bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Cyproheptadine on Growth and Behavior in Pediatric Feeding Disorders
Condition: Feeding Behaviors
MeSH terms: Feeding and Eating Disorders
Intervention: Cyproheptadine
Intervention MeSH terms: Cyproheptadine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 1 Year
Maximum age: 10 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to examine the effect of standard dosing of cyproheptadine for
      both cycled and continuous administration, as compared to no medication, on appetite
      stimulation and growth in the pediatric gastroenterology feeding team patient population. The
      secondary aim is to evaluate the effect, if any, of the suspected tachyphylaxis that is
      commonly associated with cyproheptadine use. The third aim will be to examine the type and
      duration of side effects of cyproheptadine in this population. The ultimate goal will be to
      create a standardized protocol for cyproheptadine therapy in children with feeding disorders
      and suboptimal growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All children aged 1-10 years, presenting to initial intake appointment with the
             Pediatric Gastroenterology Feeding Team Clinic at the Children's Hospital of Wisconsin
             (CHW), with BMI Z score of < or equal to 0 (normal WHO BMI defined as Z score of -1 to
             1), who have a parent willing to participate, will qualify for inclusion in the study.
             Children with vomiting due to presumed volume intolerance may be included in the
             study.

        Exclusion Criteria:

          -  Untreated organic disease Anatomical barrier to swallowing or known swallowing
             disorder Diagnosis of severe developmental delay or mental retardation Significant
             brain pathology or seizure disorder that may affect oropharyngeal motor skills On
             medication with known effects on appetite or interactions with cyproheptadine
Aspirin as a Novel Anti-Inflammatory Modality in the Fontan Patients
Condition: Fontan Procedure
Intervention: Aspirin
Intervention MeSH terms: Aspirin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Patients who have undergone the Fontan procedure (a congenital heart surgery) may develop
      complications many years after their operation. Studies have shown that some of these
      patients develop an ongoing inflammatory state, which may be the cause of these late
      complications. Aspirin is a common over the counter anti-inflammatory medication used for
      many other chronic diseases. This study may help determine if aspirin therapy can limit the
      inflammation seen in Fontan patients and prevent these late complications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults who have Fontan repair of single ventricle

        Exclusion Criteria: Persons with the following history, conditions, or behavior will be
        excluded

          -  Active protein losing enteropathy within the past three years

          -  Congestive heart failure

          -  Active arrhythmias

          -  Taking Coumadin (Warfarin)

          -  Bleeding disorder

          -  Known esophageal varicies

          -  Consuming more than 10 alcoholic drinks per week.

          -  Pregnant

          -  Planning to become pregnant
SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients"
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Dupilumab; Placebo
Intervention description: Pharmaceutical form: solution for injection Route of administration: subcutaneous; Pharmaceutical form: solution for injection Route of administration: subcutaneous
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 188.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To evaluate the effect of dupilumab on sleep quality in adult participants with moderate to
      severe atopic dermatitis (AD).

      Secondary Objectives:

      To evaluate the effect of dupilumab on objective and subjective quantitative sleep
      parameters, AD related outcomes, and daytime consequences of sleep deprivation.

      To continue to assess the safety and tolerability throughout the study.
    

Eligibility criteria:

        Inclusion criteria:

        Participants, male or female 18 years or older,

          -  with diagnosed chronic AD, demonstrated 1) inadequate response to topical medications,
             2) expected severity of AD and 3) sleep disturbance.

          -  had applied skin emollients (moisturizers) at least 7 days before screening.

          -  had applied medium potency topical corticosteroids (TCS) on all active AD lesions at
             least 7 days before screening.

          -  willed and able to comply with all clinic visits and study-related procedures.

          -  provided signed informed consent.

        Exclusion criteria:

        Participants excluded from the study:

          -  with known hypersensitivity to Dupixent, clinical depression, drug abuse history,
             sleep problems not related to AD, irregular sleep pattern, active/acute infections,
             severe medical conditions, laboratory abnormalities, any condition that might present
             unreasonable risk to participants or interfered with study assessment, or any severe
             concomitant illness(es) that would adversely affect the participant's participation in
             the study, and contraindications of topical corticosteroids.

          -  at Baseline, presence of any conditions listed as criteria for study drug
             discontinuation.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation
Condition: End-stage Renal Failure; Graft Rejection
MeSH terms: Kidney Failure, Chronic
Intervention: Tacrolimus (Kidney transplant maintenance immunosuppression); Kidney transplant maintenance immunosuppression
Intervention description: Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml; Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml
Intervention MeSH terms: Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Kidney transplant; Rejection; Adherence; Quality of life

Summary:

      The current anti-rejection drug regime for kidney transplant recipients in use at the West
      London Renal & Transplant Centre (WLRaTC) consists of induction therapy with the very potent
      monoclonal antibody Campath 1-H (Alemtuzumab) followed by long-term maintenance with the
      Calcineurin inhibitor Tacrolimus

      The recent development (and licensing in the UK) of an extended-release, once daily
      formulation of Tacrolimus holds out the promise of simpler drug regimes for our patients. In
      the context of our current successful use of Tacrolimus monotherapy maintenance after Campath
      1-H induction, the extended-release Tacrolimus formulation will enable us to offer a regime
      where the only long-term immunosuppressive treatment that most of our patients need will be a
      single drug, taken once a day.

      The investigators wish to assess the efficacy of such a regime in a structured comparison
      with our current protocol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Live donor kidney transplant recipients

          -  heart-beating-Deceased donor kidney transplant recipients

          -  Patients suitable for induction therapy with Alemtuzumab

        Exclusion Criteria:

          -  Recipients of Non-heart-beating deceased donor kidney transplants

          -  Recipients of simultaneous kidney/pancreas transplants

          -  ABO incompatible/desensitized transplant recipients

          -  Positive flow cross-match/desensitized transplant recipients

          -  Patients with heavy prior exposure to myelosuppressive therapy

          -  Patients with previous malignancy

          -  Patients with HIV,Hepatitis-C, or Hepatitis-B infection
Effects of Metformin on Hepatic FFA Metabolism
Condition: Type 2 Diabetes; Dyslipidemia
MeSH terms: Diabetes Mellitus, Type 2; Dyslipidemias
Intervention: Metformin; Placebo
Intervention description: 1000 mg metformin twice daily in 3 months; 2 tablets twice daily in 3 months
Intervention MeSH terms: Metformin
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 50 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Type 2 diabetes; Hepatic fatty acid oxidation; Dyslipidemia; Metformin

Summary:

      Background: Metformin treatment has beneficial effects on both glucose and lipid metabolism.
      Whereas there is general agreement that the blood glucose lowering effect of metformin
      results from inhibition of hepatic gluconeogenesis, it is less clear exactly how the drug
      lowers blood triglyceride concentration. There are indications that it enhances hepatic free
      fatty acid (FFA) oxidation thus diminishing substrate for reesterification and resecretion as
      very-low-density-lipoprotein (VLDL) triglycerides (TG). However, the liver is not easily
      accessible for sampling in humans and data on the clinical effects of metformin in the liver
      are therefore lacking. This may change due to the increasing use of the positron emission
      tomography (PET) technique. Using PET isotopes (11C or 18F) coupled to either palmitate or a
      fatty acid analogue, it is possible to non-invasively measure hepatic fatty acid handling.

      Aim: To determine how 3 months metformin treatment (1000 mg twice daily) affects hepatic
      lipid and glucose metabolism in patients with newly diagnosed type 2 diabetes.

      Design: Randomized, placebo controlled, double-blind parallel study with patients receiving
      either metformin or placebo. A control group of BMI and age-matched non-diabetic individuals
      will receive metformin for 3 months.

      Hypothesis: Metformin lowers VLDL-TG secretion and circulating triglycerides by increasing
      hepatic fatty acid oxidation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recently diagnosed type 2 diabetes

          -  Age 50-70 years

          -  BMI<40

        Exclusion Criteria:

          -  Insulin treatment

          -  NASH (non alcoholic steatohepatitis)

          -  Cancer

          -  Anemia

          -  HbA1C>8.5 %

          -  Chronic or acute pancreatitis

          -  Alcohol or medicine abuse

          -  Allergy towards metformin

          -  Claustrophobia

          -  Severe obesity (weight >130 kilogram)
Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.
Condition: Bariatric Surgery Candidate; Glucose Intolerance; Insulin Resistance
MeSH terms: Insulin Resistance; Glucose Intolerance
Intervention: Dexmedetomidine; 0.9% Sodium-chloride; Fentanyl; Morphine Sulfate
Intervention description: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.; The same infusion rate used in the dexmedetomidine group.; Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).; Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.
Intervention MeSH terms: Fentanyl; Dexmedetomidine; Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Blinded
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Impaired Glucose Tolerance; Obese patients; Dexmedetomidine

Summary:

      This study investigated the effect of dexmedetomidine in obese patients undergoing bariatric
      surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Obese patient (BMI>30)

          -  American Society of Anesthesiologists grades II or III

          -  Diagnosis of impaired glucose tolerance

          -  Undergoing sleeve gastrectomy

        Exclusion Criteria:

          -  Baseline glucose > 200mg/dl

          -  Diagnosis of Diabetes

          -  Under corticosteroids treatment

          -  Oral hypoglycemic medication within 7 days previous surgery

          -  Use of insulin within 24h previous surgery

          -  Allergy to any drug used in the study
Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination.
Condition: Hepatitis B Vaccine
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Engerix™-B Kinder
Intervention description: Intramuscular injection, 1 dose
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 301.0
Sex: All
Minimum age: 7 Years
Maximum age: 8 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatitis B vaccine; Challenge dose

Summary:

      The purpose of this study is to assess the persistence of immunity to hepatitis B in children
      who received three consecutive doses of HBV vaccine (EngerixTM-B) in infancy. The Protocol
      Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol.

          -  A male or female of 7 to 8 years of age (from and including the 7th birthday up to but
             excluding the 9th birthday) at the time of enrolment.

          -  With documented evidence of previous vaccination with three consecutive doses of
             Engerix™-B in Germany

          -  Written informed consent obtained from the parents or guardians of the subject at the
             time of enrolment.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

        Exclusion Criteria:

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational product

          -  Evidence of previous hepatitis B booster vaccination since administration of the third
             dose of Engerix™-B vaccine.

          -  History of or intercurrent hepatitis B disease.

          -  Hepatitis B vaccination at birth.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             during the period starting from 30 days before HBV vaccine challenge and ending 30
             days after.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding HBV vaccine challenge or planned administration during the study period.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to the HBV vaccine challenge.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination
PO vs. IV Acetaminophen Given Perioperatively for 24 hr Post-op Pain Control Following Total Hip or Knee Replacement
Condition: Post-op Pain
MeSH terms: Pain, Postoperative
Intervention: Oral acetaminophen; IV acetaminophen
Intervention description: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.; Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 515.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hip replacement; Knee replacement; randomized trial; acetaminophen; post-op pain management

Summary:

      The purpose of the study is to evaluate post-op pain requirements in patients undergoing hip
      or knee replacement surgery who perioperatively receive either Oral acetaminophen or IV
      acetaminophen
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age and older

          -  Able to provide written consent

          -  Able to read and write in English

          -  Weighing over 50 kg

          -  Will undergo total hip or total knee joint replacement

        Exclusion Criteria:

          -  Non-verbal patients

          -  Unable to use numeric pain scale

          -  Allergic to the test article

          -  Documented hepatic impairment or failure

          -  Current illicit drug use

          -  Requires traumatic or emergent surgery

          -  Pregnant women

          -  Women who are breastfeeding

          -  Prisoners

          -  Cognitively impaired requiring Legally Authorized Representative (LAR) or Power of
             Attorney (POA)

          -  Unable to swallow oral capsules
Oral Ketorolac for Pain Relief During IUD Insertion
Condition: Contraception
Intervention: Ketorolac; Placebo
Intervention description: Oral Tablet; Oral Tablet
Intervention MeSH terms: Ketorolac
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 71.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: intrauterine device

Summary:

      Ketorolac is a non-steroidal anti-inflammatory drug (NSAID), similar to ibuprofen but it is
      used to treat more severe pain. Ketorolac (Trade name: Toradol) is typically used after
      surgical procedures. When taken orally, it should not cause sedation. The purpose of this
      study is to determine if oral ketorolac is effective at reducing pain during IUD placement
      versus a placebo tablet.
    

Eligibility criteria:

        Inclusion Criteria:

          -  non-pregnant

          -  English speaking women

          -  18 years of age or older desiring an IUD for contraception

        Exclusion Criteria:

          -  enrollment in another study

          -  pre-medication with any type of analgesic medication

          -  contraindication to an IUD

          -  weight under 50 kg

          -  allergy to non-steroidal anti-inflammatory medications

          -  past medical history of liver disease, renal disease, peptic ulcer disease or recent
             gastrointestinal bleed,

          -  daily narcotic pain use

          -  positive cultures for gonorrhea or chlamydia.
Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Erenumab; Topiramate; Erenumab matching placebo; Topiramate matching placebo
Intervention description: 70mg/1mL (70 mg) or 2x70mg/1mL (140 mg) in pre-filled syringe, administered every 4 weeks; Film-coated tablet taken orally:
25 mg administered once daily (first week of titration phase). After the first week, titration was done according to the summary of product characteristics (SmPC) in 25 mg increments each week and aimed to reach the recommended daily treatment dose of 100 mg (50/75/100 mg). 50/75/100 mg were administered twice daily during titration phase and maintenance phase.; Erenumab matching placebo pre-filled syringue administered every 4 weeks; Topiramate matching placebo administered daily
Intervention MeSH terms: Topiramate; Erenumab; Antibodies, Monoclonal
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 777.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Migraine; Episodic migraine; Chronic migraine; Headache; erenumab; topiramate; CAMG 334; Calcitonin Gene-related Peptide; CGRP; CGRP receptor agonist; monoclonal antibody; treatment failure

Summary:

      This study used a single-cohort, 2-treatment arm, parallel-group randomized, double-blind,
      double-dummy design in adult patients with episodic migraine and chronic migraine, who had to
      be either naïve or not suitable for or could have failed up to three prophylactic treatments
      out of: propranolol/metoprolol, amitriptyline, flunarizine. Patients were stratified into
      groups according to their number of migraine days during the baseline period.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Documented history of migraine in the 12 months prior to screen

          2. at least 4 days per month of migraine symptoms

          3. >=80% diary compliance during the Baseline period

          4. Patients must be either naïve or not suitable or have failed previous migraine
             prophylactic treatments

        Key Exclusion Criteria:

          1. Older than 50 years of age at migraine onset

          2. Pregnant or nursing

          3. History of cluster or hemiplegic headache

          4. History or evidence of major psychiatric disorder

          5. Score of 19 or higher on Beck Depression Inventory (BDI)