bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess the Stability, Efficacy and Safety of the Silent™ Hip Prosthesis in Primary Total Hip Replacement
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to determine if the Silent™ hip, when used as part of an
      artificial hip joint, is stable and effective in treatment of patients with joint disease
      requiring a total hip replacement. Patients who enter the study will be evaluated at regular
      intervals following hip surgery using patient, clinical, standard and special x-rays (RSA) to
      allow the position of the Silent Hip within the bone to be accurately monitored.
    

Detailed description: 
      The Primary Objective of this study was to evaluate the short-term stability of the Silent
      Hip, implanted using a manual or navigated technique, using radiostereometric analysis (RSA).
      The study was also intended to provide the clinical data necessary to demonstrate conformance
      with the essential requirements of the Medical Device Directive. Secondary objectives were to
      determine the efficacy of the Silent™ Hip femoral prosthesis from a clinical and radiological
      prospective, to assess the safety of the device and to evaluate the impact of the procedure
      on the Subjects' Quality of Life.
    

Intervention name(s): DePuy Silent™ Hip femoral prosthesis
Intervention type(s): Device
Intervention description(s): A short cementless, femoral component for use in total hip arthroplasty
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hip; Cementless; Conservative
A Study of LY2979165 and LY2140023 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be comprised of 2 parts, Part A and Part B, both in healthy male
      participants.

      Part A of the study will investigate the safety of intravenous (IV) ketamine administration
      after single oral doses of LY2979165 (capsules) or LY2140023 (tablets). Part A will be
      completed before starting Part B.

      Part B of this study will investigate whether different dose levels of LY2979165 or
      LY2140023, when administered before ketamine, result in changes to the images on a brain scan
      seen with ketamine alone. Brain imaging is currently used for a number of reasons including
      understanding where in the brain medicines have their effects. Ketamine is an anesthetic used
      in this study to activate particular regions of the brain.

      The single oral doses of LY2979165 to be used in both parts of the study are 20 and 60 mg
      with matching dummy drug (placebo) for each dose.

      The doses for LY2140023 are 10, 40, and 160 mg with matching placebo for each dose.

      Screening is required within 28 days prior to the start of the study and follow up 7-14 days
      after the last dose of study drug. The study will last up to 8-weeks for an individual
      participant.
    


Intervention name(s): LY2979165; LY2140023; Placebo; Ketamine
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): Capsules administered orally; Tablets administered orally; Administered orally; Administered intravenously (IV)
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Immediate Treatment Outcomes of b-CPAP vs Oxygen Therapy in Preterm Babies Presenting With RDS at KCMC
Condition: Respiratory Distress Syndrome in Premature Infant
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome
Study type: Interventional

Summary: 
      Bubble - Continuous positive airway pressure (CPAP) has been reported to be effective,
      cheaper, simpler and more accessible compared to mechanical ventilator and surfactant
      treatment for preterms with respiratory distress syndrome in the neighbouring countries. This
      study aims to implement and determine the effectiveness of bCPAP and its immediate outcomes
      compared to oxygen therapy in preterm babies presenting with respiratory distress syndrome
      (RDS).
    

Detailed description: 
      Effective treatment of preterm babies with RDS requires exogenous surfactant and/or
      mechanical ventilation but these are of limited availability in developing countries.

      bCPAP is generated by exhalation against a constant opening pressure that produces positive
      end-expiratory pressure. This in-turn helps in maintaining lung volume at the end of
      expiration, preventing atelectasis, improving oxygenation, reducing respiratory fatigue and
      eventually preventing respiratory failure. bCPAP (Rice 360◦c low cost bCPAP device)
      consisting of 3 components: : (i)An air compressor connected to an oxygen concentrator with a
      gas flow fate of 3-4 L/min; (ii) A nasal interface (short nasal prongs) connecting the baby's
      airway to a two limb circuit i.e the inspiratory limb connected to the bCPAP machine and the
      expiratory limb connected to the water bottle and; (iii) An expiratory limb with the distal
      end submerged 6 cm in water to generate an end expiratory pressure

      At the neonatal unit at Kilimanjaro Christian Medical Center (KCMC), the standard of care for
      Preterm babies with RDS is receiving oxygen therapy via nasal prongs from oxygen cylinders.
    

Intervention name(s): bCPAP Arm; Oxygen Arm
Intervention type(s): Device; Other
Intervention description(s): bCPAP (Rice 360◦c low cost bCPAP device); Oxygen therapy from oxygen cylinders
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a multi-center, randomized, double-blind Phase III clinical trial. The aim of
      the study is to describe the immunogenicity and safety of the quadrivalent cell
      culture-derived influenza vaccine compared to the trivalent egg-derived influenza vaccine
      among subjects.
    

Detailed description: 
      Subjects are randomly assigned in a 4:1 ratio to NBP607-QIV versus Agrippal S1. To assess the
      immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from
      sera obtained at pre-vaccination and 28 days post-vaccination. To assess the safety,
      solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28
      days post-vaccination are assessed and reported. The serious adverse events are collected
      during 6 months post-vaccination.
    

Intervention name(s): NBP607-QIV; Agrippal S1
Intervention type(s): Biological; Biological
Intervention description(s): For subjects 6 months to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 18 years of age, single intramuscular dose (0.25mL/0.5 mL); For subjects 6 months to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 18 years of age, single intramuscular dose (0.25mL/0.5 mL)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Evaluation of Efficacy of Cryotherapy for Skin Anesthesia During Arterial Puncture
Condition: Cryotherapy Effect
Study type: Interventional

Summary: 
      the purpose of this study is to evaluate the cryotherapy effect by vapocoolant spray to
      reducing pain during puncture for artérial blood gas
    

Detailed description: 
      Blood gas analysis by arterial puncture is the Gold Standard in the assessment of a patient's
      acidbase status and oxygenation. This procedure, which can be repeated depending on the
      clinical condition of patient, is however associated with a potentially painful experience
      for patients.

      The known anesthetic properties of cold can be an interesting alternative to evaluate in the
      reduction of pain induced during arterial puncture for gas analysis in critically il
      patients.
    

Intervention name(s): Cryotherapy
Intervention type(s): Device
Intervention description(s): patients recieving cryotherapy for skin anesthesia for artérial blood gas
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cryotherapy; vapocoolant spray; arterial puncture; intensive care unit
EU Post Market Clinical Follow-Up Study of the Venclose System for Saphenous Vein Incompetence
Condition: Chronic Venous Insufficiency
MeSH terms: Venous Insufficiency
Study type: Interventional

Summary: 
      This is a prospective, non-randomized study in which patients who meet eligibility criteria
      and consent to participate will undergo a minimally invasive procedure using radiofrequency
      (RF) energy for ablation of the great saphenous vein (GSV).
    

Detailed description: 
      Subjects who meet eligibility criteria will undergo a procedure using the Venclose
      Radiofrequency (RF) System to treat the great saphenous vein.

      The technique involves percutaneous access and insertion of the endovenous sectional
      radiofrequency (EVSRF™) catheter into the target vein under ultrasound guidance and relies on
      the use of local anesthesia and thermal energy, from a radiofrequency generator, applied to
      the target vein. After each treatment, the EVSRF™ catheter is withdrawn a single length of
      the heating coil and another treatment is performed, until the entire vessel has been
      treated.

      After the treatment procedure, subjects will be evaluated four (4) times to assess vein
      recanalization and reflux, and to determine the incidence of adverse events.
    

Intervention name(s): Venclose RF System
Intervention type(s): Device
Intervention description(s): Treatment of great saphenous vein (GSV) using Venclose RF System
Other intervention name(s): RF ablation, EVSRF
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GSV; superficial vein reflux; venous reflux; venous insufficiency; varicose veins
White Adipose Tissue Clocks and High Calorie Feeding
Condition: Healthy
Study type: Interventional

Summary: 
      Peripheral tissues (e.g. liver, adipose, muscle) express self-sustained circadian clocks that
      coordinate daily metabolic rhythms. The timing of clock rhythms in peripheral tissues is
      highly sensitive to feeding-fasting signals across the sleep-wake transition. Nutritional
      insults such as high fat overfeeding (HF-OF) have been shown to attenuate clock gene
      expression in peripheral tissues resulting in a deleterious re-programming of the circadian
      metabolome. Studies in humans have only superficially investigated how the circadian clock
      machinery is impacted by nutritional signals. The overall goal of this pilot project is to
      take the first steps toward developing translational methods to investigate links between
      changes in energy flux and the circadian system in human tissues. Using an innovative ex vivo
      cell culture approach the investigators will examine the impact of 3-days of HF-OF compared
      to eucaloric (EU) feeding on the expression of core clock genes in human subcutaneous adipose
      tissue (SAT). The Investigators hypothesize that compared to EU, the amplitude of clock gene
      expression in SAT measured over 24hrs will be attenuated following short-term HF-OF. This
      pilot project will serve as a launch point for designing future studies into the effects of
      diet and exercise on the circadian control of metabolism in adipose tissue depots as well as
      other tissues (e.g. muscle).
    


Intervention name(s): Eucaloric feeding; Overfeeding
Intervention type(s): Other; Other
Intervention description(s): 3 days of a diet designed to maintain energy balance; 3 days of a diet designed to induce a 40% positive energy balance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Volunteers
Study of the Pathogenesis of Rett Syndrome
Condition: Rett Syndrome
MeSH terms: Rett Syndrome; Syndrome
Study type: Interventional

Summary: 
      OBJECTIVES: I. Extend current knowledge of the phenotype and natural history of Rett syndrome
      (RS).

      II. Continue the search for a cytogenetic and/or DNA marker. III. Study the effects of
      cholinergic drugs based on preliminary evidence for reduced levels of brain acetylcholine,
      while continuing supportive care to modify seizures, respiratory abnormalities, and motor
      disturbances, and improve nutrition, behavior, and learning.

      IV. Identify targets for future therapeutic interventions, e.g., growth factors, to influence
      neurologic recovery.
    

Detailed description: 
      PROTOCOL OUTLINE: Patients receive a comprehensive clinical evaluation including an
      ophthalmologic exam; speech, communication, and developmental assessment; nutritional
      evaluation; neurologic exam; respiratory monitoring; and cytogenetic studies.

      Selected patients with malnutrition are given night feedings of Pediasure with Fiber by
      nasogastric tube. Specific recommendations for feeding techniques and diet are made.

      Selected patients with seizures or severe hyperventilation and progressive rigidity are
      nonrandomly assigned to dextromethorphan or topiramate therapy.

      Oral dextromethorphan is maintained 6 months to 1 year; duration of therapy depends on
      response. Oral topiramate is given for 6 months to 1 year, and Aricept for 6 months to 1
      year.

      Concurrent anticonvulsants may require dose adjustments while on above protocols. Supportive
      care for constipation, scoliosis, and weight loss is allowed.
    

Intervention name(s): dextromethorphan; topiramate; Donepezil
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Topiramate; Dextromethorphan; Donepezil
Primary purpose: Treatment
Keywords: Rett syndrome; neurologic and psychiatric disorders; rare disease
A Prospective Pharmacodynamic Study of Dabigatran
Condition: Blood Coagulation Tests
Study type: Observational

Summary: 
      The ability to explain bleeding or clotting complications in patients treated with dabigatran
      remains challenging. In addition, there is limited data on how coagulation tests perform in
      patients treated with therapeutic doses of dabigatran. Predicted responses of coagulation
      tests to therapeutic doses of dabigatran may be helpful in better understanding abnormal
      responses to dabigatran. The purpose of the study is to define a therapeutic reference range
      for peak and trough coagulation tests in patients taking FDA approved doses of dabigatran and
      to determine which tests may be most clinically useful for monitoring dabigatran.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients taking FDA-approved doses of dabigatran and control subjects not taking an
        anticoagulant or antiplatelet were eligible for inclusion.
      
Biospecimen description: 
      Blood plasma
Phase II Efficacy Study Looking at a Single-dose of One of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an exploratory, 4 arm, parallel group, placebo-controlled study comparing three doses
      of AIN457 to placebo. Subjects with a diagnosis of moderate to severe chronic plaque
      psoriasis will be randomized to receive either AIN457 at one of the three doses studied or
      placebo.
    


Intervention name(s): AIN457; Placebo
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Plaque psoriasis, skin condition, thickening, flaking, skin disease, autoimmune disease
Effect of Anesthetic Method on Optic Nerve Sheath Diameter in Patients Undergoing RALP
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the effect of anesthetic method on the optic nerve
      sheath diameter in patients undergoing robot-assisted laparoscopic prostatectomy.
    

Detailed description: 
      The purpose of this study was to evaluate the difference between the optic nerve sheath
      diameter measured during anesthesia with sevoflurane-remifentanil-dexmedetomidine and the
      optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil in
      patients undergoing robot-assisted laparoscopic prostatectomy.
    

Intervention name(s): Dexmedetomidine; Without dexmedetomidine
Intervention type(s): Drug; Other
Intervention description(s): Anesthesia with sevoflurane-remifentanil-dexmedetomidine; Anesthesia with sevoflurane-remifentanil
Other intervention name(s): With Dexmedetomidine; With normal saline
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Lundbeck TOMs Orthostatic Hypotension
Condition: Orthostatic Hypotension; Idiopathic Parkinson Disease
MeSH terms: Parkinson Disease; Hypotension, Orthostatic; Hypotension
Study type: Interventional
Phase: Phase 4

Summary: 
      Orthostatic hypotension (OH), which consists in a significant reduction in blood pressure
      levels upon standing from a seated position, may affect approximately one in three patients
      with Parkinson's disease (PD). It usually presents as dizziness, lightheadedness, feeling
      faint, or feeling like you might black out while standing. This can significantly impact the
      quality of life (QoL) of PD patients, resulting in difficulties with balance, walking, and
      increased risk of falls. The main aim of this study is to evaluate whether the use of
      technological devices (a computerized system for analyzing abnormalities in walking in
      clinical settings and a wearable sensor to detect changes in postural unsteadiness in the
      home environment) may improve the detection of complications and the response to medical
      therapies for OH in patients with PD.
    


Intervention name(s): Droxidopa 100 MG [Northera]
Intervention type(s): Drug
Intervention description(s): droxidopa taken three times a day titrated up to a maximum of 600 mg.
Intervention MeSH terms: Droxidopa
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Supplementation of Dual Probiotic Strains Reduced Fasting Triglyceride and Enhanced Apolipoprotein A-V Levels
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effect of dual probiotic strains containing
      Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032 on triglyceride and
      apolipoprotein A-V.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled study was conducted on 128 nondiabetic and
      hypertriglyceridemic (Plasma Triglyceride, 150-500 mg/dL) subjects. Over a 12 week test
      period, the probiotic group consumed 2g of powder daily containing dual probiotic strains,
      while the placebo group consumed the same without probiotics.
    

Intervention name(s): dual probiotics; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032); 2g of powder daily without probiotics
Other intervention name(s): probiotic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Apolipoprotein A-V; LDL particle size; probiotic; triglyceride
Treatment of Type 2 Diabetes With Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid and Metformin 1000 mg Bid
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      A phase III randomised, double-blind parallel group extension study to investigate the
      efficacy and safety of twice daily administration of the free combination of linagliptin 2.5
      mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with
      metformin 1000 mg twice daily over 54 weeks in type 2 diabetic patients previously completing
      the double-blind part of study 1218.46
    


Intervention name(s): Linagliptin + metformin; Linagliptin+metformin; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Linagliptin tablet low dose + metformin tablet 500 mg bid; Linagliptin low dose tablet + metformin 1000 mg tablet bid; Metformin 1000 mg tablet bid
Intervention MeSH terms: Metformin; Linagliptin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment