Kornimate/medical-research-clean huggingface dataset:
the effects of a botanical moisturizer, an oral supplement, and an unscented soap on eczema and itch

Conditions: Atopic Dermatitis (Eczema)

Summary: the purpose of this study is to examine the effects of a botanical moisturizer, an oral supplement, and an unscented soap on eczema severity, itch, mood, and various skin measures (such as skin hydration) in those with mild to moderate eczema.


Eligibility criteria:
inclusion criteria: * sex: female and male; * age : 18 years old and above; * phototype: i to iv; * type: caucasian; * subjects with active eczema condition the body (showing flakiness, irritation, itch and intense dryness); * subjects with a scorad of 25 - 50; * subjects with dry skin on the study areas (cutaneous hydration rate \< 50 a.u); * subject barely wearing makeup; * subjects must not take antibiotics and / or apply any antifungal treatments (body/scalp) for 1 month before study start and during the entire study duration; * no change in hygiene, cosmetics, and make-up habits - except for the product(s) under study - during the entire study duration; * subjects agreeing not to change lifestyle habits during the study duration. * healthy subject; * subject having given her free informed, written consent; * subject willing to adhere to the protocol and study procedures; * subject with polish citizenship. exclusion criteria: * for women with childbearing potential: pregnant or nursing woman or woman planning to get pregnant during the study; * cutaneous pathology on the study zone (other than eczema); * use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the cutaneous acceptability/efficacy of the study product (the subjects are allowed to use their topical corticosteroids during the study if needed; the information about the treatment and the number of applications must be noted in the daily log); * subject having undergone a surgery under general anesthesia within the previous month; * excessive exposure to sunlight or uv-rays within the previous month; * subject enrolled in another clinical trial during the study period (concerns the studied zones).

Keywords: eczema skin care oral supplement antioxidant l-histidine botanical itch dry skin
a phase iii clinical trial to evaluate the protective efficacy of three doses of oral rotavirus vaccine (orv) 116e

Conditions: Viral Gastroenteritis Due to Rotavirus

Summary: the trial is a phase iii randomized, double-blind, placebo-controlled trial with the primary objective of evaluating the efficacy of three doses of orv 116e, 10\^5.0 ffu, against severe rotavirus gastroenteritis, in comparison with a placebo in india.

the trial is a phase iii randomized, double-blind, placebo-controlled trial with the primary objective of evaluating the efficacy of three doses of orv 116e, 10\^5.0 ffu, against severe rotavirus gastroenteritis, in comparison with a placebo in india. the clinical trial is not a global trial. three administrations of orv 116e will be co-administered with childhood vaccines (which will include vaccines against diphtheria, pertussis, tetanus, haemophilus influenzae b and hepatitis b and opv) at 6 to 7 weeks, greater than or equal to 10 weeks and greater than or equal to 14 weeks of age. 6800 subjects will be enrolled in three sites - delhi, pune (maharashtra) and vellore (tamil nadu) and followed up till the age of 2 years (24 months + up to 14 days). multiple trial sites are included to ensure greater demographic distribution to obtain evidence of cross immunity and quicker recruitment of the necessary number of subjects. the subjects to be included from these sites would be representative of the population of india. the protocol has been reviewed by the institutional review boards of the society for applied studies (new delhi), kem hospital research centre (pune), christian medical college (vellore). ethics clearance has also been obtained from the department of biotechnology, government of india and western institutional review board.

Eligibility criteria:
inclusion criteria: * at least one parent(s) or legally acceptable representative's consent for participation and are able to understand study procedures * subjects aged 6 to 7 weeks at recruitment * no plans to move in the next 24 months exclusion criteria: * administration of rotavirus vaccine in the past * presence of any illness requiring hospital referral (temporary exclusion) * known case of immunodeficiency disease, known hiv positive * known case of chronic gastroenteritis disease * any other conditions which in the judgment of the investigator warrant exclusion (e.g. no exclusion criteria but seems "ill", investigators suspects neglect) * diarrhea on the day of enrollment (temporary exclusion)
laparoscopic gastric plication operation for patients with severe or morbid obesity

Conditions: Morbid Obesity

Summary: the purpose of this study is to collect data prospectively on the safety and efficacy of the laparoscopic gastric plication operation for patients with severe or morbid obesity. the 95% confidence interval for average percentage of weight loss and body mass index will be computed at 6 months, one year and then annually. analysis of comorbid conditions changes, quality of life and adverse events will be performed. with 50 subjects in the study, limited power is expected and no formal hypothesis testing will be performed.

the laparoscopic gastric plication (lgp) is a new restrictive bariatric surgical technique that has the potential to eliminate the complications associated with other restrictive procedures (i.e., gastric banding, sleeve gastrectomy) by creating a restriction without the use of an implant and without performing gastric resection. lgp is notably similar to a sleeve gastrectomy in that it generates a gastric tube by means of eliminating the greater curvature but does so without gastric resection.

Eligibility criteria:
inclusion criteria: * age: 18 - 60 years * bmi 35-39.9 kg/m2 with one or more severe co-morbid conditions or bmi 40-55 kg/m2 * willingness to comply with dietary restrictions required by the protocol * history of obesity for at least 5 years * history of at least 6 months of documented failures with traditional non-surgical weight loss methods * willingness to follow protocol requirements which include: signing the informed consent form, completing routine follow-up visits for the study duration, and completing all pre- and post-operative laboratory and diagnostics tests in addition to the quality of life questionnaire * if female with childbearing potential, using an appropriate form of contraception exclusion criteria: * age less than 18, age greater than 60 * pregnancy * history of major depressive disorder or psychosis * previous bariatric surgery or previous gastric surgery * presence of achalasia * any condition that, in the judgment of the investigator, would place a subject at undue risk, or could potentially compromise the results or interpretation of the study

Keywords: obesity morbid obesity bariatric surgery laparoscopic gastric plication
non-invasive method for predicting the presence of gastroesophageal varices in patients with cirrhosis

Conditions: Gastroesophageal Varices; Portal Hypertension

Summary: gastroesophageal varices are a complication of portal hypertension in cirrhosis.endoscopy is an unsatisfactory screening test.in this prospective clinical study,we will enroll patients with cirrhosis of various causes, all of whom undergo laboratory tests, elastography, and serum proteomic differential protein testing, including liver elastography (lsm) and spleen elastography (ssm). baveno vi or expanded bavenovi criteria are validated by comparing patients' lsm, ssm, serum differential protein, platelet count, and egd data to evaluate the clinical value of ssm and differential proteins in excluding cirrhosis of cirrhosis.at the same time, based on ssm and serum differential protein, a new predictive model of variceal varices will be established to evaluate the diagnostic value of ssm and differential protein for esophagogastric varices, and a non-invasive method for reliably predicting and evaluating cirrhosis with esophageal varices will be found.


Eligibility criteria:
inclusion criteria: 1. the age ranged from 18 to 75 years. 2. clinical or pathological diagnosis of cirrhosis; 3. electronic gastroscopy is planned; 4. to agree and sign the informed consent; exclusion criteria: 1. hepatocellular carcinoma or other malignant tumors have been or are currently diagnosed; 2. orthotopic liver transplantation patients; 3. patients who have undergone transjugular intrahepatic portosystemic shunt (tips),or previous surgical shunt; 4. pregnant women; 5. neurological or psychiatric disorders;
biological rhythms and vestibular system

Conditions: Unspecified Disorder of Vestibular Function, Bilateral

Summary: the purpose of this study is to study the relationship between the vestibular system and chronobiology

the purpose of this study is to study the relationship between the vestibular system and chronobiology. two parts will be performed. in the first one patients with bilateral vestibular areflexia will be compared to control subjects. in the second the effect of vestibular stimulation on circadian rhythms will be evaluated

Eligibility criteria:
inclusion criteria: * no treatment changing vigilance/wakefulness * moderate caffein uptake (2 to 3 cups a day) * moderate smoker (5 cigarettes a day) * regular sleeping habits exclusion criteria: * sleeping duration \ 9 hours * night workers * pregnancy * sleep or wakefulness disorders * progressive neurodegenerative disorders * progressive psychiatric disorders * thyroid disease * type 1 diabetes * not able to practice physical activity * drug or alcohol addiction during the last 6 months

Keywords: circadian rhythm exercise reflex, vestibular ocular postural balance
thromboembolism prevention efficacy and safety trial (tempest)

Conditions: Arthroplasty

Summary: the purpose of this study is to gain additional safety information as well as to determine after the study drug has been given to patients who have undergone total hip replacement surgery, whether the study drug is effective in preventing late deep vein thrombosis (blood clots in legs) or pulmonary embolism (blood clots in lungs).


Eligibility criteria:
inclusion criteria: * patients scheduled for primary elective unilateral total hip arthroplasty (i.e. first time the hip is being replaced on the operative side). * patients who have given written informed consent to participate in this study. exclusion criteria: * patients with a contraindication to contrast venography * patients with an increased risk of bleeding. * patients with a predefined risk for prethrombotic episodes or a history of thrombophilia. * other inclusion or exclusion criteria to be determined by the physician and study sponsor.

Keywords: venous thromboembolism thromboembolism pulmonary embolism deep vein thrombosis
the iliac arterio-venous fistula for treatment of neurally mediated syncope study

Conditions: Neurally Mediated Syncope

Summary: the purpose of the study is to investigate the efficacy of the rox coupler in treating patients with tilt test proven neurally mediated syncope.

neurally mediated syncope (nms) is a debilitating condition, with no proven therapeutic measures. the rox coupler is a device used to create an iliac arterio-venous anastamosis which allows a shunt of 0.8 litres per minute. the haemodynamic changes following creation of an arterio-venous anastomosis at the iliac level leads to an increase in cardiac preload, reversing finding thought to induce nms. this a randomised controlled study to evaluate the effect of iliac arterio-venous anastamosis in patients with neurally mediated syncope. the head up tilt test is used as an objective measure to evaluate the effect of the arterio-venous anastamosis in patients with nms. participants with tilt test proven nms will be eligible for the study ( if they satisfy all other eligibility criteria). participants will be randomised to rox coupler intervention or standard therapy. the primary outcome measure will be absence of loss consciousness on tilt table testing at 3 months post intervention.

Eligibility criteria:
inclusion criteria: * absence of transient loss of consciousness associated with reflex bradycardia or hypotension on tilt testing at 3 months following randomised intervention exclusion criteria: * time to first episode of syncope after randomised intervention * number of syncopal episodes in the first 3 months after randomised intervention. * tilt table response at 6 months following randomised intervention i.e. 3 months after unblinding * number of syncopal episodes at 6 months after intervention i.e. 3 months after unblinding
permanent pacing for drug-refractory symptomatic patients with obstructive hypertrophic cardiomyopathy.

Conditions: Obstructive Hypertrophic Cardiomyopathy

Summary: the present trial is undertaken as a pilot study on selected patients, to evaluate the ability of acute hemodynamic testing to optimize pacing therapy and to predict the response of obstructive hypertrophic cardiomyopathy (ohcm) to pacing, in terms of reduction of left ventricular outflow tract (lvot) pressure gradient and functional capacity improvement. the primary objective is to demonstrate a long-term reduction in lvot obstruction at rest and/or after valsalva/exercise \> 30% in patients responding to acute stimulation test


Eligibility criteria:
inclusion criteria: * unequivocal diagnosis of hcm, on the basis of 2-dimensional echocardiographic demonstration of a hypertrophied (wall thickness \>15 mm or \> 13 mm in familial hocm) and non dilated lv in the absence of another cardiac or systemic disease capable of producing the same magnitude of hypertrophy; * patients in whom coronary disease has been excluded; * presence of severe refractory symptoms (nyha class ii-iv), as evidenced by moderate-to-severe functional disability resulting from exertional dyspnea or chest pain sufficient to support a desire for alternative treatment modalities, following administration (in standard dosages) of beta-blocker and either disopyramide or verapamil, independently or in association; * peak instantaneous lv outflow tract gradient \> 50 mm hg (resting or provoked), estimated by continuous wave doppler; exclusion criteria: * end-stage phase of hcm (unless crt therapy is considered); * ejection fraction \<50% (unless crt therapy is considered); * severe mitral valve disease (+++) not related to systolic anterior movement and/or papillary muscle abnormalities; * age below 18 years.
the utility of the validated intraoperative bleeding scale in spine surgery

Conditions: Intraoperative Blood Loss; Thoracolumbar Spine Surgery

Summary: this is a single-center, prospective, observational study that will compare the blood transfusion rate between intraoperative bleeding severity characterized using the validated intraoperative bleeding scale (vibe).

primary aim: assess the association between the vibe scale and intraoperative and postoperative blood transfusion rates for posterior thoracolumbar spine surgery. primary hypothesis: patients with higher recorded vibe grades during the five stages of spine surgery (exposure, decompression, instrumentation, fusion, and closing) will have a higher rate of receiving blood transfusions. secondary aims: determine the association between the vibe scale and other postoperative outcomes and complications.

Eligibility criteria:
inclusion criteria: * ages 18 to 88 years * patients receiving elective open, posterior thoracolumbar surgery exclusion criteria: * patients receiving non-elective or trauma surgery * patients with pathologic spine fracture or metastatic disease to the spine * patients receiving thoracolumbar surgery through anterior or lateral approach * patients receiving spine surgery for debridement of suspected or confirmed infection

Keywords: blood loss thoracolumbar spine surgery vibe blood transfusion
rabeprazole specific clinical experience investigation for the long-term combination therapy with low-dose aspirin

Conditions: Gastric Ulcer; Duodenal Ulcer

Summary: to investigate the safety and efficacy of long-term combination therapy with rabeprazole and low-dose aspirin.


Eligibility criteria:
inclusion criteria: 1. patients taking long-term low-dose aspirin for prevention of thrombus/embolism at the start of administration of rabeprazole (including patients who start low-dose aspirin on the same day as the start of administration of rabeprazole). 2. patients with a history of gastric/duodenal ulcers. 3. patients requiring long-term use of rabeprazole for prevention of recurrence of gastric/duodenal ulcers induced by low-dose aspirin. exclusion criteria: 1. patients with gastric/duodenal ulcers at the start of administration of rabeprazole. 2. patients with active upper gastrointestinal bleeding at the start of administration of rabeprazole. 3. patients with contraindication for rabeprazole.

Keywords: stomach ulcer duodenal ulcer rabeprazole recurrence
comparison of the breast tumor microenvironment

Conditions: Triple Negative Breast Cancer; Hormone Receptor Positive Malignant Neoplasm of Breast

Summary: the goal of the project is to identify a molecular signature of tumor stroma from "normal" adjacent breast tissue obtained prospectively at the time of breast conserving surgery before and after receiving intraoperative radiation therapy (iort) in subjects that have luminal a and triple negative breast cancer. iort is considered as being standard of care.

there is evidence that the normal tissue around a tumor plays a role in determining how the tumor behaves, including how it will respond to treatments and how likely it is to recur. in breast cancer, radiation is used to decrease the chance of recurrence in the area where the tumor is removed. this risk of recurrence varies between different types of breast cancer. the investigators seek to study the proteins produced in normal tissue surrounding breast tumors. the tissue will be taken from women who are receiving radiation to the breast at the time of their surgery (known as intraoperative radiation), one specimen taken before radiation and one after. a new process will be used to stabilize the tissue rapidly and allow the proteins to be identified before they break down. this will allow us to identify differences in the proteins produced by cells before and after radiation and between two types of breast cancers, luminal a (less likely to recur) and triple negative (more likely to recur). identifying these differences in proteins may allow them to be used in the future as markers to predict the likelihood of tumors recurring.

Eligibility criteria:
inclusion criteria: * female, age greater than or equal to 40 * core biopsy proven invasive breast carcinoma or ductal carcinoma in situ (dcis), all subtypes excluding invasive lobular carcinoma due to increased risk for multifocal disease * human epidermal growth factor receptor 2 (her2) negative regardless of hormone receptor status * clinically less than or equal to 3cm unifocal lesion * clinically node negative * must have diagnostic mammogram performed within last 6 months * eastern cooperative oncology group performance status (ecog ps) less than or equal to 1 * appropriate renal, liver, and hematologic lab values * ability to give informed consent exclusion criteria: * multifocal disease * clinically n1 disease at diagnosis * invasive lobular carcinoma * metastatic disease * patients for whom rt would be contraindicated (e.g., connective tissue disorder or prior ipsilateral breast radiation) * patients with known brca1/2 mutations * pregnant or nursing

Keywords: triple negative breast cancer microenvironment iort hormone receptor positive, her 2 negative
bone and inflammatory outcomes - nutrition and exercise trials

Conditions: Healthy; Bone; Inflammation

Summary: this study investigates whether dairy products will positively impact loading exercise-induced bone turnover and bone cell activity and/or the post-exercise inflammatory response in healthy young adults compared to a carbohydrate drink and/or water.

introduction: two million individuals at a cost of around 4.6 billion dollars a year in canada suffer from osteoporosis. it is important to investigate strategies that can reduce bone loss and/or increase bone mass. similarly, inflammation is associated with many different disease states, and investigating strategies to reduce systemic inflammation is prudent. nutrition and exercise may be inexpensive and accessible strategies to improve bone health and inflammation and should be explored in different contexts and implemented. our proposed research combines both nutrition and exercise along with the assessment of bone turnover and inflammatory markers in healthy young adults. design: randomized controlled crossover trial participants: healthy, university aged males and females. methods: during the study participants will complete 4 different acute exercise and nutritional supplement trials, in random order. the four trials are: 1) exercise+carbohydrate (cho), 2) exercise+milk (milk), 3) exercise+greek yogurt (gy), and 4) exercise+water (w). the whole study will take a maximum of 16 weeks and each supplement trial will be separated by 2-4 weeks. outcomes: several markers of bone turnover and bone cell activity as well as markers of inflammation will be measured in the blood, before exercise and at different times post-exercise and post supplement consumption.

Eligibility criteria:
inclusion criteria: * between the ages of 18-30 years * normal bmi (18.5-24.9) kg/m\^2 * low to moderately physically active (0-2 times/week) * no allergy to dairy protein or lactose intolerance * on no medication related to a chronic condition * on birth control or naturally cycling with a regular menstrual cycle) exclusion criteria: * regular smoker (cigarettes, e-cigarettes (e.g., vapes) or cannabis) * any chronic condition, inflammatory, or auto-immune condition

Keywords: bone health females dairy exercise inflammation