Kornimate/medical-research-clean huggingface dataset:
efficacy of ranibizumab therapy with aflibercept in patients with diabetic macular edema

Conditions: Retinal Diseases

Summary: the purpose of this study in to compare the efficacy of treatment of diabetic macular edema (dme) using ranibizumab (lucenti®), aflibercept (eylea®) and aflibercept (eylea®) plus ranibizumab (lucentis®). it is a randomized clinical trial that will evaluate the efficacy of the combination of two substances currently used in the treatment of dme. will be allocated in different four groups randomly pacients who receive treatment with intravitreal injections of ranibizumab, aflibercept or a combination of aflibercept and ranibizumab.

interventions will be carried out with intravitreal injections in patients with formal indications of diabetic macular edema treatment previously assessed with complete eye examination in goiania eye institute(instituto de olhos de goiânia) patients will be divided into four groups: * in the first group will be held three applications of intravitreal ranibizumab 0.1 ml, with one application every month and follow up with optical coherence tomography on days 1, 3, 5, 10 and 30 following the application. * in the second group will be held three applications of intravitreal aflibercept 0.1 ml, with one application each month followed by monitoring with optical coherence tomography on days 1, 3, 5, 10 and 30 subsequent * the third group will be held two applications of ranibizumab 0.1 ml interspersed with one application of aflibercept 0.1 ml in the second month and subsequent evaluation with optical coherence tomography on days 1, 3, 5, 10 and 30. * in the fourth group will be held two applications of 0.1 ml aflibercept interspersed with one application of ranibizumab 0.1 ml in the second month and subsequent evaluation with optical coherence tomography on days 1, 3, 5, 10 and 30.

Eligibility criteria:
inclusion criteria: * patients with diabetic macular edema exclusion criteria: * patients without diabetic macular edema, or with diabetic macular edema with other disease that can make confuse about the diagnose

Keywords: diabetic macular edema aflibercept ranibizumab
study of cmp-cps-001 in healthy volunteers

Conditions: Healthy Volunteers

Summary: the objective of this clinical study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of cmp-cps-001 administered as a subcutaneous injection in adult healthy volunteers.

this is a randomized, double-blind (sponsor-open), and placebo-controlled study. the sad part will be conducted in approximately 48 healthy volunteers, in 4 cohorts of 12, randomized 3:1 to receive a single subcutaneous dose of cmp-cps-001 or placebo. participants will be followed for 42 days after dosing. the mad part will be conducted in approximately 48 healthy volunteers, in 4 cohorts of 12, randomized 3:1 to receive 3 monthly doses of cmp-cps-001 or placebo. participants will be followed for 56 days after the last dose.

Eligibility criteria:
inclusion criteria: * healthy adults 18 to 55 years inclusive at time of informed consent * bmi ≥18.0 and ≤32 kg/m2 at screening, and ≤110 kg * willing and able to sign informed consent form exclusion criteria: * any significant disease or disorder which, in the opinion of the investigator, may either put the study participant at risk because of participation in the study, may influence the results of the study, or may affect the study participant's ability to participate in the study * clinically relevant illness within 7 days before the first dose of study drug * history of intolerance to subcutaneous injection or relevant abdominal scarring * laboratory results outside normal ranges at screening and judged as clinically relevant by the investigator for liver function, kidney function, and platelets * positive viral serology test results for human immunodeficiency virus type 1 or 2 antibodies, hepatitis b surface antigen or hepatitis c virus antibody * any other safety laboratory result considered clinically significant and unacceptable by the investigator

Keywords: healthy volunteers antisense oligonucleotides urea cycle disorder
a clinical study to evaluate the efficacy and satisfaction of ultrasound therapy combined with skinceuticals a.g.e for improving facial aging

Conditions: Skin Aging

Summary: a prospective, single-center, single-blind, randomized split-face, controlled trial will be conducted. the goal of this clinical trial is to evaluate the efficacy and satisfaction of ultrasound therapy combined with skinceuticals a.g.e in improving facial aging, and to explore the medical value of ultrasound therapy combined with skinceuticals a.g.e. participants will be treated with ultrasound combined with skinceuticals a.g.e on one randomized side face and ultrasound combined with standard cream on the other side.


Eligibility criteria:
inclusion criteria: 1. chinese subjects aged 18-65 years inclusive; 2. the subject 's facial skin is rough, flaccid, and lack of elasticity; 3. subjects with multiple facial fine lines (perioral/periocular/forehead, etc.), decree lines or puppet lines area with static fine lines trend, the lower part showed signs of loosening; 4. subjects who have consistent facial skin status on both sides and plan to receive ultrasound therapy; 5. subjects are willing to follow the requirements of the study protocol and complete the corresponding procedures; 6. subjects understand the nature of the study and sign the informed consent form (icf). exclusion criteria: 1. subjects with contraindications to ultrasound treatment (such as malignant tumor, acute systemic infection, severe heart disease, bleeding tendency, etc.) or contraindications to a.g.e use (or allergic to other skin care components); 2. subjects with facial skin diseases, infection, inflammation or allergic constitution that may affect the judgment of the test results; 3. subjects with hypertrophic scar or scar constitution; 4. receiving treatment of tightening medical treatment program (thermage/fotona 4d/ultrasound/microneedle, etc.) or planning to receive other tightening medical treatment program and drugs during this treatment in the past 3 months; 5. patients who have oral or topical cosmetic products that may affect the test results within the past 2 weeks; 6. subjects who have participated in drug clinical trials or other trials within the past 30 days (or are participating in), or have used drugs affecting the test results within 1 week; 7. female subjects who are pregnant, lactating or plan to become pregnant; 8. other subjects who are not suitable for participating in this study as assessed by the investigator.
venclose digirf system post market study

Conditions: Venous Reflux; Chronic Venous Insufficiency

Summary: a post-market, multi-center, prospective, interventional study for treatment of chronic venous disease of the great and small saphenous veins and incompetent perforator veins.


Eligibility criteria:
inclusion criteria: 1. subject is age 18 and older 2. subject has ceap clinical class c2 and higher. 3. has been diagnosed with refractory symptomatic disease attributable to the gsv/ssv or ipv to be treated. 4. gsv/ssv or ipv to be treated that has an outward flow reflux duration of ≥ 0.5 seconds immediately after release of manual distal compression with subject standing or in reverse trendelenburg. 5. for gsv/ssv cohort only: gsv/ssv to be treated in a leg that has a diameter ≥4.5 mm. 6. for ipv cohort only: no more than two ipvs to be treated in a leg that have a diameter of ≥ 3.5 mm. 7. for ipv only: ipvs must be located under a healed or active ulcer. 8. is able to ambulate. 9. is able to comprehend and has signed the informed consent form (icf) to participate in the study. 10. is willing and able to comply with the clinical investigation plan and follow-up schedule. exclusion criteria: 1. has had previous treatment for venous insufficiency in the same target vein. 2. has venous insufficiency secondary to venous obstruction proximal to the intended treatment site. 3. has thrombus in the vein segment to be treated. 4. has untreated critical limb ischemia from peripheral arterial disease. 5. is undergoing active anticoagulant therapy for acute deep vein thrombosis or other conditions (e.g., warfarin, direct oral anticoagulant or low molecular weight heparin) or has a history of deep vein thrombosis within the last 6 months or hypercoagulable state. 6. subjects with known bleeding and/or clotting disorders. 7. has abi \<0.8 8. subject is pregnant or breastfeeding 9. for gsv/ssv only: has a bmi \>35. 10. for ssv only: has refluxing small saphenous vein thigh extensions (ex. giacomini vein). 11. unable to ambulate, or restrictive ambulation. 12. has had prior venous procedures in the study limb within the last 30 days (including thrombolysis, thrombectomy, stenting, ablation, phlebectomy, visual or foam sclerotherapy). 13. has undergone or is expected to undergo any major surgery within 30 days prior to or following the study procedure. 14. has a condition, judged by the treating physician, that may jeopardize the subject's well-being and/or confound the results or the soundness of the study.
lifestyle improvement for teens with bariatric surgery

Conditions: Obesity, Adolescent; Bariatric Surgery Candidate

Summary: the purpose of this study is to conduct a proof of concept study to assess feasibility, acceptability, and effectiveness of an metabolic and bariatric surgery (mbs) -supported healthy lifestyle behavioral intervention among adolescent patients, their families, and their clinical team.


Eligibility criteria:
inclusion criteria * must meet national institutes of health criteria to qualify for mbs for adolescents (bmi \>35 kg/m2 and at least one existing co-morbidity \[e.g. elevated blood pressure, hypercholesterolemia, etc.\] or a bmi\>40kg/m2). * received psychological clearance for surgery exclusion criteria: * is not medically referred by a physician for bariatric surgery * refuses to participate in the study
breast cancer biomarker sample collection for the dtectdx v2 assay proof of concept protocol

Conditions: Breast Cancer

Summary: the major purpose of this study is to evaluate a laboratory developed test that measures multiple breast cancer-specific biomarker proteins and multiple antibodies in your blood samples. the biomarker and antibody results along with your personal medical profile will be evaluated to determine your risk for the presence of a malignancy in the breast as compared to your breast evaluation assessment conducted by your physician.


Eligibility criteria:
inclusion criteria: * adult women from 25 years of age to below 75 years of age * breast evaluation results of acr bi-rads® category 3 or 4 by imaging and physicians clinical and radiological evaluation * study visit and blood collection within 4 weeks (28 days) of acr bi-rads assessment * patient agrees to with additional health data being gathered at 6 months post assessment for diagnostic follow-up * samples collected under irb approval and informed consent * testing performed under irb approval or waiver (as applicable) * previous approved procedures to enroll patients: breast augmentation \& cyst aspiration exclusion criteria: * adults from 76 years of age or older and below 25 years of age * final breast evaluation results other than a acr bi-rads category 3 or 4 * subjects that have had a breast biopsy performed during the 6 months prior to the study visit * samples not collected under irb approval and informed consent * testing not performed under irb approval or waiver (as applicable) * prior breast cancer diagnosis.
comparison of oral valganciclovir and placebo for the prevention of cytomegalovirus (cmv) after lung transplantation

Conditions: Cytomegalovirus Infections

Summary: the study evaluated the efficacy and safety of a prolonged, continuous course of valganciclovir (valgan) in the prevention of cmv by comparing 3 months of vaglanciclovir, the standard of care upon initiation of the study, to 12 months of valganciclovir.

a multi-center two phase, double-blind, placebo controlled, randomized prospective study of 130 lung transplant recipients. patients will be screened and consented prior to transplant. all consented patients will receive iv ganciclovir within 24 hours of transplant for not more than 14 days. patients will enroll in phase i of the study is an open label safety and efficacy analysis of three months of oral valganciclovir in adult transplant recipients who are at risk for cmv. after completion of 3 months of open label therapy, patients that meet the criteria for phase ii of the study will be randomized to 9 months of blinded therapy (placebo/valgan). phase ii of the study is designed to assess the efficacy of short course sequential iv ganciclovir followed by oral valganciclovir as compared to the extended period of oral valganciclovir prophylaxis in the prevention of cmv disease in at risk lung transplant recipients

Eligibility criteria:
inclusion criteria for phase i: * adult lung transplant recipients age 18 or older * at risk for cmv (donor or recipient serology must be positive for cmv) * adequate hematological and renal function, * on intravenous (iv) ganciclovir within 24 hours of surgery * agreement to use effective methods of contraception * negative pregnancy * tolerate oral medications within 2 weeks of transplant * negative baseline cmv pcr * able to understand and sign the informed consent exclusion criteria for phase 1: * repeat transplantation * mechanical ventilation at study entry * oral or intravenous ganciclovir treatment outside the study protocol * invasive fungal infection * participation in another investigational study * acute cmv infection or disease * anti-cmv therapy within 30 days before enrollment * uncontrolled diarrhea or malabsorption * allergic reaction to study drug * required use of prohibited medications * lactating women * pregnancy * renal failure inclusion criteria for phase ii: * negative serial post transplant pcrs at day 75 * negative bronchial cultures for cmv * adequate hematological and renal function at day 75 * iv ganciclovir for up to 2 weeks post operation and open label up to day 90 * effective contraceptives * negative pregnancy exclusion criteria phase ii: * renal failure * serious adverse events (sae) related to study drug * cmv disease (study endpoint) * withdraw consent for phase ii

Keywords: acute rejection non-cmv infections resistance
clinical significance of occult central nervous system disease in adult acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia

Summary: central nervous system involvement at diagnosis remains an obstacle to a long-term cure of patients affected by acute lymphoblastic leukemia. the investigators have previously reported that flow cytometry (fcm) is better than conventional cytology (cc) in demonstrating the presence of leukemic cells in the patients'(pts) cerebrospinal fluid (csf), especially in samples with low cell counts. in the framework of the national campus all program aimed at improving the management of adult all patients in the context of the gimema protocols, in the present study the investigators retrospectively evaluated the incidence of occult cns positivity and its impact on outcome in 241 adult pts with newly diagnosed all from 13 centers.

demographic and of laboratory data of 241 adult patients with all were retrospectively recorded. all patients underwent diagnostic lumbar puncture and each cerebrospinal fluid sample was examined by cc and fcm. the investigators identified patients with the only fcm positivity and the investigators correlated this condition with clinical and of laboratory data and with clinical outcome.

Eligibility criteria:
inclusion criteria: * all at onset * age \>18 years exclusion criteria: * all relapsed or refractory * age \<18 years

Keywords: acute lymphoblastic leukemia flow cytometry
keeping it lite: exploring hiv risk in vulnerable youth with limited interaction and digital health intervention

Conditions: HIV Infections; Sexual Behavior

Summary: despite advances in hiv diagnostics, care and prevention strategies, infection rates among adolescent and young adult sexual and gender minorities (sgm) continue to rise in the united states (us). there is an urgent need to describe the epidemiology and trajectories of hiv acquisition in this population and to offer age and culturally appropriate scalable prevention interventions to those at highest risk of infection in the us. this project will engage and retain young sgm in an innovative longitudinal cohort, enroll participants in a dynamic established digital health retention platform (hmp; healthmpowerment), monitor hiv risk and prevention behaviors and explore the socioecological factors that influence the use of new hiv prevention technologies (ug3 phase), while also allowing targeted testing of novel digital health interventions (uh3 phase). in aim 1, the investigators will enroll and retain a large (n=6000; 3000/year), diverse cohort of sexually active, sgm adolescents and young adults, ages 13-34, using innovative digital recruitment, engagement and retention strategies. over the course of the study, the investigators will longitudinally characterize the sexual behavior, hiv transmission risk, and prep uptake trajectories of sgm youth utilizing epidemiological trajectory analyses to identify the most effective points of intervention (aim 2). this study will capitalize upon productive existing partnerships and digital health expertise to articulate the drivers of the ongoing hiv epidemic among the most vulnerable populations in the us in order to identify the most effective, expeditious and scalable strategies to address this ongoing public health crisis.


Eligibility criteria:
inclusion criteria: * for young adults ages 18-34: self-identified sgm young adults ages 18-34 who meet at least one of the following criteria: * 1) condomless anal or vaginal intercourse (cai) with a cisgender man in the last 6 months or * 2) sex with cisgender men and bacterial sti in the last 6 months or * 3) anal or vaginal sex with a known hiv-infected partner in the last 6 months. * for adolescents 13-17: self-identified sgm adolescents ages 13-17 who have engaged in any sexual activity (e.g., oral, anal or vaginal sex) exclusion criteria: * under age 13 * over age 34
a clinical study to determine the effect of ym178 on the pharmacokinetics of warfarin in healthy subjects

Conditions: Overactive Bladder; Pharmacokinetics

Summary: this study investigates whether ym178 has an effect on the pharmacokinetics of warfarin, to exclude any drug-drug interaction between ym178 and warfarin, and evaluates the safety and tolerability of warfarin alone and combined with ym178.


Eligibility criteria:
inclusion criteria: * female subject must be of non-child bearing potential, i.e. postmenopausal, surgically sterilized (e.g. tubal ligation), hysterectomy in medical history, or must practice adequate (double barrier) non-hormonal contraceptive methods to prevent pregnancies. * body mass index (bmi) ≥ 18.5 and \< 30 kg/m2, inclusive exclusion criteria: * female who is pregnant * any of the liver function tests (i.e. alanine aminotransferase (alt), aspartate aminotransferase (ast) and alkaline phosphatase (ap)) above the upper limit of normal (uln) * any clinically significant history of disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic as judged by the medical investigator * abnormal pulse and/or blood pressure measurements and the pre-study as follows: pulse \ 90 bpm; mean systolic blood pressure \> 140 mmhg; mean diastolic blood pressure \> 90 mmhg (blood measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically * a marked baseline prolongation of qt/qtc interval after repeated measurements of \>450 ms, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of long qt syndrome (lqts) * use of any prescribed or otc (over-the counter) drugs (including vitamins, natural and herbal remedies, e.g. st. john's wort) in the 2 weeks prior to admission to the clinical unit, except for paracetamol (up to 3 g/day) * any use of drugs of abuse within 3 months prior to admission to the clinical unit * history of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the clinical unit * history of drinking more than 21 units of alcohol per week (1 unit = 270 ml of beer or 40 ml of spirits or 1 glass of wine) (\> 14 units of alcohol for female subjects) within 3 months prior to admission to the clinical unit * donation of blood or blood products within 3 months prior to admission to the clinical unit

Keywords: ym178 mirabegron ddi phase i warfarin pharmacokinetics
comparison of zometa retention and effect in multiple myeloma and breast cancer

Conditions: Multiple Myeloma; Breast Cancer

Summary: the investigators major aim is to determine whether there is a difference in the retention of zoledronic acid in multiple myeloma patients, compared to patients with breast cancer metastasis to bone. in addition the investigators wish to analyze if the retention of zoledronic acid is correlated to the extent of bone resorption/formation, and if there is a tendency to changes in retention with sequential treatment.

the clinical benefit from treatment with bisphosphonates has been documented in a large number of clinical studies, and bisphosphonates are now widely used for treatment of pain and prevention of bone fractures or vertebral collapse for example in patients with cancer metastasis to bone or multiple myeloma. repeated intravenous administration of the more potent bisphosphonates (pamidronate and zoledronic acid) are often used for treatment of osteolytic disease caused by disseminated cancer or multiple myeloma, while the less potent oral bisphosphonates are often prescribed for treatment of benign osteoporosis. the recommended dose and time schedule for treatment with the more potent bisphosphonates is based on concerns of avoiding toxicity and at the same time obtaining maximal clinical benefit. clinical studies in multiple myeloma and bone metastasis show significant activity of pamidronate (90 mg by iv infusion during 2-4 hours) or zoledronic acid (4 mg iv during 15 min) repeated every 4 weeks after a treatment period of 9 months and beyond, but the optimal duration of treatment is not known. this is a particular important issue since the use of potent bisphosphonates have been brought in connection with osteonecrosis. in the present study we will compare the retention of zometa with the effect on bone markers in patients with multiple myeloma or breast cancer with metastases to bone.

Eligibility criteria:
inclusion criteria: * patients diagnosed with breast cancer and metastases to bone. * patients diagnosed with multiple myeloma. * patients who are scheduled to receive zometa. * post-menopausal women (at least 10 months since last period). * newly diagnosed patients must have clear signs of osteolysis. exclusion criteria: * anti-estrogen treatment. * patients given chemotherapy during or less than 7 days before study begin. * patients receiving glucocorticoids less than 5 days prior to study begin or during the study period (14 days)

Keywords: bone marker bisphosphonate zometa retention breast cancer multiple myeloma ctx bone specific alp