Kornimate/medical-research-clean huggingface dataset:
a study of darbepoetin alfa in anemic subjects not receiving chemotherapy who have completed the 20010103 study

Conditions: Anemia; Cancer

Summary: the purpose of this study is to determine the safety of darbepoetin alfa beyond 16 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy.


Eligibility criteria:
inclusion criteria: - subjects completing the planned 16 weeks of treatment on the 20010103 anemia of cancer protocol exclusion criteria: * subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy * subjects who have other diagnoses not related to the cancer which can cause anemia * known history of seizure disorder * cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia * uncontrolled hypertension * clinically significant systemic infection or chronic inflammatory disease present at the time of enrollment * subject of reproductive potential who is not using adequate contraceptive precautions * concerns for subject's compliance with the protocol procedures

Keywords: oncology cancer-related anemia
acupuncture for painful temporomandibular disorder

Conditions: Temporomandibular Disorders (TMD)

Summary: temporomandibular disorder (tmd) is a common musculoskeletal pain condition affecting the jaw, and acupuncture is often used for treatment, though its neurological mechanisms are unclear. this study investigates the neural mechanisms of acupuncture in tmd using functional mri (fmri), structural mri (smri), and diffusion tensor imaging (dti), alongside machine learning to predict treatment outcomes. this study aims to enhance understanding of acupuncture's effects on tmd and improve personalized treatment approaches.

a randomized, single-blind, sham-controlled trial will enroll 48 patients, divided into acupuncture and sham acupuncture groups. the study will consist of a 1-week baseline, 4-week treatment, and 8-week follow-up period, with 30-minute sessions three times a week for 12 sessions. primary outcomes include changes in visual analog scale (vas) scores at week 4, with secondary outcomes including vas changes at week 8, jaw function, and scores on pain, sleep, and mental health scales. multimodal mri scans will assess brain changes at baseline, post-treatment, and follow-up. our research is a randomized controlled trial (rct) combining smri, fmri, and dti to explore the efficacy of acupuncture in tmd treatment, using multi-modal imaging to provide a comprehensive biological profile of tmd patients. our study aims to (1) analyze brain structural and functional network changes post-acupuncture, explore the relationship between central imaging and clinical symptom changes, and (2) predict individual treatment outcomes for tmd.

Eligibility criteria:
inclusion criteria: 1. having a history of pain-related tmd for at least three months; 2. aged between 18 and 70 years; 3. voluntary participation in the trial with signed informed consent. exclusion criteria: 1. having received occlusal splint, injection therapy, acupuncture, biofeedback, transcutaneous nerve stimulation, or tmd-specific medication (e.g., corticosteroids, benzodiazepines, sedative hypnotics, muscle relaxants, opioids, antidepressants, or anticonvulsants) for managing facial pain within one month before the screening period; 2. having suffered from pain of dental origin, trauma, sinus pathology, neuropathic origin, inflammatory systemic diseases and cancer; 3. having a history of rheumatoid arthritis; 4. presence of mental illness or substance abuse; 5. pregnant, lactating, or planning to become pregnant; 6. participants with common contra-indications for mri such as claustrophobia or metal implants.

Keywords: temporomandibular disorders acupuncture magnetic resonance imaging randomized controlled trial protocol
effect of early limited formula on total serum bilirubin among newborns with hyperbilirubinemia

Conditions: Hyperbilirubinemia, Neonatal

Summary: the investigators propose to conduct an exploratory pilot study, enrolling 30 exclusively breastfeeding newborns 36-96 hours of age, whose total serum bilirubin (tsb) is within 0.1-3 mg/dl of the american academy of pediatrics (aap)-recommended treatment thresholds for phototherapy (pt). these newborns will be randomly assigned to receive either 10 cc extensively hydrolyzed formula following each breastfeeding using cup, spoon or syringe, or to continue exclusive breastfeeding. infants will be followed at 1, 2, 3 and 6 months to assess breastfeeding duration and use of formula and complementary foods. our hypothesis is that limited, small amounts of formula administered without a bottle immediately following breastfeeding might reduce the incidence of severe hyperbilirubinemia among newborns at increased risk of tsb exceeding aap-recommended thresholds for beginning phototherapy.

inclusion criteria * healthy infants ≥ 35 weeks * neonates 36-96 hours old * exclusively breastfeeding * tsb 0.1-3 mg/dl below aap-recommended pt threshold * tsb \< 6 hours ago * mothers english-speaking or spanish-speaking outcome measures * primary outcome: total serum bilirubin * secondary clinical outcomes: phototherapy, hospital readmission, exclusive and partial breastfeeding at 1 week, 1 month, 2 months, and 3 months; breastfeeding self-efficacy

Eligibility criteria:
inclusion criteria: * healthy infants ≥ 35 weeks * neonates 36-96 hours old * exclusively breastfeeding * tsb 0.1-3 mg/dl below aap-recommended pt threshold * tsb \< 6 hours ago * mothers english-speaking or spanish-speaking exclusion criteria: * infants who have already received formula * infants who have received or are receiving level ii or level iii * infants who have already lost ≥ 10% birth weight * infants with glucose-6-phosphate dehydrogenase deficiency, positive direct antigen testing, cephalohematoma or other extensive bruising

Keywords: hyperbilirubinemia breastfeeding limited formula
epidemiology of long qtand asian sudden death in sleep

Conditions: Cardiovascular Diseases; Heart Diseases; Arrhythmia; Death, Sudden, Cardiac; Long QT Syndrome

Summary: to conduct a cross-sectional epidemiologic study of the determinants of prolonged heart rate corrected qt interval (qtc) among 300 men and 300 woman in the population with the highest known risk of suds: southeast asian refugees in thailand. .

background: sudden and unexplained death in sleep (suds) is a leading cause of death of young men in several asian populations. the immediate cause is ventricular fibrillation in the absence of known disease. a strong environmental component may be inferred from the regional nature of suds in groups that are culturally and genetically distinct and the rapid decline in rates of suds after migration of southeast (se) asian refugees to the united states. risk of suds rises sharply to a peak among men aged 35 years of age, then declines with increasing age. in a pilot studies of se asian refugee men in thailand with the highest known risk of suds, the investigators documented high-prevalences of prolonged heart rate corrected qt interval (qtc), thiamine deficiency, hypokalemia, and a positive association between poor thiamine status, measured by erythrocyte transketolase activity (etk), and qtc. these limited studies were unable to precisely quantify the relationship between qtc and thiamine status, lacked sufficient power to examine the relationship between qtc and hypokalemia, did not include other electrolytes, and did not address the striking differences in risk of suds by sex and age. design narrative: the study was cross-sectional in design. during a 14-month period, informed consent was obtained from subjects selected in an age-stratified random sample of refugees scheduled for routine medical screening. blood samples, 12-lead and 24-hour ecgs, and interview data were collected to test the following hypotheses: (1) mean qtc was greater in men than women, (2) mean qtc was greater in men aged 30-39 years than in men younger or older; no similar relationship was expected among women, (3) qtc was positively correlated with poor thiamine status, measured by erythrocyte transketolase activity, (4-6) qtc was negatively correlated with serum levels of potassium, magnesium, and total calcium, and (7) qtc was associated with abnormalities of autonomic control of the heart, as indicated by power spectral analysis of heart rate variability. secondary aims included studying interactions of thiamine status and electrolytes in the prolongation of qtc, dynamic analysis of qt variation by heart rate level in 24-hr ecgs, and collection of blood specimens for later genetic studies

Eligibility criteria:
no eligibility criteria
does the application of cold decreases the pain associated in the pose of a patch of capsaicine at high concentration on the carrier patients of localized neuropathic pains ? - didocap

Conditions: Localized Neuropathic Pain

Summary: nursing study, prospective, randomized, two-center open-label. patients will be randomized into two groups during their first laying qutenza®: * patients receiving the laying of qutenza® without refrigerated cushion * patients receiving the laying of qutenza® associated with a refrigerated cushion the objective of the study is to evaluate the effectiveness of the application of cold to the reduction of pain (burning) after one hour of patch installation high concentration capsaicin (qutenza®) in patients localized neuropathic pain.


Eligibility criteria:
inclusion criteria: * major * do not opposing the participation in the study * monitoring in the case of localized neuropathic pain * diagnostic with neuropathic pain score ≥ 4 * neuropathic pain conventional treatment failure of first-line * front advantage of laying a first patch qutenza® * with ability to understand the proposed study exclusion criteria: * patch installation on the feet, face, mucous membranes * eutectic mixture of local anesthetics (emla) pose premedication * having already received prior to the installation of a patch of qutenza® * allergy to components qutenza® * known and poorly stabilized hypertension * known cryoglobulinaemia * pregnant or lactating women * patient enjoying a measure of legal protection (guardianship, guardianship ...) * private patient freedom * no affiliation to a social security scheme. * refusal to participate in the study
evaluate the impact, safety, tolerability and immunogenicity of the coronavac vaccine in kidney transplant recipients

Conditions: SARS-CoV Infection; Coronavirus Infection; Vaccine Adverse Reaction

Summary: since the beginning of the sars-cov-2 pandemic, 1031 (8.7%) of the 11875 kidney transplant recipients being followed up at hospital do rim have been infected. the overall lethality rate was 24%, reaching 53% among those over 70 years old. among the survivors, there is also a high incidence of renal dysfunction with loss of the renal graft and definitive return to dialysis. patients receiving pharmacological immunosuppression, including transplant recipients, have not been included in the studies carried out to date. in addition, kidney transplant recipients may have reduced vaccine responses compared to the general population. the severity, the high incidence of renal dysfunction and loss of renal graft, and the high lethality associated with covd-19 justify the investigation of the epidemiological impact and immunogenicity of the vaccine against sars-cov-2 infection.


Eligibility criteria:
inclusion criteria: 1. adults over 18 years old; 2. time after transplantation greater than 3 months; 3. time after treatment with anti-thymocyte globulin longer than 4 weeks; 4. able and willing (in the investigator's opinion) to comply with all study requirements; 5. provide written informed consent exclusion criteria: 1. planned receipt of any vaccine (authorized or experimental), within 30 days before and after vaccination; 2. prior receipt of an experimental or authorized vaccine with the possibility of impacting the interpretation of the study data (for example, vectorized vaccines by adenovirus, any vaccines against coronavirus); 3. administration of immunoglobulins and / or any blood products in the three months prior to the planned administration of the candidate vaccine; 4. any history of angioedema or anaphylaxis; 5. pregnancy, lactation or willingness / intention to become pregnant during the study; 6. diagnosis or current treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ); 7. history of severe psychiatric illness that possibly affects your participation in the study; 8. hemorrhagic disorder (eg, factor deficiency, coagulopathy or platelet disorder) or a previous history of significant bleeding or hematoma after im injections or venipuncture; 9. continued use of anticoagulants, such as coumarins and related anticoagulants (for example, warfarin) or new oral anticoagulants (for example, apixaban, rivaroxaban, dabigatran and edoxaban); 10. current suspected or known addiction to alcohol or drugs.
management of recurrent implantation failure

Conditions: Recurrent Implantation Failure (RIF)

Summary: this is the first study to investigate, whether pregnancy and implantation rates would improve in patients with recurrent implantation failure (rif), if all embryos were to be frozen and transferred in a consecutive natural cycle.

there is growing evidence that elective frozen-thawed embryo transfer in a non-stimulated cycle (freeze-all policy) would eliminate the risk of controlled ovarian stimulation and resulting in better endometrial receptivity and lower uterine contractility as compared with fresh intracytoplasmic sperm injection (icsi) cycles. rif refers to women who fail to achieve a clinical pregnancy, in a minimum of three embryo transfer cycles with at least four good-quality embryos were transferred in a woman \< 40 years. it affects approximately 10% of icsi cases. many management protocols aimed to enhance icsi outcome in cases of rif, however, none of them examined the effect of freeze all policy in this category of patients.

Eligibility criteria:
inclusion criteria: 1. gonadotropin-releasing hormone agonist and recombinant follicle-stimulating hormone (fsh) in a long protocol cycles; 2. female partners were under age of 40 years; 3. all the patients had a history of recurrent implantation failure i.e: failed to achieve a clinical pregnancy after at least three fresh icsi cycles where at least 8 good embryos were transferred; 4. their embryos were pushed to day 5 resulting in blastocysts, and undergo embryo transfer day 5 or vitrification on day 5; 5. endometrial thickness ≥ 7 mm; 6. selected embryos for embryo transfer were blastocysts. - exclusion criteria: couples with testicular or epididymal sperm were excluded. -

Keywords: recurrent implantation failure freeze all policy endometrial receptivity implantation clinical outcome
study of ct and mr in the lung cancer

Conditions: Lung Cancer Squamous Cell; CT; Genes; Response; MRI

Summary: lung cancer is one of the leading causes of cancer-related deaths in china. despite advances in systemic therapy and improvement nonsurvival rates for patients with advanced lung cancer, morbidity and mortality remain high. recently, many studies reported that patients with positive driving genes such as egfr(epidermal growth factor receptor,egfr), alk(anaplastic lymphoma kinase,alk), ros1(c-ros oncogene 1 receptor,ros1), braf (v-raf murine sarcoma viral oncogene homolog b1, braf)and so on have clearly targeted drugs, which bring survival benefits to patients. however, about half of patients still lack a clear driving gene target, which may have improved survival due to higher response rates to radiation therapy and other chemotherapy medications. development of noninvasive imaging biomarkers such as ct (computed tomography,ct)and mri (magnetic resonance imaging,mri)may not only evaluate the response to therapy ,but also could predict the efficacy of drug therapy and whether the driving gene is positive or not, through analysing the relationship between clinical related data and imaging features to find the imaging characteristics for making clinical decisions, and, consequently, contribute to an improved prognosis.

to explore the value of ct and mr using multiple sequences, including t2-tse-blade, t2 maps starvibe, and ishim-dwi in evaluating the driving genes and prediction of response to therapy and os in patients with lung cancer. patients with biopsy-proven lung cancer were prospectively enrolled for imaging on ct and a 3t mri scanner . the mri protocol included t2-tse-blade, t2 maps,ishim-dwi and starvibe sequences, and so on. patients received treatment according to nccn( national comprehensive cancer network) guideline. ct and mri features were analyzed to find the correlation between pretreatment imaging features and driving genes and therapy response. the study will include 400 patients. inter-reader agreements of tn staging were analyzed excellent for ct and mri. diagnostic accuracy of ct and mri will be calculated separately.

Eligibility criteria:
inclusion criteria: 1. consecutive patients with preoperative pathologically con-firmed lung cancer by endoscopy and preoperative imaging data were included. 2. no contraindications for mri examination. no contraindications for iodinated contrast. 3. the patients participate in this study with informed consent. exclusion criteria: 1. the patients couldn't performed msct or mr scanning or artefacts affect the evaluation. 2. the patients are extremely anxious and uncooperative about surgery or neoadjuvant therapy . 3. patientsthe patients refuse to participate in the project. 4. other situations considered by investigators not meet the inclusion criteria.

Keywords: lung cancer imaging features driving genes prediction therapy response
a study evaluating the pharmacokinetics of doravirine (mk-1439) in participants with severe renal impairment (mk-1439-051)

Conditions: Renal Impairment

Summary: this study will evaluate the effect of severe renal impairment on the pharmacokinetics of doravirine.


Eligibility criteria:
inclusion criteria: * is a non-smoker or moderate smoker * has a body mass index (bmi) ≥ 18.5 and ≤ 40.0 kg/m\^2 * other than renal impairment, participant is judged to be in good health based on medical history, physical examination, vital signs, and laboratory safety tests * female informed of the risks of pregnancy, agree not to become pregnant while participating in this study. female of childbearing potential must either be sexually inactive for 14 days prior to dosing and throughout the study, or uses one acceptable birth control method * female of non-childbearing potential must have undergone sterilization procedures at least 6 months prior to dosing. * participants with severe renal impairment only: has baseline estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73m\^2 exclusion criteria: * is mentally or legally incapacitated or has significant emotional problems * has a history or presence of clinically significant medical or psychiatric condition or disease * has history or presence of alcoholism or drug abuse within the past 2 years * has history or presence of hypersensitivity or idiosyncratic reaction to the study drug, any inactive ingredients, or related compounds * has history or presence of renal artery stenosis * has had a renal transplant or nephrectomy * has rapidly fluctuating renal function as determined by historical measurements * female is pregnant or lactating * has positive results for the urine or saliva drug and urine or breath alcohol screen at screening or check-in * has positive results at screening for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag), or hepatitis c virus (hcv) * is unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to dosing and throughout the study. certain medications including those to treat kidney disease will be permitted. other medications may be permitted following consultation with the sponsor clinical monitor. * is unable to refrain from or anticipates the use of inducers of cytochrome p450 3a (cyp3a) or permeability glycoprotein (p-gp) transporters for at least 28 days prior to dosing and throughout the study. * has been on a diet incompatible with the on-study diet, within 28 days prior to dosing, and throughout the study * has donated blood or had significant blood loss within 56 days prior to dosing * has donated plasma within 7 days prior to dosing * has participated in another clinical trial within 28 days prior to dosing
antibiotic resistance in danish eds.

Conditions: Antibiotic Resistance, Bacterial

Summary: the spread of multiresistant bacteria is an increasing problem which will mean increased costs, morbidity and mortality in the coming years. emergency departments (ed) play a key role in the early identification and management of patients who are carriers of multiresistant bacteria, but today there is very limited knowledge about both prevalence in the eds and risk factors for the carrier status of methicillin resistant staphylococcus aureus (mrsa), extended spectrum beta lactam producing enterobacteria (esbl), vancomycin resistant enterococci (vre), carbapenem resistant enterobacteria (cpe) and toxin-producing clostridium difficile (cd). this knowledge is necessary to prioritize and target the preventive response to the spread of multiresistant bacteria. the aim of this project is to provide a comprehensive overview of prevalence and risk factors for carrier status at a national level, and to develop screening tools for early identification of mrsa, esbl, vre, cpe and cd carriers among patients admitted to danish emergency departments. for hospitalized patients in 8 emergency departments in 4 danish regions, a total of 10,600 patients are asked for possible risk factors for resistant bacterial carrier status, and are swabbed in the throat, nose and rectum openings and examined for mrsa, vre, cpe, esbl and cd with the same analytical method of 4 clinical microbiological departments. the results are analyzed so that the prevalence of resistant bacteria can be described at the hospital level, regional level and national level. risk factors are analyzed for applicability for carrier identification, and based on this, screening models for the identification of carriers are developed. the vision for the project is that, based on the collected data, a comprehensive picture of the extent of the problem in denmark can be drawn up and new screening tools for early identification of carriers can be developed so that the intra-hospital spread of resistant bacteria can be met through early intervention with infectious hygiene measures. the project has been granted a grant of dkk 3,000,000 from the ministry of health and the elderly on december 7, 2016 and dkk 554,871 from the region of southern denmark on 28 august 2017.


Eligibility criteria:
* must be over 18 years * must be admitted to one of the emergency departments selected for the project for more than 4 hours. * must be mentally competent * to consent to participate exclusion criteria: * admitted more than 16 hours before inclusion * no operation in rectum less than 2 weeks before the admission