bioihbjkbjnl/mcl2 huggingface dataset:
Does Immobilization of the Shoulder in External Rotation Reduce the Recurrence Rate of Shoulder Dislocation?
Condition: Shoulder Dislocation
MeSH terms: Joint Dislocations; Shoulder Dislocation; Recurrence
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Dislocation of the glenohumeral joint is the most common traumatic joint dislocation. The
      usual treatment of first time traumatic anterior dislocation of the shoulder is reduction
      followed by immobilization in a sling for a period of one to three weeks. The incidence of
      recurrence is high and age at the time of primary dislocation is the chief prognostic factor
      in determining the risk of recurrence. There is no agreement according to the effect of
      immobilization,neither to the length of immobilization time. The Bankart lesion with avulsion
      of the inferior-anterior capsulolabral complex is almost invariably present in patients with
      anterior shoulder dislocation. Recent and ongoing studies by Eijii Itoi et al,Akita
      university Japan, gives evidence of the immobilization with the arm held in external rotation
      may reduce the risk of subsequent instability by approximating the Bankart lesion to the neck
      of the glenoid giving a more anatomical healing. We have started a prospective randomized
      study. The patients are assigned to two groups with informed consent. One group are
      immobilized in internal rotation for 3 weeks and the second group are immobilized in external
      rotation for 3 weeks. We will compare the rate of relaxation between the groups. Because age
      is the main prognostic factor we use stratified randomization with two age groups: One group
      of patients aged between 16 and 24 years and one group aged between 25 and 40 years.The time
      of observation after initial treatment will be 2 years with follow up after 4 and 10 years.
      Eleven hospitals and two primary trauma care centers in Norway participate in the study. A
      subgroup of 50 patients are also planned to be examined with CT and MRI.
    

Detailed description: 
      See earlier protocol in 2005
    

Intervention name(s): Arm1:Immobilization in external rotation; immobilization in internal rotation
Intervention type(s): Procedure; Procedure
Intervention description(s): Immobilization in external rotation (ER) All patients in the ER group use a prefabricated shoulder immobilizer (Don Joy Ultrasling Er,15˚ version).To control the position,a line at the top of the immobilizer is to be parallel with the frontal plane when the arm is correctly placed in 15 degrees of external rotation.; All the patients in the internal rotation(IR) group are immobilized with their arm/shoulder in internal rotation by using a normal collar and cuff device.
Other intervention name(s): Immobilization in external rotation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: shoulder dislocation; anterior; traumatic; primary; first time; initial; immobilization; external; rotation
A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, parallel group, multicentre clinical study to evaluate
      the efficacy, safety, pharmacokinetics and immunogenicity of SB2 compared to Remicade in
      subjects with moderate to severe Rheumatoid Arthritis (RA) despite Methotrexate (MTX)
      therapy.
    


Intervention name(s): Remicade (infliximab); SB2 (proposed biosimilar to infliximab)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; Infliximab; Biosimilar
Text Message Quit Vaping Intervention for Young Adults
Condition: Tobacco Cessation
Study type: Interventional

Summary: 
      This research study, conducted by Truth Initiative, will help us learn how text messaging can
      help young adults between 18 and 24 years of age quit vaping.
    

Detailed description: 
      The Quit Vaping Study (QVS)'s primary aim is to conduct a fully powered comparative
      effectiveness trial to evaluate the effectiveness of a quit vaping text message program in
      promoting abstinence from e-cigarettes among young users aged 18-24. This study is a 2-arm
      randomized controlled trial conducted among young users aged 18-24 recruited through online
      channels. Participants will be randomized to a quit vaping text message intervention or to an
      assessment-only control condition and followed for 7 months to roughly correspond to 6-months
      post-treatment. The secondary aim is to examine potential mediators of program effectiveness,
      including treatment engagement and changes in self-efficacy and perceived social support for
      quitting.
    

Intervention name(s): This is Quitting; Assessment only Control
Intervention type(s): Other; Other
Intervention description(s): Text message-based intervention for quit vaping support.; Assessment only
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Arm 1: Intervention - Text message intervention Arm 2: Control - Assessment only
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: E-cigarette Cessation; Vaping Cessation; Mobile Intervention; Digital Intervention
Validity and Reliability of the WAL-K Test
Condition: Cerebral Palsy; Gait Disorders in Children
MeSH terms: Cerebral Palsy
Study type: Observational

Summary: 
      Adapting the environment in which a child with Cerebral Palsy lives or adapting himself
      according to the environment facilitates independence in daily life activities. There is a
      need for practical performance tests to evaluate the gait adaptation of children with
      cerebral palsy in the clinic. However, no study has been found to evaluate gait adaptation in
      children with cerebral palsy. Therefore, the aim of the study is to evaluate the validity and
      reliability of the WALK test, which was previously developed for children with special
      learning disabilities, in individuals with cerebral palsy.
    

Detailed description: 
      According to the International Classification of Functioning, Disability, and Health,
      physical, social, and behavioral environmental factors; can affect a child's disability,
      activity limitations, and participation. Adapting the environment in which a child with
      Cerebral Palsy lives or adapting himself according to the environment facilitates
      independence in daily life activities. There is a need for practical performance tests to
      evaluate the gait adaptation of children with cerebral palsy in the clinic. However, no study
      has been found to evaluate gait adaptation in children with cerebral palsy. Therefore, the
      aim of the study is to evaluate the validity and reliability of the WALK test, which was
      previously developed for children with special learning disabilities, in individuals with
      cerebral palsy. The study will be conducted by Afyonkarahisar University Faculty of Health
      Sciences.
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Participants will consist of children diagnosed with diparetic, hemiparetic, quadriparetic
        cerebral palsy with a functional level of 1, 2, or 3 according to Gross Motor Function
        Classification System (GMFCS) in Afyonkarahisar Special Education and Rehabilitation Center
        in Afyonkarahisar province.
      
Keywords: cerebral palsy; gait
Near Infrared Technology and Laparoscopic Resection of Pancreatic Lesions: the COLPAN Project
Condition: Pancreatic Neuroendocrine Tumors; Clear Cell Renal Carcinoma; Solid Pseudopapillary Tumors of the Pancreas
MeSH terms: Neuroendocrine Tumors; Carcinoma, Renal Cell; Kidney Neoplasms; Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether the use of Near-Infrared Technology can
      guide the laparoscopic resection of hypervascular neoplasms of the pancreas.
    


Intervention name(s): NIR
Intervention type(s): Device
Intervention description(s): Laparoscopic use of NIR
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Intravenous Remifentanil Plus Morphine or Morphine Alone for Postthoracotomy Pain
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Background; Post-thoracotomy pain remains a major problem. This double-blind, randomized
      study tested the effects of coadministration of patient controlled remifentanil+morphine
      combination on postthoracotomy pain, analgesic consumption and side effects compared with
      morphine PCA alone
    

Detailed description: 
      Methods; Sixty patients were allocated randomly to receive an intravenous patient-controlled
      analgesia with morphine alone (M), or morphine plus remifentanil (MR), in a double-blind
      manner. Postoperatively patients were allowed to use bolus doses of morphine (0.2 mg kg-1) or
      morphine (0.2 mg kg-1) plus remifentanil (0.2 µg kg-1) mixture every 10 min without a
      background infusion. Pain, discomfort, sedation scores, total and bolus patient-controlled
      morphine consumption, rescue analgesic requirement and side-effects were recorded for up to
      24 h after the start of patient-controlled analgesia.
    

Intervention name(s): Remifentanil+morphine
Intervention type(s): Drug
Intervention description(s): Morphine, Remifentanil+Morphine
Other intervention name(s): Morphine Group (M); Remifentanil+Morphine Group (MR)
Intervention MeSH terms: Morphine; Remifentanil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Postthoracotomy pain,; patient controlled analgesia,; remifentanil and; morphine.
Side Pole Static Ankle Foot Orthosis in Children With Neurological Disorders
Condition: Neurological Disorder
MeSH terms: Nervous System Diseases
Study type: Observational

Summary: 
      Transverse-plane foot deformities are a frequently encountered issue in children with
      neurological disorders. They are the source of many symptoms, such as pain and walking
      difficulties, making their prevention very important. It is thus important to prevent the
      occurrence of transverse-plane foot deformities and limit their development regarding the
      high risk of morbidity. In order to prevent such deformities, in the department of pediatric
      physical medicine and rehabilitation department of Lyon, since 2001 the investigator use a
      side pole static ankle foot orthosis (SPS AFO) in children with a neurological disorder
      predisposing such deformities. The aim of the study this study is to describe the use,
      tolerability and potential side effects of this orthosis in children with neurological
      disorders from the investigator's department
    


Intervention name(s): No intervention as it is a observational study
Intervention type(s): Other
Intervention description(s): No intervention as it is a observational study
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patient from the department of physical medicine and pediatric rehabilitation L'Escale
        (Lyon, France)
      
Keywords: Foot deformity; Orthopaedic management; prevention; side pole static ankle foot orthosis
Immunogenicity and Safety Study of a Single Prime-Boost Vaccination Schedule With a H5N1 Influenza Vaccine in Adults
Condition: Influenza; Avian Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The main objective of the study is to assess the immune response to a non-adjuvanted H5N1
      influenza vaccine in an adult population when administered according to a single prime-boost
      schedule.
    


Intervention name(s): Influenza vaccine (whole virion, Vero cell derived); Influenza vaccine (whole virion, Vero cell derived)
Intervention type(s): Biological; Biological
Intervention description(s): Dose A (Vietnam strain) for priming vaccination (Day 0) - Dose B (Indonesia strain) for booster vaccination (Day 360); Dose A (Vietnam strain) for priming vaccination (Day 0) - Dose A (Indonesia strain) for booster vaccination (Day 360)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Gene Therapy in Treating Patients With Advanced Recurrent or Persistent Ovarian Cancer or Primary Peritoneal Cancer
Condition: Ovarian Cancer; Peritoneal Cavity Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Inserting the p53 gene into a person's cancer cells may improve the body's ability
      to fight cancer or make the cancer more sensitive to chemotherapy.

      PURPOSE: Phase I trial to study the effectiveness of gene therapy using the p53 gene in
      treating patients with advanced recurrent or persistent ovarian cancer or primary peritoneal
      cavity cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the maximum tolerated dose and toxicities of intraperitoneal
      adenoviral p53 gene therapy in patients with advanced, recurrent, or persistent ovarian
      carcinoma. II. Evaluate the vector pharmacokinetics and biologic efficacy of gene transfer,
      gene expression, and cell death in these patients. III. Determine the immunologic response to
      therapy in these patients.

      OUTLINE: This is a dose escalation study of adenoviral p53 gene therapy. Patients undergo
      removal of ascites, if present, from the peritoneal cavity followed by a bolus infusion of
      adenovirus p53 once a week for 3 consecutive weeks, followed by a 2 week rest. Treatment
      continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
      Patients who experience palliative results with at least stable disease may continue
      treatment weekly without the rest period. Cohorts of 3-6 patients are treated at each level
      of adenovirus p53. The maximum tolerated dose is defined as the dose level below that at
      which 2 of 6 patients experience dose limiting toxicity. Patients who receive the MTD without
      unacceptable toxicity may continue to receive treatment on a weekly basis.

      PROJECTED ACCRUAL: Approximately 15-20 patients will be accrued over 16-18 months for this
      study.
    

Intervention name(s): Ad5CMV-p53 gene
Intervention type(s): Biological
Primary purpose: Treatment
Keywords: stage IV ovarian epithelial cancer; recurrent ovarian epithelial cancer; peritoneal cavity cancer
Accelerated Enhanced RECOVERy Following Minimally Invasive Colorectal Cancer Surgery (RecoverMI)
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The goal of this clinical research study is to learn if RecoverMI care can help to shorten
      the time that patients are in the hospital after surgery and if it can help them recover
      sooner.

      RecoverMI includes the following parts:

        -  Preoperative Education

        -  Early oral intake

        -  Early mobilization

        -  Telemedicine
    

Detailed description: 
      Study Groups:

      If you are found to be eligible to take part in this study, you will be randomly assigned (as
      in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one group
      is the same, better, or worse than the other group.

        -  If you are assigned to Group 1, you will receive standard enhanced care after your
           surgery.

        -  If you are assigned to Group 2, you will receive routine care after surgery, but you
           will also receive accelerated recovery, early discharge, and Telemedicine. Participants
           will be loaned an iPad to use for video-conferencing and text messaging in this study.

      This is an investigational study. The study doctor can explain how RecoverMI is designed to
      work.

      Up to 32 participants will be enrolled in this study. All will take part at MD Anderson.
    

Intervention name(s): Accelerated Recovery Plan; Early Discharge; Telemedicine; Standard Enhanced Care
Intervention type(s): Behavioral; Behavioral; Other; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Colorectal cancer; Colorectal cancer surgery; Polyp(s); Accelerated Enhanced Recovery; RecoverMI; Fluid diary; Questionnaires; Surveys; RecoverMI device
Amyloid Imaging And Safety Study Of Subcutaneous Bapineuzumab In Subjects With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study in individuals with mild to moderate Alzheimer's Disease is designed to assess:(1)
      safety and tolerability (2) the capacity of subcutaneous bapineuzumab to reduce brain amyloid
      load as measured by positron emission tomography (PET) scans.
    


Intervention name(s): Experimental Bapineuzumab
Intervention type(s): Drug
Intervention description(s): Bapineuzumab 2 mg, Bapineuzumab 7 mg, Bapineuzumab 20 mg, Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pragmatic Study Comparing the Clinical Evlauation Methods ( C) and / or Ultrasound Method ( B or D) in Rheumatoid Arthritis to Adapt Treatment
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      This study compares different methods of clinical evaluation (C) and/or ultrasound (B or D)
      concerning the rheumatoid arthritis in order to monitore the treatment. This study will
      provide the exact number of patients in remission according the 3 methods.

      It could allow to assess the concordance between the 3 evaluated methods. This study will
      permit to define the best method which limit the evolution of structural damages ( principal
      criteria).
    

Detailed description: 
      The aim of this study is to evaluate the Xrays evolution at 1 year ( at least one new erosion
      versus no erosion with the Sharp modified by van der Heijde) of patients affected by
      rheumatoid arthritis (ACR/EULAR 2010). The first approach is the assessment of remission
      defined by modified SDAI in order to evaluate in all cases the same number of joints
      [Simplified Disease Activity Index algebric sum of 5 parametres : number of painful joints
      (28 joints) , number of synovitis (38 joints), global evaluation of patient and and
      practitioner with VAS, and PCR ≤ 3.3mg/l] (mode C). The second one is a combined approach:
      clinical-ultrasound (same criteria but with MTPs and shoulders in B mode so a 26 joints
      evaluation with clinical examination and 12 joints evaluation in B mode) (mode B). The last
      one is an ultrasound approach (remission defined as the absence of power Doppler on 38 joints
      (28 of SDAI plus 10 MTPs joints) (mode D) in a pragmatical context (study assessed by private
      rheumatologists and hospital rheumatologists).

      This trial is a National randomized multicentre trial that compares three modes of follow to
      adjust the therapeutic adaptation in Rheumatoid Artritis.
    

Intervention name(s): Xrays; Ultrasound (B mode ); Ultrasound (D mode)
Intervention type(s): Device; Device; Device
Intervention description(s): Clinical evaluation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Rheumatoid arthritis / ultrasonography / synovitis
Treatment of Cartilage Lesions in Flanders Today
Condition: Lesion of Joint Capsule of Knee Region
Study type: Interventional

Summary: 
      The hypothesis of this study is to investigate whether surgical intervention is necessary for
      patients who suffer from cartilage lesions of the knee, or whether this surgical intervention
      can be avoided or postponed by using conservative treatment options such as physiotherapy,
      nutrition supplements, intra-articular injections, bracing.

      Forty patients suffering from cartilage lesions in their knee joint will be selected
      preoperatively. All these patients fulfil certain inclusion- and exclusion criteria. They
      will be asked to respond to 3 different questionnaires. These questionnaires include the
      visual analogue scale to evaluate pain (VAS), the Knee injury and Osteoarthritis Outcome
      Score or KOOS and the International Knee Documentation Committee (IKDC) form to evaluate the
      effect of their cartilage lesion on activities in daily life. Six months later +/- 20
      patients will have had surgery and +/- 20 patients will have had conservative treatment, both
      groups of patients will be asked to respond again to the 3 different questionnaires. The
      outcome of the results will tell us more of the evolution both between groups and in each
      group separately.
    


Intervention name(s): Surgery; Conservative comparator
Intervention type(s): Procedure; Other
Intervention description(s): Knee surgery; Kinesitherapy, intra-articular injection, wearing a brace, thermotherapy, intake of supplements.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Cartilage lesions in the knee joint
Herbal Treatment for Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and effectiveness of an herbal product
      for the treatment of attention deficit hyperactivity disorder (ADHD) in children and
      adolescents.
    

Detailed description: 
      ADHD is a common childhood disorder associated with concentration problems and disruptive
      behavior. Evidence suggests that herbal remedies may be as effective as standard drug
      therapies in treating ADHD symptoms. This study will determine the safety and efficacy of an
      herbal treatment in children and adolescents with ADHD.

      This study will last 9 weeks. Participants will be randomly assigned to receive either an
      herbal product or placebo three times a day for the duration of the study. Participants will
      come in for weekly study visits at which their ADHD symptoms and any side effects will be
      assessed by self-report rating scales.
    

Intervention name(s): Hypericum perforatum; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 300 mg capsule taken three times a day; 300 mg given three times a day, containing rice protein powder
Other intervention name(s): St. John's Wort
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adolescent; Child; Phytotherapy