bioihbjkbjnl/mcl2 huggingface dataset:
A Novel Patient Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest
Condition: Cardiac Arrest With Successful Resuscitation
MeSH terms: Heart Arrest
Study type: Interventional

Summary: 
      This study will test the feasibility and acceptability of deploying a decision aid for
      surrogate decision makers of comatose survivors of cardiac arrest early during
      hospitalization. This decision aid is to inform, educate and support decision makers charged
      with determining goals of care during post-cardiac arrest treatment.
    

Detailed description: 
      Survival and neurological recovery after out-of-hospital cardiac arrest are highly variable,
      driven in part by inconsistent hospital care following successful resuscitation.
      International guidelines for post-cardiac arrest care recommend delaying neurologic
      prognostication until 72-hours after resuscitation because early prognostication is imprecise
      and may precipitate inappropriate withdrawal of life sustaining therapy (WLST). Early WLST
      has been observed in-post cardiac arrest care. In order to encourage better guideline
      concordant care, the study proposes the implementation of an educational tool to support and
      inform surrogate decision makers in post-cardiac arrest care and neuro-prognostication. This
      pilot study will test the feasibility of implementing an educational tool for surrogate
      decision makers, the acceptability of such an intervention and early measures of knowledge
      translation. This study will inform the creation of a randomized controlled trial to test the
      ability of the tool to encourage guideline concordant timing of post-cardiac arrest
      neuro-prognostication.
    

Intervention name(s): Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest
Intervention type(s): Other
Intervention description(s): a decision aid has been created that is a four page document meant to support surrogate decision makers for comatose survivors of cardiac arrest
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neurologic Prognosis; Guideline Concordance; Surrogate Decision Makers
Evaluation of a School-based Programme Aimed at Promoting Well-being in Adolescents
Condition: Adolescent Well-Being; Resilience, Psychological
Study type: Interventional

Summary: 
      The aim of this pilot study is to evaluate a universal school-based multi-component
      intervention whose target is to build well-being and emotional resilience in adolescents.
    

Detailed description: 
      Adolescence is an important developmental phase for prevention and intervention initiatives
      for well-being and mental health. Accordingly, school has been recommended as an optimal
      location for such initiatives. Universal programmes - programmes that are designated for all
      individuals in a population - have a number of advantages, including reducing the risk of
      stigma and yielding high recruitment rates.

      A Lust for Life is a universal school-based multi-component intervention whose target is to
      build well-being and emotional resilience in adolescents. The programme was informed by
      evidence-based psychological approaches including cognitive behaviour therapy, positive
      psychology and mindfulness and consists of six lessons, each delivered by the adolescents'
      school teacher on a weekly basis. The lessons involve classroom discussions, videos,
      classroom activities and homework assignments.

      Study participants will complete the Adolescent Mental Health Continuum-Short Form,
      Connor-Davidson Resilience Scale-10, Emotional Literacy and Intervention Inventory-Pupil
      Checklist, and Mindful Attention Awareness Scale for Children at pre-intervention. Following
      this, schools randomly assigned to the experimental group will receive A Lust for Life, while
      those randomly assigned to the control group will be placed on a twelve-week waiting list.
      The questionnaire measures and a Brief Satisfaction Scale will be completed by participants
      at post-intervention. In addition, a six-week follow-up assessment will determine whether the
      effects of the programme are sustained over a period of time. The programme will be delivered
      in the waiting list control group schools after the six-week follow-up assessment.
    

Intervention name(s): A Lust for Life; Waiting list control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A Lust for Life is a universal school-based multi-component programme whose target is to build well-being and emotional resilience in adolescents. The programme was informed by evidence-based psychological approaches including mindfulness, cognitive behaviour therapy and positive psychology. It is delivered in six weekly lessons by the adolescents' school teacher and involves classroom discussions, videos, classroom activities and homework assignments.; Control group placed on a twelve-week waiting list.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sacroiliac (SI) Screws: The Effect of SI Screw Removal on Patient-Reported Pain and Functional Outcomes
Condition: Sacroiliac Joint; Pain; Pelvis
Study type: Interventional

Summary: 
      Chronic pain following surgical stabilization of a pelvic fracture is very prominent and can
      have a major affect on a patient's quality of life. Persistent pain after radiographic
      evidence of fracture union commonly leads to implant removal. But, the routine removal of
      orthopaedic fixation devices after fracture healing remains an issue of debate.
    

Detailed description: 
      Many surgeons remember patients whose intractable, hardly explainable local symptoms and
      complaints of pain resolved quickly after a hardware-removal procedure. However, implant
      removal requires a second surgical procedure in scarred tissue, poses a risk for nerve
      damage, infection and re-fractures, and is not a guarantee of pain relief.

      Rates of implant removal vary based on anatomic location and implant selection. Many studies
      have introduced and assessed the outcomes of hardware removal in the ankle, tibia and femur.
      But, there is currently no controlled trial that assesses the benefits and harms of
      sacroiliac (SI) screw removal in pelvic fracture patients.

      Reports in literature are not consistent concerning the incidence of painful hardware and the
      outcome and pain relief after hardware removal. There is conflicting evidence that removing
      hardware decreases acute pain in ankle, tibia, and femur fractures but there is a need to
      explore the effect of SI screw removal in pelvic fracture patients. The investigators propose
      to prospectively randomize patients with a pelvic fracture requiring the use of SI screws for
      stabilization to removal versus non-removal of SI screws and track which group has less pain
      and need for narcotic pain medications.
    

Intervention name(s): SI Screw Removal Surgery; Non-screw removal treatment (non-operative management)
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Screw Removal vs. Non-screw removal; Complications; SI Screw Stabilization
Exercise Protocols in Postural Balance Of Elderly Women
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      To determine and compare the effects of a training program with Pilates and Facilitation
      Neuromuscular Proprioceptive on balance and function in elderly women.
    

Detailed description: 
      Older women living in Teresina and participating in a local church project called "Pão dos
      Pobres" were randomly divided into three groups: Proprioceptive Neuromuscular Facilitation
      (PNFG), Pilates (PG) and Control(CG). Intervention: A training program (50 minutes session)
      was performed with the PNFG and the PG, 3 times a week, for 4 weeks. The elderly in CG
      suffered no intervention and continued with their daily activities. Main Outcome Measures:
      The stabilometric parameters, Berg Balance Scale score, functional reach test and Timed Up
      and Go test (TUG test) were measured before and one month after, in all participants.
    

Intervention name(s): training program
Intervention type(s): Other
Intervention description(s): Participants were randomly allocated to 1 of 3 groups: Pilates group (n=20), which underwent one-month (three times per week) training program with the Pilates method; PNF group (n=20), that underwent one-month (three times per week) training program using the PNF method; and Control group (n=18), that received no intervention during that one month and continued with their daily activities.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Physical activity; Rehabilitation; Older adults; Pilates; Proprioceptive neuromuscular facilitation
A Study to Assess Immune Response in Pediatric Kidney Transplant Recipients Treated With Daclizumab (Zenapax)
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will assess whether daclizumab impairs the ability of children receiving a kidney
      transplant to elicit a primary immune response. The anticipated time on study treatment is 1
      day, and the target sample size is 82 individuals.
    


Intervention name(s): DT; Daclizumab; KLH
Intervention type(s): Biological; Drug; Biological
Intervention description(s): Diphtheria and Tetanus Toxoid (DT) will be administered intramuscularly as a 1/3 dilution (0.33 flocculation units). The participants will be rechallenged with DT 6 months after Day 29 if failed to show >=1.5 fold increase in lymphocyte proliferative response but have a humoral response.; The fifth dose (1 milligram per kilogram [mg/kg]) of daclizumab will be administered in this study to participants who already received four doses (one dose at 1 mg/kg within 24 hours post-transplant and then every other week for 3 doses).; KLH will be administered intradermally with a dose of 250 mcg for participants aged 2 to less than 12 years, and 500 mcg for participants aged 12 to 19 years. The participants will be rechallenged with KLH 6 months after Day 29 if failed to show specified increase in lymphocyte proliferative response or humoral response.
Other intervention name(s): Zenapax
Intervention MeSH terms: Daclizumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Talampanel for Amyotrophic Lateral Sclerosis (ALS)
Condition: ALS
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy, tolerability and safety of oral
      administration of talampanel compared to a placebo in subjects with ALS.
    


Intervention name(s): Talampanel; Talampanel; placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): capsules Talampanel, 3 times per day, 52 weeks; capsules Talampanel, 3 times per day, 52 weeks; capsules, placebo, 3 times a day, for 52 weeks
Other intervention name(s): AMPA antagonist; AMPA antagonist
Intervention MeSH terms: alpha-Amino-3-hydroxy-5-methyl-4-isoxazolepropionic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ALS
Combination Chemotherapy in Hodgkin's Disease or Non-Hodgkin's Lymphoma Not Responding to Previous Treatment
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

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.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating
      patients who have Hodgkin's disease or non-Hodgkin's lymphoma that has not responded to
      previous treatment.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy of gemcitabine, dexamethasone, and cisplatin in patients with
           relapsed or refractory Hodgkin's disease or aggressive non-Hodgkin's lymphoma.

        -  Determine the qualitative and quantitative toxicity of this regimen in these two patient
           populations.

      OUTLINE: This is a multicenter study. Patients are stratified according to disease (Hodgkin's
      disease vs non-Hodgkin's lymphoma).

      Patients receive oral dexamethasone on days 1-4, cisplatin IV over 1 hour on day 1, and
      gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6
      courses in the absence of disease progression or unacceptable toxicity.

      Patients are followed at 4 weeks, 3 months, and then every 3 months thereafter.

      PROJECTED ACCRUAL: A total of 44-88 patients (22-44 per stratum) will be accrued for this
      study within 4-10 months.
    

Intervention name(s): cisplatin; dexamethasone; gemcitabine hydrochloride
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Dexamethasone; Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent adult Hodgkin lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult immunoblastic large cell lymphoma; anaplastic large cell lymphoma
Effect Of Power Breath Device On Arterial Blood Gases And Diaphragmatic Excursion After Valve Surgery
Condition: Heart Valve Diseases
MeSH terms: Heart Valve Diseases
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effect of power breath device on arterial blood
      gases, diaphragmatic excursion and the 6 min walk test after cardiac valve surgery.
    

Detailed description: 
      No more studies have been done on the effect of IMT by power breath on valvular surgery, So,
      this study will see the effect of power breath device on arterial blood gases, diaphragmatic
      excursion and six minute walk test after valve surgery to know enhanced recovery protocols in
      valvular surgery that accelerate the functional recovery, minimize the length of the hospital
      stay and decrease cost of treatment.
    

Intervention name(s): Power breath plus; Incrementing the training load; Diaphragmatic breathing exercises
Intervention type(s): Other; Other; Other
Intervention description(s): Power breath plus use a variable load calibrated spring. It can be adjusted from the lowest load setting (17cmH2O) when training began and increased as the patient breathing muscles adapt and become stronger (maximum load setting 274cmH2O). Use a comfortable chair, preferably straight-back so that the spine is straight at all times during the exercise. patients will be instructed to exhale calmly, followed by a maximal forced inspiration to total lung capacity using a mouthpiece and a nasal clip as an aid to prevent air leaks and will ask to make 10 breaths for 3 sets once daily for 7 days with 2min rest between sets; The resistance will be increased incrementally, based on the rate of perceived exertion (RPE) scored by the patient on the modified Borg Scale. If the RPE is less than 5, the resistance of the inspiratory trainer will be increased incrementally by 2cmH2O. The resistance will not change if the level of perceived exertion is rated from 6 to 8, and the resistance will be decreased by 1 to 2 cmH2O if the level of perceived exertion is rated 9 or 10.; Training by using incentive spirometer:
Loosen any tight clothing, especially around neck.
Each patient will be instructed to sit upright with placing incentive spirometer at the same level of his mouth to promote optimal lung expansion while using the spirometer.
The patient will be instructed to exhale letting all the breath out.
patient will asked to close the lips around the mouthpiece of the spirometer.
patient will be instructed to inhale slowly, breathing in until unable to do any more, this would raise the balls to the top of the column.
patient will be asked to hold the breath as long as possible (at least five seconds) then exhale slowly.
Session will be in the form of 30 times in sets, each set consist of 5-6 repetitions with rest 1 minute between sets.
Intensity of exercise will be increased by increasing time of session, time of holding the breath and numbers of repetitions according to patient's status.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Evaluation of Safety and Pharmacokinetics of Single Doses of VBY-376 in Healthy Adults
Condition: Chronic Hepatitis C Infection
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate the safety and pharmacokinetics of single doses of VBY-376 in healthy
      subjects.
    

Detailed description: 
      Single dose escalation study of 5 dose levels of VBY-376. Eight subjects per group will
      receive one dose of VBY-376 then have multiple blood draws for pharmacokinetic evaluation and
      followed for safety with laboratory evaluations, ECG's, vital signs, and adverse events.
      Safety data will be reviewed before proceeding to the next dose.
    

Intervention name(s): VBY 376
Intervention type(s): Drug
Intervention description(s): Doses of 50mg and higher or placebo will be evaluated.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: VBY-376 Hepatitis C pharmacokinetics safety
Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes
Condition: Pregnancy
Study type: Interventional
Phase: Phase 3

Summary: 
      DHA, a type of fatty acid, is important in early development, both in terms of reproductive
      physiology of gestation and in postnatal behavioral and cognitive function. In adults, DHA
      has been shown to lower triglycerides and is important to cardiovascular health and autonomic
      control, lowering heart rate and blood pressure and increasing heart variability. Little is
      known about how fatty acids impact cardiac control in infants, children or the fetus. Our
      hypothesis is that maternal DHA supplementation (600 mg/day) will lower fetal HR and increase
      fetal HRV.
    

Detailed description: 
      We have observed that maternal DHA supplementation during pregnancy results in lower fetal
      heart rate (HR) and higher heart-rate variability (HRV). In another study, we found that
      infants on DHA supplemented formula have lower HR. Because DHA supplementation in infancy is
      associated with improved neurobehavioral outcomes and infants with lower HR and higher vagal
      control have been found to have improved developmental outcomes, the first aim is to conduct
      a randomized, placebo-controlled trial to determine whether maternal DHA supplementation
      during pregnancy results in lower HR and higher HRV in the fetal period. We will document
      other fetal neurobehaviors (body and breathing movements) as they are hallmarks of fetal
      well-being and influence HR and HRV.
    

Intervention name(s): DHA; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Docosahexaenoic Acid (DHA) from algal oil; Placebo capsule
Other intervention name(s): Docosahexaenoic acid; Algal oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: DHA
Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline
      compared to placebo for smoking cessation. Abstinence from cigarette smoking and other
      tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period
      will also be evaluated.
    


Intervention name(s): varenicline tartrate (CP-526, 555-18); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg twice a day for 12 weeks, starting with a 1-week titration period.; matching placebo 1 tablet twice a day for 12 weeks
Other intervention name(s): Chantix, Champix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      An 18 months randomised double-blind study with two parallel arms with start dose of inhaled
      SERETIDE 50/100mcg BD or FLIXOTIDE 100mcg BD, Phase I is 6 months where the patient will be
      up-titrated until well controlled is achieved, After 6 months the treatment continues without
      changes during 9 months = PhaseII. The aim is to investigate and evaluate the assumption that
      the combination therapy with SERETIDE controls mild persistent asthma better than inhaled
      corticosteroids(FLIXOTIDE) alone.
    


Intervention name(s): Seretide; Flixotide
Intervention type(s): Drug; Drug
Intervention description(s): Seretide; Flixotide
Intervention MeSH terms: Fluticasone; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: asthma; exacerbation; persistent; bronchial hyperresponsiveness; mild; GINAII