cyrilzakka/clinical-trials huggingface dataset:
Oxidative Stress and Nutritional Supplementation Intervention Study

A major means whereby oxidative stress promotes aging-related disease is by activating inflammatory pathways. Decreasing oxidative stress and inflammation should ameliorate many of the problems associated with aging, including vascular dementia, Alzheimer's disease, osteoporosis, muscle wasting, insulin resistance, type 2 diabetes, and metabolic syndrome. Animal and human studies have demonstrated that consumption of vitamin D and phase 2 protein inducers decrease oxidative stress and associated inflammation. The flax lignan secoisolariciresinol diglucoside (SDG) is metabolized to enterolactone, a potent phase 2 protein inducer. Animal and human studies have shown that consumption of flax seed or its component SDG decreases hypertension, serum cholesterol, atherosclerosis, the growth of experimentally-induced cancers as well as metastases of human breast tumours implanted into nude mice, and delays the development of type 2 diabetes. Vitamin D plays a role in modulating inflammation, enhancing immunity (while suppressing autoimmune injury) and exerting control over cell differentiation. Adequate levels of vitamin D also appear to promote better glycemic control. The investigators predict that consumption of SDG in persons with adequate vitamin D status will decrease oxidative stress and associated inflammation. If this hypothesis is upheld, this research has the potential to greatly decrease healthcare costs while allowing healthier aging.


Eligibility Criteria:
Inclusion Criteria:

* adults residing in a long term care facility
* resident for a minimum of four weeks prior to entry
* able to comply with study protocol
* able to follow simple instructions
* able to give informed consent or has a legally acceptable representative who is able to provide consent

Exclusion Criteria:

* Age below 60 or above 80 years.
* Individuals at risk of hypotension or with symptomatic hypotension.
* Fasting hypoglycemia.
* Unstable diabetes
* Diabetics taking insulin
* Current cancer or diagnosed with cancer in the past 2 years.
* Women with an immediate family history or personal history of breast cancer or ovarian cancer
* Significant liver disorder
* Significant gastrointestinal disorder including inflammatory bowel disease but not constipation
* Significant kidney disorder
* Unstable or severe cardiac disease, recent MI or stroke either in past 6 months or significantly (i.e., severely) affecting physical mobility.
* Unstable other medical disease including, but not limited to, pulmonary disorder, epilepsy and genitourinary disorder.
* Migraine with aura within the last year (as this is a risk factor for stroke).
* Current diagnosis of a bleeding condition, or at risk of bleeding.
* Significant immunocompromise.
* Other unstable conditions.
* Current use of hormone replacement therapy except thyroid medication
* Current use of warfarin, clopidogrel, ticlopidine, dipyridamole or their analogues.
* Intolerances or allergies to flax or vitamin D.
* Estimated probability of longevity of less than one year based on medical opinion
The Bowel CLEAnsing: A National Initiative

The purpose of this study is to compare diet, type of bowel preparation and time of colonoscopy to determine if one method is better than the other and, if they are the same, identify the one which is the most convenient for the patients.

The objective of the current proposed trial is thus to compare the cleanliness achieved with PEG high-volume (2L+2L) split-dose versus PEG (1L+1L)+Bisacodyl low-volume split-dose, or PEG high volume (4L) non-split day before versus PEG low volume (2L) non-split same day preparation, according to time of endoscopy (early or later), as well as assess the role of diet (low residue or clear liquid diet) according to these different Canadian outpatient preparation regimens.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients
* 18 years or older
* Able to comprehend the trial
* Have an indication for full colonoscopy

Exclusion Criteria:

Subjects are excluded from enrollment into the study if any of the following are present:

General exclusion criteria:

* Subject refusal
* Previous bowel preparation in the last 14 days
* Pregnancy or breastfeeding
* Reduced mobility

Medical/Endoscopic exclusion criteria:

* Suspected or diagnosed with bowel obstruction
* Any colonic surgery
* Toxic megacolon
* Ileus
* Ischemic colitis
* Decompensated heart failure
* Severe acute renal failure
* Severe liver disease
* Severe electrolyte imbalance
Ease of Use and Blood Clotting for the Gambro Polyflux HD-C4 Big Dialyzer

The purpose of this study is to collect information on the ease of use and thrombogenicity of the Polyflux HD-C4 Big and Fresenius Optiflux 180NR or 200NR dialyzers under conditions of routine clinical use for hemodialysis.

This ease of use study involves the use of FDA 510(k) cleared hemodialyzers and will have no impact on the patient's routine dialysis therapy. This study is aimed at obtaining feedback from the nursing and technical staff regarding the use and thrombogenicity of the Polyflux HD-C4 Big, and Fresenius Optiflux 180NR or 200NR dialyzers. The dialysis nursing staff will complete ease of use and thrombogenicity assessments following routine dialysis therapy. Any adverse events will be tracked for the study patients.

Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis patients 18 years of age or older

Exclusion Criteria:

* n/a
Impact of an E-learning Tool on Patient Satisfaction, Knowledge and Medication Adherence in Solid Organ Transplantation: A Randomized Controlled Trial

Solid organ transplant recipients (SOTR) must follow complex medication regimens and require a substantial amount of education for effective self-management. The current standard of care for post-transplant medication teaching is a Self Medication education program conducted in hospital by the pharmacist. The Transplant Medication Information Teaching Tool (TMITT) is a web-based e-learning tool for SOTR developed at the Toronto General Hospital. The ability to control the content, sequence, pace and timing of education in order to achieve personal learning objectives, as well as the opportunity for ongoing review and reinforcement of information, may be an attractive, convenient and effective teaching modality.

SOTR will be randomly assigned to receive the standard of care or the standard of care plus the TMITT intervention. Primary objectives are to compare patient satisfaction and medication knowledge between the two groups at baseline and 3 months using modified versions of previously published questionnaires. Medication adherence as measured by a multidimensional approach including both subjective and objective components, will also be compared at 3 months. Our hypothesis is that an education strategy that includes both the standard pharmacist teaching followed by a tailored online e-learning intervention post-discharge will lead to improved patient satisfaction, knowledge and medication adherence.


Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing solid organ transplantation at Toronto General Hospital during the study period

Exclusion Criteria:

* non-English speaking/reading
* no internet access at home
* planned discharge to a rehab facility without internet access
* not on a calcineurin inhibitor (CNI) or sirolimus
* attending the Self Medication class on the same day as hospital discharge
* cognitive impairment that precludes participation in Self Medication program (as per the assessment of the transplant pharmacist)
* incapable of providing informed consent
Furthering Equity Through Infant Feeding EDucation and Support

The purpose of this study is to identify whether adding clinically integrated breastfeeding peer counseling (ci-BPC) to standard lactation care is associated with a reduction in disparities in breastfeeding intensity and duration for Black and Hispanic/Latine families.

FEEDS is a randomized control trial comparing standard lactation care to standard lactation care plus a ci-BPC. This trial will take place at three hospitals in the Chicago land area, Swedish Hospital, Highland Park Hospital, and University of Chicago Medicine Hospital. The aims of the study are: (1) To determine whether ci-BPC reduces disparities in breastfeeding outcomes for Black and Hispanic/Latine participants, (2)To determine whether ci-BPC improves breastfeeding knowledge, attitude, access to support, and empowerment and (3) To understand implementation outcomes, facilitators, and barriers.

Eligibility Criteria:
Inclusion Criteria:

* 12 and 20 weeks gestation
* English or Spanish speaking
* Planning to parent their infant
* Planning to deliver at SH, HPH or UCM
* No prior exposure to ci-BPC

Exclusion Criteria:

* considering pregnancy termination or adoption
* Prior exposure to ci-BPC
Interest of the Automated Management of Deep Neuromuscular Blockade Monitoring (CURATP)

Neuromuscular blockade (NMB) recommendations updated in 2018 by the Société Française d'Anesthésie et Réanimation (SFAR) recommend the use of NMB agents to facilitate surgical procedure during abdominal surgery by laparotomy or laparoscopy.

This study aims to evaluate deep NMB monitoring with automated management of NMB depth measurement (ATP mode) versus non-automated monitoring (PTC/TOF), in order to improve the maintenance of deep NMB during abdominal surgery.

The beneficial effects of deep NMB on the surgical conditions and thus the per and post operative surgical morbidity have been demonstrated in several studies, but the evidence are not yet consistent enough to make recommendations.

The monitoring of per operative NMB remains the rule, using the Train Of Four (TOF) at the ulnar nerve at the adductor of the thumb. However, when deep NMB for the most resistant muscles of the body is required (diaphragm and abdominal wall), the Post Tetanic Count (PTC) should be used.

In order to better adjust the NMB to the conditions of muscle relaxation required during surgery, an automatic mode called ATP for Automatic TOF/PTC has been developed (TofScan, Idmed, Marseille, France).

The investigators hypothesized that the use of the ATP would be able to better insure deep NMB, and to limit interventions on patients and/or on the NMB monitor during surgical procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be included if they meet all the following criteria :
* Age ≥ 18 years
* Scheduled Abdominal surgery by laparoscopy (digestive, urological and gynaecological) with a planned procedure duration of more than one hour, requiring deep NMB by rocuronium
* ASA I, II or III
* Free subject, without guardianship, curatorship or subordination
* Signed informed consent

Exclusion Criteria:

* Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection.
* Induction in rapid sequence,
* Use of an other NMB agent than rocuronium
* Predictable difficult intubation
* Persons participating in another clinical trial
Randomized, Single-Masked, Long-Term, Safety and Tolerability Study of VEGF Trap-Eye in AMD

Rollover study for subjects in prior VEGF Trap-Eye Phase I and II studies. Primary objective is to assess long-term safety and tolerability of continuing intravitreal treatment in subjects with wet age-related macular degeneration.

Randomized, Single-Masked Phase II study for subjects previously enrolled in Phase I and II studies for wet age-related macular degeneration with VEGF Trap-Eye intravitreal injection as treatment.Long term (3 years) treatment is intended to measure safety and tolerability, as well as frequency of re-treatment and the effect of VEGF Trap-Eye on best corrected visual acuity (BCVA).

Eligibility Criteria:
Inclusion Criteria:

* Prior participation in VEGF Trap-Eye Phase I and II studies

Exclusion Criteria:

* Any ocular or systemic adverse events that would preclude participation
* Presence of any condition that would jeopardize subject's participation
Cisplatin and S-1 With or Without Nimotuzumab in Untreated Advanced Gastric Adenocarcinoma

In this open-label, single-center, small sample size, randomised, parallel-group, controlled study, the investigators aim to assess efficacy and safety of addition of nimotuzumab to CS chemotherapy in patients with previously untreated advanced gastric adenocarcinoma. Sixty-two patients are required and randomly assigned (1:1) to each group.

The control regimen (CS chemotherapy) is recommended as the standard first-line regimen for advanced adenocarcinoma of the stomach or gastroesophageal junction in japan.


Eligibility Criteria:
Inclusion Criteria:

1. provision of written informed consent;
2. male or female; and aged ≥ 18 years;
3. Histologically verified, untreated, metastatic or locally advanced inoperable adenocarcinoma or signet ring cell carcinoma of the stomach or gastroesophageal junction;
4. At least one radiographically documented measurable lesion according to Response Evaluation Criteria In Solid Tumors Version 1.1(RECIST1.1) Criteria;
5. An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; and a life expectancy ≥ 3months;
6. No previous palliative chemotherapy;
7. Adequate function of vital organs: white blood cells (WBC) ≥ 4.0×109/L, neutrophils (ANA) ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin ≥ 90g/L (blood transfusion is permitted if necessary), serum bilirubin ≤ 1 times the upper normal limit (UNL), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 times the UNL, alkaline phosphatase (AKP) ≤ 5 times the UNL, creatinine (Cr) ≤ 1 times the UNL, normal electrocardiography (ECG).

Exclusion Criteria:

1. pregnant or lactating patients, or reproductive women without effective contraception;
2. Patients with only non-measurable disease: small lesions (longest diameter \< 10mm or pathological lymph nodes with ≥ 10 to \< 15mm short axis), Bone lesions, leptomeningeal disease, ascites, pleural or pericardial effusion, lymphangitic involvement of skin or lung; abdominal masses/abdominal organomegaly identified by physical exam that is not measurable by reproducible imaging techniques.
3. Symptomatic of brain metastasis;
4. Patients with clinically severe comorbidity including diabetes mellitus, hypertension, heart disease, or chronic active hepatitis (HBV carrier can be enrolled if circumstance permits );
5. No previous radiotherapy for measurable lesions.
A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease

The main purpose of this study is to learn more about tirzepatide in participants with obesity disease. The study will also measure how Tirzepatide affects body weight with a low-calorie diet and increased physical activity. The study will last around 72 Weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have a BMI of greater than or equal to ≥27 kg/m² and \<less than 35 kg/m² with at least 2 obesity-related health problems or ≥35 kg/m² with at least 1 obesity-related health problems. Health problems are IGT, hyperlipidemia, or NAFLD.
* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

Exclusion Criteria:

* Have diabetes.
* Acute or chronic liver disease other than NAFLD.
* Have a self-reported change in body weight \>5 kg within 3 months prior to screening.
* Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months.
* Have renal impairment measured as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2, calculated by Japanese Society of Nephrology coefficient-modified Chronic Kidney Disease-Epidemiology equation during screening.
* Have a known clinically significant gastric emptying abnormality.
* Have had a history of chronic or acute pancreatitis.
* Have thyroid-stimulating hormone outside of the range of 0.4 to 6.0 micro units per milliliter (μIU/mL) at screening.
* Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity.
* Have a history of significant active or unstable major depressive disorder or other severe psychiatric disorder within the last 2 years.
* Have a cardiovascular condition within 3 months prior to randomization
* Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome type 2.
Insulin Sensitivity and Secretion During Pregnancy and Post Partum in Women With Gestational Diabetes.

Aim of the study:

To define insulin requirement during pregnancy and to identify the rapid changes in insulin sensitivity around parturition and the first 6 months post partum. Such knowledge would be clinically useful and markedly improve insulin treatment before and after parturition for women with type 1 diabetes and serve to identify the best possible timing of testing women with gestational diabetes mellitus (GDM) for the development of type 2 diabetes post partum.

Method:

Botnia clamp in women before, immediately after delivery and 6 months post partum. The investigators will compare 20 women with GDM in late pregnancy, day 15 post partum and 6 months post partum with 20 normal women investigated at the same time points. In addition the investigators will collect feces samples from the mother and baby in order to determine microbiota.

Perspectives:

Diabetes is a common condition with important implications for pregnancy outcome and long-term morbidity for mother and offspring. Accordingly, tailoring the best treatment is expected to have beneficial consequences both for the pregnant women and the future generation.


Eligibility Criteria:
Inclusion Criteria:

* Written consent before study start.
* Pregnant.
* GDM for the GDM group.
* No diabetes for the control group.

Exclusion Criteria:

* Women with multiple pregnancy.
* New pregnancy before all three examinations has been done.
* Severe, debilitating, concurrent diseases.
* Serious or intolerable adverse reactions associated with the studies.
Palliative Care Intervention in Patients With Solid Tumors Participating in Phase I Clinical Trials

Patients enrolled in phase I clinical trials could potentially benefit from palliative care concurrently, yet limited evidence is available to support such a change in care. The primary purpose of this study is to test the feasibility of a palliative care intervention (PCI) for patients participating in a phase I therapeutic clinical trial

PRIMARY OBJECTIVES:

I. Describe the feasibility of implementing a PCI for patients on phase I clinical trials (study accrual and retention).

II. Describe the initial impact of a PCI on key patient outcome measures (quality of life \[QOL\], psychological distress, satisfaction with communication, symptom intensity, symptom distress, and patient satisfaction) over time.

OUTLINE:

PCI PART I: Patients undergo comprehensive palliative care (PC) assessment based on baseline data and complete goals of care discussion.

PCI PART II: Following the first dose of phase I investigational treatment, patients meet with the interdisciplinary team (IDT), where PC recommendations are made. This is followed by two patient educational sessions that will cover QOL-related domains, including physical, social, emotional, and spiritual well-being. Supportive care referrals are made based on IDT recommendations.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with solid tumors who are being assessed for participation in phase I clinical trials of investigational cancer therapies
* Able to read or understand English
* Ability to read and/or understand the study protocol requirements, and provide written informed consent

Exclusion Criteria:

* Patient diagnosed with hematologic or brain cancers
The Weekend Effect and Its Possible Influence on the Prognosis of Patients With Non-varicose Upper Gastrointestinal Bleeding

The hypothesis is that the mortality of patients with non-varicose upper gastrointestinal bleeding after performing early gastroscopy who are admitted on weekends and night hours is higher than those admitted on weekdays or during daytime hours.

The aim of the study is to evaluate the impact of the schedule (day or night) and the day of admission (working or weekend / night) on the mortality of patients with non-varicose upper gastrointestinal bleeding after performing an early gastroscopy.

A retrospective observational study will be carried out in patients admitted to the bleeding unit of the Santa Creu I Sant Pau Hospital, where we observed hospital mortality and 30 days after performing an early gastroscopy, the duration of admission, signs of hemorrhagic activity in a period of less than 12 h. After early gastroscopy and types of endoscopic treatments, data will be collected by reviewing medical records.

The number of patients expected to be included in this study is 1320 patients. Patients will be included the day they enter the bleeding unit for an early gastroscopy.

Eligibility Criteria:
Inclusion criteria:

* Patients older than 18 years.
* Patients admitted to the Bleeding Unit with a diagnosis of upper gastrointestinal bleeding.
* Patients who have undergone an early endoscopy to determine the source of bleeding.
* In case of readmissions during the study period, we consider only the admission closest to his death or discharge.

Exclusion criteria:

* Patients diagnosed with gastrointestinal bleeding varicose.
* Patients who present with gastrointestinal bleeding and did not perform early gastroscopy (during the first 24 hours)
* Patients admitted for different medical conditions, who developed upper gastrointestinal bleeding during the course of hospital stay.
Study to Determine the Utility of Wound Vacuum Assisted Closure (VAC) Compared to Conventional Saline Dressing Changes

The purpose of this study is to look at the use of the wound vacuum assisted closure (VAC) versus standard wet to dry dressing in treating lower leg fasciotomies.


Eligibility Criteria:
Inclusion Criteria:

* four compartment fasciotomies performed on one or both lower extremities
* subject and/or subject's legally authorized representative (next-of-kin) has voluntarily signed and dated informed consent.

Exclusion Criteria:

* inability to place wound VAC
* contraindications for wound VAC use
* pregnant females
* prisoners
Valopicitabine When Administered Alone and in Combination With Interferon to Treatment-Naive Patients With Hepatitis C

This study is being conducted in treatment-naive patients (no previous hepatitis C treatment) to evaluate the safety of valopicitabine (NM283) alone and together with pegylated interferon, a drug approved by the Food and Drug Administration for the treatment of hepatitis C infection. This study is also evaluating the ability of valopicitabine to decrease the amount of hepatitis C virus in the body. The results for patients taking valopicitabine alone will be compared with the results for patients taking valopicitabine together with pegylated interferon.


Eligibility Criteria:
Inclusion Criteria:

* Documented clinical history compatible with genotype-1, chronic hepatitis C infection
* Treatment-naive (patient has received no previous therapy for hepatitis C viral infection)

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Patient is pregnant
* Patient is co-infected with hepatitis B or HIV

Other protocol-defined exclusion criteria may apply.