bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Supervised Ground Walk Training and Treadmill Walk Training in COPD Patients
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Pulmonary Rehabilitation became a vital part of management in COPD patients in form of
      activity modification, dietary and pharmacological optimisation. But access to traditional
      supervised aerobic (treadmill) walking is debatable fact due to economical and staffing
      expertise in developing countries like India. The investigators designed a randomised
      controlled trial to evaluate the effectiveness of ground based walking over traditional
      treadmill walking in improving quality of life in COPD patients.
    

Detailed description: 
      Background: COPD is increasing mortality and morbidity globally. Pulmonary rehabilitation is
      a promising management in COPD management. Exercise training in form of aerobic (walking,
      cycling) and strength training is an important part of pulmonary rehabilitation. However
      access to traditional supervised exercise programs is questionable debate even in developed
      western countries. Unsupervised ground walk programs are often told by physicians but not
      properly prescribed.

      Objective: To assess whether ground or treadmill walk is better in improving functional
      capacity and quality of life in COPD patients Design: Randomised controlled trial Procedure:
      Two arms 1) supervised ground walk training 2) supervised treadmill walk training. The
      intensity and progression of walk is based on 6 minute walk test. Quality of life will be
      gauged through Chronic respiratory questionnaire and functional capacity through 6 minute
      walk test.

      Statistical analysis: Descriptive analysis for characterisation. Normality though Kolmogorov
      and Variables will be compared through paired and unpaired student t tests
    

Intervention name(s): Ground walk training; Supervised Treadmill Walk training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 3 times a week and 6 weeks; 3 times a week and 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Treadmill training vs ground walk training
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ground walk; treadmill walk; Functional walk capacity; COPD; Quality of Life
Determining Change In Blood Pressure Due to Environment and Loudness
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Determine the effects of environment and sound on initial and average triplicate screening
      blood pressure done according to clinical practice guidelines with an automated device.

      Standardly obtained blood pressures obtained in a noisy, busy, public space will be higher
      than attended blood pressures obtained (1) in the same environment but with earplugs to
      minimize sound and (2) in a quiet, private space without surrounding activity.
    


Intervention name(s): Level of noise and environment (public vs private) while taking blood pressure measurement
Intervention type(s): Other
Intervention description(s): Each participant will have 4 sets of 3 blood pressure measurements taken. The participants will be randomized to the order in which the level of noise in their environment changes and whether they are in a public or private setting prior to each set of measurements.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Analysis of ROM Plus to Detect Rupture of Membranes
Condition: Rupture of Amniotic Membranes
MeSH terms: Rupture
Study type: Observational

Summary: 
      Specific objectives include confirmation: i) that the ROM PLUS consistently and accurately
      diagnoses rupture of membranes (ROM), ii) that the technique can be understood and applied in
      clinical practice, and iii) that the ROM PLUS is easier to use than the conventional method.
    

Detailed description: 
      This study is designed to assess the sensitivity and specificity of ROM PLUS- a rapid, point
      of care, qualitative immunochromatographic test for the detection (in vitro) of amniotic
      fluid in cervico-vaginal secretions of women with suspected rupture of membranes (ROM) during
      pregnancy. The ROM PLUS detects a specific Combo protein present in amniotic fluid of
      pregnant women in all trimesters of pregnancy. This specific protein combo is unique and
      found only in amniotic fluid, therefore can be used as a specific marker for the diagnosis of
      ROM. This biomarker is an isoform of a similar biomarkers called Amni-Sure and ActimProm and
      was recently approved by the FDA for clinical use. Like these protein markers ( AmniSure or
      ActimProm) which have been used to diagnose PROM, this particular protein isoform tested for
      ROM PLUS is in low concentration in other body fluids such as maternal blood, cord blood,
      urine and semen.
    

Intervention name(s): Sterile speculum exam; ROM Plus Exam; Chart Reveiw
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Sterile vaginal speculum exam to include Nitrazine, ferning and pooling observations; Vaginal swab exam for ROM Plus Test; Post delivery blinded chart review by expereienced obstetrician
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy pregnant women between 15 or greater weeks gestation reporting with signs or
        symptoms of rupture of membranes.
      
Keywords: ROM PLUS; conventional clinical tests of rupture of membranes (ROM); speculum exam; visualization of leakage; pooling of amniotic fluid in the posterior fornix; nitrazine testing; ferning
RAC Pilot - The Feasibility and Effectiveness of a Brief Preventive Intervention Following Psychological Trauma
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Post-Traumatic; Psychological Trauma
Study type: Interventional

Summary: 
      The investigators proposed to compare a modified Prolonged Exposure intervention to treatment
      as usual within a hospitalized injured trauma survivor sample, to determine with this
      intervention could prevent the development of PTSD.
    


Intervention name(s): modified Prolonged Exposure; Treatment as usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): May include consult to health psychology and any follow-up deemed appropriate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Parent-Child Early Approaches to Raising Language Skills (PEARLS) Intervention
Condition: Deafness, Bilateral
MeSH terms: Deafness; Hearing Loss, Bilateral
Study type: Interventional

Summary: 
      The purpose of this research study is to develop and evaluate a parent training program,
      which aims to improve language. The study is being conducted to see if teaching parents
      positive parenting techniques and behavior strategies will improve the rate of language
      development in children with cochlear implants when compared to standard speech therapy
      (e.g., auditory-verbal therapy).
    


Intervention name(s): Parent-Child Early Approaches to Raising Language Skills; Standard Care Speech therapy
Intervention type(s): Behavioral; Other
Intervention description(s): The PEARLS intervention will teach parents evidence-based language strategies and sensitive parenting (e.g., warmth, respect for autonomy, linguistic stimulation) to promote language development in young deaf children with cochlear implants (CI).; Families will participate in auditory-verbal therapy, which is the standard speech therapy with children with hearing loss.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: cochlear implants; language development; parenting intervention; maternal sensitivity; facilitative language techniques
Sleeve Gastrectomy With Cruroplasty and Omental Rape for Treatment of Morbid Obesity With Reflux Disease
Condition: Obesity, Morbid; GERD
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      in this study the investigators will test anew technique to mange patients with morbid
      obesity and GERD by doing sleeve gastrectomy plus cruroplasty and omental rape around the
      gastroesophageal junction
    

Detailed description: 
      in this study the patients that have morbid obesity concomitant GERD will managed by sleeve
      gastrectomy plus cruroplasty then stripe from the momentum is fashioned and is raped around
      the gastroesophageal junction
    

Intervention name(s): sleeve gastrectomy+ cruroplasty+ omental rap
Intervention type(s): Procedure
Intervention description(s): sleeve gastrectomy+ cruroplasty+ omental rap
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influence of Rapeseed Proteins on the Postprandial Metabolic Response
Condition: Health, Subjective
Study type: Interventional

Summary: 
      The aim of the study is to investigate the effect of rapeseed proteins on the postprandial
      metabolic response. Therefore, study participants will receive a meal rich in fat and
      carbohydrates with and without rapeseed protein or with soy protein that serves as control.
    

Detailed description: 
      The current study is a monocentric, controlled intervention study that will be conducted as
      cross-over design. Three interventions are planned and participants will be invited to
      consume a test meal with added rapeseed protein isolate, a test meal with added soy protein
      isolate and a test meal without additional protein. The evening before, the subjects will
      receive a standardized dinner. After a 12-hour fasting overnight, a cannula will be placed.
      Blood samples will be taken before and after eating the test meal rich in carbohydrate and
      fat. The test meal consists of pasta with oily tomato sauce with either 25 g of rapeseed
      protein, 25 g of soy protein or no additional protein. A total of 11 blood samples will be
      collected over a period of 6 hours. In the meantime, the blood pressure and pulse will be
      measured repeatedly and information on satiety will be recorded. The interventions will be
      interrupted by a period of, at least, 2 weeks.
    

Intervention name(s): rapeseed or soy protein or no protein
Intervention type(s): Dietary Supplement
Intervention description(s): 25g rapeseed protein in comparison to 25g soy protein or no protein - dosage of 25 g per day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: rapeseed, protein, postprandial, glucose
Generalizability and Spread of an Evidenced-based Fall Prevention Toolkit: Fall TIPS
Condition: Patient Fall
Study type: Observational

Summary: 
      The goal of our project is to evaluate the effectiveness of the Fall TIPS program with regard
      to inpatient falls and fall-related injuries.
    

Detailed description: 
      This study will explore the effectiveness of the Fall TIPS (Tailoring Interventions for
      Patient Safety) program in regard to inpatient falls and fall-related injuries in three large
      hospital systems with different Electronic Medical Records (EMRs). We will collect and
      evaluate data on the perceived effectiveness of the Fall TIPS implementation process along
      with stakeholders' views of the toolkit. We will use an interrupted time series approach for
      evaluation of pre and post-Fall TIPS data related to patient falls and injurious falls. We
      will systematically analyze the costs and benefits of the Fall TIPS program from two
      perspectives: (1) the hospital, and (2) society as a whole. The hospital perspective will
      assist other hospitals in evaluating the decision to invest in implementing and adopting the
      Fall TIPS program, while the societal perspective will be instructive from a public policy
      stance

      By the end of the study, we will produce a set of recommendations to facilitate adoption,
      implementation, and maintenance of the Fall TIPS program, along with a manuscript that will
      answer the following research questions:

        1. Does Fall TIPS reduce the incidence of falls and injurious falls?

        2. Were there differences in Fall TIPS effectiveness among different healthcare systems and
           hospitals as well as variations associated with differing patient characteristics
           (gender, age, ethnic/racial), EMRs, and degrees of adherence with the Fall TIPS
           protocol?

        3. Do the benefits associated with Fall TIPS outweigh the costs from hospital and societal
           perspectives?

        4. What Fall TIPS components were most/least useful and what recommendations will improve
           the overall utility and ease of use of the Fall TIPS Toolkit?

        5. What aspects of the implementation model were most/least helpful for promoting Fall TIPS
           adoption and use?
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population includes all adult patients admitted to medical, surgical, neurology
        and oncology units at participating hospitals during the time of the study. Participating
        hospitals include the Partners Healthcare System, Montefiore Medical Center, and
        NewYork-Presbyterian/Columbia University Medical Center.
      
Keywords: Fall Risk; Patient Falls; Fall Prevention; Patient Safety
Culturally Appropriate Nutrition Communication for Mexican American Women
Condition: Lifestyle Risk Reduction; Nutrition Poor; Chronic Disease; Obesity; Cancer, Breast
MeSH terms: Breast Neoplasms; Malnutrition; Chronic Disease
Study type: Interventional

Summary: 
      A randomized controlled trial to test the effects of culturally appropriate nutrition
      communication for Mexican American women.
    

Detailed description: 
      An unbalanced randomized controlled trial with pre-test and immediate post-test was employed
      to test the effects of different types of message features and appeals. The study was
      conducted online with Mexican American women aged 18-29 years old. Messages focused on sugary
      beverage consumption and the main outcomes were acceptance and receptivity to the message
      (i.e., perceived effectiveness), perceptions of social norms, and knowledge. The
      investigators also measured a number of hypothesized mediators and moderators of the effects.
    

Intervention name(s): Health Communication
Intervention type(s): Other
Intervention description(s): Spoken word poems set to images performed by youth who wrote the poems. Videos were produced by The Bigger Project and were posted publicly to the Bigger Picture Project website and YouTube. Duration of videos ranges from 2 minutes to 6 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: sugar sweetened beverages; Health Communication; Values-based messages; Latinas; Latinx; Hispanic; Experiment; Message testing; tailoring
Drug Interaction Study of Azithromycin and Theophylline
Condition: Chronic Obstructive Pulmonary Disease; Asthma
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Macrolides are potent inhibitors of cytochrome P450 isoenzyme 3A4（CYP3A4）and thus interfere
      with the pharmacokinetics of many other drugs that are metabolised by this enzyme like
      theophylline.The aim of this study is to determine whether azithromycin can effect
      theophylline metabolism in patients.
    

Detailed description: 
      In this non-blinded,auto-control study,patients with Chronic Obstructive Pulmonary
      Disease（COPD）or asthma will serve as their own controls during the 2-week treatment phase.The
      subjects will be co-administered oral doses of sustained release theophylline (100mg
      tablets,twice daily) and azithromycin (2x250mg capsules,once daily )in the first week.Then
      patients will received theophylline therapy alone with the same dose in the second week.Blood
      samples for the measurement of theophylline plasma concentrations will be collected on Days 8
      and 15 prior to dosing.All adverse events whether elicited by query, spontaneously reported
      or observed by clinic staff will be evaluated by the investigator and reported in the
      subject's case report form.
    

Intervention name(s): Theophylline with azithromycin; Theophylline alone
Intervention type(s): Drug; Drug
Intervention description(s): Drug: Theophylline(100mg,sustained release tablets). Multi-dose of theophylline(100mg,twice daily) will administered at 8 am and 8 pm from day 1 to day 7.
Drug:Azithromycin(250mg, capsules). Multi-dose of azithromycin(500mg,once daily) will administered at 8 pm from day 1 to day 7.; Drug: Theophylline(100mg,sustained release tablet). Multi-dose of theophylline(100mg,twice daily) will administered at 8 am and 8 pm from day 8 to day 14.
Intervention MeSH terms: Azithromycin; Theophylline
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: azithromycin; theophylline; CYP3A4
A Two-stage Translation of the Chinese Version Menstrual Distress Questionnaire
Condition: Non-disease State
Study type: Observational

Summary: 
      This study attempted to do the two-stage design of the translation of the MDQC (Menstrual
      Distress Questionnaire Form C-Cycle) Chinese version, and to do the validity and reliability
      test.
    

Detailed description: 
      Premenstrual syndrome is defined as recurrent moderate physical, psychological, behavior
      symptoms that occur during the luteal phase of menses and resolve with menstruation. It
      affects 20 to 32 percent of premenopausal women.

      A diagnosis of PMS consists of determining the timing of the symptoms in relation to menses,
      meaningful change between post- and premenstrual symptom severity, and a clinically
      significant severity of the symptoms. The ICD-10 requires only one distressing symptom for a
      diagnosis of PMS. The American College of Obstetricians and Gynecologists (ACOG) diagnosis is
      that it occurs 5 days before menses and remit within 4 days of onset of menses no recurrence
      at least until day 13 of the cycle. A differential diagnosis to distinguish PMS from other
      medical and psychiatric conditions is important for appropriate treatment. No hormone or
      laboratory test indicates a PMS diagnosis. The current diagnostic standard requires
      confirmation of subjective symptom reports by prospective daily diaries. The Menstrual
      Distress Questionnaire (MDQ) is a method for measuring perimenstrual symptoms. It is a
      46-item self-report inventory for use in the assessment of physical or psychological symptoms
      that occur in the premenstrual, menstrual, or intermenstrual phases. There are two forms of
      the MDQ: form C (Cycle) and form T (Today). Form C of the MDQ is designed for screening.
      Women use this form to describe their symptoms and reactions during each of the three phases
      of their most recent menstrual cycle. It may be administered at any time during the cycle.
      Form T is designed for treatment evaluation, and research application.

      This study attempted to do the two-stage design of the translation of the MDQ (Form C-Cycle).
      Previous studies have translated only 14 items of the MDQ (Form C - Cycle) and only done the
      internal reliability test. This study is expected to do a two-stage translation of the MDQ
      (Form C - Cycle) Chinese version, and to do the reliability and validity test.
    

Intervention name(s): questionnaire
Intervention type(s): Other
Intervention description(s): Filling the menstrual distress questionnaire, short-form McGill pain questionnaire, present pain index, visual analog scale
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy females aged 20-40 years with regular and predictable menstrual cycles, fluent in
        speaking, reading, and writing Chinese in Taiwan
      
Keywords: Menstrual Distress Questionnaire, Two-Stage Translation
Study of Metabolic Modifications in Children With Noonan Syndrome
Condition: Child Syndrome
MeSH terms: Noonan Syndrome; Syndrome
Study type: Interventional

Summary: 
      Noonan syndrome (NS) is a rare genetic disease (incidence 1/2500 live births) characterized
      by the association of craniofacial manifestations, cardiopathies, short stature, and tumor
      predisposition. The genetic causes of Noonan Syndrome are mutations of genes involved in the
      Ras/Mitogen-Activated Protein Kinases (MAPK) pathway, mainly the gene encoding the tyrosine
      phosphatase Shp2 (50% of patients).Shp2 appears to be involved in many facets of energy
      metabolism control (glucose homeostasis, adipose tissue function…), through mechanisms that
      are poorly understood. Several metabolic anomalies (reduced adiposity, improved glucose
      tolerance) have been recently identified in an original mouse model carrying Shp2 mutation.
      Moreover, recent clinical survey has shown that adult Noonan Syndrome patients are protected
      from developping overweight and obesity when compared to the general population. However, the
      metabolic status associated with Noonan Syndrome condition has not been explored to date.
    

Detailed description: 
      Differential hormone sensitivity is associated with Noonan Syndrome and participates in the
      development of some symptoms. The investigators have demonstrated that MAPK upregulation in
      Noonan Syndrome is responsible for partial growth hormone (GH) insensitivity, and subsequent
      growth retardation.

      Clinical traits evocative of energy metabolism dysfunctions have been recently reported in
      Noonan Syndrome patients, although the origins and consequences of these metabolic changes
      have not been documented to date. The aim of this study is to explore the metabolic status of
      children with Noonan Syndrome.

      Children with Noonan Syndrome will be compared with age- and sex-matched healthy children.
      The investigators hypothesize than Noonan Syndrome children have an increased insulin
      sensitivity compared to GHD children.

      Study parameters will be collected including: clinical measurements (height, weight, body
      mass index, waist circumference, and blood pressure), glucose and insulin levels at baseline
      and after an oral glucose tolerance test (OGTT), body composition measured by dual-energy
      x-ray absorptiometry (DXA).

      The study will include only one visit.
    

Intervention name(s): Oral Glucose tolerance test
Intervention type(s): Other
Intervention description(s): Oral glucose tolerance test (OGTT): glucose and insulin levels will be measured at time points 0, 90 and 120 min or 30, 60, 90 and 120 after 1.75 g/Kg (max 75 g) glucose administration depending of the patient weight.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Insulin sensitivity; Metabolism; Noonan syndrome; Shp2