bioihbjkbjnl/mcl2 huggingface dataset:
Prebiotic Properties of Phenolic Compounds
Condition: Healthy
Study type: Interventional

Summary: 
      Gas evacuated per anus originates by-and-large in the colon, where unabsorbed meal residues
      are fermented by colonic bacteria. Within subjects, gas output varies in relation to the
      diet. However, there is a great interindividual variability: gas evacuation in subjects
      maintained on a similar diet may differ substantially, and this depends on the composition
      and metabolic pathways of the colonic microbiota. Hence, the volume of gas production and
      anal evacuation is determined by two main factors: the diet, particularly the amount of
      fermentable residues, and the individual composition of colonic microbiota. A series of
      recent studies suggest that some non-absorbable, fermentable meal products (prebiotics) serve
      as substrate to colonic bacteria and change their composition, thereby producing beneficial
      effects to the host. These products are fermented by bacteria and at initial intake increase
      gas production and may induce gas-related symptoms. However, after 7-10 days administration
      some prebiotics induce an adaptation of intestinal microbiota towards more efficient
      metabolic pathways with less gas production and the initial symptoms disappear. Some data
      suggest that phenolic compounds have prebiòtic properties. Aim of the study: to explore the
      prebiotic effect of a combination of two polyphenol-rich berry extracts (cranberry and
      chokeberry). Design: single-centre, single arm, open label, proof-of-concept study in healthy
      subjects. Intervention: a combination of a polyphenol rich extract of chokeberry (Aronia
      melanocarpa) and a polyphenol rich extract of cranberry (Vaccinium macrocarpon Aiton) will be
      administered for 18 days. Outcomes: during 2 days immediately before, at the beginning and at
      the end of the administration phase participants will be put on a standard diet and the
      following outcomes will be measured: a) number of gas evacuations during daytime for 2 days
      by means of an event marker; b) perception of digestive sensations by daily scales; c)
      microbiota composition by fecal analysis; d) metabolites in urine.
    


Intervention name(s): Prebiotic
Intervention type(s): Dietary Supplement
Intervention description(s): Combination of a polyphenol rich extract of chokeberry (Aronia melanocarpa) and a polyphenol rich extract of cranberry (Vaccinium macrocarpon Aiton) will be administered for 18 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: intestinal gas; healthy subjects; microbiota; prebiotics
Influence of Spinal Manipulative Therapy Upon Stroop Task Performance
Condition: Motor Response Time
Study type: Interventional

Summary: 
      The purpose of this study is to determine if spinal manipulative therapy can affect cognitive
      processing as determined by performance on a Stroop task. It is specifically hypothesized
      that number of errors and response times will decrease as a result of spinal manipulative
      therapy.
    


Intervention name(s): Spinal manipulative therapy
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Common Genetic Variation and Type 2 Diabetes
Condition: Pre-diabetes
MeSH terms: Diabetes Mellitus; Prediabetic State
Study type: Observational

Summary: 
      Type 2 diabetes is a common metabolic disorder arising from a complex interaction between
      genetic predisposition and the environment. The development of this disorder is preceded by
      impaired glucose tolerance and elevated fasting glucose which also carry adverse
      cardiovascular risk. To date a few common genetic variants have been reliably associated with
      predisposition to type 2 diabetes. However, it is uncertain how these genes interact to alter
      insulin secretion and insulin action prior to the development of type 2 diabetes. We propose
      to utilize an established population-based cohort to determine how common genetic variants
      associated with type 2 diabetes alter the response to an oral glucose challenge in people
      without overt type 2 diabetes. This will enable us to understand how common variants alone or
      in combination alter whole-body glucose physiology and predispose to type 2 diabetes.
    


Intervention name(s): Oral glucose tolerance test
Intervention type(s): Other
Intervention description(s): one time 75g oral glucose tolerance test for measurement of insulin secretion and action
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy, non-diabetic
      
Biospecimen description: 
      Samples for hormone measurement and DNA extraction
A Trial Comparing Mechanical Diagnosis and Treatment to Manual Therapy
Condition: Chronic Lower Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Mechanical diagnosis and treatment (MDT) and Manual Therapy (MT) have both demonstrated
      efficacy in the management of CLBP. The use of a Point of Care (POC) design in this study
      will allow for comparison of these two treatment modalities in a clinical setting. The
      purpose of this study is to demonstrate the feasibility of recruiting, enrolling and
      collecting outcome data on CLBP patients utilizing the POC methodology.
    

Detailed description: 
      20 new patients entering the chiropractic clinic who meet inclusion criteria including
      demonstrating a directional preference upon physical examination during their initial
      evaluation will be recruited. Patients will be queried as to interest and those interested
      will be consented. Patients will then be randomized utilizing a computer generated
      randomization chart to receive either MDT or MT delivered in a pragmatic manner. Outcomes
      will include: Pain (PEG), Quality of Life (PROMIS Global Health Survey (GHS)), psychosocial
      questions and Self Efficacy (2 Question). Outcomes will be collected at baseline, 4 weeks and
      8 weeks post baseline.
    

Intervention name(s): Mechanical Diagnosis and Therapy; Manual Therapy
Intervention type(s): Procedure; Procedure
Intervention description(s): Identification of directional preference.; Mechanically based treatment based on taking joint to end range and thrusting or soft tissue manipulation.
Other intervention name(s): McKenzie; Spinal Manipulative therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic lower back pain; Manual Therapy; Mechanical Diagnosis and Treatment
Mesh Fixation and Closure of Peritoneum Following Laparoscopic Hernia Repair Using N-butyl Cyanoacrylate
Condition: Hernia, Inguinal
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      Fixation of mesh and peritoneal closure during TAPP repair using n-butyl cyanoacrylate.
    

Detailed description: 
      During transabdominal pre peritoneal (TAPP) hernia repair a mesh should be fixed at four
      pre-determined points. Number of attempts to fix the mesh with a novel non-penetrating
      fixation device (LiquiBandFix8) will be recorded. This novel device uses n-butyl
      cyanoacrylate and a defined amount of glue can be delivered with this 5mm laparoscopic
      instrument (liquid anchors).

      In addition, closure of peritoneum should be accomplished using this device.
    

Intervention name(s): LiquiBandFix8
Intervention type(s): Device
Intervention description(s): Using LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of cogniVida™ on Learning and Memory and in Comparison to Placebo After Long-term Supplementation
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to examine the efficacy of cogniVida™ on learning and memory
      performance (executive function, associative, spatial and verbal memory) as well as on mood
      and attention parameters after four, eight and eleven weeks of supplementation and in
      comparison with placebo.

      cogniVida™ is considered a dietary supplement, and therefore it is not an approved drug by
      the Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug
      Administration does not strictly regulate herbs and dietary supplements. The investigators do
      not claim that this supplement is meant to treat any ailment.
    


Intervention name(s): cogniVida™ 100 mg/day; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 4 capsules 25 mg (total 100 mg) cogniVida™ once a day; 4 capsules of placebo identical to cogniVida™ once a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Cognition; Attention; Memory; Mood
A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II, randomized, double-blind, placebo-controlled multicenter study to
      evaluate the efficacy and safety of rontalizumab compared with placebo in patients with
      moderately to severely active systemic lupus erythematosus (SLE).
    

Detailed description: 
      The study will be conducted in 3 parts. Parts 1 and 2 of the study will include a
      double-blind treatment period of 24 weeks and a safety follow-up period of 48 weeks for
      participants who do not continue onto Part 3. Patients meeting the eligibility criteria for
      enrollment in Part 3, will enter Part 3 after completion of the Week 24 visit but prior to
      completion of the Week 72 visit. In Part 1, participants will be randomized in a 2:1 ratio
      (active drug:placebo) to receive either rontalizumab 750 mg or matching placebo intravenously
      every 4 weeks for 24 weeks. Part 2 was will be initiated upon the completion of recruitment
      for Part 1. In Part 2, participants will be randomized in a 2:1 ratio (active drug:placebo)
      to receive either rontalizumab 300 mg or matching placebo subcutaneously every 2 weeks for 24
      weeks. After Week 24, patients will enter a 48-week safety follow-up period, or, after the
      open label extension became available via protocol amendment, will have the option of
      entering Part 3 of the study, if eligible. In Part 3, all participants will receive
      rontalizumab 750 mg intravenously every 4 weeks for 120 weeks (up to 144 weeks total).
    

Intervention name(s): Placebo; Rontalizumab
Intervention type(s): Drug; Drug
Intervention description(s): Placebo was supplied as a sterile liquid solution.; Rontalizumab was supplied as a sterile liquid solution.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rhuMAb IFNalpha; SLE
Health Benefits of Chronic vs. Acute Exercise in Overweight Adults
Condition: Obesity
Study type: Interventional

Summary: 
      Compare the effects of single session of exercise vs. chronic exercise training on key risk
      factors associated with Metabolic Syndrome (e.g., glucose tolerance, blood lipid profile, and
      blood pressure) in overweight adults.
    


Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Subjects will exercise on a treadmill for 1 hour at moderate intensity (i.e., 90% of the exercise intensity found to elicit their ventilatory threshold during the preliminary testing, which is equivalent to approximately 60% of their maximal predicted heart rate).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: insulin sensitivity; exercise
Clinical Evaluation of NeoPlex4 Assay and NeoPlex System
Condition: Adrenal Hyperplasia, Congenital; Congenital Hypothyroidism; Cystic Fibrosis
MeSH terms: Congenital Hypothyroidism; Cystic Fibrosis; Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Hypothyroidism; Hyperplasia
Study type: Observational

Summary: 
      The purpose of this study is to assess the agreement of clinical performance between the
      proposed NeoPlex 4 assay and NeoPlex System and the comparator devices in clinical use in
      newborn screening programs for detection of T4, TSH, 17-OHP and IRT.
    

Detailed description: 
      The proposed (investigational) NeoPlex4 assay measures levels of thyroxine (T4), thyrotropin
      (hTSH), 17-alpha-OH-progesterone (17-OHP) and immunoreactive trypsinogen (IRT) from dried
      blood specimens (DBS) collected from neonates to screen for congenital hypothyroidism (CH),
      congenital adrenal hyperplasia (CAH) and cystic fibrosis (CF). The Clinical Evaluation of the
      xMAP® NeoPlex4™ Assay (NeoPlex4) for Detection of T4, TSH, 17-OHP and IRT using the NeoPlex
      System is a multi-center method concordance study on a combination of prospectively collected
      neonatal dried blood spots and pre-selected archived frozen dried blood spots that have been
      demonstrated to be positive for 17-OHP (CAH), IRT (CF), and T4 or TSH (CH). The study will be
      conducted at selected sites that routinely perform newborn screening testing in the United
      States.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Specimens will be derived from prospectively collected neonatal specimens and banked
        neonatal specimens originating from hospitals, birthing centers, and/or clinics. Newborn
        screening is currently performed on all neonates; there is no selection criterion for
        subjects.
Proprioceptive Training and Low Back Pain
Condition: Proprioceptive Training; Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Proprioceptive weighting changes may explain differences in postural control performance.
      Deficits in proprioception are found in a subgroup of patients with low back pain.

      The aim of the study is to clarify whether proprioceptive training has a positive effect on
      proprioceptive postural control in individuals with recurrent low back pain.
    


Intervention name(s): Proprioceptive training; Sham proprioceptive training
Intervention type(s): Other; Other
Intervention description(s): 12 weeks; Three times daily inspiratory muscle training (2x30 breaths) at an intensity of 10% Pi,max
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety Study of HSV2 DNA Vaccine to Treat Patients With Recurrent Genital Herpes Caused by HSV-2
Condition: HSV-2
MeSH terms: Herpes Genitalis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate how well the vaccine is tolerated at sites where
      administrations are given and any effects it may have on subjects' wellbeing. The study will
      also test the ability of vaccine to cause particular immune responses in the body and
      evaluate the effect it has on herpes outbreaks
    

Detailed description: 
      Herpes simplex virus type 2 (HSV-2) infection is a serious public health problem, with up to
      20% of the US population infected. Following primary infection, HSV-2 establishes a latent
      infection that can lead to recurrent disease when the virus reactivates. Genital lesions are
      often experienced with viral recurrence and these can be uncomfortable and painful, resulting
      in significant anxiety and social distress. There are no commercial vaccines available for
      therapy of HSV-2 infection.The aim of a therapeutic vaccine would be to enhance such natural
      responses by boosting the appropriate cellular immune response to HSV-2 in those latently
      infected individuals who experience frequent and unwanted reactivations. The purpose of this
      study is to evaluate the safety and tolerability profile of the pPJV7630 HSV-2 DNA vaccine as
      administered by Particle Mediated Epidermal Delivery (PMED )
    

Intervention name(s): pPJV7630 administered by PMED
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DNA vaccine; immunotherapy; Herpes Simplex Virus Type 2 (HSV2); Particle Mediated Epidermal Delivery
Enjoyment of Infant Formulas Based on Cow or Goat Milk Protein
Condition: Feeding Behavior; Feeding, Bottle
Study type: Interventional

Summary: 
      To assess parental perceptions on infant feeding behavior and enjoyment with a goat milk
      formula compared to a cow milk formula
    

Detailed description: 
      This is a feasibility study to determine the utility of two new standardized psychometric
      tools for paediatricians to assess and manage feeding difficulties in formula fed infants.
      Baby Eating Behaviour Questionnaire (BEBQ) and Montreal Children's Hospital Feeding Scale
      (MCH-Feeding Scale) will be used in this study.

      The secondary objectives are to determine if these tools can then measure the changes in
      behaviour after introducing two formula that differ in the sources of protein, ie formula
      made from whole goat milk compared to a conventional formula made from cow milk proteins. The
      quality of life and general health outcomes of these infants will also be monitored.
    

Intervention name(s): CMF; GMF
Intervention type(s): Other; Other
Intervention description(s): Taking a infant formula based on cow milk protein fractions, 4-5 feeds per day given by bottle, 180-210 ml/feed, total 800-900ml per day for one mounth; Taking a infant formula based on whole goat milk, 4-5 feeds per day given by bottle, 180-210 ml/feed, total 800-900ml per day for one mounth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Personalized Smartphone-assisted Coaching System to Improve Glucose Homeostasis in Adults With Prediabetes
Condition: Prediabetes; Hyperglycemia; Postprandial Hyperglycemia; Impaired Glucose Tolerance; Impaired Fasting Glucose
MeSH terms: Hyperglycemia; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      Sweetch is a personalized mobile-health platform coaching system (mobile phone app) designed
      to promote adherence to physical activity guidelines for people with prediabetes.
    

Detailed description: 
      The mobile phone app Sweetch seeks to increase leisure time physical activity rather than
      formal exercise through the use of a behavioral analytics engine that continuously process
      various aspects of the user's life habits, taking into account the user's demographics,
      behavioral change status, schedule, actual activity patterns, and more. The rationale behind
      this approach is that long-term adherence and patient engagement are more likely to be
      achieved when demands on manual user data entry are kept at a minimum. Compared to similar
      smartphone-assisted prevention apps, there are two novel features of the Sweetch app that may
      increase its efficacy. First, it uses a "just-in-time" adaptive intervention" approach that
      tailors recommendations to the user's day-to-day routine and his or her readiness for
      behavioral change. Second, and most importantly, it requires no direct involvement by the
      user, since all the necessary data is collected using built-in tracking pedometers,
      accelerometer and GPS (Global Positioning System) sensors on smartphones. In contrast,
      interventions that focus on dietary changes (i.e. calorie reduction, change in macronutrient
      content), require active user tracking at every meal, which is difficult to maintain in the
      long-term even with the use of sophisticated, electronic calorie counting tools. For these
      reasons, the Sweetch app may achieve greater long-term adherence, which is usually a limiting
      factor to efficacy of mobile health interventions.
    

Intervention name(s): Sweetch App + DBWS; Sweetch App Alone
Intervention type(s): Other; Other
Intervention description(s): Usual care for prediabetes management, Sweetch app, weight monitoring via digital body weight scale (DBWS).; Usual care for prediabetes management, Sweetch app alone.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Mobile Health
Rotator Interval and Intra-articular Corticosteroid Injection for Frozen Shoulder
Condition: Adhesive Capsulitis
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      The purpose of this study is to compare ultrasound guided capsular corticosteroid injection
      into the rotator interval/anterior capsule and the GH joint with ultrasound guided
      corticosteroid injection into the GH joint only. Both methods will be compared with placebo
      injections.

      Primary outcome measure: pain reduction at week 6 Secondary outcome measures: improvement of
      function (SPADI, Life quality, ROM).

      0-hypothesis: no difference between the methods.

      The investigators want to find out if the clinical effect of the combined capsular and
      intra-articular injections are better than placebo and better that intra-articular injections
    

Detailed description: 
      3 groups, 50 patients in each, follow-up visits after 3, 6, 12 and 26 weeks.
    

Intervention name(s): Triamcinolone hexacetonide; Triamcinolone hexacetonide
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg; 1 ml (20 mg) + 6 ml Lidocaine 10 mg/ml
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: adhesive capsulitis; corticosteroids; injection; pain
Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Under Fasted Conditions
Condition: Pain
Study type: Interventional

Summary: 
      The objective of this study designed to characterize the pharmacokinetics and comparative
      bioavailability of Roxane Laboratories' codeine sulfate tablets after oral administration of
      60 mg doses as 1 x 60 mg, 2 x 30 mg and 4 x 15 mg under fasted conditions.
    


Intervention name(s): Codeine Sulfate
Intervention type(s): Drug
Intervention description(s): 15 mg, 30 mg and 60 mg Tablet
Intervention MeSH terms: Codeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment