bioihbjkbjnl/mcl2 huggingface dataset:
Women With Polycystic Ovary Syndrome Have Increased Plasma Chitotriosidase Activity
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      In the present study, serum chitotriosidase activity and its relationship with insulin
      resistance were determined in patients with Polycystic Ovary Syndrome (PCOS).
    

Detailed description: 
      ChT activity is increased in patients with PCOS in concordance with insulin resistance. These
      findings may reflect the pronounced risk for metabolic syndrome and atherosclerotic diseases
      in this particular patient group.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        34 women with PCOS and 44 healty women as control group.
      
Biospecimen description: 
      No biospecimens were to be retained
    
Keywords: polycystic ovary syndrome; chitotriosidase activity
Fizzy Drinks Study
Condition: Glycemic Response; Gastric Emptying; Satiety
Study type: Interventional

Summary: 
      The objective of this study is to compare the effect of different levels of carbonation
      isocaloric beverages on glycemic response (using protocol based on standardized glycemic
      index testing methodology), gastric emptying and satiety. It is hypothesized that carbon
      dioxide will delay gastric emptying, and in turn, attenuate glycemic response and enhance
      satiety. The use of a non-nutrient (gas) in improving glycemic response and satiety would
      have important health implications for the beverage industry.
    

Detailed description: 
      15-20 healthy subjects will be recruited for the study by means of advertisements, flyers and
      personal communications.

      A randomized, cross-over design experiment with three treatments will be carried out. Three
      different beverages will be prepared:- No carbonation (NC): Potable water + sugar- Low
      carbonation (LC): Potable water + sugar + little CO2- High carbonation (HC): Potable water +
      sugar+ high CO2.

      The outcome measures assessed will be glycemic response, gastric emptying and satiety.
      Glycemic response will be measured by taking capillary blood samples (<5ul) by fingerpricking
      with one-time use sterilized lancets. Gastric emptying will be assessed by ultrasonography
      methodology developed by Okabe et al, 2015. Satiety will be measured using electronic visual
      analogue scales assessing hunger, fullness, desire to eat, prospective consumption and
      thirst. In addition, participants will be asked to rate the level of effervescence of
      beverage, sweetness of beverage, amount of beverage consumed, as well as how pleasant the
      beverage was immediately after drinking of test beverage. Feelings of bloatedness will be
      assessed using electronic visual analogue scales administered at 0, 15, 30, 45, 60, 90,120
      min from drinking of test beverage. At the end of the test session, ad libitum lunch will be
      served, and the amount of food and drinks consumed will be measured (by weight difference
      before and after serving).
    

Intervention name(s): No Carbonation; Low carbonation; High carbonation
Intervention type(s): Other; Other; Other
Intervention description(s): 500 ml of beverage consisting of water + 10% glucose and no carbonation; 500 ml of beverage consisting of water + 10% glucose and low carbonation; 500 ml of beverage consisting of water + 10% glucose and high carbonation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Relapser Genotype 2 Hepatitis C Infected Patients
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and
      Ribavirin (RBV) in patients with genotype 2 hepatitis C, who relapsed after previous
      treatment.
    


Intervention name(s): MP-424 (generic name:Telaprevir); Ribavirin; Peginterferon alfa-2b
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 750mg q8h for 12 weeks; 400 - 1000 mg/day based on body weight for 24 weeks; 1.5mcg/kg/week for 24 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Genotype 2
A Study to Evaluate the Use of a Graded Infusion of Intravenous Glucose in the Assessment of Insulin Secretion Rates (MK-0000-078)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A two period pilot study to determine if a graded glucose infusion using a glucose (20%
      dextrose [D20]) intravenous infusion can be properly implemented and will be well tolerated
      in healthy subjects.
    


Intervention name(s): Comparator: graded infusion of intravenous glucose
Intervention type(s): Procedure
Intervention description(s): A stepwise graded infusion of glucose (20% dextrose [D20]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12mg/kg/min. Procedure will be identical in Period 1 and Period 2.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Influence of Non-invasive Ventilation on Metabolism in Healthy Volunteers
Condition: Energy Expenditure; Non-invasive Ventilation; Metabolism
Study type: Interventional

Summary: 
      Before inclusion in the trial. Careful medical history and medication use will be asked. Once
      included, 5 healthy subjects non-invasive ventilation(V60, Philips, Eindhoven, The
      Netherlands) will be administered at a level of positive end expiratory pressure (PEEP) of 4
      cmH2O and without additional inspiratory support. Inspiratory support will then increase by 2
      cmH2O every 2 minutes until 8 cmH2O is achieved for 2 minutes. The energy expenditure is
      measured using indirect calorimetry (Q-NRG®, Cosmed, Italy). To measure respiratory effort,
      the reversed RPE-scale was created for the purpose of the study. It uses the validated "rate
      of perceived exertion" scale (RPE-scale) which was altered by adding a reversed part. This
      could result in a score of -10 (no respiratory effort) until +10 ( maximal respiratory
      effort) where 0 represents the basal respiratory condition. Monitoring of heart rate, blood
      pressure and cardiac output will be done ( Nexfin®, BMEYE, Amsterdam, The Netherlands).

      After termination of the study clinical observation by principal investigator or
      co-investigator will be done for 15 minutes or until all side effects have worn off. If no
      side effects are observed, subjects will be released.
    


Intervention name(s): non-invasive ventilation
Intervention type(s): Device
Intervention description(s): non-invasive ventilation will be performed on every subjects
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study to Compare Conivaptan Pharmacokinetics in Subjects With Mild & Moderate Kidney Function Impairment to Subjects With Normal Kidney Function
Condition: Kidney Diseases; Hyponatremia
MeSH terms: Kidney Diseases; Hyponatremia
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to compare a conivaptan PK in subjects with mild or moderate kidney function
      impairment to subjects with normal kidney function after a 48-hour continuous infusion of
      conivaptan.
    


Intervention name(s): conivaptan hydrochloride
Intervention type(s): Drug
Intervention description(s): intravenous
Other intervention name(s): Vaprisol; YM087
Intervention MeSH terms: Conivaptan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Pharmacokinetics; Protein Binding; Conivaptan; Vaprisol; Kidney Diseases
Effects of Combined Robot-assisted Therapy With Mirror Priming in Stroke Patients
Condition: Chronic Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of combining robotic-assisted training
      and mirror therapy on upper extremity motor and physiological function, daily functions,
      quality of life and self-efficacy in stroke patients.
    

Detailed description: 
      Based on trigger theory, this study designed a combining robotic-assisted training and mirror
      therapy. Before robotic-assisted training, a mirror therapy is performed to double the
      healing effect of robotic-assisted training.

      This study hypothesized that combining robotic-assisted training and mirror therapy can
      improve the performance of hand function in stroke patients and promote daily life function,
      quality of life, and self-efficacy compared to single machine-assisted therapy.
    

Intervention name(s): Robotic training with mirror therapy; Robotic-assisted training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive 18 intervention sessions for about 6 consecutive weeks in a clinical setting (1 hour per session, 3 sessions per week). For each intervention session, participants will first receive 20 minutes mirror therapy followed by 40 minutes robotic-assisted training (robotic-assisted training includes 10 minutes active/passive training mode and 30 minutes robot-participant interactive training mode).; The training procedure will be the same as the robotic-assisted training with mirror therapy group except that sham mirror therapy will be provided in the first 20 minutes in the intervention session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Mirror therapy; Robotic Training; Neurorehabilitation
The Effect of Potato Fries Processing on Food Intake, Satiety and Blood Glucose
Condition: Obesity; Overweight; Diabetes; Metabolic Syndrome
MeSH terms: Overweight; Metabolic Syndrome
Study type: Interventional

Summary: 
      Potato is one of the world's most popular foods and is widely accepted as a staple food. The
      objective of this study is to determine the effect of altering commercial blanching and
      cooling times during manufacture of frozen fries produced by the on blood glucose, satiety
      and appetite. It hypothesized that the processing regime predetermines the physiologic
      responses to ingested product and therefore it is possible to produce healthier product lines
      of potato fries.
    


Intervention name(s): dietary treatment
Intervention type(s): Other
Primary purpose: Prevention
Micronutrient Supplementation in Children With ASD
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      An open-label examination of changes in metabolites with use of micronutrients in children
      with autism spectrum disorder (ASD). Investigators will also measure behavioral measures
      monthly at school with teachers and parents report.
    

Detailed description: 
      Children enrolled in Oak Hill School will enroll in this study and take micronutrient
      supplement once a day for 8 weeks period. Behavioral measures and metabolites taken from
      Dried Blood Spots (DBS) will be collected pre and post treatment. Behavioral measures will be
      taken again at 12 weeks, after 4 weeks of not dosing.
    

Intervention name(s): Micronutrient
Intervention type(s): Drug
Intervention description(s): Subject will take micronutrient supplement daily for 8 weeks
Intervention MeSH terms: Micronutrients; Trace Elements
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
European Trial of Immunosuppression in SPK Tx
Condition: Diabetes Mellitus, Type 1; Diabetic Nephropathy
MeSH terms: Diabetic Nephropathies; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      1. To determine and compare the efficacy of Tacrolimus/Rapa versus Tacrolimus/MMF-based
           immunosuppression (in conjunction with initial short-term steroids and polyclonal
           antibody administration) in Type 1-diabetic patients undergoing simultaneous
           pancreas/kidney allograft transplantation.

        2. To evaluate the safety of Tacrolimus/Rapa versus Tacrolimus/MMF in terms of drug-related
           complications and overimmunosuppression-associated complications, particularly under
           monitoring of the pharmacokinetic profile of all drugs administered.
    

Detailed description: 
      This will be a controlled, randomised study, to be performed in 15-20 pancreas
      transplantation centers throughout Europe. Patients will be randomised into one of two
      treatment groups. Group 1 will receive Tacrolimus and Mycophenolate Mofetil (= best group in
      EuroSPK001 trial). Group 2 will receive Tacrolimus and Sirolimus. Both groups will receive in
      association short-term corticosteroids and polyclonal antibody preparation. Patients will be
      randomly assigned to one of the 2 treatment groups in a 1:1 ratio before transplantation. The
      study will last 3 years, with a first interim analysis of the data at 6 months and a complete
      analysis at 1 year.
    

Intervention name(s): sirolimus versus mycophenolate mofetil
Intervention type(s): Drug
Intervention MeSH terms: Mycophenolic Acid; Sirolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: simultaneous pancreas/kidney transplantation; Immunosuppression
A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma; Menorrhagia; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      The main objective of this study is to assess safety and efficacy of elagolix compared to
      placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in
      premenopausal women. The primary hypothesis is that elagolix, compared to placebo, reduces
      HMB associated with uterine fibroids in premenopausal women.
    


Intervention name(s): Elagolix; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Tablet; Oral; Tablet
Other intervention name(s): ABT-620; elagolix sodium; Orilissa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Elagolix; ABT-620; Uterine Fibroids; Heavy Menstrual Bleeding (HMB)
Sleep Quality Underwent Heart Transplant, an Observational Study
Condition: Ventricular Dysfunction
MeSH terms: Ventricular Dysfunction
Study type: Observational

Summary: 
      The SQ_Heart has been designed as an observational study that evaluates the difference in
      sleep quality between 11 patients with VAD (Ventricular Assisted Device) and 98
      Cardiotransplant patients.
    

Detailed description: 
      The Primary objective of the SQ_Heart study is to evaluate the significant difference in
      sleep quality between patients with VAD (Ventricular Assisted Device) and cardiotransplant
      patients, using the Pittsburgh scale Sleep Quality Index (PSQI), with a cut-off of > 5 for
      poor sleepers.

      Patients, to be enrolled, must provide:

        -  Age ≥ 18 and < 90;

        -  Cardiotransplant patients, with VAD or non;

        -  patients with VAD.

        -  subjects able to sign informed consent.

      All the patients will have to complete some questionnaires:

        -  questionnaire about the diagnosis of pathology and lifestyle;

        -  questionnaire about the perceived quality of sleep through the use of Pittsburgh Sleep
           Quality (PSQI);

        -  questionnaire about the perceived quality of life (Euro Quality of Life 5D-5L).

      Questionnaires are necessary for the data collection for the study.
    

Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Cardiotransplant patients with VAD (Ventricular Assisted Device) or non; Patients with VAD
      
Keywords: cardiotransplant
The Effect of Poorly Designed School Furniture on Children's Head and Scapulae Postures
Condition: Ergonomics
Study type: Observational

Summary: 
      investigate the compatibility of school furniture design
    


Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Two hundred and fifty-seven normal children were evaluated for eligibility; thirty-five
        children were excluded because they failed to fulfill the inclusion criteria and sixteen
        parents refused to enrolled in this study.
Exercise Promotion in Primary Care
Condition: Physical Activity; PreDiabetes; Diabetes
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      The investigators conducted a pilot study to determine if telephone counseling, in a health
      care setting that routinely assesses physical activity of its members, is a feasible approach
      to improve physical activity among patients with diabetes and prediabetes. The investigators
      built on an existing innovation at Kaiser Permanente, in which physical activity is assessed
      at every outpatient visit. The primary aims were to (1) pilot study elements, including
      database identification of patients; recruitment, training and engagement of health care
      providers; patient recruitment; data collection procedures; and a 24-week intervention, and
      (2) to assess feasibility and obtain feedback from key stakeholders on the approach.
    


Intervention name(s): Motivational interviewing telephone counseling
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (EU Extension Study)
Condition: Primary Immunodeficiency (PID)
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a continuation of the study ZLB06_001CR with the objective of assessing
      efficacy, tolerability, safety of IgPro, as well as long-term health-related quality of life
      in patients with PID.
    


Intervention name(s): IgPro20
Intervention type(s): Biological
Other intervention name(s): IgG with Proline (IgPro); Hizentra
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Immune globulin subcutaneous; SCIG; primary immunodeficiency; PID
Adult Study Oxytocin - fMRI
Condition: Schizophrenia; Oxytocin; Social Cognition; Functional Magnetic Resonance Imaging (fMRI)
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      In this study, investigators will examine the behavioral effects and neurophysiological
      mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset
      schizophrenia. Such research is a necessary first step towards identifying whether intranasal
      oxytocin administration can serve as an adjunct treatment for social impairments in
      schizophrenia.

      Aim 1: To examine the effects of exogenous oxytocin on patterns of neural activation as
      measured by fMRI during a well-characterized affect-labeling task in patients with
      recent-onset schizophrenia and healthy comparison subjects.

      Hypothesis A: Patients will exhibit amygdalar hyperactivity and PNS hypo-activity when
      passively viewing faces, which will be normalized by administration of oxytocin.

      Hypothesis B: Patients will exhibit hypo-activity of the vPFC when affectively labeling faces
      and this hypo-activity will be normalized by oxytocin administration.
    


Intervention name(s): Oxytocin; Saline Nasal Spray
Intervention type(s): Drug; Drug
Intervention description(s): 40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.; 40 IU of the saline nasal spray will be administered once at the beginning of the visit.
Other intervention name(s): Syntocinon; Placebo
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Oxytocin; Syntocinon; Social Cognition; Schizophrenia; Functional Magnetic Resonance Imaging (fMRI)
Pharmacokinetic Interaction Between Diltiazem and ACT-541468 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this study is to investigate whether repeated administration of a
      cardiac medication (diltiazem) can affect the pharmacokinetics (i.e., amount and time of
      presence in the blood) of ACT-541468
    

Detailed description: 
      Because ACT-541468 appears to be mainly metabolized by CYP3A4, it is deemed of interest to
      investigate the potential influence of diltiazem, a well-known CYP3A4 inhibitor on the
      pharmacokinetic profile of ACT-541468.

      Safety of the concomitant administration of the two drugs will also be assessed
    

Intervention name(s): ACT-541468; Diltiazem
Intervention type(s): Drug; Drug
Intervention description(s): Oral capsule (25 mg) as single dose; Two oral capsules (2 x 120 mg) once daily from Day 1 to Day 7
Intervention MeSH terms: Diltiazem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pharmacokinetic; interaction
A Trial of DDI Between SHR1459 and Efavirenz With Healthy Subjects
Condition: B-cell Tumors
Study type: Interventional
Phase: Phase 1

Summary: 
      This study used a single-dose, open and fixed sequence design to compare the pharmacokinetics
      in healthy subjects.
    


Intervention name(s): SHR1459 tablet; Efavirenz tablet
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg/tablet; administered orally; 600 mg/tablet; administered orally
Intervention MeSH terms: Efavirenz
Intervention model: Single Group Assignment
Intervention model description: Compare the pharmacokinetic effects of efavirenz on SHR1459 in healthy subjects.
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Video Monitor Size on Adenoma Detection Rate
Condition: Colon Adenoma
MeSH terms: Adenoma
Study type: Interventional

Summary: 
      The goal of this study is to compare the adenoma detection rate achieved while using either a
      24" video monitor or a 32" video monitor.
    

Detailed description: 
      Gastrointestinal endoscopists perfoming routine endoscopic procedures and their patients will
      be randomized to one of two endoscopy rooms at the MGH Ambulatory Endoscopy Center at Charles
      River Plaza. The two rooms will have identical equipment with the exception that one room
      will have the current standard size video monitor (NDS 26") used at this facility while the
      other room will have a larger video monitor (NDS 32"). The ADR achieved by each physician in
      each room will be compared.
    

Intervention name(s): Monitor size
Intervention type(s): Device
Intervention description(s): Subjects will be randomized to perform their colonoscopy procedures while viewing a large (32") video monitor or the standard (24") video monitor.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic