Kornimate/medical-research-clean huggingface dataset:
a new approach in inguinal hernia repair: double repair. a prospective, randomized, controlled clinical trial

Conditions: Hernia

Summary: this is a new inguinal hernia repair technique.

in this study we are revealing a new inguinal hernia repair technique. it is constructed from two layers. deep layer is modified shouldice technique, the other superficial one is moloney technique.

Eligibility criteria:
inclusion criteria: * inguinal hernia exclusion criteria: * recurrences, child

Keywords: inguinal hernia new repair modified shouldice double
vascular effect of cimicifuga racemosa

Conditions: Postmenopausal Symptoms

Summary: postmenopausal women with vascular symptoms will use cimifuga racemosa or placebo and the effects will be evaluated using flow-mediated dilatation of the brachial artery.

the interruption of the secretion of ovarian steroids after menopause, determines a change in the vascular pattern in several levels. thus, several vascular effects might interfere with women's health. the use of hormone replacement therapy has contributed to the improvement in these effects. in previous studies, the investigators observed the effects of hormonal replacement therapy in improving such effects in postmenopausal women. the aim of the present study is to evaluate the effects of cimicifuga racemosa on the flow-mediated dilatation of the brachial artery.

Eligibility criteria:
inclusion criteria: * women with postmenopausal vascular symptoms * women without menstrual cycles within the last 12 months and follicle stimulating hormone (fsh) \> 30 international units(iu)/litre * women that were not using drugs with potential vascular effect within the last 1 year * women that were not using hormone replacement therapy within the last 1 year exclusion criteria: * smoking * blood pressure \> 160/90 mm hg. * breast and or endometrial cancer * history of acute myocardial infarction * diabetes * vaginal bleeding of any origin * hepatic disease * thrombophlebitis or thromboembolic disorders

Keywords: postmenopause vascular effects cimicifuga racemosa
a pilot study of tumor-derived exosomes as diagnostic and prognostic markers in breast cancer patients receiving neoadjuvant chemotherapy

Conditions: Breast Neoplasms

Summary: this is a pilot study evaluating the use of tumor derived exosomes as a marker for response to therapy in women receiving neoadjuvant chemotherapy for newly diagnosed breast cancer. tumor derived exosome analysis may be a novel diagnostic and prognostic biosignature in breast cancer, which could prove to be a tool for earlier diagnosis, more effective treatments, and improved markers of response in order to increase survival rates.


Eligibility criteria:
inclusion criteria: * women with biopsy proven invasive carcinoma of the breast * women with locally advanced breast cancer and breast tumors measuring \>/= 2cm who are deemed candidates for preoperative chemotherapy * age \>/= 18 years old * expected survival \>/= 6 months * eastern cooperative oncology group performance status of 0, 1, or 2 at initiation of study * initial required laboratory values: absolute neutrophil count \>/= 1.5 x 10(9)/l platelet count \>/= 100,000 x 10(9)/l creatinine clearance \>/= 50ml/min (calculated by cockcroft-gault method) liver function tests (ast, alt, total bilirubin) \</= 2.5 x uln urine or serum hcg negative (if female of childbearing potential) * women may be enrolled on ongoing therapeutic preoperative chemotherapy trials exclusion criteria: * no prior chemotherapy for breast cancer * no limitations for prior radiation therapy * no active, serious infection or medical or psychiatric illness likely to interfere with participation in this trial * non-pregnant and non-nursing patients only. patients of reproductive potential must agree to use an effective means of birth control * no prior liver transplant or bone marrow transplant
brain-connects: intensive rehabilitation program for subacute stroke patients in an inpatient rehabilitation facility

Conditions: Stroke

Summary: this is an observational study aiming to describe an intensive rehabilitation program for stroke patients in an inpatient rehabilitation facility, measuring the time and reporting activities performed during the therapy sessions (physiotherapy, occupational and speech language therapy). indeed, functional and cognitive outcomes will be reported, and data about feasibility and safety of the rehabilitation program will also be recorded.

this is an observational descriptive study that will be performed in an inpatient intensive rehabilitation unit. stroke patients admitted in our neuro-rehabilitation unit who follow the inclusion criteria, will be invited to participate. the main objective of the study is to register the time spent in different activities during therapy session performed in the intensive rehabilitation program. at the end of each session a sum of the minutes spent in each activity will be performed and at the end of the rehabilitation program the average of time spent in each therapy will be calculated. indeed, throughout these data the total amount of time spent on rehabilitation (hours and minutes) will be obtained. secondary objectives are to report changes on functional, cognitive and health status outcomes during different time-frames. this outcomes will be assessed at baseline (admission on neuro-rehabilitation unit), at discharge of rehabilitation unit (average of 30 days after stroke), at 3 months and 6 months after stroke. safety and feasibility of the program will also de recorded. feasibility will be assessed by adherence to the prescribed program, including the register of the following parameters: attendance rate (number of planned sessions attended), training session modification (dose reduction or early termination of the individual session) and reasons for training interruption (2 or more days without training session) as fatigue, dizziness, fever... safety will be assessed registering any adverse event related to rehab (ie. episodes of falls,..)

Eligibility criteria:
inclusion criteria: 1. aged 18 or over, 2. first-ever intracerebral ischemic or hemorrhagic stroke confirmed by neuroimaging, 3. less than 3 weeks of stroke onset, 4. moderate-to severe impairment (national institute of health stroke scale \[nihss\] score between 5 and 13), 5. functionally independent prior to stroke (rankin \> 2), 6. no major cognitive deficits affecting comprehension (mini-mental state examination \>24), (7) ability to understand spanish and/or catalan exclusion criteria: * patients with any other neurological or psychiatric condition will be excluded.

Keywords: stroke intensive rehabilitation time physiotherapy occupational therapy speech language therapy
iowa cochlear implant clinical research center study of ssd using med-el cochlear implants

Conditions: Hearing Loss, Unilateral; Hearing Loss, Profound

Summary: the purpose of this study is to understand the speech perception in noise and in quiet and localization benefits in a laboratory setting in listeners that receive a cochlear implant in an ear with severe to profound hearing loss and have normal, or near-normal hearing in the opposite ear. we will also evaluate the functional benefit of restoring hearing to the impaired ear via questionnaires that subjects will be answering while listening in their natural environment.


Eligibility criteria:
inclusion criteria: 1. participants will be adults who utilize english as their primary language. 2. unilateral severe to profound sensorineural hearing loss for a duration of at least 6 months (to ensure stability of hearing loss), but no greater than 10 years. 3. contralateral ear with normal, or near-normal, hearing. 4. poorer ear (ear to be implanted): severe to profound sensorineural hearing loss, defined as pure-tone thresholds 70 db hl or greater for the frequencies 500, 1000, 2000, 3000, and 4000 hz with monosyllabic word understanding, as measured using the cnc word test at 60 dba under earphones, less than or equal to 20% 5. better ear (contralateral ear): normal or near-normal hearing defined as pure-tone thresholds no poorer than 30 db hl at 250, 500, 1000, 2000, and 3000 hz and no poorer than 40 db hl at 4000 hz with monosyllabic word understanding, as measured using the cnc word test at 60 dba under earphones, of greater than or equal to 85%. 6. willingness to comply with all study requirements. 7. patent cochlea and normal cochlear anatomy. exclusion criteria: 1. medical or psychological conditions that contraindicate undergoing surgery. 2. ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array. 3. unrealistic expectations on the part of the candidate and/or candidate's family, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices. 4. unwillingness or inability of the candidate to comply with all investigational requirements. 5. active middle ear infection. 6. tinnitus primary motivation for implantation.
increasing patients' engagement in breast cancer surgery decision-making

Conditions: Breast Cancer Stage 0; Breast Cancer Stage I; Breast Cancer Stage II; Breast Cancer Stage III

Summary: this trial studies how well a breast cancer surgery decision aid works in increasing patient engagement in decision making for patients with newly diagnosed stage 0-iii breast cancer. the trial also examines barriers to patient engagement even with the use of a decision aid, and if barriers are more likely to be experienced by socioeconomically disadvantaged patients.

the primary and secondary objectives of the study: primary objectives: i. test the effectiveness of a breast cancer surgery decision aid in increasing patient engagement in decision making (measured by knowledge and power) in clinics serving a high proportion of socioeconomically disadvantaged patients. ii. test the extent to which the effect of a decision aid on patient engagement is mediated through the mitigation of barriers and determine if persistent barriers are disproportionately experienced by socioeconomically disadvantaged patients. secondary objectives: i. characterize how persistent barriers influence patient engagement in decision making in order to identify targets for adjunct interventions that could be implemented in clinics serving a high proportion of socioeconomically disadvantaged patients. trial design: outline: this is a multi-site cluster randomized trial using a stepped wedge design. ten clinics will be recruited for participation. all clinics will begin in the usual care arm. clinics will be randomized to the timing with which they cross-over to the decision aid intervention, with new clinics crossing over every 10 weeks. arm i: usual care arm ii: decision aid intervention the only difference between patients enrolled before institutional crossover and patients enrolled after institutional crossover is those who are enrolled after institutional crossover will have been offered the decision aid as accepted practice in the clinic.

Eligibility criteria:
inclusion criteria: * newly diagnosed with stage 0-iii breast cancer * eligible patients must be planning breast surgery as a component of their definitive treatment * patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study * patients with hearing impairment requiring the use of an interpreter are not eligible for this study * patients must be able to speak english with the fluency required to have a direct discussion around treatment decision-making (i.e. without interpreter) * clinic stakeholder (surgeons and clinic staff): breast surgeon(s) and nursing staff, medical assistant, or mid-level provider at each participating clinic who participates in the care of patients newly diagnosed with breast cancer * institutional: 10 clinics that annually provide surgical care for 120-300 patients newly diagnosed with breast cancer will be selected to participate in this study * institutional: surgeons at eligible clinics must consent to the study as a requirement for site participation
a multi-site post marketing surveillance study for systane in indian patients

Conditions: Moderate to Severe Dry Eye

Summary: this study is a multi-site, unmasked pms study. the purpose of the study is to evaluate the physical effects of systane lubricant eye drops.

this study is a multi-site, unmasked pms study. the purpose of the study is to evaluate the physical effects of systane lubricant eye drops. the assessed effects include: corneal and conjunctival staining, and ocular signs and symptoms. this is a two week prospective study.

Eligibility criteria:
inclusion criteria: * 18 years of age or older, of both sexes, and any race. * willing and able to make all required visits and follow study instructions. * a sodium fluorescein corneal staining sum of \>/ 3 in either eye. a best-corrected visual acuity of 0.6 log mar or better in each eye as assessed during an etdrs chart exclusion criteria: * a history or evidence of ocular or intraocular surgery in either eye within the past 6 months. * lasik patients can be included if lasik surgery was \> 6 months prior to the initiation of the study. * a history of intolerance or hypersensitivity to any component of the study medications.

Keywords: systane, dry eye
vitamin k supplement for inhibition of the progress in aortic valve calcification

Conditions: Aortic Valve Calcification

Summary: in this mono-center,open,three-armes, controlled, randomized phase i study the progress of aortic valve calcification with and without vitamin k supplementation will be investgated. this will be done by means of measurements of concentrations from osteocalcine and mpg in blood serum, echocardiography, cardiac computed tomography and cardiac mri

patients will be allocated to two groups with either 1. additional intake of 2 mg vitamin k1 daily 2. controll group without additional intake of vitamin k treatment group a will include 100 patients, the controll group should include 100 patients. none of all patients should require renal dialysis.

Eligibility criteria:
inclusion criteria: * aortic valve calcification,verified by echocardiography exclusion criteria: * chronic or acute intestinal diseases * terminal renal failure * allergic reaction on soya containing products * recent additional intake of vitamin k * oral anticoagulation with vitamin k antagonists (marcoumar) * systemic therapy with corticosteroids * anamnestic venous thrombosis (pelvet or legs)or embolization of lung arteria * pregnant or breastfeeding women * persons without mental ability or capacity to understand and follow the instructions of the investigator * women of childbearing age without safe contraceptional devices * minority

Keywords: aortic valve calcification vitamin k supplementation
treatment strategies for primarily generalized colorectal cancer

Conditions: Colorectal Cancer

Summary: for patients with primarily generalized colorectal cancer two treatment strategies are compared to establish which strategy gives best overall survival. the traditional strategy is to first resect the primary colorectal tumour and then treat the metastases with chemotherapy followed if possible by surgery. the alternative strategy is to first treat the metastases with chemotherapy followed if possible by surgery and only resect the primary colorectal tumour if there is hope for cure or if symptoms develop that necessitates treatment.

patients are randomized between the two treatment strategies mentioned above. after initial treatment the patients are categorized as palliative or treated with curative intent. patients are followed with quality of life evaluations every 6 months. outpatient visits, hospital care, examinations and treatment are recorded as well as complications and side effects. survival is recorded and for those patients treated with curative intent the tumour situation 3 years after randomization is evaluated.

Eligibility criteria:
inclusion criteria: * patients with primarily generalized colorectal cancer diagnosed by pathology or typical appearance on x-ray or at endoscopy and where there is uncertainty regarding best treatment strategy exclusion criteria: * patients not willing to participate or unable to sign informed consent. * patients with other malignancy with metastatic potential * patients where synchronous resection of primary tumour and metastases is planned * patients not fit for chemotherapy or surgery * patients with locally unresectable primary tumours * patients with symptoms from primary colorectal tumour necessitating resection

Keywords: colorectal cancer metastases treatment strategies colorectal cancer with synchronous metastases
safety and tolerability of ciclesonide and formoterol fumarate inhaled once daily in patients with asthma (18 to 75 y) (by9010/m1-506)

Conditions: Asthma

Summary: the aim of the study is to compare the efficacy of two doses of a fixed combination of ciclesonide/formoterol fumarate versus ciclesonide alone versus formoterol fumarate alone in patients with asthma. the study duration consists of a baseline period (2 to 3 weeks) and a treatment period (8 weeks). the study will provide further data on safety and tolerability of ciclesonide/formoterol fumarate.


Eligibility criteria:
main inclusion criteria: * written informed consent * good health with the exception of bronchial asthma (for at least 6 months) * fev1 \> 60% to \< 80% of predicted (if pretreated with inhaled steroids only) * fev1 \> 60% to ≤ 85% of predicted (if pretreated with inhaled steroids in combination with other asthma controller) main exclusion criteria: * concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or long-acting beta2-agonists * chronic obstructive pulmonary disease (copd), i.e. chronic bronchitis or emphysema, and/or other relevant lung diseases causing alternating impairment in pulmonary function * current smoking or cessation of smoking within the last 6 months or previous smoking with a smoking history ≥ 10 cigarette pack-years * use of other drugs not allowed * pregnancy or intention to become pregnant during the course of the study, breast feeding, or lack of safe contraception in women of childbearing potential

Keywords: asthma ciclesonide formoterol fumarate long-acting beta2-agonists laba steroids
nano drug interventional therapy using digital subtraction angiography（dsa） for liver carcinoma

Conditions: Liver Cancer

Summary: the purpose of this study is to evaluate the safety and efficacy of nano drug（gemzar® mix with compound glycyrrhizin injection） interventional therapy using digital subtraction angiography（dsa） for liver cancer.

by enrolling patients with liver cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of nano drug interventional therapy using digital subtraction angiography（dsa）for liver cancer. the nano drug is made by mixing gemzar® with compound glycyrrhizin injection. the nano drug's size is detected by laser diffraction particle size analyzer.

Eligibility criteria:
inclusion criteria: 1. age:18-80 2. karnofsky performance status \>60 3. diagnosis of liver cancer based on histology or the current accepted radiological measures. 4. classification tumor,nodes,metastasis-classification(tnm) stage: ⅱ,ⅲ,ⅳ 5. will receive interventional therapy 6. life expectancy: greater than 3 months 7. patients' routine blood test, liver function and kidney function have no obvious abnormalities 8. ability to understand the study protocol and a willingness to sign a written informed consent document exclusion criteria: 1. patients with other primary tumor except liver cancer 2. history of coagulation disorders or anemia

Keywords: liver cancer nano drug
validation of a urine-based assay with genomic markers for predicting recurrence for non-muscle invasive bladder cancer

Conditions: Non-muscle Invasive Bladder Cancer

Summary: a study to validate, in a prospective manner, the ability of the predefined genomic health bladder cancer assay to detect recurrence in patients undergoing surveillance for non-muscle invasive bladder cancer.


Eligibility criteria:
inclusion criteria: * patients with a prior diagnosis of non-muscle invasive, ≤t1, urothelial cell carcinoma of the bladder scheduled to undergo surveillance cystoscopy. exclusion criteria: * patients younger than 18 years * patients with a diagnosis of small cell carcinoma, adenocarcinoma or squamous cell carcinoma of the bladder * patients who have had a cystectomy or prior diagnosis of muscle invasive disease (t2 or greater) * patients who are unable or unwilling to give informed consent
dose escalation of lapatinib with paclitaxel in ovarian cancer

Conditions: Ovarian Cancer

Summary: this trial will be a phase i dose-escalation study of lapatinib and paclitaxel for platinum-resistant ovarian cancer, which will establish the phase ii dose for subsequent efficacy trials.

while abcb1 (p-glycoprotein 1) upregulation after paclitaxel administration is well known, there is currently no clinically available method for preventing or overcoming it. to develop a therapy able to prevent abcb1 upregulation and paclitaxel resistance, several abcb1 inhibitors have been evaluated in combination with paclitaxel in preclinical model systems. pulsed-dose lapatinib and paclitaxel are synergistic and inhibition of abcb1 by lapatinib increases sensitivity to paclitaxel. lapatinib is fda approved, orally available, and previously studied in combination with weekly paclitaxel for breast cancer at doses of 1000mg to 1250mg daily (7000-8250mg per week). this trial will use twice-daily dosing of lapatinib at a starting dose of 750 mg for 2 days (1500mg a day and 3000mg weekly dose), which is less than half of the continuous dose and has been shown to achieve plasma concentrations at 48 hours that are associated with synergy. therefore, these findings can be translated into a novel, well-tolerated, and convenient combination regimen with significant potential for clinical activity. this trial will be a phase i dose-escalation study of lapatinib and paclitaxel for platinum-resistant ovarian cancer, which will establish the phase ii dose for subsequent efficacy trials.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed ovarian cancer who recur within 12 months of platinum-based chemotherapy * ecog performance status less than or equal to 2 * adequate organ and marrow function at baseline * ability to sign a written informed consent document exclusion criteria: * hypersensitivity to lapatinib or paclitaxel * uncontrolled intercurrent illness * receiving medications that inhibit or induce cyp3a4 * malabsorption syndrome * congestive heart failure * receiving any other anti-cancer investigational agents * baseline neuropathy greater than grade 1

Keywords: platinum-resistant