bioihbjkbjnl/mcl2 huggingface dataset:
PhosphoRus, Proton Imaging and Amyloid BuRdEn (PREPARE) ON AMYLOID BURDEN AND COGNITION
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Observational

Summary: 
      Normal cells primarily produce energy with the help of the "mitochondria". These "small
      organs" are also called the "powerhouses of the cell" turn the sugars, fats and proteins that
      is eaten into forms of chemical energy that the body can use to carry on living. This process
      is called oxidative phosphorylation. In addition to the help from the mitochondria and
      oxidative phosphorylation, most cells can produce energy by lactic acid fermentation. This
      process is less energy efficient but faster and used by the brain, muscle or other organs
      under specific circumstances and energy demands, even in the presence of abundant oxygen. It
      is also called aerobic glycolysis. Aerobic glycolysis and oxidative phosphorylation are the
      two major mechanisms involved in brain energetics.
    

Detailed description: 
      The consequences of Alzheimer's disease (AD) (deposition of amyloid plaques and
      neurofibrillary tangles) are known. The cause of these deposition of proteins is not. Some
      scientist argue that an increase in oxidative phosphorylation activity and a lack of ability
      to shift to aerobic glycolysis are the underlying source of these changes. The purpose of
      this study is to test whether there is a correlation between neuroenergetic levels of aerobic
      glycolysis/oxidative phosphorylation and risk for Alzheimer's disease. The study will examine
      these neuroenergetic adaptations in a group of 15 elderly participants (age range: 70-85 y/o)
      with amnestic mild cognitive impairment (aMCI) and 30 cognitively normal controls (NL).
      Multimodal (MR/PET) and multinuclear (31P/1H) neuroimaging will allow us to gain access to a
      uniquely comprehensive and highly consistent view of neuroenergetic adaptations in both the
      clinical and preclinical stages of Alzheimer's disease.
    

Intervention name(s): Measure of OxPhos upregulation; lactate (measured with 1H-MRSI)
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): OxPhos upregulation [i.e., lower phosphocreatine (PCr)-to-ATP ratio levels] in the PET AG mask. PIB+ NL subjects will show OxPhos downregulation (i.e. increased PCr/ATP ratio that indicate the presence of metabolically inert PCr that cannot be used as ATP) when compared to PIB- NL subjects in the PETAG mask; PIB+ NL subjects will show increased levels of lactate (measured with 1H-MRSI) when compared to PIB- NL subjects in the PETAG mask.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults (male and female) aged >70 years in overall excellent health with normal cognition
        (CDR=0), and at least high school graduate level education.
Motion Capture Analysis of Sacroiliac Joint Motion After Manipulation
Condition: Sacroiliac Joint Pain
MeSH terms: Arthralgia
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of manipulation on sacroiliac joint
      motion using a Polhemus motion capture system.
    

Detailed description: 
      The Sacroiliac (SI) joint is a diarthrodial joint with the contradictory biomechanical
      function of transmitting compressive loads from the lumbar spine to the lower extremity while
      maintaining a nutating motion in the pelvis.

      Recent studies identify the Sacroiliac (SI) joints as a significant source of pain in
      patients with chronic low back pain, contributing up to 27%. Recent studies have demonstrated
      that historical and physical examination findings and radiological imaging alone are
      insufficient to diagnose SI joint pain.

      The purpose of this study is to examine the effects of manipulation on sacroiliac joint
      motion using a Polhemus motion capture system. The Absolute angular deviation of sacroiliac
      joint motion will be assessed during the normal gait cycle with the Polhemus Liberty motion
      capture system. Six sensors will be attached to specific anatomical landmarks of the pelvis
      which recorded motion characteristics while walking on a treadmill at 5 mph. The subjects
      then receive a HVLA manipulation to the SI joint and were retested at the same treadmill
      speed.

      The Motion capture system tracks objects at a speed of 240 updates per second on all sensors
      simultaneously. The latency of data sampling is less than 4ms; 240 x 60 sec x 8 Sensors
      totaling 115,200 data points per minute. The system generates and tracks electromagnetic
      fields (EMF), computes position and orientation of sensors in an X, Y, and Z coordinate
      system while interfacing with a computer. The EMF source contains electromagnetic coils that
      emit a magnetic field. The source is the system's reference frame for sensor measurements.
      The sensor contains electromagnetic coils (accelerometers) that detect the position and
      orientation of the magnetic fields emitted by the EMF source.
    

Intervention name(s): Manipulation
Intervention type(s): Procedure
Intervention description(s): HVLA manipulation to Sacroiliac Joint
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: manipulation; manual therapy; Sacroiliac joint; effects on manipulation on sacroiliac joint
A Double-blind Study of Controlled Release OROS Hydromorphone Compared to Placebo in Patients With Chronic Osteoarthritis (OA) Pain
Condition: Chronic Pain
MeSH terms: Osteoarthritis; Chronic Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy of OROS Hydromorphone in reducing moderate to severe chronic pain in
      patients with Osteoarthritis (OA) Pain
    


Intervention name(s): OROS hydromorphone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): hydromorphone 12, 16, 24, 32, 40, 48, or 64 mg tablets; Placebo
Intervention MeSH terms: Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: OA; Chronic Pain; Osteoarthritis; OA Pain; Osteoarthritis Pain; Pain; Hip Pain; Knee Pain; Joint Pain
ENterogermina® (Bacillus Clausii) In the manaGeMent of diarrheA in Children
Condition: Gastroenteritis
MeSH terms: Gastroenteritis; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary:

        -  To demonstrate the efficacy of Enterogermina® in reducing the duration of acute diarrhea
           in children

      Secondary:

        -  To evaluate the safety of Enterogermina® in acute diarrhea in Indian children
    


Intervention name(s): Bacillus Clausii; Oral rehydration therapy
Intervention type(s): Drug; Other
Intervention description(s): For 5 days; For 5 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PK, Safety and Tolerability of Single and Multiple Doses of Oxfendazole Tablets
Condition: Filariasis
MeSH terms: Filariasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study evaluates the pharmacokinetics (PK), safety and tolerability of oxfendazole, after
      administration as a tablet formulation in healthy male and female participants.
    

Detailed description: 
      This is a randomized, placebo-controlled, double blinded, single center phase I
      bioavailability study with two Single Dose cohorts and one Multiple Doses cohort in a total
      of 30 healthy male and female healthy volunteers (10 per cohort).
    

Intervention name(s): Oxfendazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oxfendazole is a benzimidazole anthelminthic drug.; The placebo tablet is made using the same non-active ingredients and matches the investigational tablet.
Intervention MeSH terms: Oxfendazole
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Onchocerciasis; Parasitic Diseases; Neglected Disease; Phase I; Safety; Tolerability; Pharmacokinetics; Bioavailability; Volunteers
Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery
Condition: Cardiac Surgery Subjects; Subjects Undergoing CABG and/or Cardiac Valve Replacement
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, randomized study of sitaxsentan administered intravenously to
      subjects who are undergoing elective CABG, cardiac valve replacement, or combined CABG and
      cardiac valve replacement procedures that require CPB.
    


Intervention name(s): sitaxsentan (Thelin); sitaxsentan (Thelin); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): sitaxsentan (1.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB.; Sitaxsentan (2.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB.; Placebo will begin immediately following cross-clamp release and 12 hours post-CPB.
Other intervention name(s): sitaxsentan, Thelin; sitaxsentan, Thelin
Intervention MeSH terms: Sitaxsentan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multi-center; placebo-controlled; randomized study of sitaxsentan administered to subjects post-cross-clamp release and 12 hours post-CPB
Full Length Versus Proximal Renal Arteries Ablation
Condition: Hypertension, Resistant to Conventional Therapy
MeSH terms: Hypertension; Coronary Vasospasm
Study type: Interventional

Summary: 
      Catheter-based renal sympathetic modification has been documented to be effective option for
      blood pressure control in patients with resistant hypertension, but the safety is still
      concerned around worldwide. Based on anatomic findings, blocking renal sympathetic nerves at
      proximity may be enough for successful renal sympathetic modifications. This study was
      designed to compare the efficacy and safety of full length versus proximal ablation of
      bilateral renal arteries.
    

Detailed description: 
      After baseline assessment was completed, patients with resistant hypertension were enrolled,
      and randomly divided into two groups. This study is going to recruit 40 patients (group 1 VS
      group 2 = 1:1) with a follow-up duration of one year. Group 1 received ablation from distal
      to ostial of bilateral renal arteries, group 2 received ablation at proximal of bilateral
      renal arteries. RDN was performed with saline irrigated catheter. Office and ambulatory blood
      pressure was measured.
    

Intervention name(s): Thermocool®Rcatheter; Thermocool®Rcatheter
Intervention type(s): Device; Device
Intervention description(s): The full length RDN was performed discretely from distal to proximal by point to point using Thermocool®Rcatheter; The proximity renal denervation was performed discretely at 10-15 mm of proximal renal artery, using Thermocool®Rcatheter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetics of the Fixed Dose Combination of BI 1744 CL Plus BI 54903 XX Via Respimat® B Versus the Mono Products of BI 1744 CL Via Respimat® A and BI 54903 XX Via Respimat® B in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study was to compare the systemic exposure of BI 1744 BS and CD
      1857 XX (the active metabolite of the pro-drug BI 54903 XX) at steady state following
      inhalation of the fixed dose combination (FDC) of 6.2 μg BI 1744 CL plus 727.3 μg BI 54903 XX
      (as ethanolic solution for inhalation, EIS) with the systemic exposure following inhalation
      of the mono compounds of 10 μg BI 1744 CL (as aqueous solution for inhalation, AIS) and 727.3
      μg BI 54903 XX (EIS), respectively, when administered once-daily via Respimat® Inhaler
      (Respimat® A for AIS and Respimat® B for EIS) for 14 days in healthy volunteers. Secondary
      objectives were to compare exposure to BI 1744 BS and CD 1857 XX after a single dose of the
      BI 1744 CL/BI 54903 XX (6.2 μg/727.3 μg) FDC and the mono compounds, respectively; to compare
      exposure to BI 54903 XX after a single dose and at steady state after multiple doses of the
      BI 1744 CL/BI 54903 XX (6.2 μg/727.3 μg) FDC and the mono compounds, respectively; to compare
      the safety and tolerability of BI 1744 CL and BI 54903 XX when administered as BI 1744 CL/BI
      54903 XX (6.2 μg/727.3 μg) FDC and as the mono compounds, respectively.
    


Intervention name(s): BI 1744 CL/BI 54903 XX FDC; BI 54903 XX; BI 1744 CL
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Olodaterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison Between TICL and ICL+AK for High Myopic Astigmatism
Condition: Astigmatism; High Myopia
MeSH terms: Myopia; Astigmatism
Study type: Interventional

Summary: 
      To compare the outcomes of a toric Implantable Collamer Lens (ICL) and a spherical
      Implantable Collamer Lens combined with astigmatic keratotomy (AK) in the correction of high
      myopic astigmatism.
    


Intervention name(s): Toric Implantable Collamer Lens; ICL + Astigmatic keratotomy
Intervention type(s): Device; Device
Intervention description(s): uses Toric Implantable Collamer Lens implantation to correct the high myopic astigmatism.; uses Implantable Collamer Lens implantation combined with Astigmatic keratotomy to correct the high myopic astigmatism
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective comparative case series
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: astigmatism; high myopia; phakic intraocular lens; astigmatic keratotomy; toric
Drug Utilization Prevalence in a Pediatric Care Medical Center
Condition: Infectious Diseases; Metabolic Diseases; Cancer
MeSH terms: Communicable Diseases; Infections; Metabolic Diseases
Study type: Observational

Summary: 
      One year prospective analysis of drug utilization and prescription point prevalence of
      medications in a pediatric tertiary care university medical center. Off-label use of
      medications in the study population will be also registered.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Admitted children for medical treatment in two different pediatric departments
      
Keywords: Prescription point prevalence; Drug utilization; Define Daily Dose
A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to assess the safety of long term therapy with
      Certolizumab Pegol in those subjects participating in study C87085 [NCT00552058].
    

Detailed description: 
      This study consisted of:

        -  Induction Period (dosing at Weeks 0, 2, and 4)

        -  Maintenance Dosing (dosing every 4 weeks up to Week 260)

        -  End of Treatment Visit that occurred at Week 262/Withdrawal Visit and a Safety Follow-up
           Visit (SFU; 12 weeks after final dose)
    

Intervention name(s): Cimzia
Intervention type(s): Biological
Intervention description(s): Active substance: Certolizumab Pegol
Pharmaceutical form:first reconstituted, lyophilized powder formulation of CZP and after implementation of Amendment 2 (after 401 subjects were enrolled) prefilled syringe
Concentration: 200 mg/ml
Route of Administration: Subcutaneous use
Other intervention name(s): Certolizumab Pegol; CDP870; CZP
Intervention MeSH terms: Certolizumab Pegol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CDP 870; Certolizumab Pegol; CIMZIA; Crohn's Disease; Crohn Disease; CD Induction; Induction; Clinical response; Clinical remission
Estimation of the Effective Dose (ED) 95 of Intrathecal Hyperbaric Prilocaine 2% for Scheduled Cesarean Delivery.
Condition: Pregnant Women
Study type: Interventional
Phase: Phase 2

Summary: 
      Prilocaine is a local anesthetic drug which as an intermediate duration of action shorter
      than bupivacaine 0,5% that is usually used for spinal anesthesia in scheduled cesarean
      section. No study has yet investigated the use of hyperbaric (HB) prilocaine 2% for
      intrathecal anesthesia in cesarean section. The aim of this study is to determine the
      Effective Dose (ED) 95 of hyperbaric (HB) prilocaine 2% by using the Continual Reassessment
      Method (CRM)
    


Intervention name(s): Hyperbaric prilocaine 2%; Hyperbaric prilocaine 2%; Morphine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Varying dose according to sensitive response of previous subjects. All study doses of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine; The dose of 60 mg of Hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine; 100µg morphine
Other intervention name(s): Tachipri; Tachipri
Intervention MeSH terms: Morphine; Prilocaine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Scheduled cesarean delivery,spinal anesthesia,local anesthesia
A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System
Condition: Tibial Fractures
MeSH terms: Fractures, Bone; Tibial Fractures
Study type: Observational

Summary: 
      This investigation is a prospective, multi-center clinical investigation. It is anticipated
      that a total of 80 subjects will be enrolled. Neither subjects nor investigators are blinded
      to treatment and the clinical investigation includes a historical control which will be
      compared to the T2 Alpha Tibia Nailing System.

      Total duration of enrollment, 12 month follow-up and analysis is expected to take 31 months.
      The clinical investigation has been designed to follow the surgeon's standard of care for
      tibia fractured subjects, in addition to a 12 month follow-up visit.

      The primary endpoint of this clinical investigation is to confirm efficacy/performance at 12
      months, as measured by the SF-36 Physical Component Summary (PCS). Confirmation of
      efficacy/performance at 12 months will be based on an equal or higher (non-inferior) SF-36
      Physical Component Summary (PCS) result of the T2 Alpha Tibia Nailing System compared to the
      benchmark literature.
    

Detailed description: 
      The objective of this clinical investigation is to demonstrate the safety and
      efficacy/performance of the T2 Alpha Tibia Nailing System. Efficacy/performance of the
      procedure will be measured by an equal or higher (non-inferior) SF-36 Physical Component
      Summary (PCS) score result of the T2 Alpha Tibia Nailing System compared to the T2 Tibia
      benchmark literature at 12 months.

      In addition, demonstration of bone consolidation in correct alignment will be measured by
      Investigator assessment by 12 months. Safety of the T2 Alpha Tibia Nailing System will be
      demonstrated through reporting of device related intra-operative and post-operative Adverse
      Events/incidents by 12 months.
    

Intervention name(s): T2 Alpha Tibia Nailing System
Intervention type(s): Device
Intervention description(s): The T2 Alpha Tibia Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Approximately 80 subjects are to be enrolled in this clinical investigation. Subjects
        participating in this clinical investigation will be recruited from the investigator's
        standard subject population, where all subjects presenting for treatment of tibial
        fractures will be evaluated for clinical investigation participation based on the
        eligibility criteria.
Triggering of Follicular Maturation
Condition: Increase Pregnancy Rate
Study type: Interventional
Phase: Phase 3

Summary: 
      The follicular phase of the menstrual cycle involves the hourly release of
      gonadotropin-releasing hormone, which binds to receptors on the gonadotropes. This results in
      the secretion of follicle stimulating hormone and luteinizing hormone in hourly pulses that
      regulate follicular growth. At midcycle, rapidly rising estradiol from the dominant follicle
      and a small rise in progesterone lead to a gonadotrophic surge. An increase in the amplitude
      of Luteinizing hormone and Follicle stimulating hormone pulses initiates oocyte maturity and
      triggers ovulation approximately
    


Intervention name(s): Recombinant Human Chorionic Gonadotrophin; human chorionic gonadotrophin + gonadotrophin releasing hormone agonist
Intervention type(s): Drug; Drug
Intervention description(s): 250 unit intramuscular; 250 unit intramuscular + 1 mg subcutaneous
Other intervention name(s): Ovitrelle
Intervention MeSH terms: Chorionic Gonadotropin; Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety Study in Volunteers From 16 to 65 Years of Age: FSME IMMUN NEW vs. ENCEPUR
Condition: Encephalitis, Tick-borne
MeSH terms: Encephalitis, Tick-Borne; Encephalitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety of a vaccination schedule consisting of two
      vaccinations (21-35 days apart) with the tick-borne encephalitis (TBE) vaccine FSME-IMMUN NEW
      (5 consecutive lots) in comparison to another licensed TBE vaccine (Encepur® adults, with
      polygeline) (2 lots) in healthy volunteers aged 16 to 65 years.
    


Intervention name(s): Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
A Pharmacokinetic Study of CKD-501 in Patients With Impaired Hepatic Function
Condition: Liver Dysfunction
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate pharmacokinetics of CKD-501 in patients with
      impaired hepatic function compared with normal hepatic function.
    

Detailed description: 
      A Phase 1, Non-randomized, Open, Parallel-Group study.
    

Intervention name(s): CKD-501
Intervention type(s): Drug
Intervention description(s): CKD-501 0.5mg, PO(per oral), once
Other intervention name(s): Lobeglitazone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: CKD-501
Safety,Tolerability,Pharmacokinetics and Efficacy of CFZ533 in Moderate to Severe Myasthenia Gravis
Condition: Myasthenia Gravis, Generalized
MeSH terms: Myasthenia Gravis; Muscle Weakness
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate safety, tolerability,
      pharmacokinetics/pharmacodynamics and efficacy of CFZ533 as an add-on therapy to standard of
      care in patients with moderate to severe myasthenia gravis (MG).
    


Intervention name(s): Placebo; CFZ533
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: CFZ533, Myasthenia Gravis