Kornimate/medical-research-clean huggingface dataset:
randomized study of the safety and effectiveness of the sight sciences visco™360 viscosurgical system versus slt in primary open angle glaucoma (visco360 study)

Conditions: Open-Angle Glaucoma

Summary: the purpose of this study is to evaluate the safety and effectiveness of the sight sciences visco™360 viscosurgical system in reducing intraocular pressure (iop) in adult, pseudophakic subjects with open-angle glaucoma.


Eligibility criteria:
inclusion criteria: * diagnosed with primary open-angle glaucoma (poag) in the study eye. * pseudophakic with posterior chamber iol (pciol) * able and willing to attend follow up visits for two years post-operative * able and willing to sign informed consent exclusion criteria: * phakia or aphakia * previous glaucoma procedure with or without an implantable glaucoma device (including incisional surgery, alt, iridectomy/iridotomy, etc.) \[subjects with one prior slt application (\>3 months prior to screening) or prior ecp (performed \> 12 months prior to screening) can be enrolled\]. * use of more than 3 ocular hypotensive medications (combination medications count as 2 medications) * diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic, pseudoexfoliative, pigmentary or neovascular glaucoma * abnormal angle anatomy as determined by gonioscopy (e.g. peripheral anterior synechiae, rubeosis or other angle abnormalities) * participation in any clinical trial ≤ 30 days prior to screening
3d vs 2d hd laparoscopy in cholecystectomy

Conditions: Cholecystolithiasis

Summary: the 3d-systems have emerged also to the world of surgery, and the three-dimensional laparoscopic systems are gradually entering the operating rooms. in the normal laparoscopy there are only two-dimensional view, which is somewhat challenging when operating in three-dimensional environment. even though the 3d-systems have been widely studied in laboratory circumstances, there are still no evidence of benefits of 3d vs 2d in clinical point of view and no prospective randomized trials have been published. therefore, the purpose of this study is to investigate is there something to gain in changing into 3d laparoscopic system for cholecystectomy (lcc).


Eligibility criteria:
inclusion criteria: * patients scheduled for laparoscopic cholecystectomy exclusion criteria: * some other surgical operation planned during lcc * expected major risk of conversion (e.g. multiple previous abdominal operation, previous peritonitis, previous cholecystitis) * operating surgeon experience less than 5 3d laparoscopy operations

Keywords: 3d laparoscopy cholecystectomy
reducing dementia risk with digital health coaching

Conditions: Alzheimer Disease; Dementia; Mild Cognitive Impairment; Cognitive Decline

Summary: the digital cognitive multi-domain alzheimer's risk velocity (dc marvel) study is a 2-year randomized controlled trial on dementia prevention. the purpose of this study is to determine the effect of a digital cognitive health program on dementia risk, cognitive function, and general health outcomes in middle age to older adults compared to a control group that receives health education.

alzheimer's disease (ad) is expected to affect 131 million people worldwide by 2050, but as many as 40% of these cases may be prevented by targeting modifiable risk factors such as diet, physical activity, cognitive engagement, and smoking. neurotrack technologies, inc. will test the efficacy of a digital multi-domain lifestyle intervention with health coaching for cognitive health designed to change behaviors associated with increased risk for ad. this digital intervention addresses the challenge of scaling effective multi-domain lifestyle interventions for cognitive health and has the potential to improve risk behaviors, thereby reducing and/or delaying cognitive decline in older adults at risk for ad.

Eligibility criteria:
inclusion criteria: * age 45-75 * bmi 18.5 - 39.9 kg/m2 * fluent in english (written and spoken) * a minimum of 2 of the following risk factors for ad from anu-adri: high school education or less; overweight, or class i or class ii obese (bmi 25-39.9 kg/m2); history of diabetes; history of hypertension; history of high cholesterol; history of smoking; history of traumatic brain injury * maximum of 1 of the following protective factors for ad from anu-adri: high level of physical activity; high fish consumption; high level of cognitive engagement * ability to send and receive text messages * own a smartphone, have a reliable internet connection, and willing to use email * ability to participate in light to moderate physical activity * willingness to be randomized exclusion criteria: * physician diagnosis of: mental health condition (e.g., eating disorder, alcohol/substance use, schizophrenia, etc.); neurologic conditions (e.g. epilepsy, stroke, multiple sclerosis, parkinson's disease, brain tumor, or severe traumatic brain injury); dementia, probable dementia, or mild cognitive impairment; other significant health condition (e.g. congestive heart failure, chronic obstructive pulmonary disease, coronary artery disease, renal failure, chronic kidney disease, pulmonary hypertension) * recent cardiovascular event or recent treatment for cancer (within the last year); on dialysis; or on active organ transplant list * visual problems that prevent viewing screen at a normal distance (e.g., legal blindness, detached retina, occlusive cataracts) * history of learning disability * currently participating in a formal cognitive training coaching program or other lifestyle change program (e.g. diabetes prevention program) * currently pregnant or planning on becoming pregnant in the next two years

Keywords: dementia prevention risk reduction multi-domain lifestyle intervention behavior change
a phase i dose escalation study of intratumoral vcn-01 injections with gemcitabine and abraxane® in patients with advanced pancreatic cancer

Conditions: Pancreatic Adenocarcinoma; Metastatic Pancreatic Adenocarcinoma

Summary: the purpose of this study is to determine the safety and tolerability of three intratumoral injections of vcn-01 combined with abraxane®/gemcitabine, and to determine the recommended phase ii dose of vcn-01 combined with abraxane®/gemcitabine.

investigational treatment is a dose-escalation regimen consisting of three vcn-01 intratumoral injections (once every 28 days at the same dose) in combination with intravenous abraxane® and gemcitabine.

Eligibility criteria:
inclusion criteria: * male/female patients aged 18 years or over * patients must provide written informed consent * life expectancy above 3 months * patients willing to comply with treatment follow-up, and to accept a biopsy at day 29 after initiation of the treatment * patients with histologically confirmed diagnosis of unresectable pancreatic adenocarcinoma with symptoms related to the primary tumor. abraxane® plus gemcitabine should be the appropriate standard of care to be administered. * ecog performance status 0 or 1 * adequate baseline organ function (hematologic, liver, renal and nutritional) * use a reliable method of contraception in fertile men and women exclusion criteria: * active infection or other serious illness or autoimmune disease * treatment with live attenuated vaccines in the last three weeks * known chronic liver disease (liver cirrhosis, chronic hepatitis) * treatment with another investigational agent within its five half-lives prior to vcn-01 infusion * viral syndrome diagnosed during the two weeks before inclusion * chronic immunosuppressive therapy * known concurrent malignant hematologic or solid disease * pregnancy or lactation. patients must agree to use effective contraception or be surgically sterile. * patients receiving full-dose anticoagulant / antiplatelet therapy * patients with li fraumeni syndrome or with previous known retinoblastoma protein pathway germinal deficiency

Keywords: cancer pancreatic adenocarcinoma locally advanced metastatic gemcitabine oncolytic virus abraxane®
β-relieved - response in acute flare and in prevention of episodes of re-flare in gout - extension 3 (e3)

Conditions: Acute Gouty Arthritis Flares

Summary: this was an 18-month, multi-center, open-label, clinical extension study. patients completing earlier second extension studies (cacz885h2356e2 and cacz885h2357e2) continued to be treated in this combined extension 3 study for any new gouty arthritis flare on demand with one subcutaneous (s.c.) injection of canakinumab 150 mg.


Eligibility criteria:
inclusion criteria: * patients who have completed the second extension studies cacz885h2356e2 or cacz885h2357e2 * patients treated with canakinumab in the core studies or subsequent extensions exclusion criteria: - pregnant or nursing (lactating) women

Keywords: gouty arthritis
empower: electronic media powering positive health changes in youth

Conditions: Hypertension; Prehypertension; Overweight; Obesity; Hypertrophy, Left Ventricular

Summary: the purpose of this study is to evaluate the effectiveness of a technology-based behavioral healthy lifestyle intervention on adiposity (body mass index z-score), blood pressure (mean clinic systolic bp), and heart size (lvm) in comparison to standard care.


Eligibility criteria:
inclusion criteria: * overweight or obese * speaks english exclusion criteria: * no smart phone / smart phone data plan * not willing to send/ receive text messages or download and use the study applications * neurological impairment/ developmental delay * new / changes in anti-hypertensive medication or medication known to affect blood pressure within the last 6 months * prior diagnosis of congenital heart disease or cancer * pregnancy * taking medication with weight gain as a side effect * taking medications for weight loss/ participation in another weight loss program

Keywords: blood pressure cardiovascular disease children adolescent pediatrics end-organ damage
effect of dhea on skin aging in postmenopausal women

Conditions: Skin Aging; Quality of Life

Summary: the purpose of the study is to determine the response of skin parameters related to skin aging to the local action of dhea in postmenopausal women.

humans, along with the others primates, are unique among animal species in having adrenals that secrete large amounts of the inactive precursor steroids dehydroepiandrosterone(dhea)and especially its sulfate dhea-s. the marked reduction in the formation of dhea-s by the adrenals during aging results in a dramatic fall in the formation of androgens and estrogens in peripheral target tissues, a situation that has been proposed to be associated with age-related diseases including skin atrophy, insulin resistance and obesity. moreover, much attention has been given to the benefits of dhea administered to postmenopausal women, especially on the bone, skin, vagina and well being after oral as well as percutaneous administration of the precursor steroid. therefore this study proposes to study the effect of 0.3% dhea cream during a period of 12 months administered twice daily to postmenopausal women. during the study several biological and clinical parameters will be evaluated. in summary, these include blood steroid levels, distribution of hormonal receptors in the skin, sebaceous gland activity, skin hydration, skin wrinkles and finally skin genomic evaluation. subjects will be evaluated at specific time intervals for the above mentioned parameters as well as tolerability and adverse reactions.

Eligibility criteria:
inclusion criteria: * healthy postmenopausal women who have taken hormonal replacement therapy for at least two years but not during the last 6 months prior to the study. * aged between 60 and 65. exclusion criteria: * significant dermatologic, metabolic and endocrine disease. * diagnosis of cancer or history of hormone-dependant cancer. * over exposure to sun or tanning session during the previous two months. * narcotic addiction, alcoholism or smoking.

Keywords: skin aging menopausal symptoms
cognitive behavioural therapy for treatment of chronic non-specific low back pain

Conditions: Low Back Pain

Summary: to explore the effect of adding cognitive-behavioral therapy to physical therapy interventions in patients with chronic non-specific back pain.

studies suggest that patients with lbp benefited when standard rehabilitation approaches were supplemented with graded exercise . there is adequate information to allow clinical implementation of graded exercise by physical therapists, in contrast, there is less information available for physical therapy implementation of graded exposure. lbp rehabilitation based on graded exposure principles therefore, the purpose of this study is to review the available evidence for graded exposure and to describe physical therapy application of graded exposure for patients enrolled in clinical trial.

Eligibility criteria:
inclusion criteria: 1. patient's age between 25-40 years. 2. patients have persistent chronic non-specific lbp for at least 3 months with or without leg pain. leg pain won't exceeds mechanical behaviors. 3. score of 24 fear avoidance questionnaire. 4. symptoms of hypersensitivity, secondary punctate or pressure hyperalgesia and fear of movement as a central sensitization symptoms exclusion criteria: * 1-history of previous back surgery. 2- history of previous hip, knee or ankle surgeries. 3- systemic inflammatory diseases. 4-tumors. 5-red flags of back pain 6-patients with disc pathology and radicular pain 7- spinal fracture or spinal surgery 8- systemic disease or tb of spine widespread constant non-specific pain disorder, pain without a clear mechanical behavior

Keywords: graded eposure and activity
does topical steroid treatment impair the adrenal function?

Conditions: Hypothalamus-Pituitary-Adrenal Axis Assessement; Topical Steroid Therapy in Chronic Skin Diseases

Summary: the purpose of this study is to determine if topical steroids treatment for different skin diseases suppress the adrenal cortisol production.

adrenocortical suppression is a potential complication of systemic corticosteroid treatement but also of non systemic therapy like topical therapy. the normalcy of hypothalamic-pituitary-adrenal axis ( hpa axis) of patients with chronic skin diseases like atopic dermatitis, pemphigus or psoriasis which are treated with topical steroids, will be assessed with the low dose (1mcg) adrenocortocotropin ( acth) stimulation test. during this test serum cortisol levels are measured before, 30 and 60 mn after intravenous administration of 1mcg of acth (synacthen).the results will be compared with age and sex matched subjects with normal hpa axis as assessed by low dose acth stimulation test.

Eligibility criteria:
inclusion criteria: * patients receiving daily topical steroids for at least two weeks on 10% or more of body surface. exclusion criteria: * patients treated with any form of corticosteroids except topical steroids. * patients with known pituitary disease * pregnant patients

Keywords: secondary adrenal insuffiency hypothalamus-pituitary-adrenal axis impairement topical steroids
clinical evaluation of fenfuro (fenugreek seed extract) in type-2 diabetic subjects: an add-on study

Conditions: Type 2 Diabetes Mellitus

Summary: this study is an open label, two armed trial evaluating the safety and efficacy of fenfuro capsule twice daily for 90 days in 100 patients with type 2 diabetes that will be conducted in single center in india. the primary outcome measures will be the determination of decrease in plasma glucose levels from baseline to last visit. the secondary outcome will be the determination of safety of fenfuro capsule in type 2 diabetic subjects.

diabetes mellitus, involving rise in blood sugar levels, has shown to be a highly prevalent disease. treatments and treatment regimens include combinations of oral anti-diabetic drugs (oads), anti-hypertensive medications and anti-dyslipidemic agents, but these have been less than successful in managing their respective disease targets with clinical goals. now-a-days, the treatment strategies for diabetes mellitus type 2 which are opted by general population include natural supplements. this choice is based upon the involvement of very less side effects along with high effectiveness of the natural supplements as compared to the synthetic medications. one of those natural supplements is fenugreek seeds extract i.e. fenfuro which has been used as a nutraceutical in the present study for the management of type 2 diabetes mellitus. fenugreek has been extensively used as a source of anti-diabetic compounds from long time. thus, fenfuro, prepared from fenugreek seeds extract, is supposed to have anti-diabetic properties as well. previous studies on fenugreek seeds extract have shown effective and safe anti-diabetic and anti-hyperlipidemic properties of it. it has shown to decrease blood glucose levels as well as lipid profile of the diabetic patients. in this proposed study, fenugreek seed extract will be used as an add-on to the existing therapy in patients with type-2 diabetes. the efficacy and safety of the extract will be evaluated using standard methodology.

Eligibility criteria:
inclusion criteria: * agrees to written as well as audio-visual informed consent. * patients of either sex. * aged 18-65 years. * fasting plasma glucose level \<180 mg/dl. * hba1c level more than 7.5%. * not receiving any steroids. * patient on anti-diabetic therapy. exclusion criteria: * uncooperative subjects. * diabetes other than type-2 diabetes mellitus. * evidence of renal \& liver disease. * history of any hemoglobinopathy that may affect determination of hba1c. * lactating and pregnant or planning to conceive females. * physically/ mentally unwell as certified by physician-in-charge. * participation in any other clinical trial with in the last 30 days. * subjects with allergy to investigational product.

Keywords: fbs,hba1c, ppbs
ambivalence model of craving: re-examining the drinking-craving relationship

Conditions: Alcohol Dependence

Summary: the current study combines both clinical trial and daily process methodology to examine the dynamic longitudinal relationships between daily approach and avoidance inclinations (i.e., craving) and drinking behaviors in those diagnosed with an alcohol use disorder (aud) prior to, during, and after receiving a brief alcohol intervention. it is hypothesized that daily avoidance inclinations will significantly moderate the effect of daily approach inclinations on drinking behaviors, and that significant increases in avoidance inclinations will be observed prior to treatment entry, followed by significant decreases in approach inclinations during treatment.


Eligibility criteria:
inclusion criteria: * current diagnosis of alcohol dependence * live within commuting distance of the program site, * regular access to a phone to call into an ivr system and * provide informed consent exclusion criteria: * acute psychosis or severe cognitive impairment * current or previous treatment for an alcohol use disorder within the past 6 months, * taking medications that may modify alcohol use, * current drug use diagnosis other than nicotine or marijuana abuse, * lack of sufficient familiarity with the english language to comprehend the recruitment and consent procedures, and * legally mandated to attend treatment
utilization of oral sucrose to decrease pain in infants during immunizations

Conditions: Pain; Procedural Pain

Summary: the study explores the potential benefits of a sugar water solution for decreasing pain in infants during routine immunizations.

acute pain during early life may alter infant pain responses, cognitive development, and behavioral outcomes. immunization injections represent a relatively brief exposure to acute pain, yet assessment studies demonstrate that infants respond with significant distress during the injections. this study will examine the analgesic potential of oral sucrose in diminishing the pain associated with immunization injections in 6 week to 4-month-old infants. the proposed mechanism of action is via the activation of endogenous opioids that attenuate nociceptive information at the level of the dorsal horn. comparison: administration of oral sucrose 2 minutes prior to immunizations compared to administration of sterile water 2 minutes prior to immunizations

Eligibility criteria:
inclusion criteria: * currently between 2 and 4 months of age * birth between 37 and 42 weeks' completed gestation; * birth weight greater than 2.5 kg * no evidence of acute or chronic disease processes. exclusion criteria: * they are experiencing concurrent illness * they received an analgesic/sedative 6 hours prior to the office visit * the infant has breast fed 30 minutes prior to the visit or wishes to breast feed during or immediately after the immunization * the infant has been introduced to solid food * the infant may not receive a pacifier * the infant is diagnosed with a major congenital disorder where the behavioral responses to painful stimuli may be altered * language barriers preclude the process of obtaining parental consent.

Keywords: pain procedural pain sucrose infant newborn
adverse effects of ala-pdt for the treatment of moderate to severe acne vulgaris: a prospective study

Conditions: Acne Vulgaris

Summary: to understand, prevent and treat the adverse reactions more comprehensively, we sought to systemically document the adverse effects of ala-pdt for moderate to severe acne vulgaris.

to understand, prevent and treat the adverse reactions more comprehensively, we sought to systemically document the adverse effects of ala-pdt for moderate to severe acne vulgaris.

Eligibility criteria:
inclusion criteria: * (1) patients diagnosed with moderate to severe acne and graded grade iii-iv according to investigator's global assessment (iga) ; * (2) patients unsuitable for drug treatment owing to various reasons and who voluntarily participated and signed informed consent following information about other alternatives; * (3) patients who read the instructions and were willing to follow the program requirements. exclusion criteria: * (1) patients who had a history of photosensitive diseases; * (2) patients who had modified-pdt; * (3) patients who had oral isotretinoin in the past 3 months, used oral contraceptives or antibiotics and underwent local or facial surgery in the past 4 weeks; * (4) female patients who were pregnant or lactating.
dbrct on the effect of grip strength in brachial plexus vs distal forearm nerve blocks

Conditions: Postoperative Mobility

Summary: this is a double-blind prospective randomized control trial. the primary hypothesis is that the preservation of motor function is superior in distal forearm blocks compared to supraclavicular block. the secondary outcomes include patient satisfaction, surgeon's satisfaction, rate of block success, onset and duration of block.


Eligibility criteria:
inclusion criteria: 1. american society of anesthesiologists physical status i to iii 2. aged 18 and above 3. able to provide own consent 4. elective ambulatory surgery in the hand with an expected surgical time of less than 15 minutes that is normally performed with a peripheral nerve block covering the median and ulnar nerve distributions and intravenous sedation without general anesthesia exclusion criteria: 1) surgery outside the median and ulnar nerve distribution in the hand 2) bilateral surgery 3) body mass index of more than 45 kg/m2 (higher chance of failure) 4) neck or clavicle deformities 5) infection at the injection site 6) existing neurologic disease 7) insulin dependent diabetes 8) diabetes with peripheral neuropathy or end organ damage 9) allergy to la agents 10) coagulopathy 11) past surgery on the same upper limb 12) any other contraindication to supraclavicular block or forearm blocks 13) contraindication to monitored anesthesia care with peripheral nerve block as the mode of anesthesia. -

Keywords: ultrasound supraclavicular block distal forearm block grip strength satisfaction