Kornimate/medical-research-clean huggingface dataset:
adjuvant chemotherapy after preoperative chemoradiotherapy to treat rectal cancer

Conditions: Rectal Cancer

Summary: the purpose of this study is to evaluate the disease-free survival in patients with locally advanced rectal cancer treated with preoperative chemoradiotherapy with fluoropyrimidines and surgery followed by adjuvant combination chemotherapy with oxaliplatin/5-fu/leucovorin vs 5-fu/leucovorin.

preoperative chemoradiotherapy with fluoropyrimidines followed by surgery is one of the standard treatments for patients with locally advanced rectal cancer; however, the role of adjuvant chemotherapy is still controversial. the aim of this study is to investigate the efficacy of adjuvant folfox for rectal cancer who underwent fluoropyrimidine based chemoradiotherapy and complete total mesorectal excision.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed adenocarcinoma of the rectum 2. patients who treated with preoperative chemoradiation with fluoropyrimidines followed by curative surgery without microscopic residual tumor. 3. ajcc/uicc pathologic stages of ypt3-4 or ypn+ 4. curative surgery not less than 3 and not more than 8 weeks prior to randomization 5. no prior chemotherapy, radiotherapy and immunotherapy except preoperative chemoradiation for rectal cancer 6. ecog ps 0-1 7. adequate organ function 8. informed consent exclusion criteria: 1. macroscopic or microscopic evidence of remaining tumor 2. any histologic feature other than adenocarcinoma or arisen from chronic inflammatory bowel disease 3. more than 8 weeks after curative surgery

Keywords: rectal cancer adjuvant chemotherapy folfox
a safety, tolerability, and efficacy study of vc-02™ combination product in subjects with type 1 diabetes mellitus and hypoglycemia unawareness

Conditions: Type 1 Diabetes Mellitus With Hypoglycemia

Summary: vc02-101 will evaluate an experimental cell replacement therapy intended to provide a functional cure to subjects with type 1 diabetes and hypoglycemia unawareness.

the purpose of this trial is to test if vc-02™ combination product can be implanted subcutaneously in subjects with type 1 diabetes and hypoglycemia unawareness and maintained safely for up to two years. it will also test if vc-02 is an effective treatment for these subjects.

Eligibility criteria:
inclusion criteria: * men and non-pregnant women * diagnosis of t1dm for a minimum of five (5) years * hypoglycemia unawareness or significant glycemic lability * stable diabetic treatment * willingness to use a continuous glucose meter * acceptable candidate for implantation exclusion criteria: * history of islet cell, kidney, and/or pancreas transplant. * six (6) or more severe, unexplained hypoglycemic events within six (6) months of enrollment * uncontrolled or untreated thyroid disease or adrenal insufficiency * diabetic complications such as severe kidney disease or renal dysfunction, proliferative retinopathy, diabetic foot ulcers, amputations attributable to diabetes, and/or severe peripheral neuropathy * non-compliance with current anti-diabetic regimen * detectable stimulated serum c-peptide during screening period assessment.
scapular dyskinesis with impingement syndrome

Conditions: Scapular Dyskinesis; Impingement Syndrome, Shoulder

Summary: the goal of this study is to diagnose scapular dyskinesis-which can appear as a cause or result of various shoulder disorders-through screening tests in patients with shoulder impingement syndrome, the most common shoulder condition. by identifying scapular dyskinesis, the study aims to maximize treatment outcomes through appropriate rehabilitative exercise therapy.


Eligibility criteria:
1. inclusion criteria patients diagnosed with unilateral shoulder impingement syndrome in the outpatient clinic (based on clinical symptoms and mri) from the irb approval date until march 1, 2027 individuals who provided written informed consent after receiving a thorough explanation of the study prior to any procedures age 20 years or older 2. exclusion criteria individuals who did not receive a subacromial steroid injection for shoulder impingement syndrome individuals with a history of surgical treatment or fracture in the affected shoulder individuals who refused to participate in the study individuals with neurological disorders affecting the ipsilateral upper extremity
exercise intervention for employees of the university of bern

Conditions: Neck Pain; Musculoskeletal Diseases; Occupational Health; Efficiency; Exercise Therapy; Work Performance; Presenteeism

Summary: as part of a swiss national science foundation snsf project (on-site multi-component intervention to improve productivity and reduce the economic and personal burden of neck pain in swiss office-workers, nexpro = neck exercises for productivity, snsf no. 32003b_182389, basec no. 2019-01678), the investigators first developed a physiotherapeutic exercise intervention to improve the strength and mobility of the neck muscles. in the snsf project nexpro, the intervention took place on-site in the office. however, in view of the digital transformation, it is important to adapt the intervention delivery method to the new virtual work setting. the aims of the present project are therefore to implement, further develop and contextually adapt the exercise intervention in order to reduce musculoskeletal complaints and to reduce health-related presenteeism. the final product is a user-friendly virtual 6-week short exercise intervention that employees of the university of bern can use independently, regardless of time and place. the effectiveness of the newly developed short exercise intervention (pain reduction, reduction of presenteeism) will be assessed during a short pilot phase.


Eligibility criteria:
inclusion criteria: * employees of the faculty of human sciences of the university of bern who * suffer from neck pain or would like to prevent neck pain * are between 18 and 65 years of age * understand german (written and oral) * have a predominantly sedentary job * have given written consent to participate in the study. note: neither gender, age, education nor group affiliation play a role. the investigators particularly welcome participation from mid-level employees. if students are willing to participate, they may also do so, but this group will not be actively recruited. exclusion criteria: * existing severe neck pain grade iv (neck trauma, neck injury, specific pathologies (e.g. congenital cervical anomalies, stenosis, radiculopathy), inflammatory conditions (e.g. rheumatoid arthritis), history of cervical surgery) * if physical activity is contraindicated by the doctor for any reason (e.g. due to unresolved hypertension).
circulating p3np and cardiovascular events in hemodialysis patients

Conditions: Cardiovascular Events; Cardiac Fibrosis

Summary: this study evaluates whether circulating levels of aminoterminal propeptide of type iii procollagen (piiinp) can predict the cardiovascular events in hemodialysis patients.

type iii collagen abundantly exists in the cardiovascular system including the aorta and heart. the aminoterminal propeptide of type iii procollagen (piiinp) is an extension peptide of type iii procollagen, which is cleaved off stoichiometrically during conversion from type iii procollagen to type iii collagen and liberated to serum. elevated serum concentrations of piiinp are considered a marker of higher collagen turnover and tissue fibrosis including the heart and vascular system. in this study, the investigators prospectively examined whether serum levels of piiinp could be a biomarker for predicting cardiovascular events in hemodialysis patients.

Eligibility criteria:
inclusion criteria: * end-stage kidney disease patients who had been undergoing maintenance hemodialysis over one year in toujinkai hospital at the point of january 1, 2005 exclusion criteria: * histories of coronary events and/or interventions * congestive heart failure of new york heart association grades iii to iv * moderate or worse valvular heart disease * permanent pacemaker implantation * idiopathic cardiomyopathy * chronic obstructive pulmonary disease * malignancy * acute hepatitis, chronic hepatitis, or liver cirrhosis including carrier of hepatitis virus
personalized medicine in the elderly with vision impairment and mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: globally, approximately 55 million people suffer from dementia, and 60-70% of cases are due to alzheimer's disease (ad). increasing scientific evidence highlights that the pathological changes underlying ad and other forms of dementia begin long before the onset of symptoms. mild cognitive impairment (mci) is a clinical condition that in people over 65 shows a prevalence ranging from 3% to 22%. the characteristics of mci are the presence of a subjective memory disorder and a reduced ability to learn new information with normal general cognitive functioning, normal ability to perform daily activities and the absence of other conditions, such as depression, that could justify the memory disorder. currently, the diagnosis of mci is based exclusively on clinical evaluation, including neuropsychological tests. currently, there are no therapies available to prevent and/or treat dementia and the options for intervention are represented by treatments such as physical exercise and cognitive treatment. these practices refer to the concept of cognitive reserve. computerized cognitive training (cct) is characterized by being a personalized intervention, allows multi-domain training and increases the cognitive processes of patients with mci. the national low vision center has been using a software called nlife eyefitness for several years, certified as a class i medical device. it allows you to carry out individualized rehabilitation exercises at home, using your own pc or tablet, with monitoring by the center's operators. the exercises currently present stimulate attention, short-term visual memory, reaction time, executive function, working memory and, therefore, also appear suitable for stimulating subjects with mci.


Eligibility criteria:
inclusion criteria: * patients aged ≥ 60 years with a diagnosis of amci * signing of informed consent exclusion criteria: * age \<60 years * history of dementia * diabetes mellitus * uncontrolled hypertension * diagnosis of major depression * glaucoma * age-related macular degeneration * media opacity and vitreoretinal pathologies that may preclude a correct evaluation * • failure to obtain informed consent
derris scandens benth extract vs naproxen in knee oa

Conditions: Knee Osteoarthritis

Summary: derris scandens benth (family : leguminosae) is a woody vine growing throughout southeast asia, including thailand. the stem of d.scandens has been widely use in thai traditional medicine, foe example of myalgia. previous study shown that d.scandens benth extract has the anti-inflammatory activity. although nsaids are efficaciously in the treatment of osteoarthritis,but the gi side effect is still concerned. in this study we aim to investigate the efficacy and safety of d. scandens benth extract compared with naproxen for therapy of patients with knee osteoarthritis.


Eligibility criteria:
inclusion criteria: * age \>=50 yr * known case of primary knee osteoarthritis * womac pain subscale (item1) \>= 5 * signed informed consent exclusion criteria: * hypersensitive to nsaids * history of peptic ulcer or melena * unable to walk , i.e. patient with severe spinal stenosis, myocardial infarction * history of intra-articular injection of knee within 3 months * status post knee replacement

Keywords: derris scandens benth extract osteoarthritis womac 6-minute walk
postoperative analgesia y after uniportal video-assisted thoracoscopic surgery

Conditions: Post-operative Pain, Acute; Post-operative Pain; Thoracic Diseases; Post-Op Complication

Summary: ultrasound-guided erector spinae plane block (espb) is an interfascial blockade during thoracic anesthesia, first described by forero in 2016, and is highlighted by technically feasibility and less complication rate. the patient is placed as decubitus position. the anesthesiologists use echo to identify the ipsilateral transverse process at t5 level, and insert the needle to 2-3 cm lateral to the spinous process until contact the transverse process. then the injected local anesthetic will penetrate via erector spinae muscle to paravertebral space to affect and relieve pain.


Eligibility criteria:
inclusion criteria: * adult patients, over 20 years old, u * undergoing elective uniportal vats lobectomy. exclusion criteria: * patient refusal, * body mass index \> 35 kg/m2, * american society of anesthesiologists (asa) grade above 3, * contraindication to nerve block, * allergy to analgesic agents, * regular opioid used for chronic pain prior to this time surgery, * conversion to thoracotomy or vats procedure, * postoperative intubation, * postoperative intensive care unit admission.

Keywords: uniportal video-assisted thoracoscopic surgery ultrasound-guided erector spinae plane block surgical thoracoscopic intercostal nerve block cumulative intravenous morphine consumption visual analogue scale enhanced recovery after surgery
a trial to evaluate natural orifice transvaginal endoscopic cholecystectomy with laparoscopic assistance

Conditions: Gallbladder Disease

Summary: the study will document being able to successfully remove a subject's gallbladder through the vagina (laparoscopic visualization)using a small collection of study surgical tools.


Eligibility criteria:
inclusion criteria women will be enrolled in this study who: 1. are willing to give consent and comply with evaluation and treatment schedule, able to understand and complete study questionnaires; 2. at least 18 years of age; 3. have a clinical diagnosis of gallbladder disease indicated for cholecystectomy; 4. asa classification i or ii (appendix ii); 5. have a negative serum pregnancy test (for women of childbearing potential); and 6. absence, on visual inspection, of adhesions judged to be a potentially complicating factor in transvaginal access and operation. exclusion criteria subjects will be excluded from the study for any of the following: 1. bmi \> 35; 2. use of immunosuppressive medications (within 6 months of surgery; single burst dosages and inhalable steroids are acceptable); 3. suspicion of gallbladder cancer, tumor, polyps, or mass; 4. acute cholecystitis or acute pancreatitis; 5. presence of common bile duct stones; 6. history of cervical or vaginal cancer (or precancerous findings on most recent pap test); 7. pelvic inflammatory disease; 8. evidence of abdominal abscess or mass; 9. diffuse peritonitis; 10. use of anticoagulants or anti-platelet agents (use of daily cardio protective doses of aspirin, up to 81 mg/day, is acceptable and shall not constitute an exclusion criterion) or the presence of coagulopathy; 11. clinical diagnosis of sepsis; 12. history of ectopic pregnancy, pelvic inflammatory disease, or severe endometriosis; 13. history of peritoneal or vaginal trauma; 14. co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or that could impact the scientific integrity of the trial; 15. planned concurrent surgical procedure; 16. prior or planned major surgical procedure within 30 days before or after study procedure; 17. history of transvaginal surgery; 18. history of (or symptomatic for) abdominal adhesions; 19. participation in any other investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints; 20. previously enrolled in the current series of 4 trials investigating the ees notes gen1 toolbox; 21. any contraindication listed in a study device instructions for use (ifu) document (if that device may be used in the study procedure); or 22. any condition which precludes compliance with the study (investigator discretion).

Keywords: gallbladder disease cholecystectomy gallbladder disease indicated for cholecystectomy
trophy pah pivotal study - treatment of pulmonary hypertension for pah pivotal study

Conditions: Pulmonary Arterial Hypertension

Summary: theis is a prospective, multicenter, blinded, randomized sham controlled pivotal clinical trial with a crossover at 6m, to assess the safety and effectiveness of pulmonary artery denervation with the tivus™ system in subjects with pah. the study will assess improved and/or maintained exercise tolerance in patients with pah through the analysis of exercise tolerance, hemodynamic changes, clinical worsening and the quality of life who got treated by the tivus system.


Eligibility criteria:
inclusion criteria: 1. written informed consent to participate in the study obtained from the subject, according to local regulations, prior to initiation of any study mandated procedure. 2. male or female ≥ 18 years of age at the time of screening 3. subject with known pulmonary arterial hypertension (pah), which has been diagnosed as idiopathic pah, connective tissue disease pah, anorexigen induced, familial pah or corrected congenital heart defects more than 1 year prior to enrollment, confirmed by right heart catheterization performed prior to screening and showing all of the following: * mean pulmonary artery pressure (mpap) ≥25 mmhg at rest * pulmonary capillary wedge pressure (pcwp) or left ventricular end diastolic pressure (lvedp) ≤15 mmhg * pulmonary vascular resistance (pvr) at rest \>3 wood units (240 dyne\*s/cm\^5) 4. subject is on maximally tolerated medical therapy for pah, as determined by his pah physician 5. subject is adhering to a stable drug regimen (i.e., with no changes of dose or medication for a minimum of 3 months prior to enrollment) 6. subject is able to tolerate iv contrast used for the angiograms during treatment 7. subject is who functional class ii or iii exclusion criteria: 1. subject is treated with parenteral prostanoids and has not been on a stable dose for at least 3 months 2. subjects with portal-pulmonary hypertension, group 2, 3 and 4 ph 3. pregnant women or women planning a pregnancy within 12 months of study enrolment 4. subject with significant co-morbid conditions which, at the discretion of the pi, are deemed to prohibit study entry 5. subject with life expectancy of less than a year 6. concurrent enrollment in another device or drug trial except for observational studies (unless specifically approved by the sponsor) 7. subject with pulmonary artery anatomy that precludes treatment with the tivus system 8. subject who has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 6 months 9. subject experiencing a current episode of acute decompensated heart failure 10. subject who has cardiac pacemakers/icd/crt-d that were implanted fewer than three months prior to enrollment. 11. subject who has implantable cardiomems device, or other implanted device that might be contraindicated for therapeutic ultrasound energy.
effect of cpap vs control on nocturnal dipping in normotensive patients with obstructive sleep apnea

Conditions: Sleep Apnea, Obstructive

Summary: this is an open-label, parallel, prospective, randomised control trial evaluating the effect of continuous positive airway pressure (cpap), the standard treatment for obstructive sleep apnea (osa) versus control (diet and lifestyle advice) on dipping status and blood pressure parameters in 100 non-dipper normotensive patients with moderate to severe obstructive sleep apnea and without established cardiovascular or metabolic disease.


Eligibility criteria:
inclusion criteria: * newly diagnosed moderate-severe osa (by standard criteria) * absence of known hypertension and antihypertensive medication * office blood pressure \<140/90mmhg * age 18 - 70 years * able to provide written, informed consent exclusion criteria: * pregnancy * previous diagnosis of osa or previous cpap treatment * diagnosis of diabetes mellitus * active treatment for malignancy or severe psychiatric disorder * history of cardiovascular disease or cerebrovascular disease * moderate or severe chronic kidney disease (ckd) defined as a egfr of ≤ 44ml/min/1.73m2 * dipper on abpm * morbid obesity, defined as bmi ≥40 * professional drivers or drivers with a history of road-traffic accident due to sleepiness * severe excessive daytime sleepiness defined as epworth sleepiness scale (ess) \>15

Keywords: continuous positive airway pressure non-dipper normotensive
a study to measure calorie consumption and usage in participants with obesity using ly3437943

Conditions: Obesity

Summary: the main purpose of the study is to look at the effect of the study drug compared to placebo on calorie intake, energy metabolism, and appetite. the study will last up to 6 months and may include up to 20 visits.


Eligibility criteria:
inclusion criteria: * bmi greater than 30 kg/m2 * history of at least 1 self-reported unsuccessful dietary effort to reduce body weight exclusion criteria: * change in body weight of greater than 5 kg (11 pounds) within 3 months prior to start of study * any of the following treatments for obesity within 1 year prior, or plan to undergo any of these during the study period: liposuction, cryolipolysis, or abdominoplasty * prior or planned bariatric or gastric sleeve surgery, endoscopic therapy, or device-based therapy for obesity * type 1 or type 2 diabetes, history of ketoacidosis, or hyperosmolar state * family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 * acute or chronic hepatitis * had within 90 days prior: acute myocardial infarction, cerebrovascular accident (stroke), coronary artery revascularization, hospitalization for unstable angina, or hospitalization due to congestive heart failure * history of active or unstable major depressive disorder or other severe psychiatric disorder within 2 years prior * history of chronic or acute pancreatitis * blood transfusion or severe blood loss within the last 3 months or hemoglobinopathy, hemolytic anemia, sickle cell anemia * clinically significant multiple or severe drug allergies * started treatment with or changed dose within 12 months prior any medications that are associated with significant weight gain * history of substance use disorder

Keywords: food diet
short-term cardiovascular benefits of wearing particulate-filtering respirators

Conditions: Autonomic Nervous System Imbalance; Blood Pressure; Inflammation; Vasoconstriction; Blood Coagulation Disorders

Summary: an intervention study to assess the short-term cardiovascular effects of reducing personal air pollution exposure by wearing particulate filtering respirators.

a group of healthy adult college students fulfilling the recruitment criteria were randomly divided into two sub-groups. one sub-group weared the particulate filtering respirators for 2 continuous days during which the respirator was required to wear as much as possible both indoor and outdoor. the other group acted as normal at the same time. the measurements on health effects including heart rate varibility, blood pressure, circulating biomarkers as well as the ambient air pollution were performed in both groups during the intervention period. after a 3-week rest period,the two groups interchanged their roles of wearing the respirator or not. the same measurements of both health effects indicators and ambient air pollution were repeated.

Eligibility criteria:
inclusion criteria: * equal to or older than 18 years old, * no history of smoking and alcohol addiction. * no chronic diseases,such as hypertension,diabetes,chronic obstructive pulmonary disease or other respiratory/cardiovascular diseases reported by volunteers. * no respiratory or allergic diseases, like asthma, rhinitis,or other allergic diseases. exclusion criteria: * current smokers * chronic drug use due on cardiovascular or respiratory diseases

Keywords: heart rate variability blood pressure circulating biomarkers respirator fine particulate matter