bioihbjkbjnl/mcl2 huggingface dataset:
Sun Protection Factor Assay (SPF Assay 104/2016)
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): BAY987517
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z44-036)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug-Drug Interaction Study Between CJ-12420 and Clarithromycin in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective: To assess the effect of the coadministration of multiple dose of CJ-12420
      and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.

      Secondary Objective(s): To assess the safety of the coadministration of multiple dose of
      CJ-12420 and clarithromycin in healthy subjects
    

Detailed description: 
      An open-label, randomized, 6-sequence, 3-period, 3-treatment crossover design
    

Intervention name(s): CJ-12420 200mg + Clarithromycin 500mg; CJ-12420 200mg; Clarithromycin 500mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.; To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.; To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.
Other intervention name(s): CJ-12420 200mg for 5 days + Clarithromycin 500mg for 5 days; CJ-12420 200mg for 5 days; Clarithromycin 500mg for 5 days
Intervention MeSH terms: Clarithromycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug-Drug interaction; Pharmacokinetics
Dual Task in Institutionalized Elderly
Condition: Aging
Study type: Interventional

Summary: 
      Objectives: To evaluate the effects of eight weeks of cognitive motor training (dual task) in
      the risk of falls, balance, independence in basic activities of daily living (BADL) and
      handgrip in institutionalized elderly.

      Methods: The sample was divided in two groups: double task group (DTG), consists of five
      elderly, undergoing a training consists of motor and cognitive activities and control group
      (CG) consists of four seniors who underwent conventional kinesiotherapeutic training, based
      on global stretching and strengthening exercises, both held in 16 sessions.
    

Detailed description: 
      Experimental, prospective and quantitative study, whose sample was selected for convenience
      in a long-term care institution for the elderly (LTCF) in the city of Uberaba - MG. The
      volunteers were divided into two groups, named dual task group (DTG) consists of five
      seniors, and control group (CG) consists of four elderly. All participants of both groups
      answered a questionnaire with sociodemographic and economic characteristics of the sample.
      Participants underwent a pre- and post evaluation containing vital signs parameters (blood
      pressure, respiratory rate and heart rate), anthropometric data (weight and height) and
      different tests to evaluate the balance, functional mobility, risk of falls, muscle strength
      and independence to carry out basic activities of daily living. The performed tests were
      Timed Up and Go (TUG) conventional, motor TUG and TUG cognitive, beyond Romberg test and
      Sensitized Romberg, Berg Balance Scale, and modified Katz scale (with maintenance of the six
      original activities of the scale, but with simulation to the performance of each task,
      measuring the spent time).
    

Intervention name(s): Cognitive motor training; kinesiotherapeutic conventional treatment
Intervention type(s): Other; Other
Intervention description(s): Initially an intervention consisting of double duty activities (motor-cognitive) and the control group will be subjected to a conventional treatment based on stretching and strengthening will be held.; Standardized global stretching and strengthening with squat exercise, plantar flexion in foot and elbow flexion supporting body weight in the hands arranged on the wall
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dual task; aging
Stem Cell Research on Subjects at Genetic High Risk for Schizophrenia
Condition: Genetic High Risk for Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      This study aims at finding endophenotypes of schizophrenia at neuronal level by obtaining
      stem cells which is derived from adipose cells of subjects with heavy genetic loading for
      schizophrenia then differentiating them into neuronal cells.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        -  Subjects at genetic high risk for schizophrenia

          -  Healthy control
      
Biospecimen description: 
      5-10mL of adipose cells in tumescent solution

      5-10mL of venous blood
    
Keywords: schizophrenia; stem cells; neurons; genetic hish risk for schizophrenia
Clinical Investigation on the Effects of Bayberry Juice Treatment in Adult Subjects With Features of Fatty Liver Disease
Condition: Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      Chinese bayberry, one of six Myrica species native to China, is rich in anthocyanins, and
      cyanidin-3-O-glucoside (C3G) was identified as a major anthocyanin component. In previous
      animal studies from us and other investigators, anthocyanins have been shown to ameliorate
      dyslipidemia and hepatic steatosis in different rodent models. The aim of the present study
      was to examine the effects of Chinese bayberry juice (CBJ) on the serum lipid profile and on
      levels of biomarkers related to antioxidant status in young adults with features of fatty
      liver disease.
    


Intervention name(s): Chinese bayberry juice; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Consume 500 mL CBJ/d (250 mL CBJ twice daily)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: oxidative stress; dyslipidemia; inflammation
A Study of LY900014 in Participants With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in
      participants with type 2 diabetes mellitus. The study will be conducted in participants with
      type 2 diabetes on insulin injection therapy to investigate how the body processes LY900014
      and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog).

      Screening is required within 28 days prior to the start of the study. For each participant,
      the total duration of the clinical trial will be between 3 and 8 weeks.
    


Intervention name(s): LY900014; Insulin Lispro
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): Ultra-Rapid Lispro; LY275585; Humalog
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Metabolic Syndrome and Degenerative Meniscus Lesions Related Knee Function
Condition: Metabolic Syndrome; Meniscus Lesion; Obesity, Abdominal; Knee Arthritis
MeSH terms: Metabolic Syndrome; Obesity, Abdominal; Syndrome
Study type: Observational

Summary: 
      Studies have suggested that Obese patients with metabolic syndrome(MetS)were correlated with
      knee joint degeneration and osteoarthritis. However, no studies demonstrate the relationship
      between obese patients with metabolic syndrome and degenerate meniscus lesions and its knee
      function.The aim is to detect the correlation between obese patients with metabolic syndrome
      and degenerate meniscus injuries.
    

Detailed description: 
      Obese patients with metabolic syndrome(MetS)were correlated with knee joint degeneration and
      osteoarthritis. However, no studies demonstrate the relationship between patients with
      metabolic syndrome and degenerate meniscus lesions or knee function. Participants were
      recruited from First Affiliated Hospital of Jinzhou Medical University. 100 BMI<24 people
      without Metabolic syndrome volunteers aged between 35-70 years old and 80 Metabolic syndrome
      patients with BMI>27 were included in the study. Obese patients with MetS were assessed knee
      function and degenerate meniscus tears verified by magnetic resonance imaging. And patients
      with a mild or no osteoarthritis with Kellgren and Lawrence grade<2 verified by X ray. We
      tested the relationship between metabolic syndrome and degenerate meniscus lesions. Obese
      patients with MetS and volunteers were detected by Mcmurry's test and MRI image to measure
      degeneration grade of meniscus tears. Number of MetS components were accounted and the knee
      function KOOS, IKDC score or degenerate meniscus tears were analyzed.
    

Intervention name(s): Metabolic syndrome and meniscus injuries
Intervention type(s): Other
Intervention description(s): Metabolic syndrome
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        participants from Jinzhou City, west of Liaoning Province
      
Keywords: Metabolic Syndrome; degenerate meniscus lesions; obesity; knee function
Bioequivalence of Two Insulatard® Formulations in Healthy Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to test for bioequivalence
      between two formulations of Insulatard® in healthy subjects.
    


Intervention name(s): isophane human insulin
Intervention type(s): Drug
Intervention description(s): Single dose of each formulation, administered subcutaneously (s.c., under the skin) on two separate dosing visits
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of CYP-001 for the Treatment of Steroid-Resistant Acute Graft Versus Host Disease
Condition: Graft vs Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and efficacy of two infusions
      of CYP-001 in adults with steroid-resistant GvHD.
    

Detailed description: 
      This is a multi-centre, open label, dose escalation study to assess the safety, tolerability
      and efficacy of two infusions of CYP-001, in adults who have steroid-resistant GvHD.

      Participants will receive standard of care treatment throughout the study, according to local
      procedures. The first eight participants will be enrolled in Cohort A and receive a CYP-001
      dose of 1 million cells per kg, up to a maximum dose of 100 million cells, on Day 0 and Day
      7. Subject to a safety review of data from Cohort A, an additional eight participants will be
      enrolled into Cohort B and receive a CYP-001 dose of 2 million cells/kg, up to a maximum dose
      of 200 million cells, on Day 0 and Day 7. The primary evaluation period concludes for each
      participant 100 days after the first dose of CYP-001. Participants will have study visits on
      Days 0, 3, 7, 14, 21, 28, 60 and 100. Subsequently, participants will enter a long term
      follow-up period, which concludes 2 years after the first dose of CYP-001.
    

Intervention name(s): Mesenchymoangioblast-derived mesenchymal stem cells
Intervention type(s): Biological
Intervention description(s): The active agent in CYP-001 is allogeneic mesenchymoangioblast-derived mesenchymal stem cells (MCA-derived MSCs), which are produced using the proprietary Cymerus™ platform technology. Cymerus™ refers to the process of generating cell-based products from intermediate cells, MCAs, which in turn are derived from induced pluripotent stem cells or iPSCs. The iPSCs used in the Cymerus™ process were derived from blood donated by a fully-consented healthy adult donor, and were reprogrammed using a transgene-free, viral-free and feeder-free technique.
Other intervention name(s): CYP-001
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Evaluating the Effect of Formulation on the Bioavailability of Ipatasertib in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I, open-label, randomized, 2-period crossover study was designed to determine the
      relative bioavailability of ipatasertib administered as capsule and tablet formulations to
      healthy adult volunteers. Participants will be randomized to one of two treatment sequences
      to receive a single oral administration of ipatasertib in tablet or capsule formulation
      followed, after a washout period, by a single oral administration of ipatasertib in the
      second formulation. Pharmacokinetics will be assessed, and standard physical and clinical
      evaluations will be performed throughout the study. Time on study is expected to be 2 weeks.
    


Intervention name(s): ipatasertib (Capsule); ipatasertib (Tablet)
Intervention type(s): Drug; Drug
Intervention description(s): Orally administered single dose of Ipatasertib formulated as a capsule.; Orally administered single dose of Ipatasertib formulated as a tablet.
Intervention MeSH terms: Ipatasertib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Routine Antibiotic Use in the Outpatient Treatment of Severely Malnourished Children Without Complications
Condition: Severe Acute Malnutrition
MeSH terms: Malnutrition; Severe Acute Malnutrition
Study type: Interventional

Summary: 
      This study will be conducted as a randomized, double-blind, placebo-controlled trial to
      compare routine antibiotic prescription vs. no routine antibiotic prescription in the
      management of uncomplicated cases of severe acute malnutrition treated in the community in
      terms of nutritional recovery. The investigators hypothesize that there will be no
      significant difference in terms of the risk of nutritional recovery among children
      uncomplicated cases of severe acute malnutrition treated in the community that receive
      routine antibiotic prescription and those who receive no routine antibiotic prescription.
    


Intervention name(s): Amoxicillin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 80 mg/kg/day for 7 days; 7 days
Intervention MeSH terms: Amoxicillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety Study of Mibefradil When Given Four Times a Day in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to determine the safety and pharmacokinetics of a 7 day course
      of oral mibefradil given four times a day in healthy volunteers. This is a dose escalation
      study in which the total daily dose of mibefradil will be increased with each cohort.
    

Detailed description: 
      This study will establish the safety, detailed pharmacokinetics, and, possibly, maximum
      tolerated dose (MTD) of ascending doses of mibefradil administered four times a day (QID) in
      healthy volunteers. The knowledge gained will then guide the details of a study of Interlaced
      Therapy™ in patients with recurrent High Grade Glioma (HGG). Non-clinical studies are
      currently on-going in the efficacy of Interlaced Therapy™ in ovarian cancer, pancreatic
      cancer, and intracranial malignancy.
    

Intervention name(s): mibefradil; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 25 mg tablets for oral administration given for 7 days at a total daily dose beginning at 100 mg per day divided into four doses. Doses will be incremented in successive cohorts by 25 mg/day up to 400 mg/day.; 1 out of 6 patients per cohort will receive placebo tablets identical in appearance and number to the active mibefradil arm.
Other intervention name(s): Posicor®; mibefradil dihyrdochloride; RO 40-5967; sugar pill
Intervention MeSH terms: Mibefradil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Clinical Trial, Phase I; Human Volunteers; Healthy Volunteers; mibefradil; Posicor®
Pilot and Feasibility Trial of a Telehealth Dietary Intervention for MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional

Summary: 
      This project aims to determine the feasibility of delivering a comprehensive behavioral
      lifestyle intervention including dietary and exercise components via an evidence based,
      internet-delivered telehealth coaching platform. Further, investigators will gather
      preliminary data on the change in multiple sclerosis clinical outcomes and cardiometabolic
      risk factors after participation in the intervention. The outcomes will inform the design of
      a larger randomized controlled trial.
    


Intervention name(s): DIET-MS
Intervention type(s): Behavioral
Intervention description(s): Following the completion of testing, all 20 participants will be placed into the DIET-MS group and will follow the prescribed diet plan for 12 weeks. At the end of the 12 weeks, the participants will return to complete follow up testing.
Intervention model: Single Group Assignment
Intervention model description: All 20 participants will be placed into the intervention group.
Masking: None (Open Label)
Primary purpose: Other
Keywords: diet; MS; Telehealth
Role of Sympathetic Activation in Ischemia Reperfusion Injury
Condition: Central Sympathetic Nervous System Diseases
MeSH terms: Nervous System Diseases; Autonomic Nervous System Diseases; Reperfusion Injury; Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to assess the effect of forearm ischemia-reperfusion injury on
      sympathetic nerve activity. To determine whether reduced sympathetic responsiveness is a
      contributor to the protective effects of remote ischemic preconditioning. In addition it will
      assess whether pharmacologic inhibition of the sympathetic nervous system can ameliorate
      ischemia reperfusion injury induced endothelial dysfunction.
    

Detailed description: 
      This is a randomized single blind study where subjects will be allocated to undergo one of
      the 4 protocols. Participants will be given placebo or 0.2mg of Moxonidine to take orally 20
      minutes prior to the first endothelial function measurement.

      This medication acts by reducing the activity of nerves believed to be involved in the
      conditioning process. The placebo pill, designed to have no effect, will be used as a
      comparison. Comprehensive tests will occur which include Microneurography, Endothelial
      function ,Blood Sampling, Temporary block of arm blood flow and Remote conditioning
    

Intervention name(s): Moxonidine 0.2 MG; placebo
Intervention type(s): Drug; Other
Intervention description(s): Subjects will be allocated to undergo conditioning or non conditioning assigned in a randomized order. Participants will be given placebo or 0.2mg of Moxonidine to take orally 20 minutes prior to the first endothelial function measurement.; Subjects will be allocated to undergo conditioning or non conditioning assigned in a randomized order. Participants will be given placebo or 0.2mg of Moxonidine to take orally 20 minutes prior to the first endothelial function measurement.
Intervention MeSH terms: Moxonidine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Ischemia; re-perfusion; Remote conditioning
A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150 Tablet
Condition: Healthy Volunteer; Pharmacokinetics of YM150
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the effect of food on the pharmacokinetics of YM150 in healthy make
      adult subjects.
    

Detailed description: 
      To evaluate the effect of food on the pharmacokinetics of YM150 in healthy non-elderly adult
      male subjects using a 2×2 crossover design. Also, to evaluate the safety of YM150.
    

Intervention name(s): YM150
Intervention type(s): Drug
Intervention description(s): oral
Intervention MeSH terms: Darexaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: YM150; Food effect
An Open-Label Study of N-Acetyl Cysteine in Children With Autism
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to test the tolerability and efficacy of N-Acetyl Cysteine (NAC)
      in children with Autism.
    

Detailed description: 
      N-Acetyl Cysteine (NAC) is a compound that increases the levels of Glutathione, the body's
      main antioxidant. Glutathione is a compound in the blood that is part of a natural defense
      system (the antioxidant system). Anti-oxidants protect the body from damage caused by
      internal toxins called free radicals. It is possible that children with Autism tend to have
      lower levels of glutathione, an important compound in our bodies that helps combat the
      effects of toxic free radicals. We hope that by studying the antioxidant system in more
      detail, we will increase our understanding of the reasons why people develop Autism so that
      we can design better ways to treat individuals with this condition. This study is meant to
      test the safety tolerability of N-Acetyl Cysteine and its effectiveness in the treatment of
      behavioral difficulties in children with autism. It will also examine the possible benefit of
      this agent in improving the core deficits in autism such as social deficits.
    

Intervention name(s): N-Acetyl Cysteine
Intervention type(s): Drug
Intervention description(s): Dosage of orally administered N-Acetyl Cysteine is as follows:
Days 1-30: 900 mg, once per day Days 31-60: 900 mg, twice per day Days 61-90: 900 mg, three times per day
Other intervention name(s): NAC
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: N-Acetyl Cysteine