Kornimate/medical-research-clean huggingface dataset:
biomarkers in post thrombotic syndrome

Conditions: Postthrombotic Syndrome With Ulcer of Left Lower Extremity; Extracellular Matrix Alteration

Summary: this study aims to deepen the investigators knowledge of post thrombotic syndrome and mmps (and other related molecules such as timps, ngal and cytokines) to find a predictive molecular system to better classify the risk of patients to develop a pts after a dvt episode, in order to monitorate more strictly the patients at high risk for developing this complication.

post-thrombotic syndrome (pts) is a problem that can develop in nearly half of all patients who experience a deep vein thrombosis (dvt) of lower limbs. pts symptoms include chronic leg pain, swelling, redness, and skin ulcers. pts lowers patients' quality of life after dvt, specifically with regards to physical and psychological symptoms and limitations in daily activities. secondly, the treatment of pts adds significantly to the cost of treating dvt. pts also causes lost work productivity: patients with severe pts and venous ulcers lose up to 2 work days per year nowadays, there are no effective measures to reduces significatively pts onset following a dvt episode. biomarkers can be of use in further exploring the etiology as well as in developing risk stratification tools for pts. the relationship between pts and specific biomarkers may help guide prevention and therapy based on a patient's individual risk profile. recent studies showed that mmps play a significant role in vascular remodeling and endothelial dysfunction and they may explain a role in aneurysm formation as well as in all the clinical manifestations of venous disease (both for acute and chronic related events) but the cellular and molecular mechanisms involved in thrombus resolution and vein wall fibrosis remain undefined. the presence of mmps and timps in acute venous occlusion model suggests that there is an important early interplay between protease and inhibitor during events that precede the development of venous disease. this study aims to deepen the investigators knowledge of pts and mmps (and other related molecules such as ngal and cytokines) to find a predictive molecular system to better classify the risk of patients to develop a pts after a dvt episode, in order to monitorate more strictly the patients at high risk for developing this complication. patients will be recruited at their first episode of dvt and will be followed up according to standard protocols for dvt at 1,4,8,12,24, 36 months. at each visit blood sample will be collected from venipuncture in order to evaluate mmps (and other related molecules) plasma levels. these data will be related to clinical findings.

Eligibility criteria:
inclusion criteria: * acute dvt of lower limbs. * no known prior history of dvt * availability to make follow-up appointments. exclusion criteria: * prior history of dvt * neoplasia * arterial aneurysms * venous ulcers
aneuploidy rates of in vitro matured oocytes

Conditions: Aneuploidy

Summary: in general, nearly 85% of retrieved oocytes are mature and reproductively useful after the retrieval, whereas the remaining percentage are still at metaphase i or germinal vesicle stage (mi: 4% and gv: 11 %, respectively). the objective of our study is to assess if immature oocytes co-cultured with autologous cumulus cells is a safer strategy than just leaving the oocytes in standard culture.

under controlled ovarian stimulation, patients with normal functional ovarian reserves produce a good number of oocytes at retrieval. however, in addition to quantity, oocyte maturity is an important variable for the success of reproductive technologies. in general, nearly 85% of retrieved oocytes are mature and reproductively useful, whereas the remaining percentage are still at metaphase i or germinal vesicle stage (mi: 4% and gv: 11 %, respectively). due to the limited expectations held for in vitro maturation in said stimulated cycles, the rescue of immature oocytes is not widely used in current clinical practice and these oocytes are usually discarded due to the possibility of abnormal embryonic development or an increased rate of abortion. the objective of our study is to assess if immature oocytes co-cultured with autologous cumulus cells is a safer strategy than just leaving the oocytes in standard culture.

Eligibility criteria:
inclusion criteria: * 18-35-year-old women * bmi: \>18 and \< 30 kg/m2 * normal female karyotype * normal uterus and ovaries at transvaginal ultrasound exclusion criteria: * \> 35 years * pco syndrome carriers * null follicle aspiration * history of chemotherapy or radiotherapy
tace with thermosensitive nanogel versus embosphere for hcc

Conditions: Unresectable Hepatocellular Carcinoma

Summary: to verify the safety and efficacy of tace withthermosensitive nanogel embolic agent for hcc.

this is a prospective, multicenter, randomized controlled, non-inferiority design trial. participants who meet the criteria will be randomly assigned into the experimental group or the control group，with a ratio of 1:1. in the experimental group the thermosensitive nanogel embolic agent will be used in the tace procedure, while in the control group the embosphere microspheres will be used. the primary endpoint is disease control rate of the target lesions at 1 month after the last tace treatment.

Eligibility criteria:
inclusion criteria: 1. chinese liver cancer staging scheme, stage iib-illa, as well as those with stage ia-ila hcc, unsuitable or unwilling to undergo surgical resection, transplantation, or ablation; 2. liver function status: child-pugh a or b 3. eastern cooperative oncology group score: 0-2 points; 4. with at least one measurable, unembolized liver tumor lesion (1-10 cm) ; 5. willing to participate in this trial and sign the informed consent. exclusion criteria: 1. the target lesion has been embolized before or require combined with other treatment(s); 2. diffuse or with extrahepatic metastasis; 3. coagulation dysfunction (pt prolonged beyond the upper limit of normal for 3 seconds); 4. severe renal dysfunctions (creatinine clearance rate \<30 ml/min); 5. severe liver dysfunctions (alanine aminotransferase or aspartate aminotransferase exceeding the upper limit of normal by 5 times); 6. main portal vein was completely occluded and no collateral blood supply was established; 7. with uncorrectable arteriovenous fistula or portal vein fistula; 8. severe cachexia or hepatic encephalopathy; 9. with active infection; 10. significant reductions in white blood cells or platelets (white blood cells\<3.0x109/l, platelets\<50x109/l) that cannot be corrected; 11. pregnant or lactating women; 12. difficulty in selective catheterization; 13. with the severe risk of non-target embolization; 14. severely allergic to contrast agents or the embolic materials; 15. participating in ongoing trial; 16. unsuitable judged by the investigator.

Keywords: hepatocellular carcinoma transarterial chemoembolization
evaluating rxi-109 to reduce the progression of subretinal fibrosis in subjects with nvamd

Conditions: Age-related Macular Degeneration; Subfoveal Choroidal Neovascularization; Subretinal Scarring; Subretinal Fibrosis

Summary: this study is designed to evaluate the safety, tolerability and clinical activity of rxi-109 administered by intravitreal injection to reduce the progression of subretinal fibrosis in subjects with advanced neovascular age-related macular degeneration (nvamd).

evaluate the safety, tolerability and pharmacokinetics (pk) of single and multiple doses of rxi-109 when administered by intravitreal injection. evaluate the clinical activity of single and multiple doses of rxi-109 when administered by intravitreal injection. study participation is intended to be seven months from time of initial treatment with rxi-109.

Eligibility criteria:
inclusion criteria: * subjects presenting with advanced nvamd in the study eye with bcva ≤20/100 potentially due to subretinal fibrosis involving the fovea * bcva ≥20/800 in the contralateral eye and better than the study eye * ≥50 years of age * subfoveal choroidal neovascularization (cnv) of any type exclusion criteria: * presence of other causes of cnv including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis * evidence of inflammation (grade 1 or higher) in the anterior or posterior chamber

Keywords: age-related macular degeneration rxi-109 nvamd retinal scarring subretinal scarring retinal fibrosis subretinal fibrosis eye diseases
iressa v bsc (best supportive care) in first line nsclc

Conditions: NSCLC

Summary: the purpose of the study is to determine if the addition of iressa to best supportive care treatment will increase the progression free survival of chemo-naïve, poor performance status patients, with stage iiib or iv nsclc.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed nsclc * nsclc - locally advanced (stage iiib) or metastatic (stage iv) disease, not amenable to curative surgery or radiotherapy * not suitable for chemotherapy * who performance status 2 or 3 exclusion criteria: * newly diagnosed cns mets * less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy related toxicity * other co-existing malignancies * alt/ast greater than 5 x upper limit of normal * anc less than 1.0 x 109/l or platelets less than 100 x 109/l
intervention to promote survivor resilience and adjustment: efficacy and sustainability

Conditions: Traumatic Brain Injury

Summary: the aims of this traumatic brain injury (tbi) study are: 1. to evaluate the short and long-term efficacy of two structured outpatient intervention programs, resilience and adjustment intervention (rai) vs. rai with follow up booster sessions (rai+) on resilience 2. to evaluate the short and long-term impact of intervention on emotional well-being and postinjury adjustment with the rai vs. the rai+ 3. to evaluate the short and long-term impact of the rai and the rai+ on abilities including problem solving, communication, and stress management 4. to determine if demographic, lifestyle, injury, or treatment response information can predict maintenance of gains

participants will be assigned to either of two treatment groups: (1) resilience and adjustment intervention (rai), or (2) rai+. after randomization, a second appointment will be scheduled. all participants will begin the 7-session treatment during their second appointment. the intervention consists of seven 60-minute sessions scheduled over seven weeks (see attached rai implementation manual). the intervention will be implemented by experienced, licensed therapists (ph.d. level interventionists). participants will be randomly assigned to one of the therapists. the rai and rai+ groups will both complete the post-treatment measures immediately after the seventh treatment session and then 3, 4, and 9 months later. data collection at 3, 4, and 9 months post-treatment will be completed via phone. furthermore, the rai+ group will complete 3 booster sessions, spaced approximately 7-10 days apart, beginning 3 months after completion of the seventh treatment session (booster sessions will occur between the 3 and 4 month data collection described above). data will be analyzed to identify any therapist effects, as well as treatment effects. for the rai and rai+ groups, demographic, injury severity, and history information will be collected at intake using standard procedures and protocols. all participants will complete the 4 outcome measures (connor-davidson resilience scale, cd-risc; mayo portland adaptability inventory-4, mpai-4; 13 item stress test; and brief symptom inventory-18, bsi-18) at 5 time points (intake, post-treatment, and 3, 4 and 9 month follow-up).

Eligibility criteria:
inclusion criteria: * mild, moderate, or severe tbi defined as: damage to brain tissue caused by an external mechanical force as evidenced by loss of consciousness due to brain trauma, post-traumatic amnesia (pta), skull fracture, or objective neurological findings that can be reasonably attributed to tbi on physical examination or mental status examination. * at least 3 months post-tbi. exclusion criteria: * active substance abusers (e.g., intoxicated at arrival to intake). * individuals at imminent risk of psychiatric hospitalization, or in imminent danger of hurting themselves or others, as judged by the investigators, will be excluded from the study.
treatment of meibomian gland dysfunction and dry eye in contact lens wearers

Conditions: Meibomian Gland Dysfunction; Dry Eye

Summary: the pilot study objective is to evaluate the potential benefits of lipiflow® system treatment of contact lens wearers with meibomian gland dysfunction and evaporative dry eye by assessing for improvement in meibomian gland function and reduction of dry eye symptoms in comparison to an untreated control.

this is a prospective, non-significant risk, open-label, randomized clinical trial of lipiflow® treatment of contact lens wearers with meibomian gland dysfunction and evaporative dry eye. all subjects undergo examination to determine study eligibility and to capture the baseline status. subjects are randomized to receive lipiflow® treatment (treatment group) or no lipiflow® treatment (untreated control group). the treatment group is evaluated one month after receiving lipiflow® treatment. study endpoints are evaluated at 3 months by comparing the treatment group to the untreated group. to facilitate subject recruitment, the untreated control group receives crossover lipiflow® treatment (crossover treatment group) at 3 months. the crossover treatment group is evaluated one month after receiving lipiflow® treatment (4 months visit).

Eligibility criteria:
inclusion criteria: * diagnosis of meibomian gland dysfunction and dry eye * at least 18 years of age * willing to comply with randomization, attend all study visits and follow patient instructions * habitual soft contact lens wearer 2 to 18 hours/day and 4 to 7 days/week * no change in contact lens type or dimensions for the past 3 months * clinician assessment of acceptable contact lens fit and disinfecting solution * tear film interferometry of 100 units or less exclusion criteria: * systemic disease conditions that cause dry eye * use of systemic medications known to cause dryness * history of any of the following ocular conditions in the past 3 months: surgery, trauma, herpes infection, recurrent inflammation, punctal plug insertion or punctal occlusion * presence of any of the following active conditions: ocular infection, ocular inflammation, moderate to severe allergic conjunctivitis, severe eyelid inflammation, eyelid abnormality that affects lid function, or ocular surface abnormality that compromises corneal integrity * use of other treatments for meibomian gland dysfunction or dry eye except over the counter lubricants or dietary supplements * participation in another ophthalmic drug or device trial in the past month * employee, relative of employee or associate of the clinical site
maintenance versus reduction of immunosuppression for renal transplant patients hospitalized with covid-19 disease

Conditions: COVID; Kidney Transplant; Complications; Immunosuppression

Summary: this will be a randomized trial of maintenance versus reduction in immunosuppression in adult patients (age \>18 years old) with functioning renal transplants admitted to hospital with confirmed covid-19 disease.

the optimal management of immunosuppression in renal transplant patients with covid-19 disease is unclear. on one hand, many centers advocate reduction of immunosuppression in infected patients, with the rationale that such an approach will unleash the anti-viral t-cell response. however, on the other hand, some centers advocate there may be rationale to maintain baseline immunosuppression in order to mitigate against development of an uncontrolled over-activation of the immune response. the investigators propose to address this knowledge gap by performing a randomized clinical trial that will test formal comparisons of maintenance versus reduction in immunosuppression.

Eligibility criteria:
inclusion criteria: * adults ≥18 years * covid positive by rt-pcr or serology * ≥ 6 months post-transplant * use of anti-metabolite (mycophenolate or azathioprine) and calcineurin inhibitor (cyclosporin or tacrolimus) * informed consent; first admission during study period * participation within 72 hours of hospitalization exclusion criteria: * icu care or need for invasive ventilation or use of pressors at screening/randomization * covid-19 disease severity score more than 5 at screening/randomization * known donor specific antibody * egfr \<20ml/min/1.73m2 * hematocrit \<24% * biopsy proven and treated rejection within last 3 months * institutionalized individuals (prisoners) * pregnancy * participation in another clinical study with an investigational medicinal product within 30 days or within 5 half-lives of such, whichever is longer, prior to randomization and during the study * any other conditions, which, in the opinion of the investigator would make the subject unsuitable.
discovery of new early detection biomarkers of acute respiratory distress syndrome

Conditions: Acute Respiratory Distress Syndrome

Summary: the goal of this project is to find a series novel biomarkers by differential proteomic techniques that can improve the early diagnosis and develop a more efficient therapy to enhance ards patient survival rate.

acute respiratory distress syndrome(ards) has a very poor prognosis and high mortality. to improve the early diagnosis of ards, there is an urgent need for novel biomarkers of ards. the goal of this project is to find a series novel biomarkers by differential proteomic techniques that can improve the early diagnosis and develop a more efficient therapy to enhance ards patient survival rate. clinical data and blood sample were recorded before treatment and after treatment. acute physiology and chronic health evaluation iii (apache iii) scores were calculated at enrolment. studying blood specimens from different period ards patients by proteomic analysis. it can provide information on a complex composition of proteins that are differentially expressed, which could be used for discovering high sensitivity and specificity ards biomarker.

Eligibility criteria:
inclusion criteria: * the berlin definition of acute respiratory distress syndrome * ats definition of severe pneumonia exclusion criteria: * age below 18 years * pregnancy * expected survival under 24 hours

Keywords: ards biomarkers proteomic
rna sequencing of individual versus wastewater - sars-cov2

Conditions: Infection Viral

Summary: the aim is to compare the percentage of the different sars-cov2 lineages that are detected in wastewater samples with matched clinical samples. about 1,400 swab samples from patients living in nice were tested by biogroup between oct 19th and oct 23rd (week 43 of 2020). the sequence of 81 pcr positive samples, corresponding to all samples that were unambiguously assigned to one of the wastewater catchment areas and their lineage was determined. these values were compared to values measured in wastewater.


Eligibility criteria:
inclusion criteria: * whole population tested in nice during w43 of 2020 exclusion criteria: * none
bosentan and pulmonary endothelial function

Conditions: Pulmonary Arterial Hypertension

Summary: 6 months therapy of bosentan, an endothelin antagonist, will lead to improvement in pulmonary microvascular endothelial function.


Eligibility criteria:
inclusion criteria: * pulmonary arterial hypertension; idiopathic and connective tissue disease associated * confirmed or invasive haemodynamic: * mean pulmonary arterial pressure greater than or equal to 25 millimeters of mercury * pulmonary capillary wedge pressure less than 15 millimeters of mercury * no prior pulmonary hypertension specific therapy * ability to provide informed consent exclusion criteria: * contra-indications to medications used to test endothelial function; acetylcholine, sodium nitroprusside, ng-monomethyl-l-arginine, l-arginine * advanced renal disease * previous allergic reaction to contrast agents
squeaking in ceramic-on-ceramic total hip arthroplasty using delta tt cup

Conditions: Osteoarthritis, Hip; Osteonecrosis of Femoral Head; Femoral Neck Fractures; Rheumatoid Arthritis of Hip; Posttraumatic Arthropathy

Summary: this study will evaluate clinical outcome on patients who undergo ceramic on ceramic (coc) bearing total hip arthroplasty (tha) using delta tt cup.

this study will evaluate clinical outcome on patients who undergo ceramic on ceramic (coc) bearing total hip arthroplasty (tha) using delta tt cup. specifically the study intends to address the following research topics: 1. the incidence of squeaking after coc tha using delta tt cup. 2. the dislocation rate and survival rate of coc tha using delta tt cup.

Eligibility criteria:
inclusion criteria: * older than 18 years old * non-inflammatory degenerative joint disease such as osteoarthritis or avascular necrosis * rheumatoid arthritis * post-traumatic arthritis * fractures of femoral neck exclusion criteria: * local or systemic infection * septicaemia * persistent acute or chronic osteomyelitis * confirmed nerve or muscle lesion compromising hip joint function * unstable medical illness * rapidly progressive neurological disease

Keywords: total hip arhtroplasty squeaking dislocation ceramic bearings
post-cabgdm: empagliflozin in perioperative cabg

Conditions: Diabetes Mellitus, Type 2; Coronary Artery Disease; Coronary Artery Bypass Surgery; Acute Kidney Injury

Summary: introduction: diabetes mellitus (dm) is a condition known to be associated with coronary artery disease (cad) and its role as promoter of atherosclerosis is well stablished. the revascularization surgery is commonly indicated to patients with multivessel coronary disease and kidney injury is a prevalent complication in post operation. this work aims to evaluate the impact of a strategy to control diabetes mellitus using inhibitors of sodium-glucose cotransporters (isglt2) in diabetics patients with assigned myocardial revascularization with cardiopulmonary bypass

random prospective study non-blinded with 144 diabetics patients designated to myocardial revascularization with cardiopulmonary bypass . 72 patients will be randomly set to usual treatment provided by health care service and 72 patients will be randomly assigned treatment based on isglt2 (empaglifozin). patients will receive treatment as set for 3 months until 3 days prior to surgery. creatinine levels will be measured immediately after surgery and in the following 3 days in post-op. to evaluate the possibility to reduce the acute kidney injury in a randomized group treated with therapy based on isglt2.

Eligibility criteria:
inclusion criteria: * age \> 18 * type 2 diabetes mellitus * multivessel cad documented by coronary angiography with formal indication for crm. exclusion criteria: * egfr \<30ml / min / 1.73m2 or dialysis therapy; * inability to sign the informed consent form; * contraindication to cabg on pump; * need for urgent or emergency cabg; * terminal or disabling illness with reduced life expectancy; * pregnancy in progress.

Keywords: diabetes coronary artery disease sglt2i cabg acute kidney injury