bioihbjkbjnl/mcl2 huggingface dataset:
Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache
Condition: Postdural Puncture Headache
MeSH terms: Post-Dural Puncture Headache; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      Postdural puncture headache (PDPH) is a major complication of neuraxial anesthesia that can
      occur following spinal anesthesia and with inadvertent Dural puncture during epidural
      anesthesia. The presence of Pyridostigmine in CSF would be expected to increase the level of
      acetylcholine in CSF and subsequently in the brain through inhibition of cholinesterase. The
      increased level of acetylcholine would produce cerebral vasoconstriction.
    


Intervention name(s): Pyridostigmine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Parturients with postoperative Postdural puncture headache and a Visual analogue scale (VAS score) of ≥5 will receive either 60 mg oral Pyridostigmine every 6 hours or Placebo tablets similar in shape to pyridostigmine tablets every 6 hours.; Parturients with postoperative Postdural puncture headache and a Visual analogue scale (VAS score) of ≥5 will receive Placebo tablets similar in shape to pyridostigmine tablets every 6 hours.
Intervention MeSH terms: Pyridostigmine Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PK/PD Study With G-Pump (Glucagon Infusion) in T1DM Patients
Condition: Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to assess the safety, speed of absorption, and onset of action of
      G-Pump™ (glucagon infusion) at three subcutaneous doses as compared to Novo GlucaGen®, all
      delivered via an OmniPod® infusion pump to patients with type 1 diabetes.
    


Intervention name(s): Novo Nordisk GlucaGen®; G-Pump™ (glucagon infusion)
Intervention type(s): Drug; Drug
Intervention description(s): single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg; single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg
Intervention MeSH terms: Glucagon
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypoglycemia; Glucagon; Artificial Pancreas
Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon?
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      This study is being conducted to determine if eszopiclone is as effective as ramelteon when
      used as a pre-medication (sleeping pill) in sleep studies performed to diagnose and treat
      sleep apnea.
    

Detailed description: 
      Many Veterans suffer from sleep disordered breathing with a high prevalence of undiagnosed
      obstructive sleep apnea. One test that can be effective in the diagnosis of sleep apnea is
      the polysomnogram (PSG). Split-night PSG consists of a diagnostic phase in the first half of
      the night and a continuous positive airway pressure titration (CPAP) in the second half of
      the night. CPAP is the standard, most effective therapy for obstructive sleep apnea. Due to
      the unfamiliar sleep environment of the laboratory and instrumentation that must be used
      (application of electroencephalogram leads), patients are frequently not able to sleep
      adequately. In these cases, the PSG must be repeated. Oral hypnotic agents are often used as
      a pre-medication to increase the yield of PSG in an attempt to decrease the need for repeat
      studies.

      Numerous data is available on the effects of premedication with oral short-acting hypnotics
      on PSG quality and efficacy of CPAP titration. In one study, eszopiclone, a nonbenzodiazepine
      gaba-receptor agonist short-acting hypnotic, has been shown to improve PSG quality and CPAP
      titration. Another short-acting hypnotic, ramelteon, was recently approved by FDA but the
      effects of ramelteon in improving PSG quality and efficacy of CPAP titration are unclear. The
      advantage of ramelteon over eszopiclone is the lack of drug dependency or abuse potential.
      This study aims to evaluate the efficacy of ramelteon compared to eszopiclone when
      administered prior to split-night PSG and CPAP titration.
    

Intervention name(s): Rozerem (Ramelteon); Lunesta (Eszopiclone); Historical Controls
Intervention type(s): Drug; Drug; Other
Intervention description(s): 8 mg taken orally 30 minutes before a split-night PSG; 3 mg taken orally 30 minutes before the start of a split-night PSG; Chart review matched for demographics and comorbidities of the study drug groups.
Other intervention name(s): Ramelteon; Eszopiclone
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: obstructive sleep apnea; eszopiclone; ramelteon; polysomnography
Phase I Open Label Single-Dose Study to Compare the Pharmacokinetics of NP101 Healthy Volunteers
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to compare the pharmacokinetics (PK) profiles among five NP101
      patches in healthy volunteers.

      The secondary objective is to evaluate the safety of NP101 in healthy volunteers.
    


Intervention name(s): NP101 Sumatriptan Iontophoretic Transdermal Patch
Intervention type(s): Drug
Intervention description(s): NP101 transdermal patch delivering sumatriptan for 4 hours.
Intervention MeSH terms: Sumatriptan
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Gum Arabic as Fetal Hemoglobin Agent in Sickle Cell Anemia
Condition: Sickle Cell Anemia
MeSH terms: Anemia; Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether Gum Arabic is effective as fetal hemoglobin
      inducing agent for sickle cell anemia patients.
    

Detailed description: 
      : High level of fetal haemoglobin (Hb F) decreases sickle cell anaemia (SCA) severity and
      leads to improved survival. Butyrate proved to increase HbF production in vivo and in vitro
      studies. Nonetheless, its short half-life limited its utilization in clinical practice. Gum
      Arabic (GA) is edible, dried, gummy exudate from Acacia Senegal tree. GA fermentation by
      colonic bacteria increases serum butyrate concentrations. The investigators hypothesized
      regular intake of GA will increase serum butyrate level. The latter will induce fetal
      hemoglobin production and ameliorate patients' symptoms. 47 patients hemoglobin SS aged 5-42
      years, on regular follow up in Military hospital were recruited from April 2014 to January
      2015 Patients received dose of G A 30g/day for 12 weeks. Hb F, complete blood count and
      Erythropoietin level were measured. The main outcome of interest was the level of HbF after
      12 weeks.
    

Intervention name(s): Gum Arabic
Intervention type(s): Dietary Supplement
Intervention description(s): oral ingestion of 30 gram every day for 12 weeks
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
SDR Monitoring in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Observational

Summary: 
      The study evaluates the anatomical distribution of the assessed Electromyogram (EMG)
      responses ensuring after sensory nerve root stimulation and obtained IOM grading during
      selective dorsal rhizotomy (SDR) with regard to level and, side of the body and gender as
      well as pain management and outcome data.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Male and female pediatric and adolescent patients undergoing SDR
Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1128688 After Multiple Oral Administrations in Healthy Women
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this trial is to investigate the safety and tolerability of BAY1128688 and
      to determine the concentration of this substance in blood after repeated administration by
      the oral route. The investigational substance will be administered in tablet form to healthy
      women.
    


Intervention name(s): BAY1128688; Placebo; BAY1128688
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Part A: Single dose and multiple dose for 14 days (postmenopausal women); Part A: Single dose and multiple dose for 14 days (postmenopausal women); Part B: Multiple dose for 28 days (premenopausal women)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
A Study to Evaluate the Long-term Use of Valsartan in Children 6 Months to 5 Years Old With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, safety and tolerability of long-term
      use (up to 18 weeks) of valsartan in children 6 months to 5 years old with hypertension.
    


Intervention name(s): Valsartan
Intervention type(s): Drug
Intervention description(s): Extemporaneous suspension of valsartan, orally.
Intervention MeSH terms: Valsartan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Children; pediatrics; High Blood Pressure; Hypertension; Valsartan
Indirect Resin Composite Inlays Cemented With a Self-adhesive, Self-etch or a Conventional Resin Cement
Condition: Dental Leakage
MeSH terms: Dental Leakage
Study type: Interventional

Summary: 
      The present study was designed to provide further evidence in this particular research
      prospective, and this study hence aimed to clinically evaluate the 5-years adhesion
      durability of indirect resin composite inlays luted with three different resin cement
      strategies in MOD Class II restorations. The formulated null hypothesis was that there is no
      significant difference in the clinical performances of the three different resin cement
      strategies for luting indirect resin composite inlays in MOD Class II restorations for
      5-years.

      The research question was as follows: Do self-adhesive resin cements in class II restorations
      present better clinical performances than conventional etch-and-rinse and self-etch resin
      cements according to the USPHS criteria?
    

Detailed description: 
      Objective: To clinically evaluate the 5 years adhesion durability of indirect resin composite
      inlays luted with three different resin cement strategies in MOD Class II restorations.

      Materials and Methods: A randomized clinical trial was conducted following the protocol, 40
      patients with three large cavities for each one that indicated for indirect MOD Class II
      restorations were enrolled in the current study. Then, 120 indirect resin composite inlay
      restorations (SR Nexco) were placed and luted with three different resin cement strategies;
      an etch-and-rinse (Variolink N), self-etch (Panavia F2.0) and self-adhesive (RelyX Unicem).
      Each resin cement was used for luting 20 inlay restorations. A single operator placed all
      restorations according to the manufacturer's instructions. Immediatelly after placement, the
      restorations were finished and polished. Clinical evaluation was performed at baseline and at
      1, 3 and 5 years intervals after placement by two independent examiners using modified USPHS
      criteria. The changes in the USPHS parameters during the 5 years period were analyzed with
      Fredman test. The baseline scores were compared with those at the recall visits using
      Wilcoxon signed rank test, where the level of significance was set at p˂0.05.
    

Intervention name(s): Etching
Intervention type(s): Procedure
Intervention description(s): Etching enamel surface using phosphoric acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Resin Composite; Randomized Clinical Trial; Operative Dentistry
Comparison of Conventional Lightwand Intubation Versus Video-laryngoscope Guided Lightwand Intubation in Simulated Cervical Spine-immobilized Patients
Condition: General Anesthesia
Study type: Interventional

Summary: 
      Among advanced intubation equipment for difficult intubation, a lighted stylet (lightwand) is
      a widely used equipment in cervical immobilized patients. However, a lightwand, which is used
      blind, is difficult to make midline positioning and can increase airway complications and
      hemodynamic changes. In contrast, videolaryngoscope can view vocal cord indirectly through
      camera, however, it requires cervical movement. Therefore, investigator hypothesized that the
      combined use of video-laryngoscope and lightwand for intubation can improve the efficacy of
      intubation compared to the use of lightwand alone in cervical immobilized patients.
    


Intervention name(s): Video-laryngoscope guided lightwand; lightwand alone
Intervention type(s): Device; Device
Intervention description(s): After anesthetic induction,the difficult airway is simulated by wearing a semi-hard neck collar. For intubation, video-laryngoscope is inserted into the oral cavity ntil the epiglottis tip was visible without lifting the epiglottic vallecula. Then, the endotracheal tube with lightwand is inserted toward the midline under the epiglottis and the intubation is performed looking the transilluminated light of lightwand.; After anesthetic induction,the difficult airway is simulated by wearing a semi-hard neck collar. Then, the endotracheal tube with lightwand is inserted and the intubation is performed with conventional method (blind technique by confirming transillumination).
Other intervention name(s): Video laryngoscope (VL310, Zhejiang UE Medical, Zhejiang, China); LightWand (3960, GE Healthcare, Englewood, USA)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intubation; light wand; video laryngoscopy; cervical spine immobilization
Semiquantitative Urine Pregnancy Test Results At ≥9 Weeks of Gestation
Condition: Pregnancy
Study type: Observational

Summary: 
      Purpose of study is to obtain data on urinary HCG concentrations at >9 weeks of gestation.
    


Intervention name(s): NO intervention
Intervention type(s): Other
Intervention description(s): This study was a cross-sectional study. It had no intervention.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        pregnant women at >9 weeks gestation
Pain Control in Colorectal Surgery: Liposomal Bupivacaine Block Versus Intravenous Lidociane
Condition: Colorectal Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the analgesic impact of intravenous perioperative lidocaine infusion with
      preoperative liposomal bupivacaine TAP block in colorectal surgery. This is to be integrated
      into the standard ERAS protocol currently utilized at Carolinas Medical Center. Primary
      endpoints will be postoperative pain as measured by verbal rate scale (VRS), postoperative
      morphine equivalents utilized per day, and over 30 days. Secondary endpoints will include
      date of ambulation, return of bowel function (first flatus), tolerance of goal diet,
      incidence of post-operative nausea and vomiting during hospital stay, length of stay
      (hospital and PACU), post-operative morbidity (Clavien-Dindo, related to both anesthesia and
      surgery), cost of hospitalization (operative, PACU, postoperative stay, and total) and
      quality of life on follow up.
    


Intervention name(s): Exparel; IV Lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): 2. Liposomal bupivacaine TAP block (experimental arm)
Block will be administered after induction of anesthesia and before incision by a specifically trained attending surgeon or surgical fellow with the colorectal service.
A single vial of liposomal bupivacaine (20 mL 1.3%, 13.3mg/mL, 266 mg) will be diluted in 50cc bupivacaine to a volume of 60cc prior to administration. This will be divided into 2 doses for bilateral TAP blocks.
The LB will be administered under ultrasound guidance in the transversus abdominis plain per manufacturer recommendations.
Adhesive tapes will be applied at the level of the TAP block puncture sites.; 1. Intravenous Lidocaine infusion (control arm, current standard of care)
100 mg/5mL intravenous bolus of lidocaine 2% PF 5mL will be initiated by anesthesia service prior to general anesthesia induction.
1.5 mg/kg/hr to begin prior to incision and continue until discontinued 1 hr postoperatively in PACU. Patients will be monitored in PACU for at least 30 minutes after discontinuation of lidocaine drip.
Adhesive tapes will be applied at the presumed level of TAP block puncture sites.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Probiotics and Examination-related Stress in Healthy Medical Students
Condition: Healthy; Stress-related Problem; Anxiety
Study type: Interventional

Summary: 
      Probiotics are live microorganisms exhibiting multiple properties beneficial to health. An
      increasing body of evidence indicates that probiotics may support healthy brain function and
      may relieve stress. Recent research in this area has examined lactic acid bacteria in detail,
      but little is known about the stress-relieving effects of Saccharomyces, a yeast with
      probiotic properties.

      Psychological stress is a factor that allows people to successfully cope with various daily
      life situations. On the other hand, excessive stress may lead to bodily harm and decrease
      performance, e.g. academic achievements. Probiotics may help manage stress, but little is
      known whether probiotics improve performance under stress.

      The aim of this trial is to examine whether the healthy medical students may demonstrate
      better performance in academic examinations when supplementing their diet with a yeast
      probiotic strain Saccharomyces boulardii (CNCM I-1079) or bacterial probiotic strain
      Lactobacillus rhamnosus GG (ATCC 53103). The secondary aim of the trial is to evaluate the
      potential effects of this supplementation on state anxiety as well as on biochemical and
      physiological stress markers.
    


Intervention name(s): Lactobacillus rhamnosus GG (ATCC 53103); Saccharomyces boulardii (CNCM I-1079); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 30 days of supplementation, 6x10^9 CFU/day; 30 days of supplementation, 5x10^9 CFU/day; 30 days of supplementation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Healthy medical students were assigned
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Psychobiotics; Probiotics; Examination; Stress
Safety and Tolerability Study of K0706 in Subjects With Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a safety, tolerability and pharmacokinetic study in subjects with Parkinson's disease
    


Intervention name(s): K0706; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once a day administration after fast; Once a day administration after fast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of SLS-002 (Intranasal Racemic Ketamine) in Adults With Major Depressive Disorder at Imminent Risk of Suicide
Condition: Depressive Disorder, Major; Suicidal
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Suicide
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy, safety, and tolerability of SLS-002
      (intranasal racemic ketamine) in addition to standard of care on symptoms of Major Depressive
      Disorder (MDD) and suicidality, in participants who are assessed to be at imminent risk for
      suicide, as measured by the change from baseline on the Montgomery-Asberg Depression Rating
      Scale (MADRS) total score at 24 hours post first dose.
    

Detailed description: 
      This is a 2-part study: Part 1 is open-label, while Part 2 is a randomized, double-blind,
      placebo-controlled, multicenter study. The study will enroll participants with MDD for whom a
      physician has assessed to be at risk for suicide. The study will consist of a screening
      evaluation, a treatment period, and a safety follow-up period. Participants' safety will be
      evaluated throughout the study. If you or a loved one are having thoughts of suicide, please
      seek immediate medical help. Go to the emergency room or call the National Suicide Prevention
      Lifeline at 1-800-273-8255.

      Potential participants may visit http://frontiersstudy.com/
    

Intervention name(s): SLS-002; Placebo; Standard of care; Intranasal device
Intervention type(s): Drug; Drug; Other; Device
Intervention description(s): Intranasal racemic ketamine hydrochloride 90 milligrams (mg); Intranasal placebo; Standard of care treatment will be determined by the treating physician(s) based on clinical judgement and practice guidelines; Device to deliver intranasal solution
Other intervention name(s): Ketamine hydrochloride
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Part 1 is a single group. Part 2 is a parallel group 1:1 randomization of SLS-002 to placebo, plus standard of care.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Depressive disorder; SLS-002; Mental disorders; Suicide; Suicidal Ideation; Mood disorders; Behavioral symptoms; Self-injurious behavior; Ketamine; Antidepressive agents; Psychotropic drugs