Kornimate/medical-research-clean huggingface dataset:
clinical trial of transtek body fat analyzer (gbf-835-n2 & other 7 models)

Conditions: Weight; Body Fat Disorder

Summary: the clinical protocol of the clinical testing of this device: 1. objective of the test: to verify the functions and efficiency of devices. 2. test methods and procedures: comparison test. 3. device under test (dut): transtek body fat analyzer, model: gbf-835-n2, gbf-835-n2 plus, ls202-b1, ls202-b1 plus, ls206-e1, ls206-e1 plus, gbf-1251-b1, and gbf-1251-b1 plus. 4. comparison device: transtek gbf-1251-b and tanita bc-533. 5. study endpoints: dut and the comparison device are substantial equivalence. 6. statistical methodology used: description of statistical methods.

1. test purpose: the aim of clinical test is to collect bmi, body fat, total body water, muscle mass, bone mass, calorie, and visceral fat reading value which measured by dut and reference device. 2. target subject: the subject database shall contain at least 30 male and 30 female subjects and all above 10 years old. 3. test procedures: 1. record the name, age, gender, and height of each subject. 2. let subject seated calmly for two minutes before test, dry the feet. 3. use device to measure weight, body fat, total body water, bone mass, and muscle mass; record reading value. 4. for each subject, repeat 3) to get 3 pairs measurements. 5. repeat step 1) to 4) for every device (dut: gbf-835-n2, gbf-835-n2 plus, ls202-b1, ls202-b1 plus, ls206-e1, ls206-e1 plus, gbf-1251-b1, and gbf-1251-b1 plus; and reference device: gbf-1251-b and bc-533). 6. repeat step 1) to 5) for each subject. 4. note: 1. no motion and speaking are allowed during the measurement. 2. all dut use the same algorithms and contact the patient at the same body locations (feet), and operate on the same frequency. 3. test environment: temperature: 22±1℃; relative humidity: 40\~70%.

Eligibility criteria:
inclusion criteria: * male, female exclusion criteria: * below 10 years old

Keywords: weight total body water body fat muscle mass bone mass bmi visceral fat calories
primary palliative care for emergency medicine (prim-er)

Conditions: Emergencies

Summary: this proposal builds upon the evaluation of primary palliative care education, training, and technical support for emergency medicine (prim-er) implemented in 33 emergency departments (eds). this is a retrospective cohort study that seeks to measure the effect of prim-er on older adults with serious illness on aspects of: 1) ed disposition to an acute setting; 2) healthcare utilization in the 6 months following the index ed visit; 3) survival following the index ed visit; and 4) determine site, provider, and patient-level characteristics that are associated with variation in impact of prim-er across sites.


Eligibility criteria:
inclusion criteria: * patients must demonstrate one-year mortality of at least 30 percent (score \> 6) according to the gagne index, a validated instrument used to measure all cause one-year mortality in community-dwelling older adults, calculated based on their prior 12 months before the index ed visit of medicare claims. exclusion criteria: * ed patients transferred from a nursing home on the index ed visit will be excluded since prediction of mortality and disposition of such patients differs from community-dwelling adults. * patients currently receiving hospice at the time of the index ed visit will also be excluded since they have already received services.

Keywords: emergency department palliative care
non-invasive treatment for long covid (post covid-19 condition) brain fog

Conditions: Long COVID

Summary: this study aims to assess the effects of both acute and chronic exposures to hypoxia and hypercapnia in patients with long covid syndrome.


Eligibility criteria:
inclusion criteria: * english speaking * diagnosis of long covid exclusion criteria: * any history of: * coronary artery dissection or aortic dissection * neurological disease (e.g. dementia, alzheimer's disease, or other brain-related disease) * cerebrovascular disease or stroke * aneurysm * if currently has: * moderate-severe chronic obstructive pulmonary disease * uncontrolled moderate-severe asthma * moderate-severe bronchiectasis * moderate-severe interstitial lung disease, requiring the use of supplemental oxygen * a necessity to use supplemental oxygen, for any reason * new or worsening symptoms (decompensation) of heart failure * right heart disease due to chronic pulmonary disease/sleep apnea * uncontrolled myocardial ischemia or angina * uncontrolled heart arrhythmias * heart or lung infection (e.g. myocarditis or pericarditis) * left main coronary artery stenosis * moderate-severe aortic stenosis * pulmonary embolism, pulmonary infarction, or other blood clots * severe respiratory disease * chronic kidney disease * chronic liver disease * females of childbearing potential will complete a urine pregnancy test at their baseline visit to rule out pregnancy * bmi \>40 * study staff unable to obtain adequate signal for cerebral blood flow

Keywords: brain fog brain blood flow heart rate variability fatigue
peng and lfcn block versus fic block for multimodal analgesia after total hip replacement surgery: a retrospective analysis

Conditions: Regional Anesthesia Morbidity; Arthropathy of Hip; Hip Arthropathy

Summary: background: optimal pain control with limited muscle weakness is paramount for a swift initiation of physical therapy and ambulation. fascia iliaca compartment block (ficb) has been recommended since it offers the best pain control with low risk of motor block. pericapsular nerve group block (peng) with lateral femoral cutaneous nerve (lfcn) block has been proposed as an effective alternative to ficb that offers similar pain control with a considerably lower risk of motor block. this study aimed to compare the afore mentioned blocks and determine which one yielded the lowest nrs score.

this single-center, retrospective investigation was conducted at asst nord milano bassini hospital. the study was approved by the ethics committee "comitato etico milano area 3". the main outcome of the study was the comparison of postoperative pain at 6, 12 and 24 hours, expressed as nrs (numeric rating scale), between peng and lcfn . secondary outcomes included total opioid consumption expressed as milligrams of morphine equivalents (mme), time to first opioid request, time to first postoperative ambulation.

Eligibility criteria:
inclusion criteria: * elective total hip replacement surgery for non-traumatic hip disease, age \>18 years, complete clinical chart included the type of peripheral nerve block performed, signed consent form for spinal anesthesia and peripheral nerve block. exclusion criteria: * incomplete chart, a peripheral nerve block other than peng or fic block was performed

Keywords: total hip replacement surgery primary hip arthritis
safety and efficacy study of gene therapy drug (neovasculgen) to treat secondary raynaud's phenomenon

Conditions: Secondary Raynaud's Phenomenon

Summary: the purpose of this study is to determine whether pl-vegf165 (neovasculgen) is effective in the treatment of digital ulcers related to secondary raynaud's phenomenon associated with systemic scleroderma

this is a randomized, open, comparing clinical trial assessing the therapeutic efficacy of pl-vegf165 (neovasculgen) in treating scleroderma-associated raynaud's syndrome. each patient of clinical group will undergo several intramuscular injections with a treatment dose of pl-vegf165 (neovasculgen) in hand where digital ulcers locate. in the control group patients will receive only standard of care without gene therapy drug. study participants at the first study visit will complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive capillaroscopy. after this initial assessment, the patients of clinical group will undergo intramuscular injections of pl-vegf165 (neovasculgen) in a hand altered with digital ulcers. patient will report the severity of their raynaud's symptoms weekly over the six month study period. at three month post-injection, the patient will complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive capillaroscopy. at six months post-injection, the patient will again complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive capillaroscopy.

Eligibility criteria:
inclusion criteria: * obtained voluntary informed consent for participation in the clinical study * presence of systemic scleroderma features satisfied to criteria of american college of rheumatology classification * presence at least one active digital ulcer at baseline exclusion criteria: * presence of another systemic connective tissue disease; * absence at least one active digital ulcer at baseline; * smoking within 3 months or smoking cessation using nicotine products; * subjects currently taking sildenafil, tadalafil or vardenafil; * history of sympathectomy over previous 12 months * not able or unwilling to give voluntary informed consent for the study or follow requirements of the clinical study; * decompensated chronic visceral diseases; * clinically significant laboratory abnormalities; * hiv, hbv and hcv antibodies in serum; * alcohol or drug addiction; * participation in other clinical studies (or administration of study products) within 3 months prior the study; * conditions limiting study compliance (dementia, psycho-neurological diseases, drug addiction, alcoholism, etc.); * malignancies including post-surgical period with chemo- and (or) radiation therapy); * vascular malformations; * pregnancy or breastfeeding.

Keywords: gene therapy, plasmid, vegf, systemic scleroderma,secondary raynaud's phenomenon
the survey of treatment and metabolic status of type 1 diabetes mellitus (t1dm).

Conditions: Type1 Diabetes Mellitus

Summary: this study is a multicenter cross-sectional research project, planning to enroll 1000 patients with type 1 diabetes mellitus (t1dm). by reviewing clinical data, physical examinations, questionnaires, continuous glucose monitoring, and subcutaneous fat ultrasound, we aim to understand the current status of treatment and metabolism in chinese t1dm patients and analyze the potential factors that may affect their blood sugar control and metabolic indicators. a cost-effectiveness analysis will be conducted on chinese t1dm patients using continuous glucose monitoring systems to identify the groups that benefit most from these systems.

this study is a multicenter cross-sectional research project, planning to enroll 1000 patients with type 1 diabetes mellitus (t1dm). this study will collect multicenter data on t1dm patients, including sociodemographic information, anthropometric measurements, glycemic indices (glycated hemoglobin, fasting blood glucose, postprandial blood glucose), acute and chronic complications, other important metabolic indicators (blood lipids, vitamin d), insulin treatment methods, blood glucose monitoring status, diabetes education, diet and exercise, social and psychological support, and extra-pancreatic autoimmune diseases. the aims are: 1. to understand the current state of treatment and glycemic metabolism in chinese t1dm patients and to analyze the potential factors that may affect their glycemic indices. 2. to understand the current status of continuous glucose monitoring (cgm) usage in chinese t1dm patients and to analyze the impact of cgm on blood glucose control, acute and chronic complications, and quality of life in t1dm patients. 3. through cost-benefit analysis, to identify potential beneficiary groups for cgm, providing objective evidence for the demand of this technology to healthcare professionals and diabetes patients; to provide effective information for the formulation of medical insurance reimbursement policies for continuous glucose monitoring.

Eligibility criteria:
inclusion criteria: * volunteer to participate and be able to sign informed consent * patients with type 1 diabetes * at least one of the following three clinical characteristics must be met: the disease presents initially with diabetic ketoacidosis (dka) or ketonuria; the presence of islet-related autoantibodies, such as islet cell antibodies, tyrosine phosphatase antibodies, or glutamic acid decarboxylase (gad) antibodies, is detected positively; both fasting and postprandial c-peptide levels are ≤0.6 ng/ml. exclusion criteria: * other types of diabetes. * patients who cannot cooperate with the use of continuous glucose monitoring, clinical data collection, and questionnaire completion.

Keywords: continuous glucose monitoring (cgn) glucose fluctuations
gestational weight gain in primary care

Conditions: Gestational Weight Gain

Summary: excess weight gain in pregnancy is linked to a number of adverse outcomes for mothers and their offspring, and in 2011, 59 % of women in nova scotia gained weight in excess of recommendations. a number of factors influence how much weight a woman gains, including lack of knowledge, age, the number of previous pregnancies she's had, smoking, ethnicity, income, and education. although a clinician's advice also plays a role, simply giving advice does not necessarily translate into patient behaviour change. on the other hand, advice that is given through a patient-centred approach is significantly associated with increased patient acceptance of and adherence to recommendations, and increased intentions and attempts at behaviour change. in addition, this approach has been shown to decrease costs to the health care system. patient-centredness can measured from the perspective of the clinician, an observer, or the patient. research suggests that the patient's perspective of patient-centredness is the perspective most significantly associated with improved health outcomes. clinicians avoid discussing weight-related matters for a number of reasons, including a lack of time and general discomfort in raising the subject. there are some tools that can address some of these barriers, and example being the "5as of obesity management". this tool is based on principles of behaviour change science and patient-centredness. pilot data on the use of this tool showed a two-fold increase in the initiation of weight-related discussions between clinicians and their patients. our team was instrumental in the development, dissemination and initial evaluation of this tool, and dr. piccinini-vallis has recently led a national multidisciplinary endeavor to adapt it to pregnancy, which has resulted in the "5as of healthy pregnancy weight gain" tool. it is now time to evaluate whether the use of this tool is acceptable to clinicians and whether its use translates into any patient outcomes.


Eligibility criteria:
inclusion criteria: * family physicians providing prenatal care * patients who are pregnant exclusion criteria: * multiple pregnancy * abnormal pregnancy * inability to read and inability to speak english

Keywords: pregnancy gestational weight gain primary care guidelines
xist gene deletion in breast cancer therapy

Conditions: Breast Cancer

Summary: very little is known about the role of x-inactive specific transcript rna in human breast cancer and in regulating different response to therapy . the relation between the breast cancer predisposing gene brca1 \& x-inactive specific transcript rna has been investigated but still controversial. loss of x chromosome inactivation (xci) is observed in breast cancer . other studies sheds light on a possible mechanism of breast carcinogenesis mediated by xist misbehaviour.

breast cancer is an important cause of morbidity and mortality in women .genetics of female contributes to her risk of having breast cancer . this disease is still discovered in their late stages due to the negligence of females inspite of self inspection and clinical examination of the breast .the identification of markers that could predict the tumor behavior is important in breast cancer management , staging, evaluation of therapeutic response and development of new therapeutic modalities .xist (x-inactive specific transcript) rna is a long non -coding rna which plays an important role in inactivation of x_ chromosome which act as an example for long non _ coding rna mediated gene regulation .very little is known about the role of xist in human breast cancer and in regulating different response on therapy . the relation between the breast cancer predisposing gene brca1 \& xist has been investigated but still controversial .loss of x chromosome inactivation (xci) is observed in breast . some studies provide evedience that brca1 is involved in xist regulation on the active x chromosome but not its localization .other studies sheds light on a possible mechanism of breast carcinogenesis mediated by xist misbehaviour .

Eligibility criteria:
inclusion criteria: * newly diagnosed patients of breast cancer admitted to south egypt cancer institute at different stages of the disease exclusion criteria: * other malignant diseases. male breast cancer . female with other sex linked diseases . patients received chemotherapy for breast cancer .
liver sbrt in combination with immune checkpoint inhibition in patients with metastatic non-small cell lung cancer

Conditions: Liver Metastases; Non-small Cell Lung Cancer

Summary: determine the feasibility of liver stereotactic body radiation therapy (sbrt) given in combination with systemic therapy (immune checkpoint inhibitors) in adult patients with metastatic nsclc with liver metastases.


Eligibility criteria:
inclusion criteria: * adult patients (≥18 years of age) * histologically or cytologically confirmed nsclc with liver metastases * eligible for immune checkpoint inhibitors per treating medical oncologist * disease must be measurable per recist criteria * ecog performance status of 0 - 2 * adequate organ function per protocol. * allowable prior therapy includes adjuvant durvalumab, prior radiotherapy outside the upper abdomen. * patients must be willing and able to sign an informed consent form. * participants of childbearing potential willing to undergo pregnancy test and use contraception per appendix. exclusion criteria: * liver tumor burden which cannot be targeted with sbrt per treating radiation oncologist * presence of uncontrolled intercurrent illness or significant comorbidities precluding participation in a clinical study as determined by investigator * diagnosis of underlying parenchymal end stage liver disease (cirrhosis) or biliary disease (primary biliary cirrhosis). * other invasive malignancy active within 1 years, excluding in situ cancers * presence of psychiatric or substance abuse disorders that would interfere with compliance or safety * has a known history of active bacillus tuberculosis (tb), hepatitis b or hepatitis c infection * has received a live (active) vaccine within 30 days of enrollment. * active autoimmune disease that has required systemic treatment in the past 1 years aside from hormone replacement therapy (ie. thyroxine, insulin, or physiologic corticosteroid replacement therapy) * baseline corticosteroid use (\>10 mg prednisone daily or equivalent) at study entry * pregnancy or breast feeding
performance and safety of otinova® ear spray

Conditions: Otitis Externa

Summary: the purpose of this study is to assess the performance and safety of otinova® ear spray when used in the treatment of external otitis symptoms.

after being informed about the study and potential risks, all patients giving written informed consent will receive treatment with otinova® ear spray for 7 days, twice daily.

Eligibility criteria:
inclusion criteria: * male or female ≥ 5 years old * clinical diagnosis of otitis externa based on otoscopic exam: a.defined as a clinical score of at least 1, on a scale from 0 to 2 (none, mild/moderate, severe), for at least one of the oe signs (swelling, erythema and otorrhea) * ability to correctly administer otinova as spray (not requiring tamponade), as judged by the investigator * subject agrees to refrain from water immersion of the ears during the investigation * subject agrees to refrain from using other ear treatment products during the investigation * for pediatric patients, provision of informed consent by subject and legal -subject, and if applicable legal representative(s), are willing to comply with the protocol and attend all investigation visits. exclusion criteria: * duration of oe signs/symptoms longer than 6 weeks * suspected perforated eardrum or eardrum fitted with drainage tube * post-mastoid surgery * prior otologic surgery within 6 months of enrollment (must be successfully healed) * conditions which may make it difficult to evaluate the therapeutic response (e.g malignant oe, abscess, granulation, polyps, congenital disorders) * history of malignant tumors in the external ear canal, or currently receiving chemotherapy or radiation therapy * known allergy or sensitivity to any component of the device * use of topical or systemic antibiotics, corticosteroids or other treatment that could affect the study result within 7 days prior to enrolment * pregnancy or lactation at time of enrolment * subjects with any other condition that, as judged by the investigator, may make investigation procedures inappropriate * participation in another clinical investigation within 30 days of screening
cardioversion vs. catheter ablation for persistent atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the aim of this randomized study is to evaluate the efficacy of two different approaches for conversion of persistent atrial fibrillation, the non-invasive one (external electrical cardioversion) and the invasive one (catheter ablation).

this randomized study compares two treatment strategies in patients with persistent atrial fibrillation: cardioversion vs. catheter ablation. cardioversion is a low risk standard treatment option for patients with persistent atrial fibrillation. however, mid- and long term efficacy (regarding the maintenance of sinus rhythm) is low. catheter ablation is an invasive treatment which has been reported to result in up to 60-70% of patients in stable sinus rhythm. however, it is a potentially dangerous invasive procedure with potentially fatal complications. comparison: external cardioversion vs. catheter ablation

Eligibility criteria:
inclusion criteria: * age \>20 years and \<75 years * documented persistent atrial fibrillation for at least 3 months (documented in at least 2 ecgs or holter-ecgs during the previous 3 months before inclusion and persistent atrial fibrillation in a 7-d-holter) * documented sufficient anticoagulation for at least 4 weeks before inclusion exclusion criteria: * paroxysmal atrial fibrillation * nyha iv (if recompensation is not possible) * contraindication for warfarin * disturbance of blood coagulation * myocardial infarction, ptca/stenting, bypass-operation, stroke, intracranial bleeding less than 3 months before * reversible causes of atrial fibrillation (i.e. hyperthyroidism) * pregnancy * la-diameter \> 55mm * lv-function \< 30% ef * aortic or mitral stenosis or regurgitation iii°-iv° * prosthetic valves

Keywords: atrial fibrillation catheter ablation