cyrilzakka/clinical-trials huggingface dataset:
Beneficial Effects of Probiotics on Improvement of Gut Dysbiosis and Ascending Cholangitis in Patients Received Pancreaticoduodenectomy

To determine whether probiotics have beneficial effect on gut dysbiosis and postoperative ascending cholangitis in patients with pancreaticoduodenectomy.

Gut dysbiosis and postoperative ascending cholangitis (POAC) occurred after pancreaticoduodenectomy (PD). To date, no clinical trial has evaluated the association between gut dysbiosis, POAC and probiotics. POAC is a common morbidity after pancreaticoduodenectomy or in obstructive jaundice patients with endoscopic retrograde biliary drainage (ERBD). It frequently induces longer hospital stay and makes the major obstacle for postoperative chemotherapy. This phenomenon reveals the important role of ampullary vater in control of retrograde bacterial inflow into bile duct. However, the exact difference of gut microbiota after pancreaticoduodenectomy is still unknown. Probiotics is reported efficacy in restore the normal flora of gut microbiota. So, this study is to evaluate the effects of probiotics consumption, Yugart 2 bottles per day for 1 month on gut microbiota in control of ascending cholangitis before and after pancreaticoduodenectomy through the analysis of microbial community by next generation sequencing.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with peri-ampullary lesions and scheduled to receive pancreaticoduodenectomy (PD) were designed as experimental group; subjects with pancreatic lesions and scheduled to receive distal pancreatectomy (DP) were designed as control group.
* Subjects that already received PD for more than 6 months to join the study and aim to evaluate the effect of probiotics on gut microbiota and postoperative ascending cholangitis (POAC).
* Subjects with the amount of two bottles a day (one provided in the morning and the other in the afternoon) for a duration of 4 weeks.

Exclusion Criteria:

* Subjects are currently participating in any other clinical trials or studies.
Body Composition and Acute Stroke

Body composition appears to be a prognostic factor for the severity and functional outcome of stroke patients. In this study the prognostic value of two bioimpedance parameters will be studied (skeletal mass index and phase angle) and two temporal muscle measurements (thickness and surface area) to predict the functional outcome of patients at discharge and at 6 months

A stroke commonly causes weakness and loss of independence. Predicting functional outcomes is a major challenge because it guides rehabilitation care or institutionalization choices. Various factors, including the extent of the initial deficit or the size of the lesion, have been shown to play a role in residual disability after stroke. Premorbid physiological status has been less studied in stroke. However, loss of muscle mass and premorbid strength are prognostic factors for poor short- and medium-term functional recovery.

In this work, the body composition of patients in the acute phase of a stroke will be studied to determine whether its alteration is a poor prognostic factor in the short term (discharge from the initial hospitalization) and in the medium term (follow-up visit at 6 months). It will be studied using impedance analysis and morphological measurements on the temporal muscle.

In a cohort study of hospitalized patients in the acute phase of a stroke, measurements using a bioimpedance meter (InBody BWA) will be performed to measure a skeletal mass index (SMI) and phase angle. The properties of the temporal muscle (thickness and surface) will also be measured at T1, within 72 first hours after the stroke. Clinical and morphological data will also be collected (weight, height, initial deficit, lesion volume).

The aim of the work is to determine whether these body composition factors have an impact on the functional outcome of patients assessed at discharge and 6 months later. Functional assessment will be performed with modified Rankin score (mRS).

It is hypothesized that all body composition factors studied will be factors independent of the short- and medium-term functional prognosis.

Eligibility Criteria:
Inclusion Criteria:

* volunteer stroke patients in acute phase
* Age ≥ 18 years
* Having had a brain MRI
* Able to understand assessment guidelines
* Not having objected to participate in the study after being duly informed

Exclusion Criteria:

* Person under tutorship or curatorship
* Person under court protection
* Persons deprived of their liberty
* Pregnant or breastfeeding women
* Have a pacemaker or defibrillator
DOREFA (Retinal Detachment: Function and Anatomy)

Patients with retinal detachment do not always recover good visual function. Sometimes simple causes are responsible. Other causes can only be discovered thanks to high-resolution imaging provided by the latest generation of OCT.

This study is possible thanks to surgical teams who have a strong recruitment potential, with the experience of a joint project in 2007-2008 (PHRC national - Etude DOREMY, Etude FRIENDS) to define more strict intervention criteria. The principal objective of this study is to better define with regard to time:

* The onset of surgically curable or transient macular affections, and losses in visual acuity that can be qualified as "explained"
* But above all to better understand the relationships between anatomical analyses obtained using OCT and autofluorescence and functional analysis using visual acuity and microperimetry.
* In the near future, two techniques (OCT and microperimetry) will certainly become essential tools in the evaluation of macular function. Better understanding of these relationships is the first necessary step in any study concerning the therapeutic prevention of retinal lesions related to retinal detachment: This study will make it possible to define criteria for the evaluation of anatomical and functional recovery, their relationship with each other and finally their evolution over time. This is an essential first phase before possible therapies can be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have provided written informed consent
* Retinal detachment with pre-operative raised macula, re-attached during a surgical intervention with one month of follow-up
* Patients undergoing surgery as the first-line treatment (ab extern surgery or gas vitrectomy)
* Patients who accept to be followed for at least 12 months at the investigating center.

Exclusion Criteria:

* Persons who are not registered with social security agency
* Macular affections pre-existent to the DR
* Retinal detachment requiring several interventions to obtain a reapplication
* Lazy eye with pre-operative
* Brightness of the circles not allowing the realization of the examinations
Evaluation of Adam's Forward Bend Test and Smartphone Application in Screening of Adolescent Idiopathic Scoliosis

Scoliosis is a lateral curvature of the spine when the Cobb´s angle more than 10˚ on the frontal plane. Curve detection before skeletal maturation gives a good opportunity for early treatment or prevention of curve progression. Purpose of this study was to evaluate Adam's Forward Bend Test and Scoliometer HD in screening of Adolescent Idiopathic Scoliosis

The student was asked to stand erect, knees straight, feet at the same level and hands freely hanging.

They was observed from the back for shoulders, pelvic, and knees level. Student was asked to bend forward with his knees straight, feet together and hands freely and loosely hanged(Forward Bend Test).

Scoliosis was detected with rib cage rotation and hump appearance (positive test).

Absence of hump appearance means negative test. After Forward Bend, the students were screened using the Scoliometer HD Application.

The students were asked to bend forward with arms dangling and palms pressed together. The smart phone (Scoliometer HD) was placed on the student back with the central dark area in the application placed on the spinous processes of the lumber and thoracic regions to measure the angle of trunk rotation. Students with a scoliometer HD reading ≥7 degrees (≥20 ̊ Cobb's angle) were referred to orthopedic consultation and their parents were informed about the findings of the screening by the school manager and social worker.

Then the data were collected for statistical analysis

Eligibility Criteria:
Inclusion Criteria:

* Age range from 10 to 15 year.
* Males ( parents of girls refused their participation).
* Students who have structural scoliosis.

Exclusion Criteria:

* Congenital deformities.
* Neuromuscular disorder (Cerebral palsy and spinal muscle atrophy).
* Syndromic disorders (Muscular dystrophy, Osteogenesis imperfect and spinabifida).
Managing High-alert Medication Administration and Errors

High-alert medications are drugs that may lead to serious harm when they are wrongly administered to patients. Safe medication administration is the crucial role of nursing staff.

High-alert medications are drugs that may lead to serious harm when they are wrongly administered to patients. Safe medication administration is the crucial role of nursing staff. This study aims to investigate the relationships between medication safety climate and nurses' knowledge about high-alert medications with managing their administration and errors.

Eligibility Criteria:
Inclusion Criteria:

* Nurses

  * willing to participate in the study
  * work in surgical intensive and critical care units
  * Sign a consent

Exclusion Criteria:

- Nurses

* Work in outpatient units and other units
* Did not sign a consent
The Influence of the Microbiome on Rotavirus Vaccine Immunogenic Response in Infants in Karachi, Pakistan

This is a nested case-control study within an ongoing rotavirus vaccine immunogenicity trial in Karachi, Pakistan. The primary study aim is to compare the fecal microbiota composition and diversity of infants who do (control) and do not (case) demonstrate immune seroconversion to rotavirus vaccination. The infants will be matched for vaccination dose, age and breast-feeding practices.


Eligibility Criteria:
Inclusion Criteria:

* Infants already consented and enrolled in the overarching study: Immunogenicity of Rotavirus Vaccine Under Different Age Schedules and the Impact of Withholding Breast Feeding around the Time of Vaccination on the Immunogenicity or Rotarix Vaccine trial (NCT01199874)

Overarching study (NCT01199874)inclusion criteria:

* 6 weeks 0 days to 7 weeks 6 days age at the time of enrollment
* Healthy infant free of chronic or serious medical condition as determined by history and physical exam at time of enrollment
* written informed consent obtained from parents or guardians for overarching study Nested study additional inclusion criteria
* written informed consent obtained from parents or legal guardians for this nested study
* availability of a baseline, pre-vaccination fecal sample

Exclusion Criteria:

Overarching study (NCT01199874)exclusion criteria

* hypersensitivity to any of the vaccine components
* Use of any investigational drug or vaccine other than the study vaccine within 30 days of first dose of study vaccine or during the study
* use of any immunosuppressive drugs
* previous intussusceptions or abdominal surgery
* enrollment in any other trials
* birth weight less than 1500 grams; or if birthweight is unknown, weight less than 2000 grams on or before 28 days
* immunoglobulin and/or blood products use since birth or during the study period Nested study additional exclusion criteria
* positive serum anti-rotavirus IgA (\> or= 20U/mL) at 6 weeks of age, indicative of rotavirus infection prior to vaccination
FLorida Puerto Rico Atrial Fibrillation Stroke Study (FLiPER-AF)

In this study, FL-PR Stroke Registry will be used to determine novel data on disparities in stroke care and outcomes for patients with Atrial Fibrillation (AF) in 'real life' hospital setting. Investigators will evaluate clinical practice for AF detection and treatment in stroke patients within large stroke hospital systems of care with multi-ethnic patient populations and thereby representative of the states of Florida and Puerto Rico. The results of this study will be of critical importance for secondary stroke prevention by identifying gaps in stroke care for patients with AF and by recognizing the needs for developing targeted interventions to reduce disparities in diverse populations of stroke patients with AF and improve systems of care for all stroke patients with AF.


Eligibility Criteria:
Inclusion Criteria:

* age is 18 and older
* primary diagnosis of ischemic stroke
* enrolled in the Florida - Puerto Rico Stroke Registry

Exclusion Criteria:

* primary diagnosis of intracerebral hemorrhage
* diagnosis of subarachnoid hemorrhage
* stroke not otherwise specified
* no stroke related diagnosis
* admission for elective carotid intervention only
Multifocal Contact Lenses vs Bifocal Spectacles for Congenital Cataracts

In this study, the investigators provide participants who had congenital cataract the multifocal contact lenses and bifocal spectacles in the purpose of seeking out a better way to make a definite diagnosis with high efficiency and accuracy, and report a prospective, randomized controlled study aiming at comparison of multifocal contact lenses and bifocal spectacles.

Children diagnosed as cataract without treatment were enrolled to a prospective, randomized controlled study. Patients were assigned to four groups: participants in group A wearing multifocal contact lenses a week and then bifocal spectacles a week;in Group B, the participants wearing bifocal spectacles a week and then multifocal contact lenses;in Group C, the participants wearing multifocal contact lenses four a year;in Group D, the participants wearing bifocal spectacles four a year. Investigators compare the acuity, refraction, contrast sensitivity and the results of questionnaire between A and B , C and D groups.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as binocular cataract
* after the surgery of binocular intraocular lens implantation more than one month

Exclusion Criteria:

* diagnosed as xerophthalmus
* diagnosed as other eye diseases or systemic diseases
Laparoscopic Cholecystectomy After ERCP

Evaluation of outcomes of early and late laparoscopic cholecystectomy after ERCP

Evaluation of both benefits and harms of doing laparoscopic cholecystectomy early within first 72 hours and late from the third day up to 2 months after ERCP

Eligibility Criteria:
Inclusion Criteria:

* female patient
* 18-60 years old

Exclusion Criteria:

* male patient
* extremes of age less than 18 and more than 60
Assessment of the Ankle Joint Axis Using a Long Ankle View Radiograph

The study is a reliability (reproducibility) study on a single measurement procedure. Reliability (reproducibility) will be assessed by repeating the whole measurement procedure twice. The measurement procedure studied is the generation of a long ankle view image based on a radiographic assessment followed by a manual assessment of the medial-distal tibial angle.

The study is a reliability (reproducibility) study on a single measurement procedure. Reliability (reproducibility) will be assessed by repeating the whole measurement procedure twice. The measurement procedure studied is the generation of a long ankle view image based on a radiographic assessment followed by a manual assessment of the medial-distal tibial angle (MDTA).

In order to assess the value of different assessment methods of the MDTA, several variants will be considered, which are all applied to the same long ankle view image. To determine the intra- and interrater reliability of the manual assessment, this assessment will be done twice by different observers (one doctoral student, one radiologist) and repeated within each observer.

Eligibility Criteria:
Inclusion

* Clinical indication for a radiographic assessment of the lower half of one leg
* Age above 20

Exclusion Criteria:

* Previous bony procedures (surgery), fractures or anomalies of the lower leg, which does not allow a reliable assessment of the MDTA
* Symptomatic or clinically obvious malalignment at any level of the lower extremity
* Pregnancy
Food-Effect on PK and PD of Single Oral Dose of CJ-12420 in Healthy Male Subjects

* Primary: To evaluate food effect on the pharmacokinetics (PK) of a single oral dose of CJ-12420 in healthy male subjects.
* Secondary

  * To explore food effect on the pharmacodynamics (PD) of single oral dose of CJ-12420 in healthy male subjects(PD/PK group)
  * To evaluate the safety of single oral dose of CJ-12420 in healthy male subjects under fed or fasting condition.


Eligibility Criteria:
Inclusion Criteria:

* Male volunteers in the age between 20 and 45 years old(inclusive)
* Body mass index (BMI) in the range of 19 to 28 kg/m2 and weighing at least 50 kg (inclusive)
* Medically healthy with no clinically significant vital signs (sitting position blood pressure, pulse rate)

  1. 90 mmHg ≤ systolic blood pressure ≤ 140 mmHg
  2. 50 mmHg ≤ diastolic blood pressure ≤ 95 mmHg
  3. 45 beats per minute ≤ pulse rate ≤ 95 beats per minute
* Understand the requirements of the study and voluntarily consent to participate in the study

Exclusion Criteria:

Subjects will be excluded from the study if there is evidence of any of the following criteria: Last three criteria will be applied ONLY to PD/PK group.

* History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary,immunologic, psychiatric, musculoskeletal or cardiovascular disease or any other condition, which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
* History of allergy or sensitivity to any drug, including any prior serious adverse reaction to PPIs (e.g. omeprazole, rabeprazole, lansoprazole)
* History of symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus or Zollinger-Ellison syndrome, previous positive H. pylori

The following criteria will be applied ONLY to PD/PK group

* H.pylori positive, as determined by the urea breath test
* Urine cotinine test positive
* Subject who were unable to be applicable for pH meter catheter
Phase II Study to Standardize Allergen Extracts: Determination of Biological Activity in HEP Units

Today a variety of diagnostic tools to detect allergenic agents are available such as skin tests, provocation tests and blood tests. Due to its high sensitivity and low costs the skin prick test is the most commonly used test to identify allergies in patients. By using this kind of skin test, up to 25 different agents can be tested in parallel, rendering the skin prick test a cheap, easy-to-handle and rapid diagnostic tool. However, as research proceeds, new tools appear with the intention to make future applications even more convenient -for both, the patient and the physician. For that purpose the development of the so called "Easyprick" Allergen Test System is under way, consisting of a foil that carries ready-to-use, allergen-soaked sponges which can easily be applied to the skin after pricking.

Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic and non-allergenic components. In order to control variability and to achieve consistency and reproducibility for optimal safety and sensitivity/specificity, it is essential to standardize the amount of allergen used in prick tests. The present study aims to standardize eight allergen extracts by using this method. Standardized extracts will then be applied in the Easyprick Allergen Test System which will be evaluated and compared to the conventional prick test in a second study.

* Trial with medicinal product


Eligibility Criteria:
Inclusion criteria:

* 18-65 years old,
* a positive clinical history for inhalant allergy to at least one of the allergens to be tested,
* at least one positive prick test (mean wheal diameter = 3mm) when tested with already standardized extracts of the allergens under investigation.
* a mean wheal size of = 7mm2 obtained in a prick test with histamine dihydrochloride (10mg/ml).
* Written informed consent

Exclusion criteria: -currently suffering from allergy symptoms,

* history of systemic reactions to allergens,
* severe diseases influencing the results of the present study by discretion of the investigator,
* immunotherapy with an allergen preparation known to interfere with the allergens under investigation during the past two years,
* skin lesions in the skin test areas
* pregnancy or nursing,
* treatment with prohibited concomitant medications (antihistamines, corticosteroids, anti-depressants, neuroleptics or specific immunotherapy)
* alcohol or drug abuse,
* impaired in understanding nature, meaning and the scope of the study or are incapable of giving written informed consent,
* Participation in another clinical trial within the last 30 days.
Novel Determinants and Measures of Smokeless Tobacco Use: Study 1

The extent of toxicity varies considerably across different brands of smokeless tobacco (ST) products and data suggest that greater toxicity may result in greater health risks. However, little is known about the actual extent of exposure to toxicants from current smokeless tobacco products and factors that might moderate the extent of this exposure. The goals of this project are to address the following questions:

1. What are the characteristics of the range of smokeless tobacco products in current use and how do these products impact user behavior;
2. What are novel and the best measures of smokeless tobacco use, behavior and exposure; and
3. What are some of the determinants of smokeless tobacco use.

Study 1 is a multi-site descriptive study assessing tobacco toxicants in various smokeless tobacco products and tobacco toxicant exposure found in 600 subjects in three sites: University of MN Twin Cities, Oregon Research Institute in Eugene OR, and at West Virginia University in Morgantown, WV (200 subjects per site). The study will examine the relationship between brands of U.S. smokeless tobacco products that contain different levels of tobacco-specific nitrosamines (TSNAs), other carcinogens and nicotine, and biomarkers of exposure and effects on health (e.g., cardiovascular risk factors). Additionally, the study will examine factors that influence the extent of toxicant exposure and effect besides the levels of toxicants in the product. Subjects will attend an orientation where they will sign a consent form and then return for one clinic visit where they will provide blood (UMN only), urine samples, buccal samples and expectorated chews to be examined for nicotine levels, toxicant exposure and potential for tobacco-related health risks. A subsample of subjects (10 per brand of smokeless tobacco) will be asked for a tin of their unused product for testing (they will be reimbursed for the cost of their tin) and will be asked for three samples of expectorated chews that will be collected, frozen and shipped to the CDC where they will be analyzed for tobacco constituents. Subjects will complete several questionnaires on their tobacco use history, alcohol, diet, physical and mental health. Subjects will also keep a daily diary of their tobacco and alcohol use.

Eligibility Criteria:
Inclusion Criteria:

1. Using a consistent and daily amount of ST for the past year;
2. In good physical health (no unstable medical condition);
3. Stable, good mental health (e.g., no recent unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria).

Exclusion Criteria:

1. Subjects must not be currently using other tobacco or nicotine products.
2. Female subjects cannot be pregnant or nursing.