Kornimate/medical-research-clean huggingface dataset:
low-intensity shockwave therapy for non-bacterial prostatitis/pelvic pain syndrome

Conditions: Chronic Prostatitis

Summary: the aim of the study is to investigate and compare the treatment efficacy and safety of eswt vs sham treatment for cp/cpps patients.this is a triple-blind, randomized, parallel group sham-controlled clinical study.


Eligibility criteria:
inclusion criteria: 1. participant must 18 to 60 years of age. 2. participant has signed and dated the appropriate informed consent document. 3. participant has had a clinical diagnosis of cp/cpps defined as symptoms of discomfort or pain in the perineal or pelvic region for at least a three (3) month period within the last six (6) months exclusion criteria: 1. participant has evidence of facultative gram negative or enterococcus with a value of ≥ 1000 cfu/ml in mid-stream urine (vb2). 2. participant has a history of prostate, bladder or urethral cancer. 3. participant has undergone pelvic radiation or systemic chemotherapy. 4. participant has undergone intravesical chemotherapy. 5. participant has unilateral orchialgia without pelvic symptoms, active urethral stricture or bladder stones, or any other urological condition associated with luts, any neurological disease or disorder affecting the bladder. 6. participant has undergone prostate surgery or treatment. 7. participant with penile or urinary sphincter implants. 8. participant has been diagnosed with cancer during the last 5 years, or had any surgery in the pelvis. 9. participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol. 10. pi-rads score 4-5 in the baseline prostate mpmri 11. pi-rads score 3, psa\>3 and age \> 40 years 12. positive (suspicious for malignancy) dre.
dynamic cerebral autoregulation of remote ischemic conditioning combined with intravenous thrombolysis for acute ischemic stroke

Conditions: Remote Ischemic Conditioning

Summary: the purpose of this study is to determine the impact of remote ischemic conditioning on dynamic cerebral autoregulation in patients with acute ischemic stroke receiving intravenous thrombolysis.

in this study, cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. the experimental group receive basic treatment and remote ischemic conditioning for 200mmhg, 2 times within 6 hours to 24 hours from thrombolysis. the control group receive basic treatment and remote ischemic conditioning control for 60mmhg, 2 times within 6 hours to 24 hours from thrombolysis . both groups underwent dynamic cerebral autoregulation measurements at days 1 to 2 and 7 to 10 of onset and recorded the relevant indexes, and blood samples were collected before and 24 hours after intravenous thrombolysis, we aimed to determine the impact of remote ischemic conditioning combined with intravenous thrombolysis on dynamic cerebral autoregulation in acute ischemic stroke patients. we hypothesized that remote ischemic conditioning would improve dynamic cerebral autoregulation in patients with acute ischemic stroke receiving intravenous thrombolysis.

Eligibility criteria:
inclusion criteria: 1. age≥18 years, \< 80 years, regardless of sex; 2. patients with clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis; 3. baseline nihss \>= 5, and \<= 25; 4. baseline gcs ≥8; 5. signed and dated informed consent is obtained exclusion criteria: 1. patients who undergo endovascular treatment; 2. mrs ≥ 2 before the onset of the disease; 3. severe organ dysfunction or failure; 4. those who have a history of atrial fibrillation; 5. the patients who have the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb, acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc; 6. pregnant or lactating women; 7. patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons; 8. he/she is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission; 9. other conditions that the researchers think are not suitable for the group.

Keywords: remote ischemic conditioning dynamic cerebral autoregulation
metformin prostate cancer adjuvant trial

Conditions: Prostate Cancer; Prostate Cancer Recurrent

Summary: this is a phase ii clinical study to determine if metformin can increase prostate specific antigen (psa) doubling time for patients with prostate cancer who have failed primary treatment with radiation, or surgical patients that are at high risk for recurrence based on surgical pathology. men with confirmed prostate cancer and rising serum psa levels will receive metformin and will be monitored for psa response and disease progression.

prostate cancer patients who have received treatment with radiation therapy or surgery, who have indicators of high-risk disease will be administered 750mg metformin extended release twice per day for a period of 9 months. metformin is an fda-approved drug that is prescribed to treat high blood sugar levels in patients with type 2 diabetes. to track prostate cancer response in study participants, investigators will obtain prostate specific antigen (psa) levels every three months for the duration of the trial.

Eligibility criteria:
inclusion criteria: * male \> 18 years of age * biopsy confirmed adenocarcinoma of the prostate * able to swallow and retain oral medication * hemoglobin a1c \<7.0% * able and willing to participate in the full 12 months of the study * able to understand instructions related to study procedures * able to read and write english exclusion criteria: * metastatic prostate cancer * prostate specific antigen doubling time \< 6 months * prior chemotherapy, hormonal therapy, oral glucocorticoid therapy, gonadotropin-releasing hormone analogue therapy * current or previous use of 5α-reductase inhibitors, antiandrogen drugs, metformin, oral or injectable diabetes drug * diagnosis of type 1 diabetes mellitus * known hypersensitivity to metformin * any condition associated with increased risk of metformin associated lactic acidosis * participation in any investigational or marketed drug trial within 30 days prior to screening or during study period * any unstable, serious co-existing medical conditions including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to screening * history of megaloblastic anemia * abnormal liver function test (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase or serum creatinine above upper limit of normal) * history of other malignancies, with the exception of adequately treated non-melanoma skin cancer, stage 1 melanoma, non-muscle invasive bladder cancer, or other solid tumors curatively treated with no evidence of disease for at least 5 years * history or current evidence of substance abuse within 12 months of screening * history of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or post an additional risk to the subject

Keywords: prostate cancer prostate cancer recurrent
research on the efficacy of the "t.o.p. computer training" procedure in the treatment of alcohol dependence

Conditions: Alcohol Dependence

Summary: the investigators evaluate the efficacy of a computerised program (t.o.p. tool) consisting of an approach avoidance training (aat) (to retrain action tendencies for alcohol-related stimuli), a visual probe training (vpt) (to retrain attentional bias for alcohol-related stimuli) and the combination of both training procedures versus placebo training, as an add-on to treatment as usual (psycho-education and cognitive behavioral therapy). the investigators include hospitalized detoxified alcohol-dependent patients, who receive a four week training procedure, existing of a pre-assessment, 6 training sessions and a post-assessment. outcome measures consist of behavioral measures (consumption of alcohol - self report over 1 year), questionnaires (audit; craving on 9-point likert scale) and approach avoidance and visual probe measurement tasks. a six month and 1 year follow-up is included (behavioral measures and audit). further, the investigators will also assess credibility (9-point likert scale) of the training procedure before the start of the training and immediately after the assessment of the aat and vpt training.


Eligibility criteria:
inclusion criteria: * hospitalized alcohol-dependent patients, choosing for abstinence en committed to treatment * detoxification (with benzodiazepines) is terminated * dutch speaking exclusion criteria: * neurological condition, such as korsakoff syndrome * cognitive problems (cut-off \<26/30 on the montral cognitive assessment) * psychotic disorders * visual and motor problems at the hands * non-dutch speaking * mental retardation * patients who are illiterate

Keywords: approach avoidance training attentional bias training alcohol depencence relapse
investigating the long-term efficacy and safety of two doses of nn-220 (somatropin) in short stature due to noonan syndrome

Conditions: Genetic Disorder; Noonan Syndrome

Summary: this trial is conducted in asia. the aim of the trial is to investigate the long-term efficacy and safety of two doses of nn-220 (somatropin) in short stature due to noonan syndrome.


Eligibility criteria:
inclusion criteria: * japanese children with noonan syndrome clinically diagnosed in one of the following ways: 1. clinically diagnosed by at least two medical experts using van der burgt score list, 2. clinically diagnosed by one medical expert using van der burgt score list and diagnosed by result of genetic testing for noonan syndrome, 3. clinically diagnosed by one medical expert using van der burgt score list and diagnosed by the same medical expert based on the results of centralised evaluation of facial change using van der burgt score list * height sds (standard deviation score): -2 sds or below (according to the japanese reference data) * age: boys 3 to below 11 years, girls 3 to below 10 years * height records must be available within the period between 40 and 64 weeks prior to visit 1 (screening) * prepubertal children (definition for girls breast and pubes of tanner stage is i, and none of menses, and for boys testicular volume below 4 ml, and pubes and penis of tanner stage is i) exclusion criteria: * children with known or suspected hypersensitivity against human growth hormone (hgh) or related products (including any components of the trial products) * children with diabetic type diagnosed with the japanese diabetes society classification * children with history or presence of active malignancy * children who have received gh (growth hormone) treatment * children who have received systemic administration of the following medications within two years prior to visit 1 (screening): thyroid hormone (except replacement therapy), antithyroid hormone, androgen, oestrogen, progesterone, anabolic steroid, adrenocortical steroid treatment period for at least 13 weeks), derivative of gonadotropin releasing hormone and somatomedin c (igf-i)
study of subtalar arthrodesis using allostem® versus autologous bone graft

Conditions: Degenerative Osteoarthritis; Post-traumatic; Arthrosis; Rheumatoid Arthritis & Other Inflammatory Polyarthropathies; Rheumatoid Arthritis of Subtalar Joint

Summary: the purpose of this clinical trial is to evaluate the outcome of implanting allostem® graft with appropriate rigid internal fixation hardware as an alternative to autograft bone graft with rigid fixation in subtalar arthrodesis procedures. the primary objective of this clinical trial is to compare the overall fusion rate of the investigational to the control treatment. fusion will be determined by clinical findings, radiographs and computed tomography (ct) of the subtalar joint 24 weeks (6 months) after the trial surgery.


Eligibility criteria:
inclusion criteria: 1. must be diagnosed with degenerative osteoarthritis, post-traumatic arthritis, inflammatory arthritis (ie: rheumatoid arthritis) or other conditions of the hindfoot requiring subtalar arthrodesis. 2. patients must be able to attend follow-up examinations for the duration of the trial. 3. the patient is at least 18 years of age and skeletally mature, or less than 80 years of age at the time of surgery. 4. is willing and able to comply with the clinical trial plan and able to understand and sign the patient informed consent form. exclusion criteria: 1. younger than 18 years old or older than 80 years old. 2. has a condition that prevents ambulation or completion of any of the trial measurements. 3. requires fusion of additional hindfoot or ankle joints simultaneously (i.e. a pantalar, tibiotalocalcaneal or triple arthrodesis). concomitant midfoot or forefoot procedures, such as osteotomies, tendon or metatarsal procedures are not exclusionary. 4. has treatment planned for the arthrodesis which does not require the use of screws. 5. has any active infection of the hindfoot, a systemic infection or bacteremia. 6. has received any treatment within the past 12 months which may interfere with bone metabolism \[bisphosphonates (fosamax, actonel, boniva, reclast) and calcitonin (miacalcin)\]. 7. is scheduled to have any surgical procedure on the contralateral foot within 6 weeks before or after the study procedure.

Keywords: other hindfoot conditions requiring subtalar arthrodesis post-traumatic arthritis
the effects of spironolactone on calcineurin inhibitor induced nephrotoxicity

Conditions: Disorder Related to Renal Transplantation

Summary: the purpose of this study is to assess whether the diuretic drug spironolactone can prevent chronic damage to transplanted kidneys caused by the medication that prevents rejection. spironolactone prevents the effects of the hormone aldosterone. aldosterone is suspected of being involved in the processes leading to chronic rejection of transplanted kidneys. hence, by blocking the effects of aldosterone we hope to be able to prevent loss of kidney function in transplant patients.

aim: the purpose of this study is to assess whether spironolactone can prevent the formation of fibrosis in transplanted kidneys. background: calcineurin inhibitors (cni) are one of the cornerstones of immunosuppressive therapy after kidney transplantation. the introduction of cni has caused a significant decrease in acute rejections. however, cni also have known side effects. these include the formation of tubulointerstitial fibrosis in the transplanted kidney, contributing over time to impaired kidney function and reduced graft survival. the mineralocorticoid aldosterone may be involved in the development of renal fibrosis. recent observations suggest that aldosterone plays a central role in the pathogenesis of cni nephrotoxicity and that the mineralocorticoid-receptor-blocker spironolactone could be a useful agent to prevent it. methods: this study is a randomized, placebo-controlled, double-blind study in which 170 renal transplant patients will be recruited from two nephrological departments in southern denmark. patients will be randomized to three years of treatment with either spironolactone or placebo added to the standard immunosuppressive treatment. renal graft biopsies, various molecular tests of tissue, blood and urine, chrome-edta clearance, 24-hour bloodpressure measurement and blood samples will be performed at inclusion, after 1 year, 2 years and upon completion.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years 2. proteinuria \< 3 g/24 hours 3. creatinine clearance ≥ 30 ml/min 4. s-potassium \< 5,5 mmol/l 5. negative pregnancy test at the inclusion and anticonception exclusion criteria: 1. intolerance to spironolactone 2. creatinine clearance \< 30 ml/min 3. s-potassium ≥ 5,5 mmol/l 4. resin or digoxine treatment 5. pregnancy or planned pregnancy 6. relevant organic, systemic or mental illness 7. anticipation of lack of compliance or understanding the study

Keywords: fibrosis calcineurin inhibitor kidney transplant chronic rejection
specialize dysphagia training and knowledge/competency of nurses

Conditions: Dysphagia

Summary: the aim of this research is to determine the effect of specialized dysphagia training on knowledge and competency of nurses.


Eligibility criteria:
inclusion criteria: * nurses of both gender * at least one year of experience * nurses working at govt. hospital exclusion criteria: * undergraduate nursed working as intern at hospital

Keywords: dysphagia swallowing disorder dysphagia screening nurses role assessment
docetaxel in combination with iressa in previously treated patients with pancreatic cancer

Conditions: Metastatic Pancreatic Carcinoma

Summary: the purpose of this study is to find out what activity the combination of docetaxel and iressa have against metastatic pancreatic cancer.

iressa will be taken orally once daily without interruption. docetaxel will be administered intravenously once weekly for two out of every three weeks. patients will also receive dexamethasone the night prior, morning of, and the evening after docetaxel treatment to help prevent an allergic reaction. every week that chemotherapy is given, blood tests and vital signs will be taken. after the first 6 weeks of therapy a ct scan (or other radiological procedure) will be done to assess the progress of the disease. if the cancer is responding to the treatment and no unacceptable side effects have occured, treatment with iressa and docetaxel will continue. ct scans (or other radiological procedure) will be performed at week 12 and every 9 weeks thereafter to monitor the progress of the disease.

Eligibility criteria:
inclusion criteria: * metastatic pancreatic carcinoma (excluding pancreatic endocrine tumors); histologic confirmation of either the primary or metastatic site. * ecog performance status of \< 1 * \> 4 weeks since completion of previous chemotherapy * \> 4 weeks since participation in any investigational drug study * peripheral neuropathy of grade \< 1 * patients must have failed a gemcitabine-containing regimen administered in the metastatic, adjuvant, or locally advanced setting. * absolute neutrophil count (anc) \> 1,500/mm3 * hemoglobin \> 9.0gm/dl * platelets \> 100,000/mm3 * total bilirubin \< 2.0mg/dl * ast and alkaline phosphatase \< 5 x upper limit of normal (uln) * albumin \> 2.5gm/dl * ca 19-9 \> 1.5 x uln exclusion criteria: * prior therapy with taxane or with epidermal growth factor receptor (egfr) inhibitors * more than one prior chemotherapy treatment * clinically significant cardiac disease * major surgery within 4 weeks of the start of study treatment * evidence of central nervous system (cns) metastases or carcinomatous meningitis or history of uncontrolled seizures, central nervous system disorders. * uncontrolled serious medical or psychiatric illness * pregnant or breast-feeding women * other active malignancy * inability to swallow tablets or evidence of a gastrointestinal malabsorption syndrome * known severe hypersensitivity to iressa * concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or st. john's wort. * history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 * any evidence of clinically active interstitial lung disease * ascites requiring paracentesis

Keywords: pancreatic carcinoma iressa docetaxel
a multi-site clinical evaluation of the aries flu assay in symptomatic patients

Conditions: Respiratory Tract Infection; Bronchitis; Pneumonia

Summary: the aries flu assay is a real-time pcr based qualitative assay for the direct detection and differentiation of respiratory viral nucleic acid in nasopharyngeal swabs specimens. the objective of this study is to establish the diagnostic accuracy of aries flu assay.

the aries flu assay is a real-time polymerase chain reaction (pcr) based qualitative in vitro diagnostic test for the direct detection and differentiation of respiratory viral nucleic acid in nasopharyngeal swabs specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings. the objective is to establish the diagnostic accuracy of aries flu assay through a multi-site, method comparison on prospectively collected, left-over, and de-identified, nasopharyngeal swab specimens. diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).

Eligibility criteria:
inclusion criteria: * the specimen is from a patient suspected of having respiratory tract infection for whom a requisition has been made for viral testing * the specimen is from a male of female subject who was either hospitalized, admitted to a hospital emergency department or visiting an outpatient clinic. * the specimen is a nasopharyngeal swab exclusion criteria: * the specimen is not a nasopharyngeal swab * the specimen was not properly collected, transported or stored according to the instructions provided by the sponsor.

Keywords: aries flu
observational, prospective clinical study to evaluate biomarkers as indicators of acute bacterial or viral infections

Conditions: LRTI; UTI; Gastroenteritis; Systemic Infections/Bacteremia/Meningitis; Fever Without Source

Summary: this is an observational prospective study of an in-vitro diagnostic (ivd) assay planned to enroll 632 subjects. the study will be conducted in two stages: stage a is aimed at identifying individual biomarkers and constructing a multi-parametric diagnostic model, whereas stage b is aimed at testing the multi-parametric diagnostic model using a fresh cohort of patients. a collection of clinical, radiological and laboratory data will be gathered in order to establish a final diagnosis. blood samples will be analyzed and the levels of approximately 700 and 250,000 biomarkers will be determined using immunoassays and molecular measurements respectively. a final diagnosis will be determined based on a majority decision of a panel of three or more independent physicians. based on the final diagnosis, the accuracy of individual biomarkers and combined sets of biomarkers for differentiating between distinct groups of patients will be evaluated.


Eligibility criteria:
inclusion criteria: patients who are at least one month old and are willing (either the subject or his legal guardian) to sign an informed consent will be eligible for inclusion. for the infectious and non-infectious disease groups, additional inclusion criteria have to be met. these will include: in the infectious disease group: * peak fever \>37.5°c (99.5°f) * clinical suspicion of an acute infectious disease * symptoms duration ≤ 12 days in the non-infectious disease control group: - a non-infectious disease or healthy individuals exclusion criteria: patients who will meet one or more of the following criteria will be excluded from the study: * evidence of another episode of acute infectious disease in the last two weeks * diagnosed congenital immune deficiency (cid) * current treatment with immunosuppressive therapy such as: active chemotherapy,post-transplant drugs,high dose steroids (\>1 mg/kg/day prednisone or equivalent). * active radiotherapy * immune-modulating/suppressive drugs including monoclonal antibodies, intravenous immunoglobulin (ivig), cyclosporine, and anti-tnf agents * current treatment with immune stimulants such as: interleukin (il)-2, granulocyte-monocytes/granulocyte colony-stimulating factor (gm/g-csf),interferon. * an active hematological malignancy * a diagnosis of myelodysplastic syndrome or myeloproliferative disease * a proven or suspected human immunodeficiency virus (hiv)-1, hepatitis b virus (hbv), or hepatitis c virus (hcv) infection