Kornimate/medical-research-clean huggingface dataset:
nitrocamptothecin or fluorouracil in treating patients with recurrent or refractory pancreatic cancer

Conditions: Pancreatic Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. it is not yet known whether nitrocamptothecin is more effective than fluorouracil for pancreatic cancer. purpose: randomized phase iii trial to compare the effectiveness of nitrocamptothecin with that of fluorouracil in treating patients who have recurrent or refractory pancreatic cancer and who have been treated previously with gemcitabine.

objectives: i. compare survival of patients with recurrent or refractory pancreatic cancer after treatment with nitrocamptothecin versus fluorouracil. ii. compare the clinical benefit and objective response rate to these treatment regimens in these patients. iii. compare and evaluate time to treatment failure in these patients with these treatment regimens. iv. compare the toxicities of these treatment regimens in these patients. outline: this is a randomized, open label, multicenter study. patients are randomized to one of two treatment arms. arm i: patients receive nitrocamptothecin orally on days 1-5. arm ii: patients receive fluorouracil iv over 30 minutes on day 1. treatment repeats weekly for 8 courses in the absence of disease progression or unacceptable toxicity. patients with tumor regression or stabilization may receive additional courses of treatment. patients with disease progression or unacceptable toxicity may crossover to the alternate treatment arm. patients are followed every 3 months for one year. projected accrual: a total of 400 patients (200 per treatment arm) will be accrued for this study within 15 months.

Eligibility criteria:
disease characteristics: histologically or cytologically confirmed recurrent or refractory adenocarcinoma of the pancreas must have received prior gemcitabine and progressed patient characteristics: age: over 18 performance status: karnofsky 50-100% life expectancy: at least 2 months hematopoietic: granulocyte count greater than 1,500/mm3 hemoglobin at least 9 g/dl platelet count greater than 100,000/mm3 hepatic: sgot and sgpt no greater than 3 times upper limit of normal (uln) (no greater than 5 times uln if tumor involves liver) bilirubin no greater than 2.0 mg/dl renal: creatinine no greater than 2.0 mg/dl other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception prior concurrent therapy: biologic therapy: no concurrent immunotherapy chemotherapy: see disease characteristics at least 2 weeks since prior gemcitabine and recovered no prior chemotherapy except gemcitabine no other concurrent chemotherapy endocrine therapy: no concurrent corticosteroids or hormones radiotherapy: no concurrent radiotherapy surgery: at least 2 weeks since prior major surgery no major surgery within 8 weeks following initiation of study treatment

Keywords: recurrent pancreatic cancer adenocarcinoma of the pancreas
the effects of gum chewing on energy intake and expenditure

Conditions: Obesity

Summary: the purpose of this study is to determine if chewing gum increases energy expenditure and decreases food intake.


Eligibility criteria:
inclusion criteria: * bmi 27-37, between the ages of 18 and 38 exclusion criteria: * history of chronic disease (e.g. liver, kidney, or heart disease, or diabetes) * medications that affect energy expenditure, appetite, or body composition (e.g. antidepressants, beta blockers, antipsychotic, or weight loss medications) * a history of irregular menstrual cycles in women (indication of onset of menopause or other metabolic disturbances such as polycystic ovary syndrome) * a history of phenylketonuria (pku) * symptoms of depression * a history of eating disorders * concurrent participation in a weight loss program * cigarette smoking or other tobacco use * jaw problems such as temporomandibular joint disorder (tmj) * allergies to any of the common components in gum (sweeteners, mint flavors, etc) * heavy gum chewing prior to study ( \> 3 times per week) * pregnancy or lactation.

Keywords: obesity
validation of the korean version of the walking impairment questionnaire in patients with peripheral arterial disease

Conditions: Peripheral Arterial Occlusive Disease

Summary: the aim of the study is to validate the korean version of walking impairment questionnaire in patients with peripheral arterial occlusive disease.

first, the original version of wiq will be translated into korean, then it will be translated into english, again. the translated version will be sent to the original author to compare with the original version. after correcting, the korean version will be completed. the patients with peripheral arterial disease will fill in the korean version of wiq before starting treatments. baseline results of arterial function test, toe-brachial index and treadmill test will be recorded. three months later, the patients will complete the questionnaire again. arterial function test, toe-brachial index and treadmill test also will be taken again after treatment and the correlation of wiq and other exams will be evaluated.

Eligibility criteria:
inclusion criteria: * 19\~ 80 years * claudication * ankle brachial index \< 0.9 or tbi \< 0.7 (in patients with dm and abi higher than 1.3) * patients who can complete the treadmill test (slope 12%, 2.4km/hr) exclusion criteria: * critical limb ischemia * ankle pressure \< 40mmhg * claudication due to other causes (i.e. spinal stenosis, arthritis, etc) * patients with high risk of coronary artery syndrome during treadmill test

Keywords: walking impairment questionnaire peripheral arterial occlusive disease korean version
validation of ella platform for serum nfl and gfap measures in multiple sclerosis patients

Conditions: Multiple Sclerosis

Summary: serum neurofilament-light chain (nfl) and glial fibrillary acidic protein (gfap) measured by single molecule array (simoa) are novel biomarkers of multiple sclerosis patients (ms) activity and progression. its use is limited due to low availability and high costs. ella is a cheaper platform with increasing availability. recently, we compared simoa and ella platforms to assess serum nfl levels in 203 ms patients from the ofsep-hd study. there was a strong correlation (spearman r = 0.86, p \< 0.0001) between both platforms. as for simoa, serum nfl levels measured by ella were correlated with age and edss and were significantly higher in active ms, suggesting that these assays are equivalent and can be used in any center for routine care. however, the accuracy of local measures acquired with ella has not been determined. the aim os this study is to assess the concordance of multi-site ella instruments, accuracy of gfap measures as compared to simoa, and the predictive value of nfl and gfap measured by ella in ms.


Eligibility criteria:
inclusion criteria: * patients from the ofsep hd cohort. * at least one native (no thaw-freeze cycle) serum sample in local or in centralized biological resource center exclusion criteria: * no bio-collection or insufficient sample volume * no ofsep minimal sheet at baseline
a study of tadalafil in men with benign prostatic hyperplasia (bph) and erectile dysfunction (ed)

Conditions: Benign Prostate Hyperplasia; Erectile Dysfunction

Summary: the purpose of this study is to see whether tadalafil can reduce the signs and symptoms in men with erectile dysfunction (ed) and benign prostatic hyperplasia-lower urinary tract symptoms (bph-luts) and improve their quality of life.


Eligibility criteria:
main inclusion criteria: * present with a history of ed and signs and symptoms of bph. * are sexually active with an adult female partner, and expect to remain sexually active with the same adult female partner for the duration of the study. main exclusion criteria: * current treatment with nitrates. * prostate-specific antigen (psa) greater than 10.0 nanogram (ng)/ml at 1st screening. * psa greater than or equal to 4.0 to less than or equal to 10.0 ng/ml at 1st screening if prostate malignancy has not been ruled out to the satisfaction of a urologist * suffering from other urinary disease like cancer, or infection * serious cardiovascular disease * history of significant renal insufficiency
interventional study of anxiety symptoms in the implantable cardioverter defibrillator (icd) patient

Conditions: Anxiety

Summary: this study will compare the effectiveness that cognitive behavioral therapy has on decreasing the amount of anxiety, as well as the number of inappropriate firings that a patient with an icd may experience.

this study is an interventional study of patients with icds followed in the cleveland clinic device clinic. patients with icds experience some level of anxiety which can impact the number of shocks that they receive from their device. 100 of these patients will be randomized into one of 2 groups; those receiving three sessions of cognitive behavioral therapy (cbt) and those receiving usual care. we hypothesize that if these icd patients receive short term (cbt) they will experience less anxiety and have a lower rate of device firings than the patients that did not receive cbt. furthermore, we will study mechanistic pathways involved in the reduction of anxiety in icd patients. we will extract initial heart rate variability (hrv) data from device interrogation. we hypothesize that the cbt intervention arm will have a higher normalization of hrv. patients will repeat questionnaires at 3, 6 and 12 months.

Eligibility criteria:
inclusion criteria: * currently has an implantable cardioverter defibrillator (icd) * experiences moderate to high anxiety as demonstrated by the the scores on the questionnaires that will be administered exclusion criteria: * unwilling to comply with follow-up requirements at 3, 6 and 12 months.

Keywords: anxiety implantable cardioverter defibrillator (icd) defibrillators, implantable
a sleep intervention (sleep-extend) for young adults at-risk for type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the study is a prospective unblinded randomized trial to evaluate the feasibility of conducting a sleep extension intervention trial and the sleep extension intervention among the young adults. the study also wants to assess whether a sleep-extension intervention has an impact on the insulin resistance levels of young adults. the intervention consists of an education session and to extend the sleep time at least one hour but can be up to 2 hours per night for 4 weeks.

insulin resistance has been shown to put a person at risk for developing type ii diabetes. there is a correlation between sleep deprivation and insulin resistance.the study wants to assess the feasibility by enrolling 20 subjects in a year. the study also wants to assess the feasibility of the sleep extension intervention among young adults by examining the number of subjects that are randomized to intervention arm will complete the study. another intent of the study is to examine how sleep behaviors affect risks for developing type 2 diabetes and to determine their willingness to participate in a 4-week home-based program (intervention) focused on personal sleep behaviors. subjects enrolled in the study and are randomized to intervention group and control group. the intervention group will receive one education session consisting of strategies for sleep hygiene which is the routine for going to sleep and instructions on extending time in bed by at least one hour but can be up to 2 hours total per night for 4 weeks. at the end of 4 weeks subjects will have a blood draw and will complete the questionnaires.

Eligibility criteria:
inclusion criteria: * age must be 18-25 years old * self-report short sleep * bmi ≥ 30 (the world health organization's classification of being obese) * insulin resistance determined by serum analysis * be willing to extend time in bed by one hour total per night * read and speak english. exclusion criteria: * night shift worker; * sleep disorder diagnosis; * medical diagnosis of diabetes or pre-diabetes; * currently pregnant or lactating or with history of gestational diabetes; * actively participating in a weight loss program; * hospitalization in past 3 months for any medical or psychiatric condition; * having a major chronic illness (e.g. cancer, lupus)

Keywords: sleep behavior insulin resistance
nsaa non-interventional study protocol

Conditions: Duchenne Muscular Dystrophy

Summary: the purpose of this non-interventional study is to evaluate the feasibility of remotely administering the north star ambulatory assessment (nsaa) to participants with duchenne muscular dystrophy (dmd). the itakecontrol (itc) software platform will be utilized to remotely administer and score the nsaas.


Eligibility criteria:
inclusion criteria: 1. evidence of a signed and dated informed consent document indicating that the participant's legally authorized representative (lar) has been informed of all pertinent aspects of the study, along with evidence of age-appropriate child assent. 2. confirmed diagnosis of dmd 3. participant with dmd aged 4 to12 (inclusive) at t enrollment date 4. participant with dmd is ambulatory without assistive devices, braces, or aids throughout the study 5. caregiver has access to and/or willingness to learn use of a smart phone and the itc study mobile application 6. participant and caregiver are based in the us throughout study 7. participant and caregiver are fluent in the english language (verbally and in writing) exclusion criteria: 1. non-ambulatory dmd participant at any study timepoint 2. caregiver/participant unwilling or unable to administer/perform the nsaa 3. anticipated deterioration of participant's ambulatory status during the study
multicentric european study in patients with vertebral metastases

Conditions: Spinal Metastases

Summary: train-metastra is a retrospective study that will be performed in order to collect a large and harmonised amount of clinical and imaging data concerning vertebral metastases, focusing in particular on the risk of fractures. this type of dataset will be created from the medical records of 2000 patients admitted in the last ten years in the four european clinical centers participating in metastra project: "computer-aided effective fracture risk stratification of patients with vertebral metastases for personalised treatment through robust computational models validated in clinical settings", funded by the european union under the call "horizon-hlth-2022-tool-12-two-stage/computational models for new patient stratification strategies". the project is coordinated by the university of bologna (unibo) (pi prof. luca cristofolini) and involves 15 european partners, including sarl voisin consulting life sciences vcls, university of szeged (hungary), university of sheffield (uk) and frontendart (hungary). this type of dataset is not currently available in the literature and it will be pivotal to the development of the metastra computational models for the stratification of the risk of fracture of patients affected by spinal metastases.


Eligibility criteria:
inclusion criteria: * alive or dead * age 18 -99 years old * both male and female * diagnosis of cancer metastases at the spine * any sins score * admitted for hospitalisation or outpatient visit from jan 2012 to dec 2022 n ≥ 1 non-stabilised metastatic vertebra * presence of baseline ct scan, and/or mri and x-rays, showing the presence of metastatic lesions that are not surgically treated * at least one follow-up visit at ≥ 3 months after the first evaluation or treatment exclusion criteria: * minor patients * patients with diagnosis of primary spine tumour, degenerative spinal diseases, deformity or trauma * patients without non-stabilised vertebral metastases * patients without baseline ct scan or mri * patients without follow up visits

Keywords: risk of fracture spinal instability decision support system artificial intelligence-based models mechanistic personalised model
predicting local and distant recurrence in t1 colorectal cancer

Conditions: Colorectal Cancer; Colorectal Neoplasms; Colorectal Adenocarcinoma; Colorectal Cancer Stage I; Colorectal Neoplasms Malignant; Colorectal Cancer Recurrent

Summary: tumor recurrence significantly affects survival rates following the local resection of submucosal colorectal cancers (t1 crc). despite this, there are currently no reliable biomarkers established to predict recurrence in t1 crc. this study seeks to improve the prediction of recurrence-free survival in individuals who have survived t1 crc.

the incidence of invasive submucosal colorectal cancer (t1 crc) is increasing, likely as a reflection of improved screening and endoscopy use. current treatment options for t1 crc focus on less invasive methods (i.e., endoscopic submucosal dissection), and treatment decisions are based on the risk of lymph node metastasis (lnm). up to 70-80% of t1 crc patients may undergo surgery, with adjuvant chemotherapy recommended only for those with lnm. however, current clinical practice guidelines are considered to be overly aggressive and recommend the administration of aggressive treatment to many patients who may be cured with non-invasive therapy alone. this results in the overtreatment of many patients, especially those that are currently defined as 'high-risk' t1 crc. existing surveillance methods may not adequately predict the prognosis of t1 crc, lacking established biomarkers for assessing disease-free survival. this study seeks to validate tissue-based biomarkers (micro-rna and messenger rna) that are associated with tumor recurrence after curative resection. the identification of patients at high risk of recurrence may help in the selection of patients who truly benefit from additional oncologic surgery or adjuvant therapy. previous research by this group has identified mirna signatures for detecting postoperative tumor recurrence and metastasis in crc, highlighting their potential as biomarkers for disease progression.

Eligibility criteria:
inclusion criteria: * stage i, pt1 colorectal cancer (tnm classification, 8th edition). * received standard diagnostic, staging, and stage-specific curative-intent resection (endoscopic or surgical, as per local guidelines). * confirmed cancer-free survivorship at the time of study inclusion. exclusion criteria: * lack of informed consent. * induction of neoadjuvant systemic therapy before colorectal cancer resection. * synchronous colorectal and non-colorectal cancer diagnosed at or before surgery.

Keywords: endoscopic submucosal dissection (esd) endoscopic submucosal resection surgery t1 pathological t1 (pt1) messenger rna micro rna formail-fixed paraffin embedded tissue transcriptomics
tdcs and urge in bfrbs

Conditions: Repetitive Compulsive Behavior

Summary: the goal of this study is to find out if brain stimulation can help people stop skin-picking or nail-biting. the study wants to answer two main questions: 1. does brain stimulation reduce the urge to pick skin or bite nails after those urges are triggered? 2. does brain stimulation reduce how often people pick their skin or bite their nails? participants will: * talk about their skin-picking, nail-biting, and other mental health concerns * be placed in situations that make them want to pick or bite * rate how strong their urges are before and after brain stimulation researchers will compare real brain stimulation to a placebo (a fake version that looks the same but has no effect) to see if the real stimulation works to reduce skin-picking and nail-biting urges and behaviors.


Eligibility criteria:
inclusion criteria: * ability to provide informed consent (as established by clinical interview), and voluntary, signed informed consent prior to the performance of any study specific * ability and willingness to perform study-relevant clinical assessments and tdcs * endorses mild to extreme intensity of urges to pick or bite their skin or nails exclusion criteria: * any unstable medical, psychiatric, or neurological condition (including active or otherwise problematic suicidality) that may necessitate urgent treatment * daily use of psychotropic medications that substantially lower seizure threshold (e.g., clozapine) * history of psychosis, mania, major neurological disorder, significant head trauma, or seizures/epilepsy * current suicidal intent * any major neurological disease or history of major head trauma, including concussion with extended loss of consciousness, or of psychosurgery * current or suspected pregnancy * endorsing possible contraindications for tdcs

Keywords: picking biting transcranial stimulation
ultrasound imaging of quadriceps muscle in patients with knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: echo intensity (ei) assessment using ultrasonography helps monitoring disease-induced muscle quality changes. however, there are no study investigating the reliability of ei in patients with knee osteoarthritis (oa). the primary aim of the present study was to investigate the inter and intra-rater reliability of ei evaluation by grayscale histogram analysis of quadriceps femoris muscle in patients with knee oa. the second aim was to compare the mean grayscale values obtained using both the free hand tool (fht) and rectangular marquee tool (rmt) methods in imagej. thirty patients with knee oa were included in this cross-sectional study. the echogenicity measurements of the rectus femoris, vastus inter-medius, vastus lateralis and vastus medialis were performed by two different researchers. reliability analysis of ei measurements were calculated with using intraclass correlation coefficient (icc), standard error of measurement (sem) and coefficient of variation (cv) and bland and altman plot analysis.


Eligibility criteria:
inclusion criteria: * patients had tibiofemoral joint oa in at least one knee according to the american college of rheumatology classification criteria with knee pain most days of the past month and osteophytes apparent on knee radiograph were included to the study exclusion criteria: * patients were excluded if they had a history of lower limb joint replacement and fracture, rheumatoid arthritis, diabetic neuropathy or polyneuropathy, and cardiovascular and neuromuscular problems.

Keywords: reliability,echo intensity,knee osteoarthritis
the tricure eu pivotal study

Conditions: Tricuspid Valve Regurgitation; Heart Valve Disease; Cardiovascular Diseases

Summary: prospective, multi-center study to assess safety and performance of the tricares topaz tricuspid valve replacement system

the study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the tricares topaz tricuspid valve replacement system.

Eligibility criteria:
inclusion criteria: * adult patients * tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential) * institutional heart team evaluates patient as being at increased operative risk exclusion criteria: * patient in need of emergent intervention * patient who is hemodynamically unstable * anatomical contraindications for implantation with study device * patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet