cyrilzakka/clinical-trials huggingface dataset:
Prograf-Advagraf Cross Over Conversion Study

The present study is aimed at evaluating the impact of a switch from Prograf to Advagraf on renal function, trough tacrolimus levels, drug-related adverse effects and adherence in stable recipients of kidney-pancreas transplants. MPA pharmacokinetics will also be evaluated. The results of this study have the potential to change current practice.

Tacrolimus (Prograf ©) has become part of the standard of care for patients receiving solid organ transplants and is part of the immunosuppressive protocol used by kidney-pancreas transplant recipients at University Health Network (UHN). Tacrolimus is associated with several toxicities, and as a result, careful therapeutic drug monitoring of tacrolimus is a key component of post-transplant management. Trough serum concentrations of tacrolimus are measured routinely and are used to guide dosing. Tacrolimus trough levels are known to correlate with total drug exposure. The Prograf formulation of tacrolimus has a fairly short serum half-life and must be dosed twice daily to maintain therapeutic serum concentrations. This results in two high peak levels each day which have been shown to correlate with toxicity. Thus, avoidance of high peaks may be desirable to minimize tacrolimus toxicity.

Advagraf is a new preparation of tacrolimus that is formulated to provide similar drug exposure to tacrolimus but with a once daily dosing regimen, which avoids the 2 daily high tacrolimus peaks observed with Prograf. In this way, it is hoped that Advagraf may provide similar therapeutic efficacy as Prograf but with fewer adverse effects. In addition, the simpler dosing regimen is expected to enhance patient adherence. Tacrolimus has also been shown, along with many other drugs, to have a variable impact on mycophenolate acid (MPA) pharmacokinetics. There are currently few data on whether Advagraf impacts MPA pharmacokinetics to the same or a lesser degree than Prograf.

Eligible kidney-pancreas recipients will be recruited and after obtaining informed consent, randomized to continue their current total daily Prograf dosage or switch to the equivalent once daily dose of Advagraf. Patients will continue randomized therapy for 12 weeks and will then cross over to the opposite therapy for another 12 weeks. Patients will be followed and maintained on the same medication designated at week 24. Bloodwork results, adherence and AEs (adverse events) will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* recipient of kidney and pancreas transplant
* aged 18 years or older
* 12 months or more since time of transplant
* stable allograft function (creatinine \< 180 µmol/l and eGFR \> 40 ml/min)
* targeted to a tacrolimus trough level of 5-10 ug/ml that has been stable during the prior 3 mo.

Exclusion Criteria:

* episode of acute rejection within 6 months of screening
The Extended Gestational Age Medical Abortion Study

This open-label, comparative study will compare the efficacy, safety, and acceptability of 200 mg mifepristone followed in 24-48 hours by 800mcg buccal misoprostol or 400mcg sublingual misoprostol for termination of pregnancy in existing outpatient early medical abortion services among women 57-63 days' versus 64-70 days' gestation.


Eligibility Criteria:
Inclusion Criteria:

* intrauterine pregnancy of greater than 56 days and less than 71 days
* eligible for medical abortion according to study doctor assessment
* willing and able to sign consent forms
* speak English or Spanish (in US sites); speak the local language(s) (in international sites)
* agree to comply with the study procedures and visit schedule
Nab-paclitaxel Combined With Gemcitabine as Adjuvant Therapy for Pancreatic Cancer After Curative Resection

Pancreatic cancer has an extremely poor prognosis with a 5-year survival rate of less than 5%. About 25% of patients have the opportunity for radically surgical resection when diagnosis. However, the recurrence rate is up to 85% within 2 years. Data from clinical trials indicated that gemcitabine-based adjuvant chemotherapy reduced recurrence and enhanced overall survival for patients who have undergone surgery to remove their tumor. Nab-paclitaxel could enhance the intratumoral concentration of gemcitabine; recent studies showed that nab-paclitaxel plus gemcitabine significantly improved progression-free survival and overall survival of metastatic pancreatic cancer patients. The present study is intended to investigate the activity and safety of the combination of gemcitabine and nab-paclitaxel as adjuvant chemotherapy in treating patients with pancreatic cancer after curative resection.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed content obtained prior to treatment
* Age ≥ 18 years and ≤ 75 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Patients must have histologically confirmed pancreatic adenocarcinoma (or any mixed pathology if adenocarcinoma is predominant) after curative resection (R0). The pathological staging does not exceed the stage IIB.
* No tumor lesions are seen by abdominal and thoracic CT scan 4\~8 weeks after surgery, and no serious adverse events are occurred during this period
* The expected survival after surgery ≥ 6 months
* White blood cell (WBC) ≥ 3 × 109/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelets (PLT) ≥ 100 × 109/L; Hemoglobin (Hgb) ≥ 9 g/dL
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]/ alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) ≤ 2.5 × institutional upper limit of normal (ULN); Total bilirubin (TBIL) ≤ ULN; Creatinine (CRE) ≤ 1.5 × ULN
* Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 × ULN

Exclusion Criteria:

* Active second primary malignancy or history of second primary malignancy within the last 3 years
* Patients who have received any form of anti-tumor therapy before surgery, including chemotherapy, radiotherapy, interventional chemoembolization, radiofrequency ablation, and molecular targeted therapy
* Use of any other investigational agents
* Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, internal hemorrhage, pancreatic leakage, bile leakage, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* History of allergic reactions attributed to compounds of similar chemical or biological composition to nab-paclitaxel or gemcitabine
* Metabolic acidosis, acute or chronic, including ketoacidosis
* Pregnant or nursing women
* Human immunodeficiency virus (HIV)-positive patients
* Patients who are unwilling or unable to comply with study procedures
Comparison Between High-density Electroencephalography and Conventional Electroencephalography for Comatose Patients

The purpose of this study is to measure whether high-density electroencephalography can improve the detection of electrophysiological signs of awareness compared to conventional electroencephalography in post-anoxic comatose patients


Eligibility Criteria:
Inclusion Criteria:

* post anoxic coma
* over 18 years old
* agreement from families
* alive 4 days after the beginning of coma

Exclusion Criteria:

* traumatic coma
* non-traumatic but not anoxic coma
* patients with severe comorbidity previous to coma
* refusal of families to participate to the study
* contraindication to a high-density electroencephalography exam
Postoperative Pain in Adult Patients.

Each surgical intervention associated with even a minor tissue injury is a source of pain which needs to be effectively controlled. Although the Polish national guidelines for post-operative pain management have been published, many patients experience moderate and severe pain in the postoperative period. The aim of this study is (1) to assess pain severity among adult patients after different types of surgeries; (2) to identify demographic and clinical factors associated with postoperative pain.


Eligibility Criteria:
Inclusion Criteria:

* adult
* elective surgery
* the American Society of Anesthesiologists score 1-3

Exclusion Criteria:

* diagnosed mental illness, alcohol abuse disorders, intellectual disability
* traumatic events within the last 6 months (e.g. death, breakdown of a relationship, job loss)
* problems with verbal communication
Sexual Risks in Prep Users

Primary purpose of the study: to describe sexual behavior of Prep users, whatever mode of intake, ie continuous or on-demand; it has been shown in some studies, an increase of sexual risks in Prep users, and therefore an similar increase of STIs (sexually transmitted diseases); using a self-questionnaire, we'd like to evaluate sexual behavior before, and 6 months after, starting Prep.

Secondary purposes: to describe medical characteristics of Prep users (past medical condition, demographic characteristics, vaccinations, kidney function, serological results, urine and anal/pharyngeal swabs), clinical and biological Prep safety, STIs occurrence, and antibiotic prescriptions, continuous or on-demand intake, Prep indication.


Eligibility Criteria:
Inclusion Criteria:

* non HIV-infected subjects
* men aged 18 years or older
* having non protected sexual relationship
* taking Prep (emtricitable/tenofovir disoproxil fumarate) either every day, or on-demand
* affiliated to social security

Exclusion criteria:

* HIV-infected patients
* refusal of study participation
* not on Prep
* not fluent in French language
* safeguarding justice
* on guardianship or trusteeship
Imaging NSCLC Treatment Response to Immunotherapy

This feasibility study will aim to assess the potential for functional imaging biomarkers (18FDG PET-CT and DW-MRI) to differentiate immunotherapy induced inflammation, indicative of response from non-response in patients with stage IV non-small cell lung cancer (NSCLC).

30 patients, recruited from within the PEAR Study (Phase 1 dose escalation of palliative radiotherapy with anti-PD1 antibody pembrolizumab in thoracic tumours) will be scanned both before and after receiving immunotherapy for NSCLC. Immunotherapy induced changes in tumour ADC on DW-MRI (a surrogate of apoptotic tumour cell death) will be compared with changes in near contemporaneous, anatomically co-registered 18FDG PET-CT SUV (a non-specific marker for GLUT expression and hence metabolic activity in both tumour and tumour infiltrating lymphocytes). For treatment response, an increase in ADC (reflecting apoptosis within the tumour) is expected, while 18FDG uptake is expected to decrease compared with baseline tumour uptake. In the presence of significant inflammatory cell recruitment, the investigators hypothesise a similar increase in ADC on DW-MRI but without associated reduction in 18FDG PET-CT SUV. Thus the relationship between the ADC change on DW-MRI and the 18FDG change should distinguish between response and non-response in the presence of inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Recruited to PEAR: Phase 1 dose escalation of palliative radiotherapy with anti-PD1 antibody pembrolizumab in thoracic tumours Study

Exclusion Criteria:

* MRI incompatible metal implants
* Claustrophobia
A Pilot Study of the Safety of MC-1101 in Both Normal Volunteers and Patients With Early Dry AMD

The safety and comfort of repeated administrations of a topically-administered ophthalmic formulation of MC-1101 will be established through investigator assessments and subject reporting over a 3 day period. Safety assessments will be performed on both normal, healthy subjects as well as those with the signs and symptoms of early non-exudative age-related macular degeneration (dry AMD).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of dry AMD or;
* Normal, healthy volunteer

Exclusion Criteria:

* Uncontrolled systemic disease
* Women who are pregnant, nursing, or planning a pregnancy during the study's duration
Assessing How Normal Variations in CT Scanning Affects Its Interpretation

The purpose of the study is to see how measurements of tumor differences vary with slight changes in CT scan parameters. Reproducible radiomic features can be extracted for abdominal tumors, and specifically colorectal liver metastases, imaged with clinical CT scanners even in the setting of variable scan parameters and variable contrast timing. Participants will be consented to undergo an additional CT of their abdomen.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age on the day of signed informed consent
* Patients scheduled and approved for contrast enhanced CT that includes imaging of the abdomen and pelvis following the Department of Radiology standard of care protocol as per local institutional guidelines
* Patients with measurable colorectal liver metastases on prior imaging, with at least one tumor greater than 2.0 cm in axial maximal diameter

Exclusion Criteria:

* Patient who is pregnant and/or lactating
* Patient scheduled for CT that includes the abdomen with a multiphasic contrast enhanced protocol (e.g. Triple Phase or Quadruple Phase Liver CT)
* Patient who require reduced intravenous contrast dose based on the Department of Radiology contrast policy as per local institutional guidelines
* Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or follow up procedures
Heat Strain Prevention in Elderly Agricultural Workers

The study explores a multi-component heat strain prevention program for older agricultural workers in response to climate change. It assesses hydration, rest breaks, reflective clothing, and shade provision. Utilizing a quasi-experimental design, it targets 120 elderly workers, evaluating core temperature, heart rate, and heat strain symptoms. The goal is to establish the program's effectiveness in safeguarding worker health and safety amidst increasing temperatures, offering evidence-based recommendations for this vulnerable group and potentially other occupations affected by climate change.

This intervention study is designed to assess the efficacy of a sustainable heat strain prevention program tailored for elderly agricultural workers. It targets a specific population of 120 workers aged 60 years and above from Manial Shiha village. The study utilizes a quasi-experimental pretest-posttest design, dividing participants into intervention and control groups.

The core of the study involves a 4-week Sustainable Prevention Program, emphasizing practical and adoptable strategies like adequate hydration, regular rest breaks, the use of lightweight reflective clothing, and the provision of portable shade covers. This program is delivered through interactive methods including lectures, demonstrations, and group discussions, supplemented with educational materials.

Physiological responses to the program will be rigorously measured, employing core temperature sensors and heart rate monitors to provide objective data on the physical impact of the interventions. These measures, along with self-reported symptoms and heat strain levels collected through structured questionnaires, form the basis for a comprehensive evaluation of the program's effectiveness.

The study aims to provide a quantifiable reduction in heat strain indicators, offering insights into the program's potential for broader application in similar vulnerable populations

Eligibility Criteria:
Inclusion Criteria:

* Age 60 years or older
* Actively working in agricultural occupations (farming, field labor, etc.)
* Available to participate during the 4-week intervention timeline
* Fluent in spoken and written Arabic
* Agree to wear physiological monitoring devices during work

Exclusion Criteria:

* Unable to provide informed consent
* Cognitive impairments affecting ability to understand and implement program guidelines
* Dependence on supportive equipment like canes or wheelchairs
* Chronic medical conditions expected to worsen with heat exposure (e.g. uncontrolled cardiovascular disease, kidney failure)
* Required regular medications that impair thermoregulation
* Allergies or sensitivities to monitoring devices and their attachments that cannot be mitigated
Studying the Incidence of Erectile Dysfunction in Patients Complaining of Congenital Penile Curvature

Patients complaining of congenital penile curvature were subject to Penile duplex study to assess their curvature. Their penile duplex data including Peak Systolic velocity, End Diastolic velocity and Resistivity index were recorded as well as their assessing the degree of curvature and the quality of their erection using the erection hardness grading scale.


Eligibility Criteria:
Inclusion Criteria:

* Complaining of congenital curvature

Exclusion Criteria:

-
The Impact of a Continuous Performance Task on the Stress Response

The goal of this clinical trial is to learn about the impact of taking a continuous performance attention test on the physiological stress response in college students. The main questions it aims to answer are:

* Does taking an attention test cause participants to have increases in heart rate, blood pressure, and sweat?
* Does taking an attention test cause participants to have a decrease in heart rate variability?
* Are there relationships between participants' levels of anxiety, perceived stress, and mindfulness to their physiological changes?

Participants will

* Answer questionnaires about anxiety, stress, and mindfulness
* Have baseline measurements taken for blood pressure, sweat, and heart rate variability
* Take the PEBL Continuous Performance Task (a 14 minute attention test) while having the measurements listed above taken again

The PEBL Continuous Performance Task is an example of a mental stressor which requires vigilance and effort. We hypothesize that a sympathetic nervous system response will be evident in comparing physiological parameters during the attention task versus the preceding resting baseline period. Exploratory analyses will assess relationships between psychological measures of anxiety, stress, and mindfulness with this physiological response and the number of errors on the attention test.

Eligibility Criteria:
Inclusion Criteria:

* English language proficiency
* First year, first semester student enrolled in Students Together Empowering Peers course at the University of Redlands

Exclusion Criteria:

* severe mental health issues
* currently taking anti-anxiety medication
Nutrition and Prostate Cancer

The purpose of this study is to assess the efficacy of Fermented Soy vs. placebo in 72 adults with localized prostate cancer prior to radical prostatectomy.

This is a parallel group, double-blind, randomized clinical trial with two arms. The primary aim is to assess the efficacy of Fermented Soy vs. placebo in 72 adults with prostate cancer. This study has 1 primary aim and 3 (1a thru 1c) sub aims. Aim 1 is to assess the effect of Fermented Soy (QC) on PSA (prostate specific antigen) In parallel, in Aims 1a-1c will assess tumor-specific effects of QC:

Aim 1a: Identifying the anti-tumor effects of QC. This will be done by culturing multiple human cancer cell lines with QC at a range of concentrations, followed by readouts at different time points, of tumor cell apoptosis, proliferation, and senescence.

Aim 1b: Identify a hierarchy of tumors that are responsive to QC. From the data in aim one an attempt will be made to identify a hierarchy of anti-tumor effects.

Aim 1c: Investigate the signaling pathways in tumor cells that are modified by QC. To do this, full genomic profiling will be conducted for breast and prostate tumor cell lines, and will be done in conjunction with analysis of the relevant signaling pathways, and will include P53 and P21 activation pathways.

Eligibility Criteria:
Inclusion Criteria:

* Histologically verified Prostate Cancer (at any stage)
* Scheduled to be treated by radical prostatectomy within the next 4-10 weeks
* Understanding and willingness to provide consent

Exclusion Criteria:

* Previous (within 6 months of enrollment) or concurrent hormonal therapy or chemotherapy; specifically, treatment with 5-alpha reductase inhibitors (finasteride and dutasteride)
* History of hormone dependent malignancies
* Concomitant thyroid disease or currently taking thyroid hormone replacement medication
* Current high-dose soy consumption, micronutrient, or herbal supplements, on soy or vegetarian nutrition, or any other extreme dietary habits
* Current or past history of any liver or pancreas disease
* History of allergy or hypersensitivity to soy-containing products
* Malabsorption conditions that might interfere with absorption of the investigational product
[18F]Florbetazine ([18F]92) for Beta Amyloid PET Imaging in Alzheimer's Disease

\[18F\]Florbetazine (\[18F\]92) is a molecularly targeted imaging agent for Aβ protein with a novel diaryl-azine scaffold. It has shown specific binding affinity to Aβ aggregates in postmortem human AD brains and excellent brain pharmacokinetic properties with little non-specific retention in white matter in animal studies and a limited number of patients with Alzheimer's Disease (AD).

The purpose of the current study is to examine the binding properties of \[18F\]Florbetazine in human subjects and to compare the cortical and white matter binding with \[11C\]PiB or \[18F\]Florbetapir in the same subjects.

Imaging of the brain will be completed in healthy adult normal control participants and participants with cognitive impairment (including probable AD and dementia due to other conditions) to characterize \[18F\]Florbetazine uptake in the brain and its binding properties. \[11C\]PIB or \[18F\]Florbetapir PET imaging along with MRI will be completed in the same participants and the data will be compared with 18F-\[18F\]Florbetazine.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Age ≥ 40 years
* Healthy participants or patients with probable Alzheimer's disease or with dementia due to other causes

Exclusion Criteria:

* Has allergy to \[18F\]Florbetazine or any of its excipients ;
* Has hypersensitivity to \[11C\]PIB or any of its excipients ;
* Incapable of providing written informed consent or lacking a legally authorized representative (LAR) to provide informed consent ;
* Unwilling or unable to undergo PET scans tracer injections ;
* Unwilling or unable to undergo MRI;
* Any condition that, in the Investigator's opinion, could increase the risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection/analysis of the data (e.g., renal or liver failure, advanced cancer);
* Women who are currently pregnant or breastfeeding;