bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis; Disease Progression
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will explore the impact of lumacaftor/ivacaftor (LUM/IVA) on disease progression
      in subjects aged 2 through 5 years with cystic fibrosis (CF), homozygous for F508del (F/F).
    


Intervention name(s): LUM/IVA; LUM/IVA; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): FDC tablets or granules for oral administration.; FDC granules for oral administration.; Placebo matched to LUM/IVA for oral administration.
Other intervention name(s): Lumacaftor/Ivacaftor; VX-809/VX-770; Lumacaftor/Ivacaftor; VX-809/VX-770
Intervention MeSH terms: Ivacaftor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Adult Normative Performance of the Quotient ADHD System
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      This study is being conducted to enhance and extend the clinical utility of the Quotient®
      ADHD System Adolescent and Adult Version Test by adding large numbers of well-screened
      controls to the existing Quotient® ADHD System database of adolescents and adults (ages
      15-55).
    

Detailed description: 
      This study consists of one study visit. Subjects will be recruited using the clinic's
      relevant patient population. A "Study Recruitment Flyer" will also be posted in various
      clinic locations (Attachment BBD0111-1). Interested volunteers will participate in an initial
      screening, which may be done by telephone or in person that will be conducted by the clinic's
      research staff. Upon preliminary confirmation that the subject meets all inclusion criteria
      and does not meet any exclusion criteria, an appointment will be scheduled for the study
      visit.

      At the study visit, study will be explained in detail. Adults will be asked to provide
      written informed consent, parents/guardians of individuals <18 year old will provide written
      informed consent and minor individual's will provide written assent, prior to any study
      procedure being performed.

      Following consent, a medical history, including current medications the subject is taking,
      will be obtained. Subjects will complete standard self assessment questionnaires to screen
      for presence of mental health issues including ADHD, anxiety disorder, depressive disorder or
      bipolar disorder using the ADHD Self Rating Scale (ASRS), Zung Self-Rated Anxiety Scale
      (SAS), Zung Self-Rated Depression Scale (SDS), and Mood Disorder Questionnaire (MDQ).

      Subjects will not be excluded from the study based on responses to the mental health
      questionnaires, but results will be considered in the analysis of results.

      The subjects will take the 20-minute Quotient® ADHD System Test for Adolescent and Adult
      assessment.

      Subject's assessed to be Non-ADHD will be eligible to have their Quotient tests added to the
      Quotient Adolescent and Adult Normative Database.

      Study Enrollment:

      200 Normal control subjects with oversampling of 10%. Total enrollment is expected to be 220.

      Study Population:

      Male and female subjects from age 15 through 55 years of age. Optimally, there will be
      approximately 25 subjects per age and gender category but enrollment will not be restricted
      or limited to these desired categorical goals.

      Age Ranges Males Females 15-25 25 25 26-35 25 25 36-45 25 25 46-55 25 25
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Well-screened, Healthy Non-ADHD Controls, Ages 15-55 from a single private practice clinic.
      
Keywords: ADHD Normative Control Group
Comparison of Gut Microbiota in Sedentary and Active Women
Condition: Sedentary
Study type: Observational

Summary: 
      Gut microbiota comparison of active and sedentary women
    

Detailed description: 
      Observational study comparing gut microbiota of people who did not practice any physical
      exercise (sedentary) with the gut microbiota of people who at least practice exercise a
      minimum of 3 hours per week but they were not professional athletes. Since the hormonal
      status and gender are factors that influence gut microbiota, this study has been conducted in
      premenopausal women.
    

Observational model: Cohort
Sampling method: Probability Sample
Study population: 
        Healthy women who do not perform exercise at all or practice at least 3 hours of exercise
        per week
      
Biospecimen description: 
      Bacterial DNA extracted from feces
    
Keywords: physical activity; sedentarism; fecal enzymatic activity
A Study to Compare Rosuvastatin/Ezetimibe and Rosuvastatin in Patients With Diabetes Mellitus and Hypercholesterolemia
Condition: Diabetes Mellitus and Hypercholesterolemia
MeSH terms: Diabetes Mellitus; Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      A Study to Compare Rosuvastatin/Ezetimibe Combination and Monotherapy in Patients with
      Diabetes Mellitus and Hypercholesterolemia.
    

Detailed description: 
      This trial is conducted to compare the efficacy and safety between Rosuvastatin/Ezetimibe
      combination and Rosuvastatin monotherapy in patients with Diabetes Mellitus and
      Hypercholesterolemia for 8 weeks.
    

Intervention name(s): Rosuvastatin+Ezetimibe; Rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Rosuvastatin 5mg+Ezetimibe 10mg; Rosuvastatin 5Mg Tablet
Other intervention name(s): Rosuvamibe ® 10/5mg; Monorova ® 5mg
Intervention MeSH terms: Rosuvastatin Calcium; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vascular Responses to High vs Low Repetition Resistance Exercise Training in Young Men
Condition: Weight-Lifting Exercise Program
Study type: Interventional

Summary: 
      This study evaluates the effects of two types of resistance exercise training
      (higher-repetition, lower load vs lower-repetition, higher load vs control) on regional and
      local measures of arterial stiffness in trained young men.
    


Intervention name(s): Lower-repetition, heavier-load; Higher-repetition, lighter-load
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8-12 reps/set at ~80% 1 repetition maximum; 20-25 reps/set at ~30% 1 repetition maximum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Examining the Effectiveness of the myPlan App to Prevent Dating Violence With Adolescents
Condition: Intimate Partner Violence
Study type: Interventional

Summary: 
      Intimate partner violence (IPV), including violence in teen dating relationships [teen dating
      violence (TDV)], is a common and a serious threat to adolescent health, safety, and
      well-being. TDV may include psychological/emotional abuse, sexual harassment or coercion,
      stalking (including cyberstalking), and physical or sexual violence. For many, the first
      experience of violence is in a dating or casual relationship with a partner or acquaintance
      during adolescence. Therefore, the objective of this study is to examine the effectiveness of
      an adapted version of the myPlan app for adolescents (ages 15-17 years) to prevent and
      respond to TDV. myPlan is an app available for mobile download or by web browser that
      interactively assists users to assess the health and safety of user's intimate relationship,
      receive personalized strategies on how build healthier relationships, stay safe and healthy
      while navigating an unsafe relationship, and get connected to support and resources.
    


Intervention name(s): Personalized Healthy Relationship and Safety Planning Tool; Usual Care Teen Relationship and Health Website
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The app delivers evidence-based information and resources in three sections:
My Relationship: contains a series of activities (e.g., "quizzes") to raise awareness of common myths about unhealthy relationships, determine characteristics of healthy relationships, examine the red flags in an unhealthy relationship, and assess risk factors for more severe abuse. Participants are provided with personalized messages about their relationship health and safety based on the answers they endorse.
My Strategies: personalized strategies to increase participants' safety and well-being based on responses in the previous section.
My Resources: direct links to the National Dating Abuse hotline, textline, and chatline, as well as personalized health and safety resources.; The control group website will provide participants with tools to learn about health topics including examining healthy relationships. The resources will be targeted to adolescents. The control group website is not personalized to the participant or their relationship.
Other intervention name(s): myPlan Teen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Intimate Partner Violence; Dating Violence; Relationships; Safety Planning; Adolescent; Technology; App; Teen
TMP001 in Relapsing-remitting Multiple Sclerosis
Condition: Remitting-Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the impact of TMP001 in the treatment of patients with
      relapsing-remitting multiple sclerosis (RRMS). Therefore the average total number of contrast
      enhancing lesions (CELs) on brain MRI scans at weeks 12, 16, 20, and 24 during treatment with
      TMP001 is compared to the average total number of CELs on brain MRI scans at week -4 and
      baseline in these patients .

      Based on promising preclinical results, the investigators assume a comparable effect of
      TMP001 on reduction of contrast-enhancing lesions as shown for other immunomodulatory
      substances in recent clinical studies.
    


Intervention name(s): TMP001
Intervention type(s): Drug
Intervention description(s): 600mg TMP001 as gelatine capsules á 200mg taken orally twice per day for a duration of 24 weeks
Intervention MeSH terms: Tarenflurbil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple sclerosis; relapsing remitting; nonsteroidal anti-inflammatory drug; contrast enhancing lesions
Dry Needling Versus Conservative Treatment in the Rectus Femoris Muscle Approach.
Condition: Dry Needling; Stretch; Rectus Femoris Muscle
Study type: Interventional

Summary: 
      In recent years, dry needling techniques have become widespread in the field of
      musculoskeletal pain treatment. Specifically, the management of myofascial trigger points has
      been the focus of these techniques.

      One of the objectives has been to improve the flexibility of those muscles that, due to the
      presence of myofascial trigger points, had a decrease in this parameter.

      This study aims to determine whether the application of a dry needling technique is more
      effective than analytical stretching of the muscle.
    

Detailed description: 
      Hypothesis of the study Deep dry needling of latent trigger points of the rectus femoris
      produces greater effects on flexibility, strength and pain than superficial dry needling or
      stretching.

      - Overall objective: To compare the differences that occur in flexibility, strength and pain
      threshold to pressure after the application of deep dry needling, superficial dry needling
      and stretching on latent trigger points of the rectus femoris.

      - Specific objectives To determine the changes produced by deep dry needling on flexibility,
      strength and pain threshold to pressure.

      To determine the changes produced by superficial dry needling on flexibility, strength and
      pain threshold to pressure.

      To determine the changes in flexibility, strength and pain threshold to pressure produced by
      conventional assisted stretching.

      To check if the changes remain after 7 days of the application of the techniques.

      To assess the inter-rater reliability of the Goniometer APP in the study sample.
    

Intervention name(s): Deep Dry Needling; Superficial Dry Needling; passive stretching
Intervention type(s): Other; Other; Other
Intervention description(s): In-and-out into different directions technique to encounter sensitive spots in an MTrP region.; This technique involves inserting a needle at a depth that is into the subcutaneous tissue and may be combined with manipulation of the needle while in situ.; Type of stretching in which you stay in one position for a set time. In this case, hip extension and knee flexion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Deep Dry needling; Superficial dry needling; muscle stretching; rectus femoris
A Study in Healthy Men to Test How BI 1595043 is Taken up in the Body When Given With or Without Food
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the relative bioavailability of BI 1595043
      under fed state (Test, T) and under fasted state (Reference, R).
    


Intervention name(s): BI 1595043
Intervention type(s): Drug
Intervention description(s): BI 1595043
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
High-cutoff Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients
Condition: End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Inflammation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to test whether a dialyzer with a higher than usual permeability
      for proteins can eliminate proinflammatory proteins from the blood of patients on regular
      maintenance hemodialysis who have chronically elevated levels of inflammation markers such as
      C-reactive protein (CRP) in their blood.
    

Detailed description: 
      Patients with ESRD on chronic hemodialysis patients frequently have elevated markers of
      inflammation (e.g. serum CRP values). Hemodialysis may clear the blood from low molecular
      weight toxins and retention products such as creatinine, potassium, or urea. The dialyzer
      clearance of middle to high molecular weight substances such as cytokines and cytokine
      receptors is low. Nearly 50% of chronic dialysis patients have persistent subclinical
      inflammation which is strongly associated with cardiovascular disease and mortality. The
      study tests the hypothesis that removal of proteins in the weight range of 10.000-30.000 D
      via a more permeable dialyzer membrane reduces chronic inflammation in these patients.
    

Intervention name(s): HCO1100 dialyzer; regular dialysis polyamide
Intervention type(s): Device; Device
Intervention description(s): Thrice weekly dialysis using the HCO1100 dialyzer for 4.5h, 2 weeks; Continuation of the regular hemodialysis using polyamide high-flux hemodialysers
Other intervention name(s): Gambro HCO1100; Gambro Polyflux 11
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: kidney failure chronic; renal dialysis; inflammation; monocytes; end stage renal disease on regular thrice weekly hemodialysis
Breeze3:Study of Gabapentin Extended Release in the Treatment of Vasomotor Symptoms(Hot Flashes)in Postmenopausal Women
Condition: Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 3

Summary: 
      Depomed's Gabapentin Extended Release is an investigational, extended release formulation of
      Gabapentin that is being studied for the treatment of Hot Flashes/Hot Flushes in
      postmenopausal women
    

Detailed description: 
      The primary study objective is to assess the efficacy of G-ER dosed at 1800mg daily (600mg
      AM, 1200mg PM), compared to placebo in reducing the average daily frequency and severity
      score of moderate to severe hot flashes in postmenopausal women at weeks 4 & 12 of the
      efficacy treatment period, compared with baseline.
    

Intervention name(s): Gabapentin Extended Release; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Gabapentin ER 1800mg daily; Sugar pill
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hot Flushes; Vasomotor Symptoms; Menopausal Hot Flashes
Zinc and the Synthesis of Zinc Binding Proteins (Protocol B)
Condition: Zinc Deficiency
Study type: Observational

Summary: 
      The specific aim of this protocol is to examine differential expression of specific mRNAs and
      proteins that occur when the dietary intake of zinc is acutely reduced below the dietary
      requirement for a period of ten days.
    

Detailed description: 
      Methods to assess the dietary zinc status of individual humans or populations are lacking.
      The study is a three period observational study of biomarkers of zinc status before, during
      and after zinc depletion. The entire dietary study will take 24 days composed of three parts:

        -  Dietary Acclimation (Phase 1): 7 days

        -  Dietary Zinc Restriction (Phase 2): 10 days

        -  Dietary Zinc Repletion (Phase 3): 7 days

      The dietary treatments and all blood draws will be carried out in the General Clinical
      Research Center (GCRC) at University of Florida. Previous research from has shown that both
      metallothionein gene expression and specific zinc transporter genes in blood leukocyte
      subsets are directly proportional to dietary zinc intake. By using cDNA array analysis and
      quantitative PCR technology with blood RNA, those genes most sensitive to zinc nutrition will
      be identified for the purpose of developing zinc status assessment methods on how zinc
      functions in human biology.

      Additionally, buccal mucosal cells will be collected in the GCRC by using swabs, i.e., in a
      noninvasive manner, to further characterize the expression pattern of the genes under study.
      This method has the potential for nutrition studies in the field (international nutrition,
      etc).
    

Intervention name(s): Acclimation; Dietary zinc depletion; Dietary zinc repletion
Intervention type(s): Other; Other; Other
Intervention description(s): 11 mg Zn/day as a controlled intake level; < 1 mg Zn/day achieved by providing a liquified diet of defined nutrient content; 15 mg Zn/day as a daily supplement plus normal habitual diet without restriction
Other intervention name(s): Adaptation; Phase 1; Phase 2; Phase 3
Intervention MeSH terms: Zinc
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        UF campus community
      
Biospecimen description: 
      Blood cells in clotted blood
    
Keywords: zinc; reticulocyte; PBMC; whole blood; transcriptome; microarray
Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study
Condition: Placenta Accreta; Postpartum Hemorrhage; Cesarean Section; Tranexamic Acid
MeSH terms: Postpartum Hemorrhage; Placenta Accreta; Placenta Previa; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this pilot study is to determine if intravenous tranexamic acid (TXA) is
      effective for reducing blood loss during high risk surgical procedures related to placenta
      previa and placenta accreta. TXA is currently used in other types of surgery for patients who
      are expected to have a large blood loss, such as orthopedic or open heart surgery.
    

Detailed description: 
      To date, no novel or pharmacologic methods of reducing blood loss have been described for
      women at risk for placenta accreta. Intravenous tranexamic acid (TXA), a drug with
      anti-fibrinolytic activity, is routinely used in elective orthopedic and cardiac surgery to
      reduce blood loss. Intravenous tranexamic acid is currently FDA approved for use in patients
      undergoing cardiac surgery or total knee arthroplasty or total hip arthroplasty to reduce
      peri- and post-operative blood loss and to reduce the need for blood transfusion. There has
      been growing interest in the application of tranexamic acid in obstetrics and gynecology. In
      multiple international studies, intravenous TXA has been shown to significantly reduce blood
      loss when given prophylactically with cesarean delivery or vaginal delivery without an
      increase in morbidity from adverse thrombotic events. TXA has not been studied in the
      particular population of patients requiring cesarean hysterectomy for placenta previa or
      accreta. This inexpensive, low risk medication has potential to greatly reduce perioperative
      morbidity and cost when used in a high risk obstetrical population.
    

Intervention name(s): Tranexamic Acid; Placebo Drug
Intervention type(s): Drug; Drug
Intervention description(s): 50 cc Normal Saline IV
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention