Kornimate/medical-research-clean huggingface dataset:
an online cognitive assessment in cancer patients

Conditions: Cancer-Related Cognitive Difficulties; Cancer-Related Cognitive Impairment

Summary: the purpose of this study is to test the feasibility (acceptability and usability) and usefulness of the campfire (cognitive assessment and monitoring platform for integrative research) system, a patient-facing portal able to collect and produce reports for clinicians on patient reported outcome measurement information system (promis-cognitive function/anxiety/depression) outcomes via mychart and nih toolbox, an inperson brief objective cognitive function battery. this study will aim to determine the value of the campfire system for patients and providers as a tool for monitoring cognitive symptoms throughout the course of chemotherapy

campfire is a health informatics platform and research tool that seeks to improve clinical research and treatment of cognitive sequelae of cancer and chemotherapy. campfire provides curated digital assessments with content specifically for cognitive and psychosocial function assessment, and automates and integrates the data collection, analysis and visualization process into clinical workflows. campfire is designed to both improve the availability of data on cognitive impairments among cancer patients, and to improve the integration of the produced data into the care process to efficiently improve outcomes. key to the overall success of campfire is the inclusion of well-validated measures to assess function in cognitive domains often affected in cancer patients, including attention, executive function, working memory, verbal and visuospatial abilities and verbal fluency. the subjects will be asked to complete a cognitive assessment survey through a link to campfire promis in their mychart account prior to beginning chemotherapy, between 6 - 9 weeks and prior to a post-chemotherapy follow up clinic visit. subjects will also be asked to complete a brief cognitive assessment (nih toolbox) on an ipad in the jpwci prior to their scheduled clinic visits at the same three study assessment time points.

Eligibility criteria:
inclusion criteria: * must have diagnosis of cancer * must be scheduled to receive any standard course of curative intent cytotoxic chemotherapy * must have a computer, a general knowledge of how to use a computer and access to the internet * must be able to speak and read english * must be 21 years or older * must provide informed consent exclusion criteria: * must not be currently hospitalized or have been hospitalized for any psychiatric illness within the last year * must not be diagnosed with neurodegenerative disease (e.g., alzheimer's disease, parkinson's disease) * must not have any cns disease (e.g., movement disorder, multiple sclerosis)

Keywords: cancer cognition
predicting response to immunotherapy for melanoma with gut microbiome and metabolomics

Conditions: Melanoma (Skin)

Summary: this study will investigate the effects of gut microbiome diversity (richness in terms of many bacterial species in the gut) on responses and side effects of immunotherapy in advanced melanoma patients. immunotherapy for melanoma is especially damaging for the gut with colitis which can lead to death and significant morbidity with repeated hospital admissions. the richness of the microbiome in the gut may be protective against colitis and other side effects but this needs to be confirmed. there is also some preliminary evidence that the gut microbiome diversity can enhance responses to immunotherapy in cancer but this has been shown in small numbers of melanoma patients.

this pilot project will assess the gut microbiome with metagenome sequencing before and after starting immunotherapy in stage 3 and 4 melanoma patients. the project will assess the impact of the gut microbiome on treatment response rates and side effects induced by immunotherapy. 200 stage 4 and 250 stage 3 melanoma patients naive to immunotherapy will be recruited from melanoma clinics. stool samples will be donated pre-treatment and at follow-up visits throughout treatment. an additional sample will also be requested in the event of disease progression or toxicity necessitating treatment delay or discontinuation. an accompanying stool sample questionnaire will be completed at each sampling time point with the optional completion of a 24-hour recall food diary. blood samples will also be taken before and after starting immunotherapy treatment, with gastrointestinal, food frequency, quality of life questionnaires administered at baseline. an optional tumour biopsy if safe and accessible, is requested from patients in the stage 4 cohort before and after starting immunotherapy. microbiome data from melanoma patients will be compared with the twinsuk healthy control gut microbiome data on more than 3000 healthy adults. this analysis will help us assess if there are major differences between the microbiome composition in the melanoma cases prior to therapy compared to the control gut microbiome data from twinsuk.

Eligibility criteria:
inclusion criteria: - patients aged over the age of 18 years with advanced melanoma due to receive first line systemic treatment with immunotherapy with a checkpoint inhibitor alone or in combination. exclusion criteria: * patients who have had systemic anti-cancer treatment for locally advanced or metastatic disease. * patients unable to consent because of language barrier or inability to consent. * patients unable to collect or send the stool samples for geographical, social or psychological reasons. * persons benefitting from protection system of adults (including guardianship and curatorship) * pregnant or breastfeeding women
the effect of resveratrol based nutritional supplement on choroidal thickness

Conditions: Eye Disease

Summary: choroidal thickness represents blood-flowing of eyes. the investigators detect the choroidal thickness of the young participant using sd-oct to see the effect of resveratrol based nutritional supplement on choroidal thickness.

34 young, healthy participants were included in this study; they were randomly divided into two groups by age and gender matched.100 mg longevinex® capsule was given to the study group and 100mg placebo capsule to the control group. all participants underwent oct scanning with spectral domain optic coherence tomography (sd-oct) at baseline and 1 h following longevinex® or placebo administration. the choroidal thickness was measured manually by the heidelberg eye explore software(version 5.3.3.0, heidelberg engineering) with a vertical line to the retinal pigment epithelial layer.

Eligibility criteria:
inclusion criteria: 1. male and female patients 23-28 years of age. nonsmokers. 2. patients were considered to be healthy on the basis of electrocardiogram (ecg), and clinical laboratory safety tests (haematology, plasma biochemistry, urinalysis and hepatitis b, hepatitis c and hiv serology) performed at screening. 3. avoid ingesting grapefruit, grapefruit juice or other grapefruit juice containing products, and any herbal-based nutrient supplement or prescribed medications( grapefruit, cranberry, blueberry products, peanuts and peanut butter, grape and grape products, and red wine ) during the same period of time. 4. patients should abstain from alcohol-containing beverages at least two days prior to and during the study. exclusion criteria: 1. uncontrolled blood pressure exceeding diastolic pressure of 100 mm hg (sitting) during the screening period and uncontrolled diabetes mellitus 2. participation in another simultaneous medical investigation or trial renal failure requiring dialysis or renal transplant or liver dysfunction history of other disease,or other findings giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug, might affect interpretation of the results of the study, or render the subject at high risk from treatment complications. 3. iop over 30 mmhg. 4. any previous retinal laser photocoagulation to the study eye in treatment naive. any previous intravitreal injection in study eye (triamcinolone or other) in treatment naive. 5. any previous vitrectomy in study eye (posterior or anterior associated with vitreous loss in cataract surgery). 6. intracapsular cataract extraction (posterior capsule needs to be present). 7. aphakia or absence of the posterior capsule in the study eye, structural damage to the center of the macula in the study eye preexisting to crvo likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s).
a randomised, comparing fixed doses of pramipexole to investigate the efficacy and safety in patients with rls.

Conditions: Idiopathic Restless Legs Syndrome

Summary: the objective of double blind phase in this trial is to compare the efficacy and safety at the fixed dose of 0.25 mg,0.5 mg and 0.75 mg pramipexole in rls. the objective of open label phase in this trial is to investigate the long term safety and efficacy of pramipexole in rls.


Eligibility criteria:
inclusion criteria: 1. male or female patients between 20 and 80 years 2. patients with a diagnosis of restless legs syndrome (rls) according to the following diagnosis criteria of national institute of health (nih)/international restless legs syndrome study group (irlssg): 1. an urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs. 2. the urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting. 3. the urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues. 4. the urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night. 3. patients with a total score larger than 15 on the irls at visit 2 exclusion criteria: 1. premenopausal women who meet any of the following 1) to 3) 1) patients who are pregnant or possibly pregnant 2) patients who are lactating 3) patients who wish to become pregnant during the study period 2. patients who cannot take adequate contraceptive measures 3. patients with a history of akathisia induced by neuroleptics 4. patients with diabetes mellitus requiring insulin therapy 5. patients who are judged to have microcytic anaemia by the investigator or sub-investigator 6. patients with a history or signs of peripheral neuropathy, myelopathy, multiple sclerosis, parkinson's disease or other neurological diseases that may result in the occurrence of secondary rls in the physical function tests or neurological tests 7. patients with other sleep disorders such as abnormal behaviour during rapid eye movement (rem) sleep, narcolepsy and sleep apnoea syndrome (patients with an apnoea-hypopnoea index (ahi) exceeding 15 determined by polysomnography at the relevant trial site or those with loud snoring at least 5 nights/week and an experience of respiratory arrest during sleep or excessive daytime sleepiness)
effects of transport on patients with traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: hospitalized patients are often moved from their rooms to other hospital locations, particularly imaging facilities. for patients with traumatic brain injury, such movements may raise the risk of secondary brain injuries. the purpose of this study is to monitor brain injured patients during transport and to measure the resulting changes in intracranial pressure. this will allow for documentation of the frequency of secondary injury and help in understanding their causes.

secondary insults, such as hypoxia and hypotension, may worsen a brain injury. we hypothesize that secondary brain insults may occur frequently during in-hospital transport in patients with traumatic brain injury (tbi). we additionally hypothesize that automated data collection devices used during transport could more reliably document the frequency of these events and help us to understand the causes. during transport of patients with tbi, intracranial pressure and arterial blood pressure will be continuously recorded to a monitor and saved for later analysis. additional continuous measurements of pulse oximetry, end-tidal carbon dioxide, and mechanical ventilation settings will be made. the study will identify patients at risk for secondary insults, the etiology of these insults, and assist in development of a road map to prevent future incidents.

Eligibility criteria:
inclusion criteria: * presence of traumatic brain injury and intracranial pressure monitoring * requiring mechanical ventilation * presence of an indwelling arterial catheter for monitoring blood pressure * age of at least 18 years exclusion criteria: * age less than 18 years * diagnosis of brain death * non-english speakers * prisoners * mentally ill persons

Keywords: traumatic brain injury in-hospital transport
comparison of the surgical facemask with the double-trunk mask on oxygenation in covid-19

Conditions: Covid19; Hypoxemia

Summary: this study will compare the impact of two systems above low-flow nasal cannula on the arterial oxygen tension in patients with covid-19. the two systems are the surgical mask (sm) and the double-trunk mask (dtm).

hospitalized patients with covid-19 typically present with hypoxemia. in some patients, hypoxemia can be corrected with low flow nasal cannula. when placed above nasal cannula, some systems have demonstrated their interest in improving the performance of patient's oxygen delivery. for example, two recent studies have shown that adding a double-trunk mask (dtm) or surgical mask (sm) above nasal cannula has the potential to improve the pao2 despite no change in oxygen output (duprez et al., j clin monit comput 2020; montiel et al., ann intensive care 2020). however, there is no study comparing the relative effectiveness of these 2 systems.

Eligibility criteria:
inclusion criteria: * covid-19 positive * spo2 between 92 and 96% with low-flow oxygen therapy * oxygen output at baseline between 3 and 7 l/min. exclusion criteria: * pulmonary disease with hypercapnia * confusion * contra-indications to arterial blood gas sampling (peripheral arteriopathy, bleeding disorder)

Keywords: double-trunk mask surgical mask
evaluating pegfilgrastim and a multi-day topotecan regimen in subjects with relapsed or refractory ovarian cancer

Conditions: Ovarian Cancer

Summary: this trial will provide data on the safety and efficacy of pegfilgrastim, in terms of duration of grade 4 neutropenia, when administered on the last day or the day after a multi-day, myelosuppressive chemotherapy regimen for ovarian cancer.


Eligibility criteria:
inclusion criteria: - subjects with histologically confirmed primary peritoneal carcinoma, epithelial ovarian cancer, or tubal carcinoma relapsed after or refractory to 1 or 2 prior regimens of therapy - measurable or evaluable disease - gog performance status of 0 to 2 - subjects must be at least 2 weeks from major surgery and recovered from all associated toxicities or sequelae - at least 2 weeks from radiation therapy and recovered from all associated toxicities - adequate hemopoietic function evidenced by: \*anc greater than 1.5 x 10\^9/l, \*platelets greater than 100 x 10\^9/l and \*hemoglobin greater than or equal to 10 g/dl - ast and alt less than 1.5 x uln; total serum bilirubin less than or equal to 2.0 mg/dl; serum creatinine less than or equal to 1.5 mg/dl or calculated creatinine clearance greater than or equal to 60 ml/min exclusion criteria: - epithelial ovarian tumors of low malignant potential - prior therapy with topotecan - active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of chemotherapy - prior malignancy within the last 5 years, with the exception of surgically cured basal/squamous skin cell carcinoma, and/or carcinoma of the cervix in-situ - history of impaired cardiac status (e.g., severe heart disease, cardiomyopathy, or congestive heart failure) - any premalignant myeloid condition or any malignancy with myeloid characteristics (e.g., myelodysplastic syndromes, acute or chronic myelogenous leukemia - subject is pregnant (e.g., positive hcg test) or breast feeding - subject is of child-bearing potential and does not agree to using adequate contraceptive precautions - any psychiatric, addictive or other kind of disorder which compromises the ability of the subject to give written informed consent and/or to comply with study protocol procedures - other investigational procedures are excluded. subject is currently enrolled in, or has not yet completed at least 30 days since ending another investigational device or drug trial(s) or is receiving other investigational agent(s)

Keywords: ovarian cancer topotecan neutropenia neulasta®
anterior pelvic prolapse reconstruction with tiloop® total 6

Conditions: Cystocele; Uterine Prolapse

Summary: the purpose of this study is to determine the influence of anterior pelvic prolapse reconstruction with a titanised polypropylene mesh on rate of erosion and patients quality of live.

this multicentre, non-randomised, observational clinical device investigation will be performed to obtain post-marketing information on the tiloop® pelvic floor reconstruction meshes and in particular on the rate of rare erosions of the device under investigation as well as on the improvement of patients' quality of life. it is expected that the rate of erosions is equal or lower compared to competitor devices currently on the market. to verify this, it will be shown that within the first year the erosion rate found for the product under investigation is in the range of 7.9 ± 5.4 %, which is the mean erosion rate found in the recent literature. erosion, in the sense of the hypothesis, is any erosion 1 requiring more than simply the cut off of a single short filament. it is also expected that the patient's quality of life is meliorated after implantation of a tiloop® total 6 mesh. to verify this, it will be shown that by means of a validated questionnaire the subjective quality of life after 6 months is significantly better than before implantation.

Eligibility criteria:
inclusion criteria: * women with a symptomatic genital descensus : at least stage ii (ics-classification according pop-q system), or stage i with a symptomatic requiring intervention. this applies to primary as well as recurrent intervention * existence of a cystocele. * patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation * patient information has been handed out and all written consents are at hand. * patient has attained full age. exclusion criteria: * pregnancy or unfinished family planning. * known intolerance to the mesh-implants under investigation. * patients with acute (last 12 months) carcinoma. * patients with history of radiotherapy in the pelvic area. * genital descensus without any complaints. * patients with implanted pelvic floor mesh. * systemic steroid treatment. * lack of written patients' informed consent. * lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol. * patient is institutionalised by court or official order (mpg §20.3). * participation in another clinical investigation.

Keywords: polypropylene mesh prolapse cystocele surgical mesh
efficacy and safety study of caldolor (intravenous ibuprofen) in hospitalized adult and pediatric burn patients

Conditions: Burns

Summary: the primary objective of this study of caldolor administered to hospitalized adult and pediatric burn patients is to determine the efficacy of caldolor on reducing fever when compared to placebo when administered every 6 hours for at least 24 hours.


Eligibility criteria:
inclusion criteria: 1. patients with second and/or third degree thermal burns covering more than 10 percent total body surface area (including face) with anticipated hospital stay greater than 72 hours. 2. adequate intravenous access 3. have fever, documented by temperature greater than or equal to 38.0 degree celsius (100.4 degree fahrenheit) exclusion criteria: 1. patients with electric burns 2. use of acetaminophen, non-steriodal anti-inflammatory agents (nsaids) or other fever reducing medications within 4 hours prior to dosing 3. patients taking warfarin or lithium 4. active, clinically significant asthma 5. history of allergy or hypersensitivity to any component of intravenous ibuprofen, nsaids, aspirin (or related products), or cox-2 inhibitors 6. pregnant or nursing 7. history of severe head trauma that required current hospitalization, intracranial surgery or stroke within the previous 30 days, or any history of intracerebral arteriovenous malformation, cerebral aneurism or central nervous system mass lesion 8. have a history of congenital bleeding diathesis (e.g. hemophilia) or any active clinically significant bleeding, or have underlying platelet dysfunction including (but not limited to) idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, or congenital platelet dysfunction 9. have gastrointestional bleeding that required medical intervention within the previous 6 weeks (unless definitive surgery has been performed) 10. have a platelet count less than 20,000 mm\^3 11. be on dialysis 12. be receiving full dose anticoagulation therapy or activated protein c within 6 hours before dosing (clopidogrel, prophylaxis with enoxaparin or subcutaneous heparin is acceptable) 13. inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an institutional review board \[irb\]), and agree to abide by the study restrictions (if the patient is incapacitated, informed consent will be sought from a legally acceptable representative.) 14. refusal to provide written authorization for use and disclosure of protected health information (if the patient is incapacitated, informed consent will be sought from a legally acceptable representative.) 15. have received another investigational drug within the past 30 days 16. be otherwise unsuitable for the study in the opinion of the investigator
comparison of oxygen adminstration by nasal cannula and high flow cannula during bronchoscopy

Conditions: Respiratory Disease

Summary: randomized controled trial to compare oxygen desaturation during fiberoptic bronchoscopy using oxygen administered with nasal prongs and high flow nasal cannula. drops in oxygen saturation are frequent during bronchoscopy and limit the procedure compromising patient security. the investigator's aim is to contribute to select better way of oxygen administration which could prevent desaturations during bronchoscopy in children.


Eligibility criteria:
inclusion criteria: * elective flexible bronchoscopy exclusion criteria: * admitted in neonatal intensive care * previous respiratory support: oxygen any device, non invasive or invasive ventilation * patient who may benefit with continuous positive pressure during procedure

Keywords: children desaturations bronchoscopy oxygen high flow oxygen