bioihbjkbjnl/mcl2 huggingface dataset:
Functional Magnetic Resonance Imaging (fMRI) Study of Memory in Children
Condition: Childhood Absence Epilepsy [Pyknolepsy]
MeSH terms: Epilepsy; Epilepsy, Absence
Study type: Observational

Summary: 
      Memory is a cognitive function whose development is still poorly documented in children, but
      which is often disturbed in temporal epilepsy. There are no studies about the disorders of
      episodic memory. The investigations using functional MRI (fMRI) are scarce, they do not
      involve this field and none are dedicated to children. The objectives of this project are to
      study the neuronal networks involved in episodic memory in normal children, as well as the
      disorders of episodic memory in children with epilepsy and the mechanisms of cognitive and
      cerebral reorganization in epilepsy.
    

Detailed description: 
      Twenty children aged from 6 to 18 years with temporal and/or frontal epilepsy and 20 normal
      children in the same age range will undergo the following examinations in a unique day in the
      Unit Hospital F. JOLIOT(CEA in ORSAY, France):

        1. complete neuropsychological evaluation including episodic memory,

        2. structural MRI to quantify, using VBM, the potential abnormalities of the anatomical
           structures, to perform cognitive-morphological correlations, and to localize the
           neuronal networks activated on fMRI,

        3. functional MRI using an original task of episodic memory, specifically dedicated to
           children and being under behavioural validation laboratory.

      The analysis of fMRI data will be performed using SPM and taking into account the existence
      of epilepsy or not, of cerebral lesion or not, age, handedness, the side and location of
      epileptogenic focus, the age of seizure onset, and the type of antiepileptic treatment.

      This study has been approved by the Ethic Committee in september 2004 (CCPPRB BICETRE,
      promotion of ASSISTANCE PUBLIQUE - HOPITAUX de PARIS).
    

Intervention name(s): Study of memory using MRI
Intervention type(s): Behavioral
Intervention description(s): Study of memory using MRI
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Inclusion Criteria:

          -  Parents or legal tutors of the children having given written consent to participate to
             the study, after having being fully informed.

          -  Patients presenting with a temporal and/or frontal epilepsy and being able to perform
             the tasks of the protocol.

          -  Controls being recruited among brothers, sisters, and friends of the patients and
             being right-handlers, without any neurological history or learning disorders.

        Exclusion Criteria:

          -  Any contra-indication to MRI or being claustrophobia or blind.
      
Keywords: Memory; Epilepsy; Children; Magnetic resonance imaging; Functional magnetic resonance imaging
Survivorship Care in Reducing Symptoms in Young Adult Cancer Survivors
Condition: Breast Carcinoma; Cancer Survivor; Depression; Fatigue; Leukemia; Lymphoma; Malignant Bone Neoplasm; Malignant Digestive System Neoplasm; Malignant Female Reproductive System Neoplasm; Malignant Male Reproductive System Neoplasm; Pain; Sleep Disorder; Soft Tissue Sarcoma
MeSH terms: Neoplasms; Sarcoma; Breast Neoplasms; Digestive System Neoplasms; Gastrointestinal Neoplasms; Genital Neoplasms, Female; Bone Neoplasms; Genital Neoplasms, Male; Sleep Wake Disorders
Study type: Interventional

Summary: 
      This randomized clinical trial studies survivorship care in reducing symptoms in young adult
      cancer survivors. Survivorship care programs that identify the needs of young adult cancer
      survivors and ways to support them through the years after treatment may help reduce
      symptoms, such as pain, fatigue, sleep disturbance, depression, and distress, in young adult
      cancer survivors.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To test the impact of providing the essential elements of survivorship care on
      survivorship outcomes as indicated by reduction in symptoms (pain, fatigue, sleep
      disturbance, depression, distress) in young adult cancer survivors diagnosed with cancer
      between the ages of 18 and 39 years when compared with usual care.

      SECONDARY OBJECTIVES:

      I. To improve confidence in survivorship knowledge and promote healthy lifestyle behaviors.

      II. To provide evidence on barriers, needs and care preferences that will support long term
      follow-up recommendations for this population.

      OUTLINE: Participants categorized as high-need are randomized to 1 of 2 arms. Participants
      categorized as low-need are assigned to Arm I.

      ARM I: Participants receive usual care. After 12 months, participants may receive a
      survivorship clinic visit and boosters as in Arm II.

      ARM II: Participants attend a survivorship clinic visit that includes care plans, screening
      recommendations, physician coordination, health promotion education, symptom management and
      palliative care, late effects education, psychosocial and medical assessments, and referrals
      for services and care as appropriate. Participants also receive phone-based survivorship
      boosters over approximately 15-30 minutes at 4-8 weeks and 12-16 weeks after the initial
      clinic visit.

      After completion of study, participants are followed up at 6 and 12 months.
    

Intervention name(s): Management of Therapy Complications; Quality-of-Life Assessment; Questionnaire Administration; Telephone-Based Intervention
Intervention type(s): Procedure; Other; Other; Behavioral
Intervention description(s): Receive survivorship care; Ancillary studies; Ancillary studies; Receive phone-based booster intervention
Other intervention name(s): Quality of Life Assessment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Comparasion of the Immediate Effect of Myofascial Relaxation Technique and Kinesiology Taping
Condition: Diabetes Mellitus; Plantar Fascia
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      As a result of glycation of collagen fibers in diabetes mellitus, an increase in thickness
      and stiffness is observed in the plantar fascia, which is a connective tissue. These changes
      in the plantar fascia affect the windlass mechanism of the foot, normal range of motion and
      foot plantar pressure distribution. These biomechanical effects may cause the development of
      diabetic foot ulcers in the later stages of the disease. We hypothesis that myofascial
      release technique and kinesiology taping methods have an effect on plantar fascia stiffness
      and plantar pressure distribution in diabetic patients. The aim of this study is to
      investigate the immediate effects of the two methods on the stiffness of the plantar fascia
      and foot sole pressure distribution in diabetic patients.
    


Intervention name(s): Kinesiology Taping Appliying; Myofascial Release Technique Appliying
Intervention type(s): Other; Other
Intervention description(s): Kinesiology tape will be applied to left foot plantar fascia of the participants in diabetes mellitus and control group.
During taping, participants will lie in the prone position while the knee joint will be kept 90 degrees of flexion and the ankle joint in a neutral position. A "Palm Shape" taping procedure will be applied to the plantar fascia.; Myofascial release technique will be applied (during 5 minutes) to right foot plantar fascia of the participants in diabetes mellitus and control group
During appliying technique, participants will lie in the prone position while the knee joint will be kept 90 degrees of flexion and the ankle joint in a neutral position.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stiffness; creep; plantar fascia; diabetes mellitus
Pharmacokinetic Interaction Study in Indonesian Tuberculosis Patients Indonesia
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Pharmacokinetic study in TB patients to determine the effect of rifampicin on the
      pharmacokinetic profile of moxifloxacin.
    

Detailed description: 
      Tuberculosis is an infectious disease that still causes many victims in the developing world,
      especially in Indonesia. Rifampicin, isoniazid and ethambutol are the cornerstone of the
      current treatment. The disadvantage of the current treatment is the long, six-months,
      duration of the treatment. This long duration contributes to suboptimal adherence to the TB
      drugs.Thus, there is a very urgent need to evaluate drugs that may help shortening TB
      treatment. The fluoroquinolone moxifloxacin has shown early bactericidal activity (EBA) in
      patients with pulmonary TB, and has shown rapid and reliable sterilization. Rifampicin is a
      strong inducer of the CYP enzymes, but it also induces phase II metabolism. As moxifloxacin
      is metabolized by phase II metabolism, rifampicin could cause a decrease in the plasma
      concentrations of moxifloxacin. Therefore, a pharmacokinetic interaction study is warranted.
    

Intervention name(s): moxifloxacin
Intervention type(s): Drug
Intervention MeSH terms: Moxifloxacin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tuberculosis
Emervel for the Correction of Lower Face Wrinkles & Folds
Condition: Nasolabial Folds; Marionette Lines; Wrinkles
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to

        1. evaluate the naturalness of facial expressions in motion (2D video images), by treating
           investigator assessment

        2. evaluate naturalness of facial expressions (photographs), by treating investigator
           assessment

        3. evaluate perceived attractiveness and age of subject (2D videos), by treating
           investigator assessment

        4. evaluate aesthetic improvement, by subject and treating investigator assessments

        5. evaluate subject satisfaction

        6. evaluate nasolabial fold (NLF) severity, by treating investigator assessment

        7. evaluate marionette lines (MLs) severity, by treating investigator assessment

        8. evaluate dynamic facial strain in animation using 3D digital photogrammetric analysis

        9. evaluate all adverse events reported during the study.
    


Intervention name(s): Emervel Classic and/or Deep Treatment Group
Intervention type(s): Device
Intervention description(s): Severity of Wrinkle Severity treated by product type:
Emervel Classic:
Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 2/2, 2/3 or 3/3; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 2/2, 2/3 or 3/3
Emervel Deep Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 3/3, 3/4 or 4/4; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 3/3, 3/4 or 4/4
Both products may be used in the same subject, but only in different anatomic locations. The same study product should be used within the same wrinkle or fold type (e.g., left and right NLFs treated with the same product)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Influence of a Cognitive Behavioral Approach on Changing Patient Expectations in Shoulder Pain
Condition: Rotator Cuff Impingement Syndrome; Rotator Cuff Injury; Shoulder Pain
MeSH terms: Shoulder Pain; Shoulder Impingement Syndrome; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      Background: Despite similar treatment outcomes for surgery or conservative care, the number
      of surgeries for the care of rotator cuff (RTC) related shoulder pain has increased. With the
      increase in surgery, there is an increased risk of harms, increased costs, and high re-tear
      rates. Patient expectations are beliefs or attitudes that include pre-treatment thoughts and
      beliefs regarding the need for specific treatment methods and the timing and intensity of
      these methods. Brief interventions designed to alter and enhance treatment expectations for
      conservative care and have been shown to improve patient expectations, but to date, no
      studies have explored whether such interventions can influence patient decisions to pursue
      surgical care. The investigators propose a comprehensive intervention that involves Patient
      Engagement Education, and Restructuring of Cognitions (PEERC) that is designed to change
      expectations, will reduce the likelihood that patients will choose to have shoulder surgery
      and improve functional outcomes. The cognitive behavioral therapy (CBT) approaches that form
      the core of our PEERC protocol are patient-centered and are designed to empower the patient
      in their own recovery process.

      Purpose/Aims: To examine the effect of the PEERC protocol on the decision to have surgery
      (primary), and improve global well-being, pain catastrophizing, pain, functional outcomes,
      and follow up expectations (secondary).
    


Intervention name(s): Patient Engagement Education and Restructuring of Cognitions
Intervention type(s): Behavioral
Intervention description(s): This protocol, informed by principles of CBT, involves three components: 1) engagement, 2) education and 3) cognitive restructuring and behavioral activation. A health coach who is responsible for engaging patients, educating them about pain modulatory mechanisms, and reinforcing cognitive and behavioral coping skills, will deliver the PEERC protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Clinical Efficacy and Safety Evaluation of Co-administered HGP0904, HGP0608 and HGP0816 in Patients With Hypertension and Dyslipidemia
Condition: Hypertension; Hyperlipidemia
MeSH terms: Hypertension; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      A phase 3 study to evaluate efficacy and safety of Co-administered HGP0904, HGP0608 and
      HGP0816 in Patients with Hypertension and Dyslipidemia
    

Detailed description: 
      This study is designed as a multi-center, double-blinded, randomized, phase 3 clinical trial
      to evaluate the efficacy and safety of Co-administered HGP0904, HGP0608 and HGP0816 in
      Patients with Hypertension and Dyslipidemia
    

Intervention name(s): HGP0904; HGP0608; HGP0816; HGP0904 Placebo; HGP0816 Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypertension; Hyperlipidemia
Studying the Effect of Freeze-Dried Table Grape Powder on Blood Estrogen Levels in Postmenopausal Women
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Estrogen can cause the growth of breast cancer cells. Studying samples of blood
      and urine in the laboratory from participants receiving freeze-dried table grape powder may
      help doctors understand the effect of this drug on blood estrogen levels.

      PURPOSE: This clinical trial is studying the effect of freeze-dried table grape powder on
      blood estrogen levels in postmenopausal women.
    

Detailed description: 
      OBJECTIVES:

        -  To measure the change in levels of plasma estrone (E1), estradiol, E1-conjugates, and
           E1-sulfates in postmenopausal women after 6 weeks of daily ingestion of 94 grams of
           freeze-dried table grape powder.

        -  To conduct bioavailability research on the freeze-dried table grape powder in humans
           through the analysis of participants' blood and urine samples.

      OUTLINE: Participants receive oral freeze-dried table grape powder once daily on days 1-42 in
      addition to their usual diet. Treatment continues in the absence of toxicity.

      Participants undergo blood sample collection at baseline, periodically after the first dose,
      and on the last day of the study for pharmacokinetic and bioavailability analysis. Samples
      are examined by mass spectrometry to measure plasma levels of estrone (E1), estradiol,
      E1-conjugates, E1-sulfates, testosterone, and androstenedione. Participants also undergo spot
      urine collection and weight and height measurement periodically during study.

      Participants complete food diaries on days 1-3, 21-23, and 40-42 to assess their intake of
      grapes, grape juice, and red wine and to examine the constancy of their caloric intake over
      the course of the study.
    

Intervention name(s): standardized freeze-dried table grape powder; laboratory biomarker analysis; pharmacological study
Intervention type(s): Dietary Supplement; Other; Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Female

          -  Postmenopausal (defined as women who have had both ovaries removed or no menstrual
             period for at least 12 consecutive months)

          -  Able to give informed consent and complete food records alone or with assistance
      
Keywords: breast cancer
12 Week Evaluation of the Safety and Efficacy of 4 Dosing Strategies of CP-526,555 and Placebo for Smoking Cessation.
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to measure the safety and efficacy of four dosing strategies of
      CP-526,555 for 12 weeks compared with placebo for smoking cessation. Post-treatment follow-up
      of smoking status to one year from randomization was performed in a non-treatment extension
      Protocol A3051018
    


Intervention name(s): CP-526,555 (varenicline)
Intervention type(s): Drug
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Influence of Cytochrome CYP3A4-induction by St. John's Wort on the Steady State Pharmacokinetics of Ambrisentan
Condition: Drug Interactions
Study type: Observational

Summary: 
      The aim of the present study is to assess the impact of CYP3A4-induction by SJW on steady
      state ambrisentan and the impact of the cytochrome P450 2C19 (CYP2C19) genotype (*2 and *3
      allele vs. wild type; ~2-5% poor metabolisers in Caucasian population) on the
      pharmacokinetics of ambrisentan in healthy volunteers.
    


Intervention name(s): St. Johns wort
Intervention type(s): Drug
Intervention description(s): Administration of ambrisentan: 5 mg p.o. q.d. on day 1 and days 3-20
Administration of SJW: 300 mg p.o. three times a day (t.i.d.) on days 11-20
Other intervention name(s): Jarsin
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy subjects
      
Keywords: Steady-state; Ambrisentan; St. Johns Wort
Autonomic Nervous Activity in Women With Gestational Diabetes
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Observational

Summary: 
      Through complex hormonal pathways, insulin resistance can lead to the activation of the
      sympathetic nervous system, and vice versa. Schobel et al. showed that in PE patients,
      mus-cle sympathetic nerve activity (MSNA) is increased compared with normotensive pregnant
      and non-pregnant women. Studies assessing heart-rate variability and plasma noradrenalin
      concentrations also suggest increased sympathetic activity in PE. It has been hypothesized
      that sympathetic over-activity is a precursor of PE, normally compensated for by vasodilating
      mechanisms, but resulting in PE when the mechanisms fail. In addition to sympathetic
      activity, various markers of inflamma-tion are also associated with reduced insulin
      sensitivity, suggesting that chronic sub-clinical inflamma-tion could be part of the insulin
      resistance syndrome. The role of sympathetic over-activity and inflammatory markers in
      gestational diabetes has not been investigated
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Gestational diabetic women having or not hypertension with two control groups, one pregnant
        on non-pregnant. All the women are studied during night time to study the arousal of the
        sympathetic activity in the early morning hours
      
Keywords: Inflammatory factors; Coagulation factors; Sympathetic activity
Study of a Sleep Apnea System for the Treatment of Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      This is a prospective study of the Attune Sleep Apnea System for the treatment of obstructive
      sleep apnea. The objective of the study is to demonstrate safety and effectiveness of the
      Attune Sleep Apnea System to support FDA marketing clearance of the device.
    


Intervention name(s): Attune Sleep Apnea System
Intervention type(s): Device
Intervention description(s): Console and mouthpiece sleep apnea system
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Trial to Assess the Safety, Tolerability and Pharmacokinetics of MDT-637 in Subjects With Intermittent, or Mild-to-Moderate Persistent, Asthma
Condition: Drug Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of MDT-637, when inhaled
      by subjects with Intermittent, or Mild-to-Moderate Persistent, Asthma.
    


Intervention name(s): MDT-637; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Inhaled doses of MDT-637 over a 24 hour period at 3 visits
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Respiratory Syncytial Virus Infection; RSV