cyrilzakka/clinical-trials huggingface dataset:
Effect of EGb 761® on Patients With Mild to Moderate Alzheimer's Disease

The aim of this study is to measure the effect of EGb 761® versus placebo on the ratio of the isoform of the protein precursor of beta amyloid platelets, in patients with mild to moderate Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* female or male of 50 to 85 years old with a care giver
* Mini Mental Status (MMS) test between 16 to 26 inclusive
* Clinical Dementia Rating (CDR) test inferior or equal to 1
* National Institute of Neurological and Communicative Disorders and Stroke / Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) test positive for an Alzheimer's disease
* Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) test positive for dementia

Exclusion Criteria:

* patient already treated by medicines which could interfere with the study
* low level of vitamin B12 and folate which are considered as clinically relevant
* clinically relevant pathologies (eg: pulmonary illness, cardiovascular illness; evolutive cancer, neurological illness, blood illness....)
Lifestyles and Endothelial Dysfunction

Objectives: To analyze the relationship of physical activity, fitness, energy intake and dietary pattern with the circadian pattern of blood pressure, central and peripheral blood pressure pulse wave velocity and biological markers of endothelial dysfunction in active and sedentary people without atherosclerotic disease.

Objectives: To analyze the relationship of physical activity, fitness, energy intake and dietary pattern with the circadian pattern od blood pressure, central and peripheral blood pressure pulse wave velocity and biological markers of endothelial dysfunction in active and sedentary people without atherosclerotic disease.

Methods:

Design: Cross- sectional study 1ª step of clinical trial later. Project multicentric with seis research groups.

Subjects: From subjects of PEPAF project cohort, that remain in last control 3105 (1.163 active and sedentary 1942) and 2346 were excluded for actives. By Random sampling included 352 subjects who remained sedentary, 588 who have become active and 560 of which were excluded for being active in baseline assessment, a total of 1,200. Each of the six groups included 250 subjects.

Measurements: We evaluated height, weight, abdominal perimeter, blood pressure clinic, ambulatory blood pressure with Radial pulse wave acquisition device (BPro), central blood pressure, (aortic) and Augmentation index with Pulse Wave Application Software (A-Pulse) and Sphigmo cor System Px (Pulse Wave Analysis), pulse wave velocity (PWV) with Sphigmo cor System Px (Pulse Wave velocity), nutritional pattern with a food consumption survey, physical activity 7 Par-day questionnaire and the accelerometer (MTI/CSA 7164) and physical fitness with cicloergometro (PWC170) and endothelial dysfunction biomarkers (endoglin and osteoprotegerin).

Eligibility Criteria:
Inclusion Criteria:

* Healthy people
* Ages 20-80 years old

Exclusion Criteria:

* Cardiovascular disease
* Respiratory failure
* Patient ends
* Pregnancy
A Phase 2 Study of PLX3397 in Patients With Recurrent Glioblastoma

The objective of this study is to evaluate the response of subjects with recurrent glioblastoma to continuous therapy of PLX3397.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥18 years old with a life expectancy of at least 8 weeks
* Radiographically proven recurrent (≥ first relapse), intracranial Glioblastoma (GBM)
* For all patients, availability of at least 10 unstained slides (or archival tumor block sufficient to generate at least 10 unstained slides) from any previous GBM surgery
* Previous treatment with external beam radiation and temozolomide chemotherapy
* Before the first dose of PLX3397,adequate recovery from toxicity of prior therapy as follows:

\>28 days for cytotoxic therapy \>42 days for nitrosoureas \>28 days for bevacizumab \>7 days for non cytotoxic therapy such as interferon, tamoxifen, thalidomide, cis-retinoic acid, or erlotinib

* Women of child-bearing potential must have a negative pregnancy test within 7 days of initiation of dosing and must agree to use an acceptable method of birth control while on study drug and for 3 months after the last dose. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year. Men of child-bearing potential must also agree to use an acceptable method of birth control while on study drug.
* Karnofsky performance status of ≥60
* Adequate hematologic, hepatic, and renal function (absolute neutrophil count ≥1.0 x 109/L, Hgb \>9 g/dL, platelet count ≥50 x 109/L, Aspartate aminotransferase/Alanine aminotransferase (AST/ALT) ≤2.5x Upper Limit of Normal (ULN), creatinine ≤1.5x ULN)
* Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements

Exclusion Criteria:

* Investigational drug use within 28 days of the first dose of PLX3397
* GBM progression within 3 months of previous radiation by Response Assessment in Neuro-Oncology (RANO) criteria
* History of Grade 2 Common Toxicity Criteria for Adverse Events (CTCAE v4) or greater acute intracranial hemorrhage
* Previous failure of bevacizumab or other vascular endothelial growth factor (VEGF) therapy except in a first line setting
* History of malignant glioma with co-deletion of 1p/19q
* A concurrent active cancer that requires non-surgical therapy (e.g. chemotherapy, radiation, adjuvant therapy). Prior history of other cancer is allowed, as long as there was no active disease within the prior 3 years.
* Refractory nausea and vomiting, malabsorption, biliary shunt, or significant bowel resection that would preclude adequate absorption
* Patients with serious illnesses, uncontrolled infection, medical conditions, or other medical history including abnormal laboratory results, which in the investigator's opinion would be likely to interfere with a patient's participation in the study, or with the interpretation of the results
* Women of child-bearing potential who are pregnant or breast feeding
* corrected QT interval (QTc) ≥450 msec at Screening
QuitAdvisorMD: A Point-of-care Tool for Brief Smoking Cessation Interventions

QuitAdvisorMD: A point-of-care tool for brief smoking cessation interventions Under a Phase II SBIR grant supported by NIH/NIDA, we are developing QUITAdvisorMD: a point-of-care, patient-centered resource for counseling patients who smoke or use tobacco products. It is based on the principles of Motivational Interviewing, a non-confrontational and very effective method for intervening and treating these patients; the 5 A's of behavioral interventions; and the Transtheoretical Model of Change. Through a point and click interface, the tool uses a series of interview questions designed to motivate patients to stop smoking by first assessing their stage of change and then offering effective stage-based interventions and interview techniques. The tool also offers stage-tailored patient information, a clinician educational reference, and the ability to communicate support information patients via email and/or text message.


Eligibility Criteria:
Inclusion Criteria:

* any physician providing care for members of Southern Health through primary care and have access to a point-of-care computing device (Smartphone, desktop PC, etc) during patient visits.

Exclusion Criteria:

* Lack of appropriate computing device
Colon Neoadjuvant FOLFOXIRI Study

Objective tumour response rate to FOLFOXIRI to pre-operative therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years of either sex.
* ECOG performance status 0-1
* Measurable disease by RECIST 1.1 criteria.
* Histologically confirmed rectal adenocarcinoma (defined as either mid- or low rectal cancer that is located within 12 cm from the anal verge OR below the peritoneal reflection) that is previously untreated.
* 'High risk' rectal cancer, or rectal cancers that are considered marginally operable where there is a significant risk of positive surgical margin:

  * T3 (low-lying tumour at or below the levators) or T4, or
  * Tumour infiltrating perirectal fat, or
  * Any T-stage (T1-4) and node-positive tumour (invading surrounding structures or peritoneum)
* Adequate bone marrow, renal and hepatic function as defined by: absolute neutrophil count \>= 1.5 x 109/L, hemoglobin \>= 9 g/L, platelets \>= 100 x 109/L, calculated creatinine clearance \>= 55 ml/min, total bilirubin =\<1.5 x the upper limit of normal, alanine aminotransferase (ALT) =\<2.5 upper limit of normal.

Exclusion Criteria:

* Known distant metastasis, even if the metastasis has been resected.
* History of another invasive malignancy within the last 5 years, except for treated basal cell carcinoma of the skin, cervical intraepithelial neoplasia, or non-invasive DCIS of the breast.
* Upper rectal cancer that is located above the peritoneal reflection.
* Primary tumour associated with any one of the following features:

  * Frank intestinal obstruction, or
  * Endoscope unable to pass through the tumour's lumen plus worsening local obstructive symptoms. Note: Patients with such features should be assessed by the surgical team regarding stomal bypass prior to study enrolment. Such patients can still be considered for study enrolment after undergoing stomal bypass.
* Known hypersensitivity reaction to the study drugs (i.e. fluoropyrimidine, irinotecan, oxaliplatin)
* Known peripheral neuropathy of grade 2 or more in severity.
* Patients who have received an experimental anticancer therapy within the last 28 days.
* Previous pelvic radiotherapy. Previous oxaliplatin or irinotecan for the treatment of colon or rectal cancer
* Patient with hip prosthesis
* Major surgery within the last 28 days. Exception: Any patient who underwent stomal bypass for obstructing primary tumour within the last 14 days are still eligible, as long as the patient has sufficiently recovered from the surgery at the investigator's discretion.
Dietary Intervention Study for Hypertension (DISH)

The primary objective of this multicenter cooperative clinical trial was to determine if dietary modification would enable drug controlled hypertensive patients to remain at 'goal blood pressures' after antihypertensive medication was withdrawn. The proposal made use of the HDFP hypertensive population who had five years of treatment for their hypertension. Additionally, the group of investigators proposed to determine if dietary treatment would permit patients not previously adequately controlled under the HDFP program to achieve normalization of blood pressure with a combination of dietary modification and drug treatment. The study also proposed to search for predictors (i.e., levels of hormonal agents such as plasma renin activity) of responsiveness to dietary manipulation among the hypertensive population as well as to identify psychological attributes that might be of importance in managing these patients.

BACKGROUND:

The background against which the proposal was made had been developed from the combined information of the Veterans Administration Cooperative Study and the Hypertension Detection and Follow-up Study. Data from both these studies clearly established the importance of reducing sodium content by means of diuretic administration as a mainstay of the treatment of elevated blood pressure. The risks of the lifetime of treatment were undefined, but the cost of indefinite treatment of high blood pressure was sufficiently high to stimulate careful examination of alternative modes of management of such patients. The demonstrations by Parijs and others that moderate reduction in sodium intake led to improved management of hypertension and data suggesting that increased potassium intake may enhance this blood pressure lowering effect associated with sodium restriction was cited by the investigators as a basis for the trial. Any additional data regarding modest sodium restriction and potassium ingestion would have impact on utilizing such therapy in preventing hypertension and as adjunctive therapy.

DESIGN NARRATIVE:

The study was intended to take advantage of the availability of patients at the three centers at the completion of the Hypertension Detection and Follow-up Program Study. These patients were enrolled as 'stepped-care' participants and had been treated with antihypertensive drugs for at least five years. The main objective of the study was to determine the contribution of dietary modification to maintenance of normal blood pressure after withdrawal of medication. Two types of diet change were followed: 1) reduction of sodium intake coupled with increased potassium intake; and 2) reduction of weight in the subgroups of patients that were obese.

Eligibility Criteria:
Men and women with hypertension. Diastolic blood pressure equal to or above 95 mm Hg and 90 mm Hg, respectively for home and clinic readings.
Balanced Propofol Sedation During Upper Endoscopy in Morbidly Obese Patients

The purpose of this study is to evaluate the safety of propofol-based, gastroenterologist-administered sedation in severely obese patients (BMI≥35) undergoing upper endoscopy.

The investigators aim to test the hypothesis that it is safe to use balanced-propofol, gastroenterologist-administered sedation in obese patients.

The purpose of this study is to evaluate the safety of propofol-based, gastroenterologist-administered sedation in severely obese patients (BMI≥35) undergoing upper endoscopy. We will use changes in pulmonary and hemodynamic parameters as the primary safety measure in this study. We will compare these results in 30 non-obese patients and in 30 obese patients.

The term balanced propofol sedation refers to using a low dose of propofol in combination with small amounts of an opioid and midazolam.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing an endoscopic esophagostroduodenoscopy (EGD)
* Capable of providing written informed consent and willing and able to comply with all procedures of the study
* Adults between the ages of 18 and 85 inclusive (and of legal age to consent)
* ASA score of I, II, or III

Exclusion Criteria:

* Severe acute illness that is not resolved or stabilized prior to enrollment. Study entry will be based on the investigator's judgment
* Need for sleep or narcotic analgesic medication on a continuous basis during the proceeding 6 months
* Pregnancy
* A history of drug addiction or alcohol abuse within the past 12 months. Alcohol can be consumed in moderation. The consumption of alcohol should be within the routine pattern for the individual before the study.
* A history of seizure disorder.
* Allergy to propofol, soy beans, or eggs.
* Prior history of difficult intubation.
* Prior history of severe complications during conscious sedation. Study entry will be based on the investigator's judgment.
HOFOT Fine Motor Program

The aim of this study is to determine if an 8 week fine motor intervention program will lead to improve fine motor skills as measured by a standardized assessment (PDMS-3) in pre- and post-test.

The aim of this study is to determine if an 8 week fine motor intervention program will lead to improve fine motor skills as measured by a standardized assessment (Peabody Developmental Motor Scale, 3rd edition) in pre- and post-test. The hypothesis is that a daily fine motor program will improve overall fine motor skills within 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* preschooler aged 3-5 years old enrolled in local preschool

Exclusion Criteria:

* None other than denial of parent consent or lack of child assent
Impact of COVID-19 on Personal Protection Among Dentist in Egypt

Dentist exposed to coronavirus (COVID-19) may not have adequate access to personal protective equipment (PPE), safety procedures, and diagnostic protocols. Our objective will be to evaluate the reality and perceptions about personal safety among dentist in Egypt

This is a cross-sectional, online survey-based study administered to Dentist in Egypt. A 20-item questionnaire will be developed and distributed using Google Forms.

Participants were recruited through social networking websites and applications (Twitter, Instagram, Facebook, LinkedIn, and WhatsApp). The questionnaire will be conducted from 24 May 2020 and until 30 june 2020.

The survey will be delivered in Enlish. Participants will be able to complete the survey only once and will be allowed to terminate the survey at any time they desired. The survey will be anonymous and confidential. An introductory paragraph outlining the purpose of the study will be posted along with the survey.

Eligibility Criteria:
Inclusion Criteria:

All dentist actively working in Egypt

Exclusion Criteria:

* non dentist
* resident outside egypt
Evaluation of Granulosa Cells Function After IVF Protocols

This study is intended to evaluate ovarian cells after being submitted do different in vitro fertilization protocols. The investigators will analyze hormones secretion and intracellular mechanisms of these cells comparing the GnRH agonist protocol and the GnRH antagonist protocol.


Eligibility Criteria:
Inclusion Criteria:

* Patient age limit: 39 years
* Follicle Stimulating Hormone (FSH) \< 10 micrometer (mU) / Liter
* Antral follicular count \> 12
* Regular menses (25 to 35 days)
* More than 3 oocytes after ovarian punction
* Anti Mullerian between 1 e 3 ng/ml

Exclusion Criteria:

* Patients submitted to intracytoplasmatic sperm injection (ICSI)
* Ovarian mass or cyst
* Clinical / endocrine pathologies
Hydronephrosis on Ultrasound With CT Finding in Patients With Renal Colic

The purpose of this study is to determine the overall sensitivity and specificity of hydronephrosis on point-of-care bedside ultrasound to identify hydronephrosis as compared to hydronephrosis found by CT.


Eligibility Criteria:
Inclusion Criteria:

* Emergency Department patients 18 yrs or older with suspected renal colic in whom the clinician intends to obtain a CT scan to diagnose kidney stone.
* Informed consent will be required prior to enrollment in the study.

Exclusion Criteria:

* Known renal disease (any ESRD, transplant, PCKD), dementia, trauma, language barrier, incarcerated patients, and patients who do not undergo CT.
GI Tract Biomarkers in Infants With Different Diets

Childhood obesity is increasing with more than one-third of adolescents currently overweight and one in five with obesity. The lifelong incidence of obesity-related morbidities is also increasing with childhood obesity. It is not yet known how obesity develops in an individual, specifically in early childhood. Further, it is unclear what mechanistic role a child's earliest nutrition or changing intestinal flora has in the etiology of obesity. Very young children are developing appetite and satiety patterns early in life. Nutrition and gut microbial flora have impact on how these processes unfold, but specific mechanisms are not yet well understood. The investigators hypothesize that formula-fed infants with changes in their microbial flora are more likely to have altered carbohydrate metabolism, evidenced by greater imbalances of fatty acid production, and are more likely to have accelerated growth trajectory due to satiety disruption. The investigators further hypothesize that altered carbohydrate metabolism, e.g. imbalances of short- and long-chain fatty acid levels in the gut, stimulate cellular stress and affect specific gut hormones. This study will compare the microbiome of the intestinal microbial flora in two groups of infants, one breast fed and the other formula fed, using longitudinally collected fecal samples from both groups. Samples will be subjected to shotgun metagenomic analysis and simultaneous metabolomic analysis. A bioinformatics approach will elucidate key differences among and between sample groups, and will further analyze bacterial gene expression levels related to carbohydrate metabolism. This study will compare the expression of human proteins involved in cellular stress response and gut peptide signaling by applying quantitative Reverse Transcriptase-Polymerase Chain Reaction to human messenger RNA isolated from the longitudinally collected samples from both groups. Finally, this study will monitor the trajectory of growth and feeding over the first 2 years of life. The project's focus on the influence of different early feeding types, microbial flora changes, and altered carbohydrate metabolism leading to disruption of gut-brain signaling will provide critical data for host:microbiome interactions and translational therapeutic targets.


Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy, male or female term infants
* Exclusively breast or formula feeding
* Never been exposed to oral or intravenous antibiotics or probiotics

Exclusion Criteria:

* Maternal antibiotic use while breast-feeding
* Infant or maternal use of probiotics
* Current or recent (\<14 days) gastrointestinal infection (viral, bacterial, or fungal)
* Gastrointestinal mucosal disease, or significant constipation
* Consuming formula that is not standard cow's milk formula
* Infants on acid suppression medications or infants receiving high-density formula (\>20 calories/ounce) may be enrolled and will be analyzed separately
Cardiovascular and InflammAging Study

Evidence from previous studies supports a strong relationship between fruit and vegetable consumption and reduced cardiac risk. This could be mediated via improvements on blood pressure, platelet function and vascular reactivity. Certain vitamins and polyphenols found in fruits and vegetables, have antioxidant and anti-inflammatory effects and play a major role on the function of immune cells. Previous studies have also demonstrated the importance of omega-3 fatty acids on humans' health and their positive effects on the cardiovascular system and blood lipids regulation, as well as their involvement on inflammatory response. Nutritional regimens with adequate intake of micronutrients, fruit and vegetables, omega-3 fatty acids, low in sugar and saturated fats, such as the Mediterranean diet or vegetarian diets, can reduce chronic inflammation and oxidative stress and improve cardiovascular risk profile. Considering that the population's fruit and vegetable and omega-3 intakes are below recommendations, whole food-based supplements could provide an accessible form of supplementation to bridge the gap between actual and recommended intakes. This study is aiming to assess whether long-term separate ingestions of an encapsulated juice powder concentrate and a plant-based omega fatty acid supplement, or a combined ingestion of the two, can affect biomarkers of cardiovascular health, low-grade inflammation and indicators of biological aging in older adults.


Eligibility Criteria:
Inclusion Criteria:

* Post menopausal
* Non-smokers
* BMI 18.5 to 40 kg/m2
* Vegetable intake ≤ 2 servings/ day
* Intake of fruits ≤ 2 servings /day
* Adherence to a 6-week washout period for dietary supplements not ingested for specific medical conditions.

Exclusion Criteria:

* Age \<55 and \>80 years
* Smokers (or ex-smokers who quit smoking less than 3 years ago)
* Aversion to stop the intake of multivitamins, multiminerals or omega fatty acid supplements
* Subjects with histamine intolerance
* Hypertension, starting with grade 2 according to the classification of the European Society of Hypertension: systolic blood pressure \> 160mmHg, diastolic blood pressure \>100 mmHg
* All medication taken for less than 3 months or with changes on the dosage over the last 3 months and medication for any of the conditions listed below.
* Clinically relevant infectious diseases
* Diabetes mellitus type I and type II
* Rheumatic diseases
* Auto-immune diseases
* Any stents and coronary artery diseases (CAD)
* Cancer patients
* Pregnancy
* Significant lifestyle changes, e.g. changes in diet or physical activity profile