Kornimate/medical-research-clean huggingface dataset:
validation of a new optimized nighttime providence brace for personalized treatment of adolescent idiopathic scoliosis

Conditions: Scoliosis; Idiopathic Scoliosis

Summary: adolescent idiopathic scoliosis affects 3-4% of the canadian population, of which about 10% will need a brace treatment during pubertal growth spurt. our team has developed an innovative conception method for brace design by optimizing for the immediate in-brace correction. the model is customized to each patient. in this project, the investigators will evaluate the effectiveness of this platform's customized treatment and validate its clinical application.


Eligibility criteria:
inclusion criteria: * ais diagnosis * risser 0-2 * primary curve angles 20 degrees - 40 degrees * if female, either premenarchal or less than 18 months postmenarchal. exclusion criteria: * patients with a pre-existing cardiovascular condition * patients with a symptom of a neurological disorder * patients with any other disorder of the musculoskeletal system affecting the lower limbs * pregnancy

Keywords: scoliosis spine deformity nighttime brace optimization
yallaferon in chinese population

Conditions: HPV Infection

Summary: the purpose of this study is to evaluate the efficacy of yallaferon in chinese population with hpv-16 and/or hpv-18.


Eligibility criteria:
inclusion criteria: * age 25 to 65 years of age the sex life of female patients; * high-risk hpv 16 and/or 18 positive * agree to sign icf exclusion criteria: * cervical intraepithelial neoplasia (cin); * combined with a severe fungal, trichomonas vaginitis; * severe primary diseases associated with cardiovascular, liver, kidney and hematopoietic system; * allergies or allergy to the drug known ingredients. * within 30 days to accept other clinical trials of drugs or are participating in clinical trials; * pregnant and lactating women and to be pregnant women; * the researchers do not consider it appropriate clinical trials.
a study of tq-b3525 in subjects with relapsed/refractory peripheral t-cell lymphoma（ptcl）

Conditions: Peripheral T-cell Lymphoma

Summary: this is a study to evaluate the efficacy and safety of tq-b3525 in subjects with relapse/refactory peripheral t-cell lymphoma who have received at least 1 lines of therapeutic schedules. tq-b3525 tablet administered 20mg orally, once daily in 28-day cycle.


Eligibility criteria:
inclusion criteria: * 1. understood and signed an informed consent form; 2. 18 years and older, eastern cooperative oncology group(ecog) performance status score of 0 to 2, life expectancy ≥ 3 months; 3. diagnosis of peripheral t-cell lymphoma (ptcl); 4. has received at least one line systemic treatment and disease progression after the last treatment; 5. has at least one measurable lesion; 6. adequate organ system function; 7. male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；no pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration. exclusion criteria: * 1. other types of t-cell lymphoma; 2. has central nervous system violation; 3. has received other pi3k inhibitors or car-t treatments; 4. has diagnosed and/or treated additional malignancy within 3 years prior to the first administration; 5. has type i diabetes or uncontrolled type ii diabetes; 6. has history of interstitial lung disease; 7. has history of interstitial lung disease; 8. has multiple factors affecting oral medication; 9. has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1; 10. has received systemic steroid treatment within 7 days before the first dose; 11. has received other systemic anti-tumor medications within 4 weeks before the first administration, or still within the 5 half-life of the medication, which occurs first; 12. has active infections which need drug treatment; 13. has received surgery, or unhealed wounds within 4 weeks before the first administration; 14. has a history of autologous hematopoietic stem cell transplant within 3 months; 15. has a history of allogeneic hematopoietic stem cell transplant; 16. grade ii or higher cardiovascular disease within 6 months before the first administration; 17. qtcf \> 480ms, left ventricular ejection fraction (lvef)\ 1g within 7 days; 19. has active hepatitis b or c; 20. has psychotropic substances abuse or a mental disorder; 21.has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.
oxidative stress in polycystic ovary syndrome with periodontal disease and dental caries lesions

Conditions: Polycystic Ovary Syndrome; Dental Caries

Summary: this study evaluates the oxidative stress parameters in females with polycystic ovary syndrome (pcos) and clinically healthy. because of the fact that both oral disease included periodontitis and dental caries, and metabolic syndrome are associated with systemic inflammation, these two disorders may be linked through a common pathophysiologic pathway

power analysis was performed with the g-power software package to determine sample size. to cover possible data loss, 10% of a group were added to each group. medical and dental examination will be performed both of control and experimental groups. age and body mass index (bmi) will be recorded. in dental examination decayed, missing, or filled teeth (dmft) index will be used according to world health organization (who 1997) criteria. all teeth were visually using the international caries detection and assessment system (icdas-ii). to analyze the correlation between oral health status and polycystic ovary syndrome linear regression test and for comparison of both the groups (case and control), two sample t test and chi square test were used.

Eligibility criteria:
inclusion criteria: * females with polycystic ovary syndrome exclusion criteria: * history of ovarian surgery, patients with thyroid or prolactin hormone level abnormalities, non-classic 21-hydroxylase deficiency and hormonal therapy, steroid drug use past 6 months, obese patients (body mass index, bmi \> 35), acute or chronic upper respiratory tract diseases, dental fluorosis, patients using fluoride supplements or orthodontic appliances will not be included in the study.
score predicting lesion development on ct following mild tbi

Conditions: Traumatic Brain Injury; Mild Traumatic Brain Injury

Summary: mild traumatic brain injury (mtbi) is one of the most common reasons behind emergency department (ed) visits. a small portion of mtbi patients will develop an intracranial lesion that might require neurosurgical intervention. several guidelines have been developed to help direct these patients for head computerized tomography (ct) scanning, but they lack specificity, mainly focus on ruling out lesions, and do not estimate the risk of lesion development. the aim of this retrospective observational study is to create a risk stratification score that predicts the likelihood of intracranial lesion development, lesion progression, and need for neurosurgical management in patients with mtbi presenting to the ed. eligible patients are adults (≥ 15 years) with mtbi (defined as admission glasgow coma scale (gcs) 13-15) who presented to the ed within 24 hours of injury to any ed in stockholm, sweden between 2010-2020. reasons for ed visit and internal classification of disease (icd) codes will be used to screen for patients. machine-learning models will be applied. the primary outcome will be a traumatic lesion on head ct, defined as a cerebral contusion, subdural haematoma, epidural haematoma, subarachnoid haemorrhage, intraventricular haemorrhage, diffuse axonal injury, skull fracture, traumatic infarction or sinus thrombosis. the secondary outcomes will be any clinically significant lesion, defined as an intracranial finding that led to neurosurgical intervention, discontinuation or reversal of anticoagulant or antiplatelet medication, hospital admission \> 48 hours due to the tbi, or death.


Eligibility criteria:
inclusion criteria: * adult (≥ 15 years) * presented to emergency department within 24 hours of tbi * gcs 13-15 at presentation to the emergency department exclusion criteria: * no ct scan performed * patient from another region in sweden/another country * penetrating tbi * secondary transfer from other emergency department * medical record missing

Keywords: neurosurgery
valvosoft® pivotal study

Conditions: Aortic Valve Calcification; Aortic Valve Stenosis

Summary: the objective of the study is to evaluate the safety and performance of a new non-invasive ultrasound therapy (niut) with valvosoft in the treatment of calified aortic stenosis


Eligibility criteria:
inclusion criteria: 1. subject suffering from severe symptomatic calcific aortic valve stenosis as defined by esc/eacts guidelines for the management of valvular heart disease 2021; and 2. subject is not recommended by the local heart team for immediate tavr/savr; or 3. subject who refuses tavr/savr, documented by local heart team (not allowed in france); and 4. age ≥18 years; and 5. subject willing to provide a written informed consent prior to participating in the study; and 6. subject who can comply with the study follow-up or other study requirements; and 7. subject is eligible for the valvosoft procedure according to clinical review committee (crc). exclusion criteria: 1. subject with severe aortic regurgitation; or 2. subject with unstable arrhythmia not controlled by medical treatment; or 3. subjects with implanted mechanical valve in any position or bio-prosthetic valve in aortic position; or 4. subject has a chest deformity not allowing optimal placement of valvosoft applicator and visualization of the aortic valve; or 5. cardiogenic shock or other hemodynamic instability; or 6. left ventricular ejection fraction ≤30%; or 7. subject with mean avai \<0,24 cm²/m2; or 8. history of heart transplant; or 9. subject requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after valvosoft procedure; or 10. cardiac imaging evidence of vegetation; or 11. acute myocardial infarction (mi) within one month prior to enrolment; or 12. valve depth not suitable for niut (depth \>125mm with respect to the valvosoft imaging probe); or 13. stroke or transient ischemic attack (tia) ≤1 month prior to enrollment; or 14. subject who is pregnant, or plan to become pregnant during the 12-months study follow-up period; or 15. subject who is participating in another research study for which the primary endpoint has not been reached; or 16. balloon aortic valvuloplasty (bav) ≤3 months prior to enrollment; or 17. current endocarditis; or 18. leukopenia (wbc \<4000 cell/μl), anemia (hgb \<8 g/dl), thrombocytopenia (platelet count \<15.000 cell/μl), or history of coagulopathy or hypercoagulable state; or 19. life expectancy \< 6 months due to non-cardiac co-morbid conditions; or 20. other medical, psychological, or social condition which, in the opinion of the investigator, precludes the subject from study participation; or 21. subjects who do not have social security and who are under legal restraint; or 22. subjects who cannot read or write or are mentally not or partially capable of giving informed consent.

Keywords: aortic valve stenosis aortic valve calcification aortic valve stenosis ultrasound non invasive
effect of dutasteride on hif-1alpha and vegf in the prostate

Conditions: Benign Prostatic Hyperplasia

Summary: the purpose of this study is to determine whether dutasteride may influence the expression of angiogenesis factors such as hypoxia inducible factor (hif)-1alpha and vascular endothelial growth factor (vegf) in patients with lower urinary tract symptoms/benign prostatic hyperplasia (luts/bph).

a total of 41 patients awaiting transurethral resection of the prostate (turp) will be divided into two groups (1:1); twenty patients will receive no medication and 21 will receive 0.5 mg dutasteride daily for 2 to 4 weeks until turp. in both groups, the extent, intensity and intracellular location of hypoxia inducible factor (hif)-1alpha and vascular endothelial growth factor (vegf)will be evaluated. microvessel density will be also compared in the two groups.

Eligibility criteria:
inclusion criteria: * informed consent * 50 years old or older * international prostate symptom score (ipss) \>8 * maximum flow rate (qmax) \<15 ml/s * transurethral resection of the prostate (turp) exclusion criteria: * urethral catheter * urinary tract infection (uti) * liver disease * renal disease * unexplained hematuria * prostate specific antigen (psa) \> 4ng/ml (included if prostate biopsy was negative) * interstitial cystitis * bladder cancer or prostate cancer * pelvic surgery or irradiation

Keywords: prostate, dutasteride vascular endothelial growth factor hypoxia inducible factor
remicade safety line (crohn's disease)(study p03288)(completed)

Conditions: Crohn's Disease

Summary: this observational study is in line with the german educational plan with the aim to implement a tool to increase and monitor the awareness for tuberculosis screening and to reinforce the patient eligibility for a treatment with remicade according to the summary of product characteristics (smpc).


Eligibility criteria:
inclusion criteria: * subjects with crohn's disease. exclusion criteria: * as per smpc
genetic variation in oct1 and response to metformin

Conditions: Type 2 Diabetes

Summary: type 2 diabetes its microvascular and macrovascular complications have become a major global health problem. metformin is often used as first-line therapy for this disorder given that it is cheap, may cause weight loss and does not have significant side-effects in healthy patients. on the other hand, as many as one third of all patients with type 2 diabetes initially treated with metformin never achieve a meaningful response to this intervention. recently, genetic variation in the organic cation transporter 1 (oct1) gene which encodes a protein, oct1, mediating metformin uptake by the liver, its primary site of action, has been shown alter metformin action. in oct1-deficient mice the glucose-lowering effects of metformin are completely abolished. moreover a polymorphism with a 20% minor allele frequency in caucasians also alters the effect of metformin on glucose tolerance (the net result of glucose uptake and glucose release) after ingestion of 75g of glucose. however, it is unknown if this polymorphism affects suppression of endogenous glucose production or stimulation of peripheral glucose uptake by metformin, or both, and to what degree. we propose to utilize established methodology to measure glucose turnover in response to a mixed meal to determine how common genetic variation in oct1 alters response to metformin in healthy volunteers. this will clarify the effect of these variants on response to metformin in humans. the knowledge gained from this study will help to design future studies examining the role of oct1 genotype in determining initial therapy for type 2 diabetes.


Eligibility criteria:
inclusion criteria: - 1. heterozygous or homozygous for the nssnps r61c, g401s, 420del, g465r, g174s (see supplementary info (3)) or without any nssnps that could potentially alter gene function. 2. age 18 - 40. 3. willingness to participate in this study. exclusion criteria: - 1. fasting glucose \> 100mg/dl on one occasion. 2. use of medication other than stable thyroid hormone replacement or oral contraception. 3. subjects must not be pregnant or \< 6 months postpartum at the time of study. 4. prior abdominal surgery other than hysterectomy, appendectomy or tubal ligation.

Keywords: metformin type 2 diabetes oct1
a phase i, single-center, mixed methods study on the health outcomes of visual self expression

Conditions: A Healthcare Professional, a Patient or Caregiver in the Radiation Oncology Department at the University of Pennsylvania

Summary: to gain understanding about the impact of visual art making on biomarkers, such as cortisol, alpha amylase, oxytocin, etc. to examine whether and to what extent there are changes in levels of stress and immune function in patients and caregivers adults (including family caregivers and medical professionals)


Eligibility criteria:
inclusion criteria: * adults between the age of 18 - 70 * a healthcare professional, a patient or caregiver in the radiation oncology department at the university of pennsylvania * subjects must be capable of giving informed consent exclusion criteria: * any healthcare professional or patient/caregiver not working in or being seen at radiation oncology department at the university of pennsylvania
neratinib in extended adjuvant treatment for her2+ early breast cancer with pcr but high-risk features: a hebei multi-center real-world study

Conditions: HER2-positive Breast Cancer

Summary: neratinib is an oral, irreversible pan-her tyrosine kinase inhibitor. current treatment guidelines recommend neratinib as an extended adjuvant therapy for her2-positive breast cancer patients to further reduce the risk of recurrence. even when her2-positive breast cancer patients achieve pathological complete response (pcr) after neoadjuvant therapy, those with high-risk factors (such as large tumors \[ct3/t4\] or lymph node-positive disease) still face a risk of cancer returning. however, there is limited data on the effectiveness and safety of neratinib in these patients. this study aims to provide real-world evidence on how well neratinib works in high-risk her2-positive breast cancer patients who achieved pcr, helping to improve treatment strategies for chinese patients.

this study is a single-arm prospective study with historical controls as external comparators

Eligibility criteria:
inclusion criteria: 1. age ≥18 years, female 2. clinical stage ≥ct3 or ≥cn1, regardless of hormone receptor (hr) status 3. her2-positive: her2 ihc 3+ or ihc 2+ with ish+ 4. achieved pathological complete response (pcr) after neoadjuvant therapy 5. completed 1 year of standard adjuvant therapy (including trastuzumab), with ≤6 months between the last adjuvant treatment and starting neratinib 6. no evidence of recurrence or metastatic disease (confirmed by clinical/imaging exams after completing standard adjuvant therapy and before starting neratinib) 7. left ventricular ejection fraction (lvef) ≥50% 8. ecog performance status 0-1 exclusion criteria: 1. hypersensitivity to any component of the investigational drug 2. inability to swallow oral medication 3. participation in another interventional clinical trial within 4 weeks before enrollment, or planned participation during this study 4. use of any investigational drug within 14 days prior to treatment initiation 5. concurrent chemotherapy, radiotherapy, immunotherapy, or biologic therapy for breast cancer 6. severe psychiatric disorders preventing compliance with informed consent, treatment, or follow-up procedures 7. pregnancy, lactation, or plans for pregnancy in the near future 8. other significant medical conditions or laboratory abnormalities that, in the investigator's judgment, make participation unsuitable
prospective multi-center study on vanguard with e1 bearing

Conditions: Varus Deformity; Valgus Deformity; Posttraumatic Deformity; Osteoarthritis, Knee; Unspecified Disorder of Knee Joint

Summary: evaluate clinical performance of vanguard knee with e1 bearing in korean patient population

e1™ vitamin e doping of highly cross-linked polyethylene is a proposed method for insuring long-term oxidative stability of highly cross-linked ultra-high molecular weight polyethylene for use in total joint arthroplasty. in vitro research and development studies have shown that this material has improved wear performance, retention of mechanical properties, and a high resistance to oxidation due to the anti-oxidative properties of vitamin e. biomet inc, has received fda clearance to market tibial polyethylene components made of e1™ for use in the vanguard total knee replacement system. vanguard total knee system™ the vanguard™ knee system was designed to incorporate features from prior designs, including: acg, maxim, \& ascent. the vanguard knee includes a streamlined design, rounded sagittal profile, and a deeper trochlear groove. the femoral component is available in cruciate retaining (cr), posterior stabilizing (ps), and super stabilized (ssk). tibial bearings are available in various levels of constraint required by the surgeon (cr, ps, as, etc.). for this study, only vanguard with ps bearing will be used. the purpose of the study is to evaluate clinical performance of vanguard knee with e1 bearing in tka in korean patient population. the clinical performance will be evaluated based on patient outcomes, radiographic assessment and survivorship.

Eligibility criteria:
inclusion criteria: patients will be included in this study if they received vanguard knee with e1 bearing per the approved indications for use for vanguard knee. specifically * painful and disabled knee joint resulting from osteoarthritis or traumatic arthritis where one or more compartments are involved * correction of varus, valgus, or posttraumatic deformity * correction or revision of unsuccessful osteotomy exclusion criteria: exclusion criteria for this study should comply with the stated contraindications on package inserts of vanguard™ knee and the e1™ tibial bearing. these indications are stated below: absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement relative contraindications include: * uncooperative patient or patient with neurologic disorders who are incapable of following directions, * osteoporosis * metabolic disorders which may impair bone formation * osteomalacia * distant foci of infections which may spread to the implant site * rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram * vascular insufficiency, muscular atrophy, neuromuscular disease * incomplete or deficient soft tissue surrounding the knee
catheter ablation of drug-refractory persistent atrial fibrillation with the heartlight(tm) laser balloon in comparison with irrigated radiofrequency current ablation

Conditions: Persistent Atrial Fibrillation

Summary: aim of the study is to compare the safety and efficacy of pulmonary vein isolation using the endoscopic ablation system in comparison to irrigated radiofrequency current ablation in patients with drug-refractory persistent atrial fibrillation.


Eligibility criteria:
inclusion criteria: * 18 to 80 years * persistent atrial fibrillation * failure of at least one antiarrhythmic drug * others exclusion criteria: * contraindications for pulmonary vein isolation (pvi) * previous pvi attempts * inability to be treated with oral anticoagulation * presence of intracardiac thrombi * pregnancy * others