Kornimate/medical-research-clean huggingface dataset:
telemetric arrhythmia and syncope diagnosis - evaluation of arrhythmia treatment efficacy

Conditions: Atrial Fibrillation; Arrhythmias, Cardiac

Summary: the purpose of this study is to assess efficacy of prolonged full disclosure ecg monitoring and signal analysis using advanced gsm telemetric technology to prescribe the most appropriate treatment of arrhythmia.

non-invasive methods enabling long-term ecg monitoring in patients with paroxysmal symptoms, such as tachycardia or palpitations increase the probability of detecting infrequent but dangerous events with profound clinical significance. patients with recommendation for the first catheter ablation of paroxysmal atrial fibrillation in the reference center will be included in the study. eligible patients will have 14-day telemetric ecg monitoring. based on detected arrhythmia events, patient's medical history and available documentation the most appropriate treatment will be recommended. patients will undergo invasive procedures of ablation or pacemaker implantation or can be treated pharmacologically. after the invasive treatment or initiation of pharmacotherapy the 14-day telemetric ecg monitoring will be repeated to assess efficacy of the treatment. patients with no record of arrhythmia requiring treatment during the first 14 days ecg monitoring will terminate participation in the study. the referring physician will be informed. further diagnosis or treatment should be performed at the referring physician's center according to the best clinical practice.

Eligibility criteria:
inclusion criteria: * age - between 18 and 80 years old * physician recommendation for ablation treatment of arrhythmia * patient informed consent * declarative and feasible compliance (patient understands basic instructions regarding device use) exclusion criteria: * inability to comply with the study protocol * lack of patient cooperation

Keywords: ablation, cardiac arrhythmia, atrial fibrillation, telemonitoring, telemetry
efficacy and safety of vildagliptin in combination with pioglitazone in drug naive patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. the purpose of this study is to assess the safety and effectiveness of the combination of vildagliptin, an unapproved drug, and pioglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.


Eligibility criteria:
inclusion criteria: * not previously treated with oral antidiabetic agents as defined by the protocol * blood glucose criteria must be met * body mass index (bmi) in the range 22-45 exclusion criteria: * pregnancy or lactation * type 1 diabetes * evidence of serious diabetic complications * evidence of serious cardiovascular complications * laboratory value abnormalities as defined by the protocol * known sensitivity to pioglitazone * other protocol-defined exclusion criteria may apply

Keywords: type 2 diabetes vildagliptin
buccal plate expansion technique versus guided bone regeneration technique in socket preservation in the aesthetic zone.

Conditions: Bone Resorption After Tooth Extraction

Summary: introduction and evaluation of a new technique for socket preservation involving internal expansion of the buccal plate of the extraction socket using internal flapless corticotomy and bone grafting the extraction socket with application of bioresorbable membrane biomaterials in comparison with the conventional guided bone regeneration technique for a conventional socket preservation method hoping to maintain or improve hard and soft tissue contour of the alveolar ridge post tooth extraction.


Eligibility criteria:
inclusion criteria: * patients requiring tooth extraction in the maxillary anterior teeth and premolars ranging to the second premolar. * cause of tooth extraction is due to caries, trauma or failed endodontic treatment. * only teeth with intact buccal bone plate will be considered for this study. * patients who are cooperative, motivated and hygiene conscious. * patients whose age is \>18 years exclusion criteria: * systemic conditions/disease that contraindicated surgery. * patients on drugs that may compromise bone healing. * radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery. * smokers. * patients with psychologic disorder. * pregnancy or lactation. * presence of acute periodontal or periapical pathology.
evaluation of the extraction-site, - midline incision vs off-midline incision-

Conditions: Colon Cancer

Summary: the purpose of this study is to evaluate the midline extraction incision in patients with colon cancer. a prospective randomized controlled trial is conducted to compare midline extraction incision with off-midline extraction incision.

laparoscopic colon surgery is less invasive and more cosmetic than open surgery. but the extraction-site incision is 4 to 5 cm, and it is the largest and most painful incision in laparoscopic colon surgery. the purpose of this study is to evaluate the midline extraction incision in patients with colon cancer. a prospective randomized controlled trial is conducted to compare midline extraction incision with off-midline extraction incision. the investigators hypothesize that the use of the midline extraction incision in laparoscopic colon surgery will result in more cosmetic effect and better quality of life compared to the off-midline extraction incision.

Eligibility criteria:
inclusion criteria: * tumor size is less than 5cm * no history of laparotomy * no bowel obstruction by tumor exclusion criteria: * patients who can't respond to medical question * patients who receive steroids or insulin therapy * uncontrolled dm * severe respiratory failure(hot)
evaluating the effect of nutritional supplementation on growth of short and lean adolescents boys

Conditions: Growth Problem; Low Weight; Short Stature

Summary: study design: double blind, randomized, placebo controlled study. participants will be randomly assigned either to the intervention group or the placebo control group. randomization for the two study groups will be made in a ratio of 1:1. the primary objective of the study is to assess the effect of 6-12 months treatment with nutritional supplementation standardized formula, in short and lean boys adolescents on weight standard deviation score (sds) and height sds the secondary objectives of the study are to assess the effect of 6-12 months treatment with nutritional supplementation standardized formula, in short and lean boys adolescents on bmi sds, growth velocity, time to puberty, quality of life and self-esteem the study will continue for 6 months of intervention versus active placebo, with additional optional 6 months (an extension period), in which participants at both groups, the intervention and the placebo, will be offered to continue their participation in the study with the study supplement. all analyses of the effect's on primary and secondary outcome measurements will take into account the consumption rate of the study formula/placebo


Eligibility criteria:
inclusion criteria: * boys aged ≥10years old * prepubertal - tanner stage 1 (gonadarche) (testicular volume\<4) * height and weight ≤ 10th percentile for age and gender. * height-sds ≥ -2.5 sds * bmi-sds\>-3 sds * low proportion between weight and height * signing inform consent forms exclusion criteria: * diagnosis of growth hormone (gh) deficiency or treatment with gh * any known chronic disease or dysmorphic syndrome including: bone diseases, organic brain diseases, neurological disease, past or current malignancy, chronic cardiac, renal or pulmonary problems * any known gastrointestinal disease including malabsorption * any known organic reason for growth retardation
allosure guided immuno-optimization for covid-19: an early experience

Conditions: Solid Organ Transplant Rejection; COVID-19

Summary: the utilization of allosure to help guide immunosuppression management in solid organ transplant recipients diagnosed with covid-19

an observational case series of patients with solid organ transplants who have been admitted with suspected covid-19 utilizing allosure dd-cf dna to help guide immunosuppression management balancing the treatment of sepsis and avoiding allograft rejection.

Eligibility criteria:
inclusion criteria: * liver, heart, lung or kidney organ transplant recipient with a suspected or confirmed diagnosis of covid-19 exclusion criteria:
canadian study of the microvention flow re-direction (fred) endoluminal device stent system in the treatment of intracranial aneurysms

Conditions: Intracranial Aneurysms

Summary: the study objective is to evaluate the safety and effectiveness of the microvention fred system when used in the treatment of wide-necked intracranial aneurysms.


Eligibility criteria:
inclusion criteria: * subject whose age is ≥ 18 years; * subject has a single target aneurysm located in the following zones: * zone 1 - petrous through cavernous of the ica * zone 2 - ophthalmic segment of the ica * zone 3-posterior circulation, basilar artery (not including the basilar bifurcation), vertebral artery * subjects with a single target intracranial aneurysm located along the internal carotid artery, or the vertebral or basilar artery for whom existing endovascular options (coiling, stent-assisted-coiling) could be ineffective or because aneurysm is predisposed to recurrence due to having any of the following characteristics: * aneurysms with a neck \> 4mm, dome to neck ratio ≤2 or no discernible neck * fusiform aneurysms of any size requiring treatment; * the parent artery must have a diameter of 2.5 - 5.0mm distal/proximal to the target intracranial aneurysm (ia); * subject fulfills study requirements, and the subject or his/her legally authorized representative provides a signed informed consent form; * negative pregnancy test in a female subject who has had menses in the last 24 months; * subject is willing to return for the 1-month and 6-month follow-up evaluations exclusion criteria: * subject who is pregnant or breastfeeding; subject who suffers from a subarachnoid hemorrhage in the last 60 days; * subject who suffers from any intracranial hemorrhage in the last 30 days; * subject currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region; * subject with stenosis of the parent artery (\>50%) proximal to the target aneurysm; * subject with known platelet dysfunction or a contraindication to or inability to tolerate anticoagulants/antiplatelet agents; * subject with contraindications or severe allergies to anticoagulants or antiplatelet medications (aspirin, heparin, ticlopidine, clopidogrel, prasugrel or ticagrelor); * subject with known hypersensitivity to metal, such as nickel-titanium and metal jewelry * subject with documented contrast allergy, or other condition, that prohibits imaging. * evidence of active bacterial infection at the time of treatment; * subject who has had a previous intracranial stenting procedure associated with the target aneurysm; * subject with life-threatening diseases.
czech pharmaco-epidemiological study on disease modifying drugs

Conditions: Multiple Sclerosis

Summary: multiple sclerosis (ms) is a severe autoimmune disease that affects mainly young individuals. it is estimated that there are 17-20,000 affected persons in the czech republic. currently, ms remains an incurable but treatable disease. as of now, there are many drugs that are able to reduce the inflammatory part of the disease that prevails in its initial phases. the problem is the great variability of the severity of clinical course (from relatively benign to severe malignant courses) and different responses of particular patients to particular drugs. a personalized approach with long life monitoring and adjustment of treatment according to the activity of the disease is essential. from this point of view registries represent one of the most important source of long term data that is used for evaluation of effectiveness and safety of different drugs in areal life setting. the objective of this study is to compare effectiveness and safety profile in ms patients treated with a different disease modifying drugs (dmds) and ocrelizumab using data from the real clinical practice from the czech national multiple sclerosis patient registry (remus).


Eligibility criteria:
inclusion criteria: * each participant must provide informed consent to registry remus in accordance with local regulations * the patient is treated by any kind of dmds * confirmed diagnosis of multiple sclerosis exclusion criteria: * patient withdrawal of informed consent to registry remus
infrared bioeffect system for the treatment of cutaneous warts

Conditions: Cutaneous Warts; Human Papilloma Virus

Summary: local hyperthermia at 44℃ can promote some alterations of immulogical indicators. the procedure is convenient in clinic, has high tolerance with less trauma and less pain. based on domestic and abroad clinical practice, the investigators observed initially that local hyperthermia brought great benefits to cutaneous warts. in comparison with liquid nitrogen, the safety and efficacy of controllable infrared bioeffect system to treat skin disease has been evaluated. this proved it could be used in treatment of skin warts, and clinical trial met the requirements of standards for quality control of clinical trials on medical devices, and can be used in product registration and declaration.

mild local hyperthermia with a certain temperature range has been successfully used in the treatment of some diseases. it has been utilised in the treatment of some neoplasm, fungal and hpv infections. investigators' study found that local hyperthermia at 44°c could cleared hpv in more than half of the patients with plantar warts. investigators also note the fact that in patients with multiple lesions, the clearance of the target lesion is commonly followed by clearance of other distant lesions, a phenomenon suggesting that local hyperthermia could aid in establishing a specific immune response to eliminate hpv.so the purpose of the study is to evaluate the safety and efficacy of controllable infrared bioeffect system to treat cutaneous warts. this trial was designed into two groups, one was experimental group (thermal therapy group), the other one was control group (liquid nitrogen cryotherapy group). the ratio of participants was 1:1 in experiment group and control group. the main evaluation indicator was the recovery rate after 4 months of initial treatment.

Eligibility criteria:
inclusion criteria : 18-70 years old signed informed consent clinical diagnosed hpv induced cutaneous warts no local or systemic therapy within 3 months effective contraception for 6 months after signed informed consent exclusion criteria: hbsag(+), hcv-ab(+), hiv-ab(+) skin lesions associated with other infections pregnant or breast-feeding woman unsuitable to be treated by liquid nitrogen cryotherapy scar diathesis

Keywords: hyperthermia human papilloma virus cutaneous warts
safety and tolerability of pro-155 ophthalmic solution 0.09% in healthy volunteers.

Conditions: Inflammation; Cataract

Summary: study to evaluate the safety and tolerability of pro-155 ophthalmic solution 0.09 % in healthy volunteers.

a phase i, open label and unicentric clinical trial to evaluate the safety and tolerability of pro-155 ophthalmic solution 0.09 % in healthy volunteers.

Eligibility criteria:
inclusion criteria: * healthy male and female. * age ≥ 18 years old at screening visit exclusion criteria: * any ocular or systemic condition. * patient with one blind eye. * visual acuity of 20/40 in any eye. * use of ocular or systemic medications. * contraindications or sensitivity to any component of the study treatments. * contact lens users. * ocular surgery within the past 3 months.. * women who were not using an effective means of contraception or who were pregnant or nursing. * participation in any studies of investigational drugs within 90 days previous to the inclusion.

Keywords: pro-155 ocular nsaids safety and tolerability ocular inflammation ocular paint
roadmap for succeeding in bundled payment for orthopedic joint replacements

Conditions: Osteoarthritis

Summary: the objective of the study is to provide a road map that can help organizational leaders understand how to sequence their financial and human capital investments related to bundled payment arrangements. although specific strategies will vary between organizations, providing evidence from a health system with extension experience bundling care for orthopedic joint replacements can be instructive for other providers entering new building arrangements. insights from the experience of the health system can help other organizations prioritize effort and focus energy around strategies that increase the likelihood of succeeding under comprehensive care for joint replacement (cjr) and other bundled payment contracts.

this study will analyze data from a health system with the longest standing experience with bundled payments for orthopedic procedures. the goal of this work is to provide insights from this health system's six years of experience and offer a road map that other organizations around the country can use as they plan and implement their own bundled payment programs. the investigators will conduct a retrospective analysis on quality and cost data from a health system with extensive experience with bundled payments for orthopedic joint replacements. the study design will consist of three parts: first, the team will report trends in quality and cost outcomes over time using descriptive statistics; second, the team will perform multi-variable regression analyses on the data to identify significant predictors of different quality and cost outcomes and provide statistical tests on the trends; third, the team will evaluate changes in physician and hospital level variation along the outcomes.

Eligibility criteria:
inclusion criteria: * participants in this study will be physicians participating in the bundled payment arrangement at the health system in question. all physicians will be included in the analysis. exclusion criteria: * no exclusion criteria

Keywords: bundled payment
defendor: a multicenter prospective observational post-registration study of extimia® (inn: empegfilrastim) to evaluate efficacy and safety in patients with solid tumors

Conditions: Patients With Solid Tumours Who Receive Myelosupressive Therapy

Summary: this study was designed to evaluate the efficacy and safety of extimia® (inn - empegfilgrastim) in reducing the frequency, duration of neutropenia, the incidence of febrile neutropenia and infections caused by febrile neutropenia in patients with solid tumours receiving myelosuppressive therapy


Eligibility criteria:
inclusion criteria: 1. signed informed consent form; 2. histologically verified diagnosis; 3. age between 18 and 80 years; 4. if the patient had previously received chemotherapy for these indications, then it should be completed at least 30 days before the first administration of the study drug; 5. ecog performance 0-2; 6. haematology: * anc ≥ 1,5 х 10(9) /l; * platelets ≥ 100 х 10(9) /l; * hemoglobin ≥ 90 g/l; 7. biochemistry: * creatinine ≤ 1,5 uln; * total bilirubin ≤ 1,5 uln; * ast/alt ≤ 2,5 uln; * alkaline phosphatase ≤ 5 uln; 8. life expectancy of at least 6 months from the date of the first drug administration in the study; 9. ability of the patient to comply with the protocol requirements. exclusion criteria: 1. documented hypersensitivity to empegfilgrastim, filgrastim, pegfilgrastim, and / or their constituent excipients: pegylated drugs, protein recombinant drugs; 2. systemic use of antibiotics less than 72 hours before the first drug administration in the study; 3. concurrent or less than 30 days before the start of the study, radiation therapy (with the exception of point radiation therapy for bone metastases); study; 4. concurrent participation in clinical trials, participation in clinical trials within the previous 30 days, previous participation in this study; 5. surgical treatment less than 21 days (3 weeks) prior to study enrollment; taking any experimental medications less than 30 days before enrollment in this study; 6. history of bone marrow or hematopoietic stem cell transplantation; 7. presence of acute or active chronic infections; 8. other diseases (with the exception of the main one) that could affect the assessment of the severity of the symptoms of the underlying disease: that may mask, enhance, change the symptoms of the underlying disease or cause clinical manifestations and changes in the data of laboratory and instrumental research methods; 9. inability to administer the drug by intravenous infusion or subcutaneous injection.
assessing the effects of robotic pets on patients with dementia in the acute care hospital setting

Conditions: Dementia; Delirium

Summary: robotic pets can provide a source of affection and companionship for patients. this is especially important as individuals with dementia may receive infrequent visitation from family members if their families struggle with how to cope and communicate with their loved one. several options such as the "joy for all™" and "paro" robotic pets offer a source of companionship that is both interactive and comforting. sarasota memorial health care system (smhcs) researchers are seeking to make companion pets available to patients with dementia to provide them with a supplemental enrichment experience that enhances their overall care and lowers their risk for superimposed delirium. the intervention will consist of providing a robotic pet to the patient within 48 hours of admission, which the patient will keep with them throughout their hospital stay and upon discharge. smhcs researchers will evaluate the effects of the robotic pet interaction on patient delirium scores, as measured by the nursing delirium screening scale (nu-desc), length of stay, and the use of intravenous psychotropic medications, code greys, falls occurrence, restraint use, and iv dislodgement in patients with mild-to-moderate dementia. the nu-desc scale is a short assessment tool, estimated to take approximately 3-5 minutes to complete and is already part of standard care at smhcs. this tool is used by nursing staff with minimal additional training and shows consistent sensitivity (85.7%) and specificity (86.8%) in detecting delirium. the nudesc score may be positive in a patient with dementia, since some characteristics of dementia can be similar to delirium. however, patients with dementia are at higher risk for developing delirium, so the nudesc is a helpful tool for the nurse. a score of 2 or higher is considered screening positive for delirium. for this study, the nudesc tool will be used as a guideline to assist in the screening of delirium. the patients will have to score a 4 or less to be included in the study. patients that are scoring \>4 will be excluded. theoretic framework of acceptability (tfa) is a questionnaire which will be used to assess health care provider acceptability of the companion animal. this tool is currently not in use at smhcs, but it will be used as part of this study to assess whether health care providers accept (or reject) the robotic pets as companion animals.


Eligibility criteria:
inclusion criteria: * patients with: * dementia indicated in the patient's chart * admitted to the designated medical-surgical units at sarasota memorial health care system * ages 65 and older * nudesc score will be 0-4 during study enrollment. exclusion criteria: * patients who are: * \<65 years old * nudesc score \>4 during study enrollment * patients at risk for alcohol withdrawal or substance abuse withdrawal * enhanced isolation precautions (c.diff) * presenting with paranoia, hallucinations, or severe agitation

Keywords: dementia memory impairment delirium