bioihbjkbjnl/mcl2 huggingface dataset:
Heat and Moisture Exchanger and Low-flow Gas
Condition: Gynecological Surgery; General Anesthesia
Study type: Observational

Summary: 
      The aim of the present study was to measure the inspired gas temperature and humidity of the
      anesthetic circuit in the Dräger Primus machine and esophageal temperature with or without
      and heat and moisture exchanger (HME) and low-flow gas during anesthesia in patients
      submitted to gynecological surgeries.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Thirty adult patients scheduled to gynecologic surgeries were randomly assigned in two
        groups to received fresh gas flow of 1 l.min-1 with or without in circle anesthesia system.
        Relative humidity, absolute humidity, temperature of gases and esophageal temperature were
        measured at 15 min (T0)after respiratory circuit installation and then every 30 min up to
        120 min afterwards.
      
Keywords: low flow gas; Heat and moisture exchanger; Humidity; Temperature; Core temperature; Women
Obsessions and Suicidality in Youth With Bipolar 1 Disorder
Condition: Obsessions; Suicide; Bipolar I Disorder; Obsessive-Compulsive Disorder
MeSH terms: Suicide; Obsessive-Compulsive Disorder; Obsessive Behavior
Study type: Observational

Summary: 
      Obsessive-compulsive disorder (OCD) is a common co-morbidity with bipolar I disorder, a
      comorbidity that is known to increase suicide risk. This study aimed to assess the presence
      of OCD in youth diagnosed with bipolar I disorder & to evaluate the association between OCD
      and suicide in the same cohort.

      Eighty subjects diagnosed with bipolar I disorder were enrolled in this study, subjects were
      divided according to the presence or absence of OCD to Group A: Bipolar disorder patients
      with OCD (n = 26), Group B: Bipolar disorder patients without OCD (n = 54). The following
      scales were applied: Dimensional Yale-Brown obsessive compulsive scale (DYBOCS)- Beck scale
      for Suicidal ideations (BSSI) - Hamilton depression rating scale (HDRS) and Young mania
      rating scale (YMRS).

      The results revealed that DYBOCS score of group A was 30.23±0.43, & of group B was 18.50±1.88
      with a significant difference (p<0.01). There was a significantpositive correlation between
      BSSI and age, age of onset and YMRS in Group A (p<0.01).

      The study demonstrated that OCD is a common comorbidity in youth with bipolar I disorder and
      may be associated with a greater risk of suicide than in youth with bipolar I disorder
      without co-morbid OCD. Furthermore, co-morbidity of OCD with bipolar I disorder in youth may
      be associated with younger age of onset and more severe symptoms profile.
    


Intervention name(s): Psychometric assessment
Intervention type(s): Diagnostic Test
Intervention description(s): Eighty subjects diagnosed with bipolar I disorder were enrolled in this study, subjects were divided according to the presence or absence of OCD to Group A: Bipolar disorder patients with OCD (n = 26), Group B: Bipolar disorder patients without OCD (n = 54). The following scales were applied: Dimensional Yale-Brown obsessive compulsive scale (DYBOCS)- Beck scale for Suicidal ideations (BSSI) - Hamilton depression rating scale (HDRS) and Young mania rating scale (YMRS).
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Eighty subjects diagnosed with bipolar I disorder were enrolled in this study, subjects
        were divided according to the presence or absence of OCD to Group A: Bipolar disorder
        patients with OCD (n = 26), Group B: Bipolar disorder patients without OCD (n = 54).
      
Keywords: BSSI; DYBOCS; Bipolar disorder
VAXCHORA Pediatric Study to Assess Safety and Immunogenicity
Condition: Cholera (Disorder)
MeSH terms: Cholera
Study type: Interventional
Phase: Phase 4

Summary: 
      VAXCHORA (Cholera Vaccine, Live, Oral) is a vaccine indicated for active immunization against
      disease caused by Vibrio cholerae serogroup O1. VAXCHORA is approved for use in adults 18
      through 64 years of age travelling to cholera-affected areas. The primary goals of this Phase
      4 study are to evaluate the safety and immunogenicity of a single dose of VAXCHORA (1 x 10e9
      cfu/dose) in children ages 2 years to <18 years of age in developed countries.
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blind, single-crossover study with three age
      cohorts and two treatment groups within each cohort.
    

Intervention name(s): VAXCHORA (Cholera Vaccine, Live, Oral); Placebo
Intervention type(s): Biological; Other
Intervention description(s): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.; Placebo control for this study is normal (0.9%) saline.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This is a randomized, placebo-controlled, double-blind, single-crossover study with three age cohorts and two treatment groups within each cohort.
The main study consists of a screening period of 30 days, a treatment period from Day 1 to Day 29, and a follow-up period through Day 181. Cohort 1 has an optional sub-study consisting of a long-term follow-up period through Day 730.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Influence of GanedenBC30 (Bacillus Coagulans GBI-30, 6086) on the Gut Microbiome in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of a GanedenBC30, a probiotic bacteria
      (Bacillus coagulans strain GBI-30, 6086), on the gut microbiome in healthy adults. Subjects
      will complete a 2-week run-in period prior to receiving GanedenBC30. The study is open-label
      and subjects will act as their own controls as the microbiome is unique to individuals.
      During the run-in period, subjects will collect two stool samples and complete daily bowel
      habit diaries in order to understand usual habits and profile the microbiome for each
      subject. 30 subjects will take part in this research study conducted at Nutrasource
      Diagnostics Inc. Subjects will take GanedenBC30 for four weeks. Stool samples will be
      collected at the end of the study and daily bowel habit diaries maintained for the duration
      of the study.
    


Intervention name(s): GanedenBC30
Intervention type(s): Other
Other intervention name(s): Bacillus coagulans GBI-30, 6086
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety and Efficacy Study of MIS416 to Treat Secondary Progressive Multiple Sclerosis
Condition: Secondary Progressive Multiple Sclerosis
MeSH terms: Neoplasm Metastasis; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether MIS416 administered once weekly over 12
      months is safe, tolerable, and improves a range of signs and symptoms associated with
      secondary progressive multiple sclerosis.
    

Detailed description: 
      The primary objectives of the study are to:

        1. Determine the efficacy of MIS416, relative to placebo, when administered repeatedly via
           weekly intravenous (IV) administration to subjects with Secondary Progressive Multiple
           Sclerosis, as assessed by its effect on measures of neuromuscular function.

        2. Determine the safety and tolerability of a weekly regimen of MIS416.

      The secondary objectives of the study are to:

        1. Determine the effect of MIS416 on disease activity and neurodegeneration by assessing
           changes in Magnetic Resonance Imaging (MRI) markers including lesions, whole brain
           atrophy (WBA) and Magnetization Transfer Ratio (MTR).

        2. Determine the effect of MIS416 on Patient Reported Outcomes (PRO) related to disability
           and health status.

        3. Assess, in a subset of subjects, the pharmacodynamic (PD) effects of MIS416, including
           effects on serum, Peripheral Blood Mononuclear Cell (PBMC), and Cerebral Spinal Fluid
           (CSF) cytokine/chemokine levels and expression patterns.
    

Intervention name(s): MIS416; Saline
Intervention type(s): Biological; Drug
Intervention description(s): Intravenous administration weekly for 52 weeks; Intravenous administration weekly for 52 weeks
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: multiple sclerosis; SPMS
A Comparison of Hip Extension and Nordic Hamstring Exercise Programmes on Isokinetic Hamstring Strength
Condition: Hamstring Injury
Study type: Interventional

Summary: 
      This study aimed to compare the effect of two hamstring strengthening programmes on hamstring
      muscle strength in Gaelic footballers. 26 Gaelic footballers were recruited and randomly
      assigned to one of two 4-week hamstring strengthening programmes, namely the hip extension
      exercise programme and the Nordic hamstring exercise protocol. Isokinetic hamstring and
      quadriceps strength were measured before and after the intervention.
    

Detailed description: 
      Recruitment:

      Participants were recruited from the local university sports clubs. Club chairpersons were
      asked to send an email to club players. Players interested in participating in the study
      expressed an interest by replying to the email. Potential participants were asked to attend a
      meeting where they had the study explained to them. Those who were interested were then
      assessed for inclusion and exclusion criteria.

      Group allocation:

      A four block randomisation method was used to allocate participants to the Nordic hamstring
      exercise protocol or the hip extension exercise protocol.

      Interventions:

      The Nordic hamstring exercise protocol or the hip extension exercise protocol

      Testing procedure:

      The isokinetic strength of the participants' hamstrings and quadriceps were recorded before
      and after the exercise intervention.

      A 10 point visual analogue scale was used to record the level of muscle soreness experienced
      after each training session.
    

Intervention name(s): Nordic hamstring exercise; Hip extension exercise
Intervention type(s): Other; Other
Intervention description(s): The exercise protocol consisted of the following sets and repetitions Week 1 - 2 sessions with 2 sets of 6 repetitions. Week 2 - 2 sessions with 3 sets of 6 repetitions Week 3 - 2 sessions with 4 sets of 8 repetitions. Week 4 - 2 sessions with 4 sets of 10 repetitions.; The exercise protocol consisted of the following sets and repetitions Week 1 - 2 sessions with 2 sets of 6 repetitions. Week 2 - 2 sessions with 3 sets of 6 repetitions Week 3 - 2 sessions with 4 sets of 8 repetitions. Week 4 - 2 sessions with 4 sets of 10 repetitions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Hamstring strength; Isokinetics; Nordic hamstring exercise; Eccentric strength; Hip extension exercise
Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Children & Adolescents With Bipolar I Mania
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate
      (SEROQUEL) compared with placebo in the treatment of children and adolescent patients with
      Bipolar I mania.
    


Intervention name(s): quetiapine fumarate
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bipolar I Mania
Fluid Optimization in Liver Surgery
Condition: Cancer of Liver
MeSH terms: Liver Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to analyze hemodynamic changes, in patients undergoing liver
      resection, through the Vigileo/FloTrac system.
    

Detailed description: 
      To reduce bleeding, hepatectomies are performed with low central pressure (CVP) combined with
      extrahepatic control flow.

      This management can lead hemodynamic instability and reduction in oxygen delivery so an
      advanced monitoring should be used.

      This study analyzes hemodynamic changes, in patients undergoing liver resection, through the
      Vigileo/FloTrac system.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        In this study were enrolled patients scheduled for elective major hepatic surgery.
      
Keywords: intraoperative monitoring; fluid management
Analysis of in Vitro Biological Reaction of Diaphragmatic Prothesis When Congenital Diaphragmatic Hernia (CDH) Repair
Condition: Congenital Diaphragmatic Repair
Study type: Observational

Summary: 
      In case of CDH, the incomplete development of a part of the diaphragm allows abdominal
      viscera to herniate into thorax cavity during fetal development and impaired lung and heart
      development.

      After birth, CDH patients who survived thanks to an active reanimation management undergo
      diaphragmatic repair. In case of large defect, a patch is needed to complete diaphragmatic
      closure. Thanks to primary cell culture from foreskin, peritoneal epithelium or cremaster
      dedicated to incineration investigators want to analyse biological integration of actually
      used prothesis and others innovations.
    


Intervention name(s): Foreskin resection
Intervention type(s): Procedure
Intervention description(s): During the pediatric surgery consultation, the doctor will decide between Foreskin resection, orchidopexie or inguinal hernia repair.
Other intervention name(s): orchidopexie; inguinal hernia repair
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children that benefits of a foreskin resection, inguinal hernia repair or orchidopexy
Ocular Sarcoidosis Open Label Trial of ACTHAR Gel
Condition: Ocular Sarcoidosis; Panuveitis; Anterior Uveitis
MeSH terms: Uveitis; Uveitis, Anterior; Iridocyclitis; Panuveitis; Sarcoidosis
Study type: Interventional

Summary: 
      Treatment with ACTHAR Gel will result in a reduction of ocular inflammation in patients with
      active ocular sarcoidosis that requires systemic immunosuppressant therapy (hypothesis)
    

Detailed description: 
      The initial treatment of ocular sarcoidosis usually relies on a combination of topical
      glucocorticoids and oral glucocorticoids, both of which are associated with significant
      ocular and systemic toxicities. Steroid-sparing therapies are limited by variable and
      unpredictable efficacy, prolonged time until clinical response, medication intolerance, and
      difficulties obtaining payor approval. As a result, it is not uncommon that treating
      physicians must choose between excessive glucocorticoid toxicity versus poor control of
      ocular inflammation. Ongoing ocular inflammation, in turn, leads to eventual visual loss and
      occasionally blindness.

      There is a need for a more reliable, expeditious therapy that can be used as an alternative
      to glucocorticoids in sarcoidosis uveitis. Adrenocorticotropic hormone, through activation of
      melanocortin receptors on leukocytes, can dampen immune responses through non-glucocorticoid
      dependent mechanisms. The proposed study will aim to define whether there is effectiveness
      for ACTHAR gel in these patients, delineate an effect dosing regimen, and provide information
      about the safety of this approach for moderate to severe ocular sarcoidosis.

      ACTHAR is a 39-amino acid peptide natural form of adrenocorticotropin hormone (ACTH) that was
      initially approved in 1952 by the FDA. It has since been approved for 19 indications
      including respiratory sarcoidosis, multiple sclerosis, and infantile spasms.
    

Intervention name(s): Repository Corticotropin Injection; Repository Corticotropin Injection -Treatment Extension
Intervention type(s): Drug; Drug
Intervention description(s): Treatment with ACTHAR Gel for 24 weeks
Initial treatment with 80 units daily for ten days (induction phase)
Maintenance treatment with 80 units twice weekly (maintenance phase); 24 open label extension permitted in subjects who respond to treatment
Other intervention name(s): H.P. Acthar Gel; ACTH Gel; ACTH; H.P. Acthar Gel; ACTH Gel; ACTH
Intervention MeSH terms: Adrenocorticotropic Hormone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ocular Sarcoidosis
Impact of Evolocumab in Cardiac Transplant Patients With CAV
Condition: Heart Transplant
Study type: Interventional
Phase: Phase 2

Summary: 
      Coronary allograft vasculopathy (CAV) is diffusely accelerated atherosclerosis of a
      transplanted heart. Evolocumab (repatha) is an FDA-approved drug for lowering LDL in patients
      who have not received a heart transplant. This drug works as a PCSK9-inhibitor. The primary
      objective of this study is to measure the impact of PCSK9-inhibitors on serum LDL in heart
      transplant patients with CAV after 12 weeks compared to baseline.
    

Detailed description: 
      Heart transplant remains the treatment of choice for patients with advanced heart failure.
      Coronary allograft vasculopathy (CAV) is diffusely accelerated atherosclerosis of the donor
      heart, and limits long term survival after transplant. The pathophysiology of CAV is complex
      and involves smooth muscle proliferation, inflammatory infiltrates, and lipid deposition. To
      date, only statin therapy has reduced CAV-related mortality. PCSK9 inhibitors are a new lipid
      lowering therapy shown to reduce cardiovascular clinical events in patients with coronary
      artery disease. We hypothesize that PCSK9 inhibition via evolocumab will significantly lower
      LDL and be well-tolerated in transplant patients with CAV. This phase II, open label, single
      center trial with enroll up to 40 heart transplant patients with CAV for treatment with
      evolocumab for one year. The primary outcome will be percent change in LDL at 12 weeks.
      Secondary outcomes will include change in CAV progression, impact of evolocumab on
      immunosuppression regimens and transplant rejection, and change in serum lipids after 52
      weeks. Results of this study are intended to provide safety data in heart transplant patients
      with CAV and assess secondary outcomes including CAV progression and impact on
      immunosuppression and transplant rejection.
    

Intervention name(s): Evolocumab
Intervention type(s): Drug
Intervention description(s): Enrolled study participants will be treated with evolocumab (Repatha) 140 mg injected subcutaneously every 2 weeks for 52 weeks. All study participants will receive instruction on correct self-administration by research pharmacists. Study drug will be mailed to patients on a monthly basis for self-administration by patients. The evolocumab dose (140 mg every 2 weeks) will remain constant for the duration of the study. Side effects will be assessed on a quarterly basis. Serious adverse events considered related to treatment, death, and pregnancy will all result in immediate discontinuation of the study drug.
Other intervention name(s): Repatha
Intervention MeSH terms: Evolocumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: coronary allograft vasculopathy; lipid; heart transplant
Open Label of Clinical Trial of Sulforaphane in Children With Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label, 4-month study examining the effects of Sulforaphane (SF) on behavior
      in children with ASD and the correlation between behavior change and urinary metabolites. The
      goal is to determine a potential mechanism of action of SF in this population.
    

Detailed description: 
      Sulforaphane (SF) is an isothiocyanate found in high levels in crucifers belonging to the
      family Brassicaceae (including broccoli, cabbage, cauliflower, brussels sprouts, Chinese
      cabbage and turnips). Many previous studies have documented that consumption of these
      vegetables is associated with a reduced risk of cancer (lung, breast, colon, rectum, and
      prostate).(Juge et al. 2007) The mechanism of action of these beneficial effects is believed
      to be due to the ability of SF to up-regulate genes that improve cellular response to
      oxidative stress, inflammation, DNA-damaging electrophiles, and radiation.(Singh et al. 2014)
      In a recent small, randomized controlled trial in children with autism, SF was shown to have
      beneficial effects on aberrant and social behavior.(Singh et al. 2014) The mechanism of
      action of this beneficial effect has not been established in children with ASD. Our primary
      goal is to examine changes in urinary metabolites in children with autism who receive SF to
      determine if changes in behavior are associated with changes in urinary metabolites.
    

Intervention name(s): Sulforaphane
Intervention type(s): Dietary Supplement
Intervention description(s): Children with ASD will receive Sulforaphane in this study
Intervention MeSH terms: Sulforaphane
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment