bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness and Safety Study on Different Timing of Preventive Ileostomy Closure After Surgery for Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the appropriate timing to do preventive ileostomy
      closure after total mesorectal excision of rectal cancer. To evaluate the effectiveness and
      safety of preventive ileostomy closure at different time (12 weeks / 24 weeks after radical
      resection of rectal carcinoma). This study was expected to demonstrate that the early
      preventive ileostomy closure after total mesorectal excision of rectal cancer does not
      increase the risk of complications.
    

Detailed description: 
      A temporary stoma may, in fact, result in reduced quality of life because of feelings of
      physical and mental restriction, debilitating nuisance, among other problems. Skin
      irritation, prolapse, and retractionare quite common after ileostomy. A high incidence of
      parastomal hernia, ileus, and increased salt and fluid loss has been reported, which may also
      contribute to greater willingness of both the surgeon and patient to close the temporary
      stoma as soon as possible.

      Currently, it remains unclear whether stoma closure should be performed after the end of
      chemotherapy or during chemotherapy (12 weeks or 24 weeks after radical resection of rectal
      carcinoma).

      The aim of this study is to assess the possible impact of stoma closure timing on
      postoperative results and to evaluate that the early preventive ileostomy closure after total
      mesorectal excision of rectal cancer does not increase the risk of complications.
    

Intervention name(s): stoma closure at different times
Intervention type(s): Procedure
Intervention description(s): Early closure: stoma closure in 12 weeks after surgery for rectal cancer; Late group: stoma closure in 24 weeks after surgery for rectal cancer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Dose-ranging Pediatric Study of an Adjuvanted Pandemic Influenza Vaccine
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a pediatric dose-ranging study to evaluate the safety and immunogenicity of
      vaccination with different MF59-adjuvanted H5N1 vaccine formulations.
    


Intervention name(s): H5N1 antigen combined with MF59 adjuvant
Intervention type(s): Biological
Intervention description(s): Eligible subjects will be stratified by age at the time of enrollment into one of 2 age cohorts and within each age cohort will be randomly assigned (equally) to 1 of 6 study vaccine groups. Subjects in each study vaccine group will be scheduled to receive 2 injections of aH5N1 vaccine 3 weeks apart
Other intervention name(s): aH5N1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pandemic; Influenza; Vaccine; MF59; Adjuvant
Nilotinib in Cognitively Impaired Parkinson Disease Patients 001
Condition: Parkinson's Disease; Parkinson's Disease Dementia; Diffuse Lewy Body Disease
MeSH terms: Parkinson Disease; Lewy Body Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This pilot study will test Nilotinib's ability to alter the abnormal protein build up in
      Parkinson disease and Diffuse Lewey Body Disease patients . Patients will receive Nilotinib
      at different doses for 6 months. Patients will then be tested to see if there is change in
      three areas: 1) has the disease symptoms changed. 2) has levels of a specific misfolded
      protein changed in the fluid around their brain and spine. 3) Have inflammatory markers
      changed in the patient's blood and fluid around their brain and spine. If successful, this
      drug could be used to slow down or stop the progression of disorders that involve abnormal
      collection of misfolded proteins. However, the main purpose of this pilot study is to check
      for the safety of using this medication at this level.
    


Intervention name(s): Nilotinib
Intervention type(s): Drug
Other intervention name(s): Tasigna
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
RIMAG Study: Trial of Rituximab Versus Placebo in Polyneuropathy Associated With Anti-MAG IgM Monoclonal Gammopathy
Condition: Polyneuropathy
MeSH terms: Polyneuropathies; Paraproteinemias; Monoclonal Gammopathy of Undetermined Significance
Study type: Interventional
Phase: Phase 3

Summary: 
      Polyneuropathy associated with anti-MAG monoclonal IgM gammopathy is responsive of mainly a
      sensory deficit in predominantly males ,aged 40-70 years. Significantly high serum anti-MAG
      antibodies are linked with demyelinating features of the peripheral nerves.Rituximab, an
      anti-CD 20 monoclonal antibody is a new drug which reduces B-lymphocytes. This study will
      test the safety and efficacy of rituximab in the treatment of patients with anti-MAG
      polyneuropathy.
    

Detailed description: 
      Acting of a polyneuropathy for which there is not any treatment of reference today (see
      supra), a test of double-knowledge versus placebo is justified. Acting of a chronic
      polyneuropathy, the clinical evaluation must be led over one one year period. Acting of a
      sensitive polyneuropathy and the awaited benefit being the IMPROVEMENT OF the CLINICAL SIGNS,
      the principal criterion is a sensitive score in addition validated in chronic sensitive
      polyneuropathies immunodeficiency syndrome.

      The patients answering the criteria of inclusion and none inclusion (see V-2) will be
      randomized in 2 groups: the first group will receive a perfusion IV of rituximab to the
      amount of 375 mg/m2 of body surface, once per week, during 4 weeks (see VII-3); the second
      group will receive 4 perfusions IV of placebo according to same methods'. The evaluation (see
      VI-1) will be carried out at the time of the randomization, then repeated in 3 months, 6
      months, 9 months and 1 year.
    

Intervention name(s): Rituximab
Intervention type(s): Drug
Intervention description(s): Rituximab
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Anti-MAG monoclonal gammopathy; Polyneuropathy; Rituximab
A Study to Assess ACH-0145228 When Administered as Immediate Release Tablet Versus Powder-In-Capsule in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an open-label, 3-sequence, 3-period crossover study in healthy adult
      participants to assess the relative bioavailability of ACH-0145228 when administered as an
      immediate release tablet versus powder-in-capsule.
    


Intervention name(s): ACH-0145228: Immediate Release; ACH-0145228: Powder-in-capsule
Intervention type(s): Drug; Drug
Intervention description(s): ACH-0145228 (240 milligrams) will be administered orally on Day 1.; ACH-0145228 (240 milligrams) will be administered orally on Day 1.
Other intervention name(s): ALXN2050; ALXN2050
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This will be a 3-sequence, 3-period crossover study in healthy adult participants.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Factor D Inhibitor; Complement; Bioavailability; Tablet; Capsule
A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency
Condition: Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase IV, multicenter, open-label, single-arm study of somatropin (rDNA origin)
      (Nutropin AQ v1.1) in pre-pubertal children with growth hormone deficiency (GHD) naïve to
      prior recombinant human growth hormone (rhGH) treatment. The study is designed to
      characterize the immunogenicity profile of somatropin (rDNA origin) injection when
      administered daily subcutaneously for 12 months. The clinical impact of immunogenicity will
      also be assessed.
    


Intervention name(s): Somatropin
Intervention type(s): Drug
Intervention description(s): Somatropin will be administered as SC injections at a dose of up to 0.043 mg/kg/day. The dose may be adjusted for a change in body weight of at least (plus [+]/minus [-]) 2 kilograms (kg) from baseline at the Month 6 study visit or for a change in insulin-growth factor-1 (IGF-1), as per investigator assessment.
Other intervention name(s): Nutropin AQ v1.1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug Interaction Study Between AZD3480 and Aripiprazole in Healthy Subjects
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate if AZD3480 and warfarin interact with each other or
      not, i.e. show the same or altered plasma concentration profiles when co-administered
      compared to administered alone.
    


Intervention name(s): AZD3480; Placebo; Aripiprazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): AZD3480 capsules qd, oral, 22 days; Placebo qd, 12 days; single dose on day 5
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Alzheimer's disease; AZD3480; Aripiprazole
Cardiovascular Oscillations in Coronary Patients With and Without Type 2 Diabetes
Condition: Coronary Artery Disease; Diabetes Mellitus, Type 2
MeSH terms: Coronary Artery Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Coronary artery disease (CAD) and diabetes mellitus (DM) may promote alterations in heart
      responses during exercise or postural maneuver. Thus, the purpose of this study is to observe
      the influence of different postures (supine, seated and standing) and different percentages
      (15, 30, 45 and 60%) of the maximum voluntary contraction (MVC) of handgrip in the responses
      of heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean
      arterial pressure (MAP), cardiac output (CO), stroke volume (SV) and peripheral vascular
      resistance (PVR) in coronary patients with and without type 2 diabetes.
    


Intervention name(s): Isometric exercise
Intervention type(s): Other
Intervention description(s): The isometric protocol (handgrip) will be performed into 4 percentages of MVC (15, 30, 45 and 60%) to exhaustion in 3 postures (supine, seated and standing position). The percentages and the postures will be randomized. In the first day of exercise protocol the subjects will be at rest during 10 minutes and will perform 3 MVC during 5 seconds, with 5 minutes of recovery. The higher value of MVC will be used to prescribe the percentages. The subjects will perform two contractions until exhaustion in one posture in each day.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Isometric Exercise; Arterial Pressure; Autonomic Nervous System; Cardiovascular system; Posture
Pilot Study of Whole Body Vibration for Children With Cerebral Palsy (CP) From 12 Months of Age
Condition: Cerebral Palsy (CP)
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      Cerebral Palsy (CP) is the most common cause of physical disability in childhood. Up to day
      the investigators have treated children diagnosed cerebral palsy with side-alternating whole
      body vibration (System Galileo®) from the age of two years on. Considering verticalisation
      (standing and walking) at about 12 months of age in a normal developing child the
      investigators suggest the introduction of verticalisation with whole body vibration to a
      child with CP at this early age in order to enhance motor development and participation.

      In this pilot study the investigators will test the feasibility and the effect on motor
      development of whole body vibration in children with CP from 12 months of age. The
      investigators will investigate the effect of whole body vibration on motor performance,
      independence in all day living situations, quality of life and contractures compared to a
      control group.
    


Intervention name(s): Galileo® tilt table for children
Intervention type(s): Device
Intervention description(s): Two weeks of introduction and 12 weeks of training with side-alternating whole body vibration (WBV) (Galileo® tilt table)
Other intervention name(s): Novotec Medical, Pforzheim, Germany
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral Palsy; Whole Body Vibration; Infant; Motor development; Physiotherapy
Comparison of the Intraoperative and Postoperative Effects of Ultrasound-guided Erector Spina Plane Block and Posterior Quadratus Lumborum Block in Patients Undergoing Lumbar Stabilization Surgery
Condition: Postprocedural Analgesia; Opioid Consumption; Erector Spina Plan Block; Quadratus Lumborum Block
Study type: Observational

Summary: 
      The investigators aimed to compare the effects of ultrasound guided erector spina plan block
      and posterior quadratus lumborum block on intraoperative and postoperative opioid consumption
      in patients who will undergo short segment lumbar stabilization surgery.
    

Detailed description: 
      All participants will be monitored with ECG, SpO2, non-invasive blood pressure. In induction,
      1mg/kg 2% lidocaine, 2-3mg/kg propofol, 1mcg/kg fentanyl, 2mg midazolam, 0.6 mg/kg rocuronium
      will be used. Anesthesia depth will be monitored with BIS (bispectral index), and anesthesia
      will be maintained with 50% oxygen-air mixture and sevoflurane. After patient intubation,
      invasive artery cannulation will be performed on the non-dominant hand, and the patients will
      be placed in a prone position. 20 cc bupivacaine of 0.25% will be administered to both
      regions bilaterally, by following the rules of asepsis, with a 10 cm pajunk needle
      accompanied by USG, the needle site will be confirmed with 3 mm saline.

      BIS will be kept in the range of 40-50 throughout the case, and invasive arterial monitoring
      will be performed. 1 g paracetamol, 1 mg/kg tramadol and 4 mg ondansetron will be
      administered to the patients 30 minutes before the end of the surgery.

      After appropriate extubation and wakefulness, patients will be transferred to the
      postoperative anesthesia care unit (PACU), where they will be followed for 24 hours.

      An intravenous (IV) patient-controlled analgesia device (PCA) containing 100ml of tramadol at
      a concentration of 4mg/cc will be inserted. No infusion will be given, and the bolus dose
      will be set to 20mg, with a lock time of 20 minutes. In the postoperative period, 50 mg of
      dexketoprofen will be administered every 8 hours.

      VAS values, vital signs, and possible opioid side effects of the patients at 0, 1, 2, 6, 12
      and 24 hours will be recorded. After completing 24 hours, the patient will be separated from
      the IV PCA device and transferred to the service.
    

Intervention name(s): Peripheral nerve block
Intervention type(s): Procedure
Intervention description(s): Ultrasound guided peripheral nerve block
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who will undergo lumbar stabilization operation under general anesthesia in Ankara
        Bilkent City Hospital Operating Room, between the ages of 18-65, both genders, and in the
        ASA I-III risk group will be included in the study.
Sensitivity to Change of the Lower Extremity Functional Scale in Patients With Stroke
Condition: Lower Extremity Dysfunction; Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      The purpose of this study was to investigate the reliability, construct validity, and
      sensitivity to change of the Lower Extremity Functional Scale (LEFS) in individuals affected
      by stroke.
    

Detailed description: 
      The purpose of this study was to investigate the reliability, construct validity, and
      sensitivity to change of the Lower Extremity Functional Scale (LEFS) in individuals affected
      by stroke. Patients were measured with the LEFS at the beginning and end of physical therapy
      treatment, or at 8 weeks of physical therapy treatment.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Medically stable patients receiving inpatient or outpatient physical therapy care for lower
        extremity dysfunction due to stroke.
iPeer2Peer Pediatric Thoracic Transplantation
Condition: Solid Organ Transplant
Study type: Interventional

Summary: 
      With the on-going presence of a chronic illness, daily immunosuppressive medications, and the
      need for continuous medical supervision, pediatric transplant recipients face considerable
      psychosocial stresses. Treatment nonadherence is a major issue in pediatric transplantation
      and can lead to increased rates of hospitalization, rejection episodes, graft loss and death.
      An online peer support mentorship program (iPeer2Peer) is proposed as one intervention that
      could enhance patient care management, increase treatment adherence, reduce social isolation
      and improve health outcomes for this highly vulnerable population. The proposed trial will
      determine 1) implementation outcomes of the iPeer2Peer intervention in terms of: (a)
      feasibility and adoption, (b) acceptability and appropriateness and (c) level of engagement
      with the program, and 2) effectiveness of the iPeer2Peer intervention on improving health
      outcomes including disease self-management skills, treatment adherence, quality of life,
      perceived social support, stress and coping.
    


Intervention name(s): iPeer2Peer Support Mentorship Program
Intervention type(s): Behavioral
Intervention description(s): iPeer2Peer is an online peer support mentorship program that has been established in multiple chronic disease populations as a self-management intervention, including chronic pain and juvenile idiopathic arthritis. The iPeer2Peer program provides modeling and reinforcement by pre-screened and trained young adult peer mentors to adolescent mentees.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Peer Support Mentorship; Transplant; Pediatrics; Adherence
Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine
Condition: Migraine, With or Without Aura
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (25
      and 50 mg) compared to placebo for the acute treatment of a single migraine attack.
    


Intervention name(s): Ubrogepant; Placebo-matching Ubrogepant
Intervention type(s): Drug; Drug
Intervention description(s): Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.; Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety, Tolerability and Immunogenicity of the Candidate Vaccine MVA-SARS-2-ST Against COVID-19
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      Multi-center phase Ib study to evaluate the Modified Vaccinia Virus Ankara (MVA) vaccine
      against SARS-CoV-2 in seronegative (Part A) and previously SARS-CoV-2-vaccinated individuals
      (Part B).
    

Detailed description: 
      The vaccine contains a Modified Vaccinia Virus Ankara (MVA) vector expressing a stabilized
      SARS-CoV-2 spike protein (S).

      This will be a phase Ib multi-center study in approximately 60 adults aged 18-64 years.

      Part A (N=24 seronegative subjects). Each participant will receive two single injections, 28
      days apart.

        -  low dose ≥ 1 x 10e7 IU (N=8)

        -  middle dose ≥ 5 x 10e7 IU (N=8)

        -  high dose ≥ 1 x 10e8 IU (N=8)

      Part B (N=36 previously mRNA vaccinated subjects). Each participant will receive a single
      injection.

        -  low dose ≥ 1 x 10e7 IU (N=12)

        -  middle dose ≥ 5 x 10e7 IU (N=12)

        -  high dose ≥ 1 x 10e8 IU (N=12)

      All participants will be followed up for safety until D168.
    

Intervention name(s): MVA-SARS-2-ST
Intervention type(s): Biological
Intervention description(s): i.m. vaccine administration
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: MVA; SARS-CoV-2; vaccine; booster vaccination