bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Melatonin in the Prophylaxis of Coronavirus Disease 2019 (COVID-19) Among Healthcare Workers.
Condition: Covid19; SARS-CoV 2; Coronavirus Infection
MeSH terms: Infections; COVID-19; Coronavirus Infections
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      There is an urgent need to evaluate interventions that can prevent the infection with
      SARS-CoV 2 of healthcare workers at risk. Melatonin is an inexpensive and safe product with
      protective effect in both bacterial and viral infections likely due to its anti-inflammatory
      and anti-oxidative effects. This randomized controlled trial seeks to evaluate is efficacy as
      a prophylaxis in healthcare workers exposed to the virus in their clinical practice.
    

Detailed description: 
      Healthcare workers are at an increased risk of acquiring COVID-19 due to an increased
      exposure to the virus and global personal protective equipment shortages. Preventing the
      infection of healthcare workers is critical the current epidemic situation when healthcare
      systems are under extreme pressure. There is a lack of evidence surrounding potential
      preventive strategies to decrease the incidence of COVID-19 among healthcare workers.

      Melatonin, an endogenous hormone involved in circadian rhythm control, is an inexpensive and
      safe product that has shown protective effects in bacterial and viral infections likely due
      to its anti-inflammatory and anti-oxidative effects.

      SARS-CoV 2 seems to relatively spare younger children and those who are infected develop the
      severe forms of the disease very rarely. Peak melatonin serum levels are higher in younger
      children and decrease with age. These levels are also higher in women, specially during
      pregnancy, who also seem to be less affected by the virus when compared to men.

      The investigators hypothesize that elevating peak melatonin levels to a range similar to that
      of children by administering 2 mg of melatonin daily might prevent the infection with
      SARS-CoV 2 among exposed healthcare workers. The investigators also hypothesize that among
      those who develop the disease melatonin might prevent the more severe forms.
    

Intervention name(s): Melatonin 2mg; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): 2 mg of prolonged release melatonin tablets per os (P.O.) before bedtime for 12 weeks; Identically looking placebo tablets P.O. before bedtime for 12 weeks
Other intervention name(s): circadin 2 mg; Placebo
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: melatonin; prevention; covid19; Sars-CoV2; healthcare
EPIPAGE2 Cohort Study Follow up at Five and a Half Years
Condition: Very Preterm Birth
MeSH terms: Premature Birth
Study type: Observational [Patient Registry]

Summary: 
      Epipage 2 (epidemiologic study on small-for-gestational-age children) is a nationwide study
      implemented to improve our knowledge of the outcome of preterm children in France. This study
      was launched on March 28, 2011 and includes three groups of preterm children, all born before
      35 weeks: extremely preterm infants (born between 22 and 26 completed weeks of gestation),
      very preterm children (born between 27 and 31 completed weeks) and moderately preterm
      children (born between 32 and 34 completed weeks).

      These children are being studied from their birth up to the age of 12 years. At birth, data
      on maternal and infants' characteristics were collected from medical records. At one and two
      years, questionnaires sent to families and to physicians (at two years only) allowed to
      collect data about the children's life and health.

      At five and a half years, medical and psychological assessments are specifically implemented
      for the study in order to evaluate motor and cognitive disorders in this population.
    


Intervention name(s): Medical and neuropsychological assessments
Intervention type(s): Other
Intervention description(s): Assessment of health status and development will be performed in specific centers at 5 and a half years. This check-up includes a complete medical examination to look for visual, hearing, motor impairment and health problems, and psychological tests using standardized tools (WPPSI IV ((Wechsler Preschool and Primary Scales Intelligence)) and NEPSY 2 tests) to assess cognitive development of very preterm children.
A parental questionnaire will be fulfilled to investigate family's social conditions, maternal health, autism spectrum disorders (Social Communication Questionnaire), the child's quality of life and behavioral development (Strengths and Difficulties Questionnaire).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Preterm children included at birth in the EPIPAGE 2 cohort or in complementary studies
        whose famillies agree to participate to EPIPAGE 2 follow up (4600 children) + 600 children
        born at term and participating to the Elfe cohort (French longitudinal study of children)
      
Biospecimen description: 
      DNA from saliva samples collected from 5 years and a half children
    
Keywords: very preterm birth; developmental disorders; health problems; prospective population-based cohort
Retrospective Clinical Outcome of Parotid Tumor Surgery
Condition: Parotid Tumors; Postoperative Complications
MeSH terms: Parotid Neoplasms; Postoperative Complications
Study type: Observational

Summary: 
      The aim of this study was to determine the histopathological results of parotid tumors and
      postoperative complications after partial superficial or total parotidectomy with facial
      nerve dissection and superficial musculoaponeurotic system reconstruction.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients who underwent parotid surgery by a single operator in National Taiwan
        University Hospital from January 2004 to December 2012 were assessed for histopathological
        results and postoperative complications.
      
Keywords: Parotid tumor; Partial superficial parotidectomy; Facial palsy
Epirubicin in Treating Women Who Are Undergoing Surgery for Stage I, Stage II, or Stage III Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as epirubicin, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving
      epirubicin before surgery may make the tumor smaller and reduce the amount of normal tissue
      that needs to be removed.

      PURPOSE: This phase II trial is studying how well epirubicin works in treating women who are
      undergoing surgery for stage I, stage II, or stage III breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the complete pathological and clinical response rate in women undergoing
           surgery for resectable stage I-III breast cancer treated with neoadjuvant
           dose-intensified epirubicin hydrochloride.

      Secondary

        -  Determine the toxicity of this regimen in these patients.

        -  Determine the predictive value of HER2 gene amplification and topoisomerase II-alpha
           gene amplification or deletion for disease progression and pathological and clinical
           complete response in patients treated with this regimen.

        -  Correlate gene expression profiles with pathologic complete response, clinical complete
           response, less than complete response, and disease progression in patients treated with
           this regimen.

      OUTLINE: Patients receive epirubicin hydrochloride IV on day 1 and pegfilgrastim
      subcutaneously on day 2. Treatment repeats every 14 days for 4 courses in the absence of
      disease progression or unacceptable toxicity. Four weeks later, patients undergo partial
      mastectomy or simple mastectomy plus an axillary staging procedure.

      After completion of study treatment, patients are followed periodically.

      PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
    

Intervention name(s): pegfilgrastim; epirubicin hydrochloride; conventional surgery
Intervention type(s): Biological; Drug; Procedure
Intervention description(s): 6 mg in a syringe; 120 MG q 2 weeks for 4 cycles; to remove small piece of cancer
Other intervention name(s): Neulasta; Biopsy will involve a small surgical incision to remove a piece of the cancer.
Intervention MeSH terms: Epirubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II breast cancer; stage I breast cancer; stage IIIA breast cancer; stage IIIB breast cancer
A Study of the Effect of Multiple Doses of Itraconazole and Fluoxetine on the Pharmacokinetics of a Single Dose of RO5285119 in Healthy Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-center, open-label, one-sequence, 2-period, within-subject study in 2 cohorts
      will evaluate the effects of multiple doses of itraconazole and fluoxetine on the
      pharmacokinetics of a single dose of RO5285119 in healthy volunteers. In Cohort 1, subjects
      will receive a single dose of RO5285119 on Day 1 (Period 1) and, after a wash-out period of
      14 days, itraconazole on Days 1-8 of Period 2 with coadministration of RO5285119 on Day 4. In
      Cohort 2, subjects will receive a single dose of RO5285119 on Day 1 (Period 1) and, after a
      wash-out period of 14 days, fluoxetine on Days 1-12 of Period 2 with coadministration of
      RO5285119 on Day 6.
    


Intervention name(s): RO5285119; fluoxetine; itraconazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose, alone and after repeated administration of itraconazole or fluoxetine; Multiple doses; Multiple doses
Intervention MeSH terms: Itraconazole; Fluoxetine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
A Safety and Efficacy Study of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA)
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of 3 different doses of
      belimumab, administered in addition to standard therapy, in patients with rheumatoid
      arthritis (RA).
    

Detailed description: 
      The purpose of this study is to evaluate the safety and efficacy of three different doses of
      belimumab (1 mg/kg, 4 mg/kg, and 10 mg/kg), administered in addition to standard therapy,
      compared to placebo plus standard therapy in patients with RA. All patients were to be dosed
      on Days 0, 14, and 28, then every 28 days for the remainder of 24 weeks. Patients completing
      the 24-week period could enter a 24-week open-label extension; belimumab patients received
      the same dose or were switched to 10 mg/kg at the investigator's discretion and former
      placebo patients received belimumab 10 mg/kg.
    

Intervention name(s): Placebo; Belimumab 1 mg/kg; Belimumab 4 mg/kg; Belimumab 10 mg/kg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo IV plus standard therapy (SOC) for RA; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, placebo patients who opted to participate received belimumab 10 mg/kg IV plus SOC every 28 days for an additional 24 weeks.; Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.; Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA; belimumab 4 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.; Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, patients who opted to participate continued on the same dose of belimumab (10 mg/kg) for an additional 24 weeks.
Other intervention name(s): LymphoStat-B®; BENLYSTA®; LymphoStat-B®; BENLYSTA®; LymphoStat-B®; BENLYSTA®
Intervention MeSH terms: Belimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: RA
Laser in Caries Treatment - Patients´View, Pulpal Reactions and Survival of Fillings
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the excavation time, patients´ experiences, pulpal
      reactions and survival of fillings when carious tissue was removed with Er:YAG laser compared
      to rotary bur. A prospective, single-blind, randomized and controlled investigation was
      performed. Patients with at least two primary caries lesions radiographically assessed as the
      same size were recruited. In each patient one cavity was excavated with rotary bur and one
      with Er:YAG laser technique. The time requested for excavation and local anaesthesia were
      measured. The prevalence of postoperative symptoms, pulpal vitality and the quality of
      fillings will be investigated during two years after the excavation occasion.
    

Detailed description: 
      The study is a prospective, single-blind, randomized and controlled investigation. Patients
      between 15-40 years with at least two primary caries lesions radiographically assessed as the
      same size were recruited. In each patient one cavity was excavated with rotary bur and one
      with Er:YAG laser technique after a randomized allocation of the lesions to one of the
      intervention methods. The time requested for excavation to hard/firm dentin and local
      anaesthesia were measured. Directly after each treatment a questionnaire focusing on the
      experiences of the current treatment and if the laser method will be chosen in the future was
      answered. Postoperative pain was measured with a questionnaire one week after the treatment.
      Six, 12 and 24 months after the fillings were made an evaluation of pulpal status and the
      quality of the fillings will be performed.
    

Intervention name(s): excavated with rotary bur; Er:YAG laser
Intervention type(s): Device; Device
Intervention description(s): One of two identified caries lesions in the patient were randomly allocated to be excavated with rotary bur; One of two identified caries lesions in the patient were randomly allocated to be excavated with Er:YAG laser
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: prospective, single-blind, randomized and controlled investigation
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: dental caries, Er:YAG laser, rotary bur
Observational, Multi-Center Study of the Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in the Russian Federation
Condition: Chronic Hepatitis C; Genotype 1
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Observational

Summary: 
      This study seeks to assess the effectiveness, patient reported outcomes, work productivity
      and healthcare resource utilization of the interferon-free regimen of paritaprevir /ritonavir
      (r) - ombitasvir, ± dasabuvir ± ribavirin (RBV) in participants with chronic hepatitis C in a
      real life setting across clinical practice populations.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Treatment-naïve or -experienced adult male or female patients with confirmed chronic
        hepatitis C genotype 1, receiving combination therapy with paritaprevir/r - ombitasvir with
        or without dasabuvir ± RBV according to standard of care and in line with the current local
        label.
      
Keywords: Ombitasvir; Dasabuvir; Paritaprevir
A Study of Nociceptin/Orphanin FQ Peptide Receptor Occupancy in Healthy Subjects
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to conduct an assessment of brain nociceptin/orphanin FQ peptide
      (NOP) receptor occupancy (RO) in healthy subjects.
    


Intervention name(s): LY2940094
Intervention type(s): Drug
Intervention description(s): Administered orally
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Exercise With or Without Electrical Stimulation in Cystic Fibrosis (Part I): Effects on Physical Fitness
Condition: Cystic Fibrosis in Children
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      This study aims to assess the effects of programmed exercise with or without electrical
      stimulation in the cardiorespiratory fitness, strength, functional capacity and agility in a
      group of young patients with Cystic Fibrosis: A randomized controlled trial comparing two
      interventions with a control group.
    


Intervention name(s): Exercise-NMES; Exercise-No NMES
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Exercise-NMES; Exercise-No NMES
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cystic Fibrosis; Electrostimulation; Combined Training; Physical Fitness
Role of Dexamethasone for Erector Spinae Plane Block in Patients Undergoing Total Abdominal Hysterectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The aim to study the efficacy of bupivacaine 0.25% with dexamethasone and that of bupivacaine
      0.25% alone for erector spinae plane block for postoperative analgesia in patients undergoing
      total abdominal hysterectomy Group 1: bupivacaine 0.25% + dexamethasone 8 mg

        -  Group 2: bupivacaine 0.25%

        -  Group3: control group A prospective Randomized Interventional double-blind study.
    

Detailed description: 
      Optimal dynamic analgesia is recognized as the key to enhanced recovery following open
      abdominal surgery. In the last decade, there has been a significant shift away from thoracic
      epidural analgesia (TEA) that has been long considered as the gold standard. Various
      techniques have tried to replicate the analgesic efficacy of TEA. They include transversus
      abdominis plane analgesia (TAP), rectus sheath analgesia (RS), wound infusion analgesia (WI)
      and trans muscular quadratus lumborum analgesia. However, each of these techniques has
      specific limitations that prevent them from being the analgesic technique of choice for all
      open abdominal surgeries. Chin et al first described the erector spinae plane (ESP) block for
      providing analgesia following ventral hernia repair. The unique feature of the
      ultrasound-guided truncal blocks is that in all of these techniques, in contrast to
      peripheral nerve blocks, no nerve or plexus needs to be identified: Local anesthesia (LA) is
      injected in a particular muscle plane, in which the injectate spreads and reaches the
      intended nerves. This simple mechanism has made delivery of nerve blocks easy and versatile.
    

Intervention name(s): bupivacaine; dexamethasone; placebo to dexamethasone; placebo to bupivacaine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Bilateral TAP block with 20 ml of 0.25% bupivacaine; Bilateral TAP block with 4 mg/kg dexamethasone diluted with isotonic saline.; Bilateral TAP block with placebo to dexamethasone.; Bilateral TAP block with placebo to bupivacaine.
Other intervention name(s): Active Comparator; active comparator
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Bupivacaine; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective Randomized Interventional double-blind study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: erector spinae plane block; total abdominal hysterectomy; dexamethasone
Pharmacokinetics-pharmacodynamics and Safety of Dexmedetomidine in Children
Condition: Intensive Care Unit; Postoperative Care
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates pharmacokinetics and pharmacodynamics of dexmedetomidine for children
      under sedation at intensive care unit after surgery. Patients will receive dexmedetomidine
      intravenously for 50 minutes after surgery as as sedation drug.
    

Detailed description: 
      Dexmedetomidine, an alpha-2 adrenergic agonist, is being effectively used for procedural
      sedation or sedation at intensive care unit. However, the safety and efficacy profile are not
      yet established for children. Although there have been some studies regrading it, still there
      is no public guideline, therefore making it difficult to use dexmedetomidine in children.
    

Intervention name(s): Dexmedetomidine Hydrochloride
Intervention type(s): Drug
Intervention description(s): Intravenous infusion of dexmedetomidine at the rate of 0.5mcg/kg for 10 min, then 0.5mcg/kg/hr for 50 min.
Other intervention name(s): Precedex
Intervention MeSH terms: Dexmedetomidine
Intervention model: Single Group Assignment
Intervention model description: Dexmedetomidine infusion at intensive care unit
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: dexmedetomidine; pediatric; sedation
Controlled Ovarian Stimulation by HP-hMG for IVF / ICSI Cycles: Study on Ovarian Hyper Stimulation Syndrome in a Cohort of Women From 18 to 36 Years Old.
Condition: Ovarian Hyperstimulation Syndrome (OHSS)
MeSH terms: Ovarian Hyperstimulation Syndrome; Syndrome
Study type: Observational

Summary: 
      Ovarian hyper stimulation syndrome (OHSS) is a potentially serious complication of ovarian
      stimulation in IVF (In Vitro Fertilisation). The main objective of this study is to describe
      the incidence of moderate or severe forms of OHSS in women between 18 and 36 years of age
      treated with HP-hMG.
    


Intervention name(s): Highly purified menotropin (HP- hMG) treatment
Intervention type(s): Other
Intervention description(s): No intervention: patients treated by highly purified menotropin for COS according to physicians' current practice
Intervention MeSH terms: Menotropins
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women from 18 to 36 years old treated by HP-hMG for controlled ovarian stimulation (COS)
        for a first or second cycle of IVF / ICSI.
      
Biospecimen description: 
      No biological samples