bioihbjkbjnl/mcl2 huggingface dataset:
PEEK Versus Silicon Interspinous Spacer for Reduction of Supradjacent Segment Degeneration
Condition: Adjacent Segment Degeneration
Study type: Interventional

Summary: 
      A retrospective study that aims to report Adjacent Segment Degeneration (ASD) incidence and
      spinopelvic balance in short lumbosacral instrumentation for degenerative lumbar spinal
      stenosis. Although ASD is a common complication following lumbar fusion, the effect of an
      Interspinous Spacer (IS) in the supradjacent segment in short lumbosacral instrumented fusion
      and its interaction with spinopelvic balance has not been studied adequately.
    

Detailed description: 
      Methods From 55 consecutive age-, diagnosis- and gender- matched patients aged 60±11 years,
      17 (Group R) received PEEK IS; 18 (Group S) received Silicon IS and compared with 20 controls
      (Group C) without receiving any IS. The functional outcome was evaluated with VAS and ODI.
      Spinopelvic balance was evaluated using SVA, T12-S1 LL, SS, PT, PI and supradjacent segment
      disc heights. All spines were preoperatively balanced.
    

Intervention name(s): PEEK interspinous spacer
Intervention type(s): Procedure
Intervention description(s): To study the Adjacent Segment Degeneration incidence in the supradjacent segment following short lumbar fusion between PEEK and Silicon Interspinous spacers.
Other intervention name(s): Silicon interspinous spacer
Intervention MeSH terms: Silicon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: spinopelvic alignment; short lumbosacral instrumentation; PEEK; silicon spacer
A Study to Investigate the Pharmacokinetics, Safety and Tolerability of CHF 5993 pMDI in Subjects With Renal Impairment.
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is performed to characterize the pharmacokinetics of glycopyrrolate bromide after
      single administration of CHF 5993 pressurised Metered Dose Inhaler (pMDI) in subjects with
      different level of renal impairment in comparison with matching healthy volunteers. Moreover,
      the safety and tolerability of the study drug will be also evaluated.
    


Intervention name(s): Beclometasone/Formoterol/Glycopyrrolate
Intervention type(s): Drug
Other intervention name(s): CHF 5993 pMDI
Intervention MeSH terms: Beclomethasone; Glycopyrrolate; Formoterol Fumarate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase I Trial of S-1153 in Patients With HIV Infection
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the toxicity profile and determine the maximum tolerated dose (MTD), if possible,
      of S-1153 administered orally 3 times daily for 14 days. To investigate the clinical
      pharmacokinetic parameters for S-1153. To assess anti-HIV activity associated with S-1153
      administration through evaluation of CD4 and viral load measurements.
    

Detailed description: 
      Two separate schedules of S-1153 are administered on this study: single dose (2 dose
      levels/cohorts) and repeated dose administration over 14 days (escalation through 4 dose
      levels/cohorts). All doses are determined by body weight.

      Single-dose study (Cohort 1):

      (4 patients) low-dose po, following a standardized morning meal. (4 patients) low-dose po,
      fasting.

      Single-dose study (Cohort 2), administered during the first 3 levels of the repeated dose
      study and prior to the initiation of the 4th repeated dose level:

      (4 patients): intermediate-dose po, following a standardized morning meal. (4 patients):
      intermediate-dose po, fasted. Following treatment with S-1153, all single-dose patients
      (Cohorts 1and 2) are observed for 21 days.

      Repeated dose (escalation) study:

      All doses are administered for 14 days. Three patients are entered at the starting dose of
      S-1153. In the absence of dose-limiting toxicity (DLT), subsequent 3-patient cohorts are
      entered at 3 escalating doses.

      The last patient at any given dose level must be observed for 21 days prior to entry of
      patient at the next dose. If 1 of the initial 3 patients experiences DLT at a given level, 3
      additional patients will be added at that dose; if no additional toxicity occurs, escalation
      resumes. If 2 or more patients at a given dose exhibit DLT, the previous dose is declared the
      maximum tolerated dose (MTD) and 3 additional patients (6 total) are treated at that dose.
    

Intervention name(s): Capravirine
Intervention type(s): Drug
Intervention MeSH terms: Capravirine
Primary purpose: Treatment
Keywords: Dose-Response Relationship, Drug; Reverse Transcriptase Inhibitors
The Effect of Remote Postconditioning on Graft Function in Patients Undergoing Living-related Kidney Transplantation
Condition: Kidney Transplantation; Ischemic Reperfusion Injury; Remote Ischemic Postconditioning
MeSH terms: Reperfusion Injury; Ischemia
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether upper limb ischemic postconditioning can
      improve renal function and decrease ischemic-reperfusion injury in patients undergoing living
      donor kidney transplantation.
    

Detailed description: 
      Ischemic reperfusion injury after kidney transplantation is a common clinical problem
      associated with a high morbidity and mortality. To reduce the adverse effect of ischemic
      reperfusion injury after organ transplantation, various strategies including ischemic
      preconditioning or postconditioning. Remote ischemic postconditioning is one of such
      strategies where brief ischemic reperfusion injury of one organ protects other organs from
      sustained ischemic reperfusion injury. Remote ischemic postconditioning of the limb with a
      tourniquet is a safe and convenient method of postconditioning organs against ischemic
      reperfusion injury. However, the efficacy of remote ischemic postconditioning in patients
      undergoing living donor kidney transplantation needs to be established. Therefore, we
      investigate the efficacy of remote ischemic postconditioning of the upper limb with a
      tourniquet in recipients of kidney transplantation by measuring the markers of acute kidney
      injury.
    

Intervention name(s): remote ischemic postconditioning
Intervention type(s): Device
Intervention description(s): Remote ischemic postconditioning consists of three 5-min cycles of upper limb ischemia, which was induced by an automated cuff-inflator placed on the upper limb free of arteriovenous fistula and inflated to 250 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis
Condition: Non-Alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of
      EDP-305 in subjects with Non-Alcoholic Steatohepatitis
    


Intervention name(s): EDP-305 Dose 1; EDP-305 Dose 2; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Two tablets daily for 12 weeks; Two tablets daily for 12 weeks; Two tablets daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: NASH; Non-Alcoholic Steatohepatitis (NASH)
Treatment of Depression in Parkinson's Disease Trial
Condition: Parkinson Disease; Depression
MeSH terms: Parkinson Disease; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to evaluate the effectiveness and safety of two
      antidepressants--nortriptyline and paroxetine, compared to placebo in patients with
      Parkinson's disease and depression.
    

Detailed description: 
      Depression is the most common neuropsychiatric disorder found in patients with Parkinson's
      disease (PD). It causes immense personal suffering and is associated with increased
      disability and caregiver burden.

      Despite the adverse consequences of depression in patients with PD, there are virtually no
      empirical data to guide clinical treatment. This study will begin to answer some questions on
      the treatment of depression by testing a SSRI (selective serotonin reuptake inhibitor)
      antidepressant, paroxetine, a tricyclic antidepressant, nortriptyline, and placebo in a
      placebo-controlled trial.

      A total of 75 patients with PD will be randomized to each of the three arms in a balanced
      design.
    

Intervention name(s): paroxetine; Nortriptyline; placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Paroxetine CR 12.5 - 25 mg q hs; nortriptyline 25 - 75 mg q hs; matching placebo
Other intervention name(s): Paxil CR; Pamelor
Intervention MeSH terms: Paroxetine; Nortriptyline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease; Parkinson disease; depression; antidepressants; nortriptyline; paroxetine
PinPointe FootLaser for the Treatment of Onychomycosis
Condition: Infected Toenails; Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To evaluate the safety and efficacy of the PathoLase FootLaser treatment of infected
      toenails.
    

Detailed description: 
      The study is a multi-center controlled study evaluating laser treatments of infected great
      toes in a randomized blinded study of approximately 125 subjects. Right and left great toes
      are randomized to treatment or no treatment. Samples from infected areas are sampled and
      evaluated for presence of fungus with KOH, PCR and culture tests. Nail bed clearing and nail
      plate growth are measured from high resolution photographs by a blinded evaluator. Subjects
      will be evaluated at baseline and at 8, 16, 24 and 48 weeks for safety and effectiveness of
      study treatment.
    

Intervention name(s): PinPointe FootLaser
Intervention type(s): Device
Intervention description(s): Medical laser
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Toenail Fungus; PinPointe; FootLaser; Onychomycosis; Fungal nails
Evaluating Fluid Strategies in Thoracic Surgery Patients Utilizing a Goal Directed Approach
Condition: Hypotension; Kidney Injury
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to conduct a prospective, randomized, controlled trial comparing
      a restrictive vs. conservative fluid strategy in thoracic surgery patients. Excessive
      perioperative fluid has been retrospectively implicated in the development postoperative
      acute lung injury (PALI) and pulmonary edema following lung resection. However, fluid
      restriction in these patients is not without risk and may compromise end organ perfusion
      (i.e. acute kidney injury). The hypothesis is that a conservative fluid approach in thoracic
      surgery patients will result in better end organ perfusion with fewer occasions of acute
      kidney injury (AKI) without causing an increase in postoperative acute lung injury or
      pulmonary edema.
    


Intervention name(s): Plasmalyte 3ml/kg/hr group; Plasmalyte 6ml/kg/hr group
Intervention type(s): Drug; Drug
Intervention description(s): This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them; This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
Intervention MeSH terms: Plasma-lyte 148
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypotension; Kidney injury
Regional Anesthesia
Condition: Anesthetic Regional Techniques for Vaginal Surgeries
Study type: Observational [Patient Registry]

Summary: 
      Both techniques are efficacious for sacral anesthesia during vaginal surgeries. Dural
      puncture epidural technique allows partial confirmation of epidural catheter placement.
    


Intervention name(s): Whitacre spinal needle
Intervention type(s): Device
Intervention description(s): 25G Whitacre spinal needle
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        adult female Egyptian patients
A Study to Evaluate the Effect of Fimasartan on Pharmacokinetics, and the Safety of Digoxin in Healthy Male Volunteers
Condition: Essential Hypertension
MeSH terms: Essential Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of fimasartan on pharmacokinetics, and
      the safety of digoxin.
    


Intervention name(s): Digoxin + Fimasartan
Intervention type(s): Drug
Intervention description(s): Digoxin (7 days), Digoxin + Fimasartan (7 days)
Intervention MeSH terms: Digoxin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Fimasartan; Drug interaction
Effect of LY2189265 on Insulin Secretion in Response to Intravenous Glucose
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure the effect of LY2189265 to increase insulin levels in
      response to glucose intake.
    


Intervention name(s): LY2189265; Placebo; Insulin; Glucose; Glucagon
Intervention type(s): Biological; Drug; Drug; Drug; Drug
Intervention description(s): Administered subcutaneously; Administered subcutaneously; Administered intravenously; Administered intravenously; Administered intravenously
Other intervention name(s): Dulaglutide; Lispro; Dextrose; Glucagon hydrochloride
Intervention MeSH terms: Dulaglutide; Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
PK Linearity and Steady State PK of CHF 6532 in Healthy Subjects
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical pharmacology study is to evaluate the CHF 6532 linearity after
      single oral administrations of four doses of a tablet formulation and to evaluate the
      pharmacokinetic (PK) at steady state following the repeated open label b.i.d. administration
      at one dose.
    

Detailed description: 
      The study consists in two parts. The first study part (Part I) is a single dose, randomised,
      double-blind, placebo-controlled, 5-way, 5-period crossover design, in healthy subjects.

      The second study part (Part II) is a repeated dose, open label treatment in healthy subjects.

      The PK of CHF 6532 and CHF 6532 acyl glucuronide metabolite (CHF 6532-AG), the cardiac safety
      will be assessed after single or repeated administration of CHF 6532 tablet formulations in
      healthy subjects under fed conditions.

      A total of 30 healthy male and female are planned to be included where they will participate
      the 2 study parts.

      Standard safety assessments will be conducted during the Study, including safety blood and
      urine laboratory tests, vital signs, physical examinations, ECGs and observations of any
      adverse events. Blood and urines samples will be also collected for PK analysis. Holter
      recordings will be performed to build a prospective concentration-response model of QTc for
      CHF 6532 in Part I and for cardiac safety purpose at steady state in Part II.
    

Intervention name(s): Treatment A; Treatment B; Treatment C; Treatment D; Treatment E; Treatment F
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): tablet of CHF 6532; tablet of CHF 6532; tablet of CHF 6532; tablet of CHF 6532; Placebo tablet of CHF 6532; tablet of CHF 6532
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Part I: 5-way, 5-period crossover Part II: single group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
An Objective Measurement Method With The Leap Motion Sensor For Hand And Wrist's Range Of Motion
Condition: Range of Motion
Study type: Interventional

Summary: 
      The aim of the study was to develop a low cost, clinically easy to use measurement method
      with the Leap motion sensor for objectively evaluating range of motion (ROM), and to
      investigate the validity and reliability of this application.
    

Detailed description: 
      . Wrist flexion / extension, radial / ulnar deviation, supination / pronation, 1.-5. of the
      fingers DIP, PIP and MCP flexion / extension ROM measurements will be made with universal
      goniometer and developed Leap motion sensor (LMC) based measurement method.

      The study consists of two basic steps:

        1. Development of measurement method with LMC Identification of normROM measurement
           procedure Identification of ROM measurement reporting Establishing the precursor version
           of the software of the measurement method Checking ROM measurement performance criteria
           and providing feedback Measuring the movement defined on 5 persons and providing
           feedback Creation of the last available version of the measurement method

        2. Validity and reliability study Measurements of hand and wrist ROM with developed
           measurement method with LMC and universal goniometer for three times and calculation
           mean of three measurement for two methods
    

Intervention name(s): Assessment of Range of Motion with Leap Motion sensor
Intervention type(s): Device
Intervention description(s): An ROM measurement method called as HandROM by us will be developed with leap motion sensor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Range of motion; Wrist; Hand; Finger; Measurement
The German Keratoplasty Registry of the German Ophthalmological Society (DOG)
Condition: Corneal Transplantation
Study type: Observational [Patient Registry]

Summary: 
      Aim of this study is to reflect on the changing trends in absolute numbers, surgical
      techniques and indications of corneal transplantations being performed in Germany.

      In 2017, the Section Cornea of the German Ophthalmological Society provides an
      interim-assessment about the most up-to-date results of this long-term study over a period of
      sixteen years between 2001 and 2016.
    


Intervention name(s): Corneal transplantation
Intervention type(s): Procedure
Intervention description(s): PKP: Penetrating Keratoplasty DALK: Deep Anterior Lamellar Keratoplasty DMEK: Descemet Membrane Endothelial Keratoplasty DSAEK: Descemet's Stripping Automated Endothelial Keratoplasty
Other intervention name(s): PKP, DALK, DMEK, DSAEK
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        All patients in Germany treated with the different types of corneal transplantation from
        2001 to 2016.
      
Keywords: Keratoplasty Registry, PKP, DSAEK, DMEK, DALK
Dietary Correlates of the Maximal Capacity for Fat Oxidation
Condition: Maximal Rate of Fat Oxidation
Study type: Observational

Summary: 
      There is a large variability in people's ability to burn fat during exercise. It is thought
      that differences in dietary intake can partly explain this variation, however this has not
      been comprehensively studied. This will be investigated by measuring participant's habitual
      diet and rates of fat oxidation during exercise, and look for associations between the two.
    

Detailed description: 
      The capacity to oxidize (burn) fat as fuel for exercise may have important implications for
      health and performance. For example, increased fat oxidation could help to induce a negative
      fat balance and over time improve body composition. Furthermore, increasing the oxidation of
      fat could spare carbohydrate utilization during exercise which should improve endurance
      performance by preserving the bodies limited carbohydrate reserves for the latter stages of
      competition. Interestingly, there is substantial individual variation in the balance of fuels
      used for energy during exercise and in particular the maximal capacity to oxidize fat (MFO).
      Whilst habitual diet is known to affect the metabolic response to exercise, the influence of
      nutrition on the individual variability observed in maximal fat oxidation has not been
      comprehensively studied.

      Therefore, the proposed investigation aims to build on current understanding of how various
      nutritional factors influence MFO during exercise. Based on previous small intervention
      studies, it is suspected that energy balance and macronutrient content or distribution may
      exert the strongest influence on MFO during exercise. Specifically, the main hypothesis would
      be that negative energy balance; higher fat intake and/or low carbohydrate intake would be
      the strongest positive influencer's of MFO. Nonetheless, the determination of an array of
      habitual and acute nutrient intake data in a relatively large cohort of healthy individuals
      will enable an insight into the influence of a comprehensive array of nutrients on MFO during
      exercise. With a greater understanding of the nutritional factors that influence MFO during
      exercise, new nutritional interventions can be designed to promote the oxidation of fat for
      improved health and performance.
    

Intervention name(s): No intervention
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Local healthy population
      
Keywords: Maximal Rate of Fat Oxidation; Substrate Oxidation; Fat oxidation; Respiratory Exchange Ratio (RER); Exercise; indirect calorimetry; substrate crossover