bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (A)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate bioequivalence of a 2.5 mg saxagliptin/500 mg metformin (glucophage) immediate
      release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 500 mg
      metformin IR tablet co-administered to healthy subjects in a fasted and in a fed state.
    


Intervention name(s): Co-administration of Saxagliptin and Metformin IR, Fasted; Saxagliptin/Metformin, Fasting; Co-administration of Saxagliptin and Metformin IR, Fed; Saxagliptin/Metformin, Fed
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions; Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions; Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions; Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
Other intervention name(s): Onglyza; Onglyza; Glucophage
Intervention MeSH terms: Metformin; Saxagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Complicated Outcome Prediction After Liver Resection
Condition: Liver Neoplasms
MeSH terms: Liver Neoplasms
Study type: Observational

Summary: 
      Although mortality after liver surgery reduced during the last three decades to less than 2%,
      post-operative course is still complicated in a range of 20-50% of cases.The identification
      of one or few factors which could detect the real risk of complicated post-operative outcome,
      may help anesthesiologist to decide whether admit a patient to ICU or not.The primary aim of
      this study was to evaluate whether RRI, alone or along with other items, can predict
      post-operative complication after hepatic resection.
    


Intervention name(s): Liver resection for primary and secondary disease
Intervention type(s): Procedure
Intervention description(s): Liver resection in parenchyma-sparing setting for primary and secondary disease
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients resectable and affected by primary and secondary liver disease
SIT LESS 2: Effect of Sitting Less on Glucose Regulation in People With Diabetes Mellitus Type 2
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Introduction: Changes in lifestyle are responsible for an important part of the type 2
      diabetes epidemic of the last decennia. Current guidelines for physical activity focus mainly
      on high energy expenditure advising 30 minutes per day moderate to vigorous physical activity
      (most often physical exercise). Recent studies suggest that sitting has negative metabolic
      effects independent of the time spent exercising (Duvivier et al. PLOS ONE 2013).

      Low intensity physical activity (LIPA) -such as walking and standing- has been suggested to
      be an alternative to decrease the hyperglycaemic effect of sitting. Compared to exercise,
      LIPA might be a more feasible strategy. But, it remains to be determined whether reducing
      sitting time by replacing it by LIPA, results in lower 24 hour blood glucose levels and less
      blood glucose fluctuations (glycaemic variability) in type 2 diabetes patients and whether
      these effects are independent of the increase in energy expenditure

      Methods: The study population will involve 19 people with type 2 diabetes (BMI: 25-35 kg/m2)
      who perform no, or only little, exercise and who are treated with diet only or with oral
      blood glucose lowering medication. They will perform three regimes of each four days: 1) a
      sitting regime, 2) an exercise regime and a 3) sit less regime. Daily energy expenditure of
      the exercise regime will be identical to that of the sit less regime. Sitting, walking and
      standing will be objectively measured by a 24 hour physical activity monitor. The energy
      spent during exercise will be standardised and quantified by using a bicycle ergometer;
      energy intake will be standardised as well. During each regime blood glucose will be measured
      with a 24 hour continuous glucose sensor.
    


Intervention name(s): Physical activity intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glucose regulation; Glucose; Lipids
Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Protocol 610 is enrolling subjects who successfully achieved clinical benefit (reduction in
      Crohn's Disease Activity Index (CDAI) of at least 100 points) in Protocol 603. Protocol 610
      is evaluating the length of initial effect of PROCHYMAL® adult human mesenchymal stem cells
      and the ability of these cells to successfully re-induce clinical benefit.
    

Detailed description: 
      A significant number of individuals with Crohn's disease do not find relief with existing
      steroidal, immunosuppressive, or biologic therapies, and are forced to seek surgery or other
      drastic measures for treatment.

      PROCHYMAL® adult human stem cells are manufactured from healthy, volunteer donors,
      extensively tested, and are stored to be available as needed. Human and animal studies have
      shown that the cells do not require any donor-recipient matching. The cells may have both
      immunosuppressive and healing benefits in Crohn's disease. The cells naturally migrate
      specifically to sites of inflammation, so their effects are believed to be local and
      self-limiting rather than systemic.

      Protocol 610 is an extension study offered only to those subjects who successfully achieved
      clinical benefit (reduction of CDAI of at least 100 points) in Protocol 603.
    

Intervention name(s): Placebo; PROCHYMAL adult human mesenchymal stem cells
Intervention type(s): Drug; Drug
Intervention description(s): Placebo; intravenous infusion four times over two weeks; possibly repeated once
Intervention MeSH terms: Remestemcel-l
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Lithium in Inclusion Body Myositis (IBM)
Condition: Inclusion Body Myositis
MeSH terms: Myositis; Myositis, Inclusion Body
Study type: Observational

Summary: 
      IBM is the most common acquired muscle disease occurring over the age of 50. The underlying
      cause remains unknown and there is currently no effective treatment. Pathological studies
      have revealed abnormal collections of proteins in the muscle cells from patients with IBM.
      These include proteins called phosphorylated tau (p-tau). A similar process appears to occur
      in Alzheimer disease, with accumulations of p-tau developing in brain cells. Lithium
      decreases the activity of the GSK, an enzyme that has a key role in the development of p-tau.
      Lithium and other GSK inhibitors have been shown to decrease the accumulation of p-tau in
      nerve cells in animal models of Alzheimer disease. The proposed research is a pilot study to
      see if lithium might be an effective treatment for IBM
    

Detailed description: 
      Trial Status Open for Enrollment

      What is the Purpose of this Study? There is currently no effective treatment for IBM and its
      pathogenesis remains uncertain. This study is designed to test the hypothesis that treatment
      of patients with IBM with Lithium can improve muscle strength and reduce the markers of
      disease activity believed to be important in the disease pathogenesis.

      Who is Eligible to Participate? Patients diagnosed with Inclusion Body Myositis above the age
      of 30 who have adequate muscle function for quantitative muscle testing and who have a FVC
      >50%. Patients who have uncontrolled diabetes, renal insufficiency, congestive heart failure,
      cancer, hypothyroidism, current use of immunosuppressive medication, currently on warfarin or
      any known bleeding disorder are excluded.

      What is involved in this Study? This is an open label trial looking at the effects of Li on
      muscle strength. Procedures consist of a baseline muscle biopsy, blood work, and other
      screening procedures. After the muscle biopsy patients are started on Li at 300mg/d. Lithium
      doses are dependent on tolerability and target lithium levels. Monthly visits consist of
      EKGs, Li level labs, questionnaires, and muscle strength testing. At month 6, patients will
      receive another muscle biopsy. The muscle biopsies are performed to analyze p-tau levels in
      the muscle.

      How long is the Study? It is approximately 6 months long; however patients have the option to
      stay on the study for an additional 6 months.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who fit criteria diagnosed with IBM
      
Biospecimen description: 
      Muscle Biopsies will be taken at baseline and at the end of 6 months. Tissue will be frozen
      then sent out for anaylsis.
    
Keywords: Lithium; IBM; InclusionIBM; Myositis
Outcomes of Geriatric Hip Fractures in Assiut University Hospital
Condition: Hip Fractures
MeSH terms: Fractures, Bone; Hip Fractures
Study type: Observational

Summary: 
      hip fractures are common problem specially in elderly population the incidence is increasing
      nowadays because of increased incidence of motor vehicle accidents
    

Detailed description: 
      hip fractures are a common problem specially in elderly population the incidence is
      increasing nowadays because of increased incidence of motor vehicle accidents the incidence
      of morbidity and mortality is increasing today and the mortality rate is about 30% the aim of
      the study is follow up of the patients aged 65 years and older who experienced hip fractures
      for one year to evaluate the outcome of different ways of intervention in elderly population.
    

Intervention name(s): Arthroplasty or open reduction and internal fixation
Intervention type(s): Procedure
Intervention description(s): fixation of proximal femoral fractures or replacement with prosthesis
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients aged 65 years old and older with fracture acetabulum , neck of femur ,
        trochanteric , subtrochanteric and reverse trochanteric fractures admitted inside assuit
        university hospital
Comparison of Two New Generation Drug Eluting Stents in Patients With Diabetes (OCT-DES)
Condition: Coronary Artery Disease; Diabetes
MeSH terms: Coronary Artery Disease; Diabetes Mellitus
Study type: Interventional

Summary: 
      The aim of this study is a comparative evaluation of re-endothelailisation of the Integrity
      Resolute zotarolimus eluting stent (Medtronic) and of the Promus Element erolimus eluting
      stent (Boston Scientific), in patients with diabetes.

      We plan to compare endothelial coverage and neointimal proliferation using OCT and compare
      this data to published results from conventional stents.
    


Intervention name(s): Optical coherence tomography
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Diabetes Mellitus; PCI; Drug eluting stent; OCT
A Phase I Multiple Dose Pharmacokinetic Study of Nevirapine Extended Release (XR) in HIV-1 Infected Children.
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to establish the pharmacokinetic (PK) profile at steady state of
      nevirapine XR in HIV infected children from >=3 to <18 years of age. This phase I trial is an
      open-label, multiple dose, non-randomized and cross-over study. Patients who have completed
      the last visit of the PK trial (visit 7) can enter into an Optional Extension Phase (OEP)
      until the Investigational New Drug (IND) is withdrawn; until nevirapine XR becomes approved
      and is available by prescription in a given country; or, the patient enrolls in a
      compassionate use program. During this OEP, nevirapine XR safety and efficacy information
      will be collected.
    


Intervention name(s): Nevirapine Immediate Release (IR); Nevirapine Extended Release (XR)
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg Tablet or 50 mg / 5 ml oral suspension; 200 mg, 300 mg or 400 mg Tablet formulation
Other intervention name(s): Nevirapine IR; Nevirapine XR
Intervention MeSH terms: Nevirapine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
KATHY:Cognitive-behavioural Therapy for Hypochondriasis
Condition: Hypochondriasis
MeSH terms: Hypochondriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to examined if psychotherapy is an effecitive treatment for
      hypochondriasis.
    

Detailed description: 
      Background: The central feature of hypochondriasis is preoccupation or fear of having a
      serious disease based on misinterpretation of bodily signs. Psychotherapeutic treatments have
      developed with focus on different aspects of the condition. Several controlled trials have
      examined the effectiveness of different treatment strategies.

      Hypothesis: Hypochondriasis is accessible for treatment. Specific cognitive treatment focused
      on misinterpretation of bodily sensations is more effective than short-term non-specific
      psychodynamic psychotherapy.

      Method: Patients with hypochondriasis were randomisation to cognitive behavioural therapy
      (CBT), psychodynamic psychotherapy, or waiting list. Patients on waiting list were
      subsequently randomised to CBT or dynamic psychotherapy. The patients received six-teen
      sessions over a period of six month. Follow-up assessments were made six and twelve month
      after treatment.
    

Intervention name(s): Cognitive behavioral psychotherapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Proteomic Study of Urinary Stone Disease
Condition: Urinary Calculi; Hyperoxaluria; Calculi
MeSH terms: Urinary Calculi; Urolithiasis; Calculi
Study type: Observational

Summary: 
      Urinary protein levels are not routinely measured in stone patients while there is strong
      evidence that proteins play a role in the etiology of stones. The purpose of this study is to
      examine the urinary and serum proteins of stone formers compared to healthy subjects
      utilizing the high throughput method, Surface Enhanced Laser Desorption/Ionization (SELDI).
      We hypothesize that there is a unique set of proteins expressed in serum and urine in stone
      patients that can be detected by SELDI. Ultimately, this will better our understanding of
      stone disease and help develop new prevention strategies.
    

Detailed description: 
      Urinary stone disease affects 10% of the Canadian population during their lifetime and
      approximately half of these patients will have another episode within ten years. Currently,
      patients undergo metabolic testing (serum and 24 hour urine tests) to identify modifiable
      risk factors; however, no modifiable risk factors are identified in many patients, yet they
      continue to form stones. New techniques must be developed to identify stone patients at risk
      for future recurrences and ultimately to develop more specific prevention strategies.

      Urinary protein levels are not routinely measured in stone patients while there is strong
      evidence that proteins play a role in the etiology of stones. The purpose of this study is to
      examine the urinary and serum proteins of stone formers compared to healthy subjects
      utilizing the high throughput method, Surface Enhanced Laser Desorption/Ionization (SELDI).
      We hypothesize that there is a unique set of proteins expressed in serum and urine in stone
      patients that can be detected by SELDI. Once a protein is identified as a biomarker, a
      specific assay similar to a quick and affordable dipstick test may be developed to identify
      those stone patients at risk of future stones. Ultimately, this will better our understanding
      of stone disease and help develop new prevention strategies.

      Comparisons: protein profiles (serum/urine) of stone patients both during the presence of a
      stone and 6 weeks after they have passed it. comparison of stone profiles of stone patients
      with controls (non-forming stone patients).
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This observational study will compare stone formers meeting the inclusion criteria with a
        cohort of age and sex matched non-stone formers as controls.
      
Keywords: calculi; proteomics
Bioequivalence Trial of 2 Dose Strengths of BI 201335 NA Soft Gelatine Capsules
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective is to investigate the bioequivalence of 2 dose strengths of 40 mg and 120 mg BI
      201335 NA soft gelatine capsules.
    


Intervention name(s): BI 201335 NA 120 mg capsule; BI 201335 NA 120 mg capsule; BI 201335 NA 40 mg capsule; BI 201335 NA 40 mg capsule
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1capsule of BI 201335 NA 120 mg capsule; 1 capsule of BI 201335 NA 120 mg capsule; 3 capsules of BI 201335 NA 40 mg capsule; 3 capsules of BI 201335 NA 40 mg capsule
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison: Constant-rate Infusion Plus Demanding Dosing VS Variable-rate Feedback Infusion Plus Demanding Dosing
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      In the case of the newlys developed PCA, the infusion rate is increased according to the
      patient's need for bolus button, so that the pain can be controlled more efficiently.
    

Detailed description: 
      In the case of the existing iv-pca, the analgesic drug was injected into the patient at a
      constant rate (ex. 1 ml / hr) and additional pain was controlled through the bolus dose (1
      ml).

      As a result, the analgesic effect was insufficient, or the effect was excessive, causing side
      effects (nausea, vomiting, sedation, dizziness). Especially In spinal surgery, the degree of
      pain sharply decreases from day 1 to day 2. Classic iv-pca with constant infusion rate can
      not reflect this result. But in the case of the newlys developed PCA, the infusion rate is
      increased according to the patient's need for bolus button, so that the pain can be
      controlled more efficiently. If the bolus button is not pressed for a certain period of time,
      it is expected that the injection rate will be reduced and the side effect caused by the
      analgesic agent will be decreased.
    

Intervention name(s): Variable-rate Feedback Infusion mode; Constant-rate Infusion mode
Intervention type(s): Device; Device
Intervention description(s): The PCA regimen consisted of fentanyl 20 μg/kg and Ramosetron Hcl 0.3 mg (total volume including saline: 100 ml) and was programmed to deliver 1 ml /h as a background infusion and a bolus of 1.5 ml on-demand, with a 15 min lockout time. It can increment or decrement rate(0.2ml/hr) by press bolus button during a 48 h period; The PCA regimen consisted of fentanyl 20 μg/kg and Ramosetron Hcl 0.3 mg (total volume including saline: 100 ml) and was programmed to deliver 1 ml /h as a background infusion and a bolus of 1.5 ml on-demand, with a 15 min lockout time during a 48 h period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Safety and Immunogenicity of a Klebsiella Pneumoniae Tetravalent Bioconjugate Vaccine (Kleb4V)
Condition: Klebsiella Pneumoniae Infection
MeSH terms: Pneumonia; Klebsiella Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this study, the tetravalent bioconjugate candidate vaccine Kleb4V will be tested to obtain
      first-time-in-human (FTIH) data on its safety and immunogenicity in healthy adults.
    

Detailed description: 
      Kleb4V is a tetravalent bioconjugate vaccine including O antigen-polysaccharides of the most
      predominant Klebsiella pneumoniae serotypes, which will be formulated with or without
      Adjuvant System, AS03. Study participants will be randomized towards Kleb4V Low dose with or
      without AS03, Kleb4V Target dose with or without AS03, or placebo.

      The study will be conducted in two steps. In Step1 (safety cohort): safety and tolerability
      of Kleb4V without and with Adjuvant AS03 will be evaluated first in adults of 18-40 y, and
      subsequently in the target population of older adults 55-70 y. Enrolment will be staggered in
      groups of small numbers to the different doses and formulations.

      In Step 2 (target cohort): Older adults (55-70y) will be concomitantly randomized to receive
      1 of the 4 different vaccine formulations or placebo.
    

Intervention name(s): Kleb4V target dose; Kleb4V target dose + AS03; Kleb4V low dose; Kleb4V low dose + AS03; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Two doses of the non-adjuvanted Kleb4V target dose will be administered intramuscularly 2 months apart; Two doses of the adjuvanted Kleb4V target dose will be administered intramuscularly 2 months apart; Two doses of the non-adjuvanted Kleb4V low dose will be administered intramuscularly 2 months apart; Two doses of the adjuvanted Kleb4V low dose will be administered intramuscularly 2 months apart; Two doses of the Placebo will be administered intramuscularly 2 months apart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention