bioihbjkbjnl/mcl2 huggingface dataset:
Thrombosis and Neurocognition in Klinefelter Syndrome
Condition: Klinefelter Syndrome; Thrombosis
MeSH terms: Klinefelter Syndrome; Thrombosis; Syndrome
Study type: Observational

Summary: 
      The haemostatic balance and neurocognitive capability of men with Klinefelter syndrome is
      compared to healthy controls by using specific biochemical assays for coagulation and
      fibrinolysis and a selection of neuropsychological tests and brain fMRI. Furthermore, the
      effect of gonadal status and any effects of long- or short-term testosterone treatment on the
      above mentioned parameters are investigated.
    

Detailed description: 
      Klinefelter syndrome (KS) affects approximately 1 in every 600 males, but remains severely
      underdiagnosed. Men with KS are more prone to a wide range of diseases including thrombotic
      disorders. Also, neurocognitive function is impaired in KS. The background for the increased
      thrombosis proneness is not understood, and also it is not understood how testosterone
      treatment affects the thrombosis risk in KS. The effects of testosterone treatment on
      neurocognition in KS is also not completely understood. However, it is speculated that
      testosterone treatment at an early point could help improve the overall neurocognitive
      performance.

      In this study 30 males with KS receiving testosterone treatment, 30 males with KS not
      receiving testosterone treatment and 60 matched healthy male controls are included. After
      initial examination including blood testing and neurocognitive testing, the subjects are
      followed for 18 months and examined a second time. After initial examination the group of
      previously untreated KS males will be put on standard testosterone treatment according to
      current guidelines.

      Groups will be compared by measuring and array of markers for coagulation and fibrinolysis,
      including thrombin generation and fibrin structure analysis, to assess the haemostatic
      balance. Also, a wide array of neurocognitive tests and brain fMRI is applied to compare the
      neurocognitive function between the groups.
    

Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Men with Klinefelter syndrome identified through clinics for fertility, endocrinology and
        genetics. Healthy controls from the general population living in Central Denmark Region.
      
Biospecimen description: 
      Bloodsamples
    
Keywords: Testosterone; Neurocognition
Cellulite and Extracorporeal Shock Wave
Condition: Cellulite; Microcirculation
MeSH terms: Cellulite
Study type: Interventional

Summary: 
      Hypothesis: The combination of extracorporeal shockwave and a daily gluteal muscle strength
      programme is superior to the gluteal muscle strength programme alone in cellulite.

      Study design: Randomized-controlled trial

      Analysis: Intention-to-treat

      Outcome parameters: a) Photo, b) Nürnberger Score, c) circumference measurements, d)
      capillary blood flow, e) tissue oxygen saturation, f) postcapillary venous blood flow

      Intervention: Extracorporeal shock wave for six sessions with 2000 impulses at both gluteal
      and thigh regions plus a specific gluteal strength exercise training

      Follow-up: 12 weeks
    


Intervention name(s): Extracorporeal shockwave therapy; Sham extracorporeal shock wave plus gluteal strength exercise
Intervention type(s): Device; Device
Intervention description(s): Extracorporeal shockwave therapy with focussed shock waves (2000 impulses, 0,25mJ/mm2) plus daily gluteal exercises; Sham extracorporeal shock wave plus gluteal strength exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: cellulite; shockwave; microcirculation; skin
Comparative Study Using Negative Pressure Dressing With & Without Silver Alginate to Promote Healing in Chronic Wounds.
Condition: Wound Healing
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The randomized control trial will be conducted in the Department of Plastic and
      Reconstructive Surgery at Dr. Ruth K.M. Pfau Civil Hospital Karachi.General population
      admitted in Civil Hospital Karachi, for wound coverage with skin grafting meetimg inclusion
      criteria will be included.
    

Detailed description: 
      Wound will be covered with negative pressure dressings that are composed of a sterile foam
      dressing surrounded by an occlusive film that adheres to the nearby, normal skin. Suction is
      applied to the dressing and a draining tube connect to a wall fixed assisted vacuum canister.

      Patients will be provided with paper chits with A or B marked on it. Patients picking up A
      chit will be dealt as A group where wound will be covered with VAC dressings only where by
      patients picking up B chit will be dealt as B group where wound will be covered with a single
      layer of Ag+ hydrocolloid dressings. Such pattern of dressing will be followed in every
      change of dressing in 48 hours. The wound site will be photographed after every change of
      dressings. The wound site will be photographically monitored by a team of plastic surgeons to
      assess granulation tissue, by noting the size of wound, color and shine of granulation tissue
      and edema.
    

Intervention name(s): silver alginate; VAC dressing without silver alginate
Intervention type(s): Other; Other
Intervention description(s): silver alginate hydrofiber dressing; vaccum assisted dressing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Pharmacokinetics, Safety and Tolerability of CKD-387 10/500mg BE Phase1
Condition: Type2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of
      CKD-387
    

Detailed description: 
      An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics,
      safety and tolerability of CKD-387 in helalthy subjects.
    

Intervention name(s): Part A, Reference (D635 10/500mg, Astrazeneca); Part A, Reference (D635 10/500mg, Astrazeneca); Part B, Reference (D635 10/500mg, Astrazeneca); Part B, Reference (D635 10/500mg, Astrazeneca)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Once a day. Under fasting condition; Once a day. Under fasting condition; Once a day. Under fed condition; Once a day. Under fed condition
Other intervention name(s): PartA, Test(CKD-387 10/500mg); PartA, Test(CKD-387 10/500mg); PartB, Test(CKD-387 10/500mg); PartB, Test(CKD-387 10/500mg)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 part, 2x2 crossover study
Masking: None (Open Label)
Primary purpose: Other
Keywords: Type2 Diabetes Mellitus; CKD-387
Way to Be Active III (Framing Incentives)
Condition: Sedentary Lifestyle
Study type: Interventional

Summary: 
      Employers are increasingly looking for opportunities to motivate sedentary employees to
      become more physically active. Workplace walking programs have had mixed success and
      typically show most improvement among participants that are already fairly active at a
      baseline. The goal of this study is to determine whether a financial incentive program can
      motivate sedentary employees to increase the number of steps they walk per day to meet a
      minimum threshold.

      The primary outcome measure is the proportion of days a minimum activity of 7000 steps or
      more is achieved. Outcomes will be assessed each week for 3 months using incentives followed
      by 3 months of follow-up without incentives. Secondary outcomes will include the average
      steps walked per day.
    


Intervention name(s): Financial Incentives; Daily feedback
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Sedentary lifestyle; Pedometers; Obesity; Physical Activity; Financial Incentives; Behavioral Economics
Effects of Immunonutrition in Patients Undergoing Pancreaticoduodenectomy
Condition: Pancreaticoduodenectomy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether immunonutrition is effective on surgical
      site infection and Th1/Th2/Th17 differentiation in patients undergoing
      pancreaticoduodenectomy
    

Detailed description: 
      Perioperative immunonutrition is reported to improve the incidence of postoperative
      infectious complication in patients with gastrointestinal surgery. It has also been
      recognized that Th1/Th2 balance shifts toward Th2 by surgical stress. On the other hand, the
      change of Th17 status after surgery has not been established. Furthermore, The change of
      Th1/Th2 balance and Th17 status with immunonutrition on pancreaticoduodenectomy have not been
      reported yet.

      Objective of this study is to investigate the effects of perioperative immunonutrition on
      incidence of postoperative infectious complication, Th1/Th2 balance and Th17 status after
      pancreaticoduodenectomy.
    

Intervention name(s): Oral IMPACT; Oral IMPACT; Parenteral nutrition
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): oral supplementation for 5 days(1 L/d )before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA; postoperative enteral infusion of the formula with arginine, omega-3 fatty acids, and RNA; Parenteral nutrition
Other intervention name(s): oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: immunonutrition; pancreaticoduodenectomy; Th1; Th2; Th17
Metabolism and Disposition of [14C] Herombopag in Chinese Healthy Human Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single-center, open-label, single-dose design. It is planning to enroll six
      Chinese healthy adult male subjects. The metabolism and disposition of Herombopag, will be
      studied in these subjects after a single oral administration of a solution dose of [14C]
      Herombopag (5 mg, 100 uCi).
    

Detailed description: 
      The metabolism and disposition of Herombopag, will be studied in six healthy men after a
      single oral administration of a solution dose of [14C]eltrombopag (5 mg,100 uCi).

      The sutdy will investigate total radioactivity pharmacokinetics in whole blood and plasma
      、quantitatively analyze the the total radioactivity in the excreta、evaluate the predominant
      route of elimination and indentify the Metabolite profiles in plasma 、urine and faces.
    

Intervention name(s): Hetrombopag Olamine
Intervention type(s): Drug
Intervention description(s): a single oral taking
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Comparative Effects of Dexmedetomidine and Ketofol for Sedation in Patients Undergoing Trans-esophageal Echocardiography
Condition: Heart Valve Disease; Heart Septal Defects, Atrial
MeSH terms: Heart Septal Defects; Heart Valve Diseases; Heart Septal Defects, Atrial
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to compare dexmedetomidine and ketofol to find a suitable
      alternative for moderate sedation in out-patient diagnostic trans-esophageal
      echocardiography.
    

Detailed description: 
      Sample size was estimated based on previous studies with sedation in equally invasive
      procedures that in 2 groups difference in time to achieve Ramsay sedation scale was
      0.8min.(In group dexmedetomidine 12.4 & group ketofol 13.2 with S.D of 0.8). The sample size
      came out to be 22 subjects per group at a power of 90 % & confidence interval of 95 %. For
      possible dropouts, it was decided to include 10% extra subjects so finally it was decided to
      include 25 subjects per group. (Total sample size 50 subjects)

      Normality of quantitative data will be checked by measures of Kolmogorov Smirnov tests of
      normality. If data is normally distributed Student t-test will be applied for comparison of 2
      groups. Mann-Whitney U-test will be used for statistical analysis of skewed continuous
      variables or ordered categorical data. Proportions will be compared using Chi square or
      Fisher's exact test whichever is applicable. Wilcoxon Signed rank test will be used for
      skewed data or for scores (time related variables). . For comparison (time related variables)
      of Hemodynamics Repeated Measure ANOVA will be applied. All statistical tests will be
      two-sided and will be performed at a significance level of α=0.05. Analysis will be conducted
      using SPSS for Windows
    

Intervention name(s): Dexmedetomidine; Ketofol(ketamine+propofol)
Intervention type(s): Drug; Drug
Intervention description(s): drug for moderate sedation in trans-esophageal echocardiography; drug for moderate sedation in trans-esophageal echocardiography
Intervention MeSH terms: Dexmedetomidine; Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Echocardiography; Transesophageal; Dexmedetomidine; Ketamine; Propofol
Efficacy, Tolerability, and Comfort of 0.3% Hypromellose Eyedrops in Patients Undergoing LASIK Surgery
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to assess the tolerability and comfort of peri-operative 0.3%
      hypromellose eye drops in LASIK surgery patients and to assess whether pre-operative 0.3%
      hypromellose eye drops add to post-operative comfort in LASIK surgery patients compared to
      control (no pre-operative lubricant).
    


Intervention name(s): Pre-LASIK 0.3% hypromellose; Post-LASIK 0.3% hypromellose
Intervention type(s): Drug; Drug
Intervention description(s): Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.; Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Post LASIK dry eye; Pre LASIK dry eye; Hypromellose
A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Metformin
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the pharmacokinetic interactions between ASP015K
      and metformin in healthy non-elderly male subjects.
    


Intervention name(s): peficitinib; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Other intervention name(s): ASP015K
Intervention MeSH terms: Metformin; Peficitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Metformin; Drug-drug interaction; ASP015K
Outcomes Data of Bone Marrow Stem Cells to Treat Hip and Knee Osteoarthritis
Condition: Hip and Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      The purpose of this study is to determine if Bone Marrow Concentrate may be successful in the
      treatment of osteoarthritis. Bone Marrow Concentrate is known to contain a community of cells
      that has been shown to have "regenerative" properties. This study is designed to evaluate the
      short-term clinical and x-ray outcomes of injections for hip and knee osteoarthritis.

      Inclusion Criteria:

        -  Subjects must be scheduled for an autologous bone marrow hip or knee injection

        -  Subjects must have a diagnosis of hip or knee osteoarthritis

        -  Subjects must be between the ages of 18 and 85

        -  Subjects must be willing and able to sign Informed Consent

        -  Subjects must be willing and able to return for scheduled follow-up evaluations

      Exclusion Criteria:

        -  Subjects who have had any type of visco-supplementation in the treated joint within the
           last three months prior to enrollment

        -  Subjects for whom baseline data is not available
    


Intervention name(s): Procedural, Bone Marrow concentrate injection
Intervention type(s): Other
Intervention description(s): This is strictly data collection and outcomes based. The procedure is not part of this study
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Orthopedic clinic, those with a diagnosis of hip or knee osteoarthritis, scheduled for an
        Autologous Bone Marrow injection
      
Keywords: Osteoarthritis; Stem Cell Injections; Bone Marrow; Autologous
Arginine as an Adjuvant Treatment Against Tuberculosis
Condition: Tuberculosis; HIV
MeSH terms: Tuberculosis
Study type: Interventional

Summary: 
      The purpose of this study was to investigate if adjuvant treatment with arginine (the
      substrate for nitric oxide production) rich food supplements could improve clinical outcome
      in patients with smear positive tuberculosis by affecting nitric oxide production.
    

Detailed description: 
      Tuberculosis (TB) is disease of increased global public health importance. Because of
      emerging multi drug resistance and the long treatment duration there is a need to optimize
      the current chemotherapy. Host immunity is important in determining the susceptibility and
      outcome of disease as could be exemplified by co infection with HIV which dramatically
      increases the risk to develop TB.

      Previous results from our group and others show that nitric oxide produced by activated
      macrophages from arginine might be important to control the disease. However, the relative
      importance of nitric oxide in human TB has been debated. In a previous study in Gondar,
      Ethiopia, we observed an effect of adjuvant treatment with arginine capsules on sputum smear
      conversion and reduction of cough. In this study we wanted to test the hypothesis based on
      previous observations that an arginine rich food supplementation might enhance clinical
      improvement in patients with smear positive tuberculosis and if this effect could be due to
      increased nitric oxide production.
    

Intervention name(s): Peanuts; Daboqolo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 30g of peanuts daily for 4 weeks (directly observed). This dose of peanuts is equivalent to 1 gram of arginine.; 30g of Daboqolo per os daily for 4 weeks (given supervised). 30g of Daboqolo is equivalent to 0.1 g of arginine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: Arginine; Nitric oxide; Peanuts; Sedimentation rate
A Trial to Determine the Safety, Pharmacokinetics, and Efficacy of OPC-108459 Administered as a Single Intravenous Dose to Patients With Paroxysmal or Persistent Atrial Fibrillation (AF)
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the safety, pharmacokinetics, and efficacy following 30-minute continuous
      intravenous administration of OPC-108459 at 0.4, 0.8, 1.6, or 2.4 mg/kg or placebo to
      patients with paroxysmal or persistent atrial fibrillation
    


Intervention name(s): OPC-108459; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Fludrocortisone in Healthy Volunteers (AFLUCO4)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 2

Summary: 
      Fludrocortisone, in association with hydrocortisone, has demonstrated an improvement in
      survival in septic shock patients with relative adrenal insufficiency. However, the utility
      of low doses of steroids and in particular of mineralocorticoids in septic shock is still
      discussed.

      The purpose of the investigators study is to investigate the effects of 3 increasing doses of
      fludrocortisone (100 μg, 200 μg, 400 μg) in order to determine which dose allows the best
      pressor response to phenylephrine in healthy volunteers, and simultaneously assess their
      respective hemodynamic and biological effects.
    

Detailed description: 
      In a previous study (AFLUCO2) in healthy volunteers with saline-induced hypoaldosteronism,
      the investigators found that single doses of both hydrocortisone and fludrocortisone induced
      a significant decrease in the pressor response to phenylephrine, probably due to a rapid
      non-genomic vasodilatory mechanism, and that these effects were additive.

      The investigators also showed that, at the doses used in septic shock, hydrocortisone induced
      more pronounced mineralocorticoid effects than fludrocortisone and also induced systemic
      hemodynamic effects whereas fludrocortisone did not.

      The investigators now want to perform a dose-response study under normal conditions (ie
      without saline-induced hypoaldosteronism) and after repeated administrations, to determine
      the optimal dose of fludrocortisone that allows an increase in the pressor response to
      phenylephrine and to characterize its concomitant hemodynamic and biological effects.

      This placebo-controlled, randomized, double-blind, cross-over, 4-periods (fludrocortisone 100
      μg/day, 200 μg/day, 400 μg/day, or placebo) study aims to investigate hemodynamic and
      biological effects of fludrocortisone administered orally during 5 days, in healthy
      volunteers.

      Each period will be separated from the next one by a washout interval of at least 14 days.
    

Intervention name(s): Fludrocortisone 100 μg; Fludrocortisone 200 μg; Fludrocortisone 400 μg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Fludrocortisone 100 μg/day; Fludrocortisone 200 μg/day; Fludrocortisone 400 μg/day
Intervention MeSH terms: Fludrocortisone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Fludrocortisone; Mineralocorticoids; Hemodynamics; Pharmacokinetics