Kornimate/medical-research-clean huggingface dataset:
continuous evaluation of diaphragm function

Conditions: Respiration, Artificial; Mechanical Ventilation; Critical Illness

Summary: aim of mechanical ventilation is to improve gas exchange and to unload the respiratory muscles delivering a form of mechanical support to the ventilation. at the same time, it is essential that the support is individually-tailored to avoid the development of muscular atrophy, a process called "ventilatory-induced diaphragm dysfunction" aim of the present study is that the continuous ultrasonographic assesment of diaphragm function, as obtained by the device under investigation (diamon, respinor as, oslo, norway) is related to the degree of effort of inspiratory muscles, as measured by gold-standard indices such as esophageal and gastric pressure measurement. a secondary aim is that the data assessed by the device are related to a standard ultrasonographic examination performed by expert operators. in particular, we will enroll a population of critically ill patients undergoing mechanical ventilation in assisted mode, and we will perform a decremental pressure support trial, with the following aims: 1. to evaluate the performance of a continuous and automated device for the monitoring of diaphragm contractile activity, as compared to standard mechanical indices of respiratory effort such as the pressure-time product (ptp) 2. to evaluate the performance of a continuous and automated device for the monitoring of diaphragm contractile activity, as compared to the ultrasonographic assesment of muscle function performed by an expert operator.


Eligibility criteria:
inclusion criteria: * acute respiratory failure which necessitated endotracheal intubation and mechanical ventilation, with ventilation in pressure-support mode. * positive end-expiratory pressure (peep) lower than 10 cmh2o * pressure support level between 4 and 10 cmh2o * ratio between pao2 and fio2 \>200 mmhg * resolution of the cause of respiratory failure exclusion criteria: * diagnosis of chronic obstructive pulmonary disease (copd) * pregnancy * circulatory failure
identification of diagnostic and prognostic biomarkers from amyotrophic lateral sclerosis (als) skin and adipose samples

Conditions: Amyotrophic Lateral Sclerosis

Summary: the purpose of the project is to obtain skin and adipose tissue samples from patients with als to develop new diagnostic and prognostic markers of the disease. these samples will be obtained when percutaneous endoscopic gastrostomy (peg) is performed as part of their standard of care. skin and adipose tissue samples will also be obtained from disease control subjects who require a peg as part of their standard of care.

subjects who are undergoing a percutaneous endoscopic gastrostomy (peg) tube insertion as part of their standard of care will be asked if a skin and adipose sample may be collected for research during the procedure. after a participant has signed the informed consent, the sub-investigator from the department of gastroenterology will collect a skin and adipose sample during the procedure. individuals with a diagnosis of definite als and disease controls (i.e. stroke, head and neck cancer, spinal cord injury, etc.) will be included in this study. the coded skin and adipose sample will be taken to the carolinas neuromuscular/als research laboratory in the cannon research center for processing. the skin and adipose will be separated from each other and divided into halves. each half of skin and adipose will be submerged in preservative and either shipped to als-tdi or retained at -80°c in the carolinas neuromuscular/als research laboratory. the research staff at the carolinas neuromuscular/als-mda center will be responsible for shipping the sample to the als-tdi for either rna isolation using the qiagen rnaeasy kit (qiagen) or for purification of protein. subsequently, gene expression profiling on affymetrix genechips or mass spec based proteomics on a thermo orbitrap lc-ms/ms instrument will be performed, respectively. the discovery effort (if all participants are working at capacity) should not take more than 12 months. in addition to the above procedures, a member of the study team will review the medical chart to obtain additional information on the participant's medical and family history. for als patients, past alsfrs-r scores or fvc scores will be provided to the "als-tdi skin and adipose biomarker study" to enhance the usefulness of the information for research. samples will not be stored with any patient identifiers. samples will be retained and continued to be studied as new techniques become available. data from the study may be published in scientific journals. publications will not include any patient identifiers.

Eligibility criteria:
inclusion criteria: * for als patients, subjects must be diagnosed with definite als according to the el escorial criteria (eec) * all subjects must be diagnosed with a condition requiring peg (percutaneous endoscopic gastrostomy) tube insertion * subjects must be older than 18 years of age exclusion criteria: * children 18 years old and younger

Keywords: amyotrophic lateral sclerosis motor neuron disease biological markers biomarkers
a pilot study of dacomitinib with or without osimertinib for patients with metastatic egfr mutant lung cancers with disease progression on osimertinib.

Conditions: EGFR Gene Mutation; Lung Cancer; Lung Cancer Metastatic

Summary: the purpose of this study is to assess whether dacomitinib after osimertinib is effective in participants with metastatic egr-mutant lung cancers.


Eligibility criteria:
inclusion criteria: * written informed consent * advanced biopsy-proven metastatic non-small cell lung cancer * somatic activating mutation in egfr in a tumor biopsy or plasma cfdna liquid biopsy * prior treatment with osimertinib with response followed by disease progression * no prior first or second generation egfr inhibitor treatment (gefitinib, afatinib, erlotinib) * archival tissue available from a tumor biopsy done after disease progression on osimertinib or willing to undergo a tumor biopsy or liquid biopsy after disease progression on osimertinib prior to study initiation * measurable (recist 1.1) indicator lesion not previously irradiated * karnofsky performance status (kps) \>/= 70% * age \>/= 18 years old * ability to swallow oral medication * adequate organ function * ast, alt \</= 3 x uln * total bilirubin \</= 1.5x uln * creatinine \ /= 60ml/min * absolute neutrophil count (anc) \>/= 1000 cells/mm3 * hemoglobin\>/=8.0 g/dl * platelets \>/=75,000/mm3 exclusion criteria: * pregnant or lactating women * any radiotherapy within 1 week of starting treatment on protocol. * any major surgery within 1 weeks of starting treatment on protocol. * any evidence of active clinically significant interstitial lung disease * continue to have unresolved \> grade 1 toxicity from any previous treatment treatment * patients with a known mechanism of resistance to osimertinib that will clearly not respond to dacomitinib therapy (i.e. known met amplification, alk fusion, ret fusion). * symptomatic brain metastases or leptomeningeal disease requiring escalating doses of steroids

Keywords: egfr c797s egfr mutant lung cancer dacomitinib osimertinib 18-341 memorial sloan kettering cancer center
divided or single exposure (dose) study

Conditions: Opioid Use Disorder; Chronic Pain; Methadone

Summary: this study will evaluate whether once versus twice daily dosing of methadone will be an effective method for managing comorbid pain and opioid use disorder.

this study follows a successfully completed project (nct03254043) to now pursue the investigators overarching goal of optimizing methadone dosing as a method for managing comorbid chronic pain and opioid use disorder (oud) among persons receiving methadone for the treatment of oud. up to 62% of persons maintained on methadone for oud experience clinically significant pain, versus 31% in the general population. pain in methadone-maintained persons (mmp) is associated with poor oud treatment outcomes and severe distress. no effective treatment for comorbid pain and oud currently exists; though preclinical and human data suggest divided methadone dosing may be a more optimal strategy for managing pain than once daily dosing, this has never been empirically examined. this study will evaluate an intervention for comorbid chronic pain among mmp using a phase ii double-blind, randomized, placebo-controlled comparison of treatment as usual (tau) versus split daily methadone dosing for 12-weeks. methadone will be remotely managed via an electronic pillbox. outcomes will include weekly assessments of pain and oud outcomes, ecological momentary assessment of pain before and after dosing, and point-prevalence measures of laboratory-induced pain to explore mechanism of effects. if effective, this approach could transform the care of mmp with pain because it would be feasible to implement within the operational structure of a methadone clinic and would impose low provider burden. results could provide a high magnitude treatment for the substantial number of mmp who experience daily pain with no reliable form of treatment.

Eligibility criteria:
inclusion criteria: * aged 18 years of age or older * currently receiving methadone for treatment of oud for \>90 days and have been consuming the same dose for \>30 days * have previously received a take-home dose of methadone as part of routine care * willing to comply with study schedule * report pain (specific definition blinded) * have a cellular phone or be willing to carry phone provided by the study during one phase of the study exclusion criteria: * pregnant * presence of acute medical problem that requires immediate and intense medical management * presence of a serious and unstable mental illness that interferes with provision of voluntary informed consent and/or adherence to study visits * plans to leave methadone treatment during the study period * maintained on a dose of methadone that would prevent effective splitting of doses * currently receiving split doses of methadone * currently receiving treatment for pain for which the split-dosing of methadone is judged by medical staff to be contraindicated or otherwise interfere with study conduct or integrity * does not meet criteria for mild-severe disability (definition blinded)
safety of continuing chemotherapy in overt left ventricular dysfunction using antibodies to her-2

Conditions: Heart Failure; Breast Cancer

Summary: trastuzumab is an important treatment for her 2 positive breast cancer. but trastuzumab can cause injury to the heart, and this is one of the main reasons it cannot be administered as planned. heart injury can often be successfully treated using cardiac medications. the aim of scholar is to evaluate whether it is safe to continue trastuzumab in individuals with mild or moderate cardiac injury, while treating them with appropriate cardiac medications. in this way the investigators hope to be able to optimise the delivery of a treatment to patients with breast cancer that has proven survival benefits, especially when administered for a full 12-month course.

the scholar study design will be a modified phase i, non-randomized clinical study. initially a cohort of 5 participants will be enrolled. they will continue to receive trastuzumab. all participants in scholar will also be prescribed standard-of-care treatment for patients with lv systolic dysfunction, including the beta-blocker, carvedilol, and the ace-i, ramipril, as tolerated, at the maximum doses tolerated, up to carvedilol 25mg bid and ramipril 10mg once daily. if at any time 1 or more of the first 5 participants develop cdlt, de-escalation will occur. de-escalation will involve a change in the eligibility criteria to exclude patients with lvef \ 20% of participants develop cdlt, the intervention will be considered unsafe, and the study will be closed. patients will be seen by a cardiologist at the following time points (referenced from the baseline visit): baseline, 3 weeks ± 1 week, 6 weeks ± 1 week, 3 months ± 1 week, 6 months ± 1 week, 9 months ± 1 week, 12 month ± 1 week

Eligibility criteria:
inclusion criteria: * stage i-iii her-2 positive breast cancer * receiving adjuvant therapy with trastuzumab * provide informed consent * exhibit lv dysfunction as evidenced by either * lvef between 40% and the lower limit for normal (i.e. \<54% in women or \< 52% in men18), or * lvef within normal limits (i.e. ≥54% in women or ≥52% in men) and nyha class ii heart failure symptoms within the past year, or * a fall in lvef of ≥15% from baseline exclusion criteria: patients will not be eligible for scholar if they have any of the following: * nyha class iii or iv heart failure * systolic blood pressure \<90mmhg * current use of both ace-i/angiotensin receptor blocker and beta-blocker * contra-indication to both ace-i/angiotensin receptor blocker and beta-blocker
a real-world study of obinutuzumab-based therapy for previously untreated fl

Conditions: Follicular Lymphoma

Summary: this study aims to observe and explore the efficacy and safety of obinutuzumab-based therapy for previously untreated follicular lymphoma

this study aims to observe and explore the efficacy and safety of obinutuzumab-based therapy for previously untreated follicular lymphoma. this study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. the medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors.

Eligibility criteria:
inclusion criteria: * pathologically confirmed cd20 positive follicular lymphoma grade 1, 2, or 3a based on 2016 who classification * treatment naive * age ≥ 18 years * indications for treatment confirmed * must has measurable lesion in ct or pet-ct prior to treatment * considered suitable for gr, gb or gchop regimens * informed consented exclusion criteria: * transformed follicular lymphoma or 3b follicular lymphoma; * hbsag positive and / or hbcab positive with hbv dna titer; hcv antibody positive with hcv-rna; or hiv positive * central nervous system or meninges involved * any drug contraindication in the treatment plan * patients judged by other researchers to be unsuitable for inclusion in the study

Keywords: obinutuzumab lymphoma
intravitreal topotecan for prevention or treatment of proliferative vitreoretinopathy in retinal detachment

Conditions: Retinal Detachment Rhegmatogenous; Proliferative Vitreoretinopathy

Summary: intravitreal topotecan exhibits strong anti-inflammatory, anti-proliferative, and anti-fibrotic properties, making it a promising option for preventing and treating proliferative vitreoretinopathy in rhegmatogenous retinal detachment. preclinical studies have demonstrated its efficacy in proliferative vitreoretinopathy models, where no adverse events have been reported for doses of 5 µg to 30 µg. this prospective, matched cohort study aims to assess the therapeutic efficacy and safety of intravitreal topotecan for preventing and treating proliferative vitreoretinopathy in rhegmatogenous retinal detachment patients.

patients who provide informed consent for participation in the experimental study arm will undergo standard-of-care retinal detachment surgery with intravitreal topotecan (8 µg/0.05 ml), diluted in sterile saline and administered preoperatively within one week before surgery, as well as one week postoperatively. matched historical control patients who received standard-of-care retinal detachment surgery without intravitreal topotecan will be eligible for study participation. both the experimental and historical control study arms will be further divided into two groups: (i) patients with rhegmatogenous retinal detachment who exhibit high-risk characteristics of proliferative vitreoretinopathy on optical coherence tomography or have early proliferative vitreoretinopathy confirmed by clinical examination, and (ii) patients with rhegmatogenous retinal detachment who have neither high-risk characteristics of proliferative vitreoretinopathy nor a history of proliferative vitreoretinopathy.

Eligibility criteria:
inclusion criteria: 1. patients aged 18 years and older 2. patients who undergo pneumatic retinopexy, pars plana vitrectomy and/or scleral buckling for rhegmatogenous retinal detachment 3. patients who are voluntarily able and willing to participate patients undergoing combined phacoemulsification and pars plana vitrectomy and/or scleral buckling will also be included. any surgical technique will be considered, including relaxing retinotomy or retinectomy during pars plana vitrectomy. exclusion criteria: 1. patients with a history of exudative retinal detachment 2. patients with severe non-proliferative or proliferative diabetic retinopathy 3. patients with other planned ocular surgery following pars plana vitrectomy 4. female patients of childbearing age (i.e. less than 50 years old) who intend to become pregnant over the course of the study 5. patients with pre-existing bone marrow suppression or cytopenias 6. patients with pre-existing interstitial lung disease

Keywords: topotecan proliferative vitreoretinopathy rhegmatogenous retinal detachment
fragility assessment in adults with adhd and mental retardation

Conditions: Autism Spectrum Disorder; Mental Retardation

Summary: frailty is a age dependent physiological state of vulnerability. frailty is screened by the phenotypic model (5 clinical criteria) or the cumulative model (various clinical and biological criteria). currently, aging with autism spectrum disorder and mental retardation (ads-mr) is poor described. nevertheless many data indicate that people with ads-mr may present an early aging. principal aim of this study is to determine if frailty in people with ads-mr aged over 20 years depend on age. secondary aims are to evaluate frailty prevalence, to describe with details health according to age, and to verify the frailty index validity for predicting falls, hospitalisation and death, in this population of ads-mr patients aged over 20 years. this monocentric and prospective study will include 60 ads-mr patients aged over 20 years and living in languedoc-roussillon's medico-social care homes. patients are evaluated at the time of inclusion. frailty index is calculated from 104 clinical and biological criteria. furthermore the investigator staff collect data about ads severity (cars), adaptative and intellectual functionning (vineland), and psychiatric and somatic comorbidities (reiss scale, dsqiid and cirs). falls, hospitalisations or death occurrence is then collected every year during 5 years. the connection between frailty index and age will be studied using linear regression. the frailty index validity will be analysed using roc curves. modelisation of the falls, hospitalisations or death risk in the 5 years after the initial evaluation will help in identification of the more frailty predictive criteria.

calendar : this study will take place during 60 months. 4 first months will be devoted at the ethic and administrative issues. inclusion will take place during 26 months. follow-up will take 5 years. last months will be used for data analysis and articles submission. perspectives : this study will be the first describing frailty evolution during aging in patients suffering from ads-mr. it will be useful for creating a new, simple and pragmatical frailty screening tool specific for ads-mr patients in order to detect earlier which patient are the most frail.

Eligibility criteria:
inclusion criteria: * ads diagnosis using dsm-5 or cim-10 criteria, associated to mental retardation * age over 20 years * patient living in languedoc-roussillon's medico-social care home * patient benefiting from social security * patient or legal representative consent collected exclusion criteria: * patient or legal representative disagreement to participate at the sudy * pregnant woman or nursong mother * patient with down syndrom
comparison of the diagnostic accuracy of hysterosalpingo-lidocaine-foam sonography versus hysterosalpingography in tubal patency assessment to the gold standard of laparoscopy and dye testing

Conditions: Tubal Factor Infertility

Summary: this is a cross-sectional study that compares the diagnostic accuracy of hysterosalpingo-lidocaine-foam sonography combined with power doppler (hylifosy-pd) in the assessment of tubal patency, with the diagnostic accuracy of hysterosalpingogram (hsg), and to the gold standard of laparoscopy and dye testing.


Eligibility criteria:
inclusion criteria: 1. age group (18-40) 2. informed signed written consent. 3. scheduled for ldt as a part of their infertility management 4. have undergone hsg in the previous 5 years with the availability of good-quality hsg images. 5. no incident factors that might have affected the tubal status after she underwent hsg within the previous 5 years, such as ; abdominal surgery or laparoscopy, pelvic inflammatory disease, smoking, and intrauterine device insertion. exclusion criteria: 1. ldt scheduled for a therapeutic purpose due to a known tubal or ovarian pathology 2. lack of good-quality hsg images. 3. withdrawal of consent. 4. using contraception 5. women outside reproductive age 6. known allergy to lidocaine 7. active pelvic inflammatory disease 8. undiagnosed genital tract bleeding. 9. evident tubal pathology (such as hydrosalpinx) or pregnancy diagnosed by transvaginal ultrasound (tv-us) prior to performing hylifosy-pd 10- incident factors that might have affected the tubal status after she underwent hsg within the previous 5 years, such as ; abdominal surgery or laparoscopy, pelvic inflammatory disease, smoking, and intrauterine device insertion.
comorbidities and reducing inequities

Conditions: Cancer, Breast; Diabetes Mellitus; Hypertension; Cancer Prostate

Summary: black cancer patients tend to have worse outcomes than white cancer patients. some of this disparity may be due to comorbidities. the purpose of this study is to improve management of co-morbidities among cancer patients in order to improve cancer outcomes and improve health equity. comorbidities such as diabetes and hypertension can complicate cancer treatment or can make it difficult to reach optimal health after treatment. this study will offer additional support and tools to manage cancer patient's health needs. first, the study will use a mobile health application, managed by a company called welldoc, to monitor patient progress in real time and to provide ongoing guidance. second, the study will connect patients with a community health worker who will speak with them weekly to discuss self-care information, including medical scheduling or appointment needs, and assist with daily self-monitoring of blood pressure and/or blood glucose monitoring. lastly, an oncology nurse will monitor reported health and triage any medical needs and whether additional medical care is needed.


Eligibility criteria:
inclusion criteria: * black women with a diagnosis of stage 0-iv breast cancer and within a month of treatment initiation or with 6+ months of treatment left or black men with a history of prostate cancer who are on long-term androgen deprivation therapy; * blood pressure \>=120/80 or diagnosis of diabetes * individuals who develop these conditions during treatment such as those scheduled to initiate steroid-containing chemotherapy or targeted pi3k inhibitor therapies * access to a smartphone and/or internet for the duration of the study. * can understand and communicate in english exclusion criteria: - unwilling to participate in a 6-month study

Keywords: prostate cancer breast cancer diabetes mellitus hypertension community health workers mhealth