Kornimate/medical-research-clean huggingface dataset:
comparison of laparoscopic proximal gastrectomy and laparoscopic total gastrectomy

Conditions: Gastric Cancer

Summary: experimental: laparoscopic proximal gastrectomy laparoscopy proximal gastrectomy with esophago-jejunostomy, gastro-jejunostomy and jejuno-jejunostomy (double tract reconstruction). systemic en bloc lymph node dissection is mandatory. resection margin should be negative for malignancy with intraoperative frozen biopsy. active comparator: laparoscopic total gastrectomy laparoscopic total gastrectomy with esophago-jejunostomy and jejuno-jejunostomy (roux-en-y reconstruction). systemic en bloc lymph node dissection is mandatory. resection margin should be negative for malignancy with intraoperative frozen biopsy.

participating surgeons prior to this clinical trial, only the surgeons who are considered to have the standardization by review committee participated. patients registration it is required to ensure that the patients meet the inclusion criteria for this clinical trial, are free from any items of exclusion criteria, are explained about the participation in the clinical trial along with the informed consent forms. after rechecking the patients with the registration check list by accessing the web-based randomized program provided from seoul national university bundang hospital medical research collaborating center. each group 69 patients, total 138 subjects will be enrolled. randomization the registration randomization should be done with 1:1 ratio for each researcher. baseline number (bn) should be provided to the subjects in the order of acquisition of informed consent form. based on the subjects who are selected as the appropriate subjects in the end, the allocation number (an) shall be provided in the order of randomized allocation table. procedure operations are performed according to the allocated group.

Eligibility criteria:
inclusion criteria: * patients are included in the trial if they meet all of the following criteria: histologically proven adenocarcinoma through endoscopic biopsy aged 20-80 years old written signed informed consent no other malignancies proximal gastric cancer met by following conditions ; lesion located on proximal stomach (upper one third) lesion below 5cm in size lesion confined to mucosa or submucosa (ct1) no evidence of metastatic enlarged ln on #5, 6, 4d, 10 basins and other distant metastasis. performance status (ps) of 0 or 1 on eastern cooperative oncology group (ecog) scale performance status (ps) of i to iii on american society of anesthesiologists (asa) score exclusion criteria: * patients are excluded if they meet any of the following criteria: history of anemia patients who need total gastrectomy history of pre-operative chemotherapy or radiation therapy for gastric cancer patients who need combined resection (except cholecystectomy) presence of other malignancies prior treatment against systemic inflammatory disease previous gastric surgery vulnerable patients (lack of decision-making capacity, pregnant, or breast-feeding women)
pilot study on digitally supported home exercises for the management of unspecific low back pain.

Conditions: Low Back Pain

Summary: the overall purpose of the study is to investigate effect of digitally supported home exercises (dshe) in different groups for which digitally supported interventions could be beneficial. balance is altered in individuals with low back pain and requires intervention thus, the investigators will focus on the effect of dshe to improve postural balance.

the investigators want to investigate whether a digitally supported exercise program can improve the balance of people with non-specific lower back pain. during the exercise program, a computer game at home is controlled with the help of sensors attached to the body. second aim is to record the daily activities of the participants and compare them with the back pain. the 120 participants in this study will be divided into four groups (a, b, c and d). in groups a and b 20 patients are included who are in treatment for chronic back pain and receive medical training therapy (mtt). for groups c and d the investigators will invite each 40 participants who have back pain but are not in treatment for their back pain. only participants in groups a and c receive the digitally supported home exercise program. who gets the training program is randomized using stratified block randomization. the balance of all participants is measured four times. between the 2nd and 3rd measurement the digitally supported exercise program is carried out. between the 3rd and 4th assessement, participants in group a and c can exercise as much as they wish. the person who carries out the balance tests will not be informed which participant is in which group.

Eligibility criteria:
inclusion criteria group a and b * patients with chronic unspecific low back pain * patients of the medical training therapy (mtt) * adult male and female participant's (≥18 years) * informed consent as documented by signature inclusion criteria group c and d * participant reports unspecific low back pain * receiving no therapy nor medical treatment for the last 6 months * adult male and female participant's (≥18 years) * informed consent as documented by signature exclusion criteria all groups * patients with specific causes for low back pain * radicular syndrome * unable to participate currently in the program due to pain * pregnancy * medication effecting postural balance * uncorrected heavy visual impairment * allergy to adhesive tape * unable to understand and communicate in german or english
different preloads for prevention of hypotension in patients undergoing elective cs under intrathecal anesthesia

Conditions: Hypotension Drug-Induced

Summary: the aim of this study was to compare between crystalloid versus crystalloid and colloid combination preloads for prevention of hypotension following intrathecal anaesthesia in patients undergoing elective caesarean section. to examine weather baseline perfusion index could predict the incidence of intrathecal-induced hypotension during caesarean section.

intrathecal anesthesia is the most commonly used technique for elective caesarean section all over the world. one of the most common complications of this technique is hypotension. it's incidence is more than 80% without any prophylactic measures, this hypotension has adverse effects on both mother ( causing nausea and vomiting ) and foetus ( causing acidosis and neurological defects ). this complication can be managed by several ways like fluid therapy, usage of vasopressors or combination between both of them. among the type of fluids ( crystalloid or colloid ) it's still not known which one of them is better. crystalloid has a short intravascular half-life because of its rapid distribution into the interstitial space. on the other hand colloid remains longer within the intravascular space. change in baseline peripheral vascular tone due to pregnancy may affect the degree of such hypotension. the perfusion index ( pi ) derived from a pulse oximeter has been used for assessing peripheral perfusion dynamics due to changes in peripheral vascular tone.

Eligibility criteria:
inclusion criteria: * age : 18-40 years * asa 1\&2 exclusion criteria: * patients with morbid obesity. * pre-existing or pregnancy-induced hypertension. * known cardiovascular or cerebrovascular disease. * abnormal ctg tracing. * any other contraindications for intrathecal anaesthesia.
medtronic score study - study of curette use for obtaining restoration of vertebral body anatomy in balloon kyphoplasty

Conditions: Vertebral Body Compression Fractures (VCFs)

Summary: the objective of this study is to measure the effect that the scraping and scoring of vertebral cancellous bone using the kyphon® curette has on vertebral body anatomy height restoration and angular deformity correction during a balloon kyphoplasty procedure.


Eligibility criteria:
inclusion criteria: * age \>= 50 years * one painful vcf meeting all of the following criteria: * fracture due to diagnosed or suspected underlying primary or secondary osteoporosis * vcf is between t5 and l5 * vcf shows hyperintense signal on stir or t2 weighted mri * vcf has at least 15% height loss as visualized on plain radiograph * identified painful vcf has at least superior and one normal vertebrae within 2 levels inferior. * either the immediate superior or the immediate inferior vertebral body (but not both) may have a chronic fracture that does not need treatment. * patient states availability for all study visits * patient is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent exclusion criteria: * patient is unable to undergo mri * patient shows evidence of edema in vertebral bodies other than index level on mri * patient is unable to stand for pre-operative and post-operative x-rays * patient body mass index (bmi) is greater than 35 kg/m2 * patient is pregnant, or of child-bearing potential and not using contraception * vertebral body (vb) morphology or configuration is such that balloon kyphoplasty is not technically feasible or clinically appropriate for the index vcf * index fracture is result of high-energy trauma * suspected or proven cancer inside any vb * disabling back pain due to causes other than acute fracture * spine stabilization beyond balloon kyphoplasty required for index vcf * pre-existing conditions contrary to balloon kyphoplasty, such as: * irreversible coagulopathy or bleeding disorder. note that patients on coumadin or other anticoagulants may participate. investigators should follow routine practices for perioperative discontinuation and re-initiation of anticoagulants. * allergy to any device materials (e.g., bone cement) for balloon kyphoplasty. note that in patients with allergy to iodine-based contrast, other marketed approved non-iodine contrast solutions may be used. * any evidence of vb or systemic infection
sofosbuvir in treatment of covid 19

Conditions: COVID

Summary: sofosbuvir containing treatment in treatment of covid 19 egyptian patients

sofosbuvir containing treatment of covid 19 egyptian patients: a randomized-controlled trial

Eligibility criteria:
inclusion criteria: * covid positive patients. exclusion criteria: * contraindication to sofosbuvir or ribavirin.
safety and diagnostic efficacy of mangoral in participants with focal liver lesions and reduced kidney function

Conditions: Known or Suspected Focal Liver Lesions; Severe Renal Impairment

Summary: the overall objective of this study is to evaluate the safety and diagnostic efficacy of mangoral in liver mri in participants with known or suspected focal liver lesions and severe renal impairment. the diagnostic efficacy of mangoral will be assessed in terms of visualization of detected focal liver lesions in combined mri (cmri: combined mangoral-enhanced and unenhanced mri) compared to unenhanced mri.

the overall objective of this multicenter, open-label, study is to evaluate the safety and diagnostic efficacy of mangoral in participants with known or suspected focal liver lesions and severe renal impairment. study treatment is a single oral dose of mangoral (800 mg manganese chloride \[ii\] tetrahydrate, 500 mg l-alanine, and 800 iu vitamin d3). adult male and female participants with severe renal impairment or acute kidney injury and who are being evaluated for known or suspected focal liver lesions will be included. primary diagnostic efficacy in terms of visualization of detected lesions will be evaluated centrally by 3 independent readers. study mris will also be evaluated by the on-site radiologists for the assessment of secondary objectives and for clinical purposes.

Eligibility criteria:
inclusion criteria: * male and female participants 18 years and older. * known or suspected focal liver lesions based on medical history and previous laboratory and/or imaging examinations. * severe renal impairment (estimated glomerular filtration rate \[egfr\] \< 30 ml/min/1.73 m\^2) based on medical history and previous laboratory examinations, at least once, within the last 3 months prior to the baseline visit, or participants with an increase in serum creatinine ≥ 0.3 mg/dl within 48 hours or ≥ 50% within 7 days prior to the baseline visit. exclusion criteria: * participants with simple liver cysts only. * any investigational drug or device within 6 weeks prior to the baseline visit. * any magnetic resonance imaging (mri) contrast media within 6 weeks prior to baseline visit or scheduled to receive any contrast medium before the last study visit. * participants with severe hepatic impairment (according to child-pugh score c). * participants scheduled for surgery before last study visit. * participants with encephalopathy / neurodegenerative or acute neurological disorders. * participants with hemochromatosis.
extension study of tkt028 evaluating safety and clinical outcomes of replagal® in adult patients with fabry disease

Conditions: Fabry Disease

Summary: this study will evaluate safety and clinical outcomes of treatment with replagal in adult participants with fabry disease who have completed study tkt028 (nct00864851).

hgt-rep-060 was designed to provide participants who participated in tkt028 an additional 52 weeks of treatment with replagal at the standard dose of 0.2 milligram per kilogram (mg/kg) every other week (eow) to assess the effect of continued replagal therapy on long-term safety and clinical outcomes for this participant population.

Eligibility criteria:
inclusion criteria: * complete all study requirements and assessments for study tkt028 less than 30 days (+/- 7 days) prior to the first dose in this extension protocol * voluntarily signed an institutional review board/independent ethics committee- approved informed consent form after all relevant aspects of the study have been explained and discussed. * has received and tolerated at least 80% of the total planned replagal infusions in study tkt028 * female participants of child-bearing potential must agree to use a medically acceptable method of contraception at all times during the study and must have a negative pregnancy test at the time of study entry and as required throughout participation in study exclusion criteria: * has received treatment with any investigational drug (other than replagal) or device within 30 days prior to study entry. * is unable to comply with the protocol, (eg, is unable to return for safety evaluations, or is otherwise unlikely to complete the study), as determined by the investigator * has a positive test for hepatitis b surface antigen (hbsag), hepatitis c(hcv) antibody, or human immunodeficiency virus (hiv) antibody * is pregnant or lactating * is morbidly obese, defined as body mass index (bmi) \>39 kg/m2 * has any safety or medical issues, as assessed by the investigator, that contraindicate participation in the study (eg, has experienced an adverse reaction to treatment with replagal or has a known hypersensitivity to any of the components of replagal

Keywords: agalsidase alfa alpha-galactosidase replagal enzyme replacement therapy
an enhanced home-based telemedicine program using remote examination devices for children with medical complexity

Conditions: Chronic Diseases in Children

Summary: the purpose of this study is to assess if the benefits for children with medical complexity (cmc) receiving comprehensive care (cc) in an enhanced medical home can be further improved by enhanced telemedicine program (etm) provided during clinic hours using mobile devices to measure temperature\& oxygen saturation, auscultate the heart \& lungs, and view the skin, throat, \& tympanic membranes in the home.


Eligibility criteria:
inclusion criteria: * greater than or equal to 2 hospitalizations or greater than or equal to 1 icu admission in the year before joining the comprehensive care program * greater than 50 percent estimated risk of hospitalization without our care as judged by the medical director exclusion criteria: * major heart disease * mitochondrial disorders * active cancer * do-not-resuscitate (dnr) order * patients receiving compassionate care

Keywords: comprehensive care telemedicine enhanced with tytocare devices. telemedicine children with medical complexity
the impact of clinical pharmacists medication reconciliation upon patients admission to reduce medication discrepancies.

Conditions: Medication Reconcilitation Upon Hospital Admission

Summary: it is a quazai one arm study shows the impact of the role of the clinical pharmacists through medication reconciliation to patients admitted to the emergency department .the main aim is to show if the pharmacists intervention is associated with establishing a complete drug history list than the list already presented in the patient file and taken by the physician .then a description of the medication errors detected will be done .

it is a quazai one arm study in which the pre phase is the detection of the complete and accurate drug history list already presented in the patient file and taken by the physician and the post phase is the detection of the complete and accurate drug history list taken by the clinical pharmacists after medication reconciliation for the same patients. medication reconciliation will be done as a full diseases and preadmission medications history will be taken from the patients or the family through interviews, revising previous prescriptions and hospital records. * preadmission medication history will include medications trade names, doses, frequency and route of administration and treatment duration and also will include the consumption of vitamins or herbs. * the medication errors will be detected ,calculated and classified according to medication at transitions and clinical handoffs (match) toolkit for medication reconciliation and ncc merp index.

Eligibility criteria:
inclusion criteria: * patients with one or more chronic disease / drug. exclusion criteria: - patients who cannot communicate or have no family members.

Keywords: medication reconcilitation medication discrepancies admission pharmacist
photobiomodulation therapy in patients with head and neck cancer post-radiotherapy

Conditions: Head and Neck Cancer; Head and Neck Neoplasms; Xerostomia

Summary: patients with head and neck cancer post-radiotherapy may improve their perceived and amount of saliva after a 3-month photobiomodulation (pbm) therapy focuses on three main salivary glands (parotid, submandibular and sublingual glands).

the use of pbm therapy in survivors with head and neck cancer may be an effective treatment to improve xerostomia and hyposalivation as side effects of radiotherapy. although there is some scientific evidence on its benefits during or after radiotherapy, it is not sufficient to establish it as an effective treatment. for these reasons, studies of higher methodological quality such as randomized controlled trials, are needed. this study aims to demonstrate the benefits of pbm therapy on xerostomia and hyposalivation in survivors with head and neck cancer undergone radiotherapy, and whether the effects are maintained after a follow-up period.

Eligibility criteria:
inclusion criteria: * patients diagnosed with head and neck cancer * persistent xerostomia after radiotherapy * ≥18 years * irradiated with radiotherapy in the major salivary glands (parotid, submandibular and sublingual) * grade 3 for dry mouth in common terminology criteria for adverse events, ctcae (version 5.0) * have completed medical treatment with full response (complete remission) and receive medical clearance for participation. * at least one month after radiotherapy completion, to reflect the possible presence of oral mucositis (sores) and/or radiodermatitis (inflammation) that limits adherence to treatment * no use of drugs/devices/products (pilocarpine, cevimeline, amifostine, oral devices, humidifiers or herbs) to prevent or treat xerostomia before inclusion in the study, or constant usage (do not change type and dosage) during 2 months before inclusion in the study exclusion criteria: * relapse or metastasis * karnofsky activity scale \<60 * contraindications to pbm therapy (cardiac arrhythmias, pacemakers, photosensitivity, drugs with photosensitizing action, pregnancy) * patients with other comorbidities such as diabetes o polymedication

Keywords: quality of life neoplasms xerostomia low-level light therapy
impact of exercises and chair massage on musculoskeletal pain of young musicians

Conditions: Musculoskeletal Pain

Summary: the study is tested the idea of two forms of musculoskeletal pain prophylaxis (chair massage and an original set of exercises) among musicians. the hypothesis of the study was that massage and exercises could be helpful for musicians to avoid pain conected with playing musical instrument.


Eligibility criteria:
inclusion criteria: * playing a musical instrument for a minimum of 5 years * age over 18 years exclusion criteria: * neurological and oncological diseases * medical contraindication to undertake physical exercise * contraindications to perform massage * lack of consent for participation in the study

Keywords: musculoskeletal pain playing related musculoskeletal disorders physiotherapy
ultrasound assessment of diaphragmatic dysfunction in regional anesthesia

Conditions: Regional Anesthesia; Diaphragm Issues; Thoracic Surgery; Ultrasounds

Summary: awake thoracic surgery is a feasible and safe alternative to general anesthesia for pulmonary biopsy in interstitial lung disease patients, but there is still no evidence as to its superiority in terms of outcome. however, there is extensive literature about the effect of anesthetic drugs and surgery on diaphragmatic function. furthermore, in thoracic surgery, diaphragmatic dysfunction was associated with a higher occurrence of postoperative pulmonary complications. to assess the impact of general anesthesia on diaphragmatic function, the investigators conducted an observational prospective trial. the investigators measured both diaphragmatic excursion and thickening fraction at baseline and 12 hours after surgery together with pulmonary function tests and gas exchange data.

awake thoracic surgery is a feasible and safe alternative to general anesthesia for pulmonary biopsy in interstitial lung disease patients, but there is still no evidence as to its superiority in terms of outcome. however, there is extensive literature about the effect of anesthetic drugs and surgery on diaphragmatic function. furthermore, in thoracic surgery, diaphragmatic dysfunction was associated with a higher occurrence of postoperative pulmonary complications. to assess the impact of general anesthesia on diaphragmatic function, the investigators conducted an observational prospective trial. the investigators measured both diaphragmatic excursion and thickening fraction at baseline and 12 hours after surgery together with pulmonary function tests and gas exchange data. the investigators divided our population into two groups: one group of patients undergoing awake thoracic surgery with epidural anesthesia, and the other group undergoing general anesthesia. forty-one patients were recruited and the thickening fraction percentage, calculated as (end inspiratory thickness-end expiratory thickness)/end expiratory thickness, was evaluated by means of an ultrasound-assisted method, using a high frequency (10 mhz) linear probe.

Eligibility criteria:
inclusion criteria: * patients scheduled for lung biopsy from february 2019 to september 2020 exclusion criteria: * pregnancy, * body mass index \>35, * inability to provide informed consent, * american society of anesthesiologists physical status classification score of iv * recommended postoperative icu care

Keywords: ultrasounds diaphragmatic function thoracic surgery regional anesthesia