Kornimate/medical-research-clean huggingface dataset:
neurophysiological assessment of healthy and impaired human lower urinary tract function

Conditions: Lower Urinary Tract Symptoms

Summary: study part 1 will consist of sensory evoked cortical potential (sep) measurements of the lower urinary tract (lut) in healthy subjects using different stimulation frequencies from 0.25 to 3hz to find the most effective frequency in regard to acquisition time for reliable sep response rates. study part 2 will consist of a series of consecutive sep measurements in patients with lut symptoms during low bladder volume and maximum cystometric capacity to assess reliability of measurements and influence of potential concomitant luts treatments.


Eligibility criteria:
inclusion criteria: healthy volunteers: * written informed consent, * good mental and physical health, * age \>18y, patients with luts and patients with luts and treatment: * written informed consent, * age \>18y, * prior urodynamic investigation, * luts since \>6months with or without detrusor overactivity exclusion criteria: healthy volunteers: * any neurological or urological pathology, * current pregnancy or lactation, * urinary tract infection, * hematuria, * any previous pelvic or spine or craniocerebral surgery, * any anatomical anomaly of the lut or genitalia, * any metabolic disease, * any lut malignancy, * bladder capacity \<150ml, * sdv at 60ml; patients with luts and patients with luts and treatment: * current pregnancy or lactation, * urinary tract infection, * gross hematuria
impact of the chikungunya outbreak in reunion island on the quality of life after 10 years

Conditions: Chikungunya Fever; Quality of Life

Summary: qolchik study aims at evaluating impact of chikungunya infection on the quality of life of infected people during the 2005-2006 outbreak in reunion island and followed in the telechik cohort by comparing scores of sf-36 health survey.

qolchik is a prospective cohort telephone study on the quality of life of people from the telechik cohort, measured by the sf-36 health survey. telechik was a telephone survey conducted 2 years after the 2005-2006 outbreak in reunion island and drawn from the serochik study which aimed at assessing the seroprevalence of chinkungunya over the island between august and october 2006. a sample of 440 people (220 per group) was calculated and to be drawn from telechik cohort, 220 with a serodiagnosis of chikungunya and 220 with negative serology.

Eligibility criteria:
inclusion criteria: * people from the telechik cohort exclusion criteria: * people with other diseases or disorders which could impact quality of life (predefined list) * minor * elderly over 85 yo * people with a risk of exposure (in an endemic/epidemic area) after 2005-2006 reunion island outbreak

Keywords: chikungunya quality of life
three month safety and efficacy study of travatan® versus travoprost ophthalmic solution, 0.004%

Conditions: Open Angle Glaucoma; Ocular Hypertension

Summary: a multi-center, observer-masked, randomized, parallel group efficacy and safety study of travatan® versus a new formulation of travoprost ophthalmic solution, 0.004%


Eligibility criteria:
inclusion criteria: 1. patients 18 years of age or older 2. either gender 3. any race/ethnicity 4. diagnosed with open-angle glaucoma (including patients with pseudoexfoliation and pigment dispersion) or ocular hypertension exclusion criteria: 1. patients with any form of glaucoma other than open-angle glaucoma. 2. patients with a central cornea thickness greater than 620 μm 3. patients with shaffer angle grade \< 2 4. patients with a cup/disc ratio greater than 0.80 5. patients with severe central visual field loss 6. best-corrected visual acuity score worse than 55 etdrs letters (20/80 snellen equivalent) 7. chronic, recurrent or severe inflammatory eye disease 8. clinically significant or progressive retinal disease 9. other ocular pathology

Keywords: open angle glaucoma ocular hypertension
multi marker approach interest in emergency in acute respiratory insufficiency diagnostic

Conditions: Acute Respiratory Insufficiency

Summary: biomarkers have an interest in clinic diagnostic ,therapeutic and prognosis in pathophysiologic situation including cardiovascular.but interest of biomarkers in diagnostic care of severe acute respiratory insufficiency remains to clear. we propose to determine the more relevant marker combination in this case.

in urgence of a severe acute respiratory insufficiency,for thanks to an approach diagnostic, therapeutic and prognostic we propose to determine the more relevant biomarker combination. an expert committee will compare the biomarker diagnostic and prognostic relevance thanks to all elements clinico-biological and patient monitoring.

Eligibility criteria:
inclusion criteria: * oxygen saturation below or equal to 92% in ambient air. * respiratory frequence above 25 cycle per minute exclusion criteria: * minors * pregnant or lactating women * patient without social security * patient hospitalize without consent * chest pain with acute coronary electro-cardiographic change leading immediate achievement of a diagnostic coronary angiography and/or therapeutic * pneumothorax

Keywords: acute respiratory insufficiency respiratory biomarkers emergency intensive care unit prospective patient hospitalize in emergency or in intensive care unit for acute respiratory insufficiency
adjustable artificial sphincter victo in the treatment of male incontinence due to prostate surgery

Conditions: Urinary Incontinence

Summary: the aim of this prospective academic research study is to evaluate the efficacy and safety of the victo adjustable artificial sphincter in the treatment of male patients with urinary incontinence due to prostate surgery.

this is a non-interventional prospective study. the study will include male patients who underwent the victo artificial sphincter placement due to severe incontinence. before the procedure, all patients will undergo a standard diagnostic work-up. after the procedure, the patients will be invited for regular visits 3 months after device activation and subsequently every 12 months. in addition to the regular visits, patients will be allowed to contact the study center at any time if their continence worsens enough to require adjustment or if they experience any complications. the surgical technique of the victo artificial sphincter implantation has been described in detail elsewhere. a non-parametric one-way anova friedman test will be used to compare the changes of categorical variables from baseline to the end of follow-up. wilcoxon rank-sum test will be used to assess the change of the non-categorical variables. p-value \< 0.05 is considered statistically significant and no correction for multiple testing will be applied.

Eligibility criteria:
inclusion criteria: * urinary incontinence due to previous prostate surgery * primo-implantation of the artificial urinary sphincter * subject willing and able to give informed consent exclusion criteria: - none

Keywords: urinary incontinence artificial urinary sphincter pad-weight test quality of life
the effect lactate administration on cerebral blood flow during hypoglycemia

Conditions: Type1diabetes; Hypoglycemia Unawareness

Summary: it is thought that altered brain lactate handling is involved in the development of impaired awareness of hypoglycemia (iah), i.e. the inability to timely detect hypoglycemia in people with type 1 diabetes (t1dm). infusion of lactate diminishes symptomatic and hormonal responses to hypoglycemia in patients with normal awareness of hypoglycemia (nah), resembling the situation of patients with iah. it is unknown whether this attenuating effect is due to brain lactate oxidation or the result of lactate-induced alterations of global and regional cerebral blood flow (cbf). normally, hypoglycemia causes a redistribution of cbf towards the thalamus, from where the sympathetic response to hypoglycemia is coordinated, but in iah this effect is absent and global cbf is increased. we hypothesize that lactate infusion in patients with nah will result in blunting of thalamic activation and/or enhanced global cbf. if so, these results may help delineating the pathogenesis of iah which eventually creates new avenues to protect against the morbidity associated with hypoglycemia and iah. study design: single-blind placebo controlled, randomized cross-over intervention study study population: t1dm patients with nah (n=10) intervention: on two separate occasions, patients with t1dm and nah will undergo a hyperinsulinemic euglycemic-hypoglycemic glucose clamp with or without the infusion of exogenous lactate. asl-mri will be applied to measure global and regional changes in cbf. main study parameters/endpoints: the change in regional thalamic cbf in response to intravenous lactate infusion compared to placebo, during hypoglycemia


Eligibility criteria:
inclusion criteria: * diabetes duration ≥ 1 year * age: 18-50 years * body-mass index: 18-30 kg/m2 * hba1c: 42-75 mmol/mol (6-9%) * outcome clarke questionnaire: 0-1 * blood pressure: \<160/90 mmhg exclusion criteria: * inability to provide informed consent * use medication other than insulin, except for oral contraceptives or stable thyroxin supplementation therapy * presence of any other medical condition that might interfere with the study protocol, such as brain injuries, epilepsy, a major cardiovascular disease event or cardiac failure, known liver disease, anxiety disorders or a history of panic attacks. * microvascular complications of t1dm: proliferative retinopathy, symptomatic diabetic neuropathy (including autonomic neuropathy) or nephropathy; clinical/overt albuminuria or an estimated glomerular filtration rate \<60ml/min/1.73m2. * mri contraindications (pregnancy, severe claustrophobia, metal parts in body)
pretell: prevention of telomere-related complications after lung transplant

Conditions: Short Telomere Length; Lung Transplant

Summary: to evaluate the safety and efficacy of danzol in lung transplant recipients with short telomeres. subjects with short telomeres recipient of lung transplant, will be randomized in the first month post-transplant to either placebo or danazol (200mg bid) in a 2:1 ratio.


Eligibility criteria:
inclusion criteria: 1. age greater than 18 2. ability to give informed consent 3. recipient of lung transplantation 4. short telomeres assessed either pre-transplant or post-transplant with flow-fish as lymphocyte telomere length \<10th percentile predicted for age 5. clinically stable one month after lung transplant exclusion criteria: 1. patients on androgen hormones to include testosterone or high dose estrogen (estradiol 0.5 mg/day or greater) during 12 months prior to enrollment 2. patients with active thrombosis or thromboembolic disease and history of such events unless thrombosis is line related. 3. undiagnosed abnormal genital bleeding, porphyria, androgen-dependent tumor, or prostatic hypertrophy 4. patients with active hepatitis b or c 5. patients who have received a bone marrow transplant 6. clinically unstable after lung transplantation 7. current pregnancy, or unwillingness to take be on two forms of contraceptives including a barrier method of birth control or practice abstinence to refrain from pregnancy if of childbearing potential during the course of the study 8. lactating women, due to the potentially harmful effects on the nursing child 9. patients with abnormal liver function ast, alt \>3 times normal 10. subjects with a history of benign intracranial hypertension 11. subjects with a history of liver disease not limited to alcoholic hepatitis/cirrhosis, non-alcoholic steatohepatitis (nash), autoimmune hepatitis (aih), primary biliary cirrhosis (pbc), and/or history of hepatic adenoma. 12. subjects with poorly controlled or uncontrolled type i or ii diabetes mellitus 13. significant renal abnormalities gfr\< 40 ml/min/m2 14. significant cardiac dysfunction with ejection fraction less than 50% 15. moribund status such as death is expected in the coming year 16. currently taking carbamazepine, pimozide or lomitapide 17. inability to understand the investigational nature of the study or to give informed consent

Keywords: danazol short telomere lung transplant prevention leukopenia
surgical conditions during laparoscopic bariatric surgery

Conditions: Morbid Obesity

Summary: obesity affects more than 78 million adults in the united states and it is estimated that 35% of the us population is obese. currently, more than 179,000 bariatric procedures are performed in the us each year with the majority of these surgeries using laparoscopic techniques. surgeons often request deep neuromuscular blockade (nmb) during surgery, but there is no evidence that a deep nmb improves surgical conditions and that the surgeons can discriminate between a moderate and deep nmb. there is also evidence that maintaining low insufflation pressures during laparoscopic surgery may decrease postoperative pain. the goal of this prospective, randomized, assessor-blinded controlled trial is to test the hypothesis that deep nmb provides optimal surgical conditions during laparoscopic bariatric surgery in the morbidly obese patient. it will also determine if deep nmb allows the surgeon to utilize lower insufflation pressure and decreases postoperative pain requirements after laparoscopic bariatric surgery.

subjects will be randomized to one of four groups: 1. moderate neuromuscular block (nmb) + 10 mm insufflation pressure (ip); 2. moderate nmb + 15 mm ip; 3. deep nmb + 10 mm ip; or 4. deep nmb + 15 mm ip. a moderate nmb block will be defined as 2-3 twitches in the train of four (tof) and a deep nmb will be defined as 0-1 posttetanic count. the surgeons will be asked to rate their satisfaction with the surgical conditions using a five-point ordinal scale ranging from 1 (extremely poor) to 5 (optimal conditions). the first rating will occur at the beginning of the procedure when the nmb level is stable at either a deep or moderate block and the intra-abdominal pressure is either 10 or 15 mm hg (per randomization). the surgeon will be blinded to the insufflation pressure at this point. if the surgical conditions are rated as extremely poor or poor, the level of the neuromuscular block can be increased and/or the insufflation pressure can be increased to 15 mm hg.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * asa i-iii * bmi ≥ 35 exclusion criteria: * inability to obtain written informed consent * pregnancy or breastfeeding * allergy to rocuronium, sugammadex, or any anesthetic agents used in the protocol * known or suspected neuromuscular disorders * significant renal disease with a serum creatinine ≥ 2 mg/dl f. significant liver disease g. a family history of malignant hyperthermia

Keywords: morbid obesity laparoscopic surgery neuromuscular blockade
mental imagery and targeted memory reactivation in ptsd

Conditions: Nightmares, REM-Sleep Type; PTSD

Summary: with this protocol, investigators examine whether targeted memory reactivation (tmr), a technique used to strengthen memories, can accelerate remission of traumatic nightmares and post-traumatic stress disorder (ptsd) symptomatology. this protocol uses tmr during rem sleep to strengthen positive memories generated by imagery rehearsal therapy (irt), a recommended treatment of nightmares. patients with ptsd are asked to perform 3 weekly irt sessions and, while they generate a positive outcome of their recurrent nightmare, half of the patients are exposed to a sound s1 (tmr group), while the other half is not exposed to this sound (control group). all patients will perform irt every evening at home and will be exposed to the sound s1 during rem sleep with a wireless headband, which automatically detects sleep stages. clinical evaluation of the severity of ptsd and nightmares before and after (1-month follow-up and 3-months follow-up) this intervention takes place using the validated clinically administered ptsd scale for dsm-5 (caps-5, primary outcome measure). the investigators hypothesize that patients treated with irt and who are exposed, during rem sleep to a sound that had previously been associated with the new positive dream scenario of irt (tmr group), will have more reduced frequency of ptsd severity and nightmares compared to participants with stimulation of the same, but non-associated, sound during rem sleep (control group).


Eligibility criteria:
inclusion criteria: * with untreated persistent ptsd according to dsm-5 (\> 1 month), suffering from chronic nightmares * with no active specific treatment for ptsd exclusion criteria: * patients with active specific treatment for ptsd * patients with neurological disorders
the benefits of continued use of ovarian function suppression after 5 years

Conditions: Breast Cancer Female; Endocrine Therapy

Summary: to observe and evaluate the clinical efficacy and safety of continuous use of ofs for premenopausal patients with early breast cancer after 5 years use of ofs. this study is a multicenter, prospective, observational, non randomized controlled, open-label real world study based on hospital medical record system data, aimed at evaluating the benefits of continuing to use ofs after 5 years of use. the retrospective analysis plan includes patient data from september 1, 2023 to september 1, 2026. join two cohorts: the continued use group and the discontinued use group after 5 years of ofs, respectively.


Eligibility criteria:
inclusion criteria: * diagnosed with early primary breast cancer * female aged 18-60 years (including 18 year and 60 year) * hormone receptor (hr) positive her2 negative * receive 5 years of ofs treatment * ecog score 0-1 * voluntarily join this study and sign the informed consent form; * the researcher believes that it can benefit. exclusion criteria: * the patient is receiving treatment that affects ofs at the same time the patient has received ofs treatment for less than 5 years * central nervous system metastases with known obvious symptoms, such as headache, cerebral edema, blurred vision * invasive metastases with known obvious symptoms * invasive metastases with known obvious symptoms * doctors think it is not suitable for inclusion

Keywords: ovarian function suppression hormone receptor (hr) positive her2 negative early breast cancer prolonged therapy
evaluation and longitudinal follow-up of biomarkers predictive of severe forms of covid-19

Conditions: Covid19

Summary: current data in the literature demonstrate that the immune response to cov-2-sars is much more complex than initially assumed. in fact, beyond the humoral response, including the existence of neutralizing cas, the adaptive lymphocyte t-type immune response also appears to play an important role in controlling the infection and reducing the severity of the disease. at this stage, the analysis of this t response is still rudimentary and underdeveloped, but it seems crucial to be able to analyze it effectively in covid-19 patients, which could help predict the evolution of the infection. it is also currently difficult to know the evolution of this response over time and especially after the resolution of the infection. to this end, we will analyze the t lymphocyte response (elispot and quantiferon) based on the secretion of ifn (th1) and il-4 (th2) by cov-2-sars specific t cells from covid-19 patients. we will compare the t response to the quality of the systemic and mucosal humoral response. finally, we will evaluate in parallel two new biomarkers of the severity of covid-19: plasma calprotectin and the presence of antibodies to type 1 ifn antibodies.


Eligibility criteria:
inclusion criteria: * social security affiliation * signed informed consent * patients with covid infection documented by pcr and/or antigenic testing * patients belonging to the following groups: * asymptomatic patients with pcr-positive pcr * patients with mild symptoms and pcr positive * seriously symptomatic patients with pcr positive * patients in resuscitation with positive pcr * healthy individuals as controls exclusion criteria: * haemoglobin \< 8g/dl * pregnancy, breastfeeding woman * patient vaccinated within 15 days prior to inclusion

Keywords: t cells b cells immune response sars-cov-2
effect of acetazolamide on sleep disordered breathing in lowlanders older than 40 years at altitude

Conditions: Altitude Hypoxia

Summary: randomized, placebo controlled trial evaluating the effect of acetazolamide on sleep disordered breathing in lowlanders older than 40 years travelling from 760 m to 3'100 m.

this is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of preventive acetazolamide intake on the sleep disordered breathing in lowlanders older than 40 years travelling to altitude. participants living in the bishkek area, kyrgyzstan (760m), will be transferred by car within 4h to the tuja ashu high altitude clinic (3'100 m), and stay there for 2 days. acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and during the stay at altitude. outcomes will be assessed during the stay at 3'100 m. an interim analysis will be carried out when 80 participants will have completed the study or after the first year. the peto's method will be used and the trial will be stopped when pre-specified futility boundaries were crossed.

Eligibility criteria:
inclusion criteria: * healthy men and women, age 40-75 yrs, without any disease and need of medication. * born, raised and currently living at low altitude (\<800m). * written informed consent. * kyrgyz ethnicity exclusion criteria: * any active respiratory, cardiovascular or other disease requiring regular treatment or being otherwise relevant for tolerance of hypoxia or altitude exposure. * any condition that may interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day or \>20 pack-years with active smoking during the last 10 years), regular use of alcohol. * allergy to acetazolamide and other sulfonamides.

Keywords: healthy participants older than 40 years sleep disordered breathing periodic breathing prevention acetazolamide
operative vs. non-operative treatment of acute ruptures of the achilles tendon

Conditions: Ruptured Achilles Tendon

Summary: the proposed trial is a multi-centre prospective randomized controlled trial comparing outcomes of patients with acute achilles tendon ruptures treated either non-operatively or with open operative tendon repair. all patients will undergo accelerated functional rehabilitation. the primary outcome measure is achilles tendon re-rupture rate.

equivalent clinical outcomes to surgical repair; reduced morbidity and disability to subjects through elimination of a surgical repair; reduction of cost to patients by eliminating need for surgery.

Eligibility criteria:
inclusion criteria: * complete mid-substance rupture of the achilles tendon as diagnosed on clinical exam * present for initial assessment and treatment with application of a plantar-flexed cast within 48 hours of their injury. * referred to one of the participating orthopaedics surgeons in a timely fashion so as to allow for further treatment (operative repair or initiation of the rehabilitation protocol) within 14 days of their injury. exclusion criteria: * open achilles injury * achilles injury that is not a mid-substance tendon injury * any additional injury to the ipsilateral lower extremity * contraindication to surgery or anesthetic * (physical or mental) that may interfere with compliance with the rehabilitation protocol * any known factor for increased risk of achilles tendon rupture (i.e. diabetes mellitus, immunosuppressive therapy including local or systemic steroids, and fluoroquinolone use).

Keywords: achilles rupture