bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Change of Tissue Oxygenation During a Vascular Occlusion Test Using Two Different NIRS (O3TM vs. INVOS®)
Condition: Tissue Oxygen Saturation
Study type: Interventional

Summary: 
      This study evaluates the change of tissue oxygenation during a vascular occlusion test using
      two NIRS ( O3TM and INVOS®). NIRS probe will be attached on volunteer's forearm during
      vascular occlusion test and tissue oxygenation change will be recorded
    

Detailed description: 
      Near-infrared spectroscopy (NIRS) has been used to measure regional hemoglobin oxygen
      saturation of tissue. Recently, it also has been used to monitor peripheral tissue oxygen
      saturation, and micro-vascular reactivity using vascular occlusion test (VOT).

      O3 TM is recently developed NIRS and there are only two clinical trials using this device,
      until now. In one study, this device could adequately predict cerebral regional oxygen
      saturation. And in the other study, peripheral tissue oxygenation was measured during
      ischemic pre-conditioning in heart surgery and it showed correlation between O3 TM and other
      NIRS ( EQUANOX) which has been used to monitor peripheral tissue oxygenation. But in this
      study, study group was patient with heart disease and the deoxygenation and reoxygenation
      rate during VOT was not not measured, which reflects tissue oxygen extraction and
      micro-vascular reactivity.

      In NIRS devices, there are assumed cerebral arterial-venous ratio upon which oximetry values
      are calculated. In INVOS®, assumed arterial-venous ratio is 25/75. In other NIRS, assumed
      arterial-venous ratio is 30/70. But unlike other NIRS, O3 TM can change its preset
      arterial-venous ratio between 25/75 and 30/70, and there are no studies compare oximetry
      values between these two different settings.

      In this study, the investigators try to compare INVOS®, which has been used widely for
      monitor tissue oxygenation, and two different settings of O3 TM ( arterial-venous ratio;
      30/70 and 25/75). Three probes will be attached at same site simultaneously and the
      investigators will measure change of tissue oxygenation, deoxygenation rate and reoxygenation
      rate during vascular occlusion test
    

Intervention name(s): O3
Intervention type(s): Device
Intervention description(s): O3 TM and INVOS® monitoring simultaneously in single patient during 3 min of vascular occlusion test
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Generation of Normal Ranges to Analyze Body Composition of Adults Based on Bioelectrical Impedance Analysis (BIA)
Condition: Healthy
Study type: Observational

Summary: 
      The aim of the study is to generate normal ranges for φ, BIVA and BCC. The calculation of FMI
      and FFMI is based on the results of two other clinical investigations: "Generation of
      prediction equation to analyze body composition of adults based on Bioelectrical Impedance
      Analysis (BIA)" (BCA-01) and "Application and adaption of device specific body composition
      formulas to various ethnic groups" (BCA-02). The aim of BCA-01 was to develop prediction
      equations for calculating FFM, TBW, ECW and SMM based on the gold standard reference methods
      ADP, DXA, MRI, D2O and NaBr on the one hand and measurement data of the BIA devices on the
      other hand. The equations are necessary to use the device as a Body Composition Analyzer with
      an acceptable accuracy level for clinical practice. The aim of the study BCA-02 was to apply
      and adapt device specific body composition formulas to various ethnic groups.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Data of 992 healthy adults are planned to be collected.
      
Keywords: Bioelectrical Impedance Measurement; Adults
Study to Evaluate the Immunogenicity and Safety of an Investigational Pandemic Influenza Vaccine in Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to evaluate the immunogenicity and safety of prime-boost
      vaccination schedule of GSK Biologicals' investigational vaccine GSK1562902A.
    

Detailed description: 
      This protocol posting was modified according to the protocol amendment 2 (dated
      16-June-2011). The impacted section is eligibility criteria.
    

Intervention name(s): GSK Biologicals' investigational vaccine GSK1562902A
Intervention type(s): Biological
Intervention description(s): Three intramuscular injections
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects were to be stratified into three age strata (6 to 11 months, 12 to 23 months and 24 to 35 months) in the ratio of 2:1:1.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: H5N1; influenza infection; Influenza vaccine GSK1562902A
MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(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 investigate the efficacy and safety of an investigational
      treatment for type 2 diabetes mellitus.
    


Intervention name(s): sitagliptin phosphate (+) metformin hydrochloride; metformin
Intervention type(s): Drug; Drug
Intervention description(s): sitagliptin/Metformin HCl 50/500 mg tablet bid, titrating up to sitagliptin/Metformin HCl 50/1000 mg tablet over 4 weeks; for a 44-wk treatment period.; metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period
Other intervention name(s): MK0431A; Janumet™
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Does Aerobic Training Followed by Resistance Training Enhance Aerobic Capacity in Seniors
Condition: Elderly
Study type: Interventional
Phase: Phase 2

Summary: 
      In healthy young subjects a single bout of strength training following endurance training has
      been shown to improve markers for aerobic capacity in muscle compared to a single bout of
      endurance training alone. The present project tests the hypothesis: 12 weeks of training with
      sessions of endurance training followed by strength training is superior to endurance
      training alone for health participants 50-65 years of age. The outcome measures are maximal
      oxygen uptake and knee-extension strength.
    


Intervention name(s): exercise training
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: endurance training,; strength training,; aerobic capacity,; muscle strenght; physical capacity
Exercise Training in Healthy Young Men
Condition: Gaining Skeletal Muscle Mass and Strength
Study type: Interventional

Summary: 
      Resistance type exercise training has been shown to be a potent stimulus to increase skeletal
      muscle mass and strength in healthy men. Furthermore, timed protein intake is also known to
      affect the muscle adaptive response following exercise. Whether timed protein intake could
      augment the increase in muscle fiber size and/or satellite cell content following long-term
      exercise intervention remains to be established.

      We hypothesize that protein supplementation before sleep, on both training and non-training
      days, during a 12 week resistance training program further increases type II muscle fibre
      cross sectional area when compared to the placebo group.
    


Intervention name(s): Exercise + Protein drink
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Muscle mass; Strength; Cross-sectional area; Protein
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GRT9906 Prolonged Release Tablets After Dose Escalation in Healthy Subjects
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The safety and tolerability of multiple oral administrations of GRT9906 at different doses
      was investigated in this clinical study. The prolonged-release tablets slowly release the
      active compound in the intestine. In addition, absorption into the body, distribution,
      metabolization and excretion of GRT9906 was characterized. Pharmacological effects of GRT9906
      in healthy participants was assessed using pupillometry (diameter and reactions of the pupil)
      and a Cold Pressor Test where pain is measured while hands are placed in icy water for two
      minutes.
    

Detailed description: 
      The primary objective of the study was to investigate the safety and tolerability of
      escalating doses of GRT9906 after multiple oral dose administration of prolonged-release (PR)
      tablets to healthy male and female participants

      Secondary objectives were:

        -  To evaluate the pharmacokinetics (serum and urine) of escalating doses of GRT9906 after
           multiple oral dose administration of PR tablets and

        -  To assess the pharmacodynamic effects of escalating doses of GRT9906 by means of
           pupillometry and Cold Pressor Test after multiple oral dose administration of PR
           tablets.

      The doses of GRT9906 in this study were 80, 120, 160, and 200 milligrams (mg) twice daily in
      dose groups 1-4.

      Participants were screened within 28 days prior to the first dosing. Treatment periods
      consisted of 5.6 (first dose group) or 6.6 (second and subsequent dose groups) days:

        -  Day 0 was the day prior to first dosing

        -  Day T was the titration day (day before Day M1; not applicable for the 80 mg dose group)

        -  Days M1 to M4 were the days with repeated dosing

        -  Days F1 and F2 were the follow-up days (24 hours and 48 hours after the last drug
           administration)

        -  A final examination was performed within 4 to 14 days after last dosing.
    

Intervention name(s): GRT9906 PR tablet; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg GRT9906 PR tablet oral (minimal release of 80 percent after 480 minutes); Placebo tablet matching 40 mg GRT9906 PR tablet
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Single center, multiple dose, dose escalation (within dose-group randomized, double-blind, placebo-controlled, 2-way cross-over)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dose escalation
Comparison of MENOPUR Liquid and Powder in Women Undergoing Assisted Reproductive Technology (ART)
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      Development of multiple follicles and pregnancy in ovulatory women undergoing controlled
      ovarian stimulation as part of an assisted reproductive technology (ART) cycle.
    


Intervention name(s): MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL; MENOPUR powder and solvent for solution for injection, 75 IU; Placebo (for MENOPUR solution for injection in pre-filled pen); Placebo (for MENOPUR powder and solvent for solution for injection)
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): Solution for injection in pre-filled pen, subcutaneous administration; Solution for injection in vials (powder and diluent), subcutaneous administration; Solution for injection in pre-filled pen, subcutaneous administration; Solution for injection in vials (powder and diluent); subcutaneous administration
Other intervention name(s): Highly purified menotropin; Highly purified menotropin
Intervention MeSH terms: Pharmaceutical Solutions; Menotropins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Controlled Ovarian Stimulation; Assisted Reproductive Technology
India Dexamethasone and Betamethasone
Condition: Preterm Birth; Antenatal Corticosteroids
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label, randomized, two-period, crossover, study to compare the pharmacokinetics and
      pharmacodynamics of single dose Dexamethasone and Betamethasone administered orally and
      intramuscularly in 48 healthy, adult, female subjects under fasting conditions. This study is
      being conducted in Bangalore, India.
    


Intervention name(s): Dexamethasone 4 mg/ml; Betamethasone 4 mg/ml; Celestone Soluspan 6Mg/Ml Suspension for Injection; Dexamethasone Oral Tablet; Betamethasone Oral Tablet
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Intramuscular. Total dose: 1.5 mL (6 mg); Intramuscular. Total dose: 1.5 mL (6 mg); Intramuscular. Total dose: 1 mL (6 mg); Oral. Total dose: 12 Tablets (6 mg); Oral. Total dose: 12 Tablets (6 mg)
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone acetate phosphate; Betamethasone sodium phosphate; BB 1101
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antenatal Corticosteroids; Betamethasone; Dexamethasone
A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Very Low Dose-Glucagon in Subjects With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to identify the safest dose of very low dose glucagon to prevent
      hypoglycemia in patients with Type I diabetes who use insulin pumps and to measure the the
      amount of glucagon in the blood and see how the body responds to the glucagon.
    

Detailed description: 
      Glucagon is currently used to treat severe hypoglycemia. DiObex believes that glucagon
      replacement therapy with very low doses of glucagon may prevent hypoglycemia without
      compromising effective glycemic control by insulin. In this study very low doses of glucagon
      will administered to Type I diabetics who use insulin pumps. The glucagon will be
      administered subcutaneously overnight for 6, 9 or 12 hours to see if the number of mild or
      impending hypoglycemia events can be safely decreased. Three different doses of glucagon will
      be compared to a control infusion.
    

Intervention name(s): very low dose (VLD) glucagon
Intervention type(s): Drug
Intervention MeSH terms: Glucagon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: diabetes
A Trial of Tolerogenic Immunosuppression in Highly Sensitized Renal Transplant Recipients
Condition: Kidney Diseases
MeSH terms: Kidney Diseases
Study type: Observational

Summary: 
      Comparison between Campath induction and monotherapy with Tacrolimus vs Thymoglobulin
      induction and triple drug maintenance using Tacrolimus, mycophenolate, and steroids.
    

Detailed description: 
      Recent reports suggest that it might be possible to induce a state of tolerance in solid
      organ transplantation. So called "tolerogenic immunosuppression" involves induction with
      lymphocyte depleting antibodies followed by monotherapy with calcineurin inhibitors,
      cyclosporin or tacrolimus. The proposed study aims to evaluate a protocol of
      immunosuppression induction with lymphocyte depleting antibody Campath given prior to graft
      reperfusion, followed by tacrolimus monotherapy in highly sensitized patients (PRA >14% or
      past historical =/>50% and/or multiple renal transplants) undergoing renal transplantation,
      and compare it with the current standard protocol at UTMB which employs induction with
      Thymoglobulin given over 4 days followed by 3 drugs: tacrolimus, mycophenolate and steroids.
      In both groups of patients the target tacrolimus levels will be the same i.e, between 10 to
      15ng/mL, soon after the transplant. In the Campath gro up, tacrolimus will be tapered after 3
      months in patients who do not have rejection and appear to be developing donor specific
      tolerance.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with end stage renal disease , on dialysis, who are regarded as "high
        immunological risk" becuase they have lost previous transplants to rejection, or have a
        high panel reactive antibody (PRA).
      
Keywords: Kidney transplant; Tolerance induction; High Panel Reactive Antibody (PRA) kidney recipients
Preimplantation Genetic Screening (PGS) in Advanced Female Age and Male Severe Factor
Condition: Embryo Aneuploidies; Implantation Rates; Infertility
MeSH terms: Infertility; Aneuploidy
Study type: Interventional

Summary: 
      Preimplantation Genetic Screening (PGS) is used for the selection of chromosomally normal
      embryos before the transfer in IVF treatments in many cases. There is great debate in the
      scientific community as to whether this is an efficient practice in patients of different
      prognosis.

      This prospective and randomized study seeks to study the results of chromosomal diagnosis
      using the new Comparative Genomic hybridization (CGH) arrays technique by practicing
      Preimplantation Genetic Screening (PGS) in day three biopsy on one arm of the study and not
      on the other arm in order to compare the results. The investigators will study the ongoing
      pregnancy rate of each oocyte retrieval and the ongoing implantation rate with Day 5 embryos
      (blastocysts) in IVF/ intracytoplasmic sperm injection (ICSI) treatments of embryos from two
      different groups of patients: Advanced Age Female Patients (38 - 41 years of age) and Male
      severe factor (≥2 million spermatozoids/ml.).
    

Detailed description: 
      The randomized controlled trial results of advanced maternal age was completed and published
      (Rubio et al., Fertility&Sterility 2017).

      The randomized controlled trial results of the male factor indication was terminated with
      anticipation due to the change of the technology that prevented recruitment of patients using
      the old technology (that one used in the study).
    

Intervention name(s): PGS; PGS; Prolonged culture; Prolonged culture
Intervention type(s): Genetic; Genetic; Other; Other
Intervention description(s): Preimplantation Genetic Screening of the embryos and posterior transfer of ongoing Day 5 blastocysts.; Preimplantation Genetic Screening of the embryos and posterior transfer of ongoing Day 5 blastocysts.; The embryos will be in prolonged culture and on going embryos transferred on Day 5 .; Prolonged culture of the embryos and posterior transfer of ongoing Day 5 blastocysts.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: PGS; CGH; Aneuploidy; Advanced maternal age; Male factor
A Study to Compare LY2963016 and US-approved Lantus® After Single Dose Administration to Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of
      LY2963016 and US-approved Lantus®. The study involves four single injections; two doses of
      LY2963016 and two doses of US-approved Lantus®. The study will have 4 periods. In each
      period, a single injection will be administered before undergoing a euglycemic clamp that
      lasts for 24 hours. There will be at least a 7 day washout between each period. Side effects
      will be documented. Study participation is expected to last up to 14 weeks.
    


Intervention name(s): LY2963016; US Approved Lantus
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously; Administered subcutaneously
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Volunteers
High Pain Intervention in Cesarean Sections
Condition: Other Chronic Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      In previous studies the investigators have seen that the severity of pain one day after
      cesarean delivery can predict the presence of pain and depression 2 months later. The
      investigators believe those at risk for severe acute post-partum pain can be identified, and
      medical interventions can be tailored to manage postoperative pain more effectively.
    

Detailed description: 
      This study is randomizing patients into 2 different groups and seeing if by altering our pain
      management with this group of patients their acute 24 hour evoked pain is less than
      anticipated; and the incidence of persistent pain and depression when contacted 2 months
      after delivery is decreased. This study is designed to see if these additional interventions
      would prove effective for patients at risk of having high pain level after cesarean surgery.
    

Intervention name(s): Duramorph 150; Acetaminophen; Duramorph 300
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses; Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses; Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses
Intervention MeSH terms: Acetaminophen; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic pain post delivery; postpartum depression; tailored pain management
AST Clinical Investigation
Condition: Diabetes
Study type: Interventional

Summary: 
      Blood glucose monitoring system are tested in the alternative site to validate the accuracy
      of the blood glucose.
    


Intervention name(s): blood glucose monitor; blood glucose monitor
Intervention type(s): Device; Device
Intervention description(s): Blood glucose monitor is used to monitor the blood glucose level of the human-being; Blood glucose monitor is used to monitor the blood glucose level of the human-being.
Other intervention name(s): Andon blood glucose monitor; Lifescan blood glucose monitor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: blood glucose