Kornimate/medical-research-clean huggingface dataset:
3 anthracyclines, 2 types of consolidation with different ara-c doses and maintenance in adult acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: the goal: to evaluate the role of high dose ara-c plus idarubicin and mitoxantrone consolidation followed by maintenance in the setting of high total cumulative anthracyclines dose(720-660 mg/m2).

in previous russian aml multicenter studies it was shown that escalation of ara-c dose (from 5,6 g to 72 g in 4 induction/consolidation courses) in parallel with anthracyclines dose reduction (from 630 mg/m2 to 285 mg/m2)did not improve survival, but decreased feasibility. in the ongoing trial we try to learn whether anthracyclines dose escalation (up to 720-660 mg m2) will or will not equivalise the standard (5,6 g in 4 induction/consolidation courses) and high (14,8 g) ara-c doses.

Eligibility criteria:
inclusion criteria: * de novo acute myeloid leukemia - age 15-60 exclusion criteria: * secondary acute myeloid leukemia * acute myeloid leukemia from myelodysplastic syndrome * ph+ acute myeloid leukemia

Keywords: acute myeloid leukemia anthracyclines high dose cytarabine maintenance
detection of plasmatic cell-free braf and nras mutations : a new tool for monitoring patients with metastatic malignant melanoma treated with targeted therapies or immunotherapy ( malt )

Conditions: Malignant Melanoma Stage IV; Malignant Melanoma Stage III

Summary: the main objective of this project is to perform a longitudinal monitoring of braf and nras cell-free dna in a large cohort of metastatic melanomas patients before treatment and during the follow-up. results will be compared with clinical data as imaging (based on recist criteria) and the activity of lactate dehydrogenase in serum (ldh).

during a consultation of follow-up for an advanced malignant melanoma (stage iiib or iiic or iv), an investigator presents the study to the patient and give him the note of information and the informed consent. the patient can benefit from a reflexion period of of 7 days. in case of agreement, a first blood draw will take place before initiation of any treatment. between d15 and d30 a second blood draw will be taken. then a blood draw will be necessary every two months until recurrence or progression of the disease for a maximum of 22 months.

Eligibility criteria:
inclusion criteria: * patients in metastatic situation for a malignant melanoma inoperable stage iiib or iiic or stage iv * in first line of treatment by a targeted therapy (only or in association) or immunotherapy * every histological types of cutaneous or mucous malignant melanoma (excepted choroid melanomas) * the tumor must be mutates for braf or nras * the mutation status must have been realized in the laboratory pathology clinical and experimental (lpce) of the chu de nice analysis of the status on-site metastatic mutational and/or primitive tumor must * membership or beneficiary of the national insurance scheme exclusion criteria: * histories of cancer or other synchronous cancer * pregnant, breast-feeding women. a pregnancy test will be practiced to the women old enough to procreate. * vulnerable people: adults under guardianship, patients deprived of freedom, minor
efficacy of the mepitel® film on the prevention of radiodermatitis in the inguinal fold.

Conditions: Radiodermatitis; Radiation Toxicity; Radiotherapy Side Effect

Summary: the aim is to quantify the efficiency of the safetac product mepitel® film on the prevention of radiodermatitis for cancer patients treated with external beam radiation therapy near the inguinal fold(s). previous studies have looked into the differences in skin reactions for mepitel® film versus hydro-active colloid gel in breast cancer \[1, 2\] and head and neck cancer \[3\]. in breast cancer, the prevalence of radiation induced dermatitis has strongly decreased due to of modern radiotherapy techniques and fractionation. in the groin, however, this is not the case, and radiation dermatitis remains an important problem. to the best of our knowledge, no previous study has looked into the efficiency of a prophylactic mepitel® film protocol in the inguinal fold. the goal of this study is to evaluate whether the mepitel® film offers a lower degree of radiation-induced dermatitis compared to hydro-active colloid gel and thereby challenging the gold standard. references: 1. herst, p., bennett, n., sutherland, a., peszynski, r., paterson, d. and jasperse, m. (2014). prophylactic use of mepitel film prevents radiation-induced moist desquamation in an intra-patient randomised controlled clinical trial of 78 breast cancer patients. radiotherapy and oncology, 110(1), pp.137-143. 2. møller, p., olling, k., berg, m., habæk, i., haislund, b., iversen, a., ewertz, m., lorenzen, e. and brink, c. (2018). breast cancer patients report reduced sensitivity and pain using a barrier film during radiotherapy - a danish intra-patient randomized multicentre study. technical innovations \& patient support in radiation oncology, 7, pp.20-25. 3. wooding, h., yan, j., yuan, l., chyou, t., gao, s., ward, i. and herst, p. (2018). the effect of mepitel film on acute radiation-induced skin reactions in head and neck cancer patients: a feasibility study. the british journal of radiology, 91(1081), p.20170298.


Eligibility criteria:
inclusion criteria: * patients with external beam radiotherapy of the bilateral inguinal nodal region, with at least 25 fractions of 1.8-2gy per fraction. exclusion criteria: * re-irradiation. * pregnancy. * patients under the age of 18. * patients not willing to participate (no informed consent).

Keywords: radiodermatitis mepitel film inguinal fold radiotherapy
a clinical trial to evaluate pharmacokinetics of daewon dw-es(a) 625mg/5ml, daewon dw-es(b) 625mg/5ml and megace 800mg/20ml in healthy male volunteers under fed condition

Conditions: Healthy Volunteers

Summary: the purpose of this study is to evaluate pharmacokinetics of daewon dw-es(a) 625mg/5ml, daewon dw-es(b) 625mg/5ml and megace 800mg/20ml in healthy male volunteers under fed condition.


Eligibility criteria:
inclusion criteria: * adult males aged 20 to 55 years at screening. * no significant congenital/chronic disease. no symptoms in physical examination. * appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis. * be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. subject must provide written informed consent prior to study participation. exclusion criteria: * history or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders. * history of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion. history of known hypersensitivity to drugs including valsartan and pitavastatin.

Keywords: megesterol
physical therapy for temporomandibular joint (tmj) closed lock

Conditions: Temporomandibular Joint Disorders; Temporomandibular Joint Disc Displacement, Without Reduction

Summary: the aim of the present study was to investigate the effect of physical therapy (pt) on pain and mandibular function in patients with anterior disc displacement without reduction (add-r) or "closed lock" of the tmj and this in a randomized controlled trial design.

the study evaluated the effect of extra, technical pt over the traditional information on the benign nature of the disease and the advice to refrain from overuse or misuse of the masticatory system as in parafunctions.

Eligibility criteria:
inclusion criteria: * all patients were recruited from the oral pain and dysfunction clinic and strictly satisfied the rdc-tmd criteria for .for disc displacement without reduction with (group iib) or without (group iic) limitation of mouth opening, based upon history and clinical examination. additionally, pain experienced during the first examination had to be ≥ 35mm on a visual analog scale (vas) of 100mm. exclusion criteria: * patients were excluded if their medical history mentioned orofacial traumata (contusion or fracture), systemic disorders (e.g. rheumatoid arthritis, fibromyalgia), cervical disorders (operationalized as complaints, pain or referral patterns of pain provoked during movements of the cervical spine), neurologic disorders (e.g. trigeminal neuralgia, migraine or tension type headache), drug or alcohol abuse, use of antidepressant or hormonal medication. participants did not receive therapy for symptoms of tmd within the last 2 months.

Keywords: temporomandibular joint rehabilitation medicine joint diseases physical therapy
tension free vaginal tape surgery - follow up after 10 and 20 years

Conditions: Urinary Incontinence,Stress

Summary: over the past 5-7 years there has been increasing concern about the use of polypropylene tapes in female incontinence surgery. there has been a special focus on pain in the vagina and lower abdomen and pain during sexual intercourse. some have also asked if the polypropylene tape could cause impairment of the immune system leading to allergy, connective tissue disorders etc. there are still only a few publications on complications after sling surgery. in norway it is mandatory to register all incontinence surgery in the national incontinence registry (norsk kvinnelig inkontinens register (nkir). in 2019 \>99 % of all procedures were registered in this registry. data about type and severity of incontinence are registered, as well as complications at surgery. the same data are entered at a 6 months and 3 years follow up. data for the follow up visits are not complete. the nkir registry and other similar registries have been criticized for not following the women long enough and therefore missing important information regarding long-term complications. few studies have followed the women for a longer time after surgery. the main aim of this study is to find the prevalence of women still satisfied with the tvt surgery and the prevalence of long-term complications after 10 and 20 years.


Eligibility criteria:
inclusion criteria: * had tvt surgery in norway january 2001-december 2002 (20-years follow-up cohort) * had tvt surgery in norway, \< 42 years at the time of surgery in 2011-2012 (10-years follow-up cohort) exclusion criteria: * dead * not willing to participate * moved out of norway

Keywords: surgery suburethral slings tension-free vaginal tape
effect of cytosorb on blood levels of inflammatory biomarkers of sepsis.

Conditions: Sepsis; Cytokine Storm

Summary: background: there is still an evident need for useful biomarkers and effective therapeutic approaches regarding the challenging management of sepsis. the aim of the study is to evaluate the effect of each cytosorb hemoadsorption therapy course on blood levels of inflammatory biomarkers of sepsis including endocan, copeptin, interleukin-6, procalcitonin, c-reactive protein.

this observational prospective study included patients, who were diagnosed with sepsis and treated in the reanimation icu of gaziantep university hospital with cytosorb therapy between june 1st, 2016 and june 30th, 2017. sepsis was diagnosed according to the third international consensus definitions for sepsis and septic shock (sepsis-3). exclusion criteria of the study were: (i) cardiovascular disease, (ii) multiple traumas, (iii) malignancies, (v) incomplete clinical data. approval of the ethical committee (ethical committee approval number 2018/04-02) was obtained. written informed consent was taken from each patient or their next-of-kin. patient demographics including age, gender, and origin of sepsis were recorded. arterial blood samples were taken from patients before and immediately after the cytosorb therapy course.

Eligibility criteria:
inclusion criteria: * patients, who were diagnosed with sepsis and treated in the reanimation icu of gaziantep university hospital with cytosorb therapy (sepsis was diagnosed according to the third international consensus definitions for sepsis and septic shock (sepsis-3)) exclusion criteria: * cardiovascular disease, * multiple traumas * malignancies * incomplete clinical data.

Keywords: endocan copeptin interleukin-6 cytosorb sepsis
an observational study of maviret (glecaprevir/pibrentasvir) for korean chronic hepatitis c genotypes 1 to 6 patients according to the standard for re-examination of new drugs

Conditions: Hepatitis C

Summary: post-marketing surveillance study to evaluate the real world safety and effectiveness of maviret (glecaprevir/pibrentasvir) administered under a normal, routine treatment practice by korean patients with chronic hepatitis c genotypes 1 to 6

patients with type c hepatitis genotypes 1-6 who had been prescribed maviret (glecaprevir/pibrentasvir) in accordance with approved local label. the sample size for this study is due to a requirement by local authorities.

Eligibility criteria:
inclusion criteria: * participants with chronic c hepatitis genotypes 1 to 6. * participants prescribed maviret in accordance with approved local label. exclusion criteria: - patients with contraindications to the approved local labels for maviret.

Keywords: hepatitis c chronic hepatitis c genotypes genotypes 1 to 6 maviret glecaprevir pibrentasvir
a clinical study to evaluate the safety and efficacy of platelet rich plasma injection for atrophic rhinitis

Conditions: Atrophic Rhinitis

Summary: the goal of the suggested research is to develop a treatment option using platelet rich plasma injection for regeneration of atropic nasal mucosa. specific aims of the suggested research is to (1) access the effect of platelet rich plasma in the patients with atropic rhinitis . moreover, we will (2) compare the conservative treatments including saline nasal irrigation or saline nasal spray.

clinical trials of platelet rich plasma injection for regeneration of atropic nasal mucosa. * injection interval and follow-up duration * injection interval 2 weeks (upto total 3 consecutive injection) * follow-up duration: 6 months * observation items, clinical assessment items and evaluation method * access the nasal mucosal status using nasal speculum. * access the nasal mucociliary function using saccharin test (primary outcome; once per month). * fill in the nasal symptom scores using nasal obstruction symptom evaluation(nose) instrument, sino-nasal outcome test 20, and visual analog scale (secondary outcome; once per month) * the other atrophic rhinitis patients who did not want to perform platelet rich plasma injection * random allocation to saline nasal irrigation or saline nasal spray group * perform same observation items, clinical assessment items and evaluation method as well as platelet rich plasma injection group

Eligibility criteria:
inclusion criteria: * adults (\>18 years) * complaint of atrophic rhinitis symptoms including nasal crusting, nasal burning sensation, and postnasal drip * atrophic rhinitis view on nasal endoscopic finding * patients who informed sufficient about other atrophic rhinitis treatment options including young's operation, lubricants, or saline irrigation, but, want more other active treatment option. exclusion criteria: * platelet related disorders * low serum platelet (\<100,000/㎕) * other hematologic disorders * septicemia * take anticoagulant drugs

Keywords: atrophic rhinitis
efficacy and safety of paricalcitol on the treatment of secondary hyperparathyroidism in calcitriol resistant dialysis subjects

Conditions: Secondary Hyperparathyroidism; Dialysis

Summary: the primary objective of this study is to evaluate the efficacy and safety of paricalcitol in participants with moderate to severe secondary hyperparathyroidism (shpt) undergoing hemodialysis who are resistant to treatment with calcitriol.

this is a multi-center, prospective, open label, one arm, phase iv study designed to demonstrate paricalcitol efficacy and safety in the treatment of moderate to severe secondary hyperparathyroidism in calcitriol resistant participants on dialysis. following screening, participants began an 8-week controlled calcitriol therapy period. participants whose parathyroid hormone (pth) levels decreased were to be discontinued from the study. those whose pth levels did not decrease began paricalcitol therapy using a dose calculated by 0.04 to 0.1 microgram per kilogram (mcg/kg). paricalcitol was administered intravenously at anytime during the subjects' dialysis. the paricalcitol dose was to be titrated every 2 weeks until ipth was reduced or up to 4 months, after which it was to be adjusted monthly for 1 year based on serum pth, calcium, phosphorus, and albumin measurements.

Eligibility criteria:
inclusion criteria: * male and female participants \> 18 years of age, with chronic kidney disease (ckd) stage v; * participants with diagnosis of calcitriol resistance defined as: episodes of hypercalcemia and/or hyperphosphatemia (defined as an episode of calcium or phosphorus above upper limit of normal or documented by medical history stating that the treatment with calcitriol was discontinued due to hypercalcemia and/or hyperphosphatemia) that precludes treatment continuation and/or persistent pth above 600pg/ml during the calcitriol therapy; * pth value at screening visit between 600 pg/ml and 2,000 pg/ml; * stable clinical conditions; * participant has voluntarily consented to participate in the study, by signing and dating an informed consent form, approved by an institutional review board (irb)/independent ethics committee (iec), after the nature of the study has been explained and all his questions about the study have been elucidated. the informed consent must be signed before any study-specific procedures are performed. exclusion criteria: * previous parathyroidectomy; * presence of hypercalcemia (corrected ca \> 10.5 mg/dl) and/or hyperphosphatemia (p \> 6.0 mg/dl) and/or ca x p product \> 60, at screening visit (corrected ca calculated by: \[4 - participant's serum albumin (g/dl)\] x 0.8 + participant's serum ca value); * severe and/or unstable clinical conditions, e.g., congestive heart failure, advanced cancer, advanced hiv disease, severe endocrinopathies, uncompensated diabetes mellitus, life-threatening cardiac arrhythmias, etc; * abnormal liver tests (\> 1.5 times above upper limit of normal); * pregnant or breast-feeding women; * evidence of vitamin d toxicity; * known hypersensitivity to any study drug components.

Keywords: dialysis calcitriol resistant secondary hyperparathyroidism
follow-up study for participants of jointstem phase 3 clinical trial

Conditions: Knee Osteoarthritis

Summary: the purpose of this follow-up study is to investigate the efficacy and safety of autologous adipose tissue derived mesenchymal stem cells (jointstem®) in patient with severe knee osteoarthritis.


Eligibility criteria:
inclusion criteria: * participants of jointstem phase 3 clinical trial * participates who signed informed consent document of this study exclusion criteria: * no applicable
improving cardiac rehabilitation participation in women and men

Conditions: Myocardial Infarction; Unstable Angina; Coronary Disease

Summary: the purpose of this study is to determine the effect of a pre-discharge written personal endorsement to the patient by the patient's attending cardiologist or cardiac surgeon (md endorsement) to take part in the cardiac rehabilitation and secondary prevention (cr) program, in addition to the standard cr referral, compared to the standard cr referral alone, on cr program enrollment within 2 months of index hospital discharge following admission for myocardial infarction, unstable angina, coronary angioplasty, or coronary artery bypass.

there is compelling evidence that a comprehensive cr program comprising the delivery of lifestyle modifying education will reduce mortality, morbidity and improve quality of life in patients following myocardial infarction, angioplasty or, coronary artery bypass. however, less than 20% of eligible patients participate in cr programs. this study will look at a method of potentially improving enrollment and adherence to a cr program. it is expected that patients who receive the md-endorsed referral will be more likely to attend the initial orientation appointment and more closely adhere to the 6-month comprehensive cr program, as compared to the patients who receive a standard cr referral alone.

Eligibility criteria:
inclusion criteria: * patient is admitted to hospital for myocardial infarction (mi), unstable angina (ua), percutaneous transluminal coronary angioplasty (ptca), or coronary artery bypass surgery (cabs) * patient resides within 1 hour driving time from london exclusion criteria: * inability to provide written informed consent or complete survey due to language or cognitive difficulties * previous cardiac rehabilitation participation * patient scheduled to undergo ptca or cabs within two months following the index hospital discharge * inability to exercise due to musculoskeletal problems or previous or current stroke

Keywords: cardiac rehabilitation improving cardiac rehabilitation participation coronary angioplasty coronary artery bypass surgery
study of tenofovir alafenamide fumarate tablets (taf) in blocking mother-to-child transmission of hepatitis b virus

Conditions: Hepatitis B Virus; Mother to Child Transmission

Summary: this study is a single-group, multi-center and prospective clinical study designed to assess the efficacy and safety of taf in blocking mother-to-child transmission of hepatitis b virus.pregnant women whose hbsag and hbeag are positive are included in the study.eligible hepatitis b pregnant women are given taf antiviral therapy at 24-28 weeks of gestation to block mother-to-child transmission and followed up during pregnancy and after delivery.the study will be initiated with approval by the central ethics committee.subjects will start screening after signing the informed consent form. those who meet the criteria will start taking taf (25mg, oral, 1/day) at 24-28 weeks of gestation until one month after delivery.at that time, chronic hepatitis b carrier will stop taking antiviral therapy, and patients with chronic hepatitis b decide whether to continue the therapy according to the patient's condition.the babies born are immunized according to the national standard immunization program,, that is, 100 iu of hepatitis b immunoglobulin (hbig) and 10 μg/0.5 ml of hepatitis b vaccine are given within 12 hours after birth. and the same dose of hepatitis b vaccine is given at 1 month and 6 months of age.


Eligibility criteria:
inclusion criteria: * maternal age: 20 to 35 years * 20-24 week of gestation * hbsag-positive more than 6 months and hbeag-positive * hbv dna\> 1000,000 iu/ml * both husband and wife voluntarily sign informed consent * with good compliance and comply with follow-up programs exclusion criteria: * mother with co-infection of hepatitis c virus,human immunodeficiency virus * evidence of decompensated liver disease * combined with important organ lesions which will affect patient compliance and follow-up plans, pregnant women who are expected to be difficult to complete the study * have a history of spontaneous abortion, or have a birth defect or congenital malformation in the last pregnancy * mother treated with antiviral therapy within 6 months prior to enrollment(except those treated with antiviral therapy in the last pregnancy to prevent mother-to-child transmission) * have a history of kidney injury, creatinine clearance \ 300mg/l) * combined with other chronic diseases and need to take immunomodulators, cytotoxic drugs or hormonal drugs during pregnancy * the infants' biologic father is a chronic hbv infected person * symptoms of threatened abortion during early pregnancy * evidence of hepatic cell carcinoma * alanine aminotransferase (alt) \> 10 x upper limit of normal(uln ), or total bilirubin (tbil) \> 3 x uln or glomerular filtration rate (gfr) \< 90 ml (min\*1.73 m2), or serum albumin (alb) \< 25 g/l before enrollment * fetal malformations detected by b-ultrasound * participants in other research