Kornimate/medical-research-clean huggingface dataset:
identification of potential biomarkers for pain

Conditions: Fibromyalgia

Summary: the study investigates the potential of using serum biomarkers to assess pain in fibromyalgia patients.

at the heart of the opioid epidemic is the lack of an objective measure of pain, which will help evaluate the validity of the patients' perception that the current dosage of opioid is sufficient of insufficient to alleviate pain. this study will test the quantifiable proteins such as s100b and bdnf will serve as objective measures (biomarkers) of pain. fibromyalgia patients will be recruited into two groups-- one that uses opioids and the other that does not. blood will be collected every 6 months for two years. the serum will be used to assay for levels of s100b and bdnf, the pressure-pain threshold (ppt) data, as part of standard of care, will also be collected. correlation will the be assessed.

Eligibility criteria:
inclusion criteria: * diagnosed with fibromyalgia exclusion criteria: * evidence of a history of substance abuse, neurological or oncologic disease, ischemic heart disease, kidney or hepatic insufficiency.

Keywords: pain opioid fibromyalgia
a clinical study of krn321 in adult subjects with myelodysplastic syndrome

Conditions: MDS

Summary: this is a multicenter, randomized, open-label, parallel, comparative, dose-response study to evaluate the efficacy and safety study of krn321 of subcutaneous injection in adult subjects with low- or intermediate-1-risk myelodysplastic syndrome.


Eligibility criteria:
inclusion criteria: * ipss low- or intermediate-1-risk mds diagnosed at enrollment * serum epo concentration ≤ 500 miu/ml * hemoglobin concentration ≤ 9.0 g/dl at the screening examinations exclusion criteria: * previous bone marrow or hematopoietic stem cell transplantation * history of pure red cell aplasia * cardiac conditions including angina pectoris, congestive heart failure, uncontrolled arrhythmia and hypertension * those who have increased risk of thrombosis during the study * uncontrolled diabetes mellitus * concurrent active infection or chronic inflammatory disease * other causes of anemia * previous or concurrent active malignancies other than mds
collection of biological data with potential prognostic relevance in patients with myelodysplastic syndromes

Conditions: Myelodysplastic Syndrome

Summary: the present study is designed to determine the mutational status of markers (tet2 and plcb2, cytogenetic aberrations) together with methylation status of the above genes using bone marrow and matched buccal cell samples from mds patients who necessitate to start a treatment (i.e. epo, lenalidomide, azacytidine). all patients included in the study will be followed for at least 2 years.


Eligibility criteria:
inclusion criteria: * written informed consent * patients diagnosed with mds according to fab, who and ipss classifications * all clinically treatable mds patients with epo or lenalidomide or 5-azacytidine; * hb \< 10 g/dl * age ≥ 18 years * gender: male or female * sufficient amount of biological samples for molecular studies exclusion criteria: * age \<18 years * patients who do not require treatment on "watch and wait" strategy * insufficient amount of biological samples for molecular studies
randomized contralateral clinical trial with single-piece (sn60wf) vs. three piece (ma60ac) acrysof intraocular lenses (iols) on development of posterior chamber opacification (pco).

Conditions: Cataract

Summary: randomized contralateral clinical trial with single piece (model sn60wf) vs. three piece (model ma60ac) acrysof intraocular lenses (iols) on development of posterior chamber opacifiation (pco).


Eligibility criteria:
inclusion criteria: * age \> 50 years * clear cornea * pupil mydriasis ≥ 7mm * in the bag intraocular lens (iol) exclusion criteria: * ocular pathology - uveitis, glaucoma, pseudoexfoliation syndrome (pex), high myopia * previously operated eye * proliferative diabetic retinopathy * surgical complications - incomplete rhexis, post capsular rupture (pcr), zonular dialysis

Keywords: cataract patients bilateral age related undergoing phacoemulsification
stick versus quadricep exercise for knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: this study aims to compare the efficacy between boonme stick exercise and quadriceps strengthening exercise in knee osteoarthritis.patients diagnosed as knee osteoarthritis using altman criteria will be randomized into 2 groups using simple random technique. patients will be instructed and trained for both quadriceps or boonme stick exercise by one-trained physical therapist. all patients will be treated with behavioral modification, nsaids and analgesic drugs and regularly follow-up . assessment included visual analogue scale, exercise compliance, womac and patient satisfaction were done by an assessor in a blinded fashion.


Eligibility criteria:
inclusion criteria: * knee osteoarthritis using altman criteria exclusion criteria: * problem of communication ability

Keywords: osteoarthritis, exercise
efficacy and safety study of sct800 for on-demand treatment with in patients with hemophilia a

Conditions: Hemophilia A

Summary: in this trial safety and efficacy of sct800 (b-domain deleted recombinant factor viii) is being evaluated in 50 subjects, 12 to 65 years of age, with moderate to severe hemophilia a. these subjects will receive open label treatment with sct800 for approximately 6 months for on-demand treatment.


Eligibility criteria:
inclusion criteria: * 12 to 65 years old; * the activity of the coagulation factor viii (fviii:c) ≤5%, and was previously treated with fviii concentrate(s) for a minimum of 50 exposure days (eds) prior to study entry * bleeding state need to be treated with fviii; * negative assays for fviii inhibitors (\<0.6 bu/ml); * the platelet count is normal； * normal prothrombin time or inr ≤1.5； * given informed consent exclusion criteria: * hypersensitivity to recombinant coagulation factor viii concentrate or any of the excipients ;allergic to heterologous proteins (e.g. murine, bovine or hamster origin); * family history or history of fviii inhibitors (≥0.6 bethesda units \[bu\] ml-1); * received an infusion of any fviii for on-demand therapy or prophylaxis within 4 days prior to study entry (including rfviii, plasma-derived factor viii \[pdfviii\], cryoprecipitate and whole blood); * significant hepatic or renal impairment (alt and ast ≥2×uln; bun and cr≥2×uln); * hiv seropositive; * abnormal hemostasis from causes other than hemophilia a； * patients with severe heart disease, including myocardial infarction, heart failure (iii or higher level); * patients who received any anticoagulant or antiplatelet therapy within one week (including nsaids) or need to receive an anticoagulant or antiplatelet therapy during the period of clinical trials; * alcoholism, drug abuse, mental disorders and mental retardation; * elective surgery planned during the process of study; * patients who previously participated in the other clinical trials prior to study entry; * the patient or parent/legal guardian is unable or unwilling to sign an informed consent form or to comply with the requirements of clinical protocol; * other conditions confirmed by the researchers, resulting in that patients are unable to benefit from clinical observation;
feasibility of use of vibrators with vaginal dilators for vaginismus. (vibrator therapy and dilators in vaginismus)

Conditions: Vaginismus

Summary: the acceptability of vulvar vibration therapy has been evaluated in women with vulvodynia, and found to be acceptable, however has not been assessed in women with a primary complaint of vaginismus. this proposed study looks at the feasibility and acceptability of using clitoral vibration therapy, alongside current therapy, for women with vaginismus. it is likely that many, if not most, of these women will also have an element of vulvodynia. the investigators propose that the use of external clitoral or vulval vibration therapy is likely to be acceptable in most women with vaginismus, based on acceptability of vulvar vibration therapy in women with vulvodynia. it is proposed that vibrator therapy may help women with female sexual dysfunction to use vaginal dilators.

this is a nonrandomized controlled trial, with the initial cluster of patients receiving standard therapy, and the second cluster receiving standard therapy plus vibrator. recruitment will be an initial 15 participants who will receive standard therapy, and then another 15 who will receive an external vibrator. this study will take place over approximately 12 months. enrollment of patients will be from a joint psychosexual clinic led by a medical doctor and a clinical psychologist. female patients are referred to this clinic by general practitioners, from within the sexual health service, or via gynaecologists, frequently with complaint of difficulty or pain with penetrative sex. exclusion criteria will be: patients unable/ unwilling to consent, transgender male or on testosterone therapy, unable to understand written and/or verbal english, current dermtatological skin conditions requiring active treatment, genital herpes simplex virus within 3 months, or not reporting symptoms of vaginismus with no evidence of vaginismus on clinical examination. trial information will be given at the initial appointment. if the patient wishes to enrol, than an initial baseline questionnaire will be given, and a follow up questionnaire will be filled out by phone contact at 3-4 months afterward the initial consultation at the patients consent.

Eligibility criteria:
inclusion criteria: * able and willing to give informed consent (additional measures have to be in place if children, vulnerable adults or adults unable to give consent are included) * female * over the age of 18 * with symptoms and clinical signs consistent with vaginismus/ vaginismus and vulvodynia. exclusion criteria: * unwilling or unable to give consent * transgender male / on testosterone therapy * inability to understand written and / or verbal english * current dermatological skin conditions requiring active treatment * genital herpes simplex virus symptoms within preceding 3 months * not reporting symptoms of vaginismus, and no evidence of vaginismus on clinical examination.
the effect of placental cord drainage on postpartum blood loss

Conditions: Postpartum Hemorrhage

Summary: to determine if placental cord drainage decreases the blood loss after spontaneous vaginal delivery

postpartum hemorrhage complicates 3% of pregnancies in the united states and is a leading cause of maternal morbidity and mortality. acog defines pph as cumulative blood loss greater than 1000cc; however a blood loss \>500cc should be considered abnormal. primary pph occurs in the first 24 hours and is largely secondary to uterine agony. acog as well as the who recommend active management of the third stage of labor to prevent pph. this includes oxytocin administration, uterine massage, and gentle cord traction. placental cord drainage (pcd) is the unclamping of the umbilical cord to allow for drainage of the blood from the placenta. it is another technique used to shorten the third stage of labor; however, it has not been well studied

Eligibility criteria:
inclusion criteria: * singleton gestation * ages 18-45 * english speaking * third trimester gestation exclusion criteria: * operative vaginal delivery * multiple gestation * cesarean delivery * episiotomy * 3rd or 4th degree laceration * less than the third trimester of pregnancy * chorioamnionitis * history of postpartum hemorrhage * macrosomic infant
prosthetics registry and outcomes in urology at duke

Conditions: Penile Implantation

Summary: to establish the prosthetics registry and outcomes in urology at duke (proud) which will serve as a retro- and prospective data repository that our team will use to optimize patient satisfaction, lower cost and reduce morbidity associated with penile prosthesis implantation. the study team will collect retrospective data from subjects at duke university and duke raleigh hospitals who have undergone genitourinary prosthesis implantation from january 1, 1996 onward. prospective data will only be collected from patients seeking care with dr. lentz in duke raleigh.


Eligibility criteria:
inclusion criteria: * male * adult (18 years of age or older) * inflatable or semi-rigid penile prosthesis placed exclusion criteria: - inability to provide informed consent

Keywords: prostate cancer erectile dysfunction penile prosthesis
post ercp pancreatitis prevention in average risk patients

Conditions: Pancreatitis

Summary: diclophenac potassium and ceftazidime are commercially available drugs that are used in various clinical situations. they are safe and known for years. diclophenac potassium and ceftazidime have been used in some studies for the prophylaxis and treatment of pancreatitis and post-ercp pancreatitis (pep). diclophenac potassium, together with indometacin is currently standard treatment for prevention of (pep) while ceftazidime is possible alternative treatment for patients with contraindications for nonsteroidal medicines. the aim of the study is to evaluate the efficacy of ceftazidime for the prophylaxis of pep.

study type: interventional allocation: randomized endpoint classification: efficacy study intervention model: parallel assignment masking: only investigator primary purpose: prevention study phase: phase 4 conditions or focus of the study: post ercp pancreatitis intervention information * intervention names ercp * arm information * arm 1:ceftazidime * arm 2 (active comparator): diclophenac potassium

Eligibility criteria:
inclusion criteria: * o all patients undergone to ercp irrespectively about the diagnosis exclusion criteria: * o unwillingness or inability to consent for the study * age \< 18 years * previous ercp (papillotomy) * intrauterine pregnancy * breast feeding mother * allergy to aspirin or nsaids and ceftazidime * nsaid or antibiotic use within 1 week (asa 325 mg daily or less acceptable) * renal failure (cr \> 1.4) * active or recent (within 4 weeks) gastrointestinal hemorrhage * existing acute pancreatitis (lipase peak) within 72 hours prior to ercp * anticipated inability to follow protocol

Keywords: endoscopic retrograde cholangiopancreatography,
approaches to identify early biomarkers and pathogenesis of anthracycline cardiotoxicity

Conditions: Childhood Cancer

Summary: early micrornas (mirs) and cardiac magnetic resonance (cmr)-derived strain analysis and detection of genes contributing to anthracycline-induced cardiotoxicity (aic) sensitivity and resistance will identify pediatric cancer patients most and least likely to develop aic.

plan is to enroll 110 children and adults (≥9 years old) newly diagnosed at ccmc and nationwide children's hospital (55 per institution) who will receive anthracyclines as part of their chemotherapy regimen. the duration of study participation will be approximately a year. patients will have a total of four study visits: baseline 1 week after patient's anthracycline cumulative dose hits between 60 and 100 mg/m2 after the patient has completed maximal therapy one year after completion of anthracycline treatments study tasks for all four visits will be: collection of clinical data blood draw for micro rna and biomarkers cardiac mri echocardiogram one time blood draw for genetics

Eligibility criteria:
inclusion criteria: * age (≥ 9years old) * newly diagnosed with a malignancy that will receive acs as part of their chemotherapy. * parental/caregiver consent and subject assent to enrollment. exclusion criteria: * subject has contraindications to cmr.\* * subject requiring sedation for cmr * subject too large to be safely accommodated by cmr * pregnancy tests are done routinely prior to chemotherapy, if test is positive the patient will be excluded * subject's serum creatinine above guidelines for adequate renal function. see table below: age (years) male female 6-10 1.0 mg/dl 1.0 mg/dl 10-13 1.2 mg/dl 1.2 mg/dl 13-16 1.5 mg/dl 1.4 mg/dl \>16 1.7 mg/dl 1.4 mg/dl

Keywords: anthracycline induced cardiotoxicity
transcatheter self-expandable valve implantation for the treatment of severe native aortic regurgitation

Conditions: Aortic Valve Disease

Summary: prospective, multicenter, randomized trial.

patients with severe native aortic valve regurgitation (ar) who have symptoms, impaired lvef (≤55%) or left ventricular enlargement have the indications for surgery. according to data from the euro heart survey, only 21.8% with lvef 30-50% and 2.7% with lvef \<30% were referred for surgical aortic valve replacement (savr) among patients with severe native aortic regurgitation. advanced age and comorbidities were often considered as main reasons to refuse savr. the annual mortality of untreated patients with severe ar is 10-20%. pure native ar is always an exclusion criterion in all randomized controlled trials on transcatheter aortic valve implantation (tavr) because the specific anatomical features can preclude adequate valve implantation. several small, retrospective studies showed that off-label use of tavr appears to be a feasible treatment choice for ar patients at high risk for savr. the present study aims to investigate the use of tavr in ar patients.

Eligibility criteria:
inclusion criteria: 1. procedural indications: symptomatic severe aortic regurgitation; no symptom plus left ventricular ejection fraction ≤ 55% or left ventricular end-diastolic dimension (lvedd) \> 65mm or left ventricular end-systolic dimension (lvesd) \> 50mm; 2. severe aortic valve regurgitation, and mean pressure gradient \< 20mmhg; annular perimeter ≤ 85 mm; 3. the ratio of the perimeter of the left ventricular outflow tract 4mm to the perimeter of the valve annulus is 0.95-1.05; 4. sts score ≥8 or moderate to severe frailty or refused surgical valve replacement or presence of any of the following factors judged to be difficult to perform the surgical valve replacement: 1. severe aorta calcification or active ascending aorta atherosclerotic plaque 2. history of mediastinum radiotherapy 3. past mediastinitis 4. presence of unobstructed coronary bypass implants 5. previous more than two cardiothoracic surgeries 6. liver cirrhosis 7. other surgical risk factors exclusion criteria: 1. age \< 60 years old; 2. ascending aorta diameter \>45mm; 3. coronary multi-vessel disease (syntax score \>32); 4. life expectancy \<1 year; 5. left ventricular ejection fraction \<30%; 6. acute myocardial infarction within 30 days; 7. allergies or contraindications to related drugs (aspirin, clopidogrel, warfarin, or contrast agents); 8. other situations judged by the researcher as unsuitable for participating in the study.
joint microbiome study for the knee

Conditions: Knee Osteoarthritis; PJI

Summary: prosthetic joint infection (pji) is a devastating complication following arthroplasty. an utmost effort has been done to clarify risk factors and microbiology of pji. we now know the most frequent infecting microorganisms are members of the skin microbiome. these microorganisms are thought to get into the joint and infect the prosthesis during the peri-operative and/or post-operative period. nevertheless, recent studies have suggested, bacteria may be present in the joint even before the first incision, suggesting the existence of a joint microbiome. therefore, we aimed to determine the bacterial composition from different knee conditions.


Eligibility criteria:
inclusion criteria: * all patients 18 years or older who give verbal and written informed consent for the retrieval of experimental samples and data collection. * group a: subjects with lack of osteoarthritis (oa) evidence, invasive examinations, minor procedures, cartilage damage, and/or synovitis in joints. * group b: patients undergoing primary knee arthroplasty (partial or total). * group c: contralateral non-affected (native) joint without knee arthroplasty, history of septic arthritis (sa), invasive examinations and/or minor procedures. * group d: patients undergoing aseptic knee revision surgery. * group e: patients undergoing septic knee revision surgery exclusion criteria: * withdrawal of informed consent, suspicion of pji, surgical site infection (ssi) or septic arthritis (sa) before samples retrieval, use of antibiotics within 4 weeks before collecting the samples (not including perioperative antimicrobial prophylaxis), inflammatory arthritis, systemic rheumatic disorder, high risk of infection. * group a: history and/or suspicion before/at samples retrieval of sa in native joint. * group b: history and/or suspicion before/at samples retrieval of ssi or sa in the affected joint. * group c: no additional criterion. * group d: history and/or suspicion before/at samples retrieval of pji, ssi, sa in the affected joint * group e: no additional criterion.
high intensity interval training vs moderate intensity continuous training in chronic low back pain subjects

Conditions: Low Back Pain

Summary: the current guidelines for non-specific clbp, recommend a conservative approach with exercise therapy, as first line treatment. endurance and resistance training are two examples of recommended exercise therapies. however, it appears that none is recommended as superior over the other.

the lack of studies using hiit in clbp subjects, is the reason why it is needed to conduct an investigation about its effects. however, firstly it is needed to assess the feasibility and safety of the hiit protocol, to integrate it in the daily practise and future research. in a single-center, single-blinded randomized feasiblity study, the investigators aim to prove the feasibility and safety of a 12 week hiit programm.

Eligibility criteria:
inclusion criteria: * oswestry disability index (odi) score ≥ 14% * low back pain for at least 3 months. * declared suitable by their physician or hospital consultant to start an exercise programme and to perform a graded exercise testing to determine the heart rate peak. * good understanding of german or english, written and spoken. * age between 29 - 69 * no or stopped physical therapy. exclusion criteria: * pre-existing unstable heart disease or suspected angina pectoris, cardiac dysrhythmias, heart failure, aneurysm or aortic stenosis. * known pregnancy. * previous low back spinal surgery in the last 2 years. * tumour, spinal stenosis, spinal fractures or radiculopathy. * comorbid health conditions like diabetes mellitus, rheumatoid arthritis or other systemic inflammatory diseases.