Kornimate/medical-research-clean huggingface dataset:
stroke minimization through additive anti-atherosclerotic agents in routine treatment

Conditions: Atherosclerosis; Adherence, Medication; Tolerance

Summary: the overarching objective of the stroke minimization through additive anti-atherosclerotic agents in routine treatment (smaart) trial is to assess whether a polypill containing fixed doses of (2/3) antihypertensives, a statin and antiplatelet therapy taken once daily orally would result in carotid intimal thickness regression-a surrogate marker of atherosclerosis, improved adherence, and tolerability compared with 'usual care' group on separate individual secondary preventive medications among ghanaian first time stroke survivors. our ultimate objective is to design of a future multi center, double-blinded, placebo-controlled, parallel-group, randomized trial comparing the clinical efficacy of the polypill strategy vs 'usual care' in the african context to derive locally relevant, high-quality evidence for routine deployment of polypill for cvd risk moderation among stroke survivors in lmics. in this current study, we plan to recruit 120 recent ischemic stroke survivors randomized 1:1 to the polypill or usual care arms.


Eligibility criteria:
inclusion criteria: * above the age of 18 years; male or female * stroke/tia diagnosis no greater than two months before enrollment. ischemic strokes including lacunar, large-vessel atherosclerotic, cardio-embolic subtypes are eligible - * subjects with stroke may present with at least one of the following additional conditions: documented diabetes mellitus or previous treatment with oral hypoglycemic or insulin; documented hypertension \>140/90mmhg or previous treatment with anti-hypertensive medications; mild to moderate renal dysfunction (egfr 60-30ml/min/1.73m2); prior myocardial infarction * legally competent to sign informed consent exclusion criteria: * unable to sign informed consent * contraindications to any of the components of the polypill * hemorrhagic stroke * severe cognitive impairment/dementia or severe global disability limiting the capacity of self-care * severe congestive cardiac failure (nyha iii-iv) * severe renal disease, egfr \<30ml/min/1.73m2), renal dialysis; awaiting renal transplant or transplant recipient * cancer diagnosis or treatment in past 2 years * need for oral anticoagulation at the time of randomization or planned in the future months * significant arrhythmias (including unresolved ventricular arrhythmias or atrial fibrillation) * nursing/pregnant mothers * do not agree to the filing, forwarding and use of his/her pseudonymized data.
psychological impact of quarantine in rheumatoid arthritis patient during covid-19 outbreak

Conditions: Sars-CoV2; Rheumatic Diseases; Rheumatoid Arthritis; Chronic Pain

Summary: clinical data about psychological impact of quarantine are well studied in transient event or more prolonged situation like jail incarceration. in recent metaanalysis, psychological impact of quarantine was well documented in a specific population during first sars epidemy. even after the end of quarantine several patients were still with symptom of avoiding mainly agoraphobia, frequent hand washing and a carefull return to normal life covid-19 infection is already associated with psychological symptom like anxiety, depression, sleep disorders and symptoms of acute stress however psychological impact of quarantine is on none in chronic painful inflammatory rheumatism in france. the prevalence of rheumatoid arthritis is 0.5% of the population with frequent comorbidity such as anxiety and depression. during the quarantine secondary to covid-19 pandemic it's possible to evaluated the psychological impact of adult ra patients. the present study is an "emergency" being realize before the end of the quarantine.


Eligibility criteria:
inclusion criteria: * rheumatoid arthritis quarantine exclusion criteria: * non adult patient ra patient without quarantine

Keywords: psychological impact covid-19 rheumatoid arthritis
koning breast ct for breast imaging in china

Conditions: Breast Cancer

Summary: this study is conducted to compare koning breast ct (kbct) to mammography to evaluate if kbct can improve the diagnostic accuracy of breast cancer. it will also compare contrast-enhanced kbct (ce-kbct) to mammography to evaluate if ce-kbct can further improve the diagnostic accuracy of breast cancer.


Eligibility criteria:
non-contrast kbct inclusion criteria: * females at least 35 years of age of any ethnicity * had diagnostic imaging * will undergo study imaging no later than two weeks from date of diagnostic mammogram * is able to undergo informed consent exclusion criteria: * pregnancy * lactation * subjects with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker. * subjects who are unable to tolerate study constraints. * subjects who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to) * treatment for enlarged thymus gland as an infant * irradiation for benign breast conditions, including breast inflammation after giving birth * treatment for hodgkins disease * subjects who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram. * subjects who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to) * tuberculosis * severe scoliosis contrast-enhanced kbct inclusion criteria: * females at least 35 years of age of any ethnicity * had diagnostic imaging and was determined to have biopsy or surgery * will undergo study imaging no later than two weeks from date of diagnostic mammogram * is able to undergo informed consent exclusion criteria: same as the exclusion criteria as non-contrast kbct, plus the following: * abnormal glomerular filtration rate (gfr)/blood urea nitrogen (bun) or creatinine at pre contrast blood screening * previous non-ionic contrast reaction * history of renal dysfunction/kidney disease * diabetes mellitus treated with metformin * multiple myeloma * dehydration * history of nephrotoxic medication use * hyperthyroidism * pheochromocytoma * sickle cell disease

Keywords: breast ct
exemestane (aromasine) + tamoxifen - breast neo-adjuvant

Conditions: Breast Neoplasms

Summary: this is a phase ii non-randomized, open, uncontrolled and bi-centric study of hormonal induction by exemestane (aromasin) + tamoxifen to evaluate the effectiveness of exemestane (aromasin) with tamoxifen on the rate of clinical response menopausal in patients with tumors of locally advanced breast. hormone therapy will be administered at a dose of 25mg/day for exemestane and 20 mg / day for 4 months for tamoxifen.


Eligibility criteria:
inclusion criteria: * breast cancer histologically proven by a 14 g or 16 g micro-biopsy to have confirmation of the diagnosis, evaluation histology prognosis grade, hormone receptors and to obtain a sample for the study of biological factors. * menopausal patients as defined as follows: * natural menopause \>= 1 year, or * surgical ovariectomy. * t unilateral tumor\> 3 cm, n 1-2, m0 or m +, non-inflammatory. * hormone receptor positive. re positive or pr positive with histochemical technique (+ 10% of cells express the receptor) * no previous treatment of the disease by chemotherapy, hormone therapy, surgery or radiotherapy. discontinuation of replacement therapy of menopause for at least 1 month * age\>= 60 years * evaluable disease * performance status \<= 2 * biological function using the following criteria: * neutrophils \>= 2.10e9 / l, * platelets\> = 100.10e9 / l, * hemoglobin\> = 10 g / dl, * creatinine \<= 1.5 x upper normal, * total bilirubin \<= 1.25 x the upper normal * transaminases (ast and alt) \<= 1.5 x upper normal, * alkaline phosphatase \<= 2.5 x upper normal. * cardiac function: electrocardiogram (ecg) normal. * signed written consent before any procedure related to the study. exclusion criteria: * men * non menopausal patients * patients with hormone receptor negative: pr- and re - * contra-indication to anti-estrogens (risk thrombi arteria) * tumor \<3 cm operable * tumor inflammatory t4d (pev 2 or 3). * extensive hepatic lesions (\> 1 / 3 of liver volume) * uncontrolled cardiac disease such as angina, congestive heart failure, or arrhythmia requiring medical treatment or history of myocardial infarction within 3 months before. * history of cancer except skin cancer and basal cell cancer in situ of the cervix (a contralateral breast cancer had been no systemic treatment will be admitted). * chronic diseases (somatic or psychiatric) in poor prognosis. * patients who for reasons of family, social, geographical or psychological can not be followed properly. * patients under law protection

Keywords: breast cancer locally advanced menopausal patient aromasin tamoxifen efficacy
prospective, observational registry of renaissance-guided spine surgeries

Conditions: Degenerative Spine Disease; Spinal Deformity

Summary: to establish an observational registry for systematic collection of clinical data from renaissance-guided spine surgeries.

the key objective of this observational registry is to prospectively collect data to facilitate the quantification of potential short- and long-term benefits of renaissance-guided spine surgery. it establishes a common framework for collaboration between surgeons performing renaissance-guided spine surgeries in either minimally invasive (mis) or open surgical approaches. the main endpoints that will be collected are surgical endpoints (e.g. complication rates), patient reported outcomes (e.g. vas, odi), imaging parameters (e.g. coronal and sagittal alignment, mainly in reconstructive surgeries for spinal deformities) and technical parameters (e.g. use of intraoperative fluoroscopy, ratio of planned vs. executed screws).

Eligibility criteria:
inclusion criteria: patients undergoing spinal surgery in a posterior approach where the surgeon used renaissance surgical guidance system. patient capable of complying with study requirements. signed informed consent by patient. exclusion criteria: any significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study. patient cannot follow study protocol, for any reason. patient cannot or will not sign informed consent.

Keywords: spinal surgery spinal fusion deformity correction spinal instrumentation
multicentre observational study on management covid 19 positive outpatients in a french cluster.

Conditions: Covid-19

Summary: since december 2019, a new agent, the coronavirus sars-cov-2, has spread from china to the rest of the world causing an international epidemic of respiratory diseases called covid-19. oise was one of the first clusters in france, with more than 4,000 confirmed cases. a significant proportion (80%) of patients with covid-19 are ambulatory. however, few data are available for this particular population in france. thus, few clear recommendations are available. we propose to conduct a large cohort of observation of suspected or confirmed covid-19 patients on an ambulatory basis in the oise region. this observatory will make it possible to describe the epidemiological characteristics and initial management of covid-19 patients and to identify early severity factors.


Eligibility criteria:
inclusion criteria: * patients with covid 19 symptoms * patients who had a contact with a person pcr covid 19+ exclusion criteria: * none

Keywords: ambulatory outpatients covid 19 oise, france
evaluation of pre-exposure prophylaxis cascade in pregnant and breastfeeding women in cape town (formative study)

Conditions: Hiv

Summary: the overarching goal of this proposal is to evaluate the feasibility and acceptability of integrating prep into antenatal and postnatal care, to describe the cascade in women initiating prep in this setting, and to evaluate the reasons for attrition along the prep cascade in a cohort of pregnant and breastfeeding women. the specific aims are to: (1) evaluate the feasibility and acceptability of integrating prep into antenatal and postnatal/well-baby services; (2) describe the prep cascade of initiation, retention, and adherence in a cohort of 220 hiv-uninfected pregnant and breastfeeding women, (3) evaluate attrition and associated factors across the prep cascade.


Eligibility criteria:
inclusion criteria: 1. documented hiv-negative according to two fingerpick rapid tests (per routine antenatal care protocol in this setting), confirmed with a 4th generation antigen hiv test at study enrollment 2. no previous exposure triple-drug antiretroviral therapy 3. age 18 years or older 4. lives within 20 kilometers of a clinic 5. without psychiatric or medical contraindications to prep use 6. able to provide informed consent for research exclusion criteria: failure to meet any of the inclusion criteria

Keywords: pre-exposure prophylaxis prep pregnancy prevention of mother to child transmission pmtct
one-stage adjustable strabismus surgery under aivoc

Conditions: Strabismus; Surgery

Summary: the purpose of this study is to note that one-stage adjustable surgery can be enough to provide satisfactory results for the correction of strabismus in adults thanks to the use of an anesthesia type aivoc (target-controlled infusion of propofol-remifentanyl)

adjustable surgery is a surgical treatment technique for strabismus and oculomotor paralysis well known and widely used around the world. the adjustable surgery is done in 2 steps. the first step, performed under general anesthesia, is practically the same as "classic" strabismus surgery however one or more muscles are fixed by temporary sutures. in a second time once the patient is awake and after a new clinical examination the sutures are adjusted and definitively fixed. the adjustment is sometimes made the same day but more often the day after the first intervention because it requires a state of consciousness close to normal. anesthesia type intravenous intensity concentration anesthesia (aivoc) allows the realization of a surgery under anesthesia general deep (choice of a cerebral or plasma anesthetic target suitable for surgery) but allows a programmed awakening, very fast in full consciousness, condition of an immediate reliable adjustment practically upon stopping the infusion of the anesthetic agent. the goal is to present an adjustable surgery technique simplified from a logistical point of view since performed in a single step thanks to the contribution of intravenous anesthesia with concentration objective (aivoc) and to show that its results are equivalent to a second deferred time.

Eligibility criteria:
inclusion criteria: * patient with medical insurance * major patient requiring a strabismus surgery * patient who received information about study and not having expressed their opposition to participate in the study exclusion criteria: * minor patient * patient participation in another interventional study * patient having expressed their opposition to participate in the study * patient for whom it is impossible to give informed information * patient under the protection of justice, under curatorship ou under tutorship

Keywords: adjustable strabismus surgery target-controlled infusion of propofol-reminfentanyl
a clinical study evaluating the safety and efficacy of si-614 ophthalmic solution in patients with dry eye

Conditions: Dry Eye Syndromes

Summary: the purpose of this study is to assess the safety and effectiveness of si-614 solution compared with placebo solution in treating patients with dry eye


Eligibility criteria:
inclusion criteria: * be at least 18 years of age * have provided written informed consent * have dry eye in both eyes exclusion criteria: * use of contact lenses * have an uncontrolled systemic disease * have a history of an uncontrolled psychiatric condition, or substance or alcohol abuse * women who is pregnant, nursing or planning a pregnancy
recruitment maneuver after intubation

Conditions: Hypoxemia

Summary: the purpose of this study is to evaluate the safety and efficacy of a recruitment maneuver immediately after intubation in hypoxemic patients.

in the intensive care unit (icu), acute respiratory failure is a common problem. airway management in critically ill patients usually requires endotracheal intubation after rapid sequence induction. induction of anesthesia is a well known cause of dramatic changes in respiratory mechanics and gas exchange. moreover, when the intubation is for respiratory failure, the underlying pathology increases these modifications. the reduction in lung volume results in a deep hypoxemia after intubation. moreover, mechanical ventilation applied on a collapsed lung increases the risk of ventilator induced lung injury. recruitment maneuver, which consists of a transient increased in inspiratory pressure, decreases anesthesia-induced lung collapse and hypoxemia. during early acute respiratory failure, rm increases oxygenation and lung volume and may reduce lung oedema. some authors have suggested the potential benefit of an early rm after induction of anesthesia in operating room. to date, no study has evaluated the short term effect of a recruitment maneuver performed early after intubation in critically ill patients. therefore, our aim was to ascertain whether rm, performed immediately after intubation, is safe and more effective at reducing hypoxemia than usual management, in hypoxemic patients requiring intubation for invasive ventilation in the icu.

Eligibility criteria:
inclusion criteria: * adults who met acute respiratory failure requiring intubation * adults who met hypoxemia, defined by a pao2 less than 100 mm hg under a high fio2 mask driven by at least 10 l/min oxygen. exclusion criteria: * encephalopathy * coma * cardiac resuscitation * hyperkaliemia (\>5.5 meq/l) * acute brain injury and recent thoracic surgery

Keywords: intubation hypoxemia mechanical ventilation recruitment maneuver acute lung injury bacterial translocation hypoxemic icu patients requiring invasive mechanical ventilation
aquatic-based explosive strength training in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: this study was designed to assess the effect of a 12-week aquatic-based plyometric (aqua-plyo) training on postural control and functional performance in children with hemiparetic cerebral palsy (h-cp). fifty-six children with h-cp were randomly allocated to the aqua-plyo group (n = 28, received an aqua-plyo training program, trice/week, over 12 weeks) or the control group (n =28, received standard rehabilitation). both groups were assessed for postural control and functional performance pre and post-treatment.

fifty-six children with h-cp were recruited from the physical therapy outpatient clinic of college of applied medical sciences, prince sattam bin abdulaziz university, king khalid hospital, and a tertiary referral hospital, al-kharj, saudi arabia. their age ranged between 12 and 16 years, were functioning at levels i or ii on the gross motor function classification system, and had spasticity level 1 or 1+ per the modified ashworth scale. children were excluded if they had fixed deformities, had leg-length discrepancy, underwent neuromuscular or orthopedic surgery in the last 12 months, submitted to botox injection in the past 6 months, attentional neglect, cardiopulmonary problems preventing them from performing high-intense exercise training. outcome measures 1. postural control: the dynamic limits of stability (losdynamic) indices were measured through the balance master system. 2. functional performance: functional performance was quantified using the 30-second sit-to-stand test (30sec-sts), timed up and down stairs test (tuds), and the dynamic gait index (dgi). the aqua-plyo group received a 12-week aqua-plyo training, 45 minutes per session, three times a week for 12 consecutive weeks, in conformity with the national strength and conditioning association guidelines and american academy of pediatrics safety standards. the aqua-plyo program consisted of ten unilateral and bilateral lower limb plyometrics in the form of hopping/bounding/jumping activities conducted in a water medium. the aqua-plyo training included a warm-up for 10 minutes and a cool-down for10 minutes. the control group received the usual physical therapy care, 45 minutes per session, three times a week for 12 consecutive weeks. the program consisted of advanced balance training, and gait training exercises, postural and flexibility exercises, strength training exercises.

Eligibility criteria:
inclusion criteria: * hemiparetic cerebral palsy * age between 12 to 16 years * spasticity level 1 or 1+ according to the modified ashworth scale * gross motor function level i or ii according to the gross motor function classification system exclusion criteria: * structural deformities * musculoskeletal or neural surgery in the last year * botox injection in the last 6 months. * cardiopulmonary disorders limit the ability to engage in explosive exercise training * hemi-spatial neglect

Keywords: unilateral cerebral palsy balance rehabilitation exercise function activity participation
biliary externalization after pancreaticoduodenectomy

Conditions: Postoperative Complications

Summary: postoperative pancreatic fistula(popf) is the most common complication of pancreaticoduodenectomy (pd). sometimes popf is associated with biliary fistula(bf), or "mixed" fistula. the purpose of this study is to assess whether the severity of the fistulae, when present, is decreased with an external biliary stent in place.

n this single-center study we analyze patients who underwent elective pd from january_2014 to december_2017. patients are divided into two groups: standard pd (st-pd)vs pd with external biliary stent(pd-bs). demographic, preoperative, intraoperative, and postoperative variables will be analyze, including complications according to the clavien-dindo classification, and those specific to pancreatic surgeries, and mortality rates within 90 days of operation.

Eligibility criteria:
inclusion criteria: * provision of informed consent * patient age \> 18 years old; * elective pancreaticoduodenectomy performed for primary pancreatic disease. exclusion criteria: * pancreaticoduodenectomy with multivisceral resection (organ other than duodenum, pancreas, gallbladder, and bile duct); * patients with peritoneal or liver metastases found during surgery.

Keywords: pancreaticoduodenectomy pancreatic postoperative fistula
clinical study to evaluate tear characteristics following acute truetear™ use

Conditions: Dry Eye Syndromes

Summary: this study will evaluate the change in tear meniscus height (tmh) produced by intranasal stimulation with truetear™ compared with the same device applied extranasally (control).


Eligibility criteria:
inclusion criteria: * baseline ocular surface disease index© (osdi©) score of at least 23 with no more than three responses of "not applicable" * in at least one eye, a baseline schirmer test of ≤ 10 mm/5 minutes and a cotton swab nasal stimulation schirmer test of at least 7 mm higher in the same eye exclusion criteria: * chronic or recurrent epistaxis, coagulation disorders or other conditions that may increase the risk of bleeding * history of nasal or sinus surgery * vascularized polyp, deviated septum or severe nasal airway obstruction at the screening visit * intraocular and extraocular surgery in either eye within three months of the screening visit or refractive surgery within twelve months of the screening visit * cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head