Kornimate/medical-research-clean huggingface dataset:
comparison of self fixating mesh to mesh fixation with metallic tacks in laparoscopic inguinal hernia repair

Conditions: Inguinal Hernia; Adult

Summary: this study compares the use of self-fixating mesh to mesh fixation with tackers in the management of inguinal hernia by laparoscopic method. half of the participants in the study will be treated using self-fixating mesh, while the other half will be treated using conventional mesh fixed with tackers.

conventional tacker mesh fixation group patients will be undergoing mesh ﬁxation with non-absorbable tacks. monofilament polyester mesh of size 15\*11cm will be used. the tacks would be used such that they avoid bony prominences and vascular and neural structures. one tack will put at the cooper's ligament and another applied laterally superior to the iliopubic tract in the anterior abdominal wall. in any patient, the maximum number of tacks applied will not exceed four. preperitoneal space will be deﬂated under direct visualization after the mesh is placed. hernia sac and any cord lipoma will be placed behind the mesh. during the deﬂation process, repositioning of the peritoneal sac on the mesh, in particular the dorsal edge of the latter would be carefully performed to avoid displacement or folding of the mesh. self-fixating mesh group in this group,monofilament polyester mesh with polylactic acid (pla) microgrips of size 15\*11 will be used. it is an isoelastic large-pore knitted fabric with a density of 73g/m2 at implantation and 38g/m2 after microgrips absorption which will be at 18 months. the resorbable micro grips provide immediate adherence to surrounding muscle and adipose tissue during the initial days post hernia surgery, serving as an alternate method of fixation to traditional sutures, tacks, staples, or fibrin sealants. no additional tacks, staples, sutures, or fibrin sealant is used

Eligibility criteria:
inclusion criteria: 1. unilateral inguinal hernia 2. age 18-80years 3. american society of anesthesiologists (asa) grade 1 or 2 exclusion criteria: 1. patient unfit for general anesthesia or laparoscopic surgery 2. large scrotal hernias 3. irreducible hernias 4. morbid obesity 5. previous pelvic surgery 6. coagulopathy 7. those who cannot understand the vas score 8. those who did not agree to participate in the study 9. gastritis 10. gastroesophageal reflux disease 11. liver dysfunction 12. kidney dysfunction

Keywords: adult inguinal hernia inflammatory surgical mesh laparoscopy/methods postoperative pain recurrence randomized controlled trials double-blind method pain chronic pain seroma total extraperitoneal repair tacker mesh fixation self gripping
comparing palliative radiotherapy with or without carboplatin

Conditions: Lung Cancer; Head and Neck Cancer; Metastatic Cancer

Summary: the study population has locally advanced or metastatic bronchial or head and neck cancer. this study assesses the value of concomitant chemo/radiotherapy with carboplatin daily during metastatic radiotherapy versus radiotherapy alone. the realization of a systemic treatment during the radiotherapy could make it possible to obtain a benefit on the control of the evolution of the metastases and thus of the pains generated, as well as on the quality of life of the patients. in addition, a benefit in overall survival is possible.

the study population has locally advanced or metastatic bronchial or head and neck cancer. patients receive 10 injections of carboplatin (validated chemo-sensitizing molecule) or placebo (glucose) before 10 radiation sessions. the overall duration is 14 days.

Eligibility criteria:
inclusion criteria: * patients with locally advanced or metastatic bronchial or head and neck cancer * patient require palliative radiotherapy * age ≥ 18 years * ps ≤ 2 * obtaining the signed written consent of the patient * patient affiliated to a social security scheme exclusion criteria: * other chemotherapy or targeted therapy * prior radiation * patients with thrombopenia \< 100 000 * patients with neutropenia \< 2000 * patients with renal clearance \< 20 ml/min * known hypersensitivity to platinum salt * treatment with phenytoin or fosphenytoin * in previous three months, a vaccination against yellow fever, live vaccin or live attenuated vaccine * unchecked diabetes * hemorrhagic tumor * refusal of participation or inability to issue informed consent * person deprived of liberty or adult under guardianship * minor patients, pregnant or lactating women * participation in other interventional study

Keywords: irradiation placebo carboplatin
accelerated wound healing in diabetic ulcers by sitagliptin

Conditions: Diabetic Foot

Summary: the purpose of the study is to test the effect of sitagliptin on the healing of stable, nonhealing diabetic foot ulcers. this is a randomized placebo-controlled trial.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * at least 1 diabetic foot ulcer with a size between 1 and 20 sqcm * stable size of the foot ulcer for at least 2 weeks * hba1c \<= 8% under treatment with insulin, metformin, sulfonylureas, sglt2 inhibitors, glinides or glitazones exclusion criteria: * local purulent signs of inflammation at ulcer site * planned interventional or surgical therapy of a macro vessel disease of the lower limb * glomerular filtration rate \<30ml/min * liver cirrhosis child b or c * pregnancy, lactation * allergy against sitagliptin * ongoing treatment with dipeptidyl peptidase 4 (dpp4) inhibitors

Keywords: diabetic foot ulcer, sitagliptin
a study in the united states using electronic medical records (emr) to assess effectiveness of afatinib (gilotrif) following pembrolizumab and chemotherapy in the treatment of metastatic squamous cell carcinoma of the lung

Conditions: Squamous Non-small Cell Lung Cancer

Summary: this study aims to characterize the profile and outcomes for patients with squamous cell carcinoma of the lung (sqcc) who progress on 1l pembrolizumab in combination with platinum based chemotherapy and receive afatinib as second line (2l) therapy.


Eligibility criteria:
inclusion criteria: * diagnosis of squamous or mixed histology non-small cell lung cancer * treated with pembrolizumab in combination with platinum-based chemotherapy as initial therapy for advanced or metastatic disease (stage iiib or iv) * first cycle of pembrolizumab received after 06/01/2018 * permanently discontinued 1l pembrolizumab treatment * initiated second-line treatment at least 3 months prior to the date of data collection, with either : * afatinib * any chemotherapy * age ≥ 18 years exclusion criteria: -received pembrolizumab in combination with platinum-based chemotherapy as part of an interventional clinical trial
act-measurement at different location during left atrial ablation procedures

Conditions: Atrial Fibrillation

Summary: ablation of atrial fibrillation is standard therapy for symptomatic patients or patients with severely reduced systolic left ventricular ejection fraction. complications of the procedure are ischemic thrombembolic stroke. therefore periprocedural treatment with heparin is administered to acchieve a therapeutic anticoagulation. the efficacy of anticoagulation is measured by active-clotting time (act) which is measured with blood drawn mostly from the v. femoralis. despite controlled anticoagulation periprocedural stroke is published with an incidence of up to 2% and asymptomatic cerebral embolization from 2% to 15%. the act-trial has two aims: 1. analysis of the influence of the localization of blood drawing on the measured act: blood from central venous line, from la and from laa. 2. dependency of the act measured in the blood of the laa with regard to anatomic und functional laa-measurements. patients will be included scheduled for left atrial ablation procedure and will be divided in two groups: atrial fibrillation at time of procedure and sinus rhythm at time of procedure.


Eligibility criteria:
inclusion criteria: 1. patients aged 18 until 80 years with atrial fibrillation scheduled for left atrial ablation procedure (according to 20216 esc guidelines for the management of atrial fibrillation" and/or "2017 hrs/ehra/ecas/aphrs/solaece expert consensus statement on catheter and surgical ablation of atrial fibrillation" 3. signed informed consent. 4. hemoglobin \>10 g/dl in messungen up to 8 weeks before inclusion. exclusion criteria: incompliance or contraindication of oral anticoagulation prior to ablation procedure.

Keywords: anticoagulation ablation atrial fibrillation act
work-health-life-balance - mental resilience, stability & healthy nutrition

Conditions: Psychological Stress; Nutritional Quality; Burn-out Syndrome; Sleep; Depressive Disorder

Summary: new working environments (digitalization, flexibilization) can lead to increased levels of stress. a balanced work-life balance is therefore important in order to prevent negative effects of stress on mental health. this study investigates, 1. how stress, recovery, nutritional behavior, resilience and sleep behavior are related to the changed working conditions. 2. how standardized nutritional training affects individual body composition (measured using bioelectrical impedance analyses, bia), stress perception, burn-out symptoms and sleep.

the ways of working must adapt to the challenges and opportunities of the digital world. work 4.0 describes the process of change in the working environment in the digital age. adapting to rapidly changing and sometimes uncertain living and working conditions in times of digitization, dislocated working (including "home office") and altered work processes demands a considerable effort of resources from numerous employees. previously established work environments and behaviors are being evaluated and adapted to the new circumstances and requirements. such times of change often cause uncertainty and result in increased stress levels. stress, in turn, leads to a variety of symptoms in many areas of life and work, which can limit the ability to work. as a result, successful adaptation to the challenges of the new work reality of work 4.0 can fail. research questions: this study investigates, 1. how stress, recovery, nutritional behavior, resilience and sleep behavior are related to the changed working conditions and central characteristics of work 4.0. 2. how standardized nutritional training based on the austrian food pyramid affects individual body composition (measured using bioelectrical impedance analyses, bia), stress perception, burn-out symptoms and sleep.

Eligibility criteria:
inclusion criteria: * employees in austrian companies affected by digitalization * informed consent exclusion criteria: * no informed consent
insecticide resistance management in burkina faso and côte d'ivoire

Conditions: Malaria

Summary: this study evaluates the benefit to use 1) insecticide residual sprayings, 2) larvicides, 3) ivermectin for domestic animals and 4) behaviour change communication strategy to complement the universal coverage with llins through a cluster randomized trial.


Eligibility criteria:
for cross-sectional surveys only, maximum age for participating in the study was 21 y/o in côte d ivoire and 18 y/o in burkina faso.

Keywords: randomized controlled trials
early cognitive assessment and evolutionary monitoring of patients with severe ards on covid-19 pneumonia requiring mechanical ventilation

Conditions: Covid19

Summary: the new coronavirus pandemic responsible for the severe acute respiratory syndrome sars-cov2 requires, in its severe forms, the use of invasive ventilation in intensive care. the first patients seen in intensive care presented with neurological symptoms and usually not seen in non-viral ards or due to other viral causes. these were mainly restless awakenings, attempts at self-extubation and confusional syndromes. although the data in the literature do not seem to reveal the presence of sars-cov2 in the csf of these patients, certain elements seem to show parenchymal brain damage with the description of hypometabolism of the frontal regions. in addition, most of these patients present a memory complaint after going into intensive care (personal data not published). we do not know to date what is the cognitive and psychic profile of these patients, nor what will be their future evolution. some patients may require specific neuro-cognitive rehabilitation. the aim of this study is to assess the cognitive profile of patients infected with covid-19 who have used invasive ventilation in the intensive care unit of paris saint-joseph hospital since april 2020, in order to be able to compare them between them and follow their evolution in the medium term. this work could make it possible to describe the specific cognitive impairment of sars-cov2, by trying to evade other causes of cognitive disorders in patients hospitalized in intensive care for respiratory distress (hypoxia, treatments, metabolic disorders, etc.). the main objective is to follow the medium-term evolution between 3 and 6 months of the cognitive profile of patients with severe form of sars-cov2 with the use of ventilatory resuscitation.


Eligibility criteria:
inclusion criteria: * patient whose age ≥ 18 years * patient with sars-cov2 treated in the intensive care unit of the hpsj for respiratory distress, using invasive ventilation by oro-tracheal intubation from april 2020 * french speaking patient exclusion criteria: * patient with an alertness disorder with glasgow eye score \<3 and / or motor \<6 (confusion being a poor criterion for evaluating the glasgow score apart from head trauma). * patient with impossibility to communicate (mutism, aphonia, major language barrier) * patient under guardianship or curatorship * patient deprived of liberty * patient objecting to the use of his data for this research
a randomized, double-blind, placebo-controlled, multicenter study of the effects of glatiramer acetate (ga) on the retinal nerve fiber layer (rnfl) and visual function in patients with a first episode of acute optic neuritis (aon). (octagon)

Conditions: Optic Neuritis

Summary: the main objective of the study is to determine whether glatiramer acetate 20 mg once daily reduces the amount of axonal loss in the optic nerve after a first event of acute optic neuritis compared to placebo patients and to generate data supporting the potential neuroprotective effect of glatiramer acetate in a human in vivo model of axonal loss.


Eligibility criteria:
inclusion criteria: * age: 18 - 45 years * isolated, unilateral, first acute optic neuritis (aon) event consistent with inflammatory demyelinization, not explained by other etiologies. onset of aon is defined by the presentation of visual disturbances. * able to provide written informed consent prior to enrollment * willing and able to comply with the protocol requirements for the duration of the study * for women of child bearing potential: * a negative urine pregnancy test o * willing to practice an acceptable method of birth control • * willing to receive a steroidal regimen exclusion criteria: * a diagnosis of clinically definite multiple sclerosis (ms) (clinically definite multiple sclerosis) * current use of any approved disease modifying agents for treatment of ms * prior clinical episode of optic neuritis in either eye * bilateral aon * inability to undergo study evaluations in both eyes * known ocular or neurological conditions or abnormalities other than refractive error that impair visual function * retrogeniculate visual loss * refractive error of greater than +6 or -6 diopters * neuromyelitis optica (devic's disease) * systemic diseases that cause inflammatory optic neuropathy, including but not limited to sarcoidosis, systemic lupus erythematosus (sle), wegener's granulomatosis, syphilis, human immunodeficiency virus (hiv) * known ocular conditions that preclude dilation * any condition that may interfere with performance of optical coherence tomography (oct): corneal, lens or fundoscopic abnormality, a co-morbid ocular condition not related to optic neuritis as detected on the oct reading * any condition that precludes administration of glatiramer acetate, such as a known history of sensitivity to mannitol * diabetes mellitus types i or ii * gastric bypass surgery * current use of chemotherapy or radiotherapy * treatments that may cause visual loss such as plaquenil, anti-tubercular agents, interferon (ifn)-alpha therapy, monoclonal antibodies cardiac medications that may affect visual evaluations such as digitalis, amiodarone, quinine * ongoing treatment with steroids (for longer than 10 days) within the last 3 months * significant or unstable medical, systemic, psychiatric or logistical condition that affects the patient's ability to give informed consent or to complete the study procedures * use of an investigational drug within 30 days prior to randomization
laparoscopic primary diaphragm versus mesh repair for hiatus hernia: a long-term follow-up

Conditions: Hernia, Hiatal; Laparoscopic; Surgery; Recurrence; Mesh; Primary

Summary: assessment of the recurrence of hiatal hernia five to ten years after repair using sutures versus sutures reinforced with non-absorbable mesh.


Eligibility criteria:
inclusion criteria: * participant of the initial prime study * alive exclusion criteria: * no informed consent * additional hiatal hernia repair surgery during the follow-up period * pregnancy * patients that have stated they do not want to be approached for follow-up research
strabismus recovery with proparacaine and oculocardiac reflex

Conditions: Strabismus; Bradycardia; Nausea; Pain

Summary: observational study to determine if topical anesthetic and intraoperative oculocardiac reflex influence post strabismus surgery recovery.

in an observational study with de-identified data of oculocardiac reflex (ocr) and strabismus surgery under routine anesthesia, a cohort of ongoing patients received topical proparacaine immediately post op, or none. co-variables were intraoperative opioid and ocr, patient age, type of surgery. several post-operative recovery outcome variables were prospectively monitored.

Eligibility criteria:
inclusion criteria: * strabismus surgery exclusion criteria: * none

Keywords: post operative recovery oculocardiac reflex extra ocular muscle conjunctiva numbing drop heart rate
trial of gemcitabine_capecitabine versus gemcitabine_carboplatin in breast cancer

Conditions: Metastatic Breast Cancer

Summary: gemcitabine plus carboplatin in recurrent or metastatic breast cancer is a recommended scheme in national comprehensive cancer network (nccn) guideline. gemcitabine in combination with capecitabine is also effective in metastatic breast cancer (mbc) in some clinical study with small sample.

a multicenter randomized phase ⅲ clinical trial of gemcitabine in combination with capecitabine versus gemcitabine plus carboplatin as first-line treatment in triple-negative recurrent or metastatic breast cancer.the primary endpoints of the study is progression free survival (pfs). the secondary endpoints are overall response rate (orr), overall survival (os) and safety.

Eligibility criteria:
inclusion criteria: * female * 18-70 years old * ecog 0-1 * expected lifetime more than 12 weeks exclusion criteria: * pregnancy * brain metastasis, * severe infection
mid and standard frequency ventilation in infants with respiratory distress syndrome

Conditions: Ventilator-Induced Lung Injury; Respiratory Distress Syndrome; Bronchopulmonary Dysplasia; Preterm Infant

Summary: the purpose of this study is to determine, in preterm infants less than 37 weeks gestation with respiratory distress who are ventilated in the first 48 hours after birth, if mid frequency ventilation strategy using ventilator rate of ≥ 60 to ≤ 150 per minute compared with standard frequency ventilation strategy using ventilator rates of ≥ 20 to \< 60 per minute will increase the number of alive ventilator-free days after randomization and reduce the risk of ventilator induced lung injury.

in preterm infants with respiratory distress syndrome (rds) who are ventilated in the first 48 hours after birth, mid frequency ventilation (mfv) strategy, compared with standard frequency ventilation (sfv) strategy, in the first week after birth, will increase the number of days alive and ventilator-free in the 28 days after birth. this will be a randomized controlled trial with a 1:1 parallel allocation of infants to mfv or sfv using stratified permuted block design. randomization will be stratified by gestational age (≥ 23 weeks to ˂ 26 weeks, ≥ 26 weeks to ≤ 28+6/7 (less than 29 weeks), and 29+0/7 to 36+6/7). randomization of twins and higher orders (when eligible) will be to the same group. inborn and outborn infants who are receiving assisted ventilation for rds in the first 48 hours after birth will be included in this study. infants with any of the following: a major malformation, a neuromuscular condition that affects respiration, terminal illness or decision to withhold or limit support will not be eligible. infants will be randomized to mfv versus sfv. mfv delivered at rates \> 60 per minute and ≤ 150 per minute, with patient triggered ventilation and pressure support. sfv delivered at rates \< 60 per minute and ≥ 20 per minute, with patient triggered ventilation and pressure support.

Eligibility criteria:
inclusion criteria: * infants ≥ 23+0/7 weeks and ≤ 36+6/7 who are intubated and mechanically ventilated for respiratory distress syndrome (defined by use of surfactant) within 48 hours after birth * infants whose parents/legal guardians have provided consent for enrollment * inborn or outborn infants transferred to this center before 48 hours after birth * ventilator rate ≤ 80 per minute prior to enrollment exclusion criteria: * a major malformation, a neuromuscular condition that affects respiration, or terminal illness or decision to withhold or limit support.
efficacy of 1540 nanometer erbium glass laser to improve benign dermatofibromas

Conditions: Dermatofibroma of Skin

Summary: this study is to find a more effective treatment for itchy, painful or unsightly dermatofibromas, that will improve symptoms of itch and/or pain and/or improve the appearance of dermatofibromas. this is an open-label study where subjects will receive a laser treatment at week 0, and week 4, and then 2 additional follow-up visits. photographs will be taken at each visit and rated by blinded reviewers after the study to determine efficacy.

the main objective of this study is to find a more effective treatment for itchy, painful or unsightly dermatofibromas, that will improve symptoms of itch and/or pain and/or improve the appearance of dermatofibromas. a secondary objective of this study is to better understand the 1540 nanometer erbium glass laser and its impact on the skin. this is an open-label study where subjects will receive a laser treatment at week 0, and week 4, and then have 2 additional follow-up visits (no laser treatment at these visits). photographs will be taken at each visit and photographs from pre-treatment and follow-up 1 (week 8) will rated by blinded reviewers after the study to determine efficacy.

Eligibility criteria:
inclusion criteria: * female or male, age 18-65, have at least one dermatofibroma of the skin, on the trunk or extremities, diagnosed by dermatologist, dermatofibroma is either itchy, painful or unattractive to the patient. exclusion criteria: * previous treatment to the dermatofibroma(s), pregnant or nursing women, diabetic, smoker, psoriasis, lupus or other autoimmune diseases, patient with a clear history of keloids or poor wound healing. this study will exclude dermatofibroma lesions on the face and genitals.