bioihbjkbjnl/mcl2 huggingface dataset:
Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to characterize the safety of oxycodone hydrochloride (HCl)
      controlled-release (CR) tablets in opioid tolerant pediatric patients aged 6 to 16 years,
      inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid
      therapy.
    


Intervention name(s): Oxycodone HCl controlled-release tablets
Intervention type(s): Drug
Intervention description(s): Oxycodone HCl controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg - 240 mg daily) every 12 hours.
Other intervention name(s): OxyContin
Intervention MeSH terms: Oxycodone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malignant pain; Nonmalignant pain; Pediatric; Opioid; Moderate to severe malignant or nonmalignant pain
Efficacy and Functional Outcomes of Botulinum Toxin A Injections to Hamstrings in Flexed Knee Gait in Cerebral Palsy
Condition: Spastic Diplegic Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional
Phase: Phase 3

Summary: 
      The study proposes to determine if injections of BTX-A to the hamstring muscles result in
      measurable physiologic changes not observed with normal saline injections in children with
      spastic diplegic cerebral palsy who walk with a flexed-knee gait pattern.
    

Detailed description: 
      This study proposes to: (1) to determine if injections of BTX-A to the hamstring muscles
      result in measurable physiologic (body structure and body function) changes not observed with
      normal saline injections, in children with spastic diplegic CP who walk with a flexed-knee
      gait pattern; (2) to assess whether physiologic changes translate into functional (activity
      and participation) improvements; (3) to evaluate family's perception of change in function,
      activity, participation, and quality of life.

      This study will demonstrate if BTX-A injected into overactive hamstring muscles of children
      with spastic cerebral palsy (CP) and a flexed-knee walking pattern has measurable effects
      across the spectrum of dimensions of disablement of the International Classification of
      Functioning, Disability, and Health (ICF). It is a multi-center, prospective, randomized,
      double-blind trial comparing results of injection of BTX- A and placebo saline in controls,
      into overactive hamstring muscles, using multiple outcomes measures. Temporal-spatial gait
      parameters, instrumented 3DGA kinematics, passive ROM, spasticity measurement with both
      Ashworth and Tardieu scales, muscle strength/control, Gross Motor Function Measurement
      (GMFM), Pediatric Outcomes Data Collection Instrument (PODCI), Gillette Functional Assessment
      Questionnaire (FAQ), 6-Minute Walk Test, and Goal Attainment Scale (GAS), assessing all ICF
      domains, will be collected at baseline and at 1 month, 3 months, and 6 months post-injection.
      Power analysis demonstrates the need to randomize 250 children (125 with BTX-A, 125 with
      saline), allowing for attrition. Nine participating hospitals will contribute patients.
    

Intervention name(s): Botulinum Toxin A
Intervention type(s): Drug
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: cerebral palsy; spasticity; diplegia
Safety and Efficacy Study of ATGC-100 for the Treatment of Moderate to Severe Glabellar Lines in Adult Subjects
Condition: Moderate to Severe Glabellar Lines
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase I/II clinical trial will be integrated and conducted. In phase I clinical trial,
      subjects with moderate to severe glabellar lines at maximum frown are enrolled and safety is
      assessed after 12 weeks of administration of 20U of ATGC-100. In phase II clinical trial,
      subjects with moderate to severe glabellar lines at maximum frown are enrolled, and efficacy
      and safety are assessed by comparing with Botox (Allergan).
    


Intervention name(s): ATGC-100; Botox®
Intervention type(s): Biological; Biological
Intervention description(s): Clostridium Botulinum Type A; Clostridium Botulinum Type A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Executive Training and Anomia Therapy in Chronic Post-stroke Aphasia
Condition: Anomia; Post-stroke Aphasia
MeSH terms: Stroke; Aphasia; Anomia
Study type: Observational

Summary: 
      Aphasia is a devastating acquired language impairment mainly caused by stroke, in which
      anomia is a quintessential clinical feature. If speech-language therapy (SLT) has been shown
      to be effective for persons with aphasia, the relative efficiency of one SLT strategy over
      another remains a matter of debate. The influential relationship between language, executive
      functions and aphasia rehabilitation outcomes has been addressed in a number of studies, but
      only few of them have studied the effect of adding an executive training to linguistic
      therapies.The aim of this study is to measure the efficiency of a protocol combining anomia
      therapy and executive training on naming skills and discourse in post-stroke aphasic persons
      at the chronic stage
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Person with post-stroke aphasia at the chronic stage, receiving SLT rehabilitation
      
Keywords: Aphasia; Speech-Language Therapy; Anomia; Executive functions
Influenza Vaccination Among the Elderly Individuals
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Observational

Summary: 
      The aims of the study are to a) identify individuals with a poor response to influenza
      vaccination and b) identify factors associated with a poor response to influenza vaccination.
    

Detailed description: 
      This is a population-based prospective cohort study. Potential participants, males and
      females between 65 and 80 years of age, were selected randomly through the resident
      registration office in Hannover city, Germany and invited with a personalized letter to
      participate in the study.

      Initially, a blood sample (40 ml) will be drawn from each participant (day 0). Furthermore,
      participants will be vaccinated against influenza with FLUAD 2014/2015. FLUAD is a trivalent,
      surface antigen, inactivated influenza virus vaccine adjuvanted with MF59C.1. Additional five
      blood samples will be collected during the study period of four months (at days 3, 7, 21, 70
      and 130). Information about current and past infections, chronic diseases and basic
      sociodemographic data will be collected through a self-administered questionnaire.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Males and females aged 65 and 80 years from the general population
      
Keywords: Influenza vaccination; Elderly individuals; Prospective cohort study; response
Laser Acupuncture Versus Tap Water Iontophoresis on Hyperhidrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional

Summary: 
      the purpose of the present study is to assess the effect of laser acupoints on subjects with
      hyperhidrosis in comparison to tap water iontophoresis
    

Detailed description: 
      The study will be randomized control trial pre and post-experimental design. Anonymity and
      confidentiality of all procedures will be assured in compliance with relevant laws and
      institutional guidelines. All patients will sign two copies of a consent form before the
      beginning of data collection. Subjects will be recruited using publicly distributed posters
      and by online social media, subjects their hyperhidrosis examined by Hyperhidrosis Disease
      Severity Scale, Perceived Stress Scale. Recruited subjects will be randomly assigned to Laser
      Acupoint or Tap water iontophoresis groups. The participants and assessor will be blinded for
      the study hypothesis.
    

Intervention name(s): Laser Acupoint; Tap water iontophoresis
Intervention type(s): Device; Device
Intervention description(s): Step 1: The subject was in sitting position and exposure area for applying laser then therapist use tap measurement to find the point. Parameters was used in this study : PROBE :ML A1\25 TIME:01:00 FREQUENCY: 10000Hz (25mw), DUTY-CYCLE:100% DENESITY: 1J\CM2 AREA :1CM2 Step 2: Apply laser on acupuncture points by using 10000HZ for 1 minute for every point. Totally cession: 10 minutes Step 3: ensure that all point done Repeat all steps for every subject; Enough tap water is placed in the pans, then the generator is plugged in and switched on. After that, the patient's hands are placed in the pans.
The treatment is administrated by slowly increased intensity to tell the patient to feel a tingling sensation or up to 20 milliamperes and continue with this polarity for 10 minutes. After that, the polarity reversed and intensity increased again to the desired level for another 10 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Phase III Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy
Condition: Muscular Dystrophy, Duchenne
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 3

Summary: 
      The PolarisDMD study is a Phase 3, global study to evaluate the efficacy and safety of
      edasalonexent in pediatric patients with a genetically confirmed diagnosis of DMD. Male
      patients from 4-7 years of age (up to 8th birthday) will be enrolled.

      Edasalonexent is an orally administered small molecule that inhibits NF-kB, which is the key
      link between loss of dystrophin and disease pathology and plays a fundamental role in the
      initiation and progression of skeletal and cardiac muscle disease in DMD.
    

Detailed description: 
      The study includes a 52-week, randomized, double-blind, placebo-controlled period, followed
      by a 2-week follow- up. Approximately 125 boys with DMD will be enrolled in this trial, with
      2 boys receiving edasalonexent for every 1 boy receiving placebo.

      Following completion of the treatment period, patients may elect to continue in a separate
      open-label extension study.
    

Intervention name(s): Edasalonexent; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg/kg/day; Placebo
Other intervention name(s): Edasa; CAT-1004
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Muscular Dystrophies; Musculoskeletal Diseases; Neuromuscular Diseases; Duchenne muscular dystrophy; DMD; dystrophin; dystrophy; Duchenne
A Study Investigating the Efficacy and Safety of Upadacitinib (ABT-494) Given With Methotrexate (MTX) in Adults With Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study was to compare the safety and efficacy of multiple doses
      of upadacitinib versus placebo in adults with moderately to severely active rheumatoid
      arthritis (RA) on stable background methotrexate therapy who had not shown an adequate
      response to methotrexate alone.
    


Intervention name(s): Placebo; Upadacitinib
Intervention type(s): Drug; Drug
Intervention description(s): Tablets for oral administration; Tablets for oral administration
Other intervention name(s): ABT-494
Intervention MeSH terms: Upadacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Musculoskeletal Disease; Arthritis; Joint Diseases; anti-inflammatory agents; antirheumatic agents
Ticagrelor and Adenosine
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      Preclinical studies have shown that the P2Y12 receptor antagonist ticagrelor can increase the
      extracellular concentration of the endogenous nucleoside adenosine by inhibiting the cellular
      uptake of adenosine via the equilibrative nucleoside transporter (ENT). This mechanism can
      contribute to the beneficial effects and to the side effects (dyspnea) of ticagrelor in
      patients with an acute myocardial infarction. In the current research proposal, we aim to
      investigate whether ticagrelor increases adenosine receptor stimulation in humans in vivo by
      ENT inhibition.
    


Intervention name(s): Ticagrelor 180 mg single dose; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Endothelial function; Adenosine receptor stimulation
Pharmacokinetics of Voxilaprevir in Adults With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
Condition: HCV Infection
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the pharmacokinetics (PK), safety, and
      tolerability of a single dose of voxilaprevir (formerly GS-9857) in participants with normal
      hepatic function, moderate hepatic impairment and severe hepatic impairment. Participants in
      the healthy control group will be matched to participants with impaired hepatic function by
      gender, age (± 10 years), and body mass index (± 15%).
    


Intervention name(s): Voxilaprevir
Intervention type(s): Drug
Intervention description(s): 100 mg tablet administered orally
Other intervention name(s): GS-9857
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of 2% Chlorhexidine Gluconate in 70% Alcohol Compare 10% Povidone Iodine in Blood Culture in Children
Condition: Bacteremia
MeSH terms: Bacteremia
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the efficacy of 2% chlorhexidine gluconate in 70% alcohol compared with 10%
      povidone iodine in reducing blood culture contamination in pediatric patients.
    

Detailed description: 
      This is a prospective study of pediatric patients between 0-15 years of age who were admitted
      in three pediatric wards: general pediatric ward aged <5 years, general pediatric ward aged
      >5 years, and pediatric intensive care unit at a tertiary-care teaching hospital. Patients
      who needed percutaneous blood cultures were eligible for enrollment and were classified into
      two groups according to antiseptic used: 10% povidone iodine in odd months and 2%
      chlorhexidine gluconate in 70% alcohol in even months. Blood cultures were taken primarily by
      ward nurses using standard technique. The blood cultures were analysed and monitored for 5
      days. Isolated organisms and their antimicrobial susceptibilities were determined using
      standard microbiologic techniques.

      Blood culture isolates were categorized into two groups including a true pathogen and a
      contaminant by clinical criteria combined with laboratory data. A blood culture was
      classified as contaminated if common skin flora such as Coagulase negative staphylococci,
      Corynebacterium spp., Micrococcus spp., or Bacillus spp. were isolated from one of the blood
      culture samples without isolation of the same organism from another potential infection site
      (for example, intravenous catheter), or a common skin flora was isolated in a patient with
      incompatible clinical features and improved without specific treatment for that organism.
    

Intervention name(s): 2% chlorhexidine gluconate in 70% alcohol; 10%povidone iodine
Intervention type(s): Drug; Drug
Intervention description(s): skin preparation before venipuncture for blood culture in even month; skin preparation before venipuncture for blood culture in odd month
Other intervention name(s): Chloraprep; Betadine
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Povidone-Iodine; Povidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Blood culture; Contamination; Chlorhexidine gluconate; Povidone iodine
Study of CLAG + Selinexor in Relapsed or Refractory Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Selinexor has shown single-agent activity in a current phase I study enrolling patients with
      relapsed/refractory AML with durable complete remissions (CR), complete remissions with
      incomplete hematologic recovery (CRi), partial remissions (PR), and stable disease (SD)
      observed. Furthermore, common toxicities included nausea, fatigue, and anorexia and were
      manageable with supportive care agents. Additionally, CLAG chemotherapy has proven activity
      in relapsed and refractory AML, and has been shown to be a relatively well tolerated regimen
      without significant non-hematologic toxicity. Given the established role of CLAG
      chemotherapy, the single agent activity of selinexor, and their non-overlapping toxicities,
      the investigators propose a phase I/II open label study of selinexor in combination with CLAG
      for the treatment of patients with relapsed/refractory AML.
    


Intervention name(s): Selinexor; Cladribine; G-CSF; Cytarabine; Bone marrow biopsy
Intervention type(s): Drug; Drug; Drug; Drug; Procedure
Other intervention name(s): KPT-330; Leustatin®; 2-CdA; 2-Chloro-2'-deoxyadenosine; CdA; Chlorodeoxyadenosine; Plerixafor; Mozobil®; Cytosar-U ®; 1-β-Arabinofuranosylcytosine; Cytosine arabinoside; Ara-C; Bone marrow aspirate
Intervention MeSH terms: Cytarabine; Plerixafor; 2'-deoxyadenosine; Cladribine
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cardiopulmonary Resuscitation in Cases of Sudden Cardiac Arrest
Condition: Cardiac Arrest
MeSH terms: Heart Arrest; Death, Sudden, Cardiac
Study type: Interventional

Summary: 
      Determination the success rate of CPR on adults in Emergency room and predicting the factors
      that makes CPR is successful.
    

Detailed description: 
      Cardiac arrest is a medical emergency that requires immediate cardiopulmonary resuscitation
      (CPR). Return of spontaneous circulation (ROSC) is a core outcome element of cardiopulmonary
      resuscitation (CPR) both in out-of-hospital cardiac arrest (OHCA) and in-hospital cardiac
      arrest and has been considered a standard in the evaluation of successful resuscitation.

      ROSC was defined as a clinical assessment that shows signs of life comprising of a palpable
      pulse for at least 20 minutes or generating a blood pressure, the duration of ROSC is key
      element not only to the efficacy of the chain of survival but also to assess the success of
      resuscitation in emergency medical services (EMSs).

      Worldwide CPR outcomes vary due to differences in the circumstances of cardiac arrest,
      availability of equipment, and performance of the CPR team. The influencing factors of CPR
      outcome at the emergency room (ER) are patient characteristics, early detection, immediate
      CPR, initial shockable rhythm, duration of CPR of less than 10 minutes and advanced cardiac
      life support.

      In Egypt, There has been scarce studies regarding CPR and studies that measure the success
      rate of CPR and factors determining its success. This study aims to assess the success rate
      of CPR in Emergency room and factors predicting successful CPR on adults.
    

Intervention name(s): CPR
Intervention type(s): Procedure
Intervention description(s): CPR in cardiac arrest patients
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: CPR; Success Rate; Emergency medicine; Critical care; ICU and Pain Management
HYPOCHLOROUS ACID SUBSTANTIVITY AS ANTIPLAQUE AGENT (HOCl-SAP)
Condition: Hypochlorous Acid; Mouthwashes
Study type: Interventional
Phase: Phase 2

Summary: 
      Hypochlorous acid (HOCl) in a non-antibiotic antimicrobial agent used in clinical medicine.
      Nevertheless, its antiplaque oral effect has not been evaluated. Chlorhexidine (CHX) is the
      gold standard as an antiplaque agent for its high substantivity in plaque and saliva. There
      are no published studies evaluating the substantivity of hypochlorous acid compared to CHX.
      Objective: To evaluate the efficacy of mouthwashes of HOCl in substantivity evaluated by
      reduction of bacterial viability in saliva during 7 hours compared to CHX rinses and a
      placebo.
    

Detailed description: 
      Materials and Methods: A randomized, double-blind clinical trial with 75 participants was
      conducted. Participants were randomly assigned using block randomization in five groups: HOCl
      0.025% and 0.05%, CHX 0.12 and 0.2% and sterile water as placebo. Participants were
      instructed to use each rinse with 10 ml of each solution for 30 seconds after dental
      prophylaxis. Samples of saliva were taken at baseline and after 30 seconds, 1, 3.5 and 7
      hours to assess substantivity establishing the bacterial viability by the fluorescence method
      with the SYTO 9/propidium iodide dual staining. All participants were assessed with the
      Turesky visible plaque index at baseline and at 7 hours and adverse events were assessed. For
      the comparisons of the viability of the different rinses between times, the statistical test
      of generalized linear mixed model [GT1] adjusted to treatment, time and treatment-time
      interaction was used.
    

Intervention name(s): Hypochlorous Acid; Chlorhexidine; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Mouthwashes of antiplaque agents; A disinfectant and topical anti-infective agent used also as mouthwash to prevent oral plaque.; Sterile water as placebo
Other intervention name(s): HClO; Hypochlorous Acids; CHX; Placebos
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A double-blind randomized controlled trial with 75 participants was conducted. Participants were assigned using block randomization in five groups: HOCl 0.025% and 0.05%, CHX 0.12% and 0.2% and sterile water as placebo. Participants were instructed to use each rinse solution for 30 seconds after dental prophylaxis. Samples of saliva were taken at baseline and after 30 seconds, 1, 3.5 and 7 hours to assess substantivity establishing the bacterial viability by the fluorescence method.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypochlorous Acid; Chlorhexidine; Antiplaque agents; Substantivity