bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics (PD) of Julphar Insulin 30/70 and Huminsulin® Profil III
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      This study in healthy volunteers aims to demonstrate similar PK and PD properties of the new
      human biphasic insulin, Julphar Insulin 30/70 and an already approved reference insulin,
      Huminsulin® Profil III. All participants will receive both study treatments on two separate
      dosing days.
    

Detailed description: 
      Daily injections of insulin is a necessity for many patients with diabetes mellitus in order
      to treat hyperglycaemia. Julphar Insulin 30/70 and Humininsulin® Profil III are both biphasic
      insulins, i.e. consist of a mixture of short-acting soluble insulin and intermediate-acting
      isophane insulin. The new insulin, Julphar Insulin 30/70, is biosimilar to Huminsulin® Profil
      III. Demonstration of similar absorption (PK) and effects (PD) are necessary to achieve
      market approval of Julphar Insulin 30/70.
    

Intervention name(s): human biphasic insulin; human biphasic insulin, reference
Intervention type(s): Drug; Drug
Intervention description(s): investigational insulin, biosimilar human insulin suspension of 30% normal insulin and 70% basal protamined insulin; marketed product, human insulin suspension of 30% normal insulin and 70% basal (NPH) insulin
Other intervention name(s): Julphar Insulin 30/70; Huminsulin® Profil III
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Biphasic Insulins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: biphasic human insulin; biosimilar
Evaluating a Family-based Nutrition and Garden Intervention in Rural Guatemala
Condition: Malnutrition; Dietary Modification
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      This is a pilot quasi-experimental study to evaluate the impact of adding a family garden
      intervention to an existing wrap-around nutrition intervention for children with chronic
      malnutrition and their family. The existing nutrition intervention is provided by community
      health workers affiliated with Wuqu' Kawoq | Maya Health Alliance. A single community in
      rural Guatemala will participate in the intervention, with the goal to recruit approximately
      70 families in the combined nutrition/garden intervention. A nearby community, also
      participating in the nutrition intervention, will serve as a nonrandom contemporaneous
      control.

      Aims of the study include:

        1. Evaluate the impact of the garden intervention on maternal and child dietary diversity,
           child growth and household food insecurity.

        2. Use the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework to
           conduct a preliminary implementation analysis, to guide a future, well-controlled study.
    


Intervention name(s): Standard of care nutrition support; Home-based nutrition education; Home-based family gardening
Intervention type(s): Dietary Supplement; Behavioral; Behavioral
Intervention description(s): Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter); Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.; Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Guatemala; indigenous; dietary diversity; chronic malnutrition; Maya; agriculture; behavior change; food insecurity
Functional MRI Study of Vibrotactile Stimulation Effects in Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of low-intensity and prolonged
      vibrotactile sensory stimulation on brain activity and functional connectivity in
      fibromyalgia patients.
    


Intervention name(s): Vibrotactile stimulation
Intervention type(s): Device
Intervention description(s): The active treatment will involve whole-body sensory stimulation with mechanical stimuli of vibrotactile (pallesthetic) type at a relatively high rate, low intensity and long duration administered at sleep time (a total daily duration of 3 h distributed within a period of 2 h at bedtime and 1 h prior to getting up). The intensity will be 30% of power at bedtime and 45% prior to getting up.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Protein From Complementary Foods on Infant Growth, Body Composition and Gut Health
Condition: Infant Growth; Infant Body Fat; Infant Gut Microbiome
Study type: Interventional

Summary: 
      Current research shows that dairy protein accelerates infant weight gain, which is a risk
      factor for later on obesity and metabolic syndrome. However, dietary protein from other
      sources haven't been studied yet. This longitudinal study will compare two complementary
      feeding regimens with dietary protein mainly from 1) meat; 2) dairy on infant growth, body
      composition and gut microbiome from 5 to 12 months of age in formula fed infants. Healthy
      infants at approximately 5 months of age will be randomized to either a meat protein, or a
      dairy protein group with complementary protein mainly from meat or dairy. Infants will
      consume one of these diets for 7 months (6-12 months of age) and infant growth, body
      composition, growth biomarkers and gut microbiome will be measured to compare between groups
      and over time.
    

Detailed description: 
      Two observational follow-up visits will be conducted at 18 and 24 months of age.
    

Intervention name(s): a high-protein complementary diet with meat; a high-protein complementary diet with dairy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): infants will consume a high-protein complementary diet with protein mainly from meat; infants will consume a high-protein complementary diet with protein mainly from dairy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: infant growth; dietary protein; body composition; gut microbiome
Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage
Condition: Miscarriage
MeSH terms: Abortion, Spontaneous
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To compare the effectiveness of estradiol pretreatment with misoprostol and vaginal
      misoprostol alone in induction of second trimestr miscarriage.
    


Intervention name(s): Estradiol; Placebo Oral Tablet; Misoprostol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Estradiol; Placebo; Misoprostol
Intervention MeSH terms: Misoprostol; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy Evaluation of Pitaya Ovule Extract on Skin
Condition: Skin Condition
MeSH terms: Skin Diseases
Study type: Interventional

Summary: 
      To assess the efficacy of Pitaya Ovule Extract on skin
    


Intervention name(s): Placebo drink; Pitaya Ovule Extract Drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): consume 1 bottle per day; consume 1 bottle per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Metabolic Effects of Acute Cortisol Withdrawal in Adrenal Failure
Condition: Addison Syndrome
Study type: Interventional

Summary: 
      Effects of adrenal steroids is generelly drawn from studies of hypercortisolism. The effects
      of physiological cortisol substitution and withdrawal is studied and related to the clinical
      syndrome of adrenal insufficiency.
    


Intervention name(s): hydrocortisone substitution therapy versus withdrawal
Intervention type(s): Drug
Intervention MeSH terms: Hydrocortisone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cortisol; adrenal insufficiency; glucose metabolism; protein metabolism; lipid metabolism; insulin sensitivity.
Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2a, randomized, double blind, parallel group, multicenter study with an
      extension period. The study will have a maximum duration of approximately 113 weeks. This
      includes an up to 5 weeks Screening Period, a 24 week Treatment Period, a 4 week Drug Holiday
      (#1), an up to 12 month Single Blind (investigator open, sponsor open and subject blind)
      Extension Period, a 4 week drug holiday (#2), a 6 month Cross Over Open Label Extension
      Period and a 4 week Follow up Period.
    


Intervention name(s): PF-06651600; PF-06700841; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 200 mg QD during induction and 50 mg QD during Maintenance; 60 mg QD during induction and 30 mg QD during maintenance; Placebo
Intervention MeSH terms: PF-06700841
Allocation: Randomized
Intervention model description: The first 24 weeks are parallel. The single-blind extension period will have a segment for non-responder and a withdrawal/retreatment segment for responder. The cross-over extension period is parallel for non-responders.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phase 2; randomized; double-blind; placebo; alopecia areata; safety; efficacy; JAK; janus kinase; moderate; severe
Mohawk Culture, Behavior, Toxicant Exposure and Health
Condition: Thyroid Diseases; Cognition Disorders
MeSH terms: Thyroid Diseases; Cognition Disorders
Study type: Observational

Summary: 
      This study will determine the pathways between Mohawk cultural identification and specific
      behaviors related to pollutant exposure, and determine the effects of these factors and the
      pollutant exposure on physiologically and socially significant outcomes.
    

Detailed description: 
      Considerable concern now exists over possible effects on human physical and psychological
      development of endocrine disrupting environmental contaminants such as polychlorinated
      biphenyls (PCBs). Native American communities are particularly at risk owing to subsistence
      systems and a cultural ethos involving greater contact with the physical environment. The
      proposed study follows-up 220 Mohawk adolescents aged 17-21 years, who participated in a
      previous study when they were 10-16 years old. All adolescents are members of the Mohawk
      Nation at Akwesasne which is located on the St. Lawrence River and is adjacent to hazardous
      waste sites where PCBs have contaminated the local ecology. The investigation examines the
      interrelationship between Mohawk cultural identity, traditional Mohawk customs, behaviors
      related to toxicant exposure and current toxicant burden. Serum level of PCBs will be
      assessed by congener specific analysis. The study will determine the relationship of
      congeners and their hydroxylated metabolites to thyroid function (levels of triiodothyronine,
      free triiodothyronine, thyroxine, free thyroxine, thyrotropin and anti-thyroid antibodies),
      and 2) psychosocial outcomes including school behavior and performance, hyperactivity, and
      adaptation to the community. Data gathered for the past study will be employed to assess
      variation in metabolism of PCBs, as well as how earlier measures of cognition and
      hyperactivity relate to 17 year old psychosocial outcomes. Variation in susceptibility to PCB
      effects will be determined by examining the effects of concurrent toxicant exposure
      (hexachlorobenzene, Mirex, dichlorodiphenyldichloroethene, lead), diet, and indicators of PCB
      metabolism, on the focal measures of adult functioning. The proposed study will clarify the
      causal pathways between culturally identifying behavior, PCB exposure and body burden,
      thyroid functioning, cognitive functioning, social behavior and school functioning while
      identifying activities that are important to maintain cultural identify and unrelated to
      exposure.
    

Keywords: PCBs; Thyroid; Hyperactivity; School Performance; Mohawk Tribe
ART Drug Dosage Adjustment in HIV-infected Population
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine efficacy of the combination of low dose of
      Tenofovir, Efavirenz and Lamivudine in treating HIV-infection.
    

Detailed description: 
      The feedback system control (FSC) technique has been developed to rapidly identify optimal
      combinations for therapeutic purposes. Low dose of TDF+3TC+EFV combination has been test in
      vitro study by FSC which showed high efficacy and now the investigators apply it to human to
      further optimize the ART combination.
    

Intervention name(s): Tenofovir(TDF)+Lamivudine(3TC)+Efavirenz(EFV)
Intervention type(s): Drug
Intervention description(s): The first 2 weeks, TDF (300 mg) + 3-TC (300 mg) + EFV (400 mg); week 3, TDF (200 mg) + 3-TC (300 mg) + EFV (400 mg ); week 4, TDF (150 mg) + 3-TC (300 mg) + EFV (400 mg).From week5, if the HIV viral load decreased as expected or no rebound, use TDF (200 mg) + 3-TC (300 mg) + EFV (400 mg) until study complete; if the viral load increases, switch to the standard treatment regimen: TDF (300 mg) + 3-TC (300 mg) + EFV (600 mg).
Intervention MeSH terms: Tenofovir; Lamivudine; Efavirenz
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV Infections; Tenofovir; Efavirenz
Gut Hormone Response After Paleolithic-type Meals
Condition: Insulin Resistance; Satiety
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The effects of two palaeolithic-type meals will be assessed with respect to a panel of gut
      hormones, satiety, blood glucose and insulin levels as compared to a meal constructed along
      the lines of the world Health Organisation dietary recommendations
    

Detailed description: 
      In the current study the effects of two palaeolithic-type meals will be assessed with respect
      to a panel of gut hormones (including incretins), satiety, blood glucose and insulin levels.
    

Intervention name(s): PAL-2; TFH-1; Reference
Intervention type(s): Other; Other; Other
Intervention description(s): meal; Meal; Meal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Glucagon-like peptide-1; Glucose-dependent Insulinotropic Peptide; Peptide YY; Glucagon; Satiety; Meal; palaeolithic
Dutch Version Fear-Avoidance Component Scale (FACS)
Condition: Musculoskeletal Pain; Musculoskeletal Pain Disorder; Fear of Pain; Fear of Injury; Low Back Pain, Recurrent; Neck Pain; Shoulder Pain; Knee Pain Chronic; Hip Pain Chronic; PROMs
MeSH terms: Shoulder Pain; Musculoskeletal Pain; Rheumatic Diseases; Collagen Diseases; Low Back Pain; Neck Pain; Somatoform Disorders
Study type: Interventional

Summary: 
      Chronic musculoskeletal disorders such as low back and neck pain are responsible for an
      enormous global burden. Fear-avoidance (FA) can be a predictor for the transition from
      subacute to chronic low back pain. In patients with neck pain, those who were less fearful
      about harming their neck, had higher pain tolerance, which might have a positive impact on
      their level of disability. A new scale, the Fear-Avoidance Component Scale (FACS) was
      developed by Neblett, Mayer, Hartzell, Williams and Gatchel (2015) to assess FA. It consists
      of an all-encompassing set of constructs that more effectively deals with all critical issues
      of the FA concept than current scales do. Current scales have been criticized because of
      following findings: limited construct validity, little evidence on treatment responsiveness,
      a lack of evidence-based cut-off scores and items being too narrow or too general. The new
      scale comprehensively assesses all cognitive, emotional and behavioral components related to
      the updated version of the FA model by combining items of well-known scales in context of the
      FA model with items on one's perception of victimization and blame related to an injury. A
      Dutch version of the FACS is currently lacking. Subsequently, the aim of this study is to
      investigate different psychometric properties of the generated Dutch version in patients with
      musculoskeletal disorders.
    


Intervention name(s): Assessment of disability and behavior (by questionnaires)
Intervention type(s): Diagnostic Test
Intervention description(s): Assessment of disability and behavior (by questionnaires)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients with musculoskeletal disorders are compared to matched healthy controls.
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Carbidopa
Condition: Parkinson's Disease (PD)
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg)
      on the levodopa pharmacokinetics when administered in combination with a single-dose of
      controlled-release levodopa/carbidopa 100/25 mg (Sinemet® CR 100/25)
    

Detailed description: 
      Single centre, double-blind, randomized, placebo-controlled, crossover study with four
      consecutive single-dose treatment periods. The washout period between doses was to be at
      least 14 days. On each treatment period, after completion of pre-dose assessments, BIA
      9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25;
      post-dose assessments were to be completed and subjects were to be discharged 72 h post-dose.
      Subjects were to attend four treatment periods and were to receive a different dose of BIA
      9-1067 (25 mg, 50 mg and 100 mg) or placebo during each of these treatment periods.
    

Intervention name(s): BIA 9-1067; Placebo; Sinemet® CR 100/25
Intervention type(s): Drug; Drug; Drug
Intervention description(s): OPC, Opicapone; PLC, Placebo; Controlled-release levodopa/carbidopa 100/25 mg
Other intervention name(s): OPC, Opicapone; PLC, Placebo
Intervention MeSH terms: Carbidopa, levodopa drug combination; Opicapone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's disease (PD); BIA 9-1067; Opicapone
Drug Interaction Study With RV521 in Healthy Volunteer Subjects
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The main aim of this study is to determine whether RV521 interacts with any other medication
      using four licensed medicines (midazolam, itraconazole, rifampicin and verapamil) that are
      known to have specific effects on enzymes and transporter proteins that influence the
      absorption of drugs
    


Intervention name(s): Itraconazole; Verapamil; Rifampicin; Midazolam; Placebo for RV521; RV521
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Itraconazole capsules; Verapamil tablets; Rifampicin capsules; Midazolam oromucosal solution; Placebo for RV521 capsules; RV521 capsules
Other intervention name(s): Rifadin; Midazolam Prefilled Syringe; Buccolam
Intervention MeSH terms: Itraconazole; Rifampin; Verapamil; Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Detection of Probiotic Strains in Vaginal Swabs Collected From Healthy Women
Condition: Healthy
MeSH terms: Sprains and Strains
Study type: Interventional

Summary: 
      The aim of this trial is to detect the presence of various probiotic strains in vaginal swabs
      of healthy women orally consuming a probiotic supplement for 4 weeks.
    

Detailed description: 
      Participants recruited from the university community in the Southeast U.S. will participate
      in a pilot, open-label interventional study for approximately 6 weeks following obtainment of
      informed consent. Participants will be asked to maintain their usual diets with the exception
      of probiotic supplements, probiotic fortified products or foods with added fiber supplements.

      On the first day of the study, participants will take part in a 1-week pre-baseline period
      where they will begin daily questionnaires inquiring about gastrointestinal symptoms, stool
      form and number, stress, and medications taken.

      On the first day of the intervention period (Day 1), participants will self collect a
      baseline vaginal swab sample, a skin swab, a vaginal pH swab, and a stool sample.
      Participants will consume 2 capsules every morning and 2 capsules every evening for four
      weeks (from D1 to D28).

      Participants will self collect a vaginal swab sample, a skin swab, a vaginal pH swab, and a
      stool sample at Day 14 and at Day 28. An additional vaginal swab sample will be collected at
      Day 35 to assess for probiotic strains persistence.

      At the conclusion of the study, participants will be instructed to return any unused
      supplements to the study site.
    

Intervention name(s): Probiotic
Intervention type(s): Dietary Supplement
Intervention description(s): Healthy women receive a probiotic supplement containing 6 x 10^9 colony-forming units/capsule of Bifidobacterium and Lactobacillus strains.
Intervention model: Single Group Assignment
Intervention model description: interventional, single-arm, open-label, pilot study
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Probiotics; Strain recovery; Vaginal swab; Persistence