bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Flutiform, Fluticasone and Seretide in Treatment of Moderate to Severe Asthma in Paediatric Patients
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a comparator study to assess safety and efficacy of Flutiform compared with
      Fluticasone pMDI and Seretide pMDI in paediatric asthma patients with moderate to severe
      persistent, reversible asthma.
    

Detailed description: 
      This is a study involving a 2-4 week run-in phase followed by a 12 week double blind
      treatment phase. During the run-in phase, all subjects receive Flixotide. In the treatment
      phase subjects will be randomised to one of the 3 treatment groups and will receive active
      Flutiform and placebo Flixotide or Active Seretide and placebo Flixotide or active Flixotide
      and either placebo seretide or placebo Flutiform. Efficacy will be assessed by lung function
      tests, asthma symptoms, sleep disturbance due to asthma and rescue medication use. Safety
      will be assessed by adverse events, lab tests, urinary cortisol and vital signs.
    

Intervention name(s): Flutiform; Seretide; Flixotide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50/5ug (fluticasone/formoterol) 2 puffs twice daily; 50/25 ug (fluticasone/salmeterol) 2 puffs twice daily; 50ug 2 puffs twice daily
Intervention MeSH terms: Fluticasone; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: moderate to severe persistent reversible asthma
Cooperative Study of Factor VIII Inhibitors
Condition: Blood Coagulation Disorders; Hematologic Diseases; Hemophilia A; Hemorrhagic Disorders
MeSH terms: Hemostatic Disorders; Hemophilia A; Hematologic Diseases; Blood Coagulation Disorders; Hemorrhagic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To test the efficacy of prothrombin complex concentrates (Factor IX) in the treatment of
      hemophiliac patients who had inhibitors to Factor VIII.
    

Detailed description: 
      BACKGROUND:

      Despite major advances in the treatment of patients with hemophilia, a serious remaining
      challenge was presented by the occurrence of circulating inhibitors to Factor VIII. Because
      of lack of information on the natural course of patients with Factor VIII inhibitors, the
      relative efficacy of various modes of therapy was not established. The Division of Blood
      Diseases and Resources decided to sponsor a clinical investigation which would evaluate
      populations of hemophilia patients for Factor VIII inhibitors, follow up these patients to
      provide information on the natural history of the inhibitor in the hemophilia patients, and
      make available a reference center to monitor results and attain uniformity.

      Treatment of a patient with a severe inhibitor and consequent bleeding remained a problem.
      Management included protracted treatment with Factor VIII, use of immunosuppressive agents
      and prothrombin complex (or Factor IX) concentrates. The rationale for Factor IX was that it
      bypassed the defect in Factor VIII caused by the inhibitor. This method of therapy attracted
      wide popularity, but the success was greatly debated. It was intended at the very outset of
      the Factor VIII study that therapeutic trials involving patients with inhibitors would not be
      a prime function, but that such studies would be monitored if necessary. A controlled trial
      of Factor IX concentrates therapy was strongly advised by the DBDR Advisory Committee.
      Accordingly, during fiscal year 1978, a protocol for a double-blind control study was
      developed by the Factor VIII inhibitor group. The trial began in the spring of 1978, and the
      intervention terminated about one year later.

      DESIGN NARRATIVE:

      Double-blind study; patients served as their own controls. A total of 51 patients each
      received a single large dose of Konyne, Proplex, or diluted albumin (as a control). Joint
      bleeding of the elbow, knee, and ankle was evaluated six hours after each dose.
    

Intervention name(s): factor ix
Intervention type(s): Drug
Masking: Double
Primary purpose: Treatment
Antineoplaston Therapy in Treating Children With Visual Pathway Glioma
Condition: Visual Pathway Glioma
MeSH terms: Glioma; Optic Nerve Glioma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Current therapies for children with visual pathway gliomas, which are not amenable
      to or have not responded to standard therapy, provide limited benefit to the patient. The
      anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the
      treatment of children with visual pathway gliomas, which are not amenable to or have not
      responded to standard therapy.

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on children with visual pathway gliomas, which are not amenable to
      or have not responded to standard therapy.
    

Detailed description: 
      OBJECTIVES:

        -  To determine the efficacy of Antineoplaston therapy in children with visual pathway
           gliomas, which are not amenable to or have not responded to standard therapy, as
           measured by an objective response to therapy (complete response, partial response or
           stable disease).

        -  To determine the safety and tolerance of Antineoplaston therapy in children with visual
           pathway gliomas, which are not amenable to or have not responded to standard therapy.

      OVERVIEW: This is a single arm, open-label study in which children with visual pathway
      gliomas, which are not amenable to or have not responded to standard therapy, receive
      gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal)
      until the maximum tolerated dose is reached. Treatment continues for at least 12 months in
      the absence of disease progression or unacceptable toxicity. After 12 months, patients with a
      complete or partial response or with stable disease may continue treatment.

      To determine objective response, tumor size is measured utilizing MRI scans, which are
      performed every 8 weeks for the first two years, every 3 months for the third and fourth
      years, every 6 months for the 5th and sixth years, and annually thereafter.

      PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued to this study.
    

Intervention name(s): Antineoplaston therapy (Atengenal + Astugenal)
Intervention type(s): Drug
Intervention description(s): Children with a visual pathway glioma, which is not amenable to standard therapy or has not responded to standard therapy, will receive Antineoplaston therapy (Atengenal + Astugenal).
Other intervention name(s): A10 (Atengenal); AS2-1 (Astugenal)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: visual pathway glioma not amenable to standard therapy; visual pathway glioma not responding to standard therapy
Assessment of Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10
Condition: Meningococcal Disease; Meningococcal Meningitis
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This was a Phase 2b/3, multi-center, extension study of V72P10 to assess antibody persistence
      at 18 months after the vaccination course in study V72P10 (NCT00661713).

      Subjects who participated in study V72P10, and who meet all other enrollment criteria for
      this extension study, and a group of naïve subjects (defined as subjects who had never
      received rMenB+OMV NZ or other experimental MenB vaccines) of similar age to the subjects who
      were eligible to participate in this extension study, performed one study visit in which a
      single blood sample was drawn for MenB serological analyses.
    


Intervention name(s): No Vaccine; rMenB+OMV-NZ
Intervention type(s): Biological; Biological
Intervention description(s): Subjects who had received either rMenB+OMV-NZ or placebo at study month 6 in V72P10 study had a blood sample drawn for serological analyses at 18 months later (-1/+3 months).
Other intervention name(s): Serogroup B meningococcal recombinant vaccine
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal disease; Vaccines; Adolescents
Addition of Quetiapine in Obsessive Compulsive Disorder - Westenberg Study
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Quetiapine (Seroquel ®), an atypical antipsychotic registered for use in schizophrenia, which
      has a very low propensity of extrapyramidal and endocrine side-effects, has also been studied
      as an adjunct in OCD. In an open trial, ten patients with OCD who had not responded to at
      least three previous treatments with a SRI at maximum dose and duration were assigned to
      receive quetiapine in addition to a SRI for 8 weeks. Given the efficacy of quetiapine in
      treatment resistant patients, and given its rapid onset of action (4-6 weeks), it is
      postulated that the combination of a low dose atypical antipsychotic and a standard dosage of
      an SRI as a treatment for patients with OCD might increase the number of responders as well
      as the effect size.

      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation
      was changed to XR after consultation with FDA.
    


Intervention name(s): Quetiapine
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Obsessive Compulsive Disorder
Autologous Bone Marrow Stem Cell Transplantation in Patients With Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      This research investigates the use of autologous bone marrow stem cells in patients with
      spinal cord injury.
    

Detailed description: 
      The aim of this study is to evaluate autologous bone marrow stem cells transplantation as a
      safe and potentially beneficial treatment for patients with spinal cord injury.
    

Intervention name(s): Stem Cell Transplantation
Intervention type(s): Procedure
Intervention description(s): All patients will undergo autologous bone marrow stem cell transplantation into the lesion area.
Other intervention name(s): BMMSC - Bone Marrow Mesenchymal Stem Cells.
Intervention model: Single Group Assignment
Intervention model description: Mesenchymal stem cell transplantation.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal cord injury; Mesenchymal stem cells; Bone marrow
Efficacy and Safety Study of Finafloxacin Used in Helicobacter Pylori Infected Patients
Condition: Gram-Negative Bacterial Infections; Helicobacter Infections; Dyspepsia
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Gram-Negative Bacterial Infections; Helicobacter Infections; Dyspepsia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to compare the H. pylori eradication rates with
      Finafloxacin in combination with Amoxicillin or Esomeprazole.

      The secondary objective is to evaluate and compare the safety and tolerability of multiple
      oral doses of Finafloxacin plus Amoxicillin versus Finafloxacin plus Esomeprazole.
    


Intervention name(s): Finafloxacin + Amoxicillin; Finafloxacin + Esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Finafloxacin, tablets, 400 mg b.i.d. (8 X 50 mg tablets), oral administration; Amoxicillin, tablet 1000 mg b.i.d. (1 X 1000 mg tablet), oral administration; Finafloxacin, tablets, 400 mg b.i.d. (8 X 50 mg tablets), oral administration; Esomeprazole, tablet, 40 mg b.i.d. (1 X 40 mg tablet), oral administration
Other intervention name(s): Not apllicable
Intervention MeSH terms: Amoxicillin; Finafloxacin; Fluoroquinolones; Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori; Eradication; Dyspepsia
Aerobic Interval and Moderate Continuous Exercise Training on Ventricular Functions
Condition: Healthy; High Intensity Interval Training; Exercise Training
Study type: Interventional

Summary: 
      Hypoxic exposure increases right ventricular (RV) afterload by triggering pulmonary
      hypertension, with consequent effects on the structure and function of the RV. Improved
      myocardial contractility is a critical circulatory adaptation to exercise training. However,
      the types of exercise that enhance right cardiac mechanics during hypoxic stress have not yet
      been identified. This study investigated how high-intensity interval training (HIIT) and
      moderate-intensity continuous training (MICT) influence right cardiac mechanics during
      hypoxic exercise (HE).
    

Detailed description: 
      Hypoxic exposure increases right ventricular (RV) afterload by triggering pulmonary
      hypertension, with consequent effects on the structure and function of the RV. Improved
      myocardial contractility is a critical circulatory adaptation to exercise training. However,
      the types of exercise that enhance right cardiac mechanics during hypoxic stress have not yet
      been identified. This study investigated how high-intensity interval training (HIIT) and
      moderate-intensity continuous training (MICT) influence right cardiac mechanics during
      hypoxic exercise (HE).

      The young and healthy sedentary males were randomly selected to engage in either HIIT (3-min
      intervals at 40% and 80% of VO2 oxygen uptake reserve) or MICT (sustained 60% of VO2 oxygen
      uptake reserve) for 30 min/day and 5 days/week for 6 weeks or were included in a control
      group (CTL) that did not engage in any exercise. Right cardiac mechanics during semiupright
      bicycle exercise tests under hypoxic conditions (i.e., 50 watts under 12% FiO2 for 3 min)
      were measured using two-dimensional speckle-tracking echocardiography. The primary outcome
      was the change in right cardiac mechanics during semiupright bicycle exercise under hypoxic
      conditions (i.e., 50 watts under 12% FiO2 for 3 min) as measured by two-dimensional speckle
      tracking echocardiography.
    

Intervention name(s): High intensity-interval training (HIIT); Moderate intensity-continuous (MICT)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects performed HIIT (3-min intervals at 40% and 80%VO2peak) on a bicycle ergometer for 30 min/day, 5 days/week for 6 weeks.; Subjects performed MICT (sustained 60%VO 2max) on a bicycle ergometer for 30 min/day, 5 days/week for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stress echocardiography; Hypoxia test; Speckle-tracking echocardiography; High Intensity Interval Training
Fish Gelatin Supplement and Omega-3 Supplement in Obese or Overweight Subjects With Insulin Resistance
Condition: Insulin Resistance; Type 2 Diabetes
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 2

Summary: 
      The present study was conducted to test whether a fish gelatin supplement combined with an
      omega-3 polyunsaturated fatty acid supplement can exert beneficial and sex-specific effects
      on insulin sensitivity, glucose tolerance, indicators of insulin secretion, blood pressure,
      lipid metabolism, inflammation and energy intake in obese or overweight insulin-resistant men
      and women. The investigators hypothesis is that fish gelatin improves insulin sensitivity,
      glucose tolerance, lipid profile and reduces inflammation in obese or overweight
      insulin-resistant men and women.
    

Detailed description: 
      An important number of recent epidemiological studies have demonstrated the beneficial
      effects of marine omega-3 polyunsaturated fatty acids (n-3 PUFA) on cardiovascular disease
      risk factors such as reduced triglycerides, decreased platelet aggregation, plaque
      stabilization, antiarrhythmic effects, and reduced blood pressure. Dietary fish protein has
      also been shown to improve insulin sensitivity by 30% in insulin-resistant obese or
      overweight human subjects. In addition, an increasing number of studies describe and
      demonstrate the physiological and metabolic variations between men and women in regard to CVD
      and their risk factors, including type 2 diabetes, but the data are still limited. In
      agreement with the recent findings, this study was conducted to evaluate the combined and
      synergistic effects of omega-3 and fish protein supplements on insulin sensitivity, blood
      pressure, lipid metabolism and inflammation in obese or overweight insulin-resistant men and
      women having some or all the metabolic syndrome criteria including a deteriorated lipid
      profile, high blood pressure and high waist circumference in a free living situation.
    

Intervention name(s): Fish gelatin and omega-3 polyunsaturated fatty acid; Omega-3 polyunsaturated fatty acid
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Irinotecan in Treating Patients With Recurrent Glioma
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who
      have recurrent glioma.
    

Detailed description: 
      OBJECTIVES: I. Determine the efficacy of irinotecan in the treatment of patients with
      recurrent glioma. II. Assess the toxicities of irinotecan in these patients. III. Correlate
      the pharmacological parameters with toxicity and response to therapy.

      OUTLINE: This is a two arm study. Patients are stratified according to prior nitrosourea
      administration. Patients are assigned to 1 of 2 arms, with only 1 arm being open at any time.
      Patients assigned to arm I receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22.
      This is followed by a 2 week rest and continues for a maximum of 6 courses. Patients assigned
      to arm II receive irinotecan on day 1 every 3 weeks for up to 12 courses. Patients in both
      arms who received prior nitrosoureas receive reduced starting doses of irinotecan. The
      dosages may be increased once per patient after the first course if toxic effects are
      acceptable. Arm I closed as of 10/98, Arm II open as of 10/98. Patients are followed every 3
      months for the first year, every 6 months for the next 4 years, then annually until death.
    

Intervention name(s): irinotecan hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Irinotecan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent adult brain tumor; adult brain stem glioma; adult oligodendroglioma; adult mixed glioma; adult diffuse astrocytoma
Role of Tissue C4d in Differentiation Between Acut e Rejection and HCV Recurrence After Liver Transplantation
Condition: Liver Disease
MeSH terms: Liver Diseases
Study type: Interventional

Summary: 
      Assessment of the role of tissue C4d complement fragments in liver biopsy as a new marker for
      differentiating between acute rejection and Hepatitis C (HCV) recurrence in recipients post
      living donor liver transplantation (LDLT) .As each condition require different treatment
    

Detailed description: 
      Role of tissue c4d assessment by immunohistchemistry in liver biopsy in differentiation
      between recurrent hepatitis c and rejection after liver transplantation.pathological
      examination may be sometimes confusing between the rejection and recurrent hepatitis C
    

Intervention name(s): liver biopsy
Intervention type(s): Other
Intervention description(s): C4d assessment by immunohistchemistry in liver biopsy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: hepatitis C recurrence; Rejection; Liver Transplantation; Liver biopsy
The Mindfulness Intervention as Myocardial Infarction Rehabilitation Additive (MIMIRA) Study
Condition: Coronary Artery Disease; Depressive Symptoms
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Myocardial Infarction; Infarction; Depression
Study type: Interventional

Summary: 
      The Mindfulness Intervention as Myocardial Infarction Rehabilitation Additive (MIMIRA) study
      aimed at studying the feasibility and acceptability of Mindfulness Based Stress Reduction -
      an 8 week course in meditation and yoga - in patients with a recent coronary artery event and
      elevated depressive symptoms. To address these questions patients with elevated scores on a
      depression scale were invited to participate in MBSR, and there evaluation of the course as
      well as a panel of psychological risk factors and resources was measured.
    

Detailed description: 
      Depressive symptomatology in patients with coronary artery disease (CAD) has prognostic
      importance. Yet, psychological interventions in clinical practice are scarce. Here, we
      explored the feasibility and acceptability of mindfulness-based stress reduction (MBSR) in
      patients with depressive symptoms after a recent coronary event. A second aim was to
      investigate psychological risk factors and resources among participants.

      To address the research questions, depressive symptoms were first measured in a reference
      population, at 1 and 12 months after a coronary event (myocardial infarction or unstable
      angina pectoris), and a cut-off for elevated depressive symptoms were obtained from the
      median in this group. Thereafter, similar CAD patients with elevated depressive symptoms
      (above median in the reference group), from the same outpatient clinic, were consecutively
      invited to an 8-week MBSR program. Serious physical or psychiatric illness that would be an
      obstacle to participation were exclusion criteria.

      Patients who completed the MBSR-course were asked to evaluate its various facets, and
      completion rate and attendance were feasibility outcomes. Psychological variables were
      measured before, after the course as well as 12 months later.
    

Intervention name(s): Mindfulness Based Stress Reduction (MBSR)
Intervention type(s): Behavioral
Intervention description(s): An 8-week course in mindfulness meditation, yoga training and weekly group support in the form of weekly 2,5 hour meetings at the hospital.
Intervention model: Single Group Assignment
Intervention model description: Pilot and feasibility study of one cohort.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Mindfulness Based Stress Reduction; Depressive symptoms; Coronary Artery Disease; Mastery