bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Electro-acupuncture for Abdominal Obesity: Study for a Randomized Controlled Trial
Condition: Obesity, Abdominal
MeSH terms: Obesity; Obesity, Abdominal
Study type: Interventional

Summary: 
      Electro-acupuncture provides stimulation to acupoints, and has been widely used to treat
      abdominal obesity in China despite of lack of high-level evidence for treatment efficacy. The
      study will investigate whether the electroacupuncture can alleviate clinical symptoms and the
      mechanism of action in patients with abdominal obesity.
    

Detailed description: 
      The study will be a randomized controlled trial from May 2021 to December 2022, including 68
      participants with abdominal obesity. The participants will be randomly divided into 2 groups
      in a 1:1 allocation ratio.The intervention group will receive electroacupuncture; the control
      group will receive sham acupuncture. Each treatment will last 12 weeks, including 8 weeks of
      intervention period and 24 weeks of follow-up. The primary outcome is the waist circumference
      (WC), the secondary outcomes include weight, body mass index (BMI), hipline, waist-hip-ratio
      (WHR), Insulin resistance index (IRI), blood fat, metabolomics will be used analysis the
      mechanism. The adverse events will be recorded during the intervention and follow-up period.
    

Intervention name(s): Electro-acupuncture; Sham electro-acupuncture
Intervention type(s): Device; Device
Intervention description(s): The acupoints of electro-acupuncture will be selected as Zusanli ,Sanyinjiao ,Zhongwan , Tianshu , Shuifen , Daheng ,Daimai , Shuidao ,Huaroumen and Fujie . We will deliver electrical stimulation with dense-disperse waves at 50 Hz and 10 V through the electrical acupuncture stimulation instrument to the abdominal points. The bodily needles will be retained for 30 minutes . Electro-acupuncture treatment will be applied 3 times a week, once every other day, for 8 consecutive weeks.; The acupoints of sham electro-acupuncture will be selected as nonacupoints . The internal output power cord of the electrical acupuncture stimulation instrument will be interrupted. The bodily needles will be retained for 30 minutes . Sham acupuncture treatment will be applied 3 times a week, once every other day, for 8 consecutive weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Abdominal obesity; Electro-acupuncture; Randomized controlled trial
Effects of Daily Almond Intake as a Preload Before Meals Versus as a Snack Among Korean Adults
Condition: Adult Young and Healthy
Study type: Interventional

Summary: 
      The study was conducted to investigate the effects of daily almond intake based on the timing
      of almond consumption (i.e., almond consumption as a preload or between-meal snack) on body
      composition, lipid profile, and oxidative and inflammation indicators among young Korean
      adults.
    

Detailed description: 
      The current study was conducted to investigate the effects of daily almond intake on body
      composition, lipid profile, and oxidative and inflammation indicators among young Korean
      adults based on the timing of almond consumption. Participants were randomly assigned to one
      of three groups: (1) a pre-meal group (PM; n = 58) in which participants were instructed to
      consume 56 g of almonds per day as a preload when having regular meals; (2) a snack group
      (SN; n =55) in which participants were instructed to consume 56 g of almonds between meals as
      snacks; and (3) a control group (CL; n = 56) in which participants were provided
      high-carbohydrate iso-caloric control food. The three-day diet records, including two
      consecutive weekdays and one weekend day, were done once before the trial and twice during
      the trial. Body composition was assessed through multi-frequency whole-body bioimpedance
      measurement using InBody 620 (Biospace Co., Ltd, Seoul, Korea).After a 12-hour fast, blood
      samples were taken at the baseline time point (week 0) and at weeks 8 and 16 by standard
      venipuncture. The serum total cholesterol and triglycerides levels were measured by the
      enzymatic-colorimetric method using a Cobas 8000 c702 chemistry analyzer (Roche Diagnostics;
      Mannheim, Germany). HDL cholesterol and LDL cholesterol levels were determined via
      homogeneous enzymatic colorimetry.
    

Intervention name(s): almond; high-carbohydrate control food
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Flurbiprofen Axetil for Uterine Contraction Pain
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Uterine contraction pain is a common problem after abortion. Optimal analgesic for such
      suffering is still needed to be guaranteed. Flurbiprofen Axetil is a target-distributable
      non-steroidal anti-inflammatory drug (NSAID) functioning via block the synthesis of
      prostaglandin E (PGE). The investigators hypothesized that Flurbiprofen Axetil could suppress
      the uterine contraction pain after abortion effectively.
    


Intervention name(s): Saline; Flurbiprofen Axetil
Intervention type(s): Drug; Drug
Intervention description(s): Saline 5 ml injection 10 min prior to propofol administration.; Flurbiprofen Axetil 50 mg in 5 ml injection 10min prior to propofol administration.
Other intervention name(s): Ringer's solution; KaiFen
Intervention MeSH terms: Flurbiprofen; Flurbiprofen axetil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NSAIDs; Postoperative pain; Analgesia; Abortion
Study to Monitor the Effects of Androgen Suppression Treatment on the Heart
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Suppression of effects of androgens with male sex hormones, androgen suppression treatment
      (AST), has been known to reduce deaths and prolong life in advanced prostate cancer. There
      have, however, been concerns raised in previous studies that androgen suppression may be
      associated with increased rate of heart attacks, particularly in older men. This study looks
      at prostate cancer patients in The Ottawa Hospital Cancer Clinic to see if treating these
      patients with androgen suppression is associated with a decrease in blood flow to the heart
      muscles by using Positron Emission Tomography (PET) and brachial artery ultrasound.
    

Detailed description: 
      Treatment group: Prior to the initiation of AST, subjects will have a baseline N-13-ammonia
      PET scan and a brachial artery ultrasound at the University of Ottawa Heart Institute. Blood
      glucose and a lipid profile will be obtained. These tests will be repeated 6 - 9 months after
      starting AST.

      Cancer control group: The same testing and intervals will be performed. Normals control
      group: Baseline testing will be done to establish a normal.
    

Intervention name(s): PET scan and ultrasound
Intervention type(s): Radiation
Intervention description(s): Nuclear rest/stress testing of the heart using N-13-ammonia paired with brachial artery ultrasound
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Androgen Suppression Therapy; Hormonal Toxicity; Quantitative PET; Myocardial blood flow; Coronary blood flow reserve; Endothelial dysfunction; Coronary Artery Disease
Exercise Intensity and Video Games: Persons Post-stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Persons post stroke executed stepping activities under four conditions: standard of care,
      interacting with: an off-the-shelf Microsoft-Kinect game, with a self-paced repeated custom
      video game and a game-paced random custom video game. Exercise intensity (neuromuscular and
      cardiovascular), enjoyment and perceived effort were measured during and after each
      condition.
    

Detailed description: 
      Persons post stroke were first familiarized with the four exercise conditions and then
      instrumented with a metabolic system and heart rate sensor. They played the games in two
      counter balanced blocks: repeated (standard of care and self-paced repeated custom) and
      random (Microsoft-Kinect game and game-paced random custom). Games were played for 8.5
      minutes with ten minutes of rest in between so they could return to physiological baseline.
      During exercise they reported exertion and at the end of teach exercise trial they completed
      an enjoyment questionnaire. At the end of the first block, participants removed the metabolic
      system's mask and were assessed for motor recovery. Performances were video taped. At the end
      of data collection preferences for the activities were ranked and participants answered open
      ended questions. Data for neuromuscular and cardiovascular intensity, enjoyment and perceived
      effort were reduced and analyzed using a Repeated Measures Analysis of Variance (RMANOVA)
      with the appropriate post-hoc corrections. Where possible clinically meaningful changes were
      calculated.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Participants performed stepping movements that were either cued by the investigator or interacted with a video game. There were three video game exercises that all involved stepping in either a repeated or a random pattern that was either self-paced or game paced.
Other intervention name(s): Video Game Play; Standard of Care Stepping Activities
Intervention model: Single Group Assignment
Intervention model description: Repeated measures, counter-balanced
Masking: None (Open Label)
Primary purpose: Other
Keywords: active video games; virtual reality; exercise intensity; Parkinson Disease
Bioequivalence Study of Ropinirole Hydrochloride CR 2mg Tablets of Lupin Limited, India, With REQUIP XL of GlaxoSmithKline Research Triangle Park, in Healthy, Adult, Male, Subjects Under Fed Conditions
Condition: Pharmacokinetic Study
Study type: Interventional
Phase: Phase 1

Summary: 
      Study subjects were screened and enrolled for the study. Subjects were housed in the clinical
      facility from not less than 12 hours pre-dose till at least 30 hours post-dose in each
      period. After maintaining at least 10 hours of overnight fast Test or Reference product was
      administered orally (as per the randomization schedule) to each subject with about 240 mL of
      water at ambient temperature in each period by trained study personnel after consuming the
      whole standardized high fat non-veg breakfast.

      The pre-dose (0.00 hours) blood sample was collected before dosing and post-dose samples were
      collected at 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50, 10.00, 10.50,
      11.00, 11.50, 12.00, 12.50, 13.00, 14.00, 16.00, 20.00, 24.00 and 30.00 hours in each study
      period with a washout period of 7 days between the dosing of two periods. Subjects were
      continuously monitored for well being i.e., blood pressure, radial pulse and oral temperature
      before check-in, prior to drug administration and at regular intervals post dose in each
      period. The concentration of Ropinirole in plasma samples obtained from study subjects was
      determined using validated LC-MS/MS method. Pharmacokinetic and statistical analyses were
      performed on obtained drug concentration data, using appropriate software.
    


Intervention name(s): Ropinirole hydrochloride CR 2mg Tablets
Intervention type(s): Drug
Intervention description(s): Ropinirole is an orally administered non-ergoline dopamine agonist. Ropinirole is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.
Other intervention name(s): Test Product; Reference Product; REQUIP XL Tablets (containing Ropinirole hydrochloride) 2mg
Intervention MeSH terms: Ropinirole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Metabolic Syndrome and Degenerate Meniscus Tears
Condition: Metabolic Syndrome; Meniscus; Degeneration
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The aim is to determine the outcomes of calorie-restricted diet and exercise intervention;
      libitum diet and waiting list control; early arthroscopic partial meniscectomy(APM) or
      delayed APM effect on MetS patients with Degenerate menisucus lesions.
    

Detailed description: 
      The investigators recruited 180 patients with Metabolic Syndrome and knee symptoms with
      degenerate meniscus lesions by MRI from orthopaedics department from June 2017 to March 2020
      at First Affiliated Hospital of Jinzhou Medical University. Participants were diagnosed with
      MetS and degenerate meniscus tear with a mild or no osteoarthritis KL<2 verified by X ray.
      Participants were randomly dividied into calorie-restricted diet and exercise intervention
      group; libitum diet and waiting list control group; early APM (syndrome within 3-6 months)
      group or a delayed APM(syndrome more than 6 months) group as a computer sequenced number. The
      primary outcome was the change in metabolic syndrome components and knee function score of
      WOMAC, KOOS,WOMET,IKDC were determined by two fixed orthopadic surgeons who were blinded to
      the intervention.
    

Intervention name(s): Calorie restricted diet and exercise intervention; libitum diet and waiting list control group; Early arthroscopic partial menisectomy group; delayed APM group recruit participants with symptoms lasting for more than 6 months
Intervention type(s): Dietary Supplement; Procedure; Procedure; Procedure
Intervention description(s): the calorie restricted diet were prescribed a balanced diet that provided an energy deficit of 800 kcal/day from their daily energy requirement.Macronutrient content of low caloric diet, expressed as percentage of ingested energy with carbohydrates 45-65%; fat 20-35%; and protein 10- 35%[36]. Participants were guided by a dietitian for adjustments of their caloric intake weekly for six months.Participants performed 1 or 2 sets at a resistance of approximately 65% of their one-repetition maximum, with 8 to 12 repetitions of each exercise; they gradually increased the intensity to 2 to 3 sets at a resistance of approximately 80% of their one-repetition maximum, with 6 to 8 repetitions of each exercise.; libitum diet and waiting list control group, participants then underwent a calorie of 2000 calorie above based on libitum free diets recommended to adults and normal physical activity without exercise during the program.; Early APM group participants received APM with syndrome within 3 to 6 months; delayed APM group recruit participants with symptoms lasting for more than 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Metabolic Syndrome; degenerate meniscus lesions; Calorie restricted diet; exercise; arthroscopic partial meniscectomy
An App to Aid in Transitioning Off Opioid Medication
Condition: Opiate Use Disorder; Opiate Withdrawal Syndrome
MeSH terms: Substance Withdrawal Syndrome
Study type: Interventional

Summary: 
      The investigators propose to develop a smartphone app (called BetterOFF) that will help
      patients manage opioid withdrawal during opioid medication taper and detoxification. The
      BetterOFF smartphone intervention will be a resource patients can access anytime and
      anywhere. If the BetterOFF intervention were to be effective in helping patients discontinue
      opioid medication, it could be integrated into the standard of care of office-based clinical
      practices, as well as substance use programs, thereby having a substantial public health
      impact.
    

Detailed description: 
      Many of the growing number of patients prescribed long-term opioid medication (for a variety
      of reasons including a history of illicit opioid use or management of chronic pain) will
      express an interest in discontinuing medication. However, many patients, physically dependent
      on opioids, fear the withdrawal symptoms that inevitably occur with opioid medication
      discontinuation and will experience a decrease in their self-efficacy for abstinence at the
      end of a taper. As a result, tapering is often slow and done hesitantly, and relapse rates
      after an opioid taper are high and associated with broad consequences, including significant
      negative physical, mental, and social problems. Even with optimal tapering protocols,
      patients need novel approaches to manage the discontinuation of opiate agonist treatment.
      Given this important gap in opioid treatment delivery, we propose to develop a
      theoretically-driven, smartphone-delivered intervention (Better Off app) to help patients
      effectively manage the experience of opioid medication discontinuation.
    

Intervention name(s): App Development and Open Pilot
Intervention type(s): Other
Intervention description(s): Phase 1 (app development) will consist of: 1) development of the BetterOFF prototype; and 2) series of usability studies with patients interested in discontinuing opioid medication.
Phase 2 (open pilot) will involve conducting a 12-week open pilot trial (n=20) to test the feasibility and acceptability of the BetterOFF app with patients tapering from opiate medication.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Oxytocin Via Intramuscular Injection and Intravenous Bolus or Infusion for Prevention of Postpartum Hemorrhage
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      The study will evaluate whether prophylactic oxytocin administered in the third stage of
      labor via intravenous (IV) infusion or IV bolus reduces the rate of postpartum hemorrhage
      compared to intramuscular (IM) injection.
    

Detailed description: 
      The study will compare the effect of IV infusion or IV bolus to IM oxytocin administration
      with respect to mean blood loss and the proportion of women who experience blood loss greater
      than or equal to 500 ml, women who experience blood loss greater than or equal to 350 ml,
      side effects, adverse events and change in hemoglobin pre- to post-delivery.
    

Intervention name(s): Oxytocin
Intervention type(s): Drug
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Postpartum hemorrhage; Oxytocin; Prevention; Third stage of labor; Hemoglobin; Intravenous; Intramuscular; Bolus
Efficacy of Targeted Memory Reactivation for Enhancing Exposure Therapy
Condition: Claustrophobia; Obsessive-Compulsive Disorder; Arachnophobia
MeSH terms: Obsessive-Compulsive Disorder; Phobic Disorders
Study type: Interventional

Summary: 
      This study evaluates whether a scent applied during exposure therapy and during subsequent
      sleep will increase the durability of treatment effects for individuals with fear of spiders,
      contamination, and enclosed spaces.
    

Detailed description: 
      Newly acquired memories encoded during wakefulness are spontaneously re-activated during
      sleep, resulting in synaptic potentiation and strengthening of the re-activated traces.
      Targeted memory reactivation (TMR) typically involves a period of initial learning in the
      presence of an olfactory or auditory contextual cue, coupled with later presentation of the
      cue during sleep to ostensibly facilitate memory reactivation and consolidation. Numerous
      studies have found evidence of improved task performance subsequent to cue-induced neuronal
      replay, however application of TMR to treatment of naturally acquired, clinically significant
      fear has been limited.

      The present study will will provide a rigorous test of TMR's efficacy as an augmentative
      strategy for exposure therapy. It is hypothesized that participants who sleep in the presence
      of the same odor that they are exposed to during exposure therapy will exhibit reduced fear
      at follow up, relative to participants who sleep in the presence of a different odor, or a
      non-odorous control.
    

Intervention name(s): Experimental Scent; Control Scent; No-Scent Control; In-Vivo Exposure
Intervention type(s): Other; Other; Other; Behavioral
Intervention description(s): Participants will sleep in the presence of the exposure scent, delivered by an Airwick Essential Oils diffuser; Participants will sleep in the presence of a novel scent, delivered by an Airwick Essential Oils diffuser; Participants will sleep in the presence of an odorless control vehicle, delivered by an Airwick Essential Oils diffuser; Participants will receive 40 minutes of in-vivo exposure therapy to feared targets in the presence of a distinctive exposure scent.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Targeted Memory Reactivation; Memory Consolidation; Exposure Therapy; Sleep
Consumption of Chocolate in Pregnant Women.
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the acute and chronic effect of consumption of
      flavanol-rich chocolate on endothelium function in pregnant women at high risk for
      preeclampsia.
    

Detailed description: 
      Although numerous strategies have been studied, no effective prevention or treatment of
      preeclampsia is yet available for pregnant women. This is surprising considering the growing
      body of literature that supports the hypothesis of a beneficial effect of dark chocolate
      consumption through the activity of flavanols on the endothelial function and blood pressure
      regulation, to find any clinical data among pregnant women with preeclampsia.

      The primary objective of the trial is to investigate the acute and chronic effect of
      consumption of flavanol-rich chocolate on endothelial function in pregnant women at high risk
      of preeclampsia. This 12-week efficacy study will permit us to verify the sustainability of
      the effect of daily intake of flavanol-rich chocolate intake.
    

Intervention name(s): Flavanol-rich chocolate; Placebo Chocolate
Intervention type(s): Other; Other
Intervention description(s): The aim of this study is to evaluate the beneficial effect of dark chocolate consumption through the activity of flavanols on the endothelial function and blood pressure regulation, in acute (after 3 hours) and chronic effect (12 weeks), among pregnant women at high risk for preeclampsia.; Placebo intervention
Other intervention name(s): Flavanol and theobromine-free chocolate
Intervention MeSH terms: Theobromine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Randomized double blind trial; Cocoa flavonoids; Endothelial function; Blood pressure; Pregnant women; Preeclampsia; Uterine artery flow; Pulsatility index