bioihbjkbjnl/mcl2 huggingface dataset:
Bioavailability Study of Tramadol/APAP Tablets Under Fed Conditions
Condition: To Determine Bioequivalence Under Fed Conditions
MeSH terms: Malnutrition; Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the relative bioavailability of Kali and Ortho-McNeil's products
    

Detailed description: 
      To compare the relative bioavailability of Kali's Tramadol/APAP 37.5mg/325mg with
      Ortho-McNeil's Ultracet tablets 37.5mg/325mg
    

Intervention name(s): Tramadol/ APAP; Ultracet
Intervention type(s): Drug; Drug
Intervention description(s): Tablets 37.5mg /325mg; Tablets, 37.5mg/325mg
Other intervention name(s): Ultracet; Tramadol/APAP
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: bioequivalence, single-dose, fed
Quinine and Food Intake
Condition: Obesity
Study type: Interventional

Summary: 
      Rationale: The appearance of tastants in the small intestine following food ingestion results
      in the onset of digestion and absorption but can also result in the activation of a negative
      feedback mechanism from different parts of the intestine to the stomach, the small intestine
      and to the central nervous system. These processes inhibit food processing, appetite
      sensations and food intake, and furthermore they increase feelings of satiety and satiation.
      In this study, we aim to investigate the effects of oral sham feeding and intragastric
      delivery of a bitter tastant (quinine) on ad libitum food intake, satiation, gastrointestinal
      symptoms, and heart rate variability.

      Objective: To investigate the effect of oral sham feeding and intragastric delivery of a
      bitter tastant on food intake.

      Secondary Objective(s):

        1. To compare the effect of oral sham feeding and intragastric delivery of a bitter tastant
           on satiation.

        2. To assess the effect of oral sham feeding and intragastric delivery of a bitter tastant
           on gastrointestinal symptoms/complaints.

        3. To assess the effect of oral sham feeding and intragastric delivery of a bitter tastant
           on heart rate variability.
    


Intervention name(s): Quinine sham feeding quinine; Gastric quinine; Oral sham feeding placebo; Gastric placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Oral sham feeding with quinine; A gastric capsule containing quinine; Oral sham feeding with placebo (tap water); A gastric capsule containing placebo (cellulose)
Intervention MeSH terms: Quinine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Adhesive Capsulitis : A Pilot Study
Condition: Adhesive Capsulitis
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      This is a 2-arm parallel pragmatic randomized controlled trial that will compare
      pharmacopuncture therapy with physical therapy for adhesive capsulitis.
    

Detailed description: 
      Participants who voluntarily signed informed consent form and eligible for the study were
      randomly assigned in a 1:1 ratio (25:25) for pharmacopuncture therapy and physical therapy
      group. Participants of each group will receive twice a week for total 6 weeks of
      intervention. This is a pragmatic randomized controlled trial, so physicians will have
      medical decision making according to each participant's conditions.
    

Intervention name(s): pharmacopuncture therapy; physical therapy
Intervention type(s): Procedure; Procedure
Intervention description(s): This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions.; This is a pragmatic RCT, so the physicians will choose the type and time of physical therapy according to participants' conditions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Effectiveness of Kinesio Taping in Patients With Chronic Low Back Pain
Condition: Chronic Low-back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The objective of this study is to determine the effectiveness of Kinesio taping (KT) with
      Conventional Physical therapy (CPT) - Transcutaneous Electrical Nerve Stimulation (TENS) and
      Supervised Exercise therapy and CPT in the management of CLBP.
    

Detailed description: 
      Chronic low back pain (CLBP) is one of the most common causes of chronic disability which
      leads to major social and economic consequences. The role and effectiveness of the Kinesio
      taping (KT) and Conventional Physical therapy (CPT) are evident from the existing literature
      but no comparison was found on the combination of other physical therapy techniques such as
      supervised exercise therapy and Transcutaneous Electrical Nerve Stimulation (TENS) with CLBP
      in the Kingdom of Saudi Arabia
    

Intervention name(s): Kinesio taping; Conventional physical therapy
Intervention type(s): Other; Device
Intervention description(s): Kinesio taping: The tape is measured from the sacrum to the 12th thoracic vertebra with forwarding flexion of the trunk. The base is affixed to the insertion in the resting position. The muscle is elongated and the base anchored with skin displacement. The tape is then affixed with 10% stretch paravertebrally over the muscle bundles up to T12. The tape is rubbed with the muscle in the elongated state.; Transcutaneous electrical nerve stimulation device settings, such as the frequency of 80 Hz, the pulse width of 100 µs, and symmetrical biphasic waveform. Four mediums sized (2 × 2 cm) carbon-impregnated rubber cutaneous electrodes were placed bilaterally in a standard dermatomal pattern over the most painful lumbar region. The current intensity was increased up to the patient's perception of paraesthesia. The supervised exercise therapy management consisted of stretching exercises for the back, iliopsoas, gluteal and hamstring muscles, and strengthening exercises for the abdominal and back muscles. Three sets of stretching exercises, each involving a 30-sec hold and 30-sec of rest repeated three times, were performed in three sessions per week over four weeks. One set of strengthening exercises, consisting of 10 repetitions with a 5-sec hold, was performed in three sessions per week over four weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low back pain; Chronic; Kinesio taping; TENS; Exercises
Natural History of Pain After Shoulder Arthroplasty Conducted With Multimodal Analgesia
Condition: TSA; Bruise; Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      This study aims to identify the timeline of pain following total shoulder replacement with
      the goal of developing data for a subsequent randomized trial. The investigators believe that
      with using HSS's current protocol, many patients have postoperative pain that is no worse
      than their preoperative pain. Previous HSS anesthesia protocols for total shoulder
      arthroplasty patients have not formally followed patients past their hospital discharge, and
      the investigators believe that some patients do experience moderate to severe subacute
      postoperative pain. Therefore, this study's primary outcome is to look at the numeric pain
      scores at 14 days after surgery. Future studies will look at measures of preventing bruising
      and subsequent pain after shoulder replacement.
    

Detailed description: 
      This is a pilot study, with the goals of

        1. developing data for a subsequent randomized trials

        2. describing the pain trajectory after total shoulder arthroplasty given comprehensive
           multimodal perioperative analgesia

        3. gathering preliminary data about which shoulder arthroplasty patients are at high risk
           for moderate or severe postoperative pain (NRS with movement, POD14, moderate >= 4- 6;
           Gerbershagen 2011; severe >= 7-10, Krebs 2007) Potential factors include fibromyalgia
           score, catastrophizing score, anxiety/depression score, gender, preoperative opioid use

        4. gathering preliminary data on the potential association between the predictors listed in
           (c) and NRS pain score with movement on POD 14.

        5. estimating incidence and severity of postoperative bruising on POD 14
    

Intervention name(s): Surveys
Intervention type(s): Other
Intervention description(s): The study is just using validated surveys to assess pain and mood states after surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing TSA for Osteoarthritis, Reverse, Anatomic procedures
Effect of Keratinized Mucosa on Peri-implant Health
Condition: Keratinized Mucosa; Dental Implant; Free Gingival Graft
Study type: Interventional

Summary: 
      The aim of this clinical study is to evaluate the significance of keratinized mucosa and to
      investigate the influence of free gingival graft procedure on peri-implant health status in
      patients after prothesis delivery.
    

Detailed description: 
      The study will be conducted in Faculty of Dentistry, Kutahya Health Sciences University . The
      patients who applied to the Department of Periodontology, received dental implant treatment,
      and required routine follow-up for the maintenance of peri-implant health will be included.
      Clinical and radiographic examinations will be performed at baseline (prothesis delivery) and
      at the end of the 3rd, 6th month, 1st year following the prosthetic loading. During clinical
      examination probing depth (PD), modified plaque index (mPI) and modified bleeding index (mBI)
      measurements will be evaluated with the Williams periodontal probe. These measurements will
      be taken at four points of the implant (mid-buccal, mesio-buccal, disto-buccal and
      mid-lingual) and these four measurements will be averaged for each implant. In addition, the
      amount of keratinized mucosa (KM) in the implant sites will be evaluated by measuring the
      mucosal margin and mucogingival junction on the vestibular surface with the same probe. After
      clinical examination, a periapical radiograph will be taken using a parallel technique to
      determine marginal bone loss surrounding the implant. The distance between the implant neck
      and the most coronal part of the alveolar crest will be measured on the mesial and distal
      surfaces for each implant on the obtained radiographs and the average of the two measurements
      will be taken. The parameters checked during clinical and radiographic examination will be
      compared between patients with or without keratinized mucosa and whose keratinized mucosa has
      been increased by free gingival graft.
    

Intervention name(s): Free gingival graft procedure
Intervention type(s): Procedure
Intervention description(s): Free gingival graft procedure applied to implants with KM<2 mm to increase the width of keratinized mucosa surrounding them
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Investigation of KLYX in Patients With Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomised, assessor-blind, multi-centre pilot study to investigate the comparative
      safety and efficacy of KLYX and glycerine enema in the symptomatic treatment of constipation
      in Chinese patients.
    


Intervention name(s): KLYX; Glycerine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Glycerol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Assess the Safety and Adhesive Performance of the VIPER System When Compared to Esteem™
Condition: Ostomy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to assess the safety and adhesive performance of the
      VIPER System when compared to the Esteem™ Cut to Fit One Piece Closed End Pouch when used by
      healthy volunteers.
    


Intervention name(s): VIPER; Esteem™ Cut to Fit One Piece Closed End Pouch
Intervention type(s): Device; Device
Intervention description(s): Comparison of ostomy systems; Comparison of ostomy systems
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Non-invasive Transcranial Electrical Stimulation in MS
Condition: Multiple Sclerosis; Cognitive Impairment
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The goal is to investigate the effects of non-invasive transcranial electrical stimulation on
      cognition in MS.
    

Detailed description: 
      The participants' baseline cognitive function will be assessed with a tablet-based,
      videogame-like software specifically designed as a medical device to test and train cognitive
      function for populations with cognitive disorders. After baseline test assessment,
      participants will receive stimulation while playing the training version of the software.
      After the stimulation, cognitive performance will be evaluated again with the testing
      version. Investigators will assess changes in cognitive performance associated with
      stimulation.
    

Intervention name(s): non-invasive transcranial electrical stimulation
Intervention type(s): Device
Intervention description(s): Non-invasive transcranial electrical stimulation across the prefrontal cortex.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Addressing Uncontrolled Diabetes in Primary Care: A Lifestyle Redesign Approach
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      This study is examining the feasibility of implementing an occupational therapy intervention
      addressing diabetes management in a primary care clinic within the Los Angeles County
      Department of Health Services (LAC-DHS), as well as the impact of this intervention approach
      on clinical outcomes, efficiency and patient-centeredness of care. This implementation
      science study is evaluating two emerging trends in healthcare delivery: (1) the integration
      of nontraditional providers into primary care medical home (PCMH) settings to facilitate the
      delivery of high-quality, comprehensive primary care while reducing the burden on physicians;
      and (2) the potential value of using occupational therapists to address chronic disease
      management in this setting
    


Intervention name(s): Lifestyle Redesign
Intervention type(s): Behavioral
Intervention description(s): Individualized lifestyle intervention incorporating the following topics: Diabetes knowledge; access to healthcare; communication with healthcare providers; incorporation of diabetes self-care tasks within daily habits and routines; social support; and emotional well-being. Participants receive approximately 8 hours of intervention by a licensed occupational therapist with training in diabetes education, motivational interviewing and the intervention protocol.
Other intervention name(s): Resilient, Empowered, Active Living with Diabetes (REAL)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Body Mass Index on Thoracic Paravertebral Block Analgesia
Condition: Pain, Postoperative; Acute Pain; Thoracic Paravertebral Block; Body Mass Index; Thoracic Surgery, Video-Assisted
MeSH terms: Aortic Dissection; Pain, Postoperative; Acute Pain
Study type: Interventional

Summary: 
      Obesity has become one of the world's leading health problems. It is known that obesity
      causes many diseases and negatively affects the quality of life. For this reason, many
      conditions that are thought to be effective in obesity and concern the quality of life of
      patients have been scientifically researched and continue to be investigated. One of them is
      postoperative pain. Although there are studies stating that there is no relationship between
      body mass index (BMI) and postoperative pain, when the literature data is examined, it is
      thought that obesity is a risk factor for postoperative pain and changes pain sensitivity and
      analgesic needs of patients. There are also studies in the literature stating that the level
      of postoperative pain increases in parallel with each unit increase in BMI.

      After thoracic surgery, many analgesic methods have been suggested, including thoracic
      epidural analgesia (TEA), thoracic paravertebral block (TPVB), intercostal nerve blocks
      (ICSB), erector spina plane block (ESPB), serratus anterior plane block (SAPB). This study
      will compare the effects of BMI on postoperative pain in patients undergoing TPVB for
      postoperative analgesia and thoracoscopic surgery.
    


Intervention name(s): Thoracic Paravertebral Block
Intervention type(s): Procedure
Intervention description(s): Thoracic paravertebral block will be applied to the patients under real-time ultrasound guidance.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
NEM® Versus Placebo in Exercised-induced Joint Pain, Stiffness, & Cartilage Turnover in Healthy Men & Women
Condition: Exercise-induced Joint Pain; Exercise-induced Joint Stiffness; Exercise-induced Joint Cartilage Turnover
MeSH terms: Arthralgia
Study type: Interventional

Summary: 
      This study is intended to evaluate the effect of the dietary supplement NEM® brand eggshell
      membrane versus placebo in reducing exercise-induced joint pain, stiffness & cartilage
      turnover in healthy men & women. Half of the study participants will receive NEM, once daily,
      orally while the other half of the study participants will receive placebo, once daily,
      orally while performing an exercise regimen every other day for two weeks.
    

Detailed description: 
      Moderate exercise can induce discomfort in joints when done infrequently or when done too
      intensely or for too long a period. This discomfort is often realized as either pain or
      stiffness in the joint that was the focus of the exercise. For example, one's knees will hurt
      after jogging for several miles, particularly if jogging for the first time. This study is
      intended to evaluate whether NEM® brand eggshell membrane can alleviate joint pain or
      stiffness, either directly following exercise or 12 hours post-exercise versus placebo. The
      study will also evaluate NEM's effect, on cartilage turnover via the cartilage degradation
      biomarker c-terminal cross-linked telopeptide of type II collagen (CTX-II). Participants will
      perform a minimum of 40 steps per leg utilizing an aerobics step at the clinical site. They
      will follow this exercise regimen on alternating days for 2 consecutive weeks. Changes in
      pain & stiffness (immediate & 12-hour) will be compared to both baseline and to the placebo
      group. Urine samples will also be collected at baseline and at the end of Week 1 & Week 2.
      The change in CTX-II from baseline will be compared to the placebo group.
    

Intervention name(s): NEM® brand eggshell membrane; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dietary supplement for the support of joint health.; Placebo
Other intervention name(s): Natural Eggshell Membrane
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: treatment versus placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: exercise-induced; joint pain; joint stiffness; cartilage turnover; CTX-II
A Randomized, Single Blind, Placebo Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Oral Doses and Repeat Escalating Oral Doses of GSK2251052 in Healthy Adult Subjects
Condition: Infections, Bacterial
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK2251052 ((S)-3-(aminomethyl)-7-(3-hydroxypropoxy)-1-hydroxy-1,3-dihydro-2,1-benzoxaborole
      hydrochloride) is a Gram negative antibacterial compound currently in development for the
      treatment of hospital acquired Gram negative infection (including E. coli, K. pneumoniae, and
      Enterobacter spp.) This study will be conducted in two (2) parts, with single oral doses
      being explored in Part A (500, 1000, and 2000 mg) and repeat oral doses (1000 and 2000 mg,
      b.i.d.) being explored in Part B. Parts A and B will be single-blind, randomized,
      placebo-controlled, dose-rising studies in healthy subjects to evaluate the safety,
      tolerability and pharmacokinetics of oral GSK2251052.
    


Intervention name(s): GSK2251052; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg tablet, dose levels detailed in Arm description; matching placebo tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: pharmacokinetics; tolerability; single dose; antibiotics; repeat dose; GSK2251052; safety
Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids
Condition: Glucocorticoids Toxicity; Glucose Intolerance
MeSH terms: Glucose Intolerance
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the effect of acute administration of oral prednisone in white blood
      cells counts and glucose tolerance and the relationship of these measures with changes in
      gene expression in healthy volunteers. White blood cells counts, glucose tolerance and gene
      expression will be study before and after prednisone administration.
    

Detailed description: 
      Prednisone is a potent anti-inflammatory drug that has large variability in its response. The
      large inter individual variability in the response to prednisone has a genetic component, but
      the genetic determinants of this variability remain unknown. We propose to use two relevant
      phenotypes, changes in white blood cell counts and changes in glucose tolerance induced by in
      vivo administration of prednisone, to characterize gene expression patterns and identify
      variants that are involved in the in vivo response to prednisone.
    

Intervention name(s): Prednisone
Intervention type(s): Drug
Intervention description(s): Prednisone 60 mg tablet once
Other intervention name(s): generic, not applicable
Intervention MeSH terms: Prednisone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: glucocorticoids; efficacy; metabolic toxicity