bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation
Condition: Functional Constipation
MeSH terms: Constipation
Intervention: Magnesium Oxide; MIYAIRI-BM
Intervention description: Magnesium oxide 250 mg per day for children with weight < 15 kg, 500 mg per day for weight <15-30 kg, and 1000 mg per day for weight > 30 kg; MIYAIRI-BM 1 g (1package) per day for children with weight < 15 kg, 2g per day for weight 15-30 kg, and 3g per day for weight > 30 kg
Intervention MeSH terms: Magnesium Oxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 153.0
Sex: All
Minimum age: 6 Months
Maximum age: 10 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To compare the differences of fecal microflora between constipated and non-constipated
      healthy children, and evaluate the efficacy of probiotics in reducing symptoms of
      constipation and the influence of intestinal microflora in children with functional
      constipation.
    

Eligibility criteria:

        Inclusion Criteria:

        Rome III Diagnostic Criteria for functional constipation for children aged 6 months - 4
        years old is as the following:

          1. Two or fewer defecations per week.

          2. At least one episode per week of incontinence after acquiring toileting skills.

          3. History of excessive stool retention.

          4. History of painful or hard bowel movements.

          5. Presence of a large fecal mass in the rectum.

          6. History of large-diameter stools that may obstruct the toilet. Children aged 6 months
             - 4 years old is evaluated as functional constipation if two of the situations
             mentioned above lasted for one month.

        Rome III Diagnostic Criteria for functional constipation for children aged 4 years old and
        above is as the following:

          1. Two or fewer defecations in the toilet per week.

          2. At least one episode of fecal incontinence per week.

          3. History of retentive posturing or excessive volitional stool retention.

          4. History of painful or hard bowel movements.

          5. Presence of a large fecal mass in the rectum.

          6. History of large diameter stools that may obstruct the toilet. Children aged 4 years
             old and above is evaluated as functional constipation if two of the situations
             mentioned above happens at least once per week

        Exclusion Criteria:

          1. gastroesophageal reflux disease

          2. inflammatory bowel disease

          3. cardiopulmonary diseases

          4. liver disease

          5. renal disease

          6. genetic diseases

          7. endocrinal diseases

          8. received abdominal surgeries
Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS)
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Acthar Gel; Placebo
Intervention description: Acthar Gel 1 mL (80U) for subcutaneous injection; Placebo for subcutaneous injection
Intervention MeSH terms: Adrenocorticotropic Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: While Care Provider and Outcomes Assessor were also blinded, it was considered a double-blind study.
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Relapsing, Remitting Multiple Sclerosis; RRMS

Summary:

      This study will enroll about 66 participants who experienced a relapse of RRMS that steroids
      did not help. The doctor will put participants into a treatment group. Each person has an
      equal chance of being in either one of two groups (like flipping a coin). One group will
      receive a shot of study medicine (called Acthar Gel) under their skin every day for 14 days.
      The other group will receive a shot every day for 14 days, too, but there is no medicine in
      it (called placebo).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Had a clinical diagnosis of relapsing-remitting multiple sclerosis (RRMS)

          -  Had a relapse with onset ≤42 days prior to the Baseline Visit

          -  Had started treatment with 3 to 5 days (inclusive, over a period of up to 7 days) of
             specific high dose corticosteroids within 28 days of the onset of the first relapse
             symptom

          -  Had failed to obtain improvement of at least 1 point in one or more functions on the
             Function Systems Score (FSS) 14 days following their first dose of high dose
             corticosteroids

          -  Has an Expanded Disability Index Scale (EDSS) score of 2.0 to 6.5 (inclusive) at the
             Baseline Visit
ORthopaedic Trauma Anemia With Conservative Versus Liberal Transfusion
Condition: Anemia
MeSH terms: Anemia
Intervention: Blood and blood products for transfusion
Intervention description: Randomization would not occur until the patient's Hgb dropped below 7 g/dL. If the patient is randomized to the liberal arm, they would be transfused to keep their Hgb >7 g/dL. If the patient is randomized to the conservative arm, they would not be transfused until their Hgb drops below 5.5 g/dL. If the patient's Hgb does not drop below 7.0 g/dL, randomization will not be done.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 161.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if there is a difference in outcomes between
      liberal transfusion (transfusing when hemoglobin drops below a set higher value number) and
      conservative transfusion (transfusing when hemoglobin drops below a set lower value number).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Trauma patients admitted to participating hospital with any Orthopaedic injury who
             have been determined to be stable by the Trauma Service (General Surgery) and are no
             longer within the resuscitation phase of initial treatment. This is defined as a
             normal urine output (greater than 0.5 ml/kg/hr) and a systolic blood pressure greater
             than 90 mmHg for greater than 6 hours without fluid bolus or transfusion during that
             time

          -  Age 18-50

          -  Hemoglobin less than 9 g/dL or expected drop below 9 g/dL with planned surgery

        Exclusion Criteria:

          -  Pregnant ( urine pregnancy test will be done as standard of care)

          -  Prisoner

          -  Head injury (Glasgow Coma Scale less than 8 over 48 hours from presentation)

          -  Known cardiac (coronary artery disease, atrial fibrillation, stent placement,
             congestive heart failure), renal (acute or chronic renal insufficiency or failure,
             defined as having Serum Creatinine >1.2 at time of enrollment), liver (Childs C
             cirrhosis) or pulmonary disease (chronic obstructive pulmonary disease, abnormal
             pulmonary function tests or history of poor pulmonary function from any cause
             including acute traumatic conditions such as ARDS)

          -  Unlikely to follow up in the surgeon's estimation

          -  Sickle Cell Anemia

          -  History of cancer

          -  Preexisting weakness, paresthesias, deformities, or other conditions which might
             affect functional outcome in the surgeon's opinion

          -  Spinal cord injury

          -  Patients with burns expected to require operative treatment

          -  COVID positive
Treatment of OSA Associated Hypertension With Alpha 2 Agonist or Diuretic
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension
Intervention: Guanfacine; Hydrochlorothiazide
Intervention description: Guanfacine 1mg for 2 weeks followed by guanfacine 2mg for 4 weeks.; Hydrochlorothiazide 12.5 mg for 2 weeks followed by hydrochlorothiazide 25 mg for 4 weeks
Intervention MeSH terms: Hydrochlorothiazide; Guanfacine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Patients who have obstructive sleep apnea (OSA) frequently stop breathing while they sleep.
      They often develop high blood pressure. We are not sure what drug is best to treat the high
      blood pressure. This study will give the patients guanfacine or hydrochlorothiazide (HCTZ)
      for 6 weeks after 2 weeks of placebo. The blood pressure response will be evaluated by 24
      hour monitoring.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients ranging from 20 - 80 years

          2. Body mass index (BMI) of 20-38 to include the typical obese OSA patients and avoid the
             practical difficulties in blood drawing from the massively obese

          3. Hypertension with blood pressures > 140/90 but less than 180/105 mmHg.

          4. Apnea-hypopnea index above 10

        Exclusion Criteria:

          1. Receiving medications other than anti-hypertensives known to influence the sympathetic
             nervous system, sleep medicines (including heavy alcohol use) or drugs with adverse
             interactions with study medication.

          2. Women who have premenstrual syndrome, or those who are pregnant or capable of
             pregnancy and unwilling to use effective non-hormonal contraception

          3. Shift workers or have symptoms of narcolepsy, restless legs syndrome or insomnia, in
             order to minimize confounding effects of other sleep disorders

          4. Have apneas which are primarily central

          5. Have sleep fragmentation caused by syndromes such as chronic pain or movement
             disorders

          6. Have diseases such as asthma or chronic obstructive pulmonary disease that compromises
             respiration.

          7. Have known coronary or cerebral vascular disease, history of arrhythmias,
             cardiomyopathy, history of psychosis, current alcohol or drug abuse.

          8. Have any contraindications to any study materials, such as heart block.

          9. Have secondary hypertension

         10. Have creatinine levels above 2.5 mg %, more than 1+ proteinuria by dipstick, hematuria
             or electrolyte disorders.
Effect of Tadalafil on Insulin Secretion and Insulin Sensitivity in Obese Men.
Condition: Obesity
MeSH terms: Insulin Resistance; Hypersensitivity
Intervention: Tadalafil; Placebo
Intervention description: Tadalafil capsules: 5 mg, one per day, at night, during 28 days.; Calcined magnesia capsules: one per day, at night, during 28 days.
Intervention MeSH terms: Tadalafil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 18.0
Sex: Male
Minimum age: 30 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Obesity; Tadalfil; Insulin secretion; Insulin sensitivity

Summary:

      Obesity is a chronic disease of multifactorial etiology that develops from the interaction of
      the influence of nutritive , metabolic , cellular and molecular psychological factors.

      Tadalafil is Is a drug inhibiting the enzyme phosphodiesterase-5 (PDE-5), responsible for
      inactivating the vasodilator nitric oxide. USING paragraph was mainly treat erectile
      dysfunction, and recently approved for the treatment of pulmonary hypertension , it is
      innovative because of its longer life means, provides efficacy after 36 hours and the highest
      selectivity.

      The aim of this study is to evaluate the effect of tadalafil on insulin sensitivity and
      insulin secretion in obese men.

      The investigators hypothesis is that the administration of tadalafil improve the insulin
      sensitivity and insulin secretion in obese men.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men

          -  Age: 30-50 years

          -  BMI: 30 to 39.9 kg/m²

          -  No Pharmacotherapy during the last 3 months

          -  Signature Consent under Information

        Exclusion Criteria:

          -  Cholesterol: ≥ 240 mg / dl

          -  Triglycerides: ≥ 400 mg / dl

          -  Fasting glucose: ≥ 126 mg / dl

          -  Diabetes mellitus.

          -  Hypertension

          -  Patients with renal, liver and / or thyroid disease

          -  Consumption of drugs with known effects on glucose or insulin metabolism.

          -  Use of cigar and / or drugs

          -  Hypersensitivity to tadalafil
Fibrinogen Concentrate vs Cryoprecipitate
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Intervention: Fibrinogen Concentrate; Cryoprecipitate
Intervention description: Subject will be administered Fibrinogen Concentrate to control bleeding after open heart surgery when randomized to Fibrinogen Concentrate group; Subject will be administered Cryoprecipitate to control bleeding after open heart surgery when randomized to Cryoprecipitate group
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 60.0
Sex: All
Minimum age: 1 Day
Maximum age: 12 Months
Healthy volunteers: No

Summary:

      One of the most common hemostatic derangements in pediatric open- heart surgery is an acute
      acquired hypofibrinogenemia. This compromises fibrin clot generation and platelet
      aggregation, resulting in increased bleeding and allogenic blood transfusions.

      Currently, fresh frozen plasma and cryoprecipitate are used to supplement fibrinogen in
      pediatric cardiac patients. We propose that replacing cryoprecipitate with fibrinogen
      concentrate will be as effective in treating post-CPB bleeding and will decrease total blood
      product exposure when used as part of a blood transfusion algorithm.

      We plan to include all patients undergoing cardiac surgery on CPB less than 12 months and a
      fibrinogen level <250mg/dL while on bypass.

      We hope to demonstrate that fibrinogen concentrate is at least as effective as the standard
      of care in the management of peri- operative bleeding in neonatal patients undergoing
      cardiopulmonary bypass. If we are able to demonstrate that fibrinogen is at least as
      effective as the standard of care, then we would plan a multi-center trial to demonstrate the
      safety and efficacy of this medication. If we are able to demonstrate that fibrinogen
      concentrate is effective, fibrinogen concentrate could replace allogenic products and
      potentially decrease transfusion related morbidity in mortality in this population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Neonates of at least 32 weeks of gestational age and infants up to 12 months of age
             with the diagnosis of congenital heart disease, requiring open heart surgery with
             cardiopulmonary bypass

        Exclusion Criteria:

          -  Pre-existing coagulopathy, including unexplained bleeding or history of clotting
A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Aripiprazole Lauroxil
Intervention description: Monthly IM injection
Intervention MeSH terms: Aripiprazole; Aripiprazole lauroxil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Alkermes; ARISTADA; Aripiprazole Lauroxil; Schizophrenia

Summary:

      This study will evaluate the safety and tolerability of aripiprazole lauroxil (also known as
      ARISTADA, ALKS 9070).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has demonstrated tolerability to test doses of oral aripiprazole during screening; OR
             has a history of tolerated use of aripiprazole

          -  Has a diagnosis of schizophrenia

          -  Is clinically stable

          -  Has received at least 3 doses of risperidone long acting injection (Risperdal Consta)
             or paliperidone palmitate (Invega Sustenna) prior to screening.

          -  Has no antipsychotic medication regimen change for 4 weeks prior to Day 1

          -  Agreed to abide by the contraceptive requirements o the protocol

          -  Resides in a stable living situation

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Is currently pregnant or breastfeeding, or is planning to become pregnant during the
             study

          -  Has received Invega Trinza, aripiprazole lauroxil, or IM depot aripiprazole within 6
             months of screening

          -  Has participated in a clinical trial involving any investigational product within the
             past 3 months, or is currently participating in a clinical trial involving an
             investigational product

          -  Has a positive urine drug test for illicit use of amphetamines, barbiturates, cocaine,
             methadone, opiates, phencyclidine at screening

          -  Additional criteria may apply
Musculoskeletal Ultrasound Assessment of Therapeutic Response of Tofacitinib in Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tofacitinib 5mg po bid
Intervention MeSH terms: Tofacitinib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Musculoskeletal Ultrasound; Tofacitinib; biomarker

Summary:

      This proposal will evaluate if musculoskeletal ultrasound (MSUS) measures or multi-biomarker
      disease activity (MBDA) improve in patients treated with tofacitinib over 3 months, and
      whether early MSUS measures/MBDA can predict response to therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient must meet 1987 ACR criteria

          2. Age > 18 years of age

          3. Baseline DAS28/ESR>=3.2

          4. Stable concomitant DMARDs

          5. Stable prednisone <10mg or equivalent

          6. Power Doppler score of >=10

          7. Female subjects of childbearing potential must test negative for pregnancy

          8. Male and female subjects of childbearing potential must agree to use contraception
             throughout the study

          9. Negative QuantiFERON Gold test at screening

        Exclusion Criteria:

          1. No active TB

          2. Prednisone >10 mg

          3. Pregnancy or breast feeding

          4. Prior treatment with tofacitinib

          5. Concomitant biologic therapy (TNF inhibitors, IL-6 inhibitors, etc.)

          6. Active infection with HIV, hepatitis B or C, or herpes zoster

          7. Subjects with any uncontrolled clinically significant laboratory abnormality or any of
             the following laboratory abnormalities:

               1. Evidence of hematopoietic disorder or hemoglobin <9 g/dL

               2. Absolute lymphocyte count <0.75 x 109/L (<750/mm3)

               3. Absolute neutrophil count <1.2 x 109/L (<1200/mm3)

               4. Platelet count <100 x 109/L (<100,000/mm3)

               5. Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) >1.5 times
                  the upper limit of normal (x ULN)

               6. Estimated GFR <40 ml/min

          8. Subjects who have received live or live attenuated vaccines within 6 weeks prior to
             the first dose of study drug (or the zoster vaccine)

          9. Subjects who require concomitant treatment with medications that are potent inhibitors
             of cytochrome P450 3A4 (CYP3A4), both moderate inhibitors of CYP3A4 and potent
             inhibitors of CYP2C19, and potent CYP inducers (See Appendix)
Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients
Condition: Immunosuppression; Stem Cell Transplant; Bone Marrow Transplant
Intervention: Tacrolimus; Tacrolimus
Intervention description: Recommended starting dose will be in accordance with the established protocol (0.04 mg/kg/dose of ideal body weight), initially administered sublingually for four consecutive doses.; Recommended starting dose will be in accordance with the established protocol (0.04 mg/kg/dose of ideal body weight), oral administration after sublingual four consecutive doses
Intervention MeSH terms: Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Researchers are trying to learn more about using sublingual (absorption under the tongue)
      tacrolimus in blood and marrow transplant patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals will be identified from within the adult allogeneic BMT program at Mayo
             Clinic in Rochester, Minnesota

          -  Adults prescribed tacrolimus for treatment or prevention of Graft Versus Host Disease
             (GVHD)

        Exclusion Criteria:

          -  Vulnerable populations

          -  Patients with contraindications to tacrolimus, inclusive of hypersensitivity, history
             of posterior reversible encephalopathy syndrome or calcineurin-inhibitor induced
             thrombotic microangiopathy

          -  Lacking the capacity to consent in English and declining to participate in research