bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents According to Different Vaccination Schedules
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The proposed study is aimed to assess the antibody response and short-term persistence of
      Novartis Meningococcal B Vaccine after one, two or three doses and to evaluate the optimal
      vaccination schedule in an adolescent population.
    


Intervention name(s): rMenB+OMV NZ; Placebo
Intervention type(s): Biological; Biological
Other intervention name(s): Serogroup B Meningococcal Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Meningococcal disease; Neisseria meningitidis serogroup B; prevention; vaccination; adolescents
3 Snip Punctoplasty With and Without Mitomycine C.
Condition: Punctal Stenosis
MeSH terms: Constriction, Pathologic
Study type: Interventional

Summary: 
      Punctal stenosis is a progressive constriction of the puncta with resultant epiphora. One of
      the most effective treatment options is 1- to 4-snip punctoplasty combined with or without
      Mitomycin-C.
    


Intervention name(s): 3-snip punctoplasty; 3-snip punctoplasty and Mitomycin C
Intervention type(s): Procedure; Procedure
Intervention description(s): punctoplasty, more commonly known as watery eye surgery, is an ophthalmic surgical procedure performed to correct punctal stenosis (a condition that causes tears to overflow from the eyes) by widening the punctal opening to allow the tears to drain with ease.; punctoplasty, more commonly known as watery eye surgery, is an ophthalmic surgical procedure performed to correct punctal stenosis (a condition that causes tears to overflow from the eyes) by widening the punctal opening to allow the tears to drain with ease.
Mitomycin C is a chemotherapeutic agent that acts by inhibiting DNA synthesis
Intervention MeSH terms: Mitomycins; Mitomycin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
AML2003 - Standard-Therapy vs Intensified Therapy for Adult Acute Myeloid Leukemia Patients <= 60 Years
Condition: Leukemia, Nonlymphocytic, Acute
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 4

Summary: 
      AML2003 is a prospective randomized trial, to investigate the value of early allogeneic stem
      cell transplantation in aplasia after induction therapy for high risk patients with acute
      myeloid leukemia.
    

Detailed description: 
      AML2003 is a prospective randomized trial, to investigate the value of early allogeneic stem
      cell transplantation in aplasia after induction therapy for high risk patients with acute
      myeloid leukemia. A rapid analysis of risk-factors (cytogenetics, FLT3 status, clearance of
      blasts after first induction) and the donor situation is of utmost importance. For this "fast
      search" diagnostic, which is accomplished in all enclosed patients, significant resources are
      provided, to take the load off the participating centers. Furthermore, the relevance of
      autologous transplantation and the benefit of additional substances within the postremission
      therapy such as m-AMSA or mitoxantrone will be investigated. There is an up-front
      randomisation in four therapy arms with two cross-classifying factors of two stages
      (intensified vs. standard therapy and Ara C vs. Ara C+ mitoxantrone + m-AMSA). Thus, the
      intergroup treatment schedule of the German Competence Network is integrated into the AML2003
      study as a central element and 25% of the patients are treated accordingly. In the
      intensified therapy arms a risk-adapted and priority-based therapy is implemented, including
      early allogeneic and consolidating autologous stem cell transplantation, respectively. In
      addition to the clinical questions , a detailed concomitant research program was initiated
      for the AML2003 study, to get a better view of the heterogeneity of AML and to open new ways
      for "custom-made" therapies.
    

Intervention name(s): Cytarabine vs. Cytarabine+Amsacrine+Mitoxantrone; early allogeneic PBSCT within induction therapy; autologous PBSCT
Intervention type(s): Drug; Procedure; Procedure
Intervention MeSH terms: Cytarabine; Mitoxantrone; Amsacrine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute myeloid leukemia; risk adapted treatment; early allogeneic stem cell transplantation; autologous stem cell transplantation
The Effects of California Strawberries on Parameters of Cardiovascular Health
Condition: Childhood Obesity; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Pediatric Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The prevalence of childhood obesity has been increasing over the past couple of decades.
      Similar to adults, overweight and obesity in young children and adolescents is associated
      with an increased number of cardiovascular risk factors including dyslipidemia, hypertension,
      insulin resistance and Type 2 diabetes. Epidemiological and clinical studies suggest that
      foods and ingredients rich in select flavonoids, such as cocoa, red grape products, tea,
      citrus fruits, and strawberries are protective against the development of cardiovascular
      disease. Strawberries are rich in flavonoids, particularly anthocyanins, flavanols,
      flavonols, ellagic acid and its glucose ester, ellagitanin. A number of in vitro studies have
      observed that these isolated compounds, as well as strawberry extracts have the potential to
      affect outcomes of cardiovascular health, including vascular reactivity, cellular signaling
      and oxidant defense6,7. We hypothesize that strawberry intake will lead to improvements in
      select measures of cardiovascular function in overweight and obese adolescent males.
    


Intervention name(s): flavonoid-rich freeze-dried strawberry powder; macronutrient-matched control powder
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 50g of flavonoid-rich freeze-dried strawberry powder; 50g macronutrient-matched powder that will lack strawberry flavonoids
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: strawberry, cardiovascular, obesity, adolescent
Randomized Study of Yohimbine Treatment for Type 2 Diabetes Patients Carrying a Specific Genetic Risk Variant
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators have recently discovered a genetic variant in an adrenergic receptor that
      leads to increased risk for type 2 diabetes. The investigators have also seen that blockers
      of that receptor improves impaired insulin secretion in animals. The investigators will now
      test the blocker in patients with type 2 diabetes with or without the risk variant in an
      effort to make diabetes treatment more individualized.
    

Detailed description: 
      We have recently discovered a genetic variant in an adrenergic receptor that leads to
      increased risk for type 2 diabetes. We have also seen that blockers of that receptor improves
      impaired insulin secretion in animals. We will now test the blocker in patients with type 2
      diabetes with or without the risk variant in an effort to make diabetes treatment more
      individualized. Patients will receive two different doses of the blocker and the effect will
      be measured with oral glucose tolerance tests. The study is a randomized placebo-controlled
      study.
    

Intervention name(s): Yohimbine
Intervention type(s): Drug
Intervention description(s): Yohimbine capsule
Intervention MeSH terms: Yohimbine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: genetics; type 2 diabetes; insulin secretion
Study of Usefulness of Genotyping to Predict Docetaxel Exposure and Adverse Events
Condition: CYP3A Phenotyping; CYP3A5 and MDR1 Genotyping; Docetaxel Toxicity; Associations Between Genetic Data and Docetaxel Toxicity
Study type: Observational

Summary: 
      Twenty patients with verified high risk breast cancer will be included in the study. Patients
      will receive three cycles of docetaxel followed by three cycles of CEF for their adjuvant
      treatment. The phenotype of CYP3A and the genotype of CYP3A5 and MDR1 will be assessed. Also
      the effect of docetaxel in the activity of CYP3A will be measured by peroral midazolam.

      Primary Object:

      The primary object of this study is to define, if it is possible to predict the clearance
      and/ or toxicity of docetaxel by assessing

        -  activity of CYP3A4 by midazolam test (CYP3A4 phenotype)

        -  CYP3A5 genotype

        -  MDR1 genotype

      Secondary object:

      The secondary object of this study is to define whether the treatment with docetaxel alters
      the activity of CYP3A4 enzyme in previously untreated breast cancer patients.
    


Intervention name(s): docetaxel + CEF
Intervention type(s): Drug
Intervention description(s): Docetaxel 80 mg/m² of body surface area (BSA) will be given as an i.v. infusion during 60 minutes on day 0 in a 20-day schedule. The cycle is repeated three times.
Three weeks after the last docetaxel regimen, all patients will receive the CEF-combination treatment. In CEF-combination cyclophosphamide will be given 600 mg/m²of BSA as an i.v. infusion during 15 - 30 minutes on day 0 in a 20-day schedule. This is followed by fluorouracil given 600 mg/m² of BSA as an i.v. infusion during 15 - 30 minutes . Epirubicin will be given 60 mg/m² of BSA as an i.v. infusion during 15 - 30 minutes. This combination therapy will be repeated three times.
Intervention MeSH terms: Docetaxel
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Twenty patients with verified high risk breast cancer.
      
Biospecimen description: 
      Blood samples for genotyping and phenotyping as well as analysis of docetaxel concentrations.
    
Keywords: docetaxel toxicity; CYP3A activity; CYP3A5; MDR1; peroral midazolam
Prophylactic Administration of Levosimendan in Patients Undergoing Coronary Surgery
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The present pilot study aims to investigate the effectiveness of the preoperative infusion of
      levosimendan in patients with impaired left ventricular function undergoing coronary artery
      bypass grafting.
    

Detailed description: 
      Myocardial revascularization in patients with impaired left ventricular function remains a
      serious problem in cardiac surgery. Despite the recent developments with the use of new
      surgical techniques (mini-extracorporeal circulation, off pump surgery) the perioperative
      morbidity and mortality are relatively high. Therapeutic solutions with the use of inotropic
      drugs, as adrenergic agonists and phosphodiesterase inhibitors, have offered important
      improvement to the hemodynamic status of these patients, but they have not considerably
      decreased mortality. These drugs owe their positive inotropic action to the increase of
      intracellular calcium and thereafter they improve the myocardial function.

      Levosimendan (SIMDAX) is a new calcium sensitizer which increases the myocardial
      contractility without particular promotion of the intracellular calcium accumulation.
      Contemporary experimental and clinical data demonstrated the effectiveness of this drug in
      the reduction of surgical mortality to the patients with low left ventricular ejection
      fraction (LVEF) who undergo coronary artery bypass grafting (CABG).

      This is an original prospective randomized controlled study focused on the preoperative use
      of this drug in patients with impaired left ventricular function which is associated with a
      high operative risk (i.e. EuroSCORE). Perioperative myocardial stunning is particularly
      evident in this cohort of patients. Prophylactic administration of levosimendan the day
      before the operation could be translated in improved myocardial performance intraoperatively
      and during the early postoperative period.
    

Intervention name(s): Levosimendan infusion; Placebo infusion
Intervention type(s): Drug; Drug
Intervention description(s): Prophylactic 24h infusion of levosimendan at a dose of 0.1 mg/kg/min; Twenty-four hour administration of placebo
Intervention MeSH terms: Simendan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: coronary artery disease; levosimendan; coronary artery bypass grafting; cardiac surgery
Bioavailability of Desogestrel 0.075 mg Tablets With Regards to Reference Product
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      This Pivotal study investigated the bioavailability in women of 2 tablet formulations
      containing Desogestrel 0.075 mg. The Pivotal study was performed at a single site with 30
      subjects. Participants took 2 tablets of the test product and reference product in 2 periods
      and 2 sequences (either test after reference or reference after test). There was a washout of
      14 days between each study period.
    

Detailed description: 
      The primary objective of the study is to investigate the relative bioavailability of
      Desogestrel of 2 tablet formulations with Desogestrel 0.075 mg to demonstrate bioequivalence
      of both formulations in terms of rate and extent of absorption:

        -  Test Product: Product manufactured by Laboratorios Andrómaco S.A.

        -  Reference Product: Cerazette [Trademark], product of Merck Sharp and Dohme Ltda.,
           Brasil.

      The 90% confidence intervals for the intra-subject coefficient of variation (Test versus
      Reference Product) for the main pharmacokinetic parameters area under the plasma
      concentration-time curve from time zero to time t (AUC0-t) and from time zero to 72 hours
      (AUC0-72), and maximum plasma concentration (Cmax) for total metabolite etonogestrel was
      determined.

      Participants were confined in the study site for approximately 36 hours during each study
      period (for 12 hours pre-dosing and for 24 hours post dosing) during which pharmacokinetic
      (PK) blood samples were obtained. 16 blood samples were taken up to 24 hours after the
      administration in each period. Participants returned to the site to provide additional blood
      samples at 48 h, and 72 h postdose.

      The washout period between the two study periods was 14 days. The samples from each
      participant were analyzed with 2 methods of highperformance liquid chromatography-tandem mass
      spectrometry bioanalytical assays to quantify total Dienogest and Ethinyl estradiol in
      plasma.

      The safety objective was to evaluate the tolerability of both formulations in women by
      collecting adverse events.
    

Intervention name(s): Desogestrel 0.075 MG; Desogestrel 0.075 MG
Intervention type(s): Drug; Drug
Intervention description(s): Test Drug; Reference Product
Other intervention name(s): Investigational Medicinal Product; Cerazette (Trademark)
Intervention MeSH terms: Desogestrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
mCVI Confirmatory Clinical Study: Algorithm Verification
Condition: Algorithm Verification
Study type: Observational

Summary: 
      This single center confirmatory clinical study is to verify the algorithm of mCVI® to
      accurately capture pulse rate and respiratory rate in 20 healthy subjects in comparison to
      commercially-available Masimo pulse oximeter devices. This is a non significant risk device.
    

Detailed description: 
      In this confirmatory clinical study the mCVI® device is a mobile application used to simply
      verify the algorithm when the mobile video reads a patients pulse rate and respiratory rate
      while spontaneously breathing. There is no facial recognition technology. There is no
      immediate feedback given to the research team to act upon or provide for further clinical
      care decisions. In real time, the mCVI® device will be compared to two commercially available
      Masimo pulse oximeter devices in a single visit.
    

Intervention name(s): There is no intervention
Intervention type(s): Other
Intervention description(s): There is no intervention
Observational model: Family-Based
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Volunteers
A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients
Condition: Hepatitis B
MeSH terms: Hepatitis B
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a
      study drug) after liver transplantation.
    

Detailed description: 
      A 52-week, Multi-center, Open label, Single arm, Phase 3 Study to Evaluate the Efficacy and
      Safety of Hepabulin IV in HBsAg positive Liver Transplantation recipients
    

Intervention name(s): Hepabulin IV
Intervention type(s): Drug
Intervention description(s): I.V.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Liver Transplantation; HBV; HBV Recurrence; HBsAg Positive
Bioequivalence Study of Torrent Pharmaceutical Limited's Pantoprazole Sodium 40 mg Delayed Release Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      To compare the single dose bioavailability of Torrent's Pantoprazole Sodium Delayed - Release
      Tablets 1 × 40 mg and PROTONIX® (Pantoprazole Sodium) Delayed - Release Tablets 1 × 40 mg of
      Wyeth Pharmaceutical Inc. Dosing periods were separated by a washout period of at least 7
      days.

      Study Design:

      randomized, open label, two treatment, two period, two sequence, single dose, crossover study
      in healthy human adult subjects
    


Intervention name(s): Torrent's Pantoprazole Sodium Delayed - Release Tablets
Intervention type(s): Drug
Intervention MeSH terms: Pantoprazole
Interleukin-2 in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill acute myelogenous
      leukemia cells.

      PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients with
      acute myelogenous leukemia that has relapsed following previous treatment.
    

Detailed description: 
      OBJECTIVES: I. Assess the therapeutic activity of interleukin-2 (IL-2) in patients with
      slowly progressing acute myeloid leukemia with limited bone marrow blastosis either in first
      relapse after autologous bone marrow or peripheral blood stem cell transplantation, or with
      more advanced disease (i.e., refractory to chemotherapy regimens). II. Characterize the acute
      side effects of IL-2 in these patients.

      OUTLINE: This is an open label, nonrandomized, multicenter study. Patients are stratified
      into two categories of prior failed treatments (first relapse after autologous bone marrow or
      peripheral blood stem cell transplantation vs first or subsequent relapse either refractory
      to or not eligible for further conventional treatment). Interleukin-2 (IL-2) is administered
      as a continuous intravenous infusion on 5 consecutive days at daily escalating doses for the
      first cycle. When the individual maximum tolerated dose (MTD) has been determined, 3 more
      cycles are given at the MTD. There are 3 days of rest between each treatment cycle. After the
      induction phase, maintenance cycles of IL-2 are administered starting 4 weeks after the last
      induction treatment. Maintenance cycles of IL-2 are administered subcutaneously on 5
      consecutive days every 4 weeks for 2 years, and subsequently every other month for a maximum
      of 3 years. Treatment continues until disease progression or unacceptable toxicity for a
      maximum of 5 years. Patients are followed every 4 weeks during the first 2 years, then every
      8 weeks during the next 3 years or until documented progression, and then every 3 months
      until death.

      PROJECTED ACCRUAL: A maximum of 86 (57 transplanted; 29 patients nontransplanted) patients
      will be accrued into this study within 2 years.
    

Intervention name(s): aldesleukin
Intervention type(s): Biological
Intervention MeSH terms: Aldesleukin
Primary purpose: Treatment
Keywords: recurrent adult acute myeloid leukemia
Integrative Cognitive-Affective Therapy for Adolescent Eating Disorders
Condition: Eating Disorder; Emotional Disorder
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      Recently, Integrative Cognitive-Affective Therapy (ICAT), a novel intervention for bulimia
      nervosa (BN) and binge eating disorder (BED) that targets emotion regulation deficits, has
      shown promise in reducing eating disorder symptoms as well as improving emotion regulation
      capacities in adults. However, this treatment has not been investigated in an adolescent
      sample. Given the contributing role of emotion regulation in adolescent eating disorder
      symptoms and limited treatment options for adolescents with BN and BED, the aim of this study
      is to adapt the existing adult ICAT treatment for adolescents with clinically significant
      binge eating (ICAT-A) and to evaluate the extent to which ICAT-A is helpful in reducing binge
      eating and associated eating disorder symptoms in a younger sample.
    


Intervention name(s): Integrative cognitive-affective therapy for adolescents (ICAT-A)
Intervention type(s): Behavioral
Intervention description(s): Participants will receive a 21-session individual psychotherapy approach with 4 phases. In addition, there will be 7-13 additional conjoint parent sessions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment