bioihbjkbjnl/mcl2 huggingface dataset:
Naltrexone Maintenance Treatment of Alcoholism
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the long-term effectiveness of naltrexone treatment
      in alcohol-dependent patients who respond to short-term treatment. Those who respond to
      short-term treatment will be randomized to a 1-year, double-blind, placebo-controlled
      maintenance phase with a 6-month posttreatment followup.
    


Intervention name(s): Naltrexone Tablet; Matched Placebo Tablet
Intervention type(s): Drug; Drug
Other intervention name(s): Revia; Placebo
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Naltrexone 50 mg was provided for 3 months to all study participants, who were masked regarding the identity of study medication. At 3 months, full and partial responders were randomized to an additional 9 months of double blind treatment with naltrexone or matched placebo. Full responders were defined as complete abstinence for the last six weeks of the acute phase. Partial responders were defined as having no more than 2 heavy drinking days in any given week and/or a 50% reduction in weekly alcohol consumption from baseline over the last six weeks of the acute phase.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
LESS-TLH Versus LESS-LAVH
Condition: Benign Uterine Disease
MeSH terms: Uterine Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      During the last 2 decades, several studies have tried to define the best surgical approach to
      hysterectomy for benign uterine diseases1. Accumulating evidence demonstrates that abdominal
      hysterectomy has a higher incidence of complications, a longer hospital stay and a slower
      convalescence in comparison with laparoscopic hysterectomy (LH). The main advantage of LHs is
      the absence of a wide abdominal scar, which results in fewer wound-related complications and
      in a significant decrease of postoperative pain.

      Technologic advances in endoscopic instrumentation and optics have allowed the development of
      an even less invasive procedure than conventional LH using multiple ports: laparoendoscopic
      single-site (LESS) surgery, also known as single-port access (SPA) laparoscopy3. In the LESS
      approaches, total laparoscopic hysterectomy (TLH) and laparoscopically-assisted vaginal
      hysterectomy (LAVH) are all feasible, with comparable conventional LH. However, it is yet to
      be determined which of two alternative and less invasive approaches (LESS-TLH and LESS-LAVH)
      should be preferred. In particular, none has focused on postoperative pain as the primary
      outcome of the study. The investigators have therefore designed the randomized trial to
      investigate specifically differences in postoperative pain after LESS-TLH and LESS-LAVH.
    


Intervention name(s): LESS-TLH; LESS-LAVH
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Endogenous Modulation of Pain and Stretch Tolerance
Condition: Pain Threshold
Study type: Interventional

Summary: 
      This study investigates the role of two endogenous inhibitory mechanisms; exercise-induced
      hypoalgesia (EIH) and a conditioning painful stimulus (CPM) on passive joint range of motion,
      passive resistive torque and pain sensitivity. The study is a randomized, repeated-measures
      cross-over study.
    

Detailed description: 
      The increase in range of motion following stretching is related to changes in the tolerance
      to stretch. The mechanistic relationships behind these changes in subject sensation are
      however unknown but could be related to endogenous modulation of pain.
    

Intervention name(s): Exercise induced hypoalgesia (EIH); Static stretch (SS); Rest; Conditioned pain modulation (CPM)
Intervention type(s): Other; Other; Other; Other
Intervention description(s): An EIH response was induced by a 3-minute isometric contraction of the hand flexor muscles at 25% of maximal voluntary contraction (MVC).; Two bouts of 30 seconds of static stretching (SS) of the knee flexors.; The participants rested in a seated position for 10 minutes; A CPM response was induced by way of the cold pressor test.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This was a randomized, repeated-measures cross-over study. Passive knee extension range of motion was measured three consecutive times with five-minute intervals between measurements. Both groups underwent a static stretch protocol consisting of two bouts of thirty-second constant-angle static stretching of the knee flexors with a one-minute rest between bouts. Subjects were instructed to keep the limb relaxed as the lower leg was passively moved towards extension. Following stretching, the post-stretch measurement was performed. Finally, subjects in the pain group were instructed to immerse their non-dominant hand into a container with circulating water at 1˚C to 4˚C and keep it there for 2 minutes. A Biodex system 4 pro dynamometer was used to quantify range of motion and passive resistive torque. Pressure pain thresholds was assessed using a handheld pressure algometer (Somedic AB, Hörby, Sweden).
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Stretch tolerance; Stretching Exercises; Exercise induced hypoalgesia
Oxycodone in Serum After Postoperative Oral Oxycodone in Caesarean Sections Under Spinal Anesthesia
Condition: Analgesic Adverse Reaction; Cesarean Delivery Affecting Newborn
Study type: Observational

Summary: 
      All patients undergoing an elective caesarean section under spinal anesthesia will, according
      to the hospital routines, receive 10 mg oxycodone slow-release tablet when arriving at our
      postoperative care unit (PACU). Blood samples will be taken at 0 hour, 1 hour, 2 and 6 hours
      after administration in order to investigate bioavailability.
    

Detailed description: 
      After written informed consent, blood samples will be taken before administration, after 1
      hour, 2 hours and 6 hours. Need of rescue analgesia (morphine iv) and level of pain, as well
      as side effects will be registered
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with single fetus in cephalated position admitted for elective caesarean section in
        spinal anesthesia
      
Biospecimen description: 
      Serum from blood
    
Keywords: oxycodone, caesarean, spinal anesthesia
Nasal Intubation Using the Blind Intubation Device
Condition: Intubation
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether nasal tracheal intubation using Blind
      Intubation Device is safe and effective in anesthetized patients with Mallampati class 3
    

Detailed description: 
      The Blind Intubation Device (BID,Anhui Xiao Shan Hygienic Material Co.Ltd,Jixi County,China)
      is newly introduced for awake nasal intubation using a transillumination principle. For oral
      and maxillofacial surgery patients with anticipated difficult airways, the BID has a high
      rate of successful awake nasal intubation.Since the BID is more readily accessible,disposable
      and considerably less expensive,these advantages speak well for its use in China.However,to
      date,there is no study on its usage in anesthetized patients.The investigators hypothesized
      that a BID would be effective for nasal intubation in anesthetized patients with high
      Mallampati class and would result in fewer hemodynamic responses. To examine our hypothesis,
      the investigators would like to perform a prospective,randomized,controlled study to compare
      the effectiveness of the BID technique with a direct laryngoscope for nasal intubation in
      anesthetized patients with Mallampati class 3. The primary outcome measures are the
      hemodynamic changes during intubation. The investigators also would like to compare the
      intubation time required and associated airway complications in both groups as our second
      outcome.
    

Intervention name(s): Macintosh laryngoscope; Blind Intubation Device
Intervention type(s): Device; Device
Intervention description(s): nasal intubation with macintosh laryngoscope after general anesthesia induction; nasal intubation using Blind Intubation Device after general anesthesia induction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: nasal; intubation; direct laryngoscope; blind; normal airway
Quinagolide Vaginal Ring on Lesion Reduction Assessed by MRI in Women With Endometriosis/Adenomyosis
Condition: Endometriosis
MeSH terms: Endometriosis; Adenomyosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a randomized, double-blind, placebo-controlled, proof-of-mechanism phase 2 trial
      investigating the effect of quinagolide extended-release vaginal ring on reduction of lesions
      assessed by high-resolution magnetic resonance imaging in women with endometrioma, deep
      infiltrating endometriosis, and/or adenomyosis.
    


Intervention name(s): Quinagolide 1080 µg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Vaginal ring containing Quinagolide 1080 µg for daily releases; Matching placebo
Other intervention name(s): FE 999051
Intervention MeSH terms: Quinagolide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Endometrioma; Adenomyosis; Deep infiltrating endometriosis
Silk'n HST Device Usability and Self Selection Study
Condition: Wrinkles
Study type: Interventional

Summary: 
      This is a Usability study, conducted for the purpose of testing Silk'n HST Device usability.
    

Detailed description: 
      Study objectives:

      To test the Silk'n HST Device usability, i.e., the self-selection, labeling comprehension,
      and safe and effective device use by potential end users, under actual use conditions.
      Additionally, this study was aimed to evaluate if contraindicated subjects self-exclude from
      use of the device.

      Investigation Design:

      The study is a usability study. Twenty five potential participants were enrolled in a single
      location (shopping mall). Participants received the Silk'n HST device in its original package
      with the complete user manual and performed a full treatment. Post-treatment questionnaire
      and labeling comprehension exam were conducted following treatment. Out of the twenty five
      subjects five participants contraindicated to the study inclusion criteria were self-exclude
      from use of the device.

      Success criteria:

      Using the device, all 20 tested subjects are able to complete device related tasks, including
      applying and operating the Silk'n device without assistance in a timeframe of up to one hour
      and with minimal attempts to ask for assistance.

      Additionally, measurable usability criteria for specific, critical steps, such as
      time-to-completion, frequency of attempts to ask examiner, numerical ratings, etc., were
      evaluated using observer evaluation and user post-test questionnaire responses.

      Sample Size:

      Twenty five subjects identified as potential end users of the device including five subjects
      with contraindication to the device were recruited to the study. The number of subjects is
      appropriate considering the device and user related risks, low probable occurrence and
      severity of these risks, and the design of the study. Furthermore, usability studies are not
      seeking statistical significance.
    

Intervention name(s): Silk'n HST treatment
Intervention type(s): Device
Intervention description(s): Intervention includes treatment with the Silk'n HST on the periorbital areas as instructed in the user's manual
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pre-surgical Antisepsis Using an Alcoholic Solution of Chlorhexidine Digluconate and Potassium Sorbate
Condition: Antisepsis
Study type: Interventional
Phase: Phase 4

Summary: 
      The present study evaluates the effects of bactericidal load reduction after surgical hand
      scrub antisepsis using the reference antiseptic product propan-ol-1 60% as control versus a
      surgical hand scrub antisepsis with addition of a solution of chlorhexidine digluconate and
      potassium sorbate in order to test if pass the standard european norm 12791.
    

Detailed description: 
      The investigators conducted a crossover clinical trial to evaluate the antiseptic
      effectiveness of preoperative surgical scrubbing using propan-ol-1 60% by scrub using the
      reference antiseptic product propan-ol-1 60% as control versus a surgical hand scrub
      antisepsis with addition of a solution of chlorhexidine digluconate and potassium sorbate in
      order to test if pass the standard european norm 12791. Samples will be taken from the hands
      of each volunteer after a surgical hands antiseptic.
    

Intervention name(s): Hand antisepsis with Clorhexidine and solution
Intervention type(s): Drug
Intervention description(s): Hand antisepsis by scrub Surgical Hand scrubbing using chlorhexidine digluconate with the addition of an alcoholic solution of chlorhexidine digluconate and potassium sorbate. both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side
Other intervention name(s): Clorhexidine and alholic solution dicluconate cloehexidine and potassium sorbate
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover Assignment Crossover design is used
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Combined Inspiratory Muscle and 'Whole Muscle' Training in Children With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      To study the effects of an 8-week combined inspiratory muscle training and exercise
      (resistance+aerobic) program on of a lung volume, inspiratory muscle strength (maximal
      inspiratory pressure, PImax) and cardiorespiratory fitness (maximal oxygen uptake, VO2peak)
      (primary outcomes)and dynamic muscle strength, body composition and quality of life (QoL) in
      children with Cystic Fibrosis (CF) (secondary outcomes).
    

Detailed description: 
      The investigators hypothesized that the combined training program would significantly benefit
      most of the aforementioned variables (especially, primary outcomes).
    

Intervention name(s): Other
Intervention type(s): Other
Intervention description(s): inspiratory muscle training (IMT) + aerobic and strength training 8-week duration IMT twice a day (mostly at home) + 3 weekly sessions of inhospital resistance + aerobic training
Other intervention name(s): Exercise training
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Keywords: cystic fibrosis; exercise; children; cardiorespiratory fitness; muscle strength; pulmonary function; quality of life
Study to Evaluate the Effect of Single Doses of LX4211 and Canagliflozin on Intestinal Glucose Absorption in Healthy Adult Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of LX4211 and the comparator drug
      canagliflozin on intestinal glucose absorption and metabolism after a single dose in healthy
      subjects in comparison to placebo.
    


Intervention name(s): LX4211 400 mg; canagliflozin 300 mg; LX4211 Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Canagliflozin; (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Bioequivalence Study of Torrent Pharmaceuticals Ltd's Quetiapine Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      Primary objective of the present study was to compare the single dose bioequivalence of
      Torrent's Quetiapine Fumarate Tablets 1 × 25 mg. Dosing periods of the fed were separated by
      a washout period of 7 days.

      Study Design:

      Open label, Randomized, Two-Way, Crossover, Single-Dose Bioequivalence Study
    


Intervention name(s): Torrent's Quetiapine Fumarate Tablets
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Cognitive Effects of Aerobic Exercise for MCI Adults
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The specific aims for the study will be to determine if aerobic exercise enhances cognition
      for older adults who are at greater risk for developing Alzheimer's disease, and to evaluate
      whether change in insulin sensitivity predicts cognitive performance for subjects randomized
      to the aerobic exercise group. Sedentary older adults diagnosed with mild cognitive
      impairment will participate in a 6-month supervised protocol of either aerobic exercise or
      stretching. Cognitive testing and blood collection will occur at baseline, and months 3 and
      6. Before and after the 6-month intervention, insulin sensitivity, maximum aerobic capacity,
      and body fat composition and distribution (via CT scan) will be assessed for all subjects.
      The results of this study may provide support for a relatively simple and inexpensive
      treatment strategy that specifically targets many of the health factors that directly
      influence risk of cognitive decline for older adults.
    

Detailed description: 
      The specific aims for the study are 1) to determine if aerobic exercise enhances cognition
      for older adults with mild cognitive impairment, 2) to evaluate whether change in insulin
      sensitivity predicts cognitive performance for subjects in the aerobic exercise group, and 3)
      to relate exercise effects on insulin sensitivity and cognition to growth factor expression,
      inflammatory markers, catecholamines, beta-amyloid, and body-fat composition. Using a
      randomized controlled parallel group design, 40 sedentary older adults diagnosed with mild
      cognitive impairment will participate in a 6-month supervised protocol of either aerobic
      exercise or stretching. Cognitive testing and blood collection will occur at baseline, and
      months 3 and 6. Before and after the 6-month intervention, insulin sensitivity (via
      hyperinsulinemic-euglycemic clamp), maximum aerobic capacity (via respiratory gas exchange
      and cardiopulmonary fitness measures), and body fat composition (via DEXA scan) and
      distribution (via CT scan) will be assessed for all subjects. The results of this study may
      provide support for a relatively simple and inexpensive treatment strategy that specifically
      targets many of the health factors that directly influence risk of cognitive decline for
      older adults.
    

Intervention name(s): Aerobic exercise
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: MCI; aging; cognition; exercise; aerobic; insulin
A Study to Investigate the Effects of Food and Morning Versus Evening on Single and Multiple Doses of ONO-5334 in Healthy Post Menopausal Women
Condition: Healthy Post Menopausal Women
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study will investigate the effects on pharmacodynamics and pharmacokinetics of food and
      morning versus evening on single and multiple doses of ONO-5334 in healthy post menopausal
      women.
    

Detailed description: 
      This study consists of 2 parts. Part 1; The study will investigate the effects of morning
      versus evening dosing on the pharmacodynamics of multiple doses of 150 mg of ONO-5334 in
      healthy post menopausal women. The study design will be single-blind and 16 subjects will be
      enrolled. Part 2; The study will investigate the effects of food on the pharmacokinetics of a
      single dose of 150mg of ONO-5334 in healthy post menopausal women. 12 subjects will be
      enrolled.
    

Intervention name(s): ONO-5334; ONO-5334
Intervention type(s): Drug; Drug
Intervention description(s): 150 mg for 5 days administered in the morning or in the evening; 150 mg QD for one day. Administered either in the fasted state or after the standard meal or high fat meal.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
An Extension Study of Duloxetine in Fibromyalgia (Extension of F1J-JE-HMGZ, NCT01552057)
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the safety and efficacy of duloxetine in participants
      with fibromyalgia at long-term use.
    


Intervention name(s): Duloxetine
Intervention type(s): Drug
Intervention description(s): Administered Orally
Other intervention name(s): LY248686; Cymbalta; Ariclaim; Xeristar; Yentreve
Intervention MeSH terms: Duloxetine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Arthroscopic Rotator Cuff Repair: Suture Anchors Versus Arthroscopic Transosseous Fixation
Condition: Rotator Cuff Tears
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      Arthroscopic transosseous fixation of rotator cuff tears has become an alternative to
      arthroscopic suture anchor.

      This novel technique that allows surgeons to perform a standardized arthroscopic transosseous
      (anchor free) repair of rotator cuff tears can improve postoperative pain and reduce the
      incidence of shoulder stiffness.

      The aim of the this study is to compare clinical outcomes of two groups of patients: patients
      that received an arthroscopic transosseous fixation using the ArthroTunneler tunneling device
      (Tornier Inc, Edina, Minnesota) versus patients that received an arthroscopic rotator cuff
      repair using suture anchors.
    


Intervention name(s): Arthroscopic transosseous fixation; Suture anchors
Intervention type(s): Device; Device
Other intervention name(s): ArthroTunneler transosseous tunneling device (Tornier Inc)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment