cyrilzakka/clinical-trials huggingface dataset:
ALA and Prostate Cancer

The problem is the lack of data from randomized controlled trials to throw light on the ALA-prostate cancer issue. There is therefore a need to acquire evidence from a randomized controlled study to illustrate the effect of ALA on a surrogate marker for prostate cancer, namely prostate specific antigen (PSA). Demonstration that atrial fibrillation recurrence was reduced after cardioversion and that there was no adverse effect of 1 years of ALA feeding on PSA would go a considerable way to providing the required evidence that ALA in the human diet has no adverse effect on the prostate and so allow its use for cardiovascular risk reduction. hypothesis: The effect of ALA on PSA levels over time will be no different from the control, so providing supportive data for the view that ALA is not cancer promoting.

In addition disturbing news on alpha-linolenic acid (ALA) has recently been reviewed by Brouwer and colleagues (J Nutr:2004). Their analyses suggests that ALA, as found in canola oil and other healthy foods, may cause prostate cancer even though there is good evidence that canola oil will prevent heart disease. This issue urgently needs further research.

In studies largely from the Harvard group, but suggested by additional studies from Uruguay and Spain, a link has been identified between ALA intake and prostate cancer. The Harvard studies are cohort studies where groups of approximately 40,000 doctors or health professionals have been followed up for periods of 10 years and the dietary intakes of ALA related to the subsequent development of aggressive prostate cancer. It must be stressed that these are not randomized crossover studies which are the currently accepted gold standard for evidence-based medicine and regulatory decision making. Nevertheless they raise concern over the health profile of a fatty acid with a growing reputation for cardiovascular disease prevention and a component of other healthy foods such as walnuts, flax, canola and soy.

The same Harvard group identified the deleterious effects on cardiovascular health of trans fatty acids in their cohort studies and this has resulted in a major effort to remove trans fatty acids from the food supply. On the other hand their identification of the benefits of vitamin E in their cohort studies has not been confirmed by subsequent randomized controlled trials. Although Dr Willett, the senior member of the Harvard group, has drawn surprisingly little attention to the negative findings with ALA, it remains a sticking point with regulators in the current debate over the inclusion and use of ALA in the food supply. This concern has been sufficient for the Natural Health Products Directorate of Health Canada to ask for a full proposal from us before we start studies on ALA in the prevention of atrial fibrillation due the apparently negative impact of ALA consumption on prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Blood samples available from Bordeaux

Exclusion Criteria:

* Blood samples not received from Bordeaux
Blood Coagulation Profile After Liver Resection.

Liver resection is the treatment of choice in patients with primary or metastatic liver neoplasms, benign liver neoplasms and numerous biliary diseases. In these patients, in the postoperative period,several factors can induce a transient alteration of the synthesis hepatic coagulation factors such as size of the lesion liver, underlying liver disease (e.g. malignancy), pre-existing cirrhosis, duration of both surgery and vascular clamping, and blood loss. So far, some studies have shown that conventional coagulation tests indicate a hypocoagulable state which may lead to excessive transfusions of blood products or an increased risk of thromboembolic events related to delayed initiation of thromboprophylaxis in the postoperative period. In an attempt to optimizing the state of coagulation, recently there is increased interest for viscoelastic coagulation testing (thromboelastography and rotational thromboelastometry). The results of these studies have shown that these patients often have a hypercoagulable and non hypocoagulable profile as evidenced by conventional coagulation tests.

the purpose of the study is to evaluate whether the combination of coagulation tests conventional systems and new thromboelastography can increase the quality of surveillance of the coagulation state after liver surgery, in order to optimize the management of postoperative blood coagulation of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Elective liver resection surgery for liver cancer primary or metastatic
* Admission to surgical intensive care unit at the end of the surgery.

Exclusion Criteria:

* Renal disease (creatinine clearance \< 30 ml/min)
* pregnancy
* Benign liver disease
* Emergency surgery
* Reintervention
Impact of Artificial Intelligence-based Patient Reinforcement on Quality of Colonoscopy

In order to improve bowel preparation for colonoscopy and consequently enhance detection rate of malignant and premalignant findings, a prospective, randomized and controlled three-arm study was developed. Patients who undergo ambulatory colonoscopy are randomly assigned into a control group with standard preparation, a phone call supported preparation group or a group supported by an artificial intelligence based chatbot. Primary endpoint is defined as quality of bowel preparation (Boston Bowel Preparation Score), secondary endpoints are patients satisfaction, comprehensiveness of bowel preparation, sedation dose, rate of coecal intubation and the rate of adenoma and polyp detection, anxiety referred to colonoscopy and patients satisfaction with preparation support.

Adequate bowel preparation is crucial for detection of adenoma and polyps of the colon, which can transform into malignant and premalignant lesions. In particular ambulatory performed colonoscopy is often insufficient due to inadequate preparation by patients at home. To focus this issue, a artificial intelligence based chatbot was developed to help patients who undergo bowel preparation by answering questions concerning bowel preparation. To compare the effect of this program, a three-arm randomized, controled multicentric clinical trial was developed. All patients who undergo ambulatory colonoscopy and meet the inclusion criteria (18 y.o., informed consent, WhatsApp access) were randomized in a standard preparation group (medical briefing and preparation brochure), a group receiving phone calls with instructions for bowel preparation and a third group with access to the chat bot answering questions concerning bowel preparation and examination conduct. As the primary end point, the quality of bowel preparation measured as Boston Bowel Preparation Scale was defined. As secondary endpoints patients satisfaction, comprehensiveness of bowel preparation, sedation dose, rate of coecal intubation, the rate of adenoma and polyp detection, anxiety referred to colonoscopy and patients satisfaction with preparation support were measured.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* smartphone with access to WhatsApp
* indication for ambulatory colonoscopy
* ASA I or II

Exclusion Criteria:

* no informed consent given or possible
* no access to a smartphone with WhatsApp
* \<18 years old
* Pregnancy/Lactation
* Allergy to Moviprep©
* ASA (American Society of Anesthesiologists) state \>II
* extended abdominal surgery in past history
* no indication for ambulatory colonoscopy
Cognitive Remediation Program for Hospitalized in the Long Term Patients With Deficit Schizophrenia

Schizophrenia is a chronic disease with deficit in social interaction and lost of autonomy in daily life. Negative symptoms as blunted affect, avolition, social deficit and anhedonia and cognition were prognosis and functioning key's factors. Psychotropic medications have shown only poor effect to improve negative symptoms and cognition as attention, memory and cognitive flexibility. So, cognitive remediation programs were developped to focus cognitive disorders. The IPT (Integrated Psychological Treatment) is one of the most complete program with modules on cognitive and social abilities. The aim of this study is to evaluate the efficacy of IPT+ program to improve autonomy capacities of long stay inpatients suffering from schizophrenia 6 at the end of the program With IPT+ this study will improve autonomy capacities for patients suffering from deficit schizophrenia and allowed patients to go out hospital earlier than before.

Schizophrenia is a chronic disease with deficit in social interaction and lost of autonomy in daily life. Negative symptoms as blunted affect, avolition, social deficit and anhedonia and cognition were prognosis and functioning key's factors. Psychotropic medications have shown only poor effect to improve negative symptoms and cognition as attention, memory and cognitive flexibility. So, cognitive remediation programs were developped to focus cognitive disorders. The IPT (Integrated Psychological Treatment) is one of the most complete program with modules on cognitive and social abilities. The aim of this study is to evaluate the efficacy of IPT+ program to improve autonomy capacities of long stay inpatients suffering from schizophrenia 6 at the end of the program The secondary objectives are to evaluate autonomy 6 months after the program, to evaluate the efficacy of the program on negative symptoms, quality of life, cognitive functions, social cognition and duration of hospitalisation.

This study propose a randomised controlled study with 2 arms, with blind evaluation to compare the IPT+ versus treatment as usual (TAU). The follow up will be 6 month for the With IPT+ this study will improve autonomy capacities for patients suffering from deficit schizophrenia and allowed patients to go out hospital earlier than before.

Eligibility Criteria:
Inclusion criteria:

* age \> 18 and \< 60
* Diagnosis of schizophrenia on DSM 5
* criteria of deficit schizophrenia with the schedule for deficit syndrome
* inpatient at inclusion with at least 6 month of hospitalisation during the last 2 years
* clinically stable
* able to understand, talk and read french
* signing consent form

Exclusion criteria:

* change in psychotropic treatment during the last month
* psychotherapy in the last 8 months or planned during the study
* CDSS score \> 9
* drug dependency during the last year
* unstable somatic disease
* somatic disease with impact on cognition
Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty

The purpose of the study is to assess the efficacy of triptorelin 11.25 mg pamoate in the delay of premature onset of puberty in girls less than 9 years and boys less than 10 years. This is measured by assessing the proportion of children who have a suppressed Luteinizing Hormone (LH) response to Gonadotropin Releasing Hormone (GnRH) test performed 3 months after injection with triptorelin 11.25 mg.


Eligibility Criteria:
Inclusion Criteria in the screening phase:

* Onset of sex characteristics (Tanner method) breast development in girls or testicular enlargement in boys before the age of 8 years in girls and 9 years in boys.
* Weight ≥ 20 kg.

Inclusion Criteria in the treatment phase:

* Proven central precocious puberty defined as onset of sex characteristics development (according to Tanner method) diagnosed before the age of 8 years in girls and 9 years in boys.
* Age at evaluation less than 9 years for girls and 10 years for boys.
* A pubertal response of LH to GnRH test in both sexes (stimulated LH ≥ 5 IU/l).
* Difference Bone age (BA) (according to Greulich et Pyle method) - Chronological age (CA) \> 1 year.
* Testosterone level ≥ 0.5 ng/ml in boys.

Exclusion Criteria:

* Patient with a peripheral precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroids secretion.
* Patient with a cerebral tumour requiring a neurosurgery or cerebral irradiation.
* Patient with a Body Weight ≥ 125% of the ideal weight for the height and age (growth curves).
* The patient has received a previous treatment with a GnRH analogue, or medroxyprogesterone or cyproterone acetate.
Dietary Effects on Weight Loss and Lipid Profile in Sedentary Men

Negative-calorie diet is among the popular dieting guides for weight loss; however, there is still little knowledge about this method. The present study aimed to determine the effects of negative-calorie diet on weight loss and lipid profile, and to compare its efficiency with low-calorie diet in men.


Eligibility Criteria:
Inclusion Criteria:

* Non-smokers
* Weight-stable (± 2 kg, for more than one year)
* No history of regular exercise (in at least three months before the study).

Exclusion Criteria:

* History of medical disorders (CVD and other such as diabetes, depression, eating disorders, chronic medications, kidney disease, cancer, food allergies or intolerances to items used in meals, abnormality in thyroid or Electrocardiograph
* History of anti-obesity medication or weight loss drugs or dietary supplementations for weight control.
Common Variants in Candidate Genes and Premature MI Risk

To examine the impact of an interaction between common genetic susceptibility markers and environmental exposures on risk for early onset myocardial infarction in cases with myocardial infarction and matching controls.

BACKGROUND:

Inherited factors play a role in the pathogenesis of myocardial infarction (MI), and there is growing interest in identifying common genetic susceptibility markers that interact with common environmental exposures to contribute to the occurrence of myocardial infarction (MI) in the population.

DESIGN NARRATIVE:

The study had a case-control design. The preliminary data addressed the contribution of common genetic and environmental factors to the risk of MI among women under 45 years of age. Those data showed that common polymorphisms in genes coding for two clotting factors, coagulation Factor V and coagulation Factor II, were risk factors for MI only among cigarette smokers in this sample. These relationships, and others observed, provided strong evidence of gene-environment interactions between thrombotic and atherosclerotic factors in early-onset MI. One intent was to determine whether the risk of early-onset MI was related to interactions between environmental factors (e.g., cigarette smoking, exercise, alcohol consumption) and common polymorphisms in genes coding for thrombotic factors (coagulation Factor V, coagulation Factor II, plasminogen activator inhibitor-1, and beta-fibrinogen) and atherosclerotic factors (the adhesion molecule E-selectin and metalloproteinase stromelysin-1; the lipid metabolism enzymes paraoxinase, lipoprotein lipase, cholesterol ester transfer protein; and the apolipoproteins apolipoprotein E and apolipoprotein B). Additionally, there were plans to determine whether the risk of early-onset MI was related to interactions between plasma lipoprotein(a) levels (which were largely genetically determined) and environmental risk factors and/or polymorphisms in the candidate genes. Interactions among candidate polymorphisms were also assessed.

Newly-diagnosed cases of MI and controls will be interviewed in person to assess medical and behavioral characteristics related to MI risk. A venous blood sample will be obtained and processed into aliquots of plasma and white cells. DNA extracted from the white cells will be tested using the polymerase chain reaction (PCR), PCR/restriction fragment length polymorphisms (RFLP), and oligonucleotide ligation assays to determine the genotypes of interest. Plasma will be tested for lipid, lipoprotein, and homocysteine concentrations. Analyses will address both the overall association between the genotypes and MI risk, along with posited gene-environment and gene-gene interactions.

Eligibility Criteria:
No eligibility criteria
Ketamine for Treatment Resistant MDD

This study aims to openly test the long-term safety, tolerability and effectiveness of repeated administration of IM/SC ketamine for treatment resistant MDD.

Major depression disorder (MDD) is a common psychiatric disorders with considerable impact on patients' quality of life, social and occupational function. MDD also significantly increase suicide rate. About a third of the patients with MDD suffer from moderate to severe symptoms that are fully or partially unresponsive to accepted pharmaco and / or psycho therapy. Ketamine is a widely used anesthetic. Multiple studies done over the recent years had shown its therapeutic effects in resistant depressive patients. Unlike regular antidepressants, ketamine exerts its effect within hours to few days which implies an alternative mechanism of action not fully studied. So far, there are only few reports on using repeated ketamine administration to maintain the antidepressant effect or on intra-muscular or sub-cutaneous application that can be safer and more tolerable than the intravenous route.

In the present study, the investigators aim to openly assess the safety, tolerability and effectiveness of repeated, individually tailored IM or SC ketamine for treatment resistant major depression. The investigators intend to explore questions regarding optimal dose, treatment frequency and duration. The investigators will also assess potential cognitive effects of long-term ketamine treatment and look for possible treatment outcome predictors using the Neurotrax computerized cognitive battery.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with unipolar/bipolar depression with MADRS Score\>= 20
* Inadequate response to \>= 3 adequate treatment trials \[\>=2 trials in the present episode\]
* If on psychopharmacological Tx, it should be stable since 4 weeks prior to enrollment
* QTc WNL

Exclusion Criteria:

* Hypersensitivity to ketamine
* Other major psychiatric diagnosis
* High suicidality
* Unstable physical illness
* S/P CVA / brain SOL
* Pregnant or breast feeding women
* Illicit drug/alcohol abuse during last year
* History of ketamine abuse
Evaluation of Endoscopic Treatment Effect Based on HVPG

This study aims to evaluate the endoscopic treatment effect and related influencing factors of patients with esophageal and gastric varices based on HVPG. By enrolling and collecting patients with esophageal and gastric varices at different stages of liver cirrhosis, the changes in portal pressure before and during endoscopic treatment were detected. The endoscopic treatment effect of different patients was evaluated by combining the changes in HVPG and the condition of varicose veins, the effects of different endoscopic treatment methods on HVPG were analyzed, and the correlation between HVPG changes and endoscopic efficacy was explored.


Eligibility Criteria:
Inclusion Criteria:

1. Age range: 18-80 years old;
2. Patients with confirmed cirrhosis through clinical, imaging or pathological evidence, with causes including viral hepatitis, alcoholic liver disease, non-alcoholic fatty liver disease, etc.;
3. Patients with esophageal and gastric varices confirmed by endoscopic examination and varicose vein bleeding in the past;
4. Endoscopic treatment (such as band ligation, sclerotherapy or colloid injection) is an appropriate secondary prevention method;

Exclusion Criteria:

* (1) Combined with hepatocellular carcinoma or other malignant tumors; (2) Autoimmune cirrhosis, schistosomal cirrhosis, hepatic venous occlusion, etc.; (3) Combined with other diseases that affect portal hypertension, such as portal vein thrombosis; (4) Recently (within 6 months) received other treatments, such as TIPS, liver transplantation, or other treatment measures that may affect the study; (5) Accompanied by severe cardiopulmonary diseases (such as severe heart failure, COPD, etc.);
Non Elective Vulnerable Elderly Radiotherapy

To evaluate whether patients defined "non-fit for curative non-surgical radio-chemotherapy" and therefore treated with RT alone addressed only to non-elective sites of disease, could obtain a non-inferior loco-regional control compared to similar historical cohorts.

The current standard approach for head and neck malignancies cannot be considered the gold standard for elderly patients, except in carefully selected cases. Given the relevance of this population, scientific societies also suggest to propose prospective studies for this subset of frail patients (European Organization for Research and treatment of cancer (EORTC), European Society for Medical oncology (ESMO)). In addition, it is necessary to collect data on specific categories, which are as homogeneous as possible. Therefore, the purpose of this study is to evaluate efficacy and safety of a tailored RT approach administered with a curative intent in a subset of frails elderly patients not candidates neither to standard concurrent RT-CT / RT-cetuximab nor to palliative treatment/best supportive care.

Eligibility Criteria:
Inclusion Criteria:

* locally advanced non-metastatic HNSCC patients older than 70 years
* Primary tumor clinically and radiologically detectable and measurable (staging according to ed. TNM VII and also VIII.
* patients defined by the tumor board (ENT, Oncologist, Radiotherapist, Nutritionist) as 1) not eligibles for RTCT / RT-cetuximab treatment 2) not amenable to radical surgery and 3) not candidates for treatments with palliative intent/best supportive care
* Availability of staging with CT/PET for distant metastasis and CT/MRI for primary tumor
* Karnofsky performance status (KPS) ≥60/100
* Oropharynx , Hypopharynx and Larynx, Oral cavity: stage III and IV and Unknown primitive P16-POSITIVE

Exclusion Criteria:

* Age less than 70 years

  * Staging exams done 45 days before the date of the beginning of the treatment
  * Subsites: nasopharynx, salivary glands, paranasal sinuses. Metastatic disease
  * Gross total excision
  * All subsites concerned if N3.
  * Squamous cell neoplasms of the glottic larynx T1-T2 N0.
  * Unknown primary HPV negative or EBV positive.
  * Presence of distant metastases or sub-clavicular lymphadenopathies.
  * Previous surgery on T and/or N except diagnostic tonsillectomy.
  * 3D-conformational radiotherapy technique