Kornimate/medical-research-clean huggingface dataset:
near-infrared fluorescence lymphatic imaging assessment of lymphatic response to pneumatic back/neck lymphatic drainage delivered by a pneumatic manual lymphatic drainage device

Conditions: Neck Pain; Back Pain

Summary: the purpose of this study is to objectively assess lymphatic function before, during, and immediately after neuroglide treatment in lower trunk and leg lymphatic vessels, torso, axillary regions, inguinal regions, upper extremities, and cervical/neck and to determine any vas (visual analog scale, a commonly used measure of pain perception) score change after neuroglide treatment.


Eligibility criteria:
inclusion criteria: * ambulatory and possess all four limbs * female participants of childbearing potential must have a negative urine pregnancy test within 36 hours prior to study drug administration * female participants of childbearing potential must agree to use a medically accepted method of contraception for a period of one month following each imaging session in the study * weight less than 400 lbs exclusion criteria: * women who are pregnant or breast-feeding * persons who are allergic to iodine or indocyanine green * heart failure, poorly controlled kidney disease (glomerular filtration rate \<30 mls per minute), hypoproteinemia, pulmonary hypertension, or hypothyroidism * any circumstance where increased lymphatic or venous return is undesirable
clinical study of hir+x therapy for newly diagnosed elderly patients with dlbcl intolerant to chemotherapy

Conditions: DLBCL; Diffuse Large B-Cell Lymphoma

Summary: to explore the application of hir (zebtorizumab, lenalidomide) + x (targeted drug) guided by ngs molecular typing, the aim is to assess the therapeutic efficacy and safety in newly diagnosed unfit or frail elderly patients with dlbcl aged ≥70 years, and to investigate the genetic subtypes that may benefit from hir-x.


Eligibility criteria:
inclusion criteria: 1. age ≥ 70 years; 2. ecog score 0-3; 3. rated as "unfit" or "frail" on the simplified geriatric assessment (sga); 4. histologically confirmed cd20-positive diffuse large b-cell lymphoma \[diagnostic criteria according to who 2016\], excluding transformed type 2 dlbcl; 5. previously untreated, newly diagnosed patients; 6. cardiac, hepatic, and renal function: creatinine \< 2 times the upper limit of normal (uln); alt (alanine aminotransferase) / ast (aspartate aminotransferase) \< 2.5 x uln; total bilirubin \< 2 x uln; 7. at least one measurable lesion; 8. intolerance to standard chop chemotherapy regimen or unwillingness to receive chemotherapy; 9. sufficient understanding and voluntary signing of the informed consent form. exclusion criteria: 1. patients with central nervous system involvement at the onset of the disease; 2. known human immunodeficiency virus (hiv) infection; 3. pregnant or lactating women; 4. other tumors requiring treatment; 5. uncontrolled active infection; 6. active hepatitis with hbv-dna copy number unable to be controlled within 2000/ml despite antiviral treatment; 7. individuals who cannot understand, comply with the study protocol, or sign the informed consent form.

Keywords: dlbcl genetic subtypes zebtorizumab lenalidomide unfit
italian registry of hiv-1 infected patients with drug-resistant virus to reverse transcriptase inhibitors, integrase and viral protease.

Conditions: HIV-1-infection; Multi-Antiviral Resistance

Summary: the prestigio registry is an observational, prospective, multicentre study that includes patients, regularly followed by italian infectious disease centres, with hiv-1 infection and documented resistance to the 4 classes of antiretroviral drugs: nucleoside reverse transcriptase inhibitors (nrti), non-nucleoside reverse transcriptase inhibitors (nnrti), protease inhibitors (pi), and integrase inhibitors (insti). main objective of this register is to evaluate in the study population: * the long-term effectiveness of different antiretroviral regimes; * evolution of the genotype and phenotypic susceptibility of antiretroviral drugs used in patients with virological failure; * mortality; * incidence of opportunistic aids-related infections and chronic conditions (comorbidity); * determinants of clinical outcomes including virological/immunological/inflammatory markers. * antiretroviral therapy (art) compliance and health assessments; * drug-economy indications related to the clinical management of this complex sub-population.

the prestigio register consists of a systematic and continuous collection of data on clinical, laboratory and treatment characteristics of patients with documented resistance to the 4 classes of antiretroviral drugs that meet the defined inclusion and exclusion criteria. all the clinical centres of infectious diseases of the different italian regions can participate in the implementation of the registry. based on an analysis conducted on data collected in an aifa register, established for the purpose of monitoring the use of dolutegravir (dtg) 50 mg bis in die (bid) and containing about 200 patients with the criteria specified in this protocol, the size currently conceivable for this register in italy is about 300 patients. the collection of clinical information and biological samples will begin once the ethics committee of the participating centers has approved the participation in the registry and will continue for at least three years.

Eligibility criteria:
inclusion criteria: * subjects with hiv-1 infection; * age \>14 years; * documented resistance to the 4 classes of antiretroviral drugs (nrti, nnrti, pi, ini), defined as resistance (at least intermediate) to at least one of the drugs in each class according to the stanford algorithm. resistance can be documented either at the time of inclusion in the study or previously documented throughout the patient's therapeutic history. exclusion criteria: * none

Keywords: hiv aids drug resistance
effects of fenofibrate on endothelial progenitor cells in diabetes

Conditions: Diabetes; Diabetic Retinopathy

Summary: long-standing diabetes is often complicated by retinopathy. the mechanisms that induce the development of diabetic retinopathy are incompletely understood and include alterations in bone marrow derived vasculogenic cells called "endothelial progenitor cells". fenofibrate is a ppar-alpha agonist used for the treatment of mixed dislipidemia and hypertriglyceridemia. in a trial conducted in type 2 diabetic patients, the drug fenofibrate has reduced retinopathy-related endpoints suggesting a direct effect of the drug on the mechanisms that drive the development of this complication. herein, the investigators hypothesize that fenofibrate treatment can increase circulating epc levels in diabetic patients with retinopathy, compared to placebo.

long-standing diabetes is often complicated by retinopathy. the mechanisms that induce the development of diabetic retinopathy are incompletely understood and include alterations in bone marrow derived vasculogenic cells called "endothelial progenitor cells". fenofibrate is a ppar-alpha agonist used for the treatment of mixed dislipidemia and hypertriglyceridemia. in addition to lowering triglyceride-rich lipoproteins, ppar-alpha agonism with fenofibrate has several additional molecular benefit on the vessel wall, such as reduction of inflammation. in a trial conducted in type 2 diabetic patients, the drug fenofibrate has reduced retinopathy-related endpoints suggesting a direct effect of the drug on the mechanisms that drive the development of this complication. preliminary data of ours on the effects of fenofibrate on cultured epc show that this drug has the potential to improve epc and, consequently, may benefit patients with retinopathy. herein, the investigators hypothesize that fenofibrate treatment can increase circulating epc levels in diabetic patients with retinopathy, compared to placebo.

Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes * diabetic retinopathy * age 18-70 * both sexes exclusion criteria: * age \ 70 at enrollment * hereditary muscle disorders * uncontrolled hypothyroidism * elevated alcohol consumption * renal failure * hepatic failure * allergy to fenofibrate or excipients * acute / chronic pancreatitis * pregnancy and lactation.

Keywords: stem cells regeneration angiogenesis prevention
role of prophylactic metoclopramide with tramadol in trauma patients

Conditions: Trauma; Opioid Analgesic Adverse Reaction

Summary: tramadol is widely used as analgesic in trauma patients. however, it causes side effects, most notably nausea and vomiting. this study aim to determine the role of prophylactic metoclopramide in preventing tramadol induced nausea and vomiting.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older on day of presentation to etd sgh * sustained from traumatic injuries of extremities (fracture of hand \& wrist, radius, ulna, humerus, femur, tibia, fibula and/or foot \& ankle; laceration wounds of extremities; soft tissue injury) * patient who is able to give consent exclusion criteria: * known allergy to metoclopramide * concurrently taking medication with anti-emetic effect, including antihistamines, phenothiazines and dopamine antagonists. * a history of vomiting since time of injury * patients who had already received tramadol or metoclopramide in the previous 8 hours prior to arrival at etd * below age of 18 on day of presentation, or patients who could not consent to the study * any alteration in level of consciousness * hemodynamic instability or primary diagnosis requiring time critical intervention * pregnancy or lactation * history or known case of vertiginous disorder * currently undergoing chemotherapy or radiotherapy
efficacy and safety of alirocumab (sar236553/regn727) versus placebo on top of lipid-modifying therapy in patients with heterozygous familial hypercholesterolemia not adequately controlled with their lipid-modifying therapy

Conditions: Hypercholesterolemia

Summary: alirocumab (sar236553/regn727) is a fully human monoclonal antibody that binds pcsk9 (proprotein convertase subtilisin/kexin type 9). primary objective of the study: to evaluate the effect of alirocumab on low-density lipoprotein cholesterol (ldl-c) levels after 24 weeks of treatment in comparison with placebo. secondary objectives: * to evaluate the effect of alirocumab in comparison with placebo on ldl-c at other time points * to evaluate the effects of alirocumab on other lipid parameters * to evaluate the safety and tolerability of alirocumab

the maximum study duration was planned to be 89 weeks per participant including participants who successfully completed the 78-week treatment period had the possibility to join an open-label extension study (lts13463, nct01954394) at the end of the treatment period.

Eligibility criteria:
inclusion criteria: * participants with heterozygous familial hypercholesterolemia who were not adequately controlled with their lipid-modifying therapy exclusion criteria: * age \< 18 years or legal age of adulthood, whichever is greater * ldl-c \< 70 mg/dl (1.81 mmol/l) and with cardiovascular disease * ldl-c \< 100 mg/dl (2.59 mmol/l) and without cardiovascular disease * fasting serum triglycerides \> 400 mg/dl (4.52 mmol/l) * known history of homozygous familial hypercholesterolemia the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Keywords: pcsk9
feasibility and safety of a wireless palpator

Conditions: Lung Cancer; Thoracic Neoplasm

Summary: evaluation of the ability of the palpator to detect hidden (occult) lung tumours that cannot be visualized or palpated using the traditional methods of visual inspection, grasper palpation, and vats ultrasound.

all procedures will be performed with the patient under general anesthesia with single lung ventilation through double-lumen endotracheal intubation. three to four thoracoports, no larger than 12 mm, will be inserted in the intercostal spaces as needed. after vats port placement, the pleural cavity will be insufflated with co2 to a maximum pressure of 8 mm hg to assist with lung deflation. a standard vats pleuroscopy will be performed to visually search for the nodule and its position confirmed with sequential assessment using a grasper, the palpator, the vats ultrasound probe, and then finger palpation. this will ensure that all patients will have the opportunity to avoid a large thoracotomy if the lesion can't be identified by the palpator. if the lesion can be detected either visually or by grasper palpation, this information will be recorded, but will be excluded from the analysis of palpator feasibility.

Eligibility criteria:
inclusion criteria: * age \> 18 years * peripheral occult sub-pleural (\>5 mm) solitary lung nodule \< 50 mm on ct scan scheduled for surgical removal using a vats approach exclusion criteria: * semi-solid nodules (ground glass nodule). * pregnancy or potentially pregnant women. * mentally challenged. * inability to consent for the study. * patients less than 18 years old. * patients with pulmonary nodules easily located during vats (\> 50 mm, pleural puckering, invading chest wall) * patients who have chest anatomy precluding vats resection.

Keywords: palpation tactile image sensor lung ultrasound vats procedures
testing a personalized normative feedback intervention for vaccine hesitancy

Conditions: COVID-19; Vaccine Hesitancy

Summary: rationale: the highest rates of coronavirus disease (i.e., covid-19) vaccine hesitancy in the us are among young adults (yas) aged 18-25. our preliminary studies show that social norms - perceptions of peers' vaccination attitudes/behaviors - are most strongly related to yas' vaccine intentions/uptake. most yas underestimate the perceived importance of vaccination and their peers' intentions to be vaccinated. the proposed research will develop and test an intervention to correct misperceived norms for vaccination hesitancy and uptake. methodology: rapid prototyping with 20 unvaccinated yas will help refine the content and design of the online intervention. then, a diverse national sample (n=600) of unvaccinated yas will be randomized to treatment or an attention-matched control. the treatment condition will receive personalized normative feedback (pnf) designed to correct normative misperceptions for vaccine hesitancy and uptake. normative feedback will be derived from the us census bureau's household pulse survey. follow-up surveys will be administered at 1, 2, 3, and 6 months to assess key outcomes including vaccine uptake, intentions, and reasons for vaccine hesitancy. aims and data analysis: * aim 1: develop and refine a pnf intervention for vaccine hesitancy/uptake with user feedback from yas. rapid analysis of qualitative data will involve looking for themes in responses. changes will be made iteratively to refine intervention content, design, and delivery. * aim 2: evaluate intervention efficacy for increasing vaccine uptake and reducing time to first vaccine dose, relative to control, over the following year. * aim 3: examine mediators (changes in perceived norms) and moderators (intellectual humility, identification with other people and young adults) of intervention efficacy. a longitudinal moderated mediation model will be examined. impact: findings will clarify the causal role of psychological determinants of vaccine hesitancy (social norms, intellectual humility, group identification). if preliminary intervention efficacy is supported, this intervention could be a low-cost, and easily disseminated strategy to promote yas' vaccine uptake and contribute to public health efforts to address the covid-19 pandemic.


Eligibility criteria:
inclusion criteria: * 18-24 years old (at screening) * reside in the united states. * have not received a covid-19 vaccine (at screening) * pass attention checks. exclusion criteria: * not meeting inclusion criteria. * not fluent in english. * not providing consent. * unwilling to participate.
intracranial hypertension and optic nerve sheath diameter

Conditions: Cerebral Stroke; Cerebral Venous Thrombosis

Summary: intracranial hypertension (ich) is a mortality risk factor in severe traumatic brain injury (tbi), in purulent meningitis, in hepatic encephalopathy and in reye's syndrome. it is also a risk factor for severe neurologic sequelae in survivors. intracranial pressure (icp) monitoring is likely to guide therapeutics, and certain research on adults or on children, suggest that ih therapeutic approach, for instance for bacterial meningitis, would improve the prognosis. two monitoring techniques are currently recommended. they are reference methods for icp measure : * monitoring with intraventricular catheter, * intra-parenchymal monitoring using optical fiber catheter. non invasive methods have been suggested, including ultrasound measurement of optic nerve sheath diameter (onsd) which is the most interesting one. the onsd measured ultrasonically is correlated with icp level in adults with severe tbi. a diameter over 5,9 mm predicts ich within the first 24 hours. in children, onsd average values have been worked out, and an onsd increase is found in children suffering from hydrocephalus with ih and in children with tbi. ich precocious detection is fundamental in children sensitive to ich because their cerebral development is not finished yet. difficulties met for icp monitoring implementation in infants and its invasive nature are often disliked by clinicians. a non-invasive exam is then essential to allow a better care of children with ich in intensive care unit.


Eligibility criteria:
inclusion criteria: for the 97 patients: * children from 2 months to 16 years * in the intensive care unit * tbi : moderate (gcs between 9 and 12) to severe (gcs \<9), whatever the mechanism involved * informed consent form signed by parents non inclusion criteria: * obesity (bmi \> 97th percentile for the age) * patient already under replacement therapy. * patient taking aeds * patient with long-term systemic corticosteroid therapy * history of neurological disease or learning difficulties * no covered by a national health insurance

Keywords: paediatrics optic nerve sheath diameter ultrasound
dynamic renal assessment: novel methods to assess kidney functional reserve

Conditions: Chronic Kidney Diseases

Summary: this is a feasibility study to assess new, more practical ways of measuring renal reserve.

quantification of glomerular filtration rate (gfr) over time is the standard assessment of kidney function. in clinical practice, the endogenous marker, 'serum creatinine' concentration, is used as a static assessment of kidney function to estimate gfr. however, serum creatinine fails to increase until at least 50% of kidney tissue is lost,\[2\] thus is an inadequate indicator of early ckd. gfr like many other physiological processes is not static and augments temporarily to stimuli such as exercise and protein intake, by up to 25% from baseline in healthy individuals.\[3\] similar to cardiac function stress tests which predict adverse outcomes, inability to respond to renal stressors or 'reduced renal reserve' has been demonstrated to occur prior to development of ckd (e.g. in patients with diabetes and previous acute kidney injury (aki)) and is associated with vulnerability to future aki, despite the presence of apparently normal kidney function measured by serum creatinine concentration.\[4\] renal reserve is lost with progressive ckd,\[4\] and has also been demonstrated to relate to severity of histological lesions.\[5\] current measurements of renal reserve (stimulated increase in gfr due to augmented renal blood flow above basal fasting values) involve administration of a compound that is freely filtered by the glomerulus, unaffected by tubular function and is physiologically inert, with assessment before and after an oral protein load or amino acid infusion which induces arterial vasodilation, increasing renal blood flow and gfr the study proposes a comparison of two novel methods of 'dynamic renal function testing' with renal reserve testing.

Eligibility criteria:
inclusion: patients with sickle cell nephropathy, diagnosed clinically or histologically. sickle cell patients will be confirmed hb ss and egfr (ckd-epi) ≥ 135 ml/min/1.73m2 or previous living kidney donation age ≥ 4no contraindication or known allergy to any trial medications. willing and able to provide written informed consent exclusion: aged \< 40 unable or unwilling to provide informed consent breastfeeding or pregnant women patients involved in other interventional research studies.
relative bioavailability and food effect study

Conditions: Pain

Summary: initial studies have used a powder in capsule formulation of ph797804. in future studies an immediate release tablet will be used. the purpose of this study is to compare blood levels of ph797804 following an oral dose of the powder in capsule formulation and the tablet formulation. in addition the effect of food blood levels of ph797804 will be investigated


Eligibility criteria:
inclusion criteria: * healthy male or female subjects aged 21 to 55 years * healthy is defined as no clinical relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead ecg and clinical laboratory tests * willing to use acceptable methods of contraception as outlined in the study protocol * body mass index between 18 to 30 kg/m2 * subjects who are willing and able to comply with the scheduled visits, treatment plan and other study procedures exclusion criteria: * subjects with evidence or history of clinically significant disease * pregnant or nursing females * females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception from at least 14 days prior to the first dose until day 15 of period 4 * subjects with conditions possibly affecting drug absorption (eg gastrectomy) * a positive approved immunoassay/elisa blood test for tb * subjects with a history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men * subjects who have use prescription or nonprescription drugs, vitamins and/or dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication * subjects who have been administered medications capable of inducing hepatic enzyme metabolism (eg barbiturates, rifampin, carbamazepine, phenytoin or primidone) within 14 days (or 5 half-lives of the inducing agent, whichever is longer) of day 1 or within 28 days of administration of st john's wort

Keywords: relative bioavailability effect of food