cyrilzakka/clinical-trials huggingface dataset:
Reliability and Validity of Mediterranean Colorectal Cancer Registry

The study will examine the validity and reliability of the Mediterranean Colorectal Cancer Registry. Aspects of the analysis will cover parallel forms reliability, test-retest reliability, split half internal consistency and face validity of the Mediterranean Colorectal Cancer Registry.

Although central cancer registry programs have many benefits (the determination of national cancer incidences, strategic planning of health care systems etc.) data entry in such programs is often collected in restricted variables and physicians participating in the registration process may not be able to interact with each other during the management of their patients. For these reasons, a complete record in national general cancer registries can only be established retrospectively and the direct contribution to patient-specific diagnosis / treatment is limited. On the other hand, local registries have many advantages like easy integration of the data into the hospital electronic systems and multidisciplinary proactive enrollment.

Thus, characteristics of ongoing colorectal cancer registries (Swedish, South Australian, Oregon, Lublin, Ontario etc.) reported previously in the English medical literature are reviewed and an electronic form is tabulated for the Mediterranean Colorectal Cancer Registry. This study will examine the validity and reliability of this registry. Aspects of the analysis will cover construct validity, content validity, parallel forms reliability, test-retest reliability, split half internal consistency and face validity.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with colorectal cancer.

Exclusion Criteria:

* Patients reluctant to participate in the study.
Mechanistic Effects of Health Coaching to Reduce Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations

The researchers are trying to explore the benefit of Health Coaching on patients with severe symptoms of COPD.


Eligibility Criteria:
Inclusion Criteria: Men and women 40 years or older with a clinical diagnosis of COPD with shortness of breath.

Exclusion: terminal illness, inability to communicate by phone
Quantitative Stress Echocardiography to Diagnose Myocardial Ischaemia

Patients with chest pain on exertion need a reliable non-invasive test to identify if they have inducible myocardial ischaemia. This would reduce the use of diagnostic coronary arteriography, avoid its risks and costs, and guide clinical decisions. Conventional stress echocardiography has poor reproducibility because it relies on qualitative and subjective interpretation. Quantitative approaches based on precise and reliable measurements of myocardial velocity, strain, strain rate and global longitudinal strain have been shown to be able to accurately diagnose myocardial ischaemia. A more accurate test using myocardial velocity imaging was not implemented by ultrasound vendors although it provided an objective measurement of myocardial functional reserve on a continuous scale from normality to severe ischaemia.

The investigators propose an original approach to create a diagnostic software tool that can be used in routine clinical practice. The investigators will extract and compare quantitative data obtained through myocardial velocity imaging and speckle tracking in subjects who undergo dobutamine stress echocardiography.

The data will be analysed using advanced computational mathematics including multiple kernel learning and joint statistics applied to multivariate data across multiple dimensions (including velocity, strain and strain rate traces). This approach will be validated against quantitative coronary arteriography and fractional flow reserve. The results will be displayed as parametric images and placed into a reporting tool. The output will determine the presence and severity of myocardial ischaemia. These new tools will have the capacity for iterative learning so that the precision of the diagnostic conclusions can be continuously refined.


Eligibility Criteria:
Inclusion Criteria:

* Chest pain, chest pain equivalent

Exclusion Criteria:

* acute coronary syndrome with elevated troponin, severe heart valve disease, uncontrolled hypertension (resting SBP \>200mmHg), cardiomyopathy, contraindication to dobutamine, pregnancy
Treatment of Chronic Frontal Sinusitis by a Simple Technique Using Dilation Balloons

The sinuplasty balloon offers a more physiological first of the sinuses which minimizes risks associated to traditional surgery. Its atraumatic characteristic also helps to reduce the risk of bleeding (so any use of Pack), limit scarring ransom, reduce the post-operative pain, ensure faster return to daily life activities (reduction of the average length of hospitalization). Patient's quality of life would be improved (SNOT-22 questionnaire) and reduction of post-operative pain score seams decrease on EVA.

The economic impact of the sinuplasty balloon appears very favourable and fits into the strategy of development of the ambulatory practice.

The primary objective is to estimate the cost-utility ratio of the sinuplasty balloon after frontal sinus surgery, compared to surgery by rigid instrumentation, in a randomized single-blind controlled study.

The secondary objectives is to compare:

* the two types of surgery
* the quality of life
* the feeling of pain in patients but also the occurrence of surgical times or complications between the two proposed techniques.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman of age ≥ to 18 years.
* Patient for which a frontal sinus surgery (Draf 1 type) is programmed for any type of frontal sinusitis unresponsive to drug treatment properly leads.
* Patient affiliated to a social protection scheme Written informed consent of the patient
* Signed informed consent

Exclusion Criteria:

* Polyposis sinonasal or other sinus to be the subject of a simultaneous complementary intervention
* Sinuso-nasal tumors
* Osteogenesis
* Fragile patients or patient needing gesture contraindicating surgery by rigid instrumentation
* Contraindication with balloon using
* Contraindication to general anesthesia
* Immunosuppressive therapy
* Patient under judicial protection
* Pregnancy or Breastfeeding
* Exclusion period determinated with concurrent participation in other experimental studies
* Contrast medium allergy background
* Impossibility to give the informed study documentation to the subject (emergency situation, lack of understanding, etc...)
Plasma Therapy of COVID-19 in Severely Ill Patients

This randomized blinded multi-center phase 2 trial will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma among adults with severe COVID-19. Adults ≥18 years of age may participate. A total of 219 eligible subjects will be randomized in a 2:1 ratio to receive either high-titer anti-SARS-CoV-2 plasma or non-convalescent fresh frozen plasma (control plasma).

There are few effective therapies for coronavirus disease 2019 (COVID-19) associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Exposure to viruses results in an adaptive immune response that commonly include antibodies with neutralization activity. Plasma from subjects who have recovered from viral infections has been used to both prevent or treat disease. Notable examples of the successful use of convalescent plasma (CP) include influenza, measles, Argentine hemorrhagic fever, Middle East respiratory syndrome (MERS), Ebola and severe acute respiratory syndrome (SARS-CoV). Small clinical trials and observational studies of CP therapy in patients with COVID-19 have suggested a possible clinical benefit.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent prior to performing study procedures or have a legally authorized representative available to do so.
* Age ≥18 years
* Evidence of SARS-CoV-2 infection by PCR test of naso-/oro-pharyngeal swab or tracheal aspirate sample within 14 days of randomization
* Peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air or requiring supplemental oxygen, non-invasive or invasive mechanical ventilation at screening
* Evidence of infiltrates on chest radiography
* Females of childbearing age and males, must be willing to practice an effective contraceptive method or remain abstinent during the study period.

Exclusion Criteria:

* Participation in another clinical trial of anti-viral agent(s) for COVID-19
* Receipt of any anti-viral agent(s) with possible activity against SARS-CoV-2 \<24 hours prior to study drug administration \[1\]
* Mechanically ventilated (including veno-venous (VV)-ECMO) ≥ 5 days
* Severe multi-organ failure
* History of prior reactions to transfusion blood products meeting definitive case definition criteria, at least severe severity, and probable or definite imputability per National Healthcare Safety Network (NHSN)/Centers for Disease Control and Prevention (CDC) criteria
* Known Immunoglobulin A (IgA) deficiency
* Females who are pregnant

  1. Use of remdesivir as treatment for COVID-19 is permitted.
Erector Spinae Block vs Conventional Analgesia for Postoperative Analgesia in PCNL

50 adult patients scheduled for percutaneous nephrolithotomy in Sohag university hospitals will be devided in two groups one of them will receive Sonographic guided erector spinae plane block using 20 ml volume of bupivacaine 0.25 percent and the other will receive conventional analgesia of 0.1 mg/kg IV morphine


Eligibility Criteria:
Inclusion Criteria:

* ASA 1 to ASA 2 18 to 60 years

Exclusion Criteria:

* patient refusal Significant neurological , psychiatric or neuromascular disease Drug abuse Pregnant or lactating women Suspected coagulopathy Morbid obesity Known allergy to some medications Septicaemia and local infection at block site
Bone Resistant Tuberculosis

The recommendations for the treatment of MDR tuberculosis are based on pulmonary tuberculosis since there is a lack of specific recommendations for TB bone and osteoarticular disease, including those due to multi drug resistance strains (MDR IOATB). Given the lack of data regarding MDR IOATB, it may be helpful to study the diagnosis, medical treatment, surgical indications and prognosis of a cohort of MDR IOATB patients.

Due to the lack, in the guidelines regarding bone and osteoarticular infections due to MDR M. tuberculosis strains, this study aims to characterize the diagnosis, management and outcome of patients with osteoarticular infection due to MDR M. tuberculosis in France (MDR IOATB).

Aim: descriptive study of diagnosis, therapeutics and outcome of patients with bone and osteoarticular infection with MDR IOATB in France.

Set up: patients registered in the database of the National Reference Center (CNR) for MDR IOATB in France, treated for MDR IOATB between January 1, 2007 and December 31, 2018 will be included and analyzed.

Study design: retrospective study on historical cohort

Eligibility Criteria:
Inclusion Criteria:

* Any patient with an MDR IOATB whose sample and / or strain has been referred to the National Reference Center (CNR) for mycobacteria in France, will be included.

Exclusion Criteria:

* Patient refusing to have their data used.
* Patients under guardianship or curators, patients under legal protection will not be included.
Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID)

The purpose of this study is to determine whether a long-term use of a new human immunoglobulin G with proline (IgPro) is safe and effective in the treatment of primary immunodeficiency.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with primary humoral immunodeficiency who have participated in the study ZLB04_009CR (NCT00419341), namely with a diagnosis of Common Variable Immunodeficiency (CVID) as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies) or X-linked Agammaglobulinemia (XLA) as defined by PAGID and ESID
* Women of childbearing potential must be using and agree to continue using medically approved contraception and must have a negative pregnancy test at screening
* Written informed consent

Exclusion Criteria:

* Ongoing serious bacterial infection at the time of screening
* Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin's lymphoma, and immunodeficiency with thymoma
* Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined by total urine protein concentration \> 0.2 g/L)
* Other significant medical conditions that could increase the risk to the patient
* Females who are pregnant, breast-feeding or planning a pregnancy during the course of the study
* A positive result at screening on any of the following viral markers: Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) or Hepatitis B virus (HBV)
* Aspartate aminotransferase (ASAT) or Alanine aminotransferase (ALAT) concentration \> 2.5 times Upper Normal Limit (UNL) at Completion Visit of study ZLB04_009CR (NCT00419341)
* Creatinine concentration \> 1.5 times UNL at Completion Visit of study ZLB04_009CR (NCT00419341)
* Participation in a study with an investigational product other than IgPro20 within 3 months prior to enrollment
* Evidence of uncooperative attitude
* Any condition that is likely to interfere with evaluation of the study drug or satisfactory conduct of the trial
* Subjects who are employees at the investigational site, relatives or spouse of the investigator
Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients

Background: Hypo- and hypernatremia are common in hospitalized patients. The differential diagnosis of dysnatremia is challenging.

Osmotically inadequate secretion of antidiuretic hormone (ADH) is the predominant mechanism in most dysnatremic disorders. ADH measurement is cumbersome. It is derived from a larger precursor peptide along with copeptin, which is a more stable peptide directly mirroring the production of ADH.

Objective: To evaluate the additional value of copeptin to improve a currently used algorithm in the differential diagnosis of (A) severe hypoosmolar hypo- and (B) severe hypernatremia.

Design: Prospective observational study.


Eligibility Criteria:
Inclusion Criteria:

* hyponatremia \<125 or hypernatremia \>155 mmol/L

Exclusion Criteria:

* no informed consent
Dietary Treatment for Post Bariatric Weight Regain

Metabolic surgery has, among all obesity treatments, the best long term efficacy, but weight regain (weight regain, WR) or insufficient weight loss (IWL) are relatively common. These are hard to treat, with dietary treatment often failing, and redo surgery being commonly proposed.The ketogenic diet is vastly utilised to obtain weight loss in obesity, but little data is available regarding its application on post bariatric patients. Ad hoc designed studies are needed to confirm the efficacy and safety of a VLCKD in the treatment of WR and IWL. The aim of this study is to test whether the ketogenic diet is a safe and effective treatment in post bariatric weight regain, compared to its application before bariatric surgery.

Metabolic surgery is, to date, the strategy for the treatment of obesity with the greatest long-term efficacy. However, especially in those lost to surgical and nutritional follow-up, weight regain (weight regain, WR) or insufficient weight loss (IWL) are relatively common. In particular, depending on the type of surgery considered, it has been observed that up to 40% of subjects undergoing surgery report a WR long term, where data on IWL are still insufficient to draw well-defined estimates. WR and IWL are hard to treat, with dietary treatment often failing, and redo surgery being commonly proposed, with increased risk of complications and little effect.

The ketogenic diet is one of the pivotal dietary therapies for the treatment of obesity, with excellent evidence in terms of weight loss and improvement in complications of excess weight. Very little data is available regarding its application on post bariatric patients: Correa and colleagues reported in a retrospective case series the efficacy and safety of a very low calorie ketogenic diet (VLCKD) in 11 patients with IWL or WR after gastric bypass, reporting a good safety profile, good tolerability, and an average weight loss of 9 kg in 2 months of therapy. Although promising, the data in the literature are extremely scarce, and therefore ad hoc designed studies are needed to confirm the efficacy and safety of a VLCKD in the treatment of WR and IWL.

The objective of this study is to test whether the application of a ketogenic diet is a safe and effective treatment in post bariatric weight regain, compared to its application before bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

-obesity (BMI ≥ 30 Kg/m2)

Exclusion Criteria:

* Type 1 diabetes mellitus
* Renal failure (GFR\<60)
* Liver failure (decompensated cirrhosis)
* Congenital metabolic diseases
* Pregnancy
* lactation
* Major psychiatric disorder
* Alcoholism
* drug addiction
* patients who are not self-sufficient and without adequate family and social support
Liraglutide in the Prevention of Type 2 Diabetes After Gestational Diabetes

Obese women with history of gestational diabetes are in great danger to develop type 2 diabetes (T2D) within 5-10 years after delivery. Aim of the study is to investigate if 12 months' liraglutide treatment could decrease the risk of T2D in obese women who have had gestational diabetes. The women are randomized either to liraglutide (Victoza ® 1.8 mg) or placebo group, once daily. Same laboratory tests are taken and instructions given at baseline 6 month and one year. After one year visits once a year until 5 years with same laboratory tests and measurements are taken.

Incidence of type 2 diabetes (T2D) is increasing along with pandemia of obesity. Gestational diabetes is the major risk factor for T2D in women and more than every tenth will develop gestational diabetes during pregnancy. T2D can be prevented by weight loss. Health care professionals should take advantage of this opportunity to prevent this devastating disease in women.

Aim of the study is to investigate if 12 months' liraglutide treatment (1.8 mg) once daily could decrease the risk of T2D in obese women who have had gestational diabetes needing treatment with metformin and/or insulin.

100 women, who have had gestational diabetes with treatment with metformin and/or insulin and who have stopped lactation and are not pregnant are enrolled between 6 to 18 months after delivery. BMI should be ≥30 kg/m2. The women are randomized either to liraglutide (Victoza ® 1.8 mg) or placebo group. Both treatments are given by similar device s.c. once daily during 365 days. Before starting the treatment, clinical examination and laboratory test are done. Similar dietary instructions are given. Same laboratory tests are taken and instructions given at 6 months and at one year after baseline. Additional follow-up call (AE reporting) is scheduled at 3 months and a drug dispensing visit at 9 months. After one year visits once a year until 5 years with same laboratory tests and measurements are taken. Primary end-point is development of T2D (fasting P-glucose \>7 mmol/l and/ or 2 h \>11 mmol/l in oral glucose tolerance test 75g, and/or HbA1c≥ 6.5 %) from year 1 to 5.

Eligibility Criteria:
Inclusion Criteria:

* history of gestational diabetes with treatment with metformin and/or insulin
* delivery 6 to 18 months before screening
* BMI ≥30 kg/m2
* use of contraceptives (IU-device or oral contraceptive)

Exclusion Criteria:

* lactation
* pregnancy
* type 1 or type 2 diabetes
* use of antidepressives, statins or anti-hyperglycemic therapies
* severe hepatic insufficiency
* end stage renal disease
* history of pancreatitis
Establishment of a Parathyroid Tissue Bank

To develop a tissue bank library for patients with parathyroid disease who have undergone surgery and/or biopsy, and/or who may undergo surgical intervention at M. D. Anderson Cancer Center or outside centers, and/or all patients seen through the Parathyroid Center at participating sites, whether or not the patients undergo treatment for their disease. The tissue bank will contain both normal parathyroid tissue and diseased tissue, and will provide a resource for the ongoing study of parathyroid disease and management.

Fresh residual tissue samples will be obtained during parathyroid and/or pancreas tumor intervention (for pancreas tumor intervention in MEN1 patients with hyperparathyroidism and pancreatic lesions).

In addition, outside paraffin tissue blocks or slides will be requested from patients presenting to MDACC, or to participating family members who have had prior surgery outside of MD Anderson.

Forty cubic centimeters (40 ccs) of whole blood will be obtained from individuals for peripheral blood lymphocyte, plasma, and serum separation and analysis per event. Collections may be made at any or all of the following timepoints: preoperatively, during intervention, and/or at subsequent follow-up visits for up to fifteen years.

Eligibility Criteria:
Inclusion Criteria:

1. Eligible participants will include patients presenting at MD Anderson Cancer who are scheduled for surgical treatment of parathyroid disease and/or patients with MEN1, and/or those presenting with hyperparathyroidism and/or pancreatic lesion, who are scheduled for pancreas tumor intervention, as well as patients having had surgery and who have had residual tissue stored under LAB02-518, LAB03-0320 or prior front door consents, or who have had surgery at other centers and provide signed authorization to obtain the tissue from the outside institution.
2. In addition, eligible participants may include family members of MD Anderson patients who have been diagnosed with parathyroid disease and who have had surgery at other centers, and who provide a signed authorization to obtain the tissue from outside facilities AND/OR who begin care at MD Anderson and will be having intervention at MD Anderson.

Exclusion Criteria:

N/A
Effects of Low-Flow Anesthesia on Hemodynamic Parameters and Oxygenation in Morbidly Obese Patients

Low-flow anesthesia has been used for years with positive results, but its effects on hemodynamic parameters and oxygenation are not clearly known in high-risk morbidly obese patients who are prone to pulmonary dysfunction related to the obesity. Therefore, this prospective randomized study aimed to compare the effects of low-flow (0.75 L/min) and normal-flow (1.5 L/min) anesthesia on hemodynamic parameters and oxygenation in morbidly obese patients undergoing laparoscopic bariatric surgery.

Low-flow anesthesia has several potential benefits. It improves the flow dynamics of the inhaled air, increase mucociliary clearance, maintain body temperature, reduce fluid loss, result in savings of up to 75% and reduce greenhouse gas emissions and reduce treatment costs (10 - 13). However, it is necessary to examine whether the reduction of fresh gas flow affects the quality and safety of anesthesia management, especially during high-risk operations such as laparoscopic bariatric surgery.

Low-flow anesthesia has been used for years with positive results, but its effects on hemodynamic parameters and oxygenation are not clearly known in high-risk morbidly obese patients who are prone to pulmonary dysfunction related to the obesity. Therefore, this prospective randomized study aimed to compare the effects of low-flow (0.75 L/min) and normal-flow (1.5 L/min) anesthesia on hemodynamic parameters and oxygenation in morbidly obese patients undergoing laparoscopic bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* Morbidly obese patients with American Society of Anesthesiology (ASA) scores of III-IV,
* Aged 18-65 years old,
* BMI\>40

Exclusion Criteria:

* Pregnant
* Uncontrolled diabetes mellitus,
* Cardiovascular disease,
* Pulmonary disease,
* Cerebrovascular disease,
* Drug and alcohol addiction.