Kornimate/medical-research-clean huggingface dataset:
imaging and genomic biomarkers to predict response in prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate the imaging and gene expression biomarkers in prostate cancer. participants have high-risk prostate cancer and have indicated they will undergo external beam radiation therapy, brachytherapy, and androgen deprivation therapy (ebrt+btx+adt). participants can expect to be in this study for up to 5 years.

this is a pilot study to prospectively investigate potential predictive imaging and genomic biomarkers for patients with high-risk prostate cancer treated with standard of care ebrt + btx + adt. the primary imaging modalities that will be evaluated will be psma positron emission tomography (pet) and multi-parametric magnetic resonance imaging (mri). pre-treatment pet/mri scans will also be obtained as part of standard of care prior to study enrollment. response will be assessed on a mid-treatment pet/mri scan obtained for research purposes after completion of ebrt but prior to brachytherapy boost. pet/ct (computerized tomography) may be used instead if pet/mri is not technically possible. imaging response will be compared to pathology from image-directed prostate biopsies taken at the time of the brachytherapy boost. the primary genomic marker that will be evaluated is a clinically available gene-expression array, decipher, that will be obtained as part of standard of care prior to study enrollment.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * histologically confirmed adenocarcinoma of the prostate * cancer classified as high-risk or very high-risk by national comprehensive cancer network (nccn) criteria: grade group ≥4, psa \>20, or primary tumor stage ≥t3a * ecog performance status 0-1 * agreed to undergo ebrt, high dose rate (hdr) brachytherapy boost, and 6-36 months of adt as part of standard of care therapy prior to study enrollment * able to undergo a hdr brachytherapy implant: pre-radiation ipss score ≤20 with or without medical management; prostate ≤60 cc as measured by mri or ultrasound; no prior trans-urethral resection of prostate (turp); and, median lobe extending into the bladder \<1 cm * no prior or concurrent malignancy unless disease-free for at least 5 years exclusion criteria: * evidence of regional or distant metastatic disease on pre-treatment bone scan, pelvic mri, and/or ct of the abdomen/pelvis * prior pelvic radiation therapy
a bioequivalence study of tobramycin and prednisolone acetate compared to predforte

Conditions: Eye Infections; Postoperative Complications

Summary: the purpose of this study is to demonstrate the bioequivalence of the combination test agent, prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension compared to predforte (prednisolone acetate 1.0%) ophthalmic suspension. bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate.


Eligibility criteria:
inclusion criteria: * bilateral cataract surgery * avoid disallowed medications throughout study exclusion criteria: * contraindications to the use of the test agents * known allergy or sensitivity to the test agents or components * history of steroid response following topical administration of corticosteroids in the eye * wore contact lenses 48 hours prior to visit 1 * an intraocular pressure that is greater than 22 mmhg or less than 5 mmhg in either eye * any significant illness that could be expected to interfere with study * used ophthalmic, topical or systemic corticosteroids or an immunomodulator for 7 days prior to surgery

Keywords: cataract extraction anti-bacterial agents steroids
ph i/ii of vitamin d on bone mineral density & markers of bone resorption

Conditions: Breast Cancer; Bone Diseases

Summary: aromatase inhibitors are potent suppressors of breast cancer growth, but side effects include bone loss, fractures, arthralgias and myalgias. we hypothesize vitamin d administration might be beneficial in treating these symptoms and to protect bone.


Eligibility criteria:
inclusion criteria: 3.1.1 all postmenopausal women with histology-confirmed invasive primary breast cancer, who have completed primary surgical or radiotherapy (xrt) with or without adjuvant chemotherapy and are candidates to receive adjuvant therapy with aromatase inhibitors will be screened for eligibility. postmenopausal is defined as satisfying one or more of the following criteria: having had bilateral oophorectomy; aged more than 60 years; or aged 55-59 years with an intact uterus and amenorrheic for at least 12 months; or if amenorrheic for less than 12 months (after receiving hysterectomy, hormone therapy or chemotherapy). 3.1.2 at the time of study enrollment, participants will have completed primary surgical or xrt with or without adjuvant chemotherapy. chemotherapy will be completed at least 28 days prior to enrollment. 3.1.4 participants will be women between 18-85 years of age. women and minorities will be actively recruited. though breast cancer extremely rarely occurs in children and men, this study will only recruit adult females. 3.1.5 participants will have a life expectancy of at least 5 years. 3.1.6 participants will have eastern clinical oncology group (ecog) performance status 0-2. 3.1.7 ability to understand and the willingness to sign a written informed consent document exclusion criteria: 3.2.1 medications affecting bone metabolism (bisphosphonates, anticonvulsants, chronic heparin therapy, chronic glucocorticoid use \> 5 mg/day prednisone or equivalent, teriparatide). 3.2.2 use of any investigational drug within past 90 days. 3.2.3 metastatic breast cancer. high risk for osteoporosis/fractures (bmd \ 0.20) history of renal stones renal failure with creatinine over 2.0 3.2.4 considering that vitamin d3 is produced by the human body, allergy to vitamin d3 is not expected to develop. subjects with known history of allergic reaction to compounds used to manufacture capsules (rice powder) will be excluded form this study. 3.2.5 recent history of excessive alcohol or drug use. 3.2.6 as this study will recruit post-menopausal patients, thus pregnant or nursing patients are not part of this investigation. 3.2.8 this study is designed to study women after completing primary therapy for breast cancer. survivors of previous cancers and hiv-positive subjects will not be excluded.
multiomic analysis of body fluid in acute traumatic brain injury

Conditions: Brain Injuries, Traumatic

Summary: the goal of this experimental observation study is to figure out differently expressed biomarkers in body fluid in traumatic brain injury patients. the main questions it aims to answer is: * which rna, protein and metabolites are differently expressed in lesion tissues? * what molecular mechanism is participated in tbi? participants will be treated by emergency operation, and their body fluid samples will be collected in emergency room and during the operation.


Eligibility criteria:
inclusion criteria: 1. age \>18 and \<65 2. within 12 hours after brain injury 3. control group is hydrocephalus 4. gcs ≥3 and ≤8 5. closed brain injury with frontotemporal contusion 6. need emergency intracranial hematoma evacuating or cerebrospinal fluid shunting operation 7. patient's agents are informed and consent the research exclusion criteria: 1. with tbi, stroke, ich or intracranial tumor history 2. death within 24 hours 3. immunosuppression state 4. severe organ dysfunction 5. complicated infective disease 6. pregnant

Keywords: traumatic brain injury body fluid biomarker multiomic analysis
occupational and environmental origins of anca vasculitis: contribution of data from the national network for vigilance and prevention of occupational pathologies (rnv3p)

Conditions: ANCA Associated Vasculitis; Occupational Diseases; Environmental Exposure

Summary: the main objective is to identify specific risk factors for anca vasculitis of occupational and/or environmental origin (exposures identified by questioning, geographical distribution of cases) from the rnv3p data. the secondary objectives are as follows: * description of cases of anca vasculitis seen in french occupational pathology consultation centres: * reasons for consultation, * occupational and environmental etiologies described * occupational situations responsible * aptitude notices * recognition as an occupational disease * identification of specific risk factors for anca vasculitis of occupational and/or environmental origin (exposures identified on questioning, geographical distribution of cases). * for occupational and non-occupational cases of anca vasculitis: identification of difficulties encountered by patients at work and proposed work adaptations. * estimation of the number of applications for recognition of disabled worker status made within this patient group. * identification of clinical severity and autoimmune profiles of anca vasculitis of occupational and/or environmental origin.


Eligibility criteria:
inclusion criteria: * patient with anca vasculitis defined according to the international classification of diseases (icd-10), i.e. m 308, m 31, n 057 and l 95, or mentioned as the reason for consultation in the text mining summary. * seen in consultation in the occupational disease consultation centres belonging to the rnv3p * no opposition exclusion criteria: * refusal to participate
application of injectable platelet-rich fibrin for the treatment of temporomandibular joint osteoarthritis

Conditions: Osteoarthritis

Summary: the authors designed a randomized, controlled, double-blind clinical trial after the ethical approval by the university ethics committee. the patients with temporomandibular joint osteoarthritis (tmj-oa) randomly assigned one of the two treatment groups: intra-articular injection of injectable platelet-rich fibrin (i-prf) after arthrocentesis procedure as i-prf group and arthrocentesis procedure alone as control group. the primary outcome variable was pain levels at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month. the secondary outcome variables included maximum mouth opening (mmo), lateral and protrusive movements.

the authors designed a randomized, controlled, double-blind clinical trial after the ethical approval by the university ethics committee. the patients with tmj-oa randomly assigned one of the two treatment groups: intra-articular injection of i-prf after arthrocentesis procedure as i-prf group and arthrocentesis procedure alone as control group. all treatment procedures were completed by the same experienced surgeon under the local anesthesia. the procedure of arthrocentesis was performed using the standard technique and after arthrocentesis procedure, the i-prf injection was performed in the test group. the primary outcome variable was pain levels at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month. the secondary outcome variables included maximum mouth opening (mmo), lateral and protrusive movements.

Eligibility criteria:
inclusion criteria: * patients with osteoarthritis (oa) of one or two temporomandibular joint (tmj) * maximum mouth opening less than 35 mm * impeded protrusive and lateral movements * localized pain of the affected joint exclusion criteria: * systemic or malignant diseases affecting tmj-oa assessment * previous invasive or surgical treatments of tmj unrelated to oa * edentulous patients * pregnancy

Keywords: osteoarthritis injectable platelet-rich fibrin arthrocentesis
metabolic tracking and weight gain during pregnancy

Conditions: Gestational Weight Gain

Summary: in this study, the investigators aimed to have pregnant women use a hand-held device to track increases in daily caloric needs during pregnancy. weight gain was assessed over time with the goal of reducing excessive gestational weight gain relative to a group of pregnant women who received standard prenatal care.

specific aims the investigators pursued the following specific aims: 1. evaluate the impact of a mobile, real-time metabolism tracking device on gestational weight gain (gwg) (i.e. total weight gain and rate of weight gain) in pregnant women. the investigators postulated that the metabolism tracking (breezing) group would have a higher proportion of women who gain the appropriate amount of weight per iom recommendations. further, the investigators expected the women in the breezing group to gain a mean weight within +/- 3 lbs of their recommended gwg range per iom guidelines, compared to standard care-receiving controls. 2. assess changes in resting energy expenditure during pregnancy in relation to self-reported dietary intake (at baseline, 4 weeks, 8 weeks, and 12 weeks). the investigators hypothesized that energy requirements would change across the second trimester and that self-reported caloric intakes would correlate with resting energy expenditure (ree)-corrected values (from breezing) for women in the breezing group. exploratory aims 1. evaluate the associations among objective and self-reported sleep parameters (actigraphic total sleep time, sleep onset latency, wake after sleep onset, and mid-sleep point; sleep diary total sleep time, sleep onset latency, wake after sleep onset, and mid-sleep point; insomnia symptoms; and sleep disordered breathing risk) and gwg within the breezing and control groups.

Eligibility criteria:
inclusion criteria: * all english and spanish-speaking, pregnant women * gestational age \< 17 weeks at time of recruitment * aged 18 years or older exclusion criteria: * high-risk pregnancies that include the following diseases or conditions: fetal growth problems, medical history of hypertension, gastrointestinal disorders, malabsorptive diseases, hyper or hypo-parathyroid conditions, hiv, diabetes (types 1 and 2 or gestational diabetes), asthma/lung disease, cardiac disease or conditions, current smoker (i.e. women who have smoked 100 cigarettes in their lifetime and now smoke every day or some days) history of eating disorder, or other metabolic conditions known to affect maternal health and fetal development * women pregnant with multiple gestations
malnutrition and inflammation in dialysis patients in taiwan

Conditions: Hemodialysis; Hypercholesterolemia; Malnutrition; Inflammation; Kidney Failure, Chronic

Summary: according to the reports of the united states renal data system (usrds), there is a 25% annual mortality rate with nearly 50% of all reported maintenance hemodialysis (hd) patient deaths attributed to atherosclerosis-related complications. although traditional risk factors of cardiovascular disease (cvd) are common in end-stage renal disease (esrd) patients, they alone may be insufficient to account for their high prevalence of cvd. recent evidence demonstrated high plasma homocysteine levels have been established as a risk factor of chronic inflammation and atherosclerosis in patients with esrd. malnutrition and inflammation was associated with poor quality of life, morbidity and mortality. we, the researchers at national taiwan university hospital, hope to establish the best predictive profile of hd patient outcome. thus, we establish several protocols to complete this work.


Eligibility criteria:
inclusion criteria: * on hd three times a week for more than 3 months (minimizing the confounding effects of residual renal function) exclusion criteria: * malignancy; * obvious infections or inflammatory diseases; * preexisting haematological disorders; and, * clinically significant bleeding, transfusion, hospitalization, surgery, or renal transplantation
evaluation of the efficacy and safety of the doxasozin gastrointestinal therapeutic system (gits) in patients with prostate enlargement

Conditions: Prostate

Summary: the primary objectives were to determine the efficacy and safety of the gits formulation of doxazosin in taiwanese patients with prostate enlargement.


Eligibility criteria:
inclusion criteria: * taiwanese male subjects between 50 and 80 years of age who had: a primary diagnosis of bph, defined as having an enlarged prostate (confirmed by digital rectal examination \[dre\] and/or b-mode ultrasound); an ipss score of ≥12; and a qmax in the range of 5 to 15 ml/sec in a total voided volume of ≥150 ml, were eligible for the study. exclusion criteria include but not limited to: * previous prostate surgery, presence of a prostate stent or microwave thermotherapy and/or balloon dilatation within the previous 6 months * concomitant therapy or previous therapy within 14 days with agents known to affect bladder or urethral function.

Keywords: benign prostate hyperplasia
tailored anti-inflammatory (a-i) diet for hispanics with ulcerative colitis (uc)

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to test the effect of an anti-inflammatory diet that incorporates native foods of the hispanics/latino (h/l) diet on disease remission in h/l patients with ulcerative colitis (uc) and to identify biomarkers of response to dietary therapy.


Eligibility criteria:
inclusion criteria: * documented diagnosis with ulcerative colitis from medical records. * self-identify as hispanic /latino * ages 16-75 * sccai between 3-9 (no greater than 12 bowel movements a day) * fecal calprotectin \> 150mg/dl. * on stable medications for their disease for the past 3 months * likeability of latin foods (starchy vegetables, rice, tropical fruits, plantains) * no recent inflammatory bowel disease (ibd) related hospitalization in the last month. exclusion criteria: * diagnosis of crohn's disease (cd). * prior ileoanal anastomosis (j-pouch) or diversion * no recent hospitalizations on the last 4 weeks * no clostridium difficile or enteric infections on the last 4 weeks * no use of probiotics on the last 4 weeks * patients following the specific carbohydrate diet or mediterranean diet or anti-inflammatory diet * no active cancer or conditions limiting their ability to follow a diet (heart failure, end stage renal disease) * pregnancy, breastfeeding or planning to become pregnant during study period * use of total parenteral nutrition at the time of screening and during the study period * other significant or life-threatening co-morbidities * the need for antibiotic use during the study period * adults unable to consent * ages less than 16 and \> 75 years old * prisoners
narrowband uvb treatment in patients with vitiligo

Conditions: Vitiligo

Summary: the study offers narrowband uvb light therapy to patients who have 5% of their body involved with vitiligo. the hypothesis is that narrowband uvb promotes melanocyte proliferation in vitiligo lesions.

all patients will receive phototherapy, with narrowband uvb, three times a week for six months, or a total of 78 treatments. 6mm punch skin biopsies (2) will be done prior to starting therapy, once during treatment (2) and at the completion of the study (2). clinical assessments and photography will be done parallel to the skin biopsies. results (clinically and histologically) will be analyzed.

Eligibility criteria:
inclusion criteria: * age 18 years of age or greater * vitiligo with extensive skin involvement (\>5% body surface affected). exclusion criteria: * no treatment with topical steroids, calcineurin inhibitors or vitamin d analogs for at least 4 weeks prior to entering the study. * no treatment with systemic therapies, including methotrexate, etretinate, puva, or cyclosporine 4 weeks prior to entering the study.

Keywords: narrowband ubv phototherapy skin biopsies
'fitness to fly' tests in children with type ii respiratory failure

Conditions: Neuromuscular Diseases; Central Hypoventilation

Summary: the conventional hypoxic challenge test might not predict 'fitness-to-fly' equally well in all patients. patients at risk of hypercapnia with supplemental oxygen are not well studied. th investigators will study children who have either neuromuscular weakness or central hypoventilation and who require nocturnal or intermittent daytime ventilator support. the study also aims to assess feasibility of a randomised controlled trial (rct) comparing the standard hypoxic standard test to a modified test designed to better suit children with type two respiratory failure.

this study will assess feasibility of pulse oximetry (spo2), end tidal carbon dioxide (etco2) and transcutaneous carbon dioxide partial pressure (tcco2) measurement during a modified hypoxic challenge test (hct) in 12 children with neuromuscular weakness and 12 with central hypoventilation.

Eligibility criteria:
inclusion criteria: * ≤18 years * neuromuscular weakness or central hypoventilation * established nocturnal or intermittent daytime ventilatory support exclusion criteria: * unable to sit in the plethysmograph * cardiac anomaly with right-to-left shunt
extended cross-sectoral nurse follow-up after discharge from a geriatric ward - benefits and challenges. a mixed-method study

Conditions: Extended Cross-sectoral Nurse Follow-up After Discharge From a Geriatric Ward

Summary: purpose by using both quantitative and qualitative research methods to examine the impact of a coordinated home visit by a geriatric nurse and a community (home care) nurse to vulnerable older patients recently discharged from a geriatric department. the project will address the transition between health care sectors by examining how nursing care information is communicated between sectors, and whether in-home use of digital health solutions can optimize clinical assessments leading to relevant changes in treatment plans and prevention of acute readmissions. user perspectives of both health professionals, patients and their relatives will be applied. in the quantitative study the primary endpoints are acute readmissions within 30-days and 90-days. the secondary endpoints are 1 year-mortality, numbers of quantitative clinical assessments (e.g., clinical assessment scores, vital signs, poct) and their associations with clinical decision making, time to readmission, days out of hospital. financial costs will be assessed. the qualitative study will provide insight into the challenges and barriers in the transition between hospital and home and opposite as experienced by the patient. secondly, with a user perspective (i.e. patient, relatives, health professionals) the study will provide in-depth knowledge in the personal care needs of vulnerable patients and how they can be met in a cross-sectoral collaboration between an out-going geriatric nursing team and the home care nursing team. finally, the important identified complex areas of nursing care during transition will be described and suggested implemented in educational curricula of health professionals.


Eligibility criteria:
inclusion criteria: * eligible participants are patients acutely admitted to g-ouh, residents in odense municipality, and discharged to own home with arranged home care for personal care, or discharged to permanent care in a care home. exclusion criteria: * excluded from the study are patients discharged to a temporary skilled nursing facility, terminally ill patients with an anticipated short life expectancy, and incapacitated patients, e.g., patients with a diagnosis of dementia or persistent symptoms of cognitive impairment due to delirium during the whole in-hospital stay. patients with a permanent address in a care home are not excluded by their type of residence unless they are mentally incapacitated.