Kornimate/medical-research-clean huggingface dataset:
impact of triple combination cftr therapy on sinus disease.

Conditions: Cystic Fibrosis

Summary: the study's main goal is to observe how effective elexacaftor-tezacaftor-ivacaftor is for improving the symptoms and signs of cf-related sinus disease.

to determine if elexacfator-tezacaftor-ivacaftor improves the signs and symptoms of cf-related sinus disease, before and after initiation of triple combination therapy, each subject will undergo sinus ct scan and complete questionnaires related to signs and symptoms of sinus disease.

Eligibility criteria:
inclusion criteria: 1. subjects from 18 to 89 years old. 2. subjects with cystic fibrosis and comorbid chronic sinus disease (historic diagnosis based on physician assessment of signs and symptoms and medical record). 3. subjects who clinically elect to initiate elexacaftor-tezacaftor-ivacaftor therapy and/or that are ineligible for cftr modulator therapy based on their genotype, but have class i/ii mutations based on sweat chloride \> 90 mmol/l. exclusion criteria: 1. subjects under the age of 18 or over the age of 89. 2. subjects who do not elect to initiate elexacaftor-tezacaftor-ivacaftor for clinical reasons. 3. subjects who had sinus surgery within the last 6 months or will have sinus surgery during the study period. 4. subjects who have had a recent pulmonary exacerbation or viral infection within two weeks of initial visit.

Keywords: chronic sinusitis
neural mechanisms underlying astigmatism

Conditions: Astigmatism

Summary: this study is to compare the contrast sensitivity function and neural response to gratings before and after the orientation discrimination task in the astigmatism or amblyopia patients.

the presence of astigmatism can lead to substantial reductions in visual performance in a variety of clinical vision measures and functional visual tasks. however, the neural mechanisms underlying the astigmatism remains unknown. the current study recruited three groups (patients with with-the-rule astigmatism and amblyopia, patients with with-the-rule astigmatism but without amblyopia, normal controls) of subjects and patients receive perceptual learning training (orientation discrimination task) which lasts for around 15 days. this main aim is to compare the contrast sensitivity function and neural response to gratings before and after the orientation discrimination task in the astigmatism or amblyopia patients. patients with astigmatism or amblyopia were included in this study. all participants underwent an ophthalmic examination that included slit-lamp biomicroscopy, visual acuity, quick csf under full optical correction, 9-sf life quality questionnaire and fundus examination.

Eligibility criteria:
inclusion criteria: * high astigmatism exclusion criteria: * other types of disease (especially optical diseases) that may affect study
long - term low anterior resection syndrome

Conditions: Bowel; Functional Syndrome

Summary: data assessing the long-term bowel dysfunction following low anterior resection is still lacking. the aim of this study is to evaluate late functional results of patients who underwent rectal resection for rectal cancer. this included calculating lars and wexner score and identifying possible risk factors of late postoperative bowel disorders.

for the last almost 30 years, the gold standard treatment for rc is low anterior resection (lar) with total mesorectal excision (tme). unfortunately, up to 80 % of patients undergoing lar will suffer of bowel dysfunction including faecal urgency, frequent bowel movements, tenesmus or so called low anterior resection syndrome (lars). simply it has been defined as "disordered bowel function after rectal resection, leading to a detriment in quality of life". same year lars score was developed. this tool is easy to use and has been internationally and in lithuania validated. wexner score is another tool for evaluation of faecal continence. there are only five studies investigating long-term results after rectal surgery and influence it has on patients' daily life. in one study 47 of 51 patients experienced lars following ultra-low anterior resection after average 6.5 years. another study recently reported major lars in 46% of the patients with the mean median follow-up of 14.6 years. others showed that 47.5% of patients still experience lars symptoms at a follow-up period of 13.7 years. just recently published study assessed bowel function 12 years in patients undergoing rectal resection with or without preventing ileostomy. authors found that 63 (72%) patients of 87 experienced lars symptoms with more than a half complaining of major lars. moreover, just last year a study published showing that 73% of patients had lars at first follow up 5 years after the surgery. during the second visit (another 5 years later) same numbers were seen. the aim of this study was to evaluate late functional results of patients who underwent rectal resection for rectal cancer. this included calculating lars and wexner score and identifying possible risk factors of late postoperative bowel disorders.

Eligibility criteria:
inclusion criteria: * patients diagnosed with rectal cancer without metastasis * signed consent form * more than 5 years following the surgery exclusion criteria: * unwilling to participate * stage iv disease * change in operative plan - end colostomy formed

Keywords: rectal cancer bowel dysfunction low anterior resection syndrome low anterior resection syndrome score quality of life
microparticles circulating plasma concentration in atrial fibrillation after percutaneous occluding of the left atrium

Conditions: Atrial Fibrillation

Summary: the aim of the study is to compare levels of differnts types of microparticles circulating before and after percutaneous occluding of the left atrium by patients with atrial fibrillation and patients control. hypothesis is that prothesis implantation will decrease levels of microparticles circulating in blood circulation because of occluding of the left atrium .


Eligibility criteria:
inclusion criteria: atrial fibrillation group: * high embolic risk (chads-vasc2 score ≥4) * formal and final contraindication to anticoagulant therapy * no heart thrombus on eto and tdm before percuraneous occluding control group: * suspicion of stable coronary artery disease, coronary angiography scheduled and double platelet aggregation (clopidogrel and aspirine) exclusion criteria: for both groups * congestive heart failure, severe aortic stenosis, ep or tvp early.
manual therapy and physical-sport performance

Conditions: Healthy; Musculoskeletal Disorders

Summary: the study aims to observe the influence of manual therapy on physical and sporting performance. manual therapy and physiotherapy have always been associated with post-exercise or as a means of recovering from injuries. the objective is to see if a physiotherapy intervention based on manual therapy causes changes in physical and sporting performance. to do this, after a brief warm-up, a series of sports tests will be carried out, where the investigators will measure variables such as strength, range of motion, and autonomic nervous system parameters. subsequently, a series of techniques will be applied in various anatomical regions, and finally, the sports tests will be repeated, and the results will be compared.


Eligibility criteria:
inclusion criteria: * engage in low- or moderate-intensity physical activity. * engage in physical activity on 3 or more days per week. * not have any recent injury in the area of intervention that contraindicates manual intervention. * be willing to collaborate in the study. exclusion criteria: * those people who had an acute injury or one that would prevent them from carrying out physical activity had any contraindication to the application of manual techniques. * who were not available during the dates of the study and people. * who were undergoing treatment with drugs that could interfere with the tests.
alternative treatments for menopausal women

Conditions: Menopause; Hot Flushes; Osteoporosis; Dyslipidemia

Summary: to investigate the reported health benefits (lipid profile, inflammatory factors, cardiovascular status and bone density) of a novel, phytoestrogen rich, red clover treatment on women suffering from both menopause related primary (hot flushes, night sweats, sleep disturbance and weight gain) and secondary (osteoporosis, cardiovascular and changes in lipid metabolism) symptoms.

menopausal symptoms are a common phenomenon causing discomfort to many middle aged women throughout the world. the core symptoms are experienced as hot flushes (hf), night sweats, vaginal dryness and sleep disturbance. other secondary symptoms are sexual dysfunction, depression, anxiety, memory loss, fatigue, headache, joint pains and weight gain. moreover there is increased risk of further complications such as osteoporosis, cardiovascular and negative changes in lipid profile associated with the reduction in oestrogen during and post menopause. trifolium pratense or red clover (rc) has arisen as a popular source for women experiencing hf because it contains a variety of phytoestrogen's, namely isoflavones, lignans and coumestans. phytoestrogens are shown to have positive effects on menopausal disorders such as breast cancer, cardiovascular risk factors, osteoporosis and have been shown to exert non-hormonal antioxidant effects. additionally these isoflavones appear to reduce bone resorbtion, help maintain bone mineral density and improve lipid profile (reducing ldl: hdl, lipoprotein a, total cholesterol and may also reduce triglycerides). rc is particularly high in estrogenic isoflavones biochanin a, formononetin and to a lesser degree genestein and diadzein, although the two former are precursors to genestein and diadzein. asian populations with a high intake of soy (rich in genestein and diadzein) have long shown a lower reported incidence of the symptoms of menopause. the study will be carried out as a 3-month parallel randomized control intervention study, consisting of 61 menopausal women. during summer 2012, 61 participants will be randomised into 2 groups (\~30-31 in each group). the two groups are as follows: 1. menopausal women receiving rc treatment - 150ml/d red clover (80mg/d of isoflavones as aglycone) 2. menopausal women receiving placebo - 150ml placebo

Eligibility criteria:
inclusion criteria: * women aged 40-65 years * experiencing daily hot flushes * body mass index (bmi) between 20-40 * irregular menstrual bleeding * fsh levels above the normal range exclusion criteria: * simultaneous participation in other clinical trials within the last 3 months * severe cardiovascular, psychiatric, neurological, and/or kidney disease. * alcohol or drug abuse and acute illness. * blood pressure \> 160/110 * pregnant and lactating women

Keywords: red clover menopause bioactive compounds isoflavones phytoestrogen
effectiveness of the music with structured verbal training during prostate biopsy

Conditions: Pain; Anxiety; Satisfaction; Urological Nursing

Summary: transrectal ultrasound (trus) guided prostate biopsy is a gold standard method widely used in the diagnosis of prostate cancer. this procedure can be very painful and anxious for men. various pharmacological methods can be used to relieve patients' pain and discomfort during trus-guided prostate biopsy. although there is still no consensus on the solution suggestions for pain and anxiety due to biopsy, it is known that music, which is a non-pharmacological method, is effective in this regard. the aim of this study is to evaluate the effect of music with structured verbal training on patients' pain, anxiety and satisfaction levels during transrectal ultrasound-guided prostate biopsy.

although there have been several studies examining the effect of music on pain and / or anxiety during trus prostate biopsy, only one study has been found examining the effect of stress management (music and one-to-one simulation training) on patients' pain and anxiety levels. in addition, there is only one study on the effectiveness of the training method (written and video-based training) on anxiety levels of patients related to prostate biopsy. for this reason, it is thought that music will be more effective on pain and anxiety levels along with structured verbal training to alleviate the discomfort associated with patients' biopsy procedure.

Eligibility criteria:
inclusion criteria: * being over the age of 40 * male gender * transrectal ultrasound guided prostate biopsy for the first time * agreeing to participate in the study exclusion criteria: * presence of any contraindication for prostate biopsy * any analgesic used 24 hours before prostate biopsy

Keywords: anxiety nursing pain satisfaction prostate biopsy
the effects of jing si herbal tea on physical and psychological symptoms in peripheral blood hematopoietic stem cell donors

Conditions: Pain Syndrome; Emotional Stress

Summary: this study aim to explore the impact of jing si herbal tea on pain and emotional stress in peripheral blood stem cell donors.


Eligibility criteria:
inclusion criteria: * health men or women aged 20 to 55 years old * willing to take jing si herbal drink exclusion criteria: * no willing to take jing si herbal drink; * previously already take jing si herbal drink daily
alf-stone: alfuzosin in uretheric stones

Conditions: Prostatic Hyperplasia

Summary: the aim of the study is to assess the effect of alfuzosin compared with placebo, for 7 days, on the outcome of patients with uretheric stones submitted to extracorporeal shock wave lithotripsy (eswl), namely in the percentage of patients without imagiologic evidence of any stone after 72h to 96 hours. this study will also specifically focus on the evaluation of time of stone clearance and of pain reduction (numeric rating scale).


Eligibility criteria:
inclusion criteria: * patients with imagiologic evidence of uretheric stones exclusion criteria: * women pregnant or breast feeding * patients with renal impairment (creatinine \> 2mg/dl) the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
investigator's initiated phase ii study for pancreatic cancer patients

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to evaluate the efficacy, safety and tolerability of tl-118 alone or in combination with pancreatic cancer chemotherapy.


Eligibility criteria:
inclusion criteria: 1. age at least 18 years at enrollment. 2. locally advanced pancreatic cancer and/or metastatic pancreatic cancer which failed to respond to one or two lines of chemotherapy 3. the patient has histologically or cytologically confirmed pancreatic cancer. 4. patient has measurable disease by radiological imaging techniques as defined according to response evaluation criteria in solid tumors (recist). 5. ecog performance status ≤ 2 6. adequate renal function. 7. adequate hepatic function 8. adequate bone marrow reserve - 9. resolution of prior therapy acute adverse events. 10. patient is capable of swallowing. 11. patient's informed consent. exclusion criteria: 1. hypersensitivity to one or more of the tl-118 active components 2. known glucose-6-phosphate-dehydrogenase deficiency (g6pd). 3. known cns or brain metastases 4. patient has received 3 or more different prior chemotherapies for the treatment of pancreatic cancer 5. any significant change in treatment within the 14 days before screening or an un-stable medical condition that may affect patient participation or evaluation in the study. 6. concurrent use of any other investigational product or within 28 days before study entry. 7. chronic treatment with: (a) immunosuppressive agent other than systemic corticosteroid, (b) patients who are under chronic treatment with nsaids with the exception of aspirin at a daily dose ≤ 100mg. 8. use of supplements or complementary medicines/botanicals, except for conventional multivitamin supplements, calcium, selenium and soy supplements. 9. patients at increased risk of gastro intestinal bleeding such as patients with known active gastro intestinal ulcer, erosive gastritis or varices, as confirmed by gastroscopy performed within one year before screening. 10. serious or uncontrolled co-existent diseases that are likely to significantly increase the risks associated with tl-118 therapy (e.g. severe cardiovascular disease, congestive heart failure, recent myocardial infarction, significant vascular disease, active or uncontrolled autoimmune disease, active or uncontrolled infection). 11. patient has known historical or active infection with hiv, hepatitis b, or hepatitis c 12. serious or non-healing wound, ulcer or bone fracture. 13. circumstances likely to interfere with absorption of orally administrated drugs. 14. history of noncompliance to medical regimens or coexisting conditions precluding full compliance with study protocol, or any other condition that in the discretion of the investigator may preclude safe and complete study participation. 15. subjects unwilling or unable to comply with study protocol. 16. know pregnancy or breast-feeding women. 17. women of child bearing potential not exercising two methods of contraception.

Keywords: patients
assess pharmacokinetics, safety and tolerability in healthy chinese volunteers after oral doses of saxagliptin

Conditions: Type 2 Diabetes

Summary: saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. this phase i study is designed to assess the pharmacokinetics of saxagliptin and its pharmacologically active metabolite, bms-510849, following single and multiple oral doses of 5 mg saxagliptin in healthy chinese subjects.


Eligibility criteria:
inclusion criteria: * men or women (not of childbearing potential) of chinese ethnicity * weigh at least 50 kg and have a body mass index (bmi) between 19 and 24 kg/m2 * must have normal physical examination, laboratory values, ecg, pulse and blood pressure unless the investigator considers an abnormality to not be clinically significant. exclusion criteria: * history of clinically significant hypoglycaemia (low blood sugar levels) * women who are pregnant or breastfeeding

Keywords: dpp-4 inhibitors hba1c incretins pharmacokinetics
validation of digital morphometry for cancer risk in benign prostate biopsies

Conditions: Prostate Cancer

Summary: the goal of this study is to apply cutting-edge imaging approaches, incorporating machine-learning for pattern recognition and multispectral analysis, to the development and validation of intermediate endpoint biomarkers in benign tissue that characterize the response to 5α-reductase inhibitor chemoprevention as well as the risk of prostate cancer among men with negative biopsies.


Eligibility criteria:
inclusion criteria: * completed reduce trial (year 4 exit biopsy with blocks and he slides available; i.e., u.s. participants only) * compliant with assigned treatment based on either: (dutasteride group) at least 3 post-baseline serum dht levels ≥ 50% lower than baseline, or (placebo group) at least 3 post-baseline serum dht levels with none showing ≥ 50% decrease from baseline exclusion criteria: * n/a

Keywords: prostate cancer dutasteride
the metabolic effects of ginseng oligopeptide preparation on non- alcoholic fatty liver disease with obesity: a randomized controlled double-blind trial

Conditions: Non-alcoholic Fatty Liver Disease

Summary: to investigate the effect of ginseng oligopeptide on nonalcoholic fatty liver disease with obesity and clarify its intervention mechanism in theory, which will contribute to the prevention and treatment of non-alcoholic fatty liver more scientifically and effectively.the patients were randomly divided into two groups. one group of patients took ginseng oligopeptide orally, and the other group took placebo. the liver function, blood lipid, blood glucose, liver b ultrasound and other indicators were observed to further determine the efficacy.


Eligibility criteria:
inclusion criteria: * meet the diagnostic criteria for non-alcoholic fatty liver disease ; * aged 18-65 years old; * alt, ast, ggt≤2×upper limit of normal（uln）; * bmi≥28kg/㎡; * patients signed the relevant informed consent on a voluntary basis. exclusion criteria: * under 18 years old and over 65 years old; * allergic to the ingredients of ginseng oligopeptide preparation; * serum alt, ast, ggt\>2uln; * currently taking oral hepatoprotective drugs such as reduced glutathione, polyene phosphatidylcholine, and silibinin, etc.; * subjects participating in other clinical trials; * pregnant or lactating women; * complicated with serious diseases of the digestive system or other systems, such as chronic gastrointestinal diseases and chronic diseases causing digestive malabsorption,kidney disease, hematological system or autoimmune diseases; * other populations that were deemed by the investigators to be ineligible for the trial may reduce or complicate enrollment patients with chemotherapy.
patient's perception of treatment outcome with darifenacin by patients with overactive bladder

Conditions: Overactive Bladder (OAB)

Summary: this study will evaluate safety, efficacy and patient's perception of outcome after treatment with darifenacin (7.5 mg once daily (o.d.) with voluntary increase up to 15 mg o.d.) in patients with oab who are dissatisfied with prior oxybutynin extended release (er) or tolterodine extended release (er) therapy.


Eligibility criteria:
inclusion criteria: * • symptoms of oab for at least six months prior to randomization * ≥ 8 micturitions on average/24 hours * ≥ 1 urgency episodes on average/24 hours * with or without uuie * patients dissatisfied with prior oxybutynin er or tolterodine er treatment. patients must have been on either treatment for at least 1 week and up to 12 months preceding this study. it is required that either oxybutynin er or tolterodine er was the most recent oab medication taken. * patients without prior darifenacin treatment exclusion criteria: * • a mean daily urinary volume \>3000 ml or a mean volume voided/micturition of \>300 ml as verified in the micturition diary for two consecutive days prior to baseline * males with post-void residual (pvr) urinary volume \>200 ml at baseline * clinically predominant and bothersome stress urinary incontinence, as determined by the investigator * urinary retention or clinically significant bladder outlet obstruction as determined by the investigator other protocol-defined inclusion / exclusion criteria may apply

Keywords: darifenacin,overactive bladder,antimuscarinic,m3 muscarinic receptor antagonist