bioihbjkbjnl/mcl2 huggingface dataset:
Abdominal Compression Administered Early by the Colonoscopist During Water Exchange Colonoscopy
Condition: Colonic Polyp; Colonic Adenoma
MeSH terms: Adenoma; Colonic Polyps
Study type: Interventional

Summary: 
      Loop formation is the most frequent cause of cecal intubation failure during colonoscopy. To
      reduce the loop formation, external abdominal pressure is widely used and proved to be
      helpful. Properly applied pressure can also decrease patients discomfort and shorten the
      cecal intubation time.

      The loop formation during water exchange is less severe as compared with during air
      insufflation and can be reduced quite readily. Traditionally an assistant is not asked to
      administer abdominal compression until the endoscopist has struggled for some time and failed
      to reduce the loops by withdrawal. The colonoscopist can administer the abdominal compression
      whenever the scope is not advancing smoothly, probably in the early stage of loop formation.
      We test the hypothesis that colonoscopist administered abdominal compression to remove loops
      in their early stage of formation hastens cecal intubation.

      A total of 120patients will be randomized in a 1:1 ratio (n=60 per group). When the tip of
      the scope doesn't advance or paradoxical movements occur, loop reduction by withdrawal of the
      scope will be implemented. If looping persists, abdominal compression will be applied. In the
      endoscopist-administered abdominal compression (endoscopist) group, the colonoscopist will
      apply the compression with his right hand and counter the pressure by pushing the back of the
      patient with his left forearm with the colonoscope in his left hand. The compression will be
      administered at left lower quadrant when the scope is in the sigmoid colon and at left lower
      quadrant and upper abdomen, respectively, when the scope tip reaches the transverse or
      ascending colon. If the formation of loop cannot be overcome, an assistant will apply the
      abdominal compression instead. In the assistant-administered abdominal compression
      (assistant) group, an endoscopic assistant will apply abdominal compression when a loop is
      formed. The assistant will apply the compression at the left lower quadrant initially, but
      quickly shift to other parts as needed depending on the tip location of colonoscope. If
      manual compressions fail, then the patients' position will be changed.
    


Intervention name(s): endoscopist-administered abdominal compression; assistant-administered abdominal compression
Intervention type(s): Procedure; Procedure
Intervention description(s): The endoscopist administers abdominal compression when loop formation encountered.; A assistant administers abdominal compression when loop formation encountered.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: colonoscopy; cecal intubation time
Efficacy and Safety Study of Loperamide Hydrochloride/Simethicone Chewable Tablet in Treatment of Acute Diarrhea With Abdominal Discomfort and Flatulence
Condition: Diarrhea
MeSH terms: Diarrhea; Flatulence
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of combined loperamide
      hydrochloride and simethicone compared to loperamide hydrochloride monotherapy in treating
      acute diarrhea associated with abdominal discomfort caused by gastrointestinal gas
      accumulation.
    

Detailed description: 
      This is a randomized (the study drug is assigned by chance), double-blind (neither physician
      nor participant knows the treatment that the participant receives), parallel-group (each
      group of participants will be treated at the same time), multi-center (when more than one
      hospital or medical school team work on a medical research study) study. All eligible
      participants will be randomly assigned to receive either a combination of loperamide
      hydrochloride and simethicone or loperamide hydrochloride. The study includes Screening Visit
      (from -24 to 0 hours), Baseline Visit (at 0 hour) and Concluding Visit (within 48 to 96 hours
      following the start of the trial). The timing of each bowel movement, stool characteristics
      and the degree and duration of abdominal discomfort caused by gastrointestinal gas
      accumulation will be recorded for each participant for 48 hours after the first trial drug
      administration. Participants' safety will be monitored throughout the study.
    

Intervention name(s): Loperamide hydrochloride + simethicone chewable tablet; Loperamide hydrochloride; Loperamide hydrochloride + simethicone chewable placebo tablet; Loperamide hydrochloride placebo capsule
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Each tablet contains 2 milligram (mg) of loperamide hydrochloride and 125 mg of simethicone.; Each capsule contains 2 mg of loperamide hydrochloride; Placebo matched to loperamide hydrochloride and simethicone chewable tablet.; Placebo matched to loperamide hydrochloride capsule.
Intervention MeSH terms: Simethicone; Loperamide; Antidiarrheals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diarrhea; Flatulence; Abdominal discomfort; Loperamide hydrochloride; Simethicone; Placebo
Pharmacokinetics and Safety Study of Apetrol ES
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Randomized, Open Label, Single dose, Cross-over, Phase I Trial to Investigate Safety and
      Pharmacokinetics of Apetrol ES and Megace® in Healthy Male Volunteers.
    

Detailed description: 
      [Part 1] fasting [Part 2] fed
    

Intervention name(s): Apetrol ES / Megace
Intervention type(s): Drug
Intervention description(s): Sequences of administered drugs
Other intervention name(s): Apetrol ES(ES81) 625 mg / 5mL, Megace 800mg / 20mL
Intervention MeSH terms: Megestrol Acetate; Megestrol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Male Volunteers
Influence of Percutaneous Electrolysis on Endogenous Pain Modulation
Condition: Pain
Study type: Interventional

Summary: 
      Percutaneous electrolysis is a minimally invasive approach that consists in the application
      of a galvanic current through an acupuncture needle. Although several mechanisms and effects
      are attributed to percutaneous electrolysis, currently there are only a few publications that
      delve into this topic. The aim of this study is to investigate the influence of percutaneous
      electrolysis on the endogenous pain modulation. Four groups of intervention will be involved:
      no-intervention, isolated needling procedure, low intensity percutaneous electrolysis and
      high intensity percutaneous electrolysis. The effects on the pain modulation system will be
      evaluated before and immediately after the intervention, through pressure pain thresholds,
      conditioned pain modulation and temporal summation.
    


Intervention name(s): Isolated needling procedure; Low intensity percutaneous electrolysis; High intensity percutaneous electrolysis
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): The needle will be inserted into the common extensor tendon of the epicondyle (dominant elbow) for 90 seconds without galvanic current.; Once the needle is located in the common extensor tendon of the epicondyle (dominant elbow), a single impact of galvanic current will be applied with an intensity of 0.3 mA for 90 seconds.; The needle will be inserted in the target position during the same time as in the other groups (90 seconds). During the first stage of intervention the needle will be imbedded without galvanic current and when the end of the application time approaches (approximately 75 seconds) three impacts of galvanic current will be applied with an intensity of 3 mA and a duration of 3 seconds each.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Electric Stimulation Therapy; Randomized Clinical Trial; Interventional Ultrasonography; Percutaneous Electrolysis; Endogenous Pain Modulation; Pain; Conditioned Pain Modulation; Sensory Thresholds
The Preventative and Therapeutical Effect of Ursodeoxycholic Acid(UDCA) to Short Bowel Syndrome Patients
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The efficacy of UDCA in treating the parenteral nutrition-associated cholestasis(PNAC) has
      been identified by some studies in children without short bowel syndrome(SBS).Most of the
      adults who suffering PNAC have SBS. it limits the potential function of UDCA because of the
      lack of SBS patients and malabsorption of UDCA.Therefore, we design this clinical trial in
      our center of SBS to approach the preventative and therapeutical effect of UDCA to PNAC in
      adults with short bowel syndrome.
    


Intervention name(s): ursodeoxycholic acid
Intervention type(s): Drug
Intervention MeSH terms: Ursodeoxycholic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Safety and Potential Efficacy of Human Mesenchymal Stem Cells in Non-Cystic Fibrosis Bronchiectasis
Condition: Bronchiectasis
MeSH terms: Bronchiectasis
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the safety of bone marrow-derived allogeneic human Mesenchymal Stem Cells
      (hMSCs) in patients with bronchiectasis receiving standard of care therapy, and to explore
      treatment efficacy
    

Detailed description: 
      A Phase 1 investigation will be performed to test the safety of two doses of bone-marrow
      derived hMSCs (20,000,000 and 100,000,000) administered via peripheral intravenous infusion.

      Group 1: 3 subjects will receive a single administration of allogeneic hMSCs: 20 x106 (20
      million) cells delivered via peripheral intravenous infusion Group 2: 3 subjects will receive
      a single administration of allogeneic hMSCs: 1 x108 (100 million) cells delivered via
      peripheral intravenous infusion Interim safety analysis will be performed four weeks after
      the 1st subject is enrolled in each cohort. Continued safety and tolerability with review of
      adverse events (AEs) will be assessed at each visit. Efficacy parameters (pulmonary function
      tests, lung diffusion capacity, lung volumes, 6-Minute Walk Test (6MWT), and dyspnea/Quality
      of Life (QOL) questionnaires) will be assessed every 12 weeks until study completion.
      Clinical laboratory tests to assess safety will be performed at every visit.

      High Resolution Computed Tomography (HRCT) scan will be performed at the baseline visit (if
      not done within three months prior to enrollment) and then at week 24.
    

Intervention name(s): hMSCs
Intervention type(s): Biological
Intervention description(s): intravenous infusion of bone marrow-derived allogeneic stem cells
Other intervention name(s): allogeneic mesenchymal stem cell
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bronchiectasis; mesenchymal stem cell; lung; pulmonary; interstitial lung disease
Efficacy and Safety Trial With S 44819 After Recent Ischemic Cerebral Event
Condition: Post Stroke Recovery
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and safety of S 44819 in enhancing
      functional recovery after an ischemic stroke.
    


Intervention name(s): S 44819 150 mg twice a day; S 44819 300 mg twice a day; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One sachet of S 44819 150 mg and one sachet of placebo twice a day; Two sachets of S 44819 150 mg twice a day; Two sachets of placebo twice a day
Intervention MeSH terms: S44819
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With Endometriosis
Condition: Endometriosis, Pain
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to see how elagolix works compared to placebo in women with
      endometriosis and to see the effect, if any, on bone mineral density.
    

Detailed description: 
      This is a Phase II, multicenter, randomized, double-blind, placebo-controlled parallel-group
      study to assess the efficacy and safety of elagolix at two dose levels administered once
      daily for up to 6 months. Participants will be randomized (1:1:1) to one of the following
      treatment groups for the first 12 weeks of dosing: 150 mg elagolix once daily (QD); 250 mg
      elagolix QD or placebo QD. Following 12 weeks of dosing, participants will continue in the
      study for an additional 12 weeks; participants randomized to elagolix will continue to
      receive their assigned dose and participants randomized to placebo will be re-randomized to
      receive one of the two doses of elagolix for 12 weeks in a double-blind fashion. Six weeks
      after the last dose of study drug at the end of Week 24, a follow-up visit will be performed
      (end of Week 30).
    

Intervention name(s): Elagolix; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Elagolix tablets administered orally; Placebo tablet administered orally
Other intervention name(s): NBI-56418; Orilissa™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bone mineral density; Pelvic Pain; estradiol; NBI-56418
Study of Esophageal Squamous Dysplasia Prevalence at Tenwek Hospital
Condition: Esophageal Dysplasia
MeSH terms: Hyperplasia
Study type: Observational

Summary: 
      Esophageal squamous cell cancer (ESCC) is common in the developing world, and is the leading
      cancer diagnosis at Tenwek Hospital in southwestern Kenya. The investigators long-term goal
      is to understand the pathogenesis and risk factors for ESCC in Kenya, and to establish
      effective screening and prevention programs. The investigators hypothesize that asymptomatic
      esophageal squamous dysplasia (ESD) is common in their region, and the current protocol is
      designed to determine the prevalence of ESD in residents of southwestern Kenya.
    

Detailed description: 
      The prevalence of esophageal squamous dysplasia will be determined after evaluating pathology
      reports from unstained lesions and normal biopsies after staining with Lugol's iodine.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult Asymptomatic subjects residing within a 50 kilometer radius of Tenwek Hospital
      
Biospecimen description: 
      Blood and Urine specimens
    
Keywords: Dysplasia; Esophageal Squamous Cell Carcinoma
Effect of Duration of Exposure of Anesthesia With Sevoflurane on Emergence Delirium
Condition: Delirium on Emergence
MeSH terms: Delirium; Emergence Delirium
Study type: Observational

Summary: 
      Emergence delirium which is a phenomenon seen commonly in preschool kids anesthetized with
      Sevoflurane. Restless recovery from anesthesia may not only cause injury to the child or to
      the surgical site, but may also lead to the accidental removal of surgical dressings, IV
      catheters, and drains. is one of the The purpose of the study is to find whether duration of
      exposure to Sevoflurane has any effect on the incidence of Emergence Delirium.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients between 1-6 years old receiving anesthesia for non-surgical reasons
The Effect of Dairy and Non-dairy Alternatives on Satiety and Post-meal Glycemia in Healthy Young Adults
Condition: Diabetes; Obesity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study investigates the effects of commercially-available dairy (1% cow's milk and yogurt
      beverage) and non-dairy alternatives (almond and soy beverages) on satiety and post-meal
      blood glucose. Each participant will receive every treatment in this crossover design study.
    

Detailed description: 
      Regular consumption of dairy is associated with better body composition and lower incidences
      of type 2 diabetes and obesity. This may be due to dairy's ability to increase satiety and
      decrease post-prandial glycemia. However, most clinical studies have only investigated
      isolated dairy proteins (whey and casein) and the effects of whole dairy products remains
      unclear. Additionally, as non-dairy alternatives are becoming more popular there is interest
      to see if they can elicit similar benefits as dairy. Therefore, this study will test the
      effects of commercially-available dairy and non-dairy beverages when consumed with cereal at
      breakfast time.

      Thirty healthy young males and females (20-30 years, BMI 20.0-24.9 kg/m2) will be recruited
      for the randomized, unblinded, crossover study. Participants will fast overnight, and at
      baseline will consume 250 mL of 1% milk, soy beverage, almond beverage, yogurt beverage, or
      water with 54 g of Cheerios cereal. At 0 (baseline), 15, 30, 45, 60, 75, 90, 120 minutes
      (pre-meal period) 140, and 170 minutes (post-meal period) blood will be collected for glucose
      analysis and subjective appetite ratings completed. Insulin will be analyzed every 30 minutes
      and for the last two timepoints. Between 120-140 minutes, an ad libitum lunch will be
      provided to assess food intake.
    

Intervention name(s): 1% M.F. Milk; Yogurt Beverage; Soy Beverage; Almond Beverage; Water; Breakfast cereal
Intervention type(s): Other; Other; Other; Other; Other; Other
Other intervention name(s): 1% cow's milk; Neilsen Canada; Yop (Vanilla), General Mills; Soy Milk; Silk Organic Original; Almond Milk; Silk Original; Calorie-free control; Cheerios, General Mills
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Dairy; Breakfast cereal; Postprandial Glycemia; Satiety; Food Intake; Milk; Yogurt; Soy; Almond
Intrathecal Hydromorphone for Labor Analgesia
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the dose of hydromorphone which will relieve the pain of women in
      labor when delivered directly in the area around the spinal cord (i.e., intrathecal
      injection). The primary objective is to determine the dose of intrathecal hydromorphone that
      results in a pain score of less than 4 out of 10 thirty minutes after intrathecal injection
      in 50% of women. Secondary objectives include determining this dose at five and ten minutes
      after injection. Thirty women admitted to labor and delivery for planned vaginal delivery
      desiring epidural placement will be consented for the study. The starting dose of intrathecal
      hydromorphone will be 6 mcg. The up-and-down sequential allocation method of statistical
      analysis will be used, meaning that each subsequent dose will be dependent upon the result
      obtained from the prior dose - ergo, if the initial subject has pain relief, the second
      subject will receive 4 mcg (2 mcg less), but if the initial subject does not have pain
      relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone.

      After the intrathecal injection is given and the epidural is placed, visual analogue pain
      scores will be assessed 60 minutes following injection. A pain score of less than three will
      be a positive result. A pain score of three or greater will be a negative result. Blood
      pressure, heart rate, arterial oxygen saturation, fetal heart rate, and any side effects will
      also be assessed.
    


Intervention name(s): Hydromorphone
Intervention type(s): Drug
Intervention description(s): Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.
Intervention MeSH terms: Hydromorphone
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Smartphone Application, Mood and Stress
Condition: Smartphone Application; Placebo Effect; Mood; Stress
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the placebo effect in a smartphone-based
      training, ostensibly designed to improve mood and perceived stress by daily exposition to
      either mock sound or color.
    

Detailed description: 
      The overall goal of the outlined study is to investigate the placebo effect in a
      smartphone-based training, ostensibly designed to improve mood and perceived stress by daily
      exposition to either mock sound or color. During 14 days, subjects will participate in
      regular daily training sessions. During another 6 days, subjects will transfer the
      smartphone-based training to daily life.
    

Intervention name(s): No expectancy (control); Prospective expectancy; Retrospective expectancy; Prospective and retrospective expectancy
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): No expectancy instruction with regard to the efficacy of the daily smartphone-based training (exposition to either mock sound or color); Prospective expectancy instruction ("Training will have an effect on...") with regard to the efficacy of the daily smartphone-based training (exposition to either mock sound or color); Retrospective expectancy instruction ("Training already had an effect on...") with regard to the efficacy of the daily smartphone-based training (exposition to either mock sound or color); Prospective ("Training will have an effect on...") and retrospective ("Training already had an effect on...") expectancy instruction with regard to the efficacy of the daily smartphone-based training (exposition to either mock sound or color)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science