cyrilzakka/clinical-trials huggingface dataset:
Study of the Protective Effect of Mechanism of Pentoxyfilline After Major Liver Resection Under Inflow Occlusion (Pringle Manoeuvre)

The investigators hypothecate that pentoxyfilline increase significantly the liver regeneration and reduces significantly ischemia and reperfusion (I/R) injury in major liver using aspartate aminotransferase (AST) and alanine aminotransferase (ALT) as marker of I/R injury.

Liver resection is for many patients with primary or secondary hepatic malignancies the only curative treatment option. Often, the complete clearance of the hepatic tumor disease can be only achieved by extended liver resections. Clinical studies have demonstrated that intra-operative blood loss is associated reduced outcome after major liver resection. An effective strategy to reduce blood loss is the occlusion of the portal triad (Pringle manoeuvre). On the other hand, inflow occlusion results in ischemia- and reperfusion (I/R) injury. Randomized trials have shown that ischemic preconditioning (10 min clamping, 10 min reperfusion) and intermittent clamping (15 min clamping, 5 min reperfusion) result in reduction of the I/R injury. Another potential strategy to reduce I/R injury is the pharmacological protection. One promising drug is pentoxyfilline (PTF) which has vasodilative and hemorheologic effects. Furthermore, PTF suppresses the TNF release. These effects may be also protective in major liver resection under inflow occlusion (Pringle manoeuvre)and increase the liver regeneration. Therefore, we designed a randomised prospective trial to investigate the effects of PTF treatment in liver resection under inflow occlusion. The specific aims of the research project are:The investigators hypothecate that pentoxyfilline increases significantly the liver regeneration and reduces significantly ischemia and reperfusion (I/R) injury in liver using aspartate aminotransferase (AST) and alanine aminotransferase (ALT) as marker of I/R injury.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Major liver resection (hemihepatectomies and extended hemihepatectomies) for benign and malignant lesions
* Macroscopic and microscopic normal liver parenchyma
* No underlying liver disease
* Normal preoperative liver tests (quick, bilirubin, AST, ALT)
* Signed informed consent

Exclusion Criteria:

* Age \< 18 years
* Minor liver resections (less than hemihepatectomies) or wedge resections
* Macroscopic and microscopic appearance of liver fibrosis or cirrhosis
* Underlying liver disease such as viral hepatitis, cirrhosis, etc.
* Pathological preoperative liver tests (quick, bilirubin, AST, ALT)
* Intolerance to xanthine derivatives
* History of myocardial or cerebrovascular insult
* Total vascular exclusion during liver resection
* Intra-operative detection of unresectable tumor disease
* No signed informed consent
Salt-Based E-cigarette

Electronic nicotine delivery systems (ENDS) vary on a wide range of characteristics, which may impact the reinforcement value of the products compared to more harmful combustible products. A new type of low-powered ENDS device has surged in popularity-the pod system. Pods use nicotine salt e-liquids, rather than free-base nicotine solutions that have been used in other ENDS device types. Manufacturers claim that these formulations reduce the harshness of nicotine delivery, while still delivering sufficiently high levels of nicotine. However, the role of nicotine salts in the popularity and use of pod systems remains unclear because no studies have directly manipulated and examined the role of nicotine formulation (salt vs. free base) in reinforcement value and use. The primary purpose of the proposed study is to assess the impact of nicotine formulation (nicotine salt vs. free-base) in reinforcement value and tobacco use. Current smokers (n=30) will complete a one-week baseline period where they smoke as normal before attending an in-person lab visit during which they will sample a traditional cigarette and two ENDS products (nicotine salt ENDS, free base ENDS). All aspects of the device will be held constant other than the nicotine formulation (including nicotine concentration, flavor options, device brand). Participants will answer questionnaires about each product they sample and then complete a preference assessment in which they choose between the products they sampled and their own cigarette. Finally, participants will be assigned to take one of the products they sampled home to use ad libitum (1-week sampling). During the at-home baseline and sampling weeks, participants will complete electronic daily diaries cataloging their tobacco use. Biomarkers (i.e., expired carbon monoxide, cotinine) will corroborate self-reported indices of use.


Eligibility Criteria:
Inclusion Criteria:

* daily cigarette smoker
* interested in using non-cigarette tobacco product
* have a smartphone that can receive text messages and has access to the internet or have an e-mail account they check daily (necessary for daily diary completion).

Exclusion Criteria:

* additional tobacco use criteria
* additional medical criteria
Predictors of Patient Attitudes and Barriers to Skin Cancer Screening

This is a cross-sectional survey distributed to a convenience sample of patients in a waiting room of an academic dermatology clinic. The survey assesses patient experiences with full body skin exams and attitudes towards full body skin exams. The survey is designed to help investigators better understand how many patients are not getting full body skin exams, why this may be occurring, and what types of interventions may be enacted to increase the number of patients getting full body skin exams.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* English-speaking

Exclusion Criteria:

* previously completed the survey
Colorectal Cancer Survivors' Needs and Preferences for Survivorship Information

We are doing this study to learn more about colon and rectal cancer survivors. We want to know if survivors want more information about life after cancer. Do cancer survivors want to know more about their own cancer? Do cancer survivors want to know about their treatment? Do cancer survivors want to know what health care they should get in the future? We want to know what information to give to cancer survivors when they finish treatment.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older at diagnosis
* Diagnosed with first primary colorectal cancer (stage I-III)
* Completed last treatment for colorectal cancer (surgery, chemotherapy, or radiation) at least 6 months and no more than 2 years before the date of study enrollment
* Able to speak English, because questionnaire is only available in English
* Able to provide informed consent
* Received all treatment for colorectal cancer at MSKCC or QCC or, surgical treatment at an outside facility, and all other treatment (chemotherapy or radiation) at MSKCC or QCC

Exclusion Criteria:

* Undergoing active treatment for colorectal cancer
* Diagnosed with metastatic colorectal cancer
* Prior history of colorectal or any other cancer (except non-melanoma skin cancer)
* Diagnosed with new or recurrent colorectal or other cancer after the primary colorectal cancer diagnosis
* Received a survivorship care plan from the treating institution
COVID-19 Virtual Care at Home

This multicentre prospective cohort trial is designed to demonstrate effectiveness and efficiency of a virtual care model for the management of COVID-19 patients isolating at home. The investigators have reoriented existing technology and networks for this research project. The investigators are amplifying our existing virtual care platform VIRTUES, combining it with home monitoring of COVID-19 patients, to provide real-time evidence, harmonize data collection, and share data provincially to mitigate the impact of the rapid spread of the virus. The study will facilitate early detection of complications associated with the disease, treatment and management of COVID-19 patients at home. The research will be conducted provincially in Ontario.

This initiative will provide evidence to inform clinical and health system management and public health response to COVID-19 patients isolating at home.


Eligibility Criteria:
Inclusion Criteria:

* All COVID-19 positive patients of age 18 or above
* Participant must communicate in English or French language
* An email address and account

Exclusion Criteria:

* Unable or unwilling to provide informed consent
Post Market Surveillance & Post Market Clinical Follow up, International, Medical Registry to Confirm the Safety and the Performance of the Anecova Intra Uterine Culture Device

This study is designed to generate a comprehensive survey of the use on the market of the Anecova device within its intended indications according to the Instructions For Use. The Anecova Registry is part of the Anecova quality system, to enable the Post Marketing Surveillance and the Post Market Clinical Follow-up.

As soon as the very first minute of the fertilization process, very important biological events, critical for the future developmental competency of the embryo are taking place.

These biological events, after the sperm cell entry in the oocyte cytoplasm and prior to the first cleavage, include: the completion of the meiosis, the exclusion of the second polar body, the pronuclei formation, the replication of the male and female DNA and the chromosome segregation on the newly formed mitotic spindle.

If any of these events is aberrant, one or both of the two daughter cells and their descendants may carry chromosomal anomalies. In other words an uneven first cleavage in size or in content is associated with chromosomal abnormality and aneuploidy.

In vivo all these events occur in a natural environment where the presence of specific molecules and of a dynamic and physiological environment might be an advantage over in vitro culture conditions to ensure optimal cellular functions.

The Registry will capture information from the Anecova procedure, from the outcomes, from the procedure performance, from the safety and from the utilization of the Anecova Medical Device in clinical routine.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 43,
* Hormonal serum levels within normal ranges for the routinely or specifically tested hormones (FSH, LH, AMH, E2, PRL, P4, TSH),
* BMI between 18 and 29, If assessed normal antral follicular count and regular menses

Exclusion Criteria:

* Endometrial, autoimmune or hormonal specificities, as well as presence of pathology that could be potentially deleterious to the healthy development of embryos in the uterine cavity (i.e. severe endometriosis),
* Acute or chronic gynecological infection
Azacytidine + HAG Regimen vs. Azacytidine for Elderly Patients With Newly Diagnosed Myeloid Malignancy

The primary objective is to explore the efficacy and safety of azacytidine and HAG regimen versus azacytidine for elderly patients with Newly Diagnosed MDS/AML/CMML in China. This is a post-marketing, interventional, multi-center, double-arm, prospective, open-label, randomized controlled study in elderly patients with MDS/AML/CMML in China. Patients will be recruited consecutively from the study sites during the enrollment period. The enrolled patients will be given azacytidine + HAG regimen or azacytidine under the conditions of informed consent and frequent monitoring according to the clinical guideline.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60;
* Patients with newly diagnoised diseases including MDS/AML/CMML;
* The ECOG behavior status score is less than 3 points;
* Agree to sign informed consent

Exclusion Criteria:

* Patients with a history of sever heart disease;
* Patients with severe organ dysfunction;
* Patients with other malignancies
* Patients who are allergic to the treatment of drug ingredients
Metabolomic Exploration of Dysregulated Lipid Metabolism in MFN2-related CMT2A (MetaDLM_CMT2A)

Charcot-Marie-Tooth (CMT) disease is the commonest sensitivo-motor inherited peripheral neuropathies with a prevalence of about 10-30 per 100,000. To date, more than 80 genes have been found responsible for CMT. Some of these genes code for mitochondrial proteins such as mitofusin 2 (MFN2).

In the last few years, our laboratory has developed strong expertise in metabolomics. The MetaDLM_CMT2A project proposes to produce metabolomic and lipidomic maps in CMT2A plasma from a cohort of genetically and clinically characterized patients with a national recruitment.

In the perspective of future clinical trials, these biomarkers and the better understanding of lipid metabolism defects in CMT2A would be of major interest in monitoring the evolution of the disease and developing specific therapeutic approaches.


Eligibility Criteria:
Inclusion Criteria:

For all participants :

* Adult person
* Person on an empty stomach at the time of inclusion
* Person who signed the study participation consent form
* Person affiliated or beneficiary of a social security scheme

Patients Charcot-Marie-Tooth :

* Patient with symptoms of Charcot-Marie-Tooth disease on clinical examination clinical examination
* Patient with axonal neuropathy confirmed by an electrophysiological study electrophysiological study with a median nerve conduction velocity \> 38 m / s
* Patient with documented pathogenic mutation (class 4 or class 5) in the MFN2 or patient with a variant of uncertain significance, as determined by the laboratory performing the test, if the variant of unknown significance has been found in found in multiple affected individuals in a family and not found in unaffected family members in unaffected family members.

Control subject :

* Each control is matched in age and sex to a case previously included in the study.

Exclusion Criteria:

For all participants :

* Pregnant, breastfeeding or parturient woman
* Person deprived of liberty by judicial or administrative decision
* Person subject to forced psychiatric care
* Person subject to a legal protection measure
* Person unable to give consent

Patients Charcot-Marie-Tooth :

* Patient with a neuropathy other than CMT2A (such as diabetic neuropathy or any other cause of acquired neuropathy) neuropathy or any other cause of acquired neuropathy), medical history of kidney stones kidney stones or cardiovascular risk factors (dyslipidaemia diabetes, severe obesity (BMI \>35 kg/m²))
* Patient treated with Idebenone at the time of inclusion. (It is possible to include a patient treated with Idebenone if the treatment was interrupted at least 5 days before)

Control subject :

* Person with neuropathy, medical history of kidney stones or cardiovascular risk factors cardiovascular risk factors (dyslipidaemia, diabetes, severe obesity (BMI \>35 kg/m²))
Impact of Virtual Reality Hypnosis on Pain and Anxiety During Dressings Change in Burn Patients

Different non-pharmacological techniques, including hypnosis and virtual reality are currently used as complementary tools in the treatment of pain related to burn injury. A new technique called 'virtual reality hypnosis' (VRH) (Patterson et al., 2004), which encompasses a combination of both tools, is regularly used although its actual function remains unknown to this date. With the goal to improve our understanding of VRH combination effects, it is necessary to elaborate randomized and controlled research studies in order to understand their actual function in individual's perception. 100 patients who are treated as outpatients for burn care will be randomly assigned to virtual reality or VRH. Patients will receive one session of one of these techniques during burn dressing change.Physiological parameters will be recorded during dressing change. Participants will fill in a questionnaire evaluating their tendency to be absorbed and dissociated, and another evaluating their level of perceived immersion. Their level of anxiety, pain, fatigue and relaxation will be evaluated before and after the session. A short interview will also be conducted to give participants the opportunity to openly describe their experience.


Eligibility Criteria:
Inclusion Criteria:

* Burn patient treated as outpatient
* Burn surface area \> or = 5% of the total body surface area
* mainly 2nd degree burn

Exclusion Criteria:

* Psychiatric antecedents
* Claustrophobia
* Heavy hearing
* Visual impairment
* Face burn
* Conjunctivitis
* Consent not obtained
Ertapenem for Initial Empirical Treatment of Third Generation Cephalosporin Resistant Enterobacteriaceae Bacteremia

This study aims to assess whether ertapenem as an empiric treatment of third-generation-cephalosporin resistant Enterobacteriaceae (3GCRE) bacteremia is non-inferior to other carbapenems in term of 30-day mortality.

There are limited data of the efficacy of ertapenem as the empiric treatment of serious invasive infections, such as bloodstream infections (BSIs), that are due to ESBL-producing Enterobacteriaceae. Previous studies of ertapenem were done in small group of patients, in less invasive infection, as a definite 'step-down' therapy, or as compared to other non-carbapenem antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* Adults, either sex, ages 18 years or above
* Patients with 3GCRE bacteremia
* Patients admitted to any of the study sites

Exclusion Criteria:

* Discontinuation of antibiotic due to transition to hospice care
* Polymicrobial bacteremia
* Empirical antibiotic after 24 hours of first evidence of bacteremia
Randomised Prospective Trial Comparing Contact Force and Non-contact Force Guided Catheter Ablation for Cavotricuspid Isthmus Dependent Atrial Flutter

Radiofrequency ablation (RFA) is a standard treatment option for cavotricuspid isthmus (CTI) dependent atrial flutter. We plan to perform a randomized prospective trial comparing the efficacy of contact force (CF) guided CTI ablation against catheter ablation with the operator blinded to contact force parameters.

Subjects will be followed for one year post procedure in order to check for atrial flutter recurrences. This will involve an in-person visit at 3 months post procedure, and records checks at 12 months post procedure.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (over the age of 18) with 12 lead ECG documented paroxysmal or persistent CTI dependent atrial flutter planned to undergo CTI ablation.
* Able and willing to give informed consent.

Exclusion Criteria:

* Previous CTI ablation
* Previous non-CTI dependent atrial flutter (ie.patients with previous history of pulmonary vein isolation or left atrial ablation, congenital heart disease, surgical ablation)
Time To Efficacy and Onset Of Action Of Linezolid

To assess the onset of action of linezolid


Eligibility Criteria:
Inclusion Criteria:

* suspected grampositive infection
* fever \> 38 C

Exclusion Criteria:

* Infections to be treated successfully by surgical procedures
Efficacy and Safety of Growth Hormone Treatment in Spinal Cord Injury

Objectives: To evaluate the efficacy and safety of one year treatment based on daily doses of exogenous growth hormone (GH) in patients with traumatic spinal cord injury. The first six months the pharmacological treatment will be associated to rehabilitation treatment.

The main hypothesis is that GH can improve motor function of patients with traumatic spinal cord injury below the lesion level. The hypothesis is based on possible effects of GH at muscle and synaptic level. GH can also promote axonal growth and regeneration.

Design: Clinical trial placebo-controlled, double-blind intervention with blind evaluation by third parties and blinding in the analysis of data (triple-blind design).

Duration of intervention and monitoring: 364 days.

Primary outcome measures. Changes of the American Spinal Injury Association (ASIA) scale (motor score)


Eligibility Criteria:
Inclusion Criteria:

* Traumatic Spinal cord injury
* Incomplete (ASIA scale B or C)
* Level of injury: Between C4 and D12
* More than 18 months from the SCI injury.

Exclusion Criteria:

* Non traumatic Spinal cord injury
* Complete SCI (ASIA A)
* Incomplete (ASIA D or E)
* Less than 18 months from the SCI
* Intensive Care Unit (ICU) staying for a period of 2 months or more
* More than 3 urological infections in the last year
* Pneumonia in the 6 months prior to the study
* Severe respiratory failure
* History of head trauma
* Severe psychiatric disorder
* A history of heart disease, diabetes or hypertension
* Concomitant Neurological Diseases
* Regular use of substances of abuse
* Patients with severe kidney and / or liver failure.
* Patients who can not be included in an intensive rehabilitation program
* Patients who are pregnant or breast-feeding
* History of malignancy
* Impossibility to obtain informed consent
Normogram of Umbilical Artery and Fetal Middle Cerebral Artery Doppler Indices in Upper Egyptian Women

settle umbilical and fetal middle cerebral arteries Doppler indices( pulsatility index and resistive index) in normal pregnancy to generate a local reference range and calculate cerebroplacental ratio.


Eligibility Criteria:
Inclusion Criteria:

1. Singleton pregnancy between 15 and 40 weeks gestational age.
2. Sure of her date (well-known LMP or confirmed date by an early ultrasound).
3. Normal fetal anatomy.
4. No history of medical disorders.

Exclusion Criteria:

1. Multiple pregnancy
2. Fetal anomalies.
3. Associated medical disorders.
4. Obstetric complications.
Validation of an Electronic Remote Toxicity Management System in Cancer Patients

To assess the psychometric properties (validity, reliability and responsiveness) of the QuestOnco tool, an electronic Remote Toxicity Management System, in adult cancer patients receiving an active anti-cancer treatment.

In this study, a mobile phone-based remote monitoring system (QuestOnco application) was developed in order to enable the 'real-time' monitoring of patients' symptoms through use of ePROMs. In order to establish if this new application accurately and reliably identifies the anti-cancer treatment related symptoms, its psychometric properties (validity, reliability and responsiveness) have to be assessed.

Hypotheses:

* The QuestOnco application will be designed as a promising innovative tool with good psychometric properties in order to detect more rapidly the anti-cancer-related toxicity in adult cancer patients.
* The QuestOnco application is an accurate and reliable tool for the identification of the anti-cancer treatment related symptoms as much as current available questionnaires such as PRO-CTCAE and EORTC QLC-QC30 The evaluation of the psychometric properties of the QuestOnco application will be made in two phases. First, the patient's cognitive interviews will allow assessing the content validity of the items. Then focus groups including patients and professional experts will determine the QuestOnco application goals regarding the adverse symptoms management (recommendations provided within the application, connection with General practitioner, medical Oncology team or Emergency departments).

This study will assess the validity, reliability and responsiveness of the QuestOnco in a cohort of patients receiving anti-cancer treatments. The external validity will be directly compared to PRO-CTCAE (Patient-Reported Outcome Common Terminology Criteria for Adverse Events) and to EORTC QLC-QC30 questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years);
* Written and informed consent;
* Diagnosis of solid cancer;
* Metastatic or (neo)adjuvant anti-cancer treatment, including intravenous and/or oral treatments;
* Patient physically/psychologically fit to participate in the study;
* Patient able to understand, communicate and use the electronic device;
* Patient owning a smartphone or tablet with internet connection;
* Treatment supported by the French social security system.

Exclusion Criteria:

* Unable patient for signing informed consent;
* Unable to understand, communicate and use the electronic device;
* Patient under trusteeship or guardianship;
* Patient under legal or administration protection.