Kornimate/medical-research-clean huggingface dataset:
comparison of autologous platelet-rich plasma with hyaluronic acid for the treatment of osteoarthritis of the knee joint

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to compare the efficacy of platelet-rich plasma versus hyaluronic acid intra-articular injections for the treatment of osteoarthritis of knee joint. the hypothesis is that prp intra-articular injection is comparable or even better than hyaluronic acid injection.

osteoarthritis (oa) has a significant impact on our society. the limited regenerative capacity of cartilage is part of this problem. existing degenerative lesions lead to accelerated deterioration of the articular (joint) surface leading to end-stage arthritis. in particular, the most recent knowledge regarding tissue biology highlights a complex regulation of growth factors (gfs) for the normal tissue structure and the reaction to tissue damage. the influence of gfs on cartilage repair is now widely investigated in vitro and in vivo. platelet rich plasma (prp) is a simple, low- cost and minimally- invasive method that allows one to obtain a natural concentrate of autologous gfs from the blood, and it is increasingly applied in the clinical practice to treat knee degenerative pathology, such as chondropathy and early oa. the biological rational of prp is that platelets contain storage pools of gfs, cytokines, chemokines and many other mediators.although its widespread application, there are little high level studies in the literature to demonstrate the real efficacy of prp. the investigators hypothesized that intra-articular injections of prp to treat knee osteoarthritis could determine pain relief and recovery of knee function with overall clinical outcome comparable or even better than viscosupplementation, which is a common injective approach applied in this kind of pathology. to this purpose the investigators designed a double blind randomized controlled trial comparing prp vs viscosupplementation.

Eligibility criteria:
inclusion criteria: * patients with osteoarthritis of knee (by american college of rheumatology criteria) and kellgren-lawrence grade i \~ iii * more than 40 out of 100-mm vas scale for pain at screening and baseline * participant is willing and able to give informed consent for participation in the study exclusion criteria: * patients with hb values \< 10 g/dl and platelet values \< 100,000/ul * patients with a current or medical history of autoimmune disease * recent fever ( within 2 weeks) or serious illness * local infection at the site of the procedure * corticosteroid injection at treatment site within 1 month * systematic use of corticosteroids within 2 weeks * female participants who are pregnant, lactating or planning pregnancy during the course of the study * patients who have been administered with immunosuppressants within the past 6 weeks * patients who are enrolled in any other clinical trials within 4 weeks * patients who the principal investigator considers inappropriate for participation in the clinical trial for reasons other than those listed above

Keywords: osteoarthritis, platelet-rich plasma, hyaluronic acid
effect on hba1c of the initiation of cgm in adults with type 2 diabetes treated with basal insulin in finland

Conditions: Type 2 Diabetes Treated With Insulin

Summary: the goal of this clinical study is to determine the impact of starting the use of the freestyle libre 2 glucose monitoring system, over a three month period, on hba1c in adults with type 2 diabetes treated with a basal insulin regimen.

this is a post-market, multi-centre, prospective, interventional single arm study in finland. participants will use the freestyle libre 2 flash glucose monitoring system, according to the labelling, to monitor their glucose for approximately 3 months. additional therapies may be introduced, if clinically indicated, based on review of the participant's clinical data and in line with national guidance. hba1c will be tested at the start and end of the study for primary endpoint analysis.

Eligibility criteria:
inclusion criteria: * aged ≥18 to ≤ 75 years. * type 2 diabetes diagnosis ≥1 year prior to enrolment. * type 2 diabetes treated with a basal insulin injection regimen with or without other antihyperglycaemic therapy at enrolment. * current glucose lowering treatment regimen has been established for at least 3 months prior to enrolment. * screening hba1c ≥59 mmol/mol to ≤108 mmol/mol (≥7.5% and ≤12.0%, inclusive), within the last 60 days. exclusion criteria: * participant is currently prescribed prandial or pre-mixed (biphasic) insulin at enrolment. * currently participating in another study that could affect glucose measurements or glucose management. * currently receiving dialysis treatment or receives dialysis during the study. * a female participant who is pregnant. * a breastfeeding female participant.
quantification of chest wall changes after nuss bar removal utilizing three-dimensional optical surface scans

Conditions: Pectus Excavatum

Summary: pectus excavatum is the most common anterior chest wall deformity that affects up to 1:400 of newborns. if an operative correction is indicated, patients are often operated via the ravitsch or nuss bar procedure. the latter (i.e. the nuss bar procedure) is the most commonly performed procedure. during this procedure one or more metal bars are inserted behind the sternum to push the sternum back into its normal position. these bars remain in situ for two-to-three years before being removed. despite the fact that the nuss bar procedure is regarded as an effective procedure, retraction may occur after removal. a recent study has investigated this phenomenon, utilizing three-dimensional (3d) optical surface scans acquired before and after nuss bar removal. the authors found statistically significant changes to occur in chest wall dimensions directly after, as well as between 2 and 8 weeks after nuss bar explantation, in comparison to the situation just prior to bar removal. they, moreover, found the time the bar was in situ to be predictive for retraction. however, the authors also stressed that further studies are needed to reinforce their preliminary findings and perform long-term assessments. subsequently, a similar study with long-term assessments will be conducted.


Eligibility criteria:
inclusion criteria: * patients that received 1 or more nuss bar(s) to treat pectus excavatum and is/are scheduled to be removed due to the end of treatment. exclusion criteria: * patients in which the nuss bar(s) or its stabilizers are or have been dislocated. * patients that received a second operation to treat any complications regarding the initial nuss bar implantation. * patients with proven connective tissue diseases (e.g. marfan's syndrome). * patients with a diagnosis of epilepsy (as the 3d scanner utilizes flashing light to acquire the torso topography) * patients that are not fit to remain in a standing position with their arms above shoulder level for a maximum of 60 seconds.

Keywords: three-dimensional optical surface imaging chest wall changes
ertugliflozin to reduce arrhythmic burden in icd/crt patients (erase-trial) - a phase iii study

Conditions: Heart Failure With Reduced Ejection Fraction; Heart Failure With Mid Range Ejection Fraction; Implantable Cardioverter-Defibrillators; Cardiac Resynchronization Therapy

Summary: the recent study is planned to investigate the impact of ertugliflozin on total burden of ventricular arrhythmias. further objectives will be number of therapeutic interventions of implanted devices, atrial fibrillation, heart failure biomarker and changes in physical function quality of life, stress and anxiety.

this is a randomized, double-blind (patients and physicians), placebo controlled multi-center study to evaluate the effect of ertugliflozin 5mg once daily (p.o.) for 52 weeks on the ventricular arrhythmic burden and markers of physical and mental well-being as well as biomarker for heart failure with reduced ejection fraction (hfref) and heart failure with mid-range ejection fraction (hfmref) patients with icd±crt therapy. the study will be conducted in 8 experienced sites in austria with an aim to enrol 402 patients to evaluate the overall study hypothesis. therefore, three study visits will be carried out (baseline, 1-year follow-up visit and a telephone visit 4 weeks after visit 2). as part of the two on-site study visits, study-specific measures, a blood sample and an echocardiographic examination will be performed. the trial is completed by a telephone visit 4 weeks after the second on-site visit (week 52). it is anticipated that the study will run for 30 months.

Eligibility criteria:
inclusion criteria: 1. hfref or hfmref, and icd±crt therapy \> 3 months 2. at least 10 documented vt episodes (either nsvt (non-sustained ventricular tachycardia) or svt (sustained ventricular tachycardia) ± icd (mplantable cardioverter-defibrillator) treatment) within the last 12 months plus: * nt-probnp \> 500pg/ml or * left-ventricular ejection fraction (lv-ef) \< 35% or * hospitalization for heart failure within the last 12 months or * \> 100 nsvts within the last 12 months * \> 1 svt/vf (ventricular function) within the last 12 months 3. informed consent has to be given in written form. 4. estimated glomerular filtration rate (egfr) \> 30 ml/min/1.73m2 5. blood pressure before first drug dosing: blood pressure systolic \> 100 mmhg 6. blood pressure before first drug dosing: blood pressure diastolic \> 60 mmhg exclusion criteria: 1. any other form of diabetes mellitus than type 2 diabetes mellitus, history of diabetic ketoacidosis 2. ongoing ventricular arrhythmia 3. known allergy to sglt-2 inhibitors 4. haemodynamic instability as defined by intravenous administration of catecholamine, calciumsensitizers or phosphodiesterase inhibitors 5. \>1 episode of severe hypoglycemia within the last 6 months under treatment with insulin or sulfonylurea 6. planned catheter ablation for ventricular arrhythmia 7. planned explantation of icd, or planned up/downgrade to/from crt-d device 8. existing therapy with sglt-2 inhibitors

Keywords: ertugliflozin sodium dependent glucose transporter-2 inhibitor (sglt-2) heart failure icd crt ventricular tachycardia (vt)
vitamin b12 status and its impact on chronic haemodialysis patient

Conditions: End Stage Renal Disease on Dialysis; Vitamin B 12 Deficiency

Summary: to evaluate vitamin b12 level in haemodialysis patients and its impact on hematological and neurological manifestations

vitamin b12 (cobalamin) is a water-soluble vitamin involved in several normal cellular functions (1). vitamin b12 is required for the development, myelination, and function of the central nervous system; healthy red blood cell formation; and dna synthesis (2- 4). low levels of vitamin b12 have been associated with high concentrations of homocysteine (hcy) and can lead to health complications (5). hyperhomocysteinemia is an important risk factor for cardiovascular disease (6). vitamin b12 and other b vitamins are involved in homocysteine metabolism, and researchers have hypothesized that supplementation with these micronutrients can reduce the risk of cardiovascular disease by lowering homocysteine levels (7, 8). vitamin b12 deficiency is one of the causes of macrocytic anaemia with increased mean corpuscular volume (mcv), defined as more than 100 fl, which is the hallmark of megaloblastic anaemia

Eligibility criteria:
inclusion criteria: * end stage renal disease on haemodialysis pts. * parients more than 18 years . * ckd patients controled group stage 3and stage 4. exclusion criteria: * recent renal transplantation patients. * patients on sulpha drugs. * patients on methotrexate. * patients on anticonvulsant. * patients on chemotherap agent. * patients on colchicine. * patients on bile acid sequestrant. * patients on h2blockers. * patients on metformin. * patients on proton pump inhibitors . * diabetic patients. * parients with history of intestinal surgery. * patients diagnosed with malabsorption syndrome. * patient on vitamin b12 intake.
bioavailability study of tramadol/apap tablets under fed conditions

Conditions: To Determine Bioequivalence Under Fed Conditions

Summary: to compare the relative bioavailability of kali and ortho-mcneil's products

to compare the relative bioavailability of kali's tramadol/apap 37.5mg/325mg with ortho-mcneil's ultracet tablets 37.5mg/325mg

Eligibility criteria:
inclusion criteria: * healthy males and females between 18 and 45 years of age inclusive * informed of the nature of the study and given written informed consent. * have a body weight within 15% of the appropriate range as defined in the 1983 metropolitan life company tables and weighing at least 100lbs. exclusion criteria: * hypersensitivity to tramadol/ acetaminophen, opioids such as morphine and codeine, or related compounds, or a history or seizures. * any history of a clinical condition which might affect drug absorption, metabolism or excretion. * recent history (within one year) of mental illness, drug illness, drug abuse or alcoholism. * donation of greater than 500ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood. * received an investigational drug within the 4 weeks prior to study dosing. * currently taking any prescription medication, except oral contraceptives, within 7days prior to study dosing or over-the-counter medication within 3 days of the study dosing. * this prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the physician. * tobacco use(\>5 cigarettes per day)in the 3 months prior to study dosing. * if female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the two treatment periods. * females of child bearing potential must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. * medically acceptable methods of contraception that may be used by the subject and/or her partner are:oral contraceptive, progestin injection or implants, condom with spermicide, diaphragm with spermicide, iud, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence. * females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.

Keywords: bioequivalence, single-dose, fed
therapeutic equivalence and safety of two econazole nitrate cream, 1% products in tinea pedis

Conditions: Tinea Pedis

Summary: to evaluate the therapeutic equivalence of the test formulation, econazole nitrate cream, 1% to the reference product, econazole nitrate cream, 1% in the treatment of tinea pedis. to demonstrate the superiority of the test and reference (active) treatments over placebo treatment in patients with tinea pedis. to compare the safety of test, reference and placebo treatments in patients with tinea pedis.


Eligibility criteria:
inclusion criteria: * healthy male or non-pregnant, non-lactating female ≥ 18 years of age. * clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot (the non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin). * provisionally confirmed at baseline by a positive potassium hydroxide (koh) wet mount preparation * total score ≥ 4 for the clinical signs and symptoms of tinea pedis in the target area. in addition the target area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for either pruritus or scaling. exclusion criteria: * presence of any other infection of the foot or other disease process that, in the investigator's opinion, may interfere with the evaluation of the patient's tinea pedis * history of or current psoriasis, lichen planus or contact dermatitis involving the feet within the previous 12 months. * past history of dermatophyte infections with a lack of response to antifungal therapy * confluent, diffuse moccasin-type tinea pedis of the entire plantar surface or onychomycosis involving ≥ 20% of the area of either great toenail and/or involving more than five toenails in total or other concurrent dermatophytoses (e.g., tinea cruris) and any other skin disease to an extent that, in the opinion of the investigator, might interfere with the evaluation of tinea pedis or study results
parkinson's disease registry of the muhammad ali parkinson center

Conditions: Parkinson's Disease

Summary: the purpose of the parkinson's disease registry is to develop a national and international database of persons with parkinson's disease (pd). the registry will be used to facilitate the development of new therapies and healthcare services to improve the quality of life for people with pd. it will also be a means for investigators in the field of pd to quickly identify and notify subjects about other research studies for which they are eligible. objectives include: * assess current treatment approaches and develop best-practice guidelines * track the functional abilities, access to healthcare and cost of illness of people with pd over time * drive the development of innovative research projects * accelerate the process of informing patients of research projects for which they may be eligible

what do you need to know? * any individual diagnosed with pd is eligible to enroll. * participation in the registry is voluntary, confidential and free of charge. * eligible participants will be notified about opportunities to participate in clinical trials, though they are under no obligation to enter. * participants will need to complete an updated questionnaire every six months. * participants may also be asked to complete additional surveys for pd research projects. * any data provided will be used in scientific publications in summary form only. * participant names will not be released to anyone outside the parkinson's disease registry management team without written authorization, nor will names be sold for advertising or fund-raising purposes.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of parkinson's disease exclusion criteria: * no clinical diagnosis of parkinson's disease

Keywords: parkinson's disease parkinson disease registry quality of life database
study of the impact of a school program combining - promotion of hpv vaccination and hpv vaccine offer in middle school - on adherence to hpv vaccination in middle school students

Conditions: Papilloma Viral Infection

Summary: cervical cancer (ccu) is the fourth most common cancer in women worldwide. in reunion island, ccu is the third leading cause of cancer in women (standardized incidence rate on the world population (tis) in 2013 of 10.3 / 100,000) and is the eighth deadliest cancer with a rate standardized mortality of 4.8 / 100,000, almost three times higher than in mainland france where it was 1.7 / 100,000 in 2018. ccu results from infection with the human papillomavirus (hpv), which is the most common sexually transmitted viral infection. ccu prevention is mainly based on cervical smear screening and anti hpv vaccination (vhpv) which has demonstrated its effectiveness on the prevalence of hpv carriage, but also on incidence of condyloma or intermediate grade dysplasia. since hpv is mainly transmitted sexually, it is important to vaccinate before the start of sex. in reunion island, the hpv vaccination coverage rate is the lowest in france, estimated by public health france at 8.1% among girls aged 16 years in 2018, while the already low national average was established 23.7%. thus, in view of the epidemiological situation in reunion island (high incidence and mortality for the ccu, very low vhpv coverage rate), we thought it would be interesting to study the impact of a health promotion program sex and prevention of sexually transmitted infections (stis) including papillomavirus-related pathologies, with a program to promote hpv vaccination among young students in middle school.


Eligibility criteria:
inclusion criteria: * schooled in one of the classes drawn at random in the 2 colleges selected for the study, * members or beneficiaries of a social security scheme, * having agreed to participate in the study and whose parents or holder (s) of parental authority have signed a free, informed and written consent. exclusion criteria: * under the age of 9, or over the age of 17 at inclusion, * with hypersensitivity to the active substances or to any of the excipients of the vaccine (gardasil 9®), * with a permanent contraindication to vaccination. * having already initiated the hpv vaccination (complete or incomplete scheme). students with an incomplete vaccination schedule will be referred to their attending physician to complete the missing dose (s). * pregnancy or breastfeeding (based on the declaration)
babydiet-study - primary prevention of type 1 diabetes in relatives at increased genetic risk

Conditions: Type 1 Diabetes

Summary: the major goals of this project are to determine whether primary intervention through delayed introduction of dietary gluten is feasible and could reduce the incidence of islet autoimmunity in high-risk first degree relatives of patients with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * newborn offspring or siblings of patients with type 1 diabetes with a hla genotype conferring a high diabetes risk exclusion criteria: * if infants have an illness or birth defect that precludes long-term follow-up or involves use of treatment that may alter the natural history of diabetes
equivalence study of tuberculin purified protein derivative in comparison with a reference standard (ppd-s2)

Conditions: Tuberculosis Identification.

Summary: a study to determine bioequivalence of ppd material versus reference standard.

this study is a multicenter, double-blind, active-controlled parallel-group study to determine the bioequivalence of newly produced ppd material versus ppd-s2 in the detection of male and female subjects with current or previously diagnosed intrathoracic mtb infection, as documented by a positive culture for mtb (preferred method), by their primary care or attending physician and/or by the subject's current or prior medical records (ie, sensitivity determination).

Eligibility criteria:
inclusion criteria: 1. males or nonpregnant females age 18 to 60 years 2. documented ppd reactivity of 5 to 21 mm in the past, documented in a medical record. self-reported ppd reactivity will be acc 3. give written informed consent to participate 4. generally healthy, as determined by medical history and targeted physical examination, if indicated 5. possess 2 forearms that are free of burns, scars, eczema, or any physical deformity, which could impair injection of study prepar 6. comprehension of the study requirements; expressed availability for the required study period, including readings at the nomina exclusion criteria: 1. prior ppd test within the past 30 days 2. subject is of childbearing potential and unable to use contraceptives; is planning pregnancy; is pregnant or lactating 3. history of anaphylactic reaction, severe positive tuberculin reaction (eg, ulceration, necrosis) or other severe reaction to ppd in 4. subject received a bacillus calmette-guérin (bcg) vaccination in the past, or was born or lived outside the us as a child and is 5. presence of conditions that may suppress tst reactivity -

Keywords: ppd tuberculosis