bioihbjkbjnl/mcl2 huggingface dataset:
Alexithymia Frequency and Interhemispheric Transfer in Patients With a First Demyelinating Event
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Affective Symptoms
Study type: Observational

Summary: 
      Prevalence of alexithymia in multiple sclerosis (MS) is closed to 50% but is unknown in
      clinically isolated syndrome (CIS).The present study sought to characterize alexithymia in
      CIS patients and his link between psycho behavioral and cognitive disturbances.

      In this context, the objectives of the present study were to (a ) define the prevalence of
      alexithymia in CIS patients, (b ) to study this relation between psycho behavioral and
      cognitive disorders frequently encountered in MS.
    

Detailed description: 
      The aim to recruit 40 CIS patients with at least two subclinical lesions on brain MRI.
      Patients are tested only one month at least after steroids intake and after 6 weeks at least
      after any relapse. The control group include 40 right -handed participants; each of them are
      matched for age, gender, and education level with a CIS patient.

      The parameters to be evaluated are:

      The prevalence of alexithymia is assessed by The Toronto Alexithymia Scale TAS-20, a
      self-reported scale. The TAS-20 total score corresponds to global level of alexithymia, as
      the sum of these three subdomains: 1.Difficulties in Identifying Feelings (DIF); 2.
      Difficulties in Describing Feelings (DDF); 3. Externally Oriented Thinking (EOT).

      Standard neurological examination is performed by a neurologist using the Kurtzke Expanded
      Disability Status Scale (EDSS ).

      The standardized neuropsychological battery, named BCcogSEP, is administrated. The BCcogSEP
      is made of eight tests commonly impaired in MS. Fourteen scores were obtained and a score was
      considered impaired when it was inferior to 5th percentile range compared to the normal
      range. The number of impaired scores are considered and a cognitive impairment is considered
      when 4 scores are superior or equal to percentile 5th.

      For psychobehavioral assessments, the investigators estimated (a) depression (according to
      the Beck Depression Inventory; BDI (30)) and anxiety (according to the State-Trait Anxiety
      Inventory (31)); (b) apathy (according to the Lille Apathy Rating Scale (32)); (c) empathy
      (according to Interpersonal Reactivity Index; IRI).
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        MS patients admited in MS center of Lille after the first neurological inflammatory
        clinical event
      
Keywords: cognition; alexithymia
The Effects of Sodium and Potassium on Blood Pressure, Vascular Function and Renal Function
Condition: Hypertension; Blood Pressure; Vascular Function; Renal Function
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      To determine the effect of (1) increased sodium intake and (2) increased potassium intake on
      blood pressure, vascular function and renal function in untreated (pre)hypertensive subjects.
    

Detailed description: 
      This is a randomized, double-blind, placebo controlled cross-over feeding study.
    

Intervention name(s): Sodium; Potassium; Placebo
Intervention type(s): Dietary Supplement; Drug; Drug
Intervention description(s): Sodium Chloride (provided by Microz, Geleen, Netherlands): 8 capsules per day which equals a sodium intake of 3 grams.; Potassium Chloride (provided by Microz, Geleen, Netherlands): 8 capsules per day which equals a potassium intake of 3 grams.; Placebo (cellulose, provided by Microz, Geleen, Netherlands): 8 capsules per day.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: sodium; salt; potassium; blood pressure; flow-mediated dilatation; endothelial function; renal function; controlled feeding study; dietary intervention
Instrument-assisted Soft Tissue Mobilization and Kinesiotape Application in Individuals With Chronic Neck Pain.
Condition: Cervical Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Chronic neck pain causes errors in joint position sense. There are studies in the literature
      suggesting that instrument-assisted soft tissue mobilization and Kinesiotape applications
      improve the joint position sense. There is no study examining these applications acutely on
      joint position sense and pain in the cervical region. As a result of our study, we will
      compare the effects of single-session instrument-assisted soft tissue mobilization and
      Kinesiotape application on pain and joint position sense.
    

Detailed description: 
      The study will be carried out on volunteers after the approval of the ethics committee.
      Before the research, individuals and / or their relatives will be informed about the purpose
      and content of the study. Volunteer individuals between the ages of 18-45 with chronic neck
      pain will be included in the study after obtaining their informed consent.

      Participants will be randomly divided into two groups: Instrument assisted soft tissue
      mobilization and Kinesiotape Applications.

      In the instrument-assisted soft tissue mobilization group, the trapezius and
      sternocleidomastoideus muscles will be applied in a single session for 90 seconds.
      Kinesiotape application will be applied to the trapezius and sternocleidomastoideus muscles
      in one session.

      Pain will be evaluated with Visual Analog Scale and joint position sense will be evaluated
      with Cervical Range of Motion device before and after application.
    

Intervention name(s): Instrument Assisted Soft Tissue Mobilization; Kinesiotape Application
Intervention type(s): Other; Other
Intervention description(s): Bilateral Instrument assisted soft tissue mobilization application will be applied in a single session to the trapezius and sternocleideomastoideus muscles.; Bilateral Kinesiotape application will be applied in a single session to the trapezius and sternocleideomastoideus muscles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic cervical pain; Instrument Assisted Soft Tissue Mobilization; Kinesiotape; Joint position sense
Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo & Active Control in Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate that quetiapine SR (SEROQUEL®) is efficacious and
      safe in the acute treatment of patients with Generalized Anxiety Disorder.

      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation
      was changed to XR after consultation with FDA.
    


Intervention name(s): Quetiapine Fumarate; Escitalopram oxylate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Quetiapine Fumarate; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: GAD; anxiety
Effects of Early Treadmill Training on Ambulatory Ability in Stroke Patients: Electromyographic and Kinematic Analyses
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this study is to explore an alternative approach that emphasizes task
      specificity and treadmill training for ambulation training of these patients.
    

Detailed description: 
      Restoration of independent ambulatory ability is one of the most common functional goals of
      patients with hemiplegia after stroke. Ambulation training, therefore, is an important part
      of physical therapy intervention for these patients. Conventional neurologic physical therapy
      for ambulation training, based sorely on neurophysiology, prohibits early ambulation
      experience after stroke in attempt to avoid the development of abnormal gait patterns. Such
      an approach has been shown to be limited in helping these patients regain independent
      ambulatory ability.
    

Intervention name(s): Treadmill Training
Intervention type(s): Behavioral
Intervention description(s): Partian body weight support treadmill training, 30 min/day * 3 days /week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Stroke; Hemiplegia; Gait; Ambulation training; Neurologic physical therapy
Anti-inflammatory Effects Glycopyrronium
Condition: Asthma; Allergic Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Double-blind, randomized, two-way cross-over study with two treatment periods. 28 subjects
      with asthma will be randomized in 1:1 ratio to treatment A) Indacaterol/Mometasone 150/160 μg
      once daily and treatment B) Indacaterol/Glycopyrronium/Mometasone 150/50/80 μg once daily for
      period 1. For period 2, subjects will be crossed over to the other treatment arm. Subjects
      will be screened during the first visit. After inclusion subjects will be seen for 3 visits
      during the Run-in period, 3 visits during treatment period 1 and 3 visits during treatment
      period 2. During these visits patients will be clinically characterized and exposed to
      allergen challenge tests.
    


Intervention name(s): QVM149; QMF149
Intervention type(s): Drug; Drug
Intervention description(s): Anti-inflammatory effect of Glycopyrronium added to Mometasone / Indacaterol; Mometasone / Indacaterol
Other intervention name(s): Mometasone/Indacaterol/Glycopyrronium; Mometasone/Indacaterol
Intervention MeSH terms: Mometasone Furoate; Glycopyrrolate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-blind, randomized, two-way cross-over study with two treatment periods.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Anti-inflammatory; Allergen
Micro-expression Reading Skill Training in Medical Students
Condition: Communication
Study type: Interventional

Summary: 
      This study was undertaken to investigate the effectiveness of the Micro Expression Training
      Tool (METT) and the Subtle Expression Training Tool (SETT) to help improve the non-verbal
      communication skills of medical students.
    

Detailed description: 
      Teaching and assessing communication skills is an important component of medical school
      curricula, and it is not easy for medical students to develop non-verbal communication skills
      without adequate training. This study was undertaken to investigate the effectiveness of the
      Micro Expression Training Tool (METT) and the Subtle Expression Training Tool (SETT) to help
      improve the non-verbal communication skills of medical students.
    

Intervention name(s): Micro Expression Training Tool
Intervention type(s): Other
Intervention description(s): The Micro Expression Training Tool (METT) and the Subtle Expression Training Tool (SETT) to help improve the non-verbal communication skills
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
PERFORMANCE STUDY OF THE AL-SENSE
Condition: Amniotic Problems
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label, comparative, and prospective pivotal study to demonstrate that
      AL-SENSE can indicate whether wetness sensed by pregnant women may be caused by amniotic
      fluid leakage rather than by urinary incontinence.

      Subjects arriving at the hospital will receive a single AL-SENSE to use until they notice any
      wetness.

      The blinded physician will perform a diagnosis according to the standard diagnostic methods
      (clinical assessment). The standard diagnostic methods will include the following tests: (1)
      Pooling test, (2) Ferning test, (3) pH test by pH paper. A positive Pooling test or positive
      result in both the pH test and the Ferning test is defined as a positive clinical assessment.
    

Detailed description: 
      This is an open-label, comparative, and prospective pivotal study to demonstrate that
      AL-SENSE can indicate whether wetness sensed by pregnant women may be caused by amniotic
      fluid leakage rather than by urinary incontinence. Subjects arriving at the hospital and
      reporting unidentified wetness (undetermined whether this is amniotic fluid leakage or
      urinary incontinence) will receive a single AL-SENSE to use up to 12 hours or until they
      notice any wetness. The clinician will explain the proper use and handling of the AL-SENSE.

      In each case, the blinded clinician will be required to read and record any occurrence of
      color change of the AL-SENSE 10 minutes after the AL-SENSE removal and to mark if it changes
      color to blue or to green on the designated form.

      The blinded physician (other than the clinician who records the AL-SENSE results) will
      perform a diagnosis according to the standard diagnostic methods (clinical assessment). The
      standard diagnostic methods will include the following tests: (1) Pooling test, (2) Ferning
      test, (3) pH test by pH paper. A positive Pooling test or positive result in both the pH test
      and the Ferning test is defined as a positive clinical assessment.

      In cases where the AL-SENSE shows positive results but the clinical assessment results are
      negative, reference laboratories, or any other standard procedure will check for the
      possibility of BV or Trichomonas in addition to the tests noted above.
    

Intervention name(s): AL-SENSE
Intervention type(s): Device
Intervention description(s): A diagnostic pantyliner for detection of amniotic fluid leaks compared with standard clinical diagnosis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Prolongation of a Clinical Study to Evaluate the Efficacy of an Aqueous Gel Containing 2% (w/w) of Cidofovir, Directly Applied on the Cervix Exhibiting High Grade Squamous Intraepithelial Lesions.
Condition: High Grade Cervical Epithelial Neoplasia (CIN2+)
MeSH terms: Squamous Intraepithelial Lesions of the Cervix; Carcinoma, Squamous Cell; Carcinoma in Situ
Study type: Interventional
Phase: Phase 2

Summary: 
      The infections of high grade induced by the human papilloma viruses cause precancerous
      lesions of the cervical epithelium. The progression of these lesions can lead to the onset of
      cervical cancer. To reduce the risk of cancer lesions classified as 'cervical squamous
      intraepithelial neoplasia 2' (CIN2) and 'cervical squamous intraepithelial neoplasia 3'
      (CIN3), the standard treatment is the conisation of the cervix. This surgery can lead to
      complications such as infertility or a risk of preterm birth, hence the need to move towards
      a non-surgical alternative therapy.

      The colvir clinical trial was a phase-II, multi center, randomized, double blind, efficacy
      study of an aqueous gel containing 2% (w/w) cidofovir, administrated directly on cervix
      exhibiting high grade squamous intraepithelial lesion (CIN 2 and 3).

      This clinical trial is a prolongation of the colvir trial, in order to

        -  assess the long term histological and virological evolution (24 months) of 3 g of 2%
           (w/w) cidofovir gel, administrated directly on cervix exhibiting high grade
           intraepithelial neoplasia after complete response, partial response or response failure
           at the end of the Colvir study.

        -  assess the long term (24 months) rate of recurrence of histological lesions of the
           Colvir patients after conisation, in both placebo and treatment groups.
    


Intervention name(s): Cidofovir
Intervention type(s): Drug
Intervention MeSH terms: Cidofovir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colvir; high grade squamous intraepithelial lesions; cervix
The Effect of Balance Training on Neuromuscular Control in Subjects With CAI
Condition: Ankle Inversion Sprain; Instability, Joint; Treatment; Neuromuscular Control; Reaction Time
MeSH terms: Joint Instability
Study type: Interventional

Summary: 
      The goal of this study is evaluate the effect of uni-axial versus multidirectional balance
      training on muscle reaction time in subjects with chronic ankle instability. Muscle reaction
      time is measured on a trapdoor simulating an inversion sprain before and after a 6 week
      lasting balance training protocol.
    


Intervention name(s): Balance training
Intervention type(s): Other
Intervention description(s): 6 weeks lasting balance training program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Temozolomide in Treating Young Patients With High-Risk Relapsed or Refractory Neuroblastoma
Condition: Neuroblastoma
MeSH terms: Neuroblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.

      PURPOSE: This phase II trial is studying how well temozolomide works in treating patients
      with high-risk relapsed or refractory neuroblastoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the anti-tumor activity of temozolomide in young patients with high-risk
           relapsed or refractory neuroblastoma.

      Secondary

        -  Determine the duration of response in patients treated with this drug.

        -  Determine tolerability of this drug in these patients

        -  Determine the tumor expression of the cellular repair mechanisms which repair DNA damage
           (O6-methylguanine-DNA methyltransferase [MGMT] and mismatch repair [MMR] systems) in
           patients treated with this drug.

        -  Correlate MGMT and MMR expression with outcomes in patients treated with this drug.

        -  Determine if MGMT and MMR expression/activity changes in the tumor during initial
           presentation, treatment, and relapse/progression in patients treated with this drug.

        -  Determine the activity of MGMT in bone marrow taken at relapse, in terms of
           hematological toxicity, in patients treated with this drug.

      OUTLINE: This is a multicenter, open label, nonrandomized study.

      Patients receive oral temozolomide once daily for 5 days. Treatment repeats every 28 days for
      2 courses. Patients achieving stable or responding disease after completion of the 2 courses
      may receive up to 10 additional courses of treatment in the absence of disease progression or
      unacceptable toxicity.

      PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
    

Intervention name(s): temozolomide
Intervention type(s): Drug
Intervention MeSH terms: Temozolomide
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent neuroblastoma; disseminated neuroblastoma; localized unresectable neuroblastoma
Feasibility, Acceptability, and Efficacy of the Sleep Move Stand Study
Condition: Physical Inactivity; Sedentary Behavior; Sleep; Cognitive Function
Study type: Interventional

Summary: 
      The overarching goal for this project is to develop a service-learning program that provides
      students excellent hands on training and patients with an excellent service that advances
      their health and well-being. The aim of this study is to test the feasibility, acceptability
      and efficacy of an 8 week intervention on physical behaviors, cognitive function, and health
      outcomes compared to a control condition among sedentary, overweight and obese adults.
    

Detailed description: 
      The overarching goal for this project is to develop and test a service-learning health
      promotion intervention that provides students hands on training and patients with a service
      that advances their health and well-being. Inactive but healthy community members and
      patients being treated at our local hospital will be recruited to participate. Interested
      volunteers will be randomized into one of two 8 week interventions. The control group will
      receive basic education information on physical activity, sedentary behavior, and sleep that
      is consistent with standard of care. These materials will be accessed via a health coaching
      software program called Healthie. The treatment group will receive the same education
      information plus health coaching and a Fitbit activity monitor to further support behavior
      change. Participants will be blinded to their group assignment. Major outcomes include
      physical activity, sedentary behavior, sleep, cognitive function, and several health
      outcomes. Success on whether or not the program is found to be feasible, acceptable, and
      effective.
    

Intervention name(s): Education; Health coaching; Activity Monitor
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will receive standard of care education information on physical activity, sedentary behavior, and sleep via a mobile app for 8 weeks.; Participants will meet with a health coach weekly for 8 weeks; Participants will receive a Fitbit activity monitor to support goal setting and self monitoring of behaviors.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of TNP-2198 Capsules in Asymptomatic Participants With Helicobacter Pylori Infection
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Communicable Diseases; Helicobacter Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was a Phase 1, single-center, randomized, double-blind, placebo-controlled,
      multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and
      preliminary Helicobacter Pylori eradication efficacy of TNP-2198 capsules.
    


Intervention name(s): TNP-2198; TNP-2198 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TNP-2198 capsules/placebo were administered orally twice daily (BID, at 7:00 ± 1 hour in the morning and 19:00 ± 1 hour in the evening) in the fasted state for consecutive 14 days, and the last dose was taken at 7:00 am (±1 hour) on Day 15 in the fasted state, and breakfast or dinner should not be taken within 30 minutes after each dose.; TNP-2198 capsules/placebo were administered orally twice daily (BID, at 7:00 ± 1 hour in the morning and 19:00 ± 1 hour in the evening) in the fasted state for consecutive 14 days, and the last dose was taken at 7:00 am (±1 hour) on Day 15 in the fasted state, and breakfast or dinner should not be taken within 30 minutes after each dose.
Other intervention name(s): Rifasutenizol
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment