bioihbjkbjnl/mcl2 huggingface dataset:
Blackberry Flavonoid Absorption and Effects on Intestinal Bacteria
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      Intestinal bacteria can metabolize unabsorbed polyphenols (plant compounds) to produce
      smaller molecules which may impact health. In addition, evidence suggests that this process
      may be affected by body fatness. This study aims to investigate absorption of blackberry
      polyphenols, their impact on intestinal bacteria, polyphenol metabolites formed by intestinal
      bacteria, and how these processes differ for obese and lean individuals. It is hypothesized
      that polyphenol absorption and metabolism will differ between obese and lean individuals and
      that differences in intestinal microbiota may play a role.
    


Intervention name(s): Blackberries; Control
Intervention type(s): Other; Other
Intervention description(s): Participants will receive blackberries as part of a controlled diet.; Participants will receive a control food (jello) as part of a controlled diet.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Do We Need Computer Assistance To Improve the Survival of Primary Total Knee Arthroplasty. A Minimum Ten Years Follow-up
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators asked: (1) Do computer-assisted total knee arthroplasty (TKAs) provide
      better alignment and clinical function? (2) Do computer-assisted TKAs provide better
      survivorship of implants and less complication? and (3) Do correction of the mechanical axis
      of the lower limb to within 3° of neutral is a prognostic marker for late revision surgery
      due to aseptic loosening?
    

Detailed description: 
      Computer-assisted total knee arthroplasty (TKA) is reported to improve the overall accuracy
      of positioning of the femoral and tibia components. However, an acceptable target for
      alignment remains a matter for debate. A mechanical axis within 3° of neutral axis has been
      used as the primary outcome measure in many clinical trials comparing computer-assisted- and
      conventional TKA. However, the evidence supporting this arbitrary value is unreliable because
      previous reports are limited by their small sample size, inadequate radiographs, short
      follow-up and lack of clarity when defining a margin of accuracy.
    

Intervention name(s): Non-Computer Assistance TKA; Computer Assistance TKA
Intervention type(s): Procedure; Procedure
Intervention description(s): Non-Computer Assistance Total Knee Arthroplasty; Computer Assistance Total Knee Arthroplasty
Other intervention name(s): Non-Computer Assistance Total Knee Arthroplasty; Computer Assistance Total Knee Arthroplasty
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Computer Assistance; Total Knee Arthroplasty; conventional
Effects of Different I:E Ratio on Intrapulmonary Shunt Fraction and Oxygenation During One Lung Ventilation in the Lateral Decubitus Position
Condition: Lung Cancer; Lung Lobectomy
MeSH terms: Pressure Ulcer
Study type: Interventional

Summary: 
      The purpose of this study is to investigate effect of increasing inspiratory time (I:E ratio
      1:1) on intrapulmonary shunt fraction and oxygenation during one lung ventilation in the
      lateral decubitus position.
    

Detailed description: 
      Increasing inspiratory time(e.g. Inverse ratio ventilation) has been known that had advantage
      of alveolar recruitment, preventing of ateletasis. On the contrary, it has disadvantange of
      intrinsic PEEP, air trapping. There is few study on one lung ventilation in lateral decubitus
      position about this ventilation method. We were going to investigate effecf of this
      ventilation method.
    

Intervention name(s): I:E ratio
Intervention type(s): Procedure
Intervention description(s): I:E ratio 1:1 Volume controlled ventilation TV:8ml/kg EtCO2:35-40mmHg
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Impact of Suspected Preterm Labour on Cardiometabolic Profile and Neurodevelopment
Condition: Preterm Labor
MeSH terms: Premature Birth; Obstetric Labor, Premature
Study type: Observational

Summary: 
      Suspected preterm labour (SPL), define as the presence of regular and painful uterine
      contractions and cervical shortening, constitute a prenatal insult with potential long-term
      consequences. However, despite recent evidence demonstrating a suboptimal neurodevelopment at
      2 years in this population, it remains under-recognized as a significant risk factor for
      neurodevelopmental disorders or other chronic diseases. The objective of this study is to
      assess the impact of suspected preterm labour during pregnancy on cardiometabolic profile and
      neurodevelopment during childhood (6-8 years).

      Prospective cohort study including children whose mothers suffered a suspected preterm labor
      during pregnancy and paired controls. A neurodevelopment, cardiovascular and metabolic
      assessment at 6-8 years of age will be performed. A trained psychologist will carry out the
      neurodevelopment assessment. Body composition and physical fitness assessment will be
      performed by one trained pediatrician and nurse. Finally, cardiovascular assessment,
      including echocardiography and blood pressure, will be performed by two pediatric
      cardiologists. Data regarding perinatal and postnatal characteristics, diet, lifestyle and
      weekly screen time of the child will be obtained from clinical histories and direct
      interviews with the families. Primary outcome measures will include body mass index and
      adiposity, percentage of fat mass and total and regional lean mass, bone mineral content and
      density, cardio-respiratory resistance, isometric muscle strength, dynamic lower body
      strength, systolic and diastolic blood pressure, left ventricle (LV) systolic and diastolic
      function, general intelligence index, visuospatial working memory span, visual development
      test, visual acuity, index of emotional and behavioral problems.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Two cohorts of children at 6-8 years of age:

        A. Exposed cohort: children whose mothers suffered a suspected preterm labour during
        pregnancy. They are subdivided into:

          -  Moderate-late preterm births (between 32 and 37 weeks of gestation)

          -  "False suspected preterm labour" (full-term births (> 37 weeks) after suffering a
             suspected preterm labour) B. Unexposed cohort: children born at term (> 37 weeks)
             whose mothers did not suffer a suspected preterm labour during pregnancy.
      
Keywords: pregnancy; preterm labor; neurodevelopment; cardiovascular; metabolic; prematurity
Phase 1 Study of GSK2315698 in Healthy Japanese Subjects
Condition: Amyloidosis
MeSH terms: Amyloidosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first study in which GSK2315698 will be administered in Japanese population. The
      primary objective of the study is to investigate safety and tolerability, pharmacokinetics,
      and pharmacodynamics after single intravenous infusion in healthy subjects. This will be a
      single center, double-blind, randomized, placebo-controlled, dose-ascending study.

      Subjects in Cohort 1 will attend 3 dosing sessions, and will be randomized to one of the 3
      groups. Each group will receive GSK2315698 and Placebo in a defined sequence. The dose levels
      of GSK2315698 are set to 10 milligrams (mg) per hour (hr), 20 mg/hr, and 40 mg/hr, to be
      administered over 1 hour. Dosing sessions 1 and 2, and dosing sessions 2 and 3, will be
      separated by a washout period of at least 8 and 10 days, respectively.

      Subjects in Cohort 2 will attend a single dosing session, and will be randomized to receive
      either GSK2315698 20 mg/hr or Placebo, over a period of 15 hours.

      A sufficient number of subjects will be randomized such that 18 subjects (9 in each cohort)
      complete the study. The duration of participation for any subject in this study will be
      approximately 59 days.
    


Intervention name(s): Placebo; GSK2315698
Intervention type(s): Drug; Drug
Intervention description(s): 0.9% weight by volume (w/v) saline solution for intravenous infusion over 1 hour (in Cohort 1) or over 15 hours (in Cohort 2).; 200 mg/mL stock solution for intravenous infusion over 1 hour (in Cohort 1) or over 15 hours (in Cohort 2). The stock solution will be diluted to obtain dosage levels of 10 mg/hr, 20 mg/hr, or 40 mg/hr.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GSK2315698; Dose-ascending; Systemic amyloidosis
Randomized Comparison of Laparoscopic Sleeve Gastrectomy and Gastric Bypass for Morbid Obesity
Condition: Morbid Obesity; Metabolic Syndrome X; Diabetes Mellitus; Dyslipidemia; Hypertension
MeSH terms: Obesity; Metabolic Syndrome; Dyslipidemias; Obesity, Morbid
Study type: Interventional

Summary: 
      Bariatric surgery is the most effective treatment for morbid obesity. Roux-en-Y gastric
      bypass (RYGB) is a bariatric procedure with known safety and effectiveness. Laparoscopic
      sleeve gastrectomy (LSG) is a newer procedure gaining popularity. The aim of the study is to
      compare outcomes of these two surgical methods in terms of weight loss, improvement of common
      comorbidities of obesity and influence on metabolic and hormonal status.
    

Detailed description: 
      Authors of the study believe that a more detailed head-to-head comparison of RYGB and LSG is
      necessary. The former method is the established "gold standard" procedure with good outcomes
      reported in many studies. However it is much more complex and the learning curve is longer.
      The latter method was introduced as an initial procedure in superobese patients because of
      its relative simplicity. It produced good outcomes in this population of superobese patients
      and surgeons in some centers started to use it as a primary bariatric procedure. RYGB is a
      restrictive and partially malabsorptive procedure and it is believed to have additional
      benefits in patients with metabolic disorders such as type 2 diabetes and dyslipidemia.
      Purely restrictive procedures such as LSG are theoretically less beneficial in this group of
      patients. In the present study authors will look at weight loss as well as improvement in
      comorbidities and several biochemical parameters and indices to assess also metabolic action
      of these two procedures.
    

Intervention name(s): Laparoscopic sleeve gastrectomy; Roux-en-Y Gastric Bypass
Intervention type(s): Procedure; Procedure
Intervention description(s): Laparoscopic sleeve gastrectomy (LSG) is a restrictive bariatric procedure. LSG involves resection of a large part of the body and fundus of the stomach starting from the antrum up to the angle of His. The remaining part of the stomach (the gastric sleeve) is calibrated with a 36 French bougie.; Roux-en-Y gastric bypass (RYGB) is an intermediate (restrictive and malabsorptive) operation. RYGB involves creation of a 15-20 mL gastric pouch that is anastomosed to a 100cm Roux limb created at 100cm from the ligament of Treitz.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bariatric surgery; Gastric bypass; Sleeve gastrectomy; Weight loss; Lipoproteins; Insulin resistance; Incretins; Quality of life
Study Of Perennial Allergic Rhinitis In Pediatrics
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      To verify of cetirizine dry syrup to ketotifen dry syrup in the change of total nasal symptom
      score (TNSS) over the total treatment period from the score of the baseline assessment period
    


Intervention name(s): Cetirizine Dry Syrup
Intervention type(s): Drug
Intervention MeSH terms: Cetirizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Allergic; pediatric; Rhinitis; Perennial
A Safety and Tolerability Single Ascending Dose Study in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Targacept, Inc. is studying TC-2216 for a potential role in the treatment of central nervous
      system (CNS) neurobiological disorders in anticipation of seeking an indication in depression
      and/or anxiety.
    


Intervention name(s): TC-2216
Intervention type(s): Drug
Intervention description(s): Multiple ascending dose groups will be explored.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy; Healthy Volunteers
Role of the Gut Sweet Taste Receptor in the Secretion of Glucagon-like Peptide-1 and Peptide YY
Condition: Taste Disorder, Primary, Sweet
MeSH terms: Taste Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the functional significance of sweet taste
      receptors in the secretion of GI satiation peptides by using a specific sweet taste receptor
      antagonist to block sweet taste perception in the gastrointestinal tract.
    

Detailed description: 
      There is strong evidence that taste signaling mechanisms identified in the oral epithelium
      also operate in the gut. It is suggested that open-type enteroendocrine cells directly sense
      nutrient via alpha-gustducin coupled taste receptors to modulate the secretion of glucagon
      like peptide-1 (GLP-1) and peptide YY (PYY). Several nutrient responsive G-protein coupled
      receptors have been identified in the human gut, including the sweet taste responsive
      T1R2/T1R3 heterodimer, the amino acid/umami responsive T1R1/T1R3 as well as GPR120 for
      unsaturated long-chain free fatty acids.The functional significance of sweet taste receptors
      in the secretion of GLP-1 and PYY will be determined by intraduodenal perfusion of glucose
      (I) or a mixed liquid meal (II) with or without lactisole (450 ppm) in a double blind, 5-way
      crossover trial including 10 healthy subjects.
    

Intervention name(s): lactisole; mixed liquid meal
Intervention type(s): Dietary Supplement; Other
Intervention description(s): flavoring agent/sweet taste antagonist; Ensure Plus
Other intervention name(s): Dietary supplement; Dietary supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: T1R2/T1R3; gastric emptying; gut; lactisole; nutrient sensing
Motor and Cognitive Dual-task Gait Training Effect Functional Outcome in Intellectual Disability
Condition: Intellectual Disability
MeSH terms: Intellectual Disability
Study type: Interventional

Summary: 
      To find out the comparative effects of motor and cognitive dual gait training on improving
      the balance control and mobility skills among intellectual disable patients.
    

Detailed description: 
      Previous studies had done a lot of work in improving balance and mobility skills by combining
      both motor and cognitive dual gait training (CDT and MDT) techniques among Down syndrome,
      Parkinsonism and so on but not a single study was conducted in order to determine the
      comparative effects of CDT and MDT especially in intellectual disability individuals to
      improve balance so the study was conducted in order to find the comparative effect for the
      better understanding of the treatment effects.
    

Intervention name(s): Motor dual-task gait training; Cognitive dual-task gait training
Intervention type(s): Other; Other
Intervention description(s): Patients were instructed to walk either on treadmill or on the land. During walk; patients were instructed to perform five tasks. The patients performed tossing and catching the ball, rehanging loops on hoops, buttoning and unbuttoning the shirts, holding the cup in water without the spilling and receiving with returning the water. Each activity were performed for three minute and 15 minutes were provided for performing all the tasks; Patients were instructed to walk either on treadmill or on the land. During walk; patients were instructed to perform five tasks. The patients performed sharp coloring, subtraction, counting, verbal analogical reasoning and backward spelling. Each activity were performed for three minute and 15 minutes were provided for performing all the tasks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Motor and cognitive dual task gait training
Comparative Study of Safety and Efficacy of Two Hyaluronic Acids for the Treatment of Knee Osteoarthritis Pain
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this study is to determine the comparative safety and efficacy of
      intra-articular injection of hyaluronic acid, obtained from two different sources, in the
      treatment of osteoarthritic pain of the knee.
    

Detailed description: 
      This is a multicenter, randomized, double blind, parallel-controlled clinical trial using a
      non-inferiority comparison to evaluate the efficacy and safety of an intra-articular
      injection of Durolane® vs Artz® in the treatment of knee osteoarthritis. Subjects will be
      randomized 1:1 to receive either Durolane or Artz. All subjects will be followed up for 26
      weeks from the initial treatment.The screening period is expected to be up to 2 weeks in
      duration before the baseline visit. Each subject will provide a written informed consent and
      undergo a qualifying screening. Assessment at screening will include postero-anterior view of
      standing weight-bearing semi-flexed radiographs of the study knee. The osteoarthritis changes
      of the study knee will be graded 0,1,2,3 or 4 according to the Kellgren-Lawrence radiographic
      scoring criteria. Radiographic assessment will be made by an assigned and well trained
      investigator at each study center. The study knee and contralateral knee will use the Likert
      WOMAC 5-point scoring for pain assessment.

      Physical examination of the knees and vital signs will be performed (this examination will be
      repeated at end).
    

Intervention name(s): ARTZ; DUROLANE
Intervention type(s): Device; Device
Intervention description(s): Hyaluronic acid (five 2.5 mL injections); Hyaluronic acid stabilized (one 3.0 mL injection + four weekly 0 mL sham injections)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Repeat Dose Safety Study for Compound to Treat Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to describe the safety and tolerability of single and repeat
      oral doses of GSK1440115 in healthy volunteers.
    

Detailed description: 
      This study is the first administration of GSK1440115 to humans. GSK1440115 is a urotensin II
      receptor antagonist which is being developed for the treatment of asthma. This will be a
      two-part study to evaluate the safety, tolerability, and pharmacokinetics of single (Part A)
      and repeat (Part B) oral doses of GSK1440115 in healthy adult male and female (of non-child
      bearing potential) subjects. This study will be a randomized, single-blind,
      placebo-controlled, dose escalation design. Part A will evaluate a single dose of GSK1440115.
      Part B will evaluate repeat daily doses for 7 days.
    

Intervention name(s): 1440115; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Internet-based Cognitive Behavior Therapy for Stress Disorders: a Randomized Trial
Condition: Adjustment Disorder; Burnout Syndrome
MeSH terms: Burnout, Psychological; Adjustment Disorders
Study type: Interventional

Summary: 
      Stress disorders in form of adjustment disorder and burnout syndrom are highly prevalent and
      cause substantial suffering. Prior evidence suggest that these disorders may be effectively
      treated with cognitive behavior therapy (CBT), but access to psychological treatment is
      limited. One possible solution is to provide therapy via the Internet, which has been shown
      to be effective for anxiety disorders and depression. In the present study, we will
      investigate the efficacy of Internet-based CBT (ICBT) for adjustment disorders and burnout
      syndrom in a randomized controlled trial (N=100). Participants will be randomized to active
      treatment (n=50) or a control condition on waiting list.
    

Detailed description: 
      Stress disorders in form of adjustment disorder and burnout syndrom are highly prevalent and
      cause substantial suffering. Prior evidence suggest that these disorders may be effectively
      treated with cognitive behavior therapy (CBT), but access to psychological treatment is
      limited. One possible solution is to provide therapy via the Internet, which has been shown
      to be effective for anxiety disorders and depression. Internet-based CBT can be described as
      online bibliotherapy with therapist support via a secure messaging system. In this study
      psychologists will deliver the treatment. We will investigate the efficacy of Internet-based
      CBT (ICBT) for adjustment disorder and burnout syndrom in a randomized controlled trial
      (N=100). Participants will be randomized to active treatment (n=50) or a control condition on
      waiting list. We expect that participants who receive ICBT will make superior improvements
      compared to the control condition on measures of stress, burnout, depressive symptoms,
      general anxiety and general functioning.
    

Intervention name(s): Internet-based CBT
Intervention type(s): Behavioral
Intervention description(s): Internet-based treatment with therapist support using an asynchronous messaging system. The treatment is comprised of 12 modules (similar to chapters) and the treatment is 12 weeks long. The treatment is based on cognitive behavior therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment