial NCT02302716: A Study of LY2963016 Compared to LANTUS® in Adult Participants With Type 2 Diabetes Mellitus
Official title: A Prospective, Randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog LY2963016 to LANTUS® in Adult Patients With Type 2 Diabetes Mellitus: The ELEMENT 5 Study
Conditions: Diabetes Mellitus, Type 2
Summary: The main purpose of this study is to evaluate the safety and efficacy of the study drug known as LY2963016 as compared to LANTUS® in adults with type 2 diabetes mellitus who are on 2 or more oral antihyperglycemic medications (OAMs).
Interventions:
description: Administered SC
name: LY2963016
type: Drug
description: Administered SC
name: LANTUS®
type: Drug
description: Administered as per standard-of-care.
name: Oral Antihyperglycemic Medication
type: Drug
Study arms:
design_group_description: Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or neutral protamine hagedorn (NPH) QD will begin the study at their current dose SC. Participants will self titrate LY2963016 based on fasting blood glucose (FBG). Participants entering on insulin detemir or NPH twice a day will be started at 80% of the total daily dose SC. Participants will continue oral antihyperglycemic medication (OAM).
design_group_title: LY2963016
design_group_type: Experimental
design_group_description: Insulin naive participants started on 10 U LANTUS® given SC QD for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or NPH QD will be started at the same dose SC. Participants entering on insulin detemir or NPH twice a day will be started at 80% of the total daily dose SC. Participants will self titrate LANTUS® based on FBG. Participants will continue OAM.
design_group_title: LANTUS®
design_group_type: Active Comparator
Sponsor: Eli Lilly & Co.
Collaborators: Boehringer Ingelheim GmbH
Drug name mappings:
name: 甘精胰岛素生物类似药(Boehringer Ingelheim)
lang: CN
name: Insulin Glargine(Boehringer Ingelheim)
lang: EN
name: インスリン グラルギン BS
lang: JP