PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT03928275: The Response to Intralesional IL-2 and/or BCG Treatment for Cutaneous Metastatic Melanoma
Official title: The Response to Intralesional IL-2 and/or BCG Treatment for Cutaneous Metastatic Melanoma
Conditions: Cutaneous Metastatic Melanoma
Summary: The investigators aim to include 100 local participants over the next 5 years in a two-stage sequential randomized interventional study of intralesional Interleukin-2 (IL-2) and Bacillus Calmette Guerin (BCG) to assess the utility of treating cutaneous metastatic melanoma (CMM).
Interventions:
description: IL-2 is prepared as 4 million International Units (IU) per 0.8ml at a total dose of 500,000 IU in 0.1ml of sterilized saline (0.9%, m/v)/lesion.
name: Interleukin-2
other_name: Proleukin (Aldesleukin)
type: Biological
description: BCG (OncoTICE solutions 1-8 x 10-8 Colony Forming Units (CFU)) will be administered at a maximum dose of 3.2 million CFU per treatment at a maximum of 1.6 million CFU per lesion (max 2 lesions).<br/>IL-2 is prepared as 4 million International Units (IU) per 0.8ml at a total dose of 500,000 IU in 0.1ml of sterilized saline (0.9%, m/v)/lesion (in remaining lesions).
name: Combination therapy Interleukin-2 and Bacillus Calmette Guerin
other_name: BCG, strain TICE (OncoTICE) and Proleukin (Aldesleukin)
type: Biological
Study arms:
design_group_description: CMM patients will received 4 treatments of intralesional Interleukin-2 two weeks apart over an eight week period.
design_group_title: Intralesional IL-2 Treatment
design_group_type: Experimental
design_group_description: CMM patients will receive 4 treatments of combination therapy intralesional Interleukin-2 and Bacillus Calmette Guerin two weeks apart over an eight week period.
design_group_title: Combination therapy: Intralesional IL-2 and BCG Treatment
design_group_type: Experimental
Sponsor: Nova Scotia Health Authority
Collaborators: Nova Scotia Health Authority
Drug name mappings:
name: 卡介苗(Organon)
lang: CN
name: BCG Live(Organon & Co.)
lang: EN
name: 阿地白介素
lang: CN
name: Aldesleukin
lang: EN
Clinical trial NCT05519683: Home Transcutaneous Electrical Acustimulation (TEA)
Official title: Effects of Home-based TEA for Abdominal Pain in Patients With Irritable Bowel Syndrome (IBS)
Conditions: Irritable Bowel Syndrome With Constipation
Summary: This study will assess the efficacy of two active treatments with TEA and a chemical neuromodulator (escitalopram aka Lexapro) versus a sham comparator or control group on abdominal pain.
Interventions:
description: The TEA device administers a mild electrical shock through the skin, similar to acupuncture. Location sets are described in the protocol, which will be shared with results reporting but are not provided here to maintain masking and, therefore, to safeguard scientific integrity.
name: TEA
other_name: Transcutaneous Electrical Acustimulation
type: Device
description: This arm will receive treatment with the chemical neuromodulator escitalopram (Lexapro) at 10 mg once per day for 8 weeks. Lexapro is often used as a standard treatment for IBS.
name: Lexapro
other_name: escitalopram
type: Drug
Study arms:
design_group_description: The TEA device administers a mild electrical shock through the skin, similar to acupuncture. Stimulation will be performed twice daily, morning and evening for 45 minutes for 8 weeks. Location sets are described in the protocol, which will be shared with results reporting but are not provided here to maintain masking and, therefore, to safeguard scientific integrity.
design_group_title: TEA at location A
design_group_type: Experimental
design_group_description: The TEA device administers a mild electrical shock through the skin, similar to acupuncture. Stimulation will be performed twice daily, morning and evening for 45 minutes for 8 weeks. Location sets are described in the protocol, which will be shared with results reporting but are not provided here to maintain masking and, therefore, to safeguard scientific integrity.
design_group_title: TEA at location B
design_group_type: Sham Comparator
design_group_description: The TEA device administers a mild electrical shock through the skin, similar to acupuncture. Stimulation will be performed twice daily, morning and evening for 45 minutes for 8 weeks. Location sets are described in the protocol, which will be shared with results reporting but are not provided here to maintain masking and, therefore, to safeguard scientific integrity.
design_group_title: TEA at location C
design_group_type: Experimental
design_group_description: This arm will receive treatment with the chemical neuromodulator escitalopram (Lexapro) at 10 mg once per day for 8 weeks. Lexapro is often used as a standard treatment for IBS.
design_group_title: Escitalopram treatment
design_group_type: Experimental
Sponsor: University of Michigan
Collaborators: National Institute of Neurological Disorders & Stroke
National Center For Complementary & Integrative Health
Drug name mappings:
name: 草酸艾司西酞普兰
lang: CN
name: Escitalopram Oxalate
lang: EN
name: エスシタロプラムシュウ酸塩
lang: JP
Clinical trial NCT00284258: Phase II/III Trial of CPT-11/5-FU/l-LV Versus CPT-11/TS-1 as Second Line Chemotherapy of Unresectable Colorectal Cancer
Official title: Phase II/III Trial of CPT-11/5-FU/l-LV (FOLFIRI) Versus CPT-11/TS-1 (IRIS) as Second Line Chemotherapy of Unresectable Colorectal Cancer
Conditions: Colorectal Cancer
Summary: This study is designed as Phase II/III. Phase II is aimed to evaluate safety and efficacy of IRIS, and feasibility of FOLFIRI. Phase III is aimed to verify inferiority of the progression free survival of IRIS in comparison with FOLFIRI.
Interventions:
description: TS-1 was administered orally at 40-60 mg twice daily for 14 days with a rest period of 14 days as one course. CPT-11 was administered intravenously 125 mg per square meter at day1 and day14 in 4 weeks as one course.
name: CPT-11 and TS-1
type: Drug
description: Patients were administered FOLFIRI every 2 weeks in one course. FOLFIRI:CPT-11 150 mg per square meter on day1 with l-LV 200 mg per square meter administered as a 2-hour infusion before 5-FU 400 mg per square meter administered as an intravenous bolus injection, and 5-FU 2400 mg per square meter as a 46-hour infusion immediately after 5-FU bolus injection on day1 in 2 weeks.
name: CPT-11, 5-FU and l-LV
type: Drug
Study arms:
design_group_description: CPT-11 and TS-1
design_group_title: 1
design_group_type: Experimental
design_group_description: CPT-11, 5-FU and l-LV
design_group_title: 2
design_group_type: Active Comparator
Sponsor: Taiho Pharmaceutical Co., Ltd.
Collaborators: Daiichi Sankyo Co., Ltd.
Drug name mappings:
name: 替吉奥
lang: CN
name: Tegafur/Gimeracil/Oteracil Potassium
lang: EN
name: テガフール/ギメラシル/オテラシルカリウム
lang: JP
name: 盐酸伊立替康
lang: CN
name: Irinotecan Hydrochloride
lang: EN
name: イリノテカン塩酸塩水和物
lang: JP
Clinical trial NCT01203852: Pharmacogenomic Evaluation of Antihypertensive Responses 2
Official title: Pharmacogenomic Evaluation of Antihypertensive Responses 2
Conditions: Hypertension
Summary: There are many medications available for the treatment of high blood pressure (hypertension), but finding the right one for a specific patient can be challenging. In fact, it is estimated that less than 50% of people with hypertension have their blood pressure under control. The hypothesis is that genetic differences between individuals influence their response to antihypertensive medications. This study is aimed at determining the genetic factors that may influence a person's response to either a beta-blocker or a thiazide diuretic. The hope is that through this research, the investigators may someday be able to use an individual's genetic information to guide the selection of their blood pressure medicine, leading to better control of blood pressure, and less need for the current trial and error process.
Interventions:
description: Metoprolol 50 mg twice daily titrated to 100 mg twice daily<br/>Note: due to discontinuation of the manufacture of chlorthalidone 15 mg, effective Jan 1, 2013; the starting dose of chlorthalidone will be 25 mg 4 times per week (Mon, Wed, Thur, Sat) with subsequent titration to 25 mg daily.
name: Metoprolol
other_name: Lopressor
Toprol XL
type: Drug
description: Chlorthalidone 25 mg 4 times per week titrated to 25 mg daily
name: Chlorthalidone
other_name: Thalitone
type: Drug
Study arms:
design_group_description: Study participants in this group had their current hypertension treatment withdrawn, baseline labs drawn and hypertension documented. Participants were initiated on metoprolol tartrate 50 mg twice daily for two weeks, followed by dose titration to 100 mg twice daily for six additional weeks if blood pressure (BP) > 120/70 mmHg. BP measures were again recorded. Participants entered a washout where metoprolol was titrated, then discontinued, and the patient's hypertension was re-established. After another set of identical baseline labs, study participants were initiated on chlorthalidone 25 mg four days per week (Monday, Wednesday, Thursday, Saturday) 15 mg daily for two weeks, followed by 25 mg daily for an additional six weeks.
design_group_title: Metoprolol + Chlorthalidone
design_group_type: Experimental
Sponsor: University of Florida
Collaborators: National Institute of General Medical Sciences
Drug name mappings:
name: 琥珀酸美托洛尔
lang: CN
name: Metoprolol Succinate
lang: EN
name: 氯噻酮
lang: CN
name: Chlorthalidone
lang: EN
Clinical trial NCT00259168: Insulin Resistance and Vessel Function After Meals: Does Early Intervention Make a Difference?
Official title: Insulin Resistance and Postprandial Endothelial Function: Does Early Intervention Make a Difference?
Conditions: Insulin Resistance
Impaired Fasting Glucose
Summary: The purpose of this study is to determine whether attenuation/normalization of elevated blood sugar after meals ameliorates vessel wall (endothelial) function in individuals with insulin resistance.
Interventions:
name: Nateglinide
type: Drug
Study arms:
Sponsor: Bispebjerg Hospital
Collaborators: Bayer AG
Novartis AG
Drug name mappings:
name: 那格列奈
lang: CN
name: Nateglinide
lang: EN
name: ナテグリニド
lang: JP
Clinical trial NCT07508644: RSV Vaccination to Reduce Recurrent AECOPD
Official title: Open-label, Multicenter Trial of RSV Vaccination to Reduce Moderate-to-severe Exacerbations in COPD Frequent Exacerbators: Clinical Effectiveness and RSV-specific Immune Responses
Conditions: COPD
RSV
Summary: Objectives: To determine whether respiratory syncytial virus (RSV) vaccination reduces the rate of all-cause moderate-to-severe acute exacerbations of COPD (AECOPD) in high-risk patients, and to characterise RSV-specific infection and immune responses in this population.
Hypothesis: RSV vaccination in COPD frequent exacerbators receiving dual long-acting bronchodilators will reduce all-cause moderate-to-severe AECOPD by at least 20-25% over 12 months.
Design and subjects: This multicentre, two-arm, open-label, prospective study will recruit 320 COPD patients with 2 moderate or severe AECOPD in the prior year despite dual long-acting bronchodilator therapy. Eligible subjects will be allocated 1:1 to receive RSV vaccination plus standard care or standard care alone and followed for 12 months.
Interventions: Participants in the vaccine arm will receive a single dose of a licensed RSV vaccine in addition to usual COPD management. Controls will receive usual care without RSV vaccination during the study period.
Main outcome measures: The primary outcome is the rate of all-cause moderate-to-severe AECOPD per patient-year. Secondary outcomes include RSV-positive AECOPD, RSV infection incidence confirmed by virological testing, severe AECOPD requiring hospitalisation, time to first moderate-to-severe AECOPD, and changes in plasma RSV-specific antibody titres over 12 months.
Data analysis and expected results: Exacerbation rates will be compared between groups using negative binomial regression with adjustment for key covariates on an intention-to-treat basis. The investigators expect RSV vaccination to achieve a clinically meaningful (20%) reduction in all-cause moderate-to-severe AECOPD and to provide mechanistic insights linking RSV immunity, RSV infection, and exacerbation risk in COPD frequent exacerbators.
Interventions:
description: A single dose of RSV vaccination (Arexvy, GlaxoSmithKline) at the start of study
name: RSV vaccination (Arexvy, GlaxoSmithKline)
type: Biological
Study arms:
design_group_description: Patients who will receive RSV vaccination and standard of care
design_group_title: RSV group
design_group_type: Active Comparator
design_group_description: Patients who will receive standard of care (no RSV vaccination)
design_group_title: Standard of care (SOC) group
design_group_type: No Intervention
Sponsor: The Chinese University of Hong Kong
Collaborators: The University of Hong Kong
Drug name mappings:
name: 重组呼吸道合胞病毒疫苗（GSK）
lang: CN
name: Respiratory Syncytial Virus Vaccine (GSK)
lang: EN
name: 組換えRSウイルスワクチン
lang: JP
Clinical trial NCT04102449: Validation of the PsASon ULtrasound Scores in Patients With Psoriatic Arthritis Undergoing TReatment With Apremilast
Official title: Validation of the PsASon ULtrasound Scores in Patients With Psoriatic Arthritis Undergoing TReatment With Apremilast
Conditions: Psoriatic Arthritis
Summary: The main purpose of this study is to validate the ultrasound scores PsASon22 and PsASon13 in patients with active psoriatic arthritis undergoing a treatment with Apremilast.
Interventions:
description: Single arm receiving Apremilast and ultrasound examinations
name: Apremilast
type: Drug
Study arms:
design_group_description: Single group:<br/>Apremilast will be prescribed according to the patient information leaflet, i.e.:<br/>Dosage form: Oral pill Dosage and Frequency: First 6 days titration phase, followed by 30mg twice daily (in case of kidney problems 30mg once daily in the morning). Treatment duration at the discretion of the treating physician.
design_group_title: Treatment with Apremilast
design_group_type: Other
Sponsor: Medizinische Universität Graz
Collaborators: Medical University of Innsbruck
Celgene Corp.
Medical University of Vienna
Drug name mappings:
name: 阿普米司特
lang: CN
name: Apremilast
lang: EN
name: アプレミラスト
lang: JP
Clinical trial NCT00576472: Learning Impairments Among Survivors of Childhood Cancer
Official title: Learning Impairments Among Survivors of Childhood Cancer
Conditions: Acute Lymphoblastic Leukemia
Brain Tumors
Summary: Children surviving some types of cancer have a higher risk of developing learning problems after cancer treatment than do children who have not had cancer or its treatment. Cancer treatment may cause problems with learning, attention, and memory. The purpose of this study is to identify brain changes that may underlie learning problems in cancer survivors and investigate whether methylphenidate (a stimulant medication) may reduce these problems.
Subjects who have had treatment for acute lymphoblastic leukemia (ALL) or a brain tumor will be asked to take part in this research study. Siblings of some subjects will also be asked to take part, so that their results can be compared with those of children who have had cancer treatment. We hypothesize that children receiving more aggressive therapy will have lower white matter brain volumes and these volumes will be significantly lower than age-matched siblings. We also hypothesize that children who take methylphenidate will show improvements on teacher and parent report measures of attention and social skills.
Interventions:
description: Please see detailed description for dosing information and study design.
name: Methylphenidate
type: Drug
Study arms:
design_group_title: Treatment
design_group_type: Experimental
Sponsor: St. Jude Children's Research Hospital, Inc.
Collaborators: National Cancer Institute
Drug name mappings:
name: 盐酸哌甲酯
lang: CN
name: Methylphenidate Hydrochloride
lang: EN
Clinical trial NCT02533934: Sofosbuvir Based DAA Therapy in HIV/HCV Coinfected Pre or Post Liver Transplant
Official title: A Retrospective/Prospective Cohort Study to Assess Safety, Tolerability, and Efficacy of Sofosbuvir Based Direct Acting Antiviral (DAA) Therapy for Hepatitis C Treatment in HIV/HCV Coinfected Subjects Pre or Post Liver Transplant
Conditions: HIV
Hepatitis C
Cirrhosis
Summary: Retrospective/Prospective, open-label study using sofosbuvir based DAA therapy to treat HIV/HCV coinfected pre or post liver transplant participants
Interventions:
description: Treatment of Hepatitis C with sofosbuvir based HCC therapy
name: Harvoni
other_name: SOF/LDV
type: Drug
Study arms:
design_group_description: Prospective and retrospective treatment for HCV
design_group_title: Treatment with Sofosbuvir based HCV Therapy
design_group_type: Experimental
Sponsor: The University of California, San Francisco
Collaborators: National Institutes of Health Clinical Center
University of Maryland
Columbia University
Icahn School of Medicine at Mount Sinai
The Johns Hopkins University
National Institute of Allergy & Infectious Diseases
University of Pennsylvania
Georgetown University
Drug name mappings:
name: 来迪派韦索磷布韦
lang: CN
name: Ledipasvir/Sofosbuvir
lang: EN
name: レジパスビル アセトン付加物
lang: JP
Clinical trial NCT02089841: Efficacy of Artemether/Lumefantrine for the Treatment of Uncomplicated Malaria.
Official title: Efficacy of Artemether/Lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Five Years After Wide Scale Use of the Drug in Tanzania.
Conditions: Plasmodium Falciparum Malaria
Summary: Artemether-lumefantrine has been used in Tanzania as first-line treatment for uncomplicated malaria since 2007. Nonetheless, a report of increased proportion of patients with parasitaemia on day 1 following treatment with artemisinin based combination therapies has emerged from Kenya. Similarly, resistance against artemisinins has been confirmed in South-East Asia and it can spread to Africa. Therefore, the purpose of this study was to assess the efficacy of Artemether-lumefantrine for the treatment of uncomplicated malaria among children after five years of wide scale use of the drug in Tanzania.
Interventions:
description: Blood samples will be collected on blood slides and filter papers for asexual parasites assessment both by microscope and molecular genotyping respectively following treatment with artemether-lumefantrine, to assess its efficacy.
name: Artemether-lumefantrine
other_name: Coartem
type: Drug
Study arms:
design_group_description: In this single-arm study, patients will be treated with Artemether/lumefantrine, and the first, third and fifth doses of the drug will be given under the direct observation of the health workers. The patients will be followed-up for 42 days, on day 1, 2, 3, 7, 14, 21, 28 and 42 to assess the efficacy of the drug.
design_group_title: Artemether/lumefantrine
design_group_type: Experimental
Sponsor: Muhimbili University of Health & Allied Science Institute
Collaborators: Karolinska Institutet
Drug name mappings:
name: 复方蒿甲醚
lang: CN
name: Artemether/Lumefantrine
lang: EN
name: アルテメテル/ルメファントリン
lang: JP
Clinical trial NCT00800553: fMRI-behavioral Study of Cholinergic Augmentation With Donepezil in Healthy Sleep Deprived Adults
Official title: The Neural and Behavioral Correlates of How Donepezil Modulates Memory and Inhibitory Efficiency in the Context of 24 Hours of Sleep Deprivation
Conditions: Sleep Deprivation
Summary: The purpose of this study was to characterize how the anti-cholinesterase inhibitor (AChE-I) donepezil modulates brain regions involved in visual short-term memory, episodic memory and inhibitory efficiency following 24 hours of total sleep deprivation using fMRI as an additional marker for drug effect.
Interventions:
description: 5mg o.m. p.o. for approx. 2 weeks
name: donepezil
other_name: Aricept
type: Drug
description: 5mg of placebo for approx. 2 weeks
name: Placebo
type: Drug
Study arms:
design_group_description: donepezil, 5 mg p.o. for approx 2 weeks
design_group_title: donepezil
design_group_type: Experimental
design_group_description: placebo
design_group_title: placebo
design_group_type: Placebo Comparator
Sponsor: Duke-NUS Graduate Medical School Singapore
Collaborators: GSK Plc
Drug name mappings:
name: 盐酸多奈哌齐
lang: CN
name: Donepezil Hydrochloride
lang: EN
name: ドネペジル塩酸塩
lang: JP
Clinical trial NCT00301262: Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied
Official title: A Multi-Center, Parallel Group, Flexible Dose Trial With A Double-Blind, Randomized, Placebo-Controlled Phase Followed By An Open-Label Phase To Assess The Impact Of Viagra On The Sexual Satisfaction Of Men With Mild Erectile Dysfunction
Conditions: Impotence
Summary: Men's quality of life (QoL) is potentially affected by mild erectile dysfunction (ED) to the same extent as it is by moderate and severe ED. This study will provide controlled clinical data measuring efficacy, QoL parameters and satisfaction changes in men with mild ED treated with Viagra versus those treated with a placebo. With an open-label extension, this study will also provide all study subjects the opportunity to receive the active drug treatment for 6 weeks.
Interventions:
name: Viagra (Sildenafil citrate)
type: Drug
Study arms:
Sponsor: Viatris, Inc.
Collaborators: Pfizer Inc.
Drug name mappings:
name: 枸橼酸西地那非
lang: CN
name: Sildenaifl Citrate
lang: EN
name: シルデナフィルクエン酸塩
lang: JP
Clinical trial NCT04585737: Efficacy of Switching to DTG/3TC in Virologically-suppressed Adults Currently on B/F/TAF
Official title: Efficacy, Safety and Tolerability of Switching to Dolutegravir/Lamivudine in Virologically-suppressed Adults Living With HIV on Bictegravir/Tenofovir Alafenamide/emtricitabine-the DYAD Study
Conditions: HIV I Infection
Summary: Phase 4, randomized, open-label study to evaluate the efficacy, safety and tolerability of switching virologically suppressed adults living with HIV on bictegravir/tenofovir alafenamide/emtricitabine to dolutegravir/lamivudine
Interventions:
description: Experimental
name: Dolutegravir / Lamivudine Pill
other_name: Dovato
type: Drug
description: Active comparator
name: Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill
other_name: Biktarvy
type: Drug
Study arms:
design_group_description: Treatment Group 1 (n=148): FDC of DTG/3TC (50mg/300mg) administered orally, once daily (QD), without regard to food.
design_group_title: Treatment group 1
design_group_type: Experimental
design_group_description: Treatment Group 2 (n=74): Stay on baseline regimen consisting of FDC of B/F/TAF (50mg/200mg/ 25mg) (taken as prescribed) without regard to food.
design_group_title: Treatment group 2
design_group_type: Active Comparator
Sponsor: Orlando Immunology Center P A
Collaborators: ViiV Healthcare Ltd.
Drug name mappings:
name: 多替拉韦钠/拉米夫定
lang: CN
name: Dolutegravir Sodium/Lamivudine
lang: EN
name: ドルテグラビルナトリウム・ラミブジン
lang: JP