cyrilzakka/clinical-trials huggingface dataset:
The Use of Tulsi Extract for The Management of Oral Mucositis in Head & Neck Cancer Patients Undergoing Radiotherapy

After signing the informed consent, the participant will be allocated to either intervention or control group, then each participant will use either 0.15% benzydamine (Comparator) or 4% tulsi (Intervention) four times a day and also once half an hour before each radiotherapy session.

the primary outcome is the severity of oral mucositis will assess by Oral Mucositis Assessment Scale (OMAS) and secondary outcomes are pain will assess Numerical rating scale (NRS), Oral Assessment Guide (OAG), and Patient-Reported Oral Mucositis( PROMS scale) All outcomes will be recorded at baseline, and 8, 15 days

Eligibility Criteria:
Inclusion Criteria:

* Patients having clinical signs of radiotherapy-induced OM (WHO oral mucositis grading scale: Grade II, III, and IV)
* Patient should be able to read and/or understand and sign the consent form.

Exclusion Criteria:

1. Patients with HIV infections or hyperthyroidism.
2. Karnofsky performance status (KPS) less than 60%
3. Patients having an allergy to tulsi or benzydamine HCL
4. Patients who are pregnant and/or nursing.
Focused Assessed Echocardiography to Predict Fluid Responsiveness

The aims of the study are:

1. To evaluate the feasibility of echocardiography monitoring in postoperative unit;
2. To assess diagnostic value of different focussed echocardiography parameters to define fluid responsiveness for non-cardiac hypotensive spontaneously breathing patients after major abdominal surgery.

As there are different strategies of perioperative fluid management discussion which is the choice liberal or restrictive one occurs? Individualized infusion therapy should be the goal. The investigators hypothesize extended hemodynamic monitoring based on focused transthoracic echocardiography enable to differentiate the cause of hypotension more carefully and fluid overload will be avoided after major abdominal surgery.

The goals of the study are:

* To conduct one group of hypotensive patients after major abdominal surgery. To divide this group into responders and nonresponders after fluid challenge.
* To evaluate the feasibility of echocardiography monitoring in postoperative unit (having in mind such restrains as supine position, postoperative pain, bandages etc.)
* To compare the evaluation of fluid responsiveness by clinical signs and focused assessed echocardiography data.
* To identify the best focused echocardiography parameters for prognosis of fluid responsiveness.
* To determine if extended hemodynamic monitoring changes postoperative fluid management.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years old.
* Patients who sign an agreement form to participate in the study.
* Patients undergoing major abdominal surgery.
* Hypotension

Exclusion Criteria:

* Younger than 18 years old.
* Known pregnancy.
* Unconscious patients or those who do not agree to participate in the study.
* Urgent surgery.
* Normal arterial blood pressure.
Epidemiology of Young Lung Cancer - Survey

This is a 100% virtual (remote), case-case study to explore potential environmental, lifestyle and genetic factors that may be associated with driver mutations of young lung cancer in the U.S.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18 years and over; or the age of majority for their residential state at the time of enrollment
2. Documentation of primary NSCLC, any stage
3. Less than 50 years of age at the time of NSCLC diagnosis
4. Documentation of testing by a CLIA certified lab for genomic drivers of lung cancer
5. Willingness to undergo all study procedure
6. Provision of written informed consent

Exclusion Criteria:

1. Male or female aged less than 18 years; or less than the age of majority for their residential state
2. Greater than or equal to 50 years of age at the time of NSCLC diagnosis
3. No documentation of mutation testing
4. Unwilling to undergo all study procedures
5. Unable or unwilling to provide consent
Comparison Thymoglobulin® and Grafalon®

This is a prospective, multicenter, observational, non -interventional study with comparison with an historical cohort Investigators will compare the efficacy and safety of Thymoglobulin (Sanofi-Aventis) versus Grafalon (Neovii, previously ATG-Fresenius) in renal transplantation by evaluating patient survival, graft survival, delayed graft function, acute rejection, DSA occurrence and toxicities, various infections including CMV and BK virus incidence, MACE (major cardiac adverse event) and cancer.

Investigators will also compare cumulative treatment and follow up costs and other key criteria available in the ASTRE database.

This is a prospective, multicenter, observational, non -interventional study with comparison with an historical cohort Investigators will compare the efficacy and safety of Thymoglobulin (Sanofi-Aventis) versus Grafalon (Neovii, previously ATG-Fresenius) in renal transplantation by evaluating patient survival, graft survival, delayed graft function, acute rejection, DSA occurrence and toxicities, various infections including CMV and BK virus incidence, MACE (major cardiac adverse event) and cancer.

Investigators will also compare cumulative treatment and follow up costs and other key criteria available in the ASTRE database.

Justification for a non-interventional study: in the study the medicinal products will be prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the patient to the product is not decided in advance by a trial protocol but falls within current practice of the centre and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures are applied to the patients and epidemiological methods are used for the analysis of collected data.

Eligibility Criteria:
Inclusion Criteria:

* For the Grafalon prospective group: all first 11-12 patients from the 13 transplant centres receiving Grafalon according to the local practice
* For the Thymoglobulin group: a group of 130 patients matched for:

age (donor and recipient) gender indication (immunological indication versus DFG) CMV status

Exclusion Criteria:

* Patient younger than 18 years old
* Living donor
* Donor after cardiac death (because the Maastricht 3 donors are authorized recently in France)
CER-001 Atherosclerosis Regression ACS Trial

The purpose of this study is to assess the impact of ten intravenous infusions of 3 mg/kg CER 001 vs. placebo, given at weekly intervals for ten weeks, on atherosclerotic plaque volume as measured by coronary IVUS, when administered to subjects presenting with Acute Coronary Syndrome (ACS) with significant plaque volume.

Subjects will be required to have at least one epicardial coronary artery suitable for IVUS imaging. A suitable target artery for IVUS imaging will be determined at baseline as having stenosis of up to 50% and meeting all angiographic inclusion criteria. Subjects having met all eligibility criteria will be randomized to receive an intravenous infusion of CER 001 (3 mg/kg) or placebo within 14 days of event presentation. Randomized subjects will then return at 7 day intervals for nine additional infusions. A follow up IVUS will be conducted at 14 days after the last infusion. The total study duration from randomization to follow up IVUS for a completed study can range from approximately 9 to 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or female greater than 18 years of age
* Acute coronary syndrome (myocardial infarction or unstable agina)
* Angiographic evidence of coronary artery disease with suitable "target" coronary artery for IVUS evaluation

Exclusion Criteria:

* Females of child-bearing potential
* Angiographic evidence of \>50% stenosis of the left main artery
* Uncontrolled diabetes (HbA1C\>10%)
* Hypertriglyceridemia (\>500 mg/dL)
* Congestive heart failure (NYHA class III or IV)
* Ejection fraction \<35%
* Uncontrolled hypertension (SBP \>180 mm Hg)
* Known major hematologic, renal, hepatic, metabolic, gastrointestinal or endocrine dysfunction
Access to Sperm Donation for Female Couples and Unmarried Women

The Bioethics Law of August 2, 2021 now authorizes, in addition to heterosexual couples, access to sperm donation for female couples and unmarried women.

According to the Ministry of Health, since the opening of sperm donation to these new populations, requests at the national level (7000 during the first 6 months) have greatly exceeded the predicted figures (3000 per year). Welcoming this new patient population requires us, health professionals, to know it well. Indeed, to date, there is no reliable assessment in France of the life course, particularly reproductive, nor of the socio-demographic characteristics, nor of the psychological well-being of these patients.

This study via a pseudonymised questionnaire aims to fill this lack of information in order to help professionals build relevant care pathways.


Eligibility Criteria:
Inclusion Criteria:

* Heterosexual couples, OR couples of women OR single women who have requested a sperm donation at the Center for Reproductive Medicine at the Toulouse University Hospital
* Patients who have given their consent (oral or written) after clear and fair information

Exclusion Criteria:

* First consultation with the centre's psychologist already carried out.
* Not fluent in French
* Protected adults (safeguard of justice, guardianship, curatorship)
Effects of Low FODMAP Diet on Colonic Epithelial Physiology in Diarrhea-predominant Irritable Bowel Syndrome

This research is studying whether changing an individual's diet may have an impact as a treatment or outcome for Irritable Bowel Syndrome (IBS). This research will show if diet might play a role in triggering changes that may cause IBS. This study is being done to learn if a low FODMAP (fermentable, oligosaccharides, disaccharides, monosaccharides, and polyols) diet causes changes in the colon lining which mediates improvement in IBS symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Normal serum studies including serum tissue-transglutaminase antibodies, thyroid stimulating hormone levels, C-reactive protein or fecal calprotectin, complete blood count since the onset of symptoms.
* Normal stool studies including, ova and parasites since the onset of symptoms
* IBS-SSS score of ≥175 at the end of the 7-day screening period

In case of presence of any alarm features and/or elevated inflammatory markers (C-reactive protein or fecal calprotectin), patients will be eligible if they have been excluded for inflammatory bowel disease with colonoscopy in the last one year.

Exclusion criteria

* individuals already on a LFD or other dietary restriction such as gluten free diet within the past 6 months
* individuals with any known food allergy or insulin-dependent diabetes
* known history of celiac disease, inflammatory bowel disease or microscopic colitis
* prior small bowel or colonic surgery or cholecystectomy
* pregnant patients
* Antibiotics in the past 3 months
* Those who regularly use mast cell stabilizers or anti-histaminic or non-steroidal anti-inflammatory agents (NSAIDs) excluding daily baby aspirin or steroids or bile-acid binder.
Cardiac Output Measurement by TEE

Transesophageal echocardiography (TEE) has become a standard monitoring tool during cardiac surgery. It allows continuous accurate assessment of heart structures and function without interfering with the surgery and the anesthetics. The imaging of cardiac structures is used to direct optimal surgical intervention and assess surgical results. Cardiac output (CO) is the result of stroke volume (SV) multiplied by the heart rate.

Measurement of cardiac output (CO) is used to quantify the performance of the left ventricle. It is commonly achieved using a pulmonary artery catheter (PAC) (also known ad Swann-Ganz catheter). A known amount of saline solution is injected in the proximal part of the catheter and the variation of blood temperature detected at the tip. Cardiac output is measured based on the duration and degree of temperature change. This method remains an accepted gold standard. TEE allows measurement of cardiac output using a number of different 2D and 3D imaging modalities. Although current guidelines identify the Method of the Disks(MOD) as the gold standard other technique could potentially be more precise. In this study, the investigators want to assess the accuracy of four different TEE methods to measure cardiac output compared with Thermodilution as a standard of care.

The measurement of the LV performance, as reflected by measuring cardiac output (CO), is an important component of hemodynamic assessment during cardiac (and non-cardiac) surgery. It has become standard of care in guiding fluid management and inotropic therapy in both the operating room (OR) and the intensive care unit (ICU) in most centres, and is considered by far the most understood and commonly communicated parameter of cardiac performance, in addition to being consistently shown as a predictor of patients' outcome.

Several methods have been used to measure CO. The most commonly used is via thermodilution (PAC), but its invasive nature and potential for serious complications led to the utilization of the non-invasive methods, such as those based on TEE.

Since the establishment of the role of TEE in the setting of hemodynamic monitoring during cardiac surgery, various ways of quantifying LV function have been utilized. The method recommended by current guidelines is a volumetric calculation via the method of disks (modified Simpson's method, MOD). Recent advances in ultrasound technology and software development allow the utilization three-dimensional (3D) volumetric assessment and speckle tracking for cardiac deformation.

Eligibility Criteria:
Inclusion Criteria:

* age \>18
* undergoing elective CABG, AV or aortic surgery (aortic root and ascending aortic arch surgery), with CPB.

Exclusion Criteria:

* Emergency surgery
* Moderate or severe valve pathology
* Atrial fibrillation
* Patients with known contraindications to either the insertion of a PAC or the use of TEE.
Study of Safety and Efficacy of H-1337 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

The trial will evaluate the safety and efficacy of 3 dose regimens of H-1337 \[0.6% twice daily (b.i.d.), 1.0% b.i.d. and 1.0% once in the morning (q.a.m.), and timolol maleate (0.5%, b.i.d.) in both eyes for 28 days.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bilateral primary open angle glaucoma or ocular hypertension

Exclusion Criteria:

* Closed or very narrow angles (Grades 0-1) or those the investigator judges as occludable and/or with evidence of peripheral anterior synechiae \>/= 180 degrees by gonioscopy within 6 months prior to screening visit in either eye

Note: Other inclusion/exclusion criteria apply.
Comparison Between Ultrasound Guided Erector Spinae Plane Block and Dexmedotomidine in Lumber Spine Surgeries.

Ultrasound (US) guided Erector spinae plane block (ESPB) as a new trunchal fascial plane block technique was proposed in 2016. US guided ESPB has aroused the interest of many nerve block experts. The goal of this study is to evaluate the effect of US guided ESPB versus (VS) intravenous Dexmedotomidine on postoperative analgesia and intra operative hemodynamic parameters in lumbar spine surgeries.

The aim of this study is to compare the efficacy of ESPB to intravenous Dexmedetomidine in patients who are undergoing elective lumber spine surgeries regarding the effect on postoperative analgesia and intra operative hemodynamic parameters.

The use of US guided ESPB in lumbar spine surgery has not been extensively studied in clinical research. Although there is limited research available, some studies have highlighted differences in the mechanism and effectiveness of the block in different regions of the erector spinae muscle. Some scholars question the practicability of US guided ESPB in lumbar surgery. This suggests that further investigation is needed to understand the practicality and potential benefits of using ultrasound-guided ESPB in lumbar spine surgery.

Dexmedetomidine, a highly selective α₂ receptor agonist, has a sympatholytic, sedative, amnestic and opioid sparing effect. It does not cause respiratory depression and can therefore be used as an adjuvant in certain clinical settings .

Eligibility Criteria:
Inclusion Criteria:

* ASA I and II patients. aged 18 to 50 years. 70 to 80 kg.

Exclusion Criteria:

* patients under 18 years of age.

  * History of Allergic reactions to study drugs.
  * Opioid or analgesic abuse, and chronic treatment with opioids, or nonsteroidal anti-inflammatory drugs.
  * History of bleeding tendency or coagulopathy
Proprioceptive Stimulation With Manual Bilateral Rhythmic Exercise in Post-stroke Patients

The purpose of this study is to evaluate the effect of the repetitive proprioceptive bilateral stimulation for the early recovery of the voluntary muscle contraction in stroke patients.

The central nervous system (CNS) has plastic properties allowing its adaptation through development. These properties are still maintained in the adult age and potentially activated in case of brain lesion. In the present study authors hypothesized that a significant recovery of voluntary muscle contraction in post stroke patients experiencing severe upper limb paresis can be obtained, when proprioceptive based stimulations are provided. The proprioceptive based training (PBT) aims to stimulate the emergence of voluntary contraction and to foster motor recovery. It is based on motor learning principles, such as the repetition of tasks with concurrent use of feedbacks. The proposed concept is based on the concurrent repetitions of movements performed with the non-affected limb and with the affected one, passively mobilized by physiotherapist in charge of guaranteeing the optimal kinematic execution.

Eligibility Criteria:
Inclusion Criteria:

1. time since stroke up to 6 months,
2. presence of the upper limb plegia (0 point according to the Medical Research Council scale),
3. passive range of motion (ROM) completely free,
4. absence of primary joint trauma of the wrist, elbow and shoulder,

Exclusion Criteria:

1. increased muscle tone (score higher than 1 point in modified Ashworth scale),
2. apraxia (De Renzi test \< 62 points),
3. global sensory aphasia (clinical notes),
4. neglect (clinical notes),
5. cognitive impairments (Mini Mental State Examination test \< 24 points) ,
6. severe sensitivity disorders ( \< 1 point in items shoulder, elbow, wrist and thumb at the proprioceptive sensitivity section of the Fugl-Meyer scale),
7. stroke lesion located in the cerebellum (clinical notes).
Technology Intervention for Diabetes Engagement & Self-Care (TIDES)

The purpose of this 3 site, 24-week, Comparative Effectiveness Randomized Clinical Trial in Primary Care is to compare usual care to an online, multi-media, digital intervention for Persons with Type 2 Diabetes to Improve Engagement, Knowledge, and Self-Care.

Objective: Technology shows promise to enhance standard care of diabetes with cost-effective, online lifestyle interventions. Compared to Primary Care (PC) Diabetes System of Care (control), the investigators hypothesized Technology Intervention for Diabetes Engagement \& Self-Care (TIDES) would significantly improve diabetes knowledge and self-care.

Methods: Following Institutional Review Board (IRB) approval, physician letters were sent to patients with type 2 diabetes, age \>18 years with HgA1c \>8% identified via Electronic Health Record (EHR) of an integrated US health system to invite participation in a 3-site, 24-week diabetes study. Of the 270 with \>1 week email/web use invited to the shared medical visit (SMV) orientation, 166 subjects provided written informed consent. Diabetes knowledge and self-care assessments, vital signs, HgA1c, fasting glucose and lipids were collected at baseline, 3 and 6 months. Following randomization to TIDES (N=117) or usual care (N=49), TIDES group was oriented to the multimedia online intervention including a dosed sequence of learning via email, video, slide shows, food solutions, expert questions and answers,and quizzes.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes Mellitus Type 2
* Geisinger Primary Care Provider
* Access to a computer

Exclusion Criteria:

* Severe medical problems that limits travel to primary care
* Diabetes Type 1
* Cognitive Impairment
* Taking anti-psychotic meds
Panton Valentine Leucocidin

Staphylococcus aureus expresses a variety of virulence factors, including Panton Valentine leukocidin (PVL), a cytotoxin. PVL is specifically associated with primary skin and soft-tissue infections and severe necrotizing pneumonia (Gillet et al. Lancet, 2002;359:753-9). PVL-positive S. aureus pneumonia is often preceded by influenza-like symptoms, and is mainly characterized by hemoptysis, pleural effusion, rapid onset of acute respiratory distress, leukopenia and a high fatality rate (65%) (Gillet et al. Lancet, 2002;359:753-9). Ten year after the first description of this disease and a number of controversies in the scientific literature, the question arise as to whether PVL remains an independent factor of severity in S.aureus pneumonia. In addition, numerous questions remain unanswered yet; these are:

* (i) which factors, including treatment regimen, are associated with favourable outcome?,
* (ii) what is the susceptibility toward antibiotics of strains associated with this disease ?
* (iii) is there any genetic susceptibility of the host to explain both the rarity, and the explosive presentation of the disease ? To address the above questions a prospective observational study at the nationwide level will be set up. All French hospitals will be invited to describe the clinical features of all new cases of S. aureus community-acquired pneumonia with severity criteria, regardless PVL production. The study will include an investigation of a possible innate immune dysfunction in collaboration with the INSERM-U550 (Génétique Humaine des Maladies Infectieuses, Faculté Necker, Paris). Hence, in addition to collecting clinical and biological data from all pneumonia cases as well as all strains of S. aureus isolated, the patients with PVL-positive pneumonia will be sampled for immune genetic studies (ORFeome sequencing and functional studied)


Eligibility Criteria:
Inclusion Criteria:

* 2-month-old patient at minimum and weighing at least 5 kg
* Informed consent
* Subjects affiliated (or beneficiary) to a national medical insurance
* Presence of clinical, biological and radiological signs of pneumopathy to S. aureus whose clinical state justifies a hospitalization in a ICU or in a reanimation
* Presence of PVL- positive S.aureus producer (for immunogenetic study)

Exclusion Criteria:

* Patients infected by the HIV
* Patients hospitalized for more than 48 hours at the time of the diagnosis of pneumonia,
* Patients hospitalized during the previous three months excepted outpatients