cyrilzakka/clinical-trials huggingface dataset:
Oncogenous HPV DNA Integration (Intégration De l'ADN Des HPV Oncogènes)

High-risk human papillomavirus (HR-HPV) are involved in cervical cancer development. Integration of HR-HPV DNA in cellular genomes is considered as a major event in the cervical cancer development. The aim of this study is to validate the integration of the HPV-HR as an appropriate biomarker of the severity of precancerous lesions and progression of cervical lesions towards cervical cancer. HR-HPV integration status will be analyzed by Molecular Combing technology, which allows direct and high-resolution visualization of the integration of high-risk HPV genomes.


Eligibility Criteria:
Inclusion Criteria:

* women aged from 25 to 65 years
* consulting in a gynecological-obstetrical service of one of the investigator center for a colposcopy reflex after an abnormal cytology dating of less than 6 months and more than 1 month
* signature of the informed consent
* affiliated to Social Security

Exclusion Criteria:

* women vaccinated against HPV
* women who received a treatment for a cervical pathology followed by a normal
* women with a known positive HIV test
* women suffering from a chronic pathology that generate immunosuppression
* Women currently treated with immunosuppressors
* Women treated with corticoids currently or dating of less than 6 months
* protected by law
* pregnant
Double-Blind, Double-Dummy, 2-Period Crossover of a 20-Minute Versus a 4-hour IV of MOA-728 in Stable Methadone Subjects

MOA-728, an investigational drug, is currently being studied for the relief of constipation associated with postoperative ileus and treatment of opioid induced constipation in patients receiving palliative care. This study will further investigate the IV formulation of MOA-728 comparing PK/PD time points for a 20-minute versus a 4-hour infusion.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy men and nonlactating, nonpregnant women age 18 to 65 years with BMI of 18.0 to 35.0 kg/m2
* Must have been receiving methadone treatment of greater than or equal to 30 mg/day for at least one month and a positive drug screen for methadone
* High probability for compliance with and completion of the study

Exclusion Criteria:

* Significant cardiovascular, hepatic, renal , respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. Presence or history of any disorder that may prevent the successful completion of the study. Any surgical or medical condition that my interfere with the distribution, metabolism or excretion of the test article.
* Acute disease state, family history of long QT syndrome and/or sudden cardiac death, allergy to opioids or drugs. Use of any investigational or prescription drugs within 30 days, any OTC drugs including herbal supplements within 14 days and drugs required to maintain regulation of bowel movements 48 hours before study day 1.
* History of alcoholism within 1 month before study day 1, admitted alcohol abuse, or consumption of more than 2 standard units of alcohol per day.
Ultraviolet Light Exposure and Immunosuppression in Cutaneous Melanoma

This project seeks to understand differences in the serum vitamin D levels and immune status in cutaneous malignant melanoma patients with different UV exposure histories in New Mexico.

It is well established that ultraviolet radiation (UV) exposure is related to the development of melanoma. There is also evidence that immune reactions are altered after UV exposure in the skin (locally) and perhaps throughout the body (systemically). Additionally, while the role of vitamin D and melanoma development has not been fully established, UV-B exposure is essential for vitamin D production in the skin. Increased sun exposure is also related to the presence of solar elastosis, which might protect (1) or improve survival from melanoma. Thus, melanoma represents a unique model for studying UV exposure, the immune system, and vitamin D. Malignant melanoma is an antigenic cancer; therefore, the role of UV exposure-induced immunosuppression and vitamin D production in the recognition, destruction and growth inhibition of cancerous melanocytes is worth further study.

To underscore the importance of this project, the Scientific Advisory Committee of the Melanoma Research Foundation and the Steering Committee of the Society of Melanoma Research have indicated a need to collect more human data on the host immune response mechanisms in melanoma and also to focus on the skin as a whole microenvironment, moving away from only in vitro experiments.

Eligibility Criteria:
Inclusion Criteria:

* Resident of New Mexico
* Age between the 1 and 95
* Newly diagnosed with cutaneous invasive melanoma; any stage permitted (ICDO C44.0-9) between September 1, 2008 and December 31, 2011.
* SSM (superficial spreading melanoma) and NM (nodular melanoma) histological subtypes are allowed
* Access to a telephone or be able to participate in a personal interview at the clinic
* Physically and mentally competent to complete a 1-hour telephone or personal interview

Exclusion Criteria:

* Ocular melanoma, LMM (lentigo maligna melanoma) or ALM (acral lentigo melanoma), and mucosal melanoma cases.
* No access to a telephone or is not able to meet with the interviewer.
Cardiac Allograft Vasculopathy and Dobutamine Stress Echocardiography / Brain Natriuretic Peptide Coupling

Primary purpose :To early detect cardiac allograft vasculopathy and to identify patients with high risk of cardiac events, by coupling the analysis of the kinetics of the brain natriuretic peptide ( BNP) with that of the left ventricle (LV) during a dobutamine stress echocardiography.

Hypothesis : Plasma BNP elevation and abnormalities of LV kinetic during the ESD, will be associated with the presence of allograft vasculopathy and the arisen of cardiovascular events.


Eligibility Criteria:
Inclusion criteria:

* Heart transplant recipients

Exclusion criteria:

* No respect of inclusion criteria
* Pregnancy
* Severe renal failure (creatinin clearance \< or equal to 30 ml/min)
* Dobutamine stress echocardiography contraindication
TYRO Champion Dads Project Study

This impact evaluation aims to determine if the addition of 10 hours of domestic violence prevention programming is effective at improving outcomes among those program participants who are randomly assigned to the treatment group. Both study groups will receive standard TYRO Champion Dads services (the TYRO Dads and TYRO Core Communication evidence-based curricula, plus support services), but only the treatment group will be offered the additional Ray of Hope curriculum hours focused on mitigating risk factors related to domestic violence.

Anthem Strong Families (ASF) is reviewing the Ray of Hope curriculum as a possible addition to standard TCD services to better meet the needs of populations that may have unmet needs to address domestic violence in their families. The Ray of Hope curriculum is designed to help participants develop communication and conflict management skills like Core Communication but is a more robust approach since it adds a sharp focus on the dynamics of domestic violence and related risk factors.

The impact of the addition of the Ray of Hope curriculum will be assessed by comparing outcomes for participants who receive standard TYRO Champion Dads (TCD) services, which includes the TYRO curriculum plus support services, and participants who receive both standard services plus 10 Ray of Hope curriculum hours.

Goal 1: determine if treatment group participants who receive enhanced TCD services report healthier parenting attitudes compared to control group participants who receive only standard TCD services 6 months after TCD enrollment.

Goal 2: determine if treatment group participants who receive enhanced TCD services report healthier partner relationship behavior compared to control group participants who receive only standard TCD services 6 months after TCD enrollment.

Goal 3: determine if treatment group participants who receive enhanced TCD services report healthier parenting behavior compared to control group participants who receive only standard TCD services 6 months after TCD enrollment.

Goal 4: determine if treatment group participants who receive enhanced TCD services report healthier co-parenting behavior compared to control group participants who receive only standard TCD services 6 months after TCD enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age 18 and older)
* Father (children must be no more than 24 years of age)
* must have no open criminal cases (can be deferred)

Exclusion Criteria:

* Minor (under the age of 18)
* Not a father
* Has an open criminal case
Entia Liberty: Usability Validation

This study forms part of Entia's clinical evidence for regulatory submission. This study evaluates Entia Liberty's validation of the device. Participants will be trained to take an Entia Liberty test in a simulated home environment and a trained healthcare professional will perform another test from the same participant (different finger) on a separate device. The results will be compared. Usability data will be observed and the participants will complete a questionnaire after the tests have been performed.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old at the time of study entry
* Can provide written informed consent
* Patients who are currently receiving standard of care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and have received at least one cycle
* Sufficient hearing to be able to participate in a video training session

Exclusion Criteria:

* Known inherited or acquired bleeding disorder
* History of haematological malignancy
* Known poorly controlled anti-coagulation
* Inadequate use and understanding of the English language, requiring a translator
* Participant unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result
* Previously taken part in the 'PERTH-2' study involving a prototype device
Health-Related Quality of Life Outcomes in Patients With Aggressive B-Cell Lymphomas Treated With CAR-T Cell Therapy in Real Life

This study will ultimately aim at providing the scientific community with patient-reported health status data that will contribute facilitate decision-makings. Short- and long-term HRQoL and symptoms will be evaluated in a longitudinal fashion over time to improve the understanding of the impact of the disease and CAR-T cell therapy on patients-wellbeing, symptom burden and daily functioning. This study will capture useful information on the impact of treatment toxicity, the burden of procedures on HRQoL outcomes. The planned collection of PRO and physician-reported adverse events ad early time point will help to compare and integrate these two points of view in healthcare assessment.

Quality of life assessment

Eligibility Criteria:
Inclusion Criteria:

* Patients with diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL transformed by indolent lymphoma and mantle cell lymphoma.
* Scheduled to received CAR-T cell product.
* Having a baseline PRO assessment.
* Adult patients (≥ 18 years old).
* Written informed consent provided.

Exclusion Criteria:

* Having any documented or psychiatric or neurological disorder which may interfere with self-reported HRQoL assessment.
* Not able to read and understand local language.
Integration of Telemedicine and Home-Based Cardiac Rehabilitation: Feasibility, Efficacy, and Adherence

The aim of this study is to evaluate feasibility, efficacy, and adherence of home-based cardiac rehabilitation with the integration of telemedicine. Several components will be assessed such as quality-of-life, nutritional counseling, maximum metabolic activity (MET's), diabetic management, tobacco cessation, lipid, blood pressure, and psychosocial management. These tasks will be accomplished through concurrent conversations between patients and their therapist's utilizing telemedicine with observed exercise training.

The focus of this study is to determine the feasibility, efficacy, and adherence of home-based cardiac rehabilitation with the integration of telemedicine. The study consists of an initial review, rehabilitation sessions, nutrition consultation, and risk stratification. Once the patient is cleared for the rehabilitation program, they will be assigned a cardiac rehab specialist and begin the 36 rehabilitation sessions. The sessions include pre-session questions, surveys, pre-, during, and post vitals, exercise protocol, and off-the-device exercises.

Eligibility Criteria:
Inclusion Criteria:

1. Over the age of 18
2. NYHA Functional Class I, II,
3. Recent (within 60 days) status post coronary artery revascularization for atherosclerotic coronary artery disease (coronary artery bypass grafting or percutaneous coronary revascularization with stent implantation)
4. Candidate for traditional center-based cardiac rehabilitation

Exclusion Criteria:

1. Under the age of 18
2. Adults lacking capacity to consent.
3. NYHA Functional Class III, IV
4. Acute coronary syndrome
5. Systolic heart failure (LV EF \<40%)
6. Status post cardiac surgery for structural heart disease or heart transplant
7. Percutaneous coronary angioplasty
8. Adults lacking capacity to consent.
9. Pregnant women
Validation of a Point-of-care Device Measuring Ferritin With Capillary Blood

Measurement of iron is important for identifying both low and high iron levels in the body. Measuring a protein in the blood called ferritin is currently the easiest way to determine a patient's iron status. However, the test requires a blood sample that is be sent to the laboratory for measurement, which can cause delays in obtaining the result. The investigators are testing whether a point of care device that measures ferritin levels using a capillary blood sample is accurate compared to current methods of testing. This could allow measurement of ferritin immediately in the clinic with only a drop of blood, and enable treatment decisions based on these results.


Eligibility Criteria:
Inclusion Criteria:

* able to read and understand English (the consent form is in English)
* attending ambulatory hematology clinic and/or outpatient medical care

Exclusion Criteria:

-
Longitudinal Assessment of Bone Growth in Children With Cerebral Palsy

In 2003, observational growth and bone density data was obtained on children with cerebral palsy (CP) living at Hattie Larlham as part of a study comparing growth with an existing database of children with CP who live at home. The original residents included in that study are now of adult age. Due to the lack of longitudinal bone density measurements in facility-based adults with severe CP, the investigators' objective is to obtain 6-year follow-up data from the residents enrolled in the original study.


Eligibility Criteria:
Inclusion Criteria:

* Resident of Hattie Larlham Center for Children with Disabilities (HLCCD)
* Previously enrolled in the Growth in a Facility-Based Population of Children with Cerebral Palsy study in 2003

Exclusion Criteria:

* Resident of HLCCD who was not enrolled in the Growth in a Facility-Based Population of Children with Cerebral Palsy study
Effectiveness of Four Popular Diet Strategies for Weight Loss and Cardiac Risk Reduction

A single-center randomized trial at an academic medical center in Boston, Mass, of overweight or obese adults with known hypertension, dyslipidemia, or fasting hyperglycemia. Participants were enrolled starting July 18, 2000, and randomized to 4 popular diet groups until January 24, 2002.

Objective: To assess adherence rates and the effectiveness of 4 popular diets (Atkins, Zone, Weight Watchers, and Ornish) for weight loss and cardiac risk factor reduction.

Design, Setting, and Participants: A single-center randomized trial at an academic medical center in Boston, Mass, of overweight or obese adults with known hypertension, dyslipidemia, or fasting hyperglycemia. Participants were enrolled starting July 18, 2000, and randomized to 4 popular diet groups until January 24, 2002.

Intervention: A total of 160 participants were randomly assigned to either Atkins (carbohydrate restriction, n=40), Zone (macronutrient balance, n=40), Weight Watchers (calorie restriction, n=40), or Ornish (fat restriction, n=40) diet groups. After 2 months of maximum effort, participants selected their own levels of dietary adherence.

Main Outcome Measures: One-year changes in baseline weight and cardiac risk factors, and self-selected dietary adherence rates per self-report. Outcome measures included body weight, total cholesterol, LDL-C, HDL-C, triglycerides, hsCRP, insulin, glucose.

Eligibility Criteria:
Inclusion Criteria:

* BMI 27-42;
* At least one metabolic cardiac risk factor

Exclusion Criteria:

* Age under 18 years;
* Insulin therapy;
* Unstable chronic illness;
* Unwilling to follow dietary advice
Longitudinal ctDNA Surveillance for Older Women With ER+ Breast Cancer Who Omit Surgery

This prospective study recruits patients with ER+/HER2-, non-metastatic breast cancer who omit upfront surgery in favor of primary endocrine therapy for sample collection and prospective circulating tumor DNA (ctDNA) measurement to guide disease surveillance.

Age is one of the most important risk factors for the development of breast cancer. Nearly a third of all breast cancer cases occur in older women (aged ≥ 70 years), with most cases being estrogen receptor-positive (ER+). Such tumours are unlikely to be the ultimate cause of death for older women, particularly when considering other comorbidities. Our group has recently shown that risk of breast cancer-related mortality is only around 3% for older women who forego upfront surgery and instead treated with primary endocrine monotherapy. However, with omission of surgery, surveillance for tumor growth or treatment failure is important but requires patients (and their caregivers) to have regular imaging and to see their oncology team every 3 months, which can be quite burdensome. Thus, this study employs a ctDNA surveillance scheme to monitor for potential tumor growth. Partnering with Natera, this study uses a bespoke, tumor-specific ctDNA assay (Signatera) to monitor for changes in ctDNA dynamics while the patient is on endocrine therapy.

This study is for patients who choose not to undergo primary surgical intervention and are managed medically on primary endocrine therapy (any endocrine therapy permitted). Patients will undergo Signatera testing at the time of regularly scheduled clinic follow-up visits and/or at the time of surveillance imaging, which will occur every 3-6 months. Patients will also be asked to complete regular surveys while participating in the study.

Eligibility Criteria:
Inclusion Criteria:

* early-stage (stages I-III) breast cancer
* estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) and HER2 receptor negative
* able to provide blood samples
* decision made by treating physician and patient to forego upfront surgery in favor of medical management with endocrine therapy
* non-metastatic disease at diagnosis (patients need not have staging scans; patients at higher risk for de novo stage IV disease should not have any symptoms concerning for metastatic disease)
* patients may be taking any endocrine therapy
* patients may be taking any CDK4/6 inhibitor as deemed necessary by their treating physician
* any ECOG Performance Status allowed
* if patients have synchronous bilateral ER+ breast cancer, tissue from both sites should be submitted to Natera to perform ctDNA testing
* patients with multifocal/multicentric tumors are eligible and the largest focus of cancer should be submitted for testing

Exclusion Criteria:

* under 70 years of age
* breast cancer that is not estrogen receptor positive (ER+) or progesterone receptor (PR+)
* unable to provide blood samples or insufficient tumor tissue for Signatera testing
Treatment of High Risk Myelodysplastic Syndromes (MDS) Not Candidates for Allogeneic Transplantation of Hematopoietic Progenitors (ALO-HSCT)

An observational, non-interventional, prospective and multicenter study of Azacitidine in newly diagnosed High Risk Myelodysplastic Syndromes.

Primary objectives are to asses mutational status of target genes by Next Generation Sequencing, to evaluate prognostic value of geriatric assessment scales and to evaluate overall survival.

The main hypothesis is that mutation status of target genes and geriatric scales have statistical significant impact on overall survival.

Study time points will be at diagnosis, 6, 12, 18 and 24 months, always taking into account the routine clinical practice, when sample to assess mutational status will be collected. Geriatric assessment will only be performed at diagnosis.

Upon the signature of informed consent and the checking of inclusion criteria, patients will receive treatment with Azacitidine 75 mg/sqm on a 28 days based cycles (both 7-0-0 and 5-0-2 regimens are allowed) until disease progression, unacceptable toxicity or investigator decision.

150 patients are expected to be recruited at study sites.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with myelodysplastic syndrome (MDS) according to WHO criteria, including non-proliferative chronic myelomonocytic leukemia (CMML) that is considered high risk, and not candidates for transplantation.
* High-risk MDS: (following the Grupo Español Síndrome Mielodisplásico, GESDM MDS guides) and the recommendations of Valcárcel, D. et al).

Median expected OS less than 30 months. Intermediate-2 or high risk IPSS and / or high or very high risk WPSS and / or high or very high risk IPSSS-R.

IPSS of intermediate risk and / or WPSS of intermediate risk and / or IPSS-R of intermediate risk that present at least one of the following characteristics:

Cytogenetic abnormality of the IPSS-R high or very high cytogenetic risk group Platelet count \<30 x10E9/l Neutrophil count \<0.5 x 10E9 / l Presence of dense and diffuse myelofibrosis, with or without collagen formation (grades 2-3 of the European consensus) Category 3 of the LRSS score (MD Anderson low risk score system)

* Patient diagnosed with LAM de novo according to WHO criteria, with 20-30% blasts count in bone marrow, trilineal dysplasia and more than 70 years and not candidate for intensive chemotherapy.
* Willing to provide voluntary written informed consent

Exclusion Criteria:

* Serious active medical condition, not related to MDS, that could limit patient compliance and follow-up or that, in the Investigator's opinion,could compromise the patient's safety.
* Presence of other active malignant disease
* Organic function parameters: (except when the alteration is due to MDS) Hepatic: Bilirubin\> 2 x upper limit of normal (ULN) Renal: Creatinine\> 2 x upper limit of normal (ULN)
* Ejection fraction (\<40%) and / or symptomatic heart failure.
* Leukaemia secondary to Myeloproliferative Syndrome.
* Serious psychiatric or neurological disease.
* Positive Serology for HIV.
* Proliferative CMML