bioihbjkbjnl/mcl2 huggingface dataset:
Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, double-blind, placebo-controlled study of oral cromolyn sodium when
      made into a viscous preparation for the treatment of eosinophilic esophagitis.
    

Detailed description: 
      Eosinophilic esophagitis is an antigen-mediated allergic disease of the esophagus
      characterized by symptoms of gastrointestinal complaints and eosinophilic inflammation
      limited to the esophagus. Currently, first line therapeutic recommendations include
      swallowed, topical steroids or dietary therapy. While both work for the majority of patients,
      they both have limitations.

      The investigators are examining the use of oral cromolyn sodium as a treatment for this
      condition. This medication is a non-steroid that is already approved for other conditions.
      When taken orally, it is essentially not absorbed systemically, so side effects are minimal.
      There is only 1 brief, retrospective report of its use in this condition suggesting it does
      not work. However, from studying swallowed, topical steroids, it may require formulating the
      medication into a viscous preparation for it to work.
    

Intervention name(s): oral cromolyn sodium; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral cromolyn sodium; Saline
Other intervention name(s): Gastrocrom
Intervention MeSH terms: Cromolyn Sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Neural and Pharmacological Correlates of Intrusions in Patients With Posttraumatic Stress Disorder
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      There is evidence that glucocorticoids have an impact on intrusive memories in patients with
      posttraumatic stress disorder (PTSD). Hydrocortisone impairs intrusive memory retrieval
      whereas dexamethasone should strengthen intrusions in PTSD. We, the investigators, want to
      investigate (1) the effect of these two glucocorticoids on traumatic memories and (2) assess
      the neural correlates using the script-driven imagery paradigm in the functional magnetic
      resonance imaging (fMRI) scanner. We hypothesize that intrusive memories are less intensive
      under hydrocortisone-administration and more intense under dexamethasone-administration
      comparing both to a placebo-condition. Regarding the neural activation pattern we expect
      higher activation in the hydrocortisone condition in the amygdala, the hippocampus and the
      medial prefrontal cortex compared to the placebo-condition and less activation in the
      dexamethasone-condition compared to the placebo-condition.
    

Detailed description: 
      There is evidence that glucocorticoids have an impact on intrusive memories in patients with
      posttraumatic stress disorder (PTSD). Hydrocortisone impairs intrusive memory retrieval
      whereas dexamethasone should strengthen intrusions in PTSD. We, the investigators, want to
      investigate (1) the effect of these two glucocorticoids on traumatic memories and (2) assess
      the neural correlates using the script-driven imagery paradigm in the functional magnetic
      resonance imaging (fMRI) scanner. Therefore an individual trauma-and an individual neutral
      -script is assessed from each participant, recorded and replayed during fMRI-scanning. We
      hypothesize that intrusive memories are less intense under hydrocortisone-administration and
      more intense under dexamethasone-administration comparing both to a placebo-condition.
      Regarding the neural activation pattern we expect higher activation in the hydrocortisone
      condition in the amygdala, the hippocampus and the medial prefrontal cortex compared to the
      placebo-condition and less activation in the dexamethasone-condition compared to the
      placebo-condition.
    

Intervention name(s): 10 mg HydrocortisoneHöchst; Dexamethasone; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 mg Hydrocortisone Höchst are administered one hour before fMRI scanning; 2 mg Dexamethasone are administered at 10 pm the day before the fMRI experiment.; Placebo
Other intervention name(s): HydrocortisoneHöchst
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Posttraumatic Stress Disorder; Traumatic Memories; fMRI
Erector Spinae Versus Paravertebral in Pediatric PCNL
Condition: Renal Stone; Percutaneous; Nephrolithotomy
MeSH terms: Kidney Calculi; Nephrolithiasis
Study type: Interventional

Summary: 
      To compare the efficacy of ultrasound-guided erector spinae plane block versus
      ultrasound-guided paravertebral block in pediatric patients undergoing percutaneous
      nephrolithotomy
    

Detailed description: 
      Percutaneous Nephrolithotomy (PCNL) is a commonly performed surgical procedure for complex
      upper renal tract calculi. Although the skin incision for PCNL appears small, the intensity
      of intraoperative and postoperative pain is significant owing to soft tissue injury.

      Erector spinae plane (ESP) block is an interfascial block that was first described by Forero
      et al. in 2016. It can be performed by injecting the local anesthetic in the deep
      interfascial plane of the erector spinae muscle to provide both visceral and somatic
      analgesia with a sensory level from T2-4 to L1-2.

      . Paravertebral block is the technique of injecting local anesthetics in a space immediately
      lateral to where the spinal nerves emerge from the intervertebral foramina. This technique is
      used increasingly for intra-operative and post-operative.
    

Intervention name(s): Erector spinae plane block; Paravertebral block
Intervention type(s): Procedure; Procedure
Intervention description(s): Ultrasound-guided erector spinae plane block; Ultrasound-guided paravertebral block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: paravertebral block; Erector spinae plane block; Percutaneous nephrolithotomy; pediatric
Randomized Controlled Trial of Vitamin D3 Supplementation for Viral Upper Respiratory Tract Infections (URI) Prevention
Condition: Viral Upper Respiratory Tract Infection
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Common Cold
Study type: Interventional

Summary: 
      Background: Vitamin D has been shown to be an important immune system regulator. Vitamin D
      insufficiency during the winter may cause increased susceptibility to infections,
      particularly viral upper respiratory tract infections (URIs).

      Objective: To determine whether vitamin D supplementation during the winter season prevents
      or decreases URI symptoms in adults.

      Methods: A randomized, double-blind, placebo-controlled trial was conducted in 162 adults.
      Participants were randomized to receive vitamin D3 50 mcg (2000 IU) daily or matching placebo
      for 12 weeks from December 2006 to March 2007. A biweekly questionnaire was used to record
      the incidence and severity of URI symptoms
    


Intervention name(s): Vitamin D3; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Vitamin D3 (cholecalciferol) 50 mcg (2000 IU) daily x 3 months; Placebo tablets
Other intervention name(s): cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Vitamin D; Viral URI; Influenza; Colds
A Six-Month Randomized Controlled Trial (RCT) of Probuphine Safety and Efficacy in Opioid Addiction
Condition: Opioid Dependency
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Probuphine (buprenorphine implant) is an implant placed just below the skin containing
      buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This study will
      confirm the efficacy of Probuphine vs. placebo and compare Probuphine treatment verses
      treatment with sublingual buprenorphine in the treatment of patients with opioid dependence.
    


Intervention name(s): Probuphine (buprenorphine implant); placebo implant; Buprenorphine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.; Implant contains ethylene vinyl acetate; sublingual buprenorphine/naloxone tablets
Other intervention name(s): Suboxone
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: opioid dependence; opioid addiction; buprenorphine; implant; methadone; heroin; suboxone; opioid pain medication; opioid withdrawal
Short-Stay Intensive Care for Coronary Artery Bypass Patients
Condition: Coronary Artery Bypass
Study type: Interventional
Phase: Phase 3

Summary: 
      Objective: To evaluate the safety and cost-effectiveness of Short Stay Intensive Care (SSIC)
      treatment for low-risk coronary artery bypass patients Design: Randomized clinical
      equivalence trial Setting: University Hospital Maastricht, the Netherlands Patients: low-risk
      coronary artery bypass patients Interventions: 600 patients were randomly assigned to undergo
      either SSIC treatment (8 hours Intensive Care) or control treatment (care as usual, overnight
      Intensive Care).

      Measurements: The primary outcome measures were Intensive Care (IC) readmissions and total
      hospital stay. The secondary outcome measures were total hospital costs, Quality of Life
      (QoL), postoperative morbidity and mortality. Hospital costs consisted of the cost of
      hospital admission(s) and outpatient costs.
    


Intervention name(s): Control group (usual care); Short-Stay Intensive Care treatment (SSIC)
Intervention type(s): Procedure; Procedure
Intervention description(s): control group, care as usual, 24 hours intensive care stay; Short-Stay Intensive Care treatment (SSIC), 8 hours of Intensive care treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study Of The Effects Of PF-04958242 In Subjects With Age-Related Hearing Loss
Condition: Hearing Loss, Sensorineural
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to examine the safety, tolerability, and effects on hearing
      thresholds of two single doses of PF-04958242 and placebo in subjects with age-related
      hearing loss.
    

Detailed description: 
      This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to
      Biogen.
    

Intervention name(s): PF-04958242; PF-04958242; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PF-04958242 0.35 mg oral solution; PF-04958242 0.27 mg oral solution; Placebo oral solution
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Age related sensorineural hearing loss; PF-04958242
Efficacy of Combined Treatment for Young Bipolar I Disorder
Condition: Bipolar I Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the efficacy of the combination of lithium and
      carbamazepine compared with lithium and valproate treating young bipolar patients.
    

Detailed description: 
      After the diagnostic assessments, the patients are allocated for one of the following groups
      of treatment:

      Group I: lithium + valproic acid

      Group II: lithium + carbamazepine

      Patients will be followed up for 8 weeks in phase I (acute treatment), 6 months in phase II
      (continuation treatment) and 12 months in phase III (maintenance treatment). Scales raters
      will be blind to the treatment.

      During phase II and III will continue only patients that achieve response, measured according
      to initial symptoms score in phase I.
    

Intervention name(s): lithium plus carbamazepine; lithium plus valproate
Intervention type(s): Drug; Drug
Intervention description(s): Lithium: Starting at 600 mg daily, dose weekly adjusted according to blood serum level (0,6 -1,2mEq/l), efficacy and tolerability.
Carbamazepine : Starting at 200mg daily and getting 600 mg daily at the end of the first week. Dose weekly adjusted according to blood serum level (8 and 12µg/ml), efficacy and tolerability; Lithium: Starting at 600 mg daily, dose weekly adjusted according to blood serum level (0,6 -1,2mEq/l), efficacy and tolerability.
Valproic acid: Starting at 500mg daily, dose weekly adjusted according to blood serum level (50 and 125µg/ml), efficacy and tolerability.
Intervention MeSH terms: Carbamazepine; Valproic Acid; Lithium Carbonate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: BD I
A Study of the Safety of and Immune Response to Varying Doses of a Vaccine Against COVID-19 in Healthy Adults
Condition: Virus Diseases
MeSH terms: Virus Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, reactogenicity and immune response of a
      self-amplifying mRNA (SAM) lipid nanoparticle (LNP) platform with severe acute respiratory
      syndrome coronavirus 2 (SARS-CoV-2) Spike antigen (CoV-2 SAM [LNP] vaccine) in ascending
      doses when administered intramuscularly (IM) on a 0,1-month schedule to healthy adults 18 to
      50 years of age. There will be no administration of escalated doses of the study vaccine.
    


Intervention name(s): 1 µg CoV2 SAM (LNP)
Intervention type(s): Biological
Intervention description(s): 2 doses of 1 µg CoV2 SAM (LNP) vaccine in 0,1-month schedule, administered IM in the deltoid of the non-dominant arm.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effects of Macronutrients on Hepatic Lipids, Plasma Triglycerides, and Insulin Sensitivity
Condition: Metabolic Syndrome X; Liver Diseases
MeSH terms: Liver Diseases; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to assess how the macronutrient composition of the diet effects

        -  lipid and glucose metabolism

        -  intrahepatic lipids

        -  insulin sensitivity

      in healthy lean subjects and in subjects with a high metabolic risk (ie overweight and
      offsprings of patients with type 2 diabetes mellitus).
    

Detailed description: 
      The study is aimed at assessing the effects of changes in total energy, sugars, lipids, and
      protein intake on intrahepatic lipids, plasma lipids, and hepatic and whole body insulin
      resistance in

        -  lean men and women with no family history of diabetes

        -  overweight men and women

        -  lean men with a family history of type 2 diabetes

      Subjects are studied after a 6-day period of

        -  isocaloric diet with 100% calorie requirement, of which 55% carbohydrate, 15% protein,
           and 30% fat)

        -  the same isocaloric diet supplemented with 3g/kg body weight/day fructose

        -  hypercaloric high fat diet with 130% energy requirement, of which 55% carbohydrate, 15%
           protein, 60% fat

        -  hypercaloric high fat+protein diet with 145% energy requirement, of which 55%
           carbohydrate, 30% protein, 60% fat

      Measurements performed after 6 days on each diet include

        -  intrahepatic and intramyocellular lipids (1H-MRS)

        -  hepatic and whole body insulin sensitivity (hyperinsulinemic-euglycemic clamp)

        -  body weight

        -  plasma concentrations of hormones and substrates

        -  gene expression profile in skeletal muscle (vastus lateralis) and adipose tissue
           (subcutaneous abdominal)
    

Intervention name(s): diet intervention
Intervention type(s): Other
Intervention description(s): controlled hypercaloric high fructose, high fat, or high fat/high protein diet
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: fructose; dietary lipids; dietary proteins; hepatic steatosis; insulin resistance; Healthy humans; overweight humans; obese humans
Vitamin D Binding Protein (Gc) Allele Variation Effects Response to Vitamin D Treatment
Condition: Vitamin D Status
Study type: Observational

Summary: 
      We have just completed a randomized, clinical trial of 100,000 IU Vitamin D3 given as a
      single dose at the beginning of winter. We found a wide range of responses to the dose. This
      study proposes that genetic differences account for some of the variation in response of
      25(OH)D levels after treatment with oral Vitamin D.
    

Detailed description: 
      We suspect that the wide range of response is effected by other factors such as variation in
      Vitamin D binding protein (the major transporter of Vitamin D metabolites).

      Gc, also known as Vitamin D binding protein (DBP), group specific component, or Gc globulin,
      is a 52-58 kDa multifunctional plasma protein, synthesized in the liver. The gene encoding
      for Gc is located on chromosome 4, and three common co-dominant alleles give rise to three
      phenotypes (Gc1s, Gc1f, and Gc2). Gc binds actin, recruits neutrophil leukocytes and converts
      into a macrophage- and osteoclast- activating factor. It also is the major transporter of
      Vitamin D and its' metabolites. Lauridsen et al. showed that Gc phenotype correlates with
      25(OH)D levels in a group of postmenopausal women.

      This study proposes that Gc phenotype accounts for some of the variation in response of
      25(OH)D levels after treatment with oral Vitamin D.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        This study will include thirty males and females who took part in a previous study of a
        single oral dose of vitamin D.
      
Keywords: Viatmin D, 25-hydroxyvitamin D, Vitamin D binding protein
Relationship Between Dietary Protein Intake and Fatal and Non-fatal Health Outcomes
Condition: Cardiovascular Diseases; Cancer; All-cause Mortality
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      The aim of the current study was to clarify the relationship between protein intake and
      health by using a very large, general population cohort study, UK Biobank, to study the
      associations between reported protein intake (expressed in g/day, g/kg/day and % of total
      energy intake) and three health outcomes (all-cause mortality, incidence CVD and cancer).
    


Intervention name(s): None as this is an observational study
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Recruitment from the general population
Evaluation of Intraoperative Lagophthalmos Formula
Condition: Ptosis, Eyelid
MeSH terms: Lagophthalmos; Blepharoptosis; Prolapse
Study type: Interventional

Summary: 
      This is a prospective non-randomized study to evaluate the recent intraoperative
      lagophthalmos formula method for levator resection in determining postoperative eyelid height
      in congenital ptosis on Egyptian children. included 20 eyelids from 17 Egyptian children with
      congenital ptosis with levator function of 4mm or better, they underwent levator muscle
      resection guided by the recent intraoperative lagophthalmos formula
    

Detailed description: 
      This is a prospective non-randomized study to evaluate the recent intraoperative
      lagophthalmos formula method for levator resection in determining postoperative eyelid height
      in congenital ptosis on Egyptian children. The study included 20 eyelids of 17 Egyptian
      children with congenital ptosis with levator function of 4mm or better, they underwent
      levator muscle resection guided by the recent intraoperative lagophthalmos formula.

      Preoperative MRD 1 (Margin-to-reflex distance 1) and levator function were measured, then
      intraoperative palpebral fissure opening was determined from formula: Intraoperative
      lagophthalmos=9.08 - 0.48×Preoperative MRD1 - 0.26× Levator function. Postoperative MRD 1 was
      measured after 1 day, 1week,1month, 3 months and 6 months .Success was defined as
      postoperative MRD 1 ≥ 3 mm and difference between both eyelids height ≤ 1 mm at 6 months.
    

Intervention name(s): Levator muscle resection
Intervention type(s): Procedure
Intervention description(s): Surgery was performed under general anaesthesia. Two milliliters of 2% lidocaine with 1:100 000 epinephrine is injected subcutaneously. After the upper eyelid incision at the desired crease line, the orbital septum was opened and the preaponeurotic fat was identified and dissected off the levator aponeurosis. The aponeurosis was disinserted from the tarsus, and the complex of levator aponeurosis and Muller muscle was dissected free from the conjunctiva. The desired eyelid height was determined from the proposed formula.
Satisfactory Intraoperative lagophthalmos was defined as a difference of less than 1 mm between recommended by the formula and actual intraoperative lagophthalmos.
After permanent fixation, a caliper was used for precise measurement of lagophthalmos in a supine position. Additional sutures were placed on the medial and lateral sides for satisfactory eyelid contour. The redundant levator complex was excised. Eyelid crease was made by placing three interrupted sutures
Intervention model: Single Group Assignment
Intervention model description: 20 eyelids with congenital ptosis with levator function of 4 mm or better, who underwent levator muscle resection guided by the recent intraoperative lagophthalmos formula.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: congenital; ptosis; levator function; MRD 1