bioihbjkbjnl/mcl2 huggingface dataset:
Motivational Encouragement With Networks (MEN) for Healthy Eating Activity Resting Together (HEART) Health Study
Condition: Physical Activity
Study type: Interventional

Summary: 
      The purpose of this research study is to determine if a health coaching intervention that
      includes exercise, good dietary habits, and good relaxation methods helps overweight men
      improve health and lose weight. The investigator's hope is to enroll 30 men in this research
      study.
    

Detailed description: 
      Health coaching helps patients gain the knowledge, skills, tools and confidence to become
      active participants in their care so that they can reach self-identified health goals. Health
      coaching: 1) provides self-management support, 2) bridges gaps between health professionals
      and patients, 3) helps patients navigate the health care system, 4) offers emotional support,
      and 5) serves as a continuity figure. The intervention will consist of tailored health
      coaching, goal setting, and behavioral contracting for healthy actions to create a supportive
      context for participants that supports health promoting behaviors (HPBs), with efforts to
      enhance HPB reinforcement through established networks. After baseline assessment, the men
      will participate in a 45-minute educational meeting with the principal investigator (PI) to
      discuss self-reported measures from baseline instruments and the importance of health
      promoting behaviors (HPBs) to overall heart health. Afterwards, a research study team
      (research trained undergraduate and graduate student assistants) will perform case management
      and health advisement (bi-weekly continuity phone calls 2x / month) to support protocol
      adherence and tracking of participant goals over a period of 120 days. The research team will
      be guided by a coaching manual created for the purposes of the study. The M for H study will
      also create and provide health-oriented emails (2x / week), daily tracking text messaging on
      weekdays, monthly face-to-face coaching group meetings during community-based organization
      (CBO) set times (i.e. meetings, events), and access to an optional social media platform
      supporting peer interactions. After 120 days, participants will be reassessed to determine
      impacts related physical activity (PA) measures, knowledge, attitudes, & practices (KAPs),
      and interviewed to discuss M for H feasibility and acceptability. The targeted outcome for
      the 120 day period will be improvement toward the performance of >150 minutes of moderate to
      vigorous physical activity accumulated as indicated by accelerometry, increase in distance
      walked during a six (6) minute walk test, and improvement in theoretical construct measures
      indicative of performance of HPBs among participants.
    

Intervention name(s): Health coaching
Intervention type(s): Behavioral
Intervention description(s): Health coaching
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Inflammatory Arthritis and Tango
Condition: Rheumatoid Arthritis (RA); Spondyloarthritis (SA)
MeSH terms: Spondylitis; Arthritis; Spondylarthritis
Study type: Interventional

Summary: 
      The hypothesis is that pleasure brought by argentine tango practice would increase total
      physical activity of patients with chronic inflammatory arthritis.
    

Detailed description: 
      Selection and inclusion of patients will be done by principal investigator of Rheumatology
      Department. After verification of inclusion and non-inclusion criteria by principal
      investigator and signature of consent, patients will be randomized by 1: 1 randomization
      (centralized randomization by statistician into 2 groups at M0). They will participate in
      sessions in a deferred manner due to two per week for each group:

        -  Interventional "A" group: 48 sessions (on average 2/week) performed from M0 to M6 in 30
           patients.

        -  Control "B" group: 24 sessions (on average 2/week) performed from M3 to M6 in 30
           patients.

      Patients of "B" group will be not performing sessions with "A" group patients. Sessions
      lasting about 60 minutes will be proposed from Monday to Friday in a room planned from this
      activity within the CHU. They will be adapted and personalized according to each one.
      Evaluations will be carried out for group 1 (interventional) before the first session of
      tango at M0, before the session at M3 and at the end of the protocol at M6. The same
      evaluations will be carried out for group B (control) at M0, before first session of tango at
      M3 and at the end of the protocol.

      Assessment of pain and stress will be done before and after each session. Final assessment
      will be done at 6 months after randomization. Fitness assessment and tango sessions will be
      conducted by an argentine tango teacher
    

Intervention name(s): Argentine tango
Intervention type(s): Other
Intervention description(s): Argentine tango sessions will consist of:
Body perception and body control: sitting, standing then moving around four axes : space, time, energy, gravity.
Awareness of oneself, of other and music: listening, communication, touch, empathy, kinesthesia, letting go, feeling
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic inflammatory arthritis; argentine tango; physical activity
Egg Yolk and Underlying Metabolisms on Modifying HDL Levels in Individuals With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      This research compare the effects of low carbohydrate intake and consumption of 3 eggs per
      day, and low energy diet on diabetes control and biomarkers of CVD in obese people.
    

Detailed description: 
      This research study examines the effects of changes in weight, metabolism of glucose and
      cholesterol in the blood through diet and behavior modification. The main objective of this
      study was to compare the effects of low carbohydrate intake and consumption of 3 eggs per
      day, and low energy diet on diabetes control and biomarkers of CVD in obese people. In
      addition, HDL quantity and size as well as HDL function was compared between the group who
      ate the whole egg and the group who did not eat the yolk.
    

Intervention name(s): Diet intervention
Intervention type(s): Behavioral
Intervention description(s): Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metabolic syndrome; diabetes; diet; eggs; cholesterol; weight loss
Immediate Effect Of Kinesiological Taping
Condition: Hemiplegia
MeSH terms: Hemiplegia
Study type: Interventional

Summary: 
      In this study, it is aimed to examine the immediate effect of kinesiological taping on
      functionality in hemiplegic patients. 40 hemiplegic patients with a mean age of 63±15 years
      were included to the study. The patients were divided into two groups using the computerized
      randomization method. Kinesiology tape was applied to the 1st group (study group), and a
      patch tape was applied to the 2nd group (control group). The demographic and physical
      characteristics of the people who agreed to participate in the study were recorded. In both
      groups; before taping, right after taping, 45 min. after and 4 days after taping Timed Get Up
      and Go Test (TUG) were administered. Both groups were asked not to remove the tapes at the
      end of the 4th day.
    


Intervention name(s): Immediate Effect Of Kinesiological Taping On Functionality In Hemiplegic Patients
Intervention type(s): Device
Intervention description(s): Kinesiological Taping
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Hemiplegia; Kinesiology taping; Functionality
GERD After Sleeve Gastrectomy
Condition: Morbid Obesity; GERD
MeSH terms: Obesity, Morbid
Study type: Observational

Summary: 
      The main adverse effect is gastroesophageal reflux disease (GERD), with concern on the
      development of Barrett's esophagus and esophageal adenocarcinoma in the long term. However,
      the relationship between SG and GERD is complex. The aim of this study is to systematically
      evaluate all published data existing in the literature to evaluate the effect of sleeve
      gastrectomy on GERD, esophagitis, BE in order to clarify the long-term clinical sequelae of
      this procedure.

      This systematic review was conducted in accordance with the guidelines for Preferred
      Reporting Items for Systematic Review and Meta-analyzes (PRISMA).

      Published studies that contained outcome data for primary sleeve gastrectomy associated with
      the primary and secondary outcomes listed below were included.
    


Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Obese patients underwent to sleeve gastrectomy with GERD symptoms
S0353, Gemcitabine in Treating Patients With Recurrent Bladder Cancer That Has Not Responded to Previous Bacillus Calmette-Guerin
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Giving gemcitabine directly into the bladder may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well gemcitabine works in treating patients with
      recurrent bladder cancer that has progressed despite previous Bacillus Calmette-Guerin (BCG).
    

Detailed description: 
      OBJECTIVES:

        -  Determine the 8-12 week efficacy of intravesical gemcitabine, in terms of complete
           response rate, in patients with recurrent superficial transitional cell carcinoma of the
           bladder that have progressed despite prior intravesical Bacillus Calmette-Guerin (BCG).

        -  Determine the recurrence-free, worsening-free, progression-free, and overall survival of
           patients treated with this drug.

        -  Evaluate the toxicity of this drug in these patients.

        -  Correlate, preliminarily, expression levels of genes or genetic polymorphisms involved
           in the gemcitabine pathway and angiogenesis with clinical toxicity, response, and
           relapse-free survival of patients treated with this drug.

      OUTLINE: This is a multicenter study.

        -  Induction therapy: Patients receive gemcitabine intravesically once a week for 6 weeks
           (weeks 1-6) in the absence of disease progression or unacceptable toxicity. Patients
           achieving a complete response proceed to maintenance therapy at week 14.

        -  Maintenance therapy: Patients receive gemcitabine intravesically once in weeks 14, 18,
           22, 26, 30, 34, 38, 42, 46, and 50 in the absence of disease progression or unacceptable
           toxicity.

      After completion of study treatment, patients are followed every 3 months for 2 years and
      then every 6 months for 3 years.

      PROJECTED ACCRUAL: A total of 25-45 patients will be accrued for this study within 6-12
      months.
    

Intervention name(s): gemcitabine hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent bladder cancer; stage 0 bladder cancer; stage I bladder cancer; transitional cell carcinoma of the bladder
MRI-Targeted Focal Ablation of the Prostate in Men With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      This is a prospective single center trial to examine the rate of negative biopsy result and
      quality of life after focal ablation by radiofrequency energy. The primary evaluation
      involves assessing the rate of negative biopsy result using MR-US fusion biopsy six months
      after focal ablation of the prostate. Urinary and sexual quality of life will be assessed
      through validated measures. The hypothesis of our study is that focal ablative therapy will
      result in a greater likelihood of negative biopsy on followup biopsy than that observed in
      men who elect not to undergo therapy.
    


Intervention name(s): Bipolar Radiofrequency Focal Ablation
Intervention type(s): Procedure
Intervention description(s): Men identified as having suspicious regions on a pre-biopsy mpMRI will be considered for enrollment. Following an MRI-US targeted biopsy of the prostate, men testing positive will be eligible for enrollment. All men enrolled in the study will undergo focal radiofrequency ablation and evaluated in follow-up.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prostate Cancer; Focal Ablation; MRI-US Fusion Biopsy; Focal Therapy
To Demonstrate the Relative Bioavailability of Atenolol Tablets, 100 mg
Condition: Angina; Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability of atenolol tablets, 100 mg.
    


Intervention name(s): Atenolol (Tenormin) 100 mg Tablets Zeneca (Astra Zeneca Pharmaceutical); Atenolol 100 mg Tablets (Geneva Pharmaceutical, Inc.)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atenolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Angina (Chest Pain); Hypertension
Study of Pharmacokinetics and Safety of Apraglutide in Participants With Normal and Impaired Kidney Function.
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      Study of pharmacokinetics and safety of apraglutide in participants with normal and impaired
      kidney function.
    

Detailed description: 
      A two stage design, open label, multi-center, non-randomized trial to evaluate the PK and
      safety of a single subcutaneous dose of 5 mg apraglutide in subjects with varying degrees of
      renal function. The renal function was calculated by the estimated glomerular filtration rate
      (eGFR) according to the Chronic Kidney Disease Epidemiology (CKD-EPI) Creatinine Equation.

      Part 1: 8 subjects with severe renal impairment (Cohort 1) and 8 subjects with normal renal
      function (Cohort 2).

      Part 2: 8 subjects with moderate (Cohort 3) and 8 subjects with mild (Cohort 4). Enrollment
      into Part 2 was conditional on the results of Part 1.
    

Intervention name(s): Apraglutide
Intervention type(s): Drug
Intervention description(s): Single dose of apraglutide 5 mg.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal Function; Renal Impairment; Kidney Function
Effects of Acute L-NMMA Treatment on Renal Hemodynamics and Vasoactive Hormones in Patients With Congestive Heart Failure
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The study tests the hypothesis that nitric oxide availability is changed in congestive heart
      failure with regard to the regulation of renal hemodynamics, renal sodium excretion and
      release of vasoactive hormones. The study tests these hypotheses by comparing the effects of
      systemic nitric oxide inhibition with L-NMMA in congestive heart failure patients with
      healthy subjects on renal hemodynamics, blood pressure and plasma levels of vasoactive
      hormones.
    

Detailed description: 
      The purpose of the study is to investigate the effects of systemic treatment with
      Ng-monomethyl-l-arginine in congestive heart failure and healthy controls on:

        -  glomerular filtration rate and renal plasma flow

        -  blood pressure and heart rate

        -  plasma levels of vasoactive hormones

        -  lithium clearance

      The study is randomized and placebo controlled
    

Intervention name(s): Ng-monomethyl-L-arginine (drug)
Intervention type(s): Drug
Intervention MeSH terms: omega-N-Methylarginine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Keywords: Nitric oxide; Renal hemodynamics
Study Evaluating Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter study to assess the health and well-being in subjects who are
      outpatients with major depressive disorder that take desvenlafaxine succinate sustained
      release (DVS SR) or placebo for 12 weeks.
    


Intervention name(s): desvenlafaxine succinate sustained release; Genotyping
Intervention type(s): Drug; Genetic
Intervention description(s): 50 mg/day oral tablet for 12 weeks; CYP2D6 genotyping at randomization
Other intervention name(s): Pristiq
Intervention MeSH terms: Desvenlafaxine Succinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder
The Psychosocial and Economic Burden of Genital Warts
Condition: Female Genital Warts
MeSH terms: Warts; Condylomata Acuminata; Financial Stress
Study type: Observational

Summary: 
      Considering the importance of HPV(human papilomavirus) and related diseases in Brazil, and
      the lack of studies about both the economic and the psychosocial burden of these diseases,
      BEMFAM, a Brazilian non-governmental organization that provides reproductive health services
      and technical support to local governments proposes a study to measure the psychosocial and
      economic burden of genital warts.
    

Detailed description: 
      Cervical cancer is a public health issue in Brazil. The Cancer National Institute estimates
      that cervical cancer will be the second most incident among women, with 18.430 new cases in
      2010. Human papillomavirus (HPV) is related to cervical cancer and is also responsible for
      benign lesions, such as genital warts.The Brazilian Ministry of Health estimates the
      prevalence of genital warts to be 5,7% among pregnant women and 21,5% among women attending
      sexually transmitted infections treatment clinics.The study will measure the psychosocial
      burden of genital warts using HPV Impact Profile questionnaire and the economic burden of
      genital warts among women attending its six reproductive health clinics.

      There are two study objectives:

      1 - to measure the psychosocial burden of genital warts in women attending six reproductive
      health clinics in Brazil. 2- to measure the economic burden of genital warts treatment for
      women attending six reproductive health clinics in Brazil.

      Hypothesis testing:

      For objective 1, the experiment compare differences on psychosocial burden of Genital Warts
      among subgroups and therefore does not include any formal hypothesis testing about the
      psychosocial burden of the disease in agreement with the extant literature on the subject
      (Xingshu Zhu et al., 2009).

      Objective 2 aims to measure differentials in the economic burden of the disease among
      subgroups with different type of genital warts (newly diagnosed, recurrent and resistant),
      site of the lesion, age, duration of treatment, number of medical visits, type and number of
      medical procedures. No formal hypothesis will be tested.
    

Intervention name(s): women attending reproductive health clinics; medical records
Intervention type(s): Other; Other
Intervention description(s): women visiting BEMFAM´s clinics from January 2012 until Narch 2013 filled a self-administered questionnaire based on psychometric scale developes by Zhu TC et al; medical chart review of patients assisted January 2009 to December 2010
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Reproductive health clinics
      
Keywords: genital warts; HPV; psychosocial burden; economic burden; female genital warts
Botulinum Type A Toxin in the Treatment of Lateral Canthal Lines (Crow's Feet)
Condition: Lateral Canthal Lines
Study type: Interventional
Phase: Phase 2

Summary: 
      Despite the wealth of information in the literature regarding the cosmetic applications of
      botulinum type A toxin (BoNT-A), and the widespread use of the BoNT-A for cosmetic
      applications, the number of randomised, controlled clinical trials is small. Much of the
      published information is based on open-label studies or anecdotal data. Of the robust trial
      data that is available, the vast majority relates to the treatment of glabellar lines, and
      there is little data available regarding the use of BoNT-A in lateral canthal lines. This
      study aims to determine the optimum dose for the use of BoNT-A in this area.
    


Intervention name(s): Botulinum toxin type A
Intervention type(s): Biological
Other intervention name(s): AbobotulinumtoxinA (Dysport®)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: crow's feet; cosmesis; ageing
The Effects of Two Different Home-exercise Programmes on Women Suffering Long Term Neck/Shoulder Muscle Pain
Condition: Neck Pain
MeSH terms: Myalgia; Neck Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the effects of specific neck/shoulder muscle
      exercises on pain, function, biochemistry and psychological factors in women suffering
      chronic neck/shoulder pain.
    


Intervention name(s): Stretching and aerobic exercise; Strength training
Intervention type(s): Other; Other
Intervention description(s): Stretching programme for neck/shoulder muscles three times weekly and aerobic exercise för 30 minutes three times weekly.
Participants kept exercise diaries and physiotherapist provided support over the phone or through e-mail. The intervention lasted one year.; Stretching programme for neck/shoulder muscles three times weekly, aerobic exercise för 30 minutes three times weekly and weight training using dumbbells for the neck/shoulder area and exercises to strengthen core and leg muscles for 45 minutes three times weekly.
Participants kept exercise diaries and physiotherapist provided support over the phone or through e-mail. The intervention lasted one year.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic; neck; shoulder; exercise