cyrilzakka/clinical-trials huggingface dataset:
Concomitant Chemoradiotherapy With Weekly Paclitaxel and Vinorelbine and Granulocyte Colony Stimulating Factor (GCSF) Support in Patients With Advanced Breast Cancer

The goal of this study is to determine the feasibility based on toxicity and response rate of giving paclitaxel weekly with concomitant every-other week radiotherapy to limit skin toxicity. This study will also seek to determine the maximally tolerated dose of Navelbine added to this combination when followed by Filgrastim and the dose-limiting toxicities of this regimen.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the male or female breast (male or female) with gross, uncontrolled, unresectable breast and/or chest wall disease including:

  1. patients with locally advanced unresectable stage IIIa or IIIb;
  2. patients with locally recurrent (including locoregional lymph nodes) disease for which curative surgery is not thought possible
  3. patients with metastatic disease AND uncontrolled locoregional disease are eligible.
* Prior chemotherapy allowed, except for nitrosoureas and mitomycin chemotherapy or high dose chemotherapy with marrow or stem cell rescue.
* Prior palliative radiation to sites of metastases allowed (i.e. bone, brain, lung)
* 4 weeks since any prior treatments (excluding hormonal therapy). Concurrent hormonal therapy is not allowed.
* Aged 18 years or older
* CALGB performance status of 0 - 2
* Life expectance of at least 12 weeks
* Initial Laboratory Data:

  * ANC Count \> 1500/mm3
  * Platelet Count \> 100,000/mm3
  * Creatine ≤ 2.0 mg/dl
  * Bilirubin ≤ 1.5 mg/dl
  * ALT (SGPT) ≤ 3 times the upper limit of normal
* Signed informed consent

Exclusion Criteria:

* Prior breast or chest wall radiation is not allowed unless the proposed site radiation port does not overlap with prior ports
* Subjects must not be pregnant (females able to have children must have negative pregnancy test and agree to use adequate contraception)
* Patients with a documented hypersensitivity to E.coli derived proteins are excluded.
* No other serious medical condition such as uncontrolled infection that in the opinion of the investigators places patient at undue risk for study treatment
MAGESTIC Trial: MiRNA in Detecting Active Germ Cell Tumors in Early Suspected and MetastaTIC Disease Trial

This study evaluates the accuracy of blood-based biomarker testing to predict the presence of active testicular cancer.

PRIMARY OBJECTIVE:

I. To measure the accuracy of the blood-based biomarker miRNA-371 to predict pre-operatively the presence of active germ cell malignancy.

OUTLINE: This is an observational study.

Patients undergo blood sample collection during screening and throughout the study. Patients whose screening blood samples show elevated miRNA-371 proceed to standard RPLND surgery. Patients whose screening blood samples show normal levels of miRNA-371 undergo standard surveillance followed by standard RPLND surgery at the time of elevated miRNA-371 levels. Patients may also have their medical records reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Primary tumor excised by radical inguinal orchiectomy and pathology consistent with GCT (seminoma or NSGCT)
* Clinical stage of patient is either:

  * Stage I pure seminoma OR stage I pure seminoma with isolated retroperitoneal relapse or Stage IIA/B pure seminoma
  * Stage I NSGCT OR stage I NSGCT with isolated retroperitoneal relapse or Stage IIA/B NSGCT
* Suspected retroperitoneal disease: Lymphadenopathy in the retroperitoneum with no lymph node \>3 cm in greatest dimension with no more than 2 nodes enlarged
* Axial imaging within 6 weeks of enrollment
* Chest imaging (x-ray, CT or MRI) negative for metastasis within 6 weeks of enrollment
* MiRNA-371 level drawn at any timepoint after orchiectomy
* Retroperitoneal lymphadenopathy must be within an RPLND template
* Biopsy of lymph node is not required, though if biopsy of the retroperitoneal node(s) was obtained, pathology must be consistent with GCT
* Serum Alpha Feto Protein (AFP), β-Human Chorionic Gonadotropin (HCG), Lactate Dehydrogenase (LDH) - per the local laboratory assay \<1.5xlower normal level within 30 days of enrollment
* Age ≥ 16 years
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2
* Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Second primary malignancy
* History of receiving chemotherapy or radiotherapy
* Patients receiving any other investigational agent (s)
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Endothelin-1 and Cardiac Allograft Vasculopathy (CAV)

Many patients with end-stage heart failure, a condition in which the heart fails to pump enough blood to support the body's other organs, are fortunate enough to receive a heart transplant. However, despite taking medicines aimed at blunting the immune system's response to the donor heart, some of them will develop transplant-related disease in the coronary arteries supplying their hearts. Fifty years after the first human-to-human heart transplant, this disorder-cardiac allograft vasculopathy (CAV)-remains a leading cause of long-term death and has been coined the 'Achilles' Heel' of heart transplantation. Indeed, a better understanding of how CAV occurs and improved therapies to prevent and/or slow its development are desperately needed to meaningfully impact patient outcomes.

Endothelin-1 (ET-1) is a key molecular regulator of arterial health, and our prior data suggests that it is associated with accelerated CAV. In this particular study of recent heart transplant recipients, we are asking: Does ET-1 contribute to the coronary artery's capacity to dilate/constrict? To answer this question, during the cardiac catheterization at 1 year post-transplant (standard of care), we will measure blood levels of ET-1 and perform an invasive evaluation of coronary vasomotor function inn a consecutive subset of patients who will have received a 1-week course of the oral endothelin receptor antagonist (macitentan) prior this catheterization, which will allow us to test how much ET-1 contributes to coronary responsiveness.

The findings from this study may provide the necessary foundation to study whether endothelin receptor antagonists are able to effectively reduce the rate of accelerated CAV.


Eligibility Criteria:
Inclusion Criteria:

* 1) New heart transplant recipients already enrolled into a prospective cohort (parent) study
* 1a) Underwent baseline coronary angiography within the first 4 months of heart transplantation
* 1b) Have yet to complete 1-year coronary angiogram
* 2) ≥18 years old
* 3) Have a serum creatinine \< 2.0 mg/dL (to minimize risk of contrast-induced nephropathy)
* 4) Able to provide informed written consent.

Exclusion Criteria:

* 1) Multi-organ transplant
* 2) Transplant-related complications and comorbidities that preclude the ability to safely perform an invasive coronary evaluation in the cardiac catheterization laboratory
* 3) Pregnant women due to possible fetal harm; all women of childbearing potential must have a negative pregnancy test within 1 week of starting Macitentan, and 30 days after completing the one-week course of Macitentan.
* 4) Patients who are taking potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) as these drugs can expose one to higher levels of macitentan
* 5) Cirrhosis or baseline liver function tests (AST/ALT) \> 3x the upper limit of normal
The School SPIT Study - Elementary Schools in High COVID-19 Incidence Regions

This study will conduct an evaluation of a program that is being implemented SickKids / Toronto Public Health that provides take-home saliva testing kits in schools. Operationally, there is a planned randomization so that all schools have an equitable chance to receive the intervention at various time periods during the planned operational roll-out, which will require a staggered implementation consistent with the stepped-wedge study design. This study will leverage this chance implementation to do a robust evaluation of the public health intervention. Schools that are not being rolled out to week one, will begin in the "control phase" (testing at an assessment center, primary care or acute care center) and transition to the program "intervention phase" (take home saliva kits available at schools) at a randomly assigned time (wedge) over a 6-week period with all schools receiving the program by the end of the study. The investigators will evaluate the impact of the program on SARS-CoV-2 case identification in schools.

This is a prospective evaluation of a program that is being implemented using a stepped-wedge, cluster randomized design.

Eligible elementary public schools high SARS-CoV-2 incidence regions (quintiles 4 and 5) in Toronto will be randomized. The study will occur over a 7-week period with a minimum of one-week of baseline data (control phase - testing at an assessment center, primary care or acute care center) and then schools will start the program in a stepwise manner (20 crossovers per week) with take-home saliva being available to all 120 schools by the end of the study period. The primary objective of the study is to assess whether the availability of take home saliva kits at schools for symptomatic testing leads to increased diagnosis of SARS-CoV-2 cases in the school.

Eligibility Criteria:
Elementary schools will be included in the evaluation if they are:

* Considered an elementary school by the school board
* Open for in-person learning during the study period
* They have at least 200 students
* Offer at least 4 grades

Exclusion Criteria:

Schools that are middle schools only, that are not open for in-person learning, have fewer than 200 students or are not a complete elementary school (i.e. schools offering independent courses, prep schools with 1-2 grades, elementary schools with \< 4 grades) will be excluded.
A New Supplement for the Immune Response to HPV Infection

The purpose of this study is to evaluate whether a supplement in which ellagic acid plus annona muricata are combined, may modulate the immune response to high risk HPV infection. Sixty women will be enrolled in a randomized, controlled study, having a histological diagnosis of L-SIL correlated with high rish HPV types infection. Main outcome measure is the activation of onco suppressor protein by the supplement and secondary outcome is the clearance of HPV infection in the treated group.


Eligibility Criteria:
Inclusion Criteria:

* women with high risk HPV infection
* histological diagnosis of L-SIL

Exclusion Criteria:

* women with no high risk HPV infection
* women without histological diagnosis of L-SIL
Glycemic Impact of Myo-inositol in Pregnancy

Myo-inositol has been shown to decrease the rate of diabetes in pregnancy in European studies. It is not known exactly how this occurs or what it does to the sugar when the supplement is taken. This study purpose is to look at the patient's sugar levels while taking the supplement to see if the overall levels of sugar go down. We hypothesize that in addition to sugar levels, other hormones influencing diabetes will be altered.

Myo-inositol is important for glucose homeostasis and has been shown to improve insulin sensitivity. This is a prospective cohort pilot study to determine daily glycemic pharmacokinetics and metabolic influences of myo-inositol supplementation using continuous glucose monitoring system (CGMS) and pre- and post-supplement blood work in high risk pregnancies and women diagnosed with gestational diabetes mellitis (GDM). Risk factors include: obesity, previous pregnancy with GDM, family history of diabetes, glucose intolerance, and polycystic ovarian syndrome (PCOS). Women will have a CGMS device placed on day one and begin with 3 days of placebo plus folic acid (400mcg) to determine baseline glycemia and metabolic levels. For the final 4 days, women with take myo-inositol supplementation (4g) plus folic acid (400mcg). The CGMS device will be removed on day 7 when final blood work will be obtained. Self-capillary glucose testing 4 times per day is recorded to calibrate CGMS glucose values. These observations will help determine the effects of myo-inositol on overall mean glucose and other metabolic factors in high risk and GDM patients, identify pharmacokinetic discipline in pregnancy, and develop the groundwork for future prospective clinical trials for the prevention and/or augmentation in treatment GDM.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* singleton
* pregnant females between 20-28 weeks of gestation at time of enrollment PLUS (either of the following)
* High risk including women must have passed routine glucose screening and have greater than or equal to 1 of the following high risk criteria: first degree family member with diabetes mellitus, previous pregnancy with gestational diabetes, PCOS, or body mass index great than or equal to 30.
* Gestational diabetes diagnosed in current pregnancy based on IADPSG or NIH consensus diagnostic recommendation

Exclusion Criteria:

* pre-pregnancy diagnosis of diabetes mellitus
* renal disease
* immunocompromised
* currently taking immunosuppressive medications
* age \<13 years old
* non-English speaking
* multifetal gestation.
The Effect of Standardized Enteral Nutrition on Critically Ill Patients

The goal of this study is to evaluate whether a standard enteral nutrition protocol can improve the efficiency in achieving nutritional goals and improve prognosis in critically ill patients.

As investigators all know, the nutrition status in critically ill patients is associated with the prognosis of these patients. And it has been confirmed that early enteral nutrition results in better outcome. However,some epidemiological investigation reported that in most intensive care unit, the phenomenon of delayed feeding or under feeding are not uncommon. In 2007, a study reported that the percentage of early enteral nutrition within 48h is 64%, based on mechanical ventilated patients in 208 intensive care unit nationally. Other study indicated that the calorie supported by the enteral nutrition only constitute 50% of the target calorie. Several studies have showed that the application of a standard enteral nutrition protocol could result in an improvement in the delivery of enteral feedings to patients. However, there is no such study in China.The goal of this study is to evaluate whether a standard enteral nutrition protocol can improve the efficiency in achieving nutritional goals and improve prognosis in critically ill patients.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients who is expected the length of ICU stay for more than 3 days

Exclusion Criteria:

* Patients who can obtain enough calorie through independent oral feeding. Patients aged less than 18 years. Patients who are pregnant or breastfeeding. Patients who are burned. Patients with malignant tumor terminal stages of diseases
Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection

This study evaluates the efficacy of prophylaxis with oral vancomycin for preventing recurrent Clostridium difficile Infection (CDI) in patients who have experienced at least one CDI episode in the last 180 days and are receiving antibiotics for a non CDI condition. Participants will be randomized to receive either placebo or oral vancomycin in addition to their prescribed antibiotic therapy.

Many patients who have a CDI experience recurrent or relapsing symptoms. The investigators are studying whether vancomycin in low doses will help prevent further CDI episodes and how this therapy impacts patients' gastrointestinal microbiome and composition.

Patients with a history of past CDI who are receiving antibiotics for a non-CDI condition will be invited to participate. Approximately half of the participants will receive a low-dose capsule of vancomycin and half will receive a placebo. Participants will continue taking the vancomycin/placebo for 5 days after their prescribed antibiotics end.

Eligibility Criteria:
Inclusion Criteria:

* Willing to provide informed consent.
* Willing to comply with all study procedures and be available for the duration of the study.
* Documented diagnosis of at least one CDI within the last 180 days with treatment completed.
* Currently receiving systemic antibiotics for a non-CDI condition with anticipated duration of no more than 2 weeks.
* Females of childbearing potential must have a negative pregnancy test prior to randomization and agree to use adequate contraception prior to randomization, for the duration of the study, and for 4 weeks following study completion.
* Have received no more than 72 hours of non-CDI antibiotics.

Exclusion Criteria:

* History of hypersensitivity or allergy to oral vancomycin.
* Current use of oral vancomycin
* Patients on concurrent treatment with metronidazole or tetracycline monotherapy for any indication
* Patients diagnosed with inflammatory bowel disorder (Crohn's disease), or bacterial gastrointestinal infection cause by agents other than C. difficile (e.g. Salmonella sp.), toxic megacolon and/or known small bowel ileus.
* Dysphagia (inability to swallow capsules) or unwilling to swallow capsules.
* Major gastrointestinal surgery within 3 months of enrollment (does not include appendectomy or cholecystectomy).
* Any history of total colectomy or bariatric surgery.
* Unable or unwilling to fulfill study requirements.
* Expected life expectancy \< 6 months.
* Patients enrolled in another clinical trial with investigational drugs within 30 days prior to randomization.
* Women who are pregnant or breast-feeding.
* Any patient deemed not suitable for study participation at the discretion of the study investigator.
* Diarrhea (3 or more loose stools in a 24 hour period) at enrollment.
Radiation-Induced Cytokine Cascades and Their Correlation With Central Nervous System Injury

Treatment for brain cancer may include radiation therapy. Radiation therapy is the treatment of tumors with X-rays. This study is related to understanding the side effects of radiation treatment for brain tumors.

This study is being conducted by the University of Rochester Cancer Center to compare the extent of side effects of brain cancer treatment with changes in levels of blood proteins called cytokines.


Eligibility Criteria:
Inclusion Criteria:

* Any patient who will be treated to the brain or spinal axis for a CNS tum Patients so treated will be stratified according to whether or not the hypo is included in the treatment fields.
* Patients receiving external beam radiation to the brain may also be rece chemotherapy or interferon-beta. (Add. #1, 11-9-95)
* Patients receiving high dose rate (stereotactic radiosurgery) are eligible.
* Patients must sign a study specific informed consent meeting all federal a guidelines.
* Patients of any age, including children, are eligible (Add. #3, 11/25/97).

Exclusion Criteria:

* Patients who have a malignancy involving the hypothalamic-pituitary ax
* Patients who are not treated with irradiation to the brain or spinal axis.
Novel Targets for the Development of Monoclonal Antibodies for Immunotherapy)

The first objective of the project consists in the preclinical validation of new possible molecular targets associated with intratumoral T regulatory cells. The second objective consists in the selection of monoclonal antibodies with therapeutic potential, specific for the selected targets.


Eligibility Criteria:
Inclusion Criteria:

* blood donors
* age of 18 years or more
* able to sign informed consent

Exclusion Criteria:

* age below 18 years
* Positive for HIV, HCV, HBV
* not suitable for blood donation
* not able to understand or sign informed consent
Cultural Competency, Risk Management, and Patient Safety Internet-Based Curriculum for OB/GYN Resident Physicians

Additional educational training lectures were provided to healthcare workers. Outcome measure of cultural competency was completed to assess patient safety, risk management, and cultural competency of healthcare providers in an urban academic Labor and Delivery Unit.

Introduction: Patient safety, risk management, and cultural competency are essential topics for healthcare provider mastery in a high stakes, urban academic Labor and Delivery Unit.

Methods: A prospective cross sectional pilot study was performed with IRB exempt status to examine the effect of an internet based educational curriculum on topics including patient safety, risk management and cultural competency over 6 months amongst OB/GYN and Family Medicine medical students, nurses, and physicians. 76 healthcare providers participated. Assessments took place before and after curriculum implementation. Primary outcome measures were cultural competency as measured by the Tucker-Culturally Sensitive Health Care Inventory (TCSHCI) Provider Form, Pascal Metrics of Patient Safety survey for healthcare providers, patient satisfaction measured by the Press Ganey patient survey scores, and poor Labor and Delivery Outcomes. The curriculum intervention included five online lectures lasting 30-60 minutes pertaining to cultural competency, risk management, patient safety, and Team STEPPS training.

Eligibility Criteria:
Inclusion Criteria:. Inclusion criteria were OB/GYN medical students, Labor and Delivery nurses, and resident/ attending physicians in OB/GYN, Pediatrics, Anesthesia, and Family Medicine.

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Exclusion Criteria:

* .Exclusion criteria were those providers that refused participation, or those that did not complete the course by June 2013.
Comparing Two Indirect Pulp Capping Agents for Permanent Teeth

Aim of the study:

To evaluate clinical and radiographic success rates of silver diamine fluoride versus mineral trioxide aggregate as indirect pulp capping agents in deeply carious young first permanent molars.

Indirect pulp treatment has become a common maneuver in vital pulp therapy in recent years and is a procedure performed in teeth with deep carious lesions approximating the pulp but without any signs or symptoms of irreversible pulpal changes.

Silver Diamine Fluoride is used to arrest caries lesions in primary teeth but according to the AAPD,2021 more research is needed on the use of SDF to arrest caries lesions in permanent teeth.

Eligibility Criteria:
Inclusion Criteria:

* Patient and parent showing cooperation and compliance.
* Children 9-14 years old
* Vital deeply carious young first permanent molar(s) with complete root formation
* Asymptomatic teeth or without clinical symptoms of spontaneous pain
* Both genders will be included.

Exclusion Criteria:

* Children unable to return for recall visits.
* Any clinical signs of irreversible pulpitis or pulp necrosis (spontaneous pain, pain on percussion, abscess, sinus).
* Any radiographic sign of irreversible pulp pathologies or pulp necrosis (periapical radiolucency, internal or external root resorption)