cyrilzakka/clinical-trials huggingface dataset:
Ghrelin Levels in Pancreatic Cancer Patients

The primary outcome measure for this study is plasma ghrelin level.

The primary outcome measure for this study is plasma ghrelin level, and the two primary comparison are:

* Patients with cachexia versus patients without cachexia
* Patients with cachexia versus healthy controls

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological proof of pancreatic adenocarcinoma
* The control are will include healthy age-matched patients without cancer
* The test arm will include patients with pancreatic cancer and they will divided into two groups: those with and without weight loss
* Patients must have recovered from any major infections and/or surgical procedures

Exclusion Criteria:

* Patients with other serious medical illness like congestive heart failure, thyroid disease,liver disease or renal failure - conditions that will alter their nutritional state
* Patients on appetite stimulant and those receiving total parenteral nutrition
* Patients who have undergone gastrectomy or those who have gastric ulcers
* Patients receiving active chemotherapy
* No prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or for which patient has been disease free for at least five years.
Combined Treatment with Pulsed Light and Photobiomodulation Before Laser Refractive Surgery

Ametropia is the first cause of reversible visual trouble. Recently, laser refractive surgery has increased in popularity. Unfortunately, dry eye is a common side effect, representing about 25% of patients after LASIK and 20% after SMILE. Even if symptoms are usually released by artificial tears, there can be very uncomfortable for patients, decrease productivity and quality of life and be the source of unsatisfaction after surgery.

The goal of our study is to study the efficiency of a preventive associated treatment by intense-pulsed-light and low-level-light therapy with EYE-LIGHT® device before laser refractive surgery. Recent study confirmed the efficacity of this treatment in meibomian glund dysfunction, the predominant dry eye mecanism.

monocentric, randomized, simple bling, controlled study

Eligibility Criteria:
Inclusion Criteria:

* ametropia without progression for almost one year
* pachymetry \>480 um
* myopia \< -8 dioptre
* hyperopia \< +6 dioptre
* astigmatism \< -5 dioptre

Exclusion Criteria:

* other ocular disease (such as keratoconus, cataract, glaucoma, AMD, diabetic retinopathy, etc.)
* infectious or systemic pathology (e.g.: epilepsia, migraine)
* pregnancy, fitzpatrick V or VI (eye-light contraindication)
Bioequivalence Study of Rivaroxaban

The objectives of this study are to establish the bioequivalence between rivaroxaban tablet 15 mg and rivaroxaban granule formulation 15 mg, and to assess the safety and tolerability of rivaroxaban 15 mg in healthy adult male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Japanese healthy male subjects
* 20 to 40 years of age
* 17.6 to 26.4 kg / m² of body mass index (BMI)

Exclusion Criteria:

* Subject with incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
* Subject with a history of relevant diseases of vital organs, of the central nervous system or other organs, eg instable coronary heart disease, heart failure, liver failure, kidney failure, hypotension, or history of stroke or myocardial infarction
* Subject with known coagulation disorders (eg von Willebrand's disease, hemophilia)
* Subject with known disorders with increased bleeding risk (eg periodontosis, hemorrhoids, acute gastritis, peptic ulcer)
* Subject with known sensitivity to common causes of bleeding (eg nasal)
Comparison of Radial and Ulnar Artery Intervention in Patients With ST Elevated Myocardial Infarction

In the literature, there are no studies comparing these two pathways in ST elevation myocardial infarction (STEMI). In this patient group, it will be investigated whether transulnar intervention causes similar or less complications than transradial intervention, and whether it provides superiority or similarity in terms of outcomes.

The transulnar approach is known as an alternative procedure for transradial coronary angiography due to its safety and applicability. For cardiologists, experienced in trans-ulnar access, this access zone is comfortable to use. Because less spasm is developing. In addition, no significant difference was found between the transradial and transulnar routes in terms of other complications.In the literature, there are no studies comparing these two pathways in ST elevation myocardial infarction (STEMI). In this patient group, it will be investigated whether transulnar intervention causes similar or less complications than transradial intervention, and whether it provides superiority or similarity in terms of outcomes.

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years of age
* admitted for primary percutaneous intervention
* either of these two routes has not been used in the last week
* a sufficient pulse at both routes

Exclusion Criteria:

* cardiogenic shock
* stent thrombosis
* the use of either of these two arteries in the last 1 week
* either of these arteries can not be pulsed or very weak pulsed
Effect of the Combination of Plant Extracts (BSL_EP025) in Cardiovascular Health

The objective of the study is to evaluate the ability of a combination of plant extracts (BSL_EP025) to reduce the levels of LDL-cholesterol and oxidized LDL-cholesterol in individuals with LDL-cholesterol levels between 100 and 190 mg/dL.

There is a strong relationship between serum cholesterol levels and cardiovascular diseases, especially between coronary artery disease and LDL-cholesterol (LDL).

LDL is the lipoprotein responsible for delivering cholesterol to cells. However, in recent years, special attention has been given to modified LDL, especially oxidized LDL, since it plays a very important role in the initiation and progression of the atheroma plaque.

There are environmental and genetic factors that can influence the type and levels of blood lipoproteins. Among the modulable factors (environmental) it has been observed that some phytochemical compounds found in several plant extracts may reduce cardiovascular risk, due to their antioxidant and anti-inflammatory properties.

The objective of the present study is to evaluate the possible effect of the intake of a combination of plant extracts (BSL_EP025) on the levels of LDL-cholesterol and oxidized LDL-cholesterol in healthy individuals with LDL-cholesterol levels between 100 and 190 mg/dL.

Eligibility Criteria:
Inclusion Criteria:

* Men or women between 18 and 65 years of age.
* Levels of LDL-cholesterol between 100 and 190 mg/dL.
* Accept freely to participate in the study and sign the informed consent document.

Exclusion Criteria:

* Be pregnant.
* Have planned to carry out a dietary intervention or exercise practice with the aim of losing weight in the coming weeks.
* Suffer from a serious illness.
* Have diabetes.
* Having a cerebrovascular disease.
* Be taking products or drugs to control cholesterol levels or with antioxidant activity.
Early Detection of Polyps and Colon Cancer by Fluorescence Imaging - a Dose-finding Study

Patients referred for colon inspection (colonoscopy) due to suspicion of colon polyps/cancer will receive local administration of hexaminolevulinate (HAL) prior to colon inspection. Blue light illumination will induce red fluorescence of polyps and tumours, improving detection of the polyps and tumors. Different HAL doses will be tested to find the optimal image conditions. Tolerability measurements will be performed to ensure patient safety.

Colonoscopy is regarded as the "gold standard" for diagnosis of colorectal cancer. The sensitivity is uncertain but proposed to be (75-95%), however flat adenomas which are easily missed, are often not recognised. Fluorescence imaging may increase the sensitivity of standard white light colonoscopy by identifying more polyps and flat adenomas which will make the resection of adenomas more complete.

In this study hexaminolevulinate (HAL) will be administered locally as a photosensitiser, using different doses to find the optimal imaging conditions as well as making patient safety assessments.

Both standard white light and blue light (fluorescence) inspection will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspicion of colorectal cancer
* Written informed consent
* Data protection consent
* 18-85 years

Exclusion Criteria:

* Liver cirrhosis
* Hepatitis
* Abnormal liver function
* Porphyria
* Patient non-compliance
* Coagulation disorder
* Contraindication to colonoscopy
* Pregnancy and lactation
* Participation in another study
mHealth Technology in People With Parkinson's Disease

The main objective of the study is to explore the feasibility and effectiveness of this type of mHalth technology in the treatment of motor symptoms in people with Parkinson's disease.

Parkinson's disease (PD) is a neurological disease whose motor symptoms drastically affect the quality of life of those who suffer from it. There is currently high scientific evidence of the positive effect of physical exercise on the motor function of people with PD. This effect seems to be more relevant when this physical exercise is implemented with external sensory signals (eg visual, auditory). However, the health and socioeconomic context of the patient conditions their access to treatments and physical exercise programs, associationism being common as a low-cost strategy to cover the different therapies. The development of telemedicine, electronic devices and mobile health applications could be an interesting option for those patients who find themselves in the situations mentioned above. However, there are several limitations regarding the use of mobile health apps, such as that less than

1% of them are grounded in research evidence and the digital barrier. Therefore, the main objective of the study is to explore the feasibility and effectiveness of this type of mHalth technology in the treatment of motor symptoms in people with Parkinson's disease.

Eligibility Criteria:
Inclusion Criteria:

* Absence of treatment with psychotropic drugs or stable dose of the same (without drug or dose modifications in the last four weeks).

In the case of subjects who are part of the intervention group, the following will also be inclusion criteria:

* Caregiver or family member who presents the appropriate skills for collaboration in the implementation of the exercises and in the management of the mobile application.
* Availability of the necessary time for the initial training in the handling of the devices, the development of the sessions and the communication with the researchers.

Exclusion Criteria:

* Insufficient physical condition for participation.
* Sensory deficits that make participation difficult.
* Unstable clinical situation.
* Unstable mental disorder or not adequately controlled with medication (depression, agitation, etc.).
* Presence of associated pathology that involves treatment with drugs that alter cognitive abilities or interfere with the user's participation
DSA Risk Factors in MMF-based Immunosuppressed Post-transplanted Patients

Kidney transplantation is the best therapy method for patients with uremia. The main factors affecting the long-term survival of the graft were chronic antibody-mediated rejection and the death of the patients. Newborn donor special antibody (DSA) is a major risk factor for chronic antibody-mediated rejection (AMR) and poor transplantation outcomes. Detection of mycophenolate mofetil (MMF) trough concentration can help estimate its exposure. Deficient exposure of MMF can lead to AMR after transplantation surgery. The aim of this study is to estimate the risk factors of one-year DSA after transplantation.


Eligibility Criteria:
Inclusion Criteria:

* years 18-65
* single organ transplantation
* first time to accept kidney transplantation
* Triple immunosuppression protocol based on MMF, tacrolimus and glucocorticoid
* PRA negative before transplantation
* not pregnant for female

Exclusion Criteria:

* Not accept MMF
* multi-organ transplantation
* pregnancy or lactation period female
* mental illness
* past tumor, peptic ulcer, severe cardiopulmonary disease, active liver disease history
* Cannot regular follow up
Effects of Echo-optimization of Left Ventricular Assist Devices on Functional Capacity (VAFRACT)

After the implantation of a left ventricular assist device (LVAD), many patients continue to experience exercise intolerance. LVAD echo guided optimization (EO) determines a more favorable hemodynamic profile and could provide an improvement on functional capacity (FC). VAFRACT is a prospective randomized trial to evaluate the additional benefit of an EO approach on FC, measured by cardiopulmonary exercise test (CPET), in LVAD optimization free population.

The use of Left Ventricular Assist Devices (LVAD) is a viable therapeutic option to improve survival and quality of life of patients with advanced and refractory heart failure (HF). However, after the implantation of an LVAD, patients' functional capacity (FC) is still reduced with maximum oxygen uptake (VO2 peak) values calculated at the cardiopulmonary exercise test (CPET) ranging from 11 to 20 ml/kg/min. LVAD echo guided optimization (EO) determines a more favorable hemodynamic profile, in particular for the right ventricle, and could provide an improvement on FC. VAFRACT is a prospective randomized trial to evaluate the additional benefit of an EO approach on FC, measured by CPET in LVAD optimization free population.

The optimal device speed is defined as the one that allows an intermittent aortic valve opening and a neutral position of the interventricular septum without increasing aortic or tricuspid regurgitation associated or not to a dilatation of the right ventricle (RV). In this condition it is reasonable to expect a more favorable hemodynamic profile for the RV and a better response in terms of functional capacity.

Subjects studied are HF patients supported with a continuous-flow LVAD: HeartMate II (Thoratec Inc., Pleasanton, CA) and HeartMate 3 (HM 3, Abbott, North Chicago, IL). Patients are recruited from our Day Hospital of the Cardiac Surgery Department at the University Hospital of Verona.

Eligibility Criteria:
Inclusion Criteria:

* at least 3 months after LVAD implantation;
* compliance to the required follow-up schedule;
* age 18 or above or of legal age to give informed consent specific to state and national laws.

Exclusion Criteria:

* distance of less than 150 meters on the six-minute walk test (6MWT) or impossibility to perform CPET
* recent finding of any major device-related complication (sepsis, thrombosis ...).
Efficacy and Tolerability of Suprep With and Without Simethicone for Routine Colonoscopy for Colorectal Cancer Screening

The purpose of this study is to investigate Suprep bowel preparation, with and without the anti-gas medication simethicone, in terms of efficacy and patient tolerability in the preparation of patients undergoing routine colonoscopy for colorectal cancer screening.

The study will investigate sodium sulfate/potassium sulfate/magnesium sulfate (Suprep), with and without simethicone, in terms of efficacy and patient tolerability in the preparation of patients undergoing routine colonoscopy. Adult ambulatory outpatients who are scheduled for elective routine colonoscopy for colorectal cancer screening will be recruited to participate in the trial. Patients will be randomized to receive either simethicone or placebo in addition to oral sodium sulfate/potassium sulfate/magnesium sulfate solution (Suprep) and will receive verbal and written instruction on administration of solutions. During colonoscopy, three areas of the colon (right colon, transverse colon, and left colon) will be assessed during removal of the colonoscope for overall colon cleansing, presence of bubbles, and degree of haziness; this will be scored by a blinded endoscopist. A separate written patient questionnaire will be used to assess acceptability and tolerability of the preparation, as well as any adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Outpatients who require elective colonoscopy for colorectal cancer screening at Iowa Endoscopy Center and at University of Florida - Jacksonville

Exclusion Criteria:

* Allergy or hypersensitivity to any constituent of the lavage solution or to simethicone
* Presence of any contraindication to colonoscopy (i.e. uncontrolled congestive heart failure, New York Heart Association classification III-IV, history of myocardial infarction within 6 months, coagulopathy)
* Massive ascites
* Renal insufficiency
* Pregnancy
* History of colonic surgery
* History of anti-flatulence or laxative agent within one week
* Refusal/inability to give consent
* Patients undergoing colonoscopy for reasons other than colorectal cancer screening
* Mentally disabled
* Non-English-speaking patients
Observational Study of Heart Valve Disease in Patients With Parkinson's Disease Treated With Pergolide

The purpose of this study is to determine whether patients with Parkinson's disease and treated with pergolide have a higher risk of heart valve disease compared to patients with Parkinson's disease not treated with pergolide.

Pergolide is an ergot dopamine receptor agonist with demonstrated efficacy in Parkinson's disease. Last year, two studies showed that pergolide can induce unexpected heart valve disease potentially severe and frequent. The late discovery of this unknown side effect had dramatic consequences in Parkinson's disease management and the French drug agency (AFFSAPS) has recently published guidelines for its prescription. Little is known about the prevalence and the molecular mechanisms leading to this adverse event. To determine the prevalence, evolution, and potential risk factors of pergolide-induced heart valve disease, we propose an echocardiographic observational study in parkinsonian patients taking pergolide compared to matched controls. This clinical study will be performed in the Clinical Investigation Centre in collaboration with the Institute of Cardiology of the Salpétrière Hospital

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease
* Hoehn and Yahr score inferior or equal to 4
* treated with pergolide since more than 3 months (pergolide group)
* never treated by pergolide (control group)

Exclusion Criteria:

* Parkinson + syndrome, multiple system atrophy, supranuclear palsy
* hoehn and yahr score equal to 5
Follow-up During the Peripubertal Period of Preterm Children Included in the Protocol Entitled "EPIPOD".

Prematurity is associated with an increased risk of developing cardiovascular and metabolic disturbances in adulthood.

It has been demonstrated that the body composition of children born prematurely is different from that of children born under term with a deficit in fat free mass.

It can thus be wondered if this excessive adiposity does or does not predict the risk of insulin resistance in adulthood.

Children born prematurely, with a body composition measurement performed at discharge from neonatal hospitalization as part of the EPIPOD protocol, and now aged between 8 and 14 years, will be included in the INFANTPOD protocol.

Analysis of body composition, insulin resistance, renal function, pulse wave velocity, eating behaviour and of physical activity will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Children hospitalised at the Nantes University Hospital in the neonatal period
* With a body composition measurement performed at discharge from neonatal hospitalization as part of the EPIPOD protocol
* Born prematurely (under 35 weeks of amenorrhea)
* Included in the Lift cohort with follow-up up to 7 years
* Aged between 8 and 14 years at inclusion

Exclusion Criteria:

* Children with an isolated metabolic disease: insulin-dependent diabetes; endocrine disease (Cushing's, hypothyroidism)
* Age of 15 years or more
* with a chromosomal anomaly
* with contraindicating measurement of the BOP-POD: ventilatory support, continuous parenteral feeding, elimination stoma
* Refusal of either parent or child
Prospective Non-randomized Evaluation of Oncoplastic Surgery

Breast conserving therapy (BCT) is the standard treatment for intraductal or invasive breast cancer patients. However cosmetic results, e.g. symmetry and nipple displacement, are sometimes poor reducing the quality of life. The use of immediate techniques for oncoplastic surgery (iTOP) seems to improve subjective cosmetic outcome. Oncologic safety of iTOP has been demonstrated by several authors using restrospective analyses. However, no prospective observational trial has been done to objectively evaluate cosmetic and oncologic outcome comparing BCT with iTOP. The aim of this study is to investigate this issue within a prospective non randomized observational trial at the Medical University Vienna.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for unilateral breast conserving surgery due to cancer or a suspicious lesion, in whom \>10%\* of breast volume (measured by mammograms using a defined formular 37) has to be removed or breast cancer patients scheduled for mastectomy and immediate reconstruction (immediate or delayed contralateral correction is allowed)
* BIRADS IV, V or VI are eligible
* \> 18 years of age
* Psychological and physical capable of understanding and performing the trial
* Signed written informed consent \* If oncologic safety necessitates to resect more than half of one breast quadrant

Exclusion Criteria:

* Inflammatory breast cancer
* Progression after neoadjuvant therapy
* Pregnant women
* Patients unable to perform surgery under general anaesthesia
* Bilateral breast lesions
Validation of the Mutuality Scale in Patients With OSA and Their Partners

Main objective of this study is to assess the psychometric characteristics of the Mutuality Scale both in patients with Obstructive Sleep Apnea Syndrome (OSAS) and in their partners-The association between the mutuality score in OSAS patients and their adherence to the use of Continuous Positive Airway Pressure (CPAP) therapy will also be investigated.

The results of the study may allow a validation of the Mutuality Score as an instrument for measuring mutuality between OSAS patients and their partners.


Eligibility Criteria:
OSA patients:

Inclusion Criteria:

* Age 18 years and older

Exclusion Criteria:

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