cyrilzakka/clinical-trials huggingface dataset:
Relationship Between Tissue Markes in Patients With Post Cardio Respiratory Syndrome

There is a correlation between hospital mortality and changes in markers of tissue perfusion, lactate, and venous oxygen saturation and carbon dioxide gradient.

Evaluation of the serum carbon dioxide gradient (GapCO2), central venous saturation (ScvO2) and the clearance of serum lactate (Clac) in predicting hospital mortality after cardiac arrest syndrome (post-PCR).

Prospective study, unicenter - Intensive Care Unit - HNSC. Period: May/2010 to June/2011. Serial assessment of GapCO2 of ScvO2 Clac and the first 72 hours post-PCR. Excluded under 18, survival of less than 6HS, pregnant women, traumatized, post-operative hypothermia and liver disease. T-student test, 95% (p \<0.05).

Eligibility Criteria:
Inclusion Criteria:

* All patients hospitalized in the intensive care unit after cardiopulmonary arrest with any pace

Exclusion Criteria:

pregnant women, traumatized, post-operative(less 7 days), hypothermia and liver disease.

* patients hospitalized in the intensive care unit with more than 6 hours post cardiac arrest
* less 18 years old
Injection Site Tolerability, Safety, Pharmacokinetics and Pharmacodynamics Study After a Single Dose Subcutaneous Treatment of Alirocumab SAR236553 (REGN727)

Primary Objective:

Injection Site Tolerability

Secondary Objectives:

* To assess the safety profile of alirocumab SAR236553 (REGN727)
* To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553 (REGN727)

The total duration of study for each subject is up to 15 weeks including a screening period up to 3 weeks.

Eligibility Criteria:
Inclusion criteria:

* Serum troponin I level should not exceed the upper laboratory limit of normal.
* Male or female subject, between 18 and 65 years inclusive.
* Body weight between 50.0 and 95.0 kg inclusive if male, between 40.0 kg and 85.0 kg inclusive if female, body mass index (BMI) between 18.0 and 30.0 kg/m² inclusive.
* Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
* Normal vital signs after 10 minutes resting in supine position.
* Normal standard 12-lead ECG after 10 minutes resting in supine position.
* Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects
* If female, subject must use a double contraception method, except if she is sterilized for more than 3 months or postmenopausal.
* Serum LDL-C levels\>100 mg/dL at screening visit.

Exclusion criteria:

* Subjects indicated for the use of statins according to criteria in National Cholesterol Education Program adult treatment panel III Guidelines, as updated in 2004 (see Appendix C).
* Initiation of a new diet or major change to a previous diet within 4 weeks prior to Screening (Day -21 to -2). Subjects must be willing to maintain a consistent diet for the duration of the study.
* Use of a medication or nutraceutical in order to alter serum lipids within 4 weeks prior to screening (Day -21 to -2), including but not limited to statins, ezetimibe, fibrates, niacin, or omega-3 fatty acids, bile acid resins.
* Fasting serum triglycerides \>200 mg/dL measured after an 8 to 12 hour fast.
* History of a hypersensitivity reaction to doxycycline or similar compound.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Is Diverting Loop Ileostomy Necessary in Completion Proctectomy With Ileal Pouch Anal- Anastomosis: A Multicentre, Randomized Study of the GETAID Chirurgie Group. IDEAL Trial

Defunctioning ileostomy has demonstrated its benefits (rate and seriousness of anastomotic leakage) in cancer for low colorectal and coloanal anastomoses, whereas there are no such good quality evidences in case of ileal pouch-anal anastomosis (IPAA) performed for inflammatory bowel disease (IBD). However, most surgical teams do protect systematically IPAA by an ileostomy.

Total proctocolectomy with IPAA is the gold standard for surgical management of ulcerative colitis (UC). This demanding procedure is often performed in 2 or 3 stages, namely subtotal colectomy, completion proctectomy with IPAA and defunctioning ileostomy closure. Subtotal colectomy with double stoma is first performed to allow nutritional support, reduce inflammation and stop immunosuppressive agents. Completion proctectomy with IPAA is then performed on a healthier patient. Hence, the need for a systematic defunctioning ileostomy is questioned. No study addressed specifically the question of completion proctectomy, whereas it concerns 36% to 42% of patients undergoing IPAA. Globally, the overall 6-month morbidity rate is 55% in case of stoma creation vs. 30% otherwise in IPAA.

Moreover, defunctioning ileostomy has several drawbacks including an additional surgical procedure (stoma closure), a worse quality of life before closure, and the risk of dehydration that may require readmission. Following stoma closure, the risk of anastomotic leakage is around 4%. Overall, during the stoma period, 8% of patients will require reoperation. Finally, the risk of incisional hernia is 15-20% at the ex-ileostomy site.

Therefore, the aim of this trial is to assess the need for a systematic defunctioning ileostomy after completion proctectomy with IPAA.


Eligibility Criteria:
Inclusion Criteria:

* patients aged ≥ 18 years,
* patients presenting with ulcerative colitis or indeterminate colitis requiring completion proctectomy
* patients who have given informed consent

Exclusion Criteria:

* indication for total proctocolectomy in one-stage or traditional 2-stage fashion
* Crohn's disease,
* pelvic radiotherapy,
* indication for total mésorectum excision
* vulnerable patient under the French laws
A Real-World Evidence Study to Evaluate Oral Health Related Quality of Life Using an Anti-Sensitivity Toothpaste

The purpose of this study is to evaluate changes in oral health-related quality of life (OHrQoL) in participants suffering from Dentinal Hypersensitivity (DH) symptoms following the use of anti-sensitivity toothpaste for 24 weeks.

This study will be a virtual, prospective, twenty-four weeks, open label study in participants with DH (self-reported symptoms). Participants self-perception of DH will be evaluated by completion of a validated OHrQoL questionnaire (Dentin Hypersensitivity Experience Questionnaire-48 \[DHEQ-48\]) at baseline, 4, 8, 12, 16, 20 and 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Provision of consent indicating that the participant has been informed of all pertinent aspects of the study.
* The participant must be able to complete all activities as shown in the Schedule of Activities independently on their smart devices.
* Participant who has tooth sensitivity (self-reported symptoms).

Exclusion Criteria:

* A participant whose sensitivity could be caused by other factors or clinical pathology as established by the screening questionnaire, which also includes:

  * A participant who has been/is on multiple prescription medications to treat severe acid reflux on regular basis or considered surgery for acid reflux
  * A participant with full or partial denture
  * A participant who has undergone treatment within 6 months of screening or is currently under treatment for periodontal or gum disease
  * A participant with active periodontitis
  * A participant with active caries
  * A participant with any chronic and/or severe painful health conditions which lead to regular use pain medications (more than 3 days a week)
* A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients: potassium nitrate (5 percent \[%\]), sodium fluoride (0.15% weight/volume \[w/v\] fluoride ion), water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, yellow 10, blue 1.
Meningiomas and Treatment With CYPROTERONE ACETATE or Progestin

Investigators observe an increase risk of meningioma in patient treated by CYPROTERONE ACETATE or other form of progestin. Investigatorsdiscribe caractéristics of meningioma and treatement of the patients follow up in CHRU of Brest

Retrospective study in CHRU of brest, the investigators selected patient with history of méningioma and treated by CYPROTERONE ACETATE, CHLORMADINONE ACETATE and NOMEGESTROL ACETATE essentially The investigators excluded patient with risk factor of meningioma added at hormonal treatment exposition The investigators discribe the caractéristique of patients: age, sex, duration of the treatment, the caractéristique of the meningioma: localization, grade, hormonal receptors, treatment by surgery or radiotherapy and changing after discontinuation of treatment

Eligibility Criteria:
Inclusion Criteria:

* minimum 18 years
* medical follow up in CHRU of Brest
* treated by CYPROTERONE ACETATE and/or CHLORMADINONE ACETATE NOMEGESTROL ACETATE, PROGESTERONE , DYDROGESTERONE PROMEGESTONE , NORETHISTERONE, LEVONORGESTREL , oestroprogestogenic contraception
* meningioma after treatement by progestin or CYPROTERONE ACETATE

Exclusion Criteria:

* history ofbreast cancer
* history of cerebral radiotherapy
* history of neurofibromatosis
* meningioma before treatement by progestin or CYPROTERONE ACETATE
* minor patient
Insulin Therapy in Type 2 Diabetic Patients: Real-life Study on Effectiveness and Satisfaction

Diabetes mellitus is an endocrine disorder with heterogeneous etiologies, which is characterized by raised levels of glucose in a person's blood and disturbances of macromolecules such as carbohydrate, fat, and protein metabolism resulting from defects in insulin secretion, insulin action, or both.

A lack of insulin, or the inability of cells to respond to it, leads to high levels of blood glucose (hyperglycemia), which is the clinical indicator of diabetes. Type 1 DM is characterized by insulin deficiency and a tendency to develop diabetic ketoacidosis, whereas type 2 DM is characterized by variable degrees of insulin resistance, impaired insulin secretion, and excessive hepatic glucose produc Tion. Diabetes is one of the most rapidly increasing chronic diseases and an important public health problem all over the world. The global burden of diabetes is rising dramatically worldwide. Type 2 diabetes is the most common type of diabetes, accounting for around 90% of all diabetes worldwide (IDF). The prevalence of type 2 diabetes is high and rising across all regions. This rise is driven by increasing life expectancy, economic development, and increasing urbanization leading to more sedentary lifestyles and greater consumption of unhealthy foods linked with obesity.

Type 2 diabetes prevalence has increased in Egypt during the past few years. Egypt is one of the top ten nations with the greatest proportion of adults with diabetes, according to the International Diabetes Federation. In Egypt, the prevalence of diabetes was projected to be 9.6 million, with type 2 diabetes making up the bulk of cases .


Eligibility Criteria:
Inclusion Criteria:

-Patients with type 2 diabetes mellitus aged ≥18 years.

* Patients going on insulin therapy versus patients going on oral antidiabetic drugs.
* patients included if they met the following

Criteria:

* previous diagnosis of diabetes mellitus or on medical therapy of DM.
* no prescription fills for a basal insulin containing product in the 1-year pre index date period; and no prescription fills for bolus insulin or mixed insulin products on index date or in the 1-year pre-index date periods.

Exclusion Criteria:

* Patients had type 1 diabetes mellitus.

  * Pregnant patients.
  * Incapable of completing the study questionnaires.
  * were pregnant at any time during the pre-or post-index periods; or
  * were diagnosed with any other type of diabetes during the study period, including, gestational diabetes , secondary diabetes , or other abnormal glu-cose conditions .
  * Patients who were con-comitantly participating in another trial or receiving insulin treatment for reasons other than T2DM.
A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia

This study will evaluate the safety and efficacy of the BCL2 inhibitor sonrotoclax (BGB-11417) in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) and in combination with zanubrutinib in adult participants with previously untreated WM.

This study will test whether sonrotoclax (BGB-11417) can be used to improve outcomes in participants with Waldenström's Macroglobulinemia (WM) both when used alone in those who have not responded well to conventional treatments and when used in combination with zanubrutinib in those who have not yet received treatment. The main goals of the study are to determine how many participants no longer have evidence of cancer or have some improvement in the signs and symptoms of cancer after treatment, and to determine what adverse events, or side effects, participants might experience.

BCL2 is a key protein involved in cell death, and abnormal levels of BCL2 are associated with many cancers. Blocking the action of BCL2 proteins is a promising approach with potential therapeutic benefits in participants with different types of cancers, including WM. This study will enroll approximately 105 participants. All participants will receive sonrotoclax orally as a tablet.

The study will take place at multiple centers worldwide. The overall time to participate in this study is approximately 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and definitive histologic diagnosis of WM.
* Meeting ≥ 1 criterion for treatment according to consensus panel criteria from the 2nd International Workshop on Waldenström's Macroglobulinemia (IWWM).
* For Cohorts 1-3, refractory or relapsed disease at study entry unless participants had intolerance to the most recent therapy. Refractory disease is defined as not attaining at least a major response, or progressing while on or within 6 months of completing therapy. Relapsed disease is defined as attaining at least a major response to therapy and meeting the criteria for disease progression beyond 6 months after completing therapy.
* For Cohort 4, patients must not have received prior therapy for WM (except for plasmapheresis).
* Adequate organ function.

Exclusion Criteria:

* Central nervous system (CNS) involvement by WM.
* Transformation to aggressive lymphoma, such as diffuse large B-cell lymphoma.
* History of other malignancies ≤ 2 years before study entry.
* Uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy that was completed ≤ 14 days before the first dose of the study drug.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Generation 100: How Exercise Affects Mortality and Morbidity in the Elderly: A Randomized Control Study

Hypothesis: Exercise will reduce morbidity and mortality rates in an elderly population. The extent of reduction will be intensity dependent.

Literature lacks large controlled randomized studies that look at the effect of exercise training on morbidity and mortality. Generation 100 will be the first randomized, controlled clinical study where the primary objective is to study the effects of exercise training on morbidity and mortality in the elderly. Furthermore, the researchers will investigate whether there is a relationship between the exercise intensity and health benefits, with particular focus on major health problems in the elderly population. In addition to being a study, this is also an initiative to improve public health in all healthy individuals between 70-75 years of age in the Trondheim municipality. The participants will either be randomized to supervised exercise or follow current guidelines for physical activity on their own. Clinical examinations, as well as questionnaires, will be administered to all participants at baseline, after one year, after three years, and after five years. Additionally, participants will be followed-up by linking to relevant registers for up to 20 years.

Also data will be collected with the purposes of (a) investigating genetic predisposition for fitness and cardiovascular diseases, and (b) identification of potential targets for therapies.

The study seeks to determine if exercise training gives the seniors a longer active and healthy life.

Eligibility Criteria:
Inclusion Criteria:

* Born in 1936, 1937, 1938, 1939, 1940, 1941 or 1942
* Able to complete the exercise program (determined by the researchers).

Exclusion Criteria:

* Illness or disabilities that preclude exercise or hinder completion of the study
* Uncontrolled hypertension
* Symptomatic valvular, hypertrophic cardiomyopathy, unstable angina, pulmonary hypertension, heart failure and severe arrhythmia
* Diagnosed dementia
* Cancer that makes participation impossible or exercise contraindicated. Considered individually, in consultation with the attending physician.
* Chronic communicable infectious diseases.
* Test results indicating that study participation is unsafe
* Participation in other studies conflicting with participation in Generation 100
A Double-blind, Randomized, Parallel Group, Fase III Comparative Study With Rose Hip Powder Powder and Placebo Given to Patients With Mild to Moderate Osteoarthritis in the Knee or/and Hip

The trial is an investigator-initiated, double-blind, randomized, placebo-controlled phase III study.

After the patient has receiving information about the study and after given written informed consent, the patient will be screened. All patients are randomized to receive standardized rose hip powder or matching placebo for 3 weeks followed by half the dose standardized rose hip (or placebo) for the remaining 12 weeks of the study.

The patient's medical history and demographic information will be recorded. The patient will then be asked questions in accordance to the study questionnaires, and they will also be asked to complete questionnaires regarding quality of life - and finally they be instructed on how to complete the diary.

Investigator or study nurse will take telephone contact with the subject after 3 and 6 weeks of treatment, subjects will be asked about how things are going and to remember to take the capsules and whether they have completed the diary.

The contact taken after 6 weeks by phone is mainly to guide the subject on how complete the questionnaires including VAS scales.

The last patient visit will take place after 12 weeks. Any side effects will be reported to and reviewed with HybenVital ApS in collaboration with medical experts.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 40 + years
* Osteoarthritis symptoms with duration of more than 6 months
* One WOMAC-pain visual analogue scale score (VAS score) there are at least 35 mm at rest
* Subjective morning joint stiffness
* Clinical symptoms of arthritis diagnosed by the ACR (American College Rheumatology) criteria

Exclusion Criteria:

* Patients who have been treated with rose hip extracts or powder within 3 months before screening.
* Patients who have been treated with ginger, avocado or soybean extracts or powder within 3 months before screening
* Patients on steroids, TNFalpha or DMARD prior to trial.
* Patients receiving irregular medical treatment for osteoarthritis.
* Patients suffering from other joint diseases other than osteoarthritis.
* Patients who abuse alcohol
* Patients with a current psychiatric illness, drug and / or alcohol abuse
* Patients with known allergy to rose hips
* Presence of other clinically significant medical conditions
* Patients scheduled for joint or major surgery during the trial.
* Patients participating in another clinical trial, or have participated in another clinical trial within 3 months before this study.
* Patients with known compliance problems or who are uncooperative.
* Pregnant or lactating women.
Supraclavicular Nerve During Clavicle ORIF

Clavicle fractures are a common orthopedic injury and make up 2.6%-5% of all fractures. Despite the benefits of operative management, post-operative chest wall paresthesia is a well-known complication among surgeons and is well described in the literature. Studies reporting on the natural history of post-operative paresthesia report an incidence of chest wall numbness anywhere from 10-80% and this is attributed to iatrogenic injury of the branches of the supraclavicular nerve that provide sensation over the clavicle, anteromedial shoulder and proximal chest. While this may seem like an easy complication to avoid, anatomic studies give insight into the complex and unpredictable branching of the supraclavicular nerve. The aim of this study was to compare the area (cm2) and change in size over time of post-operative paresthesia (includes hypesthesia and dysesthesia) following ORIF of displaced clavicle fractures between nerve-sacrificing and nerve-preserving procedures.

This is a prospective, partially-blinded, single center, randomized controlled trial to compare the post-operative outcomes of paresthesias and morbidity between nerve-preserving and nerve-sacrificing procedures after surgical fixation of clavicle fractures. Although prior studies explore different incision orientation, most fail to specify whether or not the supraclavicular nerve branches were identified and protected and also lack a patient questionnaire that focuses on paresthesia characteristics and patient quality of life as it relates to the measured area of postoperative numbness. In this proposed study, the investigators will be able to fill this gap in knowledge and give insight into whether or not a nerve-sparing technique should be used to decrease the morbidity of postoperative chest wall paresthesia following operative fixation of clavicle fractures. This research will be important to the scientific community because it will help guide a physician's pre-operative counseling and establish realistic expectations for their patients. It could also guide a physician's surgical technique in a manner to decrease post-operative morbidity for patient's undergoing surgical fixation of clavicle fractures.

1. Group 1 - Operative treatment utilizing a supraclavicular nerve-sacrificing procedure
2. Group 2 - Operative treatment utilizing a supraclavicular nerve-preserving procedure

Eligibility Criteria:
Inclusion Criteria:

* Patients \>17 years old with a displaced, midshaft clavicle fracture
* Closed injury
* No skin compromise

Exclusion Criteria:

* Clavicle non-union/malunion
* Far proximal (medial) or far distal (lateral) clavicle fractures
* Open injury
* Skin compromise
* Prior surgery of the anterior chest wall or affected clavicle
* Pre-existing chest wall numbness, cervical root symptoms, neurologic or sensory deficits, signs of neuropathy
* We will not exclude patients on membrane stabilizing medications for nerve paresthesia (GABA agonists, tricyclic anti-depressants) but will include this on patient intake form and document it
* Traumatic brain injury
* Patients who had prior deltopectoral approach to glenoid