Kornimate/medical-research-clean huggingface dataset:
information recall on informed consent to intravenous thrombolysis in patients with acute ischaemic stroke.

Conditions: Stroke

Summary: the aim of the study is to investigate the ability to recall information given during informed consent on intravenous thrombolysis in patients with acute ischaemic stroke.

the purpose of this prospective multi-center study is to investigate whether patients with acute ischaemic stroke are able to recall information given before providing informed consent to intravenous thrombolysis after the end of treatment. patients with acute ischaemic stroke will be compared to a group of relatives who witnessed the informed consent procedure of a relative with acute ischaemic stroke, stroke patients who were not treated with intravenous thrombolysis and patients without an ischaemic stroke but similiar risk factors (admitted to the departement of cardiology and pneumology, charité, campus benjamin franklin, berlin, germany).

Eligibility criteria:
inclusion criteria (all): * age ≥18 years * able to give informed consent * ability to understand and read german * no prior i.v.-thrombolysis additional inclusion criteria - patients with acute ischaemic stroke: * suspected ischaemic stroke (according to brain ct) or mri-proven acute ischaemic stroke * indication for intravenous thrombolysis additional inclusion criteria - relatives: · relative (1st or 2nd dregree) of a patient with acute ischaemic stroke and present during the informed consent procedure additional inclusion criteria - stroke patients with a contraindication for thrombolysis: * ischaemic stroke (according to brain mri or ct) * contraindication for intravenous thrombolysis additional inclusion criteria - non-stroke patients: · present admission at the department of cardiology and pneumology, charité - universitätsmedizin berlin, campus benjamin franklin, berlin, germany exclusion criteria (all groups): * not able to give imformed consent or under legal supervision/guardianship * participation in an interventional study

Keywords: acute informed consent thrombolysis
fascia iliaca block supplemented with perineural vs intravenous dexamethasone

Conditions: Postoperative Pain

Summary: split-thickness skin grafting is the current standard of care for the reconstructive procedures in managing burn injuries and traumatic tissue defects. harvesting split-thickness skin creates a new partial thickness wound that is referred to as the donor site . donor site pain is one of the most distressing symptoms reported by patients in the early postoperative period. larger donor sites stimulate a greater number of pain receptors and consequently pain is proportional to the size of the graft harvested.often, the donor site is reported to be more painful than the recipient site,affecting early mobilization, sleep, and need for analgesics postoperatively.

most commonly split thickness auto-grafts are harvested from a convenient and minimally aesthetically intrusive site; often the lateral thigh area, which is innervated by lateral femoral cutaneous nerve (lfcn). however if a larger graft area in needed then it will be obtained from the anterior aspect of the thigh, which is innervated by the femoral nerve. regional nerve blockade has been proposed for skin graft harvest and proofed to provide better and longer standing analgesia. application of fascia iliaca compartment block involves the distribution of anesthesia to the territories of the femoral and lateral cutaneous nerves. american society of regional anesthesia and pain medicine recommendations on local anesthetics in pediatric regional anesthesia in 2018 stated that the ultrasound guided fascial plane blocks as fascia iliaca block can be successfully and safely performed using a recommended dose of 0.25-0.75 mg/kg of bupivacaine 0.25%. prolongation of analgesia after surgery under regional anaesthesia is a goal for clinicians. many investigators have sought that the ideal analgesic adjuvant that would both prolongs pain relief and avoids side effects after a single-shot peripheral nerve block. although many agents have failed this test (opioids, ketamine, clonidine, etc.), the perineural addition of dexamethasone to local anaesthetic has been shown in several studies to prolong the analgesic effect and its use has become common in clinical practice around the world. not surprisingly, much research has been performed with the aim of providing level 1 evidence via randomized controlled trials design and systematic review and meta-analysis. despite this, there is still no adequate answer as to whether perineural dexamethasone is superior to systemic administration alone.

Eligibility criteria:
inclusion criteria: • age 2 -12 years. * asa i - ii * scheduled for split thickness grafting. * availability and suitability of lateral and anterior aspects of the thigh as a donor site. exclusion criteria: * patient's guardian refusal to participate in the study. * known allergy to local anesthetics * children known to be diabetic. * coagulopathy. * children with motor or sensory deficits in lower extremities. * children who are morbidly obese (bmi≥35) because ultrasound guided regional anesthesia could be technically difficult.
control versus liberal cardiac frequency in patients in sepse with atrial fibrillation of high ventricular response

Conditions: Sepsis; Septic Shock; Atrial Fibrillation; Ventricular Fibrillation; Atrial Fibrillation Rapid

Summary: amiodarone is considered the medicine of choice in heart rate control in critically ill patients with atrial fibrillation with high ventricular response. however, a recent retrospective study showed a greater number of events in critical patients in whom there was an attempt to control versus in which there was no. therefore, the prospective and randomized comparative use of amiodarone in this group of patients has not yet been described. the aim of this study was to evaluate the safety of the use of amiodarone (restricted group) versus placebo (liberal group) in heart rate control in atrial fibrillation with high ventricular response in patients with sepsis and vasopressor cardiovascular dysfunction. for this, a unicentric, randomized, blind and prospective study will be performed, in which the restrictive versus liberal strategy is performed in a comparative way. hospital data (test results, medical evolutions complications) of patients will be analyzed to calculate safety and effectiveness. expected results: the liberal strategy is superior to the restrictive strategy and causes fewer adverse events.


Eligibility criteria:
inclusion criteria: * permanent fa presence with fc\> 110 bpm * presence of infection (any infectious outbreak) * cardiovascular dysfunction - need for vasopressor drugs (noradrenaline, adrenaline or vasopressin) to maintain sbp\> 90 mmhg * signed consent form exclusion criteria: * pregnancy * body mass index greater than 40 kg / m2 * contraindication to the use of oral or parenteral anticoagulants * acute coronary syndrome * left ventricular ejection fraction \<35% * valvular heart disease * contraindication to the use of amiodarone * child c cirrhosis * dialytic chronic renal insufficiency * chronic obstructive pulmonary disease * acute myocarditis * pulmonary thromboembolism * terminal neoplasia
trial of emergency department discharge with enhanced transitions of care compared to usual care

Conditions: Patient Discharge; Emergency Care

Summary: this is a randomized controlled trial to assess the relative effectiveness of providing enhanced transitions of care (etoc) to improve patient outcomes after discharge from the emergency department (ed). patients who are being discharged from the ed and have had a previous ed visit or hospital admission within the thomas jefferson hospital system (tjuh or methodist) within the past 90 days will be eligible for enrollment in this trial. patients who consent to enrollment will be randomized to discharge by usual care or discharge with etoc as provided by the company boardrounds.


Eligibility criteria:
inclusion criteria: * adult (18 yrs and older) patients * have had a previous ed visit or hospital admission in the 90 days prior to the current ed visit (at thomas jefferson university hospital or methodist hospital) * have just completed evaluation in the thomas jefferson university hospital emergency department for any problem, * are ready for discharge from the thomas jefferson university hospital ed, and * provide informed consent exclusion criteria: * non-english speaking patients * patients undergoing medical clearance for a detox center or any involuntary court or magistrate order * patients who live outside philadelphia area (unable to seek follow-up care in philadelphia) or other condition known to preclude follow-up (such as no reliable access to a telephone) * patients in police custody or currently incarcerated individuals * patients who have, in their clinician's best judgment, major communication barriers such as visual or hearing impairment or dementia that would compromise their ability to give written informed consent
application of chinese herbal complementary and alternative medicine (cam) to improve human health and to further botanical and horticultural sciences

Conditions: Skin Toxicity

Summary: the purpose of this research is to study a chinese herbal complementary and alternative medicine (cam) product for the temporary relief of pain and itching after radiotherapy (rt). this is an over-the-counter product with 1% menthol as an active ingredient.


Eligibility criteria:
inclusion criteria: * female subjects with newly diagnosed breast carcinoma * \> 18 years of age * post-mastectomy with or without reconstruction * stage ii-iiib with any receptor status * all races and ethnicities are eligible * patients must be able to consent in english or spanish * plan to receive adjuvant radiotherapy to the chest wall +/- regional lymph nodes * rt will involve standard fractionation use of 3d conformal or intensity-modulated rt (imrt) * willing to sign protocol consent form * patients are allowed to receive adjuvant hormonal therapy and/or targeted therapies such as trastuzumab prior to, during and/or after radiation therapy. * patients may receive chemotherapy before or after radiation therapy exclusion criteria: * prior radiation to the involved breast or chest wall * concurrent chemotherapy * unable or unwilling to sign informed consent * unable to speak english or spanish * pregnant women * clinical or pathologic stage t4 * metastatic disease * connective tissue disorder including systemic lupus erythematosus and scleroderma

Keywords: breast cancer radiotherapy complementary and alternative medicine
efficacy trial of gemcitabine containing regimens as preoperative chemotherapy in non small cell lung cancer

Conditions: Carcinoma, Non Small Cell Lung

Summary: to evaluate the rate of complete pathological response after 3 cycles of gemcitabine containing chemotherapy.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed non small cell lung cancer * no prior chemotherapy or radiation for non small cell lung cancer * no prior malignancy exclusion criteria: * pregnancy or breastfeeding * serious concomitant disorders
mri and fine needle aspiration in the diagnosis of parotid tumors

Conditions: Parotid Tumor

Summary: what value is given to mri diffusion and perfusion sequences in the diagnosis of parotid tumors? is a fine needle aspiration associated with mri systematically necessary? the aim of the research is to study the performance of diffusion and perfusion mri sequences in the diagnosis of parotid tumors on a large series of cases.


Eligibility criteria:
inclusion criteria: * major subject (≥18 years old) * minor subject (\<18 years old) * operated for a parotid tumor at strasbourg university hospital between january 2009 and june 2020 * having had in the preoperative assessment an mri of the parotid, also carried out at the strasbourg university hospital. * subject (and / or his parental authority) not having expressed, after being informed, his opposition to the reuse of his data for the purposes of this research. exclusion criteria: * subject (or his parents) who expressed his (their) opposition to participating in the study * lack of pathological or mri results * subject under guardianship, curatorship or safeguard of justice

Keywords: parotid tumor diffusion mri perfusion mri aspiration cytology fine-needle biopsy
study to investigate effects of a herbal drug compared to placebo on sleep

Conditions: Healthy; Sleep Quality

Summary: to demonstrate the influence of a herbal preparation containing hypericum, passionflower, and valerian on sleep structure, improvement of attention, and well-being in comparison to placebo.

to demonstrate the influence of the herbal combination preparation neurapas® balance on the objective sleep structure in comparison with placebo. a further aim was to investigate whether treatment with neurapas® balance versus placebo brings about an improvement in attention and well-being and whether these changes are related to the improvement in the sleep structure. 1. does the administration of 3 x 2 neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in continuity of sleep? 2. does the administration of 3 x 2 neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in sleep architecture, especially an increase in deep sleep? 3. does the administration of 3 x 2 neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in morning attentional performance? 4. does the administration of 3 x 2 neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in morning well-being?

Eligibility criteria:
inclusion criteria: * healthy male volunteers aged between 18 and 55 years * normal sleeping times (at least 6 hours a night), going to sleep between 22.00 and 1.00 hours, getting up between 6.00 and 9.00 hours * written informed consent * the volunteer is willing and able to cooperate fully * the volunteer agrees not to drink any alcohol for the duration of the study exclusion criteria: * participation in another study in the last 30 days or participation in this study at an earlier date * lack of verbal or intellectual ability to communicate adequately and to understand the information to volunteers * legal incompetence * smoker * shift worker * transatlantic flight in the last 4 weeks * taking psychotropic drugs within the last 4 weeks * taking medicines that influence the eeg within the last 4 weeks * diseases that influence the sleep eeg * history of known medication / drug / alcohol misuse according to icd-10 coding f10 - f19 * known intolerance/hypersensitivity/allergy to st. john's wort, valerian or passionflower * taking inadmissible concomitant medication (anxiolytic, neuroleptic or hypnotic drugs, cyclosporin, sedative, sleep-promoting or mood-enhancing medicines, antidepressants other than the trial medication, coumarin-type anticoagulants, oral contraceptives, tranquillisers, homeopathic remedies, digoxin, theophylline, indinavir, nortriptyline, amitriptyline) * known light-sensitivity

Keywords: sleep-eeg sleep architecture sleep duration sleep continuity rem-sleep vigilance well-being healthy volunteers
high-dose cyclophosphamide for moderate to severe refractory chronic inflammatory demyelinating polyneuropathy

Conditions: Chronic Inflammatory Demyelinating Polyneuropathy

Summary: the primary endpoint of this study is to determine what percentage of patients receiving high-dose cyclophosphamide may experience a halt in the worsening of their disease or experience improvement of their disease and for how long the benefit may last.

chronic inflammatory demyelinating polyneuropathy (cidp) is a common and under-recognized peripheral neuropathy that is thought to be immune-mediated. randomized, placebo controlled clinical trials in cidp demonstrate benefit from treatment with corticosteroids, plasmapheresis, and iv ig. however, not all patients respond to these therapies. iv cyclophosphamide, cyclosporine, interferons, total lymphoid irradiation, and mycophenolate mofetil have been proposed as appropriate therapies for refractory patients. patients with cidp often respond to immune-modulating treatment. however, the high rate of relapse and treatment-related side effects result in poor long-term outcomes for many patients. cidp is assumed to be an autoimmune disease, but the pathogenesis is poorly understood. t cell infiltrates are predominantly cd8, suggesting a t cell mediated process. there is not, however, restricted t cell receptor vbeta utilization seen in sural nerve biopsies. immunoglobulin and complement deposits noted on the myelin sheaths support an antibody-mediated process. antibodies to the p0 myelin protein are seen in a minority of patients. high-dose cyclophosphamide is believed to eradicate both b and t lymphocytes. this therapy does not damage hematopoietic stem cells, which allows for rapid white cell recovery without stem cell rescue.

Eligibility criteria:
inclusion criteria: * diagnosis of cidp according to the american academy of neurology clinical and electrophysiologic criteria * age \>18 but \< 75 years * modified rankin scale score of \>3 after two standard treatment regimens * patient must have a left ventricular ejection fraction of \>45% * serum creatinine \<3mg/dl * willingness to participate in a clinical trial exclusion criteria: * patients who are preterminal or moribund * patients with active malignancies * patients with chromosomal abnormalities or peripheral blood counts suggestive of myelodysplastic syndrome * patients with active bacterial or fungal infections requiring oral or intravenous antimicrobials are not eligible until resolution of the infection * pregnant women and breast-feeding women

Keywords: chronic inflammatory demyelinating polyneuropathy cyclophosphamide autoimmune
improve detection and management of gestational diabetes through the primary health care level in morocco

Conditions: Gestational Diabetes Mellitus in Pregnancy

Summary: a situational analysis on gestational diabetes conducted in 2015 in two districts in morocco revealed difficulties in accessing screening for gestational diabetes (gdm) and delays in receiving appropriate care. based on the results of the situational analysis, the investigators developed this proposal in close collaboration with the moroccan research group on gestational diabetes composed of representatives of the ministry of health, researchers, members of professional organizations and specialists in the domains of endocrinology, gynecology, neonatal health and nutrition. the investigators opted for an hybrid implementation effectiveness trial to evaluate both clinical effectiveness of the proposed screening and initial management strategy and its implementation at the first level of care. the objectives of this study are thus to evaluate the feasibility of a decentralized strategy of screening for gdm and the initialization of gdm treatment already through the primary level of care and to assess its potential for scaling-up. specific objectives of this study are to augment universal access to screening and management of gestational diabetes and to increase the competencies of health care providers at first level health care facilities to detect, start initial treatment and to improve follow-up of affected women. by comparing active screening and treatment initiation through first line health facilities with the existing practices, the investigators would like to explore the effect of the new model on maternal and newborn outcomes such as weight gain in pregnancy, occurrence of delivery complications and birth weight. the investigators will further assess the acceptability of screening and initial management of gdm through first line health services by health care providers and by pregnant women diagnosed with gdm and the impact of two different screening approaches on the lifestyle of affected mothers.


Eligibility criteria:
inclusion criteria: * pregnant women attending anc (screening) * women diagnosed with gdm (follow-up) * informed consent exclusion criteria: * pregnant women with pre-existing diabetes type 1 or 2 * no informed consent
epigallocatechin gallate and other antural compounds in hpv infections

Conditions: Papilloma-induced Cervical Lesions

Summary: the investigators enroll patients with a pap-test cytology reporting lsil or ascus. pateitns undergo hpv-dna test for screening. patients are treated with epigallocatechin galalte, hyaluronic acid, folic acid and vitamin b12 by oral route. after three months of treatment pap-test and hpv-dna test will be repeated.


Eligibility criteria:
inclusion criteria: * positivity to hpv-dna test * pap-test reporting lsil or ascus exclusion criteria: * hpv-related pathologies or complicances apart from lsil or ascus * diagnosis of cancer

Keywords: egcg hpv folic acid hyaluronic acid vitamin b12 lsil
cobedding in daily weight gain of neonate twins

Conditions: Preterm Newborn Twins

Summary: cobedding consists of associating twins in a common cocoon in order to maintain links developed in utero and reduce the stress of premature birth. the aim of this randomized, controlled prospective study is to compare efficacy (in term of newborn daily weight gain) and safety of cobedding versus single-bedding of preterm twins.

randomization will occur during the first 96 hours after birth.twins randomized in the cobedding arm will be kept in the same cocoon until maximum 37 amenorrhea weeks. each day, parameters (weight gain, ...) will be registered.at two years old, neuromotor development of twins will be estimated by brunet-lezine test.

Eligibility criteria:
inclusion criteria: * at time of inclusion, twins must have been separated since less than 96h following birth. * twins born between 30 to 34 weeks of gestation * no severe congenital pathology * hospitalized at the intensive neonates care unit * parents having given their non-opposition to this study within the 96 hours following twins birth -time length of cobedding estimated by the investigator to be of three weeks - exclusion criteria: inclusion criteria not fulfilled * safety reasons * prolonged lack of comfort clinically harmful for the newborn as per investigator conclusion.
clinical & radiological assessment of rotator cuff healing after single row vs. double row rotator cuff repair

Conditions: Rotator Cuff Injury

Summary: this study is to analyse whether there is a difference in clinical and radiological outcomes between single row and double row repair techniques for the treatment of shoulder's rotator cuff tears.

a tear of the rotator cuff is one of the most common disorders of the shoulder and can have a significant effect on daily activities as a result of a loss of motion and strength. the goal of rotator cuff repair is to treat the patient's current clinical symptoms and improve shoulder function and to prevent the long-term consequences of rotator cuff arthropathy. this project aims at a retrospective analysis of preexisting risk factors for sustaining rotator cuff injury as well as for failing to reach the previous functional level, used surgical technique -either single row repair or double row repair- and its significance for the functional outcome.

Eligibility criteria:
inclusion criteria: * treated by single row or double row repair technique for shoulder's rotator cuff tears * time lapse from injury to surgery ranges from one day to less than 1 year * availability of clinical and radiological outcomes from 6 months to 1 year follow up exclusion criteria: * massive irreparable tear * patient has frozen shoulder * chronically retracted tendons and atrophic rotator cuff muscles

Keywords: rotator cuff repair rotator cuff tear single row repair technique double row repair technique