bioihbjkbjnl/mcl2 huggingface dataset:
Pediatric Pelvic Injuries - Epidemiology and Demography
Condition: Pelvis Injury; Child, Only
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      A retrospective epidemiological study of pediatric pelvic injury from level 1 trauma centre.

      Hypothesis: In the pediatric population, majority of pelvic injuries is of type A according
      to AO/OTA (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association)
      classification, the treatment is mostly conservative and complications of injury and
      treatment are less common than in adults.
    

Detailed description: 
      Study design: Retrospective analysis (13 years), excluding pathological fractures. AO/OTA
      type, epidemiological data, mode of treatment, and complications were recorded. Data were
      analyzed using the Fisher exact test and the Wilcoxon test.
    

Intervention name(s): surgical treatment according to standard indication criteria; conservative treatment according to standard indication criteria
Intervention type(s): Procedure; Procedure
Intervention description(s): internal fixation according to standard indication criteria; conservative therapy according to standard indication criteria
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        358 patients (243 boys, 115 girls), mean age (SD) 14.1 ± 3.0 years
Peer Mentoring in Promoting Follow-up Care Self-Management in Younger Childhood Cancer Survivors
Condition: Cancer Survivor
Study type: Interventional

Summary: 
      This pilot trial studies a peer mentoring and online self-management program to see how well
      it works in promoting follow-up care self-management in younger childhood cancer survivors.
      Childhood cancer survivors require lifelong follow-up care to identify, monitor, and treat
      medical and psychosocial late effects stemming from their cancer, its treatment, and
      lifestyle factors. A peer mentoring program + self-management may improve disease knowledge,
      health motivation, problem-solving skills, stress management, and communication with
      caregivers and providers in adolescent and young adult cancer survivors.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Evaluate the feasibility of the self-management + peer mentoring program in a pilot trial.

      II. Assess preliminary outcomes of the peer mentoring program.

      OUTLINE:

      All Participants will be asked to complete online self-management educational modules and 6
      weekly peer mentor calls to facilitate engagement with the online modules and offer
      specialized support. We will also recruit and train peer Mentors.
    

Intervention name(s): Questionnaire Administration; Telephone-Based Intervention
Intervention type(s): Other; Behavioral
Intervention description(s): Complete interview; Complete the self management + peer mentoring intervention with videoconferencing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cancer Survivor; Young Adult; Peer Mentor
Study in Children to Evaluate the Immunogenicity and Safety of 4 Formulations of GSK Bio MenACWY-TT Conjugate Vaccine
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one
      dose of four different formulations of the MenACWY conjugate vaccine when given to healthy
      children aged 12 14 months and 3 5 years. The selection of the best formulation will be based
      on data obtained up to one month after the vaccine dose. The Protocol Posting has been
      updated in order to comply with the FDA Amendment Act, September 2007.
    

Detailed description: 
      The study will enrol subjects of 12 to 14 months of age and subjects of 3 to 5 years of age.
      Meningitec™ or Mencevax™ ACWY vaccine will serve as active control. The study will be
      conducted in two stages: The primary vaccination phase (Study Stage 1) of the study will
      include all subjects; the second (booster/persistence) phase of the study (Study Stage 2)
      will include subjects in the active control groups and in the group which was primed with the
      selected MenACWY formulation.
    

Intervention name(s): Conjugated meningococcal ACWY-TT (vaccine); DTPa/Hib containing vaccine; Meningitec; Mencevax ACWY
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): One intramuscular dose during the primary vaccination; One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age; One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age; One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (group E) and subcutaneous administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (group C, group E)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Safety; Reactogenicity; Immunogenicity; Meningococcal vaccine; Dose selection; Conjugate vaccine
Evaluating Subjective Well-being in Schizophrenic Patients Treated With quetiapineXR® and Other Atypical Antipsychotics
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      To evaluate the QOL (subjective effectiveness) in patients with schizophrenia, treated with
      atypical antipsychotics.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with schizophrenia treated with atypical antipsychotics (AAPs) to stay in
        remission
      
Keywords: Schizophrenia; remission; subjective well-being and effectiveness; Quality of Life
Electronic Chromoendoscopy for Polyp Characterization
Condition: Colorectal Polyp
MeSH terms: Polyps
Study type: Observational

Summary: 
      To assess the accuracy of predicting histology of colorectal polyps with electronic
      chromoendoscopy.
    


Intervention name(s): Prediction of Histology
Intervention type(s): Diagnostic Test
Intervention description(s): The accuracy of predicting the histology of colorectal polyps will be assessed with HD-WLE and EC
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing screening or surveillance colonoscopy
The Effects of a Mediterranean Diet in Pediatric Hyperlipidemia
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 1

Summary: 
      Children with high cholesterol levels are especially vulnerable and are at high risk for
      early onset coronary heart disease (CHD). Endothelial dysfunction, the earliest phase of CHD,
      is present in children with elevated cholesterol levels as early as 8 years of age. The long
      term objective of this study is to develop dietary interventions for the prevention and
      treatment of endothelial dysfunction in children with common lipid disorders including
      familial hypercholesterolemia (FH) and familial combined hyperlipidemia (FCH). Increasing
      evidence suggests that the Mediterranean diet and ω-3 fatty acids found in fish have
      cardioprotective effects. The specific aims of the study are to: determine whether a
      Mediterranean diet alone or combined with ω-3 fatty acid (eicosapentaenoic acid)improves
      endothelial function; evaluate the effects of the dietary interventions on lipids and
      lipoprotein subclasses; evaluate the effects of the dietary interventions on biomarkers for
      oxidative stress and inflammation. This study is a randomized, double-blind,
      placebo-controlled clinical trial that includes 34 children (ages 8-17) treated with the
      Mediterranean diet and ω-3 fatty acid supplements. A dietary educational behavioral
      intervention will be conducted over 6 months with individual counseling and group sessions.
      Endothelial function will be measured noninvasively by high resolution ultrasound of the
      brachial artery at baseline, 6, 12, 18 and 24 weeks. This study is unique because it is a new
      intervention designed for children at high risk for early CHD with a dietary component and
      supplementation with ω-3 fatty acids. If effective, this intervention would be broadly
      applicable in the community and lend valuable insight about dietary therapy to prevent the
      progression of CHD in hyperlipidemic children.
    


Intervention name(s): Omega-3 fatty acid (Eicosapentaenoic acid)
Intervention type(s): Dietary Supplement
Intervention description(s): 1.0 grams daily for 6 weeks
Other intervention name(s): PlusEPA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: endothelial function; lipids; pediatrics
Coronally Advanced Flap in Combination With Acellular Dermal Matrix and Enamel Matrix Derivatives for Root Coverage
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to compare the clinical outcomes of root coverage procedures, using
      coronally advanced flap in combination with acellular dermal matrix with or without enamel
      matrix derivatives .
    

Detailed description: 
      coverage of gingival recession defects has been considered as a matter of interest for dental
      practitioners.subjects with a paired gingival recession defect will be selected from the
      patients who sought dental treatment at our department.Random allocation of the treatment
      sites to test (CAF+ EMD+ADM) and control (CAF + ADM) groups will be performed by a person who
      is external to the study and using a computerized selection of random numbers for allocation
      of the study groups.The parameters of the study are as following items: probing depth( PD),
      clinical attachment level (CAL), width of keratinized tissue (WKT), recession depth from
      cemento- enamel junction (RD), recession width (RW), distance between mucogingival junction
      and the stent (MGJ), Plaque (PI) and gingival (GI) indices and root coverage percentage (RC)
      and the patients will be followed up for 6 months.
    

Intervention name(s): CAF+ADM+EMD; CAF+ADM
Intervention type(s): Procedure; Procedure
Intervention description(s): using coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) with enamel matrix derivatives (EMD).; using coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) without enamel matrix derivatives (EMD) for root coverage procedures.
Other intervention name(s): Alloderm®; Emdogain®; Alloderm®; Emdogain®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Coronally advanced flap; gingival recession; enamel matrix protein; acellular dermal matrix; root coverage
Evaluation of the Effectiveness of a SPA Therapy to "Neyrac-les-Bains" to the Old Subject (60-80 Years Old) With a Chronic Low Back Pain.
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      Low back pain is considered to be chronic if it has been present for longer than three
      months.

      This pathology is extremely frequent with an annual incidence between 5 in 10 % of the
      general population. Thus she is frequently met in general medicine, in particular to the
      ageing subject. It is the 2nd motive for consultation.

      The Chronic Low Back Pain is a mild pathology the forecast of which is in the favorable great
      majority of the cases but she pulled a socioeconomic cost mattering with a poly-consumption
      of care, in private individuals.

      The primary objective of this study is to determine the impact of a 3 months SPA Therapy on
      the Chronic Low Back Pain in older adults (from 60 to 80 years old) realizing a SPA Therapy
      of 3 weeks to "Neyrac-les-Bains".
    

Detailed description: 
      Realization of the protocol :

        1. Selection of the patients (realized during the consultation of programming in the
           beginning of the SPA Therapy). They are 2 thermal doctors of "Neyrac-les-Bains" (1
           general practitioner with formation of thermal medicine and a rheumatologist) which
           include the eligible patients in this study during the visit of the beginning of SPA
           Therapy.

        2. They will put back to the patients the Inform Consent Form, the Form of non-opposition
           and the 1st questionnaire (J0). The nurse of the SPA Therapy will be at their disposal
           to help them to fill the questionnaire if need.

      An urn will be arranged in the entrance hall of Neyrac- les-Bains to get back the filled
      questionnaires (J0 and J21).

      Patients will follow the conventional SPA Therapy of 3 weeks without a specific changes or
      modification of the care provided.

      Feedback :

      Assessments conducted by the using of self - questionnaires:

        -  Delivered in the issue of the visit of inclusion and at the end of the Spa Therapy ;

        -  Sent by mail at 3 and 6 months

      The expectations and fears will be evaluated by means of individual interview or focus
      groups. To avoid the biases bound to the questionnaire, the patients questioned in
      qualitative are different from patients receiving the questionnaire (not over the same period
      of SPA Therapy).
    

Intervention name(s): SPA Therapy
Intervention type(s): Other
Sampling method: Non-Probability Sample
Study population: 
        old subjects with a chronic low back pain
      
Keywords: Chronic Low Back Pain; Old subject; SPA Therapy; Pain; Function; Expectations; Fears
Bioavailability Study of Anti Nausea Medication With and Without Food
Condition: Nausea
MeSH terms: Nausea
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the effect of food on a single dose of EUR-1025 when taken with a
      meal and taken on an empty stomach.
    

Detailed description: 
      The objective of this study is to assess the effect of food on the pharmacokinetics of a
      single 24 mg dose of EUR-1025 administered as a novel modified-release capsule formulation
      under fed and fasting conditions.
    

Intervention name(s): Ondansetron
Intervention type(s): Drug
Intervention description(s): 24 mg one time
Other intervention name(s): EUR-1025
Intervention MeSH terms: Ondansetron
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Monoarticular Corticosteroid Injection Versus Systemic Administration in the Treatment of Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the efficacy and safety of intra-articular
      glucocorticoid injection to its systemic use for treatment of knee synovitis in patients with
      Rheumatoid Arthritis
    

Detailed description: 
      A randomized double-blind controlled study was conducted including 60 patients with RA.
      Patients were randomized to receive either a single intra-articular knee injection with
      triamcinolone hexacetonide 60 mg and xylocaine chloride 2% (1 mL) associated to a single
      intramuscular injection of 1 mL of xylocaine chloride 2% (IAI group) or 1 mL of xylocaine
      chloride 2% by intra-articular injection and a intramuscular injection of triamcinolone
      acetonide 60 mg and xylocaine chloride 2% (1 mL) (IM group). Evaluations were performed at
      baseline and 1, 4, 8 and 12 weeks post-intervention. The following instruments were used: the
      ACR 20%, 50 and 70% improvement criteria; VAS for knee morning stiffness, pain and edema;
      knee circumference and goniometry; Likert's scale of improvement (IVAS); daily use of oral
      glucocorticoid and NSAIDs, blood pressure and adverse effects.
    

Intervention name(s): intraarticular injection
Intervention type(s): Drug
Intervention description(s): Triamcinolone hexacetonide 60mg(3ml)by intraarticular injection Triamcinolone acetonide 60mg (3ml)by intramuscular administration
Other intervention name(s): Triancil®; Theracort®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; glucocorticoid; intraarticular injection; arthritis
Intraneural Facilitation as a Treatment for Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      We hypothesize that a standard course of INF can result in significant improvement in CTS as
      measured by clinical, electrodiagnostic, or ultrasound measures.
    

Detailed description: 
      INF is a novel non-invasive therapy based on the principle of restoring vascular function at
      the capillary level in peripheral nerve. his therapy has been shown to improve clinical
      function in patients with diabetic-associated polyneuropathy, a model for various forms of
      ischemic neuropathy. CTS is a common condition where regional compression at the wrist
      results in ischemic focal demyelination of the distal median nerve. This results in sensory
      dysfunction, pain, and eventually axon loss and weakness if the compression is sufficiently
      severe and prolonged. Standard therapy for CTS includes wrist splints, regional lidocaine
      injections, ergonomic adjustments, various forms of occupation therapy, and ultimately
      surgical release of the carpal tunnel ligament. However, all of these are either temporary in
      their effect or invasive. The diagnosis of CTS relies on clinical, electrodiagnostic or NCS,
      and ultrasound methods.
    

Intervention name(s): Intraneural facilitation (INF); Sham INF
Intervention type(s): Other; Other
Intervention description(s): INF is a novel non-invasive therapy based on the principle of restoring vascular function at the capillary level in peripheral nerve.; Will be performed by a different therapist than actual INF. The patient will be asked to do the following combination of passive range of motion (PROM) and active ROM activities to promote blood flow in the affected arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Tolerability of Human FSH Versus Recombinant FSH (Follitropin Alpha) in ICSI.
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      Purpose of the study is the comparative evaluation of the clinical efficacy and of the
      general tolerability of two different subcutaneous FSH preparations (Fostimon® IBSA Vs
      Gonal-F® Serono) when administered in patients undergoing ICSI
    

Detailed description: 
      This is a multicentric, prospective, randomised, investigator blind, controlled clinical
      trial (phase III) of two parallel groups, one receiving the test drug FSH (Fostimon® , IBSA)
      and the other the reference drug FSH (Gonal-F®, Serono). The groups will be paired on the
      major prognostic criteria.

      In effect, a double blind trial is not really feasible since the drugs presentations are very
      different. However, in IVF, drugs are usually dispensed and/or injected by a nurse and
      therefor the Investigator can be blind. Moreover, the used preparations will contain the same
      amount of gonadotrophin units (75 IU), will be repackaged in anonymous boxes and the
      following sentence will be written in the Patient Information Sheet: "You are required not to
      inform the Investigator about the product's name".

      The randomisation is necessary to get groups as comparable as possible for all the other
      aspects. The multicentric design has the double interest of facilitating the patients'
      recruitment and of decreasing the biases related to attitudes in a specific centre.
    

Intervention name(s): Follicle Stimulating Hormone; Follicle Stimulating Hormone
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection of FSH. Starting dose: 225 IU.; subcutaneous injection of FSH. Starting dose: 225 IU.
Other intervention name(s): highly purified human derived FSH; Fostimon; rec FSH; Gonal F
Intervention MeSH terms: Hormones; Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Ovarian stimulation; Infertility; ICSI; FSH
Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is a two-part trial consisting of Part A (presented in this record) and Part B
      (see NCT02047734).

      The primary objective in Part A of this study was to demonstrate the superior efficacy of
      ozanimod compared to placebo by showing a reduction in the cumulative number of total
      gadolinium-enhancing (GdE) lesions from Week 12 to Week 24 in patients with relapsing
      multiple sclerosis (RMS).
    


Intervention name(s): Ozanimod; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral capsule taken once a day; Oral capsule taken once a day
Other intervention name(s): RPC1063; Zeposia®
Intervention MeSH terms: Ozanimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment