cyrilzakka/clinical-trials huggingface dataset:
Pregnancy Outcomes in Renal Transplant Recipients

This is a retrospective study involving all patients with a history of renal transplant that attended antenatal clinics at various Toronto hospitals and subsequently delivered between January 2000 and December 2014.

The purpose of this study is to describe the incidence of adverse pregnancy-and transplant-related outcomes, and report placental ultrasound and placental pathology findings in renal transplant recipients with contemporary standards of care in Toronto.

This study also seeks to determine whether factors such as maternal age, transplant-to-pregnancy interval, hypertension, diabetes mellitus, treatment regimens, and the primary cause for renal failure are associated with higher risk of adverse pregnancy outcomes in renal transplant recipients.

Adverse pregnancy outcomes in women with renal transplants have been attributed to a number of factors. A recent systematic review suggested an association between maternal age and adverse pregnancy outcomes such as miscarriage and stillbirth. There are also some data to suggest that maternal hypertension, diabetes mellitus, elevated serum creatinine and proteinuria and some medications such as cyclosporine are associated with adverse pregnancy outcomes such as preeclampsia, intrauterine growth restriction and preterm delivery.There is no consensus on whether the transplant-to-pregnancy interval is associated with adverse pregnancy outcomes. As well, it is not clear if the findings of other studies will also hold true in a Toronto population.

This study seeks to answer the following questions:

1. What is the incidence of adverse transplant- and pregnancy-related adverse outcomes in renal transplant recipients that have had pregnancies between 2000 and 2014 in Toronto and how does this compare with earlier data from Toronto and with recently published data?
2. Are factors such as maternal age, transplant-to-pregnancy interval, hypertension, diabetes mellitus, specific treatment regimens and the primary cause for renal failure associated with an increased risk of adverse pregnancy- and transplant-related adverse outcomes in these women?

Eligibility Criteria:
Inclusion Criteria:

* All patients with a history of renal transplant that attended antenatal clinics at Mt. Sinai Hospital, Sunnybrook Health Sciences Centre and St. Michael's hospital and subsequently delivered between January 2000 and December 2014

Exclusion Criteria:

* Patients who do not meet the above criteria are excluded from the sample
Probiotic Supplementation IN NAFLD Patients

this study aimed to evaluate the effectiveness of Probiotics supplementation (lactobacillus) on NAFLD fibrosis score.

Non-alcoholic fatty liver disease (NAFLD) is a disease characterized by accumulation of fat (\> 5% of the liver tissue), in the absence of alcohol abuse or other chronic liver diseases. NAFLD can cause liver inflammation and progress to non-alcoholic steatohepatitis (NASH), fibrosis, cirrhosis or hepatocellular carcinoma (HCC).

The global prevalence of NAFLD in adults is estimated to be approximately 25%.The prevalence of NAFLD increases with increasing body mass index. in 2012 Chalasani et al, reported that 67% of overweight and 94% of obese individuals have NAFLD.

There is a consensus regarding increasing worldwide prevalence of NAFLD and its impact on health, especially the progression to liver cirrhosis and hepatocellular carcinoma. Longitudinal studies of NAFLD have reported an increase in all-cause mortality, cardiovascular mortality, and liver-related mortality , NAFLD carries a large economic burden and therefore poor health-related quality of life.

Lifestyle changes (diet and exercise) are the major and first suggestions of the guidelines ,as regard pharmaceutical interventions, agents with potential benefit in NASH include thiazolidinediones (TZDs), statins although they are well recognized in the treatment of dyslipidemia, their use as a specific treatment for NAFLD is not well evidenced.

There is some data suggest that disruptions in the gut microbiome may play a role in the pathogenesis of NAFLD and progressions to NASH.

A probiotic is a live microbial culture or cultured dairy product, which plays an important role in health. Probiotics for the treatment of NAFLD are seemingly a promising treatment option. Relatively easy availability, low cost, and absence of serious side effects make probiotics a lucrative choice.

liver biopsy remains the gold standard for NAFLD diagnosis but it is impractical as a diagnostic tool because it is invasive and expensive.

NAFLD fibrosis score constructed from routine clinical and laboratory variables can accurately predict the presence or absence of advanced fibrosis in NAFLD.

Eligibility Criteria:
Inclusion Criteria:

* Age between18 and 60
* BMI ≥ 25 kg/m2
* Sonographic findings of NAFLD +/- elevated liver enzymes (not more than 2 folds increase).

Exclusion Criteria:

* ▪ Any evidence of chronic liver diseases including viral hepatitis (B and C), auto immune hepatitis.

  * History of alcohol drinking.
  * Chronic medication use (drugs that cause elevated liver enzymes, recent antibiotic use or paracetamol use in the last month)
  * Persistent elevation of liver enzymes for 3 months.
  * History of DM.
  * History of statin therapy for cardiovascular disease (CVD).
  * History of recent operation.
  * History of gastroenteritis or diarrhea in the last 2 week.
Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)

The study is being conducted to demonstrate that vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with oral polio vaccine (OPV) without impairing the safety or immunogenicity of either vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Infants in good health

Exclusion Criteria:

* Previous administration of any oral poliovirus vaccine (OPV) and rotavirus vaccine
* Receipt of inactivated poliovirus vaccine (IPV) prior to the first dose of either study vaccine, or at any time during the course of the study
* Any condition resulting in depressed immunity
* Any allergy to any vaccine component as stated in the package circulars
* Allergies to polymyxin B, neomycin or any other antibiotics
* Receipt of intramuscular, oral, or intravenous corticosteroid treatment
* History of congenital abdominal disorders, intussusception, or abdominal surgery; clinical evidence of active gastrointestinal illness
* History of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to thrive
* Prior receipt of a blood transfusion or blood products, including immunoglobulin
* Fever, with a rectal temperature of ≥38.1°C (≥ 100.5°F) at the time of immunization
* Infants residing in a household with an immunocompromised person
Safety, Tolerability and PK of PXL770 in Healthy Male Subjects

PXL770 is a direct activator of 5' adenosine monophosphate-activated protein kinase (AMPK) being developed by Poxel S.A. for the treatment of type 2 diabetes mellitus (T2DM). In Part A of this study, we'll test the safety, tolerability and pharmacokinetics (PK) of repeated doses. In Part B, we'll co-administer PXL770 and rosuvastatin (a HMG-CoA reductase inhibitor) to assess any drug-drug interaction.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine
* body mass index in the range 18.5-29.9 kg/m²
* body weight at least 60 kg
* willing to use reliable contraception
* able to give fully informed written consent.

Exclusion Criteria:

* Pregnant or lactating woman, or sexually active woman of child-bearing potential not using reliable contraception
* Clinically relevant abnormal findings at the screening assessment
* Clinically significant vital signs outside the acceptable range at screening
* Clinically relevant abnormal medical history, surgery or concurrent medical condition
* Acute or chronic illness
* Estimated glomerular filtration rate less than 80 mL/min/1.73 m2
* Severe adverse reaction to any drug or sensitivity to the trial medication or its components
* Significant food allergy; vegetarian or vegan
* Participation in other clinical trials of unlicensed or prescription medicines, or loss of more than 400 mL blood, within the 3 months before first dose of trial medication
* Drug or alcohol abuse
* Smoking of more than 5 cigarettes daily
* Possibility that subject will not cooperate
* Positive test for hepatitis B \& C, HIV
* Objection by a General Practitioner
The Effect of n-3 Fatty Acid Supplementation on Serum Levels, and Gene Expression of type2 Diabetes Patient

The aim of this study is to determine the effects of supplementation with n-3 fatty acid or placebo for 10 weeks on the expression of Sirt-1, AdipoR1 \& AdipoR2 genes in the peripheral blood mononuclear cell (PBMC) and circulatory levels of Resistin, MCP-1 and Adiponectin of type2 diabetes patient

The aim of this study is to determine of the effects of supplementation with n-3 fatty acid or placebo for 10 weeks on the expression of Sirt-1, AdipoR1(adiponectin receptor 1) \& AdipoR2 (adiponectin receptor 2) genes in the peripheral blood mononuclear cell (PBMC) and circulatory levels of Resistin, MCP-1 (Monocyte Chemoattractant Protein-1) and Adiponectin of type2 diabetes patient. In this randomized, double-blind clinical trial, placebo-controlled, 88 men and women with type 2 diabetes are enrolled in the study from the Iranian Diabetes Association. After signing informed consent all individuals complete a general information form , 24-hour food recall for 3 days and beck depression questionnaire will be taken from the participants at the beginning and the end of the study. Selected samples are randomly classified into 2 blocks of groups receiving supplement and placebo. The supplement group, will receive mg 1800mg EPA(Eicosapentaenoic acid ) \& 900mg DHA( docosahexaenoic acid) (total=2700mg) for 10 weeks and the placebo group will also receive placebo (containing 2700 mg of edible paraffin) (similar in terms of color, shape and size). Patients are recommended to sustain their diets and medication dose (s) during the study and also advised to maintain a constant level of physical activity. Blood samples will be collected after 12 hours fasting and anthropometric variables, biochemical parameters, target gene expression and physical activity before and after the trial will be measured

Eligibility Criteria:
Inclusion Criteria:

* willingness to participation,
* diabetic patients 30- 60 years old,
* body mass index in the range 25-40,
* avoidance of dietary supplements,
* vitamins and herbal products at least 3 months before and throughout the intervention

Exclusion Criteria:

* people who have used n-3 Fatty Acid Supplementation in last 3 months,
* having chronic renal disease ,
* GI disease,
* Hepatobiliary diseases,
* hematological disorders,
* hypo- or hyperthyroidism,
* type 1 diabetes,
* treatment with orlistat or sibutramine for weight loss,
* pregnancy and lactation,
* treatment with insulin or Thiazolidinediones.
Comparative Bioavailability of Dexketoprofen Trometamol Oral Solution vs Tablet Formulations

The purpose of this study is to compare the bioavailability of 25 mg DKP.TRIS given as an Enantyum® oral solution (Test formulation) and Keral® tablet (Reference formulation). In addition, this study intends to evaluate the safety and tolerability of Test and Reference formulations.

The study was conducted in 1 site and included 26 successfully screened and randomized healthy subjects(12 female and 14 male).

The study consisted of:

* Screening Visit (performed within 3 weeks prior to 1st PK study session), for the evaluation of study eligibility.
* Two pharmacokinetic (PK) study sessions, separated by a minimum of a 7 day washout period, including the administration of one out of 2 study treatments at each study session (namely 25mg DKP.TRIS given as Enantyum® oral solution or Keral® tablet) according to the sequence as per randomisation list, and blood sampling for PK assessment on plasma at pre-defined time up to 24 hours post-dose.
* End of Study Visit (7-10 days after last treatment administration).

Eligibility Criteria:
Inclusion Criteria:

- Healthy male and female subjects between 18 to 50 years old, with a Body Mass Index (BMI) between 18 Kg/m2 and 28 Kg/m2-

Exclusion Criteria:

* History of previous allergy idiosyncrasy / sensitivity to DKP.TRIS or other NSAIDs (aspirin, ibuprofen etc).
* Any condition which might interfere with the absorption, distribution, metabolism or excretion of the drugs.
* Surgery within previous 6 months, or blood loss \> 400 mL within previous 3 months.
* Subject with positive human immunodeficiency virus (HIV), hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results.
* History of clinically significant alcohol, medicine or drug abuse.
Diagnosis of Bacteremia/Septicemia and Culture Negative Endocarditis by the Karius Sequencing-Based Infectious Disease Diagnostic Assay

Prospective study at Duke University Hospital comparing the Karius Infectious Disease Diagnostic Sequencing Assay to blood culture results in admitted patients with bacteremia/septicemia.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. A positive blood culture
3. A suitable residual blood sample collected within 24 hours of the positive blood culture OR
4. A blood sample obtained for the study obtain within 48 hours of the positive blood culture

For Endocarditis Cohort:

1. All criteria above must be met and patient is admitted to the hospital and evaluated for acute endocarditis classified per the Duke Criteria

Exclusion Criteria:

1. Inability to understand instructions and comply with study-related procedures
2. Any condition that in the opinion of the treating physician will prevent the subject from completing the study
Balloon-Stent Kissing Technique Versus Jailed Wire Technique for the Coronary Bifurcation Lesions

To compare the immediate and long-term clinical outcomes between Balloon-Stent Kissing Technique (BSKT) and Jailed Wire Technique (JWT) for the interventional treatment of coronary bifurcation lesions.

Coronary bifurcation lesions account for 15-20% of percutaneous coronary interventions (PCIs)\[1-2\]. They have lower success rate after operation, higher re-stricture ratio by radiography and frequent complications, which result in adverse clinical outcomes as compared to non-bifurcation lesions\[3-5\]. Secure and efficient treatment strategies for PCI and bifurcation lesions are research hotspots for cardiovascular surgeons. Single-side stand strategy (main-support implantation stand or side-support implantation stand when necessary) is currently preferred for bifurcation lesions\[2,6\]. However, as main-support implantation stand could lead to plaque transposition, bifurcation ridge excursion and side a sandwich, the side openings could become narrower or even blocked\[7\]. In 2011, our centre initiated the use of balloon-stent kissing technique (BSKT)\[8\] to protect the side branch, which has higher success rate after operation, lower block ratio of side branch and lower incidence of perioperative adverse events, which led to immediate clinical effect. This study compared BSKT versus Jailed Wire Technique (JWT) in the interventional treatment of coronary bifurcation lesions to further clarify BSKT's efficacy and advantages.

Eligibility Criteria:
Inclusion Criteria:

* 1. patients with CHD; 2. coronary arteriography revealed true bifurcation lesion

Exclusion Criteria:

* 1. severe carcified lesion; 2. left main lesion; 3. severe heart failure(NYHA grade 4)
Neoadjuvant Therapy With Docetaxel and Ketoconazole in Patients With High-Risk Prostate Cancer: A Pilot Study

Eligible patients with high-risk prostate cancer who are scheduled to undergo radical prostatectomy will receive four cycles of therapy with ketoconazole and docetaxel prior to surgery resection. A cycle of therapy is defined as 21 days (three weeks). Pharmacokinetic analysis will be performed with the first and second cycle of therapy. All patients will be evaluated for toxicity, tumor response, and recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically proven adenocarcinoma of the prostate.
* Patients must meet at least one of the following high risk criteria:

  * PSA \> 20
  * Gleason score 8 or greater
  * Presence of pathological Gleason grade 4 or higher as the majority sum on biopsy core
  * Greater than 50% of cores at time of biopsy positive for cancer
  * Clinical Stage T3 Disease
  * Patients must have PS of 0-1(ECOG) and medically deemed a surgical candidate for radical prostatectomy.
  * Age \> or = to 18.
  * Patients with a pre-existing peripheral neuropathy of equal to or greater than grade two are ineligible.
  * Serum Creatinine must be \< or equal to 2.0mg/dl.
  * Patients must currently not receiving any drug which is metabolized by cytochrome P450-3A4 including the statins, cyclosporin, terfenadine and erythromycin.
  * Prior to receiving any dose of docetaxel, patients should have absolute neutrophil counts \> 1,500, hemoglobin \> 8.0 g/dl and platelet counts \> 100,000/mm3.
  * Patients with bilirubin elevated above institutional upper limit of normal (ULN)must be excluded. Transaminases (SGOT and/or SGPT) may be up to 5.0 x institutional upper limit of normal (ULN) if alkaline phosphatase is \< ULN, or alkaline phosphatase may be up to 5 x ULN if transaminases are \< ULN. However, patients who have both transaminase elevation \> 1.5 x ULN and alkaline phosphatase \> 2.5 x ULN are not eligible for this study (due to decrease clearance of docetaxel and increased risk of toxicity).
  * Patients receiving concurrent warfarin are eligible but require monitoring of protime on a weekly basis.
  * Patients with clinical stage T4 disease are not eligible.
  * Patients must not had have received prior treatment with surgery, radiation or hormone deprivation.
  * Patients with other primary malignancies previously treated with chemotherapeutic agents are not eligible.
  * Patients must not have had a history of peptic ulcer disease requiring treatment with surgery or endoscleral.
  * Patients requiring corticosteroids for other systemic diseases are not eligible.
  * Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 are not eligible.
  * All patients must sign informed consent.
  * Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
Study to Evaluate the Feasibility of [18F]Florbetapir PET for Assessment in MS Patients

The purpose of this study is to evaluate the feasibility of \[18F\]Florbetapir positron emission tomography (PET) for assessment of demyelination in the patients with relapsing remitting multiple sclerosis.

The underlying goal of this study is to assess the feasibility of \[18F\]Florbetapir as an imaging tool to detect demyelination in the brain of MS research participants and compare to similarly aged healthy subjects.

Eligibility Criteria:
Eligibility criteria (for all subjects):

* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations
* Willingness to comply with study procedures
* Willingness to provide written informed consent
* Age greater than or equal to 18 and less than or equal to 60 years old at the time of the informed consent
* Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception until PET testing is completed
* For females, must be of non-childbearing potential or have a negative urine and blood pregnancy test on the day of \[18F\]Florbetapir PET injection

Inclusion Criteria (Healthy Volunteers):

* No history of or signs of acute or chronic neurological or psychiatric illness based on evaluation by a research physician.

Inclusion Criteria (MS Subjects):

* Have a diagnosis of relapsing remitting MS according to the 2010 MacDonald Criteria
* Have at least 10 demyelinating lesion on brain MRI with the following characteristics:
* Hypointense on T2 weighted images with FLAIR

Exclusion Criteria (for all subjects):

* The subject has clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
* The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological (other than RRMS), immunodeficiency, pulmonary, or other disorder or disease.
* Women who are pregnant or actively breastfeeding
* The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery)
* The subject has participated in another clinical study within the previous 30 days
* Renal impairment with a creatine clearance \<80mL/minute at screening (creatine clearance estimated by Cockcroft-Gault equation)
* The subject is scheduled to have a major surgery or procedure during the time of the study.
Comparing the Outcomes of Virtual Reality Based Serious Gaming and Lecture Based Training for Advanced Life Support

The hypothesis of this study is to reveal whether virtual reality(VR) based Advanced Life Support(ALS) serious game module can replace classroom-based ALS lecture, which is part of existing ALS training protocol in addition to skills training.

The participants consisting of students from Acibadem Mehmet Ali Aydinlar University Vocational School for Anesthesiology (N=29) were randomly divided into two groups with 15 (Conventional training group) and 14 (VR based training group) participants each. The members of the conventional group had to complete pretest at the beginning of the study. Afterwards they had to take part at an interactive classroom based lecture about ALS. The next step was the skills training with task trainers in order to teach them compression skills. Afterwards, the conventional group was divided into three blue code teams consisting of each 5 participants for the simulation session. Two independent instructors evaluated the video recordings in terms of technical and nontechnical skills. The final stage of the study were completing the post-test. The members of VR group had a similar study flow but they had to play with the VR based ALS serious game module instead of the theoretical lecture during the study flow. A survey about preference of VR based trainings was conducted for the members of the VR group. Mann Whitney U Test and Wilcoxon Signed Ranks Test were used for statistical analysis of the two groups' performances in this study.

Eligibility Criteria:
Inclusion Criteria:

* Having normal or corrected to normal vision
* No history of visually induced motion sickness

Exclusion Criteria:

* Previously experienced VR-induced motion sickness
* Other medical conditions (Epilepsy, vertigo attacks)