Kornimate/medical-research-clean huggingface dataset:
physioflow to detect cardiotoxicity in chemo

Conditions: Chemotherapy, Cancer, Cardiotoxicity, Physioflow

Summary: pulse-eccho will focus on trying to detect cardiotoxicity in cancer patients receiving chemotherapy early on in order to avoid irreversible damage. in addition to that, we will test if the physioflow is non-inferior to the conventional muga scan.

our objective is to compare the physioflow to the muga scan and see if the results are statistically the same using both techniques. this is what is known as a non-inferior study. the advantage of physioflow is that it is non-invasive, fast and it is done at the bedside or while the patient is receiving his or her chemotherapy. the patient will be tested with the muga scan, as per the standard of care, before chemotherapy is initiated and at every 3 months. the patient will also be tested with the physioflow at the same dates of the muga scan. in addition to that, the patients will be tested at each chemotherapy cycle with the physioflow. should the physioflow indicate the patient has a cardiac toxicity as the patient is receiving chemotherapy, the results will be confirmed with the muga scan.

Eligibility criteria:
inclusion criteria: 1. age above 18 years old 2. histologically confirmed diagnosis of cancer 3. ecog 0 to 2 4. provide written consent after the investigational nature, study design, risks and benefits of the study have been explained 5. able to adhere to the study visit schedule and other protocol requirements control group 1. age above 18 years old 2. no previous history of cancer 3. ecog 0 to 2 4. did not receive chemotherapeutic agents (even if outside the context of cancer) 5. provide written consent after the investigational nature, study design, risks and benefits of the study have been explained 6. able to adhere to the study visit schedule and other protocol requirements exclusion criteria: 1. age less than 18 years 2. ecog 3-4 3. suspected or proven severe aortic insufficiency 4. patient under cardiopulmonary bypass assistance (i.e.: left ventricular assisting device) 5. congenital cardiac deformities ,such as septal defects 6. refuse to comply with the specified visit schedules and requirements
return to work and qol following tbi. impact of rehabilitation service.

Conditions: Brain Injuries; Return to Work; Quality of Life

Summary: the proportion of patients who return to work after surviving severe traumatic brain injury (tbi) has been estimated in number of studies but results do not agree.this may be due to complex interaction between many factors, including available rehabilitation services. in denmark rehabilitation services vary been regions and municipalities. hospital based rehabilitation is organized by the regions. rehabilitation outside the hospitals is organized by the municipalities the first purpose of this study is to investigate a possible link between centralized hospital based rehabilitation and better return to work / quality of life. the second purpose is to investigate whether municipality size affects quality of life and return to work after severe tbi. data on return to work are derived from a national register on labor market attachment. data on quality of life are derived from a questionnaire. the study population is identified from the danish head trauma database. the completeness and accuracy of the database will be investigated as the first part of the project.


Eligibility criteria:
inclusion criteria: * age 18-64 exclusion criteria: -

Keywords: brain injuries rehabilitation services return to work quality of life
effects of green tea on level of serum uric acid in healthy individuals

Conditions: Hyperuricemia; Gout

Summary: green tea has been extensively investigated for several potential health benefits. previous studies have suggested that green tea may lower serum uric acid level in human. the purpose of this study is to investigate uric-lowering properties of green tea in healthy individuals.

elevated serum uric acid is related to the risk of development of gout, the most common inflammatory arthritis in men. allopurinol, a xanthine oxidase inhibitor, is one of the uric-lowering agents commonly used in patients suffering from recurrent and chronic gout. nevertheless, its use is limited by adverse effects and serious allergic reaction in some patients. green tea is one of the most frequently consumed beverages, particularly in japan. green tea contains high level of catechins, in which epigallocatechin gallate (egcg) is the most abundant compound among other types of catechins. antioxidant effect contributes to various potential health benefits of green tea. several in-vitro studies have found that green tea inhibits xanthine oxidase activity and subsequently decreases reactive oxygen species (ros) and uric acid production. we therefore would like to investigate the hypouricemic effects of green tea. the study consists of three periods with a total duration of four weeks. the first week is the control period. the following two weeks is the interventional period and the last week is the follow up period. thirty healthy participants will be randomly assigned into three experimental groups, receiving 2 gm/day, 4 gm/day and 6 gm/day (in capsule, two times after meal) of green tea extract during interventional period. blood and urine samples will be taken at the beginning and at the end of each study period.

Eligibility criteria:
inclusion criteria: * age 18 years or older * healthy individuals * normal renal and liver function from blood tests exclusion criteria: * presence of co-morbidity or currently ill * currently using any medication or nutritional supplement product that may affect serum uric acid level * serum creatinine higher than 1.5 mg/dl * abnormal serum aspartate aminotransferase (ast) and/or alanine transaminase (alt) * greater than 15% change in serum uric acid during control period

Keywords: hyperuricemia gout uric acid xanthine oxidase inhibitor green tea catechins antioxidant
fully covered sems versus partially covered sems with anti-migration system for malignant distal biliary obstruction

Conditions: Biliary Tract Neoplasms

Summary: the purpose of this study is to compare the duration of stent patency between partially covered and fully covered sems for palliation of malignant distal bile duct obstruction.

endoscopic stent placement has been used as a principle palliative method in patients with unresectable distal malignancy biliary obstruction. it has been pivotal in providing relief from obstructive jaundice, improving the quality of life, and allowing the maintenance of chemotherapy. although semss have been reported to be superior to plastic stents in terms of stent patency, they still have some debatable issues ; in uncovered sems, stent occlusion due to epithelial hyperplasia and tumor ingrowth through the metal mesh is a frequent problem, whereas covered semss are prone to migration. the aim of the current study is to compare the duration of stent patency between partially covered and fully covered sems as a primary objective, and investigate overall patient survival, stent occlusion rate, and incidence of adverse events including stent dysfunction as secondary objectives.

Eligibility criteria:
inclusion criteria: * 1.\> 19years 2.malignant biliary obstruction, 2 cm distal to hilum 3.unsuitable for curative surgical resection owing to metastasis, locally advanced stage, high operation risk, or patient's refusal exclusion criteria: * 1.history of biliary surgery except cholecystectomy 2.history of sems placement 3.coagulopathy (inr\>1.5, platelet\ 3 months based on karnofsky performance score 5.duodenal stricture
ff/umec/vi inhaler: qualitative analysis and subject preference survey

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: three main classes of inhaled treatment exist for chronic obstructive pulmonary disease (copd): beta2-adrenergic agonists (which may be short (saba) or long (laba) acting), long-acting muscarinic acetylcholine receptor antagonists (lama), and inhaled corticosteroids (ics). for subjects at higher risk of exacerbation, treatment with all these three classes of medication is recommended. this study aims to explore the potential utility of a device called single inhaler triple combination or fluticasone furoate/ umeclidinium/ vilanterol (ff/umec/vi) inhaler containing all three groups of compound. this is a mixed methods study with a qualitative phase and a quantitative discrete choice experiment (dce) phase and will be conducted in four stages: qualitative concept elicitation, dce development, dce piloting and testing, and conduct of the dce. the study will conducted in the united kingdom (uk), united states (us) and germany and approximately 573 subjects with copd will be included.


Eligibility criteria:
inclusion criteria: * diagnosis of copd, self-reported. * age: more than or equal to 40 years. * moderate to severe copd, indicated by a copd assessment test (cat) score of greater than or equal to 10 or modified medical research council (mmrc) score of greater than or equal to 2. * currently prescribed and receiving one of the following treatment types: ics/laba; laba/lama; ics/laba/lama (triple therapy); lama. * currently resident in the uk, us or germany. * adequate written and oral fluency in language of country of residence. * willing and able to understand the study and provide informed consent. * has access to the internet (cognitive interviews and dce survey only). exclusion criteria: * has taken part in any other stage of this study. * subjects with a current diagnosis of asthma. (subjects with a prior history of asthma are eligible if they have a current diagnosis of copd). * any co-morbidity that would inhibit the ability to provide informed consent or allow participation in a telephone of face-to-face interview.

Keywords: triple therapy copd dce qualitative
which physical therapy program is cost-effective in knee osteoarthritis?

Conditions: Osteoarthritis, Knee

Summary: knee osteoarthritis (oa) is a disease with significant levels of socioeconomic burden to the society. p the non-pharmacologic interventions in knee oa include weight loss, exercise, and physical therapy. in this study, we aimed to to compare the cost-effectiveness of inpatient and outpatient physical therapy programs in patients with knee osteoarthritis.

knee osteoarthritis (oa) is a major problem for society with a heavy economic burden. especially in the elderly population, integrated rehabilitation programs are frequently used to improve patients' symptoms and quality of life. to estimate the costs and utility of the rehabilitation programs may help clinicians decide optimal treatment strategy with proper usage of resources. therefore, we aimed to to compare the cost-effectiveness of inpatient and outpatient physical therapy programs in patients with knee osteoarthritis.the study included 52 patients with the diagnose of knee osteoarthritis. patients were divided into two groups. group 1 (n=30) received 21 sessions of inpatient physical therapy program including electrotherapy, superficial- deep heat applications and basic knee exercise program. group 2 (n=22) received the same physical therapy program at outpatient clinic.

Eligibility criteria:
inclusion criteria: -knee oa diagnosed patients based on american college of rheumatology criteria exclusion criteria: * visual disturbances * malignancy * inflammatory rheumatic diseases * pregnancy * advanced cardiovascular, kidney or liver pathologies * uncontrolled hypertension * patients who had injuries in their lower extremities * patients who underwent under total hip or knee prosthetic surgeries.

Keywords: cost-effectiveness knee osteoarthritis physical therapy
the relationship of psychological stress with therapy efficacy and prognosis of gastric cancer

Conditions: Gastric Cancer, Gastroesophageal Junction Cancer

Summary: this is the prospective, observational cohort study (g-distress) to explore the associations of psychological stress with treatment and prognosis of gastric cancer. the participants including the patients diagnosed with gastric cancer who received surgery, chemotherapy and immune checkpoint inhibitors.


Eligibility criteria:
cohort 1 inclusion criteria: 1. lower age limit of research subjects 18 years old and upper age limit of 80 years old, ecog (ecog score standard) performance status of 0 or 1 2. be proven to be primary adenocarcinoma of gastric cancer and staged ii-iii by pathological evidences 3. r0 gastrectomy with d2 lymphadenectomy 4. receiving adjuvant chemotherapy exclusion criteria: 1. history of chemotherapy, radiotherapy, immunotherapy or target therapy 2. multiple primary tumors 3. suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases 4. unavailable for r0 resection and d2 lymph node dissection. 5. patients with stage iv gastric cancer cohort 2 inclusion criteria: 1. lower age limit of research subjects 18 years old and upper age limit of 80 years old, ecog (ecog score standard) performance status of 0 or 1 2. be proven to be primary adenocarcinoma of gastric cancer and staged iii-iv by pathological evidences 3. receiving gastrectomy 4. receiving preoperative chemotherapy exclusion criteria: 1. unavailable for chemotherapy, radiotherapy, immunotherapy or target therapy 2. multiple primary tumors 3. suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases 4. unavailable for gastrectomy cohort 2 inclusion criteria: 1. lower age limit of research subjects 18 years old and upper age limit of 80 years old, ecog (ecog score standard) performance status of 0 or 1 2. be proven to be primary adenocarcinoma of gastric cancer and staged iv by pathological evidences 3. unavailable for gastrectomy 4. presence of at least one measurable lesion according to the response evaluation criteria in solid tumors version 1.1 exclusion criteria: 1. unavailable for chemotherapy, radiotherapy, immunotherapy or target therapy 2. multiple primary tumors 3. suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases

Keywords: gastric cancer stress
anti-inflammatory effects of topical erythromycin and clindamycin in acne patients

Conditions: Acne Vulgaris

Summary: the combined bacteriostatic and immunomodulatory effects of erythromycin and clindamycin will be explored. treatment effects will be extensively characterized by conventional methods including lesion counts, global assessment scales and visual grading as well as state-of-the-art methodology, including multi-modal photo analysis, perfusion by laser speckle contrast imaging, analysis of local skin surface, biopsy biomarkers and skin microbiota. this extensive response profiling, combined with the mechanistic insights from concurrent in vitro and in vivo studies in healthy volunteer challenges, will increase the understanding of erythromycin's and clindamycin's effects in acne vulgaris.


Eligibility criteria:
inclusion criteria: 1. healthy male and female subjects, 18 to 45 years of age. the health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than av following a detailed medical history, a complete physical examination including vital signs, 12-lead ecg, hematology, blood chemistry, virology and urinalysis; 2. mild to moderate inflammatory acne vulgaris on the face, ≥5 inflammatory lesions (papules and/or pustules), present at screening and baseline visit 3. a maximum of 5 nodules present at screening and baseline visit 4. inflammatory acne present for at least 6 months 5. fitzpatrick skin type i-ii (caucasian) 6. able and willing to give written informed consent and to comply with the study restrictions. 7. willing to comply with 2x2mm facial skin punch biopsies exclusion criteria: 1. severe acne where systemic treatment is needed 2. use of any topical (anti-acne) medication (prescription or otc) within 2 weeks prior to baseline 3. use of any oral/systemic treatment for acne, including oral antibiotics, excluding oac, within 4 weeks prior to baseline 4. use of systemic isotretinoin within 6 months prior to baseline 5. history of pathological scar formation (keloid, hypertrophic scar) 6. known hypersensitivity to erythromycin or clindamycin, drugs of the same class, or any of their excipients. 7. known contact dermatitis reaction to any product 8. tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment. 9. participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year. 10. loss or donation of blood over 500 ml within three months (males) or four months (females) prior to screening 11. pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding
curative efficacy of secondary prevention for patients with ischemic stroke through syndrome differentiation of tcm

Conditions: Ischemic Stroke

Summary: the purpose of this study is to assess the efficacy and safety of naoxintong capsule in the secondary prevention of ischemic stroke by the multi-center, randomized,double-blind，placebo-controlled trial design project.

the research employs a random, double-blind, multicenter, placebo parallel and controlled design to observe the clinical effect of naoxintong capsule in the treatment in ischemic stroke of the blood stasis syndrome on the secondary prevention，which is funded by science and technology commission of shanghai municipality.the therapeutic drug of the research is naoxintong capsule on the market for treatment and prevention of stroke, applicable to stroke patients caused by qi deficiency, blood stasis and venation stasis.the research will be carried out in 24 hospitals.it is a total number of 2200 volunteers，who will meet the inclusion criteria other than the exclusion criteria and agree to participate in the research.volunteers will be randomly assigned to the experimental group or the control group. the trial drug for the experimental group is naoxintong capsule, while that for the control group is a kind of placebo capsule.volunteers will be regularly followed up during the experimental period of 2 years. it will be to evaluate the clinical efficacy of naoxintong capsule on the secondary prevention by the stroke recurrence and mortality.

Eligibility criteria:
inclusion criteria: * adult volunteers aged ≤ 90 years old, ≥18 years old； * conforming to the diagnostic criteria of cerebral infarction under the 2010 version of chinese guidelines for treatment of acute ischemic stroke； * conforming to diagnostic criteria of the stasis type of tcm on the ischemic stroke； * the onset of acute cerebral infarction ≥ 10 days； * consciousness awake； * volunteers agree to accept the program and sign informed consent. exclusion criteria: * excluding the patients of the yin deficiency type of ischemic stroke.the diagnostic criteria of yin deficiency type of ischemic stroke is that sudden onset of disease；being signs or symptoms of of neurological deficit；ct or mri examination showing intracranial ischemic lesions；scarlet tongue； * the volunteers with severe heart diseases, cardiac insufficiency, hepatosis, renal insufficiency, respiratory failure, malignant tumour, alimentary tract hemorrhage, etc. who may fail to complete the two-year follow-up； * psychiatric patients； * pregnants and lactating women； * volunteers in other clinical trials； * volunteers who are not suitable for this clinical trial according to the researchers for other reasons.

Keywords: ischemic stroke；naoxintong capsule
efficacy and safety study of endoscopic submucosal dissection for early gastric cancer

Conditions: Endoscopic Submucosal Dissection; Early Gastric Cancer; Multi-center, Single-arm Clinical Trial; Historical Control Group; Quality of Life and Cost Analysis

Summary: the purpose of this study is to evaluate the safety and clinical effectiveness of esd(endoscopic submucosal dissection) for early gastric cancer analyzing short-term and long-term results of endoscopic treatment.

traditionally open-gastrectomy is the standard treatment for gastric cancer without distant metastasis, but high mortality and morbidity, the intense weight loss, food intake difficulties after surgery are fraught, including problems with the drawback of significantly degrading the quality of life. therefore, a lot of effort to seek the more simple treatment than open gastrectomy has been made, recently the endoscopic treatment for early gastric cancer is the most widely used treatment. this single-arm, multi-center study enroll early gastric cancer patients after esd compared with the retrospective control(surgical treatment) group considering the unreality of the randomized clinical trials. in addition, the quality of life assessment by the eortc c30/sto22 tools before and after esd procedure in enrolled patients will be performed and the direct cost analysis also will be conducted.

Eligibility criteria:
1. esd group inclusion criteria: * korean people aged \>=20 years * endoscopic grossly the lesion diameter ≤ 3cm * endoscopic biopsy results: well-differentiated and moderately differentiated adenocarcinoma * no ulcers in lesions * endoscopic biopsy results: in case of gastric cancer, no metastasis in ct test performed before esd procedure exclusion criteria: * subject with history of malignant disease in other organs * subject with history of stomach surgery due to peptic ulceration etc. * as the cases of an absolute contraindication of general anesthesia; subject with chronic liver disease over child score b, subject with chronic renal disease requiring hemodialysis or peritoneal dialysis, subject with heart failure more than ⅲ score according to new york heart association classification, subject with severe systemic diseases such as respiratory disease * subject with bleeding tendency * pregnant woman or woman with possibility of pregnancy * subject who cann't be obtained informed consent * subject who is unable to follow up for any other reason 2. surgery group(retrospective data collection) inclusion criteria: * subject with gastric laparoscopy or open-surgery for treatment early gastric cancer during 2002.1.1 \~2004. 12. 31 * korean people aged \>=20 years * early gastric cancer confirmed by pathology during gastric surgery; gastric cancer confirmed to the mucosal or submucosal regardless of lymph node metastasis * no history of malignant disease in other organs * no history of stomach surgery due to peptic ulceration etc.