Kornimate/medical-research-clean huggingface dataset:
using ex vivo tumoroids to predict immunotherapy response in nsclc

Conditions: Lung Cancer; NSCLC; NSCLC Stage IV

Summary: to test whether it is feasible to perform the 3d-ex functional predictive response bioassay in the context of patients with advanced/metastatic nsclc receiving immune checkpoint inhibitors in the standard of care clinical setting.

non-small cell lung cancer (nsclc), which accounts for approximately 85% of all lung cancer cases, remains the leading cause of cancer death worldwide. immunotherapy such as using immune checkpoint inhibitors (icis) to target the programmed death-1 and its ligand (pd-1/l1) has revolutionized our management of this deadly disease. however, a large proportion of patients do not derive benefit due to primary, adaptive or acquired resistance. hence, better identifying this patient population, understanding the resistance mechanism and exploring novel combinations with current soc immunotherapy are urgently needed to continue to benefit our nsclc patients. the investigators hypothesize that patient-derived immune cell containing ex-vivo tumoroids could serve these purposes. in this study, the investigators plan to develop such a 3d ex-vivo system utilizing fresh biopsied tissue from nsclc patients. the investigators plan to prospectively evaluate the value of these ex-vivo tumoroids in immunotherapy naive advanced/metastatic nsclc patients who will be receiving anti-pd-1/l1 (with or without anti-ctla-4) per standard-of-care.

Eligibility criteria:
inclusion criteria: * ability of participant or legally authorized representative (lar) to understand this study, and participant or lar willingness to sign a written informed consent * patients with advanced/metastatic nsclc * must be immunotherapy naive * males and females age ≥ 18 years * ecog performance status 0 - 2 * measurable disease by recist 1.1 * must have a lesion (either primary or metastatic lesion) that can be safely biopsied to have sufficient tissue (at minimum, 3-4 cores using 20g or larger core biopsy) to generate tumoroids * must have at least one target lesion to evaluate treatment response * will be receiving anti-pd-1/l1 with or without anti-ctla-4 per standard of care adequate organ function defined per standard of care in this setting. * women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception as required/recommended by each immune checkpoint inhibitor used in the setting of standard of care. exclusion criteria: * incarcerated * not competent to make medical decision, noncommunicative or noncompliant per investigator's judgement.

Keywords: tumoroids organoids immunotherapy immune check point inhibitor anti-pd-1 anti-ctla-4 ex vivo model 3d culture
comparison between ilux and lipiflow in the treatment of meibomian gland dysfunction (mgd): a 12-month, multicenter study

Conditions: Meibomian Gland Dysfunction; Evaporative Dry Eye Disease

Summary: the purpose of this post-approval study is to demonstrate that ilux treatment offers comparable treatment effectiveness to lipiflow for mgd treatment at 12 months post single treatment.

subjects will be expected to attend a total of 8 study visits, including screening/baseline, treatment, and follow-up visits at week 2 and months 1, 3, 6, 9, and 12.

Eligibility criteria:
inclusion criteria: * understand and sign an informed consent document; * have meibomian gland dysfunction with evaporative dry eye disease at the screening visit; * agree not to wear contact lenses for the duration of the study; * other protocol-specified inclusion criteria may apply. exclusion criteria * history of eye surgery, as specified in the protocol; * eye infection or inflammation, as specified in the protocol; * eyelid abnormalities; eyelid tattoos; * treated with lipiflow or ilux in either eye in the last 12 months; * contact lens wear within the 1 month prior to screening; * other protocol-specified exclusion criteria may apply.

Keywords: dry eye mgd
the jewels in our genes study - an african american family study of breast cancer

Conditions: Breast Cancer

Summary: the research team is studying why some african american families have multiple cases of breast cancer. this study will help to better understand if there are undiscovered genes unique to african americans that may predict early breast cancer risk. breast cancer survivors and their relatives who are also breast cancer survivors are being recruited to the study.


Eligibility criteria:
inclusion criteria: * black/african american * ever diagnosed with breast cancer * have at least one living blood relative ever diagnosed with breast cancer, who is also willing to participate * live in the u.s. exclusion criteria: * tested positive for brca mutations
the effect of ivabradine on patients with postural tachycardia syndrome

Conditions: Postural Tachycardia Syndrome

Summary: the purpose of this study is to determine whether ivabradine is an effective treatment for postural tachycardia syndrome.


Eligibility criteria:
inclusion criteria: * patients diagnosed with pots by the following criteria: 1. the presence of characteristic orthostatic symptoms of the pots for at least six months. 2. an increase in the heart rate of at least 30 beats per minute (without concomitant significant decrease in blood pressure of more than 20/10 mmhg) within 10 minutes after assuming a standing position (or during tilt test) on at least 3 separate occasions. 3. no other concomitant diseases that could explain the symptoms of pots. exclusion criteria: 1. history of systemic illness capable of affecting of affecting autonomic function (eg, diabetes mellitus, sle). 2. history of cardiovascular disease. 3. history of smoking, drug or alcohol abuse. 4. pregnancy, and also uncontrolled thyroid or adrenal disorders. 5. using any drug metabolized by cytochrome p450 3a4 enzyme during the last 72 hours.
low literacy cvd diet education for blacks

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to develop and demonstrate the efficacy of a set of original, cardiovascular (cvd) nutrition education materials designed to reduce intake of sodium (na) fat, and cholesterol and which would be appropriate for urban black adults with 5th to 8th grade reading levels.

background: the study was part of an nhlbi initiative on "cvd nutrition education for low literacy skills". the initiative originated within the prevention and demonstration branch of the deca, was approved by the september 1988 national heart, lung, and blood advisory council, and released in july 1990. design narrative: materials were designed to accomplish the objectives of conventional nutrition education/behavior change programs, but avoiding the usual dependency of traditional programs on strategies that required a high level of reading and arithmetic. guiding principles were: the need to identify the food related conceptual, cultural, and social frameworks of members of the target audience; and develop a program that built upon already-developed, alternative communication and coping skills. the core of the system was a) a protocol for office-based patient assessment and follow up, b) an educational/motivational videotape viewed in the clinical setting, c) scripts and supporting materials for a 4-week minicourse led by a clinic staff member or volunteer, and d) a package of audiocassettes and supporting printed materials to facilitate self-directed learning over an extended time period. printed materials emphasized the use of cards (hence the acronym 'cardes') that delivered single concepts about nutrition or behavior change and that permitted manipulation, selection, and reorganization of information. cardes was developed and evaluated in cooperation with howard university hospital in washington, d.c. using a randomized two-group design and a 12-24 month follow up, serum cholesterol and blood pressure levels of persons counseled with the cardes program were compared with values for a control group receiving usual care. process measures described adherence outcomes and determinants. secondary outcomes related to cvd risk factor status were also evaluated. prior to the evaluation, a pilot study determined the best sequence for delivering the information related to dietary change (i.e., na first, fat/cholesterol first, or concurrent). subsequent to the evaluation and prior to development of the final system and dissemination plan, an assessment was made of the potential utility of cardes with other black populations with low literacy skills. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
a pilot investigator-initiated study of ribavirin in indolent follicular lymphoma and mantle cell lymphoma

Conditions: Follicular Lymphoma; Mantle Cell Lymphoma

Summary: this is a a pilot investigator-initiated study of ribavirin in indolent follicular lymphoma and mantle cell lymphoma

this clinical trial is for men and women ages 18 and older with follicular lymphoma with detectable bcl2-t or mantle cell lymphoma with presence of cyclin d1 overexpression (can be newly diagnosed or relapsed). the objective of this study is to assess the possibility of treating follicular lymphoma and mantle cell lymphoma patients with ribavirin and using cell free dna (cfdna) for bcl2-t and cyclin d1 extracted from peripheral blood to measure treatment effect. clinical trials of ribavirin have been conducted in relapsed and refractory acute myeloid leukemia (aml). ribavirin, an antiviral agent with established doses, has resulted in the regression of the tumor. * ribavirin 1000 mg will be administered orally twice daily continuously for 28-day cycles. * patients will be followed for up to 7 months. * will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects.

Eligibility criteria:
inclusion criteria: * diagnosis of histologically confirmed follicular lymphoma with detectable bcl2-t or mantle cell lymphoma with presence of cyclin d1 overexpression (can be newly diagnosed or relapsed) * measurable disease (at least one tumor mass \> 1 cm in diameter) * low tumor burden: 1. no individual masses larger than 6 cm in diameter 2. no more than three masses larger than 3 cm in diameter 3. no lymphoma-related symptoms * the treating physician does not feel that treatment with chemotherapy is indicated * ecog performance status of 0-2 * adequate bone marrow and end organ function: i. anc≥1500/mm3, hemoglobin≥10 g/dl, platelet≥100/mm3 ii. crcl≥50 ml/min by cockcroff gault calculation exclusion criteria: * indication for treatment of lymphoma including large tumor burden or symptomatic disease * pregnancy or men whose female partners are pregnant * uncontrolled systemic fungal, bacterial or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment) * significant or unstable cardiac disease * hemoglobinopathy (thalassemia or sickle cell disease)

Keywords: ribavirin follicular lymphoma mantle cell lymphoma lymphoma non-hodgkin lymphoma indolent lymphoma
" the eyes have it " : ocular saccade abnormalities in prodromal alzheimer's disease

Conditions: Alzheimer's Disease

Summary: alzheimer's disease (ad) has a prolonged prodromal phase before the stage of dementia. subtle executive cognitive function deficits can be detected at this early pre-dementia phase, more than 10 years before dementia. among them, the digit symbol substitution task (dsst) has been shown to be altered very early, up to 13 years before dementia. this test, as many others executive function tests, requires a fine control of visuomotor coordination. like executive functions, eye movements, particularly voluntary-guided saccades, are under the control of the frontal lobe and fronto-parietal networks. previous studies have shown a deterioration of voluntary saccades in ad using various paradigms. there are no data in prodromal ad, although the pathological process of the disease affects very early brain structures implicated in saccades execution (eg. caudate nucleus and pre-cuneus).


Eligibility criteria:
inclusion criteria: all patient groups: * age \>60 years * normal vision work-up : (corrected binocular visual acuity \> 8/10) * written informed consent * subjects affiliated to social security group a: prodromal ad. * memory complaints. * normal or slight restriction of iadl. * "hippocampal-type" amnesic syndrome defined by poor free recall despite adequate (and controlled) encoding, decreased total recall because of insufficient effect of cuing or impaired recognition, numerous intrusions (rl/ri-16items) * cdr (clinical dementia rating scale) ≥ 0,5 * persistence of memory changes at a subsequent assessment (\>3 months) * absence of global cognitive deterioration (mmse ≥24) * exclusion of other disorders that may cause mild cognitive impairment with adequate tests * 1.5 tesla diagnosis mri with at least t2, flair transversal sections and coronal t1 sections in the coronal plan. absent or slight medio temporal/hippocampal atrophy or if available (non mandatory) characteristic csf betaa42/tau ratio group b: typical ad (mild to moderate) * ninds-adrda diagnosis criteria * mmse ≥ 20 group c: control subjects * no memory or other significant cognitive complain. * mmse ≥ 24 exclusion criteria: all groups : * clinically significant vision abnormality(p8 without glasses) * oculomotor deficit or strabismus * depression (gds) with treatment * subjects unable to give their informed consent controls : * memory or any other significant cognitive complain. * abnormalities at inclusion (v0) neuropsychology testing suggestive of a cognitive deficit.

Keywords: alzheimer's disease neurodegenerative signs
national,multicentric randomised study of the correction of genital prolapse with fascial repair or mesh-prolift

Conditions: Genital Prolapse

Summary: 180 women with genital prolapse will be submitted to genital prolapse surgical correction, half of them with human fascia, and the other half with prolift.

180 women with genital prolapse will be submitted to genital prolapse surgical correction, half of them with human fascia, and the other half with prolift.are eligible women aged between 50 and 80 years old.

Eligibility criteria:
inclusion criteria: * between 50 and 80 yrs exclusion criteria: * less than 50 and more than 80 yrs

Keywords: genital prolapse surgery fascial repair mesh prolift
exposure therapy for active duty soldiers with post traumatic stress disorder

Conditions: Stress Disorders, Post Traumatic

Summary: this study is evaluating the efficacy of virtual realty exposure therapy (vret)by comparing it to prolonged exposure therapy (pe) and a waitlist (wl) group for the treatment of post traumatic stress disorder (ptsd) in active duty (ad) soldiers with combat-related trauma. the investigators will test the general hypotheses that 10 sessions of vret or pe will successfully treat ptsd, therapeutically affect levels of physiological arousal, and significantly reduce perceptions of stigma toward seeking behavioral health services.

the rationale for this study is based on growing evidence demonstrating that vret is an efficacious treatment for ptsd and holds the potential to improve access to care for soldiers who would otherwise avoid treatment. although pe is considered one of the most effective cognitive-behavioral therapies (cbt) for treatments for ptsd, there are reasons why it may not be the most viable option for many soldiers. first, prolonged exposure requires a level of emotional engagement during exposure to the trauma that many patients are unable to obtain. second, stigma and concerns about how soldiers will be perceived by peers and leadership has a dramatic impact on whether a soldier will seek care. vret may address these concerns and may also improve treatment outcomes and access to care by augmenting the patient's re-living of the trauma with a sensory-rich environment and moderating stigma perceptions by offering non-traditional treatment that is a preferable option for many soldiers who are reluctant to seek out traditional talk therapies. despite its promise as a viable treatment option, few studies have examined vret for combat-related ptsd and there are no published studies that have compared vret to pe in the treatment of combat-related ptsd. positive results may provide new treatment options for all soldiers, but should prove to be an especially attractive option for soldiers who either do not respond to, or are reluctant to engage in other established therapies such as pe.

Eligibility criteria:
inclusion criteria: * ptsd diagnosis as assessed by caps * history of deployment in support of oif/oef * non sexually based deployment related trauma * three or more months since index trauma * stable on psychotropic medications for 30 days exclusion criteria: * index trauma in the last three months * history of schizophrenia, other psychotic or bipolar disorder * history of organic brain disorder * suicidal risk or intent or self-mutilating behavior requiring hospitalization in the last 6 months * ongoing threatening situation * current drug or alcohol dependence * history of seizures * prior history of pe for ptsd * other current psychotherapy * physical condition that interferes with proper use of virtual reality head mounted display * history of loss of consciousness since entering active duty service greater than 15 minutes

Keywords: combat disorders exposure therapy army personnel
nebivolol versus bisoprolol versus carvedilol in heart failure

Conditions: Chronic Heart Failure

Summary: the investigators test the hypothesis that different beta-blockers had a different influence on chemoreceptor response and lung diffusion capacity. both could influence exercise capacity in normoxic as well as hypoxic conditions.


Eligibility criteria:
inclusion criteria: * chronic heart failure patients in stable clinical condition exclusion criteria: * no comorbidity * nyha class iv

Keywords: exercise lung diffusion hypoxia chemoreceptor beta-blockers heart failure
periodontal therapy on the gut microbiome of inflammatory bowel disease

Conditions: Periodontal Diseases; IBD; Dysbiosis; Inflammation

Summary: periodontitis and inflammatory bowel disease have been associated by meta-epidemiologic evidence, although their mechanistic connection needs to be further explored. oral-gut axis is implicated in the pathogenesis of several chronic inflammatory conditions, but to date no studies have evaluated the impact of periodontal treatment on gut ecology. thus, the present randomised clinical trial is aimed at investigating the effect of intensive or conventional periodontal therapy on the gut microbiome and parameters of systemic inflammation of patients diagnosed with inflammatory bowel disease.


Eligibility criteria:
inclusion criteria: * clinical and instrumental diagnosis of ulcerative colitis or crohn's disease * periodontitis stage iii or iv * bmi between 20 and 29 kg/m2 * free diet * presence of at least 20 teeth exclusion criteria: * systemic diseases (including diabetes, thyroid, liver, or kidney diseases) * dietary allergies * use of antibiotics or probiotics during the previous 30 days * pregnancy or breast feeding
anomia therapy and executive function training in chronic post-stroke aphasia: pilot study of multidimensional effects

Conditions: Aphasia, Acquired; Speech Therapy

Summary: the goal of this clinical trial is to measure the effects of a speech therapy protocol combining anomia therapy and executive function training on naming and discourse in people with chronic aphasia, and to study the related brain changes. the main questions it aims to answer are: * does the protocol improve naming skills ? * do the improvements observed transfer to discourse abilities ? * are there any brain changes induced by this protocol ? researchers will compare anomia therapy alone to anomia therapy + executive function training to see if the latter works better. participants will: * have a whole language assessment and a magnetic resonance imaging (mri) scan in the hospital before and after the protocol * receive 18 sessions of the protocol, 3 times a week during 6 weeks, in the hospital * have several naming assessments during the protocol


Eligibility criteria:
inclusion criteria: * adult (18-80 years old) with post-stroke aphasia (\> 6 months post-stroke) * participant or legal representative able to understand the aims of the study * participant or legal representative who have signed an informed consent form exclusion criteria: * aphasia with severe anarthria (mutism), comprehension disorders or alexia, incompatible with the purpose of the study * contraindications for mri * history of head trauma, brain tumor, neurodegenerative disease, or any other neurological or psychiatric condition * non-affiliation to social welfare

Keywords: post-stroke aphasia speech-therapy anomia therapy executive function discourse functional magnetic resonance imaging
eus role in non-metastatic pancreatic adenocarcinoma lymph nodes staging

Conditions: Pancreatic Adenocarcinoma; Lymph Node Metastasis

Summary: aim of the study will be to investigate if endoscopic ultrasound (eus) with elastography can be purposed between the routine staging examinations in patients with pancreatic adenocarcinoma without distant metastasis for the staging of lymph nodes status ("n" in tnm classification) * in resectable pancreatic cancer the investigators will evaluate the concordance with eus elastography and histological findings of lymph nodes obtained during surgery, in order to assess the sensibility, specificity and the positive and negative predictive value of eus with elastography, the disease-free survival, the percentage of metastatic patients and the overall survival (in patients with or without metastatic lymph nodes). * in "borderline resectable" and unresectable non-metastatic ("advanced" locally") disease, the investigators will evaluate if the malignant lymph nodes samples during eus with elastography and fine needle aspiration (fna) will be related to a decreased survival. secondary aim will be to register the prognosis (in terms of survival) of the patients with para-aortic and mediastinal pathological lymph nodes (related to a decreases survival in some series in literature)

pathological lymph nodes will be assessed by eus with elastography as lymph nodes: hypoechoic, rounded, rigid (blue) and big (bigger than 1 centimeter)

Eligibility criteria:
inclusion criteria: pancreatic adenocarcinoma without distant metastasis; patients \> 18 years exclusion criteria: distant metastasis and pancreatic adenocarcinoma