Kornimate/medical-research-clean huggingface dataset:
ga-68 maa distribution in pae patients

Conditions: Benign Prostatic Hyperplasia

Summary: purpose: the purpose of this study is to evaluate ga-68 maa distribution on pet/mri after injection into the prostatic arteries in patients without prostate cancer who are being treated with prostate artery embolization for benign prostatic hyperplasia. participants: study subjects will be 5 men scheduled to undergo the pae procedure at unc hospital for benign prostatic hyperplasia. procedures (methods): study subjects will undergo pae using the standard technique. prior to embolization of the prostatic artery with the bland embolic agent, ga-68 maa will be injected. standard departmental radiation protection procedures will be followed. after the pae procedure is complete, the patient will be transported to the unc biomedical research imaging center to undergo pet/mri.

this study is an initial proof of concept evaluation to determine the feasibility of using y-90 radioembolization performed using the sniper balloon occlusion microcatheter to treat localized prostate cancer. this will be performed by evaluating ga-68 maa distribution on pet/mri after injection into the prostatic arteries in patients without prostate cancer who are being treated with prostate artery embolization for benign prostatic hyperplasia. the distribution of the radiotracer activity within the prostate and any activity in adjacent organs will be determined for when the tracer is injected into the central prostatic arteries.

Eligibility criteria:
inclusion criteria: * male * age \> 40 * prostate gland \>50 grams as measured by pre-procedural cta * have previously taken bph medication for 6 months without desired improvement of luts or has started medication and stopped due to unwanted side effects * moderate to severe luts as defined by ipss score \>18 * peak urine flow rate (qmax) \<12 ml/sec * capable of giving informed consent * life expectancy greater than 1 year exclusion criteria: * severe vascular disease * uncontrolled diabetes mellitus * immunosuppression * unable to lie flat, still or tolerate a pet/mri scan. * neurogenic bladder and/or sphincter abnormalities secondary to parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc. * complete urinary retention * impaired kidney function (serum creatinine level \> 1.8 mg/dl or a glomerular filtration rate \< 60 as approximated using serum creatinine levels) unless anuric and on dialysis. * confirmed or suspected bladder cancer * urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology * ongoing urogenital infection * previous pelvic radiation or radical pelvic surgery * confirmed or suspected malignancy of the prostate based on dre, trus or psa (\> 10 ng/ml or \> 4.0 ng/ml and \< 10 ng/ml with free psa \< 25% of total psa without a negative biopsy). * uncorrectable coagulopathy including inr \> 1.5 or platelets \< 50,000 * contrast hypersensitivity refractory to standard medications (antihistamines, steroids)
evaluation of safety and tolerability of atb-320 in participants with progressive or metastatic solid tumors

Conditions: Solid Tumors

Summary: the purpose of this study is to evaluate the safety and tolerability of atb-320 in patients with progressive or metastatic solid tumors

1. primary objective: to evaluate the maximum tolerable dose (mtd), recommended phase 2 dose (rp2d), and dose limiting toxicities (dlts) of atb-320 in patients with progressive or metastatic solid tumors. 2. secondary objective: to evaluate safety and tolerability of atb-320 in patients with progressive or metastatic solid tumors. 3. exploratory objective: to evaluate pharmacokinetics, pharmacodynamics, and efficacy of atb-320 in patients with progressive or metastatic solid tumors.

Eligibility criteria:
inclusion criteria: 1. adult (18 years or older) at the time of screening 2. histologically confirmed solid tumor 3. participants must have failed standard therapy or cannot tolerate standard therapy. 4. participants must be able to provide tissue samples, either stored at the institution or obtained from a biopsy performed prior to administration of the investigational product, and have tumor that can be safely biopsied throughout the study. 5. eastern cooperative oncology group performance status (ecog ps) of 0 or 1 6. life expectancy of ≥ 12 weeks exclusion criteria: 1. has received chemotherapy within 21 days prior to the first planned dose of the investigational product, or if less than 5 times the half-life of the chemotherapeutic has passed (whichever is shorter) 2. has received immunotherapy within 2 weeks of the first planned dose of investigational product 3. major surgery within 4 weeks prior to the first planned dose of the investigational product 4. previous malignant tumors, other than the target indication to be investigated in this study, within 3 years prior to screening (participants with locally malignant tumors such as basal cell carcinoma/squamous cell carcinoma of the skin, carcinoma in situ (cervix, breast), thyroid papillary carcinoma that have undergone potentially curative therapy are eligible to participate in the study. 5. current enrollment in any other clinical trial or has received another investigational product or medical device treatment within 28 days of first planned dose (participants who are undergoing safety follow-up phase of a clinical trial may participate if more than 28 days have passed since the last dose of the previous investigational product) 6. has received prior radiotherapy within 2 weeks of the first planned dose. participants who have received palliative radiotherapy for non-central nervous system (cns) disease within 2 weeks of first planned dose are allowed to participate after 1-week washout (participants must have recovered from any radiation-related toxicities, not require corticosteroid treatment, and without radiation pneumonitis) 7. history of hypersensitivity to the active ingredients or excipients of the investigational product or other drugs
direct application of integra bilayer matrices on bare calvarium without preliminary burring

Conditions: Wound Care; Pressure Ulcer; Venous Ulcer; Surgical Wound; Trauma Wounds; Draining Wound

Summary: this study is to determine if large, full thickness scalp wounds with exposed calvarium resulting from acutely created extirpative defects can be reliably and durably resurfaced with idrt without burring or fenestration as a preliminary step, regardless of the size of the calvarial defect.

large full thickness scalp wounds often present a reconstructive challenge, as the size of the defect and the presence of denuded bone often preclude local flap options and skin grafting as methods of coverage. integra dermal regeneration template (idrt) has shown great utility in these types of wounds due to its ability to take in wounds with diminished vascularity, but the limits of this ability have not been determined. when used for full thickness scalp defects with exposed calvarium, for example, the accepted practice is that burring of the outer table to gain access to the vascularized diploic space is a necessary prerequisite step, although this is not always possible or desirable. the clinical question being investigated is whether healthy calvarium is sufficient for durable idrt and subsequent skin graft take in wounds with a large surface area of denuded calvarium.

Eligibility criteria:
inclusion criteria: any full-thickness scalp wound extending to the cranium, devoid of pericranium that is: 1. greater than or equal to 2 cm and/or is deemed by the treating physician not to be amenable to closure by simple means, primary closure or local flap. 2. occurring in as elder patient \> 55 years old with co-morbid conditions that constitute and anesthetic risk (asa) \>=3 that demonstrates punctate bleeding from healthy appearing cortical bone following debridement/extirpation exclusion criteria: 1. hypersensitivity of bovine collagen and/or chondroitin 2. previous treatment under same protocol 3. current or planned treatment/medication know to interfere with the rate and quality of wound healing. 4. suspected signs of wound infection 5. suspected/known diagnosis of osteomyelitis, osteoradionecrosis, or non-availability of cortical bone 6. anticipated defect following debridement or tumor extirpation extending past the outer cortical layer or cranium 7. history of radiation to the field 8. history of other conditions/illness compromising the wound healing process (esrd, immunosuppression), 9. absence of punctate cortical bleeding 10. prior surgeries that would be expected to impair wound healing or vascularity of the underlying bone(e.g. history of craniectomy/bone flap, history of scalp flap/vp shunt.

Keywords: interga dermal regeneration template (idrt), bare calvarium, scalp wounds, skin graft
a behavioral trial for the treatment of methamphetamine dependence. - 1

Conditions: Substance-Related Disorders

Summary: the purpose of this study is to examine behavioral treatment for methamphetamine dependence.

to characterize meth. withdrawal symptoms using a multidimensional withdrawal questionnaire; to field test and investigate the effect of using an algorithm developed for discriminating between new use and residual carry-over of meth metabolites in urine and to evaluate the treatment response of meth. users to participation in the thrice weekly psychosocial protocol to be used as a "platform" in future pharmacotherapy trials.

Eligibility criteria:
inclusion criteria: male or female at least 18 yrs of age; dsm-4 diagnosis of methamphetamine (meth) dependence; be willing to comply with study procedures; verbalize understanding of consent and provide written consent and willingness to complete study procedures; be seeking treatment for meth dependence. exclusion criteria: additional criteria available during screening at the site.
sertraline for preventing post-stroke depression and improving rehabilitation outcomes

Conditions: Cerebrovascular Accident; Depression

Summary: this study will determine the effectiveness of sertraline administration after a stroke in preventing the onset of post-stroke depression.

persons who suffer from a stroke are at high risk for developing post-stroke major depression (psmd), an illness that has a negative impact on post-stroke physical rehabilitation and is associated with increased morbidity and mortality. unfortunately, early detection and successful treatment of post-stroke major depression improves, but does not normalize, stroke rehabilitation outcomes compared to stroke survivors who never developed post-stroke depression. therefore, preventing the onset of psmd and its associated disability is an attractive possibility. this study is a placebo controlled, 10-month double-blind trial of sertraline in the prevention of psmd in stroke survivors, with a 2-month naturalistic continuation phase. the primary outcome will be the incidence of major depression post-stroke. additional outcomes will include the severity of depressive symptoms post-stroke and the level of disability experienced by the two treatment groups. an exploratory analysis will also be conducted to elucidate participant characteristics that may be moderators of the participants' response to the preventive intervention, thereby refining the profile of disabled stroke survivors most likely to benefit from the preventive intervention. for information on a related study, please follow this link: http://clinicaltrials.gov/show/nct00781326

Eligibility criteria:
inclusion criteria: * ischemic stroke within 3 months of study entry * admitted to a upmc hospital for acute inpatient treatment or rehabilitation of stroke * speaks english * females willing to use an effective form of birth control throughout the study exclusion criteria: * meets dsm-iv-tr criteria for a major depressive episode * history of any bipolar disorder * psychotic or history of a psychotic disorder * meets dms-iv tr criteria for alcohol or substance abuse or dependence criteria within 3 months of study entry * current treatment with antidepressant medication for any reason (e.g., anxiety disorder, neuropathic pain) * primary hemorrhagic stroke * language impairment severe enough to prevent valid neuropsychiatric assessment * history of another cns disease other than prior stroke or psychiatric illness (e.g., head trauma, multiple sclerosis, hiv with cns involvement) * pulse \ 100 beats per minute * significant hyponatremia (na \<130meq) * current hypothyroid state * medically unstable including symptoms of delirium (determined by review of the subject's medical status with the treating (clinical) physician; standard blood chemistry lab work will be obtained if not checked within the preceding 30 days) * history of sensitivity to sertraline * pregnant or breastfeeding

Keywords: rehabilitation
the learning curve of probe-based confocal laser endomicroscopy (pcle) images interpretation in gastric intestinal metaplasia (gim)

Conditions: Gastric Intestinal Metaplasia

Summary: the learning curve of probe-based confocal laser endomicroscopy (pcle) images interpretation in gastric intestinal metaplasia (gim) objective: the aim of this study is to evaluate the learning curve of pcle images interpretation in gim. research design: blinded review of pcle images for the diagnosis of gim sample size: five beginner endoscopists will be assigned in this study to read approximately 80 videoclips data analysis: roc curve is analyzed by spss version 16. expected benefit and clinical application information on the learning curve for gim interpretation from pcle images in order to develop early gastric cancer detection

background and rationale: gastric cancer remains the second leading cause of cancer related death in the world. the incidence and mortality rate is predominant in east asia\[1\]. usually, gastric cancer is asymptomatic in early stage; therefore, most patients are in the advanced stage and incurable at diagnosis. the pathogenesis of intestinal type gastric cancer is sequential and multistep pathway. gastric intestinal metaplasia (gim) is the precancerous lesion for intestinal type gastric cancer\[2\]. the strategies which can detect precancerous and/or early cancerous transformation are very beneficial because only early gastric cancer can potentially be cured by endoscopic treatment. probe-based confocal laser endomicroscope or pcle is useful for gim detection with 94% in sensitivity\[3\]. however, this perfect sensitivity in pcle interpretation is provided in only expertise. we still do not know how to be an expert in gim interpretation. no study about learning curve in gim interpretation by pcle published observation and measurement: collect the accuracy in gim interpretation from pcle reported in roc curve methodology: 1. six inexperienced pcle readers were recruited. 2. all inexperienced pcle readers must attend the learning session. 3. self-review from cd is recommended for all inexperienced pcle readers 4. two-week interval for examination in gim interpretation from 20 new histology-proved pcle images (gim and normal mucosa) for 5 sessions are on schedule after training session. 5. all inexperienced pcle readers need to review the training cd at least a day before each examination. 6. the accuracy rate in each examination will be recorded individually for each inexperienced pcle reader. 7. roc curve is reported for learning curve in gim interpretation from pcle images. data collection: all data will be processed and recorded by one physician.

Eligibility criteria:
inclusion criteria: * first year fellow of gastroenterologist who never have the experienced in pcle interpretation.
phase 1 study of daewon-es(b) & megace in healthy male volunteers under fasting and fed condition

Conditions: Healthy

Summary: the purpose of this study is to evaluate pharmacokinetics of daewon dw-es(b) 625mg/5ml and megace 800mg/20ml in healthy male volunteers under fasting and fed condition.


Eligibility criteria:
inclusion criteria: * adult males aged 20 to 40 years at screening. * no significant congenital/chronic disease. no symptoms in physical examination. * appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis. * be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. subject must provide written informed consent prior to study participation. exclusion criteria: * history or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders. * history of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
integrative care for type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: a two year, two arm pragmatic trial to investigate the integration of naturopathic care with conventional medical care to provide additional benefit beyond that of conventional medical care alone in achieving adequate control of diabetes.


Eligibility criteria:
inclusion criteria: * males or females, enrolled as a patient with we-fht * ages 21-75 years old * diagnosed with type 2 diabetes and not adequately controlled (hba1c \> 7.0mmol/l) * currently seeking care with a medical doctor, nurse practitioner and/or physician assistant * willingness to adhere to randomized treatment with availability for follow-up * ability to answer self- and interviewer- administered questions in english or have an english speaking caregiver who can aid in answering self- and interviewer- administered questions * ability to provide written informed consent or give informed consent through substitute decision maker * capacity to maintain a diary and log of treatments and recommendations given during study exclusion criteria: * lacking capacity for consent * pregnancy or an intention to become pregnant in the following two years * breastfeeding * history of myocardial infarction within the past 6 months * chronic kidney (egfr \<30 ml/min) or liver disease * actively receiving care from a complex care diabetes clinic * history of severe hypoglycemia in the last year resulting in hospital emergency care \[where hypoglycemia is defined to be: 1) development of autonomic or neuroglycopenic symptoms, 2) low plasma glucose level (\<4.0mmol/l for patients treated with insulin or an insulin secretagogue) and 3) symptoms responding to the administration of carbohydrate\] or hypoglycemia unawareness * current bolus or pre-mixed insulin treatment * limited life expectancy (\< 6 months) * high level of functional dependency (inability to perform common activities of daily living) * in participants aged 65yoa to 75yoa, the following also serve as exclusion criteria: 1. recent mi or stroke (within last 6 months) 2. nyha chf functional capacity stage iii or above 3. nyha chf objective assessment stage c or greater (http://www.heart.org/heartorg/conditions/heartfailure/aboutheartfailure/classes-of-heart-failure_ucm_306328_article.jsp) 4. planned revascularization procedure (pci or coronary artery bypass graft) or coronary angiogram within 90 days after screening or randomization

Keywords: uncontrolled type 2 diabetes hba1c >7.0%
near infrared spectroscopy (nirs)

Conditions: Aortic Arch Surgery

Summary: this study is designed to assess the feasibility of evaluating cerebral saturation during critical periods of deep hypothermia circulatory arrest and selective antegrade cerebral perfusion.


Eligibility criteria:
inclusion criteria: * is male or female * is of any race or ethnicity * is greater than or equal to eighteen (18) years of age * weighs greater than or equal to 40 kilogram * is not known to be pregnant * understands english * is undergoing aortic arch surgery with planned deep hypothermia circulatory arrest, either with or without select antegrade cerebral perfusion * is able and willing to provide informed consent exclusion criteria: * is less than eighteen (18) years of age * weighs less than 40 kilogram * is known to be pregnant * does not understand english * has known sensitivity to adhesives * is unable or unwilling to provide informed consent

Keywords: near infrared spectroscopy neuromonitoring aortic arch surgery
glioma patients registry based on radiological, histopathological and genetic analysis

Conditions: Glioma

Summary: this prospective study aims to collect clinical, radiological, pathological, molecular and genetic data including detailed clinical parameters, mr and histopathology images, molecular pathology and genetic sequencing data. by leveraging artificial intelligence, this registry seeks to construct and refine algorithms that able to predict molecular pathology or clinical outcomes of glioma patients based on mr images and histopathology images, as well as revealing related mechanisms from genetic perspective.

non-invasive and precise prediction for molecular biomarkers such as 1p/19q co-deletion, mgmt methylation, idh and tertp mutations, and patients survival is challenging for gliomas. with the development of artificial intelligence, much more potential lies in the preoperative conventional/advanced mr imaging (t1 weighted imaging, t2 weighted imaging, flair, contrast-enhanced t1 weighted imaging, diffusion-weighted imaging, and perfusion imaging), and in the histopathology images of he slices of gliomas could be excavated to aid prediction of molecular pathology and patients' survival of gliomas. this study aims to collect clinical, radiological, pathological, molecular and genetic data including detailed clinical parameters, mr and histopathology images, molecular pathology (1p/19q co-deletion, mgmt methylation, idh and tertp mutations, etc) and genetic data (whole exome sequencing, rna sequencing, proteomics, etc), and seeks to construct and refine algorithms that able to predict molecular pathology or clinical outcomes of glioma patients based on mr images and histopathology images, as well as revealing related mechanisms from genetic perspective.

Eligibility criteria:
inclusion criteria: * patients must have radiologically and histologically confirmed diagnosis of primary glioma * life expectancy of greater than 3 months * must receive tumor resection * must have sufficient frozen tissues and peripheral blood samples for sequencing * must have high-quality mr images and histopathology images * signed informed consent exclusion criteria: * no gliomas * no sufficient amount of tumor tissues for detection of molecular pathology * patients who are pregnant or breast feeding * patients who are suffered from severe systematic malfunctions

Keywords: artificial intelligence mr images histopathology images sequencing mechanism
berlin atrial fibrillation registry

Conditions: Acute Ischemic Stroke; Atrial Fibrillation

Summary: investigator-initiated prospective multicentre hospital-based registry to uncover the proportion of self-reported anticoagulation in stroke patients with atrial fibrillation and assessing the proportion of stroke, intracranial bleeding and all-cause death in the short (at 3 months), mid-term (at 12 months) as well as long term (at 24 months) after ischemic stroke or transient ischemic attack in an unselected urban population in germany. in addition, annual follow-up is planned yearly up to 5 years after enrollment.


Eligibility criteria:
inclusion criteria: * acute ischemic stroke or transient ischemic attack (with clinical deficit on admission or corresponding brain mri lesion) * age ≥ 18 years * known atrial fibrillation or ecg recording documenting atrial fibrillation during the in-hospital stay for acute ischemic stroke or transient ischemic attack * written or oral informed consent * willingness to take part in the planned follow up examinations exclusion criteria: * life expectancy \< 1 year (before stroke) * assumed post-stroke life expectancy \< 1 month according to stroke severity * chronic anticoagulation for reasons other than atrial fibrillation