Kornimate/medical-research-clean huggingface dataset:
study of the ocular safety after repeated instillations of t1225 1% or 1.5% eye drops in healthy volunteers

Conditions: Eye Infections, Bacterial

Summary: to evaluate the ocular tolerance of t1225 1% and 1.5% eye drops versus vehicle after one instillation twice-daily (morning and evening), in one eye, during 3 days (from day 0 to day 2). to assess azithromycin tear, conjunctiva and plasmatic concentrations, after a 3-day treatment period

the aim of the present study was to compare ocular tolerance and safety after repeated instillations of t1225 1% and 1.5% eye drops and vehicle and to assess the residual azithromycin concentrations in tear, ocular conjunctiva and plasma samples, approximately 12 hours after the last investigational medicinal product instillation.

Eligibility criteria:
inclusion criteria: * male or female aged from 18 to 45 years old; * written informed consent; * healthy volunteers without any subjective ocular symptom; * normal ocular examination in both eyes (corrected visual acuity \>= 6/10, normal slit lamp examination, tear prism height \> 0.1mm, tear break-up time (but) \>= 10 seconds, lissamine green test score \< 4); * registered, or agreed to be registered, in the national register of healthy volunteers exclusion criteria: * ocular trauma, infection or inflammation within the last 3 months; * number of corneal stained punctuations ocular trauma, infection or inflammation within the last 3 months; * number of corneal stained punctuations \>= 5; * blepharitis, conjunctivitis, uveitis; * contact lenses; * topical ocular treatment within the last month; * ocular laser within the last 3 months; * ocular surgery, including lasik and prk, within the last 12 months; * systemic macrolide within the last month; * medication during the study (except: paracetamol and contraceptives).
antibiotic use in french nursing home

Conditions: Antibiotic Resistant Infection

Summary: context: france is still one of the biggest consumers of antibiotics in europe. an explanation for this increase in consumption would be aging. thus, part of this aging population lives in nursing home, where the urinary tract infection is the second most suspected pathology. however, it can most often be bacteriuria requiring no antibiotic therapy. in nursing home, nurses who alert prescribers when an infection is suspected by describing clinical signs.however, his propensity to perform too rapidly and systematically an examination with dipsticks leads the physician to prescribe antibiotic. this is how a program called atoum is set up to reduce the prescription of antibiotics in nursing home. the present atoum 4 study builds on this program. objective: to measure the effect of a nurse-centered multimodal intervention involving training and sensitization on urinary tract infection, asymptomatic bacteriuria, antibiotic resistance and interprofessional communication on antibiotic therapy. methods: this will be a randomized double-arm interventional study in 40 nursing home. the intervention group of 20 nursing home will receive a blended-learning intervention.

context: france is still one of the biggest consumers of antibiotics in europe. an explanation for this increase in consumption would be aging. thus, part of this aging population lives in nursing home, where the urinary tract infection is the second most suspected pathology. however, it can most often be bacteriuria requiring no antibiotic therapy. in nursing home, nurses alert prescribers when an infection is suspected by describing clinical signs. however, their propensity to perform too rapidly and systematically an examination with dipsticks leads physicians to prescribe antibiotic. this is how a program called atoum is set up to reduce the prescription of antibiotics in nursing home. the present atoum 4 study builds on this program. objective: to measure the effect of a nurse-centered multimodal intervention involving training and sensitization on urinary tract infection, asymptomatic bacteriuria, antibiotic resistance and interprofessional communication on antibiotic therapy. methods: this will be a randomized double-arm interventional study in 40 nursing home. the intervention group of 20 nursing home will receive a blended-learning intervention.the primary outcome will be the percentage of reduction in antibiotic prescription at the end of the twelve months following the first visit to nursing home. this data, aggregated by nursing home, will be obtained from the structures concerned via their prescription registration system.

Eligibility criteria:
inclusion criteria: * nursing home with registred nursing * presence of prescription registration system * situated in paris and surb of paris exclusion criteria: * n/a
comparison of quality of life and functionnal resultats after sigmodectomy between diverticulitis and cancer

Conditions: Sigmoid Cancer; Sigmoid Diverticulosis

Summary: the aim of this present study is to compare functional results and quality of life after sigmoidectomy for diverticulitis and sigmoid cancer.

rectal resection surgery can lead to numerous complications in term of gastrointestinal results with onset of fecal incontinence or in contrast constipation, and in term of genitourinary results with occurrence of dysuria, erectile dysfunction, or vaginal dryness. the low anterior resection syndrome is defined by the occurrence after rectal resection, of gastrointestinal symptoms like fecal incontinence or stool evacuation difficulties, which affect quality of life, despite conservation of anal sphincter. this syndrome is now well known and used in many countries. however, there is a lack of data concerning gastrointestinal functional results after sigmoid surgery whether it is for cancer or diverticulitis. some studies highlighted symptoms persistence in many patients after sigmoidectomy. lately, the lars score was used after sigmoidectomy for cancer. this study reveals symptoms of low anterior resection syndrome for 41 % of patients. the correlation between rectal resection and sigmoidectomy could be explain by the resection of the upper part of rectum in case of sigmoidectomy. the issue of genito-urinary disorders after sigmoidectomy are poorly researched. previous studies demonstrate a higher risk of erectile disorders after pelvic surgery and especially for cancer. currently, there is a lack of data on functional results and quality of life for patients who are going into sigmoid surgery, whether for cancer or diverticulitis. the aim of this longitudinal study is to compare digestive functional outcome, genitourinary outcomes and quality of life in patients who undergo sigmoid resection for diverticulitis and cancer.

Eligibility criteria:
inclusion criteria : * adults * patients who undergo sigmoidectomy with end to end anastomosis for sigmoid cancer and symptomatic diverticulitis * preservation of the left colic angle for upper surgical resection * lower surgical resection located \< 5cm to the recto-sigmoid junction exclusion criteria : * minors * adults under guardianship * protected persons * patients who undergo sigmoidectomy without anastomosis (ileostomy or hartmann surgery) * patients who undergo surgery in emergency * cancer of recto-sigmoid junction * patients who undergo secondarily a stoma

Keywords: lars score sigmoidectomy sigmoid cancer diverticulitis functional results
ioflupane i123 (datscan) and positron emission tomography-computed tomography fludeoxyglucose (pet-ct fdg) to assess brain function of parkinson patients with different genetic characteristics

Conditions: Parkinson Disease

Summary: parkinson disease is one of the most common neurodegenerative illnesses. the disease is characterized by decrease in dopamine levels and decrease in the number of dopaminergic neurons and dopamine receptors. there are gene mutations that increase the risk for the disease. two of those mutations are on the lrrk2 gene and on gba gene. it is yet unknown if there is a difference between the metabolic brain function of parkinson patients that carry one of the two mutations to parkinson patients with no known mutation. participants: diagnosed parkinson patients that carry a gene mutation in either lrrk2 or gba genes, parkinson patients with no known mutation and healthy volunteers as a control group. the participants will go through both examinations dat scan and pet ct scan at the tel aviv sourasky medical center nuclear medicine institute. the examination results will be given to the participants by a doctor from the neurology department.


Eligibility criteria:
inclusion criteria: * diagnosed parkinson patients with known genetic characteristics exclusion criteria: * patients unable to understand and sign an informed consent * minors * patients in medical condition that does not allow them to stay still during the examination

Keywords: parkinson fdg pet-ct i123 dat scan lrrk2 gba parkinson patients with known genetic characteristic
biomarkers in tumor tissue samples from young patients with very low risk wilms tumors

Conditions: Kidney Cancer

Summary: rationale: studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this clinical trial studies biomarkers in tumor tissue samples from young patients with very low risk wilms tumors.

objectives: * to validate the utility of cugbp2, hmga2, and meis2 mrna expression and 11p15 methylation to define a population of pediatric patients with very low risk wilms tumor (vlrwt) that have virtually no risk of relapse. * to validate the utility of wt-1 mutation and 11p15 loss of heterozygosity analysis to determine a population of vlrwt that have a higher risk of relapse when not treated with chemotherapy. * to validate the utility of nfya, stra6, tob2, pdcd4, and sp3 mrna expression to predict relapse in vlrwt. * to investigate the feasibility of broadening the definition of vlrwt through analysis of stage i and ii epithelial differentiated tumors registered on clinical trial cog-q9401 (nwts-5) for cugbp2, hmga2, meis2, and 11p15 methylation. outline: previously banked tumor tissue samples are analyzed for mrna expression of cugbp2, hmga2, and meis2 via reverse-transcriptase (rt)-pcr and are classified as loss of heterozygosity (loh), loss of imprinting, or neither via 11p15 analysis. samples are also analyzed for wt-1 mutation via quantitative pcr and 11p loh using 11p15 methylation analysis and expression of nfya, stra6, tob2, pdcd4, and sp3 via quantitative rt-pcr

Eligibility criteria:
disease characteristics: * meets 1 of the following criteria: * patient with very low risk wilms tumor registered on clinical trial cog-aren03b2 * patient with stage i or ii epithelial tubular differentiated wilms tumor registered on clinical trial cog-q9401 (nwts-5) patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: stage i wilms tumor stage ii wilms tumor epithelial predominant wilms tumor
two measures of tactile acuity in crps type i patients

Conditions: CRPS Type I of the Upper Extremity; Neuropathy of the Median Nerve; Healthy Controls

Summary: this study aims to investigate whether two different measures of tactile acuity lead to comparable results in patients diagnosed with crps type i of the upper extremity. additionally patients with a neuropathy of the median nerve and healthy controls are included.


Eligibility criteria:
inclusion criteria: * patients diagnosed with crps type i according to the "budapest criteria" * patients diagnosed with a neuropathy of the median nerve * healthy controls,matched in age and gender to both patient cohorts exclusion criteria: * intolerable hyperalgesia * lesions at the fingertips * high grade digit contracture * central neurologic disorders * psychiatric disorders

Keywords: crps type i tactile acuity 2-point-discrimination grating orientation task sensory signs
patch with onion extract and allantoin for c-section scar

Conditions: Cesarean Section; Dehiscence; Scar Keloid; Wound Heal

Summary: the wound healing is a process occurring in response to dermal injury. the resulting scar may have various characteristics ranging from fine-line and asymptomatic to hypertrophic scars and keloids. prevention or early treatment of pathological scars is the most appropriate approach. among available remedies, gels and patches containing onion extract and allantoin have been demonstrated to be safe and effective in patients with scars of various origins and severity. one of the most used natural products is a patch containing allium cepa and allantoin licensed for treatment of the scars including keloids. however, up to date, no controlled studies have evaluated the effects of such a device in women who have undergone cesarean delivery. therefore, the aim of this study was to investigate the effects of this patch on cesarean section (c-section) scars.

this is an observational non-interventional study. women who underwent c-section were consecutively recruited at university hospital of salerno. taking into account the number of c-section the study population was divided into two groups: group a included subjects without a prior history of c-section, group b subjects who had already undergone previous c-section. at baseline after stitches removal, scars assessment was made using digital photographs and the validate patient and observer scar assessment scale (posas). after 4 weeks, during the outpatient visit, women from both group a and b were asked whether had applied some natural products on the scars or not. in this occasion, the c-section of the women who had applied a patch containing allium cepa and allantoin as well as those of women who had not used any products (who represented the control group) were re-evaluated as at baseline. the observers were blinded. one of them performed the scars assessment at baseline, the other one after 4 weeks. during the outpatient visit an informed consent for participation was obtained by all the subjects costituing the study population. the participation to the study was voluntary

Eligibility criteria:
inclusion criteria: * subjects undergone cesarean delivery; * age \>18; * voluntary participation to the study; * informed consent release. exclusion criteria: * age \<18 * hypersensitivity to any constituent of the patch; * pre-term birth, obesity, * gestational diabetes, * hypertension, * infections, * dermatologic diseases * use of both systemic and topic corticosteroids; * no informed consent release.

Keywords: natural products wound healing cesarean delivery
long-term antibody persistence at 1, 3 and 5 years after a fourth dose of gsk biologicals' hib-mency-tt vaccine compared to acthib

Conditions: Neisseria Meningitidis; Haemophilus Influenzae Type b

Summary: this study is evaluating antibody persistence at 1, 3 \& 5 years post-fourth dose (i.e., at 2, 4 \& 6 years of age, respectively) in subjects vaccinated in a previous study. this protocol posting deals with objectives \& outcome measures of the extension phase at years 1, 3 and 5. the objectives \& outcome measures of the first four doses are presented in a separate protocol posting (nct00129129). this protocol posting has been amended in order to comply with the fda amendment act of september 26, 2007.

in this long-term follow-up study, no new subjects will be recruited. all subjects participating in this long-term follow-up study should have already participated in a previous study. no vaccine will be administered during the persistence phase of the study. this protocol posting has been updated following protocol amendment 3, september 2009.

Eligibility criteria:
inclusion criteria: * healthy male and female children who completed the previous four dose vaccination series study (nct00129129). the age of the child at the 3 post-fourth dose timelines are as follows: * year 1: 22 to 36 months of age. * year 3: 44 to 60 months of age. * year 5: 5 years post-dose 4 +/- 8 weeks * written informed consent obtained from the parent or guardian of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study * having completed the fourth dose vaccination of study hib-mency-tt-005/006 exclusion criteria: children should not have: * received more than 4 doses of hib or meningococcal serogroup c and y vaccine * had a history of h. influenzae type b, meningococcal serogroup c and y diseases

Keywords: humans meningococcal vaccines immunogenicity vaccines h. influenzae type b vaccine conjugate toddlers comparative study neisseria meningitidis
the effect of myofascial release technique on respiratory parameters in subjects with short hamstring muscle

Conditions: Hamstring Contractures

Summary: the aim of this study was to investigate the effect of myofascial release technique on rib cage mobility, respiratory function, respiratory muscle strength and endurance in patients with hamstring muscle shortness.

hamstring flexibility is important to maintain activities such as walking and running in daily life. hamstring muscle shortness, commonly seen in the community, is a risk factor for many musculoskeletal pathologies. clinical observations have shown that the shortness of the hamstring muscle causes spinal malalignment. this deterioration of the spine alignment may adversely affect the rib cage expansion. moreover, considering that the optimal length of the muscles provides optimal contraction, it was found that the spinal malalignment adversely affected the effective contraction of the diaphragm by changing the position of diaphragm. a different view is that, because the fascia functions as a single tissue surrounding the entire body, a restriction in the hamstring muscle can also cause a restriction in distal muscles such as diaphragm through the fascia. there are many treatment methods used to increase the flexibility of the hamstring muscle. one of these methods is the myofascial release technique. in this technique, which targets both muscle and fascia, applying light and prolonged pressure provides the myo-fascial complex to reach its optimal length, resulting in the optimal function of the muscle. in our best knowledge, no study has evaluated the effect of myofascial release technique on respiratory parameters in patients with hamstring muscle shortness.

Eligibility criteria:
inclusion criteria: * more than 15 degrees knee flexion angle during popliteal angle test, * no generalized joint laxity according to beighton criteria, and * no musculoskeletal problems of lower extremities. exclusion criteria: * history of lower extremity and/or axial skeletal fracture; * recent muscle, tendon injury in lower extremity; * history of lumbal disc herniation, arthritic and/or inflammatory disease; * obesity, diabetes and/or metabolic syndrome; * history of surgery in the last month, * using muscle relaxant medication in the last month; * received manual therapy in the last month

Keywords: hamstring muscle hamstring shortness hamstring stiffness myofascial release technique respiratory functions respiratory muscle strength respiratory muscle endurance
calls and coordination for transitions of care at re-entry

Conditions: Prisoners; Substance Use History; Chronic Medical Conditions; Psychiatric Condition; Substance Use Disorder (SUD)

Summary: the goal of this clinical trial is to learn if a short program for people being released from prison can help connect them to medical care. the main question it aims to answer is: * will there be more non-emergency, outpatient clinic visits? researchers will compare the number of clinic visits between people who use a nurse case manager (ncm) to people in enhanced usual care. participants will: * complete surveys * talk to a study team member 2-3 times, or talk to a study team member 2-3 times and talk to an ncm 6-11 times

the objective of this clinical trial is to test the effectiveness of a transitional care program adapted to meet the healthcare needs of adults after release from prison. the goal of the transitional care intervention being tested is to help the study participants connect to primary care within 60 days of release through weekly check-in calls. participants in this study are enrolled approximately 6 months before their anticipated release. one group will receive weekly phone calls for up to 60 days post-release. additionally, novel, linked administrative datasets will be leveraged to enhance, contextualize, and clarify policy implications of the clinical trial results.

Eligibility criteria:
inclusion criteria: * age 18 or older * eligibility for wi medicaid and intention to enroll before release * substance use history (i.e., "have you ever considered your alcohol or drug use to be a problem?"), and * living with, or history of, a chronic medical or psychiatric condition other than substance use disorder. this is defined as ever having been diagnosed with a medical or psychiatric chronic condition, or currently taking prescription medications for a chronic condition. exclusion criteria: * ineligible for wi medicaid * no substance use history * not living with, or no history of, chronic medical or psychiatric condition
impact of sunitinib bioavailability on toxicity and treatment efficacy in patients treated for metastatic renal cancer

Conditions: Metastatic Kidney Cancer

Summary: patients treated on the first line of sunitinib-targeted therapy for metastatic kidney cancer. collection of additional blood tubes during routine blood tests for patient follow-up, to evaluate the plasma concentration of sunitinib and its active metabolite desethyl-sunitinib (des)


Eligibility criteria:
inclusion criteria: * patient at least 18 years old * patient who read and understood the newsletter and signed the consent form * renal cell carcinoma histologically proven stage iv * metastatic stage proven on ct, synchronous or metachronous examination * patient operated on or not from the primary tumor * eligible for first-line systemic therapy with sunitinib-targeted therapy for oncology urology * affiliation to a social security scheme * effective contraception (as defined by the who) for at least 3 months at the inclusion visit, during treatment and for 1 month after the end of the research (negative pregnancy test) * postmenopausal woman: confirmatory diagnosis (amenorrhea not clinically induced for more than 12 months at inclusion visit) * general condition who 0 to 2 * life expectancy estimated at more than 6 months at baseline exclusion criteria: * non-metastatic disease * other cancer proven histologically, or in complete remission for less than 2 years * contraindication to sutent 50 mg hard capsules: hypersensitivity to the active substance or to any of the excipients * history of immunotherapy treatment for kidney cancer, previous treatment with targeted therapies for the same or previous cancer * pregnant or lactating woman or wishing to breastfeed within 6 months after the last treatment or no known contraception, * person deprived of liberty by an administrative or judicial decision or person placed under the protection of justice / sub-guardianship or curatorship * patient currently involved in an interventional trial