bioihbjkbjnl/mcl2 huggingface dataset:
The Single, Multiple Dose and Food Effect Study of SHR2285 Tablets on Pharmacokinetics and Pharmacodynamics in Healthy Subjects
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a randomized, doubled-blinded, placebo-controlled, Phase I trials. The study is
      divided into two parts. The first part is a single-dose escalated study (SAD,part 1A ) and
      food effect study (SAD, part 1B ) in healthy subjects. The second part is a multi-dose
      escalated study (MAD) in healthy subjects.
    


Intervention name(s): SHR2285 tablet; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single dose or multi-dose; single dose or multi-dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effects of a 12-week Strength Training Program in Women With Myotonic Dystrophy Type 1
Condition: Myotonic Dystrophy 1
MeSH terms: Myotonic Dystrophy
Study type: Interventional

Summary: 
      20 women with myotonic dystrophy type 1 (DM1) will complete a 12-week lower-limb strength
      training program. The training program consist of 3 series of 6 to 8 maximal repetitions of 5
      different exercises: Leg extension, leg press, hip abduction, squat and plantar flexion.
      Training sessions will be closely supervise and take place twice a week. It is hypothesize
      that the training program will induce muscular hypertrophy despite the genetic defect. The
      training program should also have positive effects on function. The participants will be
      evaluated at baseline, week 6, week 12, month 6 and month 9 to quantify the effects of the
      training program and if these effects will be maintained over time.
    


Intervention name(s): Training program
Intervention type(s): Other
Intervention description(s): 12-week strength training program of the lower limbs consisting of 5 different exercises: Leg extension, leg press, hip abduction, squat and plantar flexion. All exercises will be perform between 6 and 8 maximal repetitions.
Intervention model: Sequential Assignment
Intervention model description: Participants will complete a 12-week strength training program and return to their normal activities for the following 6 months after the end of the training program.
Masking: None (Open Label)
Primary purpose: Supportive Care
The Mininimum Effective Anaesthetic Volume of Local Anaesthetic in Ultrasound-guided "Shamrock" Lumbar Plexus Block
Condition: Mininimum Effective Anaesthetic Volume of Local Anaesthetic
Study type: Interventional

Summary: 
      The "Shamrock method" is a new ultrasound-guided lumbar plexus block. The aim of the study is
      to determine the minimum effective volume of ropivacaine 0.5% required to produce an
      effective lumbar plexus block with this method. Using the Dixon and Massey up-and-down method
      study design, 30 patients scheduled for elective total hip and knee arthroplasty will be
      included in the study.
    


Intervention name(s): lumbar plexus block
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Factors Affecting Medical Student Learning in Simulation Scenarios
Condition: Learning
Study type: Interventional

Summary: 
      Simulation is used to teach undergraduate and postgraduate healthcare professionals, however
      it is not known how best to use this resource. Using qualitative methods, this study aims to
      investigate how medical students learn during simulation scenarios and will compare students
      who are paired with peers with those who are solo during their scenarios. Video and audio
      data from simulations will be collected and analysed with anxiety and empathy questionnaire
      data and semi-structured interviews.
    

Detailed description: 
      Medical students attending a simulation day will either perform their simulation paired with
      another student from the group or solo. Video data from the scenario and audio data from the
      feedback session will be retained. One week later students will perform a second scenario and
      the feedback following this will be retained. Students will also have a semi-structured
      interview and complete anxiety and empathy questionnaires.
    

Intervention name(s): Simulation scenario; Simulation scenario
Intervention type(s): Other; Other
Intervention description(s): Students performing their scenario will be paired, not solo; Students will perform their simulation scenario solo and receive feedback within the group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Simulation; Learning; Medical Students; Empathy; Anxiety
Rowing Away From Diabetes
Condition: Diabetes Mellitus, Type 2; Glucose Intolerance; Hyperglycemia
MeSH terms: Diabetes Mellitus, Type 2; Hyperglycemia; Glucose Intolerance
Study type: Interventional

Summary: 
      Primary research question: What is the effect of indoor rowing, under the ideal circumstances
      of a laboratory setting, on glucose control in adults with impaired glucose control?

      Secondary research question: Is it possible to develop a full-scale study of the benefits of
      indoor rowing under the usual circumstances of a community setting?

      Why? It is good practice to conduct a small pilot study before embarking on an expensive
      full-scale study.

      What? Around 150 minutes of aerobic exercise and around 150 minutes of resistance exercise
      per week are necessary to meet prevailing recommendations for adults with impaired glucose
      control. Around 120 minutes of indoor rowing per week might be a less time-consuming
      alternative to prevailing recommendations because indoor rowing involves a combination of
      aerobic and resistance exercise.

      Who? Twenty men and postmenopausal women aged 45-65 years with impaired glucose regulation,
      such as those with type 2 diabetes. Eligible volunteers will not have smoked in the last
      year, will not have exercised regularly in the last six months, and will not be taking any
      form of diabetes medication other than metformin. Eligible volunteers will have stable weight
      and a body mass index of 25-40.

      Where and how? Before and after the exercise intervention, glucose control (postprandial
      blood glucose concentrations) will be assessed at Leicester Diabetes Centre and cardiac
      function (MRI) will be assessed at Glenfield Hospital. During the exercise intervention,
      participants will use an indoor rower three times per week for 12 weeks at Leicester Diabetes
      Centre. Participants will be taught how to row correctly and the duration and intensity will
      gradually increase. In order to inform the design of a full-scale trial, recruitment rate
      will be assessed, adherence will be monitored, and a third party will interview participants
      to find out if the intervention and assessments are feasible and acceptable.
    


Intervention name(s): Indoor rowing
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Change in Mandibular Bone Width Using Two Stages Splitting Approach
Condition: Narrow Mandibular Ridge
Study type: Interventional

Summary: 
      Alveolar ridge splitting technique is a commonly used procedure for horizontal ridge
      augmentation of narrow ridges to allow placement of implants. However, the commonly used
      one-stage technique can cause malfracture and subsequent necrosis of the fractured part.
    

Detailed description: 
      Twelve patients were selected randomly having posterior mandibular narrow edentulous ridge.
      The sample were selected to match a list of inclusion and exclusion criteria. In the first
      stage, all patients will underwent a mandibular ridge splitting technique using piezotomes.
      In the second stage, ridge expansion and implants were placed with only envelope flap.
      Assessment were included measurement of the buccal and lingual bone surrounding the implants
      and amount of increase in the bone width from the cone beam computed tomography.
    

Intervention name(s): 2-stage ridge splitting
Intervention type(s): Procedure
Intervention description(s): two-stage alveolar ridge splitting technique using piezoelectric device with simultaneous implant placement in order to treat narrow posterior mandibular ridges avoiding the risks of malfracture and necrosis of the split part
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
New Pharmacological Treatment for Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine if mirtazapine, a unique antidepressant that does not disturb
      sleep, will improve obstructive sleep apnea (OSA). The design is randomized, crossover,
      double blind, and placebo controlled. On two consecutive nights of one week, the patients
      receive either 30 mg mirtazapine or placebo at bedtime. The following week, the alternative
      medication is administered. The patients have known mild to moderate sleep apnea. The
      endpoints of the study are the apnea + hypopnea index (AHI), sleep quality, and the degree of
      arterial oxygen desaturation.
    


Intervention name(s): mirtazapine
Intervention type(s): Drug
Intervention MeSH terms: Mirtazapine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: sleep apnea; mirtazapine; sleep
The DEB Pilot Study
Condition: Nutritional Physiological Phenomena; Obesity
Study type: Interventional

Summary: 
      The purpose of the current study is to test if weight change is differentially affected by
      consumption of foods that are identical in carbohydrate (i.e. sugar) but vary in food form
      over 1 month.
    

Detailed description: 
      Dose: Participants are to consume 1 unit per day of the study product.

      Diet: Participants will receive no instructions for other dietary modifications; i.e., they
      will not be told to modify what or how much other food they consume.
    

Intervention name(s): Sugar Sweetened Solid Treatment; Sugar Sweetened Beverage Treatment
Intervention type(s): Other; Other
Intervention description(s): Consume Sugar Sweetened Solid Treatment (product) daily.; Consume Sugar Sweetened Beverage Treatment (product) daily.
Other intervention name(s): SSB Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized parallel arm design trial examining solid sugar vs. SSB treatments will be performed.
Masking: Single (Investigator)
Primary purpose: Prevention
Micronutrients and Health in Adult Chinese
Condition: Dysglycemia; Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Observational

Summary: 
      Adult subjects were recruited from a health examination center. Their fasting blood samples
      were collected for laboratory analyses of multiple measures including mineral, glucose,
      lipids, etc.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention.
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Adult volunteers visiting a health examination center were randomly recruited with their
        consent to particiapate the study.
      
Biospecimen description: 
      Blood samples were collected and separated by centrifugation for supernatant and blood cells.
Use of Indirect Calorimetry in Obesity
Condition: Metabolism Disorder; Overweight and Obesity
MeSH terms: Obesity; Overweight; Metabolic Diseases
Study type: Observational

Summary: 
      The investigators will retrospectively analyze and compare data of 2 groups of overweight and
      obese patients: subjects who followed a diet based on Resting Energy Expenditure (REE)
      measured by indirect calorimetry and subjects who followed a diet based on REE estimated by
      the Harris-Benedict equation. Propensity score adjustment will be used to adjust for known
      differences between the 2 groups
    


Intervention name(s): Indirect calorimetry
Intervention type(s): Diagnostic Test
Intervention description(s): Indirect calorimetry will be performed by using an open-circuit calorimeter (Sensor Medics, Italy). Indirect calorimetry is the reference method for energy expenditure determination. A canopy hood covered the patient's head and expired air is extracted by a pump to be analyzed by metabolic cart sensors; flow rate is directly measured with a digital turbine flowmeter. After an overnight fast, patients will asked to lay supine in complete physical rest, not sleeping or talking for approximately 20-25 minutes, at a room temperature ranged between 22 and 24°C. The mean REE for each participant considers the last 15-20 minutes of measurements corresponding to steady state.
Software of calorimeter will be set for minute-by-minute reading report of VO2 (Oxygen flow) and VCO2 (Carbon dioxide flow) measurement.
Parameters obtained by Indirect Calorimetry will be the Resting Energy Expenditure and the Respiratory Quotient (RQ)
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        To collect clinical data of a total population comprising patients referred to our
        Endocrinology-Diabetes Outpatient Clinic, in the period from April 2012 through October
        2016.

        In this retrospective study, will be considered patients with an age ranging from 20 to 86
        years, with overweight (25 ≤ BMI ≤ 29.9) or obesity (BMI ≥ 30), requiring dietary
        intervention for weight control.

        Statistical analysis will perform on overweight and obese patients divided into two
        subgroups: IC group and NO-IC group.

        Anthropometric status and metabolic biomarkers will re-evaluated at check-ups performed
        after 3 months, 6 months, 12 months and 18 months from the baseline.
The Use of a Language Toolkit for Toddlers
Condition: Language Acquisition
Study type: Interventional

Summary: 
      To investigate whether young children with isolated expressive language delay benefit from
      early intervention with a simple language toolkit and brief instructions provided to their
      caregivers.

      We hypothesize that children whose families are provided the language toolkit will develop
      more words over the subsequent 3 months.
    


Intervention name(s): Language toolkit; Safety counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Simple toolkit of interactive things to stimulate language.; Smoke detector and general safety counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Safety and Efficacy of PP4001 for the Treatment of Symptoms Associated With Uncomplicated Urinary Tract Infection
Condition: Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      PP4001 is a medication not yet approved by the US FDA. This is a phase 2, multi-center,
      randomized, double-blind study of 3 doses of PP4001 versus placebo in the treatment of
      symptoms associated with uncomplicated urinary tract infection. After the screening, patients
      are randomized to receive one of three doses of PP4001 or placebo. Patients are screened and
      randomized on the same day, and take 4 doses of study drug, one dose every 12 hours. Data
      about uncomplicated urinary tract infection symptoms are collected from the subjects on
      electronic handheld devices throughout the 48-hour study period. The primary endpoint is
      burning during urination.
    


Intervention name(s): PP4001; PP4001; PP4001; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 50 mg, 1 dose every 12 hours x 4 doses; 100 mg, 1 dose every 12 hours x 4 doses; 200 mg, 1 dose every 12 hours x 4 doses; Placebo, 1 dose every 12 hours x 4 doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Burning; Dysuria; Frequency; Pain; Uncomplicated Urinary Tract Infection; Uncomplicated UTI; Urinary Tract Infection; UTI; Burning during urination associated with uncomplicated urinary tract infection; Urination frequency associated with uncomplicated urinary tract infection; Pain associated with uncomplicated urinary tract infection
Drug-eluting Balloon in Acute Myocardial Infarction
Condition: Coronary Artery Disease; Atherosclerosis; Thrombosis; Acute Myocardial Infarction
MeSH terms: Coronary Artery Disease; Myocardial Infarction; Thrombosis; Atherosclerosis; Infarction
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators hypothesize that patients with Acute ST Elevation Myocardial Infarction may
      benefit from primary angioplasty with use of a drug eluting balloon/bare metal stent
      combination without impairing the process of normal vascular healing and endothelial
      function.

      The goals of this study are:

        1. To compare 6-month angiographic outcome after primary angioplasty using drug eluting
           balloon/bare metal stent combination versus drug eluting stent versus bare metal stent.

        2. To compare stent apposition and stent endothelialization after primary angioplasty using
           drug eluting balloon/bare metal stent versus drug eluting stent versus bare metal stent.

        3. To compare coronary endothelial function after primary angioplasty using drug eluting
           balloon/bare metal stent versus drug eluting stent versus bare metal stent.
    


Intervention name(s): Drug eluting balloon; Bare metal stent; Drug eluting stent
Intervention type(s): Device; Device; Device
Intervention description(s): Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel; Bare metal stent; Paclitaxel eluting stent
Other intervention name(s): Dior (EuroCor); Magic (EuroCor); Taxus Liberté (Boston scientific)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Immune Function Intervention Trial
Condition: Immune Response
Study type: Interventional

Summary: 
      The purpose of the study is to examine whether cardiovascular exercise training improves
      immune responses to vaccination in previously sedentary older adults.
    

Detailed description: 
      The extent to which exercise training or long-term physical activity influences poorly
      regulated immune function in the elderly is unclear. Preliminary evidence suggests that
      exercise training may improve various immune function measures in older adults. Although such
      findings have the potential to be of substantial public health importance, the majority of
      studies have suffered from small sample sizes, inadequate measurement of physical fitness,
      and weak research designs.

      This study is designed to overcome these limitations by employing a longitudinal randomized
      controlled trial examining the effect of exercise training on clinically relevant immune
      function measures in older adults (65-80 years). Moreover, relationships between several
      factors known to be altered by exercise training and changes in immune function will be
      assessed. As such, there are two specific aims to be addressed. In Aim 1, a 10-month exercise
      trial will determine whether moderate intensity aerobic exercise training can improve immune
      function in previously sedentary older adults. In Aim 2, the role played by physiological,
      behavioral, and psychosocial factors in the relationship between exercise training and
      improved immune function will be examined.

      150 sedentary participants will be randomly assigned to either a 10-month moderate aerobic
      exercise training program or a sedentary control group. Clinically relevant measures of
      immune function including the delayed-type hypersensitivity (DTH) response to a battery of
      antigens and the antibody response to tetanus toxoid and influenza virus vaccination will be
      assessed before, during and after the intervention. We hypothesize that exercise training
      will result in improved immune responses including higher peak antibody titers and DTH
      responses, and sustained levels of protective antibodies.
    

Intervention name(s): cardiovascular exercise training; flexibility/balance control
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Drug /Cue Interactions In Alcohol-Tobacco Comorbidity
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to determine how people react to different combinations of
      alcohol and nicotine.
    

Detailed description: 
      The present project will improve and expand upon previously published work in several ways.
      First, Study 1 will assess reactivity to alcohol and smoking cues in the same session.
      Second, both studies will include within-subjects design factors to manipulate alcohol and
      nicotine intake, as well as cue types. Third, craving indices will represent three important
      response domains: subjective, physiological, and behavioral (e.g., Niaura et al., 1991).
      Fourth, each study will evaluate a range of drinkers and smokers, which will provide maximal
      information concerning influences on alcohol and smoking cue reactivity across various
      subject populations. The proposed studies are not only important from a theory development
      perspective, but they will provide an excellent foundation for future laboratory-based and
      clinical research.
    

Intervention name(s): Tobacco; Alcoholic Beverage; Placebo
Intervention type(s): Behavioral; Other; Other
Intervention description(s): Five research sessions. Session 1: Questionnaires, interviews, computer task, medical evaluation. Sessions 2 - 5: Lab Sessions involving tobacco with brief summary at the end of the last session.; Five research sessions. Session 1: Questionnaires, interviews, computer task, medical evaluation. Sessions 2 - 5: Lab Sessions involving and alcohol with brief summary at the end of the last session.; Five research sessions. Session 1: Questionnaires, interviews, computer task, medical evaluation. Sessions 2 - 5: Lab Sessions involving placebo with brief summary at the end of the last session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Prevention Intervention; Alcohol; Tobacco; Nicotine; Craving; Cue Reactivity; Cross Cue Reactions