cyrilzakka/clinical-trials huggingface dataset:
fMRI Study of tES in Major Depression

This is a functional MRI study that will examine the effects of noninvasive transcranial electrical stimulation (tES) on brain function in individuals with Major Depression.

The purpose of this research study is to understand how a kind of brain stimulation, called transcranial electrical stimulation (tES), affects brain function in people with major depression.

tES delivers low electrical current to the head using electrodes applied to the skin, and is described as a "neuromodulation" or "neurostimulation" technique. This study uses a specific kind of tES called "transcranial direct current stimulation", or tDCS, where a constant (unchanging) electrical current is passed between two electrodes on the head.

Neuromodulation methods like tES have shown promise in changing brain function, as well as treating some brain disorders like major depression. Yet, how tES brain function remains unclear. To better understand how tES works, the investigators will use MRI (a type of brain scan) to measure brain function during tES in people with major depression.

Eligibility Criteria:
Inclusion Criteria:

* ages between 18 and 55
* diagnosis of Major Depressive Disorder made by a physician, psychiatrist, or psychologist at least one year prior
* mild-to-moderate symptoms of depression (Hamilton Depression Rating Scale 17-item, HDRS-17, score 8-23)
* stable standard or no pharmacological antidepressant regimen (SSRI, SNRI, MAOI, or trycyclic/TCA) with no change in treatment 6 weeks prior to study start

Exclusion Criteria:

* suicidal thoughts, ideation, or behavior within the past month (HDRS-17 item 3 score greater than 1)
* greater than moderate symptoms of depression within the past month (HDRS-17 score \>23)
* change in antidepressant medication within 6 weeks of study start
* diagnosis of any medical condition potentially affecting brain function, including neuropsychiatric or mental disorders, other mood disorders (bipolar disorder, anxiety, PTSD), psychotic states or disorders, developmental disorders, neurological disorders, including mild cognitive impairment, significant head injury, significant history of alcohol/substance abuse or dependence
* MRI contraindications: metal or other implants that are not MR-safe, claustrophobia, pregnancy or suspected pregnancy
* tES contraindications: skin conditions or injuries on the scalp, hair extensions, wigs, braids, etc. that cannot be removed prior to the study, metal implants or pacemakers
* other major medical conditions (e.g., cancer, stroke)
* current medication use potentially affecting brain function, including decongestants, antihistamines, benzodiazepines or other anticonvulsants, anti-psychotics, or antidepressants
* prisoners will not participate in this study
Epidemiological Study of Fabry Disease Screening in Chronic Kidney Disease Patients

Fabry disease is a rare X-linked lysosomal storage disorder caused by deficient activity of the enzyme α-Gal A resulting from mutations affecting the GLA gene.

It is characterized by severe multi-systemic involvement that leads to major organ failure and premature death in affected men and in some women. The α-Gal A deficiency results in progressive accumulation of un-degraded glycosphingolipids, predominantly globotriaosylceramide (Gb3), within cell lysosomes throughout the body.

In patients at the second or third decade, progressive proteinuria, decline in glomerular filtration rate (GFR), and tubular damage occur usually, and renal failure develops in the fourth decade. Life-threatening renal, cardiac, and cerebrovascular diseases are added in later decades.

In addition to that, Fabry disease patient will eventually face end-stage renal disease (ESRD) which was the most common cause of death in Fabry patients before the development of dialysis and renal transplantation. Thus it is critical to identify Fabry patient as early as possible, before reaching the stage of ESRD.

Additionally, early intervention of enzyme replacement therapy for Fabry Disease patient which will help the patient to preserve a better renal function and benefit from treatment outcome.

Apart from that today there is only one study published from Turkey for Fabry disease screening in CKD patient where they have screened 1453 and found that the overall prevalence of Fabry disease in CKD patient was found to be 0.2% , 3/1453 (in which 0.4% in 656 male, 0.0% in 783 female). However, there was no information available within the Asia region thereby a very low Fabry disease awareness and diagnostic awareness among nephrologist in Taiwan.

Therefore in the present study the investigators are aiming to investigate the prevalence of Fabry disease in the CKD population (CKD stage 1 \~ 5) by conducting the first and largest high risk screening prevalence study among 2,000 CKD patients over 3 years in Taiwan and the investigators hope by doing such a pilot study our data would contribute to a new paradigm of Fabry disease diagnosis in the Asia region.


Eligibility Criteria:
Inclusion Criteria:

* Patient age ≥ 18 y/o (No age limit due to cardiac variant Fabry IVS4 in Taiwan symptom of onset could be beyond 60 y/o)
* Patient with confirmed chronic kidney disease (CKD 1\~5) diagnosis whose urine protein/creatinine (UPCR) is 150mg/g or above, or urine albumin/creatinine (ACR) is 30mg/g or above.
* Patient who are willing to sign inform consent form

Exclusion Criteria:

* Patient who are unwilling to sign inform consent form
* Patient who received confirmed diagnosis of Fabry Disease
* Patient with known etiology of renal failure diagnosed with renal biopsy.
Incidence and Risk Factors for Hospitalization-Associated Disability

This prospective cohort study aims to determine the incidence of hospitalization-associated disability and its association with risk factors at the patient level and with care and hospital processes. For this, patients aged 70 years or older admitted for elective valve surgery or elective transcatheter aortic valve implantation or as a result of symptomatic moderate to severe valvular heart disease will be consecutively included from 01 October 2015 to 29 February 2016.


Eligibility Criteria:
Inclusion Criteria:

* Aged 70 years or older
* Admitted for elective heart valve surgery (replacement, repair or combined with CABG) or if admitted for elective transcatheter aortic valve implantation, or if a patient presents with symptomatic moderate to severe valvular heart disease on hospital admission as evidenced by moderate to severe valve regurgitation (≥ 2/4) or aortic valve area ≤ 1cm2 or mitral valve area ≤ 1.5cm2 and if one of the following symptoms is present: heart failure, decreased exercise tolerance, (exertional) dyspnea, (exertional) angina, (exertional) syncope
* Dutch speaking

Exclusion Criteria:

* Life expectancy less than 6 months
* Expected length of stay less than 48 hours
Effect of S-Adenosyl Methionine Treatment on Recurrence After Curative Resection of Hepatocellular Carcinoma

The aim of this study is to explore the effect of S-Adenosyl Methionine on recurrence after curative resection of Hepatocellular Carcinoma.

Hepatocellular carcinoma (HCC) is now a major health problem. Although the recent advances in treatment of HCC have significantly improved the prognosis of patients with HCC, the overall survival rate is still unsatisfactory; the 5-year survival rate is only 50-70% even after curative treatment such as hepatic resection and percutaneous radiofrequency ablation. One of the reasons for the poor prognosis of HCC is its high rate of recurrence.However,anti-relapse treatment remains a pressing work to do.

In recent years, some study reported that S-Adenosyl Methionine had an impact on promoting apoptosis and inhibiting the growth on breast cancer, colon cancer,gastric cancer and liver cancer in vitro and vivo.

In this study, we aim to examine whether S-Adenosyl Methionine have an effect on improving patients' recurrence after curative resection of Hepatocellular Carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients \> 18 years and \<=70 years of age
* Patients preoperatively diagnosed of hepatocellular carcinoma according to the criteria of American Association for the Study of Liver Diseases(AASLD)
* Within Milan criteria
* Without or mild liver cirrhosis and the liver function is Child A class.
* Without any other treatments such as TACE、PEI、PRFA before the surgery
* No evidence for extrahepatic metastasis

Exclusion Criteria:

* Patients with macro tumor thrombus or extrahepatic metastasis.
* Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction.
* Subjects accepting other trial drugs or participating in other clinical trials.
* Patients refuse to join our trial.
* Female with pregnancy or during the lactation period.
Prospective Observational Study of Adjuvant Hormone Treatment in Estrogen-receptor Positive Premenopausal Early Breast Cancer Patients

This will be a prospective, multicenter, observational study. The primary objective is to record the choice, in clinical practice, of adjuvant hormone therapy (tamoxifen, tamoxifen + LhRh, aromatase inhibitors + LhRh) in premenopausal patients with estrogen-receptor positive breast cancer.

The secondary objective is to correlate adjuvant hormone therapy choices with biological characteristics of the tumor (T size, lymph node status, grade, receptor level, Ki67, HER2 status) and patient characteristics (age, prior chemotherapy treatment).


Eligibility Criteria:
Inclusion Criteria:

1. - Premenopausal patients candidate to start adjuvant hormone therapy after breast cancer surgery
2. - Age \>18 years
3. - No previous hormonal treatment
4. - Written informed consent

Exclusion Criteria:

1- Patient's inability to provide written informed consent 2 - Stage IV disease
The Effect of Continuous, Various Doses of Furosemide Drip on Hearing as Measured by Acoustic Emission

Pediatric patients, during their illness often treated with furosemide (Lasix) continuous drip, often, with dosages above 4-6mg/kg/day (the recommended dose).

This study will monitor hearing status of these children prior to their therapy with furosemide, during this therapy and after.

This study will record hearing status, by acoustic emission, of critically ill children, treated with different dosages of furosemide drip.

Acoustic emission test will be done prior to therapy and q48 hours during their course of treatment with furosemide drip.

Dosage of furosemide drip, boluses and other relevant medications (i.e - vancomycin, muscular relaxants, aminoglycosides etc) will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* All children admitted to Pediatric ICU who are treated with furosemide continuous drip.

Exclusion Criteria:

* Children with known hearing abnormalities prior to treatment.
Family Satisfaction (FS) in the Intensive Care Unit

There is increasing awareness that high-quality care in the intensive care unit also includes care of visiting family members according to their needs. The investigators therefore want to assess family satisfaction using a questionnaire that was specially developed for this setting and recently validated for German-speaking participants.

Family members who visit patients on the ICU (intensive care unit) are not just onlookers. They experience the process of care along with their loved ones. Increasingly, the satisfaction of family members with ICU care, decision-making and information, and their empowerment to contribute towards patient care as near relatives, is being perceived as an important aspect of the general quality of ICU care.

Family satisfaction is assessed using the 34-item FS-ICU questionnaire which was recently validated for German-speaking participants.

The aim of this pilot survey is to identify opportunities for improvement of family satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* all visiting family members who consent to participate

Exclusion Criteria:

* no more than two family members per patient;
* prior participation
Phase I Study of Subcutaneous Ocaratuzumab in Patients With Previously Treated CD20+ B-Cell Malignancies

Ocaratuzumab is a third-generation, fully humanized IgG1 monoclonal antibody (mAb) targeting the CD20 surface marker on normal and malignant B lymphocytes. It has been optimized for an increased binding for CD20 and an enhanced antibody dependent cell medicated cytotoxicity (ADCC) effector function.

A previous phase I/II study of intravenously (IV) administered ocaratuzumab in refractory/relapsed follicular lymphoma patients has concluded that ocaratuzumab is safe and well-tolerated at doses up to 375mg/ m2 weekly for four weeks.

In this proposed phase I study, ocaratuzumab will be administered subcutaneously to patients with previously treated CD20+ B-cell malignancies. Three dose levels (40 mg weekly x 4 doses, 80 mg weekly x 4 doses, and 80 mg weekly x 8 doses) will be investigated for safety, tolerability, pharmacokinetic, and pharmacodynamic analyses.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years;
* Histologically confirmed diagnosis of a CD20+ B-cell malignancy;
* Received at least one prior treatment regimen;historically documented CD20-positivity is acceptable;
* Appropriate for single agent study drug therapy as prescribed by this protocol;
* ECOG performance status 0 to 2;
* Adequate hematopoietic, renal, and hepatic functions defined as:

  * Absolute neutrophil count greater than 1000 /mm³
  * Platelet count greater than 75,000/mm³
  * Hemoglobin greater than 8.5 g/dL
  * Serum creatinine ≤ 1.5x upper limit of normal
  * AST, ALT, and total bilirubin ≤ 3x upper limit of normal;
* Ability to understand and the willingness to sign a written informed consent document;
* Life expectancy of 6 months or greater.

Exclusion Criteria:

* Anti-CD20 therapy within 4 weeks of enrollment;
* Systemic chemotherapy or immunotherapy within 14 days of enrollment;
* Chronic systemic steroid therapy defined as prednisone or equivalent 10 mg/day or greater;
* Systemic cytotoxic or immunosuppressive therapy to be administered concomitantly while participating on this study;
* Active infection, chronic or severe infection requiring ongoing antimicrobial therapy.
* Positivity for hepatitis B (defined as HepBs Antigen +), hepatitis C (defined as HepC Antibody +), or HIV; HIV positive patients on antiretroviral therapy will be excluded;
* History of allergic reactions attributed to compounds of similar chemical or biologic composition;
* Significant cardiac disease (New York Heart Association classes III or IV) or unstable angina despite medication;
* Women who are pregnant or breast-feeding;
* Women of child bearing potential who are unwilling to use effective contraception for the duration of the study drug administration and 6 months after final dose of drug is administered;
* Psychiatric illness/social situations that would limit compliance with study requirements;
* Participation in other investigational studies while enrolled on this trial.
Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD

The purpose of the study CTQJ230A12304, is to evaluate the efficacy, safety, and tolerability of pelacarsen (TQJ230) compared to placebo in participants with ASCVD who have elevated lipoprotein(a) (Lp(a)), and who are on background inclisiran treatment for elevated low-density lipoprotein cholesterol (LDL-C).

This is a randomized, double-blind, placebo-controlled, multicenter, parallel group study followed by an open-label treatment period.

Eligibility Criteria:
Key Inclusion criteria:

* Male and female participants 18 to ≤80 years of age at Screening visit
* Established ASCVD, defined as documented coronary heart disease (CHD), cerebrovascular disease (CVD), or peripheral arterial disease (PAD) at Screening visit
* On stable dose of local guideline recommended lipid lowering therapy for at least 30 days prior to Screening visit
* Participants must successfully complete the run-in period of background inclisiran treatment in order to be randomized
* On standard of care (SoC) treatment for other CVD risk factors including hypertension and diabetes for at least 30 days prior to Randomization/Baseline visit
* Central laboratory reported Lp(a) ≥175 nmol/L at Screening visit
* Central laboratory reported LDL-C \>70 mg/dL (or \>1.8 mmol/L) at Screening visit

Key Exclusion Criteria:

* Prior treatment with inclisiran
* Any other PCSK9 inhibitor (e.g., evolocumab, alirocumab) use within 4 months prior to Screening visit
* Uncontrolled hypertension at Randomization/Baseline visit
* Heart failure New York Heart Association (NYHA) class IV at Screening visit or at Randomization/Baseline visit (Day 1)
* Triglycerides ≥400 mg/dL at Screening visit
* History of malignancy of any organ system within the past 5 years
* Myocardial infarction, stroke or other major bleeding, coronary or lower limb re vascularization, major cardiac or non-cardiac surgery between Screening visit and Randomization/Baseline visit (Day 1)
* Central laboratory reported platelet count \<140,000 per mm3
* Active liver disease or hepatic dysfunction at Screening visit
* Significant kidney disease at Screening visit
* Pregnant or nursing women at Screening visit
* Any uncontrolled chronic or serious medical condition which may pose an immediate risk to clinical stability of the study participant at Screening visit

  * Other protocol-defined inclusion/exclusion criteria may apply.
Oxaliplatin in Unresectable Hepatocellular Carcinoma

Primary:

* To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-Fluorouracil/Leucovorin

Secondary:

* Safety and tolerability of this regimen in these patients


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically confirmed hepatocellular carcinoma
* Patients must have measurable disease by CT scan
* Patients with unresectable, recurrent or metastatic disease may be chemonaive or may be previously treated by chemotherapy.
* The period of washout of prior chemotherapy must be greater than 4 weeks from date of randomization. The prior chemotherapy should not include platinum compounds.
* WHO performance status: 0 to 2
* Patients must have adequate organ and marrow function as defined below:

  * Leukocytes : ≥ 3,000/μl
  * Absolute neutrophil count :≥ 1,500/μl
  * Platelets : ≥ 80,000/μl
  * Total bilirubin : \< 3.0g/dl
  * ASAT/ALAT : ≤ 3 times the upper normal limits of the institute
  * Creatinine : \< 120μmol/l
* Patients with no evidence of clinically significant neuropathy.

Exclusion Criteria:

* Documented allergy to platinum compound or to others study's drugs
* Pregnant or lactating women or women of childbearing potential (e.g. not using adequate contraception)
* Hematological disorder or malignancies
* Metastasis to central nervous system
* Other serious illness or medical conditions:

  * Active infectious disease
  * Congestive heart failure, or angina pectoris. Previous history of myocardial infarction within 1 year from study entry; uncontrolled hypertension or arrhythmia.
* Concurrent treatment with any other anticancer therapy
* Concurrent treatment with other experimental drugs.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study on the Contribution of the Genetic Tumor Profile Obtained by Circulating Tumor DNA Analysis in the Multidisciplinary Molecular Biology Meeting of Eastern PACA

This study will evaluate the diagnostic performance of liquid biopsy for identifying molecular abnormalities among patients managed by the Multidisciplinary Molecular Biology Meeting. The gold standard considered in this study is the solid biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old.
* Advanced-stage malignant solid tumor managed in a non-curative context.
* Patient eligible for Multidisciplinary molecular biology meeting with available archived tumor material (frozen or FFPE block, less than 5 years old) or a biopsiable tumor lesion.
* Performance status of 0 or 1.
* Patient able to read, write, and understand the French language.
* Patient has read the information sheet and signed the informed consent.
* Patient has social security coverage.

Exclusion Criteria:

* Previous or concurrent cancer diagnosed or treated within the last 5 years, except for in situ carcinoma of the cervix, basal cell or squamous cell carcinoma of the skin, and adequately treated in situ carcinoma of the bladder.
* Severe or uncontrolled systemic disease.
* Any condition which, in the investigator's judgment (geographical, social, or psychological factors, etc.), makes the patient unable to comply with study follow-up and procedures.
* Patient considered a vulnerable person; vulnerable persons are defined in Articles L1121-5 to L1121-8:

  * Pregnant women, women in labor, and breastfeeding mothers,
  * Persons deprived of liberty by judicial or administrative decision, individuals hospitalized without consent under Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article L. 1121-8,
  * Persons admitted to a healthcare or social institution for reasons other than research,
  * Adults unable to give their consent.