bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Methylprednisolone on Glucose Homeostasis in Patients Undergoing Total Hip- and Knee-arthroplasty
Condition: Osteoarthrosis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the pathophysiological effects of a single dose of Methylprednisolone
      administered prior to total hip- and knee-arthroplasty surgery. The investigators examine the
      effect on blood glucose homeostasis.

      Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will
      receive placebo.

      The investigators hypothesize that the glucose homeostasis remains equally stable in the
      group receiving Methylprednisolone as in the group receiving placebo.
    

Detailed description: 
      The anti-inflammatory effects of glucocorticoids are well known. The beneficial effects on
      postoperative pain, postoperative nausea and vomiting are well-documented.

      Glucocorticoid might change the glucose metabolism as it induces insulin-resistance.
      Glucocorticoids are known to reduce the insulin-mediated glucose uptake by reducing the
      muscle glycogen synthase activity.

      The effect of a single high dose of glucocorticoid is poorly described in the literature, and
      therefore calls for further investigation.

      This study is embedded in a primary study registrated as: NCT02319343

      For further details please view the EudraCT registration:

      EudraCT nr.: 2014-003395-23
    

Intervention name(s): Methylprednisolone; Isotonic Sodium Chloride
Intervention type(s): Drug; Drug
Intervention description(s): Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride; Placebo
Other intervention name(s): Solu-Medrol
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Glucocorticoid; Glucose homeostasis; Knee arthroplasty, total; Hip arthroplasty, total
The Effects Of Ropinirole On Mood Or Mild Depression In Patients With Moderate To Severe Restless Legs Syndrome
Condition: Restless Legs Syndrome; Moderate to Severe Idiopathic Restless Legs Syndrome (RLS)
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome; Depression
Study type: Interventional
Phase: Phase 3

Summary: 
      Ropinirole has shown to improve mood in depressed patients as well as to improve the symptoms
      of Restless Legs Syndrome. Up to 40% of RLS patients suffer from mild depression, therefore
      it would be important for decisions no therapy to know whether a drug could improve both
      depressive and RLS symptoms.
    


Intervention name(s): Ropinirole
Intervention type(s): Drug
Intervention MeSH terms: Ropinirole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: randomised; ropinirole; depression; RLS; placebo; mood; double-blind; restless legs syndrome; germany
Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age
Condition: Tetanus; Diphtheria; Haemophilus Influenzae Type b; Poliomyelitis; Acellular Pertussis; Hepatitis B; Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria Meni
MeSH terms: Hepatitis A; Influenza, Human; Hepatitis B; Tetanus; Diphtheria; Poliomyelitis; Hepatitis; Tetany
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A
      vaccine co-administered with GSK Biologicals' 10-valent pneumococcal conjugate (GSK1024850A)
      vaccine given as a three-dose primary vaccination course at 2, 3 and 4 months of age.
    

Detailed description: 
      In accordance with the local recommended immunisation schedule, all subjects will receive 2
      doses of GSK Biologicals' Human Rotavirus Vaccine (Rotarix) at 2 and 3 months of age.
    

Intervention name(s): GSK2202083A vaccine; 10-valent pneumococcal vaccine (GSK 1024850A); Infanrix hexa™; Menjugate®
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Intramuscular, three doses; Intramuscular, three doses; Intramuscular, three doses; Intramuscular, two doses
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Phase II Study of Icaritin in Patients With Advanced Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma (HCC)
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to assess the time to progression (TTP) in patients
      with advanced HCC treated with Icaritin .
    

Detailed description: 
      Icaritin is a newly discovered small molecular compound which is high selective ERa36
      modulators ,the preclinical PK&PD and toxicity studies showed it can inhibit the growth of
      HCC cancer cells both in vitro and in vivo, combining clinical data perhaps it will be a very
      promising new drug to treat hepatocellular carcinoma (HCC) by targeting this nongenomic
      pathway. Shenogen decided to further investigate the efficacy and safety of Icaritin and to
      explore potential gene targets for treating HCC.

      The results of phase I study showed Icaritin has good safety and tolerance. The biological
      availability of Icaritin after meal is high and the half-life is relatively short.

      The phase Ib study enrolled 28 subjects. Among the 18 HCC subjects, 12 subjects received
      treatment in the oral administration group with 600 mg once, twice per day, after meal 30
      minutes, 6 subjects received treatment in the oral administration group with 800 mg once,
      twice per day, after meal 30 minutes. The results showed that in the 600mg group there are 12
      HCC patients whose therapeutic efficacy is evaluable now, one case of PR (10%), 5 cases of SD
      (50%) and 4 cases of PD (40%) were observed.Safety data showed that totally 24 AEs are
      probably related to investigational drug. Among them, 19 AEs are grade I, 5 AEs are grade II,
      no grade III or above AE.
    

Intervention name(s): Icaritin
Intervention type(s): Drug
Intervention description(s): Icaritin 600 mg orally, twice daily for a total daily dose of 1200 mg
Other intervention name(s): SNG-162
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comprehensive Exercise Training Program During Hospitalization for an Acute CF Exacerbation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      This protocol was designed to assess if when subjects with CF are admitted to the hospital
      for a pulmonary exacerbation if a comprehensive exercise program (moderate to high intensity
      aerobic, resistance, flexibility and balance exercises) was superior to our "usual care
      intervention (30 min/day of self selected mode and intensity of exercise) in improving
      aerobic capacity, muscle strength/power, flexibility and balance.
    

Detailed description: 
      This protocol was designed to assess if when subjects with CF are admitted to the hospital
      for a pulmonary exacerbation if a comprehensive exercise program (moderate to high intensity
      aerobic, resistance, flexibility and balance exercises) was superior to our "usual care
      intervention (30 min/day of self selected mode and intensity of exercise) in improving
      aerobic capacity, muscle strength/power, flexibility and balance.

      The experimental group will participate in the following regime:

      Day 1 - Evaluation including standardized tests and measures: If Day 1 is a M,W, F, day 2
      will constitute: aerobic exercise between 20-30 minutes based on patient tolerance using the
      appropriate RPE scale (13-15 on Borg with patients ages 13-21, and 6-8 on pictoral CERT with
      patients ages 6-12)to ensure correct intensity. Choices will include treadmill, stationary
      bike, game bike, or ambulating at varying intensities throughout hospital; Balance
      Activities: Standing on bosu ball while performing UE activity (throwing, catching with
      another ball, Frisbee, etc.). Standing on one leg or B LE's will be determined by patients
      currently level.

      If Day 1 is a Tuesday or Thursday, day 2 will constitute: 5-10 minutes of aerobic activity at
      warm up level (11-13 on Borg, and 4-6 on PCERT)x resistance training for UE: biceps, triceps,
      lattisimus, rhomboids/mid-trap, thoracic expansion exercises, and other muscles based on
      patient needs; resistance training for LE: quadriceps, hamstrings, gluteals (especially
      maximus and medius), and other muscles depending on patient need, core and abdominal
      strengthening, Stretches for flexibility depending on the patients individual needs: Thoracic
      expansion stretches will be done with every pt. supine and sidelying. Stretches are held for
      10 seconds and repeated 10 times, Hamstring stretches will be performed if pt unable to reach
      line with sit and reach test.
    

Intervention name(s): Aerobic exercise; Resistance exercise; Flexibility and postural exercise; Balance exercise
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cystic fibrosis; pulmonary exacerbation, exercise
A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004541)
Condition: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the ability of injections of Ji Gami(TM) N and Ji
      Gami(TM) NDO to induce hair growth in male and female subjects with hair loss.
    


Intervention name(s): Autologous cultured dermal and epidermal cells
Intervention type(s): Biological
Intervention description(s): A piece of occipital scalp is taken from the subject. The epidermal and dermal cells from this tissue are expanded in culture. The cells are then harvested and, for certain types of product, combined. These cells are then injected into the balding area of the scalp of the original subject.
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness; Hair Loss; Baldness
The Effects of Red Spinach Extract Supplementation on Isometric Strength, Resistance Exercise and Cognitive Performance
Condition: Sports
Study type: Interventional

Summary: 
      Red Spinach is a natural food which is a rich source of nitrates, which are beneficial in
      hemodynamics, cardiovascular function, and have natural hypotensive and antianginal effects.
      Red spinach extract has been shown to be beneficial in exercise performance, albeit mostly in
      aerobic exercise. In a previous study in our lab, we found that dietary nitrate consumption
      resulted in significantly greater isometric force production in teenage males. However,
      currently there is little know regarding the effects of dietary nitrate supplementation on
      isometric strength, resistance exercise and cognitive performance.
    

Detailed description: 
      This research study is designed to measure the effects of red spinach extract (RSE) on
      markers of physical and cognitive performance during and following anaerobic exercise.
    

Intervention name(s): Red Spinach Extract (RSE); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oral capsules containing 2g of Red Spinach Extract will be consumed daily for 7 days; Oral placebo capsules will be taken consisting of maltodrextrin daily for 7 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Symptoms Based Awareness Confirmation Study - CoMiSS Validation
Condition: Cow Milk Allergy
MeSH terms: Milk Hypersensitivity
Study type: Interventional

Summary: 
      The Cow's Milk-related Symptom Score (CoMiSS) tool has been developed to define a score to
      recognize cow's milk related symptoms in infants and young children.

      Many infants and toddlers with symptoms that can be related to intake of cow's milk and cow's
      milk protein allergy (CMPA) are often not diagnosed due to the lack of specific markers.

      The goal of this trial is to validate the CoMiSS tool in infants suspected of CMPA and
      investigate if the CoMiSS tool could be an alternative to the open challenge test needed to
      confirm the diagnosis of Cow Milk Protein Allergy.
    


Intervention name(s): CoMiSS questionnaire
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Allergy; Atopic Dermatitis; Immunoglobulin E (IgE); CMPA
A Predictive Model for Difficult Intubation
Condition: Difficult Intubation
Study type: Observational

Summary: 
      Failure in airway management is one of the most common anesthesia-related morbidity and
      mortality. Each individual airway assessment has limitation to predict difficult intubation.
    

Detailed description: 
      Objective: To develop a scoring model from multiple airway assessment to predict difficult
      intubation.

      Methods: This will be a retrospective analytic study. All airway assessment data from medical
      records of patients aged more than 18 years old underwent general anesthesia in Srinagarind
      hospital from January 2012 to December 2014 will be used to develop a new scoring prediction
      model.
    

Intervention name(s): Endotracheal intubation
Intervention type(s): Procedure
Intervention description(s): Endotracheal intubation under direct laryngoscopy using McIntosh blade
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients undergoing general anesthesia with endotracheal intubation
Normothermia Versus Hypothermia for Valvular Surgery Patients
Condition: Valvular Heart Disease
MeSH terms: Heart Diseases; Heart Valve Diseases; Hypothermia
Study type: Interventional

Summary: 
      Cardiopulmonary bypass (CPB) has been used successfully for cardiac surgery for over half a
      century. Hypothermia became a ubiquitous practice for adult patients undergoing CPB. To date,
      most studies have been conducted in coronary artery bypass graft (CABG) patients with
      conflicting results. Current evidence does not support one temperature management strategy
      for all patients. The purpose of this study is to compare the efficiency and safety of
      normothermic versus hypothermic CPB in valvular surgery patients.
    


Intervention name(s): Hypothermic CPB
Intervention type(s): Procedure
Intervention description(s): Patients will be cooled to 31-32oC (nasopharyngeal) after the beginning of CPB. Rewarming will begin 10-15 min before release of aortic cross-clamp. The gradient between heat-exchanger and nasopharynx during rewarming will be maintained at 3oC. The rewarming will be stopped at 36,5oC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cardiopulmonary Bypass; Hypothermia; Normothermia; Troponin I; Bleeding
Robotic-assisted Versus Conventional Total Knee Arthroplasty
Condition: Total Knee Arthoplasty
Study type: Interventional

Summary: 
      This is a multicenter, prospective and randomized controlled pre-market clinical Trial. Study
      subjects will be randomized into one of two operative groups: 1) TKA assisted with ROSA® Knee
      System; 2) TKA with conventional surgical instrumentation.
    

Detailed description: 
      The objective of this clinical trial is to measure the effectiveness and safety of the ROSA®
      Knee System in assisting surgeons with bone resections and implant positioning optimization
      through early clinical and radiographic outcomes compared with conventional surgical
      instrumentation in total knee arthroplasty (TKA).
    

Intervention name(s): ROSA assisted TKA
Intervention type(s): Procedure
Intervention description(s): Robotic assisted total knee arthroplasty
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study and Treatment of Post Lyme Disease (STOP-LD)
Condition: Lyme Disease
MeSH terms: Lyme Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to see how well antibiotics work in reducing chronic fatigue
      symptoms, such as tiredness, in patients that were treated for Lyme Disease. Fatigue is a
      common symptom of Lyme Disease. When fatigue does not improve after treatment, patients are
      considered to have Post Lyme Syndrome (PLS). The chronic fatigue seen in these patients
      appears to be related to the initial infection which causes Lyme Disease. It is believed, but
      not proven, that treatment with antibiotics may be effective in relieving chronic fatigue in
      PLS patients.
    

Detailed description: 
      You will be assigned randomly (like tossing a coin) to receive either antibiotics or a
      placebo (sugar pill). Neither you nor your doctor will know which you are receiving. You will
      learn to give yourself the injection, and you will remain on your study drug for 28 days. A
      home health care nurse will visit you twice a week to check the injection site, and at weeks
      1 and 3 the nurse will draw blood for laboratory tests. At months 1 and 6, you will be
      examined to see if you have fewer chronic fatigue symptoms after the antibiotics. This will
      include a fatigue questionnaire, a test of your mental processing speed, and a test of your
      cerebrospinal fluid.
    

Intervention name(s): Antibiotics
Intervention type(s): Drug
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
To Assess the Effects of Single Oral Dose of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc Interval in Healthy Male Volunteers
Condition: Solid Tumours
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the effect of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc
      interval in healthy male volunteers.
    

Detailed description: 
      A double-blind (Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), Placebo-controlled,
      Open-Label (Moxifloxacin) Positive-controlled, Randomized, Three-period Crossover Study to
      Assess the Effects of Single Oral Dose of Selumetinib (75 mg) on QTc Interval Compared to
      Placebo, using AVELOX (Moxifloxacin) as a Positive Control, in Healthy Male Volunteers
    

Intervention name(s): Selumetinib; Moxifloxacin; selumetinib placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Volunteers will receive 75 mg selumetinib oral dose (Treatment A); Volunteers will receive 400 mg Moxifloxacin oral dose (Treatment B); Volunteers will receive selumetinib placebo oral dose (Treatment C)
Other intervention name(s): AZD6244; Avelox®; AZD6244 placebo
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Phase I, healthy, pharmacokinetics
Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers
Condition: Smoking Cessation; Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This project will be a randomized clinical trial testing the efficacy of an
      internet-administered smoking cessation treatment for overweight and obese smokers. Research
      on internet-administered behavioral treatments for smoking cessation has found that compared
      to control treatments (e.g., self-help materials), cessation rates in internet-administered
      treatments are significantly higher. Research testing the applicability of these treatments
      to overweight and obese individuals has not yet been conducted. Given that a substantial
      portion of smokers are also overweight and at elevated cardiovascular risk, there is a need
      for directed treatment efforts for this group. The current trial proposes to be the first to
      test the effectiveness of internet-administered smoking cessation treatment for overweight
      and obese (BMI≥25) smokers. Adult participants will be randomized to receive 12 weeks of
      internet-administered treatment consisting of either: a) standard smoking cessation treatment
      with general health education, or b) standard smoking cessation treatment with cognitive
      behavioral therapy (CBT) for weight concerns. Participants in both conditions will receive
      open-label treatment with the 21 mg transdermal nicotine patch.
    


Intervention name(s): Nicotine patch
Intervention type(s): Drug
Intervention description(s): Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
Other intervention name(s): Nicotine replacement
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking cessation; Overweight; Obesity; Internet treatment
Long-Term Non-Interventional Latanoprost Study
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Ocular Hypertension
Study type: Observational

Summary: 
      This is a non-interventional, prospective, longitudinal cohort study. A total of 150
      pediatric subjects with glaucoma or elevated intraocular pressure, including 75
      latanoprost-treated subjects and 75 non-topical prostaglandin analogue treated subjects, will
      be enrolled from ophthalmic hospital clinics and academic ophthalmic centers. As a
      non-interventional study, the study subjects' continued use of latanoprost and assessments of
      ocular events will be obtained through the routine medical follow-up with treating
      ophthalmologists or other designated members of the medical care team.
    

Detailed description: 
      At least 40 subjects in each of the following age groups: 1-<5 years and 5-<18 years. No
      minimum required numbers in the <1 year age group.
    

Intervention name(s): No intervention other than routine medical care; No intervention other than routine medical care
Intervention type(s): Other; Other
Intervention description(s): Subjects continuously treated with Latanoprost for at least one month Latanoprost treatment during the study period.; Subjects not treated with any topical prostaglandin analogues or continuously treated with topical prostaglandin analogues for less than one month before the baseline examination, and unlikely to be treated with topical prostaglandin analogues during the study period.
Other intervention name(s): Observational; Observational
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric populations diagnosed with glaucoma or elevated intraocular pressure
      
Keywords: Prospective; non-interventional; longitudinal; cohort study