bioihbjkbjnl/mcl2 huggingface dataset:
I-ACT With Check Yourself
Condition: Adolescent Behavior
Study type: Interventional

Summary: 
      Adolescents have some of the highest rates of risk behaviors of all age groups and health
      behaviors developed in adolescence can persist into adulthood. These behaviors carry
      significant risks for subsequent disease, disability, and healthcare burden. Despite these
      risks, health risk screening in primary care is infrequently performed and results are rarely
      followed by targeted intervention. In response to the need for screening-linked
      interventions, our study team has developed a web-based, electronic Personalized Motivational
      Feedback tool which we refer to as "Check Yourself." Based on motivational interviewing, a
      technique to mobilize personal change, Check Yourself is designed to promote healthy choices
      for the multiple behaviors relevant to adolescents as well as to provide information to
      providers to promote discussions around health behaviors between providers and adolescents.

      Building on electronic health interventions, primary care providers can play an essential
      role in helping adolescents to make healthy behavior choices. Emerging evidence suggests that
      the consistency of preventive counseling can be increased through provider training and the
      provision of screening tools; yet, we know very little about the quality of such counseling,
      and if it impacts outcomes that are important to adolescent patients themselves.

      This study is a stepped-wedge, controlled trial comparing the effectiveness of an interactive
      adolescent-centered training for primary care providers (I-ACT) and Check Yourself to usual
      care. This study will take place in six pediatric practices. The purpose of this study is to
      determine whether this system of interventions (i.e., I-ACT, Check Yourself, and the summary
      report) is more effective than usual care in reducing health risk behaviors, improving
      adolescent motivation for health, and improving quality of care among adolescents receiving
      primary health care services.
    


Intervention name(s): I-ACT with Check Yourself
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
The Effectiveness of Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma
Condition: To See the Safety and Efficacy of the Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma Patients
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Interventional
Phase: Phase 2

Summary: 
      Outpatient department of cmch, ceitc,cimch POAG patients enrolled for the study.
    


Intervention name(s): Drugs, Investigational
Intervention type(s): Drug
Intervention description(s): To see the safety and efficacy of topical latanoprost compared with topical brimonidine in the treatment of the primary open angle
Other intervention name(s): Brimonidine
Intervention MeSH terms: Brimonidine Tartrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Using Salsalate to Target Adipocyte Macrophage Infiltration
Condition: Diabetes Risk
Study type: Interventional
Phase: Phase 1

Summary: 
      Background: The prevalence of obesity has increased throughout the last three decades due to
      genetic, metabolic, behavioral, and environmental factors. Obesity and high-fat western diets
      activate inflammatory processes, which promote development of insulin resistance as well as
      other metabolic complications. Increasing obesity rates are a major public health concern in
      the Hispanic population due to the large number of Hispanics suffering from obesity. Based on
      preliminary data, we propose a double-blind randomized clinical trial of Salsalate therapy in
      obese Hispanic young adults. Salsalate treatment shows promise for decreasing inflammation
      under conditions of weight stability by reducing macrophage infiltration of adipocytes.
      Hispanics have the greatest amount of visceral adipose tissue (VAT), liver fat, and
      inflammation when compared to other ethnic groups, thereby increasing the potential for
      treatment effects in this high-risk population.

      Purpose: The purpose of this study is to demonstrate through a "proof-of-concept" trial that
      Salsalate induced reductions in adipose tissue inflammation are possible under conditions of
      weight stability.

      Methodology: We will recruit obese Hispanic young adults (18 - 35 years) from hospitals,
      clinics, and community centers. Study Endpoints: Primary outcomes will be macrophage
      infiltration as assessed by the presence of crown-like structures (CLS) in subcutaneous
      adipose tissue (SAT) biopsies, liver fat, insulin sensitivity, and fasting glucose. We will
      also assess plasma levels of monocyte chemoattractant protein (MCP)-1, tumor necrosis factor
      (TNF)-α, interleukin (IL)-1, C-reactive protein (CRP), and SAT gene expression of nuclear
      factor kB (NF-kB) and insulin signaling pathways.

      Intervention and Follow-up: Participants will be randomly assigned to four weeks of treatment
      with Salsalate (4 g/d) or placebo and will be studied under weight maintenance conditions.
      These measures will enable us to determine if Salsalate treatment is capable of reducing
      adipose tissue inflammation and related metabolic outcomes in the absence of weight loss.
    


Intervention name(s): Salsalate (4 g/day); Placebo (4 g/day)
Intervention type(s): Drug; Drug
Intervention description(s): Given orally twice daily; Given orally twice daily
Other intervention name(s): Salicylate; Inactive control
Intervention MeSH terms: Salicylsalicylic acid; Salicylates
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Obesity; Adipose tissue inflammation; Salsalate; Hispanics
Interest of Additional Arthroscopic Portals in Diagnosis of Hidden Lesions of the Medial Meniscus in Pediatrics Knees With ACL Deficiency
Condition: Chronic Knee Instability
MeSH terms: Disease
Study type: Interventional

Summary: 
      Peroperatively observative study in pediatric orthopedic center in Lyon, France.

      50 pediatric patients included in this study, to improve the diagnosis of hidden lesions of
      the medial meniscus associated with lesions of the anterior cruciate ligament.

      All the patients need a reconstruction of the ACL because of chronic knee instability.

      All the patients underwent a multi portal arthroscopy during the ACL reconstruction :
      anteromedial and anterolateral and after intercondylar and posteromedial.

      The study consists in a peroperatively arthroscopic look, in order to diagnose lesions of the
      posterior horn of the medial meniscus which could be missed in MRI and anteromedial and
      anterolateral arthroscopy.

      Statistics of this lesions are used to study prevalence and diagnosis capacity of this
      procedures.

      First, the surgeon did a classic knee arthroscopy. Secondarily, he did an intercondylar
      portal and after a posteromedial portal.
    


Intervention name(s): Arthroscopic intercondylar and posteromedial portal
Intervention type(s): Procedure
Intervention description(s): Diagnosis of lesions of the Posterior Horn of the Medial Meniscus in Arthroscopic intercondylar and posteromedial portal in addition with standard ACL reconstruction, during the same surgery.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: ACL; Hidden lesions of the medial meniscus; Chronic knee instability; Intercondylar and posteromedial arthroscopy; Arthroscopic Posteromedial and Intercondylar portal; Diagnosis capacity of hidden lesions of the medial meniscus
Music for Sleep-onset Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The study is a randomized controlled trial evaluating the effect of bedtime music as an early
      intervention for sleep-onset insomnia in adults. The investigators use a randomized
      controlled trial design with two parallel groups. All participants receive sleep hygiene
      advice as standard treatment and participants in the intervention group are additionally
      asked to listen to a sleep playlist daily at bedtime. Subjective and objective sleep measures
      are evaluated before and after the 4 weeks intervention period. In addition, follow-up
      measures of subjective outcomes are assessed 4 weeks after the end of the intervention
      period.
    


Intervention name(s): Sleep hygiene advice; Bedtime music listening
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants receive standard sleep hygiene advice.; Participants in the intervention group listen to their preferred sleep playlist daily at bedtime for minimum 30 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Lifestyle Intervention for Polycystic Ovary Syndrome: Pulse-Based Diet and Exercise
Condition: Polycystic Ovary Syndrome; Metabolic Syndrome
MeSH terms: Polycystic Ovary Syndrome; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of our study is to evaluate the effectiveness of a lifestyle program for women
      with Polycystic Ovary Syndrome (PCOS). The investigators want to assess the effect of a
      pulse-based diet (i.e. a diet that contains lentils, chick-peas, peas, and beans) and aerobic
      exercise for improving PCOS disease features and risk factors for metabolic syndrome. We
      would like to determine the therapeutic effects of a lifestyle program that combines a
      pulse-based diet and exercise on the multiple disease measures of PCOS and metabolic
      syndrome.
    

Detailed description: 
      To date, we have developed the pulse-based and meat-based healthy meals following Therapeutic
      Lifestyle Changes (TLC)guidelines recommended by NCEP for the intervention. We have been
      recruiting and enrolling participants into the study with our few set of participants having
      completed the 4 month intervention. Baseline data have been also collected on all
      participants assessed for PCOS. Preliminary measurements on POCS characteristics, baseline
      dietary and exercise habits of women with PCOS will be soon available.

      This study involves an intervention comparing a diet containing pulses (i.e. beans, peas,
      chick peas, lentils) to a diet recommended by the National Cholesterol Education Program
      (NCEP) for improving markers of metabolic syndrome and fertility in women with poly cystic
      ovarian syndrome who are also enrolled in an aerobic exercise program. To date, seven women
      in the pulse-diet group have completed the intervention, nine women in the group receiving
      the NCEP diet have completed the intervention, four women are currently enrolled on the pulse
      diet and two women are currently enrolled on the NCEP diet.
    

Intervention name(s): Pulse-based diet; TLC diet
Intervention type(s): Other; Other
Intervention description(s): The pulse based-diet will include meals prepared with dry peas, lentils, chickpeas, and beans. Two meals will be supplied daily for 16 weeks to those participants on the pulse-based diet program. Meals will contain approximately 90g dried peas, 225 g chickpeas or beans, or 150g lentils.; Grocery gift cards will be provided weekly for 16 weeks to those participants in the placebo group. Recipe booklet will be given to follow Therapeutic Lifestyle Changes (TLC) guidelines, recommended by National Cholesterol Education Program (NCEP) and will be based on lean-meats for the protein source. The recipes will exclude pulses.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Polycystic Ovary Syndrome; Metabolic Syndrome; Pulse; Lifestyle Intervention; Aerobic Exercise; Diet
Dose Ranging Study of Pegylated Interferon Lambda in Patients With Hepatitis B and Positive for the Hepatitis B e Antigen
Condition: Hepatitis B Virus
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      At least 1 dose of pegIFNλ will be identified which is safe, well tolerated, and efficacious
      for the treatment of chronic hepatitis B virus infection (CHB)

      Amendment 7, Part B Sub Study: The primary purpose of this amendment is to obtain preliminary
      data on the safety of pegylated interferon Lambda (Lambda) when administered in combination
      with Entecavir(ETV) to patients with hepatitis E antigen-positive (HBeAg-positive) chronic
      hepatitis B(CHB) infection employing a sequential therapy approach
    

Detailed description: 
      Part B sub study is Open Label
    

Intervention name(s): pegIFN; pegIFNα-2a; PegIFN lambda; Entecavir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Syringe, Subcutaneous, 180 μg, Once Weekly, 48 weeks; Syringe, Subcutaneous 180 μg, Once Weekly, 48 Weeks; Syringe, Subcutaneous, 180 µg, Once weekly, 48 weeks; Tablet, Oral, 0.5 mg, Once daily, 12 weeks initial monotherapy followed by 48 weeks of combination therapy with PegIFN lambda
Other intervention name(s): Pegasys; BMS-914143; Baraclude
Intervention MeSH terms: Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Omalizumab as Add on Therapy for Minority Patients With Moderate to Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will be a randomized, placebo controlled, double blind study to measure the safety
      and efficacy of a new, injectable asthma medication, omalizumab, in a group of minority with
      moderate to severe asthma who are not adequately controlled with use of inhaled or oral
      steroids. Primary endpont will be change in asthma symptom utility index. Secondary endpoints
      will be changes in asthma Quality of life, asthma exacerbation rate, and lung function over
      the 12 week treatment period.
    


Intervention name(s): Omalizumab
Intervention type(s): Drug
Intervention description(s): injectable medication
Intervention MeSH terms: Omalizumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: omalizumab; severe asthma; moderate asthma; injectable asthma medication; Xolair
Silymarin (Milk Thistle Extract) in Treating Patients With Acute Lymphoblastic Leukemia Who Are Receiving Chemotherapy
Condition: Drug/Agent Toxicity by Tissue/Organ; Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Drug-Related Side Effects and Adverse Reactions
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Silymarin (milk thistle extract) is an herb that may be effective in treating
      liver disorders caused by cancer therapy.

      PURPOSE: Randomized phase II trial to study the effectiveness of silymarin in treating
      patients who have acute lymphoblastic leukemia with chemotherapy-related side effects to the
      liver.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the effect of silymarin, in terms of liver function tests, in patients with
           acute lymphoblastic leukemia receiving hepatotoxic chemotherapy.

        -  Determine the effect of this drug on free and conjugated serum silibinin values in these
           patients.

        -  Determine the serum antioxidant capacity by Oxygen Radical Absorbance Capacity in
           patients treated with this drug.

        -  Determine the oxidative damage, as determined by 8-oxodeoxyguanosine adducts, in
           patients treated with this drug.

      OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
      randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive oral silymarin daily for 28 days.

        -  Arm II: Patients receive oral placebo as in arm I. Patients are followed at day 56.

      PROJECTED ACCRUAL: A total of 50 patients (25 per treatment arm) will be accrued for this
      study.
    

Intervention name(s): silymarin
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Silymarin
Allocation: Randomized
Masking: Double
Primary purpose: Supportive Care
Keywords: drug/agent toxicity by tissue/organ; childhood acute lymphoblastic leukemia
Yoga Improves Aerobic Fitness, Glycemia and Mood State and Reduces Abdominal Obesity
Condition: Obesity; Insulin Resistance
MeSH terms: Obesity; Insulin Resistance; Obesity, Abdominal
Study type: Interventional

Summary: 
      Stretching and flexibility exercise such as yoga and functional resistance exercise are two
      forms of exercise that are growing in popularity. However, they have not been scientifically
      tested to demonstrate their ability to improve body composition, fitness, heart and metabolic
      health, and mood state in overweight/obese women. The investigators hypothesize that during
      an 11 week intervention, both forms of exercise will improve body composition, heart and
      metabolic health and mood state.
    

Detailed description: 
      This study was a 11 week protein-rich whole food diet and exercise training intervention in
      middle aged overweight/obese women. Subjects were randomized into 3 groups: Protein-rich
      whole food only consumed as 20-25 grams per serving 4-6 per day (P); protein and resistance
      exercise training (R); and protein and stretching/yoga exercise training (S). All outcomes,
      including the primary outcomes of body composition and cardiometabolic biomarkers were
      measured at baseline (week 0) and post-intervention (week 12) in all study subjects.
    

Intervention name(s): Protein whole foods; Protein Resistance Exercise Training; Protein Stretching/Yoga Training
Intervention type(s): Other; Other; Other
Intervention description(s): Protein-rich whole foods consumed at 20-30 grams of protein at each of 4-6 meals per day; Protein rich whole foods diet and resistance training 3 times per week for 11 weeks; Protein-rich whole foods diet of 20-30 grams of protein at each of 4-6 meals per day with stretching/yoga training 3 times per week for 11 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: obesity; protein-rich whole foods diet; aerobic fitness; resistance training; stretching/yoga training; glycemia; mood state
The Monica Fetal Heart Monitor
Condition: Fetal Heart Tracing
Study type: Observational [Patient Registry]

Summary: 
      The goal of this study is to compare the amount of time that the fetal heart tones are traced
      in babies just at or beyond viability using a traditional device compared to the Monica
      device.
    

Detailed description: 
      If a patient is admitted to the antepartum service and is between 24 - 28 weeks gestation,
      the investigators will approach the patient and inform her about the study. If the patient
      agrees to the study then the baby's heart tracings and contraction pattern will start to be
      monitored using the traditional device. If the patient would be receiving continuous fetal
      heart rate monitoring, then after at least 2 hours of monitoring with the traditional device,
      the traditional device would be replaced with the Monica device for 2 hours. After the Monica
      device is used for 2 hours, then the traditional device would be used once again. The entire
      length of the patient's participation in the study should be nor more than 6 hours.

      The data collection sheet shows all data elements to be collected from the medical record. In
      addition it is standard of care that the monitoring strips become part of the medical records
      and these will also be reviewed as per the data collection sheet. Time it should take to
      review a patients medical record will be about 1 hour.

      Total time of patient's involvement will be 7 hours.
    

Intervention name(s): Fetal Heart Rate Monitor
Intervention type(s): Other
Intervention description(s): Standard of care, not part of research
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The potential participants will be on the antepartum service so we will be providing them
        with antepartum and obstetrical care clinically.
Vildagliptin and the Glucagon Response to Hypoglycemia in Insulin-Treated Patients With Type 2 Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to explore whether the novel therapy of type 2 diabetes,
      vildagliptin, which inhibits dipeptidyl peptidase-4 (DPP-4), affects glucagon
      counterregulation during hypoglycemia in insulin-treated patients with type 2 diabetes.
      Vildagliptin is given, together with the on-going insulin therapy, for one month, whereafter
      hypoglycemia is induced under standardized conditions, and the glucagon response is
      determined, and compared to that after a month of placebo treatment.
    

Detailed description: 
      Vildagliptin is an inhibitor of dipeptidyl peptidase-4 (DPP-4) and inhibits glucagon
      secretion and stimulates insulin secretion. This improves glycemia in subjects with type 2
      diabetes with a very low risk for hypoglycemia. If hypoglycemia nevertheless develops, it is
      important that vildagliptin under such conditions does not inhibit glucagon secretion, since
      that would aggravate the hypoglycemia. It was indeed previously demonstrated in type 2
      diabetes that vildagliptin dos not inhibit glucagon secretion during hypoglycemia. This study
      explores whether vildagliptin affects glucagon counterregulation during hypoglycemia in
      insulin-treated patients of type 2 diabetes. Vildagliptin is given, together with the
      on-going insulin therapy, for one month, whereafter hypoglycemia is induced under
      standardized conditions, and the glucagon response is determined, and compared to that after
      a month of placebo treatment. The hypoglycemia is induced bvy a standardized clamp procedure.
    

Intervention name(s): Vildagliptin
Intervention type(s): Drug
Intervention description(s): Vildagliptin (50 mg BID) given for four weeks
Other intervention name(s): Galvus; 274901-16-5
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: DPP-4; GLP-1; Glucagon; Catecholamines; Counterregulation; Insulin-treatment; Type 2 diabetes