PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT00115297: Montelukast for Early Life Wheezing
Official title: Effects of Montelukast on Early Life Wheezing
Conditions: Lung Diseases
Asthma
Summary: This study will determine the effects of montelukast on the duration of wheezing in children 12 months to 3 years of age who visit a physician for care of a wheezing illness. Only patients from the Ankara area of Hacettepe University Medical Center in Turkey will be included in this study.
Interventions:
description: Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who are 12 months to 2 years old received 4-mg montelukast granules.
name: Montelukast
type: Drug
description: Participants who were 2 to 3 years old received placebo montelukast tablets and participants who were 12 months to 2 years old received placebo montelukast granules.
name: Placebo
type: Drug
Study arms:
design_group_description: Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who are 12 months to 2 years old received 4-mg montelukast granules.
design_group_title: Montelukast
design_group_type: Experimental
design_group_description: Participants who are 2 to 3 years old received 5-mg montelukast placebo tablets and participants who are 12 months to 2 years old received 4-mg montelukast placebo granules.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: University of Massachusetts
Collaborators: National Heart, Lung & Blood Institute
Drug name mappings:
name: 孟鲁司特钠
lang: CN
name: Montelukast sodium
lang: EN
name: モンテルカストナトリウム
lang: JP
Clinical trial NCT03962283: Rifaximin and Misoprostol Combination Therapy for Healing of Small Bowel Ulcers in Aspirin Users
Official title: Rifaximin and Misoprostol Combination Therapy for Healing of Small Bowel Ulcers in Aspirin Users With Small Bowel Bleeding: A Double Blind Randomized Trial
Conditions: Small Bowel Disease
Rifaximin
Summary: Background: Investigators have previously shown that misoprostol can heal small bowel ulcers in aspirin users with small bowel bleeding. However, the rate of small-bowel mucosal healing was low with use of misoprostol alone. There is evidence to suggest that bacteria contribute to the development aspirin-induced ulcers and antibiotics may be useful in its treatment. Rifaximin, a non-absorbed oral antibiotic that target the gastrointestinal tract have been shown to be safe and effective in a few other gastrointestinal conditions.
Small bowel capsule is the most sensitive and non-invasive way to investigate the small bowel. It plays an important role in obscure GIB investigations.
Aims: The aim of this randomized study is to test the hypothesis that misoprostol combined with rifaximin is superior to misoprostol alone for healing of small bowel ulcers in aspirin users complicated by small bowel bleeding.
Study design: 8-week double-blind randomized trial
Interventions:
description: Rifaximin 200mcg four times daily
name: Rifaximin
type: Drug
description: Placebo Rifaximin four times daily
name: Placebo oral tablet
type: Drug
Study arms:
design_group_description: ASA daily + misoprostol + Rifaximin (Rifaximin group)
design_group_title: Rifaximin
design_group_type: Active Comparator
design_group_description: ASA daily + misoprostol + Placebo Rifaximin (Placebo group)
design_group_title: Rifaximin Placebo
design_group_type: Placebo Comparator
Sponsor: The Chinese University of Hong Kong
Collaborators: Beijing Friendship Hospital
Drug name mappings:
name: 利福昔明
lang: CN
name: Rifaximin
lang: EN
name: リファキシミン
lang: JP
Clinical trial NCT05660746: Precise Infliximab Exposure and Pharmacodynamic Control
Official title: Precise Infliximab Exposure and Pharmacodynamic Control to Achieve Deep Remission in Pediatric Crohn's Disease
Conditions: Crohn Disease
Summary: Approximately 3 million people in the United States are living with inflammatory bowel disease, which includes Crohn's Disease (CD). There are limited treatment options approved for use in children and adults with Crohn's disease. Physicians need better ways to inform decisions on treatment.
The main reason for this research study is to determine if a computer program that calculates an individualized dose based on a patient's blood testing results (precision dosing) can better achieve the best possible response to infliximab compared to standard dosing (conventional dosing).
Interventions:
description: The RoadMAB Dashboard is a real-time decision support system that incorporates PK model-informed Bayesian estimation to provide precision dosing at the point of care.
name: RoadMAB
type: Device
description: Conventional dosing. Induction: 5-7.5 mg/kg at 0, 2, and 6 weeks. Maintenance: 5-10 mg/kg at every 4-8 weeks based on results of drug concentration monitoring for a flat target of 5-10 μg/mL.<br/>Precision dosing. Induction: 5-12.5 mg/kg at 0, 2, and 6 weeks to target a week6 concentration of 18-24 μg/mL with dosing support provided by the RoadMABTM clinical decision support tool. Maintenance: 5-15 mg/kg every 4-8 weeks to achieve apriori pharmacokinetic and pharmacodynamic targets (CRP, disease activity scores and fecal calprotectin) with dosing support provided by the RoadMABTM clinical decision support tool.
name: Infliximab
other_name: Avsola
Inflectra
Ixifi
Remicade
Renflexis
type: Drug
Study arms:
design_group_description: Induction Phase: 5-7.5 mg/kg at 0, 2, and 6 weeks. Maintenance Phase : 5-10 mg/kg at every 4-8 weeks based on results of drug concentration monitoring for a flat target of 5-10 μg/mL.
design_group_title: Conventional dosing
design_group_type: Active Comparator
design_group_description: Induction: 5-12.5 mg/kg at 0, 2, and 6 weeks to target a week6 concentration of 18-24 μg/mL with dosing support provided by the RoadMABTM clinical decision support tool. Maintenance: 5-15 mg/kg every 4-8 weeks to achieve apriori pharmacokinetic and pharmacodynamic targets (CRP, disease activity scores and fecal calprotectin) with dosing support provided by the RoadMABTM clinical decision support tool.
design_group_title: Precision dosing
design_group_type: Experimental
Sponsor: Cincinnati Children's Hospital Medical Center
Collaborators: National Institute of Diabetes & Digestive & Kidney Diseases
Janssen Scientific Affairs LLC
Drug name mappings:
name: 英夫利西单抗
lang: CN
name: Infliximab
lang: EN
name: インフリキシマブ（遺伝子組換え）
lang: JP
Clinical trial NCT00310791: Adrenal and Gonadal Hormone Replacement in Anorexia Nervosa
Official title: Effects of Adrenal and Gonadal Hormone Replacement in Young Women With Anorexia Nervosa
Conditions: Anorexia Nervosa
Summary: This study seeks to gain new information on why young women with anorexia nervosa are predisposed to early bone loss and osteoporosis. Through a randomized treatment trial in which participants will receive either combined therapy with the adrenal hormone, dehydroepiandrosterone (DHEA) and estrogen replacement therapy or placebo, we will determine the effects of an 18-month treatment course on bone mass, circulating markers of bone turnover, and serum levels of a factor, insulin-like growth factor I (IGF-I). We are also studying if these therapies change bone structure to increase skeletal strength compared to placebo, as assessed through cross-sectional geometric analysis of our bone density data by dual-energy x-ray absorptiometry (DXA).
Interventions:
description: Hormone replacement therapy (estrogen/progestin). 0.3 mg conjugated estrogens x 3 months, followed by 9 months of oral contraceptive (20 mg ethinyl estradiol + 0.1 mg levonorgestrel)
name: Hormone replacement therapy (estrogen/progestin)
other_name: Alesse (20 mg ethinyl estradiol + 0.1 mg levonorgestrel)
Premarin (conjugated estrogens)
type: Drug
description: Placebo (sugar pill)
name: Placebo (Sugar Pill)
other_name: Placebo
Sugar pill
type: Other
description: 50 mg tablet, 1 daily
name: Dehydroepiandrosterone (DHEA)
other_name: Prasterone
type: Drug
Study arms:
design_group_description: Placebo (sugar pill); identical to treatment medication capsule
design_group_title: Sugar Pill
design_group_type: Placebo Comparator
design_group_description: Combined therapy of dehydroepiandrosterone (DHEA) and hormone replacement therapy (ERT). Patients randomized to the DHEA + HRT arm will receive micronized oral DHEA in a dose of 50 mg daily + HRT (0.3 mg Premarin, 1 tablet daily for 3 months, follow by Alesse (20 mg ethinyl estradiol + 0.1 mg levonorgestrel for 15 months). The estrogen/progestin component of the regimen has been chosen to maximize patient compliance, as patients with AN may experience bloating or nausea if higher estrogen doses (> 20 g) are initiated too rapidly. The DHEA capsule strength will be 50 mg, the total daily dose to be studied in combination with HRT. The micronized DHEA preparation achieves more constant DHEA and DHEA-S levels. Fifty milligrams appears to be a physiological replacement dose for these young women, determined both from our pilot (10) and longitudinal studies (7).
design_group_title: DHEA + Hormone replacement therapy (estrogen/progestin)
design_group_type: Experimental
Sponsor: The Children's Hospital Corp.
Collaborators: Defense Language Institute Foreign Language Center
National Institute of Child Health & Human Development
Drug name mappings:
name: 普拉睾酮
lang: CN
name: Prasterone
lang: EN
Clinical trial NCT00781898: Treatment Study Using Depot Naltrexone (1/6) Philadelphia Coord/Data Mgmt Site
Official title: Prevention of Relapse to Opioid Addiction Using Depot Naltrexone
Conditions: Opiate Addiction
Summary: The aim of this project is to conduct a multi-site effectiveness study to determine whether the addition of a monthly injection of depot naltrexone to treatment as usual (TAU) will significantly improve outcome in parolees and probationers with a history of opioid addiction compared to TAU alone. Participants will be randomized to either treatment as usual in community programs or monthly injections of depot naltrexone for six months with treatment as usual in community programs. The effectiveness of depot naltrexone has never been studied in opioid dependent parolees. all parolee subjects will be evaluated at baseline, while in treatment, and at 6, 12 and 18 month post entry time points. The primary study outcomes are retention in treatment, drug use, re-arrests, psychosocial and medical/psychiatric functioning, and economic costs and benefit costs of naltrexone.
Interventions:
description: Vivitrol® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections.
name: Depot naltrexone
type: Drug
description: Treatment as Usual (TAU) community treatment provided to the participant
name: Treatment as Usual (TAU)
type: Other
Study arms:
design_group_title: Depot Naltrexone
design_group_type: Active Comparator
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: University of Pennsylvania
Collaborators: National Institute on Drug Abuse
Drug name mappings:
name: 盐酸纳曲酮
lang: CN
name: Naltrexone Hydrochloride
lang: EN
Clinical trial NCT01936844: Interleukin (IL)-1 Blockade in Acute Heart Failure (Anakinra ADHF)
Official title: Interleukin-1 Blockade in Acute Decompensated Heart Failure
Conditions: Heart Failure
Summary: Anakinra ADHF is a double-blind randomized clinical trial of anakinra, recombinant human interleukin-1 receptor blocker, or placebo in patients with acute decompensated heart failure with the aim to quench the acute inflammatory response, as measured by the area-under-the-curve for C reactive protein over 14 days.
Interventions:
description: Anakinra 100 mg daily twice daily for days 1, 2, and 3
name: Anakinra (high dose)
type: Drug
description: Anakinra 100 mg daily for days 4-14
name: Anakinra (standard dose)
type: Drug
description: Placebo twice daily for days 1, 2, and 3
name: Placebo
type: Drug
description: Placebo daily for days 4-14
name: Placebo
type: Drug
Study arms:
design_group_description: Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14
design_group_title: Anakinra (short)
design_group_type: Experimental
design_group_description: Placebo injections twice daily for the first 3 days then once daily for days 4-14.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Virginia Commonwealth University
Collaborators: American Heart Association, Inc.
Drug name mappings:
name: 安纳白介素
lang: CN
name: Anakinra (Amgen)
lang: EN
Clinical trial NCT05463484: Effects of a Composition on the Oral Microbiome, pH, Nitrite/Nitrate Ratio, Elastases and Inflammation in Oral Dysbiosis
Official title: Effects of a Composition Delivered Via Toothpaste on the Oral Microbiome, pH, Nitrite/Nitrate Ratio, Elastases, and Inflammation in Patients With Oral Dysbiosis: A Controlled, Randomized, Double-blind Study. Part of Stop Dysbiosis Project
Conditions: Oral Dysbiosis
Summary: Dysbiosis is a condition in which the normal function of an ecological net is altered. In dysbiosis a state of inflammation, a loss of hydration, a change in pH, a loss of the barrier function are all allies of key pathogens that initiate invasion and cytokine and pro-inflammatory mediators release that target other tissues and organs resulting in chronic inflammatory conditions.
In health there is a cross-talk between the host and the microbiota in order to maintain and promote a state of eubiosis with a local and general health gain. Dysbiosis reversion has not been solved with the use of antibacterials, antiseptics nor antibiotics.
Stop dysbiosis project is focussed on different aspects of human dysbiosis such as oral dysbiosis, skin dysbiosis, vaginal dysbiosis and cancer dysbiosis, between others including the current prospective interventional double-blind randomised clinical trial.
One of the most common oral dysbiosis is periodontal and mucosa dysbiosis that courses with inflammation of the gingiva (gingivitis). This inflammation induces specific enzymes that in a later stage destroy connective tissue. The current clinical trial analyzes the effect of a composition (Saliactive ®) delivered to the oral cavity via a daily use toothpaste (YOTUEL® microbiome toothpaste) in a group of patients with oral dysbiosis.
Interventions:
description: Fluoridated toothpaste with Saliactive®.
name: Test composition Saliactive® (olive product, betaine and xylitol)
other_name: Saliactive®
type: Drug
description: Fluoridated toothpaste without Saliactive®.
name: Placebo
other_name: Placebo fluoridated toothpaste without the test composition
type: Drug
description: Commercial Fluoridated toothpaste for gingivitis with zinc citrate.
name: Control
other_name: Control commercial Fluoridated toothpaste for gingivitis with zinc citrate.
type: Drug
Study arms:
design_group_description: Toothpaste including an olive product, betaine and xylitol (Saliactive®).
design_group_title: Test product
design_group_type: Experimental
design_group_description: Toothpaste with the same composition as the test product but without olive product, betaine and xylitol.
design_group_title: Placebo product
design_group_type: Placebo Comparator
design_group_description: Toothpaste marketed for gingivitis with zinc mineral with antimicrobial activity.
design_group_title: Control product
design_group_type: Active Comparator
Sponsor: Mucosa Innovations, S.L.
Collaborators: University of Granada
Drug name mappings:
name: 丙酸氟替卡松/昔萘酸沙美特罗
lang: CN
name: Fluticasone propionate/Salmeterol xinafoate
lang: EN
name: サルメテロールキシナホ酸塩/フルチカゾンプロピオン酸エステル
lang: JP
Clinical trial NCT00490854: A Study for Patients With Type 2 Diabetes Mellitus
Official title: A Crossover Study to Evaluate the Efficacy and Safety of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Once-Daily NPH in Insulin-Naïve Patients With Type 2 Diabetes Mellitus on Oral Agents
Conditions: Diabetes Mellitus, Type 2
Summary: The purpose of the study is to compare the human insulin inhalation powder plus oral anti-hyperglycemic medication with injected insulin (neutral protamine hegedom insulin) plus oral anti-hyperglycemic medication on lowering the blood sugar level.
Interventions:
description: patient specific, inhaled, at meals, 76 weeks
name: Human Insulin Inhalation Powder
other_name: LY 041001
type: Drug
description: patient specific dose, injected, daily, 76 weeks
name: Neutral protamine hagedorn insulin
type: Drug
Study arms:
design_group_title: 1
design_group_type: Experimental
design_group_title: 2
design_group_type: Experimental
Sponsor: Eli Lilly & Co.
Collaborators: Alkermes, Inc.
Drug name mappings:
name: 人胰岛素（诺和诺德）
lang: CN
name: Insulin human (rDNA origin, Novo Nordisk)
lang: EN
name: インスリン ヒト（遺伝子組換え）
lang: JP
Clinical trial NCT00713167: The Efficacy of Red Grape Seed Extract on Lipid Profile and Oxidized Low-Density Lipoprotein (OX-LDL)
Official title: Randomized, Cross-Over, Double Blind, Placebo-Controlled Study of Grape Seed Extract in Treating Patients With Mild Hyperlipidemia
Conditions: Hyperlipidemia
Summary: Antioxidants are potent scavengers of free radicals and serve as inhibitors of neoplastic processes. A large number of synthetic and natural antioxidants are known to induce beneficial effects on human health and disease prevention. Cardioprotective ability of grape seed extract polyphenols (GSEP) was studied in animals and humans. It has been suggested that grape seed proanthocyanidins have cardioprotective effects against reperfusion-induced injury of free radicals after ischemia. In another study, it is suggested that proanthocyanidins, the major polyphenols in red wine, might trap reactive oxygen species in aqueous series such as plasma and interstitial fluid of the arterial wall; thereby inhibiting oxidation of low-density lipoprotein (LDL) and showing an antiatherosclerotic activity. The only human model study designed to evaluate the effect of a standardized formulation of a GSEP (leucoselect-phytosome [LP]) on the susceptibility of LDL to oxidation in a group of heavy smokers, revealed that the antioxidant potential of GSEP may be effective in oxidative stress (smoking); however more investigational data are needed before wider use in clinical settings. Based on these observations, the investigators decided to evaluate the effect of GSEP in reducing OX-LDL in patients diagnosed with mild hyperlipidemia.
Interventions:
description: Drug {Each Containing: Grape Seed Extract100 mg +...}<br/>1 capsule twice daily for 2 months
name: Grape Seed Extract (Vitagrape)
other_name: Iran Ministry of Health Registration Number: 5/92/43198
Vitagrape
type: Drug
description: Placebo {Each Containing: Gelatin 17mg + Cellulose Microcrystalline (Avicel) 67 mg + Dicalcium Phosphate 216mg}<br/>1 capsule twice daily for 2 months
name: Placebo of Grape Seed Extract
type: Drug
Study arms:
design_group_description: Enrolled patients who are randomly assigned to receive Grape Seed Extract capsules
design_group_title: Grape Seed Extract
design_group_type: Experimental
design_group_description: Placebo enrolled patients who are randomly assigned to receive placebo of Grape Seed Extract
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Shahid Beheshti University of Medical Sciences
Collaborators: University of Tabriz
Drug name mappings:
name: 葡萄籽提取物
lang: CN
name: Grape Seed Extract
lang: EN
Clinical trial NCT01306331: Study of Contraceptive Efficacy & Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel
Official title: A Multicenter, Open-Label, Randomized Study of the Contraceptive Efficacy and Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel
Conditions: Contraception
Summary: This is a research study of a new experimental vaginal gel that helps in vaginal pH regulation and results in immobilization of spermatozoa by maintaining the normally low vaginal pH, even in the presence of semen. This vaginal gel is called Phexxi™ (previously known as Amphora) and was compared to a commercially available spermicide called Conceptrol®, which contains nonoxynol 9; commonly abbreviated as N-9. Conceptrol® can help prevent pregnancy. This study objective was to determine if this product prevents pregnancy when inserted into the vagina before intercourse.
Interventions:
description: • Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.
name: Conceptrol
type: Drug
description: • Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel.
name: Amphora
type: Drug
Study arms:
design_group_description: 100 mg (4% concentration) of nonoxynol-9 in 2.5 mL volume of gel
design_group_title: Conceptrol
design_group_type: Active Comparator
design_group_description: Citric acid USP, potassium bitartrate USP, and L-lactic acid USP
design_group_title: Amphora
design_group_type: Experimental
Sponsor: Evofem, Inc.
Collaborators: Health Decisions, Inc.
Drug name mappings:
name: Amphora
lang: EN
Clinical trial NCT00859898: Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 Diabetes
Official title: A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg in Combination With Metformin as Initial Therapy as Compared With Dapagliflozin 10 mg Monotherapy and Metformin Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
Conditions: Type 2 Diabetes Mellitus
Summary: The primary purpose of this study is to compare the change from baseline in hemoglobin A1C achieved with dapagliflozin 10 mg in combination with metformin XR as compared with metformin XR monotherapy and compared with Dapagliflozin monotherapy, after 24 weeks of oral administration of double-blind treatment. The safety of treatment with dapagliflozin will also be assessed in this study
Interventions:
description: Tablets, Oral, 10 mg, once daily, 24 weeks
name: Dapagliflozin
other_name: Farxiga™
type: Drug
description: Tablets, Oral, up to 2000 mg, once daily, 24 weeks
name: Metformin XR
other_name: Glucophage®
type: Drug
description: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
name: Metformin XR
other_name: Glucophage®
type: Drug
description: Tablets
name: dapagliflozin matching Placebo
type: Drug
description: Tablets
name: metformin HCl Modified Release matching Placebo
type: Drug
Study arms:
design_group_description: Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks<br/>Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks
design_group_title: Dapagliflozin + Metformin XR
design_group_type: Experimental
design_group_description: Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks.<br/>Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks.
design_group_title: Dapagliflozin + Placebo
design_group_type: Experimental
design_group_description: Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks<br/>Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks
design_group_title: Metformin XR + Placebo
design_group_type: Active Comparator
Sponsor: AstraZeneca PLC
Collaborators: Bristol Myers Squibb Co.
Drug name mappings:
name: 达格列净
lang: CN
name: Dapagliflozin
lang: EN
name: ダパグリフロジンプロピレングリコール水和物
lang: JP
name: 二甲双胍
lang: CN
name: Metformin
lang: EN