bioihbjkbjnl/mcl2 huggingface dataset:
CPAP Survival Study in Ghana
Condition: Pneumonia; Acute Respiratory Infection
MeSH terms: Pneumonia; Respiratory Tract Infections
Study type: Interventional

Summary: 
      The purpose of this study is to determine if the use of a continuous positive airway pressure
      (CPAP) machine (a device that blows air into the lungs) decreases the chance of a child dying
      from difficulty breathing.
    

Detailed description: 
      Acute respiratory infections, malaria, and sepsis remain leading causes of death in children
      throughout the world.These conditions may lead to respiratory distress and eventually failure
      if not adequately managed. In developing countries with limited resources, advanced airway
      management and support can be challenging and needs to be approached in a different manner
      than is done in developed nations. For example, the use of invasive mechanical ventilation
      for respiratory distress is not an option in many resource-limited countries due to the lack
      of available technology, infrastructure, and trained personnel. Other alternatives should be
      utilized in order to support children with reversible conditions during their acute
      respiratory distress stage. One such alternative is non-invasive positive pressure.

      Prior research demonstrated that nasal bubble CPAP can be successfully introduced and
      utilized in a developing country's emergency ward. Nurses in four Ghanaian district hospital
      emergency wards (Kintampo, Mampong,Nkoranza, and Wenchi) were able to safely apply CPAP and
      monitor the patient's response. The investigators demonstrated that patients receiving CPAP
      had a significant decrease in respiratory rate compared with those that did not with a mean
      difference of 14 breaths per minute. There were no major side effects associated with the use
      of CPAP. Now that CPAP has demonstrated to decrease respiratory rate in a non-specific
      disease population presenting with respiratory distress it is important to determine if it
      also improves survival. Therefore, the purpose of the study is to determine if the use of
      CPAP in children 1 month to 5 years of age with respiratory distress decreases mortality.
    

Intervention name(s): CPAP
Intervention type(s): Device
Intervention description(s): Appropriately sized nasal prongs will be selected for the patient, gently applied ensuring a tight seal, and securely fastened. The CPAP machine will be turned on to deliver a pressure of 5 cm H2O in the inspiratory limb of the system. Patients will be allowed to be in the position of most comfort, preferably with mouth closed to maintain pressure in the circuit.
Other intervention name(s): Continuous Positive Airway Pressure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Continuous Positive Airway Pressure; Controlled trial; Pneumonia; Children
Taekwondo for Children With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      This study uses a mixed methods design to understand the effectiveness of using taekwondo as
      an intervention for children with ASD and its effect on social interaction skills and
      everyday life. Qualitative research emphasizes that meaning can be explained and interpreted
      only by those who experience it. A pretest-posttest design will be used to describe what
      occurs after the introduction of the taekwondo intervention and understand the changes that
      occur after exposure. Collecting information through the lived experiences and observations
      from the parents will be collated with the pre and post results of the children participants'
      social interaction skills.

      Qualitative data will be collected through pre and post semi-structured interviews with the
      parents to understand their observations of their child before and after completing the
      taekwondo program. Interviews will also be conducted with the child to understand their
      perspectives on physical activity participation. Interview questions will also explore how
      the effectiveness of the program has impacted the children's engagement in daily activities.

      Quantitative research will be collected through pre and post results from the Autism Social
      Skills Profile-2 ([ASSP] assessment that will be completed by the parents. The ASSP-2
      provides a comprehensive measure of social functioning for children and adolescents with ASD.
    


Intervention name(s): Taekwondo
Intervention type(s): Behavioral
Intervention description(s): Children will participate in a 7-week taekwondo program.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: taekwondo; Autism Spectrum Disorder; occupational therapy; Social interaction skills; child participants
Epidemiology of Sleep Disturbances Among the Adult Population of the Sao Paulo City
Condition: Healthy
MeSH terms: Dyssomnias; Parasomnias
Study type: Observational

Summary: 
      Sleep disturbances are of great relevance within the context of public health as they affect
      a sizable portion of the population with far reaching consequences. Many automobile and labor
      accidents as well as poor school and work performance can be traced to sleep disturbances,
      which are also linked to cardiovascular disease, metabolic syndrome, and psycho-cognitive
      alterations.

      OBJECTIVES:

        1. Establish the epidemiologic profile of sleep disturbances among the adult population of
           the city of Sao Paulo in 2007;

        2. Investigate associations between sleep patterns and disturbances in that population,
           taking into account the following variables: social-demographic status, anthropometrics,
           clinical, activity/rest cycle, eating and physical activity habits, mood disturbances,
           sexual dysfunction in males, alcoholism, drug addiction, genetic markers, biochemical,
           hematological, endocrine, immunologic and inflammatory indicators;

        3. assess the compatibility of the results collected in the current study with those of
           epidemiologic sleep investigations of said city carried out in 1987 and 1995 with the
           aim of determining the secular sleep disturbance trend.

      METHODS:

      The two-stage cluster randomized sample included 1100 individuals of the city of Sao Paulo,
      representing the population proportionally to gender, age groups and social classes. Data
      were amassed as follows:

        1. the application of home and institution questionnaires;

        2. description of the sleep patterns and disturbances through polysomnography and
           actigraphy, performed at the Sleep Institute;

        3. collection of peripheral blood for biochemical, hematologic, endocrine and genetic
           assays.

      STATISTICS:

      Subsequent to double typing (inputting) and analysis of data consistency, descriptive and
      analytical statistical assessments will be performed with the aim of describing patterns of
      sleep disturbances associated to the explanatory variables under investigation. In the light
      of bi-varied analysis, predictive/explanatory multivaried models were adjusted.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        General population of Sao Paulo city
      
Keywords: general population
CT-Angiography Prior to DIEP Flap Breast Reconstruction
Condition: Breast Cancer
Study type: Interventional

Summary: 
      This study will Investigate whether or not preoperative computed tomography (CT) angiography
      will lower operative times and post operative complications for breast reconstruction
      performed with a deep inferior epigastric artery perforator flap (DIEP).
    


Intervention name(s): Preoperative CT angiography; No Preoperative Imaging
Intervention type(s): Other; Other
Intervention description(s): Patients will receive a CT scan to map the blood vessels to be used during surgery for breast reconstruction; No imaging will be done to map blood vessels prior to surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DIEP flap; Deep inferior epigastric artery perforator flap
Correlation Between Intestinal Microbiota, Inflamatory Biomarkers, Intestinal Morphology, Hepatic Fibrosis Degree and Vascular Reactivity.
Condition: Microbial Colonization
MeSH terms: Communicable Diseases; Infections
Study type: Observational

Summary: 
      This project aims to establish the correlation between intestinal microbiota with
      inflammatory biomarkers, intestinal morphology, vascular reactivity and degree of hepatic
      fibrosis in patients with different degrees of glucose tolerance and body adiposity.
    

Detailed description: 
      Obese patients with dysglycemia or not, from the Obesity Outpatient Clinic, and individuals
      with normal or overweight weight with dysglycemia or not, preferably from the same social
      class and type of diet of the obese will be invited to participate in the study. Dysglycemia
      will be defined by the criteria of the Brazilian Society of Diabetes. These individuals will
      be divided into four groups: obese with dysglycemia (OBD), obese with normoglycemia (OB),
      lean / overweight with dysglycemia (MD) and lean with normoglycemia (M). After the selection
      and signing of the informed consent, the patient will be referred for an anthropometric
      evaluation, with the measurement of body mass and height, waist circumference and
      determination of body fat by the bioimpedance method Biodynamic 450 (BioDynamics , Seattle,
      USA). Finally, the 24-hour reminder (R24h) will be applied as a food survey method. And the
      dietary calculation will be performed through the AVANUTRI® diet calculation program (Rio de
      Janeiro, Brazil). Clinical parameters will include: age, sex, BMI, presence of comorbidities,
      use of medications, gastrointestinal complaints, previous surgeries and smoking (absent,
      present, prior). Only after approval by the Research Ethics Committee (CEP) of the Pedro
      Ernesto University Hospital (HUPE-UERJ), will this recruitment begin.
    

Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Obese patients with dysglycemia or not from the Obesity Clinic from UERJ will be invited to
        participate in the study, and individuals with normal or overweight weight with dysglycemia
        or not, preferably from the same social class and type of diet of the obese
Comparative Effect Of Percussive Therapy Device And Manual Myofascial Release Technique
Condition: Hamstring Sprain
Study type: Interventional

Summary: 
      The present study was concerned with the comparison of effect of Theragun PRO and manual
      myofascial release technique to improve Hamstrings Flexibility in healthy Adults. It was
      randomized clinical trial on two groups one got percussion therapy by theragun PRO and other
      got treatment through manual myofascial release technique. The outcome measure was hamstring
      flexibility.
    

Detailed description: 
      Muscular flexibility is an important aspect of normal human function. Limited flexibility has
      been shown to predispose a person to reduce quality of life. Several studies developed
      protocols to improve flexibility of muscles, including manual myofascial release techniques,
      Stretching techniques or Percussive therapy. The studies about the effects of fascia
      relaxation and stretching techniques on flexibility reported that fascia relaxation increased
      flexibility of hamstrings. Many treatments likely combines the elements of a conventional
      massage and vibration therapy.

      There is a lack of scientific evidence as to how and if percussive massage treatment affects
      ROM and muscle strength. To date, there are many studies on effect of percussive therapy on
      different muscle group, but investigators did not find work on hamstring muscle group.
      Therefore, it is aimed to find Comparative effect of Percussive therapy device and manual
      myofascial release technique to improve Hamstrings Flexibility in healthy Adults.

      This was a Randomized clinical trial. Sample was taken through simple random sampling.
      Investigators will perform randomized clinical trial on two groups one got percussion therapy
      by theragun PRO and other got treatment through manual myofascial release technique. The
      outcome measure was hamstring flexibility.
    

Intervention name(s): Percussion therapy; Manual Myofascial Release technique
Intervention type(s): Other; Other
Intervention description(s): Participant lying in prone position on the couch will receive percussion therapy with Theragun PRO using standard ball head at speed of 1750 rpm, for total of 90 seconds, split into 3 sets of 30 seconds with 10 seconds rest.; Manual myofascial release technique for 90 sec continuous.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study of Maca Root for the Treatment of Antidepressant-Induced Sexual Dysfunction in Females
Condition: Antidepressant Induced Sexual Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to find out whether Maca Root is effective for treating sexual
      dysfunction in females that is caused by antidepressant drugs. An additional aim of the study
      is to document the safety and tolerability of maca root, as well as any potential side
      effects that it causes.
    

Detailed description: 
      This is a 12-week, double-blind, placebo-controlled trial comparing maca root (3.0 g/day)
      versus an inactive placebo in female outpatients with SSRI/SNRI-induced sexual dysfunction
      whose depression had remitted with SSRI treatment. Outcome measures include improvement in
      sexual functioning as per the Arizona Sexual Experience Scale (ASEX) and the Massachusetts
      General Hospital Sexual Function Questionnaire (MGH-SFQ).
    

Intervention name(s): Maca Root; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3g/day of Maca Root for 12 weeks.; Placebo provided by research pharmacy daily for 12 weeks.
Other intervention name(s): Lepidium; Inactive placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects were randomized in a double blind manner to maca root or placebo. Improvement in sexual functioning was compared between the two treatment groups.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Antidepressant Induced Sexual Dysfunction; Depression; Sexual Dysfunction
Gemcitabine and Irinotecan in Treating Patients With Metastatic Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Carcinoma, Renal Cell; Kidney Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

      PURPOSE: This phase II trial is studying the side effects and how well giving gemcitabine
      together with irinotecan works in treating patients with metastatic kidney cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the response rate in patients with epithelial (clear or nonclear cell) renal
           cell carcinoma (RCC) treated with gemcitabine hydrochloride and irinotecan
           hydrochloride.

        -  Compare the response in patients with clear cell RCC vs nonclear cell RCC treated with
           this regimen.

        -  Determine the toxicities of this regimen.

      OUTLINE: This is an open-label study.

      Patients receive gemcitabine hydrochloride IV over 30 minutes and irinotecan hydrochloride IV
      over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 6 courses in
      the absence of unacceptable toxicity or disease progression.

      After completion of study treatment, patients are followed every 3 months for 1 year.

      PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
    

Intervention name(s): gemcitabine hydrochloride; irinotecan hydrochloride
Intervention type(s): Drug; Drug
Intervention MeSH terms: Gemcitabine; Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: clear cell renal cell carcinoma; recurrent renal cell cancer; papillary renal cell carcinoma; stage IV renal cell cancer
A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentine Hypersensitivity in a Chinese Population
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of the 0.454 percentage (%)
      weight/weight (w/w) stannous fluoride (SnF2) toothpastes for the relief of dentine
      hypersensitivity (DH) in China.
    

Detailed description: 
      This study will be a single center, randomized, controlled, examiner-blind, 3 treatment arm,
      parallel group design study, stratified by maximum baseline Schiff sensitivity score (of the
      2 selected 'test teeth'), with a treatment period of 12 weeks, to investigate the clinical
      efficacy of a SnF2 toothpaste for the relief of DH in a Chinese population. The SnF2 test
      dentifrice will be compared to commercialized negative and positive control toothpastes.
    

Intervention name(s): Sensodyne Sensitivity & Gum; Crest Cavity Protection Fresh Lime; Sensodyne Repair and Protect
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Sensodyne Sensitivity & Gum toothpaste is containing 0.454% w/w SnF2.; Crest Cavity Protection Fresh Lime is containing 1150 parts per million (ppm) fluoride as Sodium fluoride (NaF).; Sensodyne Repair and Protect toothpaste is containing 5.0% w/w calcium sodium phosphosilicate (CSPS).
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Preoperative Psychological Evaluation as Predictor of Outcomes
Condition: Elective Surgery
Study type: Observational

Summary: 
      Perioperative psychological care is increasingly recognized as an essential part in the
      surgical environment. Previous studies have developed a strategy to evaluate the
      psychological influence after operations and found that postoperative psychological states
      significantly associated with the outcomes of patients. However, preoperative evaluation of
      patients the physicians do thus far is mainly the physical status assessment following the
      scale of American Society of Anesthesiologists (ASA). Whether a full-scale evaluation of
      preoperative psychological status to surgical patients could be a predictor to postoperative
      outcomes or not is not still completely understood. The investigators hypothesized that the
      preoperative psychological assessment would be an important predictor to outcomes.
    


Intervention name(s): ASA scale; Full-scale psychological assessment
Intervention type(s): Other; Other
Intervention description(s): ASA scale evaluation before operation; Full-scale psychological evaluation before operation
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All types of patients undergoing surgical operations
      
Keywords: Psychology; Postoperative outcome; Surgical Operation
Study of EndoBarrier Liner for Treatment of Type 2 Diabetes Study
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The main objective of the study is to demonstrate the safety and efficacy of the
      Gastrointestinal (GI) EndoBarrier in the glycemic control of diabetes in subjects with Type 2
      diabetes.
    


Intervention name(s): EndoBarrier Liner
Intervention type(s): Device
Intervention description(s): 52 week treatment of EnoBarrier Liner
Other intervention name(s): EndoBarrier Gastrointestial Liner; GI Sleeve
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Weight Loss; GI Dynamics; EndoBarrier
Bioequivalence Trial of Alprazolam 0.25 mg Tablets
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to confirm if two formulations of alprazolam (tablets) are
      bioequivalent.

      Test product was Zamoprax® 0.25 mg (GlaxoSmithKline) and reference product Tafil® 0.25 mg
      (Pharmacia & Upjohn). One tablet was the single dosage.

      The study was prospective, open-label, randomized, crossover, single dose, with 02
      treatments, 02 sequences and 02 periods, under fasting conditions.

      The population was composed of 28 healthy volunteers, both genders, adults between 18-50
      years.

      The comparative bioavailability of the two formulations was evaluated based in statistical
      comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations
      in blood.
    


Intervention name(s): Alprazolam 0.25 mg; Alprazolam 0.25 mg
Intervention type(s): Drug; Drug
Intervention description(s): Reference product; Test product
Other intervention name(s): Tafil®; Pharmacia & Upjohn; Zamoprax®; GlaxoSmithKline
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Mexico; Bioequivalence; Alprazolam; Pharmacokinetics