Kornimate/medical-research-clean huggingface dataset:
paula method of exercises in patients with lars syndrome:randomized controlled trial

Conditions: Low Anterior Resection Syndrome

Summary: sphincter sparing rectal resection surgery, either total mesorectal excision (tme) with a temporary loop ileostomy or partial mesorectal excision (pme), is the mainstay of rectal cancer treatment , however, these treatments are associated with the development of low anterior resection syndrome (lars). this syndrome is characterized by a constellation of symptoms such as fecal frequency, urgency and clustering of bowel movements and can lead to fecal and flatus incontinence. there is no gold standard therapy designed to treat the root cause of the problems associated with lars. paula method of exercises, based on the theory that the body has the natural ability to self-heal and that all sphincter muscles in the body affect one another other and thus, exercising one healthy region can positively impact another. the purpose of this study is to evaluate the usefulness of the paula method of exercises in patients post sphincter sparing rectal resection surgery with lars syndrome.


Eligibility criteria:
inclusion criteria: * patients 6-18 months post restorative surgery (either resection with a primary functional anastomosis or after the closure of a temporary ileostomy following curative surgery for rectal cancer) and, if applicable, at least one month post last adjuvant chemotherapy treatment * lars score of 21 or greater * age 18 or older * able to read and write in hebrew or english * able and willing to comply with the study requirements. exclusion criteria: * chronic anal incontinence prior to surgery * inability to perform exercises due to cognitive or physical limitations * actively engaged in pelvic floor muscle exercises * pregnancy.

Keywords: paula method sphincter sparing rectal resection anal incontinence rectal cancer
effect of multifunctional nutrition tube on cerebral small vessel disease patients

Conditions: Cerebral Small Vessel Diseases; Dysphagia

Summary: nasogastric tube feeding (ngt) has been widely used in cerebral small vessel disease (csvd) patients with dysphagia but has a significant risk of complications. intermittent oro-esophageal tube feeding (ioe) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. this study aims to explore the clinical effect of ioe vs. ngt on csvd patients with dysphagia. compared to ngt, ioe, as an enteral nutrition support mode, in csvd patients with dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, adl, qol, pneumonia, and adverse events, which should be considered as the preferred approach.

nasogastric tube feeding (ngt) has been widely used in cerebral small vessel disease (csvd) patients with dysphagia but has a significant risk of complications. intermittent oro-esophageal tube feeding (ioe) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. this study aims to explore the clinical effect of ioe vs. ngt on csvd patients with dysphagia. this was a randomized controlled study with 60 csvd patients with dysphagia who received comprehensive rehabilitation therapy. patients enrolled were randomly divided into the observation group (with ioe, n=30) and the control group (with ngt, n=30). at admission and after treatment, video fluoroscopic swallowing study (vfss) and functional oral intake scale (fois), body mass index (bmi), serum albumin (alb), and hemoglobin (hb), modified barthel index (mbi) and world health organization quality of life assessment instrument brief version (whoqol-bref) were recruited to assess and compare dysphagia, nutritional status, activities of daily living (adl) and quality of life (qol). the incidence of pneumonia was recorded and compared.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of csvd, confirmed by mri; * must be able to cooperate with treatment and questionnaire investigation, (generally with a mini-mental state examination (mmse) score ≥ 24) ; * clinical diagnosis of dysphagia through the functional oral intake scale (fois) and video fluoroscopic swallowing study (vfss); * age between 40 and 70 years; * enteral nutrition support was required and feasible. * no history of prior stroke. exclusion criteria: * dysphagia related to other cerebrovascular diseases or caused by neurodegenerative diseases; * complicated with severe liver and kidney failure, tumors, or hematological disorders; * simultaneously need to undergo other therapy that might affect the outcomes of this study; * pregnant or nursing females.
flotor pilot study

Conditions: Chylothorax; Esophageal Cancer; Thoracic Duct Intra-Operative Injury

Summary: this is a non-randomised study assessing the technique of using indocyanine green as a fluorescent dye to highlight the thoracic duct during oesophectomy.

the thoracic duct is the largest vessel of the lymphatic system in the body. it transports chyle (a liquid containing both lymph and emulsified fats) from most of the body, including the gastrointestinal tract, into the left internal jugular vein. it is largely located in the thorax and is at risk of injury during the thoracic part of an oesophagectomy. the reported incidence of thoracic duct injury during oesophagectomy is between 0.2 and 10.5%, although it may be under-reported in the literature. a review of prospective collected complication data from 292 consecutive oesophagectomies performed in oxford over a 5 year period revealed a chyle leak rate of 9.9%. chyle leak was associated in a doubling of median length of post-operative stay from 8 to 16 days in these patients. chylothorax has been associated with a mortality of up to 30%. over the years, a number of attempts have been made to visualise chyle leakage following thoracic duct injury including administration of enteral fat containing feed (e.g. double cream), methylene blue and lymphoscintigraphy, but no studies have been published showing a mechanism to aid thoracic duct identification at the index operation, and so prevent injuries. fluorescence is a technique which uses fluorescent dyes (fluorophores) that emit invisible (near infra-red (nir)) light when they are excited by light at a particular wavelength. in order to use this technique, a fluorescence-enabled camera is required in order to shine light at that particular wavelength on the fluorophore and to capture the light emitted. this is then displayed on a screen for the surgeon to see. indocyanine green (icg) is a fluorescent molecule that is approved by the fda (food and drug administration) and the mhra for use in humans. it is a widely used near infra-red dye for numerous operations. near infra-red guided lymphatic mapping with icg has gained much attention over recent years and its use has widely been published in breast and colorectal surgery. icg has also been successfully used to identify the thoracic duct in a number of case reports in both adults and children. icg can be injected into the small bowel mesentery to aid identification of thoracic duct injury at re-exploration. this study aims to assess the feasibility of using icg fluorescence to identify the thoracic duct during oesophagectomy, with the eventual aim of developing its routine use to prevent thoracic duct injuries.

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. * male or female, aged 18 years or above. * undergoing elective oesophagectomy exclusion criteria: * known allergy to iodine or icg * female patient who is pregnant, planning pregnancy or breastfeeding * patient has a lactose intolerance (excluded only from receiving cream method) * known significant liver failure

Keywords: fluorescence
a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of vx-661 in combination with ivacaftor

Conditions: Cystic Fibrosis

Summary: this is a phase 3, randomized, double blind, placebo controlled, parallel group, multicenter study in people with cystic fibrosis (cf) who are homozygous for the f508del cf transmembrane conductance regulator (cftr) gene mutation.

this is a phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in people with cf who are homozygous for the f508del-cftr mutation. this study is designed to evaluate the efficacy and safety of vx-661 in combination with ivacaftor (iva, vx-770). the active treatment regimen comprised of a morning dose of a fixed-dose combination (fdc) tablet of 100 milligram (mg) vx-661/150 mg iva once daily (qd) and an evening dose of iva 150 mg to be taken approximately 12 hours after the morning dose. the placebo regimen was visually matched tablets to be taken with the same schedule as the active treatment.

Eligibility criteria:
inclusion criteria: * homozygous for the f508del cftr mutation, genotype to be confirmed at the screening visit * confirmed diagnosis of cf defined as a sweat chloride value ≥60 mmol/l by quantitative pilocarpine iontophoresis * forced expiratory volume at one second (fev1) ≥40% and ≤90% of predicted normal for age, sex, and height during screening * stable cf disease as judged by the investigator * willing to remain on a stable cf medication regimen through week 24 or, if applicable, the safety follow up visit exclusion criteria: * history of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant. * an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 28 days before day 1 (first dose of study drug) * pregnant or nursing females (females of childbearing potential must have a negative pregnancy test at screening and day 1) * sexually active participants of reproductive potential who are not willing to follow the contraception requirements

Keywords: homozygous for the f508del cftr mutation
a study of the effectiveness and safety of sp2086 to treat type 2 diabetes

Conditions: Type 2 Diabetes

Summary: sp2086 is a new dipeptidy1 peptidase(dpp)-4 inhibitors. this study aims to explore the effective dose range of sp2086 in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * 20 years to 70 years ,male and female diagnosed with type 2 diabetes mellitus * patients not on an oral antihyperglycemic agent (oha) with 7.0% ≤hba1c ≤10.5%,or not on an oha for 3 months with 7.0% ≤hba1c ≤10.5% * bmi 19\~35 kg/m2 exclusion criteria: * patient has history of type 1 diabetes mellitus * patient has history of ketoacidosis * patient has history of severe unconscious hypoglycemosis * patient has history of acute and chronic pancreatitis or pancreatic injury that may lead to high risk of pancreatitis * patient has history of decompensated heart failure (nyha class iii and iv), unstable angina, stroke or transient ischemic attack, myocardial infarction, persistence and clinical * patient has history of a history of hypertension, and after antihypertensive treatment, systolic blood pressure ≥ 160 mmhg or diastolic blood pressure ≥ 100 mmhg * patient has severe liver or kidney disease,alanine aminotransferase \>2×unl, aspartate aminotransferase \>2×upper normal limit(unl)；total bilirubin \>2×unl； creatinine\>1.5 mg/dl (male,132.6μmol/l) ，\>1.4 mg/dl(female，123.8μmol/l) * patient has severe chronic gastrointestinal disease or therapy that may affect drug absorption, such as gastrointestinal surgery * patient has severe haematological diseases or other diseases leading to hemolyze and red blood cell unstable (malaria、haemolytic anaemia eg. ) * patient has other endocrine diseases, for example hyperthyroidism、hypothyroidism、hypercortisolism、multiple endocrine neoplasia and so on * patient has history of malignancy * patient has history of alcohol or drug abuse

Keywords: sp2086 phase ii monotherapy
adiponectin and inflammatory mediators in mediastinal adipose tissues

Conditions: Coronary Artery Disease; Atherosclerosis

Summary: coronary artery disease (cad), the most common type of heart disease, is caused by hardening of the arteries, or atherosclerosis that is an inflammatory process in which immune mechanisms interact with metabolic risk factors to initiate, propagate, and activate lesions in the arterial trees. epidemiological studies have found that increased cardiovascular risks are associated with increased levels of inflammatory cytokines (eg, interleukin-6 \[il-6\] and tumor necrosis factor-alpha\[tnf-alpha\]) or their hepatic product, c-reactive protein (crp). higher expression of interleukin-ibeta(il-1beta),il-6, monocyte chemotactic protein-1 (mcp-1), and tnf-alpha were observed in epicardial adipose tissues in patients with cad. these findings suggested that the pericoronary tissues could be a source of inflammatory mediators or act as paracrine that lead to vascular inflammation on cad pathogenesis. however, adiponectin, a kind of adipocytokine, produced and secreted exclusively by adipose tissue, has been reported to have a variety of anti-inflammatory functions against atherosclerosis, resulting in risk reduction for incidence of cad events. it remains unclear whether adiponectin and inflammatory mediators in mediastinal adipose tissue contribute to cad. we therefore aim to analyze the expression of adiponectin and inflammatory mediators in mediastinal adipose tissue between patients with cad and with valve diseases, and to correlate these parameters with clinical atherosclerotic risks, medications (statins or antiplatelet), and blood sugar.


Eligibility criteria:
inclusion criteria: * patient underwent cabg or valve surgery in our hospital will be included exclusion criteria: * liver disease * dhronic renal insufficiency * neoplastic diseases * taking steroids * congestive heart failure

Keywords: coronary artery disease (cad) atherosclerosis mediastinal adipose tissue adiponectin, inflammatory mediators
the efficacy and safety of a single 70% glycolic acid peel with vitamin c for the treatment of acne scars

Conditions: Acne Scars

Summary: our study involves the evaluation of a high potency chemical peel in its efficacy and safety profile for the treatment of acne scars. this chemical peel regime is a high potency peel of 70% glycolic acid combined with vitamin c that is purported to provide a good balance between yielding results and patient safety. we aim to evaluate its efficacy and safety profile of a single application. the study design is based on a single group that compares pre- vs post-intervention. 10 patients with atrophic acne scars of skin type i-iv will be recruited. potential benefits include improvement of post acne scars with a short downtime and risks include post peel hyper pigmentation and scarring. we believe that this treatment will be highly beneficial to patients with post acne scarring. this chemical peel regime has good efficacy and safety profile for the treatment of acne scars.

primary endpoints: 1. ecca (échelle d'évaluation clinique des cicatrices d'acné) grading scale for quantitative grading of acne scars. two blinded evaluators compare and rate the photograph using ecca score. 2. patient assessment based on 1 to 10 point scale; 1- nil acne scars and 10- severe acne scar secondary endpoints: 1. postacne hyperpigmentation index (pahpi) -each of these 3 variables --size, intensity, and number of lesions is weighted and the summation of the weighted variables gives the total pahpi score, ranging 6 to 22. 2. safety assessment (this is an ordinal scale) i. score of redness ii. score of swelling iii. score of oozing/crusting iv. post peel hyperpigmentation v. post peel scarring vi. assessment based on patient and doctor global assessment (global assessment from 1 - 10)

Eligibility criteria:
inclusion criteria: 1. atrophic scars 2. skin type i to iv exclusion criteria: 1. pregnancy, breastfeeding 2. active dermatitis (on the face), rosacea, allergic rhinitis, active herpes simplex 3. known hypersensitivity 4. previous keloids 5. laser ablative procedures within the last month 6. chemical peels within the last 6 months 7. used oral retinoids in the past 6 months 8. used topical retinoids in the past one week 9. used scrub, aha, skin irritant for the past 24h 10. presence of facial warts or fungal infections 11. photoallergies 12. prior poor reaction to a chemical peel 13. radiotherapy 14. skin type v and vi 15. patients with predominantly ice pick and boxcar scars

Keywords: acne scars 70% glycolic acid peel
cluster analysis of the risk of metabolic syndrome in women for reproductive age

Conditions: Metabolic Cardiovascular Syndrome

Summary: the metabolic syndrome (mets) is a cluster of clinical indices that signals increased risk for cardiovascular disease and type 2 diabetes. women with polycystic ovary syndrome (pcos) were associated with mets and insulin resistance. cluster analysis was a useful tool for identifying groups of women sharing similar metabolic risk factor patterns. oligomenorrhea, hyperandrogenism and polycystic ovary morphology were the three major components of pcos. obesity is a main risk factor in metabolic syndrome. the investigators are interesting to evaluate the relationship between risk of metabolic syndrome and their clinical and/or biochemical characteristics in women with reproductive age. design: retrospective study; medical records reviewed. participants and setting: the investigators retrospectively reviewed the medical records of female patients who visited our reproductive endocrinology clinic from jan. 1, 2009 to jun. 31, 2012.

definitions of the metabolic syndrome based on arbitrary cutoff points for several quantitative variables, where each variable is related linearly to cardiovascular risk. even consensual definitions differ between international authorities and continue to change. moreover, such cutoff s should be gender and ethic difference. cluster analysis is a statistical method base on algorithms, which seek to minimize within-group variation and maximize between-group variation for the clustering variables. this technique is suitable for defining groups, reflecting the natural structure of data without relying on inappropriate arbitrary cutoffs. we conduct this retrospective study to review the medical records of female patients who visited our reproductive endocrinology clinic from jan. 1, 2009 to dec. 31, 2012. cluster analysis was performed in our studied cases to evaluate the correlation between clinical/biochemical characteristic and risk of metabolic risk in women with reproductive age.

Eligibility criteria:
inclusion criteria: women had been fulfilled with whole anthropometric measurements, clinic and biochemical survey about cardiovascular study. exclusion criteria: 1. women who had been diagnosed with malignant tumor, asherman's syndrome, mullerian agenesis, and chromosomal anomalies; 2. women who had had menarche less than 1 years before evaluation or who were older than 49; 3. women who received hormones or drugs for major medical diseases within three months of blood sampling.

Keywords: metabolic syndrome cluster analysis pcos
zoladex® 10.8 bc rws

Conditions: Breast Cancer

Summary: this is a multi-center, retrospective-prospective, observational, active-control, non-inferiority, real world study using hospital medical record data, with objectives to evaluate e2 suppressive effect of zoladex® 10.8 mg is non-inferior to zoladex® 3.6 mg. eligible breast cancer patients who received zoladex® from january 1st, 2015 till december 31st, 2021(including december 31st, 2021) will be identified and included for retrospective data collection and analyses in this study. and prospective data will be monthly collected of eligible patients receiving zoladex® after january 1st, 2022 (including january 1st, 2022) until approximately 1000 patients being included in this study for analysis. (if site has specific identification of retrospective data and prospective data, it will be subject to the requirement of site). the first date of the presence of zoladex® treatment or prescription record for breast cancer during the study period will be considered the index date for patients. according to the zoladex® treatment at the index date, patients will be categorized into two cohorts: zoladex® 10.8 mg or zoladex® 3.6 mg. about 10-15 hospitals will be included in this study. to be considered, the hospitals need to have relatively large number of eligible patients, geographic representativeness and willingness to participate in this study. approximately 1000 eligible patients from selected hospitals during the study period will be included and matched with propensity scores. it is expected that at least 150 matched patients in each of the two cohorts will eventually be included in the primary endpoint analysis. the final subject number will be based on the actual situation of the study.


Eligibility criteria:
inclusion criteria * diagnosed with primary breast cancer * female, ≥18 years old (at index date) * hr positive * receive zoladex® 10.8 mg or zoladex® 3.6 mg treatment * premenopausal status prior to the treatment of zoladex®. baseline premenopausal status will be confirmed if the patient's last e2 measurement within 180 days prior to the index date indicated premenopausal status or there was a recorded menstrual history within 180 days prior to the index date * at least one actual or expected e2 testing measurement within 8-28 weeks of the index date exclusion criteria * patients received concurrent treatments that may affect e2 testing results