Kornimate/medical-research-clean huggingface dataset:
comparison of noses and conventional laparoscopic surgery in colorectal cancer

Conditions: Colorectal Cancer

Summary: radical surgery for rectal cancer has evolved from the initial concept of total mesorctal excision (tme) to the wide application of laparoscopic surgery in the radical treatment of rectal cancer. after 30 years' rapid development, nowdays laparoscopic tme surgery for rectal cancer has become the first choice for those patients with rectal cancer. however, the auxiliary incision of the abdominal wall which is used to remove tumor specimens is contrary to the current concept of minimally invasive surgery. avoiding abdominal wall incisions has become a common appeal of gastrointestinal surgeons and patients with rectal cancer. natural orififice specimen extraction surgery (noses) can solve the problem of abdominal wall auxiliary incision, which complete rectal cancer radical resection and gastrointestinal reconstruction under the full laparoscopic. the specimens are taken out through the natural orifice (rectum or vagina) without an auxiliary incision, which is more in line with minimally invasive practice and easier to operate. researching on the progress of laparoscopic radical resection of rectal cancer in noses aims to provide a certain reference for this operation.


Eligibility criteria:
inclusion criteria: * the inclusion criteria were as follows: (1) patients aged between 18 and 80 years; (2) histopathology confirmed as colorectal adenocarcinoma; (3) preoperative imaging (ct and mr) assessments showed that colorectal cancer did not penetrate the serosa (≤t3); (4) tumor circumference \<5 cm; (5) enhanced chest and abdominal pelvic ct scans before operation excluded liver metastasis, lung metastasis, and other distant organ metastases. exclusion criteria: * the preoperative exclusion criteria were as follows: (1) tumors could be resected by endoscopic submucosal dissection (esd) and endoscopic mucosal resection (emr); (2) body mass index (bmi) \> 30 kg/m2; (3) patients with severe perforation, bleeding, or obstruction requiring emergency surgery; (4) recurrent cases; (5) patients undergoing neoadjuvant therapy or preoperative radiotherapy; (6) anesthesiologists (asa) score ≥ iv; (7) active period of infection; (8) blood neutrophils \<3 × 109/l.

Keywords: minimally invasive surgery natural orififice specimen radical resectiong of rectal cancer laparoscopic surgery
pathological response after neoadjuvant treatment on nsclc

Conditions: Stage IIIA Non-small Cell Lung Cancer

Summary: this is a non-interventional, observational, multicenter and retrospective study. being limited to the collection of patient data already filled in the tumor thoracic registry data base and the data from stage iiia clinical trials case report forms.

this is a non-interventional, observational, multicenter and retrospective study that will not under any circumstances interfere in the physician's normal clinical practice. being limited to the collection of patient data already filled in the tumor thoracic registry (ttr) data base and the data from stage iiia clinical trials case report forms, it does not entail any diagnostic or therapeutic procedure outside of normal clinical practice. the primary objective is to assess pathological response after neoadjuvant treatment as a subrogate endpoint for overall survival and disease-free survival in resectable stage iiia non-small cell lung cancer patients. it is estimated that around 15-20 spanish sites are enrolling patients with these characteristics in the ttr or in the stage iiia clinical trials of the fundación gecp. pathologists and physician's of these sites will be invited to participate in the planet study as all cases will be clinical-pathologically re-evaluated to reach the study objectives. each pathologist will re-evaluate the specimens from the selected patients under common criteria.the sample size would be 150 patients enrolled in the study.

Eligibility criteria:
inclusion criteria: * patients with resectable stage iiia disease (according to american joint committee on cancer \[ajcc\] lung cancer edition 7 or 8) who were included in the tumor thoracic registry data base and in stage iiia clinical trials which the sponsor is fundación gecp. * patients with histologically n2 involvement confirmed * patients diagnosed as stage iiia from 2010 and 2017 * patients who have received neoadjuvant platinum-based treatment and surgery * age ≥ 18 years at time of study entry * pet /tc at diagnosis exclusion criteria: * patients who received chemoradiotherapy neoadjuvant treatment * patients who were not resected after neoadjuvant treatment * patients who were diagnosed after june 2017

Keywords: neoadjuvant treatment observational study resectable iiia patients non small cell lung cancer pathological response
a pilot study of ciprofloxacin plus gemcitabine and nab-paclitaxel chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma.

Conditions: Metastatic Pancreatic Ductal Adenocarcinoma

Summary: this is a single-center, pilot study evaluating the addition of ciprofloxacin (study drug) to standard-of-care gemcitabine and nab-paclitaxel chemotherapy in treatment-naïve metastatic pdac patients. patients who are recommended gemcitabine and nab-paclitaxel chemotherapy as a standard-of-care by their treating physician will be offered to participate in this study.

oral ciprofloxacin (study drug) will be administered twice a day throughout each 28-day cycle of gemcitabine and nab-paclitaxel chemotherapy. the patient will start taking ciprofloxacin from the evening of day 1 of chemotherapy and end on the morning of day 29 of each cycle. ciprofloxacin tablets should be taken in the morning and evening at about the same time each day. swallow the tablet whole. do not split, crush or chew the tablet. ciprofloxacin can be taken with or without food with each study visit, the physician will prescribe 1-month supply of oral ciprofloxacin to be taken home and self-administered by the patient. the physician will have to indicate "pancreatic cancer microbiome study" on the remarks column for each cycle oral ciprofloxacin is ordered.

Eligibility criteria:
inclusion criteria: * signed informed consent. written informed consent must be obtained prior to performing any study-related procedures. * age ≥ 21 years * histologically or cytologically confirmed, treatment-naïve, locally advanced or metastatic pancreatic adenocarcinoma planned to commence on gemcitabine and nab-paclitaxel chemotherapy. * patient must have measurable disease as defined by the response evaluation criteria in solid tumors version 1.1 (recist v 1.1 guidelines) * life expectancy \>3 months * eastern cooperative oncology group (ecog) performance status of 0-2 * crcl ≥ 30 ml/min exclusion criteria: * known hypersensitivity or allergy to ciprofloxacin or other quinolones * on tizanidine or theophylline and unable to stop these medication * known qtc prolongation (qtc \>500 msec) or torsade de pointes * presence of clostridium difficile-associated diarrhea or colitis * known history of myasthenia gravis * known g6pd deficiency

Keywords: ciprofloxacin gemcitabine nab-paclitaxel chemotherapy
impact of sofosbuvir and daclatasvir concentration on hcv rna

Conditions: Hepatitis C

Summary: sofosbuvir plus daclatasvir with or without ribavirin is one of the currently recommended treatment option for chronic hepatitis c. the objectives were to identify factors associated with sofosbuvir/daclatasvir plasma concentrations variations and to evaluate their impact on viral kinetics.


Eligibility criteria:
inclusion criteria: * patients with hepatitis c virus infection treated with sofosbuvir/daclatasvir * patients with at least one measurement of sofosbuvir or daclatasvir plasma concentration * follow-up of at least 3 months after the end of treatment exclusion criteria: * patients with severe renal failure (estimated glomerular filtration rate (egfr)\<30ml/min/1.73m2) * patients with liver transplantation during therapy

Keywords: cirrhosis direct acting antiviral agents hepatitis c pharmacological monitoring
safety and efficacy of mesenchymal precursor cells in diabetic nephropathy

Conditions: Diabetic Nephropathy; Type 2 Diabetes

Summary: the study investigates the safety, tolerability and efficacy of a single intravenous infusion of two doses of mesenchymal precursor cells versus placebo in subjects with diabetic nephropathy and type 2 diabetes.

this study is taking place in melbourne, australia.

Eligibility criteria:
inclusion criteria: * men and women who are ≥ 50 and ≤ 85 years old * subjects diagnosed with type 2 diabetes at least 2 years prior to screening * subjects with diabetic nephropathy and ckd stage 3b-4 * albumin-to-creatinine ratio (acr) from a spot urine sample \>30 and \< 3000 mg/g at screening * subjects must be receiving standard of care treatment for their diabetic nephropathy with an angiotensin converting enzyme inhibitor (acei) and/or an angiotensin ii receptor blocker (arb) for at least 12 weeks prior to screening. * hba1c \< 10.0% at screening exclusion criteria: * prior participation in any stem cell study * women of childbearing potential * potentially unreliable subjects and those judged by the investigator to be unsuitable for the study * history of active substance abuse (including alcohol) within the past 2 years. current alcohol abuse is defined as daily consumption of \>3 alcoholic beverages (i.e. \> 21 alcoholic beverages per week) * body weight \>150 kg * subjects with non-diabetic renal disease e.g. known polycystic kidney disease * subjects with a history of a renal transplant or who have had prior dialysis within 3 months of screening and/or have not maintained a stable level of kidney function within 3 months of screening * current or history within 6 months of screening of nyha class iii or iv heart failure * myocardial infarction or stroke within 6 months prior to screening * any concurrent medical condition/disorder or clinically symptomatic cardiovascular, gastrointestinal, hematological, pulmonary, acute or chronic infectious disease, active retinal disease or other disorder which in the investigator's opinion would interfere with the subjects ability to complete the trial, would require administration of treatment that could affect the interpretation of the efficacy and safety variables or would preclude safe involvement in the study

Keywords: diabetic nephropathy chronic kidney disease metabolic disease diabetes mellitus, type 2
efficacy, safety, tolerability and actual use study of bococizumab and an autoinjector (pre-filled pen) in subjects with hyperlipidemia or dyslipidemia

Conditions: Hyperlipidemia

Summary: this study is a multicenter, randomized study in subjects with high cholesterol receiving statins to assess the efficacy to lower ldl-c, the safety, tolerability and actual use of bococizumab and an autoinjector (pre-filled pen).


Eligibility criteria:
inclusion criteria: * treated with a statin - fasting ldl-c \>=70mg/dl and triglycerides \<=400mg/dl exclusion criteria: * pregnant or breastfeeding females - cardiovascular or cerebrovascular event or procedures during the past 90 days - congestive heart failure nyha class iv - poorly controlled hypertension

Keywords: mixed dyslipidemia
the 90% effective dose of nalbuphine in mechanical ventilated patients in the icu

Conditions: Pain

Summary: the aim of this study is to determine the effective nalbuphine dose in 90% of intubated patients in the icu, including the continuous infusion dose and a bolus dose during moving to the lateral decubitus position. pain will assessed using a behavioural pain scale (bps) requiring a score of 3-4.

the continuous nalbuphine infusion dose starts at 100ug/kg/h, if the bps scores reaches 3-4, the continuous infusion dose would be decreased by 20 ug/kg/h for next patients. if not, increased by 20 ug/kg/h. the nalbuphine bolus is injected 5 min before turning the patients and the dose (starting at 0) is increased by 0.05 mg/kg, prior to each subsequent turn to lateral decubitus until a bps score of 3-4 is obtained.

Eligibility criteria:
inclusion criteria: * mechanical invasive ventilation * sedated only with nalbuphine exclusion criteria: * pregnant or breast-feeding woman * age below 18 or over 80 years * an indication for deep sedation (e.g.the initial stage of septic shock, acute brain injury or acute respiratory distress syndrome) * renal dialysis * the inability to assess pain by the bps scale (e.g. paralysis) * bmi less than 18 or more than 35 * preadmission use of opioid analgesic for chronic pain * severe hepatic failure * state of consciousness with impossibility to use self-assessment scale; monoamine oxidase inhibitors

Keywords: mechanical ventilation nalbuphine
binge eating self-help for teens online pilot and feasibility study

Conditions: Binge Eating; Binge-Eating Disorder; Overweight or Obesity

Summary: this study is a pilot clinical trial of a new guided self-help cbt for binge eating. participants will complete an intake assessment; following determination of eligibility, participants will then complete four months of treatment (weekly guided self-help sessions). at the end of treatment, participants will complete an interview with a research clinician to assess outcomes.


Eligibility criteria:
inclusion criteria: to be included, adolescents must: 1. be in the age range ≥12 years old and ≤17 years old; 2. have a bmi that places them above the 85th percentile based on their age and sex; 3. report 2 episodes of binge/loc eating (feeling a loss of control while eating) per month for the past 3 months; 4. be otherwise-healthy youth (i.e., no uncontrolled or serious medical conditions); 5. read, comprehend, and write english at a sufficient level to complete study-related materials; 6. provide a signed and dated written assent prior to study participation; 7. provide a signed and dated written consent from one parent prior to study participant; and 8. be available for participation in the study for 4 months. exclusion criteria: prospective participants will be excluded if the adolescent: 1. has a medical or psychiatric condition that would require hospitalization or intensive care (e.g., neurological disorder, psychotic disorders, suicidality); 2. has a medical or psychiatric condition that would prohibit them from engaging in behavioral treatment or moderate physical activity (e.g., cardiovascular problems); 3. has uncontrolled medical condition(s) (e.g., uncontrolled diabetes or hypertension); 4. is pregnant or breastfeeding; 5. is taking medication(s) or participating in treatment(s) that could influence weight or appetite; 6. began taking hormonal contraceptives less than 3 months prior; 7. has a developmental or cognitive disorder (e.g., autism spectrum disorder); 8. has a concurrent feeding/eating disorder (e.g., bulimia nervosa); or 9. is participating in another clinical research study.
molecular and hormonal responses to diet-induced insulin resistance

Conditions: Healthy

Summary: this study determined the effect of 7 days of high-fat overfeeding on whole-body glycaemic control, glucose kinetics, skeletal muscle insulin signalling, and markers of skeletal muscle microvascular function in 15 healthy young individuals.

fifteen healthy, young individuals underwent metabolic testing before and after 7 days of high-fat overfeeding. we determined whole-body glycaemic control, glucose kinetics, skeletal muscle insulin signalling, and markers of skeletal muscle microvascular function. stable isotope tracers were used to assess the rate of appearance of glucose from the gut, liver glucose output and whole-body glucose disposal. insulin signalling was determined by western blotting of skeletal muscle tissue. microvascular function was assessed through the use of quantitative immunofluorescence microscopy. these measurements were performed both postabsorptively and following the ingestion of 50 grams of glucose + 15 grams of protein.

Eligibility criteria:
inclusion criteria: * aged between 18 and 40 years * physically active * non-smoker * not taking any medication known to interfere with the study * no history of cardiovascular disease or diabetes * weight stable for the last 6 months exclusion criteria: * outside of age range * sedentary * smoker * taking medication known to interfere with the study * history of cardiovascular disease or diabetes * unstable weight within last 6 months

Keywords: high-fat diet insulin glucose muscle enos isotopes
six months efficacy and safety of aliskiren therapy on top of standard therapy, on morbidity and mortality in patients with acute decompensated heart failure

Conditions: Acute Decompensated Heart Failure; Congestive Heart Failure

Summary: this study evaluated the effect of early initiation of aliskiren therapy, compared to standard therapy, in the reduction of cardiovascular death and heart failure re-hospitalization events within 6 months, in congestive heart failure (chf) patients hospitalized for an episode of acute decompensated heart failure.


Eligibility criteria:
inclusion criteria: * patient hospitalized with a primary diagnosis of worsening heart failure ≥ 18 years of age, male or female. * patients with a diagnosis of acute heart failure expressed by symptoms (dyspnea or fatigability - nyha class iii-iv) and signs of fluid overload (i.e., jugular venous distension, edema or positive rales auscultation or pulmonary congestion on chest x-ray) at the time of hospitalization. * lvef \< 40% (measured within the last 6 months). * hospitalization for adhf and remain "stabilized" for at least 6 hours (defined as sbp ≥ 110 mm hg after acute decompensated episode) and did not receive iv vasodilators (other than nitrates) and/or iv inotropic drugs at anytime from adhf presentation to time of randomization. * elevated bnp at visit 1 or at randomization (bnp ≥ 400 pg/ml). * patients with a history of chronic heart failure on standard therapy defined as requiring hf treatment for at least 30 days before the current hospitalization (nyha class ii - iv). exclusion criteria: * patients that required any use of iv vasodilators (except nitrates), and/or any iv inotropic therapy from the time of presentation for worsening hf to randomization. * concomitant use of acei and arb at randomization. * right heart failure due to pulmonary disease. * diagnosis of postpartum cardiomyopathy. * myocardial infarction or cardiac surgery, including percutaneous transluminal coronary angioplasty (ptca), within past 3 months. * patients with a history of heart transplant or who are on a transplant list. * unstable angina or coronary artery disease likely to require coronary artery bypass graft (cabg) or ptca before randomization. other protocol-defined inclusion/exclusion criteria applied.

Keywords: elevated bnp reduced lvef acute heart failure cardiovascular death chf hospitalization morbi-mortality trial outcome study endpoint driven plasma renin activity renin angiotensin aldosterone system direct renin inhibitors bnp kccq egfr
sense (subcutaneous and epidural neuromodulation system evaluation) study

Conditions: Failed Back Surgery Syndrome; Post-Laminectomy Syndrome; Low Back Pain

Summary: the purpose of the study is to demonstrate safety and efficacy of spinal cord stimulation with peripheral nerve field stimulation for the treatment of chronic low back and leg pain.


Eligibility criteria:
key inclusion criteria: * subject is 22 years of age or older * subject has chronic low back and leg pain secondary to failed back surgery syndrome (fbss) * subject has an average score of 6 or higher for average daily overall pain on the numerical rating scale (nrs) based on the 7 day pain diary * subject has attempted "best" medical therapy and has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different classes * subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation * subject agrees not to add or increase pain-related medication throughout the 12 week randomized evaluation phase of the study (starting at activation) key exclusion criteria: * subject currently participating in a clinical investigation that includes an active treatment arm * subject has been implanted with a previous neuromodulation system (pnfs, scs-pnfs or scs) or participated in a trial for a neuromodulation system * subject's overall beck depression inventory ii score is \> 24 or has a score of 3 on question 9 relating to suicidal thoughts or wishes at the baseline visit * subject with an infusion pump or any implantable neurostimulator device * subject has an existing medical condition that is likely to require repetitive mri evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor) * subject has an existing medical condition that is likely to require the use of diathermy in the future * subject has peripheral vascular disease * subject is immunocompromised * subject has documented history of allergic response to titanium or silicone * subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection * female candidates of child bearing potential that are pregnant (confirmed by positive pregnancy test)

Keywords: low back pain failed back surgery syndrome post-laminectomy syndrome spinal cord stimulation peripheral nerve field stimulation pain
implementing circulating tumor dna analysis at initial diagnosis to improve management of advanced nsclc patients

Conditions: Non Small Cell Lung Cancer; Advanced Solid Tumor

Summary: multicenter prospective cohort study aiming to evaluate the detection rate of egfr gene mutation in patients with advanced nsclc in a real-word clinical setting, based on liquid biopsy and tissue analyses.

this a multicenter prospective cohort study. this study will be proposed to newly diagnosed advanced nsclc patients. for included patients, archived paraffin embedded tumor tissue will be used for sequencing ; and blood sample will be collected for research purpose (plasma dna collection and sequencing). both tissue and liquid biopsy samples will follow usual processes and will be sent to the molecular pathology laboratory of the investigation center.

Eligibility criteria:
inclusion criteria: 1. male or female patients aged ≥ 18 years at time of proposal study, 2. histologically confirmed non-small cell lung carcinoma, 3. no previous treatment for nsclc, 4. indication to egfr status determination following has recommendation, 5. voluntary signed and dated written informed consent prior to any study specific procedure 6. patients with a social security in compliance with the french law. exclusion criteria: 1. treatment for advanced nsclc started before liquid biopsy sampling. 2. involvement in the planning and/or conduct of the study (applies to both investigator staff and/or staff at the study site).

Keywords: non-small cell lung cancer egfr detection liquid biopsy