bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Bone Marrow Transplant Recipients (ACE-BMT)
Condition: Bone Marrow Transplantation
MeSH terms: Cytomegalovirus Infections
Study type: Observational

Summary: 
      CMV is one of the most important opportunistic infection in transplant recipients. In South
      Korea, more than 95% of adults reveal sero-positivity for CMV IgG. Until now, sero-positivity
      for CMV IgG before bone marrow organ transplantation is a laboratory test of choice to
      stratify the risk of CMV reactivation after solid organ transplantation. Theoretically,
      CMV-specific cell-mediate immune response before and after bone marrow transplantation will
      further categorize the patients into high or low risk of CMV development after bone marrow
      transplantation. The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay
      in bone marrow transplant candidates to predict the development of CMV infection after
      transplantation.
    

Detailed description: 
      We will evaluate whether CMV-specific cell-mediated immune response before transplant, 1
      month, 3 months, and 6 months after transplantation will predict CMV infection after bone
      marrow transplantation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        bone marrow transplant recipients
Marijuana Drug Discrimination and Self-Administration
Condition: Marijuana Abuse
MeSH terms: Marijuana Abuse
Study type: Observational

Summary: 
      This study is designed to investigate the associations among marijuana's discriminative
      stimulus, reinforcing, subjective (e.g. craving) and physiological effects, and to assess the
      relative ability of oral THC to block these effects.
    

Detailed description: 
      Volunteers will be asked to live on a research unit for up to twenty-six (26) consecutive
      nights and will participate in a total of 38 study sessions held on 19 weekdays. Each session
      will last approximately four hours and there will be two sessions per day, therefore each
      study day will last approximately eight hours. In addition to these study sessions, an
      orientation session will be conducted on the Friday prior to admission to the inpatient unit,
      and a lottery session will be held on the last day of the study.

      During each study session participants will be asked to smoke a cigarette. The cigarette may
      contain marijuana or it may contain placebo (a blank). Participants will also be asked to
      swallow a capsule 2-hours prior to smoking the cigarette. The capsule could contain placebo
      (a blank), THC (delta-9 tetrahydrocannabinol, which is the active ingredient in marijuana
      responsible for its mood effects), or d-amphetamine. We will have participants answer
      questions about how the drugs make them feel and measure their vitals signs (blood pressure,
      heart rate, and oxygen saturation) will be measured using a non-invasive (external) vitals
      monitor.
    

Intervention name(s): THC (delta-9 tetrahydrocannabinol), d-amphetamine, oral THC
Intervention type(s): Drug
Intervention description(s): During each study session participants will be asked to smoke a cigarette. The cigarette may contain marijuana or it may contain placebo (a blank). Participants will also be asked to swallow a capsule 2-hours prior to smoking the cigarette. The capsule could contain placebo (a blank), THC (delta-9 tetrahydrocannabinol, or d-amphetamine.
Intervention MeSH terms: Dronabinol; Amphetamine; Dextroamphetamine
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Marijuana dependent volunteers
What is the Best Verbal Instruction for Contraction the Pelvic Floor Muscles?
Condition: Pelvic Floor Muscle Weakness
MeSH terms: Muscle Weakness
Study type: Interventional

Summary: 
      The aim of this study is to T to compare the effectiveness of producing a pelvic floor muscle
      contraction by different verbal instruction. Pelvic floor muscle contraction will be measured
      displacement of the pelvic floor when imaged on ultrasound.
    

Detailed description: 
      This study will examine pelvic floor muscle contraction following different verbal
      instructions. This is a cross-sectional exploratory study. Physical-therapy students will be
      recruited to complete a survey and non-invasive transabdominal ultrasound assessment.

      A bladder filling protocol will be implemented to ensure subjects will have sufficient fluid
      in their bladders to allow clear ultrasound imaging. This protocol involved subjects
      consuming 600-750 ml of water in a 1 hr. period. The participants will be tested in a
      crook-lying supine position with a pillow under their heads for comfort.

      The participants will be divided into 2 groups randomly. Both groups will be given three
      different verbal instructions to contract pelvic floor muscles. Each contraction will be
      performed 3 time with rests of 10 sec between contractions. While the first 2 contractions
      for each verbal instruction will be held for 3 sec. the last contraction will be held as long
      as the participant can conduct and the time of contraction will be measured as well. The
      pelvic floor contraction will be measured by assessing bladder displacement via diagnostic
      ultrasound.

      To image the pelvic floor a 5 MHz curved linear array transducer (Mindray M5) will be placed
      in the transverse plane immediately suprapubically over the lower abdomen angled at 15-30
      degrees from the vertical. An on screen caliper and measurement tool will be used to measure
      bladder displacement.
    

Intervention name(s): verbal instruction
Intervention type(s): Diagnostic Test
Intervention description(s): Verbal instruction for pelvic floor contraction will be given to participants. Ultrasound examination will be conducted to asses urinary bladder displacement being a marker for pelvic floor muscle function.
Other intervention name(s): diagnostic ultrasound assesment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups randomly divided. Both groups will be given three different verbal instructions to contract pelvic floor muscles.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: verbal instruction, pelvic diaphragm, muscle contraction
Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Becker Muscular Dystrophy
Condition: Becker Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2, randomised, double-blind, placebo controlled study to evaluate the
      micro-macroscopic effects on muscles, the safety and tolerability, and the efficacy of
      givinostat in patients with Becker Muscular Dystrophy. Approximately 48 eligible patients
      will be randomized in a 2:1 ratio to be treated with givinostat or placebo for a period of 12
      months.
    

Detailed description: 
      Givinostat or placebo oral suspension (10 mg/mL) will be administered orally as 2 oral doses
      daily while the subject is in fed state, according to the subject's weight.

      Study drug should be permanently stopped if any of the following occur:

        -  severe drug-related diarrhoea;

        -  any drug-related Serious Adverse Event (SAE);

        -  QTcorrected by Fridericia's formulas (QTcF) >500 msec;

        -  platelets (PLT) count ≤50 x 1.000.000.000/L (10E9/L);

        -  White blood cell (WBC) ≤ 2.0 x 10E9/L;

        -  Hemoglobin (Hb) ≤ 8.0 g/dL.

      Study drug should be temporarily stopped if any of the following occur:

        -  PLT count <75 x 10E9/L but >50 x 10E9/L;

        -  WBC < 3.0 x 10E9/L but > 2.0 x 10E9/L;

        -  Hb < 10.0 g/dL but > 8.0 g/dL;

        -  moderate or severe diarrhoea.

        -  tryglicerides >300 mg/dL In case the study drug was temporarily stopped, the study drug
           can be resumed at a level 20% smaller than the dose at which the Adverse Event leading
           to temporary stop occurred, once platelets and/or WBC and/or Hb and/or tryglicerides are
           normalized or when diarrhoea is mild
    

Intervention name(s): givinostat; placebo
Intervention type(s): Drug; Drug
Intervention description(s): suspension of givinostat (10 mg/mL); suspension manufactured to mimic givinostat
Other intervention name(s): Active Comparator: givinostat; Placebo Comparator: placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Gemcitabine Hydrochloride and Genistein in Treating Women With Stage IV Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and genistein, work
      in different ways to stop the growth of tumor cells, either by killing the cells or by
      stopping them from dividing. Giving gemcitabine hydrochloride together with genistein may
      kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving gemcitabine hydrochloride together
      with genistein works in treating women with stage IV breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the objective response rate in patients with stage IV breast cancer treated
           with gemcitabine hydrochloride and genistein.

      Secondary

        -  Determine the duration of response and survival of patients treated with this regimen.

        -  Determine the time to disease progression in patients treated with this regimen.

        -  Determine the quantitative and qualitative toxic effects of this regimen in these
           patients.

        -  Correlate plasma genistein levels with response in patients treated with this regimen.

      OUTLINE: Patients receive oral genistein once daily on days -7 to 1. Patients also receive
      gemcitabine hydrochloride IV on days 1 and 8 and oral genistein once daily on days 1-21.
      Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

      PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
    

Intervention name(s): genistein; gemcitabine; Tumor biopsy
Intervention type(s): Dietary Supplement; Drug; Procedure
Intervention description(s): Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.; Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days; Biopsy of tumor prior to dose of genistein (Novasoy)
Other intervention name(s): Novasoy; Gemcitabine hydrochloride; Gemzar®
Intervention MeSH terms: Gemcitabine; Genistein
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV breast cancer; recurrent breast cancer
Comparing Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of TEV-48125 Versus Placebo for the Preventive Treatment of Chronic Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is being conducted to evaluate two doses of TEV-48125 in adult patients with
      chronic migraine
    


Intervention name(s): Fremanezumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Fremanezumab was provided as a sterile, unpreserved, aqueous solution for injection, 225 mg/1.5 mL pre-filled syringe for single-use administration. The 675 mg dose was given as 3 injections; doses of 225 mg were given as a single injection. Study drug was administered at the clinical site.; Placebo 1.5 mL pre-filled syringes identical in appearance to active intervention. Study drug was administered at the clinical site.
Other intervention name(s): TEV-48125, anti-calcitonin gene-related peptide (anti-CGRP)
Intervention MeSH terms: Calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Riluzole may stop or slow the growth of tumor cells and may be an effective
      treatment for melanoma.

      PURPOSE: This phase II trial is studying how well riluzole works in treating patients with
      stage III or stage IV melanoma that cannot be removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine whether administration of a daily dose of riluzole results in tumor shrinkage,
           as measured by RECIST criteria, in patients with advanced melanoma.

      Secondary

        -  Determine the long-term toxicity of riluzole when administered to these patients.

        -  Compare the survival of these patients with historical controls.

      OUTLINE: Patients receive oral riluzole twice daily on days 1-28. Courses repeat every 28
      days in the absence of disease progression or unacceptable toxicity.
    

Intervention name(s): riluzole
Intervention type(s): Drug
Intervention description(s): 100 mg orally twice daily
Intervention MeSH terms: Riluzole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III melanoma; stage IV melanoma; recurrent melanoma
Effects of the T12-L1 Vertebral Manipulation on Body Temperature, Arterial Tension and Cardiac Frequency
Condition: Healthy Subjects; Spinal Manipulation; Manual Therapy
Study type: Interventional

Summary: 
      Single-blinded Randomized Controlled Trial conducted amongst a sample of healthy subjects
      divided into two different groups: the experimental treatment will consist in bilateral
      T12-L1 vertebral manipulation, whereas the control group will receive a sham intervention
      consisting solely in applying tension without properly manipulating. Body temperature,
      arterial tension and cardiac frequency will be measured before and after the intervention.
      Changes in the aforementioned variables will be measured.
    

Detailed description: 
      The current study will correspond to a single-blinded Randomized Controlled Trial with two
      arms, conducted amongst a sample of healthy subjects, who will be divided into two different
      groups: the experimental treatment will consist in bilateral T12-L1 vertebral manipulation,
      whereas the control group will receive a sham intervention consisting solely in applying
      tension without properly manipulating. Three different variables will be measured prior to
      and after the intervention: body temperature, arterial tension and cardiac frequency, to
      subsequently calculate possible changes in the variables, with the aim of establishing the
      effect of the manipulation and/or sham treatment.
    

Intervention name(s): Bilateral vertebral manipulation of the T12-L1 vertebra through manual therapy; Placebo
Intervention type(s): Other; Other
Intervention description(s): Bilateral vertebral manipulation of the T12-L1 vertebra through manual therapy; Manual tension without reaching the manipulation "thrust"
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-blinded Randomized Controlled Trial
Masking: Single (Participant)
Primary purpose: Treatment
The Effects of Short-foot Exercises in Foot Posture
Condition: Pronation Deformity of the Foot
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      Therefore, the aim of this study is to examine the effects of the short foot exercises
      compared to placebo exercises in the foot posture index after a daily period of 4 weeks.
    

Detailed description: 
      The intrinsic foot muscles collaborate in maintain the media longitudinal arch and in the
      postural control of the body.1 The plantar intrinsic foot muscles play a crucial role
      providing the foot stability and flexibility. 2 There are few studies about the relationship
      between hyperpronation and the training of the intrinsic muscles.

      A specific training program as a "short foot exercise" (SFE) may improve pathological
      conditions involving the foot and the lower extremity including plantar fasciitis,
      tendinopathies and foot hiperpronation.3 Several balance training techniques have been
      applied for improving postural stability, and the SFE have been widely accepted by
      physiotherapists to improve the longitudinal arch foot and the body segments.4 In this study,
      the foot posture will be evaluated with the foot posture index (FPI) and the navicular drop
      test (NDT). The foot posture index is a validated and useful method like a complementary tool
      for evaluating foot disorders. 5. The foot posture quantify the foot posture as normal,
      pronated or supinated. The foot posture index indicates a pronated foot position in a support
      relaxed position when IPP is equal to or superior to a +6 value. 5 The Navicular Drop Test
      quantifies, in millimeters, the descent of the navicular tuberosity. It was developed to
      evaluate the pronation of the foot and, consequently, the drop of the medial longitudinal
      arch, a excessively pronated foot (NDT≥10mm).6.

      Therefore, the aim of this study is to examine the effects of the SFE compared to a placebo
      exercise in the foot posture index after a daily period of 4 weeks.

      There is a lack of evidence of the effect of training intrinsic muscles in foot posture.

      The hypothesis of the researches is that the SFE may contribute to improving the pronated
      foot posture. This treatment may allow normalizing the foot posture and the kinematic
      interaction of the lower extremity joints during walking.
    

Intervention name(s): Short foot excercise for intrinsec muscles of the foot
Intervention type(s): Behavioral
Intervention description(s): to examine the effects of the SFE compared to a placebo exercise in the foot posture index after a daily period of 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: pronation
Dermacyd Silver Floral (Lactic Acid) - Acceptability.
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To prove the safety of the gynaecological formulation in normal conditions of use.
    


Intervention name(s): LACTIC ACID(ND)
Intervention type(s): Drug
Intervention description(s): treatment period: 21 consecutive days
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the current study is to investigate the efficacy, safety and tolerability of
      BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to
      metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control
    


Intervention name(s): linagliptin; linagliptin
Intervention type(s): Drug; Drug
Intervention description(s): Patients receive linagliptin 5 mg tablets once daily; Patients receive linagliptin 5 mg tablets once daily
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Clinical Study of Released Unitron RIC and BTE Hearing Aid Models
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      Participants will wear two sets of Unitron released hearing aids (RIC and BTE) programmed
      based on a prescriptive approach and will perform a standardized speech discrimination test
      in noise in both aided conditions as well as in unaided condition.
    

Detailed description: 
      During this study each participant will be asked to complete three randomized conditions of
      the HINT testing: unaided, aided with RIC, and aided with BTE. The investigators will be
      assessing their speech intelligibility in noise in each condition, during the same
      appointment to determine the SNR-50 (the Signal-to-Noise ratio necessary for a participant to
      recognize the speech material correctly 50 percent of the time).
    

Intervention name(s): Hearing aid model
Intervention type(s): Device
Intervention description(s): Amplification
Intervention model: Single Group Assignment
Intervention model description: 1 group with three randomized conditions (unaided, aided with RIC, aided with BTE).
Masking: None (Open Label)
Primary purpose: Treatment
Cerebellar Alterations in Individuals With a Cannabis Use Disorder
Condition: Cannabis
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      The purpose of this study is to investigate if individuals with a cannabis use disorder have
      an impaired cerebellar function by assessing possible alterations to their implicit
      adaptation during a visuomotor rotation task.
    


Intervention name(s): Visuo-motor rotation; Explicit strategy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participant moves a cursor on a screen by sliding a pen over a digital tablet. Participants perform a center-out movement, aiming to a target that appears over one of a set of eight markers radially distributed. In several block of trials, the mapping of the pen position to the cursor is rotated.; Participant is provided with an explicit instruction as to how counteract the effects of the visuo-motor rotation via aiming to a marker adjacent target
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Learning; Cerebellum