Kornimate/medical-research-clean huggingface dataset:
vitamin d can increase pathological response of the breast cancer patients treated with neoadjuvant therapy

Conditions: Vitamin D Deficiency; Chemotherapy Effect; Pathology

Summary: the aim of the study is to evaluate the relationship between the vitamin d replacement and pathological response in patients undergoing neoadjuvant therapy according to different molecular sub types. because of no study evaluating pathological response to neoadjuvant therapy with vitamin d replacement in patients with breast cancer.

calcitriol, a vitamin d metabolite, inhibits cell proliferation and pathways in invitro experiments. vitamin d affects gene expression related to breast cancer and prevents cell differentiation, growth and angiogenesis . low vitamin d may include a high risk of breast cancer, but there are also studies reporting that patients with low vitamin d levels at the time of diagnosis show more aggressive breast cancer course . breast cells can produce vitamin d by taking part in the formation of 1,25 oh vit d3 in vitamin d synthesis as well as in kidney cells. apoptosis can be caused by vitamin d receptors . there are very few studies on the effect of vitamin d replacement on breast cancer-related survival. there are studies reporting the incidence of fewer breast cancer with vitamin d replacement in contrast to there are studies showing the opposite .patients achieved pathological complete response (pcr) with neoadjuvant therapy have been shown to have better survival. there are studies showing that they do not affect the pcr ratio related to the level of vitamin d in breast cancer patients receiving neoadjuvant chemotherapy. in one study, it was shown that it increases the response rate when given with bisphosphonate .there is no study evaluating pathological response to neoadjuvant therapy with vitamin d replacement in patients with breast cancer. the aim of the study is to evaluate the relationship between the vitamin d replacement and pathological response in patients undergoing neo-adjuvant therapy according to different molecular subtypes of biopsy-diagnosed breast cancer patients.

Eligibility criteria:
inclusion criteria: * invasive breast cancer is confirmed by biopsy * enough organ function, * metabolically normal, * eligible for neoadjuvant treatment * the patients who were informed about the prerequisites with their consent exclusion criteria: * having metastatic disease * having not operated from breast cancer after neoadjuvant treatment

Keywords: neoadjuvant treatment breast cancer vitamin d3
can tranexamic acid reduce bleeding after post partum hemorrhage in cesarean section delivery

Conditions: Post Partum Hemorrhage

Summary: the purpose of this study was to evaluate the effect of early administration of tranexamic acid (txa) on post partum hemorrhage caused by uterine atony after cesarean section delivery. this was a randomised, placebo controlled trial including 74 patients. the investigators included asa1 parturients with correct haemostatic status undergoing cesarean section under spinal anesthesia. the randomization begins after the inefficacy of oxytocin injections and starting up sulprostone perfusion at the request of the surgeon. txa group received 10 mg/kg of tranexamic acid as induction dose within 12 minutes and 1mg/kg/h as maintenance within the 2 following hours. placebo group received same volumes of normal saline. the investigators compared blood loss and transfusions in both groups.


Eligibility criteria:
inclusion criteria: * asa1 parturients * aged from 20 to 40 * correct preoperative haemostatic status (prothrombine ratio \> 60 % and platelet rate \> 100 000), * cesarean section under spinal anesthesia complicated by uterine atony needing the introduction of sulprostone exclusion criteria: * abnormal placentation * severe pre-eclampsia * coagulopathy and uterine rupture * the contra indications of txa : past history of vascular occlusive event, convulsion, and allergy.

Keywords: post partum hemorrhage transfusion tranexamic acid
prospective, multicentre, randomized, controlled, cross-over study on the safety and performance of the biologic fusion option of dialogiq compared to haemodialysis without biologic fusion in hypotension prone patients on maintenance haemodialysis

Conditions: Renal Dialysis

Summary: the goal of this prospective, randomized, controlled, cross-over, multicentric study is to demonstrate the safety of biologic fusion in patients on chronic haemodialysis or hemodiafiltration prone to hypotensive episodes. the main question it aims to answer is: • which is the number and percentage of individual sessions with reached prescribed post-dialysis body weight in the prescribed treatment time in each single session in hypotensive-prone patients on high-flux haemodialysis or hemodiafiltration within each patient with treatments performed with dialogiq with (treatment a) or without (treatment b) the biologic fusion option activated? participants will in addition to their routine dialysis treatment undergo 2 physical examinations and regularly answer questionnaires. a crossover design is used to compare treatments with or without the biologic fusion function activated.


Eligibility criteria:
inclusion criteria: * male or female subjects ≥18 years of age * chronic bicarbonate standard high-flux haemodialysis or hemodiafiltration for at least 3 months * dialysis frequency 3 x per week * dialysis duration per session ≥ 4h * patient on chronic haemodialysis or hemodiafiltration prone to hypotensive episodes * no residual renal function (definition: ≤100 ml urine/day) * stable dry body weight for at least 4 weeks * subjects who are willing to give a voluntary consent to participate in the study exclusion criteria: * simultaneous participation in another interventional clinical trial (drugs or medical devices studies) * vascular access insufficiency (mean blood flow \<200ml/min) * patients treated with dialysis profiles: sodium profile, ultrafiltration (uf) profile, and temperature profile * use of the biologic fusion function during the last 9 dialysis sessions recorded at the site (retrospective screening period) * pregnant or nursing women. women of childbearing potential must agree to avoid pregnancy during the study period * factors which may interfere with full participation in the trial * any contra-indication to haemodialysis treatment per se, as described in the instructions for use (ifu) * any serious medical condition or disability, which in the opinion of the investigator limits the life expectancy and would preclude completion of the study
pain therapy after elective cardiac surgery

Conditions: Pain

Summary: the purpose of this study is to determine generation of a target controlled infusion model for the patient controlled analgesia with the strong analgesic, hydromorphone, after planned open heart surgery, during which the strong analgesic, sufentanil, was used.


Eligibility criteria:
inclusion criteria: * written informed consent, * ability to understand the nature of patient-controlled analgesia and other study-specific procedures, * elective cardiac surgery with thoracotomy and subsequent stay in the intensive care unit exclusion criteria: * use of mao inhibitors in the last 14 days, * chronic alcoholism or drug addiction in medical history, * severe obstructive or restrictive pulmonal disorders in medical history, * severe hepatic and renal disorders in medical history, * hypothyroidism, pancreatitis in medical history, * asa iv, * pregnant or nursing females

Keywords: pharmacokinetic-pharmacodynamic modeling patient-controlled analgesia target-controlled infusion hydromorphone sufentanil after thoracotomy cardiac surgery
combined effect of cftr protein modulator drugs and exercise in cystic fibrosis

Conditions: Cystic Fibrosis in Children

Summary: this study aims to assess the effects of programmed exercise combined with cftr protein modulator drugs in the cardiorespiratory fitness, strength, functional capacity and agility in a group of young patients with cystic fibrosis.

the present study is a new clinical trial that extends our previous work intended to assess the effect of programmed exercise with or without electrical stimulation on cardiorespiratory fitness, strength, functional capacity and agility in a group of young patients with cystic fibrosis (ecomirin) registered at clinicaltrials.gov (identifier: nct04153669). after finishing the study, a subset of the participants was treated with either tez/iva or lum/iva per standard of care, as they were considered candidates according to the aemps (https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-000833-37/es). those patients are expected to complete five months of pharmacological treatment without exercise by june 2020. primary objective to evaluate the effect of an exercise program on physical fitness in cystic fibrosis patients after 5 months of administration of lum/iva or tez/iva in comparison to the effect produced by the same exercise program before administration of the drug. secondary objectives other specific objectives include comparing the beneficial effects of exercise and lum/iva or tez/iva on: 1) cardiorespiratory function and muscle strength; 2) the concentration of chlorine in sweat; and 3) quality of life.

Eligibility criteria:
inclusion criteria: * in order to be included, patients must have participated in the ecomirin clinical trial (clinicaltrials.gov identifier: nct04153669). * they must have a previous cf diagnosis, defined as: sweat chlorine ≥ 60 meq/l and/or carry two variants of the cftr gene characterized as pathogenic. * age 6-18 years; eligible to receive treatment with tez/iva or lum/iva according to the aemps (lum/iva for 6-11 year-old children homozygous for the f508del mutation; tez/iva for ≥ 12 year-old children homozygous for the phe508del mutation, as well as heterozygous for the f508 mutation plus one of the following mutations: p67l, r117c, l206w, r352q, a455e, d579g, 711 + 3a g, s945l, s977f, r1070w, d1152h, 2789 + 5g a, 3272-26a g, and 3849 + 10kbc t); * agreement to collaborate in performing static and dynamic pulmonary function tests. * consent of children and/or parents or legal guardians to participate in the study after having read and understood the informed consent form. exclusion criteria: * cf patients not consenting to participate in the study at any time after reading and understanding the informed consent form will be excluded. * cf patients who are not eligible to receive treatment with tez/iva or lum/iva according to the aemps during the course of the study will be excluded. * study participants will be excluded if they test positive for any contagious viral infection that may affect the outcomes (e.g. sars-cov-2).

Keywords: cystic fibrosis electrostimulation combined training physical fitness
water drinking test during intraocular pressure fluctuation (iop) monitoring

Conditions: Healthy Subjects

Summary: the purpose of this study is to investigate the investigational device capacity to detect an intraocular pressure increase (iop)induced by water intake.

32 subjects will be enrolled in the investigation. eligible subjects will receive one session of 4-6-hour continuous iop monitoring with sensimed triggerfish® following water drinking test (wdt). sensimed triggerfish® will be installed randomly on right or left eyes and the iop recording will be initiated as soon as the adaptation of the device on the subject's eye is satisfying. sensor fitting in the eye will then be evaluated every 60 minutes, until no more spontaneous sensor movement and rotation are observed. then iop will be measured on the contra lateral eye using goldmann tonometer and the subjects will be asked to drink 1 liter of water within 5 minutes. after the water drinking, iop will be measured on the contra lateral eye 10 minutes after the beginning of the test then every 5 minutes until returned to normal. the iop will be measured again every 20 minutes until 2 hours after the water drinking.

Eligibility criteria:
inclusion criteria: * healthy volunteer without previous ocular medical history * 18 years or more at inclusion * maximal weight: 100kg * bmi lower or equal to 30 kg/m2 * subjects having provided informed consent exclusion criteria: * silicone allergy * cardiovascular disease * diabetes * narrow or closed iridocorneal angle

Keywords: glaucoma triggerfish water drinking test
fractional radiofrequency for the treatment and reduction of acne scars and wrinkles

Conditions: Acne Scars - Mixed Atrophic and Hypertrophic; Wrinkle

Summary: the objective of this clinical study is to evaluate the efficacy of fractional rf for the treatment and reduction of acne scarring or facial wrinkles.

prospective, single centre, evaluator-blind, split face study of the efficacy of fractional radiofrequency (rf) for the treatment and reduction of acne scarring and facial wrinkles. the study will evaluate the progress of 15 subjects requesting treatment of scarring or facial wrinkles. the study will involve three treatments on both sides of the face with 3-5 week intervals between each treatment. subjects will be followed at 6 and 12 weeks after their last treatment. analysis will be performed on all subjects who receive at least one treatment.

Eligibility criteria:
inclusion criteria: 1. healthy, male or female subjects over 21 years of age who are seeking treatment and reduction of their acne scarring or wrinkles. 2. able to read, understand and voluntarily provide written informed consent. 3. able and willing to comply with the treatment/follow-up schedule and requirements. 4. women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study and have a negative urine pregnancy test at baseline. exclusion criteria: 1. pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant). 2. subjects with any implantable metal device in the treatment area 3. permanent implant in the treated area, such as metal plates and screws (excluding dental implants), or an injected chemical substance. 4. current or history of any kind of cancer, or dysplastic nevi 5. severe concurrent conditions, such as cardiac disorders. 6. pregnancy or intending to become pregnant during the study and nursing. 7. impaired immune system due to immunosuppressive diseases, such as aids and hiv, or use of immunosuppressive medications. 8. history of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime. 9. poorly controlled endocrine disorders, such as diabetes. 10. any active condition in the treatment area, such as sores, psoriasis, eczema, and rash. 11. history of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin. 12. history of bleeding coagulopathies, or use of anticoagulants (excluding daily aspirin). 13. facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, if face is treated. 14. use of isotretinoin (accutane®) or other systemic retinoids within six months prior to treatment or as per investigators discretion. 15. any surgical procedure in the treatment area within the last six months or before complete healing. 16. treating over tattoo or permanent makeup. 17. excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.

Keywords: acne scars wrinkles rhytids fractional rf
interest of wicking for ossicular surgery and myringoplasty

Conditions: Post-Op Complication; Otologic Disease

Summary: myringoplasties and ossicular surgery are very common procedures. following these otological surgeries, most surgeons install a wicking. this intervention consists of placing a wick, absorbable or not, in the external acoustic meatus, after having replaced the tympanomeatal flap.

myringoplasties and ossicular surgery are very common procedures. following these otological surgeries, most surgeons install a wicking. this intervention consists of placing a wick, absorbable or not, in the external acoustic meatus, after having replaced the tympanomeatal flap. putting in place a wicking often requires to remove this wicking, feared by the patient. in addition, wicking leads to obstruction of the external acoustic meatus responsible for functional discomfort (feeling of fullness in the ear, pain, significant conductive deafness) which can last from one to several weeks depending on the type of wicking. despite these drawbacks, the rationale for wicking has never been established, the choice of wick type is often empirical, and its necessity is sometimes controversial in the literature. recent studies have studied the absence of wicking as an alternative to overcome its many drawbacks. no prospective, randomized, multicenter study has been performed to show the superiority of wicking in healing following middle ear surgery (myringoplasty, stapedo-vestibular ankylosis, ossiculoplasty) via the duct or the endaural route. the only study with a high level of evidence concerns only endoscopic surgery. this study has the advantage of showing that with comparable audiometric and healing results, the absence of wicking allows a reduced operating time, an earlier reduction in otorrhea and the feeling of blocked ears, and an earlier improvement of hearing. given this work in the literature, our hypothesis is that tympanic healing is not impaired in the absence of wicking.

Eligibility criteria:
inclusion criteria: * adult patient (age 18 = or + ), whose mother tongue is french or who understands french language * ossicular surgery (fitting of a partial or total ossicular prosthesis) or myringoplasty performed endoscopically, from the speculum, from the duct or from the endaural. * tympanic reconstruction by all types of grafts: cartilage, fascia, autologous fat * written consent signed by the participant * affiliation to a social security scheme, exclusion criteria: * pregnant or breastfeeding woman, patient under legal protection, guardianship or curatorship. * need for a retroauricular approach. * need for annulus detachment\> 60% * presence of cholesteatoma or middle ear tumor

Keywords: ossicular surgery otological surgeries wicking
neonatal brain oxygenation study

Conditions: Cerebral Hypoxia

Summary: implementing target ranges for regional cerebral saturations in extremely preterm infants in the first week of life may improve neurodevelopmental outcomes at 22-26 months corrected age compared to those without targeted cerebral saturations (csat) using near-infrared spectroscopy (nirs). infants will be randomized to a targeted cerebral saturation monitoring group with visible reading of csat or to a control group with cerebral saturation monitoring, but with blinded csat measures. those in the targeted csat group will follow a treatment guideline to maintain cerebral oxygenation in the target range. the primary outcome is neurodevelopmental outcome as determined by bayley iii cognitive scale score.


Eligibility criteria:
inclusion criteria: * very preterm infants with gestational age at least 23 weeks but less than 29 completed weeks * less than 6 hours of age exclusion criteria: * skin integrity insufficient to allow placement of nirs sensors * decision not to provide full intensive care support * congenital condition, other than premature birth, that adversely affects life expectancy or neurodevelopment
proposal for the development of a well defined database for patients with oral bisphosphonate-related osteonecrosis

Conditions: Osteonecrosis

Summary: in cooperation with merck \& co, inc. we will identify and form a database of 35 patients who have developed osteochemonecrosis of the jaws related to oral bisphosphonate use. we will study the triggers, associated medical conditions and medications, location of the lesion(s), and patient outcomes.

this study is an observational study, and not a comparative trial. the major outcome is represented by the fraction of subjects with long term healed lesions.

Eligibility criteria:
inclusion criteria: * exposed bone in the oral cavity of greater than 6-8 weeks duration unresponsive to therapy exclusion criteria: * pregnant patients * patients less than 30 yrs of age or greater than 90 yrs of age * mentally incompetent individuals

Keywords: osteonecrosis, jaws, bisphosphonate, fosamax, alendronate
attention retraining for anxiety disorder patients resistent to antidepressants

Conditions: Generalized Anxiety Disorder; Social Anxiety Disorder; Panic Disorder

Summary: the objective of this project is to test the combination of active or placebo attentional bias modification treatment (abmt) to usual treatment for anxiety disorder patients resistant to antidepressants.


Eligibility criteria:
inclusion criteria: * primary diagnosis of generalized anxiety disorder, panic disorder or social anxiety disorder according to the international neuropsychiatric interview psychiatric interview (m.i.n.i.) * current treatment for the anxiety disorder with antidepressants with an appropriate dose for at least 8 weeks; * score on oasis (overall anxiety severity and impairment scale)equal or greater than 8 exclusion criteria: * other psychiatric disorder that causes more impairment and suffering than generalized anxiety disorder, panic disorder or social anxiety disorder in the clinical evaluation * current cognitive behavior therapy * marked intellectual disability (clinically evident) * suicidal ideation or suicide plan at the time of assessment(m.i.n.i.) * psychotic disorder (m.i.n.i.) * bipolar disorder type i (m.i.n.i.) * abuse / dependence substances (m.i.n.i.)

Keywords: generalized anxiety disorder social anxiety disorder panic disorder antidepressants resistant attentional bias modification treatment (abmt) attentional retraining adjuvant therapy
institut paoli calmettes ovarian cancer database

Conditions: Ovarian Neoplasms

Summary: database of institut paoli-calmettes patients diagnosed with ovarian cancer


Eligibility criteria:
inclusion criteria: * patient with a diagnosis of ovarian cancer exclusion criteria: * diagnosis of fallopian tube cancer
investigation of clinical feature and brain function in narcoleptic patients

Conditions: Narcolepsy; REM Sleep Behavior Disorder

Summary: this study evaluates the psg and cerebral metabolism and functions in narcolepsy with/without rbd

polysomnographic (psg) work-up one night to record nocturnal sleep condition in narcolepsy with /without rbd and control subjects including sleep macrostructure, occurrence of sleep onset rapid eye movement period(soremp), sleep stages distribution, and sleep arousle and leg movement and apnea hyponea index would be calculated. functional magnetic resonance imaging (fmri) has been used in human to nonivasiverlyn investigate the neural mechanisms. this technique also apply to measures the variations in brain perfusion, structure and morphology in narcolepsy patients by assessing the blood oxygen level-dependent (bold) signal diffusion tensor imaging (dti and voxel-based morphometry(vbm) this study compare the feature of psg and fmri between narcolepsy with rbd, narcolepsy without rbd, control subject to evaluates the psg and cerebral metabolism and functions in narcolepsy with/without rbd.

Eligibility criteria:
inclusion criteria: * narcolepsy meet to the international classification of sleep disorder,3rd edition (icsd-3) , and rbd meet to the minimal diagnostic criteria according to the international classification of sleep, control subjects . exclusion criteria: history of heart disease history of central nervous system organic psychosis ahi\>15次/h history of alcohol dependence and drug abuse

Keywords: polysomnographic multiple sleep latency test fmri