Kornimate/medical-research-clean huggingface dataset:
bay38-9456 - supportive trial for spinal injury

Conditions: Erectile Dysfunction; Sexual Dysfunction; Spinal Cord Injury

Summary: bay 38-9456 10 mg and 20 mg can be given as safe and efficacious medications to patients with spinal cord injury suffering from erectile dysfunction, and that erectile dysfunction can be improved by uptitration to bay 38-9456 20 mg when the treatment with 10 mg is not sufficiently effective


Eligibility criteria:
inclusion criteria: * male with erectile dysfunction according to the nih consensus statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance), solely as a result of a traumatic injury to the spinal cord (suffering more than 6 months ago) * patients answering "yes" to the question regarding the presence of residual erectile function over the past 6 months \[at home over the past 6 months, have you experienced at least some enlargement of your penis in response to: (1) mechanical stimulation by yourself or your partner, or (2) visual stimulation?\] exclusion criteria: * history of diabetes mellitus * patients who are taking nitrates or nitric oxide donors * patients who have experienced no enlargement of penis with pde5 inhibitor and/or who have withdrew the use of pde5 inhibitor due to adrs

Keywords: vardenafil pde5 inhibitor erectile dysfunction spinal cord injury
gram stain of the first urine after puncture in percutaneous nephrolithotomy

Conditions: Percutaneous Nephrolithotomy

Summary: in this study, investigators compared the systemic inflammatory responses after percutaneous nephrolithotomy (pcnl) patients who were given an expanded empirical antibiotic regimen based on the prediction of the possibility of bacteria identified by gram staining the first urine after renal puncture and patients whose antibiotic regimen was not performed and whose antibiotic regimen was adjusted according to patient symptoms and culture results. investigators aimed to test its diagnostic value in predicting and preventing complications.


Eligibility criteria:
inclusion criteria: * patients with an indication for percutaneous nephrolithotomy due to kidney stone disease. exclusion criteria: * under 18 years old, * having an active urinary tract infection before surgery and positive urine cultures, * patients with bilateral kidney stones, * dj stent or nephrostomy placement, * solitary kidney stones, * bleeding disorders, * impaired kidney function, * a history of antibiotic use for any reason within 2 weeks before randomization were excluded from the study.

Keywords: fever gram stain percutaneous nephrolithotomy systemic inflammatory response syndrome (sirs)
dyslipaemia, atherosclerosis risk and increased hscrp and inflammatory and oxidative status in the spanish population. database analysis of previous studies performed in spain

Conditions: Dyslipaemia; Atherosclerosis Risk; Increased hsCRP; Inflammatory and Oxidative Status in the Spanish Population

Summary: the present project is aimed at determining the prevalence of ldl-c \<130 mg/dl with hscrp ≥2mg/l, and of hdl-c \< 40 mg/dl in spain together with the estimation of cardiovascular risk, to analyze the contribution of measuring hscrp for primary prevention purposes. in a subgroup of that population a number of inflammatory and oxidative status biomarkers would be also measured to better understand the meaning of elevated hscrp.the study aim to analyze data already collected in studies (11 studies will participate) carried out in spain, in 10 spanish regions, after the year 2000.


Eligibility criteria:
inclusion criteria: * have an informed consent form signed when the patient accepted to participate in the study already performed. * spanish population between * data from epidemiological studies performed after the year 2000 exclusion criteria: * spanish population outside the age range * data from epidemiological studies performed before the year 2000

Keywords: dyslipaemia atherosclerosis risk increased hscrp inflammatory and oxidative status in the spanish population
aspirin responsiveness and outcome in coronary artery bypass graft (cabg) surgery

Conditions: Coronary Artery Bypass Graft Triple Vessel; Myocardial Ischemia; Thrombosis; Antithrombotic Drugs [Platelet-aggregation Inhibitors] Causing Adverse Effects in Therapeutic Use

Summary: in patients undergoing coronary artery bypass graft (cagb) surgery, aspirin is commonly prescribed to prevent graft thrombosis and myocardial ischemia. however, there are still a significant number of grafts occluding in the postoperative period. this is partly attributed to reduced aspirin responsiveness, also called "aspirin resistance". at the moment, no standardized definition or laboratory test is available to quantify "aspirin resistance", and strong platelet reactivity in laboratory tests is not necessarily associated with increased thrombotic events. however, there is increasing evidence that reduced aspirin responsiveness in platelet function analyzers is associated with adverse long-term outcome and higher incidence of major adverse events in patients with stable coronary artery disease and in patients undergoing percutaneous coronary intervention. in patients undergoing coronary artery bypass graft surgery, the predictive value of a laboratory finding of reduced aspirin responsiveness remains unclear. therefore, the aim of this study is to prospectively evaluate whether the pre- and/or postoperative laboratory finding of reduced aspirin responsiveness defined by multiplatetm platelet function analyzer is associated with higher incidences of adverse outcome after 30 days and 12 months in patients undergoing cabg surgery.


Eligibility criteria:
inclusion criteria: * patient undergoing elective cabg surgery * therapy with aspirin until at least 2 days before surgery * written informed consent exclusion criteria: * missing written consent * no therapy with aspirin or therapy stopped more than 2 days before surgery * therapy with clopidogrel more than 3 days before surgery * emergency surgery * surgery including more than cabg * inborn or acquired platelet disorders * therapy with selective serotonin reuptake inhibitors (ssri) * severe hepatopathy (spontaneous quick \<70%) * severe kidney disease (creatinine clearance \< 30 ml/min)

Keywords: aspirin aspirin responsiveness long-term outcome cabg
gemcitabine in treating children with relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia

Conditions: Leukemia

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of gemcitabine in treating children who have relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia.

objectives: * determine the response rate in children with relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia treated with gemcitabine. * assess the toxicity of this regimen in these patients. outline: this is a multicenter study. patients are stratified according to disease histology (acute lymphoblastic leukemia vs acute myelogenous leukemia). patients receive gemcitabine iv over 6 hours weekly for 3 weeks. treatment repeats every 4 weeks for a maximum of 2 courses in the absence of disease progression or unacceptable toxicity. projected accrual: approximately 10-20 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of relapsed acute lymphoblastic leukemia or acute myelogenous leukemia * m3 marrow (at least 25% blasts in bone marrow aspirate) * refractory to conventional therapy patient characteristics: age: * 21 and under at diagnosis performance status: * ecog 0-2 or * zubrod 0-2 life expectancy: * at least 2 months hematopoietic: * not specified hepatic: * bilirubin normal * sgot or sgpt no greater than 2.5 times upper limit of normal renal: * creatinine normal or * creatinine clearance or radioisotope glomerular filtration rate at least 70 ml/min other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * no concurrent immunomodulating agents chemotherapy: * at least 2 weeks since prior chemotherapy * no other concurrent chemotherapy for cancer endocrine therapy: * no concurrent corticosteroids except for treatment of adrenal crises with suppressed pituitary/adrenal response * concurrent low-dose hydrocortisone (less than 100 mg/m2) allowed for allergic reactions to amphotericin or transfusions radiotherapy: * concurrent radiotherapy to localized painful lesions allowed surgery: * not specified other: * recovered from any prior therapy

Keywords: recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia
cancope: digital intervention for coping with cannabis craving

Conditions: Cannabis Use

Summary: the cancope study is a micro-randomized trial conducted to gather evidence about and compare the effectiveness of a momentary intervention to help young adults cope with cannabis cravings as they attempt to reduce their use.

the cancope study is designed to test the effectiveness of two distinct strategies (mindfulness and distraction) to cope with cannabis cravings in young adults (19 - 25 years) who are attempting to reduce their cannabis use. cannabis use is determined using a single-item question about the number of days out of the past 30 days the individual used cannabis. young adults who reported using cannabis \>10 out of the past 30 days, who were not pregnant or breastfeeding, and who were not currently in treatment for problems related to substance use were eligible to enroll in this four-week study. the cancope intervention was delivered to participants through the metricwire app, which was available for download on the participants' personal smartphones. participants were asked to complete five ecological momentary assessments (ema) per day, which asked questions related to cannabis use including one question about current level of craving on a scale of 0 - 10. if a participant reported a craving level \>4, a message was sent via the app encouraging the participant to try a mindfulness or distraction coping strategy, or the participant received a thank-you for completing the ema which served as an attention control.

Eligibility criteria:
inclusion criteria: * used cannabis at least 10 out of the past 30 days exclusion criteria: * currently pregnant or breastfeeding * currently in treatment for problems related to substance use
phase ii study of weekly paclitaxel (bms-181339) in patient with non-small cell lung cancer (nsclc)

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the efficacy and the safety of paclitaxel given weekly in patients with advanced or recurrent non-small cell lung cancer


Eligibility criteria:
inclusion criteria: * patients with no prior chemotherapy who meet either of the listed below: * patient with stage iiib or iv disease * patients with recurrent disease following potentially curative surgical resection * patients with previous chemotherapy up to one regimen exclusion criteria: * patients with serious, uncontrolled medical illness * patients with previous therapy with taxanes
the procaris study: prostate cancer risk assessment in general practice

Conditions: Prostate Cancer

Summary: the preferred method for early detection of prostate cancer (pca) in older men with family history is the prostate specific antigen test (psa test), although the method is imprecise. it produces a high number of false-positive results and increases the risk of over-diagnosis and over-treatment. yet, an increasing number of men get the psa test as part of unsystematic screening. genetic risk assessment may be a better way to identify men with low risk of pca. the main study hypothesis is that genetic information about low risk of pca can reduce the number of patients who get a psa test as part of unsystematic screening.


Eligibility criteria:
inclusion criteria: * patients who receive a psa test exclusion criteria: * age over 80 years * elevated psa-level (\> 4,0 ng/ml) concurrently or within previous 2 years * prostate or bladder disease * prostate cancer * non-caucasians * do not speak and understand danish

Keywords: psa test prostate cancer genetic screening
a real-world study of treatment patterns and effectiveness in met mutation-positive advanced lung cancer

Conditions: Advanced Lung Cancer

Summary: this is a descriptive observational study in which data are collected in an epidemiological manner. this study is not intended to alter or interfere with the current medical practice of the enrolled patients. data will be collected in a forward-looking manner. this is a descriptive observational study in which data are collected in an epidemiological manner. this study is not intended to alter or interfere with the current medical practice of the enrolled patients. data from patients on prior treatment will be collected retrospectively, and data from patients who will be treated later and included in the study will be collected in a prospective manner. the criteria for retrospective collection were consistent with those for prospective collection. eligible patients will be enrolled after ngs analysis of tumor tissue and informed consent has been obtained. information required for the study will be collected (every 3 months).


Eligibility criteria:
inclusion criteria: 1. patients must be ≥18 years of age. 2. provision of fully informed consent prior to any study specific procedures. 3. histologically or cytologically confirmed, unresectable stage iiib/iiic or stage iv nsclc. 4. genetic variants of tumor tissue detected by ngs. exclusion criteria: none.
fibrinogen concentrate and placenta acreta spectrum

Conditions: Obstetric Anesthesia Problems; Placenta Accreta

Summary: the aim of this study is to evaluate the relationship between fibrinogen use and bleeding in patients who underwent cesarean section with a prediagnosis of pas. the key question(s) it aims to answer are: \[does the use of fibrinogen concentrate reduce bleeding in pas patients?\] patients who had a cesarean section with a pre-diagnosis of pas were analyzed retrospectively. the choice of anesthesia applied to the patients and the relationship between the use of blood products and bleeding were evaluated.

our study was designed as a retrospective randomized study. patients aged 20-50 years and \>34 weeks of gestation who accepted the birth with a cesarean section with a pre-diagnosis of pas were evaluated retrospectively. examined. were randomized into 2 groups, 53 patients in each group: group1: gnf : the group without fibrinogen concentrate group 2: gf: the group with fibrinogen concentrate

Eligibility criteria:
inclusion criteria: * 20-50 years pas pre-diagnosed pregnant women * \>34 weeks of pregnancy * those with normal renal functions exclusion criteria: * patients with renal insufficiency * those with \<34 weeks of gestation * pregnant women with missing data

Keywords: fibrinogen concentrate obstetric anesthesia plasenta acreata spectrum postpartum hemorrhage
effects of tai chi exercises with cycling in subacute stroke

Conditions: Stroke

Summary: stroke, a debilitating cerebrovascular event, frequently leads to severe motor and sensory impairments resulting in a diminished quality of life. tai chi, an ancient chinese martial art known for its slow, flowing movements, emphasis on breath control, and mindfulness, presents an intriguing avenue for stroke rehabilitation. while cycling exercises facilitates muscle control of the lower limbs, which may allow putting more weight on the affected leg while standing, also beneficial for stroke survivors.

this is two-arm parallel design randomized controlled trial. participants will be selected by non-probability consecutive sampling technique, fifty stroke patients meeting the inclusion criteria will be randomly allocated into two groups (experimental and control) by online randomizer tool. the experimental group will receive tai chi exercises with cycling exercises and the control group will receive tai chi exercises alone. treatment session of 60 min will be given 3 times a week for 6 weeks. the following primary and secondary assessment tools will be used, functional reach test and berg balance scale for balance, dynamic gait index and wisconsin gait scale for gait assessment and stroke specific quality of life (ss-qol). the data will be analyzed using spps software version. 26.

Eligibility criteria:
inclusion criteria: * participants with the age ranged between 50-65 years. * participants with either gender. * patients who are in the sub-acute phase (from 2 weeks to less than 3 months after onset). * no visual field defect. * no abnormality of the vestibular organs. * no orthopedic disease. * the ability to understand and perform the exercise as instructed by the researcher * muscle power of at least grade three. * could walk at least 10 meters with or without assistive devices. exclusion criteria: * chronic stroke patient. * participants with aphasia and cognitive impairment. * cardiac arrhythmias * any condition for which exercise is contraindicated * fracture of the lower limb. * participants who are currently participating in another clinical trial or research study.

Keywords: cva, tai chi stroke rehabilitation gait parameters cycling
dose response and efficacy of gw842166 in pain

Conditions: Healthy Subjects

Summary: the purpose of this study is to assess the dose response and efficacy of single and repeat doses of gw842166 in healthy volunteers using pharmacodynamic pain assessments.


Eligibility criteria:
inclusion criteria: * healthy male or female subjects aged 18 to 50 years inclusive * body weight \>50 kg and bmi within the range 18.5 to 32 kg/m2 inclusive. * women who are not of child bearing potential exclusion criteria: * the subject has a positive pre-study urine screen for drugs of abuse or positive alcohol test. * a positive pre-study (hiv), hepatitis b surface antigen or positive hepatitis c antibody result within 3 months of the start of the study. * abuse of alcohol defined as an average weekly intake of greater than 28 units (21 units for women) or an average daily intake of greater than 3 units (2 units for women). 1 unit is equivalent to a half-pint (220 ml) of beer or 1 (25 ml) measure of spirits or 1 glass (125 ml) of wine. * where participation in study would result in donation of blood in excess of 500 ml within a 56 day period.

Keywords: mechanical pain, heat pain, dose, efficacy dose response, gw842166, single, pharmacodynamics, repeat dose,
fundus autofluorescence after macular hole surgery

Conditions: Macular Hole

Summary: funds autofluorescence (faf) indicates hyper fluorescence at the macular hole in the patients with macular hole. investigators investigate the association between faf and visual acuity, recovery of foveal microstructure, and faf in surgically closed macular holes.

ultrawide angle faf images were taken in 27 eyes before and after macular hole surgery and compared with swept source optical coherence tomographic (ss-oct) images.

Eligibility criteria:
inclusion criteria: * the patients were followed more than 6 months. exclusion criteria: * the patient were followed less than 6 months.

Keywords: macular hole
safety, tolerability, and pharmacokinetic (pk) study of dhes0815a in participants with human epidermal growth factor receptor (her)2-positive breast cancer

Conditions: Breast Cancer

Summary: this first-in-human, phase 1, open-label, multicenter, dose-escalation study will evaluate the safety, tolerability, and pk of dhes0815a as a single agent in participants with advanced and/or metastatic her2-positive breast cancer for whom established treatment has proven ineffective or intolerable or is unavailable. the study may include a dose-expansion cohort (based on an ongoing assessment of the totality of data obtained in this study) to further assess safety, tolerability, pk, and preliminary anti-tumor activity.


Eligibility criteria:
key inclusion criteria: * eastern cooperative oncology group (ecog) performance status of 0 or 1 * measurable disease by recist v1.1 with at least one measurable target lesion * locally advanced or metastatic her2-positive breast cancer that has relapsed or is refractory to established therapies * adequate hematologic and end-organ function * for dose-expansion cohort only: no more than two prior systemic chemotherapy-containing regimens in the advanced/metastatic setting (excluding trastuzumab emtansine, which is considered a targeted cytotoxic agent) key exclusion criteria: * treatment with chemotherapy, hormonal therapy (except hormone replacement therapy, oral contraceptives), immunotherapy, biologic therapy, radiation therapy (except palliative radiation to bony metastases), or herbal therapy as cancer therapy within 4 weeks prior to initiation of dhes0815a * history of exposure to the protocol specified doses of anthracyclines * pregnancy, lactation, or breastfeeding * major surgical procedure within 4 weeks prior to day 1 * evidence of a significant uncontrolled concomitant disease of the nervous system, pulmonary, autoimmune, renal, hepatic, endocrine, or gastrointestinal disorders; or a serious non-healing wound or fracture * known active bacterial, viral, fungal, mycobacterial, or other infection * clinically significant history of liver disease, including active viral or other hepatitis, current alcohol abuse, or cirrhosis * untreated or active central nervous system (cns) metastases * cardiopulmonary dysfunction, including inadequate left ventricular ejection function at baseline, less than 50% by either echocardiogram (echo) or multiple-gated acquisition scan (muga) * qt interval corrected through use of fridericia's formula (qtcf) \> 470 milliseconds (ms)
study of etafill in patients with cataract surgery via the anterior chamber

Conditions: Cataract Surgery

Summary: this prospective, single center, non-comparative, 90-day follow-up, post-market clinical investigation of etafill in patients undergoing cataract surgery. the performance is measured by the preservation of endothelial cells measured by specular microscopy at the follow-up visit in comparison to baseline values.


Eligibility criteria:
inclusion criteria: * patients indicated for cataract surgery via the anterior chamber * a negative urine pregnancy test at visit 1 or 2 * capability to understand information about the investigation, including patients' obligations, and willingness to take part, as evidenced by signed and dated informed consent exclusion criteria: * patients with a known hypersensitivity to ha or other components of the device. * patients with corneal scars or corneal dystrophies interfering with study measurements * abnormal intraocular pressure which would interfere with surgery and follow up (in opinion of the investigator) * any other condition that in the opinion of the investigator would interfere with the participation in this investigation * any person dependent on the investigator or employees of the investigation site institution or the sponsor. * current or previous (within 30 days of enrollment) treatment with another investigational drug and/or medical device or participation in another clinical study * patients whose participation in clinical trials is prohibited by the austrian medical devices act