cyrilzakka/clinical-trials huggingface dataset:
Panc CA Risk Model & Biomarker Testing In High-Risk Cohort

The purpose of this study is to test a double screening strategy for pancreatic cancer, based on a model developed using patient medical records. Investigators would also like to test whether adding specific blood tests, can further help identify people who have a higher risk of pancreatic cancer than the general population, and would benefit from imaging in order to detect cancer early.

This research aims to identify people who have a higher risk of pancreatic cancer than the general population, by testing a double-screening strategy for pancreatic cancer. The purpose is to allow early detection of cancer, which potentially leads to cure.

The double-screening will include a computer-based model developed using clinical data from medical records, and three different blood tests for early detection of pancreatic cancer.

Participation in this study involves having medical records followed up for up to three years, and a single donation of blood specimens.

- This is a Combined Retrospective and Prospective Review:

* The first part of the study, involves collection of retrospective data from Electronic Health Record database (for the 3 collaborating HCOs) in order to deploy our EHR model, so that a high-risk group for pancreatic cancer can be identified. All individuals stratified into low, intermediate or high risk groups by the model, will be prospectively, electronically followed to assess outcome.
* The second stage is prospective, and involves requesting biological specimen donations from participants identified as high-risk, for biomarker testing. The prospective "observation period" is up to 3 years (depending on each subject's index date at retrospective recruitment and outcome). Biological specimens will be collected during the prospective "observation period,"

Eligibility Criteria:
Inclusion Criteria:

* Study population for part 1 of study:

  -- Inclusion criteria: i) Male and females age \>= 50 years; ii) at least one clinical visit to an outpatient clinic of the HCO, within the last year, before the study start date.
* Study population for part 2 of study:

  * i) model-assigned high-risk subjects; ii) Male and females age \>= 50 years; iii) at least one clinical visit to an outpatient clinic of the HCO, within the last year, before the study start date

Exclusion Criteria:

* Exclusion Criteria for part 1 of study:

  * Personal history of PDAC or current PDAC
  * Age below 50.
* Exclusion Criteria for part 2 of study

  * model-assigned low or intermediate risk subjects
  * Personal history of PDAC or current PDAC
  * Age below 50.
Predicting Tolerance to Radiation Therapy in Older Adults With Cancer

A comprehensive geriatric assessment tool developed by Hurria and colleagues has been used in non-radiation oncology clinical settings to predict how older adults tolerate cancer treatments. The investigators think this same tool (referred to as the CGA) can be used in a radiation oncology clinic to predict for poor treatment tolerance.

A comprehensive geriatric assessment tool developed by Hurria and colleagues has been used in non-radiation oncology clinical settings to predict for toxicity in older patients during cancer treatments.1 The investigators hypothesize that the same tool (referred to throughout this document as the CGA) can be used in a radiation oncology clinic to predict for poor treatment tolerance. The primary objective of this study is to assess the association between pre-treatment functional status (as measured by the Independent Activities of Daily Living (I-ADL) components of the CGA) and poor tolerance to radiation therapy (as defined in section 2.3.1). Secondary objectives include exploration of associations between pre-treatment I-ADL status on the CGA and the occurrence of any acute grade 3-5 toxicity from radiation therapy, or any decrease in Quality of Life (QoL) measures throughout radiation therapy as assessed by the EORTC QLQ-C30 questionnaire. The investigators also want to compare the rate of physician reported acute toxicities to patient reported acute toxicities in an older cancer patient population, assess any association between elevated p16Ink4α expression in peripheral T lymphocytes and poor tolerance to or acute grade 3-5 toxicity from radiation therapy, and explore any association between other baseline components of the CGA and poor tolerance to or acute grade 3-5 toxicity from radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* ≥Age 65 years (no upper age limit)
* Diagnosis of either head and neck cancer, or lung cancer with either radiotherapy or chemoradiotherapy planned as part of standard treatment.
* Consented for receipt of External Beam Radiation Therapy (EBRT) at UNC Chapel Hill
* Able to read English (required for CGA)
* Curative treatment intent as defined by their radiation oncologist Signed, IRB-approved written informed consent
* Patients enrolled in other CGA studies will not be excluded (see LCCC 0916, 1208)

Exclusion Criteria:

* ≥Age 65 years (no upper age limit)
* Diagnosis of either head and neck cancer, or lung cancer with either radiotherapy or chemoradiotherapy planned as part of standard treatment.
* Consented for receipt of EBRT at UNC Chapel Hill
* Able to read English (required for CGA)
* Curative treatment intent as defined by their radiation oncologist Signed, IRB-approved written informed consent
* Patients enrolled in other CGA studies will not be excluded (see LCCC 0916, 1208)
Addition of Vismodegib to Neoadjuvant Chemotherapy in Triple Negative Breast Cancer Patients

To evaluate safety and efficacy of vismodegib with standard neoadjuvant chemotherapy in breast cancer patients based on the CTCAE v4 2010

1. To study changes in biomarkers involved in the Hedgehog (HH) pathway in the first biopsy as compared to the later one
2. To detect predictive factors among patients who reached pathological complete response (pCR) as compared to those with no pCR
3. To evaluate the role of the addition of vismodegib in the pCR rate
4. To evaluate clinical responses by breast MRI and rates of breast conservative surgery after neoadjuvant chemotherapy
5. To evaluate QOL with EORTC QLQ-C30 scale


Eligibility Criteria:
Inclusion Criteria:

1. Female sex
2. Ability to give informed agreement and to carry out the whole study protocol during the study period
3. The patient should be able to carry out the needs of the clinical trial and have measurable disease
4. The patient should be 18-75 year-old
5. Triple negative breast cancer (ER\<1%, Progesteron Receptor (PR)\<1%, non-overexpressing HER2). 1. Patients with oligometastatic disease (1-2 resectable metastases) could be included
6. No previous systemic therapies
7. Patients who are going to benefit from neoadjuvant chemotherapy
8. Eastern Cooperative Oncology Group (ECOG)\<2 or Karnofsky≥70%
9. Blood tests and biochemistry suitable: (absolute neutrophil count\> 1500/uL; haemoglobin\>9 gr/dL; platelets\>100000/uL (microliters); total bilirubin≤ 1.5 the upper normal limit; GOT and GPT (transaminases)≤twice the upper normal limit; fasting glucose≤150 gr/dL; HbA1c≤8%, serum creatinine≤2 mg/dL.

Exclusion Criteria:

1. Severe diseases or infectious diseases or liver, kidney or bone marrow failure that advise not to participate in the study according to investigator criteria
2. Pregnancy or breast feeding period or fertility women who are not agree with contraception methods
3. Other primary tumors except for breast in situ carcinoma (CIS), cervical neoplasia(CIN) or localized skin tumors
4. Inflammatory breast cancer or bilateral breast cancer
5. Bone fractures, peptic ulcus or healing disorders
6. Any local or systemic therapy for breast cancer
7. To be maintained on immunosuppressants (prednisone \> 10 mgr daily or others), aspirin\> 325 mgr per day or clopidogrel \> 75 mgr daily
8. Cardiomyopathy by New York Heart Association (NYHA) class II-IV; heart stroke in the previous 6 months; uncontrolled blood pressure (systolic \> 150 mm Hg and /or diastolic \> 100 mm Hg), coagulopathy or hemorrhagic diseases
9. Previous lung diseases
10. Personal history of abdominal perforation, abdominal abscess, or abdominal fistula.
11. Inability to swallow pills
12. Intolerance to galactose, malabsorption to galactose or/and glucose, or primary hypolactasia
Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization

This study evaluated the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity and anatomic outcomes compared to ranibizumab monotherapy and the durability of response observed in patients with choroidal neovascularization secondary to age-related macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of either gender age 50 years or older
* Subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD)

Exclusion Criteria:

* Choroidal neovascularization due to causes other than AMD
* Prior treatment for neovascular AMD in the study eye

Other protocol-defined inclusion/exclusion criteria may apply
Effect of Warfarin in the Treatment of Metachromatic Leukodystrophy

Objectives/Purpose:

To determine the safety and efficacy of a Vitamin K (Vit K) antagonist (warfarin) in treating Metachromatic Leukodystrophy (MLD).

Hypothesis:

Vit K has an essential role in biosynthesis of sulfatides and other sphingolopids in the brain. Administering warfarin, a Vit K antagonist, may ameliorate the phenotype in MLD by decreasing t he amount of sphingolipid storage in the neuronal cells.

Study Design Prospective: we will enroll eligible consenting subjects into the study. The study will not include a control group and the families and treating physicians are informed administration of the drug.

1. Duration of Treatment: 4 weeks
2. Pharmacological Intervention: The patients will receive warfarin 1.5 mg at the beginning of the study period. The dosage then will be adjusted to the INR values on weekly basis.
3. Clinical evaluation: The patients will undergo clinical assessment prior to starting the treatment and at the end of the treatment period. The clinical assessment will also include administration of Gross Motor Function Measure (GMFM), a clinical toll for evaluation of motor development in children.
4. Urine Sulfatide Quantification: Urine samples for quantification of the sulfatide level will be collected at the time of enrollment, after 2 weeks and at the end of treatment period.
5. Blood Monitoring: The patients will undergo blood test for PT/INR at baseline and afterwards, at weekly bases for 4 weeks. The INR will be kept in a safe range of 2-2.5. If the INR is greater than 4.0 the dosage of warfarin will be lowered and another blood draw will be performed in 3 days.

Eligibility Criteria:
Inclusion Criteria:

* Children with MLD, 1 to 10 years of age who have received and failed bone marrow transplantation or are excluded from the treatment due to delayed diagnosis or any other reasons.

Exclusion Criteria:

* Any Children with MLD who are eligible for and might receive ABMT.
* Any Children with MLD who suffer with a bleeding disorder, moderate to severe anemia or any other hematological disorders.
* Any contraindications systemic for anti-coagulation
Dysport in Hallux Abducto Valgus (HAV) Phase IIa

The purpose of this study is to investigate the efficacy and safety of treatment with multiple doses of Dysport in adults suffering from clinically significant pain associated with HAV who have not undergone surgery for their condition.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of HAV
* Painful HAV in the study foot at Baseline

Exclusion Criteria:

* Flat or square metatarsal head, metatarsus primus elevates, or severe cavus/planus in the study foot
* Other podiatric or orthopedic condition which would interfere with the evaluation of pain and/or function
* Medical history or clinical evidence of any vascular disease and/or diabetic condition
Metformin and Sitagliptin in Women With Previous Gestational Diabetes

The goal of the present research is to compare the effects of treatment with metformin and sitagliptin, alone or in association, in women with previous gestational diabetes to evaluate the impact of the two drugs on beta-cell function. The study results may contribute to give a rational approach for future investigations.

A randomized, double blinded study, on 45 women with previous gestational diabetes and impaired glucose tolerance (IGT) or impaired fasting glucose (IFG) to assess the effects of a 4-month treatment with metformin and/or a dipeptidyl peptidase-4 inhibitor (sitagliptin) on beta-cell function and insulin resistance.

At baseline, all women will have a standardized medical history, physical, and laboratory examination. Plasma glucose, insulin, pro-insulin, C-peptide, glucagon, adipokines, pro-inflammatory molecules, and lipid profile will be determined in fasting condition. A 75g OGTT will be performed after an overnight fasting and sample will be drawn at 15, 30, 60, 90 and 120 minutes for plasma glucose, C-peptide, glucagon and GLP-1 determinations. Women with IFG or IGT will be recruited and undergo to a hyperglycemic clamp with arginin bolus at the end of the test. Then the women will be randomized in 3 treatment groups: metformin (850 mg bid), sitagliptin (100 mg qd)or metformin (850 mg bid) + sitagliptin (100 mg qd). After 4-month treatment, the baseline evaluation will be repeated.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects aged ≥18 and ≤45 years
* Caucasian race
* History of previous gestational diabetes (in the screening) during pregnancy.
* Female of childbearing potential must use effective contraceptive measures for at last 1 month prior to entry into the study and should continue to use the some contraceptive method during the overall study period
* Written informed consent obtained

Exclusion Criteria:

* Patients diagnosed with type 1 insulin dependent diabetes
* Diagnosis of diabetes in the 75g OGTT performed at entry
* BMI ≤18 or ≥50 Kg/m2
* Chronic impaired renal function
* Impaired liver function as shown by transaminase levels ≥ twice above the upper normal range
* History of hypersensitivity to metformin
* Pregnant or breast-feeding women, or women planning to become pregnant during the study
* Failure to use adequate contraception (Women of current reproductive only)
* Mental condition rending the subject unable to understand the nature, scope and possible consequences of the study
* Any clinically significant major organ system disease
* Patients with underlying concomitant medication requiring a long-term use of drugs potentially acting on glucose metabolism (e.g. corticosteroids, diuretics, beta-adrenergic drugs or others)
* Treatment or likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
* History of drug or alcohol abuse within the last 2 years or current addiction to substances of abuse
* Any disease or condition that in the opinion of the investigator may interfere with the completion of the study
* Subjects unlikely to comply with the protocol
Testing Integrative Smoking Cessation for HIV Patients

The purpose of this study is to examine the feasibility, acceptability and effect of a combined smoking cessation intervention integrating contingency management (reward-based) strategies with Mindfulness training to identify the optimal dynamic strategy to promote smoking cessation among HIV patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with HIV (based on self-report).
* Be 18 years and older
* Have smoked ≥ 5 cigarettes/day in the past year
* Be interested in making a quit attempt in the next 30 days
* Own a smartphone (apple/android), and plan to keep it active for the next 6 months
* Able to consent
* Have no plans to move in the next 6 months
* Are not pregnant or planning to be pregnant in the following 6 months
* Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements

Exclusion Criteria:

* Have contraindication to NRT (past month myocardial infarction, history of serious arrhythmias/or unstable angina pectoris, dermatological disorder)
* Are currently being treated for a psychiatric condition.
* Are currently being treated for smoking cessation, alcoholism, or illicit drug use
* Are adults unable to consent
* Are individuals who are not yet adults
* Are pregnant women
* Are prisoners
Using Artificial Intelligence-based ChatBot to Improve Women's Participation to Cervical Cancer Screening Programme

This project looks to improve the return rate of HPV self-sampling (HPVss) as well as the management of women HPVss positive.

France has already implemented a cervical screening programme based on HPV test for the whole female population aged 30-65 years. Non-participant women can perform HPV test at their home. However, less than 20% of French women performed vaginal self-sampling when a kit was sent to their home. Women with lower income and educational levels participate less to cervical screening. A variety of personal, practitioner, test-related and logistical barriers negatively impact the screening participation of French women. Key barriers to participation could be addressed by overcoming disparities in HPV-related knowledge and perceptions about cervical cancer screening. This study aims to evaluate the impact of sending HPV self-sampling kit at women's home, associated with providing, through multiple mobile channels, a multi-language decision aid designed for women with lower education accessible via artificial intelligence-based ChatBot. This decision aid will help women review high quality evidence on cervical cancer disease and screening modalities.

Eligibility Criteria:
Inclusion criteria: eligible women will be:

* aged 30-65
* did not perform a pap smear in the last 4 years
* are living in deprived clusters in the Occitanie region.
* did not answer to a first "invitation" letter to perform a clinician-collected HPV testing

Exclusion criteria: ineligible women will be those:

* outside the target age group
* had a Pap smear in the past 3 years
* had hysterectomy including cervix
* are pregnant beyond 6 months
* already scheduled a screening appointment or had just attended a HPV screening
* had a cervical abnormality that was under exploration and/or treatment.
* participated to the study pilot
Spinal Cord Stimulation for Restoration of Arm and Hand Function in People With Subcortical Stroke

The goal of this study is to verify whether electrical stimulation of the cervical spinal cord can activate muscles of the arm and hand in people with hemiplegia following stroke. Participants will undergo a surgical procedure to implant a system which provides epidural electrical stimulation (EES) of the cervical spinal cord. Researchers will quantify the ability of EES to recruit arm and hand muscles and produce distinct kinematic movements. The implant will be removed after less than 30 days. Results of this study will provide the foundation for future studies evaluating the efficacy of a minimally-invasive neuro-technology that can be used in clinical neurorehabilitation programs to restore upper limb motor function in people with subcortical strokes, thereby increasing independence and quality of life.

Specifically, researchers will 1) quantify the motor potentials in arm and hand muscles generated by single pulses of electrical stimulation of the spinal cord using FDA-cleared devices 2) characterize optimal stimulation parameter ranges to maximize induced arm and hand movement, 3) measure neural changes that could be induced by the system, 4) characterize potential clinical effects by assessing patient mobility, spasticity, and neurophysiology with standard clinical tests and simple motor tasks.

Eligibility Criteria:
Inclusion Criteria:

1. Single, ischemic or hemorrhagic stroke resulting in upper extremity hemiparesis more than 6 months prior to the time of enrollment. (Prior strokes that did not cause upper extremity motor deficits are not exclusionary.)
2. Participants must be between the ages of 21 and 70 years old.
3. Scores higher than 7 and lower than 50 on the Fugl-Meyer scale

Exclusion Criteria:

1. Serious disease or disorder (ex. neurological condition other than stroke, cancer, severe cardiac or respiratory disease, renal failure, etc.) or cognitive impairments that could affect the ability to participate in study activities.
2. Pregnancy or breast feeding.
3. Receiving anticoagulant, anti-spasticity or anti-epileptic medications throughout the duration of the study.
4. Presence of any implanted medical devices.
5. Severe claustrophobia.
6. Presence of joint contractures deemed by study clinician/investigator to be too severe to participate in study activities
7. Results from the Brief Symptoms Inventory (BSI-18) and additional discussions with the Principal Investigator and a study physician that deem participant inappropriate for the study.
8. Evaluation to sign consent form score \<12.
Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.

Due to the potential for pregnancy-induced changes in the pharmacokinetics of medication, one cannot assume that the currently licensed doses of the medication to be tested under this protocol lead to adequate exposure in an HIV-infected pregnant woman. For the agents under study no or limited pharmacokinetic data during pregnancy are available. As the changes in pharmacokinetics during pregnancy are most prominent in the third trimester a pharmacokinetic curve will be recorded in the third trimester after attaining steady state.

The following agents will be studied:

Etravirine, Intelence, TMC125; Emtricitabine, Emtriva or FTC; Tenofovir, Viread, TDF; Atazanavir, Reyataz; Fosamprenavir, Telzir, FPV; Darunavir, Prezista, TMC114; Tipranavir, Aptivus, TPV; Indinavir, Crixivan; abacavir; raltegravir, Isentress; Enfuvirtide, Fuzeon; Maraviroc, Celsentri; dolutegravir; elvitegravir/cobicistat; rilpivirine, TAF, darunavir/cobicistat; doravirine; bictegravir; cabotegravir/rilpivirine long acting injectables

Eligibility Criteria:
Inclusion Criteria:

1. HIV-infected as documented by positive HIV antibody test and confirmed by an antigen test.
2. Subject is at least 18 years of age at screening.
3. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
4. Treated with a cART regimen containing at least one agent which is mentioned in Appendix 1; this agent has been taken for at least 2 weeks before the day of first PK curve evaluation.
5. Subject is pregnant
6. Subject is able to adhere to food intake recommendations, if applicable.

Exclusion Criteria:

1. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
2. Inability to understand the nature and extent of the study and the procedures required.
3. Presence of grade III/IV anemia (i.e. Hb \<4.6 mmol/L or \<7.4 g/dL).
4. Using oral cabotegravir/rilpivirine.