Kornimate/medical-research-clean huggingface dataset:
paramedian cesi vs selective nerve root prf for lower cervical radicular pain

Conditions: Neck Pain; Cervical Radiculopathy

Summary: this study aims to compare the efficacy of ultrasound-guided selective cervical nerve root pulsed radiofrequency (prf) versus fluoroscopy-guided paramedian cervical epidural steroid administration (cesi) for the treatment of lower cervical radicular pain refractory to conservative treatments. for this evaluation, a numerical rating (nrs), neck disability index (ndi), and leeds assessment of neuropathic symptoms and signs (lanss) scale will be used before and after both interventions.

chronic cervical radicular pain is a common condition that affects the quality of life of many patients and is caused by compression or irritation of the cervical nerve roots. treatment options for this condition include conservative methods such as medications and physical therapy, as well as interventions such as surgery or injections. two commonly used injections for chronic cervical radicular pain are ultrasound-guided selective nerve root prf and fluoroscopy-guided paramedian cesi. prf involves the application of pulsed radiofrequency energy (intermittent current, tissue temperature not exceeding 42 °c) to the cervical nerve root under ultrasound guidance. prf is a non-destructive technique that modulates the activity of nerve fibers without causing thermal damage. cesi involves injecting local anesthetic and steroids into the epidural space between the laminae of the vertebrae under fluoroscopic guidance. the aim of both techniques is to reduce inflammation and pain transmission from the affected nerve root. the efficacy of both cesi and selective nerve root prf has been demonstrated in clinical trials. the primary aim of the investigators in this study is to compare the efficacy of these two treatments. a total of at least 60 patients, 30 patients in each group, will be enrolled for comparison. nrs, ndi, and lanss scores before, 3 months, and 6 months after treatment will be compared both within and between groups. the secondary aim is to reveal the side effects and adverse events in these two treatment modalities.

Eligibility criteria:
inclusion criteria: * severe unilateral radicular pain due to cervical disc herniation (pain with a severity of 6 or more on a numeric rating scale of 0-10) * continued pain for more than 3 months * demonstration of herniated disc compression of the lower cervical spinal nerve roots on magnetic resonance imaging * failure in pain management with conservative methods such as analgesics and physical therapy exclusion criteria: * pain radiating to both arms, hands or neck pain in the foreground * spinal stenosis or spondylolisthesis (only those with radicular pain due to disc herniation will be included) * cognitive impairment * hepatic or renal insufficiency * severe psychiatric illness * local or systemic infection * coagulopathy

Keywords: pulsed radiofrequency treatment fluoroscopy steroids
use of nitroglycerine to improve signs of poor peripheral perfusion in patients with traumatic hemorrhagic shock

Conditions: Hemorrhagic Shock

Summary: hemorrhagic shock is a pathologic state in which intravascular volume and oxygen delivery are impaired. during circulatory failure associated with hypovolemia and low cardiac output, redistribution of blood flow caused by increased vasoconstriction results in decreased perfusion of the skin. skin temperature and capillary refill time has been advocated as a measure of peripheral perfusion.

perfusion index (pi) is a non-invasive numerical value of peripheral perfusion obtained from pulse oximetry, it is an indicator of the pulse strength at the sensor site. the pi's values range from 0.2% for very weak pulse to 20% for extremely strong pulse according to patient's physiological conditions and monitoring sites. large increases in lactate (i.e. \> 5 mmol/l) usually only occur due to hypoperfusion or muscle activity such as exercise or seizures. this study will investigate the role of nitroglycerine patch in improving the peripheral perfusion in poly traumatized patient with hemorrhagic shock for the first time.

Eligibility criteria:
inclusion criteria: * age: 20-60 years old. with the patient fully conscious or slightly drowsy. * blood pressure: systolic blood pressure below 90mmhg ,mean blood pressure below70mmhg or decrease of systolic blood pressure 40mmhg below normal value. * metabolic acidosis: ph less than 7.35 due to hypoperfusion. * capillary refill time \> 4 seconds. * normal body core temperature. exclusion criteria: * age: below 20 and above 60 years old. * head trauma with glasco coma score below 14 due to increased intracranial pressure (stroke, subarachnoid hemorrhage or brain trauma injury). * severe hypotension not responding to fluid therapy. * patient with bilateral ischemic arm injury. * patient with hepatic cell failure * patients admitted to the emergency trauma department after 6 hours of the trauma event. * preexisting conditions as severe cardiovascular disease, uncontrolled hemorrhage, failure of central venous catheterization, dialytic procedure anticipated during the study period.

Keywords: hemorrhagic shock perfusion index lactate nitroglycerin
community based interventions to improve hiv outcomes in youth: a cluster randomised trial in zimbabwe

Conditions: HIV Infection

Summary: a cluster randomised trial to determine the impact of an integrated community-based package of hiv services incorporating hiv testing, linkage to care and ongoing adherence support, combined with sexual and reproductive health (srh) services and general health counselling for 16 to 24 year olds on population level hiv viral load in a high hiv prevalence setting.

young people fare disproportionately poorly across the hiv care continuum compared to other age-groups; the prevalence of undiagnosed hiv is substantially higher, and coverage of and adherence to antiretroviral therapy is lower, resulting overall in worse virological outcomes. aim: the aim is to determine the impact of an integrated community-based package of hiv services incorporating hiv testing, linkage to care and ongoing adherence support, combined with sexual and reproductive health services and general health counselling for 16 to 24 year olds on population level hiv viral load in a high hiv prevalence setting. design: this is a two-arm cluster-randomised trial in 24 clusters randomised 1:1 to standard of care or to the intervention package. intervention: community-based package of services that includes: hiv testing and counselling, delivery of antiretroviral therapy, adherence support groups, mobile health, condoms, menstrual hygiene management, contraception and treatment of sexually transmitted infections, referral for voluntary medical male circumcision and cervical screening, risk reduction counselling and general health information and counselling. the intervention will be implemented over a two and half year period. the intervention will be implemented in 12 clusters, each with a population of approximately 2500-4000 16-24 year olds. study outcomes: the study outcomes will be determined at a population level through a community cross-sectional survey among 18 to 24 year olds two years following the implementation of the intervention. the primary outcome is the proportion with hiv with a viral load \<1000 copies/ml. the secondary outcomes will reflect each step of the hiv care cascade: proportion with hiv who know their hiv status, proportion of those who know their hiv-positive status who are currently taking antiretroviral therapy, proportion of those taking antiretroviral therapy who are virally suppressed. sexual and reproductive health knowledge, risks and behaviour will also be assessed. study population: the end-line survey will recruit 700 18-24 year olds per cluster (total 16 800). study sites: the study will be conducted in 3 provinces in zimbabwe: harare, bulawayo and mashonaland east. study duration: the planned duration of the entire study will be 4 years

Eligibility criteria:
inclusion criteria: * reside within cluster boundaries * aged 16 to 24 years exclusion criteria: * reside outside the cluster boundaries * aged below 16 years * aged above 24 years

Keywords: adolescents youth sexual and reproductive health africa community-based
intensive blood pressure and ldl lowering in diabetic patients with coronary artery disease

Conditions: Type 2 Diabetes; Coronary Artery Disease; Hypertension; Dyslipidemia

Summary: the purpose of this study is to determine whether intensive blood pressure and low density lipoprotein (ldl) cholesterol lowering could improve survival and cardiovascular outcome in japanese diabetic patients with coronary artery disease and history of acute coronary syndrome.

prevalence of type 2 diabetes in asia seems to be almost epidemic and establishment of preventive strategy against macrovascular as well as microvascular diseases are warranted because of higher cardiovascular risk in diabetic patients even without history of atherosclerotic cardiovascular diseases. benefit of lowering low density lipoprotein (ldl) cholesterol down to 70 mg/ml in caucasian patients with coronary artery disease (cad) has been well established but not in asian patients with lower risk of myocardial infarction and higher stroke risk. intensive lowering blood pressure for cardiovascular outcome in diabetic patients and patients with cad has been recommended in several guidelines without firm evidence. risk and benefit of intensive blood pressure and ldl control should be evaluated in japanese diabetic cad patients by pragmatic randomized controlled trial.

Eligibility criteria:
inclusion criteria: * type 2 diabetic patients with coronary artery disease and history of acute coronary syndrome * patients whose blood pressure and ldl cholesterol levels are above values recommended by the current guideline exclusion criteria: * patients who have active malignant tumor * patients who are on hemodialysis due to end stage kidney disease * patients whom statins are contraindicated * patients who had acute coronary syndrome or stroke within 3 months * patients who are pregnant or on breast feeding * patients whose physicians deem that attending this trial is contraindicated or inappropriate

Keywords: type 2 diabetes coronary artery disease hypertension dyslipidemia
cctg 593: testing and linkage to care

Conditions: HIV Positive; HIV Seronegative

Summary: this is a cctg sponsored project to determine if those recently screened for hiv would accept assistance to be linked into appropriate health services. after receiving their hiv results, high-risk individuals who test negative will have an option to be linked into a study that offers them pre-exposure prophylaxis (prep), and individuals who test positive will have an option to be linked into care. if they accept, tested individuals will be in contact with an alert specialist that will help facilitate their linkage. the study's primary analysis will analyze how many hiv screened individuals accept the alert specialist assistance.

design: cctg 593 is a project to evaluate the uptake and effectiveness of an alert specialist serving to 1. link newly diagnosed, hiv infected persons from hiv testing sites to hiv specialist providers, and 2. link confirmed hiv antibody negative persons with continued high risk behaviors to prep centers duration: each subject who agrees to linkage will receive alert follow-up until successful linkage or 60 days following enrollment for linkage to care or 90 days following enrollment for linkage to prep, whichever comes first. the duration of the 593 project will be for 3.5 years or until all subjects have been enrolled and successfully linked, or 60 days pass for linkage to care or 90 days for linkage to prep. sample size: up to 600 subjects will be tested and offered linkage across all cctg sites: la county-usc medical center, harbor-ucla/city of long beach department of health and human services, ucsd/san diego health and human services agency. study population: eligible subjects will include any persons 18 years of age or older who have been tested for hiv at one of the cctg testing sites (la county + usc, long beach department of health and human services, and san diego health and human services agency).

Eligibility criteria:
inclusion criteria: * age 18 years or older * has had an hiv test result form the cctg consortium testing site as either positive or negative * ability to provide informed consent * english or spanish speaking exclusion criteria: * severe active substance abuse or mental illness that the investigator feels will interfere with the ability to provide informed consent * acute medical illness that requires transfer to a non cctg hospital

Keywords: hiv screening linkage to prep linkage to care cctg 593
pilot study of growth hormon to treat sma typ ii and iii

Conditions: Muscular Atrophy, Spinal

Summary: the purpose of this study is to determine whether growth hormon can increase strength in spinal muscular atrophy type ii and iii.

this pilot study is planned as a placebo-controlled cross-over trial in a limited number of patients. it is the aim to investigate the effect of gh on the short-term changes of strength and to investigate the tolerability of the treatment. if the results of the study are positive, further studies of longer duration addressing the development of motor function and quality of life could follow

Eligibility criteria:
inclusion criteria: * genetically confirmed diagnosis of spinal muscular disease * spinal muscular atrophy type ii or iii * age between 6 years and 35 years * ability to perform the tests for measurement of muscle strength (handheld myometry) * informed consent of the patient and/or parents exclusion criteria: * pregnancy or lactation * woman with child bearing potential without contraception * overweight or bmi over 30 kg/m² * treatment with other drugs, that can influence strength 8 weeks before participation in the study or during participation * medical history or evidence of a malignant or cerebral tumor * cardiovascular, intestinal, endocrinologically or airway disease * hypertension * growth hormone deficiency * hypersensitivity to one component part of the study medication * participation on a clinical trial during the study or 3 month before * abuse to drugs or alcohol * patient incapable of contracting or not able to understand the character, meaning and consequences of the clinical trial

Keywords: growth hormone strength spinal muscular atrophy type ii and iii
biochemical markers and 2 and 3d ultrasound to id maternal & fetal complications

Conditions: Pregnancy; Fetal Aneuploidy

Summary: can a combination of prenatal screening blood tests, early ultrasound, and a 3d ultrasound of the fetal face at approximately 20 weeks gestation identify fetuses with congenital anomalies and predict maternal and fetal complications?

pts will be consented upon presenting to the department for a comprehensive ultrasound.the 3d picture is the only part of the study that is not part of standard obstetrical care.

Eligibility criteria:
inclusion criteria: * pregnant women at approximately 20 weeks * ages 18-50 * singleton pregnancy * plans to deliver at north shore university hosp * completed step-wise sequential screening exclusion criteria: * multifetal gestation * minors * patients who have undergone diagnostic genetic testing * incarcerated patients * intention to deliver at a hospital other than north shore university hosp
the safety and pk characteristics of the co-administration of jlp-2002 and comparator in healthy volunteers

Conditions: Overactive Bladder(OAB)

Summary: a randomized, open-label, single-dose, replicate crossover study to compare the pharmacokinetics and safety in healthy adult volunteers following oral administration of jlp-2002

a randomized, open-label, single-dose, replicate crossover study

Eligibility criteria:
inclusion criteria: * those who are 19 years of age or older and 55 years of age * bmi 18.5 \~ 27.5 kg/m2 * those who voluntarily agrees in writing after hearing a sufficient explanation of the purpose and procedure of the clinical trial exclusion criteria: * those with clinically significant diseases or a history of liver, kidney, cardiovascular system, endocrine system, musculoskeletal system, respiratory system, neuropsychiatric system, blood/oncology system, etc. * those with a history of gastrointestinal diseases or surgery that may affect the absorption of drugs * those who donated whole blood within 60 days from the date of eligibility assessment, or who donated component blood within 30 days * those who do not have a medically recognized contraceptive intention or plan to provide sperm from the screening date to 4 weeks from the last administration of the investigational drug * those whose blood ast, alt, or ggt levels in the screening test exceeded 3 times the upper limit of the reference range * those who showed clinically significant results in the hepatitis b test, hepatitis c test, hiv test, and syphilis test * in the case of women, those who do not show a negative response on the pregnancy test * those who judged that the investigator is not suitable for participation in clinical trials, such as showing clinically significant results in other screening tests
comparison of the safety and efficacy of hoe901-u300 with lantus in older patients with type2 diabetes insufficiently controlled on their current antidiabetic medications

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: to demonstrate the non-inferiority of h0e901-u300 to lantus, in change of glycated hemoglobin a1c (hba1c). secondary objectives: to demonstrate the superiority of h0e901-u300 in comparison with lantus in: * percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dl \[3.9mmol/l\]) hypoglycemia event from 22:00 to 08:59 next morning * percentage of participants with at least one nocturnal (from 00:00-05:59) severe and/or confirmed (≤70mg/dl \[3.9mmol/l\]) hypoglycemia event * percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dl \[3.9mmol/l\]) hypoglycemia event occurring at any time of day * hba1c change

the study consisted of a 4-week screening period, a 26-week treatment period comparing hoe901-u300 to lantus, and a 2-day safety follow-up period.

Eligibility criteria:
inclusion criteria: * participants ≥65 years old with type 2 diabetes mellitus, inadequately controlled on antidiabetic regimens either including no insulin, or with basal insulin as their only insulin. * signed informed consent. exclusion criteria: * hba1c at screening visit: * \ 10.0% for participants taking basal insulin. * \ 11.0% for insulin-naïve participants. * history of type 2 diabetes mellitus for less than 1 year before screening. * participants not on stable basal insulin dose (±10% in the last 8 weeks prior to screening visit). * change in dose of antidiabetic treatment or initiation of new glucose-lowering medications in the last 8 weeks prior to screening. * chronic (\>10 days continuous use in previous 6 months) use of bolus insulin injections, whether given separately or as part of a combination with basal insulin, e.g. premix insulin; for insulin-naïve individuals: current or previous insulin use except for a maximum of 10 consecutive days (e.g. acute illness, surgery) during the last year prior to screening. * cognitive disorder and dementia assessed clinically and by mini-mental state examination (mmse) score \<24, or any neurologic disorder that would likely affect the participant's ability to follow the study procedure. the participant would be eligible despite an mmse score \<24 if the investigator determined that the low score reflected educational or cultural background and not dementia as long as the participant was otherwise able to meet the study requirements. * participants who had end-stage renal disease (\<15 ml/min/1.73m\^2, per estimated glomerular filtration rate (egfr) measurement by modification of diet in renal disease (mdrd). the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
high resolution, high-speed multimodal ophthalmic imaging

Conditions: Retinitis Pigmentosa; Maculopathy, Age Related; Macular Dystrophy; Macular Edema; Retinal Detachment; Retinal Degeneration; Glaucoma; Vascular Inflammation; Hypertension; Stroke; Diabetes; Corneal Dystrophy; Keratoconus; Dry Eye; Trauma

Summary: knowledge of the pathogenesis of ocular conditions, a leading cause of blindness, has benefited greatly from recent advances in ophthalmic imaging. however, current clinical imaging systems are limited in resolution, speed, or access to certain structures of the eye. the use of a high-resolution imaging system improves the resolution of ophthalmoscopes by several orders of magnitude, allowing the visualization of many microstructures of the eye: photoreceptors, vessels, nerve bundles in the retina, cells and nerves in the cornea. the use of a high-speed acquisition imaging system makes it possible to detect functional measurements such as the speed of blood flow. the combination of data from multiple imaging systems to obtain multimodal information is of great importance for improving the understanding of structural changes in the eye during a disease. the purpose of this project is to observe structures that are not detectable with routinely used systems.

the goal of the project is the capture and analysis of images with the ima-mode systems, in order to evaluate the performance of these systems compared to the existing clinical imaging devices used at the national hospital of ophthalmology. this project should identify the best techniques to image the eye, and select the most promising techniques to evolve towards a possible development of a medical device.

Eligibility criteria:
inclusion criteria: * people over 18 * patient with a pathology affecting the eye or healthy volunteer * participant who signed the consent * beneficiaries of the health insurance exclusion criteria: * patients with a history of photosensitivity. * patients who have just received a photodynamic therapy treatment ( * patients taking drugs with photosensitivity as a side effect. * persons with pacemakers or other implanted electronic medical device * patients with viral conjunctivitis or any other infectious disease. * patients with skin lesions on the neck or forehead * patients at high risk of damage from optical radiation, such as aphakic patients, or patients with decreased sensitivity to light due to fundus disease. * pregnant or lactating women * participant unable to be followed throughout the study * vulnerable people * subjects with predisposition to closure of the iridocorneal angle