bioihbjkbjnl/mcl2 huggingface dataset:
Additional Insulin for Fat and Protein in Children With Diabetes Study
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Insulin, Asp(B28)-
Intervention description: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal
Intervention MeSH terms: Insulin; Insulin Aspart
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The aims of the study are to see if additional insulin doses for the fat and protein in a
      meal, given at different times, improve blood glucose levels and are safe and acceptable to
      children with Type 1 diabetes using multiple daily insulin injections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Type 1 diabetes (for at least a year)

          -  On multiple daily insulin injections, including basal long-acting insulin and
             rapid-acting insulin before each meal.

          -  HbA1c < 75 mmol/mol (9.0%)

          -  Participant and/or parent/legal guardian willing and able to give informed consent for
             participation in the study.

          -  Family have a freezer in which to safely store the test meals.

          -  In the Investigator's opinion, is able and willing to comply with all trial
             requirements.

        Exclusion Criteria:

          -  HbA1c greater than 75 mmol/mol (9.0%)

          -  Child unwilling to agree to second insulin injection at a meal-time

          -  Untreated coeliac disease or other concomitant condition likely to affect BG control

          -  Food allergies (other than controlled Coeliac Disease)

          -  Vegetarians, vegans or patients with religious dietary restrictions (as the standard
             meal contains meat)

          -  Participant taking any glucose-containing medication concurrently
Transfoveal Micropulse Laser for Center Involving Diabetic Macular Edema
Condition: Diabetic Retinopathy; Macula Edema
MeSH terms: Macular Edema; Diabetic Retinopathy; Edema
Intervention: Yellow micro-pulse laser; Diode micro-pulse laser
Intervention description: applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea; applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: micro-pulse laser; trans-foveal

Summary:

      Anti-vascular endothelial growth factor (VEGF) therapy is currently the mainstay of treatment
      for diabetic macular edema (DME). One of the main obstacles of anti-VEGF therapy is the need
      of repeated injections, which carries both economic and compliance problems to the
      patients.there is a growing evidence that recognises the effectiveness of the use of
      micropulse laser (MPL) in treatment of DME. with MPL, it is possible to deliver a
      subthreshold laser that is above the threshold of biochemical effect but below the threshold
      of a visible, destructive lesion thereby preventing collateral damage.The MPL technique is
      available at near - infrared 810 nm diode laser (diode MPL) and at 577 nm (yellow MPL). The
      current study was conducted in order to compare the efficacy of both MPL techniques in the
      treatment of center involving DME.
    

Eligibility criteria:

        Inclusion Criteria:

          -  bilateral diabetic macular edema

          -  center involving confirmed by Optical coherence tomogram (OCT)

        Exclusion Criteria:

          -  any non-diabetic macular edema

          -  significant media opacities

          -  previous laser treatment, any intraocular surgery within the past 6 months

          -  previous intravitreal injections of any drug within the past 6 months
Imaging Cardiac Amyloidosis: A Pilot Study Using F-18 Florbetapir Positron Emission Tomography
Condition: Cardiac Amyloidosis
MeSH terms: Amyloidosis
Intervention: F-18 florbetapir PET
Intervention description: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Amyloidosis; Cardiac; Heart; Imaging; Diagnosis

Summary:

      The primary aim of this pilot study is to determine whether amyloid deposits in the heart can
      be measured non-invasively by F-18 florbetapir (Trade Name: Amyvid) positron emission
      tomography (PET) in 30 individuals with documented cardiac amyloidosis. We will also enroll
      15 individuals without cardiac amyloidosis to undergo the F-18 florbetapir imaging as a
      control group.

      The primary hypothesis of this study is that a specific amyloid binding radiotracer will bind
      to the myocardial amyloid deposits and help quantify cardiac amyloid burden.

      A secondary aim of this study is to determine reproducibility of F-18 florbetapir imaging of
      the myocardium.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion criteria for amyloid subjects:

          -  Age > 18 years

          -  Biopsy proven amyloidosis outside the heart with typical echocardiographic appearance
             of cardiac involvement, or a positive cardiac biopsy.

          -  Diagnosis of AL amyloidosis by standard criteria (evidence of plasma cell dyscrasia
             with appropriate tissue staining for AL) OR

          -  Diagnosis of TTR amyloidosis (no evidence of plasma call dyscrasia and positive TTR
             staining of amyloid in tissue biopsy)

          -  Able and willing to provide informed consent to participate in the study procedures

        Exclusion Criteria:

          -  Pregnancy

          -  Serious non-cardiac medical illness which will preclude research study participation
Nicotine Replacement for Smoking Cessation During Pregnancy
Condition: Nicotine Dependence; Smoking Cessation
MeSH terms: Tobacco Use Disorder
Intervention: Nicotrol Inhaler; Placebo Inhaler
Intervention description: Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper; Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 154.0
Sex: Female
Minimum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Smoking Cessation; Pregnancy; Nicotrol Inhaler; Placebo Inhaler; Nicotine Inhaler

Summary:

      This is a clinical trial to determine if the nicotine inhaler in combination with counseling
      will help pregnant women quit smoking, and whether it is safe when compared to placebo (an
      inactive inhaler).
    

Eligibility criteria:

        Inclusion Criteria:

          -  smoking at least 5 cigarettes per day for the preceding 7 days

          -  previous attempt to quit smoking during pregnancy by self report

          -  13-26 weeks gestation

          -  at least 16 years of age

          -  able to speak English or Spanish

          -  intent to carry pregnancy to term

          -  stable residence

        Exclusion Criteria:

          -  current drug or alcohol abuse or dependence (other than methadone maintenance)

          -  twins or other multiple gestation

          -  unstable psychiatric disorder

          -  unstable medical problems (e.g., pre-eclampsia, threatened abortion, hyperemesis
             gravidarum)

          -  known congenital abnormality
Random-start Ovarian Stimulation in Egg-donors (ROSE)
Condition: Infertility
MeSH terms: Infertility
Intervention: Random start ovarian stimulation; Gonadotrophins; GnRH antagonist; GnRH agonist
Intervention description: Egg-donors will start ovarian stimulation randomly at different moments throughout the menstrual cycle.; Urinary FSH 150-225 IU/d; Cetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation; GnRH agonist triggering with triptorelin 0,2 mg for final follicular maturation.
Intervention MeSH terms: Prolactin Release-Inhibiting Factors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ovarian stimulation; random; egg donation; antagonist; gnrh agonist trigger

Summary:

      The purpose of this prospective single-center study is to evaluate the laboratory outcome
      after random start ovarian stimulation in oocyte donors. The study will be performed in
      egg-donors but this type of treatment has the potential to be implemented in general
      infertility population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal women

          -  18-35 years old

          -  FSH levels < 10 IU/liter

          -  Antral follicle count (AFC) > 10

          -  Regular cycles

          -  Body Mass Index (BMI) < 28

          -  Signed informed consent

        Exclusion Criteria:

          -  Polycystic ovary syndrome (PCOS) patients

          -  Allergy to gonadotrophins

          -  Concomitant participation in other trial
Effect of Renin-angiotensin-system Blockade on Urinary Free Light Chains in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: amlodipine, hydralazine, terazosin or hydrochlorothiazide
Intervention description: In the washout period, the Ace Inh or ARB classes of medicine(s) that are part of the patient's antihypertensive regimen will be discontinued. The patient will be started on alternative therapy with medications that are approved by the Food and Drug Administration for treatment of high blood pressure (such as amlodipine, hydralazine, terazosin or Hydrochlorothiazide) for control of their blood pressure.
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide; Hydralazine; Terazosin
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes; Hypertension

Summary:

      The purpose of this study is to study the effect of blocking the renin angiotensin system on
      urinary free light chain excretion as compared to urine microalbumin creatinine ratio in
      subjects with type 2 diabetes. The long term goal is to assess urinary free-light chains as a
      biomarker of earlier detection of kidney function impairment in subjects with diabetes
      mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 Diabetes

          -  Hypertension

          -  Estimated glomerular filtration rate (eGFR) > 30 ml/min

          -  Use of Ace Inh and ARB for control of blood pressure who are willing to be placed on
             alternate drug(s) in the washout period for blood pressure control

        Exclusion Criteria:

          -  Pregnancy

          -  Patients with chronic kidney disease stage with eGFR < 30 ml/min (CKD stage IV and V)

          -  Nephrotic range proteinuria (urinary protein > 3.5 gm/day)

          -  History or renal transplantation

          -  History of multiple myeloma

          -  Known history of hypersensitivity reaction or intolerability to Ace Inh or ARB.
Effects of Thiazide Diuretics on Sympathetic Nervous System in Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Study#1: chlorthalidone (CTD), titrated dose; Study #1: spironolactone (SP), titrated dose; Study# 2 chlorthalidone (CTD), fixed dose; Study# 2 spironolactone (SP), fixed dose; Study# 2 irbsesartan (IR), fixed dose
Intervention description: Participants in study #1 will receive 3 months of chlorthalidone (12.5-25 mg/d) at the dose titrated to achieve 24-h ambulatory BP < 130/80 mmHg; Participants in study #1 will receive 3 months spironolactone (25-75 mg/d), at the dose titrated to achieve 24-h ambulatory BP < 130/80 mmHg.; Participants in study #2 will receive 3 months of fixed-dose of CTD, at 25 mg/d.; Participants in study #2 will receive 3 months of fixed-dose SP at 25 mg daily.; Participants in study #2 will receive 3 months of fixed-dose IR at150 mg daily.
Intervention MeSH terms: Chlorthalidone; Spironolactone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Masking description: Capsule was made to appear identical in appearance so that subjects are blinded to treatment assigned.
Enrollment: 166.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Blood Pressure, High

Summary:

      Thiazide medications are often prescribed for individuals with high blood pressure, but
      research has shown that they may increase an individual's risk of developing diabetes. While
      it is unknown exactly how thiazide causes this response, it is likely that the nervous system
      is somehow involved. This study will evaluate the role of the nervous system in sugar
      metabolism, as well as determine the effect of thiazide and other medications on individuals
      with high blood pressure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Untreated stage 1 primary hypertension (systolic blood pressure between 140 to 159 mm
             Hg and diastolic blood pressure between 90 to 99 mm Hg)

        Exclusion Criteria:

          -  Cardiopulmonary disease, as determined by medical history or by physical examination

          -  Serum creatinine greater than or equal to 1.5 mg/dL

          -  Diabetes mellitus or other systemic illness

          -  Left ventricular hypertrophy by echocardiography or ECG

          -  Hypersensitivity to chlorthalidone, spironolactone, eplerenone, angiotensin converting
             enzyme (ACE) inhibitors, angiotensin receptor blocker, insulin, Evans blue dye, or
             clonidine

          -  History of substance abuse (other than tobacco)

          -  History of gouty arthritis

          -  History of ACE inhibitor-induced cough or angioedema

          -  Evidence of secondary hypertension

          -  Pregnant
Antidepressant Response in Older Adults With Comorbid PTSD and MDD
Condition: Post Traumatic Stress Disorder; Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Escitalopram; Duloxetine
Intervention description: The participant will be begun on either escitalopram 10mg or duloxetine 30mg. Subjects will begin escitalopram 10mg, continue this dosage for 4 weeks, then if the HRSD >7 at Week 4, he/she will have their dosage increased to 20mg for the remainder of the 8 week study.; Participants who have not responded to or not tolerated escitalopram in the current depressive episode will be started on duloxetine. They will take 30mg for the first 2 weeks, then, contingent on clinical assessment that the 30mg dose is sufficiently well tolerated, be increased to 60mg for the remaining 6 weeks of the study.
Intervention MeSH terms: Duloxetine Hydrochloride; Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 60 Years
Maximum age: 105 Years
Healthy volunteers: No

Summary:

      In the Investigator's ongoing studies of Posttraumatic Stress Disorder (PTSD) in older
      adults, it has been found that older adults with PTSD frequently meet the criteria for
      comorbid Major Depressive Disorder (MDD). Moreover, relative to trauma-exposed healthy
      controls (TEHCs), elders with PTSD manifest executive function deficits, fatigability, and
      mobility and physical function deficits that are consistent with what the investigator has
      observed in depressed older adults. Yet, the investigator has found that very few older
      adults with combined PTSD/MDD have received appropriate antidepressant treatment for their
      condition. These findings give rise to the questions of (1) how effective is antidepressant
      treatment for depressive symptoms in the context of PTSD/MDD and (2) are cognitive and
      physical function deficits in PTSD/MDD patients reversible with effective antidepressant
      treatment?
    

Eligibility criteria:

        Inclusion Criteria:

          1. Individual has completed IRB 7489

          2. Diagnosed with DSM 5 MDD

          3. HRSD >=18

          4. Willing to and capable of providing informed consent and complying with study
             procedures.

        Exclusion Criteria:

          1. History of allergic or adverse reaction to

          2. Non-response to adequate trial of escitalopram (at least 4 weeks at dose of 20mg) and
             duloxetine (at least 4 weeks at dose of 60mg)during the current episode.

          3. Current treatment with psychotherapy, antidepressants, or other psychotropic
             medications.
Effect of Bupropion on Seizure Threshold in Depressed Patients
Condition: MDD
MeSH terms: Seizures
Intervention: Wellbutrin SR 300Mg Extended-Release Tablet
Intervention description: Wellbutrin SR 300Mg Extended-Release Tablet
Intervention MeSH terms: Bupropion
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 Arms of randomization - one wherein patients get Wellbutrin in first ECT and another arm wherein patients get it with second ECT. Counterbalanced randomization
Masking: Double (Care Provider, Outcomes Assessor)
Masking description: Blinding to be done - Outcome assessor and care provider will be blinded to randomization arm of subject
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Wellbutrin; Electroconvulsive therapy; Right Unilateral Ultra Brief

Summary:

      The purpose of the study is to examine the effect of bupropion on seizure threshold and
      duration in depressed patients receiving right unilateral ultra-brief electroconvulsive
      therapy (ECT). The investigators plan to recruit 10 patients into the study, administer
      sustained release (SR) bupropion 4 hours prior to receiving ECT. The investigators plan to
      compare the seizure threshold and seizure durations between ECT sessions with and without
      bupropion administration. The study's implication is to examine how ECT can be optimized by
      rational combination with medications that lower seizure threshold.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female subjects, age >18.

          2. Meeting diagnostic criteria for major depressive disorder or bipolar disorder per
             DSM5.

          3. Referred for ultra brief RUL ECT.

          4. Right motor dominant.

          5. Competent to provide informed consent.

          6. Able to read or comprehend English.

          7. H/O treatment with bupropion.

          8. Concomitant treatment with benzodiazepines, dosing of which has remained stable for a
             week prior to study ECT session.

        Exclusion Criteria:

          1. Lifetime history of schizophrenia, schizoaffective disorder, mental retardation,
             seizure disorder.

          2. Current alcohol abuse or dependence within past 6 months.

          3. Current substance abuse or dependence within past 6 months.

          4. Recently received ECT within preceding 3-6 months.

          5. Currently on any formulation of bupropion.

          6. Currently on any anticonvulsants or clozapine.
Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride
Condition: Dental Caries
MeSH terms: Dental Caries
Intervention: Sodium fluoride / silica and carbopol, 0.5g; Sodium fluoride / silica and carbopol, 1.5g; Sodium fluoride / silica and carbopol, 1.5g; Fluoride free dentifrice
Intervention description: Dentifrice containing 1150 parts per million (ppm) fluoride as sodium fluoride / silica and 0.4% carbopol; Dentifrice containing 1150 ppm fluoride as sodium fluoride / silica and 0.4% carbopol; Dentifrice containing 250 ppm fluoride as sodium fluoride / silica and 0.4% carbopol; A non fluoride dentifrice was given to participants of each arm at washout period
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate and compare the effect of the amount of toothpaste used and brushing
      time on enamel strengthening (percent of surface microhardness recovery, % SMHR) and enamel
      fluoride uptake (EFU).
    

Eligibility criteria:

        Inclusion Criteria:

        General and Dental Health

          -  Good general and dental health with (in the opinion of the investigator) no clinically
             significant and relevant abnormalities of medical history or oral examination

          -  Have no current active caries or periodontal disease that may compromise the study or
             the health of the subjects

          -  Residency: Currently living in the Indianapolis, Indiana area

        Dentures:

          -  Currently wearing a removable mandibular partial denture with sufficient room in the
             posterior buccal flange area to accommodate two enamel specimens (required dimensions
             12 mm x 7 mm)

          -  Willing to have their denture modified to accommodate enamel test specimens and
             willing and capable of wearing their removable mandibular partial dentures 24 hours
             per day during the experimental periods

          -  All restorations in a good state of repair

          -  Salivary Flow: Have a salivary flow rate in the range of normal values (unstimulated
             whole saliva flow rate ≥ 0.2 mL/minute; gum base stimulated whole saliva flow rate ≥
             0.8 mL/minute)

        Exclusion Criteria:

          -  Antibiotics: Use of antibiotics two weeks prior to a treatment visit or anticipated
             use during the study treatment periods

          -  Study Scale Use: Subjects unable to measure product weights accurately using the
             assigned study scale as determined by the study staff (as demonstrated on or before
             Visit 4)

          -  A member of the site study staff who is directly working on the project or living in
             that staff's household

          -  Any employee of any toothpaste manufacturer or their spouse or family member