Kornimate/medical-research-clean huggingface dataset:
azarga transition study in taiwan for patients with uncontrolled intraocular pressure

Conditions: Glaucoma

Summary: the purpose of this study was to assess the safety and efficacy of switching to azarga from prior pharmacotherapy in patients with open-angle glaucoma.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes. * must be on a stable regimen of intra-ocular pressure (iop) lowering medication within one week of screening/baseline visit. * must have an iop of between 19 and 35 mmhg (both inclusive) in at least one eye, which would be the study eye, at screening. * must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study. * must have best corrected visual acuity of 6/60 (20/200 snellen, 1.0 logmar) or better in each eye. * other protocol-defined inclusion criteria may apply. exclusion criteria: * known medical history of allergy, hypersensitivity, or poor tolerance to any component of the medication to be used in the study deemed clinically significant in the opinion of the principal investigator. * any abnormality preventing reliable applanation tonometry in either eye. * risk of visual field or visual acuity worsening as a consequence of participating in this study, in the investigator's best judgment. * pregnant or lactating. * participation in any other investigational study within 30 days of screening visit. * other protocol-defined exclusion criteria may apply.

Keywords: open-angle glaucoma ocular hypertension pigment dispersion glaucoma
efficacy and safety of c2l-oct-01 pr in acromegalic patients

Conditions: Acromegaly

Summary: the purpose of this study is to assess the biological safety and efficacy of using the drug, c2l-oct-01 pr, 30 mg to treat acromegalic patients.


Eligibility criteria:
inclusion criteria: * subject must be diagnosed with active acromegaly. * if subject is treated with a long acting somatostatin analogue, the treatment must have been unchanged for a period of at least 12 weeks prior to entry. * if subject is treated with a 30 mg dose of a depot formulation of a somatostatin analogue, the igf-1 levels must be normal at entry. * if subject is treated with a 20 mg dose of a depot formulation of a somatostatin analogue, any value of igf-1 is acceptable. * if the subject is receiving an immediate release formulation of a somatostatin analogue or a dopamine agonist, the igf-1 values must be above 10% of the reference range based on gender and age. * if the subject is receiving a dopamine agonist, it must be stopped 14 days prior to receiving the study medication. * the subject should be able to understand the instructions, provide a written consent and abide by the study restrictions. exclusion criteria: * women of childbearing potential who are not taking adequate contraception or who are pregnant or lactating. * subjects previously treated with a growth hormone receptor antagonist (pegvisomant) within 12 weeks of study entry. * subjects who have undergone pituitary surgery within 6 months or radiotherapy within 2 years prior to admission into the study * subjects who present some form of intolerance or allergy to the test article or one of its non-active ingredients * subject who have any other condition that alters the growth hormone or igf-1 levels. * subjects with signs or symptoms related to a tumor compression of the optical chiasm.

Keywords: acromegaly
evaluation of long-term implanted sensor in patients on quality of life

Conditions: Type 1 Diabetes

Summary: evaluation of long-term implanted sensor in patients on quality of life

assess satisfaction and acceptance of long-term implanted single sensor use (eversense xl) for up to 6 months in type 1 insulin-using patients

Eligibility criteria:
inclusion criteria: 1. male or female diagnosed with type 1 diabetes mellitus 2. age \> 18 3. insulin treatment for at least 1 year (either mdi of csii) 4. hba1c \< 11% 5. signing informed consent and willing to apply with study procedure exclusion criteria: 1. history of severe hypoglycaemia in the last 3 months 2. history of dka in the last 3 months 3. any condition preventing or complicating the placement, operation or removal of the sensor including upper extremity deformities or skin condition 4. female subjects of childbearing capacity (defined as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study 5. any condition that require mri imaging or planned mri during the trial period 6. known topical or local anaesthetic allergy 7. known allergy to glucocorticoids 8. history of hepatitis b, hepatitis c or hiv 9. any bleeding disorder or taking anticoagulant medication 10. participation in other clinical trial 11. any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

Keywords: eversense type 1 diabetes
foodsteps for binge eating & food insecurity

Conditions: Binge Eating; Type 2 Diabetes; Food Insecurity

Summary: the purpose of this study is to conduct a pilot trial of a mobile intervention that targets binge eating and weight-related behaviors, to determine the feasibility, acceptability, and preliminary efficacy of the intervention among adults with recurrent binge eating, diabetes, and food insecurity.


Eligibility criteria:
inclusion criteria: * adults age 18 years or older * recurrent binge eating (≥12 episodes in the past 3 months) * type 2 diabetes mellitus * food insecure status (e.g. difficulty accessing food) * interested in losing weight and reducing binge eating * willing to use a mobile application * has a smartphone with internet access and capacity for calls and text messaging * has a valid email address * not pregnant * english-speaking exclusion criteria: * diagnosis for which the study/intervention is not clinically indicated * currently receiving clinical services for weight management or binge eating * started or recently (within the past month) changed dosage of a medication for binge eating, weight management, or diabetes
expanding prep by embedding unannounced snaps navigators in high sti testing clinical sites

Conditions: Hiv; Sexually Transmitted Infection

Summary: the goal of this study is to assess the impact of an intervention, known as snaps, to expand preexposure prophylaxis (prep) prescriptions at health + hospitals (h+h)/bellevue. in addition, evaluating whether this intervention, ie snaps, helps patients get on prep and stay on prep to prevent stis like hiv. prep is a medication that needs to be taken on a regular basis in order to be effective to prevent hiv transmission.

the objective of the investigator's proposal is to evaluate the effectiveness of an intervention to (1) increase prep initiation overall, (2) increase uptake among groups disproportionately impacted by the hiv pandemic, and (3) to preserve high prep retention while expanding use. in addition, the proposal includes innovative secondary outcomes of (4) identifying barriers and facilitators of prep use that may be unique to urban safety-net populations, and (5) estimating the hiv infections averted due to greater prep uptake from the intervention. the intervention is multi-level yet, targets the "weakest chains in the link" of prep initiation at safety-net hospitals designed for scalability, sustainability, and implementability across a wide range of settings. it consists of surveillance by sti testing, navigation by unannounced patient navigators to the sexual health clinic (shc), accelerated follow-up with providers with prep expertise, point-of-care prep counseling and laboratory testing, and seamless, consistent, longitudinal, comprehensive care (snaps).

Eligibility criteria:
inclusion criteria: historical comparison group: * all adults ≥18 years of age prescribed prep at h+h/bellevue one year prior to snaps intervention initiation. prospective group: * all patients will be considered for study participation who are accessing care at h+h/bellevue ≥ 18 years of age, * have unknown hiv status, * requesting sti testing/treatment or inquiring about prep or pep in the ed or urgent care, ob/gyn, and dermatology clinics. exclusion criteria: * patients who are hiv positive * refuse consent
effectiveness of perineural clonidine as an adjuvant with ropivacaine for popliteal nerve block in patients undergoing foot and ankle surgery

Conditions: Pain

Summary: nerve blocks are used to decrease the amount of pain you have after surgery. we are asking you to take part in a research study. this research study will test whether adding a medicine called clonidine to nerve blocks helps to improve them. nerve blocks typically last less than a day after surgery. we are looking for ways to make them work better and last longer. clonidine is approved for use as a blood pressure medicine. its use in nerve blocks is investigational, but it may help nerve blocks to last longer. adding clonidine to nerve blocks may also decrease the amount of pain medicine a person has after surgery. all people who enter this study will receive a nerve block with the normal medicine, but half of people will also have clonidine added to their nerve block. this study will enroll 60 participants from uab hospitals.


Eligibility criteria:
inclusion criteria: 1. patient undergoing foot or ankle surgery with popliteal nerve block planned for postoperative analgesia. 2. adult, 19 years of age and older. 3. subject classified as american society of anesthesiology (asa) class 1, 2, or 3. the asa defines these statuses as follows: 1-a normal healthy patient. 2-a patient with mild systemic disease. 3-a patient with severe systemic disease. - exclusion criteria: 1. any subject not classified as an asa 1, 2, or 3. 2. allergy/intolerance to local anesthetic, clonidine, and/or oxycodone. 3. subject with a history of continuous opioid use for greater than one month prior to surgery. 4. pre-existing neurologic deficit in lower extremity (surgical site). 5. clinically significant coagulopathy (hemophilia, von willebrand disease). 6. patients who fail to follow the uab department of anesthesiology algorithm for the preoperative management of an angiotensin converting enzyme inhibitor (acei) or an angiotensin receptor blocker (arb). a copy of the algorithm can be found in appendix 1. -

Keywords: nerve block motor blockade lower extremity pain nerve block
acupuncture for the treatment of chronic lymphedema

Conditions: Breast Cancer; Lymphedema

Summary: lymphedema is an accumulation of lymphatic fluid in the tissues that causes swelling, most often in the arms and/or legs, and occasionally in other parts of the body. lymphedema can occur when lymph vessels are damaged or lymph nodes are removed. lymphedema can develop right after breast cancer treatment or weeks, months, or even years later. for many people, available treatments for lymphedema are not effective. recent evidence suggests that acupuncture may help reduce the symptoms of lymphedema. the purpose of this study is to determine the effects of acupuncture on chronic lymphedema. this study will look further at whether acupuncture can reduce lymphedema and help us to understand immune changes that may be associated with improvements in lymphedema.


Eligibility criteria:
inclusion criteria: * women age 18 or older willing to sign consent. * lymphedema in an arm as a result of surgery, chemotherapy, and/or radiation therapy for breast cancer per breast surgeon or medical oncologist. * patients must have received a clinical diagnosis of lymphedema for at least 6 months and no more than 5 years after diagnosis of chronic lymphedema. * the affected arm must be \>2cm larger than the unaffected arm; this is the standard diagnosis and the one used in the mskcc studies cited above. the standard measurement techniques will be applied 20. exclusion criteria: * previous acupuncture treatment for lymphedema * diuretic use * history of primary (congenital) lymphedema * metastatic cancer * history of autoimmune disorder (including lupus, rheumatoid arthritis, systemic sclerosis) * history of other fibroproliferative disorder including cirrhosis, pulmonary fibrosis, kidney fibrosis, systemic sclerosis/scleroderma * current treatment with corticosteroids * treatment with myelosuppressive or stimulatory drugs within 6 months of enrollment * history of bone marrow transplantation

Keywords: lymphedema acupuncture 09-136
study of everolimus and sorafenib in patients with advanced thyroid cancer who progressed on sorafenib alone

Conditions: Differentiated Thyroid Cancer

Summary: the goal of this study is to determine the effect of combining everolimus and sorafenib in patients with metastatic differentiated thyroid cancer who progressed on sorafenib alone.

the purpose of this research study is to: 1. find out if sorafenib and everolimus prevent the growth of tumors that have grown when treated with sorafenib alone 2. find out how long one might benefit from treatment with sorafenib and everolimus 3. find out what side effects this drug may cause 4. measure the amount of sorafenib and everolimus in the blood and see if "markers" can be found to help understand who might benefit from sorafenib and everolimus.

Eligibility criteria:
inclusion criteria: * diagnosis of thyroid cancer, that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. * all patients will have been required to have had sorafenib for entry and have had documented progression while on previous treatment with sorafenib. * measurable disease defined as at least one malignant lesion that can be accurately measured on computerized tomography (ct) and/or magnetic resonance imaging (mri) scan. * ecog performance status \< 2. * life expectancy greater than 3 months. * intellectual, emotional, and physical ability to comply with oral medication. exclusion criteria: * restrictions regarding certain prior treatments will apply. * significant medical disease including: uncontrolled congestive heart failure; active symptoms of coronary artery disease, uncontrolled seizure disorder; active infection; uncontrolled diabetes mellitus; requirement for chronic high dose corticosteroid treatment (topical or inhaled corticosteroids are allowed); requirement for concurrent immunosuppressive drug(s); active autoimmune disease. * organ allografts. * known hiv-infection (hiv testing is not required for participation). * pregnant or breast feeding. women of childbearing potential and sexually active males must be advised to take precautions to prevent pregnancy during treatment * history of second cancer (except adequately treated basal cell or squamous cell skin cancer, in situ treated cervical cancer, colon cancer or melanoma, or any other cancer for which the patient has been disease-free for three or more years). * known hypersensitivity to everolimus or other rapamycins (e.g., sirolimus, temsirolimus) or to its excipients * use of any experimental therapy within 4 weeks prior to baseline evaluations done prior to enrollment (with the exception of sorafenib which may be continued until treatment start). therefore, all experimental treatments other than sorafenib must be discontinued 4 weeks prior to baseline studies or enrollment. * patients who did not previously tolerate sorafenib at 200 mg once daily are excluded from the study.

Keywords: differentiated metastatic thyroid cancer
a pilot study of zavesca® in patients with pompe disease and infusion associated reaction

Conditions: Pompe Disease; Hypersensitivity Reaction

Summary: hypothesis: the effectiveness of treatment of pompe disease with rhgaa enzyme replacement therapy (ert) is limited at least in part because patients develop antibodies against the provided rhgaa enzyme. treatment with zavesca® prior to infusion may dampen or eliminate the anti-rhgaa immune response in patients receiving ert, thereby allowing for greater ert efficacy. treatment with zavesca® before a enzyme replacement therapy (ert) may decrease the severity of, or eliminate infusion associated reactions (iar) in people with pompe disease receiving ert.

this study is designed to assess the effects of zavesca® as immunomodulatory therapy on anti-rhgaa immune responses in patients with pompe disease, as well as their health and disease progression. subjects will either receive zavesca® at 100 mg or 300 mg dosing levels during study participation (n=3 @ 100 mg dosing; n=3 @ 300 mg dosing). the first 3 subjects enrolled will be prescribed 100 mg zavesca® 60 minutes prior to ert infusion. the subsequent 3 subjects enrolled will be prescribed 300 mg zavesca® 60 minutes to ert infusion. eligible participants are on standard ert for pompe disease and have a history of infusion associated reaction. travel to the study site in gainesville, florida is required for 3 visits. participants are prescribed medication zavesca® and have blood tests, punch muscle biopsy, physical exams, and answer questionnaires over 3 months study participation.

Eligibility criteria:
inclusion criteria: subjects will be patients between the ages of 18 years and 65 years who have been diagnosed with pompe disease, confirmed by mutational analysis and/or gaa enzyme activity assay. * receiving rhgaa ert * willing to travel to the study site for study assessments * willingness of local medical treatment provider to continue treating study participant with addition of zavesca® to treatment plan. * willingness of study participant to modify dietary intake on day of infusion \*all subjects will continue enzyme replacement therapy as standard of care, as prescribed by local medical treatment provider during the course of the study. exclusion criteria: * subject is unable to meet the study requirements * subject's medical condition contraindicates participation or study investigators feel that participation is otherwise not in the subject's best interest * subject does not receive ert treatment * participation in other interventional studies at the time of enrollment that may interfere with this study (at the investigator's discretion) * unable to travel to the university of florida for study visits

Keywords: pompe disease enzyme replacement therapy infusion associated reaction
efficacy of two chlorhexidine solutions to control the initial subgingival biofilm formation

Conditions: Dental Plaque

Summary: the aim of the study is to compare the effect of a suspension containing chlorhexidine and alcohol and another one containing clorhexidine with no alcohol in dynamic of the subgingival biofilm formation versus a placebo suspension. the initial subgingival biofilm formation will be evaluated by means of plaque free zone (pfz).

this is a double blind, cross over, randomized clinical trial. 35 volunteers will stop mechanical supragingival biofilm removal measures for 96h following a complete scaling and polishing of the tooth surfaces. during this period they will be asked to rinse for a minute a solution containing chlorhexidine and alcohol or a solution with chlorhexidine alcohol-free or placebo. every 24h the presence of deposits will be registered with special attention to the presence of a plaque free zone between the apical border of the deposits and the gingival margin. absence of deposits is scored 0, presence of deposits and plaque free zone =1 and presence of deposits and absence of plaque free zone =2 (maliska, a. n. et al. measuring early plaque formation clinically. oral health preventive dentistry, v. 4, p. 273-278, 2006). the prevalence of scores and the rate of changes from scores 0 and 1 into 2 will be evaluated for significance. sample size was calculated taking the results from the study o maliska, an (2006) as reference.

Eligibility criteria:
inclusion criteria: * age from 18 years; * non-smokers; * have good general health; * present at least 20 natural teeth in the mouth, including the incisors, canines and premolars without restorations, crowns, gingival recession, anatomic defects, gingivitis e/or periodontitis. exclusion criteria: * • positive history of using antibiotic e/or anti-inflammatory drugs in the month previous to the initial consultation; * positive history of allergies at using triclosan; * pregnant or lactating patients; * patients in use of fixed orthodontic appliance.

Keywords: biofilms cross over trial chlorhexidine
fibroscan™ in pediatric cholestatic liver disease (force)

Conditions: Biliary Atresia; Alagille Syndrome; Alpha1 Anti-Trypsin Deficiency; Portal Hypertension; Liver Fibrosis; Cholestasis

Summary: noninvasive monitoring of liver fibrosis is an unmet need within the clinical management of pediatric chronic liver disease. while liver biopsy is often used in the initial diagnostic evaluation, subsequent biopsies are rarely performed because of inherent invasiveness and risks. this study will evaluate the role of non-invasive fibroscan™ technology to detect and quantify liver fibrosis.

noninvasive monitoring of liver fibrosis is an unmet and critical need within the clinical management of children with chronic liver disease. while liver biopsy is often used in the initial diagnostic evaluation of children with liver disease, subsequent surveillance liver biopsy is rarely performed in children because of its inherent invasiveness and risks. therefore, our understanding of the natural history of fibrosis progression in children is limited. the patchy nature of fibrosis in many important pediatric liver diseases \[e.g. biliary atresia (ba) and cystic fibrosis liver disease (cfld)\] limits the utility of sequential liver biopsy even if it were to be employed in clinical practice in pediatrics. thus, non-invasive means of assessing liver fibrosis throughout the liver would be highly desirable and clinically useful in pediatric hepatology. children is poised and uniquely qualified to conduct a comprehensive longitudinal assessment of the utility of fibroscan™-specific elastography, liver stiffness measurement (lsm) as a measure of hepatic fibrosis in children with serious chronic cholestatic liver disease.

Eligibility criteria:
inclusion criteria: * age less than 21 years at the time of enrollment * participants enrolled in a children based prospective observational cohort study (probe, basic, or logic) * willingness and ability to participate in the study for up to 24 months * one of the following three diagnoses * biliary atresia per children criteria or, * alpha-1 antitrypsin deficiency (pizz or sz) or, * alagille syndrome per children criteria exclusion criteria: * ba with known situs inversus or polysplenia/asplenia * presence of clinically significant ascites detected on physical examination * open wound near expected fibroscan probe application site * use of implantable active medical device such as a pacemaker or defibrillator * known pregnancy * prior liver transplant * unable or unwilling to give informed consent or assent

Keywords: transient elastography pediatric liver disease biliary atresia alagille syndrome alpha1 anti-trypsin deficiency liver fibrosis cholestasis