Kornimate/medical-research-clean huggingface dataset:
diffusion basis spectrum imaging of the prostate

Conditions: Prostate Cancer

Summary: diffusion basis spectrum imaging (dbsi) represents a potential leap forward in improving prostate cancer early detection: a non-invasive and accurate imaging test for clinically significant prostate cancer.


Eligibility criteria:
inclusion criteria: * over 18 years of age and willing and able to provide informed consent. * patients with no prior diagnosis of prostate cancer, who are planning to undergo prostate biopsy as clinical standard of care ("early detection cohort") * including those men with: * an elevated psa and no prior biopsy * an elevated psa and a negative prior biopsy * patients with a prior diagnosis of prostate cancer, who are currently managed with active surveillance, who are planning to undergo biopsy as clinical standard of care ("active surveillance cohort") exclusion criteria: * patients with any clinical contraindication to mri \*including but not limited to: * those with metallic implants, such as pacemakers or implantable cardioverter-defibrillators * those with cochlear implants * those with claustrophobia not relieved with medications (patients with claustrophobia who do not need medications for the scan or whose claustrophobia can be managed with medication, are eligible to participate) * those who cannot lie flat for over 1 hour * patients with prior prostate surgery for prostate cancer (e.g. radical prostatectomy, focal ablation)

Keywords: prostate cancer
evaluation of carboplatin/paclitaxel with and without trastuzumab (herceptin) in uterine serous cancer

Conditions: Endometrial Cancer

Summary: the primary objective of this study is to estimate whether the addition of trastuzumab to paclitaxel and carboplatin chemotherapy improves progression free survival when compared to paclitaxel and carboplatin alone in uterine serous papillary carcinoma (uspc) patients overexpressing her2/neu at 3+ level by immunohistochemistry (ihc)or positive by fluorescence in situ hybridization (fish).

the purpose of this study is to perform a randomized phase ii evaluation of carboplatin/paclitaxel with or without trastuzumab (herceptin) in patients with her2/neu+ advanced stage/recurrent disease with an emphasis on determining the progression free survival in uspc patients and assessing immunologic markers predictive of trastuzumab response.

Eligibility criteria:
inclusion criteria: * patients must have advanced (stage iii-iv) or recurrent histologically confirmed uspc with measurable disease. * patients must harbor a tumor her2/neu+ based upon ihc staining score of 3+ or 2+ with confirmed gene amplification by fish exclusion criteria: * patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancers, significant history of cardiac disease, uncontrolled hypertension, unstable medical issue, brain leptomeningeal, prior therapy with trastuzumab, uncontrolled seizure disorder, seropositive for hiv, active hepatitis, hemorrhagic diathesis or requiring supplemental oxygen.

Keywords: uterine serous papillary carcinoma type ii endometrial cancer her2/neu paclitaxel, carboplatin, trastuzumab
stricture definition and treatment (strident) observational study.

Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Stricture; Colon

Summary: two thirds of patients with crohn's disease require intestinal surgery at some time in their life. intestinal strictures, that is narrowing of the bowel due to inflammation and scarring, are the most common reason for surgery. despite the high frequency, associated disability, and cost there are no are no treatment strategies that aim to improve the outcome of this disease complication. the strident (stricture definition and treatment) studies aim to determine biochemical and imaging features associated with the development of strictures and in related strident studies develop strategies for treatment.

patients with asymptomatic crohn's disease strictures will be followed prospectively for 12 months using imaging (including mri/intestinal ultrasound) and biochemical analyses (including crp/calprotectin). patient's with symptomatic or asymptomatic ulcerative colitis related strictures will be followed similarly. risk factors for progression of strictures and development of symptoms will be identified.

Eligibility criteria:
inclusion criteria: * inflammatory bowel disease patients with intestinal stricture(s) identified on ct, mri or endoscopy but without associated symptoms exclusion criteria: * low rectal or anal strictures * evidence of dysplasia or malignancy from stricture biopsies or adjacent mucosal biopsies * patients for whom endoscopy is not suitable due to co-morbidities or clinical state * inability to give informed consent * suspected perforation of the gastrointestinal tract * inability to undergo mri small bowel due to a contraindication.

Keywords: inflammatory bowel disease crohn disease ulcerative colitis intestinal stricture
evaluating a chronic pain treatment program

Conditions: Chronic Musculoskeletal Pain

Summary: this interventional study seeks to evaluate the overall outcomes of a novel, emotional awareness intervention for people with chronic musculoskeletal pain and determine which patients benefit the most from this intervention. the investigators also are evaluating the effects of brief emotional communication technique embedded in the pre-treatment assessment.


Eligibility criteria:
inclusion criteria: * adults with chronic musculoskeletal pain, not accounted for by disease or tissue pathology, who are seeking or referred for this psychological treatment program exclusion criteria: * autoimmune diseases * cancer pain * illiterate * cognitively impaired * too medically ill
the effect of pneumoperitoneum and trendelenburg position on intracranial pressure: ultrasonographic measurement of optic nerve sheath diameter

Conditions: Robot-assisted Laparoscopic Prostatectomy Under General Anesthesia

Summary: the steep trendelenburg position and pneumoperitoneum during laparoscopic surgery have the potential to cause an increase of intracranial pressure (icp). previous studies have proposed that ultrasonographic measurements of the optic nerve sheath diameter (onsd) correlate with signs of increased icp. therefore, this study is aim to confirm the increased icp by ultrasonographic measurement of onsd during laparoscopic surgery.


Eligibility criteria:
inclusion criteria: * adult patients (20-90 years of age) scheduled for undergoing robot-assisted laparoscopic prostatectomy undergoing general anesthesia exclusion criteria: * patients with previous history of neurologic disease, carotid disease, transient ischemic attack, ocular disease and ocular surgery
assessing the feasibility of the use of visual aids in patient education in adults with down syndrome (ds)

Conditions: Down Syndrome

Summary: purpose: to assess the feasibility of using videos depicting people with ds to teach other adults with ds to perform healthy behaviors. hypothesis: videos of adults with ds performing healthy behaviors is a more effective way to promote healthy behaviors by adults with ds than other methods tested. this project will study whether videos showing a person with ds washing his hands correctly can improve hand washing by other adults with ds.

the subjects will be recruited and identified and consented. subjects will be randomized to one of 4 groups. i. verbal instructions on hand washing with pictures (using the illinois department of public health tools) ii. verbal instructions on hand washing and video of the adsc iii. verbal instructions on hand washing and video of an adult without ds washing his hands iv. verbal instructions on hand washing and video of an adult with ds washing his hands. videos of the handwashing process will be taken pre intervention and then again post intervention. scoring assessments will be completed upon review of the 2 files by 2 separate study team members, the second of which will be blinded to the information they will be reviewing.

Eligibility criteria:
inclusion criteria: * people with down syndrome receiving care at advocate * no known sensitivity to soap exclusion criteria: * pregnant women, prisoners * known sensitivity to soap

Keywords: down syndrome
analysis of non-invasively collected microneedle device samples from mild plaque psoriasis for use in transcriptomics profiling

Conditions: Psoriasis Vulgaris

Summary: the purpose of this study is to collect skin biopsies and non-invasive microneedle device samples from participants with mild chronic plaque psoriasis vulgaris to use for transcriptomics profiling for further investigation.


Eligibility criteria:
inclusion criteria: * participant has a history of chronic plaque psoriasis vulgaris for at least 6 months prior to the screening visit * participant has had stable psoriasis conditions for at least 3 months before screening (information obtained from medical chart or participant's physician, or directly from the participant) * participant has plaque psoriasis covering \>= 1% but \< 10% of his total bsa on day 1 * for group a: participant has one psoriasis target lesion or individual lesions within the same anatomical region (excluding palms, soles, face, scalp, and genitals), with a target lesion severity score (tlss) score of \>= 6 on day 1 allowing the collection of three microneedle device samples and one biopsy sample * for group b: participant has one psoriasis target lesion or individual lesions within the same anatomical region (excluding palms, soles, face, scalp, and genitals), with a tlss score of \>= 6 on day 1 allowing the collection of one microneedle device sample per visit (replicating the extraction on the same area at each visit) and one biopsy sample exclusion criteria: * participant is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study * participant has evidence of erythrodermic, pustular, predominantly guttate psoriasis, or drug-induced psoriasis * participant has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the sample collection or interpretation * participant is known to have immune deficiency or is immunocompromised * participant has a history of cancer or lymphoproliferative disease within 5 years prior to day 1. participants with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix are not to be excluded
ambulatory interdisciplinary rehabilitation in chronic obstructive pulmonary disease (copd)

Conditions: COPD

Summary: this randomised-controlled study is undertaken to investigate the effects of a long term low intensity outpatient training program on physical fitness and quality of life in moderate to severe copd patients.

broad evidence exists on the beneficial effects of pulmonary rehabilitation on exercise capabilities and quality of life in copd patients. clinically relevant effects have been achieved by training programs of differing design regarding setting (inpatient vs. outpatient vs. home-based), duration (short-term vs. long-term) and intensity (high vs. low intensity). while there is sufficient evidence to propose pulmonary rehabilitation its use is generally low in clinical practice. one reason may be that it is unlikely that costly programs are offered to a significant proportion of eligible patients. the ideal training program will therefore at the same time accomplish the greatest improvements regarding physical capabilities and quality of life and sustain them for the longest period at the lowest cost. the purpose of the present study is to evaluate whether a continuous, low-intensity, low-cost, physiotherapist-led outpatient pulmonary rehabilitation program is a able to achieve significant long-term improvements of exercise tolerance and quality of life in moderate to severe copd patients at a lower cost level than previously published programs.

Eligibility criteria:
inclusion criteria: * copd gold stage ii-iv * smoking history of \>20 pack years * adequate pharmacological therapy * written informed consent exclusion criteria: * respiratory insufficiency, defined as pao2\ 50 mm hg breathing room air * manifest cardiac insufficiency * uncontrolled arterial hypertension * malignant disease * symptomatic coronary heart disease resp. pathological cycle ergometry results * limited physical capabilities caused by musculoskeletal disorders * unwillingness to return for follow-up * previous or ongoing participation in exercise training programs * unability to attend at least 75% of sessions

Keywords: copd pulmonary rehabilitation
vascular reactivity in kidney disease patients

Conditions: Kidney Failure, Chronic; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: dialysis patients suffer from many problems with blood vessels and this is even more so for patients with the added complication of diabetes. diabetics have a number of reasons for vascular disease and one of the new areas of research is looking at the cells that line the blood vessels, called endothelial cells. it is thought that the number of red blood cells in the blood (haemoglobin concentration) affects the function of these cells. there is very little information available on what haemoglobin level is best for dialysis patients. as diabetics account for almost 40% of dialysis patients worldwide it is important to understand the effect different haemoglobin levels will have on the blood vessels. hypothesis: endothelial cell function and the related expansile capacity of blood vessels are affected by different haemoglobin concentrations \[hb\] in dialysis patients.

this project is going to ask dialysis patients (both diabetic and non-diabetic) to undergo a series of tests at three different time points over a one year period: a baseline set of tests, tested when haemoglobin is maintained at 130-140g/l and repeat the tests when haemoglobin is maintained at 105-115g/l. the current recommendation for haemoglobin is 110-120g/l. patients will not be required to take any study medication but a specialist kidney doctor, using their usual medications of iron and erythropoietin therapy, will change their haemoglobin levels.

Eligibility criteria:
inclusion criteria: 1. aged 18-80 years 2. patients receiving either conventional haemodialysis 3-4 x week, for a duration of \> 6 months or peritoneal dialysis for a duration \>6 months 3. stable dialysis access for at least 3 months (permcath / ptfe / avf) 4. on erythropoietin and iron therapy, with stable \[hb\] x 2 months (105 - 135g/l) exclusion criteria: 1. uncontrolled bp: requiring dry weight or medication changes within 4 weeks prior to study 2. patients with dysrhythmias 3. pre dialysis sbp\> 180 mmhg on \> 2 times within a 2 week period 4. between dialysis weight gain \> 5% of body weight (if evident \> 2 times/ 2 week period) 5. soft tissue ulcers 6. non traumatic amputations 7. unstable cardiac function: ischaemic or non ischaemic events requiring modification of therapy, or admission to hospital within 3 months of study start: according to clinical discretion 8. planned operative procedures within 6 months of study start (including transplant, cabg, ptca, vascular surgery) 9. dementia 10. clinical inability to comply with testing 11. malignancy (active / under treatment) 12. known hypo-responsiveness to ert (\>200u/kg/wk) 13. evidence of chronic gastrointestinal bleeding 14. inadequate dialysis (pru \< 65% or kt/v \< 1.2) 15. participation in investigational study within last 3 months

Keywords: diabetes hemoglobin dialysis vascular reactivity
a study of the effects of oc000459 in subjects known to suffer from grass pollen induced allergic rhinitis

Conditions: Allergic Rhinitis

Summary: the study will assess the efficacy of oc000459 200 mg twice daily orally in comparison to placebo when subjects are challenged in the vienna challenge chamber for 6 hours. this is a randomised, double blind, placebo controlled, two way crossover evaluation. there will be a screening period of up to three weeks and a washout period of at least one week between the two treatment periods. there will be a follow up one to three weeks after the last dose of study drug.


Eligibility criteria:
inclusion criteria: * males aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years. * subjects must be free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological and psychiatric disease as determined by history, physical examination and screening investigations. * fev1 within normal limits (≥90% of predicted). * atopy defined by a positive cutaneous response to mixed grass pollen within the last 12 months or at screening. * asymptomatic at screening * non smokers for at least the past 12 months exclusion criteria: * medical conditions likely to affect the outcome of the study. * nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases. * presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function * immunotherapy treatment course including inhaled or local corticosteroids in the past 28 days.

Keywords: allergic rhinitis crth2
dexamethasone or dexamethasone in combination with thalidomide as salvage therapy

Conditions: Multiple Myeloma

Summary: the purpose of this investigational trial is to find out how well patients respond and how long their response lasts when treated with a standard regimen of dexamethasone with or without thalidomide and also find out what kind of side effects patients will experience.

maintenance dexamethasone patients will receive 40 mg dexamethasone days 1-4 only, every 3-4 weeks. response will be assessed at least every 3 months while on maintenance therapy. appropriate h2 blocker and antibiotics will also be given. thalidomide thalidomide will continue at a dose of 400 mg daily, or at the dose that was reduced and judged to be well tolerated in induction therapy. thalidomide will be given as an oral, once daily dose at bedtime. those patients unable to tolerate dexamethasone may continue on thalidomide alone until criteria for removal from treatment is met.

Eligibility criteria:
inclusion criteria: * all patients must have a confirmed diagnosis of previously treated, active multiple myeloma, with hypoproliferative/low risk relapse following at least one autologous transplant. * patients must be 18 years of age or older. women of childbearing age and fertile men must use a medically acceptable means of birth control while on study and for 6 months thereafter. * patients must sign an informed consent to participate in this study, and be fully aware of the known teratogenic potential of this drug combination. * patients must have a swog performance status of 0-2. * patients must have adequate renal function, as defined by serum creatinine \< or = 3.0 mg/dl. * patients must be off chemotherapy (including steroids) and local radiotherapy for \> or equal 3 weeks prior to entering the study. exclusion criteria: * no other concurrent therapy for myeloma is permitted while on protocol. * there must be no evidence of active infection requiring iv antibiotics.

Keywords: myeloma thalidomide dexamethasone
orthodontic treatment with a part-time wearing esthetic removable appliance

Conditions: Malocclusion

Summary: the trial is aimed to investigate an orthodontic treatment with a new removable-part-time-wearing appliance, based on "high-tech" technology. the appliance should be wear only 12-14 hours a day, and is made of a single silicone aligner, made specifically for the patient, using 3-d screening technology of the patient's malocclusion. the aligner has a designed pathway "built-in" for the tooth to move, from the original position of the malocclusion to the "end point" - the correct position. the force system, that is needed in order to generate tooth movement, is produced by tiny air-balloons which are incorporated in the aligner. the study hypothesis is, that an orthodontic treatment can be done successfully with this part-time wearing appliance.

the appliance include: * silicone aligner (made specifically for the patient. * simple air pump to blow air in the tiny balloons. the patient is guided to wear the appliance 12-14 hours a day, after filling air in the balloons, under the doctor's instructions. clinical examination for follow-up will be done every 4 weeks.

Eligibility criteria:
inclusion criteria: * mild to moderate class i malocclusion * good general health * good oral hygiene exclusion criteria: * bad cooperation * any mental or health problem * severe class i malocclusion, class ii or class iii malocclusion

Keywords: malocclusion aligner crowding expansion orthodontic treatment
sleep apnea: mechanism and cerebrovascular consequences

Conditions: Sleep Apnea, Obstructive; Stroke

Summary: this study will determine the effect of ventilatory stimulation on obstructive sleep apnea in selected patients with stroke. we will select a subset of patients with stroke in the prior 3 months who are most likely to have ventilatory instability as a cause of the upper airway obstruction as indicated by the absence of obesity, an abnormal hypocapnic apnea threshold and resolution of obstructive apnea during co2 administration. following baseline polysomnography, patients will be randomly assigned to acetazolamide (250 mg hs \[at bedtime\]) versus placebo for 7 days. polysomnography will be repeated and then subjects will cross-over therapies for another 7 days followed by a final nocturnal polysomnography.

this study never enrolled patients. it was a component of a larger va merit grant and the other aims of the grant were completed but due to logistic issues and recruitment challenges this particular protocol was never made active.

Eligibility criteria:
inclusion criteria: * we will select non-obese patients (body mass index \[bmi\] \ 15 events/hr of study time). * patients with stroke will be selected based on the following criteria: 85 years old or less with a history of ischemic stroke within 3 months resulting in mild to moderate neurological impairment (rankin scale \< 3) exclusion criteria: * hemorrhagic stroke, * a history of chronic obstructive lung disease, * left ventricular ejection fraction (lvef) \<55% * evidence of nasal or pharyngeal obstruction on physical examination.

Keywords: sleep apnea stroke ventilatory control