Kornimate/medical-research-clean huggingface dataset:
embr thermal device for hot flash management in prostate cancer

Conditions: Prostate Cancer; Hot Flashes

Summary: this study is being conducted to evaluate if the embr thermal device is useful for men who experience bothersome hot flashes as a result of prostate cancer treatment.

the embr thermal device is a smart device that is worn on the inside of the wrist. it is about the size of a smart watch. the embr thermal device produces cooling or warming temperature sensations that make some people feel slightly cooler or warmer. this objective of this study is to evaluate if the embr thermal device is useful for men who experience bothersome hot flashes as a result of prostate cancer treatment. the study will take place over 4 weeks. the primary outcome is feasibility of the embr thermal device in men with prostate cancer. secondary outcomes include preliminary efficacy of the device, which will include the change in hot flash interference sleep measures (sleep impairment and fatigue). this is a remote study--all study assessments will be completed electronically.

Eligibility criteria:
inclusion criteria: * have received a diagnosis of prostate cancer and have received treatment with gnrh agonist or antagonist therapy or orchiectomy at least 1 month prior to enrollment. * may have received prior definitive radiation therapy or surgery (\>60 days prior to study). * have bothersome hot flashes (occurrence ≥ 28 times per week and at least moderately bothersome). * presence of hot flashes for \>30 days prior to study entry. * have a working smartphone (iphone 6 or greater; or android 8.0 or greater). * willing to downloading and use the embr thermal device companion app on their phone * willing to wear the embr thermal device for 4 weeks, and charge and sync the device daily * in order to complete the mandatory patient-completed measures, participants must be able to speak and/or read english exclusion criteria: * planned treatment with chemotherapy and/or any medical intervention that will impact hot flashes, sleep, or other daily activities of daily life during the 4-week study. * history of a known sleep disorder, other than insomnia (eg, obstructive sleep apnea, restless leg syndrome), or medical or psychiatric condition that affects sleep, or undergoing treatment for insomnia. * history of cognitive impairment or dysfunction. * seizure history, history of recurrent falls, or known brain metastases. * uncontrolled intercurrent illness. * individuals with a second malignancy other than non-melanoma skin cancers. * individuals taking psychotropic medications or illicit drugs that may alter cognition, concentration, or behavior. * individuals taking prescription sleep medications. * individuals who report consuming more than 7 alcoholic beverages/week and/or frequent alcohol consumption within 2 hours prior to bed.

Keywords: androgen deprivation therapy orchiectomy prostate carcinoma night sweats hormone therapy
homocysteine in patients with sepsis

Conditions: Sepsis

Summary: after stimulation by lipopolysaccharide (lps), the one-carbon metabolism of macrophages was significantly up-regulated, the expression of key enzyme 5,10-methylenetetrahydrofolate reductase increased. in vitro experiments we found that lps stimulation can increase the expression of mthfr mrna and protein in macrophages, suggesting that aerobic glycolysis may trigger cytokine storm through one-carbon metabolism. homocysteine (homocysteine, hcy) is an important intermediate product of one-carbon metabolism. a number of studies have shown that hcy is positively correlated with the level of pro-inflammatory factors, significantly enhancing cytokine storm. however, the relationship between hcy and serum pro-inflammatory factors in patients with sepsis and the effect of hcy on the prognosis of patients with sepsis are still unclear. based on the previous work, our research group intends to carry out single-center, prospective, observational clinical research to observe the relationship between homocysteine and the mortality of patients with sepsis, and to provide new indicators for accurately judging the prognosis of sepsis , to provide new targets for clinical development of drugs for the treatment of sepsis.


Eligibility criteria:
inclusion criteria: patients with sepsis and the age limits between 18-80 years. exclusion criteria: * non-septic patients with hyperhomocysteinemia caused by various reasons. ②after the onset, other medicines for the treatment of folate deficiency and hyperhomocysteinemia have been used. ③women during pregnancy and lactation. ④ suspected or did have a history of alcohol or drug abuse. ⑤patients who are participating in clinical trials of other drugs.
treating ptsd in patients with borderline personality disorder

Conditions: Stress Disorders, Post-Traumatic; Borderline Personality Disorder; Suicide; Self-Injurious Behavior

Summary: individuals with borderline personality disorder (bpd) are the quintessential multi-problem patients, often presenting to treatment with numerous dysfunctional behaviors and comorbid diagnoses. dialectical behavior therapy (dbt) is a comprehensive, cognitive-behavioral treatment for bpd that has been shown effective in reducing the primary problems it is designed to treat; namely, the frequency and severity of self-injurious and suicidal behavior, maintenance in treatment, and severe problems in living. however, the dbt treatment manual does not currently include a protocol specifying when or how to treat posttraumatic stress disorder (ptsd), a comorbid diagnosis that is prevalent in bpd patients and may maintain or exacerbate bpd criterion behaviors. similarly, many of the existing treatment outcome studies for ptsd have excluded suicidal, substance abusing, and multiply diagnosed patients, thereby making it difficult to determine the generalizability of these approaches to individuals with bpd. the research proposed here is focused on the development of a protocol based on prolonged exposure therapy to treat ptsd in bpd patients that can be integrated into standard dbt, as well as the initial evaluation of this protocol's feasibility, acceptability, and efficacy. the treatment development and pilot testing process will occur in two phases, including measure development and standardization of the treatment protocol via clinical pre-testing (phase 1); and pilot and feasibility testing of the intervention via a randomized controlled trial (rct) comparing standard dbt + ptsd protocol to standard dbt only (phase 2). information gathered during the pilot rct will be used to inform the design and conduct of a subsequent full-scale rct. this research has the potential to significantly expand and improve upon the most empirically supported treatment currently available for bpd, while also demonstrating that exposure treatments for ptsd can be implemented safely and effectively in a bpd population.


Eligibility criteria:
inclusion criteria: * female * age 18-60 * meet criteria for borderline personality disorder * meet criteria for post-traumatic stress disorder * can clearly remember at least some part of the traumatic event(s) * recent and recurrent self-injurious behavior * lives within commuting distance of university of washington, seattle campus * consents to all research protocols exclusion criteria: * male * court ordered to treatment * diagnosis of psychotic disorder, bipolar disorder, or seizure disorder requiring medication * less than 18 years of age or older than 60 years of age * problems which by their presence or severity preclude ability to attend or understand treatment and/or requires priority treatment * familial or domestic relationship with a current study participant
the efficacy and safety of intraarticular sodium hyaluronate (hyalgan) after proximal tibial osteotomy in treatment of knee osteoarthritis patients

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to assess the efficacy and safety of hyalgan after proximal tibial osteotomy in treatment of knee osteoarthritis patients. normally, oa patients who were treated with osteotomy will not be treated with any sysadoa after operation, even though their cartilage's not completely loss, so osteotomy plus ha injection should provide more benefit to patients than osteotomy alone.


Eligibility criteria:
inclusion criteria: 1. patients between 35 and 65 years with primary knee oa with malalignment 2. mild to moderate oa of grade ii or iii severity on the kellgren-lawrence scale with require treatment by osteotomy 3. malalignment is not exceed 15 degree (+,-) 4. pain on walking (15 m) ≥ 40 mm. 5. range of motion \> 90 degree 6. evidence of adequate contraceptive methods in women of childbearing age exclusion criteria: 1. previous surgery on affected knee 2. previous intraarticular intervention within the last 3 months (eg. steroid, anaesthetic, sodium hyaluronate) 3. oral sysadoa treatment (chondroitin, glucosamine, diacerein) within 2 months prior to study start 4. known or suspected infection of the affected joint 5. painful knee condition due to another cause than chondral lesions, such as sudeck's atrophy, intraarticular neoplasm, pigmented villonodular synovitis, chondromatosis 6. poor general health or other conditions which would make regular hospital attendance difficult 7. ascertained hypersensitivity to any component used in the study (eg. hyaluronic acid, diclofenac, morphine, omeprazole and paracetamol) 8. hypersensitivity to avian protein 9. ongoing or previous participation in a clinical study within the last 3 months
follow-up study of complications of acute pancreatitis

Conditions: Pancreatitis; Pancreatic Neoplasms; Metabolic Diseases; Hypertension, Portal; Respiratory Failure; Quality of Life

Summary: this is a follow-up study focusing on long-term complications of acute pancreatitis. the primary purposes include: 1. to assess the incidence of type 2 diabetes mellitus（2-dm）,impaired glucose tolerance, metabolic abnormalities of blood lipids after acute pancreatitis. 2. to observe the possible long-term clinical outcomes after acute pancreatitis attack, which may include: chronic pancreatitis, pancreatic cancer, pancreatogenic portal hypertension, autoimmune pancreatitis et al. 3. to evaluate the long-term influence of acute lung injury(pao2/fio2\<200,fio2 means fraction of inspiration o2) in ap patients during icu stay on life qualities of the patients; 4. to observe the prognosis of the local complications of acute pancreatitis(ap) patients; it might be helpful to find the most effective and targeted interventions aiming at different phases after ap attack.

currently，follow-up study is limited on glucose intolerance and life quality assessment. however, it has been shown that ap is associated to some extent with other diseases such as chronic pancreatitis, pancreatic cancer, pancreatogenic portal hypertension and autoimmune pancreatitis; in addition, for patients who have severe lung injury following ap, especially with pao2/fio2\<200 during icu stay, the long term prognosis remains unclear. thus, a large sample follow-up study is essential for elucidating the possible long-term complications. prior to follow up study, the investigators performed baseline analysis of ap patient data from the database of the first affiliated hospital of nanchang university. it is estimated that 1300 patients will be interviewed over telephone and 600 patients in the outpatient department. the content of the follow-up includes: questionnaire (the mos\[medical outcome study\] item short from health survey, sf\[short form\]-36) ; lab testing(complete blood count, blood chemistry such as liver and kidney function, c-reaction protein(crp), amy, fasting blood-glucose，1 and 2 hour postprandial blood glucose,c-peptide, blood lipids, fe-1) and ct scan. for patients who have severe lung injuries during icu stay, pulmonary function test, blood gas analysis and chest ct will be performed. after screening, the patients with chronic pancreatitis(cp), pancreatic cancer(pc), post pancreatogenic portal hypertension（pph） or autoimmune pancreatitis(aip）will be hospitalized for further therapy.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute pancreatitis from our hospital * must be signed the informed consent exclusion criteria: * failed to complete the questionnaire survey and the follow-up examination

Keywords: acute pancreatitis chronic pancreatitis pancreatic cancer pancreatic disease-associated portal hypertension autoimmune pancreatitis pao2/fio2<200 diabetes mellitus blood lipid local complications quality of life
weaning-study: "weaning by early versus late tracheostomy in supratentorial intracerebral bleedings

Conditions: Intracerebral Hemorrhage

Summary: background: one third of all ich patients require intubation and mechanical ventilation and 1/3 of all ventilated patients require tracheostomy (i.e.≈10% of all ich patients require tracheostomy). as shown previously, predisposing factors for tracheostomy are hematoma volume, hemorrhage location, presence of intraventricular hemorrhage (ivh), and occlusive hydrocephalus as well as presence of copd (huttner hb et al 2006 cvd). sustained restricted vigilance and impaired consciousness after ich is likely to result in failure of extubation, raise in incidence of ventilator-associated pneumonia, increased amount of sedative drugs and prolonged duration of neurocritical care. hence an early tracheostomy may be beneficial in terms of reduced duration of mechanical ventilation. basic hypothesis: compared to patients with conventional ("late") tracheostomy between day 12 - 14, patients with "early" tracheostomy within 72h after admission will have: * shorter cumulative time of mechanical ventilation * less incidence of ventilator-associated pneumonia * less consumption of sedative drugs * shorter duration of stay in neurocritical care unit randomization: consecutive eligible patients are randomly assigned to either "early" tracheostomy within 72h after hospital admission or "late" tracheostomy (= control group; undergoing conventional tracheostomy between day 12 - 14 if extubation fails) both groups receive plastic tracheostomy


Eligibility criteria:
inclusion criteria: * patients requiring intubation / mechanical ventilation * supratentorial intracerebral hemorrhage (including:) * primary spontaneous ich (lobar / deep) * ich related to anticoagulant therapy * with or without intraventricular hemorrhage * with or without occlusive and / or communicating hydrocephalus * hematoma volume \>0 ml and \<60 ml * age 18 - 85 years * informed consent (legal representative) exclusion criteria: * patients with elective intubation/ventilation for evd placement * patients with "do not treat" / "do not resuscitate" orders, severe co- morbidity and life expectancy of less than 3 months * absent consent of relatives for invasive (neuro-)critical care * contraindication for tracheostomy * other than primary supratentorial ich or supratentorial ich related to oral anticoagulants * pre-existing copd (known/treated) * pre-existing congestive heart failure (≥3 nyha) * pre-existing modified rankin scale (≥4)

Keywords: supratentorial intracerebral hemorrhage tracheostomy sedation weaning
demographics and outcomes of covid 19 in pregnancy at a community based hospital

Conditions: Corona Virus Infection

Summary: demographics of pregnant covid persons under investigation and those who were positive from march-may 2020. looking at demographics including age, socio-economic status and pregnancy outcomes in these groups.


Eligibility criteria:
inclusion criteria: * currently pregnant, considered pui or know covid positive patient during pregnancy, and documentation of covid symptoms within ahs. exclusion criteria: * not pregnant, no documentation of covid-19 symptoms within ahs.
gluten sensor device to promote gluten free diet adherence and quality of life in patients with celiac disease

Conditions: Celiac Disease

Summary: the current treatment for celiac disease is a strict 100% gluten free diet. little is known about the best way to promote adherence to such a strict diet and how to maximize quality of life at the same time. this pilot will look at the utility of a new innovation to promote gluten free diet adherence - a portable gluten sensor device. participants will be 30 teenagers and adults with celiac disease recruited from the celiac disease center at columbia university in new york city. before and after the intervention, participants will be asked about their adherence to a gluten free diet, quality of life, symptoms, and feelings of anxiety, and depression. this pilot data will help to inform interventions that the investigators hope to test in a larger nih-funded trial to better understand the best ways to promote adherence and quality of life in celiac patients.

little is known about the best ways to promote a strict gluten-free diet while maximizing quality of life in teenagers and adults with celiac disease. the aim of the proposed pilot is to assess the acceptability and feasibility of a novel intervention - a portable gluten sensor device. the sample for this pilot will be 30 teenagers and adults with biopsy confirmed celiac disease recruited from the celiac center at columbia university in new york city. thirty participants will pilot test a portable gluten sensor device with its associated iphone app for 3 months. at baseline and three-month follow-up, participants will complete measures of gluten free diet adherence, quality of life,symptoms, anxiety, and depression. at post-only, the investigators will collect in-depth data related to the feasibility and acceptability of the gluten sensor, as well as facilitators and barriers related to how, where, and when it was used. at the completion of the proposed pilot study, the investigators hope to have preliminary data to inform development of gluten sensor interventions that the investigators hope to test in a larger nih-funded randomized controlled trial. these findings, in combination with a larger trial, have the potential for the development of a new standard of care in the management of patients with celiac disease.

Eligibility criteria:
inclusion criteria: * individuals \>13 years old (15 teenagers and 15 adults), 30 in total with duodenal biopsy-confirmed diagnosis of celiac disease will be recruited to participate. * as we are testing a gluten sensor device, we require that participants are 13 years or older as they will need to be able to operate the gluten sensor device independently exclusion criteria: * no participants will be excluded based on gender, race or ethnicity. * patients diagnosed with celiac disease without a duodenal biopsy.

Keywords: gluten free diet
outcomes of surgical management of aneurysmal arteriovenous fistula in hemodialysis patients

Conditions: Arteriovenous Fistula Patency

Summary: to evaluate the success rate and patency after surgical management of arteriovenous fistulas aneurysms

end-stage renal failure is a disease that can affect all organs. the increasing prevalence of afﬂuent-society diseases such as obesity, diabetes, hypertension, or atherosclerosis means that the number of patients diagnosed with end-stage renal disease is systematically growing . worldwide, the number of patients receiving hemodialysis is estimated at more than 1.4 million, with the annual incident rate growing to 8%, prevalence of esrd in egypt raised to 483 patients per million. a well-functioning vascular access is a mainstay to perform an efficient haemodialysis . avf, described by brescia and cimino, remains the first choice for chronic haemodialysis . it is the best access for longevity and has the lowest association with morbidity and mortality, and for this reason avf use is strongly recommended by guidelines from different countries . the most common complications of fistulae for hd are lymphedema, infection, aneurysm, stenosis, congestive heart failure, steal syndrome, ischemic neuropathy and thrombosis. it is important to gain information about early clinical symptoms of avf dysfunction in order to prevent and adequately treat potential complications . arteriovenous fistula aneurysms are defined by an expansion of the intimal, medial and adventitial layers of the vessel wall to a diameter of more than 18 mm. aneurysmal degeneration of the venous component of surgically created arteriovenous fistulae (avfs) is a common clinical finding. prevalence rates ranging widely between 6% and 51% depending on criteria. although arteriovenous fistula aneurysms (avfas) can be prone to thrombosis and can cause cosmetic dissatisfaction, the most catastrophic complication is life-threatening haemorrhage . the decision for surgical intervention relies on the risk of perforation, ulceration, bleeding, and size of aneurysm which leaves a limited space for puncture. the surgical modalities include excision of the aneurysm and primary repair, excision of the aneurysm and interposition graft , repair by end-to-end anastomosis, ligation .

Eligibility criteria:
inclusion criteria: * all patients with pseudo-aneurysms over avf * skin changes ( ulceration - inflammation -necrosis) * huge enlargement with lack of potential site of cannulation * impending thrombosis of the fistula * risk of infection and impending rupture * significant cosmetic concerns causing distress to the patient exclusion criteria: * bad general condition, patient with severe comorbidities * thrombosed av fistula * age \< 18 years * anastomotic aneurysms * venous hypertension over avf
sutent following chemotherapy, radiation and surgery for resectable esophageal cancer

Conditions: Esophageal Cancer

Summary: the purpose of this study is to see whether or not the combination of cisplatin, irinotecan and radiation, followed by surgery, followed by oral sutent, is effective and safe for patients with resectable esophageal cancer.

survival outcomes for resectable esophageal cancer remain poor. current data strongly support an adjuvant systemic strategy to improve time to progression and survival in this patient population. adding a well-tolerated oral targeted therapy such as sutent, after a combined chemo/radiation/surgery approach in this patient population has the potential to impact on the minimal residual disease left behind by relatively effective pre-operative chemoradiation and surgery. this has the potential to improve survival. the primary endpoint is to determine the feasibility and efficacy of adjuvant sutent therapy (su11248) after concurrent neoadjuvant therapy with irinotecan, cisplatin, external beam conformal radiotherapy plus surgery for potential resectable esophageal cancer. preclinical and clinical data suggest that sutent will have activity in esophageal cancer, as the results of sutent activity in solid tumors appear to be superior to the results of other antiangiogenic compounds in development for esophageal cancer. therefore, by extrapolation from promising phase i, ii and iii sutent trials we propose to translate the target effects achieved with sutent to reduce local and systemic therapy failure, and thus metastasis in esophageal cancer.

Eligibility criteria:
inclusion criteria: * histologically proven squamous or adenocarcinoma or the esophagus \>20 cm from the incisors, including ge junction tumors (unless of gastric origin). * tumors must be technically resectable. * clinical t1n1m0, t2-3 n0-1 m0 * performance status ecog 0-1 * medically fit for chemotherapy, radiation and esophagectomy exclusion criteria: * in situ or clinical t1n0m0, and stage iv (m1a orm1b) * cervical esophageal tumors (within 20 cm of the incisors) * age \ 70 * participation in another concurrent clinical study involving study drug(s) or treatment with study drug within thirty days prior to the treatment on this study. concurrent treatment with other experimental drugs or anticancer therapy * known or suspected drug or alcohol abuse * prior treatment for this malignancy except esophageal stenting

Keywords: esophageal esophagus cancer sutent sunitinib