Kornimate/medical-research-clean huggingface dataset:
a study to evaluate cutaneous scar quality following bilateral breast reduction with the peak plasmablade 4.0

Conditions: Macromastia

Summary: the objective of this clinical study is to evaluate scar quality following incision with the peak plasmablade 4.0 using the patient and observer scar assessment scale (posas), and to compare these results to equivalently-aged scars formed following incision with a standard scalpel.

subjects attended one of two evaluation dates scheduled on january 21, 2011 and february 23, 2011. during this visit, subjects gave informed consent and were instructed on evaluating their breast reduction scars using the patient scar assessment scale. following subjects' self-evaluation, each subject was evaluated by three evaluators using the observer scar assessment scale.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 70 2. physically healthy, stable weight 3. non-smokers, or prior smokers who stopped smoking at least two weeks prior to surgery. 4. subject must understand the nature of the procedure and provide written informed consent prior to the procedure. 5. subject must be willing and able to comply with specified follow-up evaluations. 6. subjects who have participated in the peak plasmablade bilateral breast reduction study. exclusion criteria: 1. age younger than 18 or greater than 70 years old 2. anticoagulation therapy which cannot be discontinued 3. smoking (continuous; any substance) 4. infection (local or systemic) 5. cognitive impairment or mental illness 6. severe cardiopulmonary deficiencies 7. known coagulopathy 8. immunocompromised 9. prior history of breast cancer 10. kidney disease (any type) 11. currently taking any medication known to affect healing 12. subjects who did not participated in the peak plasmablade bilateral breast reduction study 13. unable to follow instructions or complete follow-up

Keywords: breast reduction plasmablade electrosurgery peak surgical medtronic advanced energy medtronic
phase 1, safety and tolerability study of xmab541 in advanced solid tumors

Conditions: Ovarian Cancer; Endometrial Cancer; Germ Cell Tumor; Testicular Germ Cell Tumor; Ovarian Germ Cell Tumor

Summary: the primary purpose of this study is to determine whether the investigational drug xmab541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. the study will also evaluate the effect of xmab541 on tumor outcomes.


Eligibility criteria:
key inclusion criteria: * age ≥ 18 years. for subjects with gcts, age ≥15 years * cldn6+ tumor * histological or cytological documentation of locally advanced, recurrent, or metastatic ovarian, fallopian tube, or peritoneal cancer, adenocarcinoma of the endometrium (endometrial cancer, uterine cancer, or carcinoma of the uterine corpus), gct * have documented progressive disease (pd) on standard-of-care therapies appropriate for the specific tumor type; have exhausted therapies with a survival benefit or the standard therapy has no survival benefit or proven to be ineffective, intolerable, or subject is not a candidate for such available therapy. * eastern cooperative oncology group performance status of 0-2 * life expectancy ≥ 3 months * adequate liver, kidney, and bone marrow function key exclusion criteria: * prior exposure to a cldn6 targeting product * ovarian cancer that is platinum refractory, or has rapid progression on most recent prior ≥ second line systemic anticancer therapy * have known active central nervous system metastases and/or carcinomatous meningitis. patients with treated brain metastases may participate, provided they are radiologically stable. * active known or suspected autoimmune disease * have any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug * clinically significant cardiovascular, pulmonary or gastrointestinal disease * positive test for hepatitis c rna * positive test for hepatitis b surface antigen or hepatitis b core antibody (hbcab)

Keywords: phase 1 ovarian cancer cldn6 testicular cancer germ cell tumor endometrial cancer t-cell engager
endometriosis: sexual dysfunction and adaptation strategies among couples

Conditions: Endometriosis

Summary: the primary objective of this study is to evaluate the presence/absence and description of persistent sexual troubles following surgical treatment for endometriosis for women, and their partners.


Eligibility criteria:
inclusion criteria: * the patient (and her partner) must have given his/her informed and signed consent * the patient (and her partner) must be insured or beneficiary of a health insurance plan * couples for whom the woman has formerly undergone surgical treatment for endometriosis, and for the partner agrees to respond to questionnaires for this study exclusion criteria: * the patient (or her partner) is participating in another study * the patient (or her partner) is in an exclusion period determined by a previous study * the patient (or her partner) is under judicial protection, under tutorship or curatorship * the patient (or her partner) refuses to sign the consent * it is impossible to correctly inform the patient (or her partner) * the patient is pregnant * the patient is breastfeeding * the patient was surgically treated for endometriosis, but was single.
driving pressure-guided positive end-expiratory pressure to prevent postoperative atelectasis in obese children: a prospective, randomized controlled clinical trial

Conditions: Driving Pressure; Positive End-expiratory Pressure; Postoperative Atelectasis; Obese

Summary: at present, the use of lung protective ventilation strategies in children is mainly based on adult and intensive care unit data. although obese children may benefit more from lung protective ventilation, there are few studies on the use of lung protective ventilation strategies in obese children during surgery. therefore, the investigators hypothesized that intraoperative use of lpv strategies in obese pediatric surgery patients can reduce atelectasis and improve the incidence of postoperative pulmonary complications.

in the lung protective ventilation group, peep was titrated individually in a sequential manner after mechanical ventilation. according to previous studies, peep was 5 cmh2o, inspiratory pressure was 20 cmh2o, and respiratory rate was set according to patient age. peep and inspiratory pressure were increased by 5 cmh2o every 30 seconds until peep was 15 cmh2o and inspiratory pressure 30 cmh2o. this was followed by a decreasing amplitude of 2 cmh2o to 3 cmh2o starting from 15 cmh2o, and each peep level was maintained for 4 to 5 respiratory cycles.the peep was at the lowest driving pressure was applied throughout the procedure. the peep level resulting in the lowest driving pressure was applied during surgery. in the traditional mechanical ventilation group, a fixed peep of 5 cm h2o was applied. the investigators compared the incidence of postoperative atelectasis between the two groups using lung ultrasound.

Eligibility criteria:
inclusion criteria: * age 3-18 years old; * according to the people's republic of china health industry standard "overweight and obesity screening threshold for school-age children and adolescents ws_t586-2018" defined as obesity; * american society of anesthesiologists (asa) grades i - ii; * children with healthy lungs and hearts; * patients with general anesthesia under tracheal intubation; * clear mind and able to cooperate with the anesthesiologist to receive treatment; * patients who plan to have elective surgery under general anesthesia and the estimated operation duration is ≥2 hours. exclusion criteria: * peep contraindications: (a) bronchopleural fistula; (b) hypovolemic shock; (c) right ventricular failure; * american society of anesthesiologists (asa) grade greater than ii; * pulmonary dysfunction, congenital heart disease children; * refusal to participate in the study and/or use personal data, preoperative intubation or ventilation of children; * children with upper respiratory tract infection within 2 weeks.
anti-stress intervention among physicians study

Conditions: Stress, Psychological; Burnout, Psychological; Subjective Stress; Occupational Stress

Summary: medical practice often comes with high stress. stress negatively affects our health and well-being and is linked to doctors making mistakes, some of which can be deadly. in this study, the effect of two quick stress-relief methods on daily stress levels is estimated. the two anti-stress exercises are designed to easily fit into daily routines: 1. box breathing (6 minutes) is known to reduce stress and lower the heart rate. it is used by the military and law enforcement, among others, to manage stress. 2. breathing and mindfulness exercise (10 minutes): this guided breathing and mindfulness intervention combines mindful breathing with simple body movements, developed to reduce the perceived level of stress. the effectiveness of these interventions is being examined in a series of n-of-1 trials. each participant can choose between the interventions. after being randomly allocated to an individual sequence of one-week intervention and control phases, the study begins. participants record their stress levels daily over the four-week study period. the intervention is only performed in the intervention phases. upon completing the study, the stress levels during the intervention phases are compared to those in the control phases. each participant will receive an individual analysis based on the collected data. in addition, the investigators will estimate the effects at the population level. three months after the study, a survey will be sent to the participants to check if the benefits have persisted.


Eligibility criteria:
inclusion criteria * physicians in training in germany * weekly working time in medical activity of at least 9 hours * regular access to a mobile phone on which the "studyu"-app can be installed * informed consent exclusion criteria * age \<18 years * specialist training already completed * no clinical activity during the study period or part of the study period (e.g. vacation, research activity, etc.) * participation in another intervention study during the study period * does not speak german * does yoga more than 4 times a month * meditates or performs breathing exercises on average more than 4 days per month * confirmed or suspected pregnancy * presence of a psychiatric disorder * presence of cardiovascular disease * presence of respiratory or pulmonary disease * presence of a neurological disease * substance abuse (for example, alcohol, drugs, or other) * planned surgery within the next 6 months * doctor's recommendation (or self-assessment) not to perform mindfulness or breathing exercises * lack of informed consent * employee of the charité - universitätsmedizin berlin (due to data protection reasons, employees of the charité - universitätsmedizin berlin will not be included in this study)

Keywords: n-of-1 trial anti-stress intervention box breathing breathing mindfulness
multivessel disease diagnosed at the time of ppci for stemi: complete revascularization versus conservative strategy.

Conditions: Coronary Artery Stenosis

Summary: the aim of the study is to find the optimal management of patients with acute myocardial infarction with st elevations treated by primary pci who have at least one significant stenosis of non-culprit coronary artery. the primary endpoint of the study will be incidence of combined endpoint of all cause mortality, nonfatal myocardial infarction and stroke during the follow up of 24 months in group of patients treated with staged revascularization (pci or cabg) in comparison with patients treated conservatively.

introduction: primary percutaneous coronary intervention (ppci) of the occlussion or significant stenosis of infarct artery is a method of choice in treatment of acute myocardial infarction with st segment elevation (stemi). it is not clear, what is the optimal management of patients with acute myocardial infarction with st elevations (stemi) treated by primary percutaneous coronary intervention (ppci) who have at least one significant stenosis of non-culprit coronary artery. numerous cardiology centers perform staged pci on significant stenoses involving the "non-infarct" coronary artery (arteries) 3-40 days after ppci, but the benefit of this staged pci for such patients has not yet been clearly demonstrated. aim of study: the aim is to find the optimal management of patients with acute myocardial infarction with st elevations (stemi) treated by ppci who have at least one significant stenosis of non-culprit coronary artery. the primary endpoint of the study will be incidence of combined endpoint of all cause mortality, nonfatal myocardial infarction and stroke during the follow up of 24 months in group of patients treated with staged revascularization (pci or cabg) in comparison with patients treated conservatively. hypothesis: our hypothesis is that complete staged revascularization of significant stenoses of the coronary arteries will improve the long-term prognosis in patients after ppci as compared to conservative management.

Eligibility criteria:
inclusion criteria: * patient with acute myocardial infarction with st segment elevation (stemi) * angiographically successful primary pci of infarct-related stenosis (timi flow grades ii-iii) * one or more other stenoses (≥70%) of "non-infarct" coronary artery (arteries) found by coronary angiography, (diameter of artery ≥ 2,5mm) * enrollment ≥48 hours following onset of symptoms exclusion criteria: * stenosis of the left main of left coronary artery ≥ 50% * hemodynamically significant valvular disease * patients in cardiogenic shock during stemi * hemodynamic instability * angina pectoris \> grade 2 ccs lasting 1 month prior to stemi

Keywords: stemi, primary pci, non-infarct, non-culprit lesion, cabg
effects of lactobacillus reuteri in premature infants

Conditions: Premature Infant Disease

Summary: this application a phase ii clinical trial to address the possible active mechanisms of probiotics and to obtain preliminary efficacy and safety data after the administration of a probiotic, lactobacillus reuteri a population of premature infants. the hypothesis is that the exogenous supplementation lactobacillus reuteri to premature infants will lead to clinical beneficial effects by modifying their intestinal microbiota and enhancing their intestinal immunological response.

the primary outcome "days to achieve full feeds" will be measure during the the first month of life secondary outcomes will be measured at baseline (before intervention), 3 weeks after intervention, once intervention discontinued and at 6 months of live

Eligibility criteria:
inclusion criteria: * preterm newborns admitted to the neonatal intensive care units with a birth weight 700-1500 g and who survive more than 3 days exclusion criteria: * chromosomal anomalies. * major congenital anomalies (complex cardiac anomalies, congenital hydrocephalus, renal dysplasia) * congenital (e.g. jejunal atresia) and acquired (e.g. gi perforation) gastrointestinal pathology precluding oral feed and/or requiring major surgical or medical intervention * parental refusal * prior enrollment into a conflicting clinical trial

Keywords: probiotics premature infants feeding tolerance
aspirin-myocardial infarction study (amis)

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Infarction; Myocardial Ischemia

Summary: to determine whether the daily administration of 1 gm of aspirin to individuals with a documented myocardial infarction would result in a significant reduction in mortality over a three year period.

background: it had been postulated that thrombosis plays a major role in the late stages of coronary artery occlusion. platelet aggregation is a large component in the formation of arterial thrombi. theoretically, an agent which prevents the aggregation of platelets would be of value in people with coronary artery disease. aspirin, in small doses, inhibits platelet aggregation for prolonged periods of time, and therefore might be expected to prevent or retard the occlusion of coronary arteries. this would be reflected in a decrease in the incidence of myocardial infarction and a decrease in mortality due to coronary artery disease. several studies had given preliminary evidence that regular administration of aspirin may be of benefit to patients with known coronary artery disease. a national heart and lung institute-sponsored study, the coronary drug project, ran a pilot trial of aspirin and placebo in men with previous myocardial infarctions. preliminary results from this trial demonstrated its feasibility and led nhlbi to sponsor a more definitive controlled study of the benefit of aspirin in the secondary prevention of coronary heart disease. an institute planning committee met four times between october 1974 and april 1975 and developed a protocol, manual of operations, and data collection forms. recruitment of patients began in june 1975, with the first patient randomized on july 2, 1975. patients who were randomized had been seen at the amis clinical center for two initial visits and one baseline visit and were free of any reasons for exclusion, such as the current use of anticoagulants and a history of adverse reactions to aspirin. patients took acetaminophen at times when they would normally take aspirin. follow-up was for a minimum of 3 years, with each patient seen at 4-month intervals and monitored for side effects and various nonfatal events, including cardiovascular problems. the primary endpoint was mortality. annually, a detailed history was obtained and a complete physical examination performed. the study involved 30 clinical centers, a coordinating center, and a central laboratory. the study completed patient recruitment in the scheduled one year period. a total of 4,524 post-mi patients were enrolled by the 30 clinical centers. three-year minimum patient follow-up ended in august 1979. design narrative: randomized, double-blind, fixed sample. eligible patients were assigned to a treatment group receiving 1 gm of aspirin daily (the equivalent of three standard aspirin tablets) or to a control group receiving a placebo.

Eligibility criteria:
men and women, ages 30 to 69. had a documented myocardial infarction.
making the most of mealtimes determinants of food intake

Conditions: Malnutrition

Summary: m3 is a multi-site cross sectional study. data were collected form 640 residents in 32 homes in canada. the primary purpose of this study was to identify food intake in residents and compare this to recommendations, as well as determine influential determinants of food intake.

this cross-sectional study has collected in-depth data at the resident, dining room, staff, and home level, focused on determinants of food intake. dietary intake is based on three non-consecutive days of weighed and estimated food intake. oral health and dyshphagia risk are assessed. person directed care practices, mealtime environments and home level variables of food cost, production and delivery are ascertained.

Eligibility criteria:
inclusion criteria: * medically stable living in selected units, residing in home for more than one month consent to participate exclusion criteria: * considered end of life by staff; tube feeding

Keywords: food intake
instrumental gait analysis on people with stroke after rehabilitation with a synchronized fes and cycle ergometer system

Conditions: Stroke

Summary: functional electrical stimulation is a modality of motor rehabilitation that consists of the programmed application of bursts of electrical current to the affected neuromuscular region that aims to improve muscle strength, increase the range of motion, facilitate movement control and decrease spasticity. the present study aimed to measure the changes in the biomechanics of the gait of people with stroke after training with functional electrical stimulation for the lower extremities.

stroke is one of the leading causes of mortality, morbidity and disability in adults in developed countries. survivors may suffer several neurological deficits or deficiencies, such as hemiparesis, communication disorders, cognitive deficits and visuospatial perception disorders. hemiplegia is a par loss of hemi-body voluntary motricity following a brain injury, usually resulting in alterations of the locomotor system with persistent disorders of movement and posture. hemiplegia significantly affects gait performance. gait recovery is an important objective in the rehabilitation program for stroke patients.the currently available treatment techniques include classical techniques of gait rehabilitation, functional electrical stimulation, electromechanic devices, robotic devices and brain-computer interfaces, among others.the evidence suggest that the combination of different rehabilitation strategies is more effective than conventional rehabilitation techniques alone. technology-based rehabilitation methods such as robotic devices need more research to demonstrate their effects on gait recovery. the present study aimed to identify the changes in the gait characteristics of subjects with stroke after a treatment program with fes for the lower extremities through instrumental gait analysis.

Eligibility criteria:
inclusion criteria: * unilateral lower extremity paresis * haemorrhagic or ischemic stroke * a minimum of six months after the acute infarction/onset of the disease * full passive range of motion in lower extremity or at least at neutral position * be able to stand freely * be able to walk with or without aid for at least 20 meters in less than 2 minutes exclusion criteria: * peripheral nervous system pathology * epilepsy * weight over 100 kg * no cognitive ability to follow the study instructions * pregnancy * use of implanted devices * instable lower extremity joints or fixed contracture

Keywords: stroke hemiparesis gait functional electrical stimulation rehabilitation gait deviation index
trial to evaluate the safety and efficacy of tp-03 for the treatment of demodex blepharitis

Conditions: Blepharitis

Summary: the purpose of this study is to compare the safety and efficacy of tp-03, an eyedrop, to its vehicle control for the treatment of blepharitis due to demodex, a microscopic mite frequently found in human hair follicles.

this phase 3 study is a randomized, controlled, multicenter, double-masked, parallel trial to compare the safety and efficacy of tp-03 to vehicle control for the treatment of demodex blepharitis. the primary objective of the study is to assess the safety and efficacy of tp-03, 0.25% compared to its vehicle from day 1 to day 43 in adult participants with mild to severe demodex blepharitis. the primary efficacy endpoint will be cure based upon collarettes. safety will be determined by assessing adverse effects related to the treatment as well as evaluating any changes in visual acuity, intraocular pressure, slit lamp biomicroscopy, endothelial cell density, hematology, blood chemistry, and urinalysis.

Eligibility criteria:
inclusion criteria: * be willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol * meet all of the following criteria in at least one eye: have more than 10 lashes with collarettes present on the upper lid; have at least mild erythema of the upper eyelid margin; have an average demodex density, upper and lower eyelids combined, of 1.5 or more mites per lash exclusion criteria: * have used lid hygiene products within 14 days of screening or unwilling to forego the use of lid hygiene products during the study * have used a prostaglandin analogue to promote eyelash growth within 30 days of screening or any plans to initiate treatment during the study * have used artificial eyelashes or eyelash extensions within 7 days of screening or be unwilling to forego their use during the study * be pregnant or lactating at the time of screening

Keywords: demodex