bioihbjkbjnl/mcl2 huggingface dataset:
A Virtual Reality System for Pain and Anxiety Management During Outpatient Hysteroscopy
Condition: Infertility; Vaginal Blood Loss
MeSH terms: Infertility
Study type: Interventional

Summary: 
      To evaluate the effectiveness of VR as a distraction technique in the management of acute
      pain and anxiety during operative hysteroscopy in the outpatient setting.
    

Detailed description: 
      A prospective, open-label, randomized control trial in a tertiary university-affiliated
      medical center between April to August 2020. Overall, 100 women will be randomly allocated to
      undergo operative hysteroscopy either with the use of VR (study group) or with standard
      treatment (control group). The primary outcome measures includ self-reported pain, anxiety
      scores, and vital parameters as pulse rate (PR) and respiratory rate (RR). Pain and anxiety
      outcomes were measured as numeric rating scores.
    

Intervention name(s): SootheVR: AppliedVR, Los Angeles, California
Intervention type(s): Device
Intervention description(s): a head-mounted display
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hysteroscopy; VR; Vurtual reality
Relative Bioavailability of Dextromethorphan Syrup in Comparison to Dextromethorphan Soft Pastilles in Healthy Male and Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the relative bioavailability of orally administered dextromethorphan
      syrup in comparison to dextromethorphan (DMP) soft pastilles in healthy male and female
      subjects who are extensive metabolisers for CYP 2D6
    


Intervention name(s): Dextromethorphan syrup; Dextromethorphan soft pastilles
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dextromethorphan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Evaluating Single Doses of ILV-095 in Healthy Japanese Male Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of single doses of
      ILV-095 in healthy Japanese male subjects.
    


Intervention name(s): ILV-095; Placebo
Intervention type(s): Biological; Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Sweetness of the Beverage in Thirst Sensation
Condition: Thirst
Study type: Interventional

Summary: 
      The purpose of this study is to determine if water and diet soft drinks with different levels
      of sweeteners have the same effect on thirst.
    

Detailed description: 
      Participants should be in the laboratory at 8.00 in order to collect the values of weight,
      height, total body water, intracellular water and extracellular water in a Segmental Multi
      Frequency Body Composition Monitor (TANITA MC 180 MA®). Then, a blood sample will be
      collected for analysis of blood glucose and osmolality. They will sit at individual tables
      for the duration of the session and were allowed to read, listen to music with earphones, or
      use their portable computers with the exception of internet access to minimize visual cues
      (e.g., unwanted publicity for beverages or visiting Web sites showing pictures of food and
      drinks), which may have effect on thirst. Breakfast will be served at 9.30 on every occasion
      and preload stimuli will be offered exactly 60 minutes after breakfast (at 10.30). Lunch will
      be provided at 13.00. Motivational ratings will be first obtained at the end of collection of
      blood sample (baseline or time 0) and every 30 minutes thereafter until the lunch time (times
      1 through 7). After lunch (time 8), participants will complete the last set of ratings and
      will bring a food diary to record all food and fluid intake until 00.00 that day.
    

Intervention name(s): Effect of sweetness of the beverage in thirst sensation
Intervention type(s): Behavioral
Intervention description(s): Effect of sweetness of the beverage in thirst sensation:
The participants will drink Water (control group),"High Sucralose" - Decarbonized Pineapple Diet Soda with a 50% increase of sucralose face to standard beverage, and "Low Sucralose" - Decarbonized Pineapple with a 50% decrease of sucralose face to standard beverage. The beverages will be presented chilled but without ice in 500 ml portions in opaque plastic containers and participants will be asked to consume the entire amount within 15 min.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Establishment of a Early Risk Model of ECMO in Children With ARDS
Condition: ARDS
Study type: Observational

Summary: 
      The key problem in the treatment of ARDS is refractory hypoxemia. Extracorporeal Membrane
      Oxygenation (ECMO) is an extracorporeal oxygenation of venous blood to eliminate carbon
      dioxide and return to the body. It has been an important part of the rescue treatment for
      ARDS. This study intends to explore the timing of ECMO. The main research hypothesis is that
      the appropriate timing of ECMO treatment can improve the weaning success rate and survival
      rate of children with severe ARDS; it is expected to provide a basis for determining the best
      timing of ECMO treatment
    

Detailed description: 
      Severe acute respiratory distress syndrome (ARDS), especially those caused by severe viral
      pneumonia, is still an important factor in the death of children, with a case fatality rate
      of 55%. The treatment includes lung protective ventilation and advanced ventilation support,
      but the effect is still not ideal for severe patients. ECMO can effectively support the
      respiratory system and provide good oxygen exchange. However, the survival rate of ECMO
      treatment in children with ARDS has a large bias.One of the key factors is the uneven timing
      of ECMO activation, which significantly affects the prognosis.This study intends to design a
      multi-center, prospective, non-randomized controlled trial , through retrospective research
      to find relevant factors affecting the prognosis of ECMO treatment, and to screen key
      indicators related to the timing of intervention; through a prospective cohort study to
      screen Good indicators and cut-off values suitable for starting ECMO , constructing and
      verifying comprehensive prediction models.
    

Intervention name(s): ECMO
Intervention type(s): Procedure
Intervention description(s): VV-ECMO
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        children with acute respiratory distress syndrome（ARDS） admitted to the pediatric intensive
        care unit（PICU） of all the study centers
      
Biospecimen description: 
      2 ml whole blood in EDTA tube
    
Keywords: ECMO; ARDS; pediatric
Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine
Condition: Liver Transplant; Kidney Transplant
Study type: Interventional
Phase: Phase 2

Summary: 
      Clinical trial applying Phenotypic Precision Medicine (PPM) to tacrolimus dosing in liver
      and/or kidney transplant recipients to show improvement in maintaining drug trough levels
      within the target range.
    

Detailed description: 
      The introduction of calcineurin inhibitors like tacrolimus has greatly reduced the incidence
      of acute rejection, improving graft and patient survival after transplantation. However,
      tacrolimus, one of the most widely used immunosuppressants and a mainstay of solid organ
      transplantation, has a narrow therapeutic index and wide pharmacokinetic variability. As
      such, there is a clear need for precision medicine to address post-transplant
      immunosuppression.

      The study team has developed a powerful platform [Phenotypic Precision Medicine (PPM)] that
      utilizes patient-specific clinical data which represents each patient's response to drug
      treatment. This platform can efficiently prescribe precise and optimized drug doses despite
      the frequent changes to patient treatment regimens following transplantation. This
      potentially can have a profound effect on drug metabolism.

      The aim of this project is to use PPM to uncover valuable and previously unknown information
      pertaining to patient dose requirements and correlate them with patient clinical and other
      contextual information. This study is also expected to reveal vital patient subpopulation
      information; and any future discovery of quantitative biomarkers as measures of
      immunosuppression will serve as a gateway towards even more effective personalized and
      relevant drug dosing.
    

Intervention name(s): PPM-based Computation Assisted Drug Dosing; Tacrolimus
Intervention type(s): Other; Drug
Intervention description(s): Tacrolimus dosing based on application of PPM.; Dosing of calcineurin inhibitor, tacrolimus
Other intervention name(s): Computation based dosing
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Phenotypic Precision Medicine (PPM); Tacrolimus; Calcineurin Inhibitors
Contributing Factors in the Pathobiology of Airway Remodeling in Obesity
Condition: Asthma; Obesity; Obesity, Morbid; Bariatric Surgery Candidate
MeSH terms: Obesity; Obesity, Morbid; Airway Remodeling
Study type: Observational

Summary: 
      There are two aims for this study. The purpose of this study is to determine the effects of
      body weight and hormones on airway fibrosis (scarring) and lung function in obese & lean
      asthma subjects compared to obese & lean non-asthma subjects (Aim 1). And in obese subjects
      with asthma undergoing bariatric surgery compared to obese non-asthma subjects undergoing
      bariatric surgery (Aim 2).
    

Detailed description: 
      Main Study

      Specific Aim 1: Determine the effects of signaling on airway fibrosis and lung function in
      obese asthma and non-asthma patients. The investigators will:

      •Perform assessments to determine if obese, early-onset asthma patients are more susceptible
      to airway fibrosis and remodeling than lean, early-onset asthma patients and obese and lean,
      non-asthma patients.◦

      Specific Aim 2: Investigate the mechanism by which bariatric surgery slows the progression of
      airway fibrosis in obese human asthma. The investigators will:

      •Perform assessments to determine if airway fibrosis in obese, early-onset asthma and obese
      non-asthma patients improves following bariatric surgery and weight loss◦
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited from the clinics of the Duke Asthma, Allergy and Airway Center,
        the Duke Metabolic and Weight Loss Surgery Center, the Duke Raleigh Weight Loss Surgery
        Center, and the Duke Diet and Fitness Center. Healthy controls without lung disease will be
        recruited from the surrounding area.
      
Biospecimen description: 
      blood plasma, bronchoscopy with endobronchial biopsy and brushings, bronchoalveolar lavage,
      RNA
Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 3

Summary: 
      The safety and efficacy of FTY720 is being evaluated in patients who receive a kidney
      transplant.
    


Intervention name(s): FTY720
Intervention type(s): Drug
Intervention MeSH terms: Fingolimod Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kidney, Transplantation, Rejection, Immunosuppression
Assessment of Bupropion on Cognitive Function and Behaviour in Healthy Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      To evaluate the effects of a 14-day repeated dose of 150 mg bupropion (therapeutic dose) on
      cognitive and executive functions, behaviour and subjective feelings, after sleep deprivation
      in 12 healthy male subjects.
    

Detailed description: 
      The aim of this controlled double-blind randomized 3-session cross-over designed study is to
      evaluate the effects of a single dose of 150 mg and a 14-day repeated dose of 300 mg
      bupropion (therapeutic dose) on cognitive and executive functions, behaviour and subjective
      feelings, and some physical parameters after sleep deprivation in 12 trained healthy
      volunteers (18-35 years old).

      Cognitive and executive functions were assessed by reaction times, critical flicker fusion
      test, Stroop test, digit symbol substitution test, span test and short term recal of
      pictures, tapping and tracking tests.

      Behaviour and subjective effects explored were :

        -  feelings frequently experienced with psychotropic drugs assessed by ARCI,

        -  some mood states as tension, depression, anger, vigor, fatigue and confusion assessed by
           both POMS and Norris visual analogic scales,

        -  sleep assessed by LSEQ,

        -  feeding behaviour assessed by food intake during a meal test and self-ratings of
           appetite and satiety,

      Physical parameters were :

        -  rest and orthostatic blood pressure and heart rate,

        -  body temperature and weight.

      Bupropion was tested versus both placebo and 20 mg methylphenidate as positive control. Each
      subject received the 3 treatments, sequently randomized, with a 17-day wash-out period
      between sessions. Each session was organized as follow :

        -  2 20-hour hospitalisations consisting in adverse effects review, physical examination,
           test training, sleep deprivation, drug compliance evaluation, drug dosing and
           dispensation, and assessments described above,

        -  2 visits consisting in adverse effects review, drug compliance evaluation and drug
           dispensation.

      The total duration of participation for the subjects was 106 days.
    

Intervention name(s): Bupropion
Intervention type(s): Drug
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: bupropion; repeated dose; healthy volunteers; cognitive function; behaviour; tolerance; Persons
Mhealth for PrEP Adherence by Young Adult MSM, Phase 2
Condition: Hiv
Study type: Interventional

Summary: 
      This Phase 2 project aims to enhance and test a mobile health intervention designed to
      increase adherence to the daily PrEP pill among culturally-diverse young adult men who have
      sex with men. The intervention will include: a) personalized PrEP pill reminders b)
      culturally- and developmentally-sensitive text messages targeting patient education,
      motivation, and stress c) a gamification avatar and d) a linked online community of peers.
      Effectively promoting PrEP adherence would reduce new HIV infections in this at-risk
      population, which is subject to health disparities
    

Detailed description: 
      The project is to develop and test the effectiveness of an individually-tailored,
      developmentally- and culturally-sensitive, mobile health (mhealth) PrEP adherence
      intervention called DOT. The intervention will target culturally-diverse, young adult men,
      ages 18-35, who have sex with men (YMSM). The recent rise in HIV infection among young
      people, particularly minority YMSM, points to the value of PrEP uptake and adherence support
      for YMSM. In PrEP efficacy trials, younger age was the most consistent correlate with low
      PrEP adherence. Our DOT mhealth intervention reflects a developmental understanding of young
      adult decision-making, and is uniquely combined with principles from social cognitive theory,
      positive psychology and behavioral economics. The proposed project is based on Dr. Weitzman's
      successful Phase 1 trial of DOT, which led to significant improvements in PrEP adherence,
      PrEP treatment self-efficacy, and intention to follow PrEP treatment guidelines among the
      YMSM that used DOT for six weeks. Our proposed Phase 2 DOT mhealth intervention is directly
      responsive to Phase 1 findings by adding: 1) texts targeting motivation, patient education,
      and stress burden 2) online community for social support 3) linkage to the federal crisis
      text line 4) virtual avatar 5) cloud-based platform to view user engagement 7) calendar for
      clinic appointments and pharmacy refills 8) enhanced personalization of pill reminders and 9)
      enhanced adherence graphing. In Phase 2, we will test the effectiveness of DOT at improving
      PrEP adherence in a randomized controlled trial.
    

Intervention name(s): DOT mobile app
Intervention type(s): Other
Intervention description(s): DOT is a mobile phone app that has daily pill reminders and supportive texts, as well as various features designed to support PrEP medication adherence.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: None (Open Label)
Primary purpose: Prevention
Exercise Training in Individuals With Coronary Artery Disease
Condition: Coronary Artery Disease; Myocardial Infarction
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      In this controlled trial, patients referred to post-myocardial infarction cardiac
      rehabilitation will be randomized to either interval or continuous training.
    

Detailed description: 
      The trial would i) compare the acute effects of each exercise type on selected cardiovascular
      indicators; ii) compare the chronic effects of each exercise type on selected cardiovascular
      indicators; iii) provide information on the association between acute and chronic effects of
      each exercise type; iv) provide insight into possible mechanisms of effectiveness of each
      exercise type; v) identify the most safe and effective exercise type for patients with
      coronary artery disease.
    

Intervention name(s): Exercise training
Intervention type(s): Other
Intervention description(s): Patients to be randomized to the 'interval training group' or 'continuous training group' will undergo exercise training sessions with different intensity levels.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exercise; interval training; continuous training; endothelial dysfunction
A Phase 1, Open-Label, Single-Dose, Pharmacokinetic and Safety Study of E7080 (24 mg) Administered to Subjects With Mild, Moderate, and Severe Renal Impairment and to Healthy Subjects
Condition: Renal Impairment; Disease Severity
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this multicenter, open-label, non-randomized, single, oral dose,
      sequential-cohort study was to determine pharmacokinetics and safety of lenvatinib (24 mg)
      administered to healthy subjects and to subjects with renal impairment.
    

Detailed description: 
      This is a multicenter, open-label, non-randomized, single-dose, sequential-cohort trial in
      subjects with renal impairment and healthy subjects. The study consists of two phases: A
      Pretreatment Phase and a Treatment Phase. The two periods in the Pretreatment Phase are: (1)
      the Screening Period (lasting up to 29 days), and (2) the Baseline Period (one day). The
      Treatment Period of the Treatment Phase lasts 8 days. The study will enroll a sufficient
      number of subjects so that 24 to 26 subjects complete the study. This will include six
      subjects with mild renal impairment (Group 1), six subjects with moderate renal impairment
      (Group 2), four to six subjects with severe renal impairment (Group 3) and eight subjects
      with normal renal function (Group 4). Subjects determined to be eligible for the protocol
      will receive a single 24-mg oral dose of E7080 on Day 1. Subjects will be discharged from
      clinical site on Day 8.
    

Intervention name(s): Lenvatinib
Intervention type(s): Drug
Intervention description(s): Lenvatinib will be taken as a single dose of 24 mg consisting of 2 x 10 mg and 1 x 4 mg capsules. Treatment will be administered orally with 240 mL of water following a 10-hour overnight fast.
Other intervention name(s): E7080
Intervention MeSH terms: Lenvatinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: renal impairment; disease severity
Denosumab China Phase III Study
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to evaluate the efficacy and safety of denosumab 60 milligrams (mg) for 12
      month treatment in Chinese postmenopausal women with osteoporosis at increased risk of
      fracture.
    

Detailed description: 
      The aim of this Phase III, randomized, double-blind, placebo-controlled, parallel-group study
      is to evaluate the efficacy and safety of denosumab (DMAb) in Chinese postmenopausal women
      with osteoporosis at increased risk of fracture. The study design consists of two phases:
      Screening and 12-month Double-Blind treatment phase. Following the Screening phase, all
      eligible subjects will be randomized to receive Double-Blind DMAb (60 mg) or Placebo study
      medication in a 3:1 ratio. DMAb 60 mg and placebo will be administered as a single
      subcutaneous (SC) injection at the beginning of the Double-Blind phase and at 6 months
      following the initial dose. All subjects will receive daily supplementation of oral elemental
      calcium (at least 600 mg) and vitamin D (at least 400 International Units [IU]). The primary
      objective is to determine the effects of DMAb compared to placebo with respect to mean
      percent change in BMD at the lumbar spine, as measured by dual-energy x-ray absorptiometry
      (DXA), from Baseline to Month 12. Secondary objectives include the evaluation between the
      DMAb and placebo treatment groups: change in BMD: at the lumbar spine (Month 6), total hip
      (Months 6 and 12), femoral neck (Months 6 and 12) and trochanter (Months 6 and 12); and serum
      biomarkers of bone formation and resorption (Months 6 and 12). Clinical safety of denosumab
      will also be assessed in this population.
    

Intervention name(s): Denosumab; Placebo; Elemental Calcium; Vitamin D
Intervention type(s): Drug; Drug; Dietary Supplement; Dietary Supplement
Intervention description(s): Injection; Injection; Oral, at least 600 mg; Oral, at least 400 IU
Intervention MeSH terms: Vitamin D; Denosumab; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment