bioihbjkbjnl/mcl2 huggingface dataset:
Cannabidiol Expanded Access Study in Medically Refractory Sturge-Weber Syndrome
Condition: Sturge-Weber Syndrome
MeSH terms: Sturge-Weber Syndrome; Brain Stem Infarctions; Klippel-Trenaunay-Weber Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the tolerability and optimal dose of cannabidiol
      (CBD) as an simultaneous treatment in children and young adults with Sturge-Weber syndrome
      (SWS) and drug resistant epilepsy.
    

Detailed description: 
      We hope to gain an understanding of the utility of pure CBD used for the treatment of
      medically refractory epilepsy in SWS in this open-label, safety dose-finding, study. Recent
      evidence suggests that CBD has multiple, beneficial, effects in patients (such as those with
      SWS that undergo neurological deterioration) suffering from medically refractory seizures. We
      hypothesize that CBD will reduce seizure frequency in children and young adults with SWS and
      will therefore help stabilize and improve their neurologic status.This trial is part of an
      expanded access program, available through a partnership with GW Pharmaceutical, which has
      been sanctioned by the FDA to study the safety and efficacy of Epidiolex (cannabidiol/CBD) in
      participants with SWS and medically refractory seizures.
    

Intervention name(s): Cannabidiol
Intervention type(s): Drug
Intervention description(s): Initiation of treatment will begin with 2mg/kg/day. The dose will be increased by 3 mg/kg/day after seven days and then by 5 mg/kg/day every seven days up to a maximum dose of 25 mg/kg/day given.
The dose of concomitant antiepileptic drugs will remain unchanged during the first 12 weeks of CBD treatment (or until 8 weeks after steady state at final dose), unless symptoms of toxicity and/or significant changes in blood levels are observed.
Other intervention name(s): Epidiolex; CBD
Intervention MeSH terms: Cannabidiol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sturge-Weber syndrome; SWS; Drug resistant epilepsy
Sleep Quality, Daytime Sleepiness and Insomnia in Patients With Endometriosis: a Case-control Study.
Condition: Endometriosis; Sleep
MeSH terms: Disorders of Excessive Somnolence; Endometriosis; Sleepiness
Study type: Observational

Summary: 
      This study included women referred to two academic centres for the diagnosis and treatment of
      endometriosis (cases) and women referred to our Institutions because of routine gynaecologic
      consultations (controls). In this age-matched case-control study, the aimdy was to assess
      quality of sleep, the average daytime sleepiness and insomnia in patients with endometriosis
      by using three different self-reported questionnaires.
    


Intervention name(s): Pittsburgh Sleep Quality Index.; Epworth sleepiness scale.; Insomnia Severity Index.; The Endometriosis Health Profile.
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Pittsburgh Sleep Quality Index is an effective instrument used to measure the quality and patterns of sleep of patients. It allows evaluating "poor" from "good" sleep by assessing seven domains. A total score ≤ 5 indicated good sleep quality while a total score > 5 was indicated poor sleep quality.; Epworth sleepiness scale is an 8-item questionnaire developed to measure average daytime sleepiness. A total score ≥ 10 indicates excessive daytime sleepiness.; Insomnia Severity Index is a 7-item questionnaire developed to measure insomnia. A total score between 0 and 7 correspond to not clinically significant insomnia, between 8 and 14 to subthreshold insomnia, between 15 and 21 to clinical insomnia (moderate), between 22 and 28 to clinical insomnia (severe).; The Endometriosis Health Profile is a patient generated instrument that evaluates disease-specific health-related quality of life in patients with endometriosis. The questionnaire is administrable to all patients with endometriosis and it consists in 30 items divided in 5 domains (pain, control and powerlessness, emotional well-being, social support and self-image). Each scale for each domain is comprised between 0 (indicating the best health status) and 100 (indicating the worst health status).
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        In this study were recruited women referred to two academic centres for the diagnosis and
        treatment of endometriosis (cases) and women referred to our Institutions because of
        routine gynaecologic consultations (controls).
Study of Genes in Relation to Seasonal Affective Disorder and Major Depressive Disorder
Condition: Seasonal Affective Disorder
MeSH terms: Depressive Disorder; Mood Disorders; Seasonal Affective Disorder
Study type: Observational

Summary: 
      The investigators are looking for volunteers who have a history of Major Depressive Disorder,
      the Winter Blues, or Seasonal Affective Disorder or healthy volunteers who do not have a
      history of these disorders for a research study on genetics.
    

Detailed description: 
      The investigators are looking for volunteers who have a history of Major Depressive Disorder,
      the Winter Blues, or Seasonal Affective Disorder or healthy volunteers who do not have a
      history of these disorders for a research study on genetics. Participation involves one 2-3
      hour visit involving two diagnostic interviews, DNA collection, and questionnaires.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        community sample
      
Biospecimen description: 
      Saliva samples for DNA collection
    
Keywords: Seasonal Affective Disorder; Major Depressive Disorder; Depression; Winter Blues
Comparison of Perioperative Outcomes Between Energy Device During Laparoscopic Gastrectomy
Condition: Postoperative Inflammation; Postoperative Fever
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      To find out which instrument can be much better for laparoscopic gastrectomy among Harmonic
      scalpel, Ligasure Maryland, Thunderbeat

      comparing postoperative CRP level in each group
    

Detailed description: 
      To find out which instrument can be much better for laparoscopic gastrectomy among Harmonic
      scalpel, Ligasure Maryland, Thunderbeat

      comparing postoperative CRP level in each group

        1. post operative 2nd day CRP level

        2. post operative 4th day CRP level

        3. post operative IL-6, 10 level in 2nd, 4th day
    

Intervention name(s): ULTRACISION Harmonic Scalpel; Ligasure Maryland; Thunderbeat
Intervention type(s): Device; Device; Device
Intervention description(s): to use ULTRACISION Harmonic Scalpel when performing gastrectomy; to use Ligasure Maryland when performing gastrectomy; to use Thunderbeat when performing gastrectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: fever, inflammation
Ankle Instability Treatment in Patients With Chronic Ankle Instability
Condition: Ankle Injuries
MeSH terms: Ankle Injuries
Study type: Interventional

Summary: 
      Ankle joint self mobilization.
    

Detailed description: 
      The intervention would consist in the administration of self mobilization with movement
      techniques in patients with chronic ankle instability in addition to an exercise program
    

Intervention name(s): mobilization with movement techniques
Intervention type(s): Other
Intervention description(s): patient will receive an anteroposterior stimuli in the talus in order to restore the range of motion
Other intervention name(s): Joint mobilizations
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety, Pharmacokinetics and Pharmacodynamics of Single Rising Doses Oral BIRB 796 BS in Healthy Human Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating single
      doses, with and without a 64 g fat breakfast at one selected dose.
    


Intervention name(s): BIBR 796 BS; Placebo; high fat standardized breakfast
Intervention type(s): Drug; Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Montelukast Asthmatic Smoker Study (0476-332)(COMPLETED)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter study to evaluate the efficacy and safety of MK0476 versus placebo in
      participants with chronic asthma who actively smoke cigarettes.
    


Intervention name(s): montelukast sodium; Comparator: Placebo; Comparator: fluticasone; Comparator: Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): montelukast 10 mg tablet once daily, 6 month treatment period; fluticasone propionate 250 mcg Placebo (Pbo) twice daily, 6 month treatment period; fluticasone propionate 250 mcg twice daily, 6 month treatment period; montelukast 10 mg Pbo tablet once daily, 6 month treatment period
Intervention MeSH terms: Fluticasone; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacokinetics of Plasma Doravirine Once Daily Over 72 Hours Following Drug Intake Cessation in Healthy Volunteers
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the pharmacokinetics of plasma doravirine once daily over 72 hours following
      drug intake cessation at steady-state in healthy volunteers
    

Detailed description: 
      The administration of combination antiretroviral therapy (cART) to HIV-infected patients has
      been associated with a dramatic reduction in AIDS-related morbidity and mortality. The key to
      successful HIV drug treatment is adhering to the prescribed combination every day. The
      approval of single tablet combinations (STRs) provides HIV care providers with a "one tablet
      once a day" therapy, making adherence much easier for patients. However, in HIV therapy,
      successful adherence also means attention to intervals between doses or dietary restrictions.
      Ideally, to guarantee long-term virological response, HIV-infected patients should take their
      cART every day at the same time. However, cART is for life and doses can be forgotten or
      delayed. For this study 14 healthy volunteers will receive Pifeltro® (doravirine 100mg
      tablets) daily for 7 days to reach steady state. Following the last dose samples will be
      taken for pharmacokinetic testing over 72 hours.

      The incidence of adverse events between enrolment to the study (day 1) and last visit (day
      20-23) will be recorded.

      Blood, urine and faecal samples from study subjects will be taken for use in planned
      exploratory research and for use in future research:

      Analyses looking at genes which affect drug disposition (pharmacogenomics); the impact of
      doravirine intake on platelet function and markers of platelet and endothelial cell
      activation; metabolic changes associated with doravirine.
    

Intervention name(s): Doravirine
Intervention type(s): Drug
Intervention description(s): Non-nucleoside reverse transcriptase inhibitor. Administered as film coated tablet.
Other intervention name(s): Pifeltro
Intervention model: Single Group Assignment
Intervention model description: Single cohort pharmacokinetic (PK) study
Masking: None (Open Label)
Primary purpose: Other
Comparison of Robot-assisted Donornephrectomy vs Hand-assisted Laparoscopic Donornephrectomy
Condition: Kidney Donation; Robotic Surgery
Study type: Observational

Summary: 
      The aim of this retrospective study was to analyze donor and recipient outcomes after
      robotic-assisted donor nephrectomy and hand-assisted laparoscopic donornephrectomy.
    

Detailed description: 
      Living donor kidney transplantation is superior to cadaveric kidney transplantation because
      of the better patient and graft survival rates, better cost-effectiveness and improved
      quality of life of the recipient. According to the current guidelines, the laparoscopic
      technique of donor nephrectomy is now recommended as "the preferential technique". The
      advantages of the hand-assisted laparoscopic donor nephrectomy (HALDN) as compared with the
      conventional laparoscopy include tactile feedback, less kidney traction, rapid kidney removal
      and a shorter warm ischemic period. HALDN is nowadays the most frequently used technique in
      the U.S. for living donor nephrectomy. The laparoscopic techniques may have helped to
      increase the expansion of the donor pool. However, laparoscopic surgery have some
      disadvantages especially ergonomic inconveniences for the surgeon, which may result in
      decreased surgeons' performance and musculoskeletal disorders. Surgical robotics can play a
      role in extending surgical careers, by allowing surgeons to perform high volume laparoscopic
      surgery in a more ergonomic way. Robotic assistance in living donor nephrectomy can offer
      improved safety by enhanced control, accuracy, stability, and vision. The aim of this
      retrospective study was to compare the robotic assisted donor nephrectomy (RADN) with the
      HALDN technique with respect to donor and recipient outcomes.
    

Intervention name(s): Robotic surgery
Intervention type(s): Procedure
Intervention description(s): Robotic-assisted donornephrectomy
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Kidney donors
      
Keywords: Donornephrectomy; Robotic-asisted donornephrectomy; hand-assisted laparoscopic donornephrectomy
Bioavailability of PRUVIN® and Its Effects in Healthy Subjects (INDIGO)
Condition: Oxidative Stress
Study type: Interventional

Summary: 
      To evaluate the effect of different doses of PRUVIN® (N-acetylcysteine [NAC] and glycine) on
      reduced glutathione levels in healthy elderly subjects
    

Detailed description: 
      This is a single-center, double-blind, randomized, placebo-controlled 4-arm study-design, to
      assess the safety, tolerability and effect of PRUVIN® on reduced glutathione levels in
      healthy elderly (age 60-85 years) subjects.

      In addition, baseline values of glutathione precursors, glutathione, and plasma markers of
      oxidative stress in a healthy young cohort (non-interventional) will be compared with those
      of the healthy elderly cohort (interventional).
    

Intervention name(s): Pruvin R; Isomaltulose
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Combination of N-acetylcysteine an glycine; Placebo as comparator to intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, randomized, Placebo-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Glutathione
Use of Plasma Rich in Growth Factors (PRGF) in Pilonidal Sinus Excision
Condition: Pilonidal Sinus
MeSH terms: Pilonidal Sinus
Study type: Interventional

Summary: 
      The use of plasma rich in growth factors in wound excision pilonidal sinus could improve the
      healing process of the wound, when compared with the usual technique of daily local healing.
      The investigators propose the objective of evaluating the efficacy of intra- and
      postoperative application of plasma rich in growth factors, to reduce healing time and
      complications, arising from its removal, compared to the standard surgical treatment.
    

Detailed description: 
      prospective randomized control trial, comparing PRGF application vs daily local care(betadine
      +saline) in sinus pilonidal wound excision. PRGF is extracted from de patient blood and
      infiltrated in the pilonidal wound every week. this treatment is compared with betadine and
      saline wound care in terms of wound healing time, pospoperative pain and other complications.

      this study try to keeps the advantages of using open technique for pilonidal desease( low
      recurrence rate and surgical site infections) and improving the disadvantages (high wound
      healing time and postperative pain with wore quality of life) when it´s compared with direct
      closure or flap techniques.
    

Intervention name(s): sinus pilonidal excision+ PRGF; sinus pilonidal excision and standard cares
Intervention type(s): Procedure; Procedure
Intervention description(s): open sinus pilonidal excision and plasma rich grow factor infiltration intra and postoperatively; sinus pilonidal excision and postoperative standard care with povidone daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Clinical and Neurobiological Effects of Cannabis Dependence in Young Adults
Condition: Cannabis Dependence; Cannabis Withdrawal
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to find out more about cognitive functioning in people who are
      cannabis dependent, relative to people who do not use cannabis, and how their brains process
      information after one month of not using cannabis. An additional goal is to characterize the
      severity of cannabis dependence using precipitated and naturalistic withdrawal with a double
      blind, placebo controlled, single administration of rimonabant. Research assessments occur
      bi-weekly throughout this 28 day study.
    


Intervention name(s): rimonabant; placebo
Intervention type(s): Drug; Drug
Intervention description(s): double blind, placebo controlled, single 90 mg dose; matched placebo
Other intervention name(s): CB1 receptor antagonist
Intervention MeSH terms: Rimonabant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Cannabis Dependence; Marijuana Dependence; Cannabis Withdrawal; Rimonabant; cannabinoid receptor type 1 (CB1) inverse agonist; Neuropsychology; functional magnetic resonance imaging (fMRI); Endocannabinoids; Cortisol
Prevalence and Effect of Detecting Common Mental Disorders in Long-term Sickness Absence
Condition: Psychiatric Disorders; Common Mental Disorders; Depression; Anxiety; Somatoform Disorder
MeSH terms: Mental Disorders; Psychotic Disorders; Problem Behavior; Somatoform Disorders
Study type: Interventional

Summary: 
      The hypothesis was that a large fraction of individuals with common mental disorders were
      undetected in long-term sickness and that detection of the disorders by screening, a
      psychiatric diagnostic examination and feedback to the individuals, primary care, and
      rehabilitation officers improved return to work, improved quality of life and reduced
      psychological distress.
    


Intervention name(s): psychiatric examination and feedback
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sickness absence, return to work, psychiatric examination, feedback, psychological distress, quality of life, attrition analysis, multiple imputation
Study Of Fluticasone Propionate/Salmeterol In Asthmatic Subjects
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the present study is to investigate whether the effects of salmeterol in
      combination with fluticasone propionate on blood markers of airway inflammation are
      maintained after chronic dosing and whether the effect is influenced by the time of allergen
      challenge relative to the time of dosing.
    

Detailed description: 
      A 12-week, randomised, double-blind, placebo-controlled, three-period, cross-over pilot study
      comparing the effect of salmeterol/fluticasone propionate, fluticasone propionate and placebo
      on perpheral blood eosinophils and serum IL-5 in response to allergen challenge in asthma
      subjects when allergen challenge is administered at 1 hour or 11-12 hours post-dose of the
      dosing interval
    

Intervention name(s): FP; SFC; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fluticasone Propionate 100 mcg BD; Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD; Matching Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: asthma; allergen challenge; IL-5; eosinophils
Drug-drug Interaction Study of Ozanimod With Pseudoephedrine to Evaluate the Effect on Blood Pressure and Heart Rate
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of ozanimod after repeated dosing on
      blood pressure and heart rate response to a single-dose administration of pseudoephedrine
      (PSE) in healthy adult subjects.

      Study Design This is a Phase 1, randomized, double-blind, placebo-controlled study.
      Approximately sixty eligible subjects will be enrolled and randomized in a 1:1 fashion with
      30 subjects in each treatment group.

      Subjects will receive placebo or ozanimod once daily (QD) for 30 days. On Day 30, a single
      oral dose of pseudoephedrine (PSE) 60 mg will be co-administered with placebo or ozanimod.

      Study Population The study will enroll approximately 60 healthy men and non-pregnant,
      non-lactating women, ages 18 to 55 years, inclusive, with a body weight of at least 110
      pounds (50 kg) and body mass index within the range of 18.0 to 30.0 kg/m2, inclusive.

      Length of Study The study duration is 65 ± 2 days.
    


Intervention name(s): ozanimod; Pseudoephedrine; ozanimod placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ozanimod; Pseudoephedrine; ozanimod placebo
Intervention MeSH terms: Pseudoephedrine; Ephedrine; Ozanimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Ozanimod; Pseudoephedrine; Healthy Adult Subjects
Study of the Effectiveness of ETIASA® (Sustained Release 5-Aminosalicylate) in Maintenance Treatment of Ulcerative Colitis (UC)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Observational

Summary: 
      The purpose of the protocol is to assess the effectiveness of Etiasa® for preventing relapse
      in Chinese patients with quiescent UC.
    


Intervention name(s): Data collection
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary care clinic