Kornimate/medical-research-clean huggingface dataset:
induction chemotherapy for locally recurrent rectal cancer

Conditions: Recurrent Rectal Cancer

Summary: this is a multicentre, open-label, parallel arms, phase iiii study that randomises patients with locally recurrent rectal cancer in a 1:1 ratio to receive either induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm)


Eligibility criteria:
inclusion criteria: * 18 years or older * confirmed locally recurrent rectal cancer after total or partial mesorectal resection for rectal or distal sigmoidal cancer either by histopathology ór clinically proven (evidence on imaging in combination with clinical findings, with consensus in mdt) * resectable disease determined by magnetic resonance imaging (mri) or deemed resectable after neoadjuvant treatment with chemoradiotherapy. * who performance score 0-1 * written informed consent exclusion criteria: * radiological evidence of metastatic disease (e.g. liver, lung) at time of randomisation or in the six months prior to randomisation. * known homozygous dpd deficiency * any chemotherapy in the past 6 months. * any contraindication for the planned chemotherapy, as determined by the medical oncologist. * radiotherapy in the past 6 months for primary rectal cancer. * any contraindication for the planned chemoradiotherapy, as determined by the medical oncologist and/or radiation oncologist. * any contraindication for surgery, as determined by the surgeon and/or anaesthesiologist. * concurrent malignancies that interfere with the planned study treatment or the prognosis of resected lrrc.

Keywords: locally recurrent rectal cancer neoadjuvant therapy induction chemotherapy resection margin
prince of wales hospital structural heart registry

Conditions: Structural Heart Abnormality

Summary: structural heart disease refers to a group of cardiac defects other than coronary artery disease. structural heart intervention is a rapidly growing field in cardiology. in the past decade, there has been paradigm shift in the management of structural heart disease from conventional open-heart surgery to transcatheter interventions. with increasing evidence supporting structural heart interventions including transcatheter aortic valve implantation or transcatheter edge to edge repair, there has important updates in recent guidelines in treating structural heart disease. besides, new device innovations bloomed over the past few years and had expanded the possible treatment options for high surgical risk patients. some breakthrough devices had been approved recently by the us food and drug administration and some other devices are occasionally used on compassionate ground. however, there has been lack of data in structural heart interventions in asia pacific regions outside japan \[8\]. in this study, we would like to analyze the epidemiological trends, patient characteristics, procedural outcomes and clinical outcomes of structural heart interventions, and compare them with historical cohorts, matched cohort receiving medical therapy and matched cohort receiving open heart surgeries.


Eligibility criteria:
inclusion criteria: * all patients undergoing structural heart interventions at the prince of wales hospital exclusion criteria: * patients that are not able to consent.
a pilot study testing salicylic acid peels versus glycolic acid peels for the treatment of melasma

Conditions: Melanosis

Summary: the purpose of this study is to find out the safety and effectiveness of glycolic acid chemical peels compared to salicylic acid chemical peels for the treatment of melasma.

participants in this study will be patients who are clinically diagnosed with at least a 2 x 2 cm patch of melasma on each side of their face (forehead or cheek). one half of the subject's face will be randomly selected to receive 4 treatments of 30% glycolic acid peels and the other half of the face will receive 4 treatments of 30% salicylic acid peels/ weeks 0, 4, 8, and 12. follow up visit will be at week 16. this study is a pilot study designed to determine feasibility of these procedures.

Eligibility criteria:
inclusion criteria: 1. subjects aged 18 years or older 2. subjects with at least a 2 x 2 cm patch of melasma on each side of the face (forehead or cheek) 3. subjects in general good health 4. subjects must be willing and able to understand and provide informed consent for the use of their tissue and communicate with the investigator 5. subjects must be willing to not apply other treatment options for melasma during the course of the study exclusion criteria: 1. subjects under 18 years of age 2. subjects who are pregnant and/or lactating 3. subjects who are unable to understand the protocol or to give informed consent 4. subjects diagnosed with mental illness 5. subjects who have concurrent active uncontrolled disease to facial area (i.e uncontrolled acne) 6. subjects who have had a chemical peel in the past 3 months 7. subjects who have used a prescribed retinoid in the past 3 months 8. subjects with a bleeding disorder 9. subjects with a history of abnormal wound healing 10. subjects with a history of abnormal scarring
pharmacokinetics and pharmacodynamics of apixaban in subjects on hemodialysis

Conditions: End Stage Renal Disease

Summary: the purpose of this study is to assess the pharmacokinetics of a single oral dose of 5 mg apixaban in subjects with normal renal function and subjects with end stage renal disease (esrd) maintained with hemodialysis.

primary purpose : to provide a clear understanding of the pharmacokinetics of apixaban in subjects with esrd and to determine the effect of hemodialysis on apixaban pharmacokinetics .

Eligibility criteria:
inclusion criteria: * the signed informed consent form. * subjects with normal renal function classified based on calculated creatinine clearance (clcr) determined by the cockcroft-gault calculation. * eligible subjects with esrd that is maintained with chronic and stable hemodialysis. exclusion criteria: * any history of abnormal bleeding or coagulation disorders including those in a first degree relative under 50 years of age. * history of significant head injury within the last two years. * any gastrointestinal surgery that could impact the absorption of study drug. * not expected to continue the hemodialysis treatment for the duration of the study. * inr, pt, or aptt above the upper limit of normal, unless agreed upon between the investigator and bms medical monitor. * history of allergy to apixaban or factor xa inhibitors.

Keywords: pharmacokinetic nos
efficacy and safety of inhaled insulin compared to metformin and glimepiride in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe, asia, north america and south america. the aim of this research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin combination therapy in treatment of subjects with type 2 diabetes and to verify the safety of use (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).

the decision to discontinue the development of aerx® is not due to any safety concerns. an analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * treated with oads for more than or equal to 3 months * hba1c greater than or equal to 8.0% and less than or equal to 11.0% * body mass index (bmi) less than or equal to 40.0 kg/m2 exclusion criteria: * recurrent major hypoglycaemia * current smoking or smoking within the last 6 months * impaired hepatic or renal function * cardiac problems * uncontrolled hypertension * proliferative retinopathy or maculopathy
lifestyle patterns and glycemic control

Conditions: Pre-diabetes

Summary: the goal of the proposed study is to evaluate the feasibility and initial efficacy of stabilizing lifestyle behaviors to improve glucose control and body composition in patients with pre-diabetes. the investigator proposes that following stable lifestyle behaviors will improve patients' glucose control, body composition, and liver fat. the results from this study has the potential to impact clinical practice and patient care.

variability in lifestyle behaviors has been associated with adverse health, specifically poor glucose control. the project proposes to test whether reducing this variability improves glycemia in patients with pre-diabetes. if successful, this simple positive lifestyle message to keep stable behaviors has the potential to improve the health of millions of adults worldwide. this project will enroll participants with pre-diabetes who have erratic lifestyle behaviors and randomize them to either maintain their usual habits (control group) or stabilize their behaviors (stability group). both groups will be followed for 12 weeks. before the start of the 12-week period, all participants will track their sleep for 2 weeks and will wear a glucose monitor to measure their glucose levels. at the start and end of the 12-week period, they will come to the research lab to undergo a glucose tolerance test. this test will measure how their body reacts to a glucose load. they will also undergo magnetic resonance imaging and spectroscopy scanning. this scan will provide information on body composition and liver fat content.

Eligibility criteria:
inclusion criteria: * pre-diabetic kg/m2 (hemoglobin a1c 5.7-6.9%) * 25 years or older * bmi between 25-39.9 kg/m2 * sleep duration ≥6 hours a night assessed with wrist actigraphy (for 14 nights) * variable bedtime, sd≥45 minutes. exclusion criteria: * chronic kidney disease (gfr\<60) * uncontrolled hypertension (≥160/100 mmhg) * obstructive sleep apnea * psychiatric or neurological disorder * prevalent cardiovascular disease * dyslipidemia (triglycerides≥200 mg/dl) * medications that affect insulin sensitivity, glucose concentrations, and body weight * non-day or rotating shift workers * travel across time zones * active participation in weight loss program or within past 3 months * current or past alcohol/drug abuse
er2 frailty levels and incident adverse health events in older community dwellers

Conditions: Frailty; Emergencies; Aging

Summary: older adults' health and functional status are heterogeneous because of the various cumulative effects of chronic diseases and physiologic decline, contributing to a vicious cycle of increased frailty 1-4. thanks to advances in medicine and hygiene, a growing number of older adults spend more years with a greater range of chronic diseases causing disability but not mortality 5. health systems need to face this new challenge 4,5. quantification of frailty and its association with the occurrence of incident adverse health events (i.e., functional decline, unplanned hospitalizations) is crucial to understand how health systems may efficiently respond to this situation 6. this study aims to examine the association of the er2 tool score and its stratification in three levels for incident adverse health events in older community dwellers and to compare this association with three validity frailty indexes which are the cardiovascular health study (chs) frailty index, study of osteoporotic fracture (sof) index and rockwood frailty index.


Eligibility criteria:
inclusion criteria: * all enrolled participants of nuage study who agreed to be part of the nuage database and biobank for future research purposes exclusion criteria: * missing data * participants' refusal to use their data for a purpose not identified during their recruitment.
validation of the gated blood pool spect: erna vs 3d echo

Conditions: Congestive Heart Failure; Ventricular Function, Left

Summary: this research study is designed to evaluate the accuracy of the techniques that are used to analyze heart function. the main purpose of this study is to analyze and compare three different methods of assessment of regional and overall heart function.

the purpose of the present study is to establish the reproducibility and to validate gated blood pool spect imaging with application of attenuation correction (acgbs) in evaluation of left ventricular regional and global function and volumes, by direct comparison with equilibrium radionuclide angiocardiography (erna) and 3-dimensional echo (3de).

Eligibility criteria:
inclusion criteria: * all patients scheduled for routine clinically requested erna study for ejection fraction measurement at the yale university cardiovascular nuclear imaging laboratory are eligible to be enrolled in the study. exclusion criteria: * unstable medical condition preventing additional imaging. * weight greater than 300lbs, prohibiting imaging on the spect/ct imaging system. * patients with intracardiac shunts, emphysema or previously demonstrated allergies to octafluoropropane (the gas in the microbubbles), will not receive intravenous contrast during 3 de image acquisition.
therapeutic exploratory phase 2 study to evaluate the safety and efficacy of mb12066 in patients with nonalcoholic fatty liver disease(nafld) except cirrhosis

Conditions: Nonalcoholic Fatty Liver Disease

Summary: this is a controlled study to determine the effectiveness and safety of mb12066 in the treatment of adult patients with nonalcoholic fatty liver disease(nafld) except cirrhosis.


Eligibility criteria:
inclusion criteria: * nafld activity score(nas) ≥ 3 (biopsy-proven) exclusion criteria: * alcohol consumption \> 20g/day * type 1 diabetes or poorly controlled diabetes mellitus (hba1c ≥ 9%) * evidence of other chronic liver disease (e.g. hbsag positive, anti-hcv positive, autoimmune hepatitis, wilson's disease, alpha-1 antitrypsin deficiency and etc.) * alt, ast \> 5x the upper limit of normal * serum creatinine ≥ 2mg/dl * fibrosis score ≥ 3 according to the nash crn fibrosis staging system * nqo1 t/t type * weight loss of more than 5kg within 6 months * bariatric surgery within 6 months * known alcohol or any other drug abuse in the last five years * insulin sensitizers, hepatoprotective agents, anti-oxidants, lipid-lowering agents, drugs induced fatty liver within 1 month
radioimmunoimaging of light chain (al) amyloidosis

Conditions: AL Amyloidosis

Summary: the purpose of the study is to determine the capability of a radiolabeled amyloid-reactive monoclonal antibody (mab) to document the presence and distribution of amyloid deposits by pet/ct imaging in patients with al amyloidosis.

to be eligible for this study, patients must have a confirmed diagnosis of al amyloidosis without significant cardiac (new york heart association class iv) disease and not be on kidney dialysis. additionally, after testing, their blood must not contain antibodies to mouse proteins. the study requires an intravenous infusion, given over 10 minutes, of the radiolabeled antibody, followed 48 hours later by a pet/ct scan. a repeat scan is done 5 days after infusion of the antibody. a 5-ml blood specimen needs to be furnished 4 and 8 weeks after the antibody infusion.

Eligibility criteria:
inclusion criteria: * patients with a confirmed diagnosis of al amyloidosis. exclusion criteria: * new york heart association class iv * on renal dialysis * serum antibodies to mouse protein

Keywords: radioimmunoimaging al amyloidosis pet/ct
endoclot for preventing rebleeding after endoscopic mucosal resection (emr)

Conditions: Endoscopic Hemostasis; Colonic Polyps

Summary: endoscopic mucosal resection (emr) has been widely used as a diagnostic and treatment techniques of gastrointestinal small lesions. postoperative rebleeding is one of the common complication following emr. several endoscopic hemostasis methods are currently in use. endoclot® absorbable polysaccharide hemostat (paph) as a new hemostasis material was previously used for surgical hemostasis, but the therapeutic effect and safety in endoscopic application remains unknown. this study has been designed to observe the effect of rebleeding prevention after emr.


Eligibility criteria:
inclusion criteria: * consecutive cases of colorectal polyps and submucosal lesions with anticipated complete removal endoscopically by emr. exclusion criteria: * severe cardiovascular diseases, liver and kidney dysfunction; * platelet and coagulation dysfunction (plt \ 2); * cases that have taken anticoagulant drugs or non-steroidal anti-inflammatory drugs within 1 month before the procedure; * cases unavailable for follow-up.

Keywords: endoscopic hemostasis endoclot absorbable polysaccharide hemostat colonic polyps
clinical efficacy of soft tissue trimmer in cases of gingival hyperplasia.

Conditions: Pain, Postoperative; Wound Heal; Gingival Hyperplasia

Summary: postoperative pain and wound healing are compared after using conventional scalpel technique in comparison with the intervention which is using soft tissue trimmer for cases of gingival hyperplasia.

in the control group: 1. following the local anaesthetic administration, a reverse bevel gingivectomy will be performed with a #15c scalpel. 2. the borderline of gingiva will be determined via the use of a pointer dental tweezers, and excessive gingival tissue will then be removed with gracey curettes 3. no periodontal packs to be applied to ensure accurate evaluations of follow-up pain and wound healing in the intervention group: 1. following the local anaesthetics administration for the soft tissue trimmer(stt) gingivectomies, soft tissue trimmer will be used with 400-rpm rotary systems and with no serum irrigation, per the manufacturer's recommendation. 2. gingivoplasties will be performed with the same soft tissue trimmer to easily provide a knife-edge appearance. 3. no periodontal packs will be applied to ensure accurate evaluations of follow-up pain and wound healing.

Eligibility criteria:
inclusion criteria: * anterior region (minimum of four teeth at each surgical site) * age range (18-45) years old * plaque-induced inflammatory gingival enlargement * altered passive eruption * no clinical attachment loss * systemically healthy individuals exclusion criteria: * gingival enlargement due to any systemic predisposing factors * pregnancy and/or lactation * allergy * conditions requiring antibiotic prophylaxis and anti-inflammatory medications. * acute or untreated periodontitis * systemic disease that could influence the outcome of the treatment (i.e. diabetes)
spinal cord injury exercise and nutrition conceptual engagement

Conditions: Spinal Cord Injuries; Metabolic Syndrome; Dietary Modification; Paraplegia; Tetraplegia

Summary: evaluate and compare the health benefits of an at home exercise program using functional electrical stimulation (fes) for lower extremity exercise with diet versus a diet alone group in adults with spinal cord injury.

the purpose of this proposal is to evaluate and compare the health benefits of home-based functional electrical stimulation leg cycle ergometry plus diet (hbfeslce + diet) to home-based (hb) diet alone. this is a randomized, baseline-controlled, prospective, interventional trial to assess the impact of a 16-week exercise and/or diet intervention on selected fitness parameters in adults with high sci. primary outcome measures will include body composition by idxa, insulin sensitivity, glucose effectiveness and bmr, while secondary outcomes will include lower extremity bmc and density, lipid profiles, and hscrp determined before and after the 16-week interventions. subjects will be randomly assigned to either hbfes lce + diet on an rt300 ergometer or home-based (hb) diet alone intervention. both groups will be routinely monitored via telemedicine while at home.

Eligibility criteria:
inclusion criteria: * adults 18-65 years of age (inclusive) * sex: male or female * women of child-bearing potential who agree to refrain from getting pregnant during the trial * c4-t4 motor complete (ais a\&b) spinal cord injury for duration greater than 12 months * \<5% change in body weight over the past 12 months exclusion criteria: * \<22% body fat * unresponsive to neurostimulation * those who have participated in an fes or ace exercise program (\>60 minutes/week) within the past 3 months * known orthopaedic limitations * coronary artery disease * type 1 diabetes mellitus, insulin-requiring type 2 or untreated diabetes mellitus (fasting glucose\>126 or hgba1c\>7.0) * uncompensated hypothyroidism (stable on medication \>1 year or not on medication) * renal disease * uncontrolled autonomic dysreflexia, recent (within 3 months) * deep vein thrombosis * pressure ulcers \> grade ii * decisional impairment * any potential causes of autonomic dysreflexia at the discretion of the pi * prisoners * pregnant or nursing women

Keywords: functional electrical stimulation exercise body composition
discharge education and telephone counseling in pediatric cardiac surgery patients

Conditions: Cardiovascular Diseases; Anxiety; Stress; Quality of Life; Counselling

Summary: it was aimed to evaluate the effect of discharge education and telephone counselling applied to parents of 0-6 years old pediatric cardiac surgery patients on postoperative patient outcomes, quality of life, anxiety, and stress levels of parents.

h0: discharge education and telephone counselling applied to parents of paediatric cardiac surgery patients has no effect on postoperative patient outcomes (weight gain, tachypnoea/cyanosis/chest pain, increase in activity, complication status), parents' anxiety, stress and quality of life. h1: discharge education and telephone counselling applied to parents of paediatric cardiac surgery patients have an effect on postoperative patient outcomes (weight gain, tachypnoea/cyanosis/chest pain, increase in activity, complication status), parents' anxiety, stress and quality of life. data collection: after the child and his family are informed about the study, their written informed consent will be obtained. according to the randomisation scheme, patients will be divided into experimental and control groups by stratified randomisation method. the parents of the patients in the study group will get pre-discharge education. the clinic's routine will continue for the children in the control group, and they won't receive any training. the researcher will conduct a telephone consultation to assess the outcomes of the patients in both groups, as well as the parents' quality of life, anxiety, and stress levels.

Eligibility criteria:
inclusion criteria: * the child's age ranges from 0 to 6 years old. * possessing congenital heart disease * planning for pediatric heart surgery * receiving inpatient care; * receiving a recent diagnosis and beginning therapy * the parent willingly consents to participate in the study; * there isn't another child in the family who has chd. * getting the parent's consent on paper exclusion criteria: * suffering from another illness * the child is nearing the end of their life. * the child and family have expressed a lack of willingness to engage in the study. * illiteracy of the parents * the child and family do not know turkish

Keywords: pediatric surgery telephone counselling discharge stress quality of life