bioihbjkbjnl/mcl2 huggingface dataset:
Farms, Animals and Adolescents: Reinforcing the Microbiome
Condition: Healthy
Study type: Observational

Summary: 
      This study will be an observational study of children who attend summer camp at the Heartland
      Farm Sanctuary (HFS). The investigators are exploring whether time-limited exposure to a
      traditional farming environment will improve children's overall health and general
      well-being.
    

Detailed description: 
      The overarching hypothesis for this study is that urban children exposed on a time-limited
      basis to a traditional farming environment will show increased beneficial bacteria in the gut
      microbiome and enhanced emotional well-being. Secondary hypotheses are that 1) increased
      presence of farm-derived immunoregulatory micro-organisms in the nose (indicating exposure)
      will be associated with measures of emotional well-being and prosocial behavior. To test
      these hypotheses, 40 urban children ages 7-13 years will be studied prior to and following a
      1, 2, or 3-week camp experience at the Heartland Farm Sanctuary summer camp program in
      Verona, WI. Assessments for behavior (via questionnaires), gut microbiota composition and
      function (via stool) and presence in the body of farm-derived immunoregulatory
      micro-organisms (via nasal swab) will be assessed at baseline (2 weeks before the start of
      camp and the weekend before camp starts), immediately following the child's 1, 2, or 3-week
      camp experience and at 1 month following completion of the camp experience. Importantly, this
      assessment schedule will allow the investigators to assess the longevity of any observed
      physical or behavioral changes induced by exposure to the farming environment.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will enroll up to 40 children ages 7-13 who attend either 1, 2, or 3 weeks of
        camp at Heartland Farm Sanctuary. In addition, parents whose children participate in the
        study will be asked to answer questionnaires about their child.
      
Keywords: Farming environment
Assess the Efficacy and Safety in Volunteers of DCF100, TIB200 and SPR300 vs. Placebo and Control(s) in a UV Pain Model
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomised, double blind, cross over clinical study in healthy human volunteers
      (including pharmacokinetic [PK] sampling and laser Doppler assessment of local blood flow in
      a subset of up to 6 subjects per cohort of 20) to assess the efficacy and safety of three
      different topical analgesics (DCF100, TIB200 and SPR300) versus placebo and active control(s)
      in a model of UV-induced inflammatory pain.
    

Detailed description: 
      This is a randomised, double blind, cross over clinical study in healthy human volunteers,
      including pharmacokinetic (PK) sampling and laser Doppler assessment of local blood flow in a
      subset of up to 6 subjects per cohort, to assess the efficacy and safety of three different
      topical analgesics (DCF100, TIB200 and SPR300) versus placebo and active control(s) in a
      model of UV-induced inflammatory pain. The study will consist of 3 cohorts of subjects (n=20
      subjects per cohort). Subjects of each cohort will receive test and reference products (no
      reference product for Cohort 3) of one investigational medicinal product (IMP) and a placebo.

      Test Products:

      Cohort 1: Ibuprofen, TIB200 gel (10%, w/w) Cohort 2: Diclofenac, DCF100 gel (2% or 4%, w/w)
      Cohort 3: Methyl-salicylate and Menthol, SPR300 gel (15%:7%, w/w; ratio of Methylsalicylate
      to Menthol)

      Reference Products:

      Cohort 1: Ibuprofen, Nurofen Max Strength gel (10%, w/w), Ibuprofen, Nurofen, oral tablet
      (400 mg) Cohort 2: Voltaren Emulgel (2%), Voltarol oral tablet (50 mg)

      Placebo:

      All Cohorts:Test product matching vehicle gel.

      Pharmacodynamic tests and PK blood draws will be performed at: pre-dose, 1, 2, 4, and 6 hours
      post dose for all treatment cohorts and treatment days (PK blood sampling in up to 6 subjects
      per cohort only).

      Safety will be evaluated by the incidence of local and systemic treatment-emergent adverse
      events (TEAEs) reported after each treatment. Safety assessments will also include vital
      signs, 12-Lead Electrocardiograms (ECGs), laboratory tests and a physical examination at
      Screening and the Follow-up visit.
    

Intervention name(s): Ibuprofen; Diclofenac; Methyl-salicylate / Menthol; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): TIB200 gel 10%, Nurofen gel 10%, Nurofen tablets; DCF100 gel 2%, DCF100 gel 4%, Voltaren gel 2%, Voltaren oral tablet; SPR300 gel (15%/7%); TIB200 placebo gel, DCF100 placebo gel and SPR300 placebo gel
Intervention MeSH terms: Ibuprofen; Diclofenac; Salicylates; Methyl salicylate; Menthol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: UVB Pain Model; PK; Topical; NSAIDs
Outcomes of a Deep Inferior Epigastric Perforator Flap Program
Condition: Breast Cancer
Study type: Observational

Summary: 
      The purpose of this study is to analyze an institution's experience with starting a
      subspecialized DIEP flap program.
    

Detailed description: 
      The purpose of this study is to analyze an institution's experience with starting a
      subspecialized DIEP flap program and to determine whether other hospitals would benefit from
      instituting a similar program. Prior studies have compared the outcome from a DIEP flap
      program with that of TRAM flaps within the same center. Other studies have calculated the
      cost of a DIEP flap and its complication rate. However, no one has examined the overall
      effects of a subspecialized reconstruction program and its impact on a health center. In this
      study, we will determine if the institutionalization of a DIEP flap program has increased our
      center's rate of breast reconstruction, as well as evaluate its outcomes and overall
      financial viability.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All women who have undergone mastectomy for breast cancer between 1999 and 2008 at the
        BIDMC.
      
Keywords: breast reconstruction; DIEP flap
A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.
Condition: Meningococcal Vaccine
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a
      0-,6- month schedule. This trial is also studying safety and immunogenicity of a
      meningococcal pentavalent vaccine.
    


Intervention name(s): MenABCWY; Saline; rLP2086; MenACWY-CRM
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): N meningitidis group A, B, C, W, and Y vaccine; Placebo; Bivalent recombinant lipoprotein 2086 vaccine; meningococcal group A, C, W-135, and Y conjugate vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effects of Hipopressive Exercises in Nonspecific Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Introduction Non-specific low back pain is very prevalent in our society. Different effective
      physiotherapy treatments have been performed in the reduction of pain and improvement of
      quality of life, however there are few studies that exist on the effectiveness of these
      treatments in protocol format based on manual therapy. On the other hand, there are no
      studies that implement a protocol of therapeutic exercises called abdominal hypopressives.

      The aim of the study is to study the effect of a manual therapy protocol on non-specific low
      back pain and the implementation of hypopressive exercises in different areas such as
      disability, pain, flexibility and quality of life.

      Material and methods

      Participants The sample will consist of subjects with non-specific low back pain. Inclusion
      criteria

      -Participants with nonspecific lumbar pain of at least 4 pain crises a month with recurrent
      low back pain.

      Exclusion criteria

        -  Light acute.

        -  Lumbalgia after trauma.

        -  Presenting sciatica or musculoskeletal disorders or injuries within three months prior
           to the study.

        -  Contraindication of one of the two treatments.

        -  Participate in this period of no functional recovery program or physiotherapy treatment.

      Study design A randomized clinical trial will be conducted. The sample will be divided into 2
      groups: Group 1 will receive a manual therapy protocol that has previously shown its
      effectiveness in non-specific low back pain being 1 session a week, while group 2 will
      receive a protocol of hypopressive therapeutic exercises.

      Evaluations

      At the beginning of the study, a clinical interview will be carried out and, in addition, 3
      evaluations will be carried out: at the beginning, at the end of the treatment and one
      follow-up per month. The investigators will use the following evaluation tools:

        -  Pain, through the Visual Analog Scale.

        -  Oswestry Low Back Pain Disability Scale.

        -  SF-36 quality of life scale.

        -  Visual Analog Scale.

        -  Algometry of spinous processes and lumbar muscles.

        -  Lumbar flexion with inclinometer and fingers test - floor.

        -  Perception of change after treatment.
    


Intervention name(s): Manual Therapy; Hypopressive exercises
Intervention type(s): Other; Other
Intervention description(s): Articulation technique L4-S1
Lumbar neuromuscular technique
Fascial technique of crossed hands
Posteroanterior mobilizations of the lumbar vertebrae; Protocol 5 Hypopressive exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: low back pain; manual therapy; hypopressive therapeutic exercises
Early Identification of Clinical Deterioration Using a Wearable Monitoring Device
Condition: Clinical Deterioration; Hemodynamic Instability
MeSH terms: Clinical Deterioration
Study type: Observational

Summary: 
      This study aims to provide myriad of physiological parameters in patients admitted in an
      internal medicine department, and which are defined as being in an increased risk of clinical
      deterioration within the first 72-hours after admission. The investigators will also conduct
      a retrospective comparison between physiological changes in patients who did deteriorate to
      those who did not. This will form the basis for the development of an algorithm for early
      prediction and warning of physiological and clinical deterioration during the first 72-hours
      of admission.
    


Intervention name(s): non-invasive monitoring
Intervention type(s): Device
Intervention description(s): Prospective monitoring with retrospective big-data analysis
Other intervention name(s): BB-613PW
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and female patients 18 years and older admitted to the internal medicine department
        and are at high-risk for clinical deterioration during the first 72-hours after admission.
        The investigators anticipate it will include patients with acute and chronic
        cardio-respiratory disease, systemic infections, etc.
      
Keywords: vital signs; clinical deterioration; early prediction; non-invasive monitoring
The Effect of Small Changes in Hydration on Cognition
Condition: Cognition; Hydration
Study type: Interventional

Summary: 
      The aim of this study is to determine whether drinking plain water when mildly dehydrated
      benefits cognitive performance and mood. Volunteers undergo a dehydration protocol designed
      to result in minor dehydration. While some participants receive two 150ml drinks of water
      others do not. Differences in cognitive functioning are assessed.
    

Detailed description: 
      As an essential nutrient, an inadequate intake of water has negative consequences: without a
      source of water death will occur in days. When Benton and Young (2015) reviewed the topic
      they concluded that in healthy adults, mild dehydration (in the range of a loss of 2% body
      mass) had been found to adversely influence mood and cognition. However, it is unclear at
      what degree of hypohydration these effects begin to emerge.

      This study was designed to determine whether small changes in hydration, of the level that
      might occur on a day to day basis, influence cognition and mood. During a dehydration
      protocol (sitting in a room heated to 30 degrees for four hours) young adult participants
      receive either drink two 150ml cups of water or nothing. Effects on memory, attention and
      mood are monitored.
    

Intervention name(s): Water
Intervention type(s): Dietary Supplement
Intervention description(s): Participants will receive two cups of 150ml plain water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
The Postprandial Calcium Absorption of a Milk Derived Calcium Permeate - RENEW Acute Study
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      This is a randomized controlled cross-over meal study with the overall aim to investigate the
      postprandial calcium absorption from calcium permeate compared with calcium carbonate. The
      hypothesis is that the bioavailability of calcium permeate is equal to or higher than calcium
      carbonate. This will be investigated in a cross-over design with 10 postmenopausal women age
      50-65 as subjects.
    


Intervention name(s): Calcium Carbonate; Calcium Permeate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects receive a single-dose of 800 mg calcium as calcium carbonate provided in 6 capsules with a standardized breakfast served in the morning.; Subjects receive a single-dose of 800 mg milk calcium as calcium permeate provided in 6 capsules with a standardized breakfast served in the morning.; Subjects receive a single-dose of 0 mg calcium as placebo with maltodextrin provided in 6 capsules with a standardized breakfast served in the morning.
Other intervention name(s): Capolac
Intervention MeSH terms: Calcium, Dietary; Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Efficiency of Kinesio Taping in Chronic Lateral Epicondylitis
Condition: Tendinopathy, Elbow
MeSH terms: Tendinopathy; Tennis Elbow; Elbow Tendinopathy
Study type: Interventional

Summary: 
      Lateral epicondylitis is a degenerative tendinosis of the extensor carpi radialis brevis
      muscle and is the most common work/sports-related chronic musculoskeletal problem affecting
      the elbow. This randomized, double-blinded, controlled study aimed to evaluate the short term
      and residual effectiveness of the Kinesio taping method on pain, grip force, quality of life,
      and functionality.
    

Detailed description: 
      Fifty patients diagnosed with chronic unilateral lateral epicondylitis with a symptom
      duration of at least 12 weeks. The study group received a true inhibitor Kinesio taping while
      the control group received sham taping for the first four weeks. In both groups, progressive
      stretching and strengthening exercises were given as a home program for 6 weeks. Patients
      were assessed with the numerical rating scale (NRS), Cyriax resistive muscle test evaluation,
      maximal grip strength, PRTEE (Patient- Rated Tennis Elbow Evaluation), and SF-36 (Short
      Form-36) by the first assessor who was blinded to taping types.
    

Intervention name(s): Tape
Intervention type(s): Device
Intervention description(s): The tape is an elastic cotton strip with an acrylic adhesive that is used with the intent of treating pain and disability
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kinesio taping; lateral epicondylitis; residual effect
Relative Bioavailability and Food Effect Study
Condition: Pharmacology, Clinical
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective: To determine oral bioavailability of the liquid formulation intended for
      pediatric use and potential food effects in healthy adults.

      Secondary objective: To evaluate safety and tolerability measured by physical examination
      findings, vital signs, electrocardiogram (ECG), laboratory parameters, and adverse events
      (AEs).
    

Detailed description: 
      Clinical pharmacology
    

Intervention name(s): Riociguat (BAY63-2521); Riociguat (BAY63-2521); Riociguat (BAY63-2521); Riociguat (BAY63-2521); Riociguat (BAY63-2521)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single oral dose of 2.4 milligram (mg) riociguat (BAY63-2521) as pediatric high-concentration suspension (0.15 mg per milliliter [mg/mL], i.e. 16 mL) under fasting conditions; Single oral dose of 2.4 mg riociguat as pediatric high-concentration suspension (0.15 mg/mL, i.e. 16 mL) under fed conditions; Single oral dose of 0.3 mg riociguat as pediatric high-concentration suspension (0.15 mg/mL, i.e. 2 mL) under fasting conditions; Single oral dose of 0.15 mg riociguat as pediatric low-concentration suspension (0.03 mg/mL, i.e. 5 mL) under fasting conditions; Single oral dose of riociguat immediate release (IR) tablet 1 mg under fasting conditions
Intervention MeSH terms: Riociguat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Relative bioavailability study
Glycaemic Control of Monthly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the optimal dose or doses of HM11260C, when
      administered once a month under the skin, to improve the control of blood sugar levels in
      patients with early-stage type 2 diabetes mellitus (T2DM).
    


Intervention name(s): HM11260C; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue); Placebo for HM11260C
Other intervention name(s): LAPS-Exendin-4
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects
Condition: Diabetes; Diabetes Mellitus, Type 2; Healthy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in the United States of America (USA). The aim of this trial is to
      investigate the safety, tolerability and pharmacokinetics (exposure in the body) of
      liraglutide-depot in healthy subjects.
    


Intervention name(s): liraglutide-depot; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be randomised to receive a single dose of liraglutide-depot, at increasing dose levels, injected s.c./subcutaneously (under the skin). Progression to next dose level (max. 8) will be based on safety evaluation.; Subjects will be randomised to receive a single dose of liraglutide-depot placebo, at increasing dose levels, injected s.c./subcutaneously (under the skin).
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy of Dry Needling Treatment in Myofascial Pain Syndrome
Condition: Trigger Point Pain, Myofascial
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia
Study type: Interventional

Summary: 
      The aim of this study is to investigate the short and long-term effects of dry-needling of
      participants with trigger points in the upper trapezius muscle.

      64 participants who diagnosed with myofascial pain syndrome will be included in the study.
      All participants will have trigger points in the upper trapezius muscles. They are randomised
      into two groups: dry needling (n=32) and exercise group (n=32). Ultrasonographic evaluation
      of trigger points (diameter, circumference and area), pain intensity and neck disability will
      be evaluated as primary outcome. Active cervical range of motion will be evaluated as
      secondary outcome.
    

Detailed description: 
      Objective: The aim of this study is to investigate the short and long-term effects of
      dry-needling of participants with trigger points in the upper trapezius muscle.

      Methods: 64 participants who diagnosed with myofascial pain syndrome will be included in the
      study. All participants will have trigger points in the upper trapezius muscles. They are
      randomised into two groups: dry needling (n=32) and exercise group (n=32). Ultrasonographic
      evaluation of trigger points (diameter, circumference and area), pain intensity and neck
      disability will be evaluated as primary outcome. Active cervical range of motion will be
      evaluated as secondary outcome.

      All treatments will be applied by an investigator and a different blinded investigator will
      evaluated all participants. Numerical Rating Scale will be used for evaluating pain intensity
      and Neck Disability Index will be used for evaluating neck disability.

      Dry-needling treatment will be applied once a week for three weeks. Servical stretching
      exercises are given to all participants. (20 repetitions in one session and 2 sessions in a
      day, three days a week.)

      All participants will be evaluated before treatment, after treatment (at 3rd week) and at 3
      month follow-ups.
    

Intervention name(s): dry-needling
Intervention type(s): Procedure
Intervention description(s): Dry needling is a technique in which a fine needle is used to penetrate the skin, subcutaneous tissues and muscles to mechanically disrupt tissue without the use of anesthesia. Treatment is often used to treat myofascial trigger points.
Other intervention name(s): exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Dry needling is a technique in which a fine needle is used to penetrate the skin, subcutaneous tissues and muscles to mechanically disrupt tissue without the use of anesthesia. Treatment is often used to treat myofascial trigger points.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: trigger point; dry-needling; ultrasonography; pain intensity; neck disability