bioihbjkbjnl/mcl2 huggingface dataset:
CloudConnect: Predictive And Retrospective Clinical Decision Support For Chronic Disease Management
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Chronic Disease
Study type: Interventional

Summary: 
      This study is to assess an approach of self-management called CloudConnect, evaluating the
      impact of CloudConnect Reports on patient engagement, adolescent/parent discussion, and
      clinical outcomes in adolescent Type 1 Diabetes (T1D).
    

Detailed description: 
      It is hypothesized that in contrast to adolescents randomized to the Control Group subjects
      will maintain a Hemoglobin A1c (HbA1c) while adolescents randomized to receiving the
      CloudConnect Report will have a lowering of HbA1c that is related to the increase in
      adolescent/parent disease-specific engagement. Moreover, the hypothesis is that the subjects
      receiving the CloudConnect Report will increase the engagement of adolescents/ parent through
      increased communication and self-management behavior, and that this increase in engagement
      will lead to improved medical outcomes.
    

Intervention name(s): CloudConnect Report; Will not receive a CloudConnect Report
Intervention type(s): Other; Other
Intervention description(s): Subjects and their parents will be asked to download the data from the study devices as well as download their insulin pump/pen. The participants will receive a weekly CloudConnect Report that is based on analysis of the data gathered from the downloads provided by the subject during that week. Participants will both receive weekly contact from the study team to discuss the communication that the subject & their parent had during the week about the participant's diabetes management.; Subjects and their parents will be asked to download the data from the study devices as well as download their insulin pump/pen. Participants will receive weekly contact from the study team to discuss the communication that the subject & their parent had during the week about the participant's diabetes management.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects (child/parent dyad, with child and parent counted as separate subjects randomized together) will be randomized to either a Control Group or an Experimental Group. Both groups will use a study CGM and activity tracker. MDI users will use an inPen to dispense their insulin treatment with their personal insulin. Subjects who use an insulin pump to care for their diabetes will use their personal pump and their personal insulin during the study. All subjects will be asked to download their equipment each week. The study team will communicate with both the subject and their parent(s) each week to discuss their diabetes management. Subjects will complete questionnaires at the beginning and end of the study.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Type 1 Diabetes Mellitus (T1D); Continuous Glucose Monitor (CGM); Activity Monitor (i.e. Fitbit); Hemoglobin A1c (HbA1c); Companion Medical inPen; Insulin Pump; Multiple Daily Injections (MDI)
Hemodynamic Effects of Dry Sauna Followed by Cold Water Immersion in Healthy Subjects
Condition: Blood Pressure; Arrhythmias
MeSH terms: Arrhythmias, Cardiac
Study type: Interventional

Summary: 
      The purpose of this study is to determine the safety on sauna followed by cold water bath, a
      common practice in many countries, 30 healthy subjects aged 40 years and older will be at the
      Montreal Heart Institute Prevention and Cardiac Rehabilitation centre.
    

Detailed description: 
      To determine the safety on sauna followed by cold water bath, a common practice in many
      countries, 30 healthy subjects aged 40 years and older will be at the Montreal Heart
      Institute Prevention and Cardiac Rehabilitation centre. A recent complete evaluation will
      have excluded any cardiac condition. Subjects will first spend 10 minutes in a dry sauna at
      85 degrees celtius. Immediately after , subjects will be immersed in a cold water bath (ICool
      , Australia) at a temperature of 5 degrees celtius for approximately one minute. Blood
      pressure , ecg , gaz exchange and thoracic impedance will be measured during sauna and cold
      water bath.

      Principal goal of study: to determine the safety of this practice. Secondary goals of study:
      to measure the blood pressure response, heart rate, presence of arrythmyas, cardiac output
      and cerebral perfusion during both conditions.

      Primary endpoint: Change in systolic blood pressure from sauna (after 10 minutes ) to cold
      water (after one minute).

      Physiologic measurements: continuous ECG monitoring, BP measurements at every 3 minutes
      during sauna and at one minute in the cold bath, gaz exchange with a portable equipment
      (Cosmed K4), bioimpedance and cerebral perfusion with a single frontal NIRS electrode.
    

Intervention name(s): Sauna and cold water bath
Intervention type(s): Other
Intervention description(s): Subjects will first spend 10 minutes in a dry sauna at 85 degrees celtius. Immediately after, subjects will be immersed in a cold water bath (ICool , Australia) at a temperature of 5 degrees celtius for approximately one minute. Blood pressure , ecg , gaz exchange and thoracic impedance will be measured during sauna and cold water bath.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Sauna; Cold water bath
Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)
Condition: Venous Thromboembolism (VTE); Pulmonary Embolism; Deep Vein Thrombosis (DVT)
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint
      evaluation (PROBE) parallel group study in subjects with confirmed VTE. This study is
      designed to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of edoxaban and to
      compare the efficacy and safety of edoxaban against standard of care in pediatric subjects
      with confirmed VTE.
    

Detailed description: 
      The objective is to demonstrate the non-inferiority of edoxaban to standard of care (SOC;
      including low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic
      pentasaccharide (SP) Xa inhibitors) in the treatment and secondary prevention of VTE in
      pediatric subjects with regard to the composite efficacy endpoint (ie, symptomatic recurrent
      VTE, death as result of VTE, and no change or extension of thrombotic burden) during the
      first 3-month treatment period.
    

Intervention name(s): Edoxaban; Standard of Care
Intervention type(s): Drug; Drug
Intervention description(s): 15 or 30 mg tablets for participants 12 years of age to <18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age; Standard of care could include low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.
Other intervention name(s): Warfarin/heparin; Enoxaparin; Fondaparinux
Intervention MeSH terms: Heparin; Enoxaparin; Warfarin; Edoxaban; Fondaparinux
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pediatric; Venous thrombolism; Pulmonary embolism
Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the effect of hepatic impairment on the
      systemic exposure of tropifexor and to evaluate the safety of tropifexor in subjects with
      hepatic impairment. The results of this study will support treatment and dosing decisions for
      patients with varying degrees of hepatic impairment.
    


Intervention name(s): LJN452
Intervention type(s): Drug
Intervention description(s): Dose A single dose
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LJN452; tropifexor; PK; safety; healthy subjects; hepatically impaired; Nonalcoholic Steatohepatitis; Nonalcoholic Fatty Liver Disease; NAFLD
Trivandrum Breast Cancer Screening Trial
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Cluster-randomized controlled trial in Trivandrum district, Kerala, India to evaluate the
      effect of triennial screening for breast cancer using clinical breast examination on breast
      cancer mortality.
    

Detailed description: 
      The study population consisted of 274 administrative regions (clusters) in Trivandrum
      district, Kerala, southern Indian. 133 clusters were randomly assigned to the intervention
      arm (3 rounds of clinical breast examination conducted 3 years apart) and were compared to
      the remaining 141 clusters assigned to a control arm that received standard of care. The
      eligibility criteria were all healthy subjects aged 30 to 69, without a personal history of
      breast cancer. Informed consent was signed by each participant. The intervention arm
      consisted of 55,843 participants and the control group consisted of 59,447 participants.
    

Intervention name(s): Clinical examination of the breast for early detection of Cancer
Intervention type(s): Diagnostic Test
Intervention description(s): Participants were invited for 3 rounds of clinical breast examination, conducted 3-years apart. Screening was conducted by health workers trained to perform clinical breast examination for early detection of cancer. Women with abnormal referable lesions underwent CBE by a trained clinician and those women with a confirmed breast lump or any other breast abnormality warranting further investigations were evaluated by triple-testing involving expert physical examination, diagnostic mammography with or without ultrasonography and fine needle aspiration cytology (FNAC) or core biopsy or excision biopsy. Those with confirmed breast cancer were referred for appropriate treatment with surgery, radiotherapy, and/or chemotherapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The control group received standard of care while the intervention group received 3 rounds of screening with clinical breast examination, each 3 years apart. After the 3 rounds of screening, the participants were followed up for an additional 4 years to accrue information on breast cancer incidence and mortality, and the vital status.
Masking: None (Open Label)
Primary purpose: Screening
New Technologies to Help Manage ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Cluster randomized controlled trial to evaluate the general effectiveness of intervention
      compared to control on medication continuity as measured by prescriptions written and other
      more proximal outcomes during the first six months of treatment.
    

Detailed description: 
      This cluster randomized controlled trial will evaluate the general effectiveness of the
      intervention (e.g. enhanced myADHDportal.com), compared to control (e.g. treatment as usual
      standard portal), on medication continuity as measured by prescriptions written and other
      more proximal outcomes during the first six months of treatment.
    

Intervention name(s): enhanced myADHDportal.com; treatment as usual standard portal
Intervention type(s): Other; Other
Intervention description(s): Version of the myADHDportal.com web software enhanced with family-management support to enable parents to be active partners in optimizing and maintaining medication continuity for their child; Standard version of myADHDportal.com web software
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Health Services Research
Prevention of Neural Tube Defects by Inositol in Conjunction With Folic Acid (PONTI Study)
Condition: Recurrent Neural Tube Defects
MeSH terms: Neural Tube Defects; Spinal Dysraphism
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to develop a randomised, double blind clinical trial to compare (i)
      folic acid plus inositol, with (ii) folic acid plus placebo, for prevention of recurrent
      neural tube defects.
    

Detailed description: 
      Women were eligible to join the PONTI pilot study if they had a history of previous
      NTD-affected pregnancy, were planning to become pregnant again, and were prepared to be
      randomised to one of the two study arms. Both study and control groups received 5 mg folic
      acid (the standard UK supplement for pregnancies at high risk of NTD); the study group
      additionally received 1 g inositol, whereas the control group was prescribed a placebo
      instead of inositol.
    

Intervention name(s): Folic Acid and inositol; Folic acid and placebo
Intervention type(s): Drug; Drug
Intervention description(s): Folic Acid and inositol; Folic acid and placebo
Other intervention name(s): Study Group; Control Group
Intervention MeSH terms: Folic Acid; Vitamin B Complex; Inositol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Prevention
Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Trifenatate in the Treatment of Asthma in Adolescent and Adult Subjects of Asian Ancestry
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomised, double-blind, double-dummy, parallel group study to evaluate the efficacy and
      safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation powder delivered once
      daily in the treatment of asthma in adolescent and adult subjects of Asian ancestry currently
      treated with high-strength inhaled corticosteroids or mid-strength ICS/LABA combination
      therapy
    

Detailed description: 
      This will be a randomized, double-blind, active-comparator, parallel group, multi-center
      study. At Visit 1 (Screening Visit) subjects who meet all of the inclusion criteria and none
      of the exclusion criteria will enter a two week Run-in period. Subjects will remain on their
      current ICS therapy throughout the Run-in period. At the end of the Run-in period (Visit 2)
      subjects meeting the randomization criteria will enter a 12 week treatment period and receive
      one of the two following treatments: 1) FF (200mcg)/VI (25mcg) administered once daily in the
      evening via a Novel Dry Powder Inhaler (NDPI) 2) Fluticasone propionate 500mcg administered
      twice daily via DISKUS™ Inhaler In addition, all subjects will be supplied with
      albuterol/salbutamol inhalation aerosol to be used as required to treat asthma symptoms.

      Subjects who have not met the randomization criteria at Visit 2 will be withdrawn from the
      study.

      Subjects meeting the randomization criteria will be randomized to one of the two treatment
      groups and will attend the clinic for 3 on-treatment visits at Week 4 (Visit 3), Week 8
      (Visit 4) and Week 12 (Visit 5). Subjects will receive treatment for 12 weeks. A Follow-up
      Visit or Contact (Visit 6) will take place 1 week after completing study medication. All
      clinic visits will take place in the morning. Subjects will participate in the study for a
      maximum of 15 weeks (Screening to Follow-up inclusive). A subject is regarded to have
      completed the study if they complete all phase of the study (Screening, treatment,
      Follow-up).
    

Intervention name(s): GW685698/GW642444; CCI18781
Intervention type(s): Drug; Drug
Intervention description(s): ICS/LABA; ICS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of Live Attenuated Japanese Encephalitis Vaccine (ChimeriVax™-JE) and Yellow Fever Vaccine (STAMARIL®)
Condition: Japanese Encephalitis; Yellow Fever
MeSH terms: Encephalitis, Japanese; Yellow Fever; Encephalitis; Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to obtain safety, tolerability, and immunogenicity data on the
      co-administration or sequential administration of Chimeravax™-JE vaccine and STAMARIL®.

      Objectives:

      Safety:

        -  Obtain safety and tolerability data of a single, fixed dose of ChimeriVax™-JE
           administered concurrently, one month before or one month after STAMARIL® to adult
           volunteers (≥ 18 to ≤ 55 years) without prior Japanese encephalitis (JE) or yellow fever
           (YF) vaccination.

      Immunogenicity:

        -  Obtain data on the antibody response to a single, fixed dose of ChimeriVax™-JE
           administered concurrently, one month before or one month after STAMARIL® to adult
           volunteers without prior JE (or YF) vaccination.

        -  Assess the durability of the immune response in adult volunteers 6 months after
           administration of ChimeriVax™-JE and STAMARIL®.
    

Detailed description: 
      All participants will receive two injections, one to each arm on Days 0 and 30, respectively.
      Immunogenicity will be tested on Days 0, 15, 30, 45, and 60, and at Month 6.
    

Intervention name(s): Live attenuated Japanese encephalitis virus; Yellow fever virus; Yellow fever virus; Live attenuated Japanese encephalitis virus; Live attenuated Japanese encephalitis virus; Yellow fever virus; Live attenuated Japanese encephalitis virus; Yellow fever virus
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): ChimeriVax™-JE, 0.5 mL, Subcutaneous on Day 0; STAMARIL®, 0.5 mL, Subcutaneous on Day 30.; STAMARIL®, 0.5 mL Subcutaneous on Day 0; ChimeriVax™-JE, 0.5 mL Subcutaneous on Day 30.; ChimeriVax™-JE, 0.5 mL Subcutaneous and STAMARIL®, 0.5 mL, Subcutaneous on Day 0; Diluent 0.5 mL, Subcutaneous on Day 30.; Diluent, 0.5 mL Subcutaneous on Day 0; ChimeriVax™-JE, 0.5 mL Subcutaneous and STAMARIL®, 0.5 mL Subcutaneous on Day 30.
Other intervention name(s): ChimeriVax-JE; STAMARIL®; STAMARIL®; ChimeriVax™-JE; ChimeriVax™-JE; STAMARIL®; ChimeriVax™-JE; STAMARIL®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Japanese Encephalitis; Yellow Fever; ChimeriVax™-JE; STAMARIL®; Adult
Safety and Performance Evaluation of CircuLite Synergy
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The purpose of the study is to demonstrate the safety and functionality of the CircuLite
      Synergy Pocket Circulatory Assist Device.
    

Detailed description: 
      The CircuLite Synergy Pocket Circulatory Assist Device is an implantable miniature,
      mixed-flow blood pump designed o provide partial left ventricular support in patients with
      advanced heart failure. Treatment for this patient population currently include lifestyle
      changes, medicines, transcatheter interventions and surgery, including implantation of
      mechanical ventricular assist devices (VADs); most of the currently available VADs require
      highly invasive, high-risk surgical procedures to implant due to large device size, and are
      therefore generally limited to use in patients with terminal heart failure. The Synergy pump
      is intended for treatment of patients with New York Heart Association (NYHA) Class III and IV
      heart failure; it is expected that the pump will provide these patients with 2-3 L/min of
      additional blood flow, giving adequate cardiac support to increase exercise tolerance and
      improve patients' quality of life. The pump's small size will allow it to be implanted in a
      less surgically invasive procedure than used with previous VADs, which should result in a
      reduction of perioperative morbidity. The device wil be implanted in a left atrial to
      subclavian artery bypass with the pump being located in the infraclavicular fossa like a
      pacemaker.
    

Intervention name(s): CircuLite Synergy Pocket Circulatory Assist Device
Intervention type(s): Device
Intervention description(s): Goal of successful implantation and follow-up for at least three months
Other intervention name(s): CircuLite; CircuLite Synergy; CircuLite Micro pump; CircuLite Synergy Partial Circulatory Assist Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heart Failure; Partial Circulatory Assist; NYHA Class IIIb; NYHA Class IV; Ventricular Assist Device; VAD
Induced Sputum Study (0000-065)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary goals of this study will be to implement innovative processing and detection
      assays to qualify induced sputum measurements of markers of allergen-induced airway
      inflammation. The results of this study are intended to form a platform to be used in the
      clinical development of novel asthma therapeutics.
    


Intervention name(s): Comparator: fluticasone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Two puffs, of 250 µg each, will be administered to each patient to obtain a 500-µg dose at each prespecified time point. A total of five (5) doses (500 µg) each of inhaled fluticasone will be administered in a 3-day period during Periods 1 and 2. Dosing will be twice a day for 3 days, ending after the morning dose on the third day.; Two puffs, of placebo, will be administered to each patient at each prespecified time point. A total of five (5) doses of placebo will be administered during the single blind run-in phase. and matching placebo will be administered in a 3-day period during Periods 1 and 2. Dosing will be twice a day for 3 days, ending after the morning dose on the third day.
Other intervention name(s): fluticasone
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Periodic Fasting Versus Daily Energy Restriction on Metabolic Health
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The aim of this study is to examine whether periodic fasting improves markers of diabetes
      risk and cardiovascular health, and will compare this to the effects observed with daily
      dieting by energy restriction, and also with no change in energy intake.

      It is hypothesized that periodic fasting, with or without weight loss, will be as effective
      as daily energy restriction to improve markers of metabolic health and energy metabolism.
    


Intervention name(s): Periodic fasting; Energy restriction; Energy balance diet
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science