Kornimate/medical-research-clean huggingface dataset:
premo study: to investigate port removal outcomes

Conditions: Neoplasms; Cystic Fibrosis

Summary: a totally implantable venous access device (tivad) that is no longer in use for intravenous therapy, should be flushed at established intervals to promote and maintain patency. no consensus has been established regarding the optimal duration of the interval between 2 maintenance sessions. this exploratory study will focus on catheter status under the current 3-monthly flush regimen.

a totally implantable venous access device (tivad) or so called implantable port that is no longer in use for intravenous therapy, should be removed or flushed at established intervals to promote and maintain patency. the maintenance procedure consists of a 10 ml 0.9% sodium chloride pulsatile flush. no consensus has been established regarding the optimal duration of the interval between 2 maintenance sessions. in het university hospitals leuven the current interval is 3 months. studies confirmed the safety and efficacy of an extended maintenance interval to once every 4 months. many patients have relatively poor compliance with their regular port flushing procedure. clinicians tend to prolong the recommended interval or even to omit the maintenance procedure. therefore in clinical practice, intervals vary widely among institutions. to the best of our knowledge, a comprehensive investigation of the risks related to catheter patency, bacterial colonization and catheter integrity, has never been performed in patients whose port is electively removed using a 3 months flushing maintenance regimen. to assess the impact of the maintenance interval, patients will be included in the study if the patient's tivad is not being used for regularly therapy for a total period of at least one year. this exploratory study will focus on catheter function and colonisation, tip position and tip thrombosis, sleeve formation, removal problems and also patient experiences at elective planned tivad removal therapy.

Eligibility criteria:
inclusion criteria: * patients of 18 years and older, with a tivad that is no longer used for intravenous therapy on a regular basis for the past 365 days after completing initially planned treatment. * patients planned for an elective tivad removal under local anaesthesia. * patients able to participate in the study and willing to sign an informed consent. * patients able to understand and read dutch. exclusion criteria: • history of fever and/or chills following last flushing procedure

Keywords: vascular access devices implantable port flush interval catheter function catheter-related infection catheter tip location catheter tip thrombus catheter sleeve patient-reported outcome measure
airway microbiome of cystic fibrosis patients

Conditions: Cystic Fibrosis

Summary: with this study, the investigators first want to investigate the respiratory tract microbiome of cystic fibrosis patients. to achieve this, the investigators will collect longitudinal samples of saliva, throat and sputum and process these to determine the microbial composition and compare them over a timecourse of a year. secondly, the investigators aim to study the influence of a topical microbiome therapy (throat spray) on the microbiome of the upper and lower respiratory tract in cystic fibrosis patients after administration for 6 weeks. bacterial and cytokine profiles of salivary, throat and sputum samples will be monitored before, during and after intervention.


Eligibility criteria:
inclusion criteria: * cystic fibrosis patients * \>6 years for intervention part of the study exclusion criteria: -

Keywords: microbiome lactobacilli probiotics
the effects of light therapy on circadian rhythms, sleep, and mood in postpartum depression

Conditions: Depression, Postpartum

Summary: the proposed study aims to establish the feasibility of light therapy for postpartum depression delivered via re-timer, demonstrate its preliminary efficacy, and illuminate relationships between circadian shifts and mood changes using a novel, home-based circadian biomarker assessment paradigm (salivary dim light melatonin onset; dlmo).


Eligibility criteria:
inclusion criteria: * within 6 months postpartum * meet dsm-v diagnostic criteria for mdd * score ≥ 20 on the structured interview guide for the hamilton depression rating scale-seasonal affective disorder version (sigh-sad). exclusion criteria: * current diagnosis of bipolar disorder, posttraumatic stress disorder, schizophrenia or psychosis, dissociative disorders, eating disorder, obsessive-compulsive disorder, somatic symptom and related disorders, substance use disorder, panic disorder, agoraphobia per dsm-v * past history of mania/hypomania, * chronic medical conditions associated with depression (e.g., thyroid conditions) * ocular or retinal pathology * history of seizures or epilepsy * color blindness * lupus * currently taking an antibiotic, medication that contains hydrochlorothiazide, or isotretinoin (accutane).
myocarditis after sars-cov2-vaccination

Conditions: Myocarditis and Cardiomyopathy

Summary: background the novel coronavirus disease 2019 (covid-19) caused by an infection with the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) has rapidly become a global pandemic with more than 190.000.000 infections and 4.250.000 reported deaths worldwide. sars-cov-2 vaccination plays an important role in containing the pandemic and the possible adverse complications of covid-19. large clinical trials have proven the safety and efficacy of the vaccines currently in use. systemic reactions usually were mild, self-limiting and could be observed more often in younger vaccine recipients. cases of myocarditis after vaccination have been reported for various vaccines. the new vaccines for sars-cov-2 also seem to be affected by this adverse reactions. the pathophysiology is uncertain so far. aim aim of this study is a systematic registration of myocarditis cases associated with sars-cov-2 vaccination which were diagnosed and/or treated in participating centers. the main goal of this study is the characterization of clinical manifestations and prognosis of the disease. study design patient history, laboratory tests and cardiovascular imaging data of patients with suspected sars-cov-2 - vaccine associated myocarditis are documented. patients with clinical suspicion of troponin-positive myocarditis within 30 days after receiving sars-cov-2 vaccine without evidence for apparent other causes e.g. infectious or autoimmune etiology were included. clinical follow-up data is acquired.


Eligibility criteria:
inclusion criteria: * sars-cov-2 vaccine-associated myocarditis (\< 30 days after vaccination) confirmed by cardiac mri without evidence of alternative etiology (infectious, auto-immune myocarditis). exclusion criteria: * missing individual consent

Keywords: sars cov-19 vaccination
clinical effects of incobotulinum toxin vs corticosteroid in plantar fascitis

Conditions: Plantar Fasciitis of Both Feet; Pain; Function

Summary: objectives: to evaluate the clinical effects of intralesional application of incobotulinum toxin vs corticosteroid in patients with plantar fasciitis . material and methods: prospective, experimental, randomized, controlled clinical study; the population will be recruited in the outpatient clinic of the rehabilitation service meeting the inclusion criteria, two randomized study groups will be formed: group a: patients who accept intralesional infiltration with incobotulinum toxin . group b: patients who accept intralesional infiltration with dexamethasone. both groups will be assessed before application, at 1 month, at 2 and 4 months post intervention. the visual analogue scale (vas), the american orthopaedic foot and ankle society (aofas) scale and the foot and ankle disability index (fadi) will be used to assess pain, foot functionality, functional disability index in activities of daily living, in physical activity and measurement of the dorsiflexion arch in 2 visits at the beginning of diagnosis and at 4 months, collecting the variables and establishing a hypothesis analysis to accept or discard normality criteria of the same with tendency and its significance in relation to p \<0.05 to establish contrast of the results with parametric or non-parametric variables according to whether or not the hypothesis of normality is discarded.

the investigators want to compare the effects on pain, ankle and foot functionality, as well as activities of daily living; of the application of incobotulinum toxin vs corticosteroid in people suffering from plantar fasciitis.

Eligibility criteria:
inclusion criteria: 1. age over 18 years. 2. any sex. 3. diagnosis of plantar fasciitis (pain in the medial plantar calcaneal tubercle which gives rise to the site of plantar fascial insertion into the heel bone and/or pain along the path of its three bands) made by a physician specializing in physical medicine and rehabilitation. 4. voluntary acceptance of participation in the study. 5. patients entitled to the mexican social security institute. exclusion criteria: 1. diagnosis of ankylosing spondylitis. 2. pregnant women. 3. previous infiltration treatment with any medication or substance applied to the plantar fascia or gastrocnemius muscles in the last six months. 4. anticoagulant treatment. 5. history of local infection in the plantar fascia in the last three months. 6. allergic to lidocaine, incobotulinum toxin or dexamethasone. 7. patients not entitled to the mexican social security institute. 8. patient's refusal to participate in the study.

Keywords: botulinum toxin plantar fasciitis corticosteroid pain foot functionality
a randomized trial of surgical treatments for vulvar and vaginal dysplasia

Conditions: Vulvar Dysplasia; Vaginal Dysplasia

Summary: 1. to compare the recurrence rate between the use of laser vaporization and ultrasonic surgical aspiration in the treatment of vulvar and vaginal dysplasias 2. to compare healing related complications, post-operative pain, and scarring between the two procedures.

first line of treatment for vulvar intraepithelial neoplasia (vin) and vaginal intraepithelial neoplasia (vain) is not well defined. laser vaporization and ultrasonic surgical aspiration are both accepted surgical modalities used in the treatment of vulvar and vaginal dysplasias, however no prospective study has been done to compare the two procedures. the specific aims of this research study include: 1. to compare the recurrence rate between the use of laser vaporization and ultrasonic surgical aspiration in the treatment of vulvar and vaginal dysplasias in a prospective, multi-institutional, randomized clinical trial. 2. to compare healing related complications, post-operative pain, and scarring between the two procedures.

Eligibility criteria:
inclusion criteria: * patients who present with vulvar or vaginal dysplasias or condylomas that require surgical intervention will be informed of the study by the treating physician * pre-operative biopsies to confirm presence of dysplasia / condyloma. patients with dysplasias of grade 3 / cis will be included at the discretion of the treating surgeon and will have had invasion confidently excluded by clinical exam and biopsy. exclusion criteria: * patients under the age of eighteen or who are pregnant will be excluded

Keywords: ultrasonic surgical aspiration co2 laser surgery vulvar dysplasia vaginal dysplasia recurrence
a new prognostic scoring system for spontaneous ruptured hepatocellular

Conditions: Rupture, Spontaneous

Summary: develop a new scoring system for hcc patients with tumor rupture.

there has been no special prognostic scoring system for hcc patients with tumor rupture in the literature. in this work, we obtained all survival risk factors of ruptured hcc patients who underwent partial hepatectomy using multivariable cox regression analysis. furthermore, we develop and validate a new postoperative scoring system for patients with spontaneous hcc rupture based on the these results.

Eligibility criteria:
inclusion criteria: * received partial hepatectomy; with child a or b liver function. exclusion criteria: * without complete data；loss of follow-up; had reveived repeated transcatheter arterial chemoembolization before rupture; received non-radical resection.

Keywords: surgery scoring system hepatocellular carcinoma homogeneity and discriminatory ability survival
psychological impact of the health measures generated by the covid19 in adolescents

Conditions: Psychological Adaptation; Psychology, Social

Summary: the lockdown of the french population is a health measure put in place in response to the pandemic linked to a new coronavirus, sars-cov-2 (covid-19). after a health campaign to recommend hygienic "barrier gestures" and social distancing, the decision to confine the population at the national level was decided by the executive from monday 16 march to monday 11 may 2020. the national confinement implies the restriction of movement to the strict necessary, outings near the home and the closure of schools and communities. these decisions have led to an unprecedented state of stress for the entire french population, the consequences of which are unknown in the short, medium or long term. the objectives of this study are to evaluate the psychological impact of the confinement on adolescents with or without chronic disease and also the difficulties and fears engendered by deconfinement .


Eligibility criteria:
inclusion criteria: * adolescents aged 11 to 18 years old * previous consultation in the centre hospitalier intercommunal de creteil * agree to participate exclusion criteria: * lack of computer equipment or internet connection
glucocorticoid administration after traumatic birth

Conditions: Traumatic Birth

Summary: this study has two components, an observational and a trial component. the observational part is being done to screen for postpartum posttraumatic stress disorder by collecting mental health assessments in women who are immediately postpartum for up to 6 weeks. additionally, the project has a small number of subjects that will participate in a clinical trial in which they would self-select to receive one dose of hydrocortisone intravenously while they are in the hospital. this pilot of up to 20 participants in the trial arm is designed to create a first indication of whether this could become an effective early intervention to prevent ptsd if given while trauma memories are first being formed. this registration will list the observational part (number of participants =100) as well as the clinical trial (number of participants =20).


Eligibility criteria:
inclusion criteria (for observation and hydrocortisone treatment groups): * screening positive for ptsd diagnostic and statistical manual of mental disorders-5 criteria a (felt a threat to life or injury to self or neonate) * postpartum hemorrhage or emergency cesarean delivery * owner of a smart phone or email account exclusion criteria (for observation and hydrocortisone treatment groups): * active uncontrolled psychological disturbances identified by current psychiatric admission * psychiatric consult during admission, or need for hospital appointed sitter during admission * non-english speakers requiring a translator * current corticosteroid use or corticosteroid use during the study period (including betamethasone for promoting fetal lung maturity) * cognitive impairment identified by medical chart review or patients requiring a legal guardian for medical decision making exclusion criteria: (additional criteria for participants that will receive hydrocortisone) * self-reported hypersensitivity to hydrocortisone * inability to consent patient and administer study drug within 12 hours of a traumatic event * weight \ 120kg * subjects with systemic active infections (e.g. viral, bacterial, fungal, protozoan, or helminthic) * subjects with uncontrolled hypertension, renal insufficiency, or decompensated congestive heart failure * subjects with inflammatory bowel disease * subjects with active or latent peptic ulcers

Keywords: posttraumatic stress disorder
reduced appetite in crohn's disease: the role of the brain in the control of food intake

Conditions: Crohn's Disease

Summary: crohn's disease (cd) is becoming more common, specifically in the western world. one of the main features of this disease is weight loss and malnutrition. although clinically common, these problems are not well understood. loss of appetite and symptoms such as tummy aches and bloating are common causes for weight loss in this group of patients. this problem has a strong negative effect on the patients' quality of life and significantly increases the cost of treating cd. enteroendocrine cells are nutrient sensors in the bowel that relay to the brain to control food intake. recent evidence has showed that these cells increase in number in active cd and secrete more hormones that negatively affect appetite. the increased levels of these hormones should have an overall negative effect on the brain and thus decrease food intake, bloating, symptoms of sickness. all these symptoms lead to malnutrition. these are hypotheses that require further proof. current technological advances in magnetic resonance imaging (mri) has enabled the mapping of changes in activity in important areas in the brain that control food intake. the involvement of the brain in control of food intake is still not fully understood. this work will be the first step in the right direction to start targeting the problems of appetite, weight loss and a poor quality of life.


Eligibility criteria:
inclusion criteria: 1. age 16-75 years 2. ulceration seen at ileocolonoscopy, aiming for a simple endoscopic score for crohn's disease (ses-cd) of 4-19, in the absence of stricturing disease or, 3. intestinal inflammation or deep ulceration seen on ct or mr enterography, with the disease activity quantified via the maria score or, 4. faecal calprotectin of \>250µg/g 5. c-reactive protein \>5mg/dl 6. harvey-bradshaw index score of 5-16 7. body mass index (bmi) 18-35 8. as for hv participants, inclusion criteria 1 and 7 will apply. exclusion criteria: 1. malignant disease 2. bmi \ 35 3. significant cardiovascular or respiratory disease 4. diabetes mellitus 5. current infection 6. neurological or cognitive impairment; significant physical disability 7. significant hepatic disease or renal failure 8. abnormal blood results other than those explained by cd including bleeding diatheses (apart from in the case of hv where all unexplained blood results are an exclusion criteria) 9. subjects currently participating in (or in the last three months) any other research project 10. pregnancy or breastfeeding or 11. if mri is contraindicated (e.g. pacemaker). 12. severe crohn's disease where a delay in a change in medical treatment for 23 weeks would not be clinically advisable. 13. as for healthy volunteer participants all exclusion criteria apart from no.12.

Keywords: crohn's disease gut brain axis reduced appetite
intravenous paracetamol versus ketoprofen when treating renal colic in emergency situations

Conditions: Renal Colic; Acute Renal Colic

Summary: the main objective of this study was to demonstrate the non-inferiority of intravenous paracetamol relative to intravenous ketoprofen when treating renal colic in an emergency ward. efficacy is measured by the change in verbal numeric scale (vns) for pain at 30 minutes.

the secondary objectives of this study are: * to compare the efficacy (non-inferiority) of intravenous paracetamol and ketoprofen at 90 minutes (vns for pain). * to compare both arms in terms of other administered drugs (for pain). * to observe and compare side effects between the two arms: cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine. * to determine predictors for the use of intravenous morphine when treating renal colic. * to compare hospitalization rates between the two groups. * to compare patient satisfaction concerning care between the two groups (vns for satisfaction) * to observe and compare changes towards complicated renal colic (obstructive pyelonephritis, hyperalgesia, urinary tract rupture, need for surgical drainage, sepsis, death)

Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient is available for a telephone interview at week 1 * patient consulting at the nîmes university hospital emergency ward with suspicion of renal colic exclusion criteria: * the patient is participating in another study * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient is pregnant, parturient, or breastfeeding * the patient has a contraindication for a treatment used in this study * the patient has an allergy to ketoprofen or paracetamol, a history of gastric or intestinal ulcers, bleeding disorders, history of asthma triggered by taking ketoprofen or substances with similar activity such as other nsaids or aspirin * the patient has a fever or is hemodynamically unstable, oligoanuria * the patient presents with an initial verbal numeric pain score of 10/10. * the patient has a history of aneurysm or aortic dissection, history of renal transplantation, history of renal or hepatic insufficiency * the patient took paracetamol or ketoprofen 4 hours before emergency treatment.
gemigliptin-rosuvastatin fix-dose combination phase 3(balance)

Conditions: Type 2 Diabetes; Dyslipidemia

Summary: to evaluate the efficacy and safety of the fix-dose combination therapy with gemigliptin 50mg and rosuvastatin 20mg with type 2 diabetes and dyslipidemia


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus with dyslipidemia * adults who are at least 19 years old exclusion criteria: * patients with type 1 diabetes, diabetic ketoacidosis, diabetic coma and pre-coma * patients with gestational diabetes or secondary diabetes * patients with nyha class iii, iv congestive heart failure or arrhythmias requiring treatment * patients with thyroid gland dysfunction deviating from the normal tsh range * patients with pituitary insufficiency or adrenal insufficiency