bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Endoscopic Papillary Large Balloon Dilation on Recurrent Rate of Patients With Recurrentstones in Bile Duct
Condition: Endoscopic Papillary Large Balloon Dilation
MeSH terms: Dilatation, Pathologic
Study type: Interventional

Summary: 
      The recurrent rate of CBDS in patients with recurrent CBDS is high. It was reported that up
      to 60% of patients had stone recurrence within two years after stone retrieval by ERCP.
      Although EPLBD is useful for for extraction of large CBDS with less operation time and
      mechanical lithotripsy.It is not known whether EPLBD could prevent the recurrence in patients
      with recurrent CBDS.Although Harada et al found that EPLBD might reduce the short-term
      recurrence of CBD stones in patients with previous ES. It is a retrospective study with a
      small sample size (n=94).

      Here a prospective, randomized controlled study including two tertiary centers was designed.
      The aim of this study was to investigate whether EPLBD could reduce the recurrence rate in
      patients with recurrent CBDS.
    


Intervention name(s): endoscopic papillary large balloon dilation
Intervention type(s): Procedure
Intervention description(s): For the patients in EPLBD group, a CRE balloon (diameter 10, 11, 12, 13.5, 15 mm; Boston Scientific) was chosen according to the diameter of bile duct. It was placed across the papilla orifice and then gradually filled with diluted contrast. When the waist disappeared, the balloon was kept inflated for 120s. The stones were then retrieved by a basket or a retrieval balloon.Mechanical lithotripsy was used if necessary
Other intervention name(s): EPLBD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Physical Exercise and Energy Balance
Condition: Physical Activity
Study type: Interventional

Summary: 
      This study is a randomized controlled trial, designed to evaluate the effect of structured
      physical exercise sessions on the spontaneous physical activity energy expenditure and
      caloric intake in overweight adults. The design employs a parallel three-group experimental
      arms: (1) a moderate exercise group (MEG); (2) a vigorous exercise group (VEG); and a control
      group (CG) without physical exercise sessions.
    


Intervention name(s): Moderate exercise; Vigorous exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The training phase of the moderate exercise group (MEG) will consist of 4 sets of 10 minutes walking/running at moderate intensity, with 5 minutes walking at low intensity for recovery between sets; The training phase of the vigorous exercise group (VEG) will consist of 4 sets of 10 minutes running at vigorous intensity, with 5 minutes walking at low intensity for recovery between sets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: spontaneous physical activity; caloric intake
Medium Chain Triglycerides (MCT) and Whey Protein Isolate (WPI) for Type 2 Diabetes Patients (Combine)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Evaluation of effect on diurnal glycaemia following consumption of MCT and whey protein in
      patients with type 2 diabetes
    

Detailed description: 
      The purpose of this study (Combine) is to evaluate the effects of Combined Intake of Medium
      chain triglycerides (MCT) at breakfast and whey protein isolate (WPI) preload at lunch and
      dinner for patients with type 2 diabetes
    

Intervention name(s): BetaQuik™; WheyBasics; Iso-voluminous water
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): MCT (Medium chain triglycerides); Whey Protein Isolate; Iso-voluminous Water as comparitor to Betaquik or WheyBasics
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Open-label - randomization-concealed trial randomized in a 1:1:1 ratio
Masking: None (Open Label)
Primary purpose: Other
A Study to Evaluate Effect of Itraconazole on the Pharmacokinetics of Cobimetinib in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, 2-period, fixed sequence, drug interaction study will investigate the effect
      of co-administration of itraconazole on the pharmacokinetics of cobimetinib in healthy
      participants. Participants will receive multiple repeating doses of cobimetinib and
      itraconazole.
    


Intervention name(s): Cobimetinib; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): 10 milligram (mg) (2* 5 mg capsules) will be administered orally on Day 1 of Period 1 and Day 4 of Period 2; 200 mg oral solution will be administered once daily from Day 1 to Day 14 of Period 2
Other intervention name(s): GDC-0973
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Safety, Tolerability and Pharmacokinetics Study of CK-3773274
Condition: Obstructive Hypertrophic Cardiomyopathy; Healthy Adult Subjects
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to:

        1. Learn about the safety of CK-3773274 after a single dose and multiple doses in Chinese
           healthy adult subjects.

        2. Learn how healthy subjects tolerate CK-3773274 after a single dose and multiple doses.

        3. Find out how much CK-3773274 is in the blood after a single dose and multiple doses.

        4. Determine the effect of doses of CK-3773274 on the pumping function of the heart.

        5. Evaluate the effect CYP2D6 genetic polymorphisms on how the body metabolizes CK-3773274.
    


Intervention name(s): CK-3773274; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CK-3773274- Tablets; Placebo- Tablets
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: CK-274; Obstructive hypertrophic cardiomyopathy; CK-3773274; oHCM
Study Of SB-497115 in Healthy Subjects and Subjects With Mild, Moderate or Severe Renal Impairment
Condition: Purpura, Thrombocytopaenic, Idiopathic
MeSH terms: Renal Insufficiency; Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to compare how one 50 mg tablet of SB-497115 is broken down
      in the body by healthy subjects versus subjects with mild, moderate or severe kidney
      problems. The study is also being done to 1) check on how well the study drug is tolerated by
      healthy subjects versus those with liver problems and 2) to check if liver impairment affects
      how the study drug binds to protein in the blood.
    


Intervention name(s): eltrombopag
Intervention type(s): Drug
Intervention description(s): eltrombopag 50 mg oral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal Impairment,; chronic immune thrombocytopenia purpura,; thrombocytopenia,; chemotherapy induced thrombocytopenia
Labor Induction With Dinoprostone in Oppose to Cervical Ripening Balloon as a Factor of BMI.
Condition: Induction of Labor
Study type: Interventional

Summary: 
      Women with a BMI>30 and women with a BMI<30 will be divided in a randomized controlled manor
      to 4 groups depending on the mode of labor induction and BMI value:

        1. Dinoprostone in women with a BMI>30.

        2. Dinoprostone in women with a BMI<30.

        3. Cervical ripening balloon in women with a BMI>30.

        4. Cervical ripening balloon in women with a BMI<30. The subjects will be followed until
           labor, and information regarding the success of induction, mode of delivery and time of
           delivery will be collected from patients' electronic files.
    

Detailed description: 
      The study is a randomized controlled test in which women with a BMI>30 and women with a
      BMI<30 will sign an informed consent and then divided to 4 groups depending on the mode of
      labor induction and BMI value:

        1. Dinoprostone in women with a BMI>30.

        2. Dinoprostone in women with a BMI<30.

        3. Cervical ripening balloon in women with a BMI>30.

        4. Cervical ripening balloon in women with a BMI<30. All subjects participating in the
           study will be induced for obstetrical indications alone.

      The subjects will be followed until labor, and information regarding the success of
      induction, mode of delivery and time of delivery will be collected from patients' electronic
      files.

      The participants will finish participation in the study after delivery.
    

Intervention name(s): Dinoprostone; Double lumen cervical ripening balloon.
Intervention type(s): Drug; Device
Intervention description(s): 10 mg of a Dinoprostone vaginal insert.; Double lumen cervical ripening balloon.
Other intervention name(s): Prostaglandin E2
Intervention MeSH terms: Dinoprostone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Primary Care and Parenting
Condition: Parenting; Knowledge, Attitudes, Practice; Development, Child
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The objective of this study to evaluate potential impact of a brief, low-cost primary
      care-based intervention of parenting self-efficacy, knowledge, and behavior.
    

Detailed description: 
      Enriching parenting behaviors in early childhood promotes child development and offers a
      promising strategy to reduce future educational disparities. However, current interventions
      are limited by cost and have not been widely disseminated. Recognized as a target for
      research to improve early childhood development and subsequent school readiness skills among
      at-risk families, the primary care setting offers an ideal opportunity to reach the millions
      of children living in poverty. However, what remains unknown is how to more efficiently
      leverage the primary care setting to deliver a sustainable and effective preventive program
      to promote positive parenting behaviors and encourage early childhood development in
      low-income families. Therefore, the investigators designed Sit Down and Play (SDP) a brief
      parent-directed program delivered in the primary care setting. Modeled after the widely
      disseminated literacy program Reach Out and Read and grounded in social cognitive theory, SDP
      is intended to take place during each pediatric well-child visit occurring in a child's first
      two years with the goal of promoting positive parenting behaviors.
    

Intervention name(s): Sit Down and Play; Handout
Intervention type(s): Behavioral; Other
Intervention description(s): Sit Down and Play (SDP) is designed to be a brief, low-cost intervention that incorporates key theoretical constructs to elicit positive parenting behaviors. It is intended to be delivered by existing clinical staff, nonprofessionals, or volunteers during each of the eight well-child visits between 2-24 months of age while a family waits to be seen by their pediatrician in the examination room; Handout providing written descriptions of strategies to encourage positive parenting behaviors
Other intervention name(s): Handout
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Effect of Donepezil on Smoking
Condition: Smoking
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this proof-of-concept pilot study is to evaluate Donepezil HCL (Aricept) for
      side effects and effects on smoking behavior and performance on neurocognitive tasks in a
      population of dependent smokers.
    

Detailed description: 
      Nicotine dependence is a major public health problem and currently available treatments are
      ineffective for the majority of smokers. Thus, there is a need to develop and test novel
      medications to assist smokers to quit smoking. This pilot feasibility study examined: (1)
      tolerability and medication adherence, and (2) the effects of donepezil versus placebo on
      smoking behavior and cognitive performance in non-treatment seeking smokers. We predicted
      that 4 weeks of donepezil would improve working memory at the highest task difficulty level
      and sustained attention. Because participants in this study were not trying to quit, change
      in smoking behavior was a secondary outcome.
    

Intervention name(s): Donepezil; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Aricept
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a double-blind, human laboratory study using a between-subject design between smokers who are randomized to either donepezil HCL (Aricept®) (n=15) or placebo (n=15) for 4 weeks. Treatment randomization will be done to match both groups for age and sex.
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Non-treatment seeking smokers, reporting consumption of at least; 10 cigarettes per day for at least the past 6 months
Impact of Initial Diagnosis on Mortality for Patients Hospitalised With Acute Myocardial Infarction
Condition: ST-elevation Myocardial Infarction; Non ST-elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      The aim of the study is to investigate the impact of an initial non-specific / non-cardiac
      diagnosis on mortality among patients hospitalised with acute myocardial infarction.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population comprises 725,860 patients hospitalised for acute myocardial
        infarction and entered into the Myocardial Ischaemia National Audit Project (MINAP)
        database between April 2004 and March 2013.
Liposomal Bupivacaine for Post Operative Pain After Knee Replacement Surgery
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Continuous femoral nerve blocks (CFNB) provide effective pain control to patients undergoing
      total knee replacement (TKR). However the resulting motor blockade can lead to decreased
      quadriceps muscle strength and delayed functional recovery.The purpose of this study is to
      compare the effect of Liposome Bupivacaine infiltration into the knee to CFNB on pain control
      and functional recovery
    

Detailed description: 
      This is a prospective, randomized, active controlled study in patients undergoing total knee
      replacement. The objective of this study is to compare the efficacy of Liposome Bupivacaine,
      in managing postoperative pain, to standard of care CFNB. Following informed consent,
      patients will be randomized to one of two groups, Liposome Bupivacaine or active control,
      CFNB group.

      266 mg Liposome Bupivacaine plus Bupivicaine HCL (150mg) will be administered via local joint
      infiltration around the knee joint prior to wound closure. In the control group a CFNB will
      be placed for 48hrs prior to surgery. Outcomes measured included pain at rest, movement and
      quadriceps muscle strength on the first and second postoperative day.

      It is hypothesized that Liposome Bupivacaine will provide effective pain control and improved
      preservation of quadriceps muscle strength, in comparison to CFNB.
    

Intervention name(s): Liposome Bupivacaine; Bupivacaine HCl
Intervention type(s): Drug; Drug
Intervention description(s): Administered via local tissue infiltration around the knee joint; Administered via CFNB
Other intervention name(s): Bupivacaine Liposome, Injectable Suspension; Standard of Care
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fibre Grain Herb Trial in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Despite the availability of multiple medications for the treatment of Type 2 diabetes,
      patients often continue to have difficulty attaining blood glucose targets and managing
      cardiovascular disease risk factors. Recent trends in non-pharmacological therapy have
      created a growing public interest in dietary supplements.

      Research by this group and others support the benefits of whole grains, viscous dietary fibre
      and ginseng in the management of diabetes. The current study investigates whether the
      co-administration of a viscous dietary fibre blend, Salba (a grain rich in omega-3 fatty
      acids), and 2 varieties of ginseng roots will further improve blood sugar control and
      cardiovascular disease risk outcomes in individuals with Type 2 diabetes already receiving
      conventional treatments.

      Patients with Type 2 diabetes receiving the recommended intervention in accordance with the
      Canadian Diabetes Association guidelines will be enrolled in a 6-month clinical study. Half
      of the participants will be randomly assigned to a 4-component intervention that comprises
      the co-administration of these four dietary/herbal supplements in addition to their usual
      treatment regimen; the other half will continue their usual treatment regimen in addition to
      taking high-oat fiber and wheat bran supplements.

      The investigators hypothesize that an intensified, multi-targeted intervention with the
      addition of these dietary and herb components will further improve long-term blood glucose
      control and cardiovascular disease risk factors beyond conventional therapy. If this
      combination of viscous fiber, Salba and ginseng is shown to be beneficial, these remedies
      could complement current conventional therapy for Type 2 diabetes with the goal to further
      improve health outcomes.
    


Intervention name(s): Dietary, Herbal; Positive Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Viscous fibre blend and Salba and American and Korean Red Ginseng capsules; Oat bran blend and wheat bran capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
[11C]MK-6884 Positron Emission Tomography (PET) Tracer Validation Trial (MK-6884-001)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this open-label, 3-part study is to investigate the safety and efficacy of
      [11C]MK-6884 as a positron emission tomography (PET) imaging agent for quantifying muscarinic
      4 (M4) positive allosteric modulator (PAM) receptor density in brain regions of interest. The
      study will enroll healthy participants (Parts 1 and 2) and participants with Alzheimer's
      Disease (AD) (Part 3). The primary efficacy hypothesis is that the average intra-subject
      test-retest (T-RT) variability of tracer uptake in brain regions of interest is ≤20%.
    


Intervention name(s): [11C]MK-6884
Intervention type(s): Drug
Intervention description(s): IV bolus dose of ~370 MBq [11C]MK-6884
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 653048 BS H3PO4 Capsule Multiple Rising Doses in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of the trial were to assess safety, tolerability, pharmacokinetics, and
      pharmacodynamics of multiple rising doses of BI 653048 BS H3PO4 compared with prednisolone.
    


Intervention name(s): BI 653048 BS H3PO4; Prednisolone low dose; Prednisolone high dose; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Transcranial Direct Current Stimulation for Postoperative Pain in Knee Arthroplasty
Condition: Knee Replacement
Study type: Interventional

Summary: 
      The objective of this study is to detect the effect of trans-cranial direct current
      stimulation on postoperative pain and opioid consumption in total knee arthro-plasty
      patients. Fifty patients undergoing unilateral TKA will be randomly assigned to receive 4
      sessions, total of 80 minutes of real (n=25) or sham tDCS (n=25). Stimulation will be given
      on 4 consecutive postoperative days, group 1 will receive real stimulation with the active
      electrode over the leg representation of the motor strip (cortical motor area of the leg) and
      the reference electrode over the arm, group 2 will receive Sham tDCS. Pain level will be
      evaluated according to visual analogue scale (VAS) and LANSS pain scale before (base line)
      after 1st, 2nd, 3rd and 4th sessions.
    

Detailed description: 
      The study aims to to detect the effect of trans-cranial direct current stimulation on
      postoperative pain and opioid consumption in total knee arthro-plasty patients.

      Fifty patients undergoing unilateral TKA will be randomly assigned to receive 4 sessions,
      total of 80 minutes of real (n=25) or sham tDCS (n=25). Stimulation will be given on 4
      consecutive postoperative days, group 1 will receive real stimulation with the active
      electrode over the leg representation of the motor strip (cortical motor area of the leg) and
      the reference electrode over the arm, group 2 will receive Sham tDCS.

      Pain level will be evaluated according to visual analogue scale (VAS) and LANSS pain scale
      before (baseline) after 1st, 2nd, 3rd and 4th sessions.
    

Intervention name(s): tDCS; Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): 25 patients received real anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days.; 25 patients received sham anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Arthroplasties, Knee Replacement