bioihbjkbjnl/mcl2 huggingface dataset:
Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis
Condition: Cystic Fibrosis; Dysbiosis
MeSH terms: Cystic Fibrosis; Fibrosis; Dysbiosis
Intervention: Vitamin D3; Placebo vitamin D3; Inulin; Placebo Inulin
Intervention description: High-dose vitamin D3 50,000 IU /week for 12 weeks; Matching to Vitamin D3 placebo capsules for 12 weeks; Chicory-derived prebiotic inulin 12 g/day for 12 weeks; Corn-derived maltodextrin 12g/day as the prebiotic placebo for 12 weeks
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cystic Fibrosis; Gastrointestinal Dysbiosis; Vitamin D; Prebiotic; Inulin; Gut microbiome; Intestinal inflammation; Intestinal absorption

Summary:

      The study will assess if administration of high-dose vitamin D and a commonly used prebiotic
      (inulin) is effective to reduce gastrointestinal dysbiosis and to improve critical intestinal
      functions in Cystic Fibrosis with the additive or synergistic effects of the combination of
      vitamin D + inulin.
    

Eligibility criteria:

        Inclusion Criteria:

          1. male and female patients (age > 18 years) with confirmed CF by genetic mutation and/or
             sweat chloride testing,

          2. not currently on oral or systemic antibiotics for pulmonary exacerbation,

          3. vitamin D deficient/insufficient (25(OH)D, 6 - 30 ng/mL) with most recent 25(OH)D in
             the past 12 months,

          4. use of CFTR modulator therapy is allowed

        Exclusion Criteria:

          1. severe vitamin D deficiency 25(OH)D ≤ 5 ng/mL or hypocalcemia or hypercalcemia,

          2. active GI disease, abdominal pain and/or diarrhea,

          3. chronic kidney disease worse than stage 3 (eGFR < ml/min per 1.73 m2),

          4. any vitamin D supplement use >2,000 IU or vitamin D analogue (patients who are taking
             more than 2,000 IU of vitamin D must agree to stop the vitamin D for 6 weeks and take
             less than 2,000 IU of vitamin D during the study),

          5. use of immunosuppressants or history of organ transplantation,

          6. current use of probiotics or prebiotics
ECT Pulse Amplitude and Medial Temporal Lobe Engagement
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: MECTA Spectrum 5000Q Amplitude
Intervention description: Current
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects randomized to right unilateral ECT with 600, 700, or 800 mA pulse amplitude.
Masking: Double (Participant, Outcomes Assessor)
Masking description: Double-blind (participant and outcomes assessor)
Enrollment: 62.0
Sex: All
Minimum age: 50 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: electroconvulsive therapy; MRI; major depressive disorder

Summary:

      Electroconvulsive therapy (ECT) remains the gold-standard treatment for patients with
      depressive episodes. During a typical four-week ECT series, most depressive episodes will
      respond to treatment and people will improve their level of functioning (return to work or
      family). Independent of the antidepressant effect of ECT, many patients experience transient
      memory impairment. This investigation will examine the impact of one ECT parameter (pulse
      amplitude or current) on brain changes (structure of connections within the brain) and
      clinical outcomes. The goal of this investigation is to determine the optimal parameter for
      an individual patient that will maintain the clinical response (reduce depression severity)
      and minimize side effects (eliminate memory issues related to treatment).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of major depressive disorder (with or without psychotic features)

          2. the clinical indications for ECT including treatment resistance or a need for a rapid
             and definitive response

          3. Hamilton Depression Rating Scale 24-item (HDRS-24) > 21

          4. age range between 50 and 80 years of age

          5. right-handedness

        Exclusion Criteria:

          1. Defined neurological or neurodegenerative disorder (e.g., history of head injury with
             loss of consciousness > 5 minutes, epilepsy, Alzheimer's disease)

          2. other psychiatric conditions (e.g., schizophrenia, schizoaffective disorder, bipolar
             disorder)

          3. current drug or alcohol use disorder, except for nicotine; and 4) contraindications to
             MRI.
Acute Hemodynamic Effects of Sildenafil in Patients With Severe Aortic Stenosis
Condition: Aortic Stenosis
MeSH terms: Aortic Valve Stenosis; Constriction, Pathologic
Intervention: Sildenafil
Intervention description: Single oral dose of 40mg or 80mg of Sildenafil
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Aortic valve stenosis; Sildenafil; Phosphodiesterase inhibitors; Hypertension, Pulmonary

Summary:

      Pulmonary hypertension is common in patients with aortic stenosis and is associated with
      worse operative and long-term outcomes. Sildenafil has been shown to reduce pulmonary artery
      pressure and improve exercise performance in patients with left-sided heart failure, but this
      has not been tested in patients with aortic stenosis. We hypothesize that Sildenafil will
      produce a clinically significant decrease in pulmonary artery pressure in patients with
      severe aortic stenosis. The dose of Sildenafil that produces a significant decrease in
      pulmonary artery pressure will be safe and well tolerated in patients with and without a
      depressed ejection fraction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe aortic stenosis (AVA < 1.0 cm2)

          -  Referred for a clinically ordered right and left heart catheterization

          -  18 years of age and older

          -  Able and willing to comply with all requirements of the study

        Exclusion Criteria:

          -  Nitrate use within 24 hours

          -  SBP < 110 mmHg or MAP < 75 mmHg

          -  Severe mitral regurgitation

          -  Severe aortic regurgitation

          -  Increased risk of priapism

          -  Retinal or optic nerve problems or unexplained visual disturbance

          -  Alpha antagonists or cytochrome P450 3A4 inhibitors use within 24 hours

          -  Current or recent (≤ 30 days) acute coronary syndrome

          -  O2 sat < 90% on room air

          -  Females that are pregnant or believe they may be pregnant

          -  Any condition which the PI determines will place the subject at increased risk or is
             likely to yield unreliable hemodynamic data

          -  Unwilling to provide informed consent
Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy
Condition: Bile Acid Malabsorption; Cholelithiasis
MeSH terms: Cholelithiasis; Cholecystolithiasis; Gallstones; Malabsorption Syndromes
Intervention: chenodeoxycholic acid
Intervention description: 1250 mg CDCA is given with a study meal
Intervention MeSH terms: Chenodeoxycholic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Investigate serial plasma samples of fibroblast growth factor 19 (FGF19) after oral
      stimulation with chenodeoxycholic acid in the same subjects before and after elective
      cholecystectomy
    

Eligibility criteria:

        Inclusion Criteria:

          -  planned elective cholecystectomy

        Exclusion Criteria:

          -  small bowel resection

          -  right sided hemicolectomy

          -  known chronic diarrheal disease (celiac disease, lactose malabsorption, Inflammatory
             bowel diseases, incl microscopic colitis)

          -  pregnancy

          -  wish for pregnancy within next three months

          -  allergy to eggs

          -  allergy to constituents in Xenbilox (capsules with chenodeoxycholic acid)

          -  acute cholecystitis within two months

          -  chronic cholecystitis

          -  cirrhosis of the liver

          -  suspected obstructive choledocholithiasis

          -  icterus
Treating Disrupted Sleep in Individuals With Inflammatory Bowel Disease
Condition: Sleep Disturbance; Fatigue; Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases; Dyssomnias; Parasomnias
Intervention: Behavioral Counseling; bupropion-SR
Intervention MeSH terms: Bupropion
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 15 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Inflammatory Bowel Disease; Physical Illness; Wellbutrin

Summary:

      The purpose of this study is to determine if either a targeted type of talk therapy (Phase I)
      or medication, Wellbutrin, (Phase II) improve sleep disturbance and/or fatigue in individuals
      with Inflammatory Bowel Disease (IBD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  IBD Group:

               -  Biopsy confirmed Crohn's Disease

               -  Qualifying scores on Multidimensional Fatigue Inventory and Pittsburgh Sleep
                  Quality Index

          -  Healthy Volunteer Group:

               -  Does not meet any exclusion criteria

        Exclusion Criteria:

          -  IBD Group:

               -  Meeting criteria for active alcohol or substance abuse or dependence

               -  Current ongoing treatment with Wellbutrin

               -  Females who are pregnant or plan to become pregnant within three months

               -  Sleep disorder such as apnea, restless leg syndrome or use of Continuous positive
                  airway pressure therapy (C-PAP)/Bilevel positive airway pressure (Bi-PAP)

               -  Current IBD flare requiring hospitalization with intravenous steroid treatment

               -  Other acute medical conditions or a history of chronic inflammatory condition
                  other than IBD

               -  Hemoglobin <10 with age and gender adjustments

               -  History of seizure disorder

               -  Acute infection within seven days

          -  Healthy Volunteer Group:

               -  History or current episode of psychiatric disorder by Diagnositic and Statistical
                  Manual (DSM-IV)

               -  Current ongoing treatment with psychoactive medications

               -  Medications for sleep in previous two weeks

               -  Females who are pregnant or plan to become pregnant within three months

               -  History of IBD, epilepsy, rheumatoid arthritis, lupus

               -  Sleep disorder such as apnea, restless leg syndrome or use of Continuous positive
                  airway pressure therapy (C-PAP)/Bilevel positive airway pressure (Bi-PAP)
Tranexamic Acid (TXA) Versus Epsilon Aminocaproic Acid (EACA) Versus Placebo for Spine Surgery
Condition: Scoliosis
MeSH terms: Scoliosis
Intervention: Tranexamic Acid; Normal Saline; Epsilon aminocaproic acid
Intervention description: For TXA, the loading dose is 10mg/kg infused over 15 minutes, while the maintenance dose is 1/mg/kg hr.; Normal saline of same volume as the intervention group will be given as the intervention group as a loading dose and maintenance dose.; For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr.
Intervention MeSH terms: Tranexamic Acid; Aminocaproic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 177.0
Sex: All
Minimum age: 10 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: antifibrinolytics

Summary:

      Tranexamic acid (TXA) and epsilon aminocaproic acid (EACA) have been reported to reduce blood
      loss in the cardiac surgery literature but they have not been reported in use head-to-head in
      the orthopedic surgery literature. In a randomized, double-blind, prospective study we
      believe that TXA will be more effective than both EACA and placebo at reducing blood loss for
      corrective spinal surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Undergoing thoracic and/or lumbar surgery for correction of adolescent idiopathic
             scoliosis, neuromuscular scoliosis, or adult deformity for correction of condition via
             posterior spinal fusion of 6 levels or greater.

        Exclusion Criteria:

          -  No renal dysfunction identified by elevated blood urea nitrogen (BUN) and creatinine
             (CR) or BUN to CR ratio greater than 20:1

          -  Hold religious and/or other beliefs limiting blood transfusion

          -  Currently use anti-coagulant medication or have past medical history leading to
             abnormal coagulation profile pre-operatively

          -  Significant past medical history preventing the use of TXA or EACA described in the
             protocol
The Efficacy of Claritin in Healthy Subjects
Condition: Healthy
Intervention: Claritin
Intervention description: Subject will be given 10mg Claritin tablet.
Intervention MeSH terms: Loratadine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Enrollment: 340.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: direct-to-consumer advertising

Summary:

      The primary goal of this study is to examine determinants of the efficacy of Claritin.
    

Eligibility criteria:

        Inclusion Criteria.

        1. Males and females between 18 and 65 years of age.

        Exclusion Criteria.

          1. Pregnant or lactating women.

          2. Upper respiratory infection within 14 days of study start.

          3. Women of childbearing potential not using specific contraception method(s) (i.e.,
             birth control pills, depo Provera, double barrier) as well as women who are
             breastfeeding.

          4. Patients with severe medical condition(s) that in the view of the investigator
             prohibits participation in the study (heart, lung, kidney, neurological, oncologic or
             liver disease).

          5. Use of any other investigational agent in the last 30 days.

          6. Use of medications that may affect skin testing. Specifically, subjects are excluded
             if they have used an antihistamine during the 4 days preceding their treatment visit.
Stopping ACE-inhibitors in COVID-19
Condition: SARS-CoV-2; COVID-19
MeSH terms: COVID-19
Intervention: ACE inhibitor, angiotensin receptor blocker
Intervention description: In patients randomized to stopping / replacing ACEI or ARB, it may be necessary to switch to another drug without direct effect on the RAS system. In patients, randomized to continuation, it may be needed to stop ACEI or ARB (e.g. hypotension with beginning sepsis) irrespective of the study.
Intervention MeSH terms: Angiotensin-Converting Enzyme Inhibitors; Angiotensin Receptor Antagonists
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: open-label, randomized design
Masking: Single (Outcomes Assessor)
Masking description: unmasked
Enrollment: 216.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ACE-inhibitors; RAS system; angiotensin receptor blockers; SARS-CoV-2; COVID-19

Summary:

      ACEI-COVID-19 is a multicenter, randomized trial testing the hypothesis that
      stopping/replacing chronic treatment with ACE-inhibitors (ACEI) or angiotensin receptor
      blockers (ARB) improves outcomes in symptomatic SARS-CoV2-infected patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female and male patients competent to make a decision

          -  Proven and symptomatic SARS-CoV2 infection ≤ 5 days

          -  Patient age ≥ 18 years

          -  Provided written informed consent

          -  Chronic (≥ 1 month) ACEI/ARB therapy for treatment of arterial hypertension, diabetes
             mellitus, heart failure or coronary artery disease

          -  Stable hemodynamic conditions allowing to stop or continue treatment with ACEI/ARB
             (systolic blood pressure ≤180mmHg)

        Exclusion Criteria:

          -  Women capable of bearing children as well as pregnant and breastfeeding women

          -  Participant in another interventional trail

          -  At screening visit, no oral medication intake possible

          -  Advanced heart failure NYHA Stage III-IV

          -  Left ventricular ejection fraction <30% or NTproBNP ≥600pg/mL in case of clinical
             signs of heart failure

          -  Acute coronary syndrome ≤ 3 months

          -  Severe arterial hypertension (concomitant use of more than 4 different
             antihypertensive drug classes)

          -  Acute respiratory distress syndrome with need for mechanical ventilation

          -  Patients who at not capable of home blood pressure monitoring

          -  Patients who cannot be switched to an alternative medication
Assessment of Alcon's Ocular Image Quantification System
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol); Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)
Intervention description: One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.; One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.
Intervention MeSH terms: Olopatadine Hydrochloride; Dextrans; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Allergic conjunctivitis

Summary:

      The purpose of this study was to evaluate ocular responses with different allergen
      provocation methods.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of allergic conjunctivitis;

          -  Active signs and symptoms of ocular allergies;

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  History of dry eye;

          -  Presence of ocular infection;

          -  Presence of severe or serious ocular conditions;

          -  Symptoms of allergic conjunctivitis;

          -  Use of topical or systemic ocular medications as specified in protocol;

          -  Ocular surgery or laser surgery within 6 months of study start;

          -  Unwilling to discontinue contact lens wear 72 hours prior to Visit 1 and during study
             period;

          -  Other protocol-defined exclusion criteria may apply.
ADVANCE CRT - D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
Condition: Tachycardia, Ventricular; Ventricular Fibrillation
MeSH terms: Tachycardia; Ventricular Fibrillation; Tachycardia, Ventricular
Intervention: Implantable Cardiac Defibrillator
Intervention description: Implantable cardiac defibrillator with programmable Fast Ventricular tachycardia detection (FVT) window
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 526.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ATP; Tachycardia; CRT-D

Summary:

      To compare the efficacy of RV and BiV ATP for the termination of ventricular arrhythmias in
      patients who are candidates to a cardiac resynchronisation therapy (CRT) and have a Class I
      or IIA indication for ICD implantation.

      The hypothesis of delivering ATP from different sites (RV or BIV) has never been evaluated in
      a prospective, controlled and randomized study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  CRT + ICD indications (Class I-IIA) according to the guidelines

          -  Patients have been implanted with a Medtronic Marquis Family ICD capable of RV-ATP or
             BIV-ATP

          -  Patients in chronic AF who undergo a complete AV ablation and that the complete AV
             block is confirmed at PHD

        Exclusion Criteria:

          -  Patient's life expectancy less than 1 year due to a non cardiac chronic disease

          -  Patient on heart transplant list which is expected in < 1 year

          -  Patient's age less than 18 years

          -  Replacements and upgrades

          -  Epicardial lead

          -  Mechanical tricuspid valve

          -  Ventricular Tachyarrhythmias associated with reversible causes

          -  Unwillingness or inability to provide written informed consent

          -  Enrollment in, or intention to participate in, another clinical study during the
             course of this study

          -  Inaccessibility for follow-up at the study center