Kornimate/medical-research-clean huggingface dataset:
adx10059 migraine prevention study

Conditions: Migraine

Summary: evaluation of adx10059 to prevent migraine attacks


Eligibility criteria:
inclusion criteria: * male and female patients aged 18 to 65 years * history of migraine * aged ≤ 50 years at onset of migraine history exclusion criteria: * cluster headache or chronic migraine headaches * currently uses, or within 3 months of screening, has used: sodium valproate or topiramate and any other drugs used specifically for migraine prophylaxis, for example beta-blockers, calcium channel blockers, tricyclic antidepressants, selective serotonin reuptake inhibitors * unable to distinguish migraine headache from tension and other types of headache * current history of psychiatric disorder requiring regular medication * known history of alcohol abuse * known clinically significant allergy or known hypersensitivity to drugs * history of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study * pregnant or breast-feeding

Keywords: migraine aura migraine headache
retinal imaging in patients with inherited retinal degenerations

Conditions: Retinitis Pigmentosa

Summary: the purpose of this study is to determine whether the structure and function of the human retina can be studied with high resolution in patients with inherited retinal degenerations using the adaptive optics scanning laser ophthalmoscope (aoslo).

retinal degenerations are a group of inherited diseases that result in progressive death of the vision cells, or photoreceptors. currently there is no treatment or cure for any of these diseases and they ultimately cause blindness in affected patients. we propose to investigate the structure and function of the human retina in patients with inherited retinal degenerations using the adaptive optics scanning laser ophthalmoscope (aoslo). we will correlate the images of retinal structure produced by the aoslo with optical coherence tomography (oct) images of the retina. in addition, we will study the vision of individual photoreceptors using the aoslo to perform a novel technique, microperimetry, in patients with retinal degenerations. we will compare the results of microperimetry with standard measures of vision used in ophthalmology clinics, including visual acuity, automated perimetry, fundus photography and multifocal electroretinography (mferg). the results of this work will provide insight into the mechanism of vision loss among patients with diverse retinal disorders. specifically, we will study cone structure and function in patients with retinal degenerations with different etiologies: retinitis pigmentosa, a disease usually caused by rod-specific mutations; cone-rod dystrophy, which primarily affects cones rather than rods; and best's disease, a disease caused by a defect in the retinal pigment epithelium (rpe). in addition, we will study the effect that lipofuscin, a byproduct of photoreceptor metabolism that accumulates in the rpe in diseases such as stargardt's disease, best's disease and age-related macular degeneration (amd), has on cone structure and function, with the goal of understanding how these diseases cause blindness. better understanding of the mechanisms of vision loss in patients with retinal degeneration should ultimately lead to treatments for these blinding conditions.

Eligibility criteria:
inclusion criteria: * subjects must speak and understand english * subjects must have pupils that dilate to at least 6 millimeters diameter. * subjects must be willing to travel to university of california (uc) berkeley. * subjects are financially responsible for their travel to the san francisco area if they are not san francisco residents. exclusion criteria: * cataract * irregular corneal astigmatism (keratoconus) * prior refractive surgery

Keywords: imaging adaptive optics scanning laser ophthalmoscope optical coherence tomography electroretinography
post approval study - evaluate the long-term safety and effectiveness of the web device

Conditions: Wide Neck Bifurcation Intracranial Aneurysms

Summary: a prospective, multicenter, single arm, interventional study. the target patient population for this study are adult subjects with wnbas of the anterior and posterior intracranial circulation. the primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.


Eligibility criteria:
key inclusion criteria: * patient must be ≥ 18 at the time of screening * patient must have a single ruptured or unruptured ia requiring treatment * patient must sign and date an irn approved written informed consent prior to initiation of any study procedures key exclusion criteria: * patient has an ia with characteristics unsuitable for endovascular treatment * patient has conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 30 days * patient has had an sah from a non-index ia or other intracranial hemorrhage within 90 days * patient index ia was previously treated * patient is pregnant

Keywords: aneurysm intracranial arterial disease cerebrovascular disorders
efficacy of caregiver training program in enhancing caregiver and patient outcomes

Conditions: Alzheimer Disease; Dementia; Caregiver Burden; Assistive Technology

Summary: as part of phase ii of the nih sbir grant, the study will conduct a randomized controlled clinical trial in which the maphabit system (mhs) will offer a caregiver training product that is linked to mhs, an alzheimer's disease or related dementias (ad/adrd) assistive technology product that uses visual maps to improve a patient's behavior and sense of autonomy. maphabit's combined areas of focus, i.e., offer a single integrated product to address the caregiver and the person under this caregiver's care, are unique and will create a new standard in the field to reduce caregiver burden in the setting of caring for individuals with ad/adrd. additionally, the study will integrate enhanced user support modules, i.e., gamifying, dashboarding, and social networking, to improve the caregiver training program (ctp) experience.the study will be a randomized controlled clinical trial, in which two conditions will be investigated: 1) control condition in which the mhs alone is incorporated in the participant's daily care and 2) experimental condition in which the mhs+ctp is implemented into the daily care received by participants. the sample size will be a total of 50 patient-caregiver dyads, 25 in each condition. the study duration will be a 6-month intervention.


Eligibility criteria:
inclusion criteria: * individual diagnosed with alzheimer's disease or other related dementia (adrd) in their mild to moderate stage of impairment * participating caregiver of individual with dementia must be the primary caregiver * proficient in english exclusion criteria: * individual not diagnosed with adrd * participating caregiver of individual with dementia is not the primary caregiver * not proficient in english

Keywords: alzheimer disease dementia caregiver burden activities of daily living assistive technology
absorption, metabolism, and excretion study of biib074

Conditions: Neuropathic Pain

Summary: the primary objectives of the study are: to determine the mass balance and routes of elimination of biib074 and its known metabolites following administration of a single oral dose of biib074 in healthy male participants and to describe the pharmacokinetics (pk) of biib074 and its known metabolites and the disposition profiles of total radioactivity in whole blood and plasma following a single oral dose. the secondary objectives of this study are: to assess the safety and tolerability of biib074 in healthy participants and to identify and characterize any additional metabolites of biib074 in plasma, urine, and feces.


Eligibility criteria:
key inclusion criteria: * all subjects must practice effective contraception during the study and be willing and able to continue contraception for 90 days after the administration of study treatment. * must be in good health as determined by the investigator, based on medical history and screening evaluations. key exclusion criteria: * history of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the investigator. * previous exposure to biib074. * other unspecified reasons that, in the opinion of the investigator or biogen, make the subject unsuitable for enrollment. note: other protocol defined inclusion/exclusion criteria may apply.
observational study to characterize the incidence of egfr mutation positive and advanced nsclc patients

Conditions: Metastatic Non-Small-Cell Lung Cancer

Summary: the present study has been designed in order to characterize the incidence of patients with advanced non-small cell lung cancer (nsclc) carrying epidermal growth factor receptor (egfr) positive mutations and their clinical management in galicia.


Eligibility criteria:
inclusion criteria: inclusion criteria for patients´ screening: * patients of both sexes aged 18 or more. * histologically confirmed advanced or metastatic non-small-cell lung cancer (nsclc) (patients stage iii b unsuitable for locoregional treatment, and stage iv). * chemo- naïve patients (non-small-cell lung cancer patients who have not received first line systemic cytotoxic chemotherapy). * patients with available tumoral tissue (primary tumor or metastatic area) or cytological samples including fine needle aspirates (primary tumor or metastatic area), bronchial alveolar lavage or bronchial scrapings and pleural effusion. * patients who have granted their written informed consent. patients must fulfill the inclusion criteria previously mentioned and the following one in order to be enrolled in the study (visit 1) for the follow-up until progression or until 9 months from the beginning of treatment have elapsed: inclusion criteria for patients´ follow-up * patients with documented positive mutation in epidermal growth factor receptor (egfr) (m+). exclusion criteria: * combined histology of non-small cell and small cell lung cancer.

Keywords: non-small cell lung cancer (nsclc) epidermal growth factor receptor (egfr) positive mutation
randomized trial of prehospital tropin levels in acute coronary syndrome (acs)

Conditions: Acute Coronary Syndrome

Summary: this study randomizes patients seen by redmond medic one into a control arm and a study arm when they present with acute coronary syndrome and have non-contributory ecg's (i.e.non-stemi). the control group is treated normally and delivered to the receiving hospital. the study group is treated normally as well, however troponin measurements are made using an i-stat blood analyzer prior to hospital arrival. the results are presented to the receiving physician. door-to-reperfusion time is monitored for both groups.


Eligibility criteria:
inclusion criteria: * over years of age * acs without st-segment elevation * patient being transported to one of two participating hospitals exclusion criteria: * less then 18 years of age. * post cardiac arrest. * acs with st-segment elevation.

Keywords: acs non stemi ecg troponin istat acute coronary syndrome without st-segment elevation
optical coherence tomography angiography characteristics of patients with surgically closed full-thickness idiopathic macular holes < 600 μm with air versus 10% sf6 tamponade

Conditions: Macular Holes; Optical Coherence Tomography

Summary: state of the art treatment for idiopathic macular holes consists of pars plana vitrectomy, internal limiting membrane staining with a blue colouring dye, internal limiting membrane peeling and filling of the vitrectomized space with a specific tamponade such as air and sf6. air and sf6 have previously shown similar closure rates, although there was a trend towards lower closure rates in large diameter imh (idiopathic macular holes) using air. imh with diameters \ 600 μm will be excluded. two idiopathic macular hole patient groups will therefore be formed: the first group (group 1) will receive air after vitrectomy and membrane peeling, the second group (group 2) will receive 10% sf6 (and 90% air) after vitrectomy and membrane peeling. after recruitment, patients will therefore be electronically randomized to one of the two groups. the groups will then be compared by the means of oct (optical coherence tomography) and octa. note: the trial was registered retrospectively on clinicaltrials.gov after start of recruitment.


Eligibility criteria:
inclusion criteria: * patient must be able and willing to give informed consent. * patient must be between 18 and 100 years of age. * patient must not have any significant media opacity which interferes with the examination. * patient must have an (stage 1-4) idiopathic macular hole requiring surgery. exclusion criteria: * unwilling or unable to provide informed consent * under 18 or over 100 years of age * significant media opacities * systemic pathologies making an examination difficult or cumbersome to the patient * primary and/or secondary epiretinal membranes (erm), except incipient erms not affecting the foveal contour and not requiring surgery * full-thickness idiopathic macular hole \> 600 μm in minimum diameter * nonclosure * lamellar holes not requiring surgery * pseudo holes * glaucoma * diabetes * anisometropia \> 2 diopters * high myopia (spherical equivalent \> 6 diopters and/or axial length \> 26 mm * other retinal or ophthalmic pathologies except moderate cataract * octa scan signal strength \< 5 * low image quality * failure of automatic layer segmentation
the effects of endoactivator on postoperative pain and root canal treatment success

Conditions: Periapical Periodontitis; Root Canal Infection

Summary: this study evaluates postoperative pain and radiographic healing of asymptomatic posterior teeth with chronic apical periodontitis following root-canal treatment performed using endoactivator for irrigation activation.

aim: to evaluate postoperative pain and radiographic healing of asymptomatic posterior teeth with chronic apical periodontitis following root-canal treatment performed using endoactivator for irrigation activation. methodology: in this clinical trial, root-canal treatment was performed on 140 posterior teeth with chronic apical periodontitis. after routine canal preparation, patients were assigned to either a control group treated using conventional needle irrigation (cni) without activation or to sonic irrigation activation with endoactivator. all treatment was completed in a single visit. patients provided self-assessments of the severity of postoperative pain at 1, 2,3 and 7 days using a verbal rating scale (vrs) and wong baker face scale. patients were recalled at 12 months for clinical and radiographic examinations. periapical healing was evaluated using a periapical index (pai), with scores of 1 or 2 considered to represent treatment success and scores of 3, 4, or 5 to represent treatment failure. data were analyzed using one-way anova and kruskal-wallis tests, with differences of p \< 0.05 considered statistically significant.

Eligibility criteria:
inclusion criteria: * 18-60 patient's age * being systemically healthy * having posterior teeth (molar or premolar) with chronic apical periodontitis lesion (pai≥3) exclusion criteria: * clinically symptomatic teeth * patients with complicated systemic disease (asa 3 - 6) * teeth with open apex * teeth having curvature more than 20 degree * not having enough tooth structure to be isolated with rubber dam * patients with severe periodontal defects or deep periodontal pockets (probing depth\> 4 mm) * a history of taking analgesics 12 hours ago or antibiotics 1 month ago * patients who cannot come to control sessions

Keywords: chronic apical periodontitis irrigation activation periapical index postoperative pain treatment outcome periapical health
phosphatidylcholine supplementation in infants

Conditions: Schizophrenia; Diminished P50 Sensory Gating

Summary: sensory gating is defined as the automatic process of inhibiting brain response to repeated auditory sounds. infants who brains respond similarly to two identical sounds presented about 1/2 second apart are more likely to have later problems with attention than infants who suppress response to the second sound. this study will examine whether providing a nutritional supplement, phosphatidylcholine, for two months in infancy will result in an increased likelihood of developing more robust sensory gating.


Eligibility criteria:
inclusion criteria: * healthy infant has an age (adjusted for gestational age at birth) of 1-7 weeks * diminished p50 sensory gating (ratio greater than or equal to 0.50) exclusion criteria: * no maternal reported tobacco use for greater than 1 year and no current tobacco use (as measured by urine cotinine levels) * trimethylaminuria, renal disease, liver disease, known chromosomal abnormality, chronic neurological disorder, premature birth, prenatal exposure to exogenous steroid use
use of sentinel lymph node biopsy in patients with early-stage, palpable node-positive hr+/her2- breast cancer having upfront surgery and adjuvant radiation

Conditions: Breast Cancer

Summary: the purpose of this study is to find out how often the researchers can avoid an alnd in patients with early-stage, node-positive hr+/her2- breast cancer who are having upfront surgery. the study researchers think that, if aus before surgery can help identify people who may have up to 3 affected lymph nodes, it will be possible to perform the less radical standard slnb during surgery.


Eligibility criteria:
inclusion criteria: * patients aged ≥18 years with biopsy-proven invasive breast cancer * patients with ctx, ct1, or ct2 tumors with palpable ipsilateral mobile adenopathy of level i/ii axillary nodes with biopsy-proven (either by pre-operative biopsy or intraoperative frozen section) nodal metastasis (cn1) who are undergoing upfront surgery * patients with tumors of the hr+/her2- subtype, defined as: 1. hr+: positive for estrogen receptor and/or progesterone receptor staining, indicated by ≥1% immunoreactive tumor nuclei 2. her2-: immunohistochemistry assay demonstrating no or faint staining in ≤10% of tumor cells (ihc 0 or 1+) or negative by dual probe in situ hybridization assay exclusion criteria: * patients with prior ipsilateral breast cancer * patients who are pregnant * patients with stage iv disease at presentation * patients with advanced regional disease (cn2/cn3)

Keywords: sentinel lymph node biopsy palpable node-positive hr+/her2 21-183
effect of the covid-19 public health crisis on the mental health and physical well-being of cancer patients, the coping with covid study

Conditions: COVID-19 Infection; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Summary: this study determines how the threat of the coronavirus has affected the mental health and physical well-being of cancer patients seen at the psychiatric oncology clinic, and how they have coped with any related stress. questionnaires that assess coping strategies and behaviors for decreasing disease transmission may help researchers create recommendations for future public health crises and pandemics.

primary objective: i. to determine how the coronavirus disease 2019 (covid-19) public health crisis affected mental well-being in cancer patients seen at the psychiatric oncology clinic. secondary objectives: i. to determine how the covid-19 public health crisis affected physical well-being and substance use in cancer patients seen at the psychiatric oncology clinic. ii. to determine how patient coping strategies and levels of apathy affected mental and physical health symptoms and substance use during covid-19 in patients seen at the psychiatric oncology clinic. iii. to determine the association of coping strategies and levels of apathy with proclivity to engage in health behaviors intended to decrease the transmission of the disease during the covid-19 pandemic in patients seen at the psychiatric oncology clinic. outline: patients complete 3 questionnaires online over 15 minutes regarding coping strategies that may have been used, mental health and physical well-being in the past month, and if they have been following certain behaviors which the world health organization (who) has recommended during the coronavirus pandemic, such as regular hand washing and social distancing.

Eligibility criteria:
inclusion criteria: * outpatients seen by providers of the psychiatric oncology clinic at least once between november 1, 2019 and february 29, 2020 and at least once between april 10, 2020 and june 10, 2020 * speaking english as indicated in their medical chart exclusion criteria: * patients who are pregnant as recorded in their medical chart * incarcerated * with a recorded diagnosis of a formal thought disorder * unable to consent
phosphoproteomic patterns as a novel biomarker for aurora and polo-like kinase inhibitors in non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: the investigators have characterized in preclinical non-small cell lung cancer (nsclc) models the proteomic expression profile associated with exposure to aurora and polo-like kinase inhibitors. the identification of proteomic expression patterns in patients with nsclc would be an important step in defining the possible role of these agents as potential targeted therapies for this clinically important disease. this study proposes to evaluate resected non-small cell lung cancer specimens for these proteomic expression profiles.


Eligibility criteria:
inclusion criteria: * subjects undergoing or who have undergone thoracic surgery for presumed lung cancer * wedge resection, lobectomy, bilobectomy, segmentectomy and pneumonectomy thoracic surgical operations are permitted. * age ≥ 18 years. * subject meets criteria for thoracic surgery as determined by the thoracic surgeon. * able to provide written informed consent. exclusion criteria: * subjects undergoing or who have undergone thoracic surgery for metastatic disease from other primary sources such as colorectal cancer, sarcoma, melanoma, breast cancer, bladder cancer, prostate cancer, esophageal cancer, pancreatic cancer, or gastric cancer will be excluded. * subjects who have received prior preoperative lung cancer anticancer therapy will be excluded.

Keywords: subjects undergoing or who have undergone thoracic surgery for presumed lung cancer. the following procedures are allowed: wedge resection, lobectomy, bilobectomy, segmentectomy and pneumonectomy thoracic surgical operations are permitted.
dysphagia and cervical spine disorders in patients with brain lesions

Conditions: Prevention; Rehabilitation

Summary: the research is about a prospective study conducted in patients suffering from dysphagia and cervical spine disorders and how they are interrelated. three questionnaires have been given to patients with neurologic deficits, the first of these investigates the occurence of dysphagia in the three stages of swallowing, the second looks into the quality of life following a stroke or other neurologic damage and the third analyses how cervical spine disorders can affect every day life. after the bedside examination, vfss or fees, the patients are submitted to swallowing and cervical resistance exercises in fixed time periods after their hospitalisation. the results will be collected and evaluated using the statistical programme spss.


Eligibility criteria:
inclusion criteria: * brain lesions and cervical spine disorders exclusion criteria: * age * peripheral damages

Keywords: spine injuries brain lesions dysphagia