cyrilzakka/clinical-trials huggingface dataset:
Patient-Specific Simulation Used for EVAR Procedure Rehearsal - Evaluation of Clinical Performance With and Without Prior Rehearsal

The purpose of this study is to evaluate the procedural and clinical benefits of patient specific pre-procedure rehearsal for operators with various experience levels as a tool for optimizing Endovascular Aneurysm Repair (EVAR) procedures.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old
2. Elective patients planned to undergo EVAR procedures with an endograft compatible with the Simbionix PRS.
3. Computed Tomography Angiography (CTA) scan of the abdominal aorta performed as standard of care. Sufficient quality/defined protocol.

Exclusion Criteria:

1. Subject is below 18 years old
2. Operator cannot complete the indicated rehearsal and practice.
3. Patients requiring emergent aneurysm treatment, e.g. trauma or rupture.
4. Arterial dissection.
5. Patients with Stage 4 of chronic kidney disease (GFR\<30 ml/min/m2).
6. Patient is indicated for use of snorkels, chimneys, fenestrated or branched graft devices
7. Pregnant or lactating women.
8. Off label stent graft use
Differences in ECG- vs. proLonged cardIac MonItor-DeTected Atrial Fibrillation in STROKE Patients (DELIMIT AF-STROKE)

The present study is an investigator-initiated, single-center, retrospective study based on data from the London Ontario Stroke Registry (LOSR), aiming to compare the characteristics and outcomes of ECG-detected and Device-Detected atrial fibrillation in patients with ischemic stroke and transient ischemic attack.

Patients with ischemic stroke and transient ischemic attack (TIA) without known atrial fibrillation (AF) are investigated with Prolonged Cardiac Monitoring (PCM) to detect AF. It is unclear if AF detected on 12-lead ECG after stroke occurrence bears the same risk of stroke as Device-detected AF. The investigators hypothesize, that Device-detected AF has a lower risk of ischemic stroke recurrence. The investigators will conduct a retrospective analysis of prospectively collected data from consecutive patients enrolled in the London Ontario Stroke Registry, (Ontario, Canada). The primary outcome will be a recurrent ischemic stroke at the end of the available follow-up window. The investigators will include ischemic stroke and TIA patients with ECG-detected AF and those with Device-detected AF on at least 7 days of Holter monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Patient with a diagnosis of ischemic stroke or TIA.
* ECG-diagnosed AF or PCM-detected AF post ischemic stroke or TIA

Exclusion Criteria:

* Individuals younger than18 years-old
* Patients without IS or TIA diagnosis
Impact of Particulate Matter in Chronic Obstructive Pulmonary Disease Patients

A prospective study will be conducted in patients with COPD. The investigators will suggest about intervention for preventing in recurrence and aggravation of adult chronic respiratory disease due to exposure to particulate matter.

Study trends and intervention plans related to particulate matter exposure and adult chronic respiratory disease in literature Measurement of particulate matter exposure by individual activities and collection of clinical information Linkage between individual particulate matter exposure and clinical information Investigation about effectiveness of intervention to avoid particulate matter

Eligibility Criteria:
Inclusion Criteria:

* COPD over 40 years of age
* Patients with pulmonary function tests with Forced expiratory volume at 1 second / forced vital capacity \<0.7 and Forced expiratory volume at 1 second1 \<80%

Exclusion Criteria:

* Patients under the age of 18
* Elderly people over 80 years old
* People with respiratory symptoms with modified Medical Research Council dyspnea scale 0
* Persons who do not understand the brief description of the particulate matter exposure device
* A person who does not agree to the study
Genotype and Phenotype in Early Onset Breast Cancer in Young Women on the Two Shores of the Mediterranean Sea

Breast cancer are common on mediterranean basin. Epidemiological data suggest that breast cancer in young women (\< 40years old) is more aggressive in the Maghreb countries comparatively to western countries. This aggressiveness could be associated with phenotypic and genotypic differences between this two populations.

The object of this study is to compare the genotypic and phenotypic differences between south and north shore of the mediterranean sea.

Eligibility Criteria:
Inclusion Criteria:

* Patient have or have had a breast cancer diagnosed before 40 years old
* Breast cancer proven by histology
* BRCA1/2 analysis proposed, realized, ongoing
* Women \>18 years old
* Patient with insurance
* Patient informed and no-opposed

Exclusion Criteria:

* Patient have or have had a breast cancer diagnosed after 40 years old
* Patient requiring tutorship or guardianship
* Adult patient protected by law
RFA for Small HCC With No-touch Technique and Dual Cooled-Wet Electrode

The purpose of this study is to prospectively compare the clinical outcomes (local tumor progression rate, technical success rate, complication rate) of no touch radiofrequency ablation (RFA) technique for Hepatocellular carcinoma (HCC) to those of conventional tumor puncture RFA technique.


Eligibility Criteria:
Inclusion Criteria:

* Child-Pugh class A
* patient with 1-2.5cm sized HCC
* 1 or 2 HCC lesions

Exclusion Criteria:

* maximum tumor diameter greater than 2.5cm
* Child-Pugh class B or C
* more than 3 HCC lesions
* invisible tumor even after US/CT or US/MR fusion
* presence of vascular tumor thrombosis or extrahepatic metastasis
* severe coagulopathy (PLT \< 50K, PT \< 50% of normal range)
Moderate Sedation Combined With Acupuncture Anesthesia in Gastroscopy and Colonoscopy on Screening Research

The purpose of this study is mainly about the feasibility and rationality of moderate sedation combined with acupuncture anesthesia in the application of gastroscopy and colonoscopy ,Then we evaluate the effectiveness and advantages of the combination of acupuncture anesthesia and drug anesthesia.

With the increase of the proportion of the patients who crave for performing painless gastroscopy and colonoscopy in recent years, it is crucial to seek a more secure and effective method of anesthesia or sedation. At present, the universal anesthetic method on gastroscopy and colonoscopy in China is the general anesthesia without intubation which usually uses propofol and opioid analgesics,Although the satisfaction of patients is high, the incidence of anesthesia-related complications and drug-related adverse reactions is high .The incidence of adverse events during the gastroscopy and colonoscopy is high, and the medical expense of anesthesia is high. At present, more than 2/3 of the patients undergo painless gastroscopy or colonoscopy are middle-aged and elderly patients, so the overdose which prolongs the recovery time、discharge time of patients and reduces the recovery quality of patients is common. The moderate sedation, which fundmentally does not affect hemodynamics、autonomous respiration and protective reflexes, is incomparable to general anesthesia . And acupuncture anesthesia also acts as a safe anesthetic method can provide safer analgesic effect.Theoretically，the combination of both of them is a relatively perfect and safe painless method.

Eligibility Criteria:
Inclusion Criteria:

1. Outpatients
2. Patients with ASA grade I-III
3. A sufficient level of education to understand study procedures and can communicate with investigators.

Exclusion Criteria:

1. Patients with serious systemic diseases such as severe cardiopulmonary disease or hepatic diseases or renal diseases.
2. Patients under the age of 18.
3. Patients who did not sign the informed consent form.
4. Patients who have a history of alcohol abuse or drug abuse.
5. People who are allergic to anesthetic related ingredients, such as soybeans, eggs and so on.
6. Patients with extreme fear or anxiety about acupuncture.
7. Patients with relative contraindications of gastrointestinal endoscopy.

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Assessment of Quality of Life and Independence, as Well as Received Social Support for Spinal Cancer.

* Evaluation of the quality of life of patients before and after surgery for benign and malignant spinal cancers, assessing whether it depends on the size of the tumor, type of cancer, malignancy and its location
* evaluation of patients' independence before and after surgery for benign and malignant spinal tumors, evaluation of what factors influenced patients' different independence
* multidimensional assessment of perceived social support of patients before and after surgery for benign and malignant spinal cancers, taking into account three sources of support: significant person, family and friends

RESEARCH PROJECT DESCRIPTION, RESEARCH METHODOLOGY:

Research objectives:

* To evaluate the quality of life of patients before and after surgery for benign and malignant spinal cancers, to assess whether it depends on the size of the tumor, type of cancer, malignancy and its location
* evaluation of patients' independence before and after surgery for benign and malignant spinal tumors, assessment of what factors influenced patients' different independence
* multidimensional evaluation of perceived social support of patients before and after surgery for benign and malignant spinal cancers, taking into account three sources of support: significant person, family and friends

Scientific (research) problems:

* What is the quality of life of patients before and after surgery for benign and malignant spinal cancers ? Is the quality of life in patients with spinal cancer dependent on tumor size, malignancy, location or type of cancer ?
* How do patients rate their independence both before and after surgery for spinal cancers at different stages of the disease?
* How do patients with spinal cancer at different stages of the disease rate the social support they received both before and after surgery?

Eligibility Criteria:
Inclusion criteria for the study:

-clinical diagnosis of spinal cancer

Study exclusion criteria:

-inflammatory and disc disease of the spinal column
Adiponectin in Obese Women With T2DN and Effects by RAS Blocker

Insulin resistance typically characterizes type 2 diabetes (T2DM) and prediabetic states and is the prominent feature of the metabolic syndrome.Adiponectin plays an important part in glucose metabolism,insulin resistance, the deterioration of renal function.we hypothesize there is a difference serum adiponectin levels between obese and non-obese women with type 2 diabetic nephropathy. Furthermore, these two groups would respond difference to the RAs blocker(Losartan).

it would be a prospective cohort study. According to BMI, all the women, aged\>30yr, diagnosed type 2 diabetic nephropathy, chronic kidney disease stage range from 1 to 4, will be divided to two group. Renal function index(included SCr, GFR, et al),glucose metabolism index( fasting glucose, plasma insulin et al),and adiponectin concentration will be observed and recorded. both two groups females will accept the treatment of RAS blocker(losartan, 100mg daily, 6 month). during the study, the above mentioned parameters will also be recorded 3 month intervals. Meanwhile, any side effects would be pay attention.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic nephropathy
* CKD at stage 1\~4

Exclusion Criteria:

* Type 1 diabetes or nondiabetic renal disease
* An elevated plasma K level.
Patient Position and Invasive Urodynamic Study Results in Males

The goal of this study is to learn whether the change or patient position might effect the results of invasive urodynamic study in males.

Males will be randomised as Group 1 and Group 2. In Group 1, invasive urodynamic study will be performed first in sitting then repeated in standing position. In Group 2, invasive urodynamic study will be performed first in standing then repeated in sitting position. Results will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Males over 18 years old and capable of standing during test

Exclusion Criteria:

* Patients not able to stand up during the test
Health Burden of Hypophosphatasia

Hypophosphatasia (HPP) is a genetic disorder caused by mutation in the tissue-non-specific alkaline phosphatase gene (TNSALP). It causes impaired bone mineralisation, fractures, tooth loss, muscle weakness and possibly other adverse health outcomes.

The infantile-onset forms are severe, and were often fatal until the recent availability of a treatment (Asfotase Alfa). The childhood-onset forms are less severe, and the adult-onset form is mild, and often unrecognised or misdiagnosed as osteoporosis.

The less severe forms of the disease are not well described, and because there has been no available treatment there has not been much research in adults. However, now that treatment is available there is a possibility of a clinical trial in adults. To know whether there is a need for a trial there is a need to determine if there is a significant personal and economic burden associated with the less severe forms of HPP.

The study consists of a clinical interview and notes review of adults and children with confirmed (by biochemical and genetic testing) HPP attending metabolic bone clinics in Sheffield to establish their clinical problems and healthcare use. There are currently about 26 adults and 8 children attending clinics in Sheffield.

The information will be used to plan a data search and health economic analysis of the burden of HPP from the UK Clinical Practice Research Database in collaboration with Pharmatelligence (a healthcare data group based within the University of Cardiff).

This is an observational retrospective study to describe the clinical problems and healthcare use of adults and children with hypophosphatasia.

Interviews will be conducted with patients with childhood- and adult-onset hypophosphatasia (and the parents of the children). Hospital notes, appointment records and GP summary care records will also be reviewed.

These sources will be used to describe their clinical problems, how these problems affect their daily function, and which healthcare services they have used.

Patients will attend for a single visit to obtain informed consent and conduct the interview.

Health problems specifically assessed in detail will include:

* Fractures
* Dental problems
* Skeletal complications
* Mobility problems
* Neurosurgical complications
* Seizures
* Respiratory complications
* Depression and anxiety
* Side effects of treatment including hypercalcaemia and hyperphosphataemia Deaths will also be recorded

Health care resource assessment will include

* Primary care episodes
* Secondary and tertiary care outpatient episodes
* In-patient episodes
* Nutritional support
* Therapy support
* Dental treatment
* Over the counter medication use

A case data report form will be developed as an iterative process through the period of the interviews to ensure that all data of potential interest is captured. Because the condition is not well described it is important that the data reported is not limited to the areas where it might be already expected to find problems.

Eligibility Criteria:
Inclusion Criteria:

* Hypophosphatasia

Exclusion Criteria:

* Unable/unwilling to give informed consent
Measurement of Critical Closing Pressure (Pcrit) During Drug-Induced Sleep Endoscopy (DISE)

This study intends to test the feasibility of measurement of the critical closing pressure (Pcrit) during drug-induced sleep endoscopy (DISE) for use in future studies, which are aimed at finding an alternative method for patient selection and response prediction before implementation of non-CPAP therapies.Twenty patients diagnosed with OSA and eligible for non-CPAP treatments are going to be included into this study and undergo these measurements. Drug-induced sleep endoscopy (DISE) is part of the standard clinical care for OSA patients that are eligible for non-CPAP therapies. We aim to expand this procedure with measurement of Pcrit, oesophageal pressure, airflow, EEG, EOG, respiratory effort, SpO2 and chin EMG during this study.

Patients from the ENT department will be recruited and informed about the study. After obtaining informed consent, the patients will undergo DISE according to the normal clinical care.The study will be performed during this clinical DISE, using a standard polysomnographic set-up (Alice 6 LDx, Philips Respironics) expanded with pressure and flow measurements. After measurements and evaluations are done, the most suitable treatment option based on the DISE and PSG findings, as defined in the standard clinical care, will be advised to the patient. The treatment and its further choice are not part of the current study protocol.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Diagnosis with OSA (AHI ≥15/hour sleep)
* Eligible for DISE as the next step in the clinical path for OSA.
* Capable of giving informed consent

Exclusion Criteria:

* Medication use related to sleeping disorders.
* Central sleep apnea syndrome.
* Medical history of known causes of tiredness or severe sleep disruption other than OSA (insomnia, PLMS, Narcolepsy).
* Seizure disorder.
* Known medical history of intellectual disability, memory disorders or current psychiatric disorders (psychotic illness, major depression, or acute anxiety attacks as mentioned by the patient).
* Inability to provide informed consent.
* Simultaneous use of other treatment modalities to treat OSA
* Esophageal ulceration, tumors, diverticulitis, bleeding varices, sinusitis, epistaxis, recent nasopharyngeal surgery
* Pregnancy or willing to become pregnant
* Excessive alcohol or drug use (\> 20 alcohol units/week or any use of hard drugs)
Palonosetron Associated to Aprepitant in Prophylaxis of PONV

The objective of this study is to investigate if aprepitant in association with palonosetron and dexamethasone could reduce the incidence of PONV in high-risk patients for this symptom, undergoing cancer surgery mastectomies.

Postoperative nausea and vomiting (PONV) is a common anesthetic complication that occurs in approximately 30% of the surgical population and can reach up to 70% in high risk patients for PONV. Advances have been made to prevent PONV, but the incidence is still high in certain groups of patients. In high risk patients, pharmacologic intervention should consist of multimodal therapy, targeting different mechanisms of action. The objective of this study is to investigate if aprepitant in association with palonosetron and dexamethasone could reduce the incidence of PONV in high-risk patients for this symptom, undergoing cancer surgery mastectomies. METHODS: this is a randomized and double blind clinical trial. Female high-risk patients for PONV(Apfel score 3 or 4) scheduled for mastectomy that agree with the study and signed the informed consent, are randomly distributed into one of two groups: Group A, aprepitant 80 mg per os one hour before the surgery and Group B will receive placebo by the same route one hour before surgery, in a blinded way. After induction of anesthesia, dexamethasone 4 mg and palonosetron 0,075mg are intravenously administered to all patients. After the end of the surgery, a patient-controlled analgesia (PCA) device will be intravenously inserted in all patients. In the postoperative period, patients will be evaluated for nausea, vomiting and pain intensity in the recovery room and after 24 hours

Eligibility Criteria:
Inclusion Criteria:

* patients submitted to breast cancer surgery
* non smokers

Exclusion Criteria:

* any contraindication to one of the drugs
* mental disease
* inability to understand the method or refusal to participate in the research
Study Evaluating DVS-233 SR in Elderly Outpatients With Major Depressive Disorder

To evaluate the overall safety and tolerability profile of two dose levels of DVS-233 SR during 6 months of open-label treatment in elderly outpatients with major depressive disorder.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients men and women aged 65 years or older.
* Mini Mental State Examination score of 24 or above.
* Subjects must have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), single or recurrent episode, without psychotic features, on study day 1, if depressive symptoms for at least 30 days prior to screening visit and minimum screening and study day -1 (baseline) scores of 16 on the Hamilton Psychiatric Rating Scale for Depression (HAM-D17).

Exclusion Criteria:

* Significant risk of suicide based on clinical judgment, including common suicidal thoughts, and suicide being considered as a possible solution, even without specific plans or intention.
* Current (within 12 months of baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder as assessed by the modified Mini International Neuropsychiatric Interview (MINI). Current (within 12 months of baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder as assessed by the modified MINI and considered by the investigator to be primary, causing a higher degree of distress or impairment than MDD. Presence (within 12 months of baseline) of a clinically important personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic). Presence of dementia.
* Depression associated with the presence of an organic mental disorder due to a general medical condition or a neurologic disorder.

Other exclusion applies.