cyrilzakka/clinical-trials huggingface dataset:
Prevalence of Psychocognitive Impairments in Adolescents Surviving Childhood Leukemia : LEA-PsyCog

The objective of the LEA-PsyCog project is to assess the prevalence of psychiatric disorders and psychocognitive impairments in adolescents surviving childhood leukemia .

The second objective is to explore the complex relationships between psycocognitive development and soiciodemodemographics data, main characteristics of leukemia, treatments, side-effects, quality of life and characteristics of proxyies environment.

3. Materials and Methods The LEA study is based on the constitution of a multi-centric prospective cohort in 11 university hospitals: Bordeaux, Clermont-Ferrand, Grenoble, Lyon, Paris (Trousseau, Robert Debré, St Louis), Marseille, Montpellier, Nancy, Nice, Rennes. Are inclued in LEA all the children diagnosed and treated for acute leukemia since January 1980 (incident and prevalent cases), surviving at month 24 for the AML and ALL grafted in complete remission and at month 48 for the ALL not grafted in first complete remission.

The LEA Psy-Cog study rests on a sample of the LEA cohort. Are included the patients 12-17-years-old from the PACA-Corse sub-cohort (administrative district of 4 million of people which corresponds to the Marseille and Nice centers). Patients from this two centers are the patients with the more important length of survey, allowing us to produce a not biaised estimation of prevalence rate. Finally, the choice of this subsample is supported by the proximity of the Mediterranean Center for Adolescent in Marseilles, specifically dedicated to the psychological follow-up of children suffering from cancer.


Eligibility Criteria:
Inclusion Criteria:

* - Age 18-year-old subordinate at the time of the diagnosis;
* Diagnosis of acute(sharp) leukaemia;
* Diagnosis from January, 1980;
* Treatment(Processing) of the acute(sharp) leukaemia introduced in one of the inquiring centers (services(departments) specialized hematology and Clermont Ferrand's pediatric oncology, Grenoble, Lyon, Marseille, Nancy, Nancy, Nice, Paris - Robert Debré/Saint Debré/Saint Louis/Trousseau Louis/Trousseau;
* Living in France;
* Possessing a national insurance scheme
* 24-month-old Survivor of recoil(drop) with regard to(compared with) the diagnosis for the Leukaemia Aiguës Myéloblastiques (LAM) and Leukaemia Aiguës Lymphoblastiques ( LAL) transplanted in 1st complete forgiveness; or in 48 months of recoil(drop) with regard to(compared with) the diagnosis for the LAL not transplanted in first complete forgiveness;

Exclusion Criteria:

* Failure to respect the criteria of inclusion beforehand quoted,
* Initial Treatment(Processing) realized except 2 participating centers (Marseille, Nice), even in case of moving in in the geographical zones covered by these centers during the phase of treatment(processing) or in the course of follow-up
Evaluation of the GORE® VIABAHN® Endoprosthesis for the Treatment of Popliteal Artery Aneurysm (PAA)

This study will assess the long term safety and performance of the GORE® VIABAHN® Endoprosthesis for the treatment of patients with Popliteal Artery Aneurysms.


Eligibility Criteria:
Inclusion Criteria:

Inclusion to the study requires the patient:

1. Received a GORE® VIABAHN® Endoprosthesis to treat a popliteal artery aneurysm
2. Had a symptomatic aneurysm or asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, or the presence of mural thrombus (\< 2 cm) in the popliteal artery;
3. Was 18 years of age or older at the time of the treatment;
4. Had an elective popliteal artery aneurysm procedure;
5. Has provided Informed Consent, personally or through lawful representation as determined by applicable local regulations and state law

Exclusion Criteria:

Prior to or at the time of implant the patient is / has:

1. Bilateral popliteal artery aneurysms with initial treatment on the same day;
2. Thrombotic occlusion of the popliteal artery or PAA;
3. Marfan syndrome or Ehlers-Danlos syndrome;
4. Unable to tolerate antiplatelet therapy;
5. Thrombophilia requiring long term anticoagulation;
6. Known allergies to the GORE® VIABAHN® Endoprosthesis components;
7. Enrolled in another investigational drug or medical device trial where participation may have affected the outcome or treatment of the subject in the popliteal artery aneurysm study with the GORE® VIABAHN® Endoprosthesis or had previous surgery for the popliteal artery aneurysm in the study limb.
Clinical Study Investigating the Effect of Sodium Nitroprusside Infusion on Thyroidal Function

Whether use of SNP during cardiac surgery has any effect on thyroid function has not yet been investigated in humans. The aim of this study was to investigate the effects of SNP administration during the rewarming period of cardiac operations on circulating levels of thyroid hormones.


Eligibility Criteria:
Inclusion Criteria:

Patients without history of:

* thyroidal disease
* hypertension
* pulmonary disease
* peripheral vascular disease
* stroke
* recent myocardial infarction within the week prior to operation
* unstable angina pectoris
* liver or kidney dysfunction
* morbid obesity
* cachexia
* sulfonylurea intake

Exclusion Criteria:

* Patients who needed positive inotropic pharmacologic support during or after the operation
* Patients who developed atrial fibrillation in the post operative period requiring amiodarone therapy
* In addition, patients receiving any medication known to interfere with any step of thyroid hormone metabolism such as

  * amiodarone
  * propranolol
  * furosemide
  * non-steroidal anti-inflammatory agents
  * steroids
  * estrogens
  * antacids
  * diphenylhydantoin
  * spironolactone
Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Single-chamber Pacemaker Implantation

This study is intended to compare the feasibility, safety and efficacy of Ensite-NavX zero-fluoroscopic navigation system to conventional fluoroscopic X-ray approach as to performing single-chamber pacemaker implantation.

Permanent pacemaker is a well-established treatment to treat patients with a wide range of heart rhythm disturbances.

Fluoroscopy is the imaging modality routinely used for cardiac device implantation and electrophysiological procedures.Due to the rising concern regarding the harmful effects of radiation exposure to both the patients and operation staffs, novel 3D mapping systems have been developed and implemented in electrophysiological procedure for the navigation of catheters inside the heart chambers.

Ensite NavX system can be used for cardiac imaging as a reliable and safe zero-fluoroscopy approach for implantation of single- or dual-chamber permanent pacemaker in patients. Our method offered a choice for some special population of patient in whom radiation exposure need to be avoided or in the extreme circumstances when the X-ray machine is out-of-order.

Eligibility Criteria:
Inclusion Criteria:

* Sick Sinus Syndrome
* complete Atrioventricular Block
* high degree second Degree Atrioventricular Block
* Bradycardia

Exclusion Criteria:

* pacemaker replacement
* severe structural l cardiac malformations
* severe cardiac enlargement
* venous malformations
TCR-Redirected T Cells Therapy in Patient With HBV Related HCC

This is a single center. single arm, open-label study to determine the safety and clinical benefit of TCR-redirected T cell therapy in patient with HBV related HCC post hepatectomy or radiofrequency ablation.


Eligibility Criteria:
Inclusion Criteria:

1. Expression of the specific human leukocyte antigen (HLA) class I profile
2. Hepatocellular carcinoma (HCC) with positive test for hepatitis B virus surface antigen (HBsAg)
3. BCLC stage C
4. At least 1 month after surgical intervention or 2 weeks after TACE (may include other type of resection/ablation) No major post-operative complication
5. Laboratory criteria:

   1. Liver function: Child A, ALT \< 200 U/L, AST \< 200 U/L, Tbil \< 17.1umol/L
   2. Renal Function: Creatinine clearance ≥ 60ml/minute
   3. Cardiac Function: No abnormality in cardiac enzyme and ECG
   4. Pulmonary Function (Lung): No abnormality in chest X-ray
6. Sexually active subjects must be willing to use an acceptable method of contraception
7. Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures

Exclusion Criteria:

1. Subject experiencing acute infection or gastric bleeding within 30 days
2. Mid to late stage cirrhosis, i.e. Child-Pugh Score ≥ 7
3. Known history of testing positive for human immunodeficiency virus (HIV)
4. Other liver complications, including alcoholic liver disease, non-alcoholic autoimmune liver disease, drug induced liver disease
5. Serious systemic conditions, such as mental illness, cerebrovascular disease, coronary heart disease, diabetes, epilepsy
6. Women who are pregnant or breast-feeding
7. History of allergic reaction to blood products or investigational products
8. History of chronic alcoholism or drug abuse/addiction
9. Require systemic medications, such as steroids during the period of study drug administration
10. Exposure to any cell therapy such as, but not limited to NK, CIK, DC, CTL, stem cells therapy 6 months prior to study drug administration
11. Use of any investigational product (IP) or investigational medical device
12. Any condition which could jeopardize the safety of the patient and his/her compliance in the study
The Influence of Different Fluid Therapy Measures on the Postoperative Outcome in Fast Track of Colon Cancer.（FTSlapCC)

To compare the influence of two different fluid administration strategies on the clinical efficacy of patients with colorectal carcinoma during the fast-track surgery.

Patients that were diagnosed with colorectal carcinoma by the First Hospital of Jilin University and were scheduled to undergo the laparoscopic surgery were prospectively included and divided into the experimental group and the control group with the random number method. After surgery, patients in the experiment group were provided with intravenous fluid administration at 1.0ml/Kg/h and encouraged to take food and drink water early after surgery, and the intravenous fluid administration was stopped immediately when the oral intake was more than 1500ml/h; patients in the control group strictly followed the fasting and were provided with the intravenous fluid administration according to "Total amount of fluid = physiological requirement + additional loss (fever + gastrointestinal decompression) + amount lost" until their intestinal function completely recovered. The blood volume change indicators (heart rate, mean arterial pressure, oxyhemoglobin saturation, inferior vena cava diameter /body surface area (VCD), intra-abdominal pressure, specific gravity of urine, BNP, etc.) and inflammation indicators (CRP, IL-6, TNF-a) of the two groups of patients were observed and a comparison was made of the recovery time of intestinal function, incidence of complications, hospitalization time after operation and hospitalization expenses of the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. the age of 18-70 years old
2. the pathological diagnosis of colon cancer patients
3. no surgical intervention.

Exclusion Criteria:

1. patients with heart, lung, liver, renal function were significantly abnormal
2. body mass index kg \>35 / m2
3. pregnancy
4. sepsis or systemic inflammatory response syndrome patients.
5. patients with severe malnutrition.
Two-Arm Study of a DNA Vaccine Encoding Prostatic Acid Phosphatase (PAP) in Patients With Non-Metastatic Castrate-Resistant Prostate Cancer

The investigators are trying to find new methods to treat prostate cancer. The approach is to try to enhance patients' own immune response against the cancer. In this study, the investigators will be testing the safety of a vaccine that may be able to help the body fight prostate cancer.

The vaccine, called pTVG-HP, is a piece of DNA genetic material that contains genetic code for a protein that is made by the prostate gland, called prostatic acid phosphatase (PAP). The vaccine will be given together with a substance called an adjuvant. Adjuvants are typically given with vaccines and can improve the effect of the vaccine. The adjuvant that will be used in this study is called granulocyte-macrophage colony-stimulating factor (GM-CSF).

The main purpose of this study is to find out whether the vaccine generates long-lived immune responses, and whether a better schedule of vaccination can be found by doing frequent laboratory testing for immune responses. The investigators also want to see if the vaccine stimulates any immune reaction against cancer cells.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Prostate Cancer
* Castrate Resistant Disease with rising PSA despite continuous treatment with orchiectomy or a LHRH agonist
* Rising PSA after treatment and withdrawal of anti-androgen
* Serum Testosterone \<50ng/mL
* Normal organ function per laboratory tests

Exclusion Criteria:

* No evidence of immunosuppression or on treatment with immunosuppressive agents
* Cannot have discontinued LHRH agonist treatment (if not previously treated by orchiectomy) within 6 months prior to study entry
* Must not be concurrently taking other medications or supplements with known hormonal effects (other than the LHRH agonist noted above).
* Cannot have any evidence for metastatic disease on bone or CT scan
* Unable or unwilling to undergo two leukapheresis procedure
CytID Analysis of Oral Lesions

The purpose of this study is to correlate the results from a standard of care biopsy with CytID™ and hpvID™ swab tests for potentially premalignant and malignant oral lesions. The biopsy is considered standard of care and will be performed regardless of the patient's enrollment in the study. The study-related data gathering will not influence the treatment decisions of the clinician.


Eligibility Criteria:
Inclusion Criteria:

* Receive care at the Avenue 360 Health and Wellness Clinic, a not for profit dental clinic in the Montrose area of Houston
* Present with a potentially malignant oral lesion (PMOL) for whom a biopsy is deemed necessary

Exclusion Criteria:

* Do not receive care at the Avenue 360 Health and Wellness Clinic, a not for profit dental clinic in the Montrose area of Houston
* Do not present with a potentially malignant oral lesion (PMOL) for whom a biopsy is deemed necessary
Brain Health on College Campuses

Center for BrainHealth is beginning a one-year pilot with local college campuses investigating the impact of (i) brain health assessment and training tools delivered through the online BrainHealth Platform and (ii) in-person educational brain health workshops delivered to college students and faculty/staff, with the overarching goal to better understand how to promote brain-healthier campuses (i.e., reflecting generally positive function across cognitive, social, emotional, and lifestyle domains). This initial study is intended to be a one-year pilot, with findings informing feasibility and efficacy as well as future, more extended and expanded study informing translation to other colleges/universities.

ONLINE Procedures

Assessments (3 times over 9 months): BrainHealth Index - An online battery of cognitive measures and questionnaires. Periodic surveys to assess new research questions (as IRB approved) and to assess participant experience

Training, habits, resources (available over 9 months): Micro-learning video modules that include Strategic Memory Advanced Reasoning Tactics (SMART) and other trainings such as stress management, sleep, and lifestyle. The habit tool supports accountability and consistency of building new and personalized habits. Curated resources (articles, podcasts, videos) around the topic of brain health are also available.

Coaching Periodic access to group and one-on-one brain-health related virtual coaching sessions.

Link wearable data Participants have the option to link their wearable data with their data collected through the BrainHealth Platform

IN-PERSON Procedures

The investigators will offer in-person and/or virtual/hybrid educational sessions on a variety of high-interest topics such as stress management, sleep, resilience, and mental well-being, with an emphasis on how practicing and implementing brain healthy strategies can impact everyday life. For faculty/staff, the investigators will also offer interactive workshops on how to create a brain healthy environment and classroom, including ways to implement and provide brain-healthy strategies and resources in their everyday operations involving students (e.g., ways to enhance mental energy and focus in the classroom, brain-based approaches to promoting growth mindset and confidence, etc.).

Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18
* Either enrolled as a student and/or employed as staff/faculty at UTD or Dallas College
* Internet and device access
* Must be able to hear and read over the computer
* Fluent English speaker

Exclusion Criteria:

* Currently or previously enrolled in The BrainHealth Project (NCT04869111)
* Diagnosed neurodegenerative disease
* History of stroke, concussion, or brain injury that currently hinders participant from functioning at their prior level
* Diagnosed with autism spectrum disorder and not functioning independently
Effects of Atazanavir Treatment on Type 2 Diabetes Mellitus Related Endothelial Dysfunction

The purpose of this study is to determine whether atazanavir use is of influence on the endothelial dysfunction associated with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria (most important):

* 18 - 70 years
* type 2 diabetes mellitus treated with diet, oral medication and/or insulin
* BMI of 18 to 35
* determinants of renal and hepatic function within twice the upper limit of normal range, abnormalities in lipid profile permitted

Exclusion Criteria (most important):

* history of smoking within past year
* history of or current abuse of drugs, alcohol or solvents
* current use of antihypertensive, cardiac or other vasoactive medication
* clinical evidence of cardiac or pulmonary disease
Effectiveness of Metaverse Space-based Exercise Video Distribution in Young Adults

This study explored whether exercise video distribution using metaverse space is effective in increasing physical activity among young people, along with mental health and locomotive function. This is a randomized parallel-group study. Participants will be assigned to 3 groups: a metaverse group, a YouTube group, and a control group. The metaverse group will receive eight 10-minute exercise videos each week with approximately 4 to 8 METs (metabolic equivalents of task) in the metaverse space to encourage exercise, and the YouTube group will receive access to the same exercise videos as the metaverse group. The control group was given no specific instructions.

The intervention period was 8 weeks, and physical activity and other items were measured before and after the intervention. These pre- and post-intervention measurements will be used to determine whether the delivery of exercise videos via Metaverse is effective in increasing physical activity in young adults.


Eligibility Criteria:
Inclusion Criteria:

* individuals aged 18-30 at the time of obtaining consent
* who owned a smartphone or computer and had internet access
* who did not belong to an exercise community, such as a sports club

Exclusion Criteria:

* individuals who had a history of a disease that prohibited exercise
* individuals whose physical activity was \> 3000 metabolic equivalents of task (METs)/week
* pregnant (or possibly pregnant) women
Evaluation of Efficacy/Safety of EVE-PMS Skin Test Panel

The EVE-PMS technology is intended for determination of intolerance or sensitivity to sex hormones, among women suffering from severe PreMenstrual Syndrome (PMS).

The system includes skin testing panel for identification of hormones to which the patients might be sensitive. Tests are applied close to the ovulation period and the skin reaction is examined in 20 minutes, 48 hours and daily during the following month. Results of skin tests and patient's history will determine the value of EVE-PMS Skin-Test Panel as a diagnostic tool for severe PMS patients.


Eligibility Criteria:
Inclusion Criteria:

1. Person is over the age of 20 but not older than age 45.
2. Person is willing to participate as evidenced by signing the written informed consent form.
3. Suffers from known dominant severe symptom of breast swelling and tenderness (level 7-10 according to standard scale of PMS symptoms severity)
4. Other severe symptoms of Premenstrual syndrome (based on WHO and ACOG criteria). This may include one or more of PMS symptoms with level 7-10 according to standard scale of PMS symptoms severity.
5. At work, school, home, or in daily routine, at least one of the PMS symptoms caused reduction of productivity or inefficiency
6. At least one of the PMS symptoms caused avoidance of or less participation in hobbies or social activities
7. At least one of the PMS symptoms interfere with relationships with others:

   i. Timing of PMS symptom(s): during the 14 days prior to onset of menstrual flow (rather than spotting) and up to 5 days during the menstrual flow.

ii. Pattern and length of PMS symptomatic period: minimum of 2 days, up to 14 days.

iii. For PMS diagnosis two out of last three consecutive menstrual cycles were monitored by daily monitoring of symptoms.

iv. Timing and length of asymptomatic phase: day 6 to at least day 10 of the menstrual cycle.

v. Cyclicity - presentation of the 'off-on' phenomenon: there should be a clear shift from no PMS symptoms to PMS symptoms.

vi. Reliable non hormonal contraception.

Exclusion Criteria:

1. Pregnant or lactating woman
2. Oral contraceptives during last three months, including hormonal IUD (trade name mirena).
3. Serious health problems.
4. Unexplained menstrual disorders.
5. Treated by hormones (estrogen and progesterone).
6. For healthy: Irregular or abnormal test results.