Kornimate/medical-research-clean huggingface dataset:
intravitreal diclofenac versus avastin as primary treatment of diffuse diabetic macular edema

Conditions: Diffuse Diabetic Macular Edema

Summary: diffuse macular edema is the main cause of visual disorders in diabetic patients. diclofenac is a cheap drug available in most of treatment centers.in animal studies the safe dosage is identified that can be used in diffuse diabetic macular edema for treatment. in this study, we are going to compare the effect of intra vitreal injection of diclofenac and bevacizumab in primary treatment of diffuse diabetic macular edema.

diffuse macular edema is the main cause of visual disorders in diabetic patients. diclofenac is a cheap drug available in most of treatment centers.in animal studies the safe dosage is identified that can be used in diffuse diabetic macular edema for treatment. in this study, we are going to compare the effect of intra vitreal injection of diclofenac and bevacizumab in primary treatment of diffuse diabetic macular edema.

Eligibility criteria:
inclusion criteria: * patients with clinically significant macular edema and diffuse macular edema exclusion criteria: * any history of focal photocoagulation * any prior intra ocular injection * history of glaucoma with high pressure * history of ophthalmic surgery * high rish pdr * active pdr
fibroblast growth factor 23 and sclerostin in relation to calcium in covid-19 patients

Conditions: COVID-19

Summary: hypocalcemia is associated with covid-19 patients and is linked to poor prognosis, fibroblast growth factor 23 (fgf23) and sclerostin inhibit vitamin d activation and are linked to hypocalcemia. levels of fgf23 and sclerostin in covid-19 patients will be detected and correlated to calcium levels.

covid 19 is a current worldwide pandemic caused by severe acute respiratory syndrome coronavirus 2 "sars-cov-2". hypovitaminosis d and hypocalcaemia have been reported to be associated with covid 19 infection, they are considered good biomarkers of clinical severity of covid 19. poor prognosis related to hypocalcemia is increased in elderly patients. fibroblast growth factor 23 and sclerostin are secreted from the bone, they decrease active vitamin d levels. their levels and their relation to calcium levels in covid-19 patients will be detected.

Eligibility criteria:
inclusion criteria: * positive covid 19 (mild to moderate - severe to critical). exclusion criteria: * known diagnosis of ckd. * known parathyroid disease. * use of phosphate binder therapy within the past 3 months. * use of calcium therapy within the past 3 months * treatment with 25(oh) vitamin d or 1,25 (oh)(2) d * underlying metabolic bone disease. * underlying renal phosphate wasting disorder.

Keywords: covid-19 hypocalcemia fibroblast growth factor 23 (fgf23) sclerostin
a 52-week study of the efficacy and safety of blu-5937 in adults with refractory chronic cough

Conditions: Cough; Refractory Chronic Cough

Summary: this is a randomized, double-blind, placebo-controlled, parallel-arm, phase 3 study of blu-5937 in participants with refractory chronic cough (rcc).

the primary efficacy objective is to assess the effect of blu-5937 on 24-hour cough frequency in adults with refractory chronic cough (including unexplained chronic cough) at 12 weeks.

Eligibility criteria:
inclusion criteria: * capable of giving signed informed consent * refractory chronic cough (including unexplained chronic cough) for at least one year * women of child-bearing potential must use a highly effective contraception method during the study and for at least 14 days after the last dose exclusion criteria: * current smoker/vaper (all forms of smoking and inhaled substances, including, cannabis/tobacco smoke and nicotine vapors) or individuals who have given up smoking within the past 6 months, or those with \>20 pack-year smoking history * diagnosis of chronic obstructive pulmonary disease, bronchiectasis, chronic bronchitis, cystic fibrosis, pulmonary sarcoidosis, idiopathic pulmonary fibrosis, uncontrolled asthma, or other significant or progressive airway/respiratory disorder that might affect cough based on clinician assessment * respiratory tract infection within 4 weeks before screening * laboratory confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection at screening * history of malignancy in the last 5 years * history of alcohol or drug abuse within the last 3 years * has a positive serologic test for human immunodeficiency virus (hiv), hepatitis b virus surface antigen, or hepatitis c virus. * previous participation in a blu-5937 trial

Keywords: respiration disorders respiratory tract diseases signs and symptoms, respiratory cough chronic cough
effects of supplementation with amino essential acids on circulating albumin levels in stroke in rehabilitation phase

Conditions: Stroke Rehabilitation

Summary: in addition to its physiological functions, serum albumin plays a role of neuroprotection in cerebrovascular stroke. the circulating levels of albumin may be reduced in patients with stroke due to the presence of a systemic inflammatory state and to the inadequacy of protein-energy intake. the circulating levels of albumin have proven to be predictors of functional recovery in ischemic stroke and cerebral hemorrhage. in the present survey it is hypothesized that it is possible to significantly improve the values of hypoalbuminemia by supplementation with essential amino acids and that, in the second place, any increase in albumin may result in a strengthening of functional recovery in patients with a stroke.

in addition to its physiological functions, serum albumin plays a role of neuroprotection in cerebrovascular stroke. the circulating levels of albumin may be reduced in patients with stroke due to the presence of a systemic inflammatory state and to the inadequacy of protein-energy intake. in the patients admitted to the montescano neuromotor rehabilitation division, the prevalence of hypoalbuminemia is high at the time of admission and remains high, even if decreased, at discharge. the circulating levels of albumin have proven to be predictors of functional recovery in ischemic stroke and cerebral hemorrhage. in the present survey it is hypothesized that it is possible to significantly improve the values of hypoalbuminemia by supplementation with essential amino acids and that, in the second place, any increase in albumin may result in a strengthening of functional recovery in patients with a stroke. several factors induce the use of free essential amino acids: they are the most efficient inducers of protein synthesis and albumin is a protein; free essential amino acids and not those contained in proteins allow a more reliable use of the isoleucine and tryptophan, true nutrients limiting the hepatic synthesis of albumin; the free essential amino acids have a faster and complete intestinal absorption of the essential amino acids derived from protein digestion.

Eligibility criteria:
inclusion criteria: * first episode of cerebral stroke * first taken in rehabilitation after hospitalization in the acute department exclusion criteria: * neoplasia * long-term corticosteroid therapy (\> 3 weeks) in the pre-event period and at the time of admission to the rehabilitation department

Keywords: serum albumin essential amino acid functional recovery
efficacy and safety of simvastatin in the treatment of portal hypertension

Conditions: Cirrhosis; Portal Hypertension

Summary: the purpose of this study is to evaluate the effects of continuous simvastatin administration on the hepatic venous pressure gradient (hvpg), as a surrogate marker of prognosis, and its safety in patients with cirrhosis and portal hypertension.

statins exert beneficial vascular effects independently of cholesterol reduction by improving endothelial dysfunction. in cirrhosis sinusoidal endothelial dysfunction further increases intrahepatic resistance and portal pressure. previous studies have shown that statins improve hepatic endothelial dysfunction in cirrhosis, suggesting that statins could be an effective therapy for portal hypertension (pht). this randomized controlled trial evaluated the effects of continuous simvastatin administration on the hepatic venous pressure gradient (hvpg), as a surrogate marker of prognosis, and its safety in patients with cirrhosis and pht.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 75. 2. clinical, analytical, ultrasound or pathological criteria of cirrhosis. 3. severe sinusoidal portal hypertension (hvpg \>12 mmhg) 4. signed informed consent exclusion criteria: 1. pregnancy or lactation 2. advanced liver disease defined as one of the following: prothrombin rate \ 5 mg/dl, hepatic encephalopathy \> grade i or child-pugh score \>12). 3. portal vein thrombosis 4. multinodular hepatocellular carcinoma or single hepatocellular carcinoma \> 5 cm. 5. heart, renal or respiratory failure 6. previous portal-systemic shunt 7. treatment with organic nitrates 8. hypersensitivity to hmg-coa reductase inhibitors 9. previous treatment with hmg-coa reductase inhibitors 10. treatment with calcium channel blockers

Keywords: statins hmg-coa reductase inhibitors cirrhosis portal hypertension variceal bleeding
a study of 68gallium psma-pet/ct scans in people with bladder cancer or skin cancer

Conditions: Bladder Cancer

Summary: the purpose of this study is to see whether 68gallium psma-pet/ct scans are an effective way to detect sites of cancer in people with metastatic bladder cancer or skin cancer. the study researchers want to learn if a 68gallium psma pet/ct scan will work better, the same, or not as well as the pet/ct scans doctors usually use for imaging bladder cancer or skin cancer (fdg-pet/ct scan).


Eligibility criteria:
inclusion criteria for urothelial carcinoma cohort: * patients with histologically confirmed metastatic urothelial carcinoma with extrapelvic nodal and/or visceral sites of disease (including lung, liver, bone, or soft tissue) * at least 3 lesions assessable by fdg pet/ct according to recist and percist guidelines where applicable, that are determined suspicious for metastasis by an mskcc attending radiologist or nuclear medicine physician. * karnofsky performance status ≥50% (or ecog/who ≤2) * participant is ≥18 years of age * patient must be able to understand and is willing to sign a written informed consent document inclusion criteria for melanoma cohort: * patients with histologically confirmed metastatic melanoma * at least 1 metastatic lesion assessable by ct or fdg pet/ct according to recist that is determined to be suspicious for metastasis by an mskcc attending radiologist or nuclear medicine physician * ecog \<= 2 * participant is \>= 18 years of age * patient must be able to understand and is willing to sign a written informed consent document exclusion criteria for urothelial carcinoma cohort: * patients with pelvic node-only metastatic disease. if the patient has lymph node only disease, at least one pet-assessable node must be located outside of the pelvis * patients with bone only disease * unable to lie flat, still, or to tolerate a pet scan * patient undergoing active treatment for non-urothelial malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized. * patients on a therapeutic clinical trial where psma imaging would interfere with the conduct of the trial * patients undergoing active surveillance with a known history of non-urothelial malignancies * women who are pregnant. all women of childbearing potential must have a documented negative pregnancy test. exclusion criteria for melanoma cohort: * unable to lie flat, still, or tolerate pet scan. * patient is on another therapeutic trial where psma imaging would interfere with the conduct of the trial. * women who are pregnant. all women of childbearing potential must have a documented negative pregnancy test.

Keywords: metastatic urothelial carcinoma 68gallium psma-pet/ct 22-157
pharmacokinetics of low molecular weight and unfractionated heparin in pregnancy

Conditions: Recurrent Pregnancy Loss; Fetal Demise; Abortion, Habitual; Antiphospholipid Antibodies; Inherited Thrombophilia

Summary: to determine, through pharmacokinetic parameters, the ideal dosing protocol for dalteparin (a low molecular weight heparin) and unfractionated heparin for women desiring pregnancy who have evidence of an acquired (specifically, antiphospholipid syndrome) or inherited thrombophilia.

this study's specific objectives include: 1. evaluating pharmacokinetic (concentration-time) and pharmacodynamic (concentration- effect) parameters for dalteparin and ufh prior to pregnancy, during the 1st, 2nd and 3rd trimesters and postpartum, using revised dosing protocols based on previous study. 2. determining therapeutic response to the heparins, i.e. live birth rate and lack of maternal or fetal complications, in relation to drug exposure, based on auc. 3. documenting maternal and fetal complications during pregnancy for dalteparin and ufh, using the revised dosing protocols.

Eligibility criteria:
inclusion criteria: * two or more consecutive, otherwise unexplained miscarriages under 10 weeks of gestation, or, an otherwise unexplained intrauterine fetal demise of at least 10 weeks of gestation, and, * persistently positive antiphospholipid antibodies, or, presence of factor v leiden, or, prothrombin 20210a, or, antithrombin, protein s, or protein c deficiency, or, hyperhomocysteinemia associated with the methylenetetrahydrofolate reductase (mthfr) polymorphism. exclusion criteria: * inability or refusal to give written informed consent. * inability or refusal to self-administer heparin throughout pregnancy. * hemoglobin value below 9.5 g/dl * heparin use is contraindicated. * renal disease. * documented history of thrombosis.

Keywords: recurrent pregnancy loss habitual abortion fetal demise antiphospholipid antibodies inherited thrombophilia
evaluation of patients with statin myopathy using an n of 1 trial design

Conditions: Statin Myopathy

Summary: this study consists of a series of prospective, randomized placebo-controlled n of 1 trials to objectively evaluate the reproducibility of subjective and objective symptoms among patients with a history of statin-related myopathy.


Eligibility criteria:
inclusion criteria: * history of muscle symptoms occuring within 3 weeks of starting a statin * need for statin therapy to achieve ldl target according to the 2009 canadian lipid guidelines * willingness to re-try statin therapy exclusion criteria: * currently tolerant of statin therapy * metabolic or inflammatory myopathy * known neuropathy * ck elevation \>3 times upper limit of normal (uln) previously on a statin or history of rhabdomyolysis * pregnant, breastfeeding, or wanting to become pregnant in the near future * participation in another clinical trial * other medical condition associated with decreased life span * inability to adhere to stringent regimen * unwilling to stop consumption of grapefruit juice subset of 5 patients also completing neuromuscular testing: inclusion criteria: - same as above exclusion criteria: * same as above but also: * angina iii of iv * decompensated heart failure * history of orthopedic problems * have any skin ulcers or other non-healed skin areas or infections in the arm or leg
muscle fatigability and trip-specific fall risk in adults with knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: the goal of this clinical trial is to learn about how fatigue affects the risk of falling in adults aged 55-70 years with and without knee osteoarthritis. the main questions this trial aims to answer are: * does fatigue increase the risk of tripping while walking? and * does fatigue increase the risk of falling in response to a trip while walking? participants will * complete questionnaires * wear a device that measures physical activity for 5-7 days * complete a 30 minute walk on a treadmill * complete the following before and after the treadmill walk: * computer test to measure mental fatigue * maximal strength testing * balance test researchers will compare adults with and without knee osteoarthritis to see if fall risk in adults with knee osteoarthritis is affected more by walking activity compared to adults without knee osteoarthritis.


Eligibility criteria:
inclusion criteria: for adults with knee osteoarthritis: * presence of occasional to frequent knee pain * knee pain that is primarily in the medial knee joint compartment * minimal morning joint stiffness for all participants: * able to walk continuously for 30 minutes without an assistive device exclusion criteria: * fracture or surgery within 1 year * history of joint replacement * lower-extremity joint injections within 3 months * history of stroke or other neurological condition * cardiovascular or pulmonary conditions that limit daily activity or that preclude participation in exercise * history of major lower extremity or back injury or pain (except for knee osteoarthritis) * history of lower extremity amputation * use an orthotic or prosthetic to walk * use of beta blockers or other medications that affect fatigue * use of medications that affect balance * diabetic neuropathy * acute illness or the presence of lesions on the torso or lower extremities * bmi greater than 35 * body weight over 265 lbs

Keywords: balance fatigue falls
effect of a high density formula on growth and safety in congenital heart disease infants

Conditions: Congenital Heart Disease

Summary: the purpose of this study is to explore the effects of high density formula in early postoperative infants with congenital heart disease and to assess its safety.

the number of infants born with chd increases every year and most chd infants are suffered with malnutrition.recent studies have shown that increasing energy intake in chd infants can improve their nutrition status.but there are no high qualified evidences supporting that high density formula can promote infants' nutrition status and ensure its safety. the hypothesis of the current study is that high density formula intake can increase infants'weight and it's safe. the current study adopts randomized,controlled intervention trial, gives high density formula(infatrini,100kcal/100ml)to chd infants in intervention group and normal density formula（neocate,67kcal/100ml）in control group. intervention begins when infants start enteral nutrition after operation and continues for 7days.

Eligibility criteria:
inclusion criteria: 1. diagnosis of congenital heart disease from symptoms, signs, ultrasonic and imaging examination 2. aged from 1 day to 12 months 3. accept extracorporeal circulation open-heart surgery 4. family members voluntarily participate in this study exclusion criteria: 1. patients have other diseases which cause nutrition disorders, such as gastrointestinal malformation, preoperative gastroesophageal reflux, genetic diseases related to the growth restriction 2. accept total parenteral nutrition 3. predicted the length of ccu stay is less than five days 4. patients have abdominal distention, diarrhea, vomiting

Keywords: high density formula heart defects infant
quality of life and adverse effects in epilepsy patients (epika)

Conditions: Epilepsy

Summary: observational, multicentre, epidemiological study to determine the hrqol of patients with epilepsy according to treatment sub-group and to validate the spanish version of the adverse events profile, produced by g. baker et al. three treatment groups will be examined: patients receiving only a new anti-epilepsy drug (aed), patients receiving a "classic" aed; patients receiving combination therapy.


Eligibility criteria:
inclusion criteria: * epileptic adult patients treated at a stable dose with one or more aeds for ≥ 3 months exclusion criteria: * symptomatic epilepsy due to malignant brain tumour or progressive brain disease. * confirmed diagnosis of a concomitant chronic disease

Keywords: observational cross-sectional health-related quality of life adverse effects baker´s aep scale validation epilepsy
approaches and metrics in fraily patients during covid-19 era

Conditions: Frailty; Oncology; Immune Deficiency

Summary: the covid-19 pandemic started in december 2019 in wuhan, the chinese province of hubei. compared to the period of the first epidemic wave (march to may 2020), in the period of the second epidemic wave (october 2020 to july 2021), deceased people have a more significant clinical complexit, as demonstrated by the higher number of comorbidities.the need to allocate significant amounts of healthcare resources to the covid-19 emergency, deferral of routine healthcare visits, and invitation to avoid medical controls, if not strictly necessary, may have led to interruptions of disease management undersupply of chronic treatments. consequently, the health status of patients with chronic pathologic conditions have worsened during and beyond the crisis. patients with cancer, autoimmune disease, and immune deficiencies represented populations with varying immunocompetence, which made translate into higher susceptibility to sars-cov-2 and, for this reason, we defined them as frail populations.the main goal of the study was to propel the field of covid-19 impact on particularly vulnerable categories of patients. the findings of this study could aid in determining the conditions under which healthcare organizations must operate in the event of a pandemic in order to protect patient's rights to care.


Eligibility criteria:
inclusion criteria: * written informed consent for participation in the study * in the period between april 1, 2021, and september 31, 2022, all covid-19 positive frail patients identified by molecular swabs taken at participating institutions were included in the study; ii) on a quarterly basis, a cohort of equal numbers of covid-19 negative frail patients wre identified and paired by disease , gender, and age. exclusion criteria: * no exclusion criteria were identified
trial to evaluate the safety, tolerability and immunogenicity of the recombinant mva bn® rsv vaccine

Conditions: Respiratory Syncytial Virus Infections

Summary: a total of 63 subjects will be recruited into three groups (18 subjects per group will receive mva bn rsv vaccine and three subjects per group will receive placebo). liquid frozen suspension of mva bn rsv. each subject will receive two vaccinations with either mva-bn rsv vaccine 1 x 108 tcid50 per 0.5 ml, 1 x 107 tcid50 per 0.5 ml or with placebo.


Eligibility criteria:
inclusion criteria: * signed and dated an informed consent form * body mass index ≥ 18.5 and \< 35. * women of childbearing potential (wocbp) must have used an acceptable method of contraception exclusion criteria: * pregnant or breast-feeding women. * uncontrolled serious infection, i.e. not responding to antimicrobial therapy. * history of any serious medical condition. * history of or active autoimmune disease. * known or suspected impairment of immunologic functions.

Keywords: rsv vaccines respiratory syncytial virus vaccines
impact of functional status on 30-day resource utilization and organ system complications following bariatric surgery

Conditions: Dependence; Perioperative/Postoperative Complications; Frailty

Summary: the goal of this observational study is to assess the effect of functional status on bariatric surgical thirty-day outcomes. the main questions it aims to answer are: * is functional status associated with higher incidence of 30-day unplanned resource utilization? * is functional status associated with higher incidences of secondary adverse events? participants will be sampled from the 2015-2019 american college of surgeons national surgical quality improvement program


Eligibility criteria:
inclusion criteria: * current procedural terminology (cpt) codes: 43644, 43645, 43770, 43775, 43842, 43843, 43845, 43846, 43847 * elective, non-emergent cases * "general surgery" surgical specialty * "general anesthesia" anesthetic technique exclusion criteria: * documented concurrent or other procedures * patients admitted to the hospital for greater than one day preceding surgery * acute kidney injury (preoperative) * end-stage renal disease (preoperative) * metastatic disease (preoperative) * wound infection (preoperative) * sepsis (preoperative)