bioihbjkbjnl/mcl2 huggingface dataset:
Drug Drug Interaction Study Evaluating the Effect of Fluvoxamine or Fluconazole on PK and Safety of PF-04965842.
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Open Label, Parallel-Cohort, Randomized, Fixed Sequence Study To Evaluate The
      Pharmacokinetic Drug Drug Interaction Between PF-04965842 and Fkuvoxamine (cohort 1) or
      Fluconazole (Cohort 2) in healthy subjects.
    

Detailed description: 
      A phase 1 study to evaluate the effect of fluvoxamine (a strong CYP2C19 and moderate CYP3A
      inhibitor) or fluconazole (a strong CYP2C19, moderate CYP2C9 and CYP3A inhibitor) on the
      pharmacokinetics, safety and tolerability of PF-04965842 in healthy subjects.

      This study will be a Phase 1, open label, randomized, fixed-sequence, parallel-cohort study
      drug-drug interaction study. The study includes 2 periods:

      In Period 1: all subjects will receive one single oral dose of 100 mg PF 04965842 tablet.
      (Treatment A). PK will be evaluated in the first 72 hours post adminstration of PF 04965842.

      In Period 2:

        -  Cohort 1: subjects will receive fluvoxamine (immediate release tablet 50 mg) once daily
           for 9 consecutive days; on Day 8, subjects will receive a single oral dose of 100 mg PF
           04965842 approximately 3 hours after fluvoxamine administration. (Treatment B). PK will
           be evaluated in the first 72 hours post administration of PF 04965842.

        -  Cohort 2: subjects will receive fluconazole capsule(s) once daily for 7 consecutive days
           (400 mg on Day 1 and 200 mg on Day 2-7 in Period 2); on Day 5, subjects will receive a
           single oral dose of 100 mg PF 04965842 approximately 1 hour after fluconazole
           administration. (Treatment C). PK will be evaluated in the first 72 hours post
           administration of PF 04965842.
    

Intervention name(s): Period 1 - Day 1: PF-04965842 administered; Period 2: Cohort 1: Fluvoxamine & PF-04965842; Period 2: Cohort 2: Fluconazole & PF-04965842
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Period 1: Single administration of 100 mg PF 04965842.; Cohort 1: Period 2: Administration of fluvoxamine from Day 1 to Day 9 and PF-04965842 on Day 8.; Cohort 2: Period 2: Administration of fluconazole from Day 1 to Day 7 and PF-04965842 on Day 5.
Other intervention name(s): Single administration of PF-04965842 in Period 1.; 9-day administration of Fluvoxamine and single administration of PF-04965842 on day 8.; 7-day administration of fluconazole and single administration of PF-04965842 on day 5.
Intervention MeSH terms: Fluconazole; Fluvoxamine; Abrocitinib
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Atopic dermatitis
Effects of Fimasartan on Insulin Secretion in Type 2 Diabetic Patients
Condition: Diabetes Mellitus; Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This study was designed to evaluate the effect of ARB in improving insulin secretion in
      patients with type 2 diabetes. The investigators also aimed to evaluate if there are
      potential synergisms between ARB and DPP4 inhibitors in improving insulin secretion and
      urinary albumin secretion in diabetic patients.
    

Detailed description: 
      Angiotensin II has been reported to insulin secretion in beta cells. Angiotensin II
      indirectly improves insulin secretion in beta cells via vasoconstriction and reduced islet
      blood flow. Chronic exposure to high glucose or high fat increases expression of AT1R
      (angiotensin type 1 receptor), leading to reactive oxidative stresses, inflammation, and
      apoptosis in beta cells, finally decreased insulin formation and secretion. Some studies
      showed the beneficial effect of blocking AT1R on insulin secretion and beta cell
      proliferation in animal models using angiotensin receptor blocker (ARB). Furthermore, 26
      weeks of valsartan treatment improved insulin secretion in humans with impaired glucose
      regulation.
    

Intervention name(s): Fimasartan; Amlodipine
Intervention type(s): Drug; Drug
Intervention description(s): 16 weeks of fimasartan vs. amlodipine followed by 2 weeks of wash-out period, then crossover; 16 weeks of fimasartan vs. amlodipine followed by 2 weeks of wash-out period, then crossover
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mass Balance Recovery and Metabolite Identification of Carbon-14 BIA 28-6156
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to determine the absorption, distribution, metabolism and elimination
      (ADME) of BIA 28-6156 in humans, further explore the PK of BIA 28-6156, evaluate the extent
      of distribution of total radioactivity into blood cells, provide additional safety and
      tolerability information and collect samples for metabolite profiling and structural
      identification.
    

Detailed description: 
      This is an open-label, single-dose, single period study in healthy male subjects. It is
      planned to enroll 6 subjects. All subjects will receive a single oral dose Carbon-14 BIA
      28-6156. Blood samples will be collected at regular intervals for PK analysis, mass balance
      and metabolite profiling and identification from pre-dose up to 240 h post-dose. Urine and
      faecal samples will be collected at regular intervals for mass balance and metabolite
      profiling and identification from pre-dose until the mass balance criteria have been met.
    

Intervention name(s): Carbon-14 BIA 28-6156
Intervention type(s): Drug
Intervention description(s): Carbon-14 BIA 28-6156 60 mg, containing NMT 3.7 MBq Carbon-14
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a prospective, multicenter, open-label, single-arm, phase 3b study which evaluates
      effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will
      consist of an open-label treatment period of 192 weeks and follow-up period of at least 48
      weeks.

      The optional shorter infusion substudy will evaluate the safety of a shorter infusion of
      ocrelizumab in a subgroup of participants with early stage RRMS enrolled in the main MA30143
      study. Approximately 700 patients will be enrolled in the substudy, and will receive
      additional 600 mg ocrelizumab administered in a shorter time frame.
    


Intervention name(s): Ocrelizumab
Intervention type(s): Drug
Intervention description(s): Ocrelizumab will be administered via IV infusion as specified throughout the treatment period.
Intervention MeSH terms: Ocrelizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics of Lidocaine in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The study to be performed will utilize already FDA-approved marketed products in healthy
      adults for the purpose to generate data for establishing rate of drug delivery of Lidoderm®
      topical patch (manufactured by Endo Pharmaceuticals) and the lidocaine 5% patch (manufactured
      by Mylan Pharmaceuticals) in healthy adults, and to ensure the safety of individuals
      utilizing these types of products.
    

Detailed description: 
      Topical drug delivery systems in the form of patches are convenient, attractive, and easy to
      use. Lidocaine is a very popular patch available on the United States market today. Accurate
      determination of the rate and extent of drug release and absorption is crucial to ensure the
      safety of individuals using these and other types of patches. The drug delivery rate can be
      determined early in the development process by using in vitro skin flux permeation studies,
      and later in humans by accurately quantifying residual drug from patches post-wear and in
      pharmacokinetic studies. In this study the investigators will employ two types of evaluation
      to determine the rate and extent of drug release and absorption from lidocaine patches,
      namely residual drug analysis post-wear and pharmacokinetic analysis in healthy adult
      volunteers. In addition, the investigators will compare the serum drug concentrations
      following patch and intravenous administration in order to determine the absolute
      bioavailability of these patches. Positive outcomes of this project will identify appropriate
      methods to determine the rate and extent of drug release and absorption from topical patches,
      and will help regulatory agencies in the development of Guidances for Industry regarding the
      characterization of drug release and absorption kinetics to ensure the safety of individuals
      utilizing these types of products.
    

Intervention name(s): Lidocaine 5% patch; Lidocaine hydrochloride; Lidoderm 5% patch
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Each subject will wear three generic Lidocaine 5% topical patches for 12 hours.; Each subject will receive a dose of 0.5 mg/kg intravenously over a period of 5 minutes.; Each subject will wear three Lidoderm® topical patches for 12 hours.
Intervention MeSH terms: Lidocaine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Peer Reviewed Research
Lepticore in Metabolic Syndrome and Weight Loss
Condition: Obesity; Hyperlipidemia; Hyperglycemia
MeSH terms: Metabolic Syndrome; Hyperglycemia; Hyperlipidemias; Weight Loss
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Metabolic syndrome is directly related to obesity. This study investigated the use of a plant
      based formulation to improve on the condition of people with metabolic syndrome.
    

Detailed description: 
      LeptiCore is a proprietary combination of various ingredients which have been shown to have
      properties which could be beneficial to weight loss in obese and overweight human subjects.
      This study evaluates the effect of Lepticore on bodyweight as well as parameters associated
      with obesity and metabolic syndrome.

      The study was an 8 week randomized, double-blind, placebo-controlled design involving 92
      obese (mean BMI>30kg/m2) participants (37 males; 55 females; ages 19-52; mean age = 30.7).
      The participants were randomly divided into three groups: placebo (n=30), LeptiCore formula A
      (low dose) (n=31) and LeptiCore formula B (high dose) (n=31). Capsules containing the placebo
      or active formulations were administered twice daily before meals with 300 ml of water. None
      of the participants followed any specific diet nor took any weight-reducing medications for
      the duration of the study. A total of 12 anthropomorphic and serological measurements were
      taken at the beginning of the study and after 2, 4, 6, and 8 weeks of treatment.
    

Intervention name(s): Lepticore
Intervention type(s): Dietary Supplement
Intervention description(s): 300 mg twice daily
Other intervention name(s): Plant based polysaccharides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Keywords: Obesity; metabolic syndrome; C-reactive protein; Leptin
Cold Applications on the Pain Level of Children With Sutures
Condition: Child, Only
Study type: Interventional

Summary: 
      Purpose:This research was conducted as an experimental study with pretest and posttest
      control groups in order to evaluate the effect of post-suture cold applications on the pain
      level of children with sutures.

      Design and Methods: This study is a randomised controlled study. In the study, there were 150
      children in the experimental group and 150 children in the control group.
    

Detailed description: 
      The experimental groups was applied at the 1st, 2nd and 6th hours after the suture
      application in the cold applications The different practitioners applied in the Visual Analog
      Scale after and before in the cold applications to the experimental and control groups
    

Intervention name(s): the cold applications in post-suture pain reduces the child's pain
Intervention type(s): Other
Intervention description(s): The experimental groups was applied cold applications immediately after 20 minutes the suture. Later, The experimental groups was applied cold applications again for 20 minutes 1 hour, 2 hours and 6 hours after the suture.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cold Application; child; Nurse; Pain; suture
WB-EMS Increase Energy Expenditure at Rest and During Uphill Walking Exercise
Condition: Sports Physical Therapy
Study type: Observational

Summary: 
      Whole-body electrical stimulation (WB-EMS) has become increasingly popular as a tool to
      provide additional benefits compared to conventional exercise. However, the effects of the
      different electrical parameters on energy expenditure (EE) and respiratory exchange ratio
      (RER) remain poorly understood. This study aims to determine and compare the effects of
      different electrical frequencies applied with WB-EMS in EE and RER at supine resting and
      during uphill walking exercise
    

Detailed description: 
      Obesity is a critical public health problem worldwide since it is a risk factor for
      cardiovascular diseases and mortality. Increased body weight and obesity are the results of
      an imbalance between energy intake and energy expenditure (EE). Body weight regulation and
      obesity are highly influenced by different factors such as genetic, physiology, and
      socioeconomics. It is well known that physical exercise is an effective strategy to increase
      EE, improve body composition, physical fitness, and cardiometabolic risk factors.
      Unfortunately, the principal barriers to abstaining from exercise are time constraints, the
      risk of injuries, and the lack of enthusiasm observed during the exercise sessions. In this
      context, whole-body electromyostimulation (WB-EMS) training is becoming increasingly popular
      worldwide as a potential and attractive alternative to traditional training methods to
      increase EE. The present study aimed to determine and compare the effects of different
      electrical frequencies applied with WB-EMS in EE and RER at supine resting and during uphill
      walking exercise.
    

Intervention name(s): WB-EMS
Intervention type(s): Other
Intervention description(s): The group has been submitted to 2 experimental conditions:
At rest with superimposed WB-EMS.
During uphill walking exercise with superimposed WB-EMS.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        We chose recreationally active males without any disease.
      
Keywords: Electrical stimulation; Energy expenditure; Obesity; Impulse intensities; Impulse frequencies
A Comparison of the Safety and Immunogenicity of Various Schedules of Dengue Vaccine in Healthy Adult Volunteers
Condition: Healthy
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 study to compare the safety, tolerability and immunogenicity of different dose
      schedules of subcutaneously (SC) administered dengue vaccine in healthy adults and to compare
      the immunogenicity of different dose schedules of the vaccine.

      Blood samples were obtained for safety labs on Days 0, 7, 14, 90, 97, 104 and measurement of
      viremia at baseline [during the screening period or on day of vaccination (Day 0)], and then
      on Days 7, 9, 11, 14, 17, 21, 90, 97, and 104. Blood samples for measurement of dengue
      neutralizing antibodies in serum were obtained at baseline [during the screening period or on
      day of vaccination (Day 0)], then on Days 30, 90 and 120.

      The entire duration for each individual subjects participation was approximately 5 months
      including recruitment and collection of data for primary outcomes (through Day 120).
    


Intervention name(s): Takeda's Tetravalent Dengue Vaccine Candidate (TDV); TDV New Formulation; Placebo; New Formulation Placebo
Intervention type(s): Biological; Biological; Drug; Drug
Intervention description(s): TDV subcutaneous injection; TDV New Formulation subcutaneous injection; Placebo subcutaneous injection; New Formulation placebo subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: safety and immunogenicity of dengue vaccine
Diets, Lipoproteins and Inflammation Markers
Condition: Cardiovascular Diseases; Metabolic Syndrome; Diet, Healthy; Vegan Diet; Inflammatory Response
MeSH terms: Cardiovascular Diseases; Metabolic Syndrome
Study type: Interventional

Summary: 
      Systematic inflammation and lipid profiles are two major therapeutic targets for
      cardiovascular diseases. The effectiveness of vegan diet has been reported (doi:
      10.3389/fnut.2022.807810).

      Aim:

      To compare the effectiveness of a nutritionally balanced vegan diet and a Myplate diet
      ((Taiwanese version) on systematic inflammation and lipoprotein subclass.

      Design: Randomized crossover design
    


Intervention name(s): Vegan diet
Intervention type(s): Behavioral
Intervention description(s): The participants were advised to eat foods in their original type.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Virtual Parent-led Support Group for Parents of Children and Youth With Eating Disorders: A Mixed Methods Feasibility Study Examining Acceptability, Cost and Parent Outcomes
Condition: Eating Disorders
MeSH terms: Feeding and Eating Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      There is a gap in the literature about the feasibility and implementation of parent-led
      support groups for parents who have children or adolescents with eating disorders. In this
      study, we will be observing the experiences of 40 parents in Ontario who will virtually
      participate in one of 3 parent-led support groups for parents of children and youth with
      eating disorders. Parents will be expected to attend the virtual sessions twice a month over
      the course of six months. We hope to evaluate the acceptability, cost, and parental outcomes
      of the parent-led support groups via surveys before, during, and after the study, as well as
      using a post-study interview.
    


Intervention name(s): Support Group for Caregivers
Intervention type(s): Behavioral
Intervention description(s): Engage parents in the community via this support group, so they can be supported by other parents who "know the system", can advise them on how to proceed, and empower them to help their children. Parents will learn psychoeducation about eating disorders and how to support their children.
Intervention model: Single Group Assignment
Intervention model description: We studied the implementation of a virtual parent-led peer support group.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: eating disorder; parent support group
Training Induced Muscle Exosome Release
Condition: Metabolism
Study type: Interventional

Summary: 
      The primary objective of this study is to quantify miR-1 release from muscle in
      extra-cellular vesicles following an acute resistance exercise bout and potential delivery to
      subcutaneous adipose tissue in young healthy and obese adults.
    

Detailed description: 
      Numerous studies in humans and animals have shown that aerobic exercise is beneficial to
      adipose tissue function and whole-body metabolism. Both acute and chronic aerobic exercise
      enhance adipocyte catecholamine sensitivity in humans and animals. Although relatively few
      studies have investigated whether adipose adrenergic signaling is affected by resistance
      exercise (RE), it is known that a single bout of RE can increase circulating NEFA and resting
      energy expenditure and decrease respiratory quotient for up to 24 hours, indicative of
      increased adipocyte lipolysis and muscle fatty acid oxidation. Furthermore, the lipolytic
      response to RE is impaired in obese men. Using synergist ablation, a model of RE in mice, the
      investigators show that adipose transcriptional responses are exosome-dependent, and that
      serum exosomes enhance adipocyte catecholamine sensitivity and lipolysis for at least 24
      hours. To the investigator's knowledge, this is the first demonstration of a potential
      mechanism whereby RE imparts metabolic adaptations in adipose. Since adipose metabolic
      function is crucial for determining whole-body metabolic outcomes, the ability of RE-induced
      exosomes to improve adipose metabolism has significant clinical implications.
    

Intervention name(s): Acute Resistance Exercise
Intervention type(s): Behavioral
Intervention description(s): Participants will perform three sets of eight repetitions, with a 90-120 second rest between sets, with a fourth set performed to failure. All resistance exercise will be performed on pneumatic resistance devices (Keiser Sports Health Equipment, Fresno, CA).
Other intervention name(s): Strength Training
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Metabolism; Muscle; Extracellular Vesicles; Exosomes; Resistance Exercise
Leptin and Ghrelin in ICU
Condition: Critically Ill
MeSH terms: Critical Illness
Study type: Interventional
Phase: Phase 4

Summary: 
      Enteral alimentation is the preferred modality of support in critical patients who have
      acceptable digestive function and are unable to eat orally, but the advantages of continuous
      versus intermittent administration are surrounded by controversy.

      This prospective, randomised study was designed to compare two enteral feeding methods with
      respect to changes in levels of leptin and ghrelin in ICU.
    


Intervention name(s): enteral feeding by nasogastric tube.
Intervention type(s): Other
Intervention description(s): method of administration enteral feeding by nasogastric tube.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: leptin levels; ghrelin levels