Kornimate/medical-research-clean huggingface dataset:
treatment of acute and chronic ligament and tendon injuries with platelet rich plasma

Conditions: Tendinopathy

Summary: platelet rich plasma has been used in previous studies to stimulate faster healing of torn ligaments and tendons in order to help reduce pain and restore normal function. this study aims to prove that non-operative treatment of acute and chronic ligament and tendon injuries with platelet rich plasma will reduce the time needed for participants to heal these injuries and restore function. we are currently enrolling patients with patellar tendon injuries in the knee.

pre-procedure diagnosis: the appropriate clinical evaluation will be dictated by the examining physician. minimal pre-procedure studies will include plain radiographs and mri. all patients will complete a pretreatment questionnaire. patients will be randomized and blinded to a treatment regimen. method of randomization: some of the participating subjects will receive platelet rich plasma and others will receive a saline injection. the platelet rich plasma experimental group will have up to 50cc of whole blood collected via venipuncture and prepared using the standard prp protocol. to blind the control group these patients will have a simulated needle stick and approximately 10 ml (2 teaspoons) of blood will be drawn. no blood will be given back to the patient. for those in the control group their ligament or tendon will be stimulated with dry needling (moving a needle up and down in the tendon, without injection). patients in the prp treatment group will also have dry needling, plus the prp will be injected into the tendon as well. platelet rich plasma injections have an equivalent risk profile to routine injections. those potential risks include skin discoloration, pain at injection site, superficial or deep infection, no relief of symptoms, worsening of symptoms, and damage to nerve and blood vessels. potential benefits include significant improvement in symptoms and reduction in time for return to function. post injection activity: all patients will use crutches for 24-48 hours after injection. all patients will have physical therapy two times a week according to a standardized protocol. follow up at the clinic for all patients will be every 3 weeks from weeks 1-12. all patients will fill out an injury location specific questionnaire, tegner activity scale, short form-12, and visual analog scale for pain, among others. additional follow-up will be done at 6 months, 1 year and 2 years. all radiographic studies will be read by a radiologist blinded to the study groups. the primary endpoint for all patients in the study will be twelve weeks. secondary enpoints are 6 months, 1 year and 2 years.

Eligibility criteria:
inclusion criteria: -acute or chronic ligament or tendon injuries exclusion criteria: * pregnant women, * children, * other injuries that require surgical intervention, * associated fractures, * systemic disease resulting in an immunocompromised state affecting ability to heal soft tissues

Keywords: prp platelet-rich-plasma platelet tendinosis tendinitis tendonitis tendinopathy enthesopathy muscle sport tendon patella patellar tendon
role of diaphragm fatigue in weaning from mechanical ventilation

Conditions: Weaning; Respiratory Muscle Function

Summary: the purpose of this study is to determine whether the diaphragm develops contractile fatigue during a weaning trial and if this is associated with weaning failure.


Eligibility criteria:
inclusion criteria: * age \> 18 year * mechanical ventilation for at least 3 days * the treating physician judges the patient to be ready to be weaned from the ventilator * informed consent exclusion criteria: * pre-existent muscle disease (congenital or acquired) or diseases / disorders know to be associated with myopathy including auto-immune diseases. * upper airway / esophageal pathology (i.e. recent surgery, esophageal varices, diaphragmatic hernia) * recent (\< 1 month) nasal bleeding * phrenic nerve lesions
intranasal aln-rsv01 administered to adult volunteers experimentally inoculated with respiratory syncytial virus

Conditions: Respiratory Syncytial Virus Infections

Summary: the purpose of this study is to determine the safety, tolerability and efficacy of intranasal aln-rsv01 versus placebo, administered once daily for 5 days to a healthy male volunteers experimentally inoculated with rsv


Eligibility criteria:
inclusion criteria: * availability for the required study period (including the inpatient phase, ability to comply with study requirements and attend follow-up study visits * able to provide written consent for participation after reading the consent form and after having adequate opportunity to discuss the study with an investigator or qualified deputy. * good general health status as determined by a screening evaluation no greater than 120 days but not less than 14 days prior to enrollment and admission to the research unit * low titers of rsv neutralizing antibody measured during screening. exclusion criteria: * significant acute or chronic, uncontrolled medical illness * presence of household member or close contact to someone who: * is less than three(3) years of age * has a known immunodeficiency * is receiving immunosuppressant drugs * is undergoing or soon to undergo cancer chemotherapy within 28 days of enrollment * has diagnosed emphysema, chronic obstructive pulmonary disease(copd), or severe lung disease * is elderly and residing in a nursing home, or * has received an organ transplant * females are not eligible for this study * evidence of or history of drug or alcohol abuse (within the past 6 months) or positive urine drug or alcohol screen other protocol-defined inclusion/exclusion criteria may apply.

Keywords: respiratory syncytial virus
platelet response to caplacizumab in the treatment of acquired thrombotic thrombocytopenic purpura

Conditions: Acquired Thrombotic Thrombocytopenic Purpura

Summary: the interpretation of platelet counts has to be revaluated in the light of caplacizumab. by effectively blocking platelet binding sites on vwf-multimers, the nanobody leads to a rapid normalization of the platelet count within 3 to 4 days. most importantly, caplacizumab uncouples platelet counts from adamts13 activity and thereby launches unprecedented thrombocyte dynamics, with potential pitfalls for over- and undertreatment. a relevant number of patients responds to caplacizumab with a brisk increase in platelet count, followed by a marked dip of platelets (patient on the left). this may mislead treating physicians into re-intensifying therapy, with a respective risk for adverse side-effects and complications. taken together, these observations call for reliable descriptions and the identification of predictive parameters to predict the platelet response upon administration of caplacizumab in a large patient cohort. here, predict-2020 is designed as a retrospective study to specifically address the following aspects: * identifying and describing clusters of platelet responses to caplacizumab * identifying potential pitfalls for treating physicians * predicting the individual thrombocyte response * correlating platelet responses with individual patient outcome


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of autoimmune thrombotic thrombocytopenic purpura * treatment with at least a single dose of caplacizumab, either i.v. or s.c. * male or female patients older than 18 years of age exclusion criteria: * hereditary thrombotic thrombocytopenic purpura

Keywords: caplacizumab platelet responses attp ittp
iron intravenous therapy in reducing the burden of severe arrhythmias in heart failure with reduced ejection fraction

Conditions: Ferric Carboxymaltose; Heart Failure With Reduced Ejection Fraction; Arrhythmias, Cardiac

Summary: an open label,single-center, non-interventional prospective study with the aim on investigating the effect of intravenous ferric carboxymaltose in restoring iron status and reducing the risk of severe arrhythmic events in participants with iron deficiency and a reduced ejection fraction (hfref).

patients with hfref already scheduled to receive iv fcm to treat iron deficiency will be included in this registry trial. these patients undergo clinical examination, echocardiography, blood testing, 6-minute walking testing, cardiopulmonary exercise testing, cardiac implantable device interrogation, 24-hour holter monitoring and quality of life quantification as part of standard clinical practice. this database will be extracted from clinical databases and stored on a separate, registry database. the study will examine the effect of iv fcm on patients' iron stores, arrhythmic burden, hospitalizations and clinical, echocardiographic, exercise-testing-derived and biological markers of disease severity such as 6-minute walking distance, peak vo2 consumption, lvef and lv global longitudinal strain and nt-probnp.

Eligibility criteria:
inclusion criteria: * diagnosis of hfref (lvef≤40%) * implanted cardiac implantable electronic device with at least 3 months of recorded arrhythmic history * patient is scheduled to receive iv ferric carboxymaltose to treat diagnosed iron deficiency exclusion criteria: * myocardial infarction, acute heart failure or life-threatening arrhythmias in the preceding 15 days * autoimmune disorders, cancer or other diseases other than heart failure that significantly affect patients' life expectancy, appetite and emotional status * known allergic reaction to ferric carboxymaltose.

Keywords: ferric carboxymaltose heart failure arrhythmias
evaluation of renal function in subjects who had undergone cardiac surgery

Conditions: Cardiac Surgery

Summary: to evaluate the differences between serum cystatin c based estimated glomerular filtration rate (egfrcys), serum creatinine based egfr (egfrcreat) and measured glomerular filtration rate (mgfr) in subjects at high risk for acute kidney injury (aki) approximately 90 days following cardiac surgery

this is an open label, single-visit study to evaluate the relationship between mgfr and egfr based either on serum creatinine (egfrcreat) or cystatin c (egfrcys) approximately 90 days following cardiac surgery. no investigational study drug will be administered.

Eligibility criteria:
key inclusion criteria: * male or female, age ≥ 45 years old * at risk for aki following cardiac surgery on the basis of at least one of the following pre-operatively assessed risk factors: 1. reduced renal function 2. diabetes with ongoing insulin treatment 3. albuminuria * have undergone non-emergent open chest cavity cardiovascular surgeries, with use of cardiopulmonary bypass (cpb), with or without hypothermic circulatory arrest key exclusion criteria: * emergent surgeries, including aortic dissection, and major congenital heart defects * past cardiac surgery off cpb * have a known allergy to iohexol

Keywords: gfr acute kidney injury aki
study to assess the efficacy, safety, and tolerability of intravitreal aflibercept compared to laser photocoagulation in patients with retinopathy of prematurity

Conditions: Retinopathy of Prematurity

Summary: the primary objective of the study is to assess the efficacy of aflibercept compared to laser in patients diagnosed with retinopathy of prematurity (rop). the secondary objectives of the study are to assess the need for a second treatment modality, to assess the recurrence of rop in the study and to assess the safety and tolerability of aflibercept.


Eligibility criteria:
key inclusion criteria: * gestational age at birth ≤ 32 weeks or birth weight ≤1500 g * patients with treatment-naïve retinopathy of prematurity (rop) classified according to the international classification for rop in at least one eye as: * zone i stage 1 plus, or 2 plus, or 3 non-plus or 3 plus, or * zone ii stage 2 plus or 3 plus, or * aggressive posterior retinopathy of prematurity (ap-rop) key exclusion criteria: * known or suspected chromosomal abnormality, genetic disorder, or syndrome * previous exposure to any intravitreal (ivt) or systemic anti-vascular endothelial growth factor (vegf) agent, including maternal exposure during pregnancy and/or during breastfeeding * clinically significant neurological disease (eg, intraventricular hemorrhage grade 3 or higher, periventricular leukomalacia, congenital brain lesions significantly impairing optic nerve function, severe hydrocephalus with significantly increased intracranial pressure) * pediatric conditions rendering the infant ineligible for study intervention at baseline or for repeated blood draws as evaluated by a neonatal intensive care unit specialist and a study ophthalmologist * presence of active ocular infection within 5 days of the first treatment * advanced stages of rop with partial or complete retinal detachment (rop stage 4 and stage 5) * rop involving only zone iii note: other protocol defined inclusion/exclusion criteria apply.
evaluation of pascal laser trabeculoplaty

Conditions: Open Angle Glaucoma; Ocular Hypertension

Summary: laser trabeculoplasty has been shown to be effective in lowering intraocular pressure (iop) in patients with primary open-angle glaucoma (poag). although initially demonstrated with the argon laser (alt), several other laser systems have also been employed with comparable efficacy. recently, selective laser trabeculoplasty (slt) has been shown to lower intraocular pressure comparable to alt. the advantage of slt is that the target eye structure, the trabecular meshwork, remains intact with minimal damage at the cellular level. in contrast, alt lowers iop at the expense of scarring of the trabecular meshwork. the purpose of this study is to evaluate the efficacy of lowering iop with pascal laser trabeculoplasty (plt) employing reduced energy levels compared to alt and a computer guided pattern of laser treatment applications.


Eligibility criteria:
inclusion criteria: 1. otherwise healthy males and females, older than 18 years of age with two (2) sighted eyes 2. have oag, pxg, or combined mechanism glaucoma - as long as their angles are open 3. have uncontrolled iop (\>24mmhg); or controlled with medicine(s) 4. if on medical treatment, have undergone a washout period of at least one month prior to pascal treatment 5. able and willing to comply with the treatment/follow-up schedule and requirements; 6. able to provide written informed consent exclusion criteria: 1. pregnant, intending to become pregnant during course of study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding 2. have an advanced visual field defect within 10° of fixation 3. have had previous glaucoma surgery, except for peripheral iridotomy 4. have corneal disease obviating the use of corneal applanation for a reliable iop measurement, or would cause difficulty in viewing the tm by means of gonioscopic lens 5. using systemic steroids 6. participation in a study of another device or drug within 3 month prior to study enrollment or during this study, and as per the investigator's careful discretion, as long as not contradictory to any of the above criteria 7. any condition which, in the investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study 8. no concomitant use of iop lowering medicine (group 1) 9. no co-existing ocular pathology with the exception of cataract.

Keywords: open angle glaucoma ocular hypertension laser trabeculoplasty
autosomal dominant polycystic kidney disease somatic mutation biorepository

Conditions: Autosomal Dominant Polycystic Kidney Disease

Summary: this study will analyze the germline and somatic mutations underlying the development of adpkd in order to better understand the genetic mechanism responsible for the cystic transformation. once identified, these mutations could help us understand better the mechanism leading to the development of this disease and may explain at least in part the phenotypic variability.

the presentation of adpkd renal and extrarenal manifestations varies widely, even within families, and has been attributed to numerous genetic factors. one principal explanation came with the discovery that renal cyst lining cells from adpkd patients undergo secondary somatic mutations, selective loss of the second copy of a respective normal polycystic kidney disease (pkd) gene. these somatic mutations can occur in either polycystic kidney disease 1 (pkd1) or polycystic kidney disease 2 (pkd2). furthermore, various cysts in the same patient have been reported to harbor different somatic mutations. these findings implicated a cellular recessive mechanism for cyst formation in adpkd, suggesting the possibility that the observed intra-familial variation in disease phenotype may, at least in part, be explained by variation in mutation type, the timing and number of somatic "second-hit" mutations in individual family members affected with the disease. however, there is currently very little known about the cellular genetic mechanism leading to cysts development and very few studies, addressing this issue.

Eligibility criteria:
inclusion criteria: * males or females * 18 years of age or older * confirmed diagnosis of adpkd * undergoing a native nephrectomy * willing and able to provide informed consent exclusion criteria: * unable or unwilling to provide informed consent
angiogenic factors in the placentas of women with covid-19

Conditions: COVID-19; Placenta Diseases; Angiogenesis

Summary: aim: there have been few studies since the beginning of the pandemic researching the histopathologies and conducting molecular investigations of the placentas of sars-cov-2 positive pregnant women. the aim of this study was to analyze the changes in the expression of angiogenic growth factors in the placentas of pregnant women infected with sars-cov-2 (the covid-19 group), and to make comparisons with the placentas of non-infected pregnant women (the control group). methods: placentas taken at birth from 20 healthy women (control) and 20 women with a positive test for covid-19 were prepared for histopathological examination. immunohistochemical staining was applied in placental tissues with ace2 (angiotensin-conversion enzyme-2), vegf (vascular endothelial growth factor), vegfr-1 (vascular endothelial growth factor receptor 1) and pdgf (platelet-derived growth factor). results: first, the presence of covid-19 in the placental tissue was assessed by the ace2 immunohistochemical method. it was seen that ace2 was expressed weakly in the placental syncytiotrophoblast cells of non-infected women, but in the syncytiotrophoblasts of the placentas of women infected with covid-19, ace2 expression was much higher. vegf in the endothelial and stromal cells of the villi of the control group was very strong, but in the villi of infected placentas it was significantly weaker. vegfr-1 was positive in the endothelial membranes of the villi of the control group, but was significantly weaker in the villi of infected placentas. pdgf expression was strong in the syncytiotrophoblast and stromal cells of the control group, but was significantly noticeably weaker in covid-19 positive placentas.


Eligibility criteria:
inclusion criteria: * covid-19 patients while pregnancy * age range 18-50 * being literate in turkish * not having any additional disease * agreeing to participate in the study exclusion criteria: * high-risk pregnancies (gestational hypertension, preeclampsia, hellp syndrome, chronic hypertension, gestational and pregestational diabetes, cholestasis, intrauterine growth retardation, etc.) * multiple pregnancy * pregnant women under the age of 18 * smoking * medication use (excluding routinely used food supplements during pregnancy) * additional disease (thyroid, renal failure, liver failure, hepatitis, heart disease, connective tissue disease, etc.) * immunosuppressive use * presence of active or chronic infection * presence of active or chronic inflammatory disease * patients who gave birth at an external center or later chose to withdraw from the study * patients who did not have covid-19 while pregnancy included in the control group

Keywords: covid-19 placenta vegf vegfr-1 pdgf immunohistochemistry
an open-label, single-dose pilot study to evaluate varisolve® (polidocanol endovenous microfoam (pem)) 0.125% [0.2%] for varicose veins

Conditions: Varicose Veins

Summary: to determine the effect and safety of varisolve® 0.125% \[0.2%\]

in patients with sfj incompetence due to reflux of the great saphenous vein (gsv) or major accessory veins, with venous disease manifested by both symptoms and visible varicosities: using duplex ultrasonography, to evaluate the efficacy of varisolve® 0.125% \[0.2%\] as assessed by the elimination of sfj reflux and/or occlusion of the treated vein

Eligibility criteria:
inclusion criteria: 1. male or female; age of consent to 75 years 2. baseline veines-sym questionnaire score less than 75 points 3. superficial venous disease manifested by both symptoms and visible varicosities 4. varicose vein clinical classification ceap 2 through 5 5. incompetence of sfj (reflux \> 0.5 seconds on duplex ultrasonography) associated with incompetence of the great saphenous vein (gsv) or other major accessory vein 6. ability to comprehend and sign an informed consent document and complete study questionnaires in english exclusion criteria: 1. incompetence of the small saphenous vein (ssv) 2. ultrasonographic or other evidence of current or previous deep vein thrombosis, occlusion or incompetence 3. leg obesity impairing the ability to access the vein to be treated and/or to follow the post-procedural compression recommendations. 4. peripheral arterial disease in the leg to be treated contraindicating post-procedural compression. 5. reduced mobility (inability to maintain a brisk walk unaided for a minimum of 5 minutes per hour per day). 6. planned prolonged automobile, bus, or air travel within 4 weeks following treatment, unless the patient can walk for at least 5 consecutive minutes every hour during travel. 7. history of pulmonary embolism or stroke. 8. major surgery, prolonged hospitalization or pregnancy within 3 months of screening. 9. current anticoagulation therapy (within 7 days of enrollment). 10. participation in a clinical study involving an investigational pharmaceutical product or device within the 3 months prior to screening. 11. previous treatment in this study or in a previous varisolve® study. 12. major co-existing disease (e.g. malignancy; pulmonary disease; renal or hepatic insufficiency; serious skin disease/condition that may compromise the ability of the patient to comply with the compression protocol, etc.) or clinically significant laboratory abnormalities. 13. known allergic response to polidocanol, or severe and multiple allergic reactions. 14. women of childbearing potential not using effective contraception for at least one month prior to study enrollment and/or unwilling to continue birth control until their last study visit. 15. pregnant or lactating women. 16. current alcohol or drug abuse.

Keywords: varicose veins