bioihbjkbjnl/mcl2 huggingface dataset:
tDCS and Female Urinary Incontinence
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Urinary incontinence (UI) is defined as any involuntary loss of urine and can be divided into
      three types: urgency, stress and mixed. Pelvic floor exercises are considered the main non
      pharmacological choice for UI treatment. Its mechanisms are not fully understood, however
      there are some evidence that central mechanisms play an important role in the continence
      control. In this context, neuromodulatory techniques, such as transcranial direct current
      stimulation (tDCS), that address cortical targets has been demonstrated promising results in
      different health conditions. However, few studies have investigated the efficacy of adding
      tDCS to exercise therapies for women with UI.
    


Intervention name(s): Real transcranial direct current stimulation + therapeutic exercises for urinary incontinence; Sham transcranial direct current stimulation + therapeutic exercises for urinary incontinence
Intervention type(s): Procedure; Procedure
Intervention description(s): Real transcranial direct current stimulation associated with therapeutic exercises for urinary incontinence
tDCS: 20 minutes, 2mA, motor supplementary area anode and supraorbital cathode (ipsilateral to the dominant lower limb).Technique based on the application of weak, direct electrical current to the brain through relatively large electrodes that are placed over the scalp, in which anodal and cathodal stimulation increases and decreases cortical excitability, respectively.; Sham transcranial direct current stimulation + therapeutic exercises for urinary incontinence
tDCS: 20 minutes (30 seconds ON), 2mA, motor supplementary area anode and supraorbital cathode (ipsilateral to the dominant lower limb).Technique based on the application of weak, direct electrical current to the brain through relatively large electrodes that are placed over the scalp, in which anodal and cathodal stimulation increases and decreases cortical excitability, respectively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Dose-escalation Study of LPM3480392 in Chinese Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, dose-increasing Phase I clinical
      trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a
      single intravenous infusion of LPM3480392 injection in healthy subject
    

Detailed description: 
      A total of 80 healthy subjects will be allocated to 1 of 8 cohorts (cohort 1~8) in the study,
      each cohort including 10 subjects (8 subjects will receive investigational new drug (IND)
      product and 2 receive placebo). Each subject in fasted state will be randomly assigned to
      receive a single dose of LPM3480392 or placebo intravenously.
    

Intervention name(s): LPM3480392; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous infusion of 30min duration; Intravenous infusion of 30min duration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate Pharmacokinetics (PK) of Etrumadenant Tablet and Capsule Formulations in Healthy Adult Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the pharmacokinetics (PK) effect of single-dose etrumadenant tablet
      and capsule formulations in fasted conditions. The effect of food on single-dose PK of tablet
      formulation will also be assessed.
    


Intervention name(s): Etrumadenant
Intervention type(s): Drug
Intervention description(s): Etrumadenant capsule and tablet formulations
Other intervention name(s): AB928
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study participants will receive 3 treatments (Treatment A, B and C) sequentially during the Treatment Period 1, 2, and 3.
Treatment A: etrumadenant capsule in fasted state Treatment B: etrumadenant tablet in fasted state Treatment C: etrumadenant tablet in fed state Each treatment will be separated by a washout period of 7 days.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Etrumadenant; Healthy participants; Pharmacokinetics; AB928; Tablet; Capsule
Phase 1 Trial of CMV Towne Vaccine in Subjects Previously Received VCL CT02 Vaccine ID or IM
Condition: Cytomegalovirus Infection
MeSH terms: Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Objectives of this trial are to:

        1. Evaluate the kinetics and magnitude of the CMV-specific immune response post-Towne
           challenge (3000 pfu) in healthy CMV-seronegative volunteers who received VCL CT02
           administered ID or IM 9 to 15 months previously as measured by: 1) ELISA and/or
           virus-neutralizing antibody titers for gB; 2) T-cell IFN-g ELISPOT; 3) T-cell
           proliferation assays (CFSE) for IE1, pp65, and/or gB; and possibly 4) cytokine and
           phenotypic flow cytometry responses to pp65, IE1, and/or gB.

        2. Evaluate the safety safety of Towne challenge in healthy CMV-seronegative adult subjects
           who have previously been immunized with a trivalent pDNA CMV vaccine (VCL-CT02)
           administered intramuscularly (IM) or intradermally (ID).

      Our hypothesis is that the immune response to Towne vaccine 3000 pfu challenge after VLC-CT02
      priming will be greater than that after Towne vaccination alone (concurrent controls will be
      administered Towne alone in a concurrent, companion trial).
    

Detailed description: 
      This is a Phase 1, single-center, open-label trial of the live, attenuated Towne CMV vaccine
      administered as a "challenge" to healthy, CMV-seronegative, adult subjects who previously
      received the CMV immunotherapeutic trivalent pDNA-based vaccine, VCL-CT02, given by
      intradermal or intramuscular routes as described in the following table; these subjects have
      been followed for 32 weeks.

      Table 6.1 Subject Distribution Group Formulation Dosing Regimen (day) Dose per
      Injection(Administered to the deltoid region) Route of Administration Number of Subjects

        1. VCL-CT02 0, 28, 56 1.0 mg Intramuscular (IM) 6

        2. VCL-CT02 0, 28, 56 100 μg/injection × 2 injections Intradermal (ID) 11 Total 17

      Up to 10 subjects from Groups 1 and 2 will be approached for enrollment in the current
      protocol. If a subject consents and meets all eligibility criteria, the subject will receive
      Towne (3000 pfu subcutaneously) between 9 and 15 months after the subject's first dose of
      VCL-CT02. Safety will be monitored and Both antibody to CMV gB and T-cell responses to CMV
      antigens will be measured at specified intervals for 252 days post Towne challenge.
    

Intervention name(s): Towne CMV vaccine
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cytomegalovirus; vaccine; T cell; antibodies
Echocardiographic Evaluation of the Effects of Dexmedetomidine in Diastolic Dysfunction
Condition: Under General Anesthesia
Study type: Interventional

Summary: 
      Dexmedetomidine is a selective α2 adrenergic agonist that can be considered a primary
      anesthetic, an adjuvant to propofol or inhalational anesthetics. Dexmedetomidine mediate its
      cardiovascular effect through activation of receptors in central and peripheral nervous
      system. The classic cardiovascular response of dexmedetomidine is the biphasic with initial
      shorten-increase in blood pressure followed by long-lasting decrease in BP and HR. There were
      several reports about these hemodynamic changs of dexmedetomidine, but not the evaluation of
      direct cardiac function of patients who was preexisted diastolic dysfunction. The purpose of
      this study is to evaluate the effects of dexmedetomidine as an anesthetic adjuvant in
      diastolic dysfunction by using the echocardiography.
    


Intervention name(s): Dexmedetomidine; normal saline(Saline 0.9%)
Intervention type(s): Drug; Drug
Intervention description(s): Formula for administrated were randomized by computer-generated randomization. The patients and anesthesiologist, who administered and conducted all this trial, were blinded to the medication allocation. An anesthesiologist, who responsible for preparation of medication was the only person, recognized of the randomization code during trial. 10 minutes after anesthetic induction, dexmedetomidine group would start the loading of dexmedetomidine (1μg/kg) during 10 minutes followed infusion of dexmedetomidine(0.5 μg/kg/min). Bispectral index was monitored continuously targeting 40±5. Target concentration of remifentanil and fresofol were controlled stepwise in accordance with BIS. Using the transesophageal echocardiography, we will evaluate the changes of cardiac function including Tei index and cardiac output.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Study Comparing Formulations of Bazedoxifene/Conjugated Estrogens
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose is to determine bioavailability of Bazedoxifene/conjugated estrogen
      formulations for future testing purposes.
    


Intervention name(s): bazedoxifene/conjugated estrogens combination
Intervention type(s): Drug
Intervention MeSH terms: Bazedoxifene; Estrogens; Estrogens, Conjugated (USP)
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
AcoArt III / Arterio-venous Fistula in China
Condition: Arteriovenous Fistula Stenosis
MeSH terms: Arteriovenous Fistula; Fistula
Study type: Interventional

Summary: 
      This trial is aimed to evaluate the safety and efficacy of DCB in treating AVF stenosis in
      chinese population.
    

Detailed description: 
      For years, first-line treatment of AVFs stenoses has been percutaneous transluminal
      angioplasty. However, restenosis and reintervention rates remain incredibly high and occur,
      according to recent studies, in up to 60% and 70% of patients at 6 and 12 months,
      respectively. Drug-coated balloons delivering paclitaxel at the angioplasty site have proved
      their superiority in the treatment of coronary and peripheral arterial stenoses. Paclitaxel
      reduces neointimal hyperplasia and drug-coated balloons,therefore, it represents an
      attractive option for AVF stenoses.
    

Intervention name(s): drug-coated balloon catheter （Orchid, Acotec）; plain balloon catheter (Admiral, medtronic)
Intervention type(s): Device; Device
Intervention description(s): After predilation, using drug-coated balloon catheter to cover the whole treated segment; After predilation, using plain balloon catheter to cover the whole treated segment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: one arm treated with drug-coated balloon catheter, the other arm treated with plain balloon catheter
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: drug eluting balloon
Adding MgSO4 to Epidural Levobupivacaine in CS for Patients With Preeclampsia
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims at evaluating the effect of adding magnesium sulphate epidurally as an
      adjunct to levobupivacaine on the quality of anesthesia and perioperative pain relief in
      patients with preeclampsia undergoing elective caesarian section (CS).
    

Detailed description: 
      Pregnant women with preeclampsia undergoing elective CS in will be included in the study. All
      patients participating in the study will be randomly divided into two groups; magnesium
      sulphate group (study group) and placebo group (control group). Patients in the study group
      will receive epidural 20 ml levobupivacaine hydrochloride 0.5% plus 5 ml magnesium sulphate
      10% (500 mg) while patients in the control group will received epidural 20 ml levobupivacaine
      hydrochloride 0.5% plus 5 ml saline 0.9%.
    

Intervention name(s): Levobupivacaine hydrochloride; Magnesium sulphate; Saline 0.9%
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients will receive epidural 20 ml levobupivacaine hydrochloride 0.5%; Patients will receive epidural 5 ml magnesium sulphate 10%; Patients will receive epidural 5 ml saline 0.9%
Other intervention name(s): Chirocaine
Intervention MeSH terms: Magnesium Sulfate; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Levobupivacaine; Magnesium; Preeclampsia; Epidural
A Single and Multiple-Dose Study of SB1578
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability, pharmacokinetics and
      pharmacodynamics of SB1578 in healthy volunteers.
    


Intervention name(s): SB1578; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): JAK2 Inhibitor; Control arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Safety; Tolerability; SB1578
Evaluation of AIT Study
Condition: Personality Disorders; Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional

Summary: 
      Specialized treatment of personality disorders (PD) in youth has been neglected for a long
      time, because these disorders were not diagnosed before the age of 18. Since 2013 the age
      threshold has been dropped in the Diagnostic and Statistical Manual (DSM)-5, and such change
      is also announced for the International Classification of Diseases (ICD)-11. There is broad
      consensus from both scientific evidence and clinical experience that specialized early
      interventions in adolescents with PD are urgently needed.

      In the last decades a number of specialized psychotherapeutic treatment programs have been
      developed. Despite their conceptual differences, many of the treatment models have shown
      significant effects in the treatment of PD in adults. However, the treatment of adolescents
      with PD remains difficult and further enhancement and development of treatments is needed.

      Given the different therapeutic approaches available, the present project aims to go beyond
      the comparison of integral therapeutic models in the classical outcome study design. While
      outcome research is important to build on the evidence of the effectiveness of an
      intervention, it contributes little to its understanding and refinement. The aim of the
      present multi-center project is to compare two therapeutic methods used in routine care:

        -  Adolescent Identity Treatment (AIT)

        -  Dialectic Behavioral Treatment for Adolescents (DBT-A)

      Treatments will be performed at different study centers and compared using the same measures
      of outcome. The main outcome will be psychosocial functioning.

      Additionally, the psychotherapy process will be investigated to explore specific and
      unspecific mechanisms of the therapeutic process, its outcome and mediators.
    


Intervention name(s): Adolescent Identity Treatment; DBT-A
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Integrative Approach for the treatment of adolescents with Personality Disorder.
Manual was published in 2013.; Dialectic Behavioral Treatment for Adolescents is the most commonly used Approach for the Treatment of adolescents with Boderline Personality Disorder
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psychotherapy; psychotherapy process; therapeutic alliance; psychotherapeutic change; psychophysiology
Study of Oglemilast for the Treatment of Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether oglemilast is safe and effective in the
      treatment of allergen-induced asthma.
    


Intervention name(s): Oglemilast; Placebo then Oglemilast
Intervention type(s): Drug; Drug
Intervention description(s): Oglemilast, 15mg oral administration, once per day and then dose-matched placebo; Dose-matched placebo and then Oglemilast, 15mg, oral administration, once per day.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: oglemilast; asthma; allergen; prevention; prophylaxis; Allergen-Induced Asthma
Mindfulness for Adolescents With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Adolescents with Type 1 Diabetes will be invited to the Mindfulness study. They will be
      randomly assigned to a Control or Active Group. The Active Group will learn Mindfulness Based
      Stress Reduction (MBSR) through an online website designed to teach the basic principles of
      MBSR in six week-long modules. They will be measured in three main areas: before learning the
      intervention, directly after learning it and 3 months after learning it to determine any
      changes in their Mindful attention awareness, Diabetes Quality of Life and HbA1c. The Control
      Group will also take the questionnaires at the beginning of the study, 6 weeks after it
      begins and then 3 months from the beginning to obtain data for all three time points when
      they have not received access to the modules/intervention.
    

Detailed description: 
      Research Design and Procedures This study will utilize a between group repeated measures
      design to measure the effects of the learned MBSR intervention over time. MBSR will be the
      independent variable. Dependent variables include mindfulness, diabetic quality of life and
      HbA1c. Adolescents with Type 1 diabetes will be randomly assigned to an intervention group or
      a wait list/control group that will be taught MBSR after all data has been collected. The
      study will utilize a 2 (experimental versus wait-list control group) by 3 (pretest [Time 1],
      posttest [Time 2], and 3 month follow-up [Time 3]) to examine within and between group
      differences overtime on two psychosocial measures including mindfulness and quality of life.
      The physiological measure understudy, HbA1c, reflects glucose control over the previous three
      month period and will be measured at Time 1 and Time 3. MBSR training will be provided via an
      online website and secure data collection site called MySweetMind.org.
    

Intervention name(s): Mindfulness Based Stress Reduction
Intervention type(s): Behavioral
Intervention description(s): Mindfulness-Based Stress Reduction (MBSR) is a well-defined and systematic patient-centered educational approach which provides training in mindfulness meditation to teach adolescents with Type 1 diabetes to take better care of themselves and live healthier and more adaptive lives by learning to become more connected to the present moment through the use of breath and training for awareness of the moment.
Other intervention name(s): MBSR
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: between and within group repeated measures design
Masking: None (Open Label)
Primary purpose: Treatment
Power Doppler in Hand Joints of Early RA Patients
Condition: Early Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      It is a prospective case-control study with women diagnosed early rheumatoid arthritis. Three
      therapeutic failures were considered: failure 1 - to the first Disease-modifying
      antirheumatic drugs (DMARDs) (methotrexate); failure 2 - to the second DMARDs (leflunomide)
      and failure 3 - to the first immunobiological drugs (adalimumab). Ultrasound was performed
      bilaterally on the 2nd and 3rd metacarpophalangeal joints (MCFs), proximal interphalangeal
      joints (IFPs), and wrists (US10). Ultrasound measurements (qualitative and semi-quantitative)
      evaluated: 1 - inflammatory: synovial and tenosynovial proliferation in gray scale and power
      Doppler (0-3); 2 - joint damage: bone erosion (qualitative and semi-quantitative) and
      cartilage damage (qualitative and semi-quantitative). Clinical and laboratory variables were
      also assessed blindly at baseline and after 12, 24 e 48 weeks.
    


Intervention name(s): Drug protocol
Intervention type(s): Drug
Intervention description(s): The following drug scheme was carried out: The patients began with methotrexate (MTX) 15 mg / week, which was increased to 25 mg / week until week 12. Subsequent steps for patients with an insufficient response (DAS28 score> 3.2 and the Physician's Global Assessment (PGA)> 4.0 [0-10 cm]) were leflunomide 20mg / day with MTX 15 mg / week from week 12 to week 24 and adalimumab twice a month and MTX 15mg / week from week 24 to week 48. The use of 5mg folic acid was advised once a week during the 48 weeks of the study. Three treatment failures were considered over these 48 weeks:
Failure 1: failure of the first DMARD (MTX) in week 12.
Failure 2: failure of the second DMARD (leflunomide) at week 24
Failure 3: failure of the first immunobiological (adalimumab) at week 48.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Woman diagnosed eith early rheumatoid arthritis naive for treatment
Impact of MK-0954A on Uric Acid in the Management of Hypertension (MK-0954A-366)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      This was a retrospective, chart review, observational study to assess the effect of MK-0954A
      (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg [Hyzaar(R)]) treatment for a period
      of at least three months on serum uric acid levels.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Data from 33 physicians from different levels of hospitals were invited to provide
        information on patients who received MK-0954A and had pre- and post-treatment serum uric
        acid and lipid profile reports during the study period. Each physician could provide up to
        30 clinical charts of patients matching the inclusion criteria for the study.
      
Keywords: Essential hypertension Uric acid Retrospective Hyzaar