bioihbjkbjnl/mcl2 huggingface dataset:
Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex
Condition: Tuberous Sclerosis Complex
MeSH terms: Tuberous Sclerosis; Epilepsy; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Study design is a Phase IIb prospective multi-center, randomized, placebo-controlled,
      double-blind clinical trial. The goal will be to enroll 80 infants with Tuberous Sclerosis
      Complex who are less than 6 months of age prior to the onset of their first seizure
    

Detailed description: 
      The central hypothesis of this Phase IIb trial is that early identification of
      electroencephalography (EEG) biomarkers and early treatment versus delayed treatment with
      vigabatrin in infants with tuberous sclerosis complex (TSC) will have a positive impact on
      developmental outcomes at 24 months of age. It would also prevent or lower the risk of
      developing infantile spasms and refractory seizures. This preventative approach would be
      expected to result in more favorable long-term cognitive, behavioral, developmental and
      psychiatric outcomes and significantly improve overall quality of life. It is a randomized,
      double-blind, placebo-controlled clinical trial design. Successful completion of this trial
      will also advance the field by demonstrating the value of systematic surveillance with EEG in
      asymptomatic infants with TSC.
    

Intervention name(s): Vigabatrin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects randomized to vigabatrin in Arm A will be treated with vigabatrin 100mg/kg/day until 24 months of age or until they show evidence of clinical seizures or electrographic seizures on video EEG. If electrographic or clinical seizures occur while on study drug, they will transition into the Open label phase of the study (Arm B) and continue to be followed until 36 months of age.; Subjects randomized to placebo in Arm A will be treated with matching placebo at 100mg/kg/day until 24 months of age or until they show evidence of clinical seizures or electrographic seizures on video EEG. If electrographic or clinical seizures occur while on study drug, they will transition into the Open label phase of the study (Arm B) and continue to be followed until 36 months of age.
Other intervention name(s): Sabril
Intervention MeSH terms: Vigabatrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Medical Records Investigation of Whether Perioperative Dexmedetomidine Will Reduce the Duration of Mechanical Ventilation or Hospital Length of Stay in Patients Undergoing Minimally Invasive Cardiac Surgery
Condition: Mechanical Ventilation; Hospital Length of Stay; Minimally Invasive Cardiac Surgery
Study type: Observational

Summary: 
      The concept of enhanced recovery after surgery (ERAS) is utilizing in multiple specialties
      widely. Early tracheal extubation is one of the components of ERAS that enhances
      postoperative recovery and reduces the length of stay in intensive care unit
      (ICU).Dexmedetomidine is a highly selective, shorter-acting α2-adrenergic receptor agonist
      that has both analgesic and sedativeeffects.It was associated with decreased mortality, time
      to extubation, and hospital length of stay in cardiac surgical patients according to previous
      studies.The purpose of this study was to investigate the effect of perioperative
      dexmedetomidine on patients undergoing minimally invasive cardiac surgery(MICS) who were
      early extubated after surgery.
    


Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): perioperative dexmedetomidine infusion
Intervention MeSH terms: Dexmedetomidine
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients were eligible for inclusion if they had undergone minimal invasive off-pump
        coronary artery bypass graft (CABG), valvular surgery or combined procedures at Far Eastern
        Memorial Hospital, New Taipei City, Taiwan between January 1, 2020 and August 31, 2020.
        Additionally patients were included if they were aged 20 years or older and were excluded
        if it was emergency surgery, if they had postoperative mechanical ventilation more than 6
        hours or if they were extubated in the operating room.
      
Keywords: mechanical ventilation; hospital length of stay; dexmedetomidine; Minimally Invasive Cardiac Surgery
Resistance Exercise Reduces the Expression of Inflammation and Fibrosis Associated Genes in Autoimmune Myositis Patients
Condition: Myositis; Exercise
MeSH terms: Myositis
Study type: Interventional

Summary: 
      The aim of this study was to investigate the effects of physical exercise on gene expression
      in muscle biopsies from patients with chronic polymyositis or dermatomyositis
    

Detailed description: 
      Eight patients with polymyositis or dermatomyositis according to the Bohan and Peter criteria
      and who had all participated in a resistive exercise trial at Karolinska University Hospital,
      Stockholm, Sweden, were included in this study. Patients were included if they had a disease
      duration more than 12 months and they had to have a stable, low disease activity and
      medication for three months before enrollment in the study. Patients with inclusion body
      myositis were excluded as well as patients with co morbidities that contradicted vigorous
      exercise (severe osteoporosis with multiple fractures, malignant disease severe lung disease)
      or if they were physically active more than once a week. The median disease duration at time
      of study start was 4.5 years (range 2,7-29 year). All patients had been treated with
      glucocorticoids and other immunosuppressive therapies with some improvement of muscle
      function but with persisting muscle impairment. At time of study seven patients were still on
      immunosuppressive treatment, five were taking prednisone with a median dosage of 2.5 mg/day
      (range 0-6.25 mg/d). Six patients were treated with azathioprine, one in combination with
      cyclosporine A, one patient was treated with methotrexate and one with IVIG 2g/kg body weight
      every three months
    

Intervention name(s): exercise
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: microarray; Inflammtion; fibrosis
Trabecular Bone Score in Multiple Sclerosis
Condition: Multiple Sclerosis; Endocrine System Diseases; Neurologic Disorder
MeSH terms: Multiple Sclerosis; Nervous System Diseases; Endocrine System Diseases; Sclerosis
Study type: Observational

Summary: 
      Assess bone quality in MS patients through TBS and evaluate the potential effects exerted by
      different drugs used in MS treatment, which may affect BMD and TBS in MS patients
    


Intervention name(s): sm tbs group
Intervention type(s): Diagnostic Test
Intervention description(s): After collecting anthropometric data, information on environmental factors and lifestyle (smoking, alcohol intake, physical activity, sun exposure, vitamin D supplementation, fish consumption) will be acquired through a questionnaire.
The genetic and environmental aspects related to multiple sclerosis will also be studied. Disability status will be assessed through the Kurtzke Extended Disability Status Scale (EDSS). [10] All recruited patients will be administered the questionnaire (Multiple Sclerosis Quality of Life-54 (MSQOL-54) composed of 14 scales and 54 items. The scales investigate physical functions, limitations with respect to physical and emotional role, pain, emotional well-being, degree of energy, perceptions of one's health, social, cognitive and sexual functioning, distress, changes in health, satisfaction with sexual functioning and quality of life in general.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        300 subjects aged between 20 and 65, belonging to the MS Outpatient Clinic of the IRCCS
        Centro Neurolesi Bonino Pulejo will be recruited
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of this trial is to determine the effects of citicoline on cognitive
      performance for attention in healthy Men and Women compared to a placebo.
    

Detailed description: 
      This study is a 12-week, randomized, double-blind, placebo-controlled trial of citicoline in
      healthy men and women. Cognitive assessments will be performed to determine whether
      citicoline administration improves attention, compared to placebo administration.
    

Intervention name(s): Placebo supplement; Citicoline supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Cellulose; Cognizin®
Other intervention name(s): Placebo; Cognizin®
Intervention MeSH terms: Cytidine Diphosphate Choline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Healing Ointment Usage Post-surgical Procedure
Condition: Surgical Wound
MeSH terms: Surgical Wound
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate benefits of a Healing Ointment in skin improvement after dermatologic procedures
    

Detailed description: 
      This is an open-label, multi-center study to evaluate the safety and efficacy of a Healing
      Ointment in skin improvement after dermatologic procedures such as Mohs surgery, skin biopsy,
      excision on the head/neck or body.

      The study is designed to enroll approximately 20 subjects, in which 10 subjects undergo
      dermatologic procedure on the head/neck and 10 subjects on the body.

      Eligible subjects apply the test product twice daily after the procedure, followed by
      efficacy and tolerability assessments, standard photography, and self-assessment
      questionnaire at each follow-up visit.
    

Intervention name(s): Cetaphil Healing Ointment
Intervention type(s): Drug
Intervention description(s): Topical ointment application twice daily
Intervention model: Single Group Assignment
Intervention model description: Multi-center, open-label study
Masking: None (Open Label)
Primary purpose: Supportive Care
Study Assessing Immunogenicity and Safety of IC43 In Intensive Care Patients
Condition: Pneumonia, Ventilator-Associated
MeSH terms: Pneumonia, Ventilator-Associated
Study type: Interventional
Phase: Phase 2

Summary: 
      Randomized, placebo-controlled, partially blinded phase 2 pilot study. Multicenter study
      (approximately 50 centers) in approximately 9 countries. Proposed start date is December
      2008. The study duration per patient is estimated to be 90 days. Overall study duration is
      estimated to be 12-18 months.
    

Detailed description: 
      This is a randomized, placebo-controlled, multi-center, partially blinded [i.e., 100 mcg and
      200 mcg IC43 with Al(OH)3,, respectively] and placebo, but unblinded for non-adjuvanted IC43
      [i.e., 100 mcg w/o Al(OH)3] phase 2 pilot study. The study population consists of male or
      female ICU patients with a need for mechanical ventilation for more than 48 hours, aged
      between 18 and 80 years.
    

Intervention name(s): IC43; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): NaCl
Other intervention name(s): IC43 Pseudomonas Aeruginosa; phosphate buffered saline (PBS)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Compliance After Orthodontic Treatment Using Thermoplastic or Hawley Retainers
Condition: Orthodontic Retention Compliance
Study type: Interventional

Summary: 
      This study aims to assess adolescent's compliance after the end of orthodontic treatment
      using either thermoplastic or Hawley retainers in the upper arch, with the aid of TheraMon
      microsensor (MC Technology GmbH).
    


Intervention name(s): orthodontic appliance
Intervention type(s): Other
Intervention description(s): Orthodontic device for retention in the upper arch, after the end of orthodontic treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hawley; thermoplastic; orthodontic retention; compliance; vacuum- formed
Clinical Assessment of a Customized Free-form Progressive Addition Lens Spectacle
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      The purpose of this study was to compare objective clinical measures of visual performance
      and subjective measures of satisfaction and preference between standard progressive addition
      lens (PAL) spectacles and a new type of free-form surfaced, optically customized PAL
      spectacle.
    

Detailed description: 
      In a double-masked crossover trial, 95 experienced wearers wore customized free-form PAL
      spectacles (Test) and standard non-free-form PAL spectacles (Control) for one week each. All
      subjects wore both Test and Control spectacles, and the pair to be worn first was randomly
      assigned. At dispensing and after 1 week of wear, subjects were tested for distance and near
      visual acuity (VA) under both high and low contrast; in addition, 30 degree off-axis VA was
      measured using a novel apparatus, as was the horizontal extent of undistorted vision at
      reading distance. Subjects also completed a set of questionnaires detailing their
      satisfaction levels, adaptation times, and preferences for Test or Control spectacles for
      different visual tasks.
    

Intervention name(s): Standard, non-free-form, non-customized PAL spectacles; Individually customized free-form surfaced PAL spectacles
Intervention type(s): Device; Device
Intervention description(s): Control spectacles include several different PAL brands as selected by patients in the UC Berkeley Optometry Clinic and purchased in the Eyewear Center; after successful fitting and purchase, potential subjects were recruited for the trial.; Test spectacles are Zeiss Individual, free-form surfaced, and customized using the iTerminal device to account for individual back vertex distance, wrap angle and pantoscopic tilt
Other intervention name(s): Zeiss Individual, Carl Zeiss Vision, Inc., Germany
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Progressive addition lenses; Customized free-form; Presbyopia; Bifocals; Subjective assessment; Visual performance; Visual acuity; Amsler grid
Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)
Condition: Vesicoureteral Reflux; Urinary Tract Infections
MeSH terms: Urinary Tract Infections; Gastroesophageal Reflux; Vesico-Ureteral Reflux
Study type: Interventional
Phase: Phase 3

Summary: 
      In this 2-year, multisite, randomized, placebo-controlled trial involving 607 children with
      vesicoureteral reflux that was diagnosed after a first or second febrile or symptomatic
      urinary tract infecton, we evaluated the efficacy of Trimethoprim-Sulfamethoxazole (TMP-SMZ)
      prophylaxis in preventing recurrences (primary outcome). Secondary outcomes were renal
      scarring, treatment failure (a composite of recurrences and scarring), and antimicrobial
      resistance.
    

Detailed description: 
      This multicenter, randomized, double-blind, placebo-controlled trial was designed to
      determine whether daily antimicrobial prophylaxis is superior to placebo in preventing
      recurrence of urinary tract infection (UTI) in children with vesicoureteral reflux (VUR).
      Eligibility criteria are described elsewhere. Patients were randomly assigned to treatment
      for 2 years with daily antimicrobial prophylaxis (trimethoprim-sulfamethoxazole) or placebo.
      The study was designed to recruit 600 children (approximately 300 in each treatment group).
      The protocol encouraged prompt evaluation of children with UTI symptoms and early therapy of
      culture-proven UTIs. It was expected that approximately 10% of children will have to
      discontinue study medication due to allergic reactions. Assuming a 20% placebo event rate and
      10% non-compliance rate, the study has 83% power to detect an absolute 10% event rate in the
      antimicrobial prophylaxis group. If the placebo event rate is instead 25%, power is 97% to
      detect an absolute 10% event rate in the treated group, even if non-compliance is as high as
      15%. The primary analysis is intention-to-treat with missing outcome data analyzed as UTI.

      In addition to collecting follow-up data on urinary tract infections, renal scarring and
      antimicrobial resistance, quality of life, compliance, safety parameters, utilization of
      health resources, and change in VUR were assessed periodically throughout the study.
    

Intervention name(s): Trimethoprim-Sulfamethoxazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.; Cherry flavored liquid suspension matched to active comparator.
Other intervention name(s): Sulfatrim; Bactrim
Intervention MeSH terms: Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination; Sulfamethoxazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vesicoureteral Reflux; Urinary Tract Infections; Renal Scarring; Antibiotic Resistance; Controlled Clinical Trial; Trimethoprim-Sulfamethoxazole; Children
A Clinical Trial on the Efficacy of a Combination Herbal Product, Biotropics' Nu Femme, on Menopausal Symptoms and Quality of Life in Women
Condition: Menopausal Symptoms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effectiveness of an herbal combination product
      called Nu Femme, on menopausal symptoms in peri-menopausal women.
    


Intervention name(s): Nu Femme; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Combination product of Labisia pumila and Eurycoma longifolia extracts
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Menopausal symptoms; Peri-menopause; Nu Femme; Labisia pumila; Eurycoma longifolia; Hot flash; Joint pain
HCV Seek, Test and Rapid Treatment for Young PWID
Condition: Hepatitis C; Drug Use
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this randomized study is to determine whether a community-based test and treat
      model of hepatitis C (HCV) care delivery will be superior to the usual care practice of
      referral to specialist clinics for the outcomes of sustained virologic response at 12 weeks
      after treatment and initiation of HCV treatment for persons who inject drugs (PWID) between
      ages 18 and 29 who are naïve to HCV treatment
    

Detailed description: 
      ST&RT is a randomized open-label clinical trial in which 54 HCV infected PWID between ages 18
      and 29 will be randomized to either receive the same-day treatment initiation of the
      FDA-approved fixed dose combination of sofosbuvir 400mg and velpatasvir 100mg (SOF/VEL) with
      follow up and medical monitoring at a community site (Intervention arm) or to receive
      referral to an HCV treatment provider's office (Usual Care Arm).
    

Intervention name(s): Sofosbuvir and Velpatasvir
Intervention type(s): Drug
Intervention description(s): Sofosbuvir/velpatasvir (Epclusa) is an FDA-approved treatment for HCV. It is provided in the intervention arm as part of a rapid treatment strategy,
Other intervention name(s): Epclusa
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PWID
Relationship Between Spinopelvic Parameters and Clinical Symptoms of Low-grade Lumbar Isthmic Spondylolisthesis
Condition: Isthmic Spondylolisthesis
MeSH terms: Spondylolisthesis
Study type: Interventional

Summary: 
      This was a retrospective study.PI and LL greatly influence IS and its progression. However,
      relationships between the spinopelvic parameters and clinical symptoms of patients with IS
      were not fully investigated in previous studies. Investigators hypothesized that spinopelvic
      parameters might be related to the clinical symptoms of IS patients. Therefore, the purpose
      of the present study was to investigate whether differences in spinopelvic parameters,
      especially spinopelvic alignment, may be associated with the clinical symptoms of low-grade
      IS patients.
    

Detailed description: 
      Isthmic spondylolisthesis (IS) is one of the most common types of spondylolisthesis, and
      spinopelvic parameters are closely related to the clinical symptoms of spinal diseases. In
      this study, investigators attempted to investigate the relationship between spinopelvic
      parameters and clinical symptoms of patients with low-grade (Meyerding grade I-II) isthmic
      spondylolisthesis (IS).

      A total of 120 patients with low-grade IS and 106 asymptomatic adults were included in this
      study. Sex, age and body mass index (BMI) were also collected. Various spinopelvic parameters
      were evaluated in whole-spine standing-position X-rays. The following spinopelvic parameters
      were measured: pelvic incidence (PI), sacral slope (SS), pelvic tilt (PT) and lumbar lordosis
      (LL). The clinical symptoms of the IS patients were assessed with the Japanese Orthopaedic
      Association (JOA) score and the visual analogue scale (VAS). Investigators compared
      spinopelvic parameters between the asymptomatic adults and the IS patients. Additionally,
      investigators investigated correlations between spinopelvic parameters and clinical symptoms.
    

Intervention name(s): PI-LL
Intervention type(s): Radiation
Intervention description(s): The pelvic parameters were collected including PI, pelvic tilt (PT), sacral slope (SS) and LL ,and compared between IS patients and the AS group. Besides, spinopelvic malalignment was defined as an absolute value of PI-LL greater than 10.In the IS group,the clinical symptoms were assessed with the Japanese Orthopaedic Association (JOA) score and the visual analogue scale (VAS). We compared spinopelvic parameters between the asymptomatic adults and the IS patients. Additionally, we investigated correlations between spinopelvic parameters and clinical symptoms.
Other intervention name(s): PI-LL mismatch
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Isthmic Spondylolisthesis; Spinopelvic parameter; Clinical symptom; Pelvic incidence; Lumbar lordosis