Kornimate/medical-research-clean huggingface dataset:
safety and performance of a pulsed field device for global mapping and ablation of the left atrium for the treatment of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to provide clinical data pertaining to the safety and performance of the globe mapping and pulsed field ablation system for treating subjects with atrial fibrillation (af).


Eligibility criteria:
inclusion criteria: 1. subjects planned for an af catheter ablation procedure, with a documented history of af. 1. diagnosis must be confirmed within 12 months before enrollment. 2. (repeat ablations) patient had 1 previous pvi procedure with cryoablation, radiofrequency ablation or pulsed field ablation 2. subjects between 18 and 75 years of age, inclusive exclusion criteria: 1. patients who have contraindications to open heart surgery 2. patients from an intensive care unit 3. patients with active systemic infection (sepsis) 4. patients who have had previous ablation in the left or right atrium 5. patients who are post-heart transplant or who are awaiting cardiac transplantation or other cardiac surgery 6. patients with cardiac implants that may interfere with device delivery or positioning (e.g. atrial septal defect closure device, left atrial appendage occluder) 7. patients with mitral valve prolapse or other heart valve abnormalities excepting mild to moderate mitral regurgitation 8. patients with new york heart association class iii or iv heart failure 9. history of a documented thromboembolic event, including stroke or transient ischemic attack (tia) 10. bleeding disorder history 11. patients with a known sensitivity to anesthesia or neuromuscular block agent 12. currently undergoing long-term treatment with steroids, not including intermittent use of inhaled steroids for respiratory disease 13. myocardial infarction within the last three months 14. atrioventricular (av) block ii° or iii° 15. left ventricular ejection fraction (lvef) of less than 35% 16. unstable angina

Keywords: globe mapping and ablation system atrial fibrillation pulsed field ablation
characteristics of lyme arthritis

Conditions: Lyme Arthritis

Summary: lyme disease is due to borrelia burgdorferi sensu lato and is transmitted by a tick vector of the genus ixodes. one of the clinical forms of this disease in the disseminated phase is the appearance of arthritis, classically mono or oligo-arthritis in the large joints.


Eligibility criteria:
inclusion criteria: * age \>18 years * diagnosis of lyme arthritis confirmed by pcr of joint fluid at cnr borrelia between 2011 and 2016 * patient who has agreed to use his medical data for research purposes exclusion criteria: - refusal to participate in the study

Keywords: lyme arthritis borrelia burgdorferi vector tick arthritis joints
predictors of difficult laparoscopic cholecystectomy, scoring systems and their implications on the outcomes , sohag experience.

Conditions: Chronic Calculous Cholecystitis

Summary: laparoscopic cholecystectomy nowadays is the most common surgery done by general surgery surgeons , so it is necessary to evaluate the difficulty of each case prior to surgery and from the first look ,to avoid complications and improve outcomes , so scoring systems are needed for better assessment of the overall condition and make good decision .


Eligibility criteria:
inclusion criteria: * patients with symptomatic gall stones exclusion criteria: * lap to open conversion due to equipment failure pregnancy common bile duct stone obstructive jaundice unfit for general anesthesia patients refusing lap cholecystectomy.
early feasibility study of uv-femtosecond laser assisted lenticular extraction

Conditions: Refractive Error - Myopia Severe; Refractive Error - Myopia Simple

Summary: the purpose of this study is to evaluate the initial safety of the uv-fs laser in humans.


Eligibility criteria:
inclusion criteria: * photopic distance visual acuity worse than best corrected visual acuity (bcva) 20/400 in the study eye; * myopia with manifest refraction spherical equivalent (mrse) of - 1.50 diopter (d) or higher in the study eye; * able to comprehend and provide documented informed consent; * willing and able to comply with schedule for follow-up visits; * minimum required endothelial cell density (ecd) in study eye as outlined in the protocol; * presence of natural lens in study eye; * a treatment simulation with spectacles or contact lenses on the study eye does not negatively impact participant's daily activities; * other protocol-specified inclusion criteria may apply. exclusion criteria: * pregnant or nursing; * acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study as clinically assessed by the investigator; * active implanted device, including but not limited to, heart pacemaker or defibrillator, for which laser use may be a contraindication; * current use of medications with known ocular side effects; * predicted residual stromal bed thickness \<300 micrometers (μm) in study eye * ocular conditions in the study eye; * previous ocular surgery in the study eye that resulted in corneal distortions within the treatment zone; * residual, recurrent or active ocular disease that may impact study outcomes; * previous or current diagnosis of dry eye; * known allergic reaction to medications expected to be used preoperatively, during laser refractive surgery, and for postoperative care; * pre-existing corneal opacities in study eye; * contact lens worn in study eye and not removed prior to study testing affected by wear per timeframe specified in the protocol; * other protocol-specified exclusion criteria may apply.
a pilot study to evaluate neurocognitive injury and longitudinal changes in white matter during radiation therapy in children with primary brain tumors

Conditions: Brain Tumor, Primary

Summary: this is a pilot study to assess the changes in white matter, in the brain, in response to radiation therapy and correlate these changes with later declines in cognitive function.


Eligibility criteria:
inclusion criteria: * pediatric patients (age 6-21) who will receive cranial radiotherapy for brian tumors. this could include but is not limited to: low grade glioma, high grade glioma (to include grade iii but not grade iv glioma), germ cell tumors, primitive neuroectodermal tumors, craniopharyngioma, or medulloblastoma. * patients should, in the estimate of the treating physician, be anticipated to have a median survival of greater than 1 year. exclusion criteria: * patients with previous central nervous system (cns) radiation or or cns tumors that, in the judgement of the investigators, are likely to undergo progression during or shortly after radiotherapy are excluded. * patients with glioblastoma, multiforme, gliosarcoma, diffuse pontine glioma, or other tumors presumed to have expected median survival per the investigators of less than 1 year. * patients who require sedation for magnetic resonance imagining (mri)are excluded. * patients at risk for nephrogenic systemic sclerosis will be excluded as a safety precaution due to the contrast used in the scans.
health benefits of tart cherry in ulcerative colitis

Conditions: Ulcerative Colitis

Summary: ulcerative colitis (uc) is a long-term inflammatory condition of the digestive tract. people with uc often have unpredictable and debilitating symptoms, including abdominal pain, diarrhoea and fatigue. in addition, they require long-term treatment with frequent negative effects, the need of surgery and hospitalisations. therefore, people with uc report a lower health-related quality of life (hrqol) compared with healthy individuals. the most common medication for inflammatory bowel disease is a strong immunosuppressant which has previously (in 2017) been found to be the most expensive medication prescribed at hospitals in the nhs. unfortunately, biologics has a lot of negative side effects and thus reducing the need of them in patients can benefit both the nhs as a whole by reducing the cost and improving the quality of life of patients by reducing the unwanted side effects of the biologics. supplementation of montmorency tart cherry juice might be a simple, safe, and low-cost intervention for improving symptoms in patients with uc. this is because it has the potential to naturally reduce inflammation in the digestive system and thus improve symptoms. research in animal models has shown a potential for improvement in physiological responses with similar supplements including blueberries, black raspberries and even montmorency tart cherries, with only one study in human participants exploring bilberry supplementation. however, despite anthocyanins concentrations from montmorency tart cherries being superior to other berries, dietary interventions using tart cherry supplementation for uc have not received any attention in human participants. the primary purpose of the proposed investigation is to undertake a placebo randomized control trial examining the ability of a montmorency tart cherry juice supplement to provide symptom relief and health related wellbeing outcomes in those with mild to moderately active uc and to understand the biological mechanisms behind any changes in symptoms.


Eligibility criteria:
inclusion criteria: * an established diagnosis of uc for at least 6 months * current mild to moderate disease activity * age between 18 and 65 years * stable use of medication for at least 3 months respectively. exclusion criteria: * diabetes * hiv * hepatitis b and c infection * abscesses * unstable medical conditions that would likely prevent the subject from completing the study * food allergies to cherries.
the role of a virtual coach in improving adherence to an activity program for overweight adults

Conditions: Overweight

Summary: hypothesis: overweight subjects using a virtual coach will demonstrate improved adherence to an exercise regime. this study is designed to examine the effect of a computer program called a "virtual coach" and find out if it helps people become more active. this program acts as a kind of a personal trainer and will give you feedback. all participants in the study will receive an activity monitor to wear during the study and a website to use to track activity. half of the participants will also receive the virtual coach software. this software will have to be downloaded onto your computer, and we will ask that you check in with the coach using the software three times a week for 12 weeks. the group you will be placed in will be selected by chance.


Eligibility criteria:
inclusion criteria: * adults age 20-55 inclusive * bmi between 25 and 35 inclusive (overweight and class 1 obese subjects) * pc computer with an available usb port, speakers and high-speed internet access in a secure setting (home or private office) * fluency in english (spoken and written) * have a primary care physician * answer "no" to all 7 questions on par-q or have letter from pcp clearing them to take part in study exclusion criteria: * disability, medical or surgical condition preventing or precluding moderate physical activity. * cognitive impairment.
study to evaluate the safety and pharmacokinetics of spi-1005

Conditions: Hearing Loss; Cancer

Summary: a study to determine the safety, tolerability, and pharmacokinetics of spi-1005 capsules in healthy adults.


Eligibility criteria:
inclusion criteria: * healthy adult male and female subjects * within 15% of their ideal weights (table of "desirable weights of adults," metropolitan life insurance company, 1983) * medically healthy subjects with clinically insignificant screening results (laboratory profiles, medical histories, ecgs, physical exam); * voluntarily consented to participate in the study; * females of childbearing potential were either sexually inactive (abstinent) for 14 days prior to screening and throughout the study or used one of the following acceptable birth control methods: intrauterine device (iud) in place for at least 3 months prior to study; barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; stable hormonal contraceptive for at least 3 months prior to study through completion of study; surgical sterilization (vasectomy) of partner at least 6 months prior to study. females of non-childbearing potential were surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study). exclusion criteria: * history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, otologic, or psychiatric disease; * history or presence of alcoholism or drug abuse within the past 2 years; * hypersensitivity or idiosyncratic reaction to compounds related to ebselen; * use of any prescription medication within 14 days (with the exception of hormonal contraceptives) prior to or during the study; * use of any over-the-counter medication including vitamins, herbal preparations, antacids, cough and cold remedies, etc., within 7 days prior or during the study; * use of any drugs or substances known to be strong inhibitors or inducers of cytochrome p450 enzymes within 28 days prior to dosing; * abnormal diet (for any reason) during the 30 days prior to dosing; * donation of whole blood within 56 days prior to the study; * plasma donation within 7 days prior to the study; * participation in another clinical trial within 30 days prior to the study; * female subjects who were pregnant or lactating; * hemoglobin \< 12.0 g/dl; * orthostatic vital signs which result in: a pulse increase of more than 30 beats per minute after 3 minutes standing (compared with semi-recumbent pulse rate); or a pulse rate greater than 100 bpm after 3 minutes standing; or a drop in systolic blood pressure decrease of at least 20 mm hg; or a diastolic blood pressure decrease of at least 10 mm hg within 3 minutes of standing (compared with semi-recumbent blood pressure).

Keywords: ebselen
study of xyotax (ct-2103) in patients with metastatic breast cancer

Conditions: Breast Cancer; Metastatic Breast Cancer

Summary: the purpose of this study is to collect information on what effects (good or bad) ct-2103 (xyotax) has on breast cancer as well as any side effects the drug may cause.

* patients will be given ct-2103 intravenously every 3 weeks. one week after the first dose of ct-2103 a physical exam, blood work and assessment of any side effects will be performed. * prior to each injection of ct-2103, a physical exam, blood work and assessment of any side effects will be performed (every 3 weeks). * every 6 weeks the patient's cancer will be re-evaluated with either a ct scan or mri to determine whether the treatment is working. * additional blood work will be performed once per week after the first two doses of ct-2103. * the participation in this study will last at least 2 cycles (6 weeks), however patients may remain on the study as long as there is no disease progression, and they are able to tolerate the study drug without severe side effects.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of invasive breast cancer, stage iv disease * age greater than 18 years * at least one measurable target lesion as defined by recist that has not been previously treated with local therapy * her2-negative breast cancer * up to one prior chemotherapy for advanced or metastatic disease * ecog performance status 0-1 * life expectancy \> 12 weeks * adequate liver and bone marrow function: ast \ 1,500/ul; platelet count \> 100,000/ul; normal pt and ptt * at least 2 weeks since prior radiation and recovered from treatment-related toxicity exclusion criteria: * prior taxanes for treatment of metastatic disease * pregnant of breast-feeding women * her2-positive breast cancer * more than 1 prior chemotherapy regimen for metastatic disease * untreated brain metastases * concurrent radiotherapy or investigational drug * prior bone marrow or stem cell transplant * history of other malignancy within the last 5 years, not including curatively-treated carcinoma in situ of the cervix or non-melanoma skin cancer * uncontrolled infection * active bleeding, or history of bleeding requiring transfusion * active cardiac disease * serious medical or psychiatric illness

Keywords: metastatic breast cancer her2-negative breast cancer ct-2103 xyotax
magnetic resonance imaging and spectroscopy biomarkers of neonatal hypoxic ischemic encephalopathy

Conditions: Hypoxic Ischemic Encephalopathy

Summary: neonatal hypoxic ischemic encephalopathy (hie) is a serious neurological condition characterised by acute or subacute brain injury arising from perinatal hypoxia. hie is thought to affect approximately 0.2% of live births, and is associated with a high risk of mortality or long-term neurological disability. accurate biomarkers for long-term neuro-developmental outcome following hie are extremely important both for clinical management and the evaluation of therapeutic approaches. according to a recent meta-analysis, the ratio of the cerebral concentrations of lactate and n-acetyl aspartate (naa), two neuro-metabolites detectable with magnetic resonance spectroscopy (mrs), currently represents the most accurate prognostic indicator of outcome following hie. however, for various technical reasons standard mrs methods do not offer optimal sensitivity for detecting lactate, which may potentially be improved with a custom lactate editing mrs sequence. in addition, while perfusion has also been suggested as a potential biomarker for neuro-developmental outcome following hie, due to a paucity of mr perfusion imaging studies in neonates, the prognostic accuracy of perfusion mr measures has not been evaluated in comparison with more established mr biomarkers. the aims of this study are: 1. to evaluate the relative sensitivity of a custom lactate editing mrs pulse sequence (specialist software) relative to the standard point resolved (press) mrs sequence for detecting lactate in neonates with suspected hie. 2. to evaluate the sensitivity and specificity of mr perfusion measures in comparison to mrs measures as predictors of neuro-developmental outcome at 2 years.


Eligibility criteria:
inclusion criteria: * newborn infants (born at \>36 weeks) with suspected perinatal asphyxia. written informed consent from both parents. exclusion criteria: * prematurity (born at \< 36 weeks). lack of written informed consent from both parents.

Keywords: magnetic resonance spectroscopy magnetic resonance imaging
a study of tirzepatide (ly3298176) in healthy participants and participants with type 2 diabetes (t2dm)

Conditions: Healthy; Type 2 Diabetes Mellitus (T2DM)

Summary: the main purposes of this study are to determine: * the safety of tirzepatide and any side effects that might be associated with it. * how much tirzepatide gets into the bloodstream and how long it takes the body to get rid of it. * how tirzepatide affects the levels of blood sugar. this study includes 3 parts (a, b and c). part a involves a single dose of tirzepatide taken as a subcutaneous (sc) injection just under the skin and will be approximately 10 weeks in duration, including screening. parts b and c involve 4 doses of tirzepatide taken once weekly (over 4 weeks) as a sc injection just under the skin and is approximately 12-14 weeks in duration, including screening. each participant will enroll in only one part. this study is for research purposes only, and is not intended to treat any medical condition.


Eligibility criteria:
inclusion criteria: * healthy participants (parts a and b) and participants with t2dm diagnosed at least 1 year before enrollment (part c) * have a screening body mass index (bmi) of greater than 18.5 and less than or equal to 40.0 kilograms per meter squared (kg/m²), inclusive * participants with t2dm (part c only): have t2dm controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (metformin for at least 30 days or sulfonylureas). participants receiving sulfonylureas may participate only if this treatment is stopped for at least 6 weeks before dosing with study drug exclusion criteria: * have known allergies to tirzepatide, glucagon-like peptide (glp)-1 analogs, or related compounds * have an abnormality in the 12-lead electrocardiogram (ecg) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study * have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase (greater than 2-fold the upper limit of normal \[uln\]) or gastrointestinal (gi) disorder (for example, relevant esophageal reflux or gall bladder disease) or any gi disease which impacts gastric emptying (for example, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (glp-1) analogs or dipeptidyl peptidase (dpp)-iv inhibitors participants with t2dm (part c only) * have had more than 1 episode of severe hypoglycemia, as defined by the american diabetes association criteria, within 6 months before entry into the study or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms all study participants (parts b and c only) * have known allergies to tirzepatide, glp-1 analogs, or related compounds, or acetaminophen
zuranolone pharmacokinetics (pk) and safety study adolescent participants with major depressive disorder (mdd)

Conditions: Major Depressive Disorder

Summary: the primary purpose of this study is to evaluate the pharmacokinetics and safety of zuranolone in adolescents (ages 12 to 17 years) with mdd.

this study was previously posted by sage therapeutics. in december 2024, sponsorship of the trial was transferred to biogen.

Eligibility criteria:
inclusion criteria: * participant meets kiddie schedule for affective disorders and schizophrenia - present and lifetime dsm-5 (ksads-pl dsm-5) criteria for mdd. * participant has a children's depression rating scale-revised (cdrs-r) total score greater than or equal to 40 at screening and day 1. * participant's parent/caregiver is able to attend all scheduled study visits, oversee administration of study drug and complete assessments per the protocol. * participant has a body weight greater than or equal to 20 kg and a body mass index greater than fifth percentile and less than ninety-fifth percentile for age at screening. * participant is a post-pubertal (has experienced menarche) female (sex assigned at birth), 12 to 17 years of age, inclusive, at the time informed consent/assent is obtained. exclusion criteria: * participant has a history of psychosis, bipolar disorder, autism, seizures, or other restricted comorbid psychiatric or neurological conditions and has treatment-resistant depression. * participant has a known diagnosis of intellectual disability or is unable to communicate with the study investigator or research team. * participant has a history of suicidal behavior or is currently at risk of suicide in the opinion of the investigator. * participant has a recent history of diagnostic and statistical manual of mental disorders, 5th edition (dsm 5) alcohol or drug use disorder or has clinically significant alcohol or drug misuse as judged by the investigator. note: other protocol-defined inclusion/exclusion criteria may apply.

Keywords: major depressive disorder mdd depression pediatrics child adolescent sage-217 zuranolone