Kornimate/medical-research-clean huggingface dataset:
an open label extension of a study of topiramate in chronic migraine.

Conditions: Migraine

Summary: the purpose of this study is to assess the long-term safety and effectiveness of topiramate for the prevention of headaches in adults with chronic migraine. topiramate has been approved to prevent migraine headaches.

migraine headaches can be disabling and can interfere with work and a person's quality of life. preventing these headaches before they start is the best option. topiramate, an anti-seizure medication, has been shown to help prevent migraine headaches from occurring. this is an open-label study that is an extension of a previous study (capss-276) of topiramate in chronic migraine. it includes patients who completed the previous study or who stopped the study early after taking study drug for at least 4 weeks of maintenance treatment due to lack of efficacy. the current study will involve a 4-week blinded transition phase during which patients will be titrated up to a daily topiramate dose of 100 milligrams (or the maximum tolerated dose, whichever is less). then there will be a 12-week open-label maintenance phase during which the topiramate dose may be adjusted according to effectiveness and tolerance, but not to exceed a daily dose of 400 milligrams. after this period, patients will be tapered off topiramate (taper/exit phase). the length of the taper/exit phase may vary based on the dose the patient was taking during the open label maintenance phase. while on topiramate, patients will record daily entries in their headache records. patients will also be asked questions to help assess their quality of life. both patients and doctors will be asked questions at the end of the study about their impressions of change with respect to the patient's migraine headaches. patients will also have physical and neurological examinations and laboratory tests performed during the study. the objective of this study is to evaluate the long-term safety and effectiveness of topiramate for the prevention of chronic migraine headaches. topiramate oral tablets, 25 milligrams per tablet, will be given in the morning and evening to a dose not to exceed 400 milligrams per day or to the maximum tolerated dose, whichever is less

Eligibility criteria:
inclusion criteria: * diagnosis of chronic migraine * successfully finished double-blind portion of the capss-276 study or discontinued the study after a minimum of 4 weeks maintenance treatment due to lack of effect of study drug * in generally good health * able to take medicine orally * if female, using birth control. exclusion criteria: * cannot have a more painful condition than the headache pain * cannot be taking any other medications not allowed by the study protocol * no abnormal liver tests * not compliant with study medication during the capss-276 study * cannot be pregnant or breast-feeding.

Keywords: migraine headache chronic prevention
evaluation of the cr plug for repair of defects created at the harvest site from an autograft in the knee.

Conditions: Knee Injury

Summary: the main objective of this study is to test the ability of an allograft plug to provide a successful repair of an osteochondral defect left at the harvest site during oats procedure.

the objective of this study is to determine how effective a plug made out of human bone (called "cr-plug") will be in the treatment at the site that your tissue was removed, thereby filling the hole created during the oats procedure.at the present, oats is used for knee articular cartilage defects or injuries smaller than the size of a dime (or 2.5 cm2) in the areas that bear weight have been commonly treated by using a tiny cylinder of the subjects' own tissue called an osteochondral autograft (oats).

Eligibility criteria:
inclusion criteria: * are male or female at least 18 years of age and up to 55 years of age * must be skeletally mature * have a grade iii or iv lesion in femoral condyle exclusion criteria: * skeletally immature * osteoarthritic knees, osteonecrotic knees, osteophyte formation * use of any investigational therapy within thirty (30) days prior to the first visit

Keywords: cartilage injury oats knee injury allograft autograft
dengue virus ns1 antigen (bio-rad) clinical protocol

Conditions: Mass Screening

Summary: the purpose of the study is to screen blood donors for the presence of ns1 antigen of the dengue virus at the american red cross in puerto rico region (and monroe county, florida) using the platelia dengue ns1 ag enzyme immunoassay.

dengue is an endemic disease that is increasingly more common in tropical climates and the dengue epidemic in puerto rico (may 2009) presents a risk to the blood supply in puerto rico. also, on july 13th 2010 federal officials reported an outbreak of dengue fever in florida after a survey of key west residents found that at least 5% had been infected or exposed to the virus. therefore this ind study is being carried out to identify blood donors carrying the dengue virus using the platelia dengue ns1 ag (bio-rad, france). prospective testing is being performed on blood donors who have read an information sheet regarding the use of donated blood samples in research. testing will occur at the american red cross, charlotte, nc ntl site.

Eligibility criteria:
inclusion criteria: the puerto rico region and monroe county, florida will maintain a log of all blood donors enrolled by collection date documenting the time of collection, centrifugation and freezing; only centrifuged and frozen ppts will be sent to the charlotte ntl for ns1 ag testing. samples frozen when received at the charlotte ntl will be tested. samples that arrive thawed will be tested if the time unfrozen is 24 hours or less. when necessary, alternate ppts (surplus samples used for nat) will be used for dengue ns1 ag testing; a log will be kept by the charlotte ntl documenting the sample identification numbers of thawed samples, approximate time unfrozen and the samples that require an alternate ppt for dengue ns1 ag testing. exclusion criteria: samples that are deemed unacceptable for testing include those held for excessive storage times when thawed (in excess of 24 hours unfrozen or otherwise as determined by the principal investigator) or that are cracked or otherwise damaged. samples having inadequate volume for initial and repeat testing in duplicate will not be tested as determined by the charlotte ntl; a log will be kept of samples unacceptable for testing and the reason that the samples are unsuitable for testing.

Keywords: prospective screening of blood donors.
role of deep brain stimulation on social cognition in parkinsonian patients

Conditions: Parkinson Disease

Summary: parkinson's disease (pd) is usually responsible of cognitive and behavioral non-motor signs with a major impact on the quality of life. social cognition is a complex system relying on emotion recognition (neurons mirror system, nms), the theory of mind (with its two parts: emotional and cognitive), but also on the social and cultural environment and the personal history. the first step in this model is represented by the nms, which seems to be altered in pd patients for both positive and negative emotions as shown in our preliminary study. the investigator purpose is to investigate the role of the treatment (levodopa and deep brain stimulation) on the functioning of the nms.


Eligibility criteria:
inclusion criteria: * parkinson's disease with motor fluctuations and dyskinesias receiving deep-brain stimulation * social insurance exclusion criteria: * no affiliation to the social insurance * patients under guardianship

Keywords: parkinson disease emotional recognition deep brain stimulation
brain stimulation and cognitive training

Conditions: Bipolar Disorder; Schizo Affective Disorder; Schizophrenia

Summary: people with serious mental illness often report difficulties with thinking skills like memory. these difficulties can make it harder to perform day-to-day activities. the purpose of this study is to test whether combining a type of non-invasive brain stimulation with computerized cognitive exercises is acceptable to participants, and whether it is helpful in improving a specific type of memory skill in people who have mental health conditions and memory deficits. this study is designed so that all participants will get both treatments: the non-invasive brain stimulation and computerized cognitive exercises. half of the participants will start with both the brain stimulation and the cognitive exercises (dual therapy), and half will start with just the computerized exercises (monotherapy). after three weeks, participants will switch to the other condition: the people who did both treatments first will switch to just the cognitive exercises alone, and the people who started with the cognitive exercises alone will then switch to doing both the brain stimulation and cognitive exercises. overall, participants will be in the study for about 7-8 weeks. the brain stimulation treatment involves 10 visits to the clinic over 3 weeks. the computerized cognitive exercises can be done at home, and involve 10 hours of exercises over 3 weeks. participants will also complete paper-and-pencil assessments at the beginning, middle, and end of treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of bipolar disorder i or ii, schizoaffective disorder, or schizophrenia * objective cognitive impairment in working memory * willingness to complete computerized cognitive training and undergo brain stimulation procedures exclusion criteria: * history of neurological illness or brain injury (e.g., stroke) * history of loss of consciousness * diagnosed intellectual disability * current substance use disorder * current mania or moderate depression or severe psychosis * serious suicidal ideation/behavior * pregnant or trying to become pregnant, or currently lactating
a study describing the care cascade and effectiveness and safety of glecaprevir/pibrentasvir in adult participants with hepatitis c virus in french addiction centers

Conditions: Hepatitis C Virus (HCV)

Summary: hepatitis c virus is liver disease and is a leading cause of death and morbidity with around 71 million people affected worldwide. widespread availability of highly effective direct-acting antivirals (daas) have dramatically changed the treatment landscape of hcv with a cure rate of over 95%. in may 2019, french health authorities expanded prescription abilities to all physicians treating adult treatment-naive patients with hcv without cirrhosis of the liver. this study will assess the treatment uptake and barriers to treatment by non-hcv specialist in france in community-based addiction centers. beyond these evaluations, data on health resource utilization in addiction centers, level of knowledge of both patients and providers on hcv infection and treatment, care cascade, effectiveness and safety of glecaprevir/pibrentasvir among patients treated in addiction centers and evolution of addiction behavior after treatment are of specific interest. glecaprevir/pibrentasvir is a drug approved to treat hcv. about 400 adult participants with a confirmed positive hcv ribonucleic acid (rna) test will be enrolled in the study at approximately 30 addiction centers in france. all participants will attend an inclusion visit. participants who are not prescribed glecaprevir/pibrentasvir at the inclusion visit will have no further follow-up in the study. participants who are prescribed glecaprevir/pibrentasvir will take three tablets once daily. the duration of the study is approximately 12 months. all study visits will occur during routine clinical practice but there may be a higher burden for participants prescribed glecaprevir/pibrentasvir. these participants will be asked to complete questionnaires after each visit.


Eligibility criteria:
inclusion criteria: * followed in an addiction center. * confirmed positive for hcv ribonucleic acid (rna). exclusion criteria: -none.

Keywords: hepatitis c virus hcv glecaprevir/pibrentasvir maviret
home-based transcranial direct current stimulation for pain management in persons with alzheimer's disease and related dementias

Conditions: Alzheimer's Disease and Related Dementias

Summary: the purpose of this project is to evaluate the preliminary effects of home-based m1-so applied tdcs (that is, tdcs with the anode over the primary motor cortex and the cathode over the contralateral supraorbital area) on clinical pain in persons with early-stage alzheimer's disease and related dementias (adrd), to evaluate the preliminary effects of home-based m1-so applied tdcs on pain-related cortical response in persons with early-stage adrd, and to evaluate the feasibility and acceptability of home-based m1-so applied tdcs for pain management in persons with early-stage ad.


Eligibility criteria:
inclusion criteria: * early-stage alzhimer's disease and related dementias (adrd) * have caregiver-reported chronic pain (average pain in the past 3 months ≥ 3 out of 10), * have a caregiver willing to participate in the study who sees the participant at least 10 hours/week * can speak and read english * have no plans to change medication regimens during the trial exclusion criteria: * history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation * alcohol/substance abuse * severely diminished cognitive function (i.e., minimental status exam score ≤ 15) * hospitalization within the preceding year for neuropsychiatric illness
peri-implantitis implantoplasty treatment

Conditions: Peri-Implantitis; Peri-implant Mucositis

Summary: this double arm, split-mouth, single centre, controlled, randomised clinical study is designed to examine the effect of implantoplasty in treatment of peri-implantitis. peri-implantitis will be treated with open flap debridement, with or without implantoplasty.


Eligibility criteria:
inclusion criteria: * peri-implantitis (according to 2018 criteria) on minimum 2 implants of similar surface and defect type * competent to give consent * exposed, modified implant surface with loss \>2mm exclusion criteria: * previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment * present or past use of bisphosphonate treatment • pregnant or nursing subjects * patients classified as \> class ii according to asa classification * implant unavailable for implantoplasty treatment * inhability to comprehend and respond to the quality of life questionnaire * examiners/operators deem original placement of implant (angle, position) suboptimal and considered to play a major role in development of peri-implantitis * history of peri-implantitis surgery prior to 6 months of screening
assessment of eye movements in stroke patients and closed-loop intervention

Conditions: Stroke

Summary: the current study evaluates first the assumption that eye-movements during free viewing behavior are potential biomarkers of visuospatial deficits in stroke population. second, it assesses the feasibility of a novel visual exploration training to ameliorate visuospatial deficits, by exploiting an auditory biofeedback system coupled with online parsed fixations.

this study is divided into two parts concerning the diagnostic and treatment of visuospatial deficits in patients affected by unilateral stroke. eye movements indices during free viewing of natural scenes will be correlated to the standard neuropsychological evaluation, describing the cognitive, motor and functional spectrum of patient status. moreover, functional and structural neuroimaging will be exploited to identify neural correlates of patient eye movements characteristics. ultimately, a subsample of randomly assigned participants, at the irccs san camillo, will undergo a novel visual exploration training, in addition to the standard rehabilitation. this protocol consists of natural scene exploration guided by an auditory biofeedback system which tracks online parsed fixations. concretely, the training maneuvers exploration toward salient regions of the presented image, as indicated by a normative sample. changes in free viewing behavior, neuropsychological assessment and neuroimaging will be discussed compared to an active control group and a healthy sample.

Eligibility criteria:
inclusion criteria: * vigilant * first unifocal ischemic or hemorragic stroke * presence of maximum two lacunae, clinically silent, smaller than 15 mm. in the structural mri * evident symptoms in the visual, attentive, memory, motor or language domain supported by the radiological exam exclusion criteria: * previous stroke history, visible at the radiological exam * multifocal deficit * incapacity to remain vigilant during the required assessments * claustrophobia and/or metallic objects which could prevent mri acquisition * presence of other neurological, psychiatric or medical conditions which may undermine interpretation of behavioral and neuroimaging results

Keywords: visuospatial
molecular analysis of suspected or high-risk lung cancer to drive individualized care (interception for suspected lung cancer)

Conditions: Lung Carcinoma; Metastatic Malignant Neoplasm in the Lung

Summary: this study evaluates the effectiveness of robotic biopsies in providing information about hereditary or cancer specific genetic variants that may have a role in diagnosis of cancer and to develop genetic results and medical record databank for future studies.

primary objectives: i. assessing whether the percentage of samples adequate for wes (whole exome sequencing)/wt (wild-type) sequencing is at least 80%. ii. development of a data bank of wes/wt and germline sequencing data for future analyses. outline: this is an observational study. patients receive genomic counseling and genomic testing education, undergo blood or saliva collection, provide previously collected tissue sample and have medical records reviewed on study. patients and healthcare providers receive results of any genetic variants found on testing.

Eligibility criteria:
inclusion criteria: * \* subject age 18 years and older * subject is scheduled for a bronchoscopy as part of standard of care * subject with a moderate to high risk of lung cancer based on clinical demographic and radiologic information or with suspected metastatic disease * ability to provide blood or saliva sample * enrolled in study irb#16-009655 * ability to provide archived tissue * subject is able to understand and adhere to study requirements and able to provide informed consent exclusion criteria: * \* individuals who have situations that would limit compliance with the study requirements * institutionalized (i.e. federal medical prison) * pregnant * prior germline genetic testing with a 40+ multi-gene panel within the last 1 year of enrollment * prior somatic tissue (250+ gene) testing within the prior 3 months of enrollment
impact of hyperbilirubinemia among hiv patients treated with atazanavir

Conditions: HIV/AIDS

Summary: the purpose of this study is to determine whether hiv patients on atazanavir who have hyperbilirubinemia have different outcomes from those without hyperbilirubinemia.


Eligibility criteria:
inclusion criteria: * diagnosis of human immunodeficiency virus * treatment with atazanavir * 18 yrs and older
artificial intelligent clinical decision support system simulation center study for technology acceptance

Conditions: Gastrointestinal Hemorrhage

Summary: the purpose of this research study is to measure the effect on of a large language model interface on the usability, attitudes, and provider trust when using a machine learning algorithm-based clinical decision support system in the setting of bleeding from the upper gastrointestinal tract (upper gib). specifically, the investigators are looking to assess the optimal implementation of such machine learning algorithms in simulation scenarios to best engender trust and improve usability. participants will be randomized to either machine learning algorithm alone or algorithm with a large language model interface and exposed to simulation cases of upper gib.

the experiment will deploy a previously validated machine learning algorithm trained on existing clinical datasets within simulation scenarios in which a patient with acute gastrointestinal bleeding (at low, moderate, and high risk for poor outcome) is evaluated. prior to the simulation, a baseline educational module about artificial intelligence, machine learning, and clinical decision support will be provided to all participants. the investigators will establish psychological safety by detailing what is available in the room, the opportunity to call a consultant, and availability of laboratory and radiographic studies. each clinical scenario will run for approximately 10 minutes based on real patient cases where vital signs change over time and laboratory values are made available at specific points in the assessment. the study will evaluate the effect of a large language model-based interaction with the machine learning algorithm with interpretability dashboard compared to the machine learning algorithm with interpretability dashboard alone. each participant will receive three scenarios in randomized order of risk. for the large language model interaction arm, participants will be provided the computer workstation a llm chatbot interface of the algorithm and interpretability dashboard for the machine learning dashboard arm, participants will be provided the computer workstation with the algorithm and interpretability dashboard.

Eligibility criteria:
inclusion criteria: * internal medicine residency trainees at study institution * emergency medicine residency trainees at study institution exclusion criteria: * n/a

Keywords: implementation science artificial intelligence decision support systems, clinical simulation training
trial of pemetrexed for patients with pancreatic cancer which cannot be treated with surgery or is metastatic

Conditions: Pancreatic Cancer

Summary: this study with pemetrexed is for patients with metastatic or unresectable pancreatic cancer who progressed after first line chemotherapy with gemcitabine.


Eligibility criteria:
inclusion criteria: * histological or cytological diagnosis of adenocarcinoma of the pancreas that is locally advanced (stage ii, iii) or metastatic (stage iv), as staged by the american joint committee on cancer (ajcc; protocol attachment s041.2; fleming et al. 1997), and not amenable to resection with curative intent. * prior systemic first line chemotherapy with gemcitabine single agent or a combination regimen including gemcitabine (not more than one prior systemic chemotherapy allowed). * uni-dimensionally measurable disease according to the recist criteria (therasse et al. 2000), defined as: at least one lesion that can be accurately measured in at least one dimension, with the longest diameter greater than or equal to 2 cm with conventional techniques or greater than or equal to 1.0 cm with spiral ct scans. ultrasound and x-ray are not allowed to measure or follow lesions. exclusion criteria: * prior radiation of equal to or greater than 25% of the bone marrow (cristy and eckerman 1987) * prior immunotherapy, biological therapy, and/or hormonal therapy for pancreas cancer. * prior systemic chemotherapy with 5-fu. * patient not yet recovered from the acute toxic effects of the treatment prior to study enrollment. * radiotherapy within the last 4 weeks before study entry