bioihbjkbjnl/mcl2 huggingface dataset:
A Six-month Study to Compare Outcome Differences and Visceral Response ... Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effect of participation in one of the following
      interventions: (1) IBS Stress Management; (2) IBS Symptom Management; or (3) IBS Educational
      Training on improving IBS associated symptoms. It is anticipated that this research will
      provide information on the usefulness of psychological approaches in treating IBS and will
      help scientists better understand the disorder.
    


Intervention name(s): IBS Stress Management; IBS Symptom Management; IBS Educational Training
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): If randomly assigned to this intervention, the session with the therapist will consist of training about IBS symptoms and their relationship to stress, as well as skills training in relaxation and ways of identifying and challenging mistaken thoughts about life events. The goal of this treatment is to lessen mental and physical stressful reactions to daily events, and therefore lessen IBS symptoms as a reaction to stress. The patient will be encouraged to apply relaxation skills to stressful situations.; If assigned to this group, the therapist will discuss feelings, over-attention to IBS symptoms, and your fear of IBS symptoms. Patients will learn how to identify thoughts that may increase your IBS symptoms and will practice how to change these thoughts to ones that make them feel more comfortable. The sessions will focus on reactions to daily life that in turn result in IBS Symptoms.; Those assigned to this group will be given educational materials about IBS and will discuss the reading material with the therapist. The reading topics include information on gut disorders, anatomy and physiology of the gut, assessment procedures, and how to manage IBS symptoms. Sessions will also consist of weekly reviews of daily records and IBS symptoms. The goal of this intervention is to provide educational training about IBS.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; Abdominal Pain; Abdominal Discomfort; Diarrhea; Constipation; IBS
Xerecept Intravenous Dose Escalation in Japanese and Caucasian Volunteers
Condition: Edema
Study type: Interventional
Phase: Phase 1

Summary: 
      1. To investigate the safety and tolerability of Xerecept during and following a 24-hour
           intravenous administration to healthy Japanese to healthy Japanese and Caucasian
           subjects

        2. To compare the PK profile of hCRF during and following a 24-hour intravenous Xerecept
           administration between healthy Japanese and Caucasian subjects
    

Detailed description: 
      none needed
    

Intervention name(s): Xerecept 1.0; Xerecept 2.0; Xerecept 3.0
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 24 hour infusion; 24 hour infusion; 24 hour infusion
Other intervention name(s): hCRF infusion; 1.0 ug/kg/hr; hCRF infusion; 2.0 ug/kg/hr; hCRF infusion; 3.0 ug/kg/hr
Intervention MeSH terms: Corticotropin-Releasing Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Xerecept; Pharmacokinetics; Japanese versus Caucasians
A Study of the Glucodynamic Effects of Dulaglutide (LY2189265) in Japanese Participants With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the glucodynamic effects of dulaglutide in Japanese
      participants with type 2 diabetes mellitus.
    


Intervention name(s): Dulaglutide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): LY2189265
Intervention MeSH terms: Dulaglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Chewing Performance Level and Gross Motor Function in Children With Cerebral Palsy
Condition: Cerebral Palsy; Chewing Problem; Gross Motor Development Delay
MeSH terms: Paralysis; Cerebral Palsy
Study type: Observational

Summary: 
      The purpose of this study is to determine the association between gross motor function and
      chewing performance level in children with cerebral palsy (CP). A cross-sectional study was
      conducted in 152 children (ages 2-10y, 51.3% male) with a diagnosis of spastic CP. The Gross
      Motor Function Classification System (GMFCS) was used to determine gross motor function
      levels of children. Chewing performance level was determined by using the Karaduman Chewing
      Performance Scale (KCPS).
    

Detailed description: 
      The purpose of this study is to determine the association between gross motor function and
      chewing performance level in children with cerebral palsy (CP). A cross-sectional study was
      conducted in 152 children (ages 2-10y, 51.3% male) with a diagnosis of spastic CP. The Gross
      Motor Function Classification System (GMFCS) was used to determine gross motor function
      levels of children. Chewing performance level was determined by using the Karaduman Chewing
      Performance Scale (KCPS).Children with a diagnosis of spastic CP aged 2 to 12 years who were
      referred due to chewing/swallowing problems by pediatric neurologists were included. The
      inclusion criteria were above the age of 24 months, and had complaints about chewing
      function. Children under the age of 24 months, requiring tube feeding or taking any oral
      nutritional supplements, and used any medicine and/or oral appliances that could affect the
      chewing performance, were excluded.
    

Intervention name(s): Evaluation
Intervention type(s): Other
Intervention description(s): Descriptive characteristics including age, height and weight were recorded. Chewing performance level was determined with the Karaduman Chewing Performance Scale (KCPS). Each child was placed in a sitting position (either on a chair or on his/her mother's arm) with the head upright and with the midline position and arms and legs supported, and required to bite and chew a standardized biscuit, and no clue was given on how to chew. The physical therapist rated the chewing performance according to the KCPS. All children underwent a physical examination by a physical therapist to determine gross motor function by applying the Gross Motor Function Classification System (GMFCS). In addition to GMFCS, number of affected limbs of the children was also noted.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Children with a diagnosis of spastic CP aged 2 to 12 years who were referred due to
        chewing/swallowing problems by pediatric neurologists
      
Keywords: chewing; cerebral palsy; chewing disorders; gross motor function
Effects of Postural and Kinesthetic Awareness on Static Standing Balance in Stroke
Condition: Chronic Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The goal of this randomized controlled trial is to check the effects of postural and
      kinesthetic awareness on static standing balance in chronic stoke patients. Participants will
      be divided into two equal groups. One group will receive routine physical therapy while other
      group will receive postural and kinesthetic awareness in addition to routine physical
      therapy.
    

Detailed description: 
      To determine effects of Postural and kinesthetic awareness on plantar pressure and static
      standing balance in chronic stroke patients. The study was conducted at the University of
      Lahore Teaching Hospital in the Department of Pediatric Physical Therapy & Neuro
      Rehabilitation Center. Total 62 stroke patients with visual spatial neglect were enrolled in
      this study, patients were equally assigned into control and experimental group. Control group
      received routine physical therapy while experimental group received routine physical therapy
      and postural and kinesthetic awareness program. Static component of berg balance scale and
      PoData Stabiliometeric plate was used for measurement of balance and plantar pressure
      respectively
    

Intervention name(s): Postural and Kinesthetic Awarness; Routine Physical Therapy
Intervention type(s): Other; Other
Intervention description(s): Firstly, patient performed therapeutic activities/exercise to achieve balance in sitting position using chair with arm rest and with planted feet then progressed to sitting on chair without arm rest with proper feet placement. Once the patient achieved balance in sitting on chair then shifted to sitting on the stool and later standing in parallel bar that leads to balance training in independent standing.; Range of motion exercises (Active assisted), stretching exercises, strengthening and positioning.
Other intervention name(s): Experimental Group; Control Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; static balance; plantar pressure; postural and kinestetic awareness; PoData Stabiliometeric plate
Effect of Gum Chewing on Bowel Cleansing Before Colonoscopy
Condition: Bowel Preparation Scale; Adenoma Detection Rate
MeSH terms: Adenoma
Study type: Interventional
Phase: Phase 4

Summary: 
      In this randomized controlled study, consecutive outpatients scheduled for elective
      colonoscopy were randomized into two groups. Group A patients (n = 150) used 2 L PEG before
      colonoscopy. Patients in group B (n = 150) were additionally advised to chew sugarless gum
      plus 2 L PEG, The overall quality of colonoscopy cleaning was evaluated using the Boston
      Bowel Preparation Scale by endoscopists who was blinded to the intervention. Difficulty of
      procedure, patients' tolerance, and adverse events were also evaluated.
    


Intervention name(s): gum+PEG; polyethylene glycol
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): chew sugarless gum; 2L PEG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Screening
The Effect of Intravenous Lactate on Brain Lactate Concentrations During Hypoglycemia
Condition: Type 1 Diabetes Mellitus With Hypoglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

Summary: 
      Patients with type 1 diabetes (T1DM) who are unable to perceive symptoms of hypoglycemia,
      referred to as impaired awareness of hypoglycemia (IAH), are at very high risk of severe
      hypoglycemia. IAH affects approximately 25% of patients with T1DM. Brain lactate may be
      involved in the development of IAH. A recent study indicated increased brain lactate
      utilization during hypoglycemia in T1DM patients with IAH, which did not occur in patients
      with normal awareness of hypoglycemia (NAH). Conversely, administration of lactate to
      patients with NAH has been shown to attenuate counterregulatory hormone responses to and
      symptomatic awareness of hypoglycemia, thus causing a situation that resembles IAH. It has,
      however, not been demonstrated whether the excess of lactate is actually taken up or
      metabolized by the brain, and if so whether this occurs under euglycemic or hypoglycemic
      conditions or both.

      This project consists of two related studies. The objective of part 1 is to investigate the
      effect of elevated plasma lactate levels that are sufficient to impair awareness of
      hypoglycemia on brain lactate concentrations during euglycemia and hypoglycemia in T1DM
      patients with NAH. The objective of part 2 is to compare the effect of exogenous lactate on
      brain lactate concentrations between T1DM patients with NAH and T1DM patients with IAH.

      Furthermore, this study aims to determine the effect of acute hypoglycemia on the
      inflammatory function and composition of peripheral blood mononuclear cells.
    


Intervention name(s): SodiumChloride; Sodium Lactate
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: type 1 diabetes mellitus; impaired awareness of hypoglycemia; lactate; MR spectroscopy
Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibition and Induction on the Pharmacokinetics of CC-220 in Healthy Subjects
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-part study to be conducted at a single study site in the US. Both parts of the
      study may be conducted in parallel.

      A total of approximately 38 subjects will participate in this study, with approximately 19
      subjects in Part 1 and approximately 19 subjects in Part 2. Each subject may only participate
      in one of the parts.
    

Detailed description: 
      This is a two part study to be conducted at a single study site. Both parts of the study may
      be conducted in parallel.

      A total of approximately 38 subjects will participate in this study, with approximately 19
      subjects in Part 1 and approximately 19 subjects in Part 2. Each subject may only participate
      in one of the parts.

      Each Part will consist of 2 study periods. Part 1 and Part 2, each subject will participate
      in a Screening phase, one baseline visit per period, one dosing phase per period, and
      follow-up telephone call.

      In Part 1, subjects will receive a single dose of CC-220 in Period 1 and, following an
      appropriate washout, multiple doses of itraconazole plus one dose of itraconazole with CC-220
      in Period 2. In Part 2, subjects will receive CC-220 in Period 1 and, following an
      appropriate washout, multiple doses of rifampin plus one dose of rifampin with CC-220 in
      Period 2.
    

Intervention name(s): CC-220; Rifampin; Itraconazole
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Itraconazole; Rifampin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cytochrome P450; Pharmacokinetics; CC-220; Healthy Subjects
Non-invasive Current Stimulation for Restoration of Vision
Condition: Stroke; Electrical Stimulation
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of the study is to evaluate effects of current stimulation of the brain on vision
      parameters, vision-related quality of life, and physiological parameters to uncover
      mechanisms of vision restoration. These include EEG-spectra and coherence measures, and
      visual evoked potentials. The design of stimulation protocols involves an appropriate
      sham-stimulation condition and sufficient follow-up periods to test whether the effects are
      stable. This is the first application of non-invasive current stimulation for vision
      rehabilitation in stroke-related visual field deficits.
    


Intervention name(s): repetitive transorbital AC Stimulation; combination of transcranial direct current stimulaton and rtACS
Intervention type(s): Device; Device
Intervention description(s): Repetitive transorbital ACS with max 30 Hz, 1,5 mA for 10 days, 20 min/day; Sequential tDCS (anodal occipital stimulation with 2 mA for 20 min/day for 10 days) and rtACS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, controlled
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Dry Needling Multifidus on Thickness of Transversus Abdominis in Healthy Individuals
Condition: Back Pain
MeSH terms: Back Pain
Study type: Interventional

Summary: 
      Intramuscular therapy (also known as dry needling) has been shown to give dramatic relief of
      musculoskeletal pain. The mechanisms of action remain unknown, and this study will examine
      for a neurophysiological effect.
    

Detailed description: 
      Consenting adults will be taught how to contract their abdominal muscles, and to contract
      transversus abdominis in particular. They will then have real time ultrasound measurements of
      the resting and contracted thickness of their left transversus abdominis muscle. After this,
      they will receive actual or sham needling to their left multifidus muscle by another
      researchers blinded to the real time ultrasound measurements. After needling or sham
      intervention is complete, the original researchers will return to re-measure transversus
      abdominis. They will be blind to intervention allocation.
    

Intervention name(s): Dry needling; Sham needling
Intervention type(s): Procedure; Procedure
Intervention description(s): Sterile monofilament needles; Applicator tubes from the sterile monofilament needles
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Back pain
The Role of a Virtual Coach in Improving Adherence to an Activity Program for Overweight Adults
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Hypothesis: Overweight subjects using a Virtual Coach will demonstrate improved adherence to
      an exercise regime.

      This study is designed to examine the effect of a computer program called a "Virtual Coach"
      and find out if it helps people become more active. This program acts as a kind of a personal
      trainer and will give you feedback. All participants in the study will receive an activity
      monitor to wear during the study and a website to use to track activity. Half of the
      participants will also receive the virtual coach software. This software will have to be
      downloaded onto your computer, and we will ask that you check in with the coach using the
      software three times a week for 12 weeks. The group you will be placed in will be selected by
      chance.
    


Intervention name(s): Virtual Coach software; Activity monitor and website
Intervention type(s): Other; Other
Intervention description(s): The intervention being tested, the Virtual Coach, is an automated empathic computer agent which will run on patient's home computer and engage the patient in dialogues to deliver personalized feedback, education and coaching based on physiological data.; The control group will use an activity monitor and a website to track activity levels.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Electrical Stimulation or Kinesio Taping on Recovery Disability in Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to analyze the effectiveness of electrical stimulation and
      kinesio taping in combination with exercise in People with Chronic Low Back Pain
    


Intervention name(s): Kinesio taping; Electrical Stimulation
Intervention type(s): Other; Other
Intervention description(s): Kinesio taping is a new taping modality which act diminishing pain.; Electrical stimulation therapy is a electrical current that allow patients diminish pain.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Electrical Stimulation Therapy; Kinesio taping; Exercise
Chronic Cardiovascular Risk Outpatient Management in South Asians Using Digital Health Technology
Condition: Cardiovascular Risk Factor; Insulin Resistance; PreDiabetes; Diabetes; Coronary Artery Disease; Hypertension; Prehypertension; Dyslipidemias
MeSH terms: Coronary Artery Disease; Prehypertension; Insulin Resistance; Dyslipidemias
Study type: Interventional

Summary: 
      This platform will enable investigation the cardiovascular risk reduction and the increase in
      participant engagement in their heart-healthy goals, through the use of virtual
      care/telemedicine with a digital platform that connects them to their own doctors, nurses,
      and dietitians.
    

Detailed description: 
      The study will use telemedicine and the mobile health capabilities of smartphones to
      facilitate communication of medical goals set by the treating physician to the subject in
      between clinic visits, and to assess the daily medical and lifestyle change compliance of
      enrolled Stanford subjects and provide virtual health coaching, as needed, to subjects to
      achieve said goals. How patients comply with their specific medical and lifestyle goals all
      affect their cardiovascular health, yet largely go unmeasured. These can now be measured with
      a notification-based system in which subject-entered activity, medication compliance, and
      dietary reporting data will be collected, assessed, and trigger appropriate responses by the
      subject's Care Team, which includes their physician, nurse, dietitian, and assigned health
      coach. We aim to collect this subject-reported activity and cardiovascular care plan
      compliance data to provide much more quantitative data on type, duration, and intensity of
      daily activities and compliance with the medication regimens of enrolled subjects.

      The study will compare anthropometric cardiovascular risk biomarkers testing at the initial
      visit and after 3 months, in subjects utilizing the HealthPals digital platform PLUS the
      standard SSATHI clinic visits, versus subjects receiving only SSATHI clinic visits.
    

Intervention name(s): Use of HealthPals (Telemedicine supported by digital health platform)
Intervention type(s): Behavioral
Intervention description(s): HealthPals is a smartphone-based chronic disease management mobile application. It uses the mobile health capabilities of smartphones to provide a secure communication portal for patients with their Care Teams to help achieve cardiovascular risk reduction through a digital health coach-based coaching for lifestyle and medication compliance.
The HealthPals app was developed by HealthPals, Inc.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group A Control Group B HealthPals
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: South Asian; Cardiovascular Risk Reduction; Metabolic Disorders; Lifestyle modifications
Study to Assess the Safety and Efficacy of CD-NP in the Treatment of Patients With Acute Decompensated Heart Failure
Condition: Acute Decompensated Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to assess the safety and tolerability of IV
      administration of CD-NP and the dose relationship of CD-NP on improvement of clinical
      symptoms and renal function in ADHF patients.
    


Intervention name(s): CD-NP
Intervention type(s): Drug
Intervention description(s): Infusion of CD-NP at one of up to 6 doses or placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: ADHF; AHF; HF