bioihbjkbjnl/mcl2 huggingface dataset:
Multicenter Investigation of Limitation of Infarct Size (MILIS)
Condition: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Infarction; Myocardial Ischemia
MeSH terms: Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Coronary Disease; Myocardial Ischemia; Infarction; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the ability of two separate therapeutic interventions, propranolol and
      hyaluronidase, to limit the ultimate size of an acute myocardial infarction. A secondary
      objective was to assess the influence of these therapies upon ventricular function and
      morbidity following myocardial infarction.
    

Detailed description: 
      BACKGROUND:

      The study of methods for minimizing the mass of ischemic infarcted myocardium associated with
      a myocardial infarction was identified as a topic of research priority in the 1973 Report of
      the Panel Chairman for the Preparation of the National Heart, Blood Vessel, Lung, and Blood
      Program. In September 1976, the Institute convened a workshop involving 32 investigators
      active in this field, respondents to past solicitations, experts on the topic of
      collaborative clinical trials, members of previous review committees, and several members of
      the Cardiology Advisory Committee. The attendees were enthusiastic about the practicality and
      timeliness of a collaborative clinical trial in this field. The concept of collaborative
      clinical trials to protect ischemic myocardium was discussed by the Cardiology Advisory
      Committee in its meeting of September 22, 1976, and was recommended affirmatively and
      enthusiastically. This trial was part of the Institute's initiatives and was reviewed and
      favorably recommended by the National Heart, Lung, and Blood Advisory Council at its December
      1976 meeting. The trial consisted of five clinical centers, six central laboratories, a
      clinical coordinating center, and a data coordinating center.

      DESIGN NARRATIVE:

      Randomized. Group A patients were randomized to propranolol therapy, hyaluronidase therapy,
      or control therapy; patients assigned to Group B (propranolol contraindicated) were assigned
      to hyaluronidase or control therapy. Single-blind for propranolol therapy, double-blind for
      hyaluronidase or control therapy; fixed sample. Detailed follow-up of clinical status and
      endpoints for a six-month period; annual health status follow-up thereafter.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Query View Report (QVR).
    

Intervention name(s): propranolol; hyaluronidase
Intervention type(s): Drug; Drug
Intervention MeSH terms: Propranolol
Allocation: Randomized
Masking: Double
Primary purpose: Prevention
Ultrasound-Guided Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer Previously Treated With External-Beam Radiation Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Implant radiation therapy uses radioactive material placed directly into or near a
      tumor to kill tumor cells.

      PURPOSE: This phase II trial is studying the side effects and how well ultrasound-guided
      implant radiation therapy works in treating patients with locally recurrent prostate cancer
      previously treated with external-beam radiation therapy.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the late treatment-related gastrointestinal (GI) and genitourinary (GU)
           adverse events in patients with locally recurrent adenocarcinoma of the prostate
           previously treated with external-beam radiotherapy who are currently receiving
           transperineal ultrasound-guided iodine I 125 or palladium Pd 103 brachytherapy.

      Secondary

        -  Determine the acute treatment-related GI and GU adverse events in patients treated with
           this regimen.

        -  Determine the overall survival of patients treated with this regimen.

        -  Determine the disease-free survival of patients treated with this regimen.

        -  Determine the disease-specific survival of patients treated with this regimen.

        -  Determine clinical patterns of tumor recurrence (time to local tumor progression or
           distant failure) in patients treated with this regimen.

        -  Determine the time to biochemical failure in patients treated with this regimen.

        -  Determine the post-brachytherapy dosimetric coverage in patients treated with this
           regimen.

      OUTLINE: This is a prospective, multicenter study.

      Patients undergo transperineal ultrasound-guided iodine I 125 or palladium Pd 103
      brachytherapy.

      Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study.
    

Intervention name(s): 125-Iodine; 103-palladium
Intervention type(s): Radiation; Radiation
Intervention description(s): Brachytherapy to the prostate via 125-iodine (I-125) seeds with a planned dose of 140 Gy; Brachytherapy to the prostate via 103-palladium (Pd-103) seeds with a planned dose of 120 Gy
Other intervention name(s): brachytherapy; brachytherapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; recurrent prostate cancer; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer
Immunogenicity and Safety of a Multi-Dose Quadrivalent Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to to assess the immunogenicity and safety of a quadrivalent
      influenza vaccine in a multi-dose presentation compared to a quadrivalent influenza vaccine
      in single-dose presentation, in children aged 6 months to 17 years.
    

Detailed description: 
      Participants aged 9 to 17 years will receive one dose of either the multi-dose quadrivalent
      influenza vaccine or the quadrivalent influenza vaccine in a single-dose presentation and
      participants aged 6 months to 8 years will receive 2 doses of either vaccine, 28 days apart.

      All participants will provide a pre-vaccination blood sample on Day 0 and a post-vaccination
      blood sample either on Day 28 (participants aged 9 to 17 years) or on Day 56 (participants
      aged 6 months to 8 years) for immunogenicity testing.

      All participants will be followed for safety evaluation up to 6 months after the last
      vaccination.
    

Intervention name(s): Multi-dose Quadrivalent Influenza Vaccine; Single-dose Quadrivalent Influenza Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, intramuscular; 0.5 mL, intramuscular
Other intervention name(s): VaxigripTetra
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Quadrivalent Inactivated Influenza Vaccine; Multi-dose Presentation
Impulsivity, Brain Function, and Substance Abuse Treatment in Cocaine Dependent Individuals
Condition: Cocaine Abuse; Cocaine-Related Disorders
MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders; Impulsive Behavior
Study type: Observational

Summary: 
      Cocaine dependence is a major public health problem; an effective primary treatment for
      cocaine dependent individuals has yet to be found. The purpose of this trial is to evaluate
      aspects of treatment response in cocaine dependent individuals.
    

Detailed description: 
      Cocaine is a strong central nervous system stimulant that is widely abused throughout the
      United States. Due to its widespread use, it is important to develop an effective treatment
      for cocaine dependence. The purpose of this study is to determine how impulsivity and
      prefrontal cortical function are related to treatment response in cocaine dependent
      individuals.

      Participants in this study will complete four separate experiments, each with a different aim
      and testing panel [cognitive function tests with and without functional magnetic resonance
      imaging (fMRI)]. The first experiment will examine memory, attention, cognitive function, and
      impulsivity; the aim is to determine the relationship between impulsivity and cognitive
      function in cocaine dependent individuals receiving treatment. The second experiment will
      examine the relationship between impulsivity and the prefrontal cortical structure and
      function. Participants will complete an fMRI during the second experiment. The third
      experiment will consist of cognitive function tests and will examine the prefrontal cortex in
      relation to treatment response, based on four different treatments: 1) L-dopamine, 2)
      naltrexone, 3) modafinil, and 4) placebo. The fourth experiment will examine the effect of
      cocaine dependence treatment on prefrontal cortex, focusing on participants receiving
      modafinil.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Cocaine Dependent Subjects
      
Keywords: cocaine abuse; Cocaine-Related Disorders
Breathing Disorders in Patients With Congestive Heart Failure
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      The investigators prospectively evaluated 89 consecutive outpatients (29 female) with stable
      congestive heart failure. The presence of sleep disordered breathing (SDB) and Cheyne-Stokes
      respiration (CSR) while awake were investigated by overnight polysomnography. Males and
      females were similar in age, body mass index, and LVEF. Prevalence of SDB was higher in males
      than females. During follow up of 25±10 months, 27% of the population died. Nonsurvivors had
      lower LVEF (p=0.01), worse NYHA class (p=0.03) a higher proportion of CSR-awake (p<0.001)
      than survivors.
    

Detailed description: 
      Bakground: There is little information in sleep disordered breathing (SDB) in women with
      congestive heart failure (CHF). We studied consecutive CHF patients in order to compare SDB
      characteristics according to gender, and to determine overall mortality impact of SDB and
      Cheyne-Stokes respiration (CSR) while awake.

      Methods: Eighty nine consecutive outpatients (29 female) with stable CHF (LVEF<45%) were
      prospectively evaluated. The presence of SDB, as characterized by obstructive sleep apnea
      (OSA) and CSR during sleep, as well as CSR while awake before sleep onset, were investigated
      by overnight polysomnography.
    

Intervention name(s): Polysomnography
Intervention type(s): Other
Intervention description(s): examination for sleep disorders
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive patients with CHF recruited from the outpatient Heart Failure Unit of the Heart
        Institute (Instituto do Coraçao do Hospital das Clinicas da Faculdade de Medicina da
        Universidade de Sao Paulo)
      
Keywords: Sleep apnea; Cheyne-Stokes Respiration; Congestive Heart Failure
Effect of a Proton Pump Inhibitor on Gleevec® in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a research study that will investigate the effects of proton pump inhibitors (often
      used to treat stomach upset) on Gleevec® (a drug that is FDA-approved to treat some types of
      cancer) in healthy volunteers. Twelve healthy volunteers (six men and six women) will be
      recruited to complete the study. This research study will compare Gleevec® in the body when
      taken with and without proton pump inhibitors (PPI). Each volunteer will receive a 400 mg
      pill of Gleevec® on two occasions. On one occasion they will take the dose of Gleevec® alone
      (without PPI). On another occasion, they will take the Gleevec® after taking 40 mg of PPI
      daily by mouth for six days. Several blood samples will be drawn to measure the
      concentrations of Gleevec® and its breakdown products in the blood, with and without the
      influence of PPI.
    

Detailed description: 
      This is an open-label, single-institution, randomized cross-over, fixed schedule study of the
      effects of proton pump inhibitors (PPI) on Imatinib Mesylate (Gleevec®) pharmacokinetics.
      Healthy volunteers will be recruited to participate in this study such that twelve subjects
      (6 men / 6 women) will complete the study. Gleevec® pharmacokinetics will be assessed after
      oral administration of Gleevec® and after oral administration of Gleevec® with concomitant
      administration of PPI (Prilosec® Delayed-Release Capsules). Gleevec® will be administered at
      a dose of 400 mg, and the PPI (Prilosec®) at a dose level of 40 mg daily for 6 consecutive
      days. Half of the subjects will receive Prilosec® starting 5 days before Day 1 through Day 1
      along with Gleevec® on Day 1, and Gleevec® alone on Day 15. The other half will receive
      Prilosec® on Days 10-15, along with Gleevec® on Day 15, and Gleevec® alone on Day 1. On days
      that both drugs are administered, the Prilosec® will be administered 15 minutes before the
      Gleevec® dose.
    

Intervention name(s): Imatinib Mesylate; Omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Dosage form: tablets Dosage: 400 mg Frequency & duration: On an 18-day schedule, one dose administered once on day 1 and once on day 15 (2 doses total); Dosage form: capsules Dosage: 40 mg Frequency: On an 18-day schedule, once daily day 10 through day 16 (for Arm A); or once daily day -4 through day 1 (for Arm B)
Other intervention name(s): Gleevec®; Prilosec®; Proton Pump Inhibitor
Intervention MeSH terms: Imatinib Mesylate; Omeprazole; Proton Pump Inhibitors
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Healthy volunteers; No condition; Pharmacokinetics study
Scalpel Versus Diathermy Skin Incision in Repeated CS
Condition: Benifits of Using Diathermy in Skin Incision
MeSH terms: Hyperthermia; Surgical Wound
Study type: Interventional

Summary: 
      This study was performed to compare both methods of skin incisions to determine differences
      in postoperative pain, hemodynamic changes, incisional time, blood loss during incision,
      wound healing, and wound complication.
    

Detailed description: 
      Our study aims to compare the use of diathermy versus scalpel in making skin incision during
      cesarean section to judge the variations in

        1. incision time,

        2. incision blood loss,

        3. hemodynamic changes,

        4. postoperative pain,

        5. wound healing

        6. wound complications.
    

Intervention name(s): skin incision with a scalpel; skin incision with diathermy
Intervention type(s): Procedure; Procedure
Intervention description(s): A Pfannenstiel skin incision was done through the subcutaneous tissue, rectus sheath and dissected from rectus muscle until peritoneum was visualized.
group 1 (skin incision with a scalpel); A Pfannenstiel skin incision was done through the subcutaneous tissue, rectus sheath and dissected from rectus muscle until peritoneum was visualized.
group 2 (skin incision with diathermy)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Omega-3 Fatty Acids in Bipolar Patients With a Low Omega-3 Index and Reduced Heart Rate Variability
Condition: Bipolar Disorders
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      This study sets out to test the hypothesis that parameters of heart rate variability, as a
      non-invasive measure of cardiovascular risk, can be improved by the addition of omega-3 fatty
      acids in euthymic bipolar patients with a low omega-3 index and reduced heart rate
      variability.
    


Intervention name(s): Omega-3 fatty acids (EPAX 6015 TG); Corn oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The study drug is a food supplement called EPAX 6015 TG. One capsule of EPAX 6015 TG contains 530 mg of EPA (eicosapentaenoic acid) and 150 mg of DHA (docosahexaenoic acid), provided as triglycerides. For the entire study period (12 weeks) patients will receive 4 capsules of EPAX 6015 TG per day.; The corn oil capsules look exactly the same as the capsules containing omega-3 fatty acids. For the entire study period patients will receive 4 capsules of corn oil per day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar disorders; Omega-3 fatty acids; Heart rate
The VOLTAIRE-X Trial Looks at the Effect of Switching Between Humira® and BI 695501 in Patients With Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the trial is to assess the PK similarity between patients receiving
      Humira® continuously vs those who alternate between BI 695501 and Humira®, in patients with
      moderate-to-severe chronic plaque psoriasis.

      The secondary objectives of this trial are to descriptively compare the safety,
      immunogenicity and efficacy profiles between patients receiving Humira® continuously vs those
      who alternate between BI 695501 and Humira®.
    


Intervention name(s): Humira®; BI 695501
Intervention type(s): Drug; Drug
Intervention description(s): Duration - 58 weeks; Duration - 58 weeks
Other intervention name(s): CYLTEZO
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Ulinastatin on Postoperative Renal Function in Patients Undergoing Robot-assisted Laparoscopic Partial Nephrectomy
Condition: Renal Mass
Study type: Interventional

Summary: 
      Ulinastatin reduces systemic inflammatory responses and protects organs from
      ischemia/reperfusion-induced injury. The aim of this study is to evaluate the effect of
      ulinastatin on postoperative renal function in patients undergoing robot-assisted
      laparoscopic partial nephrectomy. Seventy patients, aged 20 to 79 years, scheduled for
      robot-assisted laparoscopic partial nephrectomy will be divided into ulinastatin (n=35) and
      control (n=35) groups. Randomly selected patients of the ulinastatin group are given
      ulinastatin. In contrast, patients in the control group receive an equivalent volume of
      normal saline as a placebo. The primary endpoints are postoperative renal function measured
      by serum creatinine, cystatin C, and urine output.
    


Intervention name(s): ulinastatin; normal saline
Intervention type(s): Drug; Drug
Intervention MeSH terms: Urinastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Prevention of the Minor Digestive Disorders by Lactobacillus Reuteri Supplementation
Condition: Minor Digestive Disorders
MeSH terms: Digestive System Diseases
Study type: Interventional

Summary: 
      Aim of the study. To evaluate if L. reuteri DSM 17938 supplementation since the first days of
      life can reduce the onset of gaseous colic in neonates and the onset of minor digestive
      disorders such as regurgitation and constipation.

      Study Design. Double blind, randomized, controlled, multicenter study. 492 neonates of 37-42
      gestational age, breast or formula fed, will receive L. reuteri 5 drops (1x108 CFU) daily or
      placebo for 28 days.

      After the inclusion, at baseline will be performed :

        -  Paediatric visit

        -  antropometric valutation

        -  number of the daily crying minutes, number of regurgitation and number of daily
           evacuation

      The patients will receive the probiotics/placebo every days for 28 days and the 29th will be
      repeated the following analyses:

        -  Paediatric visit

        -  antropometric valutation

        -  number of daily crying minutes

        -  numbers of regurgitation

        -  numbers of evacuations

      Primary outcome :

      To define if Lactobacillus reuteri supplementation can reduce the onset of gaseous colic,
      regurgitation and of constipation.

      Inclusion criteria

        -  neonates of 37-42 week gestational age and appropriate birth weight

        -  Recruitment age: until 7 days of life

        -  Informed consent signed

      Exclusion criteria

        -  Presence of other gastrointestinal diseases.

        -  Use of FANS, aspirin or other drugs

        -  Use of antibiotics and/or PPIs e/o anti-H2

        -  Participation to other clinical trials
    


Intervention name(s): Lactobacillus reuteri; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1000000000 CFU per day (5 drops) for 28 days; 5 drops daily for 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: gaseous colic, regurgitation and of constipation