bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Adrenergic Drugs on the Fluid Balance During Surgery
Condition: Ovarian Cyst
MeSH terms: Ovarian Cysts
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim this study was to examine to what degree the slow turnover of lactated Ringer's
      solution during anesthesia and surgery can be prevented by infusing esmolol (a ß1-receptor
      blocker) or phenylephrine in patients undergoing laparoscopic gynecological surgery performed
      under intravenous anesthesia.
    

Detailed description: 
      INTRODUCTION The renal clearance of infused crystalloid fluid is very low during anaesthesia
      and surgery, but experiments in conscious sheep indicate that the renal fluid clearance might
      approach a normal rate when the adrenergic balance is modified.

      METHODS Sixty females (mean age, 32 years) undergoing laparoscopic gynecological surgery were
      randomized to control group and received only the conventional anesthetic drugs and 20 ml/kg
      of lactated Ringer's over 30 min. The others were also given an infusion of 50 µg/kg/min of
      esmolol (beta1-receptor blocker) or 0.01 µg/kg/min of phenylephrine (alpha1-adrenergic
      agonist) over 3 hours. The distribution and elimination of infused fluid was studied by
      volume kinetic analysis based on urinary excretion and blood Hgb level.
    

Intervention name(s): Esmolol administration; Phenylephrine infusion; Lactated Ringer´s solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50 µg/kg/min of the ß1-receptor-blocker esmolol was infused intravenous over 3 hours; 0.01 µg/kg/min of the alpha-1-adrenergic receptor agonist phenylephrine; Intravenous Infusion of 10 ml/h lactated Ringer's solution that contained no drug
Other intervention name(s): Drug by Qilu Pharmaceutical Co, Shandong, China; Drug by Hefeng Pharmaceutical Co, Shanghai, China.
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Esmolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: Pharmacokinetics, kidney;; Receptors, adrenergic;; Fluids, i.v.;; Sympathetic nervous system, esmolol;; Sympathetic nervous system, phenylephrine
Ergocalciferol in Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      To examine the effect of ergocalciferol treatment on 25-hydroxyvitamin D and PTH levels in
      patients with CKD stage 3 and 4
    


Observational model: Defined Population
Time perspective: Retrospective
Keywords: ergocalciferol; chronic kidney disease; secondary hyperparathyroidism; vitamin D deficiency
Safety and Efficacy Study of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children
Condition: Congenital Nasolacrimal Duct Obstruction
MeSH terms: Lacrimal Duct Obstruction
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of the study is to evaluate the application of Besivance™ (besifloxacin ophthalmic
      suspension, 0.6%) to treat congenital nasolacrimal duct obstruction in children. The
      hypothesis of the study is that Besivance™ is as safe and effective as the current standard
      of care for the treatment of nasolacrimal duct obstruction in children.
    

Detailed description: 
      The primary objective of this study is to evaluate the safety and efficacy of Besivance™ as
      an antibiotic treatment for congenital nasolacrimal duct obstruction with infection in
      children. The primary outcome measure is the change from baseline on the physician rated
      scale of Nasolacrimal Duct Obstruction (NLDO)with infection to follow-up visit #2 (Week 8) or
      at the time of treatment failure, if earlier.
    

Intervention name(s): Besivance Treatment Group; Polytrim Treatment Group
Intervention type(s): Drug; Drug
Intervention description(s): Subjects Receive Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days.; Subjects receive Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days.
Other intervention name(s): Besifloxacin,Besivance; polymyxin b/trimethoprim - ophthalmic
Intervention MeSH terms: Trimethoprim; Polymyxins; Polymyxin B; Besifloxacin; Fluoroquinolones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Pulmonary Rehabilitation in Asthmatic Patient
Condition: Asthmatic; Children
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Asthma is one of the main chronic diseases in childhood and it is characterized by the
      inflammation of airways. Individuals with chronic lung disease are more susceptible to
      present reduction in exercise tolerance due to pulmonary limitations. The pulmonary
      rehabilitation may improve the physical capacity in asthmatic patients, as observed in other
      chronic lung diseases.
    

Detailed description: 
      The asthmatic patient's clinical changes may impair their functional capacity and exercise
      tolerance. Thus, the treatment of these individuals should be extended to pulmonary
      rehabilitation. Randomized clinical trials have shown interesting results, whether in
      cardiopulmonary conditions, quality of life or in the number of crises, after applying
      pulmonary rehabilitation program in asthmatic children and adolescents. In a systematic
      review on physical training with asthmatic children and adolescents the authors concluded
      that physical activity should be recommended to this population, although some issues have
      not yet been clarified due to limitations in the clinical trial. The control of the disease
      has not been evaluated by specific questionnaires in any study. The assessment of
      inflammatory markers was rarely addressed and the same occurred in the quality of life after
      physical training. In addition, it is possible to question the intensity and frequency of
      training, factors that can significantly contribute to the intervention results. All these
      information let us know that is necessary a randomized control trial to answer questions
      about physical characteristics, quality of life, inflammatory markers, and muscles strength.
    

Intervention name(s): Intervention Group; Control Group
Intervention type(s): Other; Other
Intervention description(s): Aerobic training; Chest physiotherapy: Flutter and muscle stretching
Other intervention name(s): Pulmonary Rehabilitation; Chest Physiotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary rehabilitation; Asthma; Children; Teenager; Physical capacity
A Single-dose Study in Healthy Japanese Male Adults to Evaluate Pharmacokinetics and Pharmacodynamics of E5501 5 mg Tablet (Study E5501-J081-015)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      E5501 (5 mg, 20 mg, and 40 mg) will be administered to healthy male adults in a
      single-center, randomized, open-label, cross-over manner. This study will consist of 2 phases
      including pre-randomization (before drug administration) and postrandomization (after drug
      administration).
    


Intervention name(s): Group A: E5501 5mg, then 20mg, then 40 mg, then 5mg; Group B: E5501 20mg, then 40mg, then 5 mg, then 5mg; Group C: E5501 40mg, then 5mg, then 20 mg, then 5mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The post-randomization phase consists of the Treatment Period 1 (Visits 2-8): participants received one 5 mg tablet under fed conditions on treatment morning for 28 days. Treatment Period II (visits 9-15): 20 mg (four 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period III (visits 16-22): 40 mg (eight 5 mg tablets) under fed conditions on treatment morning for 28 days.
Treatment Period IV (visits 23-29): 5 mg tablet on treatment morning under fasted conditions for 28 days.
The washout period of 27 days or longer was set between the administration of the study drug in Treatment Periods 1, 2 and 3 and that in Treatment Periods 2, 3 and 4 respectively.; The post-randomization phase consists of the Treatment Period 1 (Visits 2-8): participants received 20 mg (four 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period II (visits 9-15): 40 mg (eight 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period III (visits 16-22): one 5 mg tablet under fed conditions on treatment morning for 28 days.
Treatment Period IV (visits 23-29): 5 mg tablet on treatment morning under fasted conditions for 28 days.
The washout period of 27 days or longer was set between the administration of the study drug in Treatment Periods 1, 2 and 3 and that in Treatment Periods 2, 3 and 4 respectively.; The post-randomization phase consists of the Treatment Period 1 (Visits 2-8): participants received 40 mg (eight 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period II (visits 9-15): one 5 mg tablet under fed conditions on treatment morning for 28 days. Treatment Period III (visits 16-22): 20 mg (four 5 mg tablets) under fed conditions on treatment morning for 28 days.
Treatment Period IV (visits 23-29): 5 mg tablet on treatment morning under fasted conditions for 28 days.
The washout period of 27 days or longer was set between the administration of the study drug in Treatment Periods 1, 2 and 3 and that in Treatment Periods 2, 3 and 4 respectively.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Sublingual Midazolam in Association With Oral Morphine in Children Analgesia After Bone Fracture
Condition: Fractures
MeSH terms: Fractures, Bone
Study type: Interventional
Phase: Phase 3

Summary: 
      It is a randomized simple-blind monocentric study; the group A will receive oral morphine
      with placebo and the group B will receive oral morphine with sublingual midazolam. The aim of
      this study is to show a more important pain decrease in the group taking midazolam versus
      placebo.
    

Detailed description: 
      Fracture is often responsible of pain in the paediatric emergency department (ED). This pain
      is very severe and needs effective drugs.

      During a study made at the ED of Necker Enfants Malades Hospital, it has been shown that the
      oral morphine had a limited action on this kind of pain. Therefore it is interesting to
      increase the analgesia by making a drug association, for example with the midazolam witch is
      a benzodiazepine with a sedative and anxiolytic action, and which has got the MMA for the
      intravenous and the intra rectal forms for children older than 6 months.

      The intravenous form has some disadvantages like an extra work and an increase of risk of
      side effects.

      That is why the sublingual form seems to be interesting in this context. Even if some studies
      have shown the benefit of midazolam as a preanesthetic medication given to children scheduled
      for a surgical procedure, none has shown the interest of sublingual midazolam associated with
      oral morphine to relieve the pain due to a displaced fracture.

      The aim of this study is to show a more important pain decrease in the group taking midazolam
      versus placebo.

      It is a randomized simple-blind monocentric study; the group A will receive oral morphine
      with placebo and the group B will receive oral morphine with sublingual midazolam . The pain
      will be quantified thanks to the visual analogical scale (VAS)before and 30 minutes after the
      drugs administration, and we will try to show a difference of 15 points(on 100) of the VAS at
      30 minutes between the two groups.

      60 patients aged from 5 to 16 years old and having a displaced fracture will be enrolled in
      this study which will last 1 year.

      Patients having a contra-indication for morphine and midazolam won't be enrolled as patients
      with femoral fracture which needs a local anaesthesia.
    

Intervention name(s): Midazolam; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.2 mg/kg of sublingual midazolam and 0.5 mg/kg of morphine; placebo at 0.2 mg/kg and morphine 0.5 mg/kg
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: midazolam; sublingual; oral morphine; children; bone fracture; bone fracture with a deformed member
Study to Evaluate the Safety and Immunogenicity of MEDI-517P in Healthy Adult Female Volunteers Who Are HPV-16 or HPV-18 DNA Positive
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of this study is to describe the safety of 40 mg MEDI-517, with a
      control of aluminum hydroxide, when given to healthy adult women who have evidence of HPV-16
      and/or HPV-18 DNA detected in cervical brushings.
    


Intervention name(s): MEDI 517; Aluminum hydroxide
Intervention type(s): Biological; Other
Intervention description(s): Vaccine is supplied in single use vials containing 0.75 mL of MEDI-517 at a concentration of 40 mg/0.5 mL formulated with SBAS4 adjuvant.; Aluminum hydroxide supplied in single use vials containing 0.75 mL of aluminum hydroxide at a concentration of 0.5 mg of aluminum in the form of aluminum hydroxide per 0.5 mL.
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Laparoscopic Cholecystectomy Care Protocol
Condition: Laparoscopic Cholecystectomy
Study type: Observational

Summary: 
      The purpose of this study is to determine compliance with the Prisma Health-Upstate
      Laparoscopic Cholecystectomy Perioperative Protocol.
    

Detailed description: 
      Evidence based medicine calls for the application of scientific advances to clinical care. In
      an effort to address the most common complications of a surgical procedure, perioperative
      protocols have recently been created in an effort to apply best practices consistently and
      enhance the recovery from surgery. In addition to evaluating the validity of the protocol
      components themselves, it is valuable to measure compliance with said protocol. Failure to
      complete the steps of a care pathway may be caused by several reasons, and a study of
      application of these steps may help future efforts at standardization of care.

      The purpose of this study is to determine compliance with the Prisma Health-Upstate
      Laparoscopic Cholecystectomy Perioperative Protocol.

      Hospital inpatient data from patient charts, office charts, and hospital medical data systems
      of Prisma Health-Upstate System will be used to review the records of all patients age 18-75
      years, inpatient and outpatient, who had surgery for choledocolithiasis between January 1,
      2016 to April 1, 2017.
    

Intervention name(s): Protocol Compliance
Intervention type(s): Other
Intervention description(s): Compliance with the Prisma Health-Upstate Laparoscopic Cholecystectomy Perioperative Protocol
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients between the ages of 18 years and 75 years who had surgery for choledocolithiasis
        at Prisma Health-Upstate.
Effects of Black Bean Pasta Consumption on Biomarkers in Young Adults
Condition: Glucose, High Blood
Study type: Interventional

Summary: 
      The study purpose is to determine the effect of eating three (3) different pasta flour
      formulations made from 100% black beans (Zenith) in a meal matrix (spaghetti sauce) on
      postprandial glycemic response in healthy adults.
    

Detailed description: 
      The 5 test treatments (white bread (negative control), whole black beans (positive control),
      and 3 different pasta formulations) will be administered randomly over five weeks. Meals will
      be combined with spaghetti sauce for a total available carbohydrate amount of 50g.

      Venous blood samples will be collected for glucose and insulin analysis at time 0 (fasting)
      and at 30, 60, 90, 120, and 180 minutes post-treatment (timing of the post-treatment blood
      draws started at time 0 [post-treatment], which is when the participant starts consuming the
      treatment meal). Blood analysis was completed by a reputable biomarker diagnostics
      laboratory, Quest Diagnostics.

      Anthropometric measures such as weight, height, waist circumference, and blood pressure were
      collected at screening and at the start of each test day. Thirteen hours before testing,
      participants consumed a standardized frozen meal to reduce the potential variation in
      glycemic responses on test day due to varying pre-evening dietary intakes. This control meal
      was selected by each participant before the start of the study. Each participant was provided
      the same frozen meal every time, since the subjects serve as their own controls. The day
      before test day, participants completed a 24 hour food recall, satiety, and gastrointestinal
      questionnaires. The morning of each test day participants completed the International
      Physical Activity Questionnaire (IPAQ), satiety, and gastrointestinal questionnaires.
    

Intervention name(s): White bread; Black beans whole boiled; Knife Mill pasta; Combo Flour Pasta; Cyclone Flour Pasta
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Toasted white bread; Whole boiled black beans with spaghetti sauce; Black bean pasta (KM) with spaghetti sauce; Black bean pasta (Combo) with spaghetti sauce (medium protein flour); Black bean pasta (Cyclone) with spaghetti sauce (low protein flour)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 5 x 5 crossover study with 3 treatments and two controls
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: glucose; insulin; legumes
Efficacy of Corifollitropin Alfa in Obese Women in Terms of Clinical and Molecular Parameters of IVF Success
Condition: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the present study is to determine, whether clinical efficacy of 150 mcg of
      Corifollitropin alfa is the same in normal weighing and obese women. Furthermore,
      investigators want to determine whether oocytes retrieved from normal weighing and obese
      women, after COH using 150 mcg of Corifollitropin alfa, are of same quality on the molecular
      level.
    

Detailed description: 
      The dosage of Corifollitropin alfa used for controlled ovarian hyperstimulation (COH) is
      adjusted according to the patient's body weight. Meaning, in women with a body weight ≤ 60
      kg, a single dose of 100 mcg of Corifollitropin alfa is administered for COH and in women
      with a body weight > 60 kg, a single dose of 150 micrograms of Corifollitropin alfa is
      administered for COH. These two protocols are comparable in safety and efficacy of follicular
      stimulation.

      On the other hand, knowledge about the clinical efficacy of 150 mcg of Corifollitropin alfa
      in obese women (BMI>30 kg/m2) is lacking.

      Cumulus cells (CC) surround the oocyte and bi-directional communication between oocyte and CC
      is necessary for the development of mature and quality oocytes. It has been proposed, that
      analysis of genes, expressed in CC, can serve as an objective indicator of the oocyte's
      maturity and developmental potential. Expression of genes in CC as hyaluronan synthase 2
      (HAS2), follicle-stimulating hormone receptor (FSHR), versican (VCAN), progesterone receptor
      (PR), vascular endothelial growth factor C (VEGFC), serine protease inhibitor E2 (SERPINE2),
      glutathione peroxidase (GPX3), pentraxin 3(PTX3) was reported to correlate with oocyte
      maturity and developmental potential.

      The effect of Corifollitropin alfa on expression of these genes however, is unknown.
    

Intervention name(s): Elonva
Intervention type(s): Drug
Intervention description(s): 20 obese women will be the study group and 20 normal weighing women will be the control group. Both groups will receive 150 mcg of Elonva for controlled ovarian hyperstimulation (COH). Gonadotropin-releasing hormone (GnRH) antagonist will be used to prevent premature luteinizing hormone (LH) surge. Additional daily doses of 200 IU of recombinant follicle stimulating hormone (rFSH) will be used if necessary. Human chorionic gonadotropin (hCG) will be used for oocyte maturation. 2 mature follicles will be aspirated separately in each patient. Cumulus cell (CC) samples will be collected and stored on -80 oC for subsequent analysis. Clinical and molecular parameters of IVF success will be assessed and compared between the groups.
The exclusion criteria will be: polycystic ovary syndrome, severely abnormal sperm parameters, and age > 38 years.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Experimental Medication For the Treatment of Generalized Anxiety Disorder
Condition: Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether an experimental anti-anxiety medication is
      effective in the treatment of Generalized Anxiety Disorder.
    

Detailed description: 
      Protocol 04-001-01

      The primary objective of the study is to assess, under controlled conditions, the safety and
      efficacy of an experimental anti-anxiety medication relative to placebo in subjects with
      generalized anxiety disorder (GAD).

      The secondary objective of the study is to study algorithms for discontinuation of an
      experimental anti-anxiety medication.

      Recruiting: Participants are currently being recruited and enrolled.
    

Intervention name(s): experimental anti-anxiety drug
Intervention type(s): Drug
Intervention MeSH terms: Anti-Anxiety Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Double Blind, Placebo controlled, Safety and Efficacy; Generalized Anxiety Disorder