Kornimate/medical-research-clean huggingface dataset:
dual energy computed tomography (ct) in finding bone metastases in patients with cancer

Conditions: Malignant Neoplasm; Metastatic Malignant Neoplasm to the Bone

Summary: this clinical trial studies dual energy computed tomography (ct) in finding cancer that has spread from the original (primary) tumor to the bone (bone metastases) in patients with cancer. diagnostic procedures, such as dual energy ct, may help find and diagnose bone metastases and may be more accurate compared to single energy ct alone.

primary objectives: i. compare the accuracy of single energy ct (sect) with virtual non-calcium (vnc) double energy ct (dect) to standard sect alone in the detection of metastatic bone lesions using positron emission tomography (pet)-ct as the reference standard. outline: computed tomography (ct) scans are routinely used in the evaluation of oncologic patients for initial diagnosis and subsequent disease staging. detection of bone metastasis on standard ct, however, is limited in sensitivity, particularly in case of osteolytic intramedullary lesions. recent studies have shown the ability to detect bone marrow edema using ct with the use of a virtual non-calcium (vnc) dual energy ct (dect) technique. because bone marrow edema is similar in composition to intramedullary bone metastases (i.e. both are of soft tissue composition as opposed to calcium or fat), vnc dect may also be helpful in the detection of bone marrow metastasis. cancer patients obtaining a positron emission tomography (pet) ct and a separate diagnostic ct scan as part of their routine clinical care will be enrolled into the study. the diagnostic ct scan will be performed on a dect scanner and the images will be reconstructed as sect images for routine clinical interpretation as well as vnc dect images. the sect images alone will be evaluated and scored, and then the vnc dect images will be added to the sect images for a second evaluation (consecutive reading session). multiple readers blinded to the pet-ct findings for detection of bony metastatic disease will participate. researchers hypothesize the addition of vnc dect to sect will be more accurate in the detection of metastatic bone marrow lesions compared to sect alone.

Eligibility criteria:
inclusion criteria: * patients being imaged with pet/ct for diagnosis and/or staging of disease at case comprehensive cancer center * patients with bone metastases on pet/ct * patients without bone metastases on pet/ct * all cancer types and both newly diagnosed and previously treated patients will be included exclusion criteria: * patients with intervening treatment during the time between diagnostic ct and pet/ct * time between the diagnostic ct and pet/ct greater than 30 days
study to assess the management of synthetic disease-modifying antirheumatic drug (dmard) at the onset of adverse events, intolerance or lack of efficacy in rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to find patterns in the use of non-biological dmards as the initial treatment of ra and how adverse events (aes), intolerance or lack of efficacy may impact therapeutic decisions in real life in the spanish andalusian region.


Eligibility criteria:
inclusion criteria: * patients of both sexes ≥ 18 years. * patients diagnosed with ra (according to the american college of rheumatology (acr) 2010 criteria) between january 2008 and december 2012 and who have initiated treatment with at least one synthetic dmard during that period. * patients who have given written informed consent for their data to be collected and reviewed. exclusion criteria: * patients who are already participating in a clinical trial/s at the moment of participation in this study. * patients with whom it is suspected there will be insufficient information to complete the study objectives.
safety and efficacy comparison of minocycline microgranules versus lymecycline in the treatment of mild to moderate acne

Conditions: Mild to Moderate Acne

Summary: this is a clinical trial to compare the benefits and possible adverse events of two antibiotic treatments for mild to moderate acne. it is expected that minocycline microgranules will be more effective than lymecycline with a better adverse events profile.


Eligibility criteria:
inclusion criteria: * both gender * 14 to 30 years old * mild to moderate acne * face localization * at least 20 non-inflammatory lesions or * at least 15 inflammatory lesions or * at least 30 total lesions and * less than 5 nodular lesions exclusion criteria: * patients younger than 14 or older than 30 years old * less than 20 non-inflammatory lesions or * less than 15 inflammatory lesions or * less than 30 total lesions * patients with severe acne * more than 5 nodular lesions or * more than 50 inflammatory lesions or * more than 125 total lesions * pregnant women * lactating women
high dose rate prostate brachytherapy as salvage for locally recurrent prostate cancer previously treated with external beam radiotherapy

Conditions: Prostate Cancer

Summary: high dose rate (hdr) brachytherapy is a form of radiation treatment using temporary radioactive seeds. this is done by placing very tiny catheters or tubes into the prostate and then inserting temporary radioactive seeds, called iridium 192, through these catheters. hdr brachytherapy gives precise radiation to the prostate with less radiation given to the normal tissues near the prostate. for patients who have been treated with external beam radiation to the prostate before, hdr brachytherapy can give radiation again to the prostate without exposing the normal tissues around the prostate to significantly more radiation. this may be safer than giving external beam radiation again. the purpose of this study is to test the safety of high dose rate temporary brachytherapy (hdr) for prostate cancer that has come back after external beam radiation. we want to find out what effects, good and/or bad, the treatment has on you and your recurrent prostate cancer.


Eligibility criteria:
inclusion criteria: * kps \> than or equal to 80 * able to give informed consent * able to complete toxicity scales and questionnaires * histologically mskcc confirmed diagnosis of recurrent prostate cancer. * documented history of definitive radiotherapy to the prostate gland * ipss of \< than or equal to 15 at the time of evaluation * psa \< than or equal to 15 ng/ml * organ confined disease exclusion criteria: * unable to tolerate general anesthesia * abnormal complete blood count. any of the following: * platelet count less than 75,000/ml * hb level less than 10 gm/dl * wbc less than 3.5/ml * abnormal coagulation profile: * inr \> 2.5 * abnormal liver function tests (\>1.5 x normal value) * abnormal renal function tests (creatinine \> 1.5) * evidence of metastatic disease (bone scan, radiographs, mri findings) * prostate volume \> 50 cc * unable to meet treatment planning criteria * history of rectal surgery * external beam radiation dose to the prostate \> 86.4 gy if standard treatment planning dose constraints were met * history of inflammatory bowel disease * expected survival \< 1 year * unable to undergo bone scan, ct or mri evaluation * unavailable for regular follow up

Keywords: recurrent
the registry to study safety and performance of the cordis vascular reconstruction device and delivery system

Conditions: Intracranial Aneurysm

Summary: the objective of the registry is to evaluate the real world safety and performance of the cordis enterprise™ vascular reconstruction device and delivery system (vrd) to facilitate endovascular coil embolization of intracranial aneurysms.

the data will be collected in consecutive subjects treated with the commercially available product and following standard clinical practice. this registry will be limited to subjects who have received only the cordis enterprise™ vrd during the index procedure. while only limited inclusion or exclusion criteria are specified, uniform, complete and accurate data will be collected peri-procedurally, during the index hospitalization, and during follow-up up to 6 months. all subjects should be treated according to the instruction for use (ifu) including conduct of the vrd placement, coiling procedure, application of antiplatelet medication and any other medical therapy to be provided according to local usual practice.

Eligibility criteria:
inclusion criteria: * the subject must be \>= 18 years of age and less than 80 years. * diagnosis of a ruptured (hunt and hess grade i - iii) or unruptured intracranial aneurysm at the time of the treatment * subject (or his/her legal representative) provides written informed consent for the use of his/her peri-procedural and follow-up data exclusion criteria: * diagnosis of hunt and hess grade iv or v subarachnoid hemorrhage at the time of the treatment * severe co-morbidity associated with a life-expectancy of less than six months * poor neurological status at baseline * known allergies to nitinol metal * known allergies to aspirin, heparin, ticlopidine, or clopidogrel or unable or unwilling to tolerate therapy * participation in an investigational drug or another device study is only allowed after written approval of the coordinating investigator or cordis medical monitor. * implantation of an intracranial stent associated with the symptomatic distribution within 12 weeks prior to the index procedure * implantation of carotid stent associated with the symptomatic distribution within 12 weeks prior to the index procedure * atrial fibrillation or known cardiac disorders likely to be associated with cardioembolic symptoms.
evaluation of health costs and resource utilization

Conditions: Ulcerative Colitis; Crohn's Disease

Summary: utilization of health resources in a testing based strategy versus an empiric dose escalation strategy to manage crohn's disease and ulcerative colitis in subjects with loss of response to infliximab or adalimumab.

the purpose of this study is to evaluate the utilization of health resources in a testing based strategy versus an empiric dose escalation strategy to manage crohn's disease and ulcerative colitis in subjects with loss of response to infliximab or adalimumab.

Eligibility criteria:
inclusion criteria: * males 18 years of age or older who are not receiving azathioprine or 6 mercaptopurine. * non-pregnant, non-lactating females, 18 years of age or older. * females of child bearing potential must have a negative serum pregnancy test prior to randomization, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. \[defined as a minimum of one year since the last menstrual period\]). * documented diagnosis of cd or uc. * active disease symptoms at visit 1 defined by: a. cd subjects: hbs \~ 6 uc subjects: pmcs \~ 4. * current infliximab therapy (naive to adalimumab) or current adalimumab therapy (naive to infliximab ). * a minimum of 13 weeks of infliximab or adalimumab treatment prior to visit 1 at the following dose: * stable dose of azathioprine, 6 mercaptopurine, methotrexate, and/or 5-aminosalicylates in the 4 weeks prior to visit 1. exclusion criteria: * contraindication to the use of either infliximab or adalimumab. * current infliximab treatment but not naive to adalimumab or * current adalimumab treatment but not naive to infliximab. * infliximab dosing prior to visit 1 was not 5 mg/kg at weeks 0, 2 and 6 and then q8w. * adalimumab dosing prior to visit 1 was not 160 mg at week 0, 80 mg at week 2, and then 40 mg q2w. * received any investigational drug within 30 days prior to visit 1. * serious underlying disease other than cd or uc which in the opinion of the investigator may interfere with the subject's ability to participate fully in the study. * history of alcohol or drug abuse which in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures. * stools positive for clostridium difficile. * pregnant or lactating women. * change in dose of azathioprine, 6 mercaptopurine, methotrexate, and/or 5-aminosalicylates in the 4 weeks prior to visit 1. * males 22 years of age or less who are receiving azathioprine or 6 mercaptopurine.

Keywords: harvey bradshaw score partial mayo clinical score infliximab adalimumab
project gnosis: the neurophysical and psychosocial health outcomes of tai chi for older adults with cognitive concerns or mild cognitive impairment

Conditions: Mild Cognitive Impairment (MCI); Sarcopenia

Summary: mild cognitive impairment (mci) in older adults is linked to muscle loss (sarcopenia) and can lead to dementia, with pain further impacting cognitive and physical performance. tai chi, a mind-body exercise, is recommended for managing mci as it supports cognitive function, mood, and physical health. the investigators' first goal is to characterize the correlation of heart rate variability and cortical activity on cognitive function and the psychosocial correlates of pain interference and social isolation on cognitive function at baseline and post-intervention (8 weeks of tai chi). the second goal is to explain the role of sarcopenia and obesity in the relationship between pain interference and cognitive function. the investigators also want to examine the index of the predictive capacity regarding sarcopenia and obesity on cognitive function outcomes.


Eligibility criteria:
inclusion criteria: 1. participants who are older adults, defined as ≥60 years old. 2. participants must have the ability to independently stand without the use of an assistive device for 20 minutes. 3. people with mild cognitive impairment (mci) (initial cohort) and without mci (age-gender matched healthy controls). a score of between \>18 and ≤26 on the montreal cognitive assessment (moca) will be used to classify mci. a score above 26 is considered normal. exclusion criteria: 1. participants with significant uncontrolled medication, and cardiovascular, respiratory, and metabolic symptoms will be excluded from participation in the study, as these symptoms could impact their engagement with the engagement of tai chi. 2. investigators will administer a brief screening questionnaire to assess (a) hypotension symptoms related to intensive treatment of hypertension and (b) hypoglycemia related to intensive treatment of diabetes, as these conditions are associated with cognitive decline. 3. investigators will capture data on potential sleep apnea and administer the stop-bang questionnaire to identify potential sleep-disordered breathing. participants with significant uncontrolled sleep apnea will be excluded as this could also impact their engagement in the intervention and influence the primary outcome measure of cognitive function. 2. currently or recently practicing tai chi. participants will be excluded if they are currently practicing tai chi. if participants have previously engaged in tai chi, there will be a washout period of at least 6 months before considering enrollment in the study.

Keywords: tai chi cognitive function
study cb-839 in combination with nivolumab in patients with melanoma, clear cell renal cell carcinoma (ccrcc) and non-small cell lung cancer (nsclc)

Conditions: Clear Cell Renal Cell Carcinoma (ccRCC); Melanoma; Non-small Cell Lung Cancer (NSCLC)

Summary: this study is an open-label phase 1/2 evaluation of cb-839 in combination with nivolumab in participants with clear cell renal cell carcinoma, melanoma, and non-small cell lung cancer.


Eligibility criteria:
addition eligibility criteria based on tumor type apply inclusion criteria: * ability to provide written informed consent in accordance with federal, local, and institutional guidelines * histological or cytological diagnosis of metastatic cancer or locally advanced cancer that is not amenable to local therapy * eastern cooperative oncology group (ecog) performance status of 0-1 * life expectancy of at least 3 months * adequate hepatic, renal, cardiac, and hematologic function * measurable disease by response evaluation criteria in solid tumours (recist) v1.1 criteria * resolution of treatment-related toxicities except alopecia exclusion criteria: * unable to receive oral medications * unable to receive oral or intravenous (iv) hydration * intolerance to prior anti-pd-1/pd-l1 therapy * prior severe hypersensitivity reaction to another monoclonal antibody (mab) * any other current or previous malignancy within 3 years except protocol allowed malignancies * chemotherapy, tki therapy, radiation therapy or hormonal therapy within 2 weeks * immunotherapy or biological therapy, or investigational agent within 3 weeks (note: some cohort exceptions allow anti-pd-1 therapy) * active known or suspected exclusionary autoimmune disease * any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other systemic immunosuppressive medications within 2 weeks * history of known risks factors for bowel perforation * symptomatic ascites or pleural effusion * major surgery within 28 days before cycle 1 day 1 * active infection requiring parenteral antibiotics, antivirals, or antifungals within 2 weeks prior to first dose of study drug * patients who have human immunodeficiency virus (hiv), hepatitis b or c * conditions that could interfere with treatment or protocol-related procedures * active and/or untreated central nervous system (cns) disease or non-stable brain metastases

Keywords: rcc melanoma (mel) nsclc immuno-oncology tumor metabolism glutaminase glutaminase inhibitor
colloid osmotic pressure during heart surgery in children

Conditions: Heart Defects, Congenital

Summary: clinical oedema is seen after open heart surgery with the use of cardiopulmonary bypass and hypothermia in children. the oedema formation is due to increased fluid transport from blood to tissue. this transcapillary fluid transport is dependent on differences in interstitial and plasma colloid osmotic pressure. the purpose of this investigation is to evaluate changes in interstitial colloid osmotic pressure before, under and after the use of cardiopulmonary bypass in children. the study hypothesis is that oedema developed during cardiopulmonary bypass and hypothermia is caused by increased micro vascular protein leakage and reduced colloid osmotic pressure gradient through the capillary membrane.


Eligibility criteria:
inclusion criteria: * the diagnosis of a congenital heart defect * scheduled for open heart surgery with the use of cardiopulmonary bypass * under 13 year of age * informed consent obtained from the parents exclusion criteria: * renal failure * liver failure

Keywords: congenital heart disease cardiopulmonary bypass capillary leak colloid osmotic pressure children
feasibility study of ultrasound elastography detecting prostate cancer

Conditions: Prostate Cancer

Summary: the main purpose of this study is to determine the accuracy and feasibility (possibility) of aixplorer® shearwave elastography (swe™) ultrasound system (made by supersonic imagine, inc.) for detecting prostate cancer in men undergoing radical prostatectomy.

the point estimate and its 95% confidence interval will be calculated using the exact binominal method. identification of suspicious cancer tissue in a 12 prostate zone schema: participants will undergo use: aixplorer® shearwave elastography (swe™), (supersonic imagine). areas of the prostate with high suspicion for harboring cancer will be recorded in a 12 zone prostate schema. for study purposes the prostate will be divided into zone 1(left lateral base), zone 2 (left base), zone 3 (right base), zone 4 (right lateral base), zone 5 (left lateral mid), zone 6 (left mid), zone 7 (right mide), zone 8 (right lateral mid), zone 9 (left lateral apex), zone 10 (left apex), zone 11 (right apex), zone 12 (right lateral apex).

Eligibility criteria:
inclusion criteria: * men with prostate cancer who elect surgery as the primary treatment of their cancer and to be performed at the moffitt cancer center. * biopsy confirmed prostate cancer with at least ten biopsies performed for diagnosis. * location of cancer specified in the pathology report. * pathology reviewed by moffitt pathologist exclusion criteria: * less than ten biopsies obtained at time of diagnosis. * location of cancer not specified. * pathology not reviewed by moffitt pathologist.

Keywords: elastography ultrasound prostate cancer screening
prospective study on monitoring parotid gland injury after radiotherapy for head and neck tumors using multimodal radiomics

Conditions: Xerostomia, Radiation-induced Parotid Damage,Predictivevalue,Head and Neck Cancer

Summary: exploring a non-invasive and objective method for ultra early quantitative assessment of radiation-induced parotid gland injury. to provide a new and early method for evaluating changes in parotid gland function in clinical practice, and to guide the timing of interventions to protect the parotid gland.

exploring the application value of magnetic resonance fingerprinting (mrf) and intravoxel incoherent motion (ivim) techniques in dynamically monitoring parotid gland injury and predicting the risk of dry mouth after radiotherapy for head and neck tumors. the study evaluated the changes in parotid gland cell density and microcirculation function by quantifying mrf (t1/t2 relaxation time, proton density) and ivim parameters (d value, d \* value, f value), combined with parotid gland volume reduction rate, to establish an early risk model for predicting dry mouth syndrome and optimize parotid gland protection strategies.

Eligibility criteria:
exclusion criteria: 1. contraindications to mri, such as metallic implants or claustrophobia. 2. severe comorbid conditions, including significant renal or hepatic dysfunction. 3. concurrent participation in another interventional clinical trial. 4. pregnant or breastfeeding. 5. any condition that may impair compliance with study procedures. inclusion criteria: 1. histologically or cytologically confirmed diagnosis of nasopharyngeal carcinoma. 2. scheduled to undergo radiotherapy as part of standard treatment. 3. aged 18 years or older. 4. no contraindications to mri scans (e.g., no implanted metallic devices). 5. written informed consent has been provided.