bioihbjkbjnl/mcl2 huggingface dataset:
Subcutaneous Progesterone Versus Vaginal Progesterone Tablets for Luteal Phase Support in In Vitro Fertilization (IVF)
Condition: In Vitro Fertilization
Study type: Interventional
Phase: Phase 3

Summary: 
      Prospective, open, randomized, parallel, multicenter, two-arm trial to evaluate the efficacy
      and tolerability of a new progesterone formulation to be used for luteal support in IVF
      (Progesterone-IBSA) administered subcutaneously at a daily dose of 25 mg versus Progesterone
      tablets administered intravaginally at 100 mg twice daily for a total dose of 200 mg.
    


Intervention name(s): Progesterone; Progesterone
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg, once a day, SC; 100 mg, twice a day, vaginally
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Luteal support in IVF
Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate a single dose of FluBlok in terms of safety,
      efficacy and effectiveness in prevention of influenza and influenza-like illness and assess
      clinical lot-to-lot consistency in manufacturing by evaluating and comparing the
      immunogenicity of three different lots of FluBlok in a subset of participants.
    

Detailed description: 
      All currently licensed influenza vaccines in the United States were produced in embryonated
      hen's eggs. There were several well-recognized disadvantages to the use of eggs as the
      substrate for influenza vaccine. Eggs required specialized manufacturing facilities and could
      be difficult to scale up rapidly in response to an emerging need such as a pandemic. It was
      usually necessary to adapt candidate vaccine viruses for high-yield growth in eggs, a process
      that could be time consuming, was not always successful, and could select receptor variants
      that might have suboptimal immunogenicity. In addition, agricultural diseases that affected
      chicken flocks, and that might be an important issue in a pandemic due to an avian influenza
      virus strain, could easily disrupt the supply of eggs for vaccine manufacturing. Therefore,
      development of alternative substrates for influenza vaccine production had been identified as
      a high-priority objective.

      One potential alternative method for production of influenza vaccine was expression of the
      influenza virus hemagglutinin (HA) using recombinant deoxyribonucleic acid (DNA) techniques.
      This alternative avoided dependence on eggs and was very efficient because of the high levels
      of protein expression under the control of the baculovirus polyhedrin promoter.
    

Intervention name(s): FluBlok®; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Dose: 0.5 mL, single dose; Route of administration: intramuscular. Recombinant Trivalent Hemagglutinin Influenza Vaccine containing 45 microgram (mcg) of each hemagglutinin derived from A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004; Dose: 0.5 mL normal saline for injection, single dose; Route of administration: intramuscular
Other intervention name(s): rHA Trivalent Recombinant Hemagglutinin Influenza Vaccine
Intervention MeSH terms: Hemagglutinins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Influenza
Crossover Study to Compare PK of Once Daily LCP-Tacro Tablets to Generic Tacrolimus Capsules Twice Daily.
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      Open label, prospective, single-center, randomized, two sequence, three period crossover
      study to compare the steady state pharmacokinetics of LCP-Tacro tables to generic tacrolimus
      capsules administered twice daily in stable African-American renal transplant patients.
    

Detailed description: 
      This is open label, prospective, single-center, randomized, two sequence, three period
      crossover study to compare the steady state pharmacokinetics of once daily dosing of
      LCP-Tacro tablets to tacrolimus capsules administered twice daily in stable African American
      kidney transplant patients.

      Approximately 72 male and female African American renal transplant patients on table
      immunosuppression regimens will be randomly assigned in a 1:1 ratio to one of two sequences:

      Sequence 1: (n=36) 18 patients requiring less than 0.15 mg/kg/day and 18 patients requiring
      equal to or greater than 0.15 mg/kg/day. Patients will continue on generic tacrolimus
      capsules on days 1-7 (24 hours PK profile on day 7) then patients are switched to LCP-Tacro
      tablets (at 15% lower dose of twice daily generic tacrolimus) on day 8.

      Sequence 2: (n=36) 18 patients requiring less than 0.15 mg/kg/day and 18 patients requiring
      equal to or greater than 0.15 mg/kg/day. Patients will receive LCP-Tacro tablets (at 15%
      lower dose than generic tacrolimus twice daily formulation) on days 1-7 (24 hour PK profile
      on day 7) patients are switched back to twice daily generic tacrolimus treatment beginning on
      day 8.
    

Intervention name(s): LCP-Tacro; Tacrolimus -IR
Intervention type(s): Drug; Drug
Intervention description(s): once-daily extended release tablet; twice daily capsules
Other intervention name(s): Envarsus XR; Prograf; Generic Tacrolimus
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cryotherapy in Treating Patients With Primary Stage I Non-Small Cell Lung Cancer or Lung Metastasis
Condition: Lung Cancer; Metastatic Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Cryotherapy kills tumor cells by freezing them. Giving cryotherapy before surgery
      may kill more tumor cells.

      PURPOSE: This phase I trial is studying how well cryotherapy works in treating patients with
      primary stage I non-small cell lung cancer or lung metastasis.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Evaluate the histologic result of treating patients with primary stage I non-small cell
           lung cancer or lung metastasis after neoadjuvant percutaneous cryotherapy (PTC).

      Secondary

        -  Provide a qualitative assessment of the histology from the ablation and tumor margins,
           comparing histologic observations with imaging-enhancement patterns by CT or PET scan
           before and after PTC.

      OUTLINE: Patients undergo CT-guided percutaneous cryotherapy (PTC) over 2 hours.
      Approximately 3 weeks after completion of PTC, patients undergo thoracotomy consisting of
      lobectomy of the primary lung cancer or wedge resection with adequate margin for the
      metastatic lesion, and mediastinal lymph node dissection.

      Tissue samples from ablation and tumor margins are collected during thoracotomy and compared
      with imaging-enhanced patterns of CT or PET scans taken at baseline and after PTC.

      After completion of study therapy, patients are followed periodically for 6 months.
    

Intervention name(s): Cryotherapy (PTC); Prednisone
Intervention type(s): Procedure; Drug
Intervention description(s): CT-guided PTC with the intent to eradicate the entire tumor(s).; Prednisone taken:
20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure
Other intervention name(s): Rayos; Sterapred
Intervention MeSH terms: Prednisone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lung metastases; stage I non-small cell lung cancer
A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic
Condition: Dyslipidemias; Cardiovascular Diseases; Hypertriglyceridemia
MeSH terms: Cardiovascular Diseases; Dyslipidemias; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Atherogenic dyslipidemia includes patients who have coronary heart disease (CHD) or CHD risk
      equivalents, whose TG level is not adequately controlled after statin monotherapy. According
      to the published ESC/EAS consensus, fibrate is suggested to be added to this type of patient
      who has insufficient improvement. The purpose of the study is to evaluate the efficacy on
      lipid control and the safety of adding fenofibrate in patients on a background of statin
      treatment.
    

Detailed description: 
      It is an open-label , single group, multi-center study. At around 30 investigate sites, 500
      dyslipidemic Chinese patients with coronary heart disease (CHD) or CHD risk equivalent, whose
      TG ≥1.70 mmol/L (150mg/dl) and <5.65mmol/L (500mg/dl) after at least 2 month statin
      monotherapy with standard dose will be enrolled. After at least 2 month statin monotherapy
      with standard dose, patients having high TG will be recruited and given statin-fenofibrate
      combination therapy for 8 weeks. Several lipid parameters and safety parameters will be
      compared between baseline, after 4 weeks treatment and after 8 weeks treatment. Primary
      efficacy endpoint is the percentage of TG decrease before and after 8 weeks treatment.
      Secondary endpoints on efficacy are the absolute change and the percent of change on TC,
      LDL-C, HDL-C, apoA1, apoB and apoB/apoA1 of baseline, after 4 weeks treatment and 8 weeks
      treatment, absolute change and percentage of change of hsCRP from baseline to 8 weeks of
      treatment. Second endpoints on safety is the incidence of AE/SAE, change on CK, ALT, AST, BUN
      and Cr before and after treatment and the number of clinical meaningful abnormal change
      defined as ALT or AST >3ULN, or CK >10ULN, or BUN >1.5ULN or Cr >1.5ULN. Other Arm type is a
      self comparator
    

Intervention name(s): fenofibrate
Intervention type(s): Drug
Intervention description(s): Fenofibrate Capsule 200mg qd orally
Other intervention name(s): ABT-799; lipanthyl
Intervention MeSH terms: Fenofibrate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lipid Regulating Agents; Drug Therapy; cardiovascular diseases; hypertriglyceridemia; Hydroxymethylglutaryl-CoA Reductase Inhibitors; fenofibrate; Dyslipidemias; Combination
DTGM Fusion Protein in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: DTGM fusion protein may be able to locate cancer cells and stop them from growing.

      PURPOSE: Phase I/II trial to study the effectiveness of DTGM fusion protein in treating
      patients who have recurrent or refractory acute myeloid leukemia.
    

Detailed description: 
      OBJECTIVES: I. Determine the maximum tolerated dose of DTGM fusion protein in patients with
      recurrent or refractory adult acute myeloid leukemia. II. Determine the dose-limiting toxic
      effects of this regimen in these patients. III. Measure the pharmacokinetics of this regimen
      in these patients. IV. Evaluate the response rate at the maximum tolerated dose and immune
      responses in patients treated with this regimen. V. Correlate in vitro sensitivity of
      leukemic blasts to this regimen with the response rate in these patients. VI. Correlate tumor
      necrosis factor genetic polymorphisms with toxicity profiles and dose-limiting toxic effects
      of this regimen in these patients.

      OUTLINE: This is a dose-escalation study. Patients are stratified according to serum level of
      anti-DTGM antibody titer (2 mg/L or less vs greater than 2 mg/L). Patients receive DTGM
      fusion protein IV over 15 minutes on days 1-5. Patients with a partial response are eligible
      for retreatment. Cohorts of 3-6 patients receive escalating doses of DTGM fusion protein
      until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
      preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the
      MTD is determined, additional patients are accrued to receive treatment with DTGM fusion
      protein at the MTD. Patients are followed monthly until disease progression.

      PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study within 3 years.
    

Intervention name(s): DTGM fusion protein
Intervention type(s): Biological
Primary purpose: Treatment
Keywords: recurrent adult acute myeloid leukemia; secondary acute myeloid leukemia
Entinostat in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors
Condition: Brain Stem Neoplasm; Pineal Region Neoplasm; Recurrent Lymphoma; Recurrent Malignant Solid Neoplasm; Recurrent Primary Central Nervous System Neoplasm; Recurrent Visual Pathway Glioma; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Primary Central Nervous System Neoplasm; Refractory Visual Pathway Glioma
MeSH terms: Lymphoma; Neoplasms; Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms; Optic Nerve Glioma; Brain Stem Neoplasms; Pinealoma; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I trial studies the side effects and best dose of entinostat in treating pediatric
      patients with solid tumors that have come back or have not responded to treatment. Entinostat
      may block some of the enzymes needed for cell division and it may help to kill tumor cells.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose of entinostat
      administered as a single-agent, once weekly to children with recurrent or refractory solid
      tumors.

      II. To define and describe the toxicities of entinostat administered as a single agent, once
      weekly to children with recurrent or refractory solid tumors.

      III. To characterize the pharmacokinetics of entinostat in children with recurrent or
      refractory cancer.

      SECONDARY OBJECTIVES:

      I. To preliminarily define the antitumor activity of entinostat within the confines of a
      phase 1 study.

      II. To assess change in histone H3 and H4 acetylation in peripheral blood mononuclear cells
      (PBMCs) as a marker of the biologic activity of entinostat.

      OUTLINE: This is a dose escalation study.

      Patients receive entinostat orally (PO) on days 1, 8, 15, and 22. Cycles repeat every 28 days
      for up to 5 years in the absence of disease progression or unacceptable toxicity.
    

Intervention name(s): Entinostat; Laboratory Biomarker Analysis; Pharmacological Study
Intervention type(s): Drug; Other; Other
Intervention description(s): Given PO; Correlative studies; Correlative studies
Intervention MeSH terms: Entinostat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Study to Evaluate the Efficacy and Safety of Two Marketed Investigational Products in Children With Diaper Rash
Condition: Diaper Rash
MeSH terms: Diaper Rash
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate whether Desitin; Zinc Oxide Diaper Rash Ointment (Desitin Original) and Desitin
      Creamy; Zinc Oxide Diaper Rash Ointment (Desitin Creamy) provide relief of the signs and
      symptoms associated with diaper rash after 12 and 24 hours of product application.
    

Detailed description: 
      Subjects received applications of the investigational products following a gentle cleansing
      of the diaper zone at every diaper change and following bathing of the child during a 24 hour
      period.

      Efficacy was assessed during this study through the documentation of the severity of diaper
      rash. Results of five anatomic areas and overall severity score by the evaluator's
      assessments, and parent/guardian's assessments all indicated that both products were
      significantly effective (P<0.05 in relieving diaper dermatitis (rash) after 12 and 24 hours
      of treatment.

      Safety was assessed through the reporting of adverse events during the course of the study.
      Overall, the reporting of no adverse events under the conditions of the protocol indicate
      that the investigational products would appear to be safe for their intended use.
    

Intervention name(s): Zinc Oxide Diaper Rash Ointment; Aloe Vera/Tocopherol/Zinc Oxide Cream
Intervention type(s): Other; Other
Intervention description(s): Desitin Original at diaper change; Desitin Creamy at diaper change
Other intervention name(s): Desitin Original, Formula 311-2; Desitin Creamy, Formula 316-1
Intervention MeSH terms: Zinc; Tocopherols; Vitamin E; Tocotrienols; alpha-Tocopherol; Zinc Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Impact of Weight Loss Surgery in Adolescents With NAFLD
Condition: NAFLD; Obesity, Adolescent
MeSH terms: Pediatric Obesity; Weight Loss
Study type: Interventional

Summary: 
      This study will assess the impact of weight loss surgery (WLS) on non-alcoholic fatty liver
      disease (NAFLD) in adolescents as well as the interaction between NAFLD and cardiometabolic
      risk.
    

Detailed description: 
      While the impact of WLS has been studied in adults, little is known about NAFLD in
      adolescents undergoing WLS. At present, only a small number of adolescents undergo WLS each
      year and thus this area has not been well studied. However, as the prevalence of severe
      obesity continues to rise the investigators anticipate that so will WLS in adolescents.

      This study will establish the impact of WLS on NAFLD in adolescents. Currently, it is assumed
      that adolescents with NAFLD diagnosed at the time of WLS have universal resolution of their
      disease with appropriate weight loss, and no further evaluation is conducted. Our group has
      shown that up to 40% of adolescents who undergo WLS have persistently abnormal
      aminotransferase levels, suggesting that many may have persistent NASH and are at risk of
      progressive liver disease. The study will elucidate the history of NAFLD following WLS. Such
      data have not been previously published and will represent a significant contribution to this
      field.
    

Intervention name(s): MRI
Intervention type(s): Other
Intervention description(s): MRI to assess hepatic steatosis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Emergence Agitation After Nasal Surgery: a Randomized Controlled Comparison Between Melatonin and Mirtazapine
Condition: Agitation
MeSH terms: Psychomotor Agitation; Emergence Delirium
Study type: Interventional
Phase: Phase 4

Summary: 
      Emergence agitation (EA) is common after nasal surgery under general anesthesia, which can
      lead to several problems, such as increased risk of injury to the patient or medical staff,
      pain, decreased patient satisfaction, hemorrhage, re-bleeding at the operation site and
      unplanned self-extubation.

      Melatonin is an oral or sublingual medication, most commonly used for insomnia and improving
      sleep in different conditions for example shift-work disorder and for helping people to
      establish a day and night cycle especially blind children or adults.

      Mirtazapine is an antidepressant used in medicine in a pill form, most commonly used for
      major depressive disorder and other mood disorders, relief of anxiety, panic disorders,
      insomnia, headache and migraine.
    


Intervention name(s): Mirtazapine; Melatonin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Every patient will be given mirtazapine 30 mg tablet; Every patient will be given melatonin 5 mg tablet; Every patient will be given a matching placebo tablet
Intervention MeSH terms: Melatonin; Mirtazapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Effects of Recombinant Human Erythropoietin on Platelet Function in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to see if a naturally-occurring hormone called erythropoietin
      changes the action of platelets in the blood. Erythropoietin is made by the kidneys to
      stimulate red blood cell production to prevent anemia. Platelets are small cells in the blood
      that help clot blood in case of injury. Platelets also sometimes form blood clots in blood
      vessels that may cause heart attacks. This study is trying to determine whether
      erythropoietin increases the clotting action of platelets. Information on erythropoietin in
      healthy subjects may eventually help in the treatment of patients with heart attacks.
    

Detailed description: 
      Anti-apoptotic effects of erythropoietin in experimental myocardial infarction and
      ischemia-reperfusion injury suggest potential for therapeutic benefit in patients with acute
      MI. Before the therapeutic potential of rHuEpo in acute MI can be tested in large clinical
      trials, more information on the effects of short-term rHuEpo on platelet function are needed.
      Accordingly, the current proposal aims to determine the effects of 3 doses of rHuEpo
      (100U/kg, 200U/kg and 400U/kg daily for 3 days) on platelet function and other safety
      measures in healthy subjects.

      Specific Aim: To determine the effects of three ascending doses of rHuEpo vs. placebo on in
      vivo and in vitro platelet function in healthy subjects treated with aspirin and clopidogrel.

      Hypotheses to be tested: 1) 1) Short-term administration of rHuEpo does not alter bleeding
      time responses to aspirin and clopidogrel when compared with placebo. 2) Short-term
      administration does not alter in vitro platelet aggregation responses to aspirin and
      clopidogrel when compared with placebo.
    

Intervention name(s): Recombinant human erythropoietin alfa (drug); Aspirin (drug); Clopidogrel (drug)
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Aspirin; Epoetin Alfa; Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Platelet function tests; Erythropoietin; Aspirin; Clopidogrel