cyrilzakka/clinical-trials huggingface dataset:
Nutrition and Pharmacological Algorithm for Oncology Patients Study

Loss of appetite is a common symptom of patients with cancer and can cause distress which impacts patients and caregivers. Patients diagnosed with head/neck, lung or pancreatic cancer will be recruited for this study to decrease the suffering and distress associated with eating during cancer treatment and improve the quality of life of patients by implementing an algorithm utilizing nutrition intervention and appetite stimulants.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a diagnosis of head/neck, lung, pancreatic cancer, or metastatic cancer from any solid tumor
2. Planned, ongoing, or recently treated patient (within the past 30 days) with chemotherapy, immunotherapy, and/or intravenous targeted biologic therapy
3. No previous use of appetite stimulants
4. All patients must sign study specific informed consent prior to being included in the study
5. No contraindication to appetite stimulants

Exclusion Criteria:

1. Patient \<18 years old
2. Contraindication to appetite stimulants
Study of Procalcitonin (PCT)-Guided Antibiotic Use in Severe Sepsis Patients Without Obvious Infection

A recent study has demonstrated that in low respiratory infections, a strategy using prescription of antibiotics based on the pro-calcitonin level allows decreasing recourse to antibiotics by 47% without prognostic modification.

The aim is to evaluate the impact on antibiotics consumption of an algorithm using procalcitonin level in patients exhibiting severe sepsis symptomatology but without clearly identified hosted germs or infectious centre.

This multicenter study is a randomized prospective open study involving 9 ICU departments in France, comparing two strategies on antibiotherapy treatment period one based on procalcitonin level(experimental group) the other on physician's appreciation(control group)

140 adult patients should be included with a severe sepsis symptomatology, whose infectious etiology has not been proven. The main non-inclusion criterium is: the presence of a pathogen agent or infectious centre clearly identified.

The primary outcome is the rate of patients undergoing antibiotic treatment at D5.

Secondary outcomes: duration of the antibiotic treatment, mortality rate and duration in stay in intensive care ward and evolution of the SOFA score between D0, D3 and D5.

Duration of patient enrollment is 30 days.


Eligibility Criteria:
Inclusion Criteria:

* hospitalized in resuscitation ward
* severe sepsis symptomatology
* at least 2 SIRS criteria
* no infectious etiology detected
* at least one organ deficiency

Exclusion Criteria:

* the presence of a pathogen agent or infectious centre clearly identified
* pregnancy
* burned
* patients with therapeutic limitation
* recent surgery
* secondary neutropenia
The Role of Cerebral Oximetry in Pediatric Concussion Assessment

The purpose of this study is to determine whether there is a difference in cerebral oxygenation as measured by near-infrared spectroscopy (NIRS) in children with concussion and healthy controls.


Eligibility Criteria:
INCLUSION CRITERIA:

All Participants

* Age 10-18 years at time of visit

Concussion Group

* Present to JHH PED within the first 24 hours following trauma.
* Diagnosis of concussion as defined by the 3rd International Conference on Concussion in Sport (McCrory), including the presence of any one or more of the following:

  1. Symptoms (ie. headache, neck pain, nausea/vomiting, dizziness, blurred vision, balance problems, sensitive to light, sensitivity to noise, feeling slowed down, feeling in a fog, difficulty concentrating, difficulty remembering, fatigue, confusion, drowsiness, more emotional, irritability, sadness, nervous)
  2. Physical Signs (ie. loss of consciousness, unsteadiness)
  3. Impaired brain function (ie. confusion)
* Glasgow Coma Score of 13-15 upon arrival to JHH PED.
* Loss of consciousness of less than 15 minutes (if applicable).
* No structural intracranial injuries identified on neuroimaging (if completed).

EXCLUSION CRITERIA

All Participants

* History of prior concussion or traumatic brain injury within preceding 6 weeks.
* History of prior intracranial disease or mass (ie. tumor, intraventricular hemorrhage, etc.)
* Presence of intracranial hardware.
* Complaints of respiratory distress, tachypnea or hypoxia, which may affect regional cerebral oxygen saturation.
* Inability to stand secondary to lower extremity disease or trauma, which is required for completion of SCAT2.
* Inability to complete SCAT2 questionnaire secondary to developmental delay.
* Child in foster care or legal guardian not available.
* Participant known to be pregnant, which alters total body blood flow and likely affects regional cerebral oxygen saturation.
* Non-English speaking.
Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO)

The purpose of this study is to compare visual improvement and total number of intraocular injections in eyes with macular edema following central retinal vein occlusion (CRVO)after initial treatment with Ozurdex (dexamethasone implant) or Avastin (bevacizumab).


Eligibility Criteria:
Inclusion Criteria:

* Presence of central retinal vein occlusion (CRVO)
* Age 18 years or older
* ETDRS (Early Treatment Diabetic Retinopathy Study) Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/40 to 20/800
* OCT Central foveal thickness \>250 microns
* Negative pregnancy test for women of childbearing potential
* Ability to provide written informed consent
* Capable of complying with study protocol

Exclusion Criteria:

* History of glaucoma in the study eye with intraocular pressure \>21mmHg on more than one topical medication. Combination drugs are considered more than one medication
* History of steroid-related glaucoma (steroid response)
* Previous intraocular injection of steroid medication within 90 days
* Avastin (bevacizumab) or Lucentis (ranibizumab) within 60 days
* Evidence of significant retinal ischemia on fluorescein angiography in the opinion of the treating physician
* Previous intraocular surgery (e.g. Cataract Surgery) with in 60 days
* Concurrent ocular disease that would limit visual acuity in the opinion of the treating physician
* Dense cataract that precludes clinical examination and retinal imaging of the retina
* History of allergy to dexamethasone, bevacizumab, betadine
* Ocular or systemic conditions that may pose a threat to the health of the subject in the opinion of the treating physician
* Unwilling or unable to follow or comply with all study related procedures
* Current participation in another clinical medical investigation or trial or has received any investigational drug within 12 weeks prior to enrollment
Microvascular Function in Patients Undergoing Transcatheter Aortic Valve Implant (TAVI) for Severe Symptomatic Aortic Stenosis: Association With Myocardial Fibrosis

Microvascular function in patients undergoing Transcatheter Aortic Valve Implant (TAVI) for severe symptomatic aortic stenosis: association with myocardial fibrosis

Severe symptomatic aortic stenosis is commonly encountered in clinical practice, affecting close to 5% of individuals older than 65 years of age, and carries a dismal prognosis if left untreated.(1,2) Chronically increased left ventricular afterload triggers a compensatory myocardial response, ultimately leading to ventricular hypertrophy, aimed at reducing chronically increased wall tension an restore cardiac performance.(3) Hypertrophy ultimately results in maladaptive changes and ultimately leads to heart failure and eventually increased risk of cardiac mortality. Myocardial fibrosis and altered myocardial perfusion appear to play a role in progressive cardiac decompensation.

Eligibility Criteria:
Inclusion Criteria:

• All patients referred to IRCCS Ospedale San Raffaele who are candidates to receive a TAVI implant for severe, symptomatic aortic stenosis under current appropriateness criteria and clinical practice guidelines will be considered eligible to take part in the study

Exclusion Criteria:

* Age \<18 years
* Inability to express informed consent to take part in the present study.
* Pregnancy or lactation
* Pre-existing known disease determining a prognosis quo ad vitam shorter than the follow up of the present study
* Significant chronic kidney disease (estimated glomerular filtration rate \<30 ml/min)
* Known significant epicardial coronary artery stenosis
* Known contraindication to adenosine administration:
* Known allergic reactions
* Second or third degree atrioventricular block before the procedure (in absence of a functional permanent pacemaker)
* Long QT syndrome
* Unstable angina
* Severe hypotension
* Acutely decompensated heart failure
* Chronic obstructive pulmonary disease with bronchospasm
* Concomitant use of dypiridamole
Ranolazine and Microvascular Angina by PET in the Emergency Department

The purpose of this study is to determine the effectiveness of Ranolazine for the treatment chest pain from disease of small vessels of the heart also known as 'microvascular angina'.

The Yale Chest Pain Center (CPC) is a unique clinical lab that provides an integrated interdisciplinary research team, access to high volume of chest pain patients largely free of coronary disease (93%) as well state of the art diagnostics including cardiac PET and a sophisticated system for serum processing and banking facilities. The CPC cohort represents a unique population with unrecognized microvascular disease and is often only accessible through the ED. We propose a one-year pilot study to understand the mechanisms of angina relief by Ranolazine (n=20) in patients with microvessel disease in the ED population as compared to controls (n=10) at baseline and at 1-month. In addition, changes in pain scores and function as measured by Seattle Angina Questionnaire (SAQ), recidivism and costs will be measured and correlated with changes in coronary flow reserve (CFR). Serum samples will be obtained and banked for future marker analysis as intermediate surrogates of outcomes.

Primary aim: To compare changes in coronary flow reserve as measured by cardiac PET in patients receiving Ranolazine versus controls.

Secondary aim: To determine if Ranolazine changes Seattle Angina Questionnaire (SAQ) scores in association with changes in Coronary Flow Reserve (CFR) versus controls.

Exploratory aim: To compare composite rate of return visits (office, emergency department and hospitalization) for chest pain within 4-weeks of enrollment between patients with and without Ranolazine.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the Yale ED CPC
* ≥ 30 years age
* chest pain or angina equivalent as their chief complaint within 24 hours of enrollment
* Coronary Flow Reserve(CFR) \<2.5 on PET scan in the ED.

Exclusion Criteria:

* Acute coronary syndrome
* Prior evidence of obstructive heart disease (history of Percutaneous Transluminal Coronary Angioplasty (PTCA), Coronary Artery Bypass Grafting (CABG) or calcium score \> 10 on PET scan)
* Resting blood pressure of systolic \>180/110 mm Hg or \<100/40
* known cardiomyopathy or heart failure
* currently on dialysis
* creatinine clearance \<30 ml/min
* liver cirrhosis
* significant aortic stenosis (murmur on exam)
* active use of cocaine or amphetamine
* current use of potent CYP3A4 inducers or inhibitors (such as ketoconazole, clarithromycin, HIV protease inhibitors)
* baseline QTc \> 580 msec
* use of drugs that prolong QTc (Haldol, erythromycin)
* pregnancy
* inability to read or understand English
* suffering from a condition that precludes interview (i.e. cognitive or communication impairment).
Cognitive Effects of 500mg Trans-resveratrol

This study investigated the potentially cognitive enhancing effects of 500mg trans-resveratrol in healthy, young humans.


Eligibility Criteria:
Inclusion Criteria:

* 18-35yrs, healthy.

Exclusion Criteria:

* Drug/alcohol abuse, taking prescription medication (apart from contraception) or herbal supplements, having food intolerances or allergies, having suffered a head-injury or neurological/neuro-developmental disorder, uncorrected sight problems, pregnant or seeking to become so, excessive caffeine use (e.g. more than 6 cups of coffee per day).
A Trial of a Video Game Intervention to Recalibrate Physician Heuristics

The objective of this study is to compare the efficacy of a video game designed to recalibrate physician heuristics in trauma triage with a standard educational program.

Treatment at trauma centers improves outcomes for patients with moderate-to-severe injuries. Accordingly, professional organizations, state authorities, and the federal government have endorsed the systematic triage and transfer of these patients to trauma centers either directly from the field or after evaluation at a non-trauma center. Nonetheless, between 30 to 40% of patients with moderate-to-severe injuries still only receive treatment at non-trauma centers, so-called under-triage. Most of this under-triage occurs because of physician decisions (rather than first-responder decisions). Existing efforts to change physician decision making focus primarily on knowledge of clinical practice guidelines and attitudes towards the guidelines. These strategies ignores the growing consensus that decision making reflects both knowledge as well as intuitive judgments (heuristics). Heuristics, mental short cuts based on pattern recognition, drive the majority of decision making. The investigators have developed an adventure video game (Night Shift) to serve as a novel method of recalibrating physician heuristics in trauma triage and will compare its efficacy with a standard educational program.

Eligibility Criteria:
Inclusion Criteria:

* Physicians who care for adult patients in the Emergency Department.
* Physicians who work at a non-trauma center.
* Physicians who work at a Level III/IV trauma center.

Exclusion Criteria:

* Physicians who work at a Level I/II trauma center.
* Physicians who do not practice in the US.
Incidence Rate of Heart Failure After Acute Myocardial Infarction With Optimal Treatment

The main purpose of this study is to build a multi-center, prospective and regionally representative acute myocardial infarction(AMI) cohort，and build a study platform for heart failure caused by AMI; To explore the 1 year incidence rate of heart failure after AMI given the optimized treatment and the treatment model affecting the incidence rate of heart failure, and finally to reduce the incidence rate of heart failure by 5%.

the study aim to enroll 12000 acute myocardial infartion (AMI) patients, including ST-segment elevation myocardial infarction (STEMI) and non ST-segment elevation myocardial infarction (NSETMI), Patients were divided into two groups(optimized group and un-optimized group) according to treatment models they accepted in 20 reginally representative hosptials of China. whether optimizaed or not is judged by 4 four aspects,including emergency treatment procedure, pre-infusion medication, reperfusion strategy selection, and early rehabilitation after reperfusion.Patients were followed at 1 month, 6 months and 12 months. The physical condition and clinical events(heart failure, death, re-infarction, revascularization, apoplexy, malignant arrhythmias, bleeding events, other adverse events)were collected at follow up.

Eligibility Criteria:
Inclusion Criteria:

* age≥18 years
* diagnosed acute myocardial infarction
* signed the informed consent form

Exclusion Criteria:

* AMI is caused by surgery, trauma, gastrointestinal bleeding or complications of PCI;
* AMI occurred in patients who have been hospitalized for other reasons;
* patients with previous history of chronic heart failure;
* researchers judging that patient's compliance was poor and could not complete the study according to the requirements.
* life expectancy is less than 12 months;
* heart transplant patients;
* patients with tumors;
Alpha Lipoic Acid Against Cardiovascular Events in Patients With Haemodialysis

Evaluate the association between possible benefit effects of oral administration of alpha lipoic acid by patients with hemodialysis and the possible reduction in cardiovascular events (CVEs); using Advanced glycation end products (AGEs) as a measure to assess endothelium function which correlate with CVEs.

Study design: double blind, Parallel, Randomized, Prospective, Controlled study. Setting: Nephrology Department, Dialysis units, Ain Shams University Hospitals, Ain Shams University, Cairo, Egypt.

Sample size:

36 patients with end-stage renal disease (ESRD) receiving dialysis treatment will be enrolled in the study and the patients will be identified by coded numbers to maintain the privacy.

Patients will be randomized into two groups each group includes 18 patients:

Control Group: 18 patients will receive their standard therapy only. Tested Group: 18 patients will receive alpha-lipoic acid (thiotacid R) product with their standard therapy.

Materials:

Thiotacid R 600 mg tablet. Each tablet contains: Thioctic acid (Alpha-lipoic acid) 600 mg; a product of EVA pharma, Cairo, Egypt.

Methods:

All Patients will be subjected to the following:

1. Informed consent
2. Demographics and history taking: Using Patient Data sheet
3. Laboratory evaluation including:

   A- Routine laboratory measurements as hemoglobin, calcium, phosphate, and albumin will be determined.

   The assessment will be done in 2 occasions:

   i. At Baseline (before the beginning of the treatment) for all groups ii. After 3 months of addition of alpha lipoic acid to their standard therapy for the tested group.
4. Follow up:

A- During-treatment follows up of the patients:

All patients will be followed up during the study for treatment tolerability by assessing adverse effects, and compliance to drug regimen.

Drug regimen: - the patients in tested group will administered Thiotacid 600 mg; orally once daily for 3 months as add on the standard therapy that are receiving.

Patients will be interviewed weekly through face to face contact with the clinical pharmacist regarding treatment tolerability, and through telephone calls in between these weekly meetings.

B- Post-treatment follows up of the patients:

All patients in control group will be followed up clinically after 3 months from the start of the study and all laboratory examinations will be carried out.

All patients in tested group will be followed up clinically after 3 months from the start of treatment and all laboratory examinations will be carried out.

Eligibility Criteria:
IPatients eligible for the study fulfilled the following inclusion criteria and free from exclusion criteria:

Inclusion criteria:

1. Clinical stable patients on hemodialysis for at least 3 months.
2. Aged between18 - 60 years old.
3. Both sexes.
4. Patients who accept to participate in the study.

Exclusion criteria:

1. The patients suffering from other diseases, which may lead to oxidative stress, such as: Inflammatory diseases, hepatic or respiratory diseases ...
2. Smokers and alcoholics
3. Non-compliant patients
The Effects of Moxibustion on Ulcerative Colitis

To investigate the mechanism and effects of moxibustion on patients with ulcerative colitis.

A total of 60 patients with UC were randomly divided into the following 2 groups: a) Herb-partition moxibustion (Treatment Group) and b) Sham herb-partition moxibustion (Control Group). All patients in the trial will be treated with moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks. MRI will be used to observe the changes on brain structure and function in patients with UC, and further research on the characteristics of the brain nerve response of these patients with herb-partition moxibustion. In addition, tissue morphology and molecular biology tests will be conducted to observe the regulation and expression of VDR and antimicrobial peptides in the intestinal mucosa of UC patients. All these steps will be done in order to provide experimental basis for the mechanism of the effects of herb-partition moxibustion in the treatment of UC.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnosis of UC
* Mayo ≤10
* Patients do not receive any medicine, or if they are receiving medicine, it should be aminosalicylates and/or prednisone (dose ≤15mg and have taken at least 1 month), and must kept the same dose as before throughout the trial;
* Patients should have not received antibiotic, biologicals within 3 months prior to entering the study;
* Signing a written informed consent.

Exclusion Criteria:

* Patients with cardiac, encephalic, hepatic, nephric, hematopoietic system, psychotic or any other serious diseases;
* Pregnancy or lactation;
* The psychiatric patients;
* Current or prior history of neurosurgery, head injury, cerebrovascular insult, or brain trauma involving loss of consciousness;
* Learning disability;
* Claustrophobia;
* Presence of metallic implants in the body;
Clinical and Radiographic Assessment After Surgical Treatment of Anterior Shoulder Dislocation

The purpose of this study is to evaluate the clinical and radiographic results after surgical treatment with implant-free allograft in the treatment of Anterior Shoulder Dislocation and to assess the safety of the surgery.

Patients will be informed about the study and potential risks. All patients giving written informed consent will undergo a screening visit to assess the eligibility criteria.

Patients who meet the eligibility requirements will perform a pre-treatment visit in order to assess their healthy state. Also, patients will undergo to the radiographic visit (RX and TX) as request by clinical practice.

All the patients will be treated with arthrotomy mini-open technique with bone allograft at the site of the shoulder lesion.

After surgery all the patients will be followed up to 24 months through clinical and radiographic visits.

Eligibility Criteria:
Inclusion Criteria:

* antero.inferior shoulder instability with bone loss

Exclusion Criteria:

* Patients incapable of understanding or wanting;
* Patients suffering from: rheumatic diseases, diabetes, infectious processes, congenital ligament laxity, epilepsy, severe osteoporosis.