bioihbjkbjnl/mcl2 huggingface dataset:
The Safety and Efficacy of Multiple-dose of JS002 in Subject With Hyperlipidemia
Condition: Hyperlipemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized,
      double-blind, placebo-controlled study to evaluate the safety and efficacy, as well as
      immunogenicity of JS002 treated repeatedly in patients with hyperlipidemia when combined with
      statin therapy.

      In this study, two dose group (150 mg, 300 mg) were set up in this study. 750 subjects are
      plan to be enrolled (the study drug will be assigned to a 2:1 ratio of JS002 or placebo).

      Each subject required a maximum of 6 weeks of screening, 52 weeks of treatment, and 8 weeks
      of follow-up.
    


Intervention name(s): JS002; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): JS002: 150mg(1mL) Q2W; Placebo 1mL Q2W.; JS002: 300mg(2mL) Q4W; Placebo 2mL Q4W.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Open-Label Trial of Sulforaphane in Premutation Carriers With FXTAS
Condition: Fragile X Associated Tremor/Ataxia Syndrome (Fxtas) (Diagnosis)
MeSH terms: Ataxia; Tremor
Study type: Interventional

Summary: 
      FXTAS is a rare genetic progressive neurodegenerative disorder, linked to a trinucleotide
      repeat expansion in the FMR1 gene. FXTAS is characterized by tremor and ataxia in addition to
      atrophy and white matter disease in the central nervous system (CNS). In addition to the
      major clinical observations of intention tremor and gait dysfunction, minor symptoms of
      parkinsonism, neuropathy, and cognitive decline also significantly impact individuals with
      FXTAS.

      The dietary supplement being tested in this study is called Sulforaphane. It is found in
      broccoli and similar cruciferous vegetables and may cause some gas and discomfort. This is
      not a study looking at clinical efficacy but instead a study of molecular outcome measures.
      Investigators want to get more information about how Sulforaphane affects specific
      biomolecular markers captured in blood.

      In this study, participants will be taking an increasing amount of the Sulphoraphane
      supplement pills (238mg/tablet), starting at 1 and increasing to 6, every morning at
      breakfast for 6 months. In addition, there will be a total of 3 visits (Initial, 3-month and
      6-month) to the MIND Institute where participants will be evaluated. At each visit (3 total)
      participants will undergo a battery of medical and neurologic exams which make take 2-3 days
      to complete each time. Participants and/or their caregivers will also be asked to fill out
      questionnaires/surveys. At the initial visit and at 6 months, we will collect blood for
      analysis. Two MRI scans will be done, also at the initial visit and at 6 months.
    


Intervention name(s): Sulforaphane
Intervention type(s): Dietary Supplement
Intervention description(s): Sulforaphane will be taken one tablet in the morning with breakfast and then every 2 weeks, the dose will be increased by one tablet until a total of 6 tablets are taken in the morning. The supplement should be taken around the same time each day.
Other intervention name(s): Avmacol
Intervention MeSH terms: Sulforaphane
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Sulforaphane
A Study to Assess the Bioavailability and to Compare the Pharmacokinetics of AZD7594 Inhaled Via Monodose Inhaler and Multiple-dose Dry Powder Inhalers (DPI) or Pressurized Metered-dose Inhaler (pMDI) in Healthy Male Subjects
Condition: Asthma; Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label,partially randomized, four-period study in healthy male subjects to
      assess the bioavailability and pharmacokinetics of a single dose of AZD7594 when administered
      intravenously, orally and inhaled via two different dry powder inhalers (DPIs) and a
      pressurized meter-dose inhaler (pMDI)
    

Detailed description: 
      This study is an open-label, partially randomized, 4-period, 5-treatment study in healthy
      male subjects, performed at a single study center. All subjects will receive the 4 of the 5
      treatments. The IV infusion will be fixed as the first treatment (Period 1), the Monodose
      inhaler will be fixed as the second treatment (Period 2) and the oral formulation will be
      fixed as the fourth treatment (Period 4). During Period 3, subjects are split into 2 equal
      cohorts, multiple-dose DPI and pMDI.
    

Intervention name(s): AZD7594 Solution for infusion (150 μg intravenous formulation); AZD7594 Oral suspension (1200 μg oral formulation); AZD7594 Inhalation powder (400 μg) by DPI Device 1 (monodose inhaler); AZD7594 Inhalation powder (400 μg) by DPI device 2 (multiple-dose inhaler); AZD7594 Pressurized inhalation suspension (400 μg) by pMDI
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Solution for infusion 0.01 mg/ml; AZD7594 150 μg IV; 0.1 - 10 mg/g oral solution; AZD7594 1200 μg oral; Inhalation powder, hard capsules 400 μg Monodose inhaler; AZD7594 400 μg by dry powder inhaler (DPI) Device 1 (Monodose inhaler); Inhalation powder, multiple-dose dry powder inhaler (DPI) 400 μg; AZD7594 400 μg by DPI Device 2 (multiple-dose DPI); Inhalation suspension 200 μg; AZD7594 400 μg by pressurized metered-dose inhaler (pMDI); 2 puffs x 200 μg = 400 μg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: AZD7594; Bioavailability; Healthy male subjects; Safety; Tolerability; Pharmacokinetics; Monodose inhaler; Multiple-dose dry powder inhaler
Chronic Ankle Instability and Proprioception
Condition: Chronic Ankle Sprains
MeSH terms: Ankle Injuries
Study type: Observational

Summary: 
      The purpose of this investigation is to determine the effects of chronic ankle instability on
      cervical spine and knee proprioception as measured using joint position sense to investigate
      whether correlation can be drawn between the two.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cohort of college aged students with a history of ankle sprains.
      
Keywords: sprain proprioception
Long-Term Antibody Persistence at 1, 3 and 5 Years After a Fourth Dose of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to ActHIB
Condition: Neisseria Meningitidis; Haemophilus Influenzae Type b
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is evaluating antibody persistence at 1, 3 & 5 years post-fourth dose (i.e., at 2,
      4 & 6 years of age, respectively) in subjects vaccinated in a previous study.

      This protocol posting deals with objectives & outcome measures of the extension phase at
      years 1, 3 and 5. The objectives & outcome measures of the first four doses are presented in
      a separate protocol posting (NCT00129129).

      This protocol posting has been amended in order to comply with the FDA Amendment Act of
      September 26, 2007.
    

Detailed description: 
      In this long-term follow-up study, no new subjects will be recruited. All subjects
      participating in this long-term follow-up study should have already participated in a
      previous study. No vaccine will be administered during the persistence phase of the study.

      This Protocol Posting has been updated following Protocol amendment 3, September 2009.
    

Intervention name(s): MenHibrix (Hib-MenCY-TT); Hib conjugate vaccine (ActHIB)
Intervention type(s): Biological; Biological
Intervention description(s): First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose; First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose
Other intervention name(s): GSK biologicals' Hib-MenCY-TT; ActHIB
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Humans; Meningococcal vaccines; Immunogenicity; Vaccines; H. influenzae type b vaccine; Conjugate; Toddlers; Comparative study; Neisseria meningitidis
Long Term Extension Study of Tapinarof for Plaque Psoriasis in Adults (3003)
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a long-term, open-label, multicenter, study to evaluate the safety and efficacy of
      topical tapinarof cream, 1% in adults with plaque psoriasis. Subjects in this study completed
      treatment in 1 of 2 Phase 3 pivotal efficacy and safety studies (Study DMVT-505-3001 or Study
      DMVT-505-3002). This study will consist of up to 40 weeks of treatment and a 4-week safety
      follow-up period.
    

Detailed description: 
      At the completion of the Week-12 visit of the pivotal study (Baseline [Day 1] in this study),
      all eligible subjects will be offered enrollment in the long-term extension study. Study
      visits during the treatment period for all subjects will occur every 4 weeks (± 3 days). The
      total duration of study participation will be approximately 44 weeks.
    

Intervention name(s): tapinarof cream, 1%
Intervention type(s): Drug
Intervention description(s): Intermittent use of Tapinarof cream, 1%, applied once daily according to PGA score
Other intervention name(s): DMVT-505
Intervention model: Single Group Assignment
Intervention model description: Subjects in this study completed treatment with tapinarof or vehicle in 1 of 2 parent Phase 3 pivotal efficacy and safety studies (Study DMVT-505-3001 or Study DMVT-505-3002). The study will consist of up to 40 weeks of tapinarof cream, 1%, and a 4-week safety follow-up period.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tapinarof; plaque psoriasis,; adult; phase 3; topical; open-label; efficacy; safety; psoriasis; long-term; therapeutic aryl hydrocarbon receptor modulating agent
Stretching and Yoga Exercise Study
Condition: Aging
Study type: Interventional

Summary: 
      The investigators propose to test the effects of an 8-week supervised, site-based, group yoga
      intervention on cognition and functional fitness in older adults. The SAY Exercise study will
      compare the yoga group to a stretching group to determine if the program improves attention
      and cognition, reduces functional limitations, enhances functional performance in everyday
      activities, as well as psychological health in sedentary older adults between 55-80 years of
      age. The investigators also propose to assess heart rate variability using a 3-lead EKG and
      salivary cortisol levels to understand the moderators of the yoga-cognition relationship.
    


Intervention name(s): Yoga Condition; Stretching Condition
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Classes lasting one hour, held 3 times per week for 8 weeks.; Classes lasting one hour, held 3 times per week for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Comparison of Two Interdental Cleaners
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      Comparison of Two interdental cleaning devices on plaque removal, gingivitis and bleeding.
    

Detailed description: 
      This study measured plaque accumulation, bleeding on probing and gingivitis using the Rustogi
      Modification of the Navy Plaque Index, BOP and Modified Gingival Index at baseline, 2-weeks
      and 4-weeks.
    

Intervention name(s): water flosser; air floss
Intervention type(s): Device; Device
Intervention description(s): Powered; Powered
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK)
Condition: ALK-activated Tumors
MeSH terms: Lymphoma; Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to estimate the maximum tolerated dose and/or recommended dose
      for expansion of LDK378 as a single agent, assess safety, tolerability and anti-tumor
      activity and characterize single and multiple-dose pharmacokinetics when administered orally
      to pediatric patients with ALK-activated tumors, with and without food.
    

Detailed description: 
      LDK378 is a novel inhibitor of ALK that is active in a broad range of ALK-activated tumor
      models, including models driven by mutated versions of ALK known to be resistant to
      crizotinib, and by ALK gene amplification.

      The primary purpose of this study was to determine the maximum tolerated dose and/or
      recommended dose for expansion in pediatric patients, and to delineate a clinical dose to be
      used in any future pediatric studies, with and without food. This study also assessed the
      safety, tolerability, PK and preliminary evidence of antitumor activity of LDK378 in
      pediatric patients with neuroblastoma, and other ALK-activated tumors.

      Fasted cohort: each daily dose of LDK378 (including days which involved PK blood sampling)
      was taken at least 2 hours after last meal & subjects did not eat until 1 hour after LDK378
      was taken. Each daily dose of LDK378 was taken with 1-2 tablespoons (15-30 mL) of an
      appropriate food (such as applesauce or non-fat yogurt) & a glass of water

      Fed cohort: each daily dose of LDK378 (including days which involved PK blood sampling) was
      taken with, or within 30 minutes after finishing a low-fat light snack containing 100-300
      calories & 1.5-2 grams of fat.
    

Intervention name(s): Ceritinib
Intervention type(s): Drug
Intervention description(s): LDK378 is a capsule taken by mouth, contents can be mixed with food for pediatric patients or mixed with water and given via nasogastric/gastric (NG/G) tube. For patients in fasted group: 1-2 tablespoons (15-30 mL) of an appropriate food such as apple sauce or non-fat yogurt and a glass of water were allowed.
For patients in the fed cohort: LDK378 was taken with, or within 30 minutes after finishing a low-fat light snack containing 100-300 calories and 1.5-2 grams of fat.
Other intervention name(s): LDK378
Intervention MeSH terms: Ceritinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LDK378; Ceritinib; pediatric; malignancies; anaplastic lymphoma kinase; ALK; ALK-activated tumors; neuroblastoma; rhabdomyosarcoma; anaplastic large-cell lymphoma; inflammatory myofibroblastic tumor
An 8-week Dose Ranging Study of CHF 718 pMDI in Asthmatic Subjects
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the dose-response of different doses of CHF 781
      Pressurized Metered Dose Inhaler (pMDI) on lung function and other clinical outcomes, to
      identify the optimal dose(s) in terms of benefit/ risk ratio for further development in the
      target patient population.
    

Detailed description: 
      This is a phase II, multicenter, randomized, double-blind, placebo and active controlled dose
      ranging 5-arm parallel group study to identify the optimal dose of CHF 781 pMDI with respect
      to lung function and other clinical efficacy and safety outcomes.

      After a 2 week run-in period under rescue albuterol as needed and background inhaled
      corticosteroid (ICS), patients will be randomized to one of the 5 study treatment groups.
      After randomization, patients will be assessed after 4 and 8 weeks of study treatment at the
      center. A follow-up phone call will be performed a week after the last visit.

      During the study, daily asthma symptoms, peak expiratory flow, rescue and background
      medication use, and compliance with the study medication will be recorded via subject diary.
      Treatment-Emergent Adverse Events (TEAEs) will be assessed and recorded throughout the study.
      At screening and subsequent visits, patients will undergo physical and vital signs
      examinations, spirometry measurements, and 12-lead ECG. Routine hematology, blood chemistry,
      and pregnancy testing will be performed before enrollment and at end of study. 24-hr urine
      cortisol and creatinine will be assessed before and after the first dose and just before the
      last dose of study treatment.
    

Intervention name(s): CHF 718 pMDI; Placebo pMDI; Beclomethasone Dipropionate (BDP)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dose Response: Test one of three different doses of CHF 718 pMDI; Placebo Control; Active Control
Other intervention name(s): QVAR® 80µg
Intervention MeSH terms: Beclomethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
OTO-104 for the Treatment of Meniere's Disease
Condition: Meniere's Disease
MeSH terms: Meniere Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of
      Meniere's disease.
    


Intervention name(s): OTO-104; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single intratympanic injection of 12 mg OTO-104; Single intratympanic injection of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Meniere's Disease; Vertigo; Definitive vertigo; Vertigo episodes; Vertigo frequency; Tinnitus; Hearing loss; Aural fullness
Low Glycemic Index and Load Diet for the Treatment of Acne
Condition: Acne Vulgaris; Diet Modification
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      Clinical trial to determine the effect of adding a diet with low glycemic index and load to
      adults for the treatment of moderate acne. Adult patients with acne where recruited in two
      groups, A and B. Group A received a normal diet according to their metabolic status and group
      B received a diet with low glycemic index and load. Outcomes were measured at week 12.
    

Detailed description: 
      Clinical trial to determine the effect of adding a diet with low glycemic index and load to
      adults for the treatment of moderate acne. Adult patients with acne where recruited in two
      groups, A and B. Both groups of treatment were treated with doxycycline 100 mg per day plus
      adapalene 0.1% gel daily for 12 weeks. During pharmacologic treatment, all patients had
      nutrition counseling monthly. Group A received a normal diet according to their metabolic
      status and group B received a diet with low glycemic index and load. At the end of the trial,
      the change in acne lesions count was analyzed and also their metabolic status. Quality of
      life was also measured.
    

Intervention name(s): Normal diet; Low glycemic diet; Adapalene 0.1% Gel; Doxycycline
Intervention type(s): Other; Other; Drug; Drug
Intervention description(s): The energy consumption of each of the participants will be calculated, using the Mifflin-St Jeor formula. Each participant will receive a standard menu of 6 days according to their metabolic requirements and a list of equivalent foods. The distribution of macronutrients will be: 45% carbohydrates, 30% lipids and 25% proteins.; The energy consumption of each of the participants will be calculated, using the Mifflin-St Jeor formula. Each participant will receive a standard menu of 6 days according to their metabolic requirements and a list of equivalent foods. A list of foods classified as having low index and glycemic load was used according to the mexican equivalent food system. The distribution of macronutrients will be: 45% carbohydrates, 30% lipids and 25% proteins. Milk and vitamin supplements will be eliminated from the diet.; Adapalene 0.1% gel daily at night for 12 weeks, applied on the face, chest and back.; Doxycycline 100 mg per day orally, before breakfast
Other intervention name(s): Adapalene
Intervention MeSH terms: Doxycycline; Adapalene
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial, two-arm
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acne Vulgaris; Low Glycemic Diet; Doxycycline; Adapalene
Comparison FX CorDiax 60 in Relation to the FX 60-Dialyzer
Condition: Hemodialysis
Study type: Interventional
Phase: Phase 4

Summary: 
      Study design: Open, randomized, cross-over, monocentric, controlled, prospective Applied
      Medical Devices: FX CorDiax 60 (high-flux), FX 60 (high-flux) Patients: 30 adult chronic
      hemodialysis patients Treatment: Each patient will be treated by post-dilution online
      hemodiafiltration once with each dialyzer type.

      Study objectives: Intraindividual comparison of removal rate of urea, phosphate,
      ß2-microglobulin (ß2-m), myoglobin, prolactin, alpha1-microglobulin and
      alpha1-acidglycoprotein and of the albumin loss with different dialyzer membranes during
      post-dilution online hemodiafiltration.

      Primary variable: Removal rate of myoglobin Secondary variable: Removal rate of urea,
      phosphate, ß2-microglobulin (ß2-m), prolactin, alpha1-microglobulin and
      alpha1-acidglycoprotein Safety variable: Hematocrit, albumin loss Sample Size: 30 subjects
    


Intervention name(s): dialyzer comparison; Dialyzer
Intervention type(s): Other; Device
Intervention description(s): Each patient will be treated by post-dilution online hemodiafiltration once with each dialyzer type (FX CorDiax 60or FX 60 ) The order of dialyzers used will be randomly assigned to the patient at the time of randomisation by lot. Every subject will be treated one time with each dialyzer. In order to achieve controlled conditions, the mid- or end-week session data will be used, only.; Comparison Dialyzer FX60 versus Cordiax60
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Rituximab for Idiopathic Nephrotic Syndrome
Condition: Idiopathic Nephrotic Syndrome
MeSH terms: Nephrotic Syndrome; Nephrosis; Nephrosis, Lipoid; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Open-label, randomized, controlled trial due to value whether the monoclonal antibody
      rituximab is non-inferior to steroids in maintaining remission in juvenile forms of SDNS.

      The investigators will enroll 30 pediatric patients affected by idiopathic nephrotic
      syndrome, who have been in treatment with steroids for at least one year. The lowest dose of
      drug required to maintain a stable remission will be between 0.4 and 0.7 mg/ kg/ day.

      This trial provides an initial run-in phase of one month during wich remission will be
      achieved by means of a standard oral prednisone course. Once remission has been achieved
      children will be randomized in a parallel arm open label RCT to continue prednisone alone for
      one month (control) or to add a single intravenous infusion of rituximab (375 mg/m2 -
      intervention). Prednisone will be tapered in both arms after one month.
    


Intervention name(s): Rituximab
Intervention type(s): Drug
Other intervention name(s): Mabthera; Anti CD-20 antibodies
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nephrotic syndrome; Proteinuria; Rituximab