bioihbjkbjnl/mcl2 huggingface dataset:
Telenutrition Weight Loss Study for Men
Condition: Obesity; Weight Loss; Men
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      This study is a 12-week pilot randomized controlled trial to test the feasibility and
      effectiveness of a home telenutrition weight loss program in men in West Virginia.
    

Detailed description: 
      This study is a 12-week pilot randomized controlled trial of a home telenutrition weight loss
      program for men with obesity and at least one additional risk factor for cardiovascular
      disease. The primary aims are to:

        1. To assess the feasibility and acceptability of the male-targeted telenutrition weight
           loss program in terms of recruitment, retention and satisfaction and

        2. To evaluate the effectiveness of the telenutrition program compared to usual care
           (informational only) with regard to primary and secondary outcome measures at 12 weeks.
           We hypothesized that men receiving virtual and telephonic support from a registered
           dietitian nutritionist would have greater weight loss and greater improvements in diet
           quality than men who were only provided educational materials.
    

Intervention name(s): Registered Dietitian Nutritionist (RDN) Support; Diet-related educational materials; Self-monitoring tools
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): RDN provided individualized medical nutrition therapy via videoconference at weeks 1, 5, and 9 and telephonic nutrition coaching support at weeks 2-4, 6-8, and 10-12.; Individualized caloric recommendations (500-750 kcal reduction) were made and food-based educational materials emphasizing general healthful eating patterns and increased intakes of nutrient-rich foods were provided.; Self-monitoring tools including: weekly weight log, fruit and vegetable tracker, and a SMART (specific, measurable, achievable, relevant, and time bound) goal planner were provided.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Telehealth; Weight loss; Diet quality; Behavioral counseling
Sucralose, Stevia, Gut Microbiome and Glucose Metabolism
Condition: Impaired Glucose Tolerance
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      This study will determine the influence of two non-caloric sweeteners on glucose metabolism
      via the gut microbiome in adult men and women.
    

Detailed description: 
      This study will determine the influence of two non-caloric sweeteners on glucose metabolism
      via the gut microbiome in adult men and women aged 35-55 years.
    

Intervention name(s): Sucralose; Stevia
Intervention type(s): Other; Other
Intervention description(s): Sweetner; Sweetner
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples
Condition: HIV-1 Infections; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized, blinded, placebo-controlled trial to demonstrate if pre-exposure prophylaxis
      decreases HIV-1 acquisition among HIV-1 uninfected individuals within HIV-1 discordant
      couples.
    

Detailed description: 
      HIV-1 uninfected individuals within HIV-1 discordant partnerships are at high-risk for
      HIV-acquisition. The majority of HIV-1 transmissions to adults in Africa occur within stable,
      HIV-1 discordant couples.

      Pre-exposure chemoprophylaxis, in which an HIV-1 uninfected individual at high risk for
      contracting HIV-1 takes antiretroviral medications to maintain blood and genital drug levels
      sufficient to prevent HIV-1 acquisition, has been proposed as a potential HIV-1 prevention
      strategy.

      This study was a randomized, blinded, placebo-controlled trial to demonstrate if pre-exposure
      prophylaxis decreases HIV-1 acquisition among HIV-1 uninfected individuals within HIV-1
      discordant couples. The HIV-1 uninfected partner was randomized in a 1:1:1 ratio to one of
      three arms: once daily Tenofovir Disoproxil Fumarate (TDF), Emtricitabine/Tenofovir
      Disoproxil Fumarate (FTC/TDF) or Placebo.

      Couples were followed up to 36 months; the HIV uninfected partner attended monthly visits and
      the HIV infected partner quarterly visits. All participants received a comprehensive package
      of HIV prevention services including individual and couples counseling, free condoms, and
      male circumcision referrals.

      Participants who seroconverted during follow-up stopped the study drug but continued with
      follow-up.
    

Intervention name(s): Tenofovir Disoproxil Fumarate (TDF); Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.; FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily; Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
Other intervention name(s): Viread + Placebo Truvada; Truvada + Placebo Viread; Placebo + Placebo
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV infection; HIV uninfected partners; Double Blind; Placebo; Seroconversion; TDF; FTC TDF; Safety; HIV Seronegativity
The Study of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer
Condition: THE Efficacy and Safety of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      assess the efficacy and safety of gemcitabine in the maintenance treatment of advanced
      non-small cell lung cancer
    


Intervention name(s): gemcitabine
Intervention type(s): Drug
Intervention description(s): gemcitabine，1000mg/m2，ivgtt，DAY1&DAY8
Intervention MeSH terms: Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Thoracic And Lumbar Burst Fracture: Correlation Between Structural Changes And Clinical Outcome Of Treatment
Condition: Traumatic Burst Fractures of the Thoracic or Lumbar Spine.; Normal Neurological Function
MeSH terms: Fractures, Bone
Study type: Observational

Summary: 
      Evaluate the correlation between the structural changes of fractures of the thoracic and
      lumbar spine burst type with clinical outcome of the treatment.
    

Detailed description: 
      The treatment of burst fractures of the thoracic and lumbar spine is still a subject of much
      discussion and debate in the literature, especially in patients without neurological deficit.
      Most authors recommend surgical treatment for patients whose fracture shows signs of
      instability: 50% loss of vertebral body height, kyphosis with more than 30 degrees,
      involvement of more than 50% of the spinal canal. The authors advocate that this type of
      treatment uses the shorter hospital stay, early patient mobility, better kyphosis correction,
      the possibility of spinal canal decompression and prevention of neurological deterioration,
      as arguments in its favor.However, observational studies in patients without neurological
      deficit, showed no difference in long-term functional outcomes in patients with this type of
      injury, regardless of the type of treatment used (surgical or conservative). This study will
      express the clinical results and morphological changes of the thoracic and lumbar spine, at a
      minimum follow-up of 24 months, comparing the findings of the patients undergoing surgical
      treatment with those found in undergoing conservative treatment.
    

Intervention name(s): Arthrodesis; Brace
Intervention type(s): Procedure; Device
Intervention description(s): Posterior approach to toracolumbar spine fusion.; Toracolumbar imobilization
Other intervention name(s): PLIF; TLIF; Jewett; Putti
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Surgical treatment Group: 14 samples Conservative Treatment Group: 11 samples
      
Keywords: vertebra; column; lumbar; toracica; fracture; burst
Safety of Maraviroc for Post-stroke Depression
Condition: Post-stroke Depression
MeSH terms: Stroke; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Post-stroke depression (PSD) is a barrier to effective rehabilitation and recovery after
      stroke. Current treatment options are limited and there is an unmet need for specific and
      effective therapeutic options.

      Objective: To examine the safety and efficacy of Maraviroc, a CCR5 antagonist, as a possible
      add-on treatment option for PSD, in an open-labeled proof-of-concept clinical trial.

      Design, Setting, and Participants: A 10-week trial of daily oral 300 mg Maraviroc in ten
      patients with subcortical stroke suffering from PSD. Follow-up: eight weeks after completing
      treatment.

      Main Outcome Measure: A change in the Montgomery-Asberg Depression Rating Scale (MADRS).
    


Intervention name(s): Maraviroc 300 mg
Intervention type(s): Drug
Intervention description(s): 10 week treatment as add-on therapy to anti-depressants
Intervention MeSH terms: Maraviroc
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluating Post-test HIV Counseling Videos for Teens
Condition: HIV; HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      The design of this randomized controlled trial (RCT) is to test the effectiveness of a
      post-test behavioral video in educating adolescents about HIV transmission and affecting
      their intentions to engage in risk-reduction behavior.
    

Detailed description: 
      Adolescents are at risk for HIV because of their engagement in high risk sexual activity.
      This study seeks to determine effective ways to educate teens about HIV and how to protect
      themselves by use of multimedia. All eligible participants who agree to enroll in this trial
      will be randomized into two arms: the behavioral intervention video (intervention group) or
      meeting with an in-person counselor (control group) as they wait for their rapid HIV results.
      The goals of the RCT involve establishing the feasibility of using touch-screen technology
      for teenagers in the ED; establishing the receptivity of teens to HIV rapid testing in the
      ED; providing data on rates, and obtaining preliminary data on the effectiveness of the video
      in changing condom efficacy, condom outcome expectancies and condom use intention. Consenting
      to rapid HIV testing is a secondary outcome.
    

Intervention name(s): Video
Intervention type(s): Behavioral
Intervention description(s): Behavioral Intervention Video
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: HIV; Teenagers; Adolescent; HIV Testing; HIV Seronegativity
Study of the Pathogenesis and Pathophysiology of Familial Neurohypophyseal Diabetes Insipidus
Condition: Diabetes Insipidus; Diabetes Insipidus, Neurohypophyseal
MeSH terms: Diabetes Insipidus; Diabetes Insipidus, Neurogenic; Diabetes Mellitus
Study type: Observational

Summary: 
      OBJECTIVES: I. Determine whether diverse mutations of the vasopressin-neurophysin II
      (AVP-NPII) gene cause autosomal dominant familial neurohypophyseal diabetes insipidus by
      directing the production of an abnormal preprohormone.

      II. Determine whether the AVP-NPII gene-directed preprohormone accumulates and destroys
      magnocellular neurons because it cannot be folded and processed efficiently.
    

Detailed description: 
      PROTOCOL OUTLINE: This project involves 2 clinical studies. Members of known kindreds
      participate in Study I; members of kindreds who have not been surveyed, genotyped, or
      phenotyped participate in Study II.

      In Study I, participants undergo clinical, hormonal, radiologic, and biochemical studies.
      Assessment on unrestricted fluid intake includes body weight, urine volume, osmolality,
      creatinine, sodium, potassium, urea, glucose, arginine-vasopressin (AVP), oxytocin, and
      aquaporin-II.

      Participants with diabetes insipidus (DI) undergo a standard fluid deprivation test; those
      without DI undergo standard water load and hypertonic saline testing.

      Previously untreated DI patients may be given intranasal or subcutaneous desmopressin or oral
      chlorpropamide (adults only) for 2 or 3 days.

      Magnetic resonance imaging of the pituitary-hypothalamic area is performed on all patients
      with and without gadolinium.

      Infants and children are studied annually for the first 5 years or until they develop DI.
      Affected adults are studied every 2-5 years. Unaffected adults are re-tested only if they
      subsequently report de novo symptoms suggestive of DI.

      In Study II, participants undergo similar genotype and phenotype testing. Kindreds
      demonstrating the familial neurohypophyseal diabetes insipidus phenotype and genotype are
      added to Study I. Kindreds found to have a different type of DI are directed into a companion
      protocol.
    

Intervention name(s): chlorpropamide; desmopressin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Chlorpropamide; Deamino Arginine Vasopressin
Keywords: diabetes insipidus; endocrine disorders; rare disease
Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if an investigational treatment is effective in
      improving the total score on the ADHD-RS-IV Preschool Version in children 4-5 years old
      diagnosed with ADHD.
    


Intervention name(s): Placebo; SPD489 (Lisdexamfetamine dimesylate); SPD489
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo matching to SPD489 (Lisdexamfetamine dimesylate) capsule for 6 weeks.; SPD489 capsule in a 5:5:5:5:6 ratio to 5, 10, 20, 30 mg orally once daily for 6 weeks.; SPD489
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: SPD489; Lisdexamfetamine dimesylate; ADHD; hyperactivity; Neurobehavioral disorder
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Repeat Doses of GSK2330672 Administration in Subjects With Primary Biliary Cirrhosis (PBC) and Symptoms of Pruritus
Condition: Cholestasis, Intrahepatic
MeSH terms: Cholestasis; Liver Cirrhosis, Biliary; Cholestasis, Intrahepatic; Pruritus; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a randomized, double-blind, placebo-controlled study to assess safety and
      tolerability of GSK2330672 administration in subjects with primary biliary cirrhosis (PBC)
      and symptoms of pruritus. It is a double-blind, crossover study with subjects receiving
      placebo or GSK23306772 in random order during two 14-day treatment periods. Additionally, the
      study will determine GSK2330672 exposure and interactions with ursodeoxycholic acid (UDCA).
      The total duration of subject participation will be 14 weeks for screening (45 days) and the
      treatment period. Subjects who are eligible for enrolment will participate in a 2-week
      placebo run-in period. Subjects will be randomized in a crossover fashion (Sequence 1 /
      Sequence 2) to receive placebo or GSK2330672 treatment during two consecutive 2-week study
      periods. Subjects will then participate in a 2-week placebo dosing follow-up period ending in
      final follow-up assessments. Study results will be utilized to form a benefit: risk profile
      for GSK2330672 in PBC that will determine plans for progression to exploratory efficacy
      trials
    


Intervention name(s): GSK2330672; Placebo; Ursodeoxycholic acid
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK2330672 oral preserved solution 1.5mg/g will be supplied in amber glass bottles and as per randomization schedule subject will receive 45 mg BID from Day 1 to 3 and 90 mg BID from Day 4 to 14 of one of the two treatment periods.; Placebo oral preserved solution will be supplied in amber glass bottles and as per randomization schedule subject will receive placebo BID from Day 1 to 14 of one of the two treatment periods. .; UDCA 250 mg will be supplied in capsule form. The subjects, who are taking UDCA at the time of Run-in-period, will be continued on the same total daily dose of drug but converted to a standardized formulation and a standardized dosing regimen administering the entire daily dose once daily in the evening before bedtime. Once daily dosing of UDCA will continue for the duration of the study.
Intervention MeSH terms: Ursodeoxycholic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Intestinal bile acid transport inhibitor; Pruritus; Primary biliary cirrhosis; Ursodeoxycholic acid; GSK2330672; Pharmacokinetics
Surgical Treatment of Early Stage Glotto-supraglottic Laryngeal Cancer Via Transoral Resection With Robotic Assistance
Condition: Laryngeal Neoplasms
MeSH terms: Laryngeal Neoplasms
Study type: Observational

Summary: 
      The main objective of this study is to determine the rate of healthy surgical margins after
      tumor resection in transoral robot-assisted surgery for glottic and/or supraglottic early
      stage (T1-T2) laryngeal cancer.
    


Intervention name(s): Transoral robot-assisted tumor resection using the da Vinci robot
Intervention type(s): Procedure
Intervention description(s): Transoral robot-assisted tumor resection using the da Vinci robot
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study is aimed at all patients with early stage (T1 or T2) glottic and / or
        supraglottic squamous cell carcinoma of the larynx, whatever their status and cervical
        lymph nodes without distant metastases (M0) and for whom endoscopic surgical treatment with
        robotic assistance is indicated following a multidisciplinary meeting.
      
Keywords: da Vinci surgical robot; laryngeal cancer
Effects of Exercise Training on Functional Physical Fitness, Balance and Walking in the Community-dwelling Older Adults
Condition: Exercise
Study type: Interventional

Summary: 
      This study aimed to determine whether a 12-week combined exercise intervention program with
      extra emphasis on balance, muscle strength, and walking ability was designed to improve
      functional fitness, balance, walking speed in community-dwelling older people.
    

Detailed description: 
      1. Written informed consent must be obtained before any study specific procedures are
      undertaken.

      2. The process of the experiment (brief describe)

        1. The 30 participants of the experimental group will be recruited from the "community
           eldercare service" activities, and this group will receive a 12-week combined exercise
           intervention program with extra emphasis on balance, muscle strength, and walking
           ability. The other 30 community-dwelling older people of the comparison group who have
           been involved in a other regular exercise style will not receive our exercise
           intervention. The comparison group only receives 2 times measurement at an interval of
           12 weeks.

        2. Subjects completed medical histories, exercise histories, and information on lifestyles
           by questionnaire and physical examination before participation in the study to ensure
           they were free from exclusion criteria. The baseline measurements will be conducted
           before the exercise intervention.

        3. The experimental group will receive a 12-week combined exercise intervention program
           with extra emphasis on balance, muscle strength, and walking ability which involved two
           2-hour sessions per week. The exercise program contained aerobic exercises, activities
           of balance, coordination exercises, strength training, and walking training.

        4. After 12 weeks group exercise, the experimental group will receive the second
           measurements.
    

Intervention name(s): exercise intervention program
Intervention type(s): Behavioral
Intervention description(s): The experimental group will receive a 12-week combined exercise intervention program with extra emphasis on balance, muscle strength, and walking ability which involved two 2-hour sessions once per week.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other