bioihbjkbjnl/mcl2 huggingface dataset:
Ramelteon in the Treatment of Sleep and Mood in Patients With Seasonal Affective Disorder
Condition: Seasonal Affective Disorder
MeSH terms: Mood Disorders; Seasonal Affective Disorder
Intervention: Ramelteon; Placebo
Intervention description: one 8 mg tablet at bed for up to 4 months; one tablet at bedtime for up to 4 months
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Seasonal Affective Disorder; Ramelteon; Psychiatry; Randomized Controlled Trial; Hamilton Depression Rating Scale- SAD Version; Circadian Rhythm

Summary:

      The purpose of this study is to determine whether treating sleep difficulties in patients
      with seasonal affective disorder also improves their depressive symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female age 18-65 yrs.

          -  A diagnosis of seasonal affective disorder

          -  A Pittsburgh Sleep Quality Index >5

          -  English speaking

          -  Be able to sign informed consent

        Exclusion Criteria:

          -  Active substance abuse

          -  Current psychotic symptoms

          -  Severe personality disorders

          -  Primary sleep disorders

          -  Severe chronic obstructive pulmonary disease (COPD)

          -  Prescription fluvoxamine(Luvox) use
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
Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients
Condition: Hepatitis B Vaccine
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: 60 µg dose hepatitis B vaccine; 20 µg dose hepatitis B vaccine
Intervention description: three-dose, 60 µg per dose; three-dose, 20 µg per dose
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 352.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis B, Vaccine; Randomized Controlled Trial; Hemodialysis; Immunogenicity

Summary:

      Intramuscular injection of 40 μg hepatitis B vaccine in a standard three-dose schedule or a
      four-dose schedule is recommended for hemodialysis patients. However, seroconversion rates
      are inadequate and persistence of immunity remains a challenge.

      This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune
      persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three
      injections at months 0, 1, and 6 in hemodialysis patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Having end-stage renal disease (ESRD) on maintenance hemodialysis

          -  Aged between 18 and 70 years at enrollment

          -  Serologically negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface
             antibody (anti-HBs) at enrollment

          -  Willing to adhere to the study protocol

        Exclusion Criteria:

          -  Being pregnant

          -  Acute cytolysis in the last three months before enrollment

          -  Any vaccination during the month preceding enrollment

          -  Intolerance or allergy to any component of the vaccine

          -  Ongoing opportunistic infection

          -  Hepatitis C virus infection

          -  Hematological disorder

          -  Cancer

          -  Unexplained fever the week before enrollment

          -  Immunosuppressive or immunomodulating treatment in the last six months

          -  Renal transplantation or upcoming renal transplantation

          -  Liver disease

          -  Other immunocompromised condition not related to ESRD

          -  An expected survival of < 6 months
Study To Determine The Pharmacokinetics Of Sulfasalazine In Children With Juvenile Idiopathic Arthritis
Condition: Arthritis, Juvenile Rheumatoid
MeSH terms: Arthritis; Arthritis, Juvenile
Intervention: Sulfasalazine
Intervention description: Sulfasalazine delayed release tablets 30-60 mg/kg/day (divided into BID doses) for 7 days. Blood sampling for Pharmacokinetic assessment to be performed on Day 7
Intervention MeSH terms: Sulfasalazine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Sulfasalazine delayed release tablets; azulfidine entabs; Pharmacokinetics; Juvenile Idiopathic Arthritis (JIA)

Summary:

      This study will characterize the steady state pharmacokinetics of sulfasalazine delayed
      release tablets in pediatric Juvenile Idiopathic Arthritis patients. Data from this study
      will fulfill the post approval commitment to the FDA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a diagnosis of oligoarticular, polyarticular, psoriatic or
             enthesitis-related JIA as determined by ILAR criteria. Patients who have been
             continuously treated with generic sulfasalazine delayed release formulation and have
             tolerated the product for at least 3 months prior to study enrolment and who are
             switched to Azulfidine-EN at least 8 days prior to Day 0 are eligible.

          -  Patients must be at least 6 years of age and has not reached his/her 18th birthday
             prior to the Baseline Visit (Day 0).

          -  Onset of JIA must have occurred prior to the patient's 16th birthday.

          -  Patients must weigh at least 20 kg.

          -  Patients must be on sulfasalazine 500 mg delayed release tablets and the total daily
             dose must be within the specified range of 30-60 mg/kg/day with a maximum daily dose
             of 3 g/day

        Exclusion Criteria:

          -  Patient currently with systemic features of systemic JIA.

          -  Hypersensitivity to sulfasalazine , its metabolites, sulfonamides or salicylates.

          -  History of sensitivity to heparin or heparin-induced thrombocytopenia.

          -  Inability to swallow whole (uncrushed) sulfasalazine 500 mg delayed release tablets as
             required by protocol
Changes in Triglyceride and Other Lipids (Levels of Fats Found in Blood) When Taking Darunavir Compared to Atazanavir in HIV-infected Patients That Have Never Received Treatment
Condition: HIV
Intervention: ritonavir; ritonavir; darunavir; emtricitabine [FTC]/tenofovir [TDF]; emtricitabine [FTC]/tenofovir [TDF]; atazanavir
Intervention description: 100 mg capsule or tablet once daily for 48 weeks; 100 mg capsule or tablet once daily for 48 weeks; 800 mg tablet once daily for 48 weeks; 200/300 mg tablet once daily for 48 weeks; 200/300 mg once daily for 48 weeks; 300 mg capsule once daily for 48 weeks
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Darunavir; Tenofovir; Emtricitabine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: HIV; AIDS; Immunodeficiency Virus, Human; PREZISTA; darunavir; TMC114; Protease Inhibitor; Truvada; Atazanavir; REYATAZ; HIV Infections; Treatment Naïve

Summary:

      The purpose of this research study is to compare changes in triglyceride and other lipids
      (levels of fats found in the blood) from Baseline (Day 1) to Week 12 for darunavir/ritonavir
      800/100 mg once daily versus atazanavir/ritonavir 300/100 mg once daily in combination with a
      fixed-dose background regimen consisting of emtricitabine [FTC]/tenofovir [TDF] 200/300 mg
      once daily). This study will also evaluate the safety (adverse events), effectiveness, and
      tolerability of darunavir/ritonavir and atazanivir/ritonavir over 48 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 RNA of 1000 copies/mL or more

          -  No previous treatment with antiretroviral drugs for more than 10 days

          -  Demonstrated sensitivity [Fold Change (FC) = lower Clinical Cut Off (CCO)] to
             tenofovir, darunavir and atazanavir

          -  Demonstrated sensitivity to emtricitabine defined as absence of M184V/I mutation

          -  Any CD4 (Cluster of Differentiation 4) cell count

        Exclusion Criteria:

          -  Body mass index >30 kg/m2

          -  Laboratory parameters as follows: fasting glucose >110 mg/dL, Low-Density Lipoprotein
             (LDL) cholesterol >130 mg/dL, triglycerides >200 mg/dL

          -  Presence of any currently active AIDS-defining illness

          -  Treatment for primary HIV infection or postexposure prophylaxis for HIV

          -  Patients with acute or chronic hepatitis A, B or C infection
Prevention of Surgical Site Infections: Effectiveness of Nasal Povidone-Iodine and Nasal Mupirocin
Condition: Surgical Site Infection
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection
Intervention: mupirocin calcium ointment, 2%; 3M Skin and Nasal Antiseptic
Intervention description: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.
After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares.; The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds.
Intervention MeSH terms: Povidone-Iodine; Anti-Infective Agents, Local; Mupirocin; Povidone; Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 1874.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      We hypothesize the application of mupirocin or povidone-iodine to the nares is equally
      effective in short term Staphylococcus aureus(SA)suppression. Our overall study objective is
      to measure the rate of deep and superficial Surgical Site Infections (SSIs) after primary
      hip, knee, shoulder and elbow arthroplasty surgery and primary spinal fusion surgery
      requiring implantation of prosthetic material, when the patient receives either nasal
      mupirocin or nasal povidone-iodine prior to surgery.

      Secondary study objectives include:

        1. Measure hospital length of stay and re-admission rates in the mupirocin and
           povidone-iodine groups.

        2. Measure adverse events related to mupirocin and povidone-iodine.

        3. Measure rate of SA resistance to mupirocin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary arthroplasty or spinal fusion surgery

          -  Age greater than 18 years

        Exclusion Criteria:

          -  Revision arthroplasty

          -  Revision spinal fusion surgery

          -  Primary spine surgery without implantation of prosthetic material

          -  Allergy to mupirocin

          -  Allergy to povidone-iodine

          -  Pregnancy

          -  Breastfeeding
Reducing Total Cardiovascular Risk in an Urban Community
Condition: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Diabetes Mellitus; Atherosclerosis; Cerebral Arteriosclerosis; Hypertension
MeSH terms: Intracranial Arteriosclerosis; Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Coronary Disease; Arteriosclerosis
Intervention: Lifestyle Changes; Antiplatelet Agents; Beta Blocker; ACE Inhibitors
Intervention description: Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise; Aspirin 81 mg q day; Oral medication; Oral medications, received 1-2 times per day
Intervention MeSH terms: Propranolol; Metoprolol; Atenolol; Lisinopril; Platelet Aggregation Inhibitors; Adrenergic beta-Antagonists; Angiotensin-Converting Enzyme Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 525.0
Sex: All
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      PLEASE NOTE: THIS STUDY IS ONLY ENROLLING PATIENTS CURRENTLY BEING TREATED AT BELAIR-EDISON
      FAMILY HEALTH CENTER.

      The purpose of this study is to compare the clinical effectiveness and cost effectiveness of
      two cardiovascular risk reduction programs - a comprehensive intensive (Cl) intervention with
      a less intensive (LI) intervention - in African American, and white low-income patients with
      known excessive cardiovascular disease risk.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently receiving medical care at Johns Hopkins University

          -  African American or Caucasian and have diagnosed CVD, defined as a prior myocardial
             infarction, revascularization procedure for coronary disease, ischemic heart disease,
             stroke, or have diagnosed type 2 diabetes and not receiving any therapy

          -  Have either no LDL-C in their medical record during the 12 months prior to study entry
             or have an LDL greater than or equal to 100 mg/dl on or off lipid lowering
             pharmacotherapy

          -  Have either no blood pressure recorded in their medical record during the 12 months
             prior to study entry or a BP greater than 140/90 mmHg or greater than 130/80 mmHg if
             the participant is diabetic or has renal insufficiency

          -  If the participant is diabetic he or she has to either have no HbA1c recorded during
             the 12 months prior to study entry or HbA1c of 7 percent or greater

        Exclusion criteria:

          -  A serious life-threatening noncardiac comorbidity with a life expectancy of less than
             5 years

          -  A serious physician-recorded psychiatric morbidity that would interfere with the study

          -  Sufficient neurological impairment that would interfere with the study
Trial of Ultrasound Guided Femoral Nerve Block on Isolated Femur Fracture Using Echo Friendly Needles
Condition: Pain
MeSH terms: Femoral Fractures
Intervention: Femoral Nerve Block; Echogenic needle; Standard of care needle; Ultrasound
Intervention description: Femoral Nerve Block for isolated femur fractures; The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible.; The control group will receive ultrasound-guided femoral nerve block using standard of care needles.; The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible.
The control group will receive ultrasound-guided femoral nerve block using standard of care needles.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study aims to determine if there is any difference in the success rate of ultra-sound
      guided femoral nerve block performed with an echogenic needle versus a standard needle.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who present to the emergency department (ED) with isolated femur fracture (no
             other injuries)

          -  Patients who are cognitively alert and are able to verbalize their pain using a visual
             analog scale (VAS)

          -  Patients who are mentally competent to consent for the study

          -  Patients who can communicate in English or Spanish

        Exclusion Criteria:

          -  Gestation

          -  Prisoners

          -  Patients who cannot communicate in English or in Spanish

          -  Patients who have other significant injuries besides a femur fracture

          -  Patients who are cognitively impaired and/or unable to verbalize their pain using a
             visual analog scale (VAS)

          -  Patients with allergies to local anesthetics

          -  Patients with severe liver disease

          -  Patients with existing peripheral neuropathies in the affected limb

          -  Patients with history of complications from previous femoral blocks

          -  Patients with contraindications for needle insertion at inguinal area

          -  Local signs of infection

          -  Patient on anticoagulants and/or with history of coagulation disorders
Anterior Pituitary Hormone Replacement in Traumatic Brain Injury
Condition: Growth Hormone Deficiency; Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Pituitary Diseases; Wounds and Injuries
Intervention: Recombinant human growth hormone
Intervention description: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)
Intervention MeSH terms: Hormones
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: TBI; Traumatic Brain injury; Growth hormone deficiency; Anterior pituitary hormone; Recombinant human growth Hormone; Genotropin

Summary:

      Fifteen to twenty percent of adults who suffer a traumatic brain injury (TBI) that requires
      hospitalization and rehabilitation have been found to have growth hormone (GH) deficiency by
      GH stimulation testing. Moreover, abnormalities have also been established for the cortisol
      and thyroid axis. The hypothesis of this proposal is that hormone replacement in TBI patients
      with documented abnormalities in the GH, thyroid, or cortisol axis will improve muscle
      function, body composition, aerobic capacity (GH) and tests of neuropsychologic function (GH,
      thyroid, cortisol).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 21 and older.

          -  Documented moderate to severe traumatic brain injury at least one year post injury.

        Exclusion Criteria:

          -  The only absolute exclusionary medication will be an anticoagulant (Coumadin) because
             of the risk of bleeding during the possible muscle biopsy procedure and daily
             injections of rhGH in the GH arm of the study.

          -  Any subject with a history of hepatitis or a 3-fold elevation of liver function tests
             (Alk phos, alanine aminotransferase (ALT), aspartate aminotransferase (AST)). We are
             uncertain of the effects of hormone replacement such as rhGH on the liver, so we will
             exclude any subjects with hepatitis. This exclusion applies only to subjects who would
             be enrolled in the GH arm of the study.

          -  Subjects who are deficient in cortisol or thyroid at screening will be excluded until
             hormone abnormalities have been corrected.

          -  Subjects with chronic pain who are being managed with narcotics will be excluded as
             the effects of central nervous system depressants may interfere with study test
             results.