bioihbjkbjnl/mcl2 huggingface dataset:
Learning and Executive Function Disorders in Children and Psychosis Risk at Adult-age
Condition: Schizophrenia; Learning Disorders; Executive Function Disorders
MeSH terms: Learning Disabilities; Schizophrenia; Psychotic Disorders; Mental Disorders
Study type: Observational

Summary: 
      The primary objective of the study aims to study transition toward schizophrenia in patients
      with learning disorders, and to compare the risk between patients with specific learning
      disorders, and patients with complexed learning disorders (by two types: patients with other
      neuro-developmental disorders including executive function disorders, and patients with
      anxiety).
    

Detailed description: 
      As secondary objectives, the study aims to:

        -  argue the clinical predicted markers (neuropsychological) transition toward psychosis.

        -  test the feasibility and the acceptability of a early diagnosis for a potential
           applicable guidance for different referent centers of learning in French territory.

        -  have a better classification of patients with learning disorders in order to target a
           prospective primary prevention of risk of psychosis via the questionnaires (AQ of
           Baron-Cohen: Autism-spectrum quotient auto-questionnaire; Inventory of Beck Anxiety
           Inventory, auto-questionnaire for panic disorder and general anxiety; Liebowitz Social
           Anxiety Scale).

        -  improve identification of the early signs and the early emerging psychological diseases
           intervention management (schizophrenia).

        -  Psychic disability: prevent and reduce non-seeking care and accompaniment situations,
           and risk of rupture of care.

        -  permitting better care of psychosocial rehabilitation with cognitive evaluation.

      This study will be conducted in Centre de référence des troubles du langage et des
      apprentissages, Hôpital Raymond Poincaré, APHP, in France.
    

Intervention name(s): Standardised semi-structured talk; Autistic spectre disorder screening; Anxiety measuring
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Comprehensive assessment of at-risk mental states (CAARMS) will be used.; Autism-spectrum quotient (AQ) auto-questionnaire will be used.; An inventory for measuring clinical anxiety: Beck Anxiety Inventory (BAI); Liebowitz Social Anxiety Scale.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients between 15 and 30 years, suffering learning disorders complicated with two orders:
        with other neuro-developmental, or with anxiety (vs specific: comparator group).
      
Keywords: learning disorders; executive function disorders; psychosis; children; adult-age
Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenia Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the pharmacokinetic and safety for the esomeprazole use for schizophrenia
    

Detailed description: 
      Investigators prepare to recruit 30 schizophrenia patients in one year. Investigators will
      conduct a 8-week open label clinical trial for evaluation of the pharmacokinetic and safety
      of esomeprazole use for the schizophrenia. Investigators will give 40 mg/day esomeprazole in
      the first two weeks and 80 mg/day from the third week to the end of the trial. Investigators
      will check the area under the concentration of metabolites of esomeprazole on Day 1, Day 14
      and Day 56 and the genotype of CYP2C19. The GI symptoms and related drug side effects will be
      evaluated.
    

Intervention name(s): esomeprazole
Intervention type(s): Drug
Intervention description(s): esomeprazole 40mg /tab oral Day1-Day14 then 40mg/2 tab oral Day15-Day56
Other intervention name(s): Nexium
Intervention MeSH terms: Esomeprazole
Intervention model: Single Group Assignment
Intervention model description: Investigators will give 40 mg/day esomeprazole in the first two weeks and 80 mg/day from the third week to the end of the trial. Investigators will check the area under the concentration of metabolites of esomeprazoleon Day 1, Day 14 and Day 56 and the genotype of CYP2C19. The GI symptoms and related drug side effects will be evaluated.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia
Combination Chemotherapy in Treating Women With Stage I Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells. It is not
      yet known which combination chemotherapy regimen is more effective in treating early breast
      cancer.

      PURPOSE: Randomized phase III trial to determine the effectiveness of different regimens of
      combination chemotherapy in treating women who have stage I breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the efficacy of 4 vs 6 courses of adjuvant fluorouracil, epirubicin, and
           cyclophosphamide, in terms of 5-year survival, in women with stage I breast cancer.

        -  Compare the toxicity of these regimens in these patients.

        -  Determine the correlation of length of survival with biological factors in patients
           treated with these regimens.

        -  Determine biological factors significant for prognosis and prediction of survival of
           patients treated with these regimens.

        -  Determine the overall survival of patients treated with these regimens.

      OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of
      2 treatment arms.

        -  Arm I: Patients receive fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day
           1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease
           progression or unacceptable toxicity.

        -  Arm II: Patients receive the same regimen as in arm I for up to 4 courses. After
           completion of chemotherapy, patients undergo radiotherapy 5 days a week for 6 weeks.
           Patients who are estrogen or progesterone receptor positive also receive oral tamoxifen
           daily for 5 years, beginning after completion of chemotherapy.

      Patients are followed every 6 months for 5 years.

      PROJECTED ACCRUAL: A total of 1,512 patients (756 per treatment arm) will be accrued for this
      study within 3 years.
    

Intervention name(s): cyclophosphamide; epirubicin hydrochloride; fluorouracil
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Cyclophosphamide; Fluorouracil; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I breast cancer
Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis
Condition: Raynaud's Phenomenon Secondary to Systemic Sclerosis
MeSH terms: Neoplasm Metastasis; Raynaud Disease; Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate pharmacodynamics (PD) in adult subjects with a
      diagnosis of Raynaud's Phenomenon secondary to Systemic Sclerosis (SSc).
    

Detailed description: 
      The purpose of this study is to evaluate the pharmacodynamic (PD) effects of topical
      Alprostadil on digital perfusion by laser Doppler capillary velocimetry and digital
      temperature recovery with thermography following standardized cold challenge and to assess
      the safety and tolerability of 3 doses of Alprostadil topical cream and placebo cream in
      adult subjects with a diagnosis of Raynaud's Phenomenon secondary to Systemic Sclerosis
      (SSc).
    

Intervention name(s): Alprostadil; Placebo
Intervention type(s): Drug; Other
Intervention MeSH terms: Alprostadil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Secondary Raynaud's Phenomenon; Secondary Raynaud's Disease; Scleroderma; Raynaud's Disease secondary to systemic sclerosis; CREST; Apricus Biosciences; laser doppler; thermography
Class II Correction Study Using the Invisalign System
Condition: Malocclusion
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      To demonstrate that growing teenagers which present up to full cusp Class II malocclusions
      can be treated using the Invisalign System.
    

Detailed description: 
      The Invisalign® System consists of a series of clear plastic aligners that are intended to
      replace conventional wire and bracket technology for many orthodontic cases. Each custom
      manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their
      original state to a final, treated state. Each aligner is worn for about two weeks, then
      replaced by the next in the series until the final position is achieved. For years,
      orthodontists and dentists have used removable appliances for orthodontic treatment. Today,
      with the application of computer technology and custom manufacturing, Invisalign treats a
      broader range of cases with greater precision.
    

Intervention name(s): Invisalign System
Intervention type(s): Device
Intervention description(s): The Invisalign® System is indicated for the alignment of teeth during orthodontic treatment of malocclusion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Orthodontic; Orthodontic Treatment; Clear Aligners; Malocclusion
Extended-release of Octreotide (LF-PB) for the Treatment of Lymphorrhea
Condition: Lymphorrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II, multicenter, double-blind, double-dummy, parallel-group,
      placebo-controlled, study to evaluate LF-PB versus placebo in female patients with brest
      cancer who are undergoing breast surgery with axillary lymphnode dissection.

      Recruited patients will be randomly assigned to one of the following treatment groups:
      Placebo, LF-PB 10 mg, LF-PB 20 mg and LF-PB 30 mg.

      Mode of administration is single intramuscular (IM) injection so the treatments arms are as
      follows:

      Placebo: 2 injections of placebo LF-PB 10 mg: 2 injections = placebo + 10 mg LF-PB 20 mg: 2
      injections = placebo + 20 mg LF-PB 30 mg: 2 injections = 10 mg + 20 mg

      The study will randomize a total of 120 patients (30 per arm) in about 10 Italian Sites.
    


Intervention name(s): LF-PB and Placebo; Placebo; LF-PB
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): extended-release of octreotide and placebo; LF-PB 10 mg and LF-PB 20 mg
Intervention MeSH terms: Octreotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Acupuncture in Adolescent Football Players
Condition: Acupuncture Therapy; Sports Medicine
Study type: Interventional

Summary: 
      Is it feasible to perform acupuncture in the training field after sport performance in
      adolescent football players?

      Does acupuncture provide a decrease in muscle soreness and improvement in overall sense of
      well-being in the adolescent football population?
    

Detailed description: 
      Previous studies on the effects of acupuncture on performance and post-exercise recovery have
      shown that it reduces perceived pain arising from exercise induced muscle soreness and
      reduces muscle spasm. Acupuncture has also been shown to serve as an adjunct to improve
      muscle strength training and to accelerate recovery from workouts and injury.

      The investigators' goal is to study approximately 50 high school football players in their
      true pre-season warm weather training environment. The investigators will measure the effects
      of acupuncture treatment on muscle soreness and overall sense of well-being by administering
      pre- and post-treatment surveys. Athletes will undergo five treatment sessions over the
      course of 2.5 weeks. The treatments will be performed by licensed acupuncturists employed at
      Mayo Clinic. The study has been approved by the Institutional Review Board at the Mayo
      Clinic.
    

Intervention name(s): Acupuncture
Intervention type(s): Procedure
Intervention description(s): Each treatment would take approximately 15-20 minutes and would take place immediately after practice for a total of five treatments. The needles are standard (0.2mm diameter #36 gauge 1 inch stainless steel) and during each treatment, 3-6 needles would be placed in the lower extremity in any of the following muscle groups: quadriceps, hamstrings, anterior tibialis, gastrocnemius-soleus complex, medial head of the gastrocnemius, peroneal muscles, or iliotibial band. The athletes would complete brief pre- and post-treatment surveys.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases
Condition: Primary Immune Deficiency Disorders; Common Variable Immunodeficiency; X-linked Agammaglobulinaemia; Hyperimmunoglobulin M Syndrome
MeSH terms: Agammaglobulinemia; Hyper-IgM Immunodeficiency Syndrome; Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes; Common Variable Immunodeficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of the study is to determine the pharmacokinetics profile of Subgam-VF.
      The secondary objectives are to assess the safety of Subgam-VF and refine the dose adjustment
      coefficient for Subgam-VF needed for subjects switching from prior intravenous immunoglobulin
      (IGIV) therapy.
    

Detailed description: 
      This will be a Phase III, multicenter, open-label, non-randomized study.

      Following a screening period, eligible subjects will commence weekly Subgam-VF treatment;
      this is a 16% subcutaneous IgG product.

      Subjects will receive Subgam-VF for 26 weeks during which time safety will be assessed.

      After Week 21, PK sampling will commence.

      Follow-up visit (one week after the last Subgam-VF infusion, Week 27). All AEs will be
      monitored up to 28 days after the last Subgam-VF infusion by telephone contact (Week 30).

      Subgam-VF will be administered subcutaneously using infusion pumps.

      Subjects will be given diaries to record adverse event data as well as any infusions
      administered at home. In addition there will be a telephone follow up by an appropriately
      qualified site staff member on day 3 after each site administered and home administered
      infusion to check for any adverse reactions including infusion site reactions and remind
      subjects to document these in their subject study diary.
    

Intervention name(s): Subgam
Intervention type(s): Biological
Intervention description(s): Subgam-VF dose will be given as 1.37 of the established IGIV dose (expressed in mg/kg/week) for 26 weeks (26 infusions) beginning one week after the last IGIV infusion. Dose of Subgam-VF will then be adjusted based on the ratio of the Immunoglobulin G (IgG) average concentration achieved with Subgam-VF compared to IGIV.
Other intervention name(s): Subgam-VF
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Primary Immune Deficiency Disorders; Common Variable Immunodeficiency; X-linked agammaglobulinaemia; Hyper-IgM Syndrome; Subcutaneous; Immunoglobulins
Young Age Soccer Player's Lower Limb Muscle Imbalance and Functional Status
Condition: Healthy
Study type: Interventional

Summary: 
      A randomized controlled trial is designed to examine the effects of low-load and
      high-velocity eccentric exercises on lower limb muscular properties, imbalances and
      functional status of 13-15 years old female football players.
    

Detailed description: 
      Twenty participants were included in the study. All participants were divided in two groups -
      control and experimental. In the experimental group (n=10) participants after team soccer
      training additional received 4 weeks eccentric exercises, in the control group (n=10) - did
      not perform additional exercises. The research group performed additional low-load and
      high-velocity - lying prone - eccentric hamstring exercise 3 times per week for 4 weeks. Pre-
      and post- training assessment included concentric/eccentric knee extension and flexion at
      60°/s and 120°/s, changes in muscle contractile characteristics and dynamic balance.
    

Intervention name(s): Low-load and high-velocity - lying prone - eccentric hamstring exercise
Intervention type(s): Behavioral
Intervention description(s): Low-load and high-velocity - lying prone - eccentric hamstring exercise 3 times per week for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Young age soccer player; Eccentric hamstring exercise; Dynamic balance; Contractile muscle properties
Inflammatory Markers in Exhaled Breath Condensates From Asthmatic Patients
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      This study aims to compare the inflammatory mediators in exhaled breathe condensates from
      allergic and non-allergic asthmatic patients.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Asthmatic patients in Allergy clinic, King Chulalongkorn Memorial Hospital (10 allergic and
        10 non-allergic) and 10 non-asthmatic controls will be enrolled to this study to collect
        exhaled breathe condensates (EBC) and measure levels of inflammatory cytokines in EBC
      
Biospecimen description: 
      Exhaled breathe condensates
    
Keywords: Asthma; Exhaled breath condensates; Cytokines
Metabolic Flexibility as a Biomarker of Adaptation to Diet and Exercise Challenges
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The objective is to develop a new metabolic flexibility biomarker, which has application in
      the study of changes diet and exercise on fuel management in humans. The new biomarker
      involves the characterization of an individual's metabolic flexibility utilizing room
      calorimeters rather than the current method, which is based on glucose clamp data. It is
      hypothesized that this new metabolic flexibility method will be a useful and noninvasive
      biomarker for measuring adaptation to exercise and diet challenges.
    


Intervention name(s): High Intensity Exercise; Low Intensity Exercise; High Carbohydrate Beverage; High Fat Beverage
Intervention type(s): Other; Other; Other; Other
Intervention description(s): While in the calorimeter, each subject will complete four bouts of exercise. Each bout is approximately 5 minutes in duration at a predetermined speed and elevation to achieve an intensity of 85% of VO2 max according to their fitness level test described previously. Subjects then sit quietly until either the next meal or the next exercise bout.; While in the calorimeter, each subject completes one exercise bout approximately 40 minutes in duration, at a predetermined speed and elevation, to achieve an intensity of 65% of VO2 max. Subjects then sit quietly until the next meal.; Participants will consume a high carbohydrate beverage (750 g) with the following composition: 2.13 MJ/d, 113g carbohydrate, 4g fat, 6g protein.; Participants will consume a high fat beverage (750 g) with the following composition: 2.11 MJ/d, 8g carbohydrate, 50g fat, 7g protein.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
A Case of Sesamoid Displacement Causing the First Metacarpophalangeal Joint Locking
Condition: Primary Disease
Study type: Observational

Summary: 
      Traumatic sesamoid displacement of the first metacarpophalangeal joint can affect thumb
      function.
    

Detailed description: 
      Although occurrence is rare, the mechanism of the displacement is commonly complex and
      varied. Understanding the mechanism is critical for treatment of the disorder. We herein
      present a locked thumb MCPJ caused by sesamoid displacement.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        1 person
      
Keywords: sesamoid displacement,; metacarpophalangeal joint,; radial condylar ridge of the metacarpal head.
Safety, PK and PD Study of ABX464 in Untreated HIV Patients
Condition: Human Immunodeficiency Virus Infections
MeSH terms: Infections; Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      ABX464 is a first in class that showed efficacy as an anti-HIV therapy. The present study is
      intended to assess the safety, the tolerability, and pharmacokinetic parameters and to
      evaluate the effect on viral load of repeated oral administrations of ABX464 in patients
      infected by HIV, not previously treated for their HIV.

      Two types of design are intended in this protocol: dosing every 3 days or dosing every day.
      The goal is to determine the best dosing regimen to reduce viral load and minimize adverse
      events.
    


Intervention name(s): ABX464; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 25, 50, 75, 100, 150 mg, i.e. 1, 2, 3, 4 or 6 capsules respectively, every 3 days or every day for 2 weeks; 1, 2, 3, 4 or 6 capsules respectively, every 3 days or every day for 2 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Food Effects on the Relative Bioavailability of Different Dosages of Risedronate
Condition: Postmenopausal; Non-lactating; Surgically Sterile
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, open-label, multi-center, 4-treatment, 4-period crossover study. The study will
      consist of a screening visit, study center admission (preceding Treatment Periods 1, 2, 3,
      and 4), 4 treatment periods (4 days each), 3 washout periods (14 to 17 days in duration
      separating each treatment period), and exit procedures.
    


Intervention name(s): risedronate; risedronate; risedronate; risedronate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): one risedronate 20 mg DR tablet; One risedronate 20 mg DR tablet; One risedronate 35 mg DR tablet; One risedronate 35 mg IR tablet
Intervention MeSH terms: Risedronic Acid; Etidronic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: bioequivalence