bioihbjkbjnl/mcl2 huggingface dataset:
A Trial Investigating the Effect of Probenecid and Ciclosporin on the Concentrations of SNAC in Healthy Subjects
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to investigate the effect of the medicines, probenecid and
      ciclosporin on the concentrations of SNAC. SNAC is an ingredient of the semaglutide tablets.
      Participants will get 3 different treatments (that is 3 treatment periods): 1) a single dose
      of 3 mg semaglutide, 2) a single dose of 600 mg ciclosporin with 3 mg semaglutide, 3) 500 mg
      probenecid twice a day for 3 ½ days with a single dose of 3 mg semaglutide on the last day.

      The sequence of treatments participants get is decided by chance. Probenecid and ciclosporin
      are available medicines. They are given by doctors. Semaglutide contains SNAC. It cannot be
      prescribed yet.

      The study will last for up to 125 days. Participants will have 17 to 18 visits at the study
      centre. This includes short visits at the centre for blood sampling only. Participants will
      have several blood draws.
    


Intervention name(s): Semaglutide; Probenecid; Ciclosporin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single dose of 3 mg semaglutide tablet alone will be administered orally. Trial product administration will take place in the morning after overnight fasting for at least 6 hours.; A dose of 500 mg probenecid (2 tablets of 250 mg) will be administered orally twice daily for 3½ days (7 trial product administrations in total). On the 4th day, the last probenecid administration will take place 2 hours prior to administration of a single dose of 3 mg oral semaglutide tablet. The last trial product administrations will take place in the morning after overnight fasting for at least 6 hours.; A single dose of 600 mg ciclosporin (6 capsules of 100 mg) will be administered orally 1 hour prior to administration of a single dose of 3 mg oral semaglutide tablet. Trial product administration will take place in the morning after overnight fasting for at least 6 hours.
Intervention MeSH terms: Cyclosporine; Probenecid; Cyclosporins
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a 3-period cross-over study. The participants will be randomised to three treatment sequences each consisting of three treatment periods. One treatment period with a single dose of 3 mg oral semaglutide alone, one treatment period with a single dose of 600 mg ciclosporin 1 hour prior to administration of a single dose of 3 mg oral semaglutide and one treatment period with 500 mg probenecid administered twice daily for 3½ days with the last dose 2 hours prior to administration of a single dose of 3 mg oral semaglutide. Pharmacokinetics of sodium N-(8-(2-hydroxybenzoyl) amino) caprylate (SNAC) and SNAC metabolites will be assessed after each single dose of 3 mg oral semaglutide.
Masking: None (Open Label)
Primary purpose: Treatment
A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen Formulation
Condition: Healthy Volunteers; Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose is to demonstrate the bioequivalence of naproxen administered as VIMOVO
      manufactured at a new facility in Sweden (AstraZeneca) to that of naproxen administered as
      VIMOVO manufactured in the USA (Patheon) and to a marketed enteric-coated naproxen
      formulation.
    

Detailed description: 
      A Phase I, Open-label, Randomised, 3-way Crossover Study to demonstrate Bioequivalence of a
      Single Oral Dose of Naproxen administered as VIMOVO manufactured at AstraZeneca AB compared
      to that of VIMOVO manufactured by Patheon Pharmaceuticals and a marketed enteric-coated
      Naproxen Formulation (Manufactured by Roche) in Healthy Volunteers.
    

Intervention name(s): VIMOVO (AstraZeneca); VIMOVO (Patheon); Marketed enteric-coated naproxen formulation
Intervention type(s): Drug; Drug; Drug
Intervention description(s): VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole; VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole; Marketed enteric-coated naproxen formulation (manufactured by Roche) 500 mg tablet
Other intervention name(s): Treatment A; Treatment B; Treatment C
Intervention MeSH terms: Naproxen; Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; crossover; bioequivalence; naproxen; esomeprazole; vimovo; healthy volunteers
Multiple CoolSculpting Treatment Study
Condition: Body Fat Disorder
MeSH terms: Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      To evaluate the safety of same-day CoolSculpting treatments and to assess the impact on serum
      lipids and liver-related tests.
    

Detailed description: 
      The study will evaluate the safety of multiple same-day CoolSculpting treatments and will
      assess any impact on serum lips or liver-related analytes,
    

Intervention name(s): The Zeltiq CoolSculpting System
Intervention type(s): Device
Intervention description(s): Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Other intervention name(s): Cryolipolysis; Lipolysis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Lipolysis; Cryolipolysis; Fat Reduction
Lamotrigine Bioequivalence Study to Compare Dispersible Tables With Compressed Tablets in China
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      It is an open-label, randomised, single dose, two-sequence cross-over study. Twenty-four
      eligible, healthy, Chinese male subjects will be enrolled after providing written informed
      consent. Subjects will be randomised into two treatment groups 1 day prior to the first
      dosing day and will be assigned to regimen sequences (AB or BA) in a balanced fashion in
      accordance with the randomisation schedule. Regimen A is five lamotrigine 5 mg
      chewable/dispersible tablets and Regimen B is one lamotrigine 25 mg standard/compressed
      tablet.

      Subjects will receive their allocated regimen on the morning of Day 1 and will undergo study
      assessments for 7 days (until Day 8). Subjects will receive their alternate randomised
      treatment after a washout period of 14-21 days from Day 1. Subjects will undergo a further
      assessment period of 7 days and will attend a follow-up visit during 8-12 days after the
      second treatment. The total observation period in this study will be 23~34 days.

      Subjects will arrive at the research unit on the evening before each lamotrigine dosing
      occasion and will remain in the unit until the 24-h post-dose evaluations have been completed
      (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 h). After this, subjects will return
      home but must return to the unit for further assessments to be made at 36, 48, 72, 96, 120,
      144 and 168 h after dosing Study Endpoints/Assessments A total of 19 serial blood samples (5
      mL each) will be collected for the measurement of plasma lamotrigine concentrations at each
      study assessment. Safety and tolerability assessments (monitoring of adverse events and
      serious adverse events, routine laboratory determinations, vital sign measurements and
      12-lead electrocardiogram) will be conducted throughout the study.
    


Intervention name(s): Lamotrigine
Intervention type(s): Drug
Intervention description(s): Lamotrigine is a selective inhibitor of a voltage-sensitive sodium channel, is an anti-epileptic drug of the phenyltriazine class.
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Analysis of Exhaled Breath by Biosensors in Adults With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The aim of this study is to investigate the pattern of organic volatile compounds (VOCs) in
      the exhaled breath detected by biosensors in adults with persistent mild asthma. The analysis
      of VOCs detected by biosensors in asthmatic adults will be compared with that in a control
      group of healthy subjects and with exhaled nitric oxide (NO).

      Identification of breath VOC patterns may be a completely noninvasive new technique for
      assessing airway inflammation. A device containing a series of nanosensors can be used for
      breath analysis of VOC patterns through integration with a suitable algorithm for pattern
      recognition.

      Preliminary data indicate that exhaled breath patterns detected by biosensors in healthy
      subjects are different from those in patients with asthma. In patients with asthma, analysis
      of exhaled breath using biosensors will be compared with exhaled NO measurement for studying
      a possible correlation with an independent method for assessing airway inflammation and with
      spirometry for assessing a possible correlation with lung function.

      Measurement of exhaled NO is a well-established, validated, and standardized method for
      assessing and monitoring of airway inflammation in patients with asthma who are
      steroid-naive. In patients with asthma, exhaled NO concentrations are correlated with blood
      eosinophil cell counts and with airway hyperresponsiveness (AHR).

      This study could contribute to the identification and development of a completely new
      non-invasive technique for assessing airway inflammation with important implications for
      diagnosis and therapeutic monitoring of patients with asthma.

      Establishing the effect of anti-inflammatory drugs on breath analysis by biosensors in
      patients with asthma is relevant for future studies aimed to use this technique in asthma
      management.
    


Intervention name(s): analysis of exhaled breath by biosensors; measurement of exhaled nitric oxide
Intervention type(s): Other; Other
Intervention MeSH terms: Nitric Oxide
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        asthma clinic, community sample
Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Combinations of Monoclonal Antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS Administered Via Intravenous Infusion in Healthy, HIV-uninfected Adult Participants
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
      antiviral activity of combinations of monoclonal antibodies PGT121, PGDM1400, 10-1074, and
      VRC07-523LS administered via intravenous infusion in healthy, HIV-uninfected adults.
    

Detailed description: 
      This study will evaluate the safety, tolerability, pharmacokinetics, and antiviral activity
      of combinations of monoclonal antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS
      administered via intravenous infusion in healthy, HIV-uninfected adults.

      Participants will initially be enrolled into one of three groups. At Day 0, Groups 1, 2, and
      3 will receive dual combinations of mAbs administered sequentially via IV. Group 1 will
      receive a combination of PGT121 and VRC07-523LS, Group 2 will receive PGDM1400 and
      VRC07-523LS, and Group 3 will receive 10-1074 and VRC07-523LS.

      Study staff will review study data from Groups 1, 2, and 3 and determine if Group 4 may begin
      to enroll. Participants in Group 4 will receive PGDM1400, PGT121, and VRC07-523LS
      administered in sequence via IV on Day 0 and at Month 4.

      Study duration will be 12 months for participants in Groups 1, 2, and 3, and 16 months for
      participants in Group 4. Participants will attend several study visits, which may include
      physical examinations, blood and urine collection, HIV testing and pretest counseling, risk
      reduction counseling, and questionnaires.
    

Intervention name(s): PGT121; PGDM1400; 10-1074; VRC07-523LS
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 20 mg/kg administered intravenously; 20 mg/kg administered intravenously; 20 mg/kg administered intravenously; 20 mg/kg administered intravenously
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Pharmacokinetics, Mass Balance, and Metabolism of [14C]HSK21542 in Healthy Adult Male Volunteers.
Condition: Peripheral Analgesic and Anti-itch
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, nonrandomized, and open design study to investigate the
      pharmacokinetics, mass balance, metabolism and excretion of HSK21542 in healthy male
      subjects.
    


Intervention name(s): [14C]HSK21542
Intervention type(s): Drug
Intervention description(s): A single intravenous dose of 2 μg/0.212 μCi/kg [14C]HSK21542 in boluses within 2 minute after fasting for at least 10 hours.
Intervention model: Single Group Assignment
Intervention model description: A single-center, single-dose, non-randomized, open-label design.
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1801 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics,
      safety and tolerability of HCP1801 in healthy subjects.
    


Intervention name(s): HCP1805; HCP1801
Intervention type(s): Drug; Drug
Intervention description(s): Dapagliflozin/Metformin (Xigduo XR) 10/1000mg; Dapagliflozin/Metformin 10/1000mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Alcohol Elimination Effect of TCI711 Probiotic (Bacillus Coagulans) on Adult Individuals
Condition: Breath Alcohol Level
Study type: Interventional

Summary: 
      Investigating the possibility of using Bacillus coagulans TCI711 to improve the efficiency of
      alcohol removal in adult individuals.
    


Intervention name(s): Bacillus coagulans TCI711
Intervention type(s): Dietary Supplement
Intervention description(s): Using Bacillus coagulans TCI711 for one month and implementing alcohol testing at weeks 0, 1, and 4.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Effect of Adding Sufentanyl to Bupivacaine in Transversus Abdominis Plane Block to Reduce the Narcotic Dosage and Pain After Cesarean Delivery
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Adding sufentanyl to bupivacain in Transversus Abdominis Plane (TAP) block under ultrasound
      guide can reduce narcotic dosage, side effects and pain after cesarean delivery.
    


Intervention name(s): Sufentanyl
Intervention type(s): Drug
Intervention description(s): As intervention 1cc sufentanyl is added to bupivacain in case group for TAP block.
As comparator 1cc normal saline is added to bupivacain in control group for Tap block.
Intervention MeSH terms: Sufentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cesarean Delivery; TAP block; sufentanyl; Narcotic dosages
Facilitated Release of Endogenous Enterokines
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The overall objective is to develop therapy for obesity and diabetes that is as effective as
      gastric bypass surgery but without the cost and safety concerns.
    

Detailed description: 
      Gastric bypass leads to rapid, sustained diabetes remission in the majority of patients who
      undergo this procedure and is also highly effective therapy for obesity. However, currently
      <1% of medically-eligible patients undergo this or other bariatric operations due to cost and
      safety concerns. The approach is based on data suggesting that the benefit of gastric bypass
      is largely due to anatomical rearrangement of the intestine which leads to accelerated
      delivery of nutrients to the jejunum. This rerouting of nutrients stimulates the release of
      multiple neural, hormonal and enterokine responses that are associated with appetite
      suppression and improved glucose control. In this pilot proposal the question under
      investigation is whether repeated rapid delivery of a mixed meal directly to the jejunum can
      promote weight loss and glucose control.
    

Intervention name(s): Mixed-Meal; Electrolyte Solution
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Per 250ml bottle: 220 calories, protein 9g, carbohydrate 33g (15g sugar), fat 6g, sodium 190mg, potassium 390mg; 500mLs by tube daily in 4 doses; Electrolyte Solution 500mLs by tube daily in 4 doses
Other intervention name(s): Ensure Nutrition Shake® (Abbott Park, Illinois, U.S.A.); Unflavored Pedialyte ® (Abbott Park, Illinois, U.S.A.)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Obesity; Diabetes Mellitus, Type 2; Nutrient
Phase II/III Study of AZD2816, for the Prevention of COVID-19 in Adults
Condition: COVID-19; SARS-CoV-2
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of the study is to assess the safety, and immunogenicity of AZD2816 for the
      prevention of COVID-19
    

Detailed description: 
      The purpose of this study is to demonstrate the safety and characterize the immunogenicity of
      AZD2816; AstraZeneca's candidate ChAdOx1 vector vaccine against SARS-CoV-2 variant strain
      B.1.351
    

Intervention name(s): AZD1222; AZD2816
Intervention type(s): Biological; Biological
Intervention description(s): 10 mM histidine/histidine hydrochloride, 7.5% (w/v) sucrose, 35 mM sodium chloride, 1 mM magnesium chloride, 0.1% (w/v) polysorbate 80, 0.1 mM edetate disodium, 0.5% (w/v) ethanol, at pH 6.6.; 10 mM histidine/histidine hydrochloride, 7.5% (w/v) sucrose, 35 mM sodium chloride, 1 mM magnesium chloride, 0.1% (w/v) polysorbate 80, 0.1 mM edetate disodium, 0.5% (w/v) ethanol, at pH 6.6
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Previously vaccinated individuals will receive 1 dose of AZD1222 or AZD2816 on Day 1. Previously unvaccinated participants will receive one of the following 2-dose vaccinations:
1 dose of AZD2816 on Day 1 and on Day 29
1 dose of AZD1222 on Day1 and on Day 29
1 dose of AZD1222 on Day 1 and 1 dose of AZD2816 on Day 29
1 dose of AZD2816 on Day 1 and on Day 85. Participants will be followed up for safety for 180 days after last study vaccine administration.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: COVID-19 Vaccine
Glypican4 and CTRP5 in Metabolic Syndrome and the Effect of Exercise on These Adipokines
Condition: Metabolic Syndrome; Obesity
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Glypican4, CTRP3, CTRP5 are emerging novel adipokines mediating obesity and inflammation
      related disorders. RBP4 and adiponectin are well known important adipokines. Therefore, we
      examine the circulating levels of theses adipokines in the subjects with or without metabolic
      syndrome. Furthermore, we tried to clarify the effect of exercise on the circulating these
      adipokines.
    


Intervention name(s): 3months Exercise
Intervention type(s): Behavioral
Intervention description(s): training session consisting of a brief warm-up, followed by an approximately 45-min session of aerobic exercise at an intensity of 60-75% of the age-predicted maximum heart rate (approximately 300 kcal/day) and a 20-min muscle strength train- ing programme (approximately 100 kcal/day), followed by a brief cool-down period.
Intervention model: Single Group Assignment
Masking: None (Open Label)
The Acute Effect of Atorvastain on Renal Function in Patients With Type II Diabetes
Condition: Healthy Subjects
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      We wanted to test the hypothesis that acute treatment with atorvastatin changes renal sodium
      excretion, glomerular filtration rate, tubular function and vasoactive hormones in patients
      with type II diabetes, not in treatment with insulin.
    


Intervention name(s): Atorvastatin
Intervention type(s): Drug
Intervention description(s): 80 mg atorvastatin daily on two following days
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Atorvastatin; Renal function; Hemodynamics; Diabetes type II; sodium excretion
Partial Weight Bearing Proximal Femoral Nail Due to Intertrochanteric Fracture.
Condition: Femur Intertrochanteric Fractures
MeSH terms: Fractures, Bone; Hip Fractures
Study type: Observational

Summary: 
      Femur intertrochanteric fractures (FITC) are one of the most common fractures of the lower
      extremity, caused by osteoporosis, caused by minor trauma in elderly patients. Today, it is
      successfully treated with proximal femoral nails (PFN) designed in different ways. After
      surgical fixation with PFN, patients are mobilized by placing full weight, but some
      complications can be seen due to the patients being osteoporotic. In this study, the
      investigators planned to investigate the effect of full weight bearing and partial weight
      bearing on complications, which were not previously described in the literature.
    

Detailed description: 
      Participants over the age of 60 who underwent PFN with the diagnosis of FITK were randomized
      (double-blinded consecutive full load on one patient and partial weight on one patient), and
      mobilized a group with full weight with the help of a walker after surgical fixation, and the
      other group with the help of a walker to give partial weight (balance). We planned to follow
      up his treatment prospectively. The compatibility of the groups will be evaluated by
      comparing the bone mineral density, calcium, alkaline phosphatase, phosphate, vitamin D
      levels and ages of the patients. Fracture types and post-treatment reduction quality of
      patients in both groups will be compared. We planned to compare the complication rates,
      Barthel Index and harris hip scores in the follow-up of the patients.
    

Intervention name(s): Group 1; Group 2
Intervention type(s): Procedure; Procedure
Intervention description(s): Even numbered patients will partial weight bearing after treatment,; patients with odd numbers will walk with full weight bearing after treatment
Other intervention name(s): partial weight bearing; full weight bearing
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        1. Patients over 65 years of age who underwent proximal femoral nail due to femoral
        intertrochanteric fracture
      
Keywords: intertrochanteric fracture; elderly fractures; weight bearing