PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT00408356: Immunological and Clinical Responses to Zinc in Children With Diarrhoea
Official title: Immunological and Clinical Responses to Zinc: A Randomized, Double-Blind Trial of Zinc Treatment vs. Zinc Treatment Plus Daily Supplementation for 3 Months Among Children Under 2 Years of Age With an Acute Diarrheal Illness.
Conditions: Diarrhoea
Summary: Zinc deficiency has been found to be widespread among children in developing countries.Clinical and field studies have consistently observed an association between zinc deficiency and higher rates of infectious diseases, including skin infections, diarrhea, respiratory infections, malaria, and delayed wound healing. Based upon the impact of zinc deficiency on diarrheal disease alone, it is estimated correction of this deficiency could save 450,000 under-five deaths annually. What is the physiological explanation for this? Zinc has been identified to play critical roles in metallo-enzymes, poly-ribosomes, the cell membrane, and cellular function, leading to the understanding that it also plays a central role in cellular growth and in the function of the immune system. With zinc deficiency epithelial barriers are compromised and multiple components of the immune system malfunction. The obvious conclusion is that zinc deficiency results in diminished immunological competence that in turn leads to an increased risk for infectious diseases and greater severity of illnesses. Whether this is the case requires substantiation. A related, but more pragmatic question is the value added of zinc supplementation in addition to zinc treatment. The scale-up strategy being pursued in Bangladesh is to provide zinc for 10 days as a treatment at the time of a diarrhea episode. This is in accordance with recently revised WHO recommendations for the treatment of childhood diarrhea (WHO, in press). Can we conclude there is no or minimal value added to continuing zinc as a dietary supplement in zinc deficient children following an acute episode? If there is added benefit, can this be explained by improvement in zinc levels and/or immune function? The aims of this study include:1. In children six to twenty-four months of age with an acute episode of diarrhea attributable to enterotoxigenic E. coli (ETEC), to describe the innate and adaptive immune response to zinc and to relate changes in immune function or zinc status to the occurrence of repeat infectious illnesses over a 9 month period of observation. 2a. In children six to twenty-four months of age with an acute episode of diarrhea with enterotoxigenic E. coli (ETEC), and other non-ETEC diarrhea, to determine the value added of zinc supplementation following treatment in terms of the future occurrence of ACD, ARI, and impetigo and 2b. to assess the impact of zinc supplementation on health services utilization and household expenditures for ACD, ARI and impetigo.
Interventions:
name: Zinc
type: Drug
Study arms:
Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators: Gates Foundation (United States)
Drug name mappings:
name: 氧化锌
lang: CN
name: Zinc Oxide
lang: EN
Clinical trial NCT01143064: Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Investigate the Efficacy and Safety of Progesterone in Patients With Severe Traumatic Brain Injury
Conditions: Brain Injuries
Summary: The SyNAPSe trial will study if giving intravenous (i.v.) progesterone within 8 hours of the injury for a total of 120 hours to severe traumatic brain injury patients improves their recovery.
Interventions:
description: Intravenous administration of 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.
name: Progesterone
other_name: BHR-100
type: Drug
description: Intravenous administration equal to 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.
name: Lipid emulsion without progesterone
type: Drug
Study arms:
design_group_title: Progesterone
design_group_type: Active Comparator
design_group_title: Lipid emulsion without progestrone
design_group_type: Placebo Comparator
Sponsor: BHR Pharma LLC
Collaborators: Syneos Health, Inc.
PRA Health Sciences, Inc.
Drug name mappings:
name: 黄体酮
lang: CN
name: Progesterone
lang: EN
name: プロゲステロン
lang: JP
Clinical trial NCT00252564: Cetuximab, Bevacizumab & 5FU/Leucovorin vs. Oxaliplatin, Bevacizumab & 5FU/Leucovorin in Metastatic Colorectal Cancer
Official title: Randomized PhIII Trial of Cetuximab, Bevacizumab & Biweekly Infusional 5FU/Leucovorin (FOLF-CB) vs. Oxaliplatin, Bevacizumab, & Biweekly Infusional 5FU/Leucovorin (Bev-FOLFOX) in First Line Treatment of Metastatic Colorectal Cancer
Conditions: Metastatic Colorectal Cancer
Summary: The purpose of this study is to compare the rates of Progression-Free Survival (PFS) at 12 months for patients treated with Bev-FOLFOX versus patients treated with FOLF-CB for first line treatment of metastatic colorectal cancer.
Interventions:
description: 5 mg/kg over 30 minutes on Days 1 and 15
name: Bevacizumab
other_name: Avastin
type: Drug
description: 85 mg/m2 on Days 1 and 15
name: Oxaliplatin
other_name: Eloxatin
type: Drug
description: 400 mg/m2 on Days 1 and 15
name: Leucovorin
type: Drug
description: 400 mg/m2, IV bolus followed by: 1200 mg/m2/day via 24-hour continuous infusion, for 2 consecutive days (total 5-FU infusion dose = 2400 mg/m2 over the 48 hour period)
name: Fluorouracil
other_name: 5FU
type: Drug
description: 400 mg/m2 over 2 hours (Cycle 1 Day 1 only) All subsequent doses (Day 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 other cycles)250 mg/m2 over 1 hour
name: Cetuximab
other_name: Erbitux
type: Drug
Study arms:
design_group_description: (Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via "T" connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.<br/>Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU<br/>Dosing on Days 1 and 15 of each 28-day cycle
design_group_title: Bev-FOLFOX
design_group_type: Experimental
design_group_description: (FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.<br/>Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU
design_group_title: FOLF-CB
design_group_type: Experimental
Sponsor: US Oncology Research LLC
Collaborators: Memorial Sloan Kettering Cancer Center
Bristol Myers Squibb Co.
Prologue Research International, Inc.
Drug name mappings:
name: 西妥昔单抗
lang: CN
name: Cetuximab
lang: EN
name: セツキシマブ（遺伝子組換え）
lang: JP
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: 贝伐珠单抗
lang: CN
name: Bevacizumab
lang: EN
name: ベバシズマブ（遺伝子組換え）
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
Clinical trial NCT07249632: A Study of Telitacicept in Patients With Ocular Myasthenia Gravis (OMG)
Official title: A Phase III Trial of Telitacicept in Patients With Ocular Myasthenia Gravis
Conditions: Myasthenia Gravis, Ocular
Summary: This is a Phase III, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Telitacicept for the treatment of Ocular Myasthenia Gravis (OMG).Approximately 120 eligible subjects aged 12 to 80 years with a diagnosis of OMG (Myasthenia Gravis Foundation of America [MGFA] Clinical Classification Type I) will be randomized in a 1:1 ratio to receive either Telitacicept or a matching placebo. Subjects must be on a stable standard-of-care therapy and have an MG Impairment Index (PRO) ocular score of ≥6 at screening and baseline.The dose is age and weight based.The primary objective is to evaluate the efficacy of Telitacicept compared to placebo in treating OMG.The primary efficacy endpoint is the change from baseline in the MGII (PRO) ocular score at Week 24. Secondary endpoints include changes from baseline in other ocular and total scores from MGII, Myasthenia Gravis-Activities of Daily Living (MG-ADL), MG Clinical Absolute Score, and the 15-item Myasthenia Gravis Quality of Life Revised scale (MG-QOL15r). Safety and tolerability will be monitored throughout the study.
Interventions:
description: The dosage is administered based on the subject's age and baseline body weight.
name: Telitacicept
type: Drug
description: The placebo contains no active ingredients. To maintain the blind, the placebo matches the active drug in all physical aspects.
name: Placebo
type: Drug
Study arms:
design_group_title: Telitacicept
design_group_type: Experimental
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: RemeGen Co., Ltd.
Collaborators: Shanghai Huashan Hospital
Beijing Hospital of the Ministry of Health
Drug name mappings:
name: 泰它西普
lang: CN
name: Telitacicept
lang: EN
Clinical trial NCT04383691: A Study of Lurasidone Compared With Placebo for the Treatment of Bipolar I Depression
Official title: A Randomized, 6-Week, Multicenter, Double-Blind, Placebo-Controlled, Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression
Conditions: Bipolar I Depression
Summary: The study evaluates the efficacy and safety of lurasidone compared with placebo in treating Bipolar I Depression.
Interventions:
description: Subjects will be administered orally, once daily, in the evening. Subjects will be treated with Lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7. Flexible dosing of study drug will be permitted beginning on Day 8.
name: Lurasidone HCl
type: Drug
description: Subjects will be administered orally, once daily, in the evening. Subjects will be treated with Placebo.
name: Placebo
type: Drug
Study arms:
design_group_description: Subjects will be administered orally, once daily, in the evening. Subjects will be treated with Lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7. Flexible dosing of study drug will be permitted beginning on Day 8.
design_group_title: Lurasidone
design_group_type: Experimental
design_group_description: Subjects will be administered orally, once daily, in the evening. Subjects will be treated with Placebo.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Sumitomo Pharma Co., Ltd.
Collaborators: Sumitomo Pharma America, Inc.
Drug name mappings:
name: 盐酸鲁拉西酮
lang: CN
name: Lurasidone Hydrochloride
lang: EN
name: ルラシドン塩酸塩
lang: JP
Clinical trial NCT05231044: A Multi-Center Study to Evaluate the Efficacy and Safety of KX01 Ointment 1% on Actinic Keratosis on Face or Scalp
Official title: A Phase 3, Double-Blind, Vehicle-Controlled, Randomized, Parallel Group, Multicenter, Efficacy, Safety and PK Study of KX01 Ointment 1% in Japanese Adult Subjects With Actinic Keratosis on the Face or Scalp
Conditions: Actinic Keratosis
Summary: This Phase III study is designed to evaluate the efficacy and safety of KX01 Ointment in adult participants when applied to an area of skin containing more than 1, clinically typical Actinic Keratosis (AK) lesions on the face or scalp.
Interventions:
description: The experimental drug, KX01 Ointment 1% is used in participants with Clinically typical AK on the face or scalp.
name: KX01 ointment 1%
type: Drug
description: Vehicle Ointment is used in participants with Clinically typical AK on the face or scalp.
name: Placebo
type: Drug
Study arms:
design_group_description: KX01 Ointment 1% is applied topically once daily for 5 consecutive days on face or scalp
design_group_title: KX01 Ointment 1%
design_group_type: Experimental
design_group_description: Vehicle Ointment is applied topically once daily for 5 consecutive days on face or scalp
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: PharmaEssentia Corp.
Collaborators: PharmaEssentia Japan KK
Drug name mappings:
name: 特班布林
lang: CN
name: Tirbanibulin
lang: EN
Clinical trial NCT00688376: Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment
Official title: Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment
Conditions: Attention Impairment
Summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of donepezil in children with persistent attention impairment that is present at least 12 months after the completion of cancer treatment.
Interventions:
description: During the 12-week Double-Blind Phase, subjects will receive oral donepezil hydrochloride tablets starting at a dose of 3 mg once daily. Doses will be increased incrementally at successive 3-week intervals on the basis of weight and tolerability. The final daily dose will be 3, 5, or 10 mg depending on body weight.<br/>During the Blinded Extension Phase, all subjects will receive active treatment (donepezil).
name: Donepezil hydrochloride
other_name: Aricept
type: Drug
description: During the 12-week Double-Blind Phase, subjects will receive matching placebo tablets (3, 5, of 10 mg) once daily.<br/>During the 12-week Blinded Extension Phase, all subjects will receive active treatment (donepezil).
name: Placebo
type: Drug
Study arms:
design_group_title: 1
design_group_type: Experimental
design_group_title: 2
design_group_type: Placebo Comparator
Sponsor: Eisai, Inc.
Collaborators: Eisai Co., Ltd.
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 NCT02176460: Colchicine for Symptom and Inflammation in Knee Osteoarthritis
Official title: A Randomized Controlled Trial of Colchicine for Symptom and Inflammation Modification in Knee Osteoarthritis
Conditions: Knee Osteoarthritis
Summary: Uric acid may be involved in the activation of the innate immune response in osteoarthritis (OA) pathology and progression. This suggests that traditional gout therapy may be beneficial for OA. Our goal therefore is to assess colchicine, an existing commercially available agent for gout, for a new therapeutic indication-knee OA. The investigators propose a randomized clinical trial (RCT) of 16 weeks' therapy with standard daily dose oral colchicine or placebo for knee OA. The investigators hypothesize that colchicine will block inflammasome mediated inflammation, thereby improve the signs and symptoms of OA, and reduce synovial fluid, serum and urine inflammatory and biochemical joint degradation biomarkers. This trial will potentially provide data to support a new treatment option for knee OA.
Interventions:
description: 0.5mg twice daily for 16 weeks
name: Colchicine
other_name: generic colchicine tablets (SIN 12490P)
type: Drug
description: 1 tablet twice daily
name: Placebo
other_name: placebo tablet
type: Drug
Study arms:
design_group_description: 0.5mg twice daily for 16 weeks
design_group_title: colchicine
design_group_type: Experimental
design_group_description: 1 tablet twice daily for 16 weeks
design_group_title: placebo tablet
design_group_type: Placebo Comparator
Sponsor: Singapore General Hospital Pte Ltd.
Collaborators: Duke-NUS Graduate Medical School Singapore
Duke University
Drug name mappings:
name: 秋水仙碱
lang: CN
name: Colchicine
lang: EN
name: コルヒチン
lang: JP
Clinical trial NCT00524849: Zometa and Circulating Vascular Endothelial Growth Factor (VEGF) in Breast Cancer Patients With Bone Metastasis
Official title: Randomized Phase 2 Study on the Relationship Between Circulating VEGF and Weekly or Every-four-week Zometa in Breast Cancer Patients With Bone Metastases
Conditions: Metastatic Breast Cancer
Bone Metastases
Summary: The primary objective of this study is to evaluate the effects of Zometa (zoledronic acid, 1 mg per week versus 4 mg every four weeks) on the circulating vascular endothelial growth factor (VEGF) levels in breast cancer patients with bone metastases. Sixty patients will be randomized into two groups.
Interventions:
description: Zometa 1 mg weekly (intravenous)
name: Zoledronic acid
other_name: Zometa
type: Biological
description: Zometa 4 mg every four weeks (intravenous)
name: Zoledronic acid
type: Drug
Study arms:
design_group_description: Zometa 4mg IV q4w, in combination with other antitumor agents one month after the initial dosing.
design_group_title: conventional Zometa
design_group_type: Active Comparator
design_group_description: Weekly Zometa in combination with other antitumor agents one month after the initial dosing.
design_group_title: weekly Zometa
design_group_type: Experimental
Sponsor: Fudan University
Collaborators: Novartis AG
Drug name mappings:
name: 唑来膦酸
lang: CN
name: Zoledronic Acid
lang: EN
name: ゾレドロン酸水和物
lang: JP
Clinical trial NCT00725270: Treatment of Schizoaffective Disorder Using Mifepristone
Official title: Treatment of Schizoaffective Disorder Using Mifepristone
Conditions: Psychotic Disorders
Depressive Disorder, Major
Depressive Disorder
Summary: This study tests the hypothesis that mifepristone will diminish cognitive distortion and alleviate psychosis in patients with schizoaffective disorder.
Interventions:
description: 600 mg of mifepristone
name: Mifepristone
type: Drug
description: Placebo comparator
name: Placebo Oral Tablet
type: Drug
Study arms:
design_group_description: Patients will be randomized to placebo
design_group_title: Placebo
design_group_type: Placebo Comparator
design_group_description: Patients will be randomized to mifepristone
design_group_title: Mifepristone
design_group_type: Experimental
Sponsor: Stanford University
Collaborators: Pritzker Family Foundation
Drug name mappings:
name: 米非司酮
lang: CN
name: Mifepristone
lang: EN
name: ミソプロストール
lang: JP
Clinical trial NCT00973349: Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults
Official title: A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Adult Subjects 18 or More Years of Age
Conditions: Influenza
Summary: This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults.
Interventions:
description: 8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
name: MF59-eH1N1_f
type: Biological
Study arms:
design_group_description: 50% of MF59 with 3.75 µg A/H1N1 antigen
design_group_title: 3.75_(50)MF59
design_group_type: Experimental
design_group_description: 0% of MF59 with 7.5 µg A/H1N1 antigen
design_group_title: 7.5 w/o MF59
design_group_type: Experimental
design_group_description: 50% of MF59 with 7.5 µg A/H1N1 antigen
design_group_title: 7.5_(50)MF59
design_group_type: Experimental
design_group_description: 100% of MF59 with 7.5 µg A/H1N1 antigen
design_group_title: 7.5_(100)MF59
design_group_type: Experimental
design_group_description: 0% of MF59 with 15 µg A/H1N1 antigen
design_group_title: 15 w/o MF59
design_group_type: Experimental
design_group_description: 50% of MF59 with 15 µg A/H1N1 antigen
design_group_title: 15_(50)MF59
design_group_type: Experimental
design_group_description: 100% of MF59 with 15 µg A/H1N1 antigen
design_group_title: 15_(100)MF59
design_group_type: Experimental
design_group_description: 0% of MF59 with 30 µg A/H1N1 antigen
design_group_title: 30 w/o MF59
design_group_type: Experimental
Sponsor: Novartis AG
Collaborators: Novartis Vaccines & Diagnostics, Inc.
Drug name mappings:
name: Influenza vaccine(Seqirus GmbH)
lang: EN
Clinical trial NCT00178503: Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children
Official title: ADHD Symptoms in Autism: Cognition, Behavior, Treatment
Conditions: Autism
Attention Deficit Disorder With Hyperactivity
Summary: This study examined the cognitive and behavioral differences in children who have an autism spectrum disorder (ASD) with or without additional symptoms of ADHD. The study also examined the effectiveness of a range of doses of methylphenidate in improving cognitive and behavioral outcomes in children with both ASD and ADHD.
Interventions:
description: Methylphenidate-extended release was taken in the morning of the MPH treatment trial. Each participant underwent 1 week of the each of the doses as determined by body weight. The lower body weight group (20 to 24 kg/44 to 52.8 lbs) took 10 mg Ritalin LA to 20 mg. The medium body weight group (25 to 33 kg/55 to 72.6 lbs) took from 10 mg Ritalin LA to 30 mg. The higher body weight group (34 to 59 kg/74.8 to 129.8 lbs) took 20 mg Ritalin LA to 40 mg.
name: Methylphenidate-extended release
other_name: Ritalin LA
type: Drug
description: Methylphenidate-immediate release was taken in the late afternoon. Each participant underwent 1 week at each of the 3 dose levels as determined by body weight. The lower body weight group (20 to 24 kg/44 to 52.8 lbs) took 2.5 mg IR-MPH and 2 weeks of 5 mg. The medium body weight group (25 to 33 kg/55 to 72.6 lbs) took 2 weeks of 5 mg IR-MPH and 1 week of 10 mg. The higher body weight group (34 to 59 kg/74.8 to 129.8 lbs) took 1 week of 5 mg IR-MPH and 2 weeks of 10 mg.
name: Methylphenidate-immediate release
type: Drug
description: Participants will take a placebo for 1 full week of the randomized drug trial. They will take one capsule in the morning and one capsule in the afternoon.
name: Placebo
type: Other
Study arms:
design_group_description: 24 Participants with ASD-ADHD underwent 1 week of placebo in the MPH treatment phase
design_group_title: MPH Trial-Placebo
design_group_type: Placebo Comparator
design_group_description: 24 Participants with ASD-ADHD underwent 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
design_group_title: MPH Trial: Low Dose
design_group_type: Active Comparator
design_group_description: 24 Participants with ASD-ADHD underwent 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
design_group_title: MPH Trial: Med Dose
design_group_type: Active Comparator
design_group_description: 24 Participants with ASD-ADHD underwent 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
design_group_title: MPH Trial: High Dose
design_group_type: Active Comparator
Sponsor: The University of Texas Health Science Center at Houston
Collaborators: National Institute of Mental Health
Drug name mappings:
name: 盐酸哌甲酯
lang: CN
name: Methylphenidate Hydrochloride
lang: EN