bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Hypocaloric Diet and Exercise in Obese Women Who Are Subjected to IVF Cycle
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to determine the impact of diet and physical exercise program on
      pregnancy rate and live birth in obese women who undergo an IVF cycle.
    

Detailed description: 
      The objective of this study is showing that obesity significantly affects the in vitro
      fertilization cycles lowering the reproductive capacity. The study is been performed in
      Hospital de la Santa Creu i Sant Pau and Fundació Puigvert of Barcelona. Patients recluted
      are obese women with sterility problems that require in vitro fertilization (IVF) with a body
      mass index BMI between 30-35. It´s a randomised study in which half of the patients undergo
      to a 6 weeks program of diet and exercice. We will analyse the response to ovaric
      stimulation, the results of the egg retrieval (ovocyte number and quality), rates of
      fecundation, embryo implantation and clinical gestation.
    

Intervention name(s): Diet and exercise
Intervention type(s): Behavioral
Intervention description(s): Total caloric intake aimed at maintaining a diet with> 50% of the caloric content in the form of carbohydrates, less than 10% in the form of saturated fats and 20% from monounsaturated / polyunsaturated (if applicable, up to 25% fat monounsaturated), less than 300 mg / day of dietary cholesterol and about 1.0 g of protein / kg ideal body weight / day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Single-Blind, Controlled Safety and Immunogenicity Study of Recombinant MVA Virus to Treat HIV Infection
Condition: HIV Infections
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      At the end of 2004 there were more than 40 million people infected Worldwide with HIV, with
      an estimated 16,000 new infections every day (UNAIDS, 2004). The HIV epidemic threatens whole
      societies particularly in Africa and Asia and rates of infections in the Western Countries
      have also increased over the last few years. However, despite more than 15 years of research,
      an effective vaccine against HIV and acquired immunodeficiency syndrome (AIDS) has still not
      been developed.

      There is considerable evidence that cellular immune responses can effectively control HIV-1
      replication during acute and chronic infections thereby possibly protecting individuals from
      infection and preventing the spread of HIV. To be truly effective in the general population,
      a vaccine must induce responses specific to immunologically conserved regions. The
      epitope-based vaccine MVA-mBN32 represent a very logical approach to this problem because its
      potential to elicit a polyfunctional immune response and to focus these responses to
      conserved epitopes.

      In this study the safety, tolerability and immunogenicity of a recombinant MVA-BN® expressing
      CTL and HTL epitopes of HIV-1 (MVA-mBN32) vs. the vector control MVA-BN® in 30 HIV-infected
      subjects will be examined. This will include a full analysis of CD4+ T helper cells and CD8+
      CTL responses to these epitopes, to establish the potential of such a homologous prime-boost
      vaccine approach to induce a broad cell-mediated response to different HIV antigens.
    


Intervention name(s): MVA-mBN32; IMVAMUNE
Intervention type(s): Biological; Biological
Intervention description(s): 3 immunizations: 1x 10E8_TCID50 MVA-mBN32; 3 immunizations: 1x 10E8_TCID50 IMVAMUNE
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Vaccine; Safety; T-cell epitope; Acquired Immune Deficiency Syndrome Virus; HIV Therapeutic Vaccine
Effect of Feeding With Nutrient Dense Formula in Malnourished Infants and Children With Congenital Heart Defects
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      Infants with congenital heart disease (CHD) are usually born with a normal weight but develop
      malnutrition over time, and about 20-50% of these children are usually malnourished.
      Malnutrition in these patients is multifactorial. To compensate for the increased need for
      infants and children with CHD, an increase in their caloric intake has been suggested.
      However, these patients may not be able to receive enough to meet the increased needs and
      catch-up growth. One of the suggested solutions in these patients to compensate for
      inadequate food intake is to increase the caloric density of milk or formula. For this
      purpose, the use of special formulas with higher calorie density or enrichment of normal
      formula or breast milk using special enrichment formula could be suggested. In the present
      study, the effect of increasing calorie intake by increasing the concentration of normal
      formula in comparison with formula with standard concentration on weight gain and other
      anthropometric indices of CHD patients with malnutrition will be compared.
    


Intervention name(s): Infant formula
Intervention type(s): Dietary Supplement
Intervention description(s): Regular infant formula will be concentrated to give a calorie density of about 90 kcal/100 mL.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Incidence and Spectrum of Acute Kidney Injury in Cirrhotics and Assessment of New Biomarkers as Early Predictors of Acute Kidney Injury
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury
Study type: Observational

Summary: 
      500 patients with normal renal function will be prospectively studied and incidence, spectrum
      and natural history of AKI (Acute Kidney Injury) will be observed in them and in 200 patients
      with abnormal renal function fulfilling AKI (Acute Kidney Injury) criteria will be
      prospectively studied for 1 year. Also biomarkers will be studied and validated as early
      predictors of AKI (Acute Kidney Injury).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        500 patients with normal renal function. 200 patients with abnormal renal function
        fulfilling AKI (Acute Kidney Injury) criteria will be prospectively studied.
Effects of HX106 on Improvement in Cognitive-Bio-Markers of Memory Function
Condition: Healthy Adults With Subjective Memory Complaints
Study type: Interventional

Summary: 
      The objectives of the current study are to evaluate the efficacy and safety of HX106 in
      healthy adults with subjective memory complaints for improving neurocognitive functions and
      to find the changes of brain using magnetic resonance imaging and their associations with the
      neurocognitive function enhancement.
    


Intervention name(s): HX106 590mg; HX106 1180mg; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Therapeutic Effectiveness of Exercise Associated to the Pharmacotherapy in Major Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Depression is a disorder that causes major harm to physical health and social life. It
      induces isolation, reduced physical and work capacity and increasing the risk of death. In
      contrast, exercise helps to maintain quality of life, also inducing improvement of cognitive
      functions, stimulation of brain plasticity and resilience, in addition to promoting
      self-esteem and social interaction. The precise mechanisms by which exercise improves
      symptoms of depression are not fully clear, but it is probably multifactorial. In this
      project, the investigators aim to investigate variables that provide additional information
      about biomarkers involved in the pathophysiology of depression and therapeutic response to
      exercise. The investigators expect to find changes in biomarkers associated with potential
      mechanisms of neuroprotection (cytokines, markers of oxidative stress, Brain-derived
      neurotrophic factor (BDNF), cortisol) after exercise program and the role in the therapeutics
      of depression. To evaluate functional assessment indices will be used ergospirometry, a test
      that determines the respiratory, cardiovascular and metabolic activity. Overall, this project
      will help to investigate alternative adjunctive treatments for depression and their
      associated biomarkers with response.
    


Intervention name(s): Physical Exercise
Intervention type(s): Other
Intervention description(s): physical exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Physical exercise; Biomarkers; Neuroprotection; ergospirometry; Major Depressive Disorder
Sleep Deprivation Study
Condition: Cognitive Change; Sleep Deprivation; Caffeine
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the measures of brain function, both
      neurophysiological (event-related potentials (ERPs) and functional (cognitive assessments),
      in response to sleep deprivation.
    


Intervention name(s): Sleep Deprivation; Caffeine; No Caffeine
Intervention type(s): Behavioral; Other; Other
Intervention description(s): Participants will be randomized into either the sleep deprivation group or the control group, who will sleep regularly.; On Day 2 morning, after the sleep deprivation or sleeping, participants will be randomized into receiving caffeinated or de-caffeinated coffee, which they will be blinded to.; De-caffeinated coffee
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2-group, randomized design
Masking: Single (Participant)
Primary purpose: Basic Science
Outcomes and Discharge of Long-stay Psychiatric Patients
Condition: Mental Disorders
MeSH terms: Mental Disorders; Psychotic Disorders
Study type: Observational

Summary: 
      An increasing number of severely ill patients require long-term care in non-hospital
      Residential Facilities (RFs). Despite the magnitude of this development, only a few detailed
      longitudinal studies on fairly larger samples of residents have provided important
      information about this population. The PERDOVE study is the first study carried out in Italy
      aimed at obtaining comprehensive data about the course and outcome of patients living in RFs,
      and test whether discharge to independent accommodations is a real option for many patients.
      The major aims are three: (1) to describe the sociodemographic, clinical, and
      treatment-related characteristics of patients treated in RFs during an index period in 2010;
      (2) to identify predictors, and characteristics associated to discharge at 1-year follow-up;
      and (3) to evaluate clinicians' predictions about the likelihood of home discharge for each
      individual patient. The primary endpoint was discharge within one year as a measure of good
      outcome. The PERDOVE study is an observational cohort study, involving 23 RFs all belonging
      to the St John of God Order, located in Northern Italy. The first step involves the
      evaluation of all RFs with a Structure Schedule, which assesses the following areas:
      logistics structure, general organization: internal rules, meals, clothing and personal
      hygiene; staff and users' characteristics and meetings, documentation system and evaluation
      activities; rehabilitative activities provided inside the RF itself. In the second step a
      research assistant completed a standardised assessment of each resident with the manager and
      staff; clinical diagnoses were made by treating clinicians. A number of standardised
      instruments were administered. At one year follow-up, changes in clinical and life conditions
      of the patients were evaluated and selected rating scales were administered again. For
      patients discharged to the community or to other RFs, a research assistant contacted the
      patient's psychiatrist and asked him/her to fill out the follow-up documentation. With regard
      to residents' discharge, investigators hypothesised that the likelihood of community
      discharge would be associated both with the level of social support outside the facilities,
      and with the degree of patients' psychological and social impairment.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Psychiatric patients staying in residential facilities.
      
Keywords: Severe mental disorders; Discharge; Outcome evaluation
Safety and Efficacy of Generic Diclofenac Epolamine Acute Pain Due to Minor Ankle Sprain
Condition: Ankle Sprain
MeSH terms: Acute Pain; Sprains and Strains; Ankle Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate the therapeutic efficacy of a generic diclofenac epolamine patch against
      Flector patch in the treatment of pain in subjects with minor ankle sprain
    

Detailed description: 
      To evaluate the therapeutic equivalence and safety of generic diclofenac epolamine 1.3% patch
      (Watson Laboratories, Inc.) and Flector® (diclofenac epolamine 1.3% patch) (Pfizer) in the
      treatment of acute pain due to minor ankle sprain.

      To demonstrate the superiority of the efficacy of the test and reference products over that
      of the vehicle control in the treatment of acute pain due to minor ankle sprain.

      To access application site reactions and patch adhesion between treatment groups.
    

Intervention name(s): Diclofenac epolamine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain; Topical patch not containing diclofenac epolamine applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain
Other intervention name(s): Flector Patch; Vehicle control
Intervention MeSH terms: Diclofenac; Diclofenac hydroxyethylpyrrolidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain due to ankle sprain
The Effects of Mirror Therapy on Upper Extremity in Stroke Patients
Condition: Cerebrovascular Accident
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this study is to compare treatment efficacy of mirror therapy (MT), mirror
      therapy combining mesh glove (MG+MT) stimulation, and controlled treatment (CT) in people
      with stroke.
    

Detailed description: 
      55% to 75% of people after stroke have a paretic arm that causes motor impairment. Among
      novel rehabilitation interventions, MT was found to be beneficial and comparatively low-cost.
      MT reduced motor impairment possibly in part of recruiting the premotor cortex or balancing
      the neural activation within the primary motor cortex toward the affected hemisphere.
      However, the benefits in certain aspects of outcomes are under debate. Another treatment, MG,
      can be used to normalize muscle tone, suppress muscle spasticity, enhance residual volitional
      activity of hand and arm, or even increasing walking speed. In addition, providing MG
      stimulation might result in plastic changes in the primary motor cortex, and induced a
      long-lasting modulated effect on motor cortical excitability. The possible mechanism of brain
      plasticity underlying MG is collective with the mechanism behind the MT. Adding MG to MT
      might augment the cortical reorganization. In sum, combining MT with MG may supplement the
      disadvantage or uncertain effects of MT and broaden the benefited outcomes.
    

Intervention name(s): Mirror box training; mesh glove stimulation; conventional intervention
Intervention type(s): Behavioral; Other; Behavioral
Intervention description(s): This protocol includes 1 hour mirror therapy and 0.5 hour functional training in a session. The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks. MT focuses on symmetrical bimanual movements and simultaneously observing the visual feedback of the unaffected upper extremity reflected by the mirror.; The MG is a two-channel electrical stimulator providing synchronous or reciprocal sensory stimulation with variant amplitudes.; Participants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach
Other intervention name(s): MT; MG; CI
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Comparative effectiveness research; Mirror therapy; Stroke rehabilitation; Clinical evaluation; Kinematic analysis; Mesh glove; Combined therapy
Efficacy of the Individual Placement and Support (IPS) Model
Condition: Substance Use Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      Hypothesis 1. Consumers with disabilities and co-occurring SUD receiving IPS will be more
      likely to be competitively employed (defined as 1 or more days of work over the past 30 days)
      at 3, 6 and 12 months following the initiation of vocational treatment goals when compared to
      a group receiving standard services.

      Hypothesis 2. Consumers with disabilities and co-occurring SUD receiving IPS when compared to
      the comparison group will 1.) be more successful in achieving their employment goals as
      indicated by the ratio of hours worked to desired hours worked; 2.) become competitively
      employed sooner; 3.) earn higher wages, 4.) have greater job satisfaction, 5.) have greater
      economic satisfaction; 6.) have greater life satisfaction, 7.) have greater self-esteem, and
      8.) have fewer days of using substances during follow-up points.
    

Detailed description: 
      Hypothesis 1. Consumers with disabilities and co-occurring SUD receiving IPS will be more
      likely to be competitively employed (defined as 1 or more days of work over the past 30 days)
      at 3, 6 and 12 months following the initiation of vocational treatment goals when compared to
      a group receiving standard services.

      Hypothesis 2. Consumers with disabilities and co-occurring SUD receiving IPS when compared to
      the comparison group will 1.) be more successful in achieving their employment goals as
      indicated by the ratio of hours worked to desired hours worked; 2.) become competitively
      employed sooner; 3.) earn higher wages, 4.) have greater job satisfaction, 5.) have greater
      economic satisfaction; 6.) have greater life satisfaction, 7.) have greater self-esteem, and
      8.) have fewer days of using substances during follow-up points.
    

Intervention name(s): Individual Placement and Support Model
Intervention type(s): Behavioral
Intervention description(s): Psychosocial intervention involving an employment specialist working with participants recruited into the study and assisting with employment.
Other intervention name(s): Supported employment intervention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: employment, disabilities
The Effectiveness of Montelukast on Atopic Dermatitis in Koreans
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      The purpose of this study is to assess the clinical effectiveness of Montelukast in children
      (2~6 years old) with atopic dermatitis and identify the pathophysiologic background of
      Montelukast on the role of modulating the atopic dermatitis measured by urinary Leukotriene 4
      (LTE4) and Eosinophil protein X(EDN).
    

Detailed description: 
      Leukotriene B4 (LTB4) and the cysteinyl-leukotrienes LTC4, LTD4 and LTE4 are potent
      proinflammatory mediators derived from arachidonic acid through the 5- lipoxygenase pathway.
      They are secreted from eosinophils and other inflammatory cells such as mast cells and
      macrophages. The primary action of leukotrienes includes contraction of human airway muscle,
      chemotaxis, and increased vascular permeability, with secondary effects of inhibiting
      allergen-induced early and late responses. Several in vivo and in vitro studies suggest a
      role for cysteinyl leukotrienes in the pathogenesis of atopic dermatitis and there is a
      rationale for the use of pharmacological agents to antagonize their effects in the treatment
      of atopic dermatitis. Levels of LTE4 measured in urine (Urinary-LTE4) may be a useful measure
      of whole-body cysteinyl-leukotriene production in vivo, because that LTE4 is a stable urinary
      metabolite of LTC4 and LTD4. Urinary-LTE4 has been measured in individuals with atopic
      dermatitis, but in small-scale studies, and the results are conflicting.
    

Intervention name(s): Montelukast first, then placebo; Placebo first, then Montelukast
Intervention type(s): Drug; Drug
Intervention description(s): Patients in "Montelukast first, then placebo" will receive 4 mg of montelukast under the age of 6 years (5 mg of montelukast at 6 years) once daily for 8 weeks. And after 2 weeks wash-out period, they will receive chewable ascorbic acid placebo for 8 weeks. Patients in "Placebo first, then Montelukast" are received chewable ascorbic acid placebo for 8 weeks. And after 2 weeks wash-out period, they will receive 4 mg of montelukast under the age of 6 years (5 mg of montelukast at 6 years) once daily for 8 weeks.; Patients in "Montelukast first, then placebo" will receive 4 mg of montelukast under the age of 6 years (5 mg of montelukast at 6 years) once daily for 8 weeks. And after 2 weeks wash-out period, they will receive chewable ascorbic acid placebo for 8 weeks. Patients in "Placebo first, then Montelukast" are received chewable ascorbic acid placebo for 8 weeks. And after 2 weeks wash-out period, they will receive 4 mg of montelukast under the age of 6 years (5 mg of montelukast at 6 years) once daily for 8 weeks.
Other intervention name(s): SINGULAIR; Ascorbic acid
Intervention MeSH terms: Ascorbic Acid; Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Atopic dermatitis; Montelukast