bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Omeprazole and Ritonavir on GSK2336805 Pharmacokinetics in Healthy Adults
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase I open label drug interaction study to evaluate the effect of
      omeprazole and ritonavir on GSK2336805.
    

Detailed description: 
      This study is a Phase I open label drug interaction study with two objectives. The first
      objective of this study (Cohort 1) is to determine if the pharmacokinetics of a single dose
      of GSK2336805 are affected by co-administration with repeat doses of omeprazole, a
      proton-pump inhibitor that is commonly used by chronic hepatitis C patients .

      The second objective of this study (Cohort 2) is to determine if the pharmacokinetics of a
      single dose of GSK2336805 are affected by co-administration with repeat doses of ritonavir, a
      HIV protease inhibitor drug that is a potent inhibitor of CYP 3A4.
    

Intervention name(s): Cohort 1 (GSK2336805 60mg x 1 dose, Omeprazole 40 mg q24h x 4 days, GSK2336805 60 mg x 1 dose and Omeprazole 40 mg x 1 dose); Cohort 2 (GSK2336805 30mg x 1 dose, Ritonavir 100mg q12h x 4 days, and Ritonavir 100mg q12h x 1 dose)
Intervention type(s): Drug; Drug
Intervention description(s): GSK2336805 and Omeprazole; GSK2336805 and Ritonavir
Intervention MeSH terms: Ritonavir; Omeprazole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetics; omeprazole; ritonavir; healthy subjects; drug interaction
Protein Source on Plasma Amino Acid Concentrations
Condition: Protein Deposition
Study type: Interventional

Summary: 
      This study will determine the effect of the same ounce-equivalents of fresh pork versus nuts,
      beans, and eggs on postprandial plasma essential amino acid availability in adults. Each
      participant will receive all four treatments.
    

Detailed description: 
      The 2015-2020 Dietary Guidelines for Americans stipulates how much Protein Foods should be
      consumed per day and per week as part of a Healthy U.S.-Style Eating Pattern. The predominant
      protein sources include lean meats, poultry, and eggs, however, nuts, seeds, and soy products
      are also included. Ounce-equivalents (oz-eq) are used as a standard unit of measure to
      compare animal to non-animal protein sources. One oz-eq of lean meat (1 oz) is equal to 0.5
      oz of nuts (1 oz-eq), 0.25 cups (1 oz-eq) of beans, and one whole egg (1 oz-eq). One
      limitation of this unit of measure is that the protein quantity and quality of the foods are
      not considered. For example, 1 oz-eq of pork loin contains ~7 g of dietary protein whereas 1
      oz-eq of almonds contains 3 g of protein. Consequently, consuming an oz-eq portion of protein
      foods from different sources could have different effects on the anabolic response to
      feeding. The purpose of this study is to assess the effect of consuming ounce equivalent
      portions of fresh pork versus nuts, beans, and eggs on essential amino acid substrate
      availability for protein anabolism. While it would seem intuitive that this research would
      show that higher protein intakes from pork and egg will lead to higher plasma essential amino
      acid responses, this research is paramount to addressing the shortcoming of using oz-eq to
      achieve the Dietary Guidelines for Americans recommendations for Protein Foods. This research
      will serve as an important resource for future Dietary Guidelines Advisory Committees to
      reevaluate the appropriateness of equating animal- and plant-based Protein Foods on the
      current ounce-equivalent basis.
    

Intervention name(s): Pork; Egg; Black beans; Almonds
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 1 oz lean pork; 1 large whole egg; 0.5 cups cooked black beans; 1 oz almonds
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Intervention With Legume Kernel Fibre in Healthy Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of the conducted study was to determine the efficacy of the native legume
      kernel fibres of Lupinus angustifolius Boregine (Boregine), Lupinus albus Typ Top (TypTop)
      and Glycine max Hefeng (Soy fibre) on prevention of risk factors for gastrointestinal or
      cardiovascular diseases.
    

Detailed description: 
      Dietary fibre is suspected to effect the faecal concentration and excretion of bile acids by
      binding the bile acids and by increasing the faecal mass. Bile acids, especially the
      secondary bile acids, are potential risk factors for colorectal cancer. A high bile
      acid-binding ability of fibre could lead to lower serum cholesterol concentrations by
      interrupting the enterohepatic circulation. There is evidence that the consumption of legume
      kernel fibre, containing both soluble and insoluble fibre fractions, may beneficially modify
      bowel health.

      Seventy-eight healthy volunteers were enrolled. Seventy-six subjects (mean age of 24 years,
      55 women and 21 men) completed the double-blind, randomized crossover trial. After two weeks
      run-in period, half of the volunteers consumed 25 g of legume fibres (Boregine, TypTop or Soy
      fibre) every day, and the other half received a reference fibre product (citrus fibre,
      Herbacel AQ Plus) for a period of two weeks. After two weeks wash-out the intervention
      changed between the groups.

      At the end of each period a quantitative stool and urine collection took place and fasting
      blood samples were drawn.
    

Intervention name(s): pure fibre-product; reference fibre
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The subjects consumed 25 g pure fibre-product per day over two weeks. One half a portion of the fibres was stirred into a selected milk product and the other half in juice.; The subjects consumed 25 g reference fibre (citrus fibre: Herbacel AQ Plus; Herbafood Ingredients) per day over two weeks. One half a portion of the fibres was stirred into a selected milk product and the other half in juice.
Other intervention name(s): Herbacel AQ Plus; citrus fibre
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: dietary fibre; legumes; lupin kernel fibre; soy fibre; bile acids; short-chain fatty acids; cholesterol metabolism; Subjects
A Comparative Study of Selatogrel (ACT-246475) Formulations in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose is to study the pharmacokinetics of selatogrel (ACT-246475) using different
      administration modes and formulations. The clinical pharmacology data will be used to support
      demonstration of bioequivalence and interchangeability of the different formulations.
    


Intervention name(s): Selatogrel; Selatogrel
Intervention type(s): Combination Product; Drug
Intervention description(s): A single subcutaneous injection of 16 mg.; A single subcutaneous injection of 16 mg.
Other intervention name(s): ACT-246475; ACT-246475
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-center, randomized, 3-period crossover.
Masking: None (Open Label)
Primary purpose: Other
A Study of the Efficacy and Safety of Varenicline in Japanese Smokers Motivated to Quit Smoking
Condition: Smoking
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of varenicline in Japanese
      smokers. Efficacy is evaluated by continuous quit rate and withdrawal symptoms of smokers.
      Safety is evaluated by adverse events, laboratory tests, and other safety tests.
    


Intervention name(s): Varenicline
Intervention type(s): Drug
Intervention description(s): 0.5 mg BID for 7 weeks
Other intervention name(s): Chantix, Champix, CP-526,555
Intervention MeSH terms: Varenicline
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of an Online Intervention to Help LGBTQ Youth Cope With Bullying
Condition: Bullying of Child
MeSH terms: Bullying
Study type: Interventional

Summary: 
      The purpose of this research study is to conduct a pilot randomized controlled trial of a
      game-based intervention is able to increase help-seeking-related knowledge, attitudes, and
      behaviors, reduce health risk factors/behaviors, and increase resiliencies among sexual and
      gender minority (SGM) youth. The goals of the proposed study are to: (1) Test the feasibility
      and acceptability of a game-based intervention to increase help-seeking-related knowledge,
      attitudes, and behaviors among SGM youth; and (2) Using a randomized controlled trial, test
      the efficacy of a game-based intervention to increase help-seeking-related knowledge,
      attitudes, and behaviors, reduce health risk factors/behaviors, and increase resiliencies
      among SGM youth.
    

Detailed description: 
      The purpose of this research study is to conduct a pilot randomized controlled trial of a
      game-based intervention is able to increase help-seeking-related knowledge, attitudes, and
      behaviors, reduce health risk factors/behaviors, and increase resiliencies among sexual and
      gender minority (SGM) youth. The goals of the proposed study are to: (1) Test the feasibility
      and acceptability of a game-based intervention to increase help-seeking-related knowledge,
      attitudes, and behaviors among SGM youth; and (2) Using a randomized controlled trial, test
      the efficacy of a game-based intervention to increase help-seeking-related knowledge,
      attitudes, and behaviors, reduce health risk factors/behaviors, and increase resiliencies
      among SGM youth.
    

Intervention name(s): Online Game; LGBTQ Resources
Intervention type(s): Behavioral; Behavioral
Intervention description(s): LGBTQ Bullying game; This group receives LGBTQ Resources
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
External Oblique Intercostal Plane Block vs. Wound Infiltration for Laparoscopic Sleeve Gastrectomy
Condition: Obesity
Study type: Interventional

Summary: 
      The morbidity and mortality associated with being overweight or obese have been known to the
      medical profession since Hippocrates, more than 2500 years ago.

      Pain that develops following bariatric surgery may prolong recovery time. Most morbidly obese
      patients have obstructive sleep apnea and cardiac comorbidities. In these patients, prolonged
      postoperative pain may cause early ambulation and delay performing deep breathing exercises.

      Using regional anesthetic techniques results in less opioid use and better pain management.
      External oblique internal costal block; It is a new block that provides dermatomal sensory
      blockage involving T6-T10 in the anterior axillary line and T6-T9 in the midline. It can be
      used as part of multimodal analgesia in laparoscopic cases.

      There is no study in the literature regarding the use of external oblique plane block in
      bariatric surgery yet.
    


Intervention name(s): ultrasound guided external oblique intercostal plane block; Wound infiltration
Intervention type(s): Other; Other
Intervention description(s): ultrasound guided external oblique intercostal plane block 30 ml local anesthetic each side; 5 ml local anesthetic for each trocar side
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Compare Pharmacokinetics and Pharmacodynamics of SAR342434 to Insulin Lispro in Subjects With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To compare exposure and activity of SAR342434 to US-approved and EU-approved Humalog®.

      Secondary Objective:

      To assess the safety and tolerability of SAR342434.
    

Detailed description: 
      The total study duration for a screened subject will be about 3 - 8 weeks (min-max duration,
      excl. screening)

        -  Screening: 2 to 28 days (D -28 to D -2)

        -  Treatment period 1 - 3: 2 days (1 overnight stay)

        -  Washout: 5 - 18 days (preferentially 7 days between consecutive dosing)

        -  End-of-study visit: 1 day between D 5 and D14 after last administration of
           investigational product.
    

Intervention name(s): SAR342434; Insulin Lispro; Insulin Lispro
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form:solution Route of administration: subcutaneous; Pharmaceutical form:solution Route of administration: subcutaneous; Pharmaceutical form:solution Route of administration: subcutaneous
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
An Open-label, Randomized, Parallel-arm Study Investigating the Efficacy and Safety of Intravenous Administration of Pamrevlumab Versus Standard of Care in Patients With COVID-19
Condition: COVID-19 Respiratory Infection; COVID-19 Pneumonia; Covid19
MeSH terms: COVID-19; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a randomized, open-label, parallel-arm study to investigate the efficacy and safety
      of pamrevlumab in patients with documented SARS-CoV-2 infection. The study consists of
      screening, a treatment period, and a follow-up period.

      The study will enroll patients who have been hospitalized and who are not currently on
      invasive mechanical ventilation. The treatment period is open ended, and patients will be
      randomized to treatment with pamrevlumab or standard of care in a 1:1 ratio according to a
      pre-generated randomization list. Pamrevlumab dosing, 30 mg/kg IV, will be administered at
      day 1, day 7 and day 14. Based on Investigator's decision, treatment may be continued every 3
      weeks after day 14, up to 11 weeks. A follow-up by visit or phone call will be performed 8
      and 12 weeks after the end of the last dose of treatment. The treatment period for an
      individual patient will not exceed 11 weeks.
    


Intervention name(s): Pamrevlumab
Intervention type(s): Drug
Intervention description(s): Pamrevlumab dosing, 30 mg/kg IV, will be administered at day 1, day 7 and day 14.
Based on Investigator's decision, treatment may be continued every 3 weeks after day 14, up to 11 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Teriparatide Use in Hip Replaced Subjects
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      A pilot study on the use of Teriparatide in severe osteoporotic women with hip fracture and
      submitted to hip replacement

      The primary objective of this study is to obtain preliminary data, in a pilot group of
      postmenopausal women with established osteoporosis and a recent hip fracture, who underwent
      hip replacement 3-6 months before screening phase, about the effect of teriparatide on:

        -  bone turnover markers: CTx, PINP and BSAP when given at the dose of 20 mcg/day by
           subcutaneous route for 18 months.

      The secondary objectives of the study are as follows:

        -  Effects of teriparatide on lumbar spine and non-prosthetic femur bone density, as
           assessed by BMD measurement with dual energy x-ray absorptiometry (DXA)

        -  Effects of teriparatide on quality of life and back pain during treatment.
    


Intervention name(s): Teriparatide
Intervention type(s): Drug
Intervention MeSH terms: Teriparatide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dose Finding Study of Pramipexole (Sifrol) in Patients With Idiopathic Restless Legs Syndrome (RLS)
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to evaluate the efficacy and safety of different doses of
      pramipexole (Sifrol) on subjective and objective symptoms of idiopathic Restless Legs
      Syndrome (RLS) and also to determine the optimal dose of pramipexole in patients with RLS by
      polysomnography and evaluation of clinical improvement.
    


Intervention name(s): Pramipexole
Intervention type(s): Drug
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study to Evaluate the Efficacy and Safety of Sitagliptin and MK0431A in Comparison to a Commonly Used Medication in Patients With Type 2 Diabetes (0431-068)(COMPLETED)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of sitagliptin and MK0431A
      in comparison to a commonly used medication in patients with type 2 diabetes.
    


Intervention name(s): Comparator: sitagliptin phosphate (sitagliptin); sitagliptin phosphate (+) metformin hydrochloride; Comparator: pioglitazone; Matching placebo to pioglitazone; Matching placebo to sitagliptin; Matching Placebo to Sita/Met FDC
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): sitagliptin 100 mg tablet q.d. orally for a 12-wk treatment period; sitagliptin/metformin HCl (Sita/Met) 50/500 mg b.i.d. orally and then 50/1000 mg b.i.d. orally for a 28-wk treatment period; pioglitazone 15 mg tablet q.d. orally for 6 weeks, followed by 30 mg q.d orally for 6 weeks, followed by 45 mg q.d. orally, up to 40 weeks.; matching placebo to pioglitazone tablet q.d. orally, for a 40-wk treatment period.
Participants were administered matching placebo the 15 mg pioglitazone q.d. orally for 6 weeks, followed by matching placebo to 30 mg pioglitazone q.d orally for 6 weeks, followed by matching placebo to 45 mg pioglitazone q.d. orally, up to 40 weeks.; matching placebo to sitagliptin q.d., orally for a 12-wk treatment period.; matching placebo to Sita/Met FDC - 50/500 mg b.i.d. for 4 weeks and then 50/1000 mg b.i.d. orally for a 28-wk treatment period (Week 12 to Week 40).
Other intervention name(s): MK0431, Januvia™; MK-0431A, Janumet™; Actos®
Intervention MeSH terms: Metformin; Pioglitazone; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Blood Endothelium Progenitor Cells and Dendritic Cells as Predictive Biomarkers of In-stent Restenosis
Condition: Atherosclerosis; Restenosis
MeSH terms: Atherosclerosis
Study type: Observational

Summary: 
      clinically relevant in stent restenosis occurs in 5-10% of the non-diabetic patients treated
      with a coronary bare metal stent. Recent research has identified endothelial progenitor cells
      as well as dendritic cells as components of neointima. Numerical and functional evaluation of
      endothelial progenitor and dendritic cells at the time of coronary stent implantation is
      assessed and the relation with clinical and/or angiographic restenosis at 6 months post-stent
      implantation is evaluated.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Non-diabetic patients scheduled for PCI with a single bare metal stent in a significant de
        novo coronary lesion
      
Keywords: Atherosclerosis; Restenosis; EPC; DC
Quality of Life in Patients With Allergic Rhinitis: Clinical Trial With Bilastine or Loratadine
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to verify whether there were differences in health-related
      quality of life of patients with allergic rhinitis treated with bilastine 20 mg compared to
      those treated with loratadine 10 mg.
    

Detailed description: 
      This was a prospective randomized double-blinded study, in which patients were recruited from
      august 2013 until august 2014. Outpatients attended in 4 otolaryngology clinics from
      Criciúma, state of Santa Catarina, Brazil were invited to participate of the study. They were
      aged between 18 and 63 years. Seventy-three patient were included, of whom 36 were treated
      with loratadine 10 mg and 37 with bilastine 20 mg with medication administered once a day for
      ten days. The primary outcome was quality of life, assessed by the modified
      Rhinoconjunctivitis Quality of Life Questionnaire (RQLQm), which was applied at baseline and
      after 10 days of treatment.
    

Intervention name(s): Bilastine; Loratadine
Intervention type(s): Drug; Drug
Other intervention name(s): Alektos; Claritin; Histadin; Loranil; Loritil; Loralerg
Intervention MeSH terms: Loratadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: quality of life; allergic rhinitis; bilastine; loratadine; clinical trial
Epidemiology of Pediatric Traumatology
Condition: Fractures in Children
MeSH terms: Fractures, Bone
Study type: Observational

Summary: 
      Fractures have been shown to account for 10-25% of injuries in children and the consequences
      of pediatric fractures are significant and result in significant restriction of activity.
      Despite this, the epidemiology of pediatric fractures remains poorly detailed.

      Investigators seek to establish the incidence of pediatric trauma and fractures and determine
      patient, trauma and injury characteristics.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children treated in the pediatric emergency department of the Strasbourg University
        Hospitals between January 2014 and December 2020 for skeletal trauma
      
Keywords: Fractures in Children; pediatric fractures