Kornimate/medical-research-clean huggingface dataset:
bovari: a non-interventional study of avastin (bevacizumab) as front-line treatment in patients with ovarian cancer

Conditions: Ovarian Cancer, Peritoneal Neoplasms

Summary: this non-interventional study will evaluate the routine use and the safety and efficacy of avastin (bevacizumab) as first-line treatment in patients with advanced ovarian cancer (epithelial ovarian cancer, fallopian tube carcinoma, primary peritoneal carcinoma). newly diagnosed patients who are initiated on carboplatin/paclitaxel chemotherapy in combination with avastin will be followed for up to 15 months of treatment and 12 months of follow-up.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * patients with newly diagnosed advanced epithelial ovarian cancer (eoc), fallopian tube carcinoma (ftc) or primary peritoneal carcinomas (ppc) with indication for first-line carboplatin/paclitaxel chemotherapy in combination with avastin exclusion criteria: * contraindications for avastin according to the summary of product characteristics
prospective evaluation of a new covered metal stent for malignant lesions of the esophagus

Conditions: Esophageal Cancer

Summary: in this study, a newly designed and fda approved fully covered metal stents will be used to palliate 20 patients with malignant lesion of the esophagus. dysphagia score will be assessed before and after treatment to confirm efficacy

the incidence of esophageal cancer is increasing, and despite advances in treatment, the prognosis is still very poor \[1-4\]. at presentation, between 50-60 % of patients have unresectable disease \[5,6\]. for these patients, palliation is the goal with a particular focus on the relief of dysphagia, which is the major etiology of morbidity \[5,6\]. presently, self expanding metal stent (sems) have become the treatment of choice for dysphagia associated with unresectable esophageal and ge junction malignancies. in this study, a newly designed and fda approved fully covered metal stents will be used to palliate 20 patients with malignant lesion of the esophagus. dysphagia score will be assessed before and after treatment to confirm efficacy the objectives are: 1. to evaluate if the newly fully covered metal stent , hanarostent can provide adequate palliation of cancerous lesions of the esophagus; 2. to determine whether it is non-inferior in efficacy and safety to the esophageal stents currently available at uva with minimal complications and improvement of symptoms

Eligibility criteria:
inclusion criteria: * inoperable malignant obstruction of the esophageal or gastric cardia * malignant fistula between the esophagus ans respiratory tree * recurrent cancer after prior radiation exclusion criteria: * patient unstable for endoscopic procedure * previous esophageal stenting * tumor growth within 2 cm of the upper esophageal sphincter * pregnant women (self reported, no pregnancy test will be done per protocol)

Keywords: esophageal cancer, malignant, dysphagia, esophagus, cancer
stress, personality, attachment and coping during the covid crisis.

Conditions: Psychiatric Disorder; Aging

Summary: because of containment due to covid-19, the french high authority for health (has) recommended reinforced monitoring of patients taken in care in the psychiatric ward, with special attention for people over the age of 65. to meet this recommendation, the geriatrics department of the hospital of charity of saint-etienne hospital and the vinatier hospital in lyon organized follow-up of these patients by telephone throughout the containment period, thus allowing continuity of care. this pandemic situation and these measures are unprecedented; it is difficult to anticipate the psychological impact on patients.

the main objective of this study is to evaluate if the type of coping strategies usually employed has an effect on the outbreak of a post-traumatic stress after containment. in addition, a second part of the study will propose to assess the factors influencing the experience of containment such as personality, attachment style or coping strategies.

Eligibility criteria:
inclusion criteria: * patients followed by teleconsultation during containment due to covid 19 * patient affiliated or entitled to a social security scheme * patient who received informed information about the study and who co-signed, with the investigator, a consent to participate in the study (for the part excluding routine care). exclusion criteria: - major neurocognitive disorder

Keywords: covid-19 teleconsultation stress containment post-traumatic stress
behavioral and neuronal correlates of human mood states

Conditions: Major Depressive Disorder; Epilepsy

Summary: optimizing treatments in mental health requires an easy to obtain, continuous, and objective measure of internal mood. unfortunately, current standard-of-care clinical scales are sparsely sampled, subject to recency bias, underutilized, and are not validated for acute mood monitoring. the recent shift to remote care also requires novel methods to measure internal mood. recent advances in computer vision have allowed the accurate quantification of observable speech patterns and facial representations. the continuous and objective nature of these audio-facial behavioral outputs also enable the study of their neural correlates. here, the investigators hypothesize that video-derived audio-facial behaviors have discrete neural representations in the limbic network and can provide a critical set of reliable longitudinal estimates of mood at low cost across home and clinic settings.


Eligibility criteria:
inclusion criteria: * age range between 18 and 65 * major depressive disorder (mdd) in a current major depressive episode diagnosed with the mini-international neuropsychiatric interview (mini) * no medical or surgical contraindication to electrode implantation * patient capable of understanding the scope of our project or signing informed consent independently. exclusion criteria: * diffuse epilepsy involving several lobes of the brain
ptsd among victims of sexual abuse and changes in structural and functional brain connectivity

Conditions: PostTraumatic Stress Disorder

Summary: the goal of this study is to identify the early modifications in fronto-temporal connectivity in female victims who developed ptsd, compared to female victims who did not develop the disorder, and to healthy control females. the investigators will compare between all these groups, structural and functional differences using different techniques (mri, fmri, dti and asl), and paradigms (cognitive tasks or at rest).

most of the transversal neuroimaging studies in posttraumatic stress disorder (ptsd) were conducted in male war veterans. few studies focused on neuroanatomical correlates of ptsd in civilian populations, and only one prospective study explored the cerebral connectivity when developing the disorder. in france, physical and sexual assaults are the most prevalent causes of ptsd, especially in the female population. neuroanatomic basis of chronic ptsd are now well-defined, implicating limbic over-activation (amygdala), associated with a default activation in prefrontal cortex. however, mechanisms implied in the modification of fronto-limbic regions connectivity, especially in the anterior cingulate cortex (acc), need further investigations. will the post-traumatic amygdalar over-activation perturbate the normal functioning of the acc, or is there a modification in the acc functioning which leads to a default in amygdala inhibition ? this question is of interest, since the prefrontal cortex, including the acc, has an essential role in different kind of cognitive activities in the normal and pathological brain, such as working memory and attentional processes. the goal of this study is to characterize early modifications in structural and functional connectivity in brain structures implied in the development of ptsd using different kinds of mri-based techniques (structural mri, fmri, dti and asl), as well as biological (cortisol) and psychophysiological (skin conductance ...) measures in female patients developing ptsd, compared to women exposed to trauma who did not develop the disorder and to healthy controls.

Eligibility criteria:
inclusion criteria: * written consent * affiliated to the national health insurance * without neurological past history * without psychoactive drugs past history exclusion criteria: * the subject can not follow the instructions * simultaneous participation to an other study using psychoactive drugs * blindness * epilepsy * addiction to psychoactive drugs * mri counter-indications (pace-makers ...) * claustrophobia * every circumstances making the subject unable to understand the nature, the objectives or the consequences of the study

Keywords: posttraumatic stress disorder working memory attentional bias connectivity structural neuroimaging functional neuroimaging diffusion tensor imaging arterial spin labelling cortisol psychophysiology early development of
early acs: early glycoprotein iib/iiia inhibition in patients with non-st-segment elevation acute coronary syndrome (study p03684am2)(completed)

Conditions: Myocardial Ischemia; Acute Coronary Syndrome

Summary: the purpose of this study is to see if early integrilin® (eptifibatide) therapy in patients with non-st-segment elevation acute coronary syndrome (acs) reduces the occurence of death, heart attack and urgent cardiac intervention (surgery) compared to placebo (with delayed provisional use of eptifibatide).

this study will enroll patients who experience symptoms of acute coronary syndrome (experiencing chest pain at rest with episodes lasting at least 10 minutes) and who are planned to undergo invasive surgical procedures after being given study drug for 12 to 96 hours. there are two different treatment groups in this study; approximately half of the patients will go to each group and the likelihood of receiving study drug vs. placebo is 50/50 (like tossing a coin). medications that are standard of care will be provided to the patients (all patients will be given aspirin and standard hospital doses of one of two other blood thinning drugs - unfractionated heparin (ufh) or low-molecular-weight heparin). which one patients receive is at the discretion of the investigator.

Eligibility criteria:
inclusion criteria: * willing and able to give informed consent and comply with study procedures and follow-up through 1 year. * plan to undergo an invasive strategy after receiving study drug for 12 to 96 hours. * able to be randomized into the trial within 12 hours of having symptoms of acute coronary syndrome. * experiencing symptoms of cardiac ischemia at rest (angina or anginal equivalent) with episode(s) lasting at least 10 minutes and have at least 2 of the following: * 60 years of age or more * electrocardiogram changes (ecg) * elevated troponin (protein released in the blood stream in people suffering from acute coronary syndrome) or ck-mb levels * or have all 3 of the following: * prior history of cardiovascular disease * elevated troponin or ck-mb levels * 50-59 years of age exclusion criteria: * pregnancy (known or suspected) * renal dialysis within 30 days prior to randomizing in study * other serious illnesses or any condition that the investigator feels would pose a significant hazard to the patient if the investigational therapy was to be initiated * stroke (hemorrhagic stroke at any time or non-hemorrhagic stroke within previous 7 days), central nervous system damage (such as neoplasm, aneurysm, intracranial surgery), bleeding disorders (including gastrointestinal bleeding), or recent major surgery or major trauma. * history of certain hematologic problems following treatment with heparin or eptifibatide. * therapy with certain related drugs within a short time before randomization into the trial.

Keywords: myocardial infarction acute coronary syndrome non-st-segment elevation eptifibatide integrilin glycoprotein iib/iiia inhibitor (gp iib/iiia) percutaneous coronary intervention (pci) coronary artery bypass graph surgery (cabg) catheterization angina ischemia cardiac ischemia cardiovascular disease
clascoterone for steroid-related acne vulgaris in transgender male patients receiving masculinizing hormone therapy

Conditions: Acne Vulgaris

Summary: mechanism-based acne treatment for transgender patients receiving testosterone currently does not exist and is an unmet medical need. this study explores clascoterone to treat testosterone induced acne. many treatments we use to treat acne in females cannot be used in transgender males because they interfere with hormone therapy. androgens have been associated with the development of acne vulgaris. recently, a topical androgen receptor inhibitor cream (clascoterone) has been fda-approved for the treatment of acne. however, clinical trials of clascoterone have excluded participants on exogenous hormones. clascoterone has been hypothesized to be effective in the treatment of acne in transgender male participants on masculinizing hormone therapy, but it has never been studied or reported in the literature.


Eligibility criteria:
inclusion criteria: * transgender male or gender diverse patient on mht * on a stable dose of mht for at least 3 months prior to the study * anticipate being on the same dose of mht for the duration of the study * have steroid-related acne vulgaris as determined by the investigator with onset or worsening after initiation of mht * have at least 20 papules or pustules on the face * consistent skin care regimen (topical and systemic medications) for at least 4 weeks prior to enrollment and continue it for the duration of the study (however, note exclusion below that topical steroids on face not allowed for 4 weeks prior to enrollment and during study)\*; * age 16 years old or older * potential participants who have ovaries and are or planning to be sexually active with partners that produce sperm will need to use a medically reliable form of birth control (including but not limited to condoms, intrauterine device, oral contraceptives) before enrollment and during the study * note inhaled steroids are allowed as long as regimen is stable one month prior to enrollment and during the study exclusion criteria: * changes in topical or systemic anti-acne medications or procedures within four weeks of study enrollment * use of topical steroids on the face within 4 weeks prior to enrollment and during study * pregnant or breast-feeding patients * unable to provide informed consent, follow the protocol, attend study visits, or any other circumstance or condition which the investigator deems may obscure interpretation of results or affect safety of the potential participant.
severe septic shock complications

Conditions: Septic Shock

Summary: adults older than 18 years old, admitted to the icu with a severe septic shock, requiring norepinephrine at more than 0.25mcg/kg/min, who have signed informed consent form, will be consecutively included, from december 2018 to december 2019. the primary goal is to look for risk factors associated with an increased in lactate clearance secondary goals are the following: 1. to look for risk factors associated with an increase risk of hospital and icu length of stay. 2. to look for risk factors associated with an increase risk of acute kidney injury. 3. to look for risk factors associated with a decrease in days alive and free of mechanical ventilation, vasopressors and renal replacement therapy. 4. to look for risk factors associated with a decrease in ventilator-free days. 5. to look for risk factors associated with a decrease in vasopressor-free days. 6. to look for risk factors associated with an increase risk of in-hospital mortality. 7. to look for risk factors associated with an increase risk of myocardial infarction and myocardial injury. 8. to look for risk factors associated with an increase risk of acute respiratory distress syndrome. 9. to compare and validate different risk scores in our cohort.


Eligibility criteria:
inclusion criteria: * adults older than 18 years old admitted to icu with severe septic shock exclusion criteria: * rejecting participation by not signing informed consent form.

Keywords: severe septic shock lactate clearance acute kidney injury days alive and free ventilation-free days vasopressor-free days
low dose daily erlotinib in combination with high dose twice weekly erlotinib in patients with egfr-mutant lung cancer

Conditions: EGFR-Mutant Lung Cancer

Summary: the purpose of this study is to test the safety of different ways of taking erlotinib. the investigators want to find out what effects, good and/or bad, combination daily low dose and twice weekly high dose erlotinib has on the patient and lung cancer. the investigators are also seeing whether different schedules of erlotinib are better at treating lung cancer that has spread to the central nervous system. cns expansion phase: the pulse continuous regimen will be then assess in patients with egfr mutant lung cancers and cns involvement. an additional expansion cohort (a) will enroll 19 patients with newly diagnosed egfr mutant lung cancer with cns involvement at diagnosis. the patients in the expansion cohorts will undergo the same treatment plan as the patients in the dose expansion cohort. a patient in the expansion cohorts will not be replaced if he/she does not finish the first 28 day (cycle 1) treatment period.


Eligibility criteria:
inclusion criteria: * mskcc pathologically-proven diagnosis locally advanced stage iii not amenable to definitive, curative treatment or stage iv or recurrent non-small cell lung cancer * documented presence of egfr mutation confirmed by mskcc or a local facility. * no prior treatment with erlotinib, gefitinib, or other egfr tyrosine kinase inhibitors * age ≥ 18 years * measurable (recist 1.1) indicator lesion not previously irradiated. * karnofsky performance status ≥ 70% * ability to take oral medications * a negative serum pregnancy test obtained within 4 weeks prior to the start of treatment in all women of child-bearing potential. * all women of child bearing potential and sexually active men must agree to use adequate methods of birth control throughout the study which includes use of oral contraceptives with an additional barrier methods, double barrier methods, depo-provera, permanent sterilization of patient or partner or total abstinence. expansion a: * brain metastases or leptomeningeal not previously treated with radiation or surgery exclusion criteria: * inadequate recovery from any toxicity related to prior treatment (to grade 2 or baseline). * inadequate hematologic function defined as anc \< 1000 cells/mm³, platelet count \<75,000/mm³ or hemoglobin \<9.0g/dl. * inadequate hepatic function defined by ast/alt \>3x upper limit of normal (uln), total bilirubin\>2x uln, alkaline phosphatase \>3x uln. * symptomatic brain metastasis requiring radiation therapy or escalating doses of steroids. * patients with clinically stable brain metastases or leptomeningeal disease (previously treated or untreated) are eligible. patients in expansion cohort a must have at least one untreated cns lesion * women who are breastfeeding or pregnant. * any evidence of clinically active interstitial lung disease.

Keywords: erlotinib 12-278 cns involvement
virus early transcription factor (vetf) multicenter phototherapy protocol

Conditions: Vitiligo

Summary: background phototherapy uvb tl01 currently represents the first choice in treatment to induce the repigmentation of vitiligo spots. the problem though is that there are no systems or scales which enable an objective evaluation of the therapy, commonly known as percentage of repigmentation. recently, a european task force (vetf, vitiligo european task force) of experts on vitiligo, within the european society of pigmentation, has proposed a gravity classification on the basis of three parameters/standards - extension, progression and the level of depigmentation - and used to classify patients in ten european centres. the aim of the trial is to validate the vetf scoring system set up in relation with the therapeutic answer to the standard treatment for vitiligo and phototherapy. leaving aside short term side effects, such as sunrush/erythema and sunburn, which are reversible and infrequent, the main problem with phototherapy is represented by the cumulative long term effects of ultraviolet rays. these can cause premature ageing of the skin (photoaging) and the appearance of skin cancer/neoplasia. therefore the aim is to get the best results from phototherapy whilst limiting its length. aims of the trial: 1. to validate the vetf scoring system. as phototherapy is currently the only universally accepted treatment for vitiligo, it seems logical to test the vetf scoring system first to evaluate the effectiveness of phototherapy. 2. secondly, the target of this multicentric trial is to compare the effectiveness of two different phototherapy protocols; a first protocol foresees non-stop treatment for 6 months; a second protocol foresees periods of interruption during the treatment. this will help to verify whether interrupting a cycle of phototherapy is useful or not. this interruption might make the ultraviolet rays more effective 'stimulus on the melanocytes', and may also reduce long term damage caused by phototherapy.


Eligibility criteria:
inclusion criteria: * aged between 18 and 60 years old exclusion criteria: * phototype i * previous treatment with any kind of phototherapy in the last 6 months. * patients with counter indications for puva or phototherapy (history of skin cancer, pregnancy, etc.). * acral vitiligo (only hands and feet are affected).

Keywords: phototherapy vitiligo scoring system