bioihbjkbjnl/mcl2 huggingface dataset:
Morphine COnsumption in Joint Replacement Patients, With and Without GaBapentin Treatment, a RandomIzed ControlLEd Study
Condition: Postoperative Pain; Total Hip Replacement
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Total hip arthroplasty is amongst the most painful procedures postoperatively, and pain
      management can be a challenge. Different measures have been introduced to manage severe
      postoperative pain in these patients. Previous studies have investigated gabapentin in acute
      postoperative pain and demonstrated reduced postoperative pain, postoperative morphine
      consumption, morphine related side effects, and postoperative pain scores. To date, this
      analgesia adjunct has yet to be investigated for total joint arthroplasty patients.
    

Detailed description: 
      The study was submitted to Health Canada and has received the letter of no objection. A
      randomized, double-blind, placebo-controlled trial will be conducted. The randomization
      scheme will be prepared and done by the pharmacy department at McMaster University. Ninety
      patients undergoing primary hip arthroplasty will be recruited from the preoperative clinic.
      Forty-five patients in each population will be allocated to a gabapentin group and the other
      forty-five patients will be allocated to a placebo group.
    

Intervention name(s): Gabapentin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 600mg gabapentin given 2 hrs preoperatively and 200mg three times a day after surgery for 3 days; Half the patients will be randomized to placebo
Other intervention name(s): Neurontin; Sugar pill
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hip; arthroplasty; postoperative pain; gabapentin
Effects of Low-Flow Anesthesia on Hemodynamic Parameters and Oxygenation in Morbidly Obese Patients
Condition: Morbid Obesity; Hemodynamic Instability; Bariatric Surgery Candidate
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      Low-flow anesthesia has been used for years with positive results, but its effects on
      hemodynamic parameters and oxygenation are not clearly known in high-risk morbidly obese
      patients who are prone to pulmonary dysfunction related to the obesity. Therefore, this
      prospective randomized study aimed to compare the effects of low-flow (0.75 L/min) and
      normal-flow (1.5 L/min) anesthesia on hemodynamic parameters and oxygenation in morbidly
      obese patients undergoing laparoscopic bariatric surgery.
    

Detailed description: 
      Low-flow anesthesia has several potential benefits. It improves the flow dynamics of the
      inhaled air, increase mucociliary clearance, maintain body temperature, reduce fluid loss,
      result in savings of up to 75% and reduce greenhouse gas emissions and reduce treatment costs
      (10 - 13). However, it is necessary to examine whether the reduction of fresh gas flow
      affects the quality and safety of anesthesia management, especially during high-risk
      operations such as laparoscopic bariatric surgery.

      Low-flow anesthesia has been used for years with positive results, but its effects on
      hemodynamic parameters and oxygenation are not clearly known in high-risk morbidly obese
      patients who are prone to pulmonary dysfunction related to the obesity. Therefore, this
      prospective randomized study aimed to compare the effects of low-flow (0.75 L/min) and
      normal-flow (1.5 L/min) anesthesia on hemodynamic parameters and oxygenation in morbidly
      obese patients undergoing laparoscopic bariatric surgery.
    

Intervention name(s): hemodynamic parameters; arterial blood gase
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): vital signs on the monitor including heart rate, mean arterial pressure, peripheral oxygen saturation and End-tidal Carbon Dioxide; Arterial blood gas including partial oxygen pressure and partial carbon dioxide pressure is an important routine investigation to monitor the acid-base balance of patients, effectiveness of gas exchange, and the state of their voluntary respiratory control.
Other intervention name(s): heart rate; mean arterial pressure; peripheral oxygen saturation; End-tidal Carbon Dioxide; partial oxygen pressure; partial carbon dioxide pressure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Morbidly obese patients; Bariatric surgery; Arterial blood analysis
A Pharmacokinetic (PK) Study Evaluating Naproxen and Esomeprazole Plasma Levels
Condition: Arthritis
MeSH terms: Arthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      A pharmacokinetic study evaluating naproxen and esomeprazole blood levels in 4 treatments,
      each containing one or both components.
    

Detailed description: 
      This study is being conducted to assess the relative bioavailability of naproxen and
      esomeprazole from a single dose of PN 400 (delayed-release naproxen 500mg / immediate-release
      esomeprazole 20mg), enteric-coated naproxen 500mg co-administered with enteric-coated
      esomeprazole 20mg, enteric-coated naproxen 500mg administered alone, and enteric-coated
      esomeprazole 20mg administered alone.
    

Intervention name(s): PN 400; EC naproxen plus EC esomeprazole; EC naproxen; EC esomeprazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A single tablet containing delayed-release naproxen (500mg) plus immediate-release esomeprazole (20mg); Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule (20mg); Enteric-coated naproxen tablet (500mg); Enteric-coated esomeprazole capsule (20mg)
Other intervention name(s): EC Naprosyn and Nexium; EC Naprosyn; Nexium
Intervention MeSH terms: Naproxen; Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the effect of a novel gut microbiota-targeted therapeutic regimen (bowel lavage
      and antibiotics with or without an antifungal) in the management of active Crohn's Disease
      (CD) that is refractory to conventional, immunosuppressive therapy.
    


Intervention name(s): Fluconazole; Vancomycin; Neomycin; Ciprofloxacin; Polyethylene Glycol 3350; Promethazine; Fluconazole placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 400mg orally once daily (Day 1-14); 500mg oral suspension 4 times daily (Day 1-14); neomycin 1000 mg orally three times daily (Days 1-3); ciprofloxacin 750 mg orally twice daily (Day 4-14); 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2; PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).; Once daily
Other intervention name(s): Diflucan; Vancocin; Neo-Fradin; Cipro; Miralax; Phenergan
Intervention MeSH terms: Promethazine; Diphenhydramine; Vancomycin; Ciprofloxacin; Neomycin; Fluconazole; Polyethylene glycol 3350
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Energy Balance Study
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      Very low carbohydrate diets and high-complex carbohydrate, low-fat diets are popular
      weight-loss methods in the United States. The purpose of the Energy Balance Study is to
      explore how extreme differences in diet affect eating behaviors, activity and calorie-use,
      and body composition.

      We will conduct a controlled feeding study (all food will be provided for the duration of the
      study) in which obese adults will be randomly assigned to one of three dietary groups: a
      low-carbohydrate-eat as much as you like diet, a high-carbohydrate-eat as much as you like
      diet, or a high-carbohydrate-calorie-restricted diet. The low-carbohydrate diet will be
      modeled after the Induction Phase of the Atkins Diet. The high carbohydrate diet will be
      based on the "Dietary Approaches to Stop Hypertension (DASH)" diet. During the first 3 weeks,
      participants will eat a typical diet adjusted so that they neither gain or lose weight. Then,
      for 6 weeks, they will eat their assigned research diet. Resting calorie use and body
      composition measurements will be taken at the end of week 2 and week 9. Frequent blood
      sampling for 24 hours will be done through a catheter (tube) placed in an arm vein at the end
      of weeks 2 and week 9 and for 12 hours at the end of week 3.

      Change in body composition, activity and energy expenditure, and blood components known to
      influence eating behavior will be measured under typical diet conditions and after one-day
      and 6 weeks of the research diet.
    


Intervention name(s): Low carbohydrate diet; High-carbohydrate ad libitum intervention; High carbohydrate diet-energy matched intervention
Intervention type(s): Other; Other; Other
Intervention description(s): Ad libitum low carbohydrate diet (<28g carbohydrate/day). Participants provided with research diet at 120% of estimated energy needs for weight maintenance and allowed to eat as much or as little of the food desired.; Participants provided with a high complex carbohydrate diet (55% carbohydrate, 18% protein, and 27% fat) at 120% of estimated energy needs for weight maintenance and allowed to eat as much or as little of the foods provided as desired; Participants provided a high complex carbohydrate diet (55% carbohydrate, 18% protein, and 27% fat) at ~70% of estimated energy needs to maintain weight. Participants required to eat all food provided and nothing else.
Other intervention name(s): Low CHO diet; Atkins Diet; High CHO-ad lib diet; DASH-ad lib diet; High CHO energy-matched diet; DASH energy-mathched diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Weight loss; low carbohydrate diets; high complex carbohydrate diets; Healthy adults; Body composition; Energy Expenditure
Phase 2, Open-Label Study for Safety, Microbiology and PK of Single or Multiple Oral C16G2 Gel Doses
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2

Summary: 
      Part A: Open-label, multiple arm, safety, microbiology and pharmacokinetic (PK) study in
      healthy adult male and female subjects 18-75 years of age. All subjects will be assessed for
      safety and microbiology parameters. A subset of subjects will be assessed for pharmacokinetic
      parameters. No longer enrolling study subjects in Part A.

      Part B: Open-label, multiple arm, safety and microbiology study in healthy adult male and
      female subjects 18-75 years of age. All subjects will be assessed for safety,
      pharmacokinetic, and microbiology parameters.
    

Detailed description: 
      Open-label, multiple arm, safety, microbiology and pharmacokinetic (PK) study in healthy
      adult male and female subjects 18-75 years of age conducted in two parts.

      Part A of the study will evaluate up to 6 study arms, depending on the microbiology response
      evaluated. Before dosing of C16G2, eligible subjects will undergo professional dental
      prophylaxis on Day 0. Clinic visits for all Study Arms include Visit 1 (Screening/Days -21 to
      0), Treatment Visits 2 through 6 (Baseline/Day 0 through Day 4), and follow-up Visits 7
      through 11 (Day 5, 8, 12, 19 ± 1 and 33 ± 2).

      All subjects will be assessed for safety and microbiology parameters for approximately 5
      weeks. A subset of subjects in Study Arms 2 and 4 will be assessed for pharmacokinetic
      parameters. Part A of the study is no longer enrolling study subjects.

      Part B of the study will evaluate up to 5 study arms, depending on the microbiology response
      evaluated during 2 interim microbiology reviews. Clinic visits for all study arms except
      Study Arm 5 include Visit 1 (Screening/Days -21 to 0), Visit 2 (Baseline/Day 0), Visits 3
      through 17 (Days 1 through 6, morning and evening visits, and Days 7, 10 and 14). All
      subjects will be assessed for safety and microbiology parameters for approximately 2 weeks.
      Before dosing of C16G2, eligible subjects will undergo professional dental prophylaxis on Day
      0. Study drug will be administered for 7 consecutive days. The Sponsor will perform a
      microbiology review to evaluate the S. mutans response in Study Arms 1 & 2 and, if
      applicable, in Study Arms 3a or 3b. In Study Arm 5, subjects will receive multiple C16G2
      doses on a single day and will be evaluated for safety, microbiology and pharmacokinetic
      parameters. Clinic visits for Study Arm 5 will include Visit 1 (Screening/Days -21 to 0),
      Visit 2 (Baseline/Day 0), Visit 3/Day 1 and Visit 4/Day 6.
    

Intervention name(s): C16G2
Intervention type(s): Drug
Intervention description(s): antimicrobial peptide
Other intervention name(s): C16G2 (1.6 mg/mL); C16G2 (3.2 mg/mL)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Continuation With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years of Age
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent
      patients with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™)
      diagnosis of MDD
    


Intervention name(s): Vortioxetine
Intervention type(s): Drug
Intervention description(s): Target dose is 10 mg/day; the dose can be down- or uptitrated to 5, 15, or 20 mg/day.
Other intervention name(s): Brintellix; Lu AA21004
Intervention MeSH terms: Vortioxetine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: children; adolescent
Efficacy, Safety and Immunogenicity Study of SARS-CoV-2 Inactivated Vaccine
Condition: SARS-CoV2 Infection
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      This phase III trial aims to assess the efficacy, safety and immunogenicity of SARS-CoV-2
      Vaccine (inactivated) and lot-to-lot consistency evaluation
    

Detailed description: 
      This trial is Randomized, observer-blind, placebo-controlled two arms parallel group,
      prospective intervention study

      Approximately 1620 subjects aged 18-59 years will be enrolled in this trial for efficacy
      evaluation. Subjects will be divided into 2 treatment arms that are the vaccinated group and
      placebo group with ratio 1:1. The vaccinated arms will be grouped into three different lot
      number (lot 1/lot 2/ lot 3) of SARS-CoV-2 vaccine.
    

Intervention name(s): SARS-CoV-2 vaccine (inactivated); Placebo
Intervention type(s): Biological; Biological
Intervention description(s): SARS-CoV-2 vaccine (inactivated) manufactured by Sinovac; Placebo manufactured by PT. Bio Farma
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects 18-59 years of age: Randomized, observer blind, placebo-controlled two arms parallel group, prospective intervention study, to evaluate efficacy, safety, immunogenicity SARS-CoV-2 vaccine (inactivated)
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: vaccine; SARS-CoV-2; infection
Clinical Observation and MRI Influence of Acupuncture on Knee Osteoarthritis
Condition: Knee Arthritis Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      To observe the therapeutic effect of acupuncture on osteoarthritis(OA) and its efficacy on
      cartilage restoration,acupuncture and physiotherapy treatment were respectively given to two
      random groups. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was
      used to evaluate the motor function of knee joints, followed by magnetic resonance imaging
      (MRI) scanning to measure T2 values in ten cartilage sub-regions in tibiofemoral joints.
    

Detailed description: 
      To observe the therapeutic effect of acupuncture on osteoarthritis and its efficacy on
      cartilage restoration,one hundred knees of 50 patients with knee osteoarthritis were randomly
      divided into acupuncture group and physiotherapy group which were respectively received
      acupuncture and physiotherapy treatment for four weeks. Western Ontario and McMaster
      Universities Osteoarthritis Index (WOMAC) was used to evaluate the motor function of knee
      joints, followed by magnetic resonance imaging (MRI) scanning to measure T2 values in ten
      cartilage sub-regions in tibiofemoral joints.
    

Intervention name(s): acupuncture; physiotherapy
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis; MRI; Cartilage; Acupuncture
Fluid Intake in Kidney Failure
Condition: Chronic Renal Failure; Kidney Transplantation
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Patients with renal impairment are usually advised to increase their fluid intake. There is
      currently, however, no evidence supporting this recommendation. In contrast,high fluid intake
      could be dangerous if urine excretion is reduced. In this study the researchers investigate
      whether increasing fluid intake from 2 to 4 litres per day has any influence on long-term
      renal outcome.
    


Intervention name(s): high fluid intake; normal fluid intake
Intervention type(s): Behavioral; Behavioral
Intervention description(s): fluid intake of 4 litres per day; Fluid intake of 2 litres per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic kidney disease; transplantation; kidney function; fluid intake; osmolarity
Acute Effects of HIIT and SSMIT on Intraocular Pressure Among Sedentary Individuals
Condition: Intraocular Pressure
Study type: Interventional

Summary: 
      Purpose to study the acute effects of both forms of aerobic exercise (HIIT and SSMIT) on
      intraocular pressure among healthy sedentary individuals
    

Detailed description: 
      40 participants were recruited and divided into 2 groups. Each group performed 2 exercise
      protocols with a 4 day washout period between them.

      The intraocular pressure was measured before the exercise and after the exercise in 5 minute
      periods up until 30 minutes post exercise.

      The intraocular pressure was measured using a handheld rebound tonometer.
    

Intervention name(s): aerobic exercise
Intervention type(s): Other
Intervention description(s): aerobic exercise HIIT : High intensity interval training SSMIT : Steady state moderate intensity training
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluating Contact Lens Optics
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      This study will evaluate changes in refractive error and visual performance between a single
      vision soft contact lens and multifocal soft contact lens
    


Intervention name(s): Single vision contact lens; Multifocal contact lens
Intervention type(s): Device; Device
Intervention description(s): Participants will wear a single vision soft contact lens during the study visit; Participants will wear a multifocal soft contact lens during the study visit
Other intervention name(s): comfilcon A; comfilcon A
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Safety, Tolerability, and Pharmacokinetics of Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Chicken Egg Antibody (IgY) (COVID-19)
Condition: Covid19
MeSH terms: COVID-19; Severe Acute Respiratory Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of Part 1 (Single Ascending Dose) is to assess the safety and
      tolerability of anti-SARS-CoV-2 IgY when given as single-ascending doses administered
      intranasally to healthy participants.

      The primary objective of Part 2 (Multiple Dose) is to assess the safety and tolerability of
      anti-SARS-CoV-2 IgY when given as multiple doses administered intranasally to healthy
      participants. A secondary objective is to assess the pharmacokinetics of anti-SARS-CoV-2 IgY
      when given as multiple doses administered intranasally to healthy participants.

      Safety will be evaluated using adverse event (AE), physical examination (including vital
      signs), electrocardiogram, and clinical laboratory data. Pharmacokinetics will be evaluated
      by serum anti-SARS-CoV-2 IgY concentration.
    


Intervention name(s): anti-SARS-CoV-2 IgY; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.; Placebo matching anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Randomized Controlled Trial Comparing Band Ligation and Cyanoacrylate Injection for Esophageal Varices
Condition: Liver Disease
MeSH terms: Liver Diseases; Esophageal and Gastric Varices
Study type: Interventional
Phase: Phase 4

Summary: 
      Compare VBL and cyanoacrylate injection (CI) in the treatment of EV in patients with advanced
      liver disease regarding eradication, bleeding, mortality, complication and recurrence rates.
    


Intervention name(s): Variceal band ligation; cyanoacrylate injection
Intervention type(s): Device; Drug
Intervention description(s): cyanoacrylate injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: advanced liver disease; esophageal varices; band ligation; cyanoacrylate injection
A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for Smoking Cessation
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to evaluate the safety and efficacy of varenicline given
      for a twelve week treatment period in comparison with placebo and Zyban for smoking
      cessation.
    


Intervention name(s): varenicline (CP-526,555)
Intervention type(s): Drug
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment