cyrilzakka/clinical-trials huggingface dataset:
Self-Care Training for Family Caregivers of Persons With Neurodegeneration

The purpose of this study is to assess whether an 8-week mindfulness program enhances psychological well-being (e.g., stress, depressive symptoms), biological indicators of stress (e.g., inflammation), and cognitive function (e.g., attentional ability) in primary family caregivers of persons with dementia or a related neurodegenerative disease. A total of 232 primary family caregivers aged 50+ years of age will be recruited for this study and randomized to one of three groups: mindfulness meditation (MM), psychoeducation (PSY) or caregiver respite (CR). All participants will complete three testing sessions: baseline (pre-intervention \[T1\]), post 8-week follow-up (post-intervention, \[T2\]), and 12-month follow-up (T3).

The purpose of this study is to assess the benefits of 2 virtual self-care programs - mindfulness meditation or a psychoeducation support group - for family caregivers of persons with a neurodegenerative disorder. Both programs are 8-weeks in length. A third arm will include a respite-ony group, which may be considered "treatment as usual". Outcomes of interest include psychological well-being (e.g., stress, depressive symptoms), biological indicators of stress (e.g., inflammation), and cognitive function (e.g., attentional ability). All participants will complete three testing sessions: baseline (pre-intervention \[T1\]), post 8-week follow-up (post-intervention, \[T2\]), and 12-month follow-up (T3). The target sample is 232 family/informal caregivers, aged 50+ years old. All sessions will be conducted using the Zoom platform. Participants will be required to go to LifeLabs for blood collection. Blood results will be shared with participants.

Eligibility Criteria:
Inclusion Criteria:

* 50+ years of age
* Currently a primary family caregiver
* Fluent in English

Exclusion Criteria:

* Existing mindfulness practice
* Diagnosed/Presenting with Post-traumatic Stress Disorder; Substance Disorder; Psychosis
* Unable to attend 8 sessions
* No access to a computer or high-speed internet
* Not willing to be randomized
Tenofovir Disoproxil Fumarate in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drug Combinations

The purpose of this study is to make tenofovir disoproxil fumarate (DF) available to HIV-infected patients who have failed other anti-HIV drug combinations, who have few treatment choices available, and whose disease may get worse. This study will allow patients to obtain tenofovir DF before it is approved for marketing.

Patients receive daily doses of tenofovir DF.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Have a viral load (level of HIV in the blood) of at least 10,000 copies/ml by PCR within the previous 2 months.
* Have a CD4 count of 100 cells/mm3 or lower within the previous 2 months. Patients with a CD4 count above 100 and as high as 200 cells/mm3 may also be eligible if they had an opportunistic (AIDS-related) infection within the past 90 days.
* Have failed treatment with at least 2 protease inhibitors (PIs) or at least 1 PI plus a nonnucleoside reverse transcriptase inhibitor (NNRTI).
* Are not able to get effective treatment with a combination of currently approved anti-HIV drugs.
* Are at least 18 years old.
* Have a negative serum pregnancy test.
* Are willing to use a barrier method of birth control (both males and females) while on the study and for 30 days after taking the drug.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have or have had kidney disease or bone disease.
* Are pregnant or breast-feeding.
* Abuse alcohol or drugs.
* Are taking, or have taken within 7 days of enrolling in the study, adefovir dipivoxil or drugs that may cause kidney problems, including aminoglycoside antibiotics, cidofovir, foscarnet, intravenous (IV) amphotericin B, IV pentamidine, IV vancomycin, and chemotherapy (e.g., cisplatin).
* Have any medical conditions or have had any medications that the study investigator believes will make him/her unsuitable for the study.
Digital Cognition in Multiple Sclerosis

A DIGITAL THERAPEUTIC TO IMPROVE THINKING IN MULTIPLE SCLEROSIS

WHO: 65 participants with a confirmed diagnosis of Multiple Sclerosis (MS)

WHY: Purpose of the study is to compare the effect of 2 tablet-based brain training digital tools on important components of thinking (cognition).

WHAT: Complete a set of tests (physical and cognitive) at baseline, 6 weeks and 14 weeks, and use one of two brain training tools on an iPad in your home, for 25 minutes a day, 5 days a week, for 6 weeks.

WHERE: UCSF WEILL INSTITUTE FOR NEUROSCIENCES (675 Nelson Rising Lane, San Francisco, CA)

The purpose of this study is to begin to test a brain training video game in people with Multiple Sclerosis (MS).

Visit 1. After informed consent, you will complete a series of questions about your functioning and mood. You will then complete a series of tests (vision, hand tapping, walking). Then, you will complete a set of thinking tests. The first set will be paper and pencil. The second set will be on a tablet or a computer. You will use your study code to sign into these tools and you won't provide any personal details for the digitized tests.

Finally, you will complete the "cognitive training tool". There are two versions of this digital, iPad based tool, which takes about 25 minutes to complete and is designed to be entertaining. You will be randomized into 1 of 2 groups: each group will play a version of the brain training game. You will not be told what group/game type you were randomized into. You will be given the tablet with the game on it to take home, and to practice this game 5 times a week for 6 weeks.

Visit 2. After the 6 weeks of at-home training, you will then come back to the research study unit to do a repeat of the initial visit (with physical and cognitive assessments). At this study visit, you will also be returning the iPad.

Visit 3. You will then return 8 weeks after Visit 2, to do a repeat of the assessments.

You will be compensated for each study visit (visit 1: $50, visit 2: $100, visit 3: $150).

Eligibility Criteria:
Inclusion Criteria:

* Adult men or women diagnosed with multiple sclerosis (MS) or clinically isolated syndrome (CIS)
* SDMT z-score range (-2 to +1)
* Wifi available in home
* Able to use a tablet (iPad)
* Able to attend 3 study visits in person.

Exclusion Criteria:

* Clinician's assessment of visual, cognitive, or motor impairment that would preclude participation.
* A clinical relapse within the last 30 days.
* Steroid treatment for clinical relapse within the last 30 days.
Untersuchung Zur Erfassung Und Kontrolle Der Lebensqualität Unter Einer Therapie Mit Pollinex Quattro Bei Heuschnupfen

Questionnaire to measure and control the quality of life of patients with hay fever who are treated or were treated with Pollinex quattro

Questionnaire including 19 questions concerning the Quality of life of patients with hayfeyer under or after therapy with a specific immuntherapy with Pollinex quattro

Eligibility Criteria:
Inclusion Criteria:

* Pollinosis/seasonal Rhinitis based on an allergy against birch/alder/Hazel pollen OR grass/rye pollen OR mugwort
* Therapy with Polinex quattro

Exclusion Criteria:

* Age \<18 years.
Immune Function Following Liver Transplantation

Post-operative care following liver transplantation is characterized by a high incidence of infective and immunological complications. Restauration of liver function following liver transplantation is progressive and characterize a period of immuno-infective vulnerability. The purpose of this study is to characterize the early post-operative immune function in children after liver transplantation.

Within a few decades, liver transplantation has become an effective treatment of end-stage liver diseases associated with high spontaneous mortality. However, the consequences of immediate transplants are frequently complicated by infective (nosocomial infection) and immunological complications (acute graft rejection) in up to 40 to 60% of liver transplanted patients. In order to ensure graft immunotolerance, immunosuppressive therapy based mainly on calcineurin inhibitors, is initiated soon after liver transplantation. Immunosuppressive therapy is intended to reduce the response of cytotoxic lymphocytes and NK cells. As a result, an important component of the immune response is blocked. In addition, function of the transplanted liver, which is a key organ for both immuno-inflammatory signalling and host defense against pathogens, is progressively restored post-operatively. Thus in this post-transplant period, there is a critical period where liver function is severly impaired and progressively get restaured. The aim of this study is to characterize the restauration of immune function in the early post-operative period and evaluate its correlation with occurence of infective or immunological complications.

Eligibility Criteria:
Inclusion Criteria:

* Child under 18 admitted for liver transplantation
* Signature of consent by the two holders of parental authority.
* Informing children as far as their age and condition allow.
* Affiliation to a social protection

Exclusion Criteria:

* Children under 6 kg
* Children transplanted for primary graft dysfunction
* Children scheduled for liver-kidney transplants
Weight Gain Prevention

The specific aim of the proposed project is to test two separate self-regulation interventions to prevent weight gain in young adults, one based on making sustained small changes in behavior to prevent weight gain and the other on making periodic larger behavior changes resulting in weight loss.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-35
* Body mass index between 23 and 30
* Interested in preventing weight gain

Exclusion Criteria:

* BMI outside of range specified
* Age outside of range specified
* History of or current eating disorder or substance abuse
* Recent weight loss greater than 5% of weight
* Currently in another research study that would interfere
Clinical and Molecular Staging of Lung Cancer Stages I and IIp

The classification of lung cancer (LC) according to the degree of anatomical extension (TNM) allows the estimation of the prognosis of the patient, although its accuracy is limited. In fact, one third of surgically-treated patients with initial disease have recurrences during follow-up, despite the negativity of node dissection at surgery. The incorporation of genetic, epigenetic and proteomic information to TNM staging will characterize more accurately the lung cancer, and thereby improve the prognostic and the prediction of the therapeutic response in these patients.In this project a prospective cohort of 320 patients with lung cancer staged I-IIp will be studied, combining the clinical and pathologic information available with genetic, epigenetic and proteomic markers in tumour samples, pulmonary tissue, regional nodes and peripheral blood, preserved in suitable systems for the application of complex analytical methodologies. Thus, a knowledge database will be created with the aim of improving the prognostic and prediction capabilities of TNM staging.This project is coordinated with related sub-projects that cover the required laboratory tests on biological samples and with Spanish collaborative group in lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* Able to understand and sign the informed consent

Exclusion Criteria:

* Absence of mediastinal disease
Limb Remote Ischemic Preconditioning Reduces Heart and Lung Injury After Abdominal Aortic Aneurysm Repair

To investigate whether limb remote ischemic preconditioning (LRIP) has protective effects against intestinal and pulmonary injury in patients undergoing open infrarenal abdominal aortic aneurysm (AAA) repair.

Remote ischaemic preconditioning may confer the cytoprotection in critical organs. We hypothesized that limb remote ischemic preconditioning (RIPC) would reduce intestinal and pulmonary injury in patients undergoing open infrarenal abdominal aortic aneurysm (AAA) repair.The primary outcomes included the biomarkers reflecting intestinal injury (serum intestinal fatty acid binding protein, endotoxin levels and diamine oxidase activity) and the variables reflecting pulmonary injury (arterial-alveolar oxygen tension ratio, alveolar-arterial oxygen tension difference and respiratory index). In addition, the severity of intestinal and pulmonary injury was assessed with different scoring methods, respectively. Markers of oxidative stress and systemic inflammation were measured as well.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of abdominal aortic aneurysm
* Must be received open abdominal aortic aneurysm repair

Exclusion Criteria:

* age \>80 years old
* Acute coronary syndrome or myocardial infraction within
* 3 months
* Chronic obstructive pulmonary emphysema
* angina pain within 48 hours of repair procedure
* ejection fraction less than 40%
* poor pulmonary function (PaO2 \<60mmHg)
* history of inflammatory bowel disease
* history of diarrhea (≥2 liquid stools per day for ≥2 days) within 1 week of surgery
* intestinal chronic inflammatory disease
Spectral CT Clinical Trial Protocol

The purpose of this study was to evaluate the expected effectiveness, ease of operation, stability, and safety of Spectral CT

Under the premise of protecting subjects and ensuring the scientific nature of this study, Spectral CT was evaluated for its effectiveness, convenience, stability and safety under normal conditions by collecting clinical cases.

Eligibility Criteria:
Inclusion Criteria:

* Recruit volunteers (ages 18 to 75);
* Negative pregnancy tests in women of childbearing age;
* Participants who agree to participate in this clinical trial and sign the informed consent;
* Enhanced scans require laboratory tests to confirm normal renal function.

Exclusion Criteria:

* Persons who do not have full capacity for civil conduct;
* Lactating women;
* People who are not suitable for enhanced scanning with iodine contrast agent;
* Patients whom the investigator considers inappropriate to participate in this clinical trial.
GenerationGemelli: Longitudinal Study for the Evaluation of the Maternal Exposome on the Health of the Newborn and Child

The study involves the establishment of a case-control study within a birth cohort. With approximately 4,000 annual deliveries, the aim is to enroll 140 cases (newborns with intrauterine growth restriction \[IUGR\] and premature birth) and 280 controls each year, starting from September 2022. A comprehensive questionnaire will be utilized to gather information about various types of maternal environmental exposures before and during pregnancy. Biological samples will be collected from both mothers and newborns (including vaginal swab, placenta sample, blood, saliva, meconium, and bronchoalveolar lavage fluid) at birth and within the early hours of the newborn's life. Laboratory examinations will include the measurement of heavy metals and essential elements, investigation of placental distress and fetal brain damage biomarkers, analysis of microbiota, and assessment of DNA methylation profiles. Clinical follow-up assessments will be conducted in both cases and controls at 12 and 24 months, during which anthropometric data, types of feeding with particular reference to breastfeeding and its duration, pediatric emergency room visits, hospitalizations, medication usage, known allergies, and neuropsychological development will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Being resident for at least two years in the city of Rome, Italy.
* Being assisted and giving birth at FPG (presumably referring to a specific hospital).
* Meeting the definition of case or control.

Definitions:

- Cases:

Women with single pregnancies diagnosed with late intrauterine growth restriction (≥32 weeks of gestational age), according to the definition of Gordjin et al., in the absence of structural and/or evident organ malformations.

Women with spontaneous preterm birth at less than 32+0 weeks of gestational age.

- Controls:

Full-term pregnant women (gestational age between 37+0 and 41+6 weeks) without intrauterine growth restriction or other structural and/or genetic disorders.
Effect of Neck Flexion on Esophagogastric Anastomotic Leakage After MIE

Esophageal cancer (EC) is the eighth most common cancer and the sixth leading cause of cancer deaths worldwide. Minimally invasive esophagectomy (MIE) is regarded as a safe and effective management for resectable EC. Gastric tube is considered to be an ideal substitute for the resected esophagus, and used for cervical esophagogastric anastomoses for digestive tract reconstruction in MIE. However, the tension at the anastomosed area can not be ignored and may cause cervical anastomotic leakage (CAL) in some cases. Continuous neck flexion is a standard post-operative posture after tracheal resection and reconstruction, and aimed to relieve the anastomotic tension. In this study, the investigators attempt to adopt the maneuver in MIE, and observe its effect on relieving the anastomotic tension and decreasing the incidence of CAL.

After the cervical esophagogastric anastomoses is completed and the skin incision is closed, the patient's occiput will be lifted, and then the neck will be maintained in flexing position by an assistant. The underside of the chin will be fixed to the anterior chest wall with two stout nylon sutures by the surgeon. The neck will be fixed in the neutral flexing position for 7 to 10 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus.
* Surgical resectable (T1-4a, N0-3, M0).
* Age≥18 and ≤75 years.
* European Clinical Oncology Group (ECOG) performance status 0,1 or 2.
* Written informed consent obtain.

Exclusion Criteria:

* Carcinoma of the cervical esophagus.
* Carcinoma of the gastro-esophageal junction (GEJ).
* Prior thoracic surgery or trauma on the right hemithorax, or previous diseases which may lead to right pleural adhesion (these patients will undergo open surgery instead of minimally invasive esophagectomy). -Dysfunction of cardiorespiratory system or other surgical contraindications.
R-CHOP Combined With Lenalidomide in the First-line Treatment for Patients With Diffuse Large B Cell Lymphoma

This is a prospective single-arm, multi-center, phase II clinical trial to observe the efficacy and safety of R-CHOP (Rituximab-Cyclophosphamide, Epirubicin, Vincristine and Prednisone) combined with lenalidomide in the first-line treatment for patients with medium to high risk/high risk diffuse large B cell lymphoma.

Diffuse large B cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma (NHL). Currently, R-CHOP is world-widely used in the first-line treatment for DLBCL. There are about one second of patients suffering relapse and drug resistance. Lenalidomide is an analog of thalidomide, the mechanism of anti-tumor action has not been fully elucidated. Lenalidomide has been proved to inhibit the proliferation of tumor cells in certain hematopoietic systems. At present, it has been approved for the treatment of multiple myeloma with good efficacy and safety. The goal of our trial is to assess the efficacy and safety of R-CHOP combined with lenalidomide in the first-line treatment for patients with medium to high risk/high risk diffuse large B cell lymphoma.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 to 70 years old (including 18 and 70)
2. Diagnosed as diffuse large B cell lymphoma
3. Subjects must be untreated (medium to high risk/high risk: International Prognostic Index (IPI) score 3-5 or aaIPI score 2-3/ Immunohistochemical staining of double expression (BCL2 ≥ 50% and C-MYC ≥ 40%) or P53 protein mutation positive ≥ 50%)
4. No receiving chemotherapy before enrollment
5. Having at least one measurable lesions
6. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2
7. Life expectancy no less than 3 months
8. enough main organ function
9. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
10. Agreeing to sign the written informed consents

Exclusion Criteria:

1. Diagnosed as high-grade B-cell lymphoma, including non-specified and double-strike or triple-strike
2. Diagnosed as grey-zone lymphoma
3. Diagnosed as central nervous system lymphoma
4. Diagnosed as primary mediastinal large B-cell lymphoma
5. Diagnosed as CD20 negative diffuse large B-cell lymphoma
6. Other malignant tumor history or active malignant tumor need be treated
7. Serious surgery and trauma less than two weeks
8. Systemic therapy for serious acute/chronic infection
9. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
10. Vaccination with live attenuated vaccine less than 4 weeks
11. HIV-positive, AIDS patients and untreated active hepatitis
12. Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months
13. Patients with a history of mental illness
14. Researchers determine unsuited to participate in this trial
Identify the Obstacles to Early Diagnosis of Cancer in Patients Over 75 Years Old, on an Outpatient Basis

A third of cancers are diagnosed in patients over 75 years of age. There are fears of the elderly talking about new symptoms. The doctor may find himself trapped by general symptoms, which can be confused with "normal aging".

Some older, younger people have lived in a world where cancer was little talked about, where there was little treatment possible.

There is an idea that doctors are not very quick to start curative treatment because they think that the elderly cannot bear it.

It is important to differentiate screening and early diagnosis.

Delayed treatment causes a decrease in survival and quality of life. Cancer can be discovered suddenly: for example, occlusion with peritonitis in case of a stenosing colonic tumor, leading to urgent management.

The elderly are often excluded from clinical studies.

In addition, the geriatric population is heterogeneous, leading to very diverse and individual care, with prioritization of issues.

Oncogeriatrics, which combines two services (oncology and geriatrics), is a specialized discipline, promoting comprehensive care for the elderly patient with cancer.

The general practitioner is at the center of care. It detects early signs and starts examinations if necessary.

Cancer care can be divided up with the different stages of care with various teams, including organ specialists.

The general practitioner is the privileged interlocutor for the patient and their family (medico-psycho-social plan), who knows their history and their experience.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 75 years old (terminal included)
* Incident diagnosis
* Has cancer whose diagnosis dates back more than 3 months
* Digestive cancer, breast cancer
* Stage of advanced cancer (TNM stage: T\> T2 (terminal included), M1)
* According to the opinion of the oncogeriatrician on the time of taking charge
* Follow-up of a geriatrics service, onco-geriatrics orientation
* Living in the Rhône department
* Non-opposition of the patient to the study

Exclusion Criteria:

* Cancer diagnosis more than 6 months old
* Patient denies