bioihbjkbjnl/mcl2 huggingface dataset:
AT247, NovoLog® and Fiasp® Administered Via Continuous Subcutaneous Infusion in Glucose Clamp Study
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 randomized, double-blind, three period, crossover study comparing the
      pharmacodynamic, pharmacokinetic, safety and tolerability profiles for Arecor ultra-rapid
      insulin aspart (AT247), NovoLog® and Fiasp® in participants with type 1 diabetes mellitus
      (T1DM) during continuous subcutaneous infusion (CSII)
    


Intervention name(s): AT247; NovoLog; Fiasp
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ultra rapid acting prandial insulin aspart; Rapid acting prandial insulin aspart; Fast acting prandial insulin aspart
Other intervention name(s): NovoRapid
Intervention MeSH terms: Insulin Aspart
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
In Vitro Maturation of Immature Oocytes
Condition: Polycystic Ovary Syndrome; Ovarian Hyperstimulation Syndrome
MeSH terms: Polycystic Ovary Syndrome; Ovarian Hyperstimulation Syndrome; Syndrome
Study type: Interventional

Summary: 
      The aim of this study is to aspirate immature oocytes from antral follicles and mature the
      oocytes in vitro. These mature oocytes will serve for fertilization and the creation of
      embryos which will be replace in the uterus as performed during normal IVF.We will record the
      efficacy and safety of this procedure.
    


Intervention name(s): In Vitro Maturation of immature oocytes
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PCOS; Fertility Preservation; Repeated IVF Failure; S/P Hyperstimulation
Addition of Homeopathy in Patients With Resistant Arterial Hypertension
Condition: Hypertension, Resistant to Conventional Therapy
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      Resistant hypertension (RHTN) is a common clinical problem faced by both primary care
      clinicians and specialists worldwide. Patients with RHTN have higher rates of cardiovascular
      events and mortality compared with patients with more easily controlled hypertension. In
      addition, RHTN is often complicated by metabolic abnormalities.

      Homeopathy, although widely used in hypertension, but no study has been taken to evaluate the
      impact on resistant hypertension. The aim of this trial was to evaluate individualized
      homeopathy on BP in patients with resistant hypertension.
    


Intervention name(s): Homeopathy; Placebo
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Resistant hypertension; Homeopathy; Blood pressure; Ambulatory blood pressure monitoring
Gastric Ultrasound in Pregnant Women at Term
Condition: Respiratory Aspiration; Pregnancy
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      Solid food or fluid residue in the stomach is always a major concern when patients need
      medical procedures under sedation or general anesthesia, due to the high risk of pulmonary
      aspiration of the stomach contents. This is especially important in emergency procedures,
      when a fasting period is not observed. The aspiration of the stomach contents into one's
      lungs can lead to serious complications (such as severe respiratory failure). Information
      from a bedside ultrasound assessment of the stomach may be a very useful tool to decide
      whether or not it's safe to proceed, cancel or delay a surgical procedure.
    

Detailed description: 
      Food residue in the stomach of patients scheduled to have surgery is considered a major risk
      factor for pulmonary aspiration of gastric contents. The resulting respiratory compromise
      after aspiration is associated with significant morbidity and mortality. The risk of
      pulmonary aspiration is especially important in pregnant women, as they may often require
      surgery without having observed appropriate fasting. A bedside ultrasound assessment fo the
      status of the gastric content would be of great value for the clinician. This technique has
      recently been shown very promising in non-pregnant patients and it is important to study its
      feasibility in the pregnant population.

      In this study, patients fast overnight and are randomized to the following groups: empty,
      fluid (250 mL of apple juice before scanning) or solid (full breakfast). Their gastric
      contents are then assessed by 3 different anesthesiologists, using ultrasound. At the end of
      the scanning, the true stomach contents are revealed. The ability of the assessors to
      accurately predict stomach contents, as well as the inter-observer agreement, will be
      examined.
    

Intervention name(s): Empty; Fluid; Solid
Intervention type(s): Other; Other; Other
Intervention description(s): overnight fast; 250mL apple juice; breakfast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Pregnancy; Respiratory aspiration; Gastric contents; Ultrasound
Nighttime Protein Intake on Overnight Lipolysis and Morning Fat Oxidation in Obese Men
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Single macronutrients will be consumed before sleep by obese men. Overnight lipolysis will be
      measured with the microdialysis technique by measuring glycerol concentration and blood flow
      in abdominal adipose tissue. Morning fat oxidation will be measured with indirect
      calorimetry.

      The investigators hypothesize that carbohydrate intake will blunt the overnight lipolysis
      rate compared to casein protein and a non-caloric placebo. The investigators also hypothesize
      that casein and placebo will not be significantly different from each other in terms of
      overnight lipolysis.
    


Intervention name(s): Casein Protein; Non-caloric placebo
Intervention type(s): Other; Other
Intervention description(s): The effect of casein protein consumed within 30 minutes of sleep on overnight lipolysis and next morning metabolism and appetite will be examined; The effect of a non-caloric placebo consumed within 30 minutes of sleep on overnight lipolysis and next morning metabolism and appetite will be examined
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Nighttime Eating; Protein; Obesity; Lipolysis; Metabolism
The Visual Effect of an Investigational Artificial Tear in the Tear Layer.
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Eye Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to investigate how the addition of a new artificial tear product
      when applied to the tear layer affects contrast sensitivity and optical aberrations over
      time. We will also determine if there are any adverse effects associated with drop
      instillation.
    

Detailed description: 
      Artificial tears are applied to the eye to treat a variety of eye conditions. These
      conditions typically are associated with dry eyes and include tear film deficiency due to
      ocular or systemic disease, lid resurfacing problems, and contact lens wear. The artificial
      tears are used to alleviate the dry eye symptoms. The administration of an artificial tear to
      the eye can disrupt the tear layer and this disruption could then result in a decrease in
      contrast sensitivity.1 - 6

      Temporal changes in tear film structure (e.g., drying of the tear layer) can distort the
      optical wavefront as it passes through the tear layer and subsequently reduce contrast
      sensitivity.1 Theoretically, any substance applied to the tear layer that alters its
      structure could affect contrast sensitivity. Previous work in our lab has demonstrated that
      Refresh Liquigel when applied to the tear layer of non-contact and contact lens wearing
      subjects can decrease contrast sensitivity.4, 5, 7 In this study, we propose to examine the
      effects of a new investigational artificial tear on contrast sensitivity and optical
      aberrations for up to 30 minutes after administration into the tear layer of normal and dry
      eye subjects. A questionnaire will also be used to determine the opinions of the subjects
      concerning this new artificial tear.
    

Intervention name(s): Optiva artificial tear by Allergan
Intervention type(s): Drug
Intervention MeSH terms: Lubricant Eye Drops
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Supportive Care
Keywords: contrast sensitivity
Nicotine as an Adjuvant Analgesic for Third Molar Surgery
Condition: Dental Crowding
Study type: Interventional
Phase: Phase 4

Summary: 
      Third molar surgery is complicated by pain and swelling for several days after surgery.
      Non-steroidal antiinflammatory drugs have been useful in combination with opioids for
      treatment. Nicotine has antiinflammatory and pain relieving properties. We will use nicotine
      or placebo as a nasal spray before surgery to determine whether nicotine affects pain or
      inflammation.
    

Detailed description: 
      This is a randomized double blind cross-over study. In each of two sittings, the third molars
      on one side of the mouth are removed. In one sitting the subject will receive a nicotine
      nasal spray (3mg) and in the other placebo. VAS and narcotic utilization will be compared
      within patients.
    

Intervention name(s): Nicotine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Nicotine nasal spray 3mg x 1 before surgery; Placebo nasal spray 0mg x 1 before surgery
Other intervention name(s): Nasal spray, nicotine; Nasal spray, placebo
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Third Molar; Pain
Metal Ion Release From an FDA-Approved Metal-on-Metal Total Hip Replacement Implant
Condition: Non-inflammatory Degenerative Joint Disease
MeSH terms: Joint Diseases; Osteoarthritis
Study type: Interventional

Summary: 
      This is a multi-center, randomized study to compare blood and urine cobalt, chromium, and
      titanium ion levels of a metal-on-metal articular bearing coupled with two different head
      sizes to that of a conventional metal-on-polyethylene bearing.
    


Intervention name(s): Total Hip Replacement
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: total hip replacement; primary cementless total hip arthroplasty; metal ion; metal-on-metal
Metabolic Effects of Plant-based Diet
Condition: Healthy Diet; Fatty Liver; Insulin Resistance; Metabolic Syndrome; Healthy Lifestyle; Healthy Nutrition
MeSH terms: Fatty Liver; Metabolic Syndrome; Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of this study is to assess the metabolic effects of plant based diet on healthy
      young adults.
    

Detailed description: 
      An internet announcement will be made and 60 participants who meet the eligibility
      requirements will be randomly selected. After being informed about study, all participants
      (60 omnivores) giving written informed consent will be assigned to the vegan and vegetarian
      groups of the study according to their preferences, while 20 participants will continue to be
      omnivores as the control group. At week 0 and 24, blood samples, urine samples, proton
      density fat fraction MRI evaluations and body composition analyze will be completed.
    

Intervention name(s): Omnivore; Vegetarian; Vegan
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): This study will evaluate effects of plant based diets (vegan and vegetarian). 60 omnivore individuals will be included. 20 of the participants will continue their omnivore diet as control group. 20 of the participants will change their diet to vegetarian, and 20 of them will change their diet to vegan.; 20 of the participants will change their diet to vegetarian diet. In this group participants will not eat any meat or meat product but can eat/drink milk products, egg and other animal products.; 20 of the participants will change their diet to vegan diet. In this group participants will not eat any kind of animal products.
Other intervention name(s): Control Group
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: plant-based; metabolic; fatty-liver
Effect of Aerobic Interval Training on Cardiovascular Function in Aging
Condition: Aging
Study type: Interventional

Summary: 
      Study objectives:

        1. To compare cardiovascular function in older compared to young healthy adults.

        2. To compare the effect of 8 weeks of aerobic interval training vs. continuous moderate
           exercise on cardiovascular function in healthy older adults.

      Hypotheses:

        1. Compared to young adults, older adults will have lower cardiovascular function.

        2. Compared to continuous moderate intensity exercise training, interval training will be
           more effective in improving cardiovascular function in older adults.
    

Detailed description: 
      Cardiovascular function will be measured at baseline in older healthy adults and young
      healthy controls. Older adults will be randomized to the aerobic interval training group,
      continuous moderate exercise group or non-exercise control group. At the end of the 8-week
      exercise intervention, baseline measures will be repeated in the older adults.
    

Intervention name(s): High intensity aerobic interval training; Continuous moderate intensity exercise
Intervention type(s): Other; Other
Intervention description(s): Supervised aerobic interval training will be performed on bicycles 4 times per week for 8 weeks. Each training session will last 40 minutes and will consist of 10-minute warm up at 70% of maximal heart rate (HRmax), four 4-minute intervals at 90% of HRmax with 3-min active recovery at 70% of HRmax and 5-minute cool down at 70% of HRmax.; Supervised exercise training will be performed on bicycles 4 times per week for 8 weeks. Each training session will last 47 minutes and will consist of continuous moderate intensity cycling at 70% of HRmax.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Markers of Bone Disease in Children on Parenteral Nutrition
Condition: Metabolic Bone Disease
MeSH terms: Bone Diseases; Bone Diseases, Metabolic
Study type: Observational

Summary: 
      Parenteral nutrition (PN) is the provision of nutrients via the intravenous route. Parenteral
      nutrition associated metabolic bone disease (MBD) was first described in children in the
      1980s. Since then, there has been little to no research into the underlying relationship and
      as a result, little evidence on which to base clinical care. In adults, MBD is associated
      with increased fractures. At the Hospital for Sick children in Toronto, an intestinal failure
      program has been set up since 2003. This is the only intestinal failure program in Canada and
      receives country wide referrals. Most of the patients have short bowel syndrome (SBS) and
      require PN for prolonged periods, or for life. About 90% of these patients have MBD, and some
      have had bone fractures. An understanding of the etiology of MBD would provide information to
      guide care, and prevent this condition. Funding for this area of research however is
      challenging because intestinal failure requiring long term PN is a rare condition, accounting
      for approximately 200 - 300 children in all of Canada. The goal of this study therefore is to
      gather pilot data on markers of MBD in children on long term PN, and to compare these markers
      to age and gender matched control patients who are fed by mouth or feeding tube. The
      information gathered from this study will help us begin to understand what is actually
      happening in the bones of children on long term PN and will form the basis for future studies
      and improved clinical care.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children on long term PN and childen not on PN.
      
Keywords: pediatric; parenteral nutrition; bone disease; long-term PN
ImproveR International (BI-001-IM)
Condition: Thrombin-specific Anticoagulant Bivalirudin During Percutaneous Coronary Intervention (PCI)
Study type: Observational

Summary: 
      The objectives of this registry are to assess the use of the thrombin-specific anticoagulant
      bivalirudin during percutaneous coronary intervention (PCI) in a real life setting. In
      particular, data will be collected to analyze experiences of bivalirudin use in respect to
      the following objectives;

        -  examine the aspects of safety and effectiveness of bivalirudin

        -  gain experience regarding the characteristics of patients in bivalirudin treatment

        -  evaluate the handling of bivalirudin and its practicality
    


Intervention name(s): Bivalirudin
Intervention type(s): Drug
Intervention MeSH terms: Bivalirudin
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Primary Care Clinic
Study of the Depth of Anesthesia on Postoperative Clinical Outcome in Patients With Supratentorial Tumor
Condition: Anesthesia, Brain Tumor, Supratentorial,Outcome
MeSH terms: Supratentorial Neoplasms
Study type: Interventional

Summary: 
      Recent studies have shown that deep anesthesia is associated with poor outcome. There is
      still lack of randomized controlled trials with large sample size on the effect of depth of
      anesthesia on the postoperative outcomes in patients undergoing brain tumor resection. The
      investigators are performing a randomized and parallel group trial. The aim of the study is
      to determine whether there is a causal relationship between the depth of anesthesia and
      postoperative clinical outcome in patients undergoing supratentorial tumor surgery.
    


Intervention name(s): Bispectral index will be targeted at 50; Bispectral index will be targeted at 35
Intervention type(s): Other; Other
Intervention description(s): The depth of general anesthesia will be monitored by bispectral index (BIS) at 50.; The depth of general anesthesia will be monitored by bispectral index (BIS) at 35.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Postoperative Pain Management in Hospital and Following Discharge From Hospital.
Condition: Arthropathy of Knee Joint
MeSH terms: Joint Diseases; Pain, Postoperative
Study type: Observational

Summary: 
      To investigate postoperative pain management in patients undergoing knee or hip replacement
      while they are in the hospital and following discharge to their home. Additionally, sample
      questions will be asked prior to surgery to predict patient's postoperative pain experience.
    

Detailed description: 
      We hypothesize that patients experience more postoperative pain at home than they do in
      hospital and factors such as preoperative anxiety, depression, and preoperative pain affect
      the level of postoperative pain experienced by patients. A total of 200 patients undergoing
      total knee surgery will be enrolled in this observational study. They will be asked to fill a
      baseline questionnaire including demographic information, medical problems, anxiety,
      depression, preoperative pain level, etc. Following routine standard anesthesia and surgery,
      patient's pain will be assessed every 4 hours when they are in the hospital after surgery,
      then daily assessment for 1 week after they are discharged home followed at 2 months, and 6
      months after surgery.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients treated at Saint Francis Hospital undergoing total knee replacement
      
Keywords: total knee arthroplasty
Safety Study of Lisinopril in Children and Adolescents With a Kidney Transplant
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The drug lisinopril is approved by the U.S. Food and Drug Administration for the treatment of
      high blood pressure, heart failure, and acute heart attacks in adult patients. In children
      over 6 years of age, lisinopril is approved for the treatment of high blood pressure.
      Lisinopril is in a group of medications called angiotensin-converting enzyme inhibitors
      (ACE). ACE inhibitors such as lisinopril work by decreasing certain chemicals that tighten
      the blood vessels so blood flows more smoothly and the heart can pump blood more efficiently.

      There is some information available about how children with high blood pressure absorb,
      distribute, metabolize, and eliminate lisinopril (this information about medication
      processing by the body is called pharmacokinetic data). However, there is no information
      about how children with high blood pressure who have received a kidney transplant process
      lisinopril. In addition to decreasing blood pressure, investigators believe that lisinopril
      may help kidney transplants work longer by reducing the activity of chemicals made by cells
      in kidney transplants that can lead to inflammation and injury. Such benefits have not been
      found with another group of blood pressure medications called calcium channel blockers, which
      are the most commonly used medication group to control high blood pressure in children after
      a kidney transplant. A clinical trial will be conducted in the future to compare which
      medication group helps kidney transplants in children last longer. To guide the selection of
      the best dose to test in future studies, investigators in this study will try to determine
      the safety profile, dose tolerability, and pharmacokinetics of lisinopril in children and
      adolescents (2-17 years of age) who have received a kidney transplant and have high blood
      pressure.
    


Intervention name(s): Lisinopril
Intervention type(s): Drug
Intervention description(s): Subjects will be randomized to Low, Medium, or High dose of Lisinopril
Intervention MeSH terms: Lisinopril
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High Blood Pressure; Hypertension; Renal Transplantation; Kidney Transplantation