cyrilzakka/clinical-trials huggingface dataset:
Hypofractionated Stereotactic Boost in Prostate Cancer

hypofractionated stereotactic boost radiation (prostate) after normofractionated radiotherapy (prostate + seminal vesicles).

The aim of this study is to assess the safety of hypofractionated stereotactic boost radiation (prostate) after normofractionated radiotherapy (prostate + seminal vesicles).

Eligibility Criteria:
Inclusion Criteria:

* Prostate adenocarcinoma proved by histology
* With at least one of this intermediate-risk criterias:

  * T2b
  * and/or PSA between 10 et 20 ng/ml
  * and/or Gleason score = 7
* Prostatic volume ≤ 80 cc
* No adenopathy(lymph node \< 1.5 cm on scanner or MRI and/or in lymph node dissection)
* No metastasis (bone scan)
* Age \>= 18 ans
* No prior pelvic irradiation
* No prior anticancer treatment (prostatectomy, chemotherapy, hormonotherapy \> 3 months)
* Performance status (ECOG) \< 1
* No contraindication of fiducials implantation, hemostasis disorders must be treated before the implantation
* Life expectancy \>= 10 weeks
* Patient affiliated to health insurance
* Informed consent signed by the patient

Exclusion Criteria:

* Cancer no histologically proved
* Unfavorable-risk(T2c and/or PSA \> 20 ng/ml and/or Gleason \> 7)
* Favorable-risk(T1c T2a and PSA \< 10 ng/ml and Gleason \< 7)
* T3 and T4
* History of cancer uncontrolled and/or treated since less of 5 years (except basal cell carcinoma of the skin)
* Contraindication to MRI
* IPSS score \> 10
* Recurrent or metastatic disease
* Allergy to gold
* Patient already included in another therapeutic trial with an experimental molecule
* Unable for medical follow-up (geographic, social or mental reasons)
Evaluation of Efficacy of a Cashew Apple Extract on Weight Management and Associated Metabolic Risk Factors in Overweight/Obese Volunteers

The purpose of this study is to assess the efficacy and safety of a cashew apple extract on weight management and associated metabolic risk factors in overweight/obese volunteers, versus placebo, after 12 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* 27 ≤ BMI ≤ 35 kg/m²
* Abdominal obesity
* Acceptance to adhere to diet and physical activity recommendations while maintaining global lifestyle habits
* Stable body weight (\<5% variation) within the last 3 months prior to screening

Exclusion Criteria:

* Allergy to nuts and products thereof and allergy to mango fruit
* Type I or II diabetes
* Smokers
* Severe chronic diseases
* History of bariatric surgery and eating disorders
* Use of weight management products or medications which could affect nutrients absorption, lipids or carbohydrates metabolism
Insulin Therapy for Postreperfusion Hyperglycemia

Glycemic control during liver transplantation is challenging especially after reperfusion of the liver graft. Insulin dose to treat postreperfusion hyperglycemia is retrospectively analyzed using historical data. The proposed dose then is prospectively applied to the patients to assess the adequacy of the insulin dose.

Hyperglycemia is common during liver transplantation ,especially after graft reperfusion. Response to insulin is frequently unpredictable during postreperfusion period with no consensus or guidelines on glycemic control. The primary aim of this mixed retrospective/prospective study is to investigate the optimal insulin dose to treat hyperglycemia during the postreperfusion period of liver transplantation.

In the retrospective study, adult liver recipients (\>18 years old) who underwent liver transplantation between 2004 and 2016 are reviewed. Delta glucose is the primary outcome variable defined as the difference in blood glucose levels before and after insulin administration. The relationship between the insulin dose and delta glucose is analyzed with a linear mixed effects analysis to find the optimal insulin dose to treat postreperfusion hyperglycemia.

In the prospective trial, the proposed insulin dose is administered to the patient who showed hyperglycemia after graft reperfusion. The frequency and magnitude of glucose reduction is the primary outcome. The secondary outcome is the incidence and degree of hypoglycemia.

Eligibility Criteria:
Inclusion Criteria:

* Liver recipients who showed hyperglycemia (blood glucose \>180mg/dL) after reperfusion of liver graft.

Exclusion Criteria:

* pediatric patients
A Research Study of How Different Doses of a New Medicine NNC0148-0287 C (Insulin 287) Work on the Blood Sugar in People With Type 1 Diabetes When it is Taken Once a Week

This study compares the new long-acting insulin 287 with the marketed insulin glargine for use in type 1 diabetes. The study will test how insulin is taken up in your blood, how long it stays there and how the blood sugar is lowered. The participant will get both of the insulins in a random order. Insulin 287 is a new medicine while insulin glargine is already approved for the treatment of diabetes and can be prescribed by a doctor. The participant will get 8 weekly doses of insulin 287 and 14 daily doses of insulin glargine. There will also be a run-in period of 2 days to 4 weeks with daily doses of insulin glargine before you start the insulin 287 period. All doses will be injected under the skin. The study will last for about 16 to 24 weeks. The participant will have 27 visits with the study doctor.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent
* Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening
* Current daily basal insulin treatment greater than or equal to 0.2 U/kg/day
* Body mass index between 18.5 and 29.0 kg/m\^2 (both inclusive)
* HbA1c less than or equal to 9.0%

Exclusion Criteria:

* History or presence of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal or endocrinological conditions. Subjects with complications associated to diabetes can be included only if they are judged to be mild by the investigator. Subjects with other comorbidities (e.g. dyslipidaemia, hypertension and hypothyroidism) can be included if they have a stable treatment and are in adequate control according to the judgement of the investigator- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
* Known or suspected hypersensitivity to trial products or related products
Type 2 Diabetes Controlled Eating Experiment

A short-term feeding study in type 2 diabetics manipulating the fat and caloric values of meals to assess both compensation and glucose control, both covertly and overtly.


Eligibility Criteria:
Inclusion Criteria:

type 2 diabetic, age 18+, informed consent, able to eat 3 meals/day 1 day/week at clinic

Exclusion Criteria:

non-diabetic, type 1 diabetic
Nicotinamide Riboside and Mitochondrial Metabolism

Vitamin B3 has recently been found to be a potent modifier of energy metabolism, especially the function of mitochondria. Mitochondria power up all cells in our bodies, by generating fuel, ATP, for cellular functions. In previous studies, it has been discovered that mitochondrial biogenesis and oxidative metabolism in adipose tissue is severely impaired in obesity, already at a young adult age. Here the investigators describe a proposal where they use nicotinamide riboside (NR), a form of vitamin B3 naturally found in milk, to activate dysfunctional mitochondria, in particular the SIRT/NAD+ pathway, and to rescue signs of obesity-related diseases. The investigators use a unique human study design: monozygotic twins either discordant or concordant for obesity, to examine the effects of NR on mitochondrial function in muscle, adipose tissue and the metabolism of the whole body. The upcoming upcoming results are important for understanding the links between mitochondrial dysfunction and chronic metabolic diseases in humans, as well as for clarifying mechanisms of the novel nutritional therapeutic approaches.


Eligibility Criteria:
Inclusion Criteria:

1. BMI \>18.5 kg/m2 in both members of the twin pair
2. Agreed to maintain current level of physical activity throughout the study
3. Agreed to avoid vitamin supplementation or nutritional products with vitamin B3 14 days prior to the enrolment and during the study
4. Written, informed consent to participate in the study

Exclusion Criteria:

1. Unstable medical conditions as determined by the principal investigator
2. Clinically significant abnormal lab results at screening (e.g. AST and/or ALT \> 2 x ULN, and/or bilirubin \> 2 x ULN)
3. Subjects who have a planned surgery during the course of the trial
4. History of or a current diagnosis of any cancer (except for successfully treated basal cell carcinoma diagnosed less than 5 years prior to screening). Subjects with cancer in full remission more than 5 years after diagnosis are acceptable.
5. History of blood/bleeding disorders
6. Immunocompromised individuals such as subjects that had undergone organ transplantation or subjects diagnosed with human immunodeficiency virus (HIV)
7. Hepatitis
8. Blood donation in the previous 2 months
9. Anemia (hemoglobin \<120)
10. Participation in a clinical research trial within 30 days prior to randomization
11. Allergy or sensitivity to study supplement ingredients
12. Individuals who are cognitively impaired and/or who are unable to give informed consent.
13. Any other condition, which in the principal investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may have posed significant risk to the subject.
Biocollection of Patients With ANCA Associated Vasculitis

As rare disease, vasculitis affects a small number of patients, the cohorts available in the literature are few and the pathophysiological mechanisms remain to be elucidated. The collection of standardized data within a patientheque as part of a multi-year follow-up will facilitate the study of the characteristics of these diseases. This may, in particular, address the main objective of identifying predictors of relapse, as well as secondary objectives for predictive factors of mortality, infectious, cardiovascular or neoplastic complications that affect the prognosis of vasculitis in order to establish a more appropriate management of the patients concerned.

Vasculitis associated with anti-neutrophil cytoplasm antibodies (ANCA) is a group of rare and severe autoimmune diseases, encompassing several entities: granulomatosis with polyangiitis (GPA), microscopic polyangiitis (PMA), and eosinophilic granulomatosis with polyangiitis (GEPA). When untreated, these diseases are fatal in a matter of months. Currently, thanks to the use of corticosteroids and immunosuppressants, this high mortality has greatly decreased and these are now chronic diseases. On the other hand, these patients are at high risk of morbidity, linked to both relapses (occurring in at least 50% of patients) and side effects of treatments. It is therefore essential to be able to define which patients are at risk of relapse and justify long-term immunosuppressive treatment to avoid recurrence of the disease, and conversely which patients have a low risk of relapse and in whom immunosuppressive treatments can be discontinued to limit the risk of side effects. However, so far no predictor or biomarker can accurately assess this risk of relapse.

Eligibility Criteria:
Inclusion Criteria:

* Major patients with no upper age limit.
* Patients assessed as part of the reference centre for rare autoimmune diseases at the CHRU in Brest.
* Patients for whom a diagnosis of ANCA-associated vasculitis is made by the physician in charge of the patient, according to the definitions of the Chapel-Hill Consensus Conference.
* Patient affiliated with Social Security
* Patient who has signed written informed consent

Exclusion Criteria:

* Minor
* Patients unable to consent.
* Patients refusing to participate in research
* Patient under legal protection (tutelage, curatorship)
* Pregnant or lactating women
* Hemoglobin (Hb) \< 7g/dL
Magnevist® Injection-enhanced MRA Compared to Non Contrast MRA for the Detection of Stenosis of the Renal Arteries

The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Magnevist (the study drug) used for MRI of the renal arteries. The results will be compared to the results of MRI taken without Magnevist and with the results of your X-ray angiography.

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria: - Has known or suspected renal artery disease - Is scheduled for X-ray angiography Exclusion Criteria: - Has any contraindication to magnetic resonance imaging - Is scheduled for any procedure before the X-ray angiography - Had previously had stents placed bilaterally in the region to be imaged
Viral Infections in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

The objectives of the study are

* to determine the prevalence of respiratory virus infections in COPD patients, during and outside acute exacerbation
* to explore the impact of these viral infections on the outcome of these patients
* to explore the association between blood procalcitonin levels and viral infections in this population.

Background

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity due to repeated exacerbations. The impact of viral infections during and outside COPD exacerbations is poorly understood and there is only scarce data on the role of new biological markers of infection for the management of COPD exacerbations.

Objectives of the project

The investigators aim to

1. describe the epidemiology of viral infections in patients admitted with an exacerbation of their COPD;
2. explore the evolution of viral infections outside exacerbations;
3. analyze the impact of viral infections on clinical outcomes;
4. explore the role of biological markers (CRP, procalcitonin) for the diagnosis and prognosis of viral infections.

Methods

The investigators will prospectively follow-up 100 patients admitted with an acute exacerbation of their COPD. Virological samples will be obtained at admission and at 3 months, to explore the evolution outside episodes of acute exacerbation. Clinical information will be obtained after one-year follow-up. Samples will be tested by RT-PCR for 15 respiratory viruses. The impact of viral infections and the role of biological markers will be explored using univariate and multivariate Cox proportional hazard models.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients known or suspected for moderate to very severe COPD and admitted in the emergency center for an acute exacerbation of their COPD
* Age above 18 years
* We plan to include 100 patients with a complete work-up and follow-up
* Written informed consent will be obtained from every participant

Exclusion Criteria:

* Patients requiring oro-tracheal intubation
* Patients unable to give their informed consent due to their clinical condition
* Other obvious cause of dyspnea (pulmonary embolism, acute pulmonary edema, lobar pneumonia)
* Patients suffering from bronchiectasis, asthma, pulmonary fibrosis and mineral dust pneumoconiosis
* Patients with a history of active tuberculosis
* Patients with a history of ischemic cerebral stroke and subsequent deglutition dysfunction
BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500 Post-Meal Glucose Control in Patients With Severe Insulin Resistance

The study is designed to compare meal time glucose control associated with BIOD-531, a rapidly absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R U-500 in patients with diabetes and severe insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 25 kg/m2
* Diabetes Mellitus using ≥ 150 units of insulin or insulin analog per day and/or ≥ 100 units of insulin or insulin analog at a single dosing session for at least 1 month prior to screening
* HbA1c \< 10.0%

Exclusion Criteria:

* History of bariatric surgery
* Corticosteroid therapy
* Significant cardiovascular or other major organ disease
* Females who are breast feeding or pregnant
* A sexually active person not using adequate contraceptive methods
Cardiovascular Magnetic Resonance for the Occluded Infarct-Related Artery Treatment

The purpose of this study is to determine whether opening an occluded infarcted artery 3-28 days after an acute myocardial infarction in high-risk asymptomatic patients with preserved infarct zone viability improves left ventricular systolic function and volumes at 6 months follow-up. The secondary purpose is to assess the changes in myocardial tissue characteristics after late percutaneous coronary intervention (PCI).

Rapid restoration of blood flow in the infarct-related artery (IRA), one of the cornerstones of contemporary treatment of acute myocardial infarction (MI) prevents myocardial necrosis and its consequences. However, due to late presentation or failed fibrinolytic therapy up to one third of patients have persistently occluded IRA after MI.

Recently, the Occluded Artery Trial (OAT) has demonstrated that percutaneous coronary intervention (PCI) with optimal medical therapy does not reduce the frequency of major adverse events compared to optimal medical therapy alone when performed on days 3-28 post MI in stable patients. Assessment of infarct zone viability was not used as an inclusion/exclusion criterion in the main OAT trial.

Several studies confirm that patients with left ventricular systolic dysfunction and preserved myocardial viability (necrosis transmurality\<50% in most segments of the infarct zone) assessed with magnetic resonance imaging benefit from revascularization.

Late opening of the occluded infarct-related artery only in patients with preserved myocardial tissue viability may lead to improvement of left ventricular volumes and function.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment 3-28 days after an acute myocardial infarction.
* Infarct related artery occlusion (TIMI 0 or 1).
* High risk: left ventricular ejection fraction (LVEF)\<50% or LVEF\>50% and proximal coronary occlusion.
* Preserved infarct zone viability (necrosis transmurality \<50% in at least 4 segments out of 17 according to AHA classification).

Exclusion Criteria:

* Unstable clinical condition
Evaluation of Long-term Coronary Stenting Outcomes in Diabetic Patients With or Without Optimal Glycemic Control

the purpose of this study is to determine whether appropriate control of diabetes around the PCI time is related with MACE and outcome of diabetic patients.

Despite recent advances in coronary revascularization, cardiovascular disease accounts for about 75% of all hospital admissions in diabetic patients.although the introduction of drug-eluting stents has reduced the rates of restenosis after PCI, diabetic patients undergoing PCI will have poorer clinical outcomes.In this study, we sought to investigate whether a pre and post procedural glycemic control in diabetic patients,as reflected by HgbA1C prior,1 and 6 months after elective PCI,was related to major advance cardiac events (MACE) during 3 year follow up.

Eligibility Criteria:
Inclusion Criteria:

* age between 18-75
* coronary stenosis \> 70%

Exclusion Criteria:

* Myocardial infarction in 72 hours prior to PCI
* LVEF \< 30%
* Residual Stenosis\>30%
* Cr level \> 2.0
* hemodynamic compromise during intervention
* Left main lesions
* PCI for vein grafts
An Open-Label Study of the Effect of an Ophthalmic Solution on Asteroid Hyalosis

To determine the safety and initial efficacy of C-KAD ophthalmic solution in patients with asteroid hyalosis


Eligibility Criteria:
Inclusion Criteria:

* Presence of asteroid hyalosis

Exclusion Criteria:

* Active ocular infection
* Glaucoma
* Ocular hypertension
* Ocular inflammatory disorders
Balance Reactions in a Virtual Environment With Avatar and/or Reinforced Visual Signal Compared to a Real Environment

The scientific literature shows that there is a degradation of balance in virtual reality. This trial investigates the introduction of a full-body avatar and/or enhanced visual cues on the reduction of the degradation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer, men and women over 18 years old

Exclusion Criteria:

* Severe visual deficiency not allowing an activity in immersive virtual reality.
* Immobilization of one of the upper limbs (splint restraint splint)
* Orthopedic and painful problems of the inferior limb
* MSSQ greater than 25
* Pregnant woman
* Person under legal protection
Effect of Intermittent Fasting on Fat Mass

This study is aimed to assess the different effect on fat mass between fasting (intervention) group and not fasting (control) group after 8 weeks 5:2 intermittent fasting (IF) among obese male student aged 18-25. Female students are excluded because if they do any restriction intake during their menstruation period which is a lot of blood lost, it will be a risk for them.

This study is designed as non-blinding randomized control trial. Subject who adhere with less than 85 percent fasting (14 out of 16) will be dropped out from this study. Total sample in this study is 62 students which are 31 students for each group.

5:2 intermittent fasting (IF) is eating pattern in which no or few calories are consumed for 13 hours (for 5 am to 6 pm) done in two non-consecutive days days per week, followed by ad libitum intake on the remaining days, without any requirement of water restriction.

Subjects will be distributed to each group by using randomization block of four.

This study will use 8 forms consist of; informed consent, subject selection form, re-anthropometric measurement form, questionnaire, semi quantitative food frequency questionnaire (SQ-FFQ), international physical activity questionnaire (IPAQ), food record book, and control and evaluation form. While the tolls are consist of food photograph book (to help in filling the food record book), body height scale, and bio-electrical impedance analysis (BIA) Seca medical body composition analyzer (mBCA) 515/514 (to measure body composition).

Eligibility Criteria:
Inclusion Criteria:

* obese male student age 18-25
* do not have experience on amputation
* willingness to participate in the whole study by signing informed consent

Exclusion Criteria:

* hypertrophy muscle students identified from body composition measurement
* in a certain diet at the moment
* consuming lipid-lowering drug at the moment
* doing regular fasting (2 days a week) for 2 months before the study begin
* suffer from chronic illness (confirmed by disease history form
* using electronic implants, for example pacemaker or pane
* using prostheses (artificial body part)
Effect of an Internet Based Compliance Enhancement Tool in Subjects With Hypercholesterolemia

The purpose of the study is to determine whether an Internet based compliance tool is superior to common diet counselling in patients with hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

* Available personal mailbox and access to the Internet
* Primary hypercholesterolemia with CV risk \> 20% over 10 years judged by the investigator or a history of ischemic heart disease or other established atherosclerotic disease (claudicatio intermittens, apoplexia cerebri (ischaemic stroke)) or stable diabetes mellitus
* Fasting LDL-C level \> 3.2 mmol/L

Exclusion Criteria:

* Known heterozygous or homozygous familial hypercholesterolemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
* Documented secondary hypercholesterolemia of any cause except stable diabetes mellitus (type 1 or type 2)
* History of serious adverse effect or hypersensitivity reactions to statins, in particular any history of myopathy