Kornimate/medical-research-clean huggingface dataset:
exercise and oxaliplatin-induced peripheral neuropathy

Conditions: Peripheral Neuropathy

Summary: this single group study was conducted to test the feasibility and acceptability of implementing an exercise intervention during oxaliplatin infusion across three months of oxalipatin-based chemotherapy in patients with gastrointestinal malignancies.10 patients were enrolled onto this study and validated questionnaires were used to evaluate the feasibility and acceptability of the intervention and collect patient-reported outcomes over the course of study enrollment.

the proposed study is a single arm study to evaluate the feasibility and acceptability of having patients exercise while receiving oxaliplatin infusions in the infusion center. the study will enroll patients receiving oxaliplatin-containing chemotherapy for gastrointestinal cancersor for cancer of unknown primary. patients will be provided with a wrist heart rate monitors to be used during the infusions. they will wear the heart monitors during the entirety of the oxaliplatin chemotherapy infusion. patients will be asked to engage in aerobic exercise using a pedal machine to move their arms and legs while in a seated position. patients will be asked to exercise for a total of 30 minutes, which will be divided into three, ten minute bouts of exercise, spaced out in 30 minute blocks of time. the comprehensive surveys including eortc-qlc-cipn20 and promis-29 qol will be completed at baseline, \~6-8 weeks into treatment, and at \~12-14 weeks after treatment initiation. the feasibility and acceptability instruments will be administered \~6-8 weeks into treatment.

Eligibility criteria:
inclusion criteria: 1. receiving care at dartmouth-hitchcock medical center in lebanon, nh 2. age \>18 years 3. eastern cooperative oncology group status 0 to 2; 4. diagnosed gastrointestinal cancer of any stage 5. scheduled to receive at least 4 cycles of oxaliplatin 6. complete the international physical activity questionnaire score equal to or greater than 99 met minutes/week (equivalent to \~30 minutes of walking) 7. have mediport access prior to enrollment in the study exclusion criteria: 1. exercise- or mobility-limiting cardiovascular, pulmonary, musculoskeletal, or psychological disease, based on the emr (electronic medical record) past medical history and/or based on consultation with the medical oncologist; 2. scheduled major surgery during the study time period; 3. pre-existing peripheral neuropathy prior to chemotherapy; 4. patient with a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator; 5. prior history of treatment with oxaliplatin, docetaxel, or paclitaxel 6. pregnant women; 7. prisoners; 8. inability to read or speak english/unable to consent; 9. prognosis of less than six months
the immune system and psychiatric disorders

Conditions: Stress Disorders, Traumatic; Depressive Disorder; Bipolar Disorder; Personality Disorders; Schizophrenia; Psychotic Disorders

Summary: the study is based on a hypothesis that there is interaction between the activity in the immune system and in the mind. to study this, the investigators register different measures for activity in the immune system on patients unselectedly admitted to an acute psychiatric ward. the psychiatric statuses and diagnoses of these patients are carefully defined as well.

our hypotheses are first that activity in the immune system influences the psychiatric status in general, second that changes in activity in psychiatric status affect activity in the immune system and third that there are connections between certain psychiatric conditions/disorders and certain features of the immune system. all patients admitted to a psychiatric acute ward covering an area with a population of 130.000 and with around 1000 admittances to an acute psychiatric ward a year (some readmittances) are asked to participate in the study. patients fill in a question form regarding psychiatric as well as somatic health with emphasis on diseases involving immune activity. when possible also slight information on the family is registered. both at the time of admittance and after recovery clinical laboratory tests on somatic status are registered. in addition the level of different cytokines is measured. the psychiatric state and precise diagnoses are registered during the stay. the data will be analysed to uncover connections between psychiatric stress in general as well as specific psychiatric diagnoses and activity in the immune system.

Eligibility criteria:
inclusion criteria: * admission to the adult acute psychiatric ward of a certain geographical area during the study period exclusion criteria: * patients that do not agree to participate in the study

Keywords: immunity immune system cytokines psychophysiology psychoneuroimmunology
claim: using the kodex-epd system to guide pacing lead placements, a first in man study.

Conditions: Cardiac Arrhythmia

Summary: prospective, multi-center (2-3 sites), non-randomized, open label, single arm 3 phase study: 1. phase 1 or evaluation phase: where the kodex-epd system will be used to exclusively monitor the entire implantation procedure; the kodex-epd system will not be used for guidance during the lead implantation workflow. 2. phase 2 - kodex-epd-assisted phase: where the kodex-epd system will be used for cardiac imaging acquisition, guidance during lead implantation in conjunction with fluoroscopic imaging 3. phase 3 - kodex-epd-guided phase: where the kodex_epd system will be used as the leading imaging modality during the lead implantation workflow. fluoro can be used; * up until the part of the lead implantation workflow that is the scope of this investigation. * as a bailout, when the operator declares failure to attempt.


Eligibility criteria:
patients scheduled to undergo lead placement for cardiac pacing. subjects who meet all eligibility criteria and give written informed consent will be enrolled in the study. inclusion criteria: 1. subject must be aged \>18 years. 2. subject must have signed a written iinformed cconsent form to participate in the study, prior to any study related procedures. 3. subject must be willing to comply with the protocol requirements. 4. subject is scheduled for a de novo pacing lead implantation or system upgrade . exclusion criteria: 1. patients for whom previous crt or conduction pacing implantation has failed. 2. patients considered for leadless cardiac pacing system. 3. patients undergoing a system revision for infection or malfunction. 4. patients undergoing planned, urgent or emergency lead revision or lead extraction. 5. subjects who have received or will receive an experimental drug or used an experimental medical device within 30 days before the planned start of treatment. 6. patients included in a clinical registry or clinical trial for an investigational product. 7. pregnant women.

Keywords: pacing lead implantation kodex-epd crt his bundle pacing lbbp
developing a simple test to diagnose overactive bladder

Conditions: Overactive Bladder; Overactive Bladder Syndrome; Detrusor Overactivity

Summary: in order to develop a test to diagnose overactive bladder from urine, it is essential that this test is at least as accurate as the tools that clinicians currently use. as such, this study will compare the performance of the device in development to the performance of existing methods.


Eligibility criteria:
inclusion criteria: * the participant is willing and able to give informed consent for participation in the study * the participant has been diagnosed with over-active bladder * aged 18 years or above * male or female exclusion criteria: * the participant is unwilling to give informed consent for participation in the study * the participant is unable to represent their own interests or is particularly susceptible to coercion (i.e. is deemed as vulnerable) * the participant has been diagnosed with neurologic disease (stroke, ms, parkinson's disease, spinal cord injury); history of uterine, cervical, vaginal or urethral cancer; history of cyclophosphamide use or any type of chemical cystitis; history of benign or malignant bladder tumours; has had botulinum injections, neuromodulation or augmentation cystoplasty * aged 17 years or younger.
exploring relevant immune-based biomarkers and circulating tumor cells during treatment with immunotherapy in genitourinary malignancies (ctc immune based biomarkers)

Conditions: Carcinoma, Renal Cell; Carcinoma, Urothelial

Summary: this pilot study purpose of this study is to describe peripheral circulating immune cell profiles at baseline and change on treatment with immune checkpoint inhibitors in renal cell carcinoma and urothelial carcinoma.


Eligibility criteria:
inclusion criteria: group a renal cell carcinoma: patients will be eligible for inclusion in this study if all of the following criteria apply: 1. histologically confirmed or radiological diagnosis of renal cell carcinoma. clear cell and non-clear cell carcinoma (such as papillary, chromophobe, collecting duct, and medullary) allowed. 2. evidence of locally advanced, high grade or metastatic disease in any site on most recent imaging scan 3. planned initiation of treatment with any of the following: * immune modulatory agent targeting any of the following: pd-1, pd-l1, ctla-4, cd27, ox40, lag3 or tumor infiltrating lymphocytes (til) * immune modulatory agent consisting of any of the following: car-t, bispecific antibody or vaccine trial. 4. age \> 18 years. 5. ability to understand and the willingness to sign a written informed consent document. group b urothelial carcinoma: patients will be eligible for inclusion in this study if all of the following criteria apply: 1. histologically confirmed diagnosis of urothelial carcinoma. non-transitional cell carcinoma (such as adenocarcinoma and squamous cell carcinoma) allowed. 2. evidence of locally advanced, high grade or metastatic disease in any site on most recent imaging scan 3. planned initiation of treatment with any of the following: * immune modulatory agent targeting any of the following: pd-1, pd-l1, ctla-4, cd27, ox40, lag3 or tumor infiltrating lymphocytes (til) * immune modulatory agent consisting of any of the following: car-t, bispecific antibody or vaccine trial. 4. age \> 18 years. 5. ability to understand and the willingness to sign a written informed consent document. exclusion criteria: a patient will not be eligible for inclusion in this study if any of the following criteria apply: 1. history of intercurrent or past condition that would make participation in this protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s).
creative arts ii study

Conditions: Epilepsy

Summary: the purpose of this study is to determine the impact of music, visual art, or creative writing on quality of life measures for epilepsy patients.

qualifying patients admitted to epilepsy monitoring unit will be approached for participation in the study. patients who consent will be randomly assigned to work with one of three creative artists (visual artist, creative writer, or therapeutic musician. the assigned artist will provide 1 intervention while the patient is admitted and 4 follow-up interventions after discharge from the hospital. follow-up sessions will be conducted remotely, either by phone or over the internet. subjects will be asked to complete study questionnaires before and after the first art intervention, and again after the last follow-up session. the study seeks to measure the impact of arts interventions on quality of life. secondary objectives include the effects of the interventions on seizure frequency and eeg spike generation, as well as the impact of creative arts interventions on patients diagnosed with non-epileptic events during hospitalization.\*

Eligibility criteria:
inclusion criteria: 1. age \> 18 years old 2. scheduled for admission to the dartmouth-hitchcock medical center epilepsy monitoring unit for diagnostic video/eeg monitoring 3. capable of giving informed consent. 4. able to follow instructions exclusion criteria: 1. active psychiatric illness that would interfere with participation with the artist. 2. active general medical condition that would impair the participant's consciousness or ability to participate. 3. any other reason that, in the opinion of the investigator, would exclude the participant from successful participation in the study.

Keywords: art music visual art writing epilepsy
point-of-care focused cardiac ultrasound in assessing the thoracic aorta

Conditions: Aortic Aneurysm, Thoracic; Aortic Dissection

Summary: the purpose of this prospective study is to compare point-of-care focused cardiac ultrasound (focus) to thoracic computed tomographic angiography (cta) in the measurement of ascending aortic dimensions. we hypothesize that focus will demonstrate good agreement with cta in the measurement of ascending aortic dimensions and accurately detect dilation and aneurysmal disease.

nonspecific chest pain is frequently encountered in the emergency department. accounting for over 13,000 deaths annually, aortic aneurysmal disease is a potential cause of chest pain.there are multiple diagnostic imaging modalities in practice to interrogate the thoracic aorta, with the most common being computed tomographic angiography (cta), trans-thoracic echocardiography (tte) and trans-esophageal echocardiography (tee), each with its own advantages and limitations. in the ed setting, point-of-care (poc) focused cardiac ultrasound (focus) is increasingly being used as an adjunct to the emergency physician's (ep) workup of undifferentiated chest pain. based on prior retrospective data focus and cta appear to have good agreement. this studies aims to confirm these findings through prospective evaluation specific aims aim 1: to prospectively compare point of care (poc) focused cardiac ultrasound (focus) to thoracic computed tomographic angiography (cta) in the measurement of ascending aortic dimensions. maximal diameter measurements of the ascending thoracic aorta by focus will be compared to cta. bland altman plots with 95% limits of agreement will be used to determine clinical and statistical significance. hypothesis: 95% limits of agreement between focus and cta will be within +/- 5 mm. aim 2: to determine the diagnostic accuracy of point-of-care focused cardiac ultrasound for the detection of thoracic aortic dilation and aneurysm with computed tomographic angiography as the reference standard sensitivity, specificity and accuracy of focus will be computed with cta as the reference standard.

Eligibility criteria:
inclusion criteria: * all patients aged 18 years and older presenting to the ed for whom a thoracic cta has been ordered. exclusion criteria: * refusal of verbal consent for ultrasound. * inability to obtain informed written consent for data collection from either the patient or the patients decision-making surrogate

Keywords: aortic dissection aortic dilation aortic aneurysm ultrasound point-of-care echocardiography
a study of subcutaneous nivolumab monotherapy with or without recombinant human hyaluronidase ph20 (rhuph20)

Conditions: Neoplasms by Site

Summary: the purpose of this study is to investigate the effects of nivolumab when given under the skin with or without rhuph20. this study will include participants with 1 of the following advanced or metastatic tumors approved for treatment with nivolumab monotherapy: * non-small cell lung cancer (nsclc) * renal cell carcinoma (rcc) * unresectable or metastatic melanoma * hepatocellular carcinoma (hcc) * microsatellite instability-high or mismatch repair deficient colorectal cancer (msi-h/dmmr crc) * in part b, other solid tumors may be considered at the discretion of the clinical trial physician * in addition to the above tumors, part e will also include participants with metastatic urothelial carcinoma (muc).


Eligibility criteria:
inclusion criteria: * histologic or cytologic confirmation of advanced (metastatic and/or unresectable) solid tumors of one of the following tumor types: 1. metastatic squamous or non-squamous nsclc 2. rcc, advanced or metastatic 3. melanoma 4. hcc 5. crc, metastatic (msi-h or dmmr) 6. in part b, other solid tumor types may be considered at the discretion of the medical monitor 7. in part e, metastatic urothelial carcinoma * measurable disease as per recist version 1.1 criteria * ecog performance status of 0 or 1 exclusion criteria: * active brain metastases or leptomeningeal metastases * ocular melanoma * active, known, or suspected autoimmune disease other protocol defined inclusion/exclusion criteria apply

Keywords: subcutaneous nivolumab rhuph20
the association between post-ercp acute pancreatitis and various genetic mutations

Conditions: Acute Pancreatitis

Summary: pancreatitis remains the most common complication of ercp, with the reported incidence ranging from 2% to 9%. although 80% of cases are mild, a significant number of patients may develop severe pancreatitis, that means additional morbidity and risk for death. ercp, despite the development of new diagnostic tools, remains a widely used procedure, so post-ercp pancreatitis is a problem with significant impact. several studies and meta-analyses helped us to recognize special factors that put an individual in high risk for the development of post-ercp pancreatitis. among these factors special interest presents the history of post-ercp pancreatitis as an independent risk factor for a new episode of post-ercp pancreatitis. it seems that some individuals have a genetically predisposed susceptibility in this particular complication. the aim of the present study is to investigate the possible genetic variation associated with post-ercp pancreatitis using whole genome sequencing.

this study includes patients who are at high risk of post-ercp pancreatitis. blood samples will be gathered to investigate the possible genetic variation associated with post-ercp pancreatitis using whole genome sequencing. dna for whole genome sequencing will be extracted using dna extraction kit (qiagen inc., hinden, germany) and the concentration \& purity of dna will be measured using nanodrop (nano drop technologies, wilmington, de, usa) or fluorometric quantitation(qubit fluorometer). genetic variations which are associated with acute pancreatitis will be searched using whole genome sequencing. post-ercp pancreatitis is the primary outcome. medical records and data of genetic variations will be reviewed for identifying possible risk factors and genetic variations associated with post-ercp pancreatitis.

Eligibility criteria:
inclusion criteria: * patients who undergo ercp with high risk factors of post-ercp pancreatitis exclusion criteria: * \<18 years old * current pancreatitis (\<72hrs before ercp) * pregnant woman, breast-feeding woman * patient refusal * contraindication of ercp * patients who would only be treated of bile duct such as a change of stent with previous endoscopic sphincterotomy * chronic pancreatitis * patients who underwent gastrectomy (billroth ii or roux-en y anastomosis) * patients who have pancreatic or distal bile duct cancer

Keywords: post-ercp pancreatitis genetic variation
the medasense study

Conditions: Pain

Summary: despite various efforts there is still the need for adequate monitoring of pain and nociception during anesthesia. in a previous protocol the investigators measured pain responses during anesthesia based on single end-points, eg heart rate,blood pressure and pulse transit time. none of these parameters provided sufficient information regarding nociception. the investigators therefore want to further investigate this matter using a composite parameter, the nociception level or nol. the nol is a novel index that measures the magnitude of the autonomic response to painful stimuli. the nol combines information from several physiological parameters, which represent different autonomic pathways. the multi-parameter approach empowered with state-of-the-art signal processing and machine learning techniques. in the current study the investigators will measure the nol in asa 1-3 patients undergoing elective surgery under general anesthesia. the investigators will measure nol responses and the occurrence of patient movement upon the administration of a painful stimulus: introduction of the laryngoscope, insertion of the endotracheal tube, insertion of the gastric tube, insertion of the bladder catheter and skin incision.


Eligibility criteria:
inclusion criteria: * age: 18-80 years; * sex: male or female; * surgery: any surgery under general anesthesia; * asa status: 1, 2 or 3. exclusion criteria: * age: \ 80 years; * unable to give written informed consent; * pregnancy/lactation; * extreme obesity: bmi \> 35; * perceived difficult intubation. * patients requiring a rapid sequence induction * patients on beta-blockers

Keywords: nociception general anesthesia
extended adjuvant treatment with letrozole in breast cancer who complete 5 years of toremifene

Conditions: Breast Cancer

Summary: the purpose of this study is to assess efficacy and safety of extended adjuvant treatment with letrozole in postmenopausal women with hormone receptor positive breast cancer who complete 5 years of toremifene

1. primary purpose to evaluate disease free survival rate (dfs) after taking 36 months with letrozole in postmenopausal women with hormone receptor positive breast cancer who complete 5 years of toremifene 2. secondary purpose * to evaluate follows after taking 36 months with letrozole in postmenopausal women with hormone receptor positive breast cancer who complete 5 years of toremifene. 1. disease free survival rate(dfs)-12 months, 24 months 2. distant disease free survival rate(ddfs), overall survival(os) * 12 months, 24 months, 36 months c. safety * change of lipid profiles * mortality and morbidity due to cardiovascular disease * incidence of fracture * change of bone density * common toxic effect

Eligibility criteria:
inclusion criteria: 1. patients have undergone surgery of the breast cancer and proven histologically to be invasive breast cancer. 2. removed the breast cancer histologically or cytologically 3. no evidence of breast cancer in controlateral breast 4. no evidence of metastasis 5. postmenopausal women with hormone receptor positive breast cancer who complete 5 years of toremifene in 30 months 6. postmenopausal state was defined the following conditions, at least one of a, b 1. serum fsh ≥ 30 miu/ml 2. amenorrhea ≥ 1 year 7. estrogen receptor(+) or progesterone receptor(+) 8. no evidence of recurrence exclusion criteria: 1. patient with hormone receptor negative 2. patients with malignancies 3. patients with other aromatase inhibitor and chemotherapy 4. patients with other hormone therapy and hormonal replacement therapy 5. patients with hormone replacement therapy during taking toremifene 6. estimated life expectancy of \<12 months 7. wbc\<3,000/mm3 or platelet count\<100,000/mm3 8. ast and/or alt ≥2xunl 9. alkaline phosphatase ≥2xunl

Keywords: breast cancer extended adjuvant hormonal therapy letrozole toremifene