bioihbjkbjnl/mcl2 huggingface dataset:
Combined Effect of Transcranial Direct Current Stimulation (tDCS) and Physical Activity on Gait and Functional Mobility in Participants With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      This study is aimed to test the efficacy of transcranial direct current stimulation (tDCS)
      combined with a physical activity (PA) program, in 80 individuals affected by Multiple
      Sclerosis (MS). In particular, this study will evaluate the efficacy of tDCS when
      administered simultaneously with PA on walking, functional mobility, and fatigue.

      The subjects enrolled will be randomly assigned to the active group (active tDCS+PA) or the
      sham group (sham tDCS+PA).

      Portions of this study may be completed remotely.
    


Intervention name(s): active tDCS; sham tDCS; Physical Activity (PA)
Intervention type(s): Device; Device; Other
Intervention description(s): tDCS is a therapeutic treatment that utilizes low amplitude direct currents (<4 mA) to induce changes in cortical excitability.; During a sham session, the device is programmed to ramp up to the desired intensity (target 2.5 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.; 20 minutes of cycling on an ergonomic cross-trainer
Other intervention name(s): Soterix 1x1 tDCS mini-CT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Raloxifene and Goserelin in Preventing Breast Cancer in Women With a Family History of Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
      development or recurrence of cancer. The use of raloxifene and goserelin may be effective in
      preventing breast cancer.

      PURPOSE: Randomized pilot study to study the effectiveness of combining raloxifene and
      goserelin in preventing breast cancer in women who have a family history of breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the feasibility of raloxifene and goserelin versus no medical intervention in
           women at high genetic risk for developing breast cancer.

        -  Compare the incidence of adverse effects in patients treated with these regimens.

        -  Compare the effect of these regimens on bone density, biochemical markers of bone
           turnover, and lipid profiles in these patients.

        -  Compare the quality of life of patients treated with these regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      participating center. Patients are randomized to one of two treatment arms.

        -  Arm I: Patients receive goserelin subcutaneously once every month and oral raloxifene
           daily for 6-12 months.

        -  Arm II: Patients are screened for breast cancer every 6 months. In both arms, patients
           undergo annual mammograms.

      Quality of life is assessed at baseline and at 1, 3, 6, and 12 months.

      Patients are followed for 5 years.

      PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this
      study.
    

Intervention name(s): goserelin acetate; raloxifene
Intervention type(s): Drug; Drug
Intervention MeSH terms: Raloxifene Hydrochloride; Goserelin
Primary purpose: Prevention
Keywords: breast cancer
Study to Assess Effect of Device and Formulation on Pharmacokinetics (PK) of AZD1402
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate and compare the pharmacokinetics profiles of AZD1402 after oral inhalation as an
      inhalation powder and a nebuliser solution.

      To further assess the safety and tolerability of single doses of AZD1402 in healthy
      volunteers.

      To evaluate the taste characteristics of the test formulations.
    

Detailed description: 
      This study will be a randomized, open-label, 3-period, 3-treatment, single dose,
      single-center, crossover study. Eighteen healthy male and female subjects will be randomized
      in this study to ensure that at least 12 subjects are evaluable. A subject will be considered
      to be evaluable if the subject completes all 3 Treatment Periods with no important protocol
      deviations. Subjects will be randomized to 1 of 6 treatment sequences and will receive each
      of the 3 single dose treatments of AZD1402 listed below.

        -  Treatment A: Dose A estimated delivered dose of AZD1402 nebuliser solution administered
           via a nebuliser.

        -  Treatment B: Dose B estimated delivered dose of AZD1402 inhalation powder administered
           via an inhaler.

        -  Treatment C: Dose C estimated delivered dose of AZD1402 inhalation powder administered
           via an inhaler.

      The study will comprise of:

        -  A Screening Period of up to 28 days before the first administration of AZD1402.

        -  Three Treatment Periods during which subjects will be resident at the Clinical Unit from
           the day before dosing with AZD1402 (Day -1) until at least 48 hours after dosing and
           discharged on Day 3.

        -  A Follow-up Visit 10 to 12 days after the last administration of AZD1402 in Treatment
           Period 3.

      Each Treatment Period will be separated by a minimum washout period of 5 days between doses.

      All subjects will sign an Informed Consent Form before they participate in any specific study
      related procedures. Subjects will attend a Screening Visit within 28 days before receiving
      their first dose of AZD1402. If they are eligible, they will return for Treatment Period 1
      when they will have baseline assessments and receive 1 of 3 treatments in a randomized order.
      For each Treatment Period, the subjects will receive a single dose of Investigational
      Medicinal Product (IMP) in the morning of Day 1 and have further assessments for 48 hours
      after dosing.
    

Intervention name(s): AZD1402
Intervention type(s): Drug
Intervention description(s): AZD1402 (PRS-060) is presented as a solution and dry powder for oral inhalation and belongs to a new class of therapeutics, Anticalin® proteins, which are modified lipocalins. AZD1402 is an inhaled IL-4Rα antagonist, which is being developed as controller therapy for asthma.
Other intervention name(s): PRS-060
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Improvement in Acoustic Voice Characteristics in Functional Dysphonia After Therapy
Condition: Functional Voice Disorder
MeSH terms: Dysphonia; Voice Disorders
Study type: Observational

Summary: 
      In a retrospective analysis of already existing clinical assessment data from patients with
      functional voice disorders the following aspects will be sampled, encoded and analysed:
      Outcomes pre and post treatment of

        1. subjective voice symptoms measured by Voice Handicap Index (VHI-9i),

        2. perceptual voice symptoms according to Grading-Roughness-Breathiness-Asthenia-Strain
           Scale (GRBAS Scale),

        3. instrumental acoustic analysis parameters Jitter (%), speaking voice profile: mean and
           range of speaking pitch and intensity, max. intensity and mean pitch of calling voice,
           singing voice: min./max. and range of pitch and intensity, maximum phonation time,
           Dysphonia Severity Index (DSI).
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with functional voice disorders
Ultrasound Guidance for Embryo Transfer
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Randomized controlled study comparing the TVUS versus TAUS guidance during the procedure of
      embryo transfer.
    

Detailed description: 
      The aim of this study was to Compare between transvaginal and transabdominal ultrasound
      guided embryo transfer as regarding clinical pregnancy rate, patient comfort, time required
      for embryo transfer and endometrial visualization at time of embryo transfer.
    

Intervention name(s): Transvaginal Ultrasound Guided ET; Transabdominal Ultrasound Guided ET
Intervention type(s): Procedure; Procedure
Intervention description(s): Use of TVUS to guide ET; Use of TAUS to guide ET
Other intervention name(s): Transvaginal US guided ET; Transabdominal US guided ET
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Embryo Transfer; ICSI; Transvaginal Ultrasound
Topiramate Augmentation in the Treatment of Obsessive-Compulsive Disorder
Condition: Obsessive-compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      A 12-week program to examine the effectiveness of topiramate in adjunctive treatment for
      adults with obsessive-compulsive disorder and who are currently on serotonin reuptake
      inhibitor medications (ages 18-65).
    

Detailed description: 
      The Compulsive, Impulsive and Anxiety Disorders Program at the Mount Sinai School of Medicine
      is conducting a study of Topiramate (Topamax) added to an SSRI for the management of
      treatment-resistant Obsessive-Compulsive Disorder. The purpose of the study is to evaluate
      the safety and efficacy of Topiramate versus placebo added to a selective serotonin reuptake
      inhibitor (SRI) in patients with treatment resistant OCD. The program is 12 weeks in duration
      and involves regular visits with a psychiatrist as well as complete psychiatric and medical
      evaluations. Treatment and medication for the study will be provided free of
      charge.Participants must be between the ages of 18 and 65 and have an onset of OCD at least 1
      year prior to screening. In addition, participants must be taking a clinically effective dose
      of an SSRI for at least 3 months and must maintain their current dose throughout the study.
      Participants must not have a primary OCD symptom of hoarding.
    

Intervention name(s): topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: OCD; Obsessive-Compulsive Disorder; OCD treatment
Fructose-induced Intestinal de Novo Lipogenesis
Condition: Obesity
Study type: Observational

Summary: 
      8 healthy volunteers, 8 pre-bypass obese subjects, 8 subjects between 12-18 months
      post-bypass, and 8 subjects matched to the post-bypass patients will be studied in two
      sub-studies Sub-study 1) after ingestion of two or three different of the following
      test-meals: A)cream and whey protein B)cream, whey protein and fructose + 13C6 fructose
      C)test meal with cream, whey protein, fructose and glucose + 13C6 fructose Their intestinal
      de novo lipogenesis will be estimated by measuring 13C-palmitate on triglyceride-rich
      lipoprotein particles associated with apoB48 in blood Sub-study 2) after ingestion of two or
      three different of the following test-meals: A)cream labelled with 13C6 palmitic acid and
      whey protein B))cream labelled with 13C6 palmitic acid, whey protein, fructose and glucose

      Their intestinal de novo lipogenesis will be estimated by measuring 13C-palmitate on
      triglyceride-rich lipoprotein particles associated with apoB48 in blood in sub-study 1

      Their exogenous lipid absorption kinetics will be assessed by measuring 13C palmitate on
      triglyceride-rich lipoprotein particles associated with apoB48 in sub-study 2
    


Intervention name(s): fat+protein meal; Fat + protein + 13C fructose meal; Fat+protein+13C fructose+glucose meal; 13C Fat + whey protein; 13C Fat + whey protein + glucose+ glucose meal
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): cream+ whey protein; cream+ whey protein +13C fructose; Cream + whey protein + glucose:13C fructose mixture; cream labelled with 13C palmitate + whey protein; cream labelled with 13C palmitate + whey protein + glucose:fructose mixture
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        8 non-obese healthy male and female subjects with BMI <25 8 obese male and female subjects
        with BMI> 35 8 post-gastric bypass male and female subjects 8 healthy subjects matched to
        post-gastric bypass subjects for age, gender and weight
      
Keywords: de novo lipogenesis; fructose; roux-en-Y gastric bypass; post-prandial triglycerides
A Study to Assess the Mass Balance Recovery, Pharmacokinetics, Metabolite Profile and Metabolite Identification of [14C]AZD4831
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The Sponsor is developing the test medicine, AZD4831, for the potential treatment of
      cardiovascular disease (CVD). CVD is a general term to describe a range of conditions that
      affect the heart and blood vessels, examples of CVD include angina (chest pain caused by
      restricted blood flow to heart muscle) and heart failure (where the heart is unable to pump
      blood around the body properly). AZD4831 is an inhibitor of a protein that has a role in the
      formation of fatty deposits in arteries (blood vessels that take blood to the body). It is
      hoped that by inhibiting this action, AZD4831 will help with the management of CVD.

      The study involves radiolabelling (labelling the molecule with radioactive 14C) which is used
      to locate the molecule within the body. The study will try to assess how much radioactivity
      can be recovered from the urine and faeces (mass balance recovery) after a single oral dose
      of [14C]AZD4831. It will also look to identify the breakdown products (metabolites) of the
      parent drug. It will additionally determine the rate and route of elimination of
      [14C]AZD4831, along with the level of test medicine in the blood. The safety and tolerability
      of the test medicine will be assessed. The dose of radiation administered is very low,
      therefore the risk associated with this is very small.

      The study will consist of a single study period involving up to six healthy male volunteers.
      Up to six male volunteers will receive a dose of 10 mg of the radiolabelled test medicine as
      an oral solution. Blood, urine and faecal samples will be collected from volunteers whilst
      they are resident in the clinical unit for up to 336 hours post-dose (Day 15). A follow-up
      visit will take place seven to ten days after discharge for safety assessments.
    


Intervention name(s): 14C]AZD4831 Oral Solution
Intervention type(s): Drug
Intervention description(s): 10 mg dose of [14C]AZD4831 Oral Solution
Other intervention name(s): [14C]AZD4831
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heart Failure with preserved Ejection Fraction (HFpEF)
Translational Investigation of Growth and Everyday Routines in Kids
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Observational

Summary: 
      The purpose of this study is to determine the effect of severe obesity on physical activity,
      sedentary behavior and cardiometabolic risk factors during childhood and adolescence and
      whether these associations are modified by race. Additionally, the study will investigate the
      contributions of (total, regional, and depot-specific) fat accumulation on changes in
      physical activity, sedentary behavior, and cardiometabolic risk factors during childhood and
      adolescence.
    

Detailed description: 
      The proposed study will establish a prospective pediatric cohort to identify intervention
      targets based on the location, timing, barriers, and facilitators of current physical
      activity and sedentary behavior in a child's day. The project will be a prospective
      examination of 340 African American and White girls and boys aged 10 to 16 years, including
      50% who are classified as severely obese. State-of-the-art technology will be used including
      accelerometry to quantify physical activity, magnetic resonance imaging to quantify fat
      accumulation, and geographic position system and ecological momentary assessment to identify
      environmental and socio-emotional barriers and facilitators. In further detail, this study
      will examine the following objectives:

      Objective 1: Determine the effect of severe obesity on physical activity, sedentary behavior,
      and cardiometabolic risk factors during childhood and adolescence and whether these
      associations are modified by race.

      Objective 2: Investigate the contribution of (total, regional, and depot-specific) fat
      accumulation on changes in physical activity, sedentary behavior, and cardiometabolic risk
      factors during childhood and adolescence.

      Objective 3: Determine barriers and facilitators of physical activity that are related to
      obesity, including environmental and socio-emotional factors.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study aims to identify and recruit 340 boys and girls aged 10 to 16 years. The sample
        will be screened on the telephone in attempt to achieve a comparable sex and race
        distribution. An oversample will be taken for severely obese youth so they comprise
        approximately 50% of the sample (with the other 50% being distributed among normal weight,
        overweight, and obese status).
      
Biospecimen description: 
      An aliquot of sample will be stored in case further tests are needed and if further consent
      is obtained from the subject.
    
Keywords: Physical Activity; Sedentary Behavior; Cardiometabolic Risk Factors; Childhood and Adolescence
Optimization of Preventive Effects of Physical Training
Condition: Primary Prevention, Cardiovascular Risk Factor Management, Size of Response to Training
Study type: Interventional

Summary: 
      Health-promoting effects of physical exercise are well-investigated especially for endurance
      activities. However, for different individuals, positive effects have different sizes, even
      non-responders are observed. Other forms of training, such as strength training and interval
      training, are less well investigated. Therefore, a comparative longitudinal training study is
      warranted to examine differences of preventive effects (outcome measures: ergometric
      descriptors of physical performance, established risk factors and prognostic factors for
      cardiovascular diseases) of continuous endurance training, interval training and strength
      endurance training.

      In a second stage, the observed non-responders will perform a different type of training
      (cross-over). It is expected, that besides a comparative general efficacy evaluation of the
      three training types, improved recommendations for optimized individualization of training
      parameters can be formulated.
    


Intervention name(s): different training programs; control condition
Intervention type(s): Other; Other
Intervention description(s): two different endurance programs and one strength endurance program; unchanged lifestyle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: primary prevention; endurance; cardiovascular risk factors; training; exercise; non-responder
HDCT and Stem Cell Transplantation for Mantle Cell and Relapsed Low Grade Non-hodgkin's Lymphoma
Condition: Low Grade Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      Low grade lymphoma patients receive R-ICE reinduction therapy followed by allogeneic stem
      cell transplanation.
    

Detailed description: 
      Low grade lymphoma patients receive R-ICE reinduction therapy followed by allogeneic stem
      cell transplanation if they have an HLA matched sibling, or an autologous transplant if they
      do not.
    

Intervention name(s): stem cell source
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: autologous and allogeneic stem cell transplantation; low grade lymphoma; mantle cell
Safety and Tolerability of a Single Intra-anal Dose of NRL001 in Healthy Volunteers
Condition: Fecal Incontinence
MeSH terms: Fecal Incontinence
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is conducted to explore the safety and tolerability and plasma pharmacokinetics of
      NRL001 after single intra-anal dose of 1mL cream at increasing concentrations.
    


Intervention name(s): Placebo control; NRL001 cream
Intervention type(s): Drug; Drug
Intervention description(s): Placebo cream; Cream for single-dose intra-anal application
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
An Efficacy, Safety and Tolerability Study of Ixmyelocel-T Administered Via Transendocardial Catheter-based Injections to Subjects With Heart Failure Due to Ischemic Dilated Cardiomyopathy (IDCM)
Condition: Ischemic Dilated Cardiomyopathy (IDCM)
MeSH terms: Heart Failure; Cardiomyopathies; Cardiomyopathy, Dilated; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to assess the efficacy, safety and tolerability of ixmyelocel-T
      compared to placebo (vehicle control) when administered via transendocardial catheter-based
      injections to patients with end stage heart failure due to IDCM, who have no reasonable
      revascularization options (either surgical or percutaneous interventional) likely to provide
      clinical benefit.
    

Detailed description: 
      The primary objective of this study is to evaluate the efficacy of ixmyelocel-T compared to
      placebo (vehicle control) on the average per patient number of all-cause deaths,
      cardiovascular hospital admissions, and unplanned outpatient or emergency department visits
      to treat acute decompensated heart failure, over the 12 months following administration of
      investigational product (IP).
    

Intervention name(s): ixmyelocel-T; Placebo
Intervention type(s): Biological; Other
Intervention description(s): 12-20 transendocardial injections of 0.4 mL of ixmyelocel-T per injection into the left ventricle.; 12-20 transendocardial injections of 0.4 mL of vehicle control per injection into the left ventricle.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ischemic dilated cardiomyopathy; Heart failure; ixCELL; ixCELL DCM; IDCM; DCM; stem cells; MSC; cell therapy