Kornimate/medical-research-clean huggingface dataset:
effects of moxaverine and placebo on ocular blood flow

Conditions: Regional Blood Flow; Ocular Physiology; Retina

Summary: a number of common eye diseases such as retinal artery and vein occlusion, diabetic retinopathy, age-related macular degeneration, glaucoma and anterior ischemic optic neuropathy are associated with ocular perfusion abnormalities. although this is well recognized there is not much possibility to improve blood flow to the posterior pole of the eye in these diseases. since many years, moxaverine is used in the therapy of perfusion abnormalities in the brain, the heart and the extremities. this is based on a direct vasodilator effect of the drug, but also on the rheological properties of red blood cells. whether moxaverine affects blood flow in the eye is unknown. the present study aims to investigate whether moxaverine may improves blood flow in the eye after systemic administration.


Eligibility criteria:
inclusion criteria: * men and women aged between 18 and 35 years, nonsmokers * body mass index between 15th and 85th percentile * normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant * normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant * normal ophthalmic findings, ametropy \< 3 dpt. exclusion criteria: * regular use of medication, abuse of alcoholic beverages or drugs, participation in a clinical trial in the 3 weeks preceding the study * treatment in the previous 3 weeks with any drug * symptoms of a clinically relevant illness in the 3 weeks before the first study day * history or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs * blood donation during the previous 3 weeks * ametropy \>= 3 dpt * acute gastric bleeding, massive cerebral hemorrhage related to stroke * women: pregnancy or lactation
bringing life to those near death

Conditions: Palliative Care

Summary: the purpose of this study is to assess whether virtual reality technology can reduce anxiety, depression, and emotional distress screening scores in palliative care patients.


Eligibility criteria:
inclusion criteria; * a terminal or end-stage condition with an expected prognosis of a year or less. * an established palliative care patient. * english-speaking. * able to wear virtual reality equipment (goggles, etc.). * subject or caregiver able to provide consent. exclusion criteria: * younger than 18 years of age. * lack of a prognosis of approximately 1 year or less.
evaluating a new echocardiography imaging procedure for evaluating heart function

Conditions: Ischemia; Myocardial Infarction; Ischemic Heart Disease

Summary: magnetic resonance imaging (mri) and echocardiography are two imaging methods that are used to obtain pictures of the heart and assess heart function. this study will evaluate a new, four-dimensional echocardiography approach of obtaining heart images to determine if it is as effective at evaluating heart function as mri.

mri is a non-invasive method of obtaining images of the body. an mri is conducted by having a person lie down on a narrow table, which then slides into a large tunnel-like tube. powerful magnets and radio waves scan the body and a computer records the resulting signals. an echocardiography is a non-invasive ultrasound test that uses sound waves to create images of the heart. it is performed by having a doctor move a wand-like device over a patient's chest. the device then converts sound waves into pictures of the heart. currently, a special mri technique is used to evaluate heart function; however, mri is expensive and cannot be used on critically ill patients. echocardiography can be performed at a patient's bedside and it may be a more effective way of assessing heart function. the purpose of this study is to determine the effectiveness of a new four-dimensional echocardiography approach at evaluating heart function. results from this study may be used to diagnose and treat patients more effectively in the future. this study will enroll healthy people who do not have heart disease and people who are receiving chemotherapy who do not have heart disease. participants will have a physical examination and a medical records review. mri scans and a four-dimensional echocardiography of the heart will be performed. there will be no additional study visits.

Eligibility criteria:
inclusion criteria: * no evidence of underlying cardiac disease based on history or electrocardiogram (ecg) * adequate intravenous access in one arm exclusion criteria: * pregnant or breastfeeding; if pre-menopausal, not practicing acceptable method of birth control * history of any other medical condition that is likely to hinder study conduct or pose a safety concern, in the opinion of the investigator * history of cardiac disease, including heart attack or heart valve disease * uncontrolled high blood pressure, defined as systolic blood pressure higher than 160 mm hg and/or diastolic pressure higher than 100 mm hg * abnormal ecg or chest pain syndrome * claustrophobia * resting heart rate greater than 110 bpm * unable to undergo mri procedure (e.g., pacemaker, metallic implants)
a study of deflazacort (emflaza®) in participants with limb-girdle muscular dystrophy 2i (lgmd2i)

Conditions: Limb-Girdle Muscular Dystrophy

Summary: this study is designed to evaluate the safety and efficacy of deflazacort in participants with lgmd2i. most participants enrolled will have a screening visit and 3 additional visits (after 1, 13, and 26 weeks of treatment).


Eligibility criteria:
inclusion criteria: * genetic diagnosis of lgmd2i (confirmed mutation in the fukutin-related protein \[fkrp\] gene). * ability to ascend 4 stairs greater than or equal to (≥) 2.5 seconds and be able to complete the ascent and descent both at screening and baseline. * ability to understand the nature of the study and the consent form and to comply with study related procedures. * must weigh between 35 to 112.5 kilograms (kg). exclusion criteria: * received ≥4 weeks of continuous, systemic corticosteroid therapy within 3 months of study screening visit. * presence of significant cardiomyopathy as defined by echocardiogram (left ventricular ejection fraction less than (\<) 30 percent \[%\]) at screening. * requires fulltime ventilator support. * history of chronic systemic fungal or viral infections. * history of recent bacterial infection (including tuberculosis) per discretion of the investigator. * diagnosis of diabetes mellitus (controlled and/or uncontrolled) defined as glycated hemoglobin (hba1c) ≥6.5% (based on historical or present diagnosis). * history of immunosuppression or other contraindications to glucocorticosteroid therapy. * requires concomitant use or greater than (\>) 1 week of drugs or substances that are moderate to strong cytochrome p3a4 (cyp3a4) inhibitors (for example, clarithromycin, fluconazole, diltiazem, verapamil, grapefruit juice) or moderate or strong cyp3a4 inducers (that is, rifampin, efavirenz, carbamazepine, phenytoin) at baseline. * participated in an interventional clinical trial within the last 3 months prior the baseline visit. * unable or unwilling to comply with the contraceptive requirements of the protocol. * female participants who are pregnant and/or breastfeeding. * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, psychiatric, or allergic disease.
study evaluating desvenlafaxine sustained-release (dvs-sr) in adult outpatients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to compare the antidepressant efficacy, safety, and tolerability of dvs-sr in subjects receiving daily doses of 50 mg or 100 mg of dvs-sr versus subjects receiving placebo.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of major depressive disorder * must be able to swallow tablets * must be at least 18 years of age. exclusion criteria: * clinical diagnosis of other psychiatric disorders * significant risk of suicide * unstable medical conditions.

Keywords: depression adult outpatients
ftih study of ecc0509 in healthy volunteers

Conditions: Nonalcoholic Steatohepatitis; Osteoarthritis

Summary: a phase 1, single-center, randomized, double-blind, placebo-controlled, single and multiple ascending dose, first-time-in-human study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ecc0509 in healthy volunteers.

this study will be conducted in up to seven cohorts of single ascending dose (sad) \& 3 cohorts of multiple ascending dose (mad). sad will consist of a staggered dosing approach with a dose range from 1mg to 80mg. staggered dosing approach will not be deployed for mad cohorts with a dose range of 8mg to 40mg. in the mad cohort, the effect of food will also be assessed by comparing the pk profile of day 10 fed conditions against day 14 fasted conditions.

Eligibility criteria:
key inclusion criteria: 1. healthy male or non-childbearing potential female 2. age ≥18 and ≤65 years old 3. bmi ≥18.0 and ≤32.0 kg/m2 4. male participants agree to use contraception 5. no clinically significant abnormal findings in physical examination, 12-lead electrocardiogram (ecg), laboratory tests, or medical history 6. able to understand and sign informed consent key exclusion criteria: 1. significant allergic reactions to any drug. 2. history of significant drug abuse or alcohol abuse within 1 year prior to screening 3. concomitant participation in any investigational study of any nature 4. use of any concomitant medication except for the occasional use of acetaminophen (up to 2 g daily) 5. donation of plasma within 7 days prior to dosing or donation or loss of 500 ml or more of whole blood within 8 weeks prior to dosing. 6. any clinically significant abnormal findings in the participant's physical examination, laboratory tests, pregnancy test, urine drug screen, alcohol breath test, or medical history which, in the opinion of the investigator, would prevent the subject from participating in the study.
daily target guided radiation therapy using the calypso 4d localization system in patients who have had a prostatectomy for prostate cancer

Conditions: Prostate Cancer

Summary: this study will evaluate the daily use of a unique daily organ tracking system on target localization in patients treated with radiation therapy after radical prostatectomy for prostate cancer. improved coverage of the target volume with radiotherapy could result in improved cancer control rates and decreased coverage of surrounding structures potentially decreasing treatment toxicity.

this prospective study evaluates the clinical utility of a novel real-time localization system of the prostate bed during adjuvant or salvage radiotherapy after radical prostatectomy. this study will also determine positioning errors using daily cone-beam computed tomography in patients set up with the calypso 4d localization system. subjects will have beacon® transponders implanted into the prostate bed. the calypso 4d localization system will localize the position of the prostate bed. cone beam ct will be used daily to measure inter-transponder distance. the calypso system will also track the prostate bed position in real time during the entire radiation treatment. the treatments will be adjusted as required to ensure accurate treatment of the clinical target volume. the time of, the number, and extent of adjustments will be recorded for analysis. daily cone-beam computed tomography images will also be retrospectively analyzed to assess for adequate target coverage. the analysis will be performed retrospectively through manual 3-d registration of the cone-beam ct dataset with the treatment planning ct scan. this information will determine the margins necessary for the ptv using the calypso 4d localization system and potentially may allow a reduction in the ptv volumes on future studies.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the prostate initially managed with prostatectomy with a detectable psa, positive surgical margins, or extra-prostatic extension. * ability to comply with study schedule * age 40 or older * zubrod ps 0 or 1 (appendix 1) * signed informed consent exclusion criteria: * node positive or metastatic prostate cancer * history of prior pelvic radiotherapy * history of abdominoperineal resection * history of inflammatory bowel disease or connective tissue disease * history of bleeding disorder or any active anticoagulant or anti-platelet medication which cannot be discontinued safely for transponder placement. * pt or inr outside normal range for institution * active implanted devices such as cardiac pacemakers and automatic defibrillators. * prosthetic implants in the pelvic region that contain metal or conductive materials (eg., an artificial hip). * patients with maximum anterior-posterior separation through the torso minus the height of the center of the prostate greater than 17 cm (technical reason for calypso system, see appendix 5). * history of hiv infection

Keywords: radiation calypso prostatectomy
safety and efficacy of bepotastine besilate ophthalmic solution in seasonal allergic conjunctivitis patients

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study is to study the safety and efficacy of bepotastine besilate ophthalmic solution in allergic conjunctivitis patients.


Eligibility criteria:
inclusion criteria: * subjects 12 years of age and older with 2-year history of allergic conjunctivitis exclusion criteria: * no active ocular or nasal infection
safety and efficacy of the penumbra™ system in acute middle cerebral artery (mca) stroke

Conditions: Stroke

Summary: stroke prognosis is intimately related to reperfusion. reperfusion in acute setting can be achieved with different strategies - varying from intravenous rtpa from mechanical thrombectomy. recently, interventional approaches have been gaining attention and playing an increasing role in stroke care. however, no solid scientifical data is available to date. the investigators want do conduct a pilot trial to test if the use of the penumbra™ system can improve clinical outcomes in a specific stroke setting.


Eligibility criteria:
inclusion criteria: * patient enrolled in acute ischemic stroke protocol * up to 3,5h from symptoms onset * clinical findings compatible with middle cerebral artery syndrome * angiotomographic evidence of proximal middle cerebral artery occlusion exclusion criteria: * nihss \< 10 * overt contraindication to thrombolysis or angiopgraphy * disagreement with informed consent term or refusal to participate

Keywords: stroke, mecanical thrombectomy
a spatial analysis of hotspots and targeted injection settings pilot intervention for hiv prevention among people who inject drugs

Conditions: COVID-19

Summary: conduct a study of people who use drugs (pwud) perceptions of and access to covid-19 vaccines as well as reasons for vaccine hesitancy/barriers

conduct a qualitative rapid longitudinal assessment of 20 pwud's perceptions of and access to covid-19 vaccines as well as reasons for vaccine hesitancy/barriers. the investigators will also assess frequency and content of covid-19 communication with peers. the investigators will also assess changes in the social network dynamics of drug use and access to illicit drugs, drug treatment, and hiv care. the brief qualitative interviews will be conducted biweekly over a period of one year. these interviews will be quickly transcribed, summarized, and provided to local and state health departments. the investigators will also use the findings from this aim to inform the proposed app and peer education pilot outlined in aims 2 \& 3. 2. development of an app provide real-time information on covid-19 vaccine availability and nearby risk reduction resources (naloxone distribution sites, syringe exchanges, drug treatment). the app will be built for mobile download and as an online webpage. 20 pwud will be included in this study component, split between the mobile and web-based app. 3. develop training materials and pilot the training of 40 pwud to promote vaccine uptake among the participants network and other community members. pwud will be trained to become peer educators to promote covid-19 vaccine uptake over 4 sessions. these 40 participants will be administered pre- and post-surveys as well as daily check-in questions through the app to assess effectiveness as peer educators.

Eligibility criteria:
inclusion criteria: * opioid use in prior 2 weeks exclusion criteria: * none
dilacheck cervical dilation measurement trial

Conditions: Cervical Dilation; Labor Pain; Labor Fast; Labor; Irregular

Summary: trial to compare the interexaminer agreement between two cervical dilation examinations conducted by labor and delivery physicians when using standard methods versus dilacheck device.

the trial seeks to compare the dilacheck device with standard digital cervical dilation examinations. 50 laboring female participants will be enrolled with 25 randomly assigned to the control arm and 25 to the treatment (dilacheck) arm. each participant will receive two cervical dilation examinations from two separate physicians. the main outcome measure is agreement between the two cervical dilation measurements. secondary outcomes include ease of use of the device and pain levels.

Eligibility criteria:
inclusion criteria: * the research population is pregnant women in the first stage of labor. subjects eligible for inclusion in the study must be: pregnant women who are admitted to a labor and delivery unit for management or induction of labor in the first stage of labor, are able to give informed consent, are 18 years of age or greater, speak english, and have a gestational age greater than or equal to 37 weeks (i.e. term pregnancy). patients are only consented if they have adequate pain control, either because they are not yet in labor (i.e. are admitted for an induction of labor) or have a functioning epidural. exclusion criteria: * exclusion criteria include progression to the second stage of labor (i.e. known dilation of ten centimeters), known rupture of membranes, any condition that renders labor unsafe for the patient (e.g. cardiac conditions, pulmonary hypertension) and any other condition that necessitates an emergent or urgent cesarean section (e.g. non-reassuring fetal status, placental abruption, hemorrhage, cord prolapse). all participants are necessarily female due to the subject matter. given the vulnerability of pregnant patients under the age of 18, this study will exclude children. there are no restrictions on eligibility based on race or ethnicity.

Keywords: cervical dilation dilation sterile vaginal examination
validation of oxyvu for assessing level of amputation with comparison to other modalities

Conditions: Critical Limb Ischemia

Summary: correlation of(oxyvu) values to to abi, tbp, and tcom in patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.

the purpose of this clinical study is to correlate tissue oxygenation values measured with a hyperspectral imaging system (oxyvu) to ankle brachial indices (abi), toe pressures (tbp), and transcutaneous oxygen monitoring (tcom) in patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.

Eligibility criteria:
inclusion criteria: * 18 to 85 years of age, males and females, varying skin tones, varying racial origins, and with and without diabetes. * patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.

Keywords: hyperspectral imaging tissue oxygenation foot amputation critical limb ischemia tissue necrosis
virtual physical activity seated exercise - phase 2

Conditions: Stroke; Chronic Stroke; Stroke, Ischemic; Stroke Hemorrhagic

Summary: this study will determine the acceptability of delivering seated exercises online and if seated exercises can improve balance, mobility, quality of life, and cardiometabolic health in those living with a stroke related mobility impairment. participants will be allocated to either a 10-week seated exercise program or a delayed 2-week boot camp program. all seated exercises sessions and assessments will be conducted virtually.

the study will be a virtual 10-week multi-site, assessor-blinded, randomized controlled trial with an embedded qualitative component. the study will be conducted in real time using secure videoconferencing software (zoom). participants will be randomized 1:1 to a 10-week seated exercise group or a delayed 2-week seated exercise group (boot camp). seated exercise sessions will be delivered and supervised by a trained instructor. participants will use their own computer, laptop, or tablet for the zoom sessions. no zoom sessions will be recorded. caregivers will be invited to attend each exercise session to provide support and assistance but are not obliged to attend. a caregiver, friend, or family member will be required for each assessment to participate in the study.

Eligibility criteria:
inclusion criteria: participants must meet the following inclusion criteria: * adult (as defined by province) * chronic stroke (more than 6 months post-stroke) * ability to stand up from a chair * mobility impairment of lower extremity (requires a walking aid, with or without close supervision) * able to safely engage in exercise and tolerate 60 minutes of exercises * able to communicate in english * have access to a tablet, computer, or laptop with internet and email access exclusion criteria: participants will be excluded if they meet any of the following criteria: * participating in formal exercise or rehabilitation activities * participating in \> 30 minutes/day of physical activity (moderate intensity) * participating in another study that may affect outcomes to this study * severe loss of vision, hearing, speech (including aphasia) or cognition that would preclude use of a computer/tablet and communication over videoconference software * a serious comorbid condition (eg., amputation, parkinson's disease, active cancer) * clinically diagnosed with acute/chronic illness or other condition which has known physical activity contraindications or limits their ability to complete each experimental condition (i.e., chronic low back pain aggravated by prolonged sitting)

Keywords: stroke seated exercise balance mobility cardiometabolic health randomized controlled trial
the "pooling" expressed breast milk: a method for improving the nutritional intake of premature infants

Conditions: Breastfeeding Mothers of Infants Hospitalized

Summary: the investigators compared a pooled mother's expressed breastmilk for 24 hours with individual pump session collection of milk to provide a more consistent caloric product without increasing bacterial contamination.


Eligibility criteria:
inclusion criteria: * mother of newborn hospitalized in intensive care unit * mother using a breast pump in the unit and / or at home * mother respected the rules of handling and transport breastmilk * no opposition mother exclusion criteria: * refusal