bioihbjkbjnl/mcl2 huggingface dataset:
Hydration Dynamics and Influence of Beverage Composition
Condition: Hydration; Fluid Retention; Dehydration
MeSH terms: Dehydration
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study examines interactions between fluid availability in the gut and fluid retention in
      the body. The relative rate of fluid uptake, the expansion of the plasma volume, and percent
      of fluid retained by the body will be measured in response to ingestion of beverages of
      different composition. Healthy, euhydrated adults will be studied. The results will help
      establish formulations of beverages that sustain if not promote acute euhydration.
    

Detailed description: 
      Using a randomized order for beverage treatments at three separate trials, subjects will
      ingest 1 Liter of one of three beverages in 10 minutes: water, a beverage with 2.5% glucose
      with 45 mmol sodium/L, or a beverage with 1.7% glucose with 60 mmol sodium/L. Before and
      repeatedly for 2 h after ingestion of the beverage, blood samples will be drawn for
      assessments of D2O, Hb, Hct, osmolality, sodium, and glucose. The rate of appearance of D2O
      will be evaluated using the area under the curve, the slope of the appearance, and half time
      to plateau. Comparisons will be made between beverages for indices of the rate of appearance
      of D2O, the change in PV over time, and cumulative urine excreted. The cumulative urine
      produced will be used to calculate a modified BHI for the two glucose-electrolyte beverages
      and water for comparison with 1.0 (expected for no beverage effect). We hypothesize faster
      absorption (D2O appearance rate), and better overall hydration (expanded PV and higher
      modified BHI) will occur for beverages containing glucose and sodium compared to water.
      Further, we hypothesize that of the electrolyte beverages, the beverage with higher sodium
      content will promote greater overall hydration (less urine excreted) than the beverage with
      lower sodium.
    

Intervention name(s): Placebo; Oral Rehydration Solution 1; Oral Rehydration Solution 2
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Ingestion of one (1) liter of beverage with observation for 2 h; Ingestion of one (1) liter of beverage with observation for 2 h; Ingestion of one (1) liter of beverage with observation for 2 h
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Mixed model.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Hydration; Deuterium oxide; Plasma osmolality; Sodium; Urine production; Fluid absorption; Euhydration
Repetitive Transcranial Magnetic Stimulation for "Voices"
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES:

      I. Determine the effect of repetitive transcranial magnetic stimulation on treatment
      refractory auditory hallucinations of patients with schizophrenia.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are randomized to one of
      two treatment arms.

      Group I: Patients receive 9 sessions of active transcranial magnetic stimulation (rTMS) which
      consists of 8 minutes of rTMS during session 1, 12 minutes duration during session 2, and 16
      minutes duration during sessions 3-9. The total duration of stimulation is 132 minutes. Each
      session was given on a separate day and in general each session occurred on consecutive days
      with the exception of weekends.

      Group II: Patients receive 9 sessions of sham stimulation, which consists of 8 minutes of
      sham stimulation during session 1, 12 minutes duration sham stimulation during session 2, and
      16 minutes duration sham stimulation during sessions 3-9. The total duration of sham
      stimulation is 132 minutes. Each session was given conducted on a separate day and in general
      each session occured on consecutive days with the exception of weekends.

      This study provided pilot data supplying the basis for our current study - NCT00308997 -- see
      our website for details
    

Intervention name(s): repetitive transcranial magnetic stimulation (rTMS); sham stimulation
Intervention type(s): Device; Device
Intervention description(s): a total of 132 minutes of stimulation at one hertz, motor threshold set at 80%, delivered to TP3 scalp site; 132 minutes of stimulation given at 80% motor threshold with coil tilted "single wing" 45 degrees away from scalp deliverd to TP3 site
Other intervention name(s): MATSTIM SUPER RAPID; MAGSTIM SUPER RAPID
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neurologic and psychiatric disorders; rare disease; schizophrenia
GOAL Life-Style Change Intervention to Prevent Type 2 Diabetes
Condition: Obesity; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Life-style change achieved in controlled experimental condition has been shown to prevent
      type 2 diabetes. The purpose of this study is to evaluate to what extent the life-style
      change can be achieved in a routine health care setting.
    

Detailed description: 
      The GOAL (Good Ageing in Lahti region) Program Life-style change implementation trial to
      prevent type 2 diabetes was set to examine and enhance the effectiveness of life-style change
      counselling in the primary health care. In the intervention, specific nutritional, physical
      activity and weight loss objectives shown effective in diabetes prevention in an earlier
      randomised controlled trial are used as a benchmark, embedded in a structured group
      counselling model with an empowerment-oriented approach and adapted into the primary health
      care setting. In the trial, effectiveness and process are evaluated, the analyses including
      gender and socio-economic differences. Participants were 361 middle-aged (50-65 yrs) adults
      at an increased risk for type 2 diabetes, recruited in 16 primary health care centres in
      Paijat-Hame, Finland. Intervention and data collection took place in year 2003.
    

Intervention name(s): Cognitive-behavioral life-style counseling
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: life-style counseling; type 2 diabetes; prediabetes; physical activity; diet; cognitive-behavioral
The Effect of ERAS on Pancreaticoduodenectomy
Condition: Periampullary Tumor
Study type: Interventional

Summary: 
      Enhanced Recovery After Surgery (ERAS) is not the program that aim to reduce postoperative
      hospital stay, but the multimodal strategies that aim to attenuate the loss of, and improve
      the restoration of,functional capacity after surgery on evidence-based medicine. The benefits
      of ERAS is proved in many surgical procedures, such as upper gastrointestinal surgery and
      colorectal surgery. However, pancreaticoduodenectomy (PD, Whipple's operation) is still one
      of most complex abdominal surgery, and there is no evidence that ERAS is beneficial on PD.

      This study investigate the clinical effectiveness of ERAS on PD.
    

Detailed description: 
      -  This study conduct totally 276 patients who underwent PD with borderline or malignant
           periampullary tumor. The patients divided into two groups. One group take conventional,
           experienced-based perioperative management, the other group take perioperative
           management based on ERAS protocol. Applied ERAS protocol is based on "Guidelines for
           Perioperative Care for Pancreaticoduodenectomy: Ehanced Recovery After Surgery Society
           Recommendations.

        -  The outcomes are analyzed for short-term surgical outcomes including operative factors,
           nutritional status, morbidity, mortality, length of stay, readmission, etc.

        -  Among all subjects who were randomized and started any study intervention (ERAS or
           standard perioperative management), the patients who underwent pancreaticoduodenectomy
           were included as the Full analysis set (FAS). All subjects who didn't undergo
           pancreaticoduodenectomy were excluded from this study.

        -  Besides, as all subjects who were randomized and received any study intervention were
           obliged to follow the study protocol and monitored for best compliance, per-protocol set
           or safety set were not defined differently
    

Intervention name(s): ERAS perioperative management
Intervention type(s): Other
Intervention description(s): Preop Counseling
Preop biliary drainage (X) when Serum Total bilirubin < 14.62mg/dl and cholangitis (-)
Preop enteral nutrition
Oral bowel preparation (mechanical bowel preparation ) (X)
Preop fasting < 6 hours
Prevention of postoperative nausea and vomiting (PONV) (O)
Nasogastric intubation (X)
Near-zero fluid balance
Somatostatin analogues (X)
Postop routine artificial nutrition (X), soft diet at POD #2
Audit
Other items are same as conventional
Other intervention name(s): Fast tract
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two study groups (Control (conventional) group and study (intervention) group) were randomly allocated and assigned to one of two groups in parallel for the whole duration of this study.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: pancreaticoduodenectomy; ERAS; Whipple's operation; Fast track
Mini Lateral Shoulder Approach
Condition: Shoulder Impingement Syndrome; Rotator Cuff Tendinopathy; Adhesive Capsulitis and Frozen Shoulder Syndrome
MeSH terms: Tendinopathy; Bursitis; Shoulder Impingement Syndrome; Syndrome
Study type: Interventional

Summary: 
      The incision is very useful and easy for the direct lateral shoulder joint exposure.
    

Detailed description: 
      The skin incision is about 4 to 5 cm made by the distal acromial edge in sagittal plane, The
      dissection takes place slightly over the acromial edge proximally and over the origin of the
      acromial deltoid part (the middle part of deltoid origin) distally.

      After clearly revealing the region of the medial deltoid origin on the acromion, the
      acromionic deltoid origin is skinned only; of the edge of the acromion, and that maybe
      accrued by electric knife pen or periosteal elevator, without exposure the clavicular deltoid
      origin in the front and the deltoid origin on the spine of scapula in the back, the origin of
      the acromial deltoid is distanced laterally and distally, where the lateral edge, the lower
      surface of the acromion, under acromial bursa and the rotator cuff are exposed clearly.

      Throw this approach can be made acromioplasty and rotator cuff tears repair especially upper
      part of rotator cuff tear very easily.

      For wound closure the acromionic deltoid origin is reattached to the acromial edge by long
      period synthetic absorbable sutures as PDS and PDO, or non absorbable sutures as Polyester
      suture, under skin and skin sutures are made.
    

Intervention name(s): Mini Lateral Shoulder Approach (MLSA)
Intervention type(s): Procedure
Intervention description(s): The skin incision is about 4 to 5 cm made by the distal acromial edge in sagittal plane, The dissection takes place slightly over the acromial edge proximally and over the origin of the acromial deltoid part (the middle part of deltoid origin) distally.
After clearly revealing the region of the medial deltoid origin on the acromion, the acromionic deltoid origin is skinned only; of the edge of the acromion, and that maybe accrued by electric knife pen or periosteal elevator, without exposure the clavicular deltoid origin in the front and the deltoid origin on the spine of scapula in the back, the origin of the acromial deltoid is distanced laterally and distally, where the lateral edge, the lower surface of the acromion, under acromial bursa and the rotator cuff are exposed clearly.
Other intervention name(s): Second Sayed Issa's Approach
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Shoulder; Shoulder approach; Lateral Shoulder approach; Shoulder impingement syndrome; Rotator cuff tendinopathy; Adhesive capsulitis; Frozen shoulder syndrome
Effects of a Caffeine- and Protein-Containing Coffee Beverage on Metabolism and Muscular Performance
Condition: Exercise Performance; Metabolism
Study type: Interventional

Summary: 
      The purpose of this randomized, double-blind, crossover study is to investigate the effects
      of Bang® Keto Coffee on resting and post-exercise metabolism and muscular performance during
      lower body resistance exercise.
    

Detailed description: 
      Resistance-trained males and females will be recruited for participation in a randomized,
      double-bind, crossover trial. After providing informed consent, each participant will undergo
      a familiarization session to become accustomed to the study procedures. Following
      familiarization, each participant will complete two laboratory visits consisting of
      metabolism and exercise performance assessments. In both visits, a baseline assessment of
      resting metabolic rate (RMR) and respiratory exchange ratio (RER) will be conducted using
      indirect calorimetry. Following the initial RMR assessment, each participant will ingest a
      coffee flavored beverage, either VPX Bang® Keto Coffee or a flavor-matched placebo. After
      beverage consumption, the participant will return to the supine position and rest prior to
      initiation of the second RMR assessment. Immediately following the second RMR assessment, the
      participant will begin a 5-minute dynamic bodyweight warm up. Participants will then begin
      squat testing procedures on a mechanized squat device. After completing the squat testing,
      participants will complete a standard 1-repetition maximum and repetitions to failure using a
      plate-loaded hip sled machine. Following the hip sled testing, participants will repeat the
      mechanized squat testing. Following completion of the exercise testing, a third and final RMR
      assessment will be performed. Following successful completion of the first condition, each
      participant will enter a wash out period, after which the visit will be repeated with
      ingestion of the alternative beverage.
    

Intervention name(s): Beverage Consumption
Intervention type(s): Dietary Supplement
Intervention description(s): Participants will consume either VPX Bang® Keto Coffee beverage or flavor-matched placebo beverage in each condition.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Effect of NWT-03 on Blood Pressure
Condition: Blood Pressure; Albuminuria
MeSH terms: Albuminuria
Study type: Interventional

Summary: 
      Part 2 of the study will assess the effect of 2g of NWT-03 (an egg-white protein hydrolysate)
      on systolic and diastolic blood pressure and flow-mediated dilation in a crossover designed
      study in healthy adults with mild hypertension.
    


Intervention name(s): NWT-03, an egg-white protein hydrolysate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): For placebo comparator, a combination of sweetener + aroma, which was equal to the combination used in the intervention period, was given; A combination of sweetener + aroma , which was equal to the combination used in the intervention period, was given.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Flow-mediated dilation
Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With Two Reference Products
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the absorption of three different inhalation products
      with the reference products in healthy volunteers.
    

Detailed description: 
      Healthy subjects will be enrolled and will receive single doses of 3 test inhalation products
      and two reference inhalation products according to a five-period cross-over design. Plasma
      tiotropium levels will be measured pre-dose and over 8 hours post-dose.
    

Intervention name(s): Tiotropium
Intervention type(s): Drug
Intervention description(s): 4 inhalations
Other intervention name(s): Spiriva Respimat; Spiriva Handihaler
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: inhalation; anticholinergic
Ussing Experiments to Evaluate the Role of Medication-induced Microscopic Colitis
Condition: Microscopic Colitis
MeSH terms: Colitis; Colitis, Microscopic
Study type: Interventional

Summary: 
      Medication use, especially NSAIDs and PPIs, prior to diagnosis is considered a risk factor
      for MC development. However, the exact pathophysiological mechanism is unclear. It is
      hypothesized that NSAIDs, PPIs, and SSRIs may have an effect on the colon permeability, due
      to an idiosyncratic reaction which results in a local immune response. MC patients are
      considered to be susceptible hosts, prone to react on administration of abovementioned drugs.
      In order to test this hypothesis and to generate new insights in the pathophysiology of MC,
      we want to perform an Ussing chamber experiment using fresh colon tissue samples. The primary
      objective is to assess ex vivo the effect of NSAIDs and PPIs on epithelial permeability of
      colon biopsy specimens of MC and non-MC patients, using the Ussing chamber system
    


Intervention name(s): Ussing experiment
Intervention type(s): Other
Intervention description(s): fresh colon mucosa (biopsy) of all participants will be mounted in an Ussing chamber and exposed to NSAIDs / PPI / control.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of High Flow Nasal Cannula vs. Standard Care on Respiratory Stability in Pediatric Procedural Sedation
Condition: Respiratory Insufficiency
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      Procedural sedation is an established and safe intervention and is widely used in diagnostic
      and therapeutic procedures for pediatric patients. Nonetheless, problems of the respiratory
      system such as upper airway obstruction, hypoventilation and apnea are frequent adverse
      events. We postulate that respiratory instability is less frequent in patients high flow
      nasal cannula vs. standard care on respiratory stability, i.e. low flow nasal cannula, in
      pediatric procedural sedation. The purpose of this pilot study is to estimate the effect of
      HFNC (high flow nasal cannula) on the respiratory instability in children undergoing upper
      gastrointestinal endoscopy under pediatric procedural sedation (PPS).
    


Intervention name(s): High Flow nasal cannula; Standard respiratory care
Intervention type(s): Other; Other
Intervention description(s): Application of humidified heated ambient air with flow rates adapted to body weight of respective subject. Incremental increase of fraction of inspired oxygen as appropriate to maintain oxygenation (defined as transcutaneous pulse oximetry above 93%).; Standard respiratory care. Oxygen delivered via low flow nasal cannula, increase of fractions of inspired oxygen to maintain desired oxygenation as defined per protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: apnea; children; hypercarbia; procedural sedation; HFNC
Hypotension in Children With Down Syndrome With Anesthesia Induction
Condition: Hypotension on Induction
MeSH terms: Down Syndrome; Hypotension
Study type: Observational

Summary: 
      Children generally undergo induction of anesthesia by inhalation of sevoflurane. Children
      with Down Syndrome experience bradycardia with induction of anesthesia using sevoflurane. It
      is unknown if this bradycardia is isolate or results in hypotension, thus requiring
      treatment. Isolate bradycardia without hypotension does not require treatment and should be
      avoided as many of these patients have underlying cardiac anomalies.
    

Detailed description: 
      Children generally undergo induction of anesthesia by inhalation of sevoflurane. This is
      particularly relevant for children with developmental delays as to avoid placement of an IV
      while awake. However, children with Down Syndrome experience bradycardia with induction of
      anesthesia using sevoflurane. It is unknown if this bradycardia is isolate or results in
      hypotension, thus requiring treatment. Isolate bradycardia without hypotension does not
      require treatment and should be avoided as many of these patients have underlying cardiac
      anomalies.
    

Intervention name(s): Non invasive blood pressure
Intervention type(s): Other
Intervention description(s): measurement of blood pressure during induction of general anesthesia
Other intervention name(s): blood pressure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This is an observational study of children with down syndrome undergoing induction of
        general anesthesia with sevoflurane. vital signs of blood pressure, heart rate and pulse
        oximetry will be recorded on the anesthesia record as standard practice
Soccer Play in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      1. To figure out the effect of soccer play (once a week for 8 weeks) on pulmonary function
           in children with cerebral palsy

        2. To find out if the leisure activity (soccer) increase the quality of life, motor
           function, gait function etc..

        3. Safety of soccer play in children with cerebral palsy
    

Detailed description: 
      1. 1 hr of play once a week for 8 weeks of soccer program was done in the experimental
           group.

        2. Both the experimental and control group were children with ambulatory cerebral palsy
           aged 5 to 12 years.

        3. Several outcomes were measured before and after the program

             -  pulmonary function test including FVC, FEV1

             -  GMFM-88, PBS, walking test, muscle power sprint test, timed up and go, gait
                parameters

             -  Child Health Questionnaire Parent Form 50 (CHQ-PF50)

             -  KIDSCREEN

        4. An accelerometer was worn before the program and during the program for a week
           (experimental group only)
    

Intervention name(s): soccer play program
Intervention type(s): Behavioral
Intervention description(s): once a week for an hour of a soccer program for 8 weeks
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: all were ambulatory children with CP age 5-12 years old.
Masking: None (Open Label)
Primary purpose: Other
Keywords: cerebral palsy