bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Complement Factors and Genetic Polymorphisms of AMD Between Patients With Systemic Lupus Erythematosus (SLE) With and Without Retinal "Pseudo-drusen-like" Deposits: Case-control Study (PL-AMD)
Condition: Lupus Erythematosus; Lupus Erythematosus, Systemic; Age Related Macular Degeneration
MeSH terms: Macular Degeneration; Lupus Erythematosus, Systemic
Study type: Observational

Summary: 
      The rationale of this research is to determine if patients with lupus and presenting retinal
      "pseudo-drusen-like" deposits have genetic and complement-related similarities with AMD
      patients.

      Based on the results obtained, this study could lead to future research that could better
      target the treatment of patients with lupus or patients with AMD (Age related Macular
      Degeneration).

      The primary objective is to check if patients with lupus, treated or not with antimalarial
      drugs, with "pseudo-drusen-like" deposits have a different complement profile (functional
      exploration of complement, complement factors, genetic complement polymorphisms involved in
      AMD) compared to patients without "pseudo-drusen-like" deposits.
    


Intervention name(s): Blood test
Intervention type(s): Procedure
Intervention description(s): Blood test for complement factors and genetic polymorphisms of AMD analysis
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with lupus, treated or not with APS, with ou without "pseudo-drusen-like" deposits
      
Keywords: Lupus Erythematosus, Systemic; Age Related Macular Degeneration; "Pseudo-drusen-like" deposits
PKP Assisted With MR Technology in OVCF With IVC
Condition: Orthopedic Disorder of Spine
MeSH terms: Musculoskeletal Diseases; Spinal Diseases
Study type: Interventional

Summary: 
      To prospectively assess the outcome of PKP assisted with and without MR technology in
      treatment of OVCF with IVC.
    

Detailed description: 
      The study is to prospectively assess the outcome of PKP assisted with and without MR
      technology in treatment of OVCF with IVC. Forty cases of OVCF with IVC undergoing PKP were
      randomized into a MR technology assisted group (group A) and a traditional C-arm fluoroscopy
      group (group B). Both groups were performed PKP and evaluated by VAS scores, ODI scores,
      radiological evidence of vertebral body height and kyphotic angle(KA) at pre-operation and
      post-operation. The volume of injected cement and Operation time was recorded. And whether
      cement touching both endplates or not(non-PMMA-endplates-contact, NPEC) in radiological
      evidence were also recorded postoperatively. The clinical outcomes and complications were
      evaluated afterwards. All patients received 10 to 14 months' follow-up, with an average of 12
      months.
    

Intervention name(s): Mixed Reality technology
Intervention type(s): Device
Intervention description(s): combine image with real body
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase II Study Evaluating ONO-4053 and Cetirizine in Subjects With Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate if ONO-4053 relieves symptoms of allergic
      rhinitis in seasonal allergic rhinitis subjects exposed to pollen under controlled
      conditions.
    

Detailed description: 
      The purpose of this study is to investigate if ONO-4053 will impact allergic rhinitis
      symptoms in subjects with seasonal allergic rhinitis when they are exposed to pollen
      administered at a fixed rate in an inhalation exposure chamber compared to the standard
      treatment Cetirizine 10mg under the same conditions.
    

Intervention name(s): Cetirizine; High dose ONO-4053; Low dose ONO-4053; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10mg tablets; Experimental; Experimental; None active
Other intervention name(s): Experimental 1; Experimental 2
Intervention MeSH terms: Cetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of InteguSeal for Surgical Skin Preparation in Patients Undergoing Total Joint Replacement
Condition: Prosthetic Joint Infection; Surgical Skin Infection
MeSH terms: Infections; Communicable Diseases; Cellulitis; Skin Diseases, Infectious
Study type: Interventional

Summary: 
      This study is being conducted to investigate the potential benefits of using a special type
      of fluid that can be applied to the skin (Integuseal) in addition to standard surgical skin
      preparation in patients undergoing total hip replacement (THA) or total knee replacement
      (TKA). Integuseal is supposed to lock down the skin bacteria and reduce skin infection and
      other problems. This study will investigate whether Integuseal is effective in reducing
      persistent wound drainage when used in addition to standard surgical skin preparation for
      total hip arthroplasty (THA) or total knee replacement (TKA).
    


Intervention name(s): Integuseal
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Impact of Underlying Renal Disease and Immunosuppressive Regimen on Ovarian Reserve in Renal Patients
Condition: Anti-Mullerian Hormone Deficiency; Immunosuppression; Ovarian Reserve; X-rays; Effects
Study type: Observational [Patient Registry]

Summary: 
      Aging, renal pathology (eg SLE, ADPKD), X-ray exposition and pharmacological treatments,
      especially previous strong immunosuppression, may negatively influence the ovarian reserve in
      childbearing age women. Anti-Müllerian hormone (AMH) is regarded as biomarker for ovarian
      reserve.

      Every female with renal disease regularly menstruating that met exclusion criteria could have
      participated. The aim was to assess ovarian reserve in female patients with normal menstrual
      cycle and kidney disease, including kidney transplant recipients.
    


Intervention name(s): AMH level measurement
Intervention type(s): Diagnostic Test
Intervention description(s): AMH level measurement using ELISA test from blood samples
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Regularly menstruating female patients suffering from renal pathology or after renal
        transplantation
      
Keywords: AMH; Immunosuppression; Ovarian Reserve; X-Ray effects
A Multiple Ascending Dose Study of BCI-838 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of
      BCI-838 and its metabolite BCI-632 in healthy male and female subjects.
    

Detailed description: 
      This study will evaluate the safety and tolerability following oral administration of
      multiple doses of BCI-838 in healthy male and female subjects. The pharmacokinetic profile of
      multiple oral doses of BCI-838 in healthy male and female subjects will also be assessed. In
      addition, the pharmacodynamic effects of BCI-838 on the central nervous system using
      quantitative electroencephalogram analysis will be studied.
    

Intervention name(s): BCI-838; BCI-838; BCI-838
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BCI-838 100 mg or matching placebo administered once daily for 7 days; BCI-838 or matching placebo administered once daily for 7 days; the dose of BCI-838 will be determined based on the safety and PK data from the preceding dosing arm.; BCI-838 or matching placebo administered once daily for 7 days; the dose of BCI-838 will be determined based on the safety and PK data from the preceding dosing arm.
Intervention MeSH terms: BCI-838
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: metabotropic glutamate receptors 2 and 3; antagonist; mGluR; ketamine; BDNF; Depression; Major Depressive Disorder; Treatment Resistant Depression; Mood Disorder; Phase 1 safety, tolerability and pharmacokinetics study
Contrast Enhanced Mammography in Diagnosing Patients With Suspicious Breast Findings
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This pilot trial studies how well contrast enhanced mammography works in diagnosing patients
      with suspicious breast findings. Diagnostic procedures, such as contrast enhanced
      mammography, may help to reclassify findings seen on diagnostic mammography and ultrasound as
      benign or likely benign with what would otherwise require biopsy for confirmation.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To obtain preliminary data to support the hypothesis that contrast enhanced mammography
      (CEM) can reduce benign tissue diagnosis (FP3) and therefore improve positive predictive
      value 3 (PPV3).

      SECONDARY OBJECTIVES:

      I. Identify specific CEM characteristics that accurately classify a finding as benign,
      high-risk or malignant.

      II. Assess the positive and negative predictive values for each digital breast tomosynthesis
      (DBT), breast ultrasound and CEM.

      EXPLORATORY OBJECTIVES:

      I. To compare the outcomes/endpoints stratified by age to determine if age affects the
      ability of CEM to accurately define a lesion as benign, probably benign or suspicious.

      OUTLINE:

      Patients undergo contrast enhanced mammography prior to scheduled standard of care core
      needle biopsy of the breast on the same day or up to 3 days later.
    

Intervention name(s): Contrast Enhanced Digital Mammography
Intervention type(s): Procedure
Intervention description(s): Undergo CEM
Other intervention name(s): CEDM; Contrast Enhanced Spectral Mammography
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Yttrium Y 90 Glass Microspheres and Capecitabine in Treating Patients With Liver Cholangiocarcinoma or Liver Metastases
Condition: Liver Cancer; Metastatic Cancer
MeSH terms: Liver Neoplasms; Cholangiocarcinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill
      tumor cells. Specialized radiation therapy, such as yttrium Y 90 glass microspheres that
      deliver a high dose of radiation directly to the tumor, may kill more tumor cells and cause
      less damage to normal tissue. Drugs used in chemotherapy, such as capecitabine, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Capecitabine may also make tumor cells more sensitive to radiation
      therapy.

      PURPOSE: This phase I trial is studying the side effects and best dose of yttrium Y 90 glass
      microspheres when given together with capecitabine in treating patients with liver
      cholangiocarcinoma or liver metastases.
    

Detailed description: 
      OBJECTIVES:

        -  Establish the maximally tolerated dose of yttrium Y 90 glass microspheres in combination
           with capecitabine in patients with intrahepatic cholangiocarcinoma or liver metastases.

        -  Characterize the toxicity of this regimen in these patients.

        -  Determine the time to tumor progression in these patients.

      OUTLINE: This is a dose escalation study of yttrium Y 90.

      Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days
      for 3 courses in the absence of disease progression or unacceptable toxicity. Patients also
      receive yttrium Y 90 glass microspheres by intra-arterial hepatic infusion on days 1-7 of
      course 2.

      After completion of study therapy, patients are followed every 3 months for 2 years.
    

Intervention name(s): capecitabine; yttrium Y 90 glass microspheres
Intervention type(s): Drug; Radiation
Intervention description(s): 1000 mg/m2 twice daily, for 14 consecutive days followed by a 7 day treatment free rest period for cycles 1, 2 and 3.; The amount of radioactivity required to deliver the desired dose to the liver is calculated using a formula. The dose depends on the cohort upon which the patient is enrolled. Y90 is administered during Cycle #2 on days 1-7.
Other intervention name(s): C14H15FN3O7; prodrug of 5'-deoxy-5-fluorouridine (5'-DFUR)
Intervention MeSH terms: Capecitabine; Doxifluridine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: advanced adult primary liver cancer; liver metastases; adult primary cholangiocellular carcinoma
A Phase 1/2a Study of the 2S,4R Enantiomer of Ketoconazole in Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study is designed to test the safety, tolerability of a newly developed form of
      ketoconazole (DIO-902) for the treatment of elevated blood sugars in type 2 diabetes. This
      study also will also examine the effect of the drug on total and LDL cholesterol and blood
      pressure. Elevated cortisol may contribute to the development of Type II diabetes. The
      investigational drug DIO-902 may reduce the level of cortisol in blood and therefore provide
      better control of blood sugar levels in patients with Type II diabetes.
    

Detailed description: 
      DiObex is developing a modified form of ketoconazole (enantiomer) (DIO-902) as an
      investigational new drug for the treatment of the elevated blood sugar associated with type 2
      diabetes. Other benefits may include reduced total and LDL cholesterol, and reduced blood
      pressure. With chronic treatment, reduced visceral fat may also be seen. Ketoconazole
      (racemic) is an approved drug for the treatment of a variety of fungal infections. The
      approved racemic ketoconazole inhibits cortisol synthesis. In patients with Cushings Disease
      racemic ketoconazole reduces glucose, cholesterol and blood pressure. Elevated cortisol may
      be a contributing causal factor in the development of type 2 diabetes; clinical trials with
      racemic ketoconazole have been carried out in these patients. The results of these clinical
      trials support the concept of treating type 2 diabetes through a lowering of plasma cortisol
      and provide evidence of the safety and tolerability of racemic ketoconazole. Racemic
      ketoconazole has, however, been associated with liver toxicity which is generally mild in
      nature. However, in rare cases (1:10,000 to 15,000 patients) severe liver toxicity may occur,
      and in extremely rare cases this adverse event may be irreversible and life-threatening.
      Preclinical results suggest that DIO-902 may be both safer and more efficacious than the
      racemic mixture.
    

Intervention name(s): 2S, 4R Ketoconazole (DIO-902)
Intervention type(s): Drug
Intervention MeSH terms: Ketoconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: safety; type 2 diabetes
Evaluation of Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers
Condition: Venous Leg Ulcer; Venous Stasis Ulcer
MeSH terms: Varicose Ulcer; Leg Ulcer; Ulcer
Study type: Interventional

Summary: 
      This study was designed to evaluate the clinical benefits and safety of OrCel in the
      treatment of venous ulcers. OrCel and standard care were compared to standard care alone.
      Standard care consisted of currently accepted compression therapy.

      Patients were treated for 12 weeks. Patients with healed ulcers were followed for an
      additional 12 weeks to assess durability of the healed wound.
    


Intervention name(s): Bilayered Cellular Matrix (OrCel)
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Venous leg ulcer; OrCel; Compression therapy
Uroflow Measurements in Urogynecology Patients Compared to Healthy Female Volunteers
Condition: Urogynecology
Study type: Observational

Summary: 
      To compare uroflowmetry measurements of patients undergoing urodynamic testing as part of an
      incontinence work-up in an urogynecology practice to healthy female volunteers.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Urogynecology clinic
Retrospective Evaluation of RMGI/GI Class V Restorations
Condition: Material, Dental
Study type: Observational

Summary: 
      Brief Summary: Retrospective study to evaluate the clinical performance of two restorative
      materials - glass-ionomer (GI) and resin-modified glass-ionomer (RMGI) materials - in Class V
      carious and non-carious cervical lesions restored by dental students.
    

Detailed description: 
      The aim of this retrospective study was to evaluate the clinical performance of glass-ionomer
      (GI) and resin-modified glass-ionomer (RMGI) materials in Class V carious and non-carious
      cervical lesions restored by dental students. Ninety-six (96) restorations performed with
      either GI (Fuji IX) (n=39) or RMGI (Fuji II) (n=57) were evaluated using the modified USPHS
      (United States Public Health Systems) criteria by two independent investigators at two
      follow-up evaluations (two years apart). The Fisher statistical test was used to compare
      USPHS criteria and examine significant differences by setting p<0.05 for statistical
      significance and the Kaplan-Meier algorithm was used to calculate the survival probability.
    

Intervention name(s): Retrospective evaluation of RMGI and GIC Class V Restorations
Intervention type(s): Other
Intervention description(s): Retrospective evaluation of RMGI and GIC Class V Restorations that were placed by dental students over the last three years were evaluated using the modified USPHS criteria using mirrors and probes.
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adults that have Class V Ionomer restorations (RMGI and GIC) placed by 3rd and 4th dental
        students at the Schulich Dental Clinic over the last three years.
      
Keywords: Glass-Ionomer Cement; Polyacid-Modified Composite Resin; Dental School
Effect of a Non-Invasive Brain Stimulation Technique on Smoking Cessation Behaviors
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      In this pilot study, the feasibility of using tDCS (a non-invasive brain stimulation
      technique) while performing a task requiring cognitive flexibility will be examined in
      smokers and initial data will be collected regarding the effect of tDCS on smoking cessation
      behaviors. Smokers will be randomized to receive either active or sham tDCS daily for 5 days
      after which they will attempt to quit smoking. Smoking behavior after the attempted quit date
      will be assessed at four weekly visits.
    


Intervention name(s): active tDCS; sham tDCS
Intervention type(s): Device; Device
Intervention description(s): two 13 minute tDCS sessions separated by 20 minutes in between; sham tDCS session given for same length of time as active
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Device Feasibility
Laryngeal Injuries After Anesthesia Induction With Three Different Sevoflurane Concentrations (Without Muscle Relaxant)
Condition: Other Specified Injuries of Vocal Cord, Sequela
MeSH terms: Muscle Hypotonia; Wounds and Injuries
Study type: Interventional

Summary: 
      Anesthesia induction and tracheal intubation can be performed with and without neuromuscular
      blocking agents (NMBAs). Tracheal intubation can be performed with sevoflurane instead of
      NMBAs; intubating conditions are similar and the incidence of vocal cord injuries are
      similar, too.
    

Detailed description: 
      We perform tracheal intubation with propofol, remifentanil and sevoflurane; sevoflurane is
      administered with three dosages. During tracheal intubation intubating conditions are noted.
      After surgery, all patients are examined by video laryngoscopy; moreover all patients are
      asked for hoarseness and sore throat.
    

Intervention name(s): sevoflurane 1,0; sevoflurane 1,2; sevoflurane 1,4
Intervention type(s): Drug; Drug; Drug
Intervention description(s): anesthesia induction with propofol, remifentanil, and sevoflurane 1,0 MAC; afterwards tracheal intubation; anesthesia induction with propofol, remifentanil, and sevoflurane 1,2 MAC; afterwards tracheal intubation; anesthesia induction with propofol, remifentanil, and sevoflurane 1,4 MAC; afterwards tracheal intubation
Other intervention name(s): sevo 2,0 %; sevo 2,5 %; sevo 3,0 %
Intervention MeSH terms: Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: hoarseness; sore throat; intubating conditions; vocal cord injuries; sevoflurane
Proteomic Analysis of Human Hepatocellular Carcinoma
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      This is a pilot study to evaluate the difference between the protein expression between
      hepatocellular carcinoma and tumor with vessel invasion in Asian patients with hepatocellular
      carcinoma.
    


Intervention name(s): Operation
Intervention type(s): Procedure
Intervention description(s): Operation for clinically evaluated resectable hepatocelluar carcinoma. Compare the different expression of protein between tumor, non-tumor and tumor with vascular invasion part.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Carcinoma, hepatocellular; Portal vein; Proteomics
Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for the Management of Breakthrough Pain
Condition: Chronic Neuropathic Pain
MeSH terms: Neuralgia; Breakthrough Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of
      ORAVESCENT Fentanyl Citrate for the Management of Breakthrough Pain in Opioid-Tolerant
      Patients with Chronic Neuropathic Pain
    


Intervention name(s): ORAVESCENT Fentanyl Citrate
Intervention type(s): Drug
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment