bioihbjkbjnl/mcl2 huggingface dataset:
Neurofeedback for Obsessive-Compulsive Disorder (OCD)
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      The aim of this study is to train patients with obsessive-compulsive disorder to control a
      region of their brain that has been associated with their symptoms. Patients in the
      experimental group will be given direct feedback regarding activity in this brain area while
      they are undergoing functional magnetic resonance imaging (fMRI) scanning, and will try to
      learn to control activity in the region during these feedback sessions. A separate group of
      patients will be given a control form of feedback that we do not believe can have clinical
      benefits. Our primary hypothesis is that the neurofeedback training will reduce OCD symptoms
      more than the control feedback.
    

Detailed description: 
      Original study design recruiting controls who were matched to the experimental group was
      changed to a randomized design prior to enrollment of the first participant.
    

Intervention name(s): neurofeedback; control feedback
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subject provided with feedback of activity in target brain area in the form of a line graph. Cued to try to make the line go up at certain times and down at other times.; Subject provided with a control/placebo type of feedback in the form of a line graph. Cued to try to make the line go up at certain times and down at other times.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Mobile Phone Text Message Program to Understand Symptoms and Improve Outcomes in Minor Head Injury Patients
Condition: Head Injury, Minor
MeSH terms: Craniocerebral Trauma; Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      Mild traumatic brain injury (MTBI) is frequently seen in the ED, post-concussive symptoms are
      common post-injury, and few MTBI patients receive treatment or follow-up for these symptoms.
      Cell phones are ubiquitous, text messaging (SMS) is a cheap and increasingly common form of
      communication, potentially allowing for accurate assessment of symptom patterns after MTBI
      and provision of basic education support . The investigators seek to assess the feasibility
      of using SMS to collect symptoms related to MTBI in patients either discharged from the ED or
      admitted to the inpatient trauma unit. The investigators also seek to explore how SMS-based
      symptom reports correlate with phone-based follow-up reports at 14 days and whether
      additional SMS-based educational feedback alters daily symptom patterns.
    

Detailed description: 
      The investigators seek to assess the feasibility of using SMS to collect symptoms related to
      MTBI in patients either discharged from the ED or admitted to the inpatient trauma unit. The
      investigators also seek to explore how SMS-based symptom reports correlate with phone-based
      follow-up reports at 14 days and whether additional SMS-based educational feedback alters
      daily symptom patterns at 3-months.
    

Intervention name(s): SMS assessments & feedback
Intervention type(s): Behavioral
Intervention description(s): Daily symptom assessments tied to tailored feedback
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Obese Patients With Type 2 Diabetes
Condition: Obesity; Diabetes Mellitus, Non-Insulin-Dependent; Obesity in Diabetes
MeSH terms: Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the effect on weight loss and weight maintenance over a period of one year when
      prescribed with a hypocaloric diet in obese patients with Type 2 Diabetes
    


Intervention name(s): Rimonabant (SR141716)
Intervention type(s): Drug
Intervention MeSH terms: Rimonabant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes; Obesity
Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this study is to see if using misoprostol makes the intrauterine device
      insertion easier and less painful in women who have never had a baby.
    

Detailed description: 
      The Intrauterine Device (IUD) is an excellent contraceptive option because of its ease of
      use, long term duration (5-10 years), low side-effect profile, and the immediate return to
      fertility after IUD removal. Despite advantages associated with the IUD, the smaller cervical
      diameter of nulliparous patients may lead to a more difficult and uncomfortable insertion.
      Some providers have started pre-medicating nulliparous patients with misoprostol prior to IUD
      insertion because of the drug's known effect as a cervical ripening agent. Limited evidence
      is available addressing the effect of misoprostol on patient comfort and provider ease of IUD
      insertion in nulliparous women. The goal of this study is to evaluate whether using
      misoprostol as a cervical ripening agent in nulliparous patients eases IUD insertion and
      decreases pain.
    

Intervention name(s): Misoprostol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.; Pills which are identical to the study drug in appearance, taste, and smell.
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Misoprostol; IUD insertion; Nulliparous Women; Contraception; Family Planning; IUD insertion in nulliparous women
Characterizing Clinical and Biomechanical Contributions to Function Following ACL Reconstruction
Condition: ACL Tears
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      Quantify differences in quadriceps function and gait biomechanics in individuals within 2
      years of ACL reconstruction compared to a healthy comparison group and establish the
      feasibility of conducting a progressive strengthening program to improve clinical and
      patient-oriented outcomes in individuals who are within 2 years of ACL reconstruction
    

Detailed description: 
      A maximal isometric muscle contraction of the quadriceps will be used to examine neural and
      peripheral contributions to quadriceps strength. Neural influences will be quantified using
      the interpolated twitch technique (voluntary activation) and early RTD. Peripheral influences
      will be quantified by examining the stimulus-evoked torque with the quadriceps relaxed
      (resting twitch) and late RTD. Knee joint biomechanics during treadmill walking and running
      will include sagittal plane (flexion, extension) movement variability (Lyapunov Exponent and
      approximate entropy), peak knee flexion angle, and peak external knee flexion and adduction
      moments. Additionally, the clinical relevance of impairments in the ACL reconstruction group
      will be determined by examining the relationship with performance on jumping tasks and
      patient function (secondary outcomes).

      The progressive strengthening program will be performed for 6 weeks and emphasize development
      of strength and power. Feasibility will be established if the researchers can recruit up to 8
      participants and retain at least 80% over the 3 week intervention program. The researchers
      will determine effect sizes for changes outcome measures.
    

Intervention name(s): Progressive strengthening program
Intervention type(s): Other
Intervention description(s): The progressive strengthening program will be performed for 3 weeks and emphasize development of strength and power. Feasibility will be established if we can recruit up to 8 participants and retain at least 80% over the 3 week intervention program. We will determine effect sizes for changes outcome measures.
Intervention model: Single Group Assignment
Intervention model description: Physical therapy exercises (progressive strengthening program)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: quadriceps strength; quadriceps voluntary activation; progressive strength program
The Summer Camp Study: Blood Glucose Control With a Bi-Hormonal Bionic Endocrine Pancreas
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This study will test the hypothesis that a wearable automated bionic pancreas system that
      automatically delivers both insulin and glucagon can improved glycemic control vs. usual care
      for young people with type 1 diabetes 12-20 in a diabetes camp environment.
    

Detailed description: 
      The bionic pancreas will be compared to usual care in a crossover design in which each
      volunteer will serve as his or her own control. Each volunteer will be under closed-loop
      glucose control for five days and usual camp level of diabetes care for five days in random
      order with a one day washout period in between.
    

Intervention name(s): Bi-hormonal Bionic Pancreas; Usual Care
Intervention type(s): Device; Other
Intervention description(s): Automated blood glucose control via a closed-loop bionic pancreas device.; Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump.
Other intervention name(s): Boston University Bionic Pancreas
Intervention MeSH terms: Pancrelipase; Pancreatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bionic pancreas; artificial pancreas; insulin; glucagon; continuous glucose monitoring (CGM); outpatient; insulin pump; pediatrics; children; camp; summer camp
Study About Effect of Saxagliptin on Circulating Endothelial Progenitor Cells and Endothelial Function in Newly Diagnosed Type 2 Diabetic Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, the investigators aim to investigate whether saxagliptin modulate endothelial
      progenitor cells number and flow-mediated dilation in newly diagnosed, treatment-naive type 2
      diabetic patients.
    


Intervention name(s): saxagliptin; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): 5mg per day for 12 weeks; 1500mg per day for 12 weeks
Intervention MeSH terms: Metformin; Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: saxagliptin; endothelial progenitor cell; flow-mediated dilation
Comparison of Breathing Event Detection by a Continuous Positive Airway Pressure Device to Clinical Polysomnography
Condition: Sleep Apnea Central; Cheyne-Stokes Respiration; Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Cheyne-Stokes Respiration; Sleep Apnea, Central
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate diagnostic agreement and determine the accuracy
      of the continuous positive airway pressure (CPAP) device compared to simultaneous, attended
      clinical polysomnography (PSG) in identifying breathing events in participants previously
      diagnosed with complex sleep apnea (CompSAS), complex sleep apnea with Cheyne-Stokes
      respiration (CSR), or obstructive sleep apnea (OSA).
    

Detailed description: 
      Study Objectives: To compare a positive airway pressure (PAP) device's detection of
      respiratory events and airway status during device detected apneas with events scored on
      simultaneous polysomnography (PSG).

      Design: Prospective PSGs of patients with sleep apnea using a new-generation PAP device.

      Settings: Four clinical and academic sleep centers.

      Patients: Forty-five patients with obstructive sleep apnea (OSA) and complex sleep apnea
      (Comp SA) performed a PSG on PAP levels adjusted to induce respiratory events.

      Interventions: None.
    

Intervention name(s): Manipulation of Positive Airway Pressure (PAP)
Intervention type(s): Other
Intervention description(s): Positive airway pressure (PAP) will be manipulated throughout the night to induce breathing events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced , and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Multicenter Randomized Open-label Study of Oseltamivir Combined With HD-DEX Versus HD-DEX in the Management of ITP
Condition: Thrombocytopenia
MeSH terms: Thrombocytopenia
Study type: Interventional
Phase: Phase 2

Summary: 
      Oseltamivirphosphate is hydrolysed to its active metabolite-the free carboxylate of
      oseltamivir. Oseltamivir is a neuraminidase inhibitor, serving as a competitive inhibitor of
      the activity of the viral neuraminidase (NA) enzyme upon sialic acid, found on glycoproteins
      on the surface of platelets. By blocking the activity of the enzyme, oseltamivir may prevent
      platelet destruction in liver.The project was undertaking by Qilu Hospital of Shandong
      University and other 4 well-known hospitals in China. In order to report the efficacy and
      safety of oseltamivirphosphate combined with high-dose dexamethasone for the treatment of
      immune thrombocytopenia (ITP) with high platelet desialylation level, compared to high-dose
      dexamethasone therapy.
    

Detailed description: 
      The investigators are undertaking a parallel group, multicentre, randomised controlled trial
      of 50 newly diagnosed ITP adult patients with high platelet desialylation level from 5
      medical centers in China. One part of the participants are randomly selected to receiver
      HD-DXM (orally at 40 mg daily for 4d) combined with oseltamivir (orally at 75 mg twice for
      10d), the others are selected to receive HD-DXM (orally at 40 mg daily for 4d ) alone. If
      platelet counts remained <30×109/L or there were bleeding symptoms by day 10, another 4-day
      course of HD-DXM was given (days 10-14).For the combination arm, patients with an initial
      response relapsed during the follow-up period, oseltamivir retreatment could be given for
      another 10 days at the discretion of the physician's advice and patients' will.

      Platelet count, bleeding , platelet desialylation level and other symptoms were evaluated
      before and after treatment. Adverse events are also recorded throughout the study. In order
      to report the efficacy and safety of oseltamivirphosphate combining with high-dose
      dexamethasone therapy compared to high-dose dexamethasone for the treatment of adults with
      newly diagnosed ITP .
    

Intervention name(s): Oseltamivir; Dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): Oseltamivir 75 mg twice per day, 10 consecutive days; HD-DXM (orally at 40 mg daily for 4d)
Intervention MeSH terms: Oseltamivir; Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oseltamivir; Dexamethasone; ITP
Proteomic Analysis of Mononuclear Cells After a High-Fat, High-Carbohydrate Meal With or Without Orange Juice
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      A high-fat, high-carbohydrate meal (HFHC) induces an increase in inflammation in
      peripheral-blood mononuclear cells in healthy subjects. A few studies have shown that orange
      juice, when consumed together with the high-fat meal, is able to revert the increase in
      inflammatory markers. The present study will assess the effect of a single HFHC meal taken
      with water, orange juice or an isocaloric glucose drink on protein expression in peripheral
      blood mononuclear cells of healthy individuals. Twelve healthy, normal weight individuals
      consumed a HFHC meal with water, water with glucose or orange juice in a cross-over design
      with at least one week interval between the meals. Blood samples were collected before, 1, 3
      and 5h after the meals.
    

Detailed description: 
      BACKGROUND:

      A high-fat, high-carbohydrate meal (HFHC) induces an increase in inflammation in
      peripheral-blood mononuclear cells in healthy subjects. A few studies have shown that orange
      juice, when consumed together with the high-fat meal, is able to revert the increase in
      inflammatory markers.

      OBJECTIVES:

      To study the effect of a single HFHC meal taken with water, orange juice (500ml) or an
      isocaloric glucose drink on protein expression in peripheral blood mononuclear cells of
      healthy individuals.

      DESIGN AND METHODOLOGY:

      Twelve healthy, normal weight individuals consumed a HFHC meal with water, water with glucose
      or orange juice in a cross-over design with at least one week interval between the meals.
      Blood samples were collected before, 1, 3 and 5h after the meals. Blood glucose, insulin and
      lipid profile were measured. Also, proteome analysis using TMT labeling was performed on
      peripheral-blood mononuclear cells collected before and at times 3 and 5h after the meal.
    

Intervention name(s): Orange juice; Water; Water with glucose
Intervention type(s): Other; Other; Other
Intervention description(s): Individuals will consume the HFHC meal with 500mL of orange juice.; Individuals will consume the HFHC meal with 500mL of water.; Individuals will consume the HFHC meal with 500mL of water with glucose.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Relative Bioavailability Study of Bupropion XL 150 mg Tablets Under Fed Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the rate and extent of absorption of Abrika Bupropion
      150 mg XL Tablet to that of Wellbutrin XL® 150 mg Tablet after a single, one-tablet dose in
      subjects fed a standard meal.
    

Detailed description: 
      Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.

      Official Title: A Randomized, Single Dose Two -Way Crossover Relative Bioavailability Study
      of Bupropion XL Tablets Formulation in Normal, Healthy Man Following a Standard Meal

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      Rate and Extend of Absorption
    

Intervention name(s): Abrika Bupropion 150 mg XL Tablet, single dose; Wellbutrin XL® 150 mg Tablet, single dose
Intervention type(s): Drug; Drug
Intervention description(s): A: Experimental Subjects received Abrika formulated products under fed conditions; B: Active comparator Subjects received GlaxoSmithKline formulated products under fed conditions
Other intervention name(s): Bupropion; Bupropion
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Bupropion; Healthy subjects
5-hydroxytryptophan and Creatine for Treatment Resistant Depression Associated With Hypoxia in Females
Condition: Major Depressive Disorder
MeSH terms: Hypoxia; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesize that the administration of two widely available, naturally
      occurring dietary supplements, 5 hydroxytryptophan and creatine monohydrate, will reduce the
      severity of depression in individuals exposed to chronic hypoxia by living at altitude. The
      purpose of this study is to determine if 8 weeks of dietary augmentation with oral 5 g
      creatine daily and 100 mg 5-HTP twice daily reduces hypoxia-related depressive symptoms
      measured by the 17-item Hamilton Depression Rating Scale (HAM-D) in women with SSRI or
      SNRI-resistant depression.
    

Detailed description: 
      Serotonin and creatine are processed separately in the brain, and deficits in these brain
      biochemicals lead to distinct clinical problems. Therefore, investigators believe that
      treatment with a combination therapy, which could correct both deficits, would have a
      synergistic effect in the treatment of hypoxia-related depression and possibly other forms of
      treatment-resistant depression. Thus, investigators propose to investigate antidepressant
      efficacy of dietary 5-hydroxytryptophan (5-HTP) and creatine, as a means to restore the brain
      neurotransmitter and metabolic imbalances linked to chronic hypoxia caused by high altitude
      residence.
    

Intervention name(s): 5-hydroxytryptophan and Creatine monohydrate
Intervention type(s): Drug
Intervention MeSH terms: 5-Hydroxytryptophan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment