Kornimate/medical-research-clean huggingface dataset:
long outcome of endoscopic submucosal dissection for small gastrointestinal stromal tumors (<2cm)

Conditions: GIST

Summary: data are currently insufficient to guide the management of very small gastrointestinal stromal tumors（gists）（\< 2 cm) discovered incidentally on endoscopy,this study is designed to collect the medical records of patients in different treatment group with long-term follow-up data,and attempts to evaluate the usefulness of regular endoscopic ultrasound（eus）surveillance and the necessity,safety and feasibility of endoscopic submucosal dissection（esd）for small gists,thus provide evidence for the revision of the guideline.

objection:to evaluate the usefulness of regular endoscopic ultrasound（eus） surveillance and the necessity,safety and feasibility of endoscopic submucosal dissection（esd） for small gists(\<2cm),thus providing evidences for the revision of the guideline. outline:this is a randomized controlled trial. eligible patients are divided into 2 group with 45 in each.the experimental group undergo esd for gists,while the investigators do no treatment to the control group.then,the 2 groups will be follow up for 5 years.all data are analysed with the statistical product and service solutions（spss）statistical software.

Eligibility criteria:
inclusion criteria: 1. male or female chinese patients of 18-70 years old. 2. patients with very small gastric gists (\< 2 cm) with no high-risk eus features. 3. patients voluntarily join this study with informed consents. exclusion criteria: 1. patients with the tumors involving the serosa layer or grow outside the lumen obviously that are not eligible for endoscopic treatment. 2. patients with distant metastasis on computed tomography(ct)scan. 3. patients with an extremely poor general condition or a very short life expectancy. 4. patients presenting with severe gastrointestinal tract bleeding that require immediate surgery.

Keywords: gist esd
anti pd-1 antibody with radiation therapy in patients with her2-negative metastatic breast cancer

Conditions: Breast Cancer

Summary: the aim of this study is to evaluate the safety and efficacy of anti pd-1 antibody with radiation therapy in patients with her2-negative metastatic breast cancer.


Eligibility criteria:
inclusion criteria: - cohort a 1. documentation of er-positive and/or pr-positive tumor (\>=1% positive stained cells) . 2. patients must satisfy the following criteria for prior therapy: - progressed during treatment or within 12 months of completion of adjuvant hormone therapy. or progressed while prior hormone therapy for advanced/metastatic breast cancer. two previous line of hormone therapy for advanced/metastatic disease is allowed. 3. patients who have hormone therapy that can be expected for advanced /metastatic disease. cohort b 4. patients who have come to be non-responsive more than two line of chemotherapy 5. prior chemotherapy with anthracycline and taxane agent cohort a and b 6. female patients who are histologically or cytologically confirmed to have breast cancer 7. patients who have distant metastatic lesion as follow - more than one bone lesion for radiation therapy 8. patients with cancer confirmed to be her2-negative.（ 9. patients with a measurable lesion based on recist 1.1. 10. patients aged \>= 20 years at informed consent 11. patients with ecog ps of 0 to 1. 12. patients without any severe disorder in the major organs. 13. patients expected to survive for ≥ 90 days. 14. patients of childbearing potential must be using an acceptable method of contraception to avoid pregnancy and must not be breastfeeding for 18 weeks after the last dose of investigational product 15. patients who have provided written informed consent themselves. exclusion criteria: - exclusion criteria: 1. patients who have neuropathy (more than grade 2) 2. patients with any active autoimmune disease or a history of known autoimmune disease. 3. patients who has a history of pneumonitis or interstitial lung disease. 4. active, untreated central nervous system metastasis. 5. patients with pericardial effusion, pleural effusion or ascites requiring treatment 6. patients with uncontrolled diabetes mellitus 7. patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 28 days of the enrollment. 8. patients who has received radiotherapy within 28 days of study registration, or radiotherapy for thorax within 56 days of the enrollment. 9. pregnant or breast-feeding women. 10. prior therapy with nivolumab, anti ctla-4 antibody therapies, any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways 11. patients considered ineligible for participation in this study by their attending physicians
treatment of larotaxel/docetaxel, +/- trastuzumab, after anthracycline-cyclophosphamide in breast cancer patients

Conditions: Breast Neoplasms

Summary: the primary objective of this study is to assess the pathological complete response (pcr) rate by treatment arm (according to chevallier criteria). the secondary objectives are: * to assess in each treatment arm the clinical response rate (rr), the rate of breast conservation, the progression-free survival (pfs), the overall survival (os), the safety and tolerability profile, the pathological complete response rate (pcr) according to nsabp and sataloff criteria, * to rank docetaxel and larotaxel alone in her2 -ve patients, or combined with trastuzumab in her2 +ve patients, according to the pcr rate.


Eligibility criteria:
inclusion criteria: * histologically proven invasive breast adenocarcinoma * localized breast cancer: stage ii and iii * tumors clinically palpable and ineligible for breast conservative surgery: unifocal tumor with diameter ≥ 3cm (clinical examination) or central unifocal tumor, or whose characteristics make pre-operative chemotherapy mandatory due to high risk factors (i.e. ipsilateral lymph nodes involvement, rapid growth rate) * after 30 june 2008, known status for her2neu by immunohistochemistry (ihc) or by fluorescent in situ hybridization (fish) exclusion criteria: * bilateral and inflammatory breast cancer * abnormal left ventricular ejection fraction * distant metastases or locoregional relapse * inadequate organ functions the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: breast cancer neoadjuvant therapy
rhythm control and potential early surgery for tricuspid regurgitation

Conditions: Severe Tricuspid Valve Regurgitation (Disorder)

Summary: the purpose of this study is to understand the clinical impact of non-surgical and surgical treatment in atrial fibrillation induced tricuspid regurgitation (aftr).


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * moderate-severe or severe tr while in atrial fibrillation. * ambulatory (not wheelchair/scooter dependent). exclusion criteria: * systolic pulmonary artery pressure\>70 mmhg with a fixed pulmonary vascular resistance \>7 wood units by catheterization. * ejection fraction \<40%. * obstructive hypertrophic cardiomyopathy. * constrictive pericarditis or tamponade. * active myocarditis. * complex congenital heart disease. * other valve disease requiring surgical intervention. * terminal illness (other than hf) with expected survival of less than 1 year. * pregnancy or breastfeeding mothers.
postoperative course following wisdom tooth surgery

Conditions: Pain, Postoperative

Summary: the purpose of this study is to determine how quality of life changes after surgical removal of wisdom teeth

a significant percentage of patients are subjected to surgical removal of 3. molars every year. the surgical mucosal and osseous procedure may lead to postoperative discomfort including pain, for the patient. information with respect to how patients regard the impact of this surgical treatment on oral health including pain and swelling is of great interest. more precise information about the postoperative course following this surgery will be beneficial in improving clinical treatment procedures with respect to alleviating the patients' postoperative period.

Eligibility criteria:
inclusion criteria: * patients of either sex of caucasian origin, between the age of 18 and 45, who are candidates for surgical removal of one mandibular 3. molar exclusion criteria: * chronic drug treatment (except birth control medication) with analgesics, anti-inflammatory treatment (both steroidal (saids) and non-steroidal anti-inflammatory drugs (nsaids)) apart from standard postoperative analgesic treatment administered by the operator. * the necessity for anti-microbial drugs. * pregnant or lactating women. * patients with diabetes. * patients who due to age or communication skills are considered unable to complete patient forms. * professional evaluation suggests an alteration of the planned surgical area or treatment form. * surgery exceeding 45 minutes, from time of first incision to completed suturing. * known or assumed intolerance or hypersensibility to ibuprofen (standard postoperative analgesic treatment). * known or assumed intolerance or hypersensibility to the standard local anaesthetic xylocain-adrenalin (lidocaine-adrenalin). * consumption of alcohol in the period from 2 days before or until the end of the primary observation period (postoperative days 0-7.

Keywords: third molar quality of life postoperative swelling postoperative pain surgical procedures, operative postoperative period
arma for postoperative gerd after sleeve gastrectomy

Conditions: Gastroesophageal Reflux

Summary: this study is a pilot trial designed to evaluate the safety and efficacy of endoscopic anti-reflux ablation in postoperative gastroesophageal reflux after sleeve gastrectomy


Eligibility criteria:
inclusion criteria: * patients with reflux symptoms after sleeve gastrectomy and are dependent on or refractory to ppi treatment * pathological esophageal acid exposure, defined by demeester score \>14.7 or acid exposure time (aet) \>4.2% on ph study exclusion criteria: * primary esophageal motility disorders * sliding hiatal hernia \>3cm * narrow gastric sleeve that precludes retroflexion of scope * gastric sleeve stricture * malignancy * pregnancy * patients not fit for general anesthesia * other cases deemed by the examining physician as unsuitable for safe treatment * refusal to participate
the patient's experience with physician assistant providers (pepap)

Conditions: Joint Diseases, Midlevel Providers, Nurse Practitioners, Physician Assistants, Patient Perceptions, Patient Preferences

Summary: our investigation was a prospective cross-sectional survey evaluating the patient experience to new patients that presented to an outpatient private practice specialized in total joint reconstruction. new patients seeing a pa during their initial visit were randomized to intervention and control groups and all were given a descriptive survey at checkout. inclusion criteria (1) new patient (2) english speaking (3) appointment with pa. there was no exclusion criteria. eligible patients were randomized to the intervention group (received biosketch card) or the control group (no card) using random number generator. patients within the intervention group received a biosketch card during rooming, pre-clinician encounter, and were not informed about involvement. both groups received standard care that was independent of the study. to blind the outcome measure, the research assistant did not explain the reason for the card upon rooming. the provider pa was not informed which patient received the card. upon discharge, the patient completed a five-question survey regarding the clinic visit.


Eligibility criteria:
inclusion criteria: * new patient * appointment with a pa exclusion criteria: * non-english speaker
aerobic training for management of post-concussion syndrome in adolescents

Conditions: Concussion; Post-concussion Syndrome; Sports Injury

Summary: sports-related concussions are common in adolescent-athletes. prolonged recovery after concussion or post-concussion syndrome (pcs) is a public health problem. this project will determine the effectiveness of an aerobic exercise program for management of pcs and it will evaluate the influence of exercise on biologic correlates of pcs.

concussion or mild traumatic brain injury (mtbi) is a public health problem and it is imperative that efficacious treatment protocols be developed to reduce the morbidity associated with pcs in adolescents. in adolescent athletes, timely return of normal neurocognitive function and return to sports safely is critical to normal development. the proposed study will fill a critical gap by systematically evaluating the potential efficacy of an aerobic training intervention for management of pcs in adolescents. to our knowledge, this will be the first randomized controlled study to evaluate the efficacy of aerobic training for treatment of pcs in adolescents as soon as four weeks after injury. the study will also improve our understanding of the pathophysiology of pcs and the biologic influence of aerobic training on pcs. the proposed study will fill a critical gap and inform the development of larger studies to assess the efficacy, and if proven efficacious, optimize the timing and intensity of aerobic training treatment protocols, thus transforming the care and limiting the adverse public impact of this condition.

Eligibility criteria:
inclusion criteria: * adolescents ages 12 to 17 years * experienced a concussion 4 to 16 weeks prior to enrollment * experiencing persistent post-concussion symptoms exclusion criteria: * sustained a moderate to severe head injury, head injury more severe than concussion or required an overnight hospital stay * younger than 12 years of age when beginning the study. * older than 17 years of age when beginning the study. * do not live with a parent/guardian. * injured more than 16 weeks ago. * do not speak or read english. * diagnosed with a developmental disability. * neurological impairment, cognitive disorders, genetic disorders, metabolic disorders, blood disorder, cardiovascular problem/disease, and/or cancer. * inpatient admission for a psychiatric disorder within the past 12 months. * taking beta-blockers, anti-depressants, and/or anti-epileptic medications that cannot be discontinued while participating in the study. * cardiovascular condition that would preclude participation in the training protocol. * any condition that precludes magnetic resonance imaging (mri). * females that are pregnant or become pregnant during the study.

Keywords: concussion mild traumatic brain injury post-concussion syndrome adolescents sports injury aerobic training stretching training
keloid radiation registry

Conditions: Keloid

Summary: radiation therapy has been, and is being used in treatment of patients with keloid. radiation is typically used as an adjunct to surgery in order to reduce the recurrence rate of keloid. radiation therapy is not free of long term side effects. radiation therapy is known to cause secondary cancers. the investigators also do not have a good understanding as to how effective radiation therapy is in preventing recurrence of keloid. purposes of this study are to determine the long term safety as well as efficacy of radiation therapy when used for treatment of keloid.

the keloid-radiation project is a clinical registry of patients with keloid who have been treated with radiation therapy. this registry aims to monitor the at least 1,000 keloid patients who received radiation therapy to their keloid and to collect epidemiological and clinical data about these patients in order to assess the long term safety and effectiveness of radiation therapy. radiation is currently being used in the treatment of keloid, thus enabling the epidemiological characteristics of patients, analysis of treatment response, modeling the influence of risk factors on patients´ risk of developing long term complications such as a cancer, as well as the detailed analysis of the dose delivered, equipment used and radiation planning. this study intends to gather data about the long term efficacy and safety of radiation therapy and rate of developing secondary cancers in patients who have received radiation therapy for treatment of their keloid.

Eligibility criteria:
inclusion criteria: 1. clinically confirmed diagnosis of keloid 2. history of radiation therapy for treatment of keloid 3. all ages 4. signed informed consent form ( by parent or legal guardian if patient is under the age of 18) exclusion criteria: * none

Keywords: keloid radiation therapy hypertrophic scar
nasal inhalation of pulmozyme in patients with cystic fibrosis and chronic rhinosinusitis

Conditions: Cystic Fibrosis; Rhinosinusitis

Summary: rhinosinusitis disorders are often associated with cystic fibrosis. they can restrict quality of life enormously and give cause to repeated ent surgery. the basic defect in cf is a dysfunction of chloride channels in exocrine glands, leading to retention of secretions and consecutive chronic inflammation with bacterial superinfections. the prospective placebo controlled cross-over study aims at the evaluation of a nasally inhalation of pulmozyme with respect to mucus retention and resulting inflammation.


Eligibility criteria:
inclusion criteria: * subject has a confirmed diagnosis of cystic fibrosis based on: 3 positive sweat chloride tests and/or genetic characterisation * subject is 5 years of age or older * subject has chronic or recurrent rhinosinusitic disorders * subject is able to comply with the procedures scheduled in the protocol * women of childbearing potential are only included into the study, if they are using an effective method of birth control during the protocol (e.g. implants, combined oral contraceptives, injectables, some iuds, sexual abstinence or vasectomised partner) exclusion criteria: * subject has a critical condition defined as: fev1 \< 30% and / or sao2 \< 93% without o2-substitution; need of o2-substitution * subject had an ent surgery within 6 months prior to study * subject shows signs of nasal bleeding * subject has an ear drum perforation * subject had an acute rhinosinusitis or a pulmonary exacerbation at study entry with need of additional systemic antibiotic therapy * subject has a new therapy with nasal topic steroids during treatment interval * subject has a new systemic steroid therapy * subject is unlikely to comply with the procedures scheduled in the protocol * subject has a known allergic reaction to the medication * subject is pregnant or breastfeeding * patient participates in another clinical trial within 30 days prior to study entry or 30 days after end of the study.

Keywords: cystic fibrosis and chronic rhinosinusitis
cost-effectiveness analysis of a rehabilitation protocol with fes cycling in persons with complete sci

Conditions: FESD; Rehabilitation; Spinal Cord Injuries; Complete Spinal Cord Injury

Summary: 20 patients were recruited by two hospitals (aoup and aouc) in italy from january 2015 to january 2018. the participants have been addressed to two different groups: the ones recruited by the aoup were submitted to an experimental protocol of rehabilitation with fes cycling, the ones recruited by the aouc were submitted to a standard protocol of manual mobilization. the primary outcome was the thigh circumferences measured at 4 different levels (5-10-15-20 cm) from the superior margin of the patella, while the secondary outcomes were the muscle tone evaluated with modified ashworth scale (mas) and the sensation of pain registered with international spinal cord injury - pain basic data set (isci-p). from these outcomes the quality adjusted life years (qalys) was obtained. the costs of the two treatments were calculated through a consultation process with the competent offices of the two hospitals. the qalys and the costs were used to calculate the incremental cost-effectiveness ratio (icer) in order to verify the cost-effectiveness ratio of the two treatments.


Eligibility criteria:
inclusion criteria: * complete spinal cord injury * loss of gait function * any episode of autonomic dysreflexia * any important range of motion limitation to hips, knees or ankles * eccitability of the muscles * fes tollerability exclusion criteria: * cognitive deficits * psychiatric diseases * cancer * recent fractures
hemoperfusion efferon сt for the extremely severe form of covid-19

Conditions: COVID-19

Summary: the development of acute respiratory and renal failure of covid-19 patients is associated with an excessive immune response and hyperproduction of anti-inflammatory cytokines, which leads to impaired endothelial function and a dysregulated balance between the coagulation and fibrinolytic systems in the blood. these factors contribute to the development of multi-organ failure, sepsis, and high mortality rates.in the absence of effective etiotropic therapy for covid-19, it is necessary to search for alternative, pathogenetically based treatment approaches, including extracorporeal methods of homeostasis support. this observational study examines the effect of early hemoperfusion using the efferon ct device for the treatment of patients with severe forms of covid-19 after their intubation on a ventilator.

on march 11, 2020, the world health organization (who) declared covid-19 a global pandemic. this disease is characterized by a variety of symptoms, many of which can lead to multiple organ failures and critical conditions.timely removal of cytokines and other medium-molecular substances from the body using sorption techniques can not only help restore the balance between pro-inflammatory and anti-inflammatory mediators, but also in some clinical situations, prevent the deterioration of vital organ function or create conditions that allow for the reversal of multiple organ dysfunction.the accumulated experience of using various devices for sorption of low- and medium-molecular toxins creates a pathophysiological basis for the development of effective methods for the use of extracorporeal hemoperfusion in the treatment of the most severe forms of covid-19. this study examines the effects of early hemoperfusion, using the efferon ct device, for the treatment of severe cases of covid-19 in patients after intubation on a ventilator. efferon ct (efferon jsc, moscow, russia) is a device for extracorporeal blood purification using direct hemoperfusion. detoxification is carried out by removing excess cytokines, myoglobin, endogenous and exogenous toxic substances from the patient's blood. the device is manufactured according to tu 32.50.50-001-12264678-2018, passed the necessary tests and is registered in russia as a medical device rzn 2019/8886.

Eligibility criteria:
inclusion criteria: * patients with extremely severe covid-19 no later than 6 hours after the start of intubation on a ventilator * patients over 18 years and under 72 years old exclusion criteria: * pregnancy or the first 3 months after childbirth * clinical or laboratory findings of sepsis * acute bleeding * presense of cancer in anamnesis * surgical interventions * acute kidney injury (kdigo \> i) * charlson comorbidity index \> 5 * thrombocytopenia with a platelet count less than 100x109/l * patients in the first 6 months after acute cerebrovascular accident or acute myocardial infarction * patients who have previously undergone extracorporeal detoxication

Keywords: covid-19 mesoporous styrene-divinylbenzene copolymer cytokines adsorption hemoperfusion