Kornimate/medical-research-clean huggingface dataset:
asa levels in tep and lichtenstein repair patients

Conditions: Hernia, Inguinal

Summary: the purpose of this study is to determine and compare the possible affects of two different inguinal hernia repair technique (tep and lichtenstein) on serum asa levels.

antisperm antibody levels are thought to be indirect indicators of spermatic duct injuries. the investigators' ultimate goal is to draw a conclusion about the effect of the type of surgery on spermatic duct integrity. the investigators are going to collect serum samples from inguinal hernia patients before and after surgery. the investigators aim to assess the effect of surgery on antisperm antibody levels of patients who undergo licthenstein and tep repair. preoperative antisperm antibody levels will serve as control levels for each patient group.

Eligibility criteria:
inclusion criteria: * to accept the terms of the randomization and all study * to have unilateral inguinal hernia and set for an inguinal hernia repair * to be a father exclusion criteria: * to have any kind of autoimmune disorders * any kind of infertility history * to have a history of inguinal and/or genital surgery and/or trauma
comparison of topical treatment for inflammatory secretions of the conjonctiva (patients with ocular prostheses)

Conditions: Ocular Inflammation; Ocular Prostheses

Summary: we propose to evaluate the efficacy of treatment with hydrocortisone and dexamethasone (in a cross-over design) in patients with ocular prostheses and significant functional discomfort.

there are more than 100,000 eye prosthesis wearers in france. half of these patients are bothered by secretions or sandy sensations, or even chronic pain. various anti-inflammatory treatments are proposed without scientific basis. a pilot study on a limited number of patients conducted in 2017 at the university hospital of rennes and published in 2019 showed the interest of dexamethasone eye drops in these patients. however, this study was retrospective and not controlled. we therefore wish to propose a prospective, placebo-controlled, single-blind clinical study to define the value of anti-inflammatory treatment in patients with ocular prostheses. we propose to evaluate the efficacy of treatment with hydrocortisone and dexamethasone (in a cross-over design) in patients with ocular prostheses and significant functional discomfort.

Eligibility criteria:
inclusion criteria: * patient aged 18 years or older; * wearing a permanent prosthesis for more than 6 months; - consultant in the ophthalmology department; * modified osdi score ≥ 20 points out of 40 ; * affiliated with a health insurance scheme, * for women of childbearing age: effective contraception (effective contraception includes oral contraception, intrauterine devices and other forms of contraception with a failure rate \<1%, for the duration of the study and up to 1 week after the last dose administered) * have given free, informed and written consent. exclusion criteria: * treatment with eye drop(s) (other than artificial tears or antiseptic) \< 1 month; * concomitant treatment with cyp3a inhibitors including cobicistat containing drugs, * known contraindications to study treatments * dermal fat grafting or complicated cavity; * gougerot-sjögren syndrome; * allergic conjunctivitis; * damaged prosthesis; * impossibility of carrying out the various tests required by the protocol for whatever reason (comprehension problems, motor disability); * pregnant or breastfeeding woman; * person already included in a riph1 research protocol with topical treatment of the cavity or systemic anti-inflammatory treatment and/or who could lead to a bias in the present study * person under legal protection (safeguard of justice, curatorship, guardianship) or person deprived of liberty.
tralokinumab for dupilumab failures

Conditions: Atopic Dermatitis

Summary: 24-week study of 20 atopic dermatitis patients who have been treated with dupilumab will receive tralokinumab 600mg at week 0 followed by 300mg q2w for 24 weeks.


Eligibility criteria:
inclusion criteria: * male or female adult ≥ 18 years of age; * all participants must have prior treatment with dupilumab for atopic dermatitis meeting one of the following conditions: * participants who stopped dupilumab treatment due to non-response, partial response, loss of efficacy must have been previously treated with dupilumab for at least 12 weeks. * participants who stopped dupilumab treatment due to intolerance or aes to the drug may enter the study with no required prior length of dupilumab treatment. ae's must be resolved prior to 1st tralokinumab dose. * females of childbearing potential (fcbp) must have a negative urine pregnancy test at baseline. fcbp who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (iud); tubal ligation; or partner's vasectomy; male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide. subject is a candidate for systemic therapy. * subject must be in general good health as judged by the investigator, based on medical history, physical examination. * able and willing to give written informed consent prior to performance of any study-related procedures. exclusion criteria: * subjects with previous exposure to tralokinumab. * known or suspected hypersensitivity to tralokinumab or any of its excipients. * women of childbearing potential who are pregnant, intend to become pregnant, or are lactating. * use of tanning beds or phototherapy within 4 weeks of baseline * use of systemic therapies (systemic steroids, cyclosporine, oral jak inhibitors etc.) for atopic dermatitis within 4 weeks * patient non-compliant with dupixent dosing based on investigator discretion. * any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is uncontrolled.
effect of sodium thiosulfate on urine chemistries of hypercalciuric stone formers

Conditions: Kidney Stones

Summary: sodium thiosulfate may be useful to prevent recurrence of calcium-containing kidney stones. it will be studied in people with high amounts of urine calcium.

the investigators study is designed as a pilot study to study the effect of sts on urine chemistries in stone formers and normal controls. it is expected to continue for a duration of 1 year and will have two groups: 20 normal controls, who are healthy subjects without known kidney disease or nephrolithiasis, and 20 subjects with documented recurrent nephrolithiasis and hypercalciuria. patients will be recruited from dr goldfgarb's stone clinic at va hospital and controls would be voluntary participants from nyu school of medicine. subjects who are pregnant or nursing, taking alcohol or drugs, have known ckd or are unable to give consent would be excluded from the study. any diuretics or citrate containing drugs would be held for a period of 2 weeks during the study period to achieve washout of the effects of those drugs on urine chemistries. oral sts 10mmol (10ml of 25% sts) bid will be administered to both groups for 7 days; four 24 hour urine collections, 2 prior and 2 at the end of the study, would be done with all participants. a diet diary would be maintained by subjects concomitantly during the study periods. the investigators then plan to compare the two groups in terms of urine chemistries to detect any changes in these parameters with thiosulfate administration. based on prior animal experiments and human studies with sts the investigators anticipate that it would have a favorable effect on the supersaturation of ca oxalate/phosphate and therefore its long term use would be helpful in preventing nephrolithiasis.

Eligibility criteria:
inclusion criteria: control arm: no longer recruiting hypercalciuria arm: * age 18-80 years old * history of calcium-containing kidney stones * no history of liver, heart or kidney disease (other than kidney stones) * non-pregnant, non-lactating * able to stop diuretics for a period of 1 week exclusion criteria: * not able to sign consent * not satisfying any of the above criteria

Keywords: nephrolithiasis calcium stones kidney stones hypercalciuria sodium thiosulfate calcium containing kidney stones
agn-229666 ophthalmic solution in japanese patients with allergic conjunctivitis

Conditions: Conjunctivitis, Allergic

Summary: this study will evaluate the safety and efficacy of agn-229666 for the prevention of allergen-mediated conjunctivitis.


Eligibility criteria:
inclusion criteria: -japanese patients living in japan with a history of allergic conjunctivitis. exclusion criteria: * presence of active eye infection (bacterial, viral, or fungal) * history of an eye herpetic infection.
ketogenic diet for recurrent glioblastoma

Conditions: Recurrent Glioblastoma

Summary: to determine whether a mild ketogenic diet can influences quality of life and survival of patients with recurrent glioblastoma

increased glycolysis and reduced oxidative phosphorylation is a characteristic property of many tumors. a change of nutrition by limiting carbohydrates and increasing the proportion of fatty acids and proteins can lead to ketogenic metabolism and might limit energy production in tumor cells and therefore inhibit tumor growth. standard treatment for glioblastoma includes resection, irradiation and temozolomide chemotherapy. if there is tumor recurrence, no standard therapy is established. therapeutic options in this situation include resection, irradiation or another chemotherapy. however, some patients cannot be treated in this situation, because none of the available treatment options seems reasonable or applicable, for example if no additional chemotherapy can be started at the time of recurrence due to myelosuppression. the pilot study examines whether in this situation a ketogenic diet can be applied to the patients and may inhibit tumor growth and influence the quality of life of the patients.

Eligibility criteria:
inclusion criteria: * age \>= 18 years * histological diagnosis of glioblastoma or gliosarcoma * on mri measurable tumor * interval of at least 6 months after primary resection * completed radiotherapy, interval of at least 3 months after completion of radiotherapy * relapse during or after temozolomide chemotherapy, other chemotherapy not possible, not reasonable or not wanted by the patient * karnofsky-index \>= 60%, ecog \<= 2 * life expectancy of at least 12 weeks * creatinine \<= 1.5 mg/dl, urea \<= 50 mg/dl * inr \<= 1,5, got \<= 7 x of normal value, gpt \<= 7 x of normal value exclusion criteria: * bowel obstruction or subileus * diabetes mellitus, hba1c \> 6,1 % * heart failure (nyha \> 2), myocardial infarction within the last 6 months, atrial fibrillation * acute infection * conditions that may strongly reduce compliance to the diet or increase risk of the diet * dementia or clinically relevant alterations of the mental state which interfere with the applicability of the diet

Keywords: glioblastoma ketogenic diet
share-d: a decision tool to help patients make informed lifestyle choices

Conditions: Health Behavior

Summary: more information is needed about effective ways to help people begin to change their lifestyle behaviours, particularly physical activity and diet. the investigators propose to test a 'tool' that can be used to guide discussions between people and health professionals about their physical activity and diet habits, so that people may be supported better in making decisions about why and how they might begin to fit more exercise and healthy food into their daily routines and make long-term changes. the investigators will explore the feasibility of using this tool in general practice, reviewing behaviours after 1 and 3 months. patients' and healthcare professionals' views of its use and how it influenced decisions will inform development of the tool's design and a study of its effectiveness in helping people to begin to change their behaviour and achieve healthy lifestyles.

healthier lifestyles, relating to physical activity and diet, reduce the risk of heart disease and stroke. however, making and sustaining lifestyle changes is difficult. more information is needed about effective ways to help people begin to change their lifestyle behaviours. the investigators propose to test the feasibility of using a 'tool' (the shared-d questionnaire) in guiding discussions between people and health professionals about physical activity and diet, and support people in making decisions about why and how they might begin to fit more exercise and healthy food into their daily routines. the 'tool' (share-d) consists of questions to help people think about their personal circumstances and their motivation, opportunities, capabilities and priorities, and includes information about heart disease and stroke. the investigators will explore the use of this tool in general practice, assessing patients' physical activity and diet behaviour after 1 and 3 months. patients' and healthcare professionals' views of its use and how it influenced decisions will help to improve the tool's design. participants' opinions regarding its format and method of delivery will inform future plans for its use and the design of a study of its effectiveness in helping people to begin to change their behaviour and achieve healthy lifestyles, hoping to lead to improved quality of life for people with heart disease and stroke.

Eligibility criteria:
inclusion criteria: * aged 18 years or over * with or at high risk of coronary heart disease * overweight or physically inactive exclusion criteria: * unable to complete questionnaires * unable to make independent changes to physical activity or diet habits
clinical characterization and outcome of anti-iglon5 disease

Conditions: Anti-IgLON5 Disease

Summary: anti-iglon5 disease is a neurological disorder associated with antibodies to iglon5, a neuronal cell adhesion protein of unknown function. most patients develop a combination of significant sleep disturbances (non-rapid eye movement (nrem) and rapid eye movement parasomnias with obstructive sleep apnoea), bulbar dysfunction (dysarthria, dysphagia, vocal cord paralysis or episodes of respiratory failure) and gait instability. early autopsy studies showed deposits of phosphorylated tau protein mainly in neurons of the brainstem tegmentum, suggesting a primary neurodegenerative disease. however, the results of subsequent studies have provided increasing support for an immune-mediated pathogenesis. first, there is a strong association with the human leukocyte antigen (hla) haplotype drb1\*10:01-dqb1\*05 : 01, which is present in \~60% of patients (compared to 2% in the normal population); secondly, recent autopsy studies have shown the absence of abnormal tau deposits; and thirdly, in live neurons in culture, iglon5 antibodies cause irreversible loss of surface iglon5 clusters and cytoskeletal changes such as dystrophic neurites and axonal bulges. together, these studies suggest that antibody-mediated disruption of iglon5 function leads to neurofilament and cytoskeletal alterations that can potentially result in tau accumulation. over the last two years, an increase in diagnoses of anti-iglon5 disease has been observed in the french reference centre of autoimmune encephalitis. this could be related to a better knowledge of the disease, or to other yet unknown factors. clinical characterisation of these patients is essential to understand the underlying reasons for the increase in diagnoses and to improve knowledge of this disease. furthermore, the response of these patients to immunosuppressive drugs and the long-term prognosis remain unknown.


Eligibility criteria:
inclusion criteria: * patients \> 18 ans * anti-iglon5 antibody positivity exclusion criteria: - lack of clinical data

Keywords: anti-iglon5 disease, autoimmune encephalitis, neural antibodies
a study of adjunctive treatment of aripiprazole in schizophrenic patients

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine monotherapy, in schizophrenic patients who are not optimally controlled on clozapine.


Eligibility criteria:
inclusion criteria: * patients with schizophrenia treated with clozapine (200-900 mg/day), who gained at least 2.5 kg while on clozapine. exclusion criteria: * patients known to be allergic to aripiprazole * hospitalized patients * patients who have previously received study medication in an aripiprazole clinical study or who have participated in any clinical trial with an investigational agent within the past month.
impact of stress and sleep management on emergency professionals

Conditions: Healthy

Summary: the investigators hypothesize that a recovery management program could have an impact on emergency nurses and physicians by improving their sleep and reducing their psychological and physiological responses when dealing with stressful situations during their professional practice. the rest study consists in developing a recovery management program for emergency professionals. the following strategies would be proposed : * sleep management according to their schedules by anticipation and recovery, * stress management through cardio-feedback techniques (cardiac coherence) also called controlled breathing techniques and mental imagery. the objectives are to evaluate the impact of this program on the physiological and psychological stress of the emergency professionals during their professional activity, as well as on their sleep. to do so, their respiratory and heart rates, as well as their activity and resting times will be recorded continuously for one week. at the end of each shift, the emergency professionals will report and evaluate the 3 most stressful events.


Eligibility criteria:
inclusion criteria: * nurses or physicians * in current position for at least one year * full time or minimum three shifts per week * location: emergency department of the edouard herriot hospital or the south lyon hospital * free and informed consent exclusion criteria: * caregivers on leave during the enrollment period * pregnant, parturient or breastfeeding caregivers * participation in another study

Keywords: sleep deprivation recovery management program stress, psychological stress, physiological emergency service hospital nurses physicians
chlorhexidine gluconate oral care for adults experiencing trauma

Conditions: Ventilator Associated Pneumonia

Summary: examine the use of 0.12% chlorhexidine gluconate as an adjunct to current oral care protocol for trauma patients on ventilator support to decrease the incidence of ventilator associated pneumonia and oral bacterial load.

to see a significant decrease in the bacterial load in the oral mucosa and subsequently, a decrease in the pathogenesis of ventilator associated pneumonia through the use of an oral rinse containing 0.12% chlorhexidine gluconate as part of an oral care protocol. current oral care protocol includes the use of 1.5% h2o2-coated swabs every four hours, toothbrushing with toothpaste every 12 hours, and use of continuous subglottic suction apparatus.

Eligibility criteria:
inclusion criteria: * adults admitted to icus located in tower two critical care units: medical, surgical, medical #2, and trauma intensive care units. * patients will be randomized to either treatment or standard group based on day of admission to intensive care units. no limitation regarding gender, race, and ethnicity so that the sample will reflect "typical" trauma population. exclusion criteria: * all patients admitted under "doe" status * all patients with acute cervical spine injuries or facial fractures that oral care will create further harm to the patient (physician order stating "no oral care to be given" will be in chart) * all patients with oral trauma or oral surgery * all minors (study will be completed in adult critical care units) * patients with allergy to chlorhexidine * patients without teeth, or with fewer than 6 teeth

Keywords: trauma mechanical ventilation ventilator associated pneumonia oral care
the effects of cannabis on male reproductive functions

Conditions: Male Reproductive Problem

Summary: the purpose of this study is to understand the direct effects of cannabis on male reproductive functions. the investigators plan to conduct a double-blind, placebo-controlled clinical trial to examine both the chronic and acute effects of cannabis use on male reproductive functions. specifically, the investigators will examine the dose-dependent effects of acute cannabis use on male reproductive parameters, including sperm counts, motility, morphology, and testosterone levels, as well as sperm epimutations. participants \[cannabis users will be randomly assigned to 1) non-vaping, 2) placebo (vaping without cannabis), and 2 doses of cannabis, 3) 20 and 4) 40mg of thc in cannabis flower obtained from the nida drug supply\], and 5) non-cannabis users (naïve control, no cannabis or placebo exposure). participants will provide surveys (cannabis use and sexual functioning and satisfaction etc.), peripheral blood, and semen.

the volcano vaporizer will be used to expose cannabis or placebo plants.

Eligibility criteria:
inclusion criteria: * regular cannabis users (21\~64 years-old men) who have used cannabis at least once a week for at least once a year or who have never used cannabis. * willingness to abstain from using cannabis on the day of the testing session (minimum 5 hours abstinence). exclusion criteria: * women * adult men, 65 or older, and men under the age of 21 * serious psychiatric conditions (e.g. psychosis, bipolar i and panic disorder) * family history of psychosis * chronic medical conditions (e.g., heart disease, diabetes) * history of adverse experiences with cannabis (e.g., anxiety and panic attacks) * use of other illicit drugs (not cannabis) in the past 2 months * heavy alcohol use (\>4 drinks, \>4 times/week) * smoking/nicotine use * infrequent cannabis use (less than once a week for only cannabis users) * bmi over 34 * current use of corticosteroids and blood thinners

Keywords: cannabis sperm counts and motility testosterone sperm epimutation
phase ii study of chemotherapy and pamidronate for the treatment of newly diagnosed osteosarcoma

Conditions: Osteosarcoma

Summary: this study is designed to test the safety and feasibility of the simultaneous administration of a biphosphonate with chemotherapy for the treatment of osteosarcoma in newly diagnosed patients.


Eligibility criteria:
inclusion criteria: * newly diagnosed, previously untreated biopsy proven high-grade osteosarcoma. patient who have undergone a definitive surgical resection as their primary surgery are still eligible for participation in this study. * no prior chemotherapy or radiation therapy * adequate renal function: creatinine \< or = to 1.5 upper limit of normal * adequate liver function as defined by bilirubin \ or = to 100,000/ram3 an absolute neutrophil count \> or = to 1,000/mm3. * adequate cardiac function as defined by shortening fraction \> or = to 28% by echocardiogram or ejection fraction \> or = to 50% by radionuclide angiogram * performance status \< or = to 2 exclusion criteria: * prior history of cancer * prior treatment for cancer * prior history of paget's disease * prior history of pericarditis, myocarditis, symptomatic arrhythmia or symptomatic cardiac conduction abnormalities * pregnancy or breast feeding

Keywords: cisplatin doxorubicin methotrexate osteosarcoma 03-074