bioihbjkbjnl/mcl2 huggingface dataset:
Resuscitation and Capillary Reperfusion
Condition: Cardiac Arrest; Cardiac Arrest, Out-Of-Hospital; Cardiopulmonary Arrest; Cardiopulmonary Arrest With Successful Resuscitation
MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest
Study type: Observational

Summary: 
      Persistent microperfusion alterations after return of spontaneous circulation (ROSC) are
      associated with poor survival. To our knowledge, no human studies evaluating microperfusion
      during cardiopulmonary resuscitation (CPR) with simple and pre-hospital available tests have
      been published. Capillary refill time (CRT) and skin-mottling-score (SMS) are parameters for
      microperfusion and evaluated in septic and cardiogenic shock. In animal studies,
      microperfusion was impaired during cardiac arrest, although not correlating with systemic
      blood pressure.

      The aim of this study is to investigate the correlation between impaired microcirculation (as
      measured with CRT and SMS) during resuscitation and ROSC resp. neurological outcome. Our
      clinical impression in daily routine is, that the appearance of a patient undergoing CPR is
      often linked to the outcome. We hypothesize, that this is due to changes in microperfusion of
      the skin.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult out-of-hospital cardiac arrest patients
      
Keywords: capillary refill time; skin mottling score; capillary lactate; microperfusion; cardiopulmonary resuscitation
Lifestyle Intervention in Obese Arab Women
Condition: Metabolic Syndrome; Diabetes
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The study protocol aims to test the hypothesis that a lifestyle intervention program aimed to
      increase leisure-time physical activity and reduce body weight will improve the parameters of
      the metabolic syndrome and quality of life among obese, non-diabetic Arab women
    

Detailed description: 
      200 obese non-diabetic Arab women, 35-54 years old, with one or more parameters of the
      metabolic syndrome (NCEP-III criteria) will be randomized to either conventional or intensive
      treatment. The intensive intervention arm will include group meetings with physical education
      instructor (twice a month),group meetings with a dietician (once per month) and personal
      dietary counselling (once per month). The targets to be achieved will be at least 7%
      reduction of the initial body weight and engagement in leisure-time sports activity for at
      least 150 min/week.Evaluation before enrollment and at the end of the trial will include:
      information on dietary and physical activity habits, quality of life parameters,
      anthropometric and blood pressure measurement, blood lipid profile, and fasting and post oral
      glucose load blood glucose and insulin levels. Duration of the intervention: 12 month.
    

Intervention name(s): Moderate Lifestyle Intervention; Intensive lifestyle intervention
Intervention type(s): Other; Other
Intervention description(s): Two educational group meetings with a dietitian in the first month of intervention; One individual counselling session with a dietitian at baseline, and at 6-month and 12-month follow-up; A monthly individual counselling session with a dietitian; A monthly group session with a dietitian; Bi-monthly group sessions with a physical activity instructor
Other intervention name(s): Lifestyle intervention; Lifestyle intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Obesity; Women; Arab; Metabolic syndrome; Lifestyle intervention; Quality of life
Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia
Condition: Myocardial Ischemia; Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Ischemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Mesenchymal stem cells from the bone marrow can be stimulated to differentiate into
      endothelial cells and participate in the development of new blood vessels in ischemic tissue.

      The aim of the study is in a phase I/II safety and efficacy study to evaluate the clinical
      effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial
      ischemia.
    

Detailed description: 
      Mesenchymal stem cells from the bone marrow can be stimulated to differentiate into
      endothelial cells and participate in the development of new blood vessels in ischemic tissue.

      The aim of the study is in a phase I/II safety and efficacy study to evaluate the clinical
      effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial
      ischemia.

      4o patients with reversible ischemia on a SPECT will be treated with direct intramyocardial
      injections of autologous isolated and expanded mesenchymal stem cells.Clinical and objective
      evaluations will be performed at baseline and during 12 months follow-up.
    

Intervention name(s): stem cell
Intervention type(s): Biological
Intervention description(s): mesenchymal stromal cell
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: myocardial ischemia; stem cell; mesenchymal; myocardial perfusion
Stuttering and Anxiety
Condition: Stuttering, Childhood; Anxiety Disorders
MeSH terms: Stuttering; Anxiety Disorders
Study type: Interventional

Summary: 
      Stuttering was defined as a common neurodevelopmental speech disorder characterized by
      repetitions, prolongations, and interruptions in the flow of speech. In other words,
      stuttering is a speech disorder characterized by involuntary disruptions to speech which
      impede the capacity to communicate effectively.

      Physiological and emotional anxiety has been reported in persons who stutter. It has been
      reported that as high as 44% of clients seeking treatment for stuttering could be assigned a
      co-occurring social phobia or social anxiety diagnosis.
    

Detailed description: 
      According to the Diagnostic and Statistical Manual of Mental Disorders, social anxiety
      disorder is characterized by marked or intense fear of social or performance-based situations
      where scrutiny or evaluation by others may occur. Feared situations often include speaking in
      public, meeting new people, and talking with authority figures.

      There are several reasons to expect that stuttering may be associated with social anxiety
      disorder. To begin with, stuttering is accompanied by numerous negative consequences across
      the lifespan which may increase vulnerability to social and psychological difficulties. These
      consequences are intensified during the school years when children become more involved in
      social and speaking situations. As a result, children and adolescents who stutter frequently
      experience peer victimization, social isolation and rejection, and they may also be less
      popular than their non-stuttering peers.
    

Intervention name(s): Stuttering severity instrument-3; Child Behavior Checklist for age 4-18
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): To measure of degree of stuttering in child; To measure of percent of anxiety in child by ask parents about his or her behaviour
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Stuttering; Anxiety
Clinical Evaluation Of Two Daily Disposable Contact Lenses And A Monthly Replacement Lens
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The objective of the study is to compare the clinical performance of silicone hydrogel daily
      disposable contact lenses, conventional hydrogel daily disposable contact lenses and silicone
      hydrogel monthly replacement contact lenses.
    


Intervention name(s): narafilcon B contact lens; nelfilcon A contact lens; lotrafilcon B contact lens
Intervention type(s): Device; Device; Device
Intervention description(s): Silicone Hydrogel Daily Disposable Contact Lenses; Conventional Hydrogel Daily Disposable Contact Lenses; Silicone Hydrogel Monthly Replacement Contact Lenses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Post-Market Clinical Follow Up Study to Collect Additional Data and Imaging
Condition: Connective Tissue Defect
Study type: Interventional

Summary: 
      This is a prospective, open label, multi-center clinical study to collect additional data and
      imaging for the ViaSure device.The intended use of the ViaSure device used in this study is
      to assess the usability and tissue response to shock wave treatment.
    

Detailed description: 
      Up to 50 subjects will be enrolled at 2 study centers. Subjects will attend a
      screening/pretreatment visit which may be performed on the same day as the treatment visit.
      Subjects may receive up to 5 treatments with the study device. Follow up visits may occur 30
      and 90 days post last treatment visit.
    

Intervention name(s): Shockwave Treatment
Intervention type(s): Device
Intervention description(s): Self-controlled, single-arm group using the Shockwave device.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Time-restricted Feeding for Treating Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome; Overweight; Obesity
MeSH terms: Polycystic Ovary Syndrome; Overweight; Syndrome
Study type: Interventional

Summary: 
      Intermittent fasting is an increasingly popular diet pattern of alternating eating and
      dieting.One particular form of intermittent fasting is the so-called time-restricted feeding
      (TRF). TRF allows for ad libitum feeding within a large window of time each day, and does not
      require any calorie counting. There is growing evidence that it can lose weight, reduce
      insulin resistance and improve cardiometabolic health. Polycystic ovary syndrome (PCOS) is
      the most common reproductive endocrine and metabolic disease affecting women of childbearing
      age. PCOS shows anovulation or oligoovulation, hyperandrogenemia and ovarian polycystic
      changes. Insulin resistance and obesity are common features of PCOS. Whether the TRF impacts
      women with PCOS is still unknown due to the paucity of data in this area. To explore the
      effects of TRF on the endocrine and metabolic profile in overweight women with PCOS, a 6-week
      single-arm trial, divided into 2 consecutive periods: (1) 1-week baseline period; and (2)
      5-week TRF period, will be implemented.
    


Intervention name(s): Time-Restricted Feeding
Intervention type(s): Behavioral
Intervention description(s): The trial consists of a 1-week baseline weight stabilization period followed by a 5-week TRF intervention period.
Participants will be instructed to eat freely from 8 a.m. to 4 p.m. daily and fast from 4 p.m. to 8 a.m. the next day.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neurologic Signatures of Chronic Pain Disorders
Condition: Chronic Pain; Chronic Migraine; Fibromyalgia
MeSH terms: Fibromyalgia; Chronic Pain; Somatoform Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      "Brain signatures" as objective measures of acute pain have been characterized with
      functional magnetic resonance image and machine learning technology. As compared to acute
      pain, chronic pain leads to greater socioeconomic burden. However, measures for chronic pain
      remain subjective and suboptimal, and the brain signatures for chronic pain are largely
      unknown. Chronic migraine and fibromyalgia are two prototypes primary chronic pain disorders
      with high disability and intractability with prevalence of around 2% for both diseases. These
      two chronic pain disorders have shared clinical presentations (abnormal pain sensitivity,
      mood and sleep disorders), pathophysiology (central sensitization) and medical treatment
      (anti-depressants), despite different body parts are involved (head vs. whole body). The
      present integrated project aims to characterize both common and disease-specific brain
      signatures of chronic pain by investigating these two chronic pain disorders. Our findings
      may shed some light on the key mechanisms of pain chronification, and may pave the way for
      the optimization of diagnosis and prognostication, as well as formulation of personalized
      medicine in chronic pain, so as to improve life quality of these patients and to reduce
      socioeconomic loss.

      The present project includes three interdisciplinary sub-projects (plus one animal study, not
      listed here):

      A: Clinical studies for chronic migraine and fibromyalgia: endophenotypes and pain
      chronification B: Functional neuroimaging of chronic pain: multimodal quantitative analysis
      of brain connectomes C. Data stream mining technology for multimodal physiological signals of
      chronic pain: real-time tracking and clinical correlation

      The specific aims of the present projects include:

        1. Identification of common and disease-specific brain signatures for chronic pain
           (sub-projects A, B, C)

        2. Investigation of clinical indicators with predictive values by machine learning analysis
           of big data (sub-projects A, B, C)

        3. Elucidation of the specific anatomical structures or neural networks underpinning pain
           chronification based on clinical neuroimaging (sub-projects A, B) In this 1st-year pilot
           study of the 4-year longitudinal study, we will establish experimental platforms for
           each sub-project, start to recruit participants and perform endophenotyping, as well as
           have a preliminary integration for sub-projects A, B and C.
    


Intervention name(s): flunarizine and/or pregabalin
Intervention type(s): Drug
Intervention MeSH terms: Pregabalin; Flunarizine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Impact of Botox® During Robotic Rehabilitation of the Wrist Following Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to see whether treating subjects for wrist rehabilitation
      following stroke with Botox® and robotic therapy is more effective than treatment with
      robotic therapy alone and no Botox®.
    

Detailed description: 
      This study will explore new ways to facilitate rehabilitation of wrist function after stroke.
      One of the challenges of recovery is muscle stiffness or excessive muscle tone that often
      limits exercise or therapy progress. Taking this into account, the investigators propose
      treating the wrist and forearm with a combination of a one-time Botox® injection and a 6-week
      robotic therapy protocol to maximize recovery.

      Botox® is a drug that is injected directly into a muscle to temporarily relax the muscle.
      Botox® is commonly used to decrease muscle tone in tight muscles in the stroke population.
      Robotics therapy provides highly repetitive mass practice with visual and haptic feedback.

      Subjects will be randomized to two groups. Group A will receive the Botox® injection and
      group B will receive a placebo saline injection. Both groups will receive the same robotics
      therapy protocol. Subjects and investigators will be blinded to group assignment. The
      investigators would like to know if there are trends between groups in a variety of outcome
      measures depending on what intervention they received. The investigators predict that the
      treatment group will have better results than the control group on the Fugl Meyer, our
      primary outcome measure. The investigators hope the results of this pilot study will guide
      development of a larger clinical trial.
    

Intervention name(s): Botox®; saline solution
Intervention type(s): Other; Other
Intervention description(s): the treatment group will receive a one time injection of Botox® at the wrist flexors and pronators of the affected arm. Each subject will receive a standard dose of 150 units total, 50u each to the flexor carpi radialis and flexor carpi ulnaris, and 25u each for the pronator teres and pronator quadratus muscle groups.; the control group will receive a one time injection of salt water in the flexor carpi radialis and flexor carpi ulnaris, and the pronator teres and pronator quadratus muscle groups.
Other intervention name(s): botulinum toxin serotype-A; salt water
Intervention MeSH terms: Botulinum Toxins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hemiparesis; robotics; stroke; Botox®; rehabilitation; wrist spasticity
Evaluation of the Efficacy and Safety of Recombinant Human Growth Hormone (rhGH) in the Treatment of Children With Short Bowel Syndrome
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized controlled, parallel group, open label versus "no treatment" trial which
      evaluate the efficacy of rhGH on weaning off parenteral nutrition in children with short
      bowel syndrome.The total follow-up is 14 months; 4 months for each group after randomization;
      At the end of the first four months: the treated group will be followed within 6 months, the
      untreated group will receive compassionately rhGH for 4 months and followed-up for 6 months
      after the end of the treatment period.
    


Intervention name(s): rhGH
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Short bowel syndrome; Growth hormone; Children
The Efficacy and Safety of Pioglitazone in Patients With Nonalcoholic Steatohepatitis
Condition: Hepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Recent studies have demonstrated that PPARγ as well as diet control could improve glycemic
      control, decrease serum ALT level, decrease hepatic fat distribution, and increase
      intrahepatic insulin sensitivity. The purposes of this study are:

      1. Primary aims:

        1. Comparison between Pioglitazone and placebo groups in terms of steatosis and liver
           function tests.

        2. Evaluation of clinical safety of Pioglitazone

      2. Secondary aims:

        1. Comparison between Pioglitazone and placebo groups in terms of liver necroinflammation
           and fibrosis.

        2. The impact of Pioglitazone on the related metabolic index, including insulin
           resistance(HOMA-IR), newly-onset diabetes, metabolic syndrome, lipid profiles (T-Chol,
           HDL-C, LDL-C, TG).

        3. Comparison between Pioglitazone and placebo groups in terms of high-sensitive C-reactive
           protein changes.

      3. Interventional aim: Assessment the association between magnetic resonance imaging study
      and intrahepatic fat distribution before and after Pioglitazone treatment.
    

Detailed description: 
      Pioglitazone belongs to thiazolidinediones and anti-diabetes drug which decreases the insulin
      resistance. It increases the use of glucose of peripheral tissues and decrease the production
      of glucose from liver and dose not influence the production of insulin. It is agonist of
      peroxisome proliferator-activated receptor-gamma (PPARγ) and by binding to the receptors of
      PPARγ in various tissues it has effects on transcription of the insulin-dependent gene. In
      animal model, pioglitazone has shown to influence the metabolism by the insulin-dependent
      mechanism.

      Recent studies have demonstrated that PPARγ as well as diet control could improve glycemic
      control, decrease serum ALT level, decrease hepatic fat distribution, and increase
      intrahepatic insulin sensitivity. Meanwhile, PPARγ could also prevent the development of
      alcohol-induced steatohepatitis, improve hepatic necroinflammatory activity, and decrease
      lipid deposition. It is not yet clearly known how the effect of P-PARγ agonist among Asian
      peoples.
    

Intervention name(s): Pioglitazone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Name: GLITOS（Pioglitazone）
Dosage form: Tablets
Dose(s): 30mg
Dosing schedule: QD
Duration: 6 months; placebo 30 mg/d for 6 months
Other intervention name(s): GLITOS
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: NASH; Pioglitazone; Treatment
Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab
      SC) as maintenance treatment in participants with moderately to severely active CD who
      achieved clinical response following administration of vedolizumab intravenous (vedolizumab
      IV) induction therapy.
    

Detailed description: 
      The drug being tested in this study is called vedolizumab SC. Vedolizumab SC is being tested
      to treat people who have moderate to severely active CD. This study will look at clinical
      remission, as well as enhanced clinical response and corticosteroid-free remission in
      participants with CD who receive vedolizumab SC maintenance therapy after having achieved a
      clinical response to vedolizumab IV induction therapy.

      The study will enroll approximately 824 participants. All participants will enter a 6 week
      Induction Phase where they will be administered open-label vedolizumab IV 300 mg via IV
      infusion at Week 0 (Day 1) and Week 2 (Day 15), and will then be assessed for a clinical
      response at Week 6. Participants who achieve a clinical response at Week 6 will be randomly
      assigned to one of the two treatment groups:

        -  Vedolizumab SC 108 mg Maintenance Arm

        -  Placebo SC Maintenance Arm

      Participants who do not achieve a clinical response will not be randomized into the
      Maintenance Period, and instead will receive a third infusion of vedolizumab IV 300 mg at
      Week 6.

      This multi-center trial will be conducted worldwide. The overall time to participate in this
      study is up to 71 weeks. Participants will make multiple visits to the clinic, plus a final
      visit 18 weeks after last dose of study drug for a follow-up assessment. Participants will
      also participate in a long-term safety follow-up, by phone, at 6 months after the last dose
      of study drug.
    

Intervention name(s): Vedolizumab SC 108 mg; Placebo; Vedolizumab IV 300 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Vedolizumab SC Injection.; Vedolizumab placebo-matching SC injection.; Vedolizumab IV Injection.
Intervention MeSH terms: Vedolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug Therapy