Kornimate/medical-research-clean huggingface dataset:
dental malocclusion and craniofacial development in oi

Conditions: Osteogenesis Imperfecta

Summary: osteogenesis imperfecta (oi) is a rare inherited disorder that causes bones to break easily. individuals with osteogenesis imperfecta break bones often and may have other problems, including hearing loss and pain and difficulty getting around. people with moderate to severe oi may also be diagnosed with dentinogenesis imperfecta (di). di is characterized by grey or brown teeth that may chip and wear down and break easily. people with di may also have skull and neck defects. these patients may have severe teeth misalignment resulting in clinically significant chewing problems. teeth misalignment in oi is very hard to treat because of the quality and quantity of bone. the overall goal of this study is to improve dental health to improve the quality of life of people with oi.

investigators will look at dental health in people with oi and will describe teeth misalignment and head and neck defects in individuals with moderate to severe osteogenesis imperfecta (oi). investigators will look at results from the longitudinal study of oi to complete the study evaluations. several x-rays will be performed for this study. participants will have a 3d scan of the mouth and a cone beam ct scan of the jaw at a baseline visit and at 3 years after the baseline visit. these study visits can be at the same time as the longitudinal study of oi study visits.

Eligibility criteria:
inclusion criteria: * males and females with clinical diagnosis of oi other than oi type i * individuals 10 years or older * participant of the brittle bone disease (bbd) longitudinal study (7701) exclusion criteria: * individuals who cannot be correctly positioned for valid radiographic analysis (e.g., due to severe scoliosis or short neck secondary to basilar invagination) * women who are pregnant
nurse case manager model on neuroblastoma caregiver's uncertainty

Conditions: Neuroblastoma

Summary: clinical problem and significance: the incidence of neuroblastoma is about 30 cases a year in taiwan. the five-year survival rate of neuroblastom is near 50% in taiwan. compared to the survival rate in western countries, the treatment in taiwan needs more efforts to improve. according to the report from the childhood cancer foundation roc, several children with neuroblastoma did not complete their treatment and or not received the protocol. in addition to the efforts in improving protocol, the reasons for those who drop-out and do not receive complete treatment need the investigators more attention to think of. purpose of study: the main purpose is to evaluate the effects of nurse case manager model on caregivers' adaptation of disease uncertainty about then child with neuroblastorna. methods: a longitudinal and prospective design will be used to perform this study. questionnaire survey and chart review will be the means of data collection for the part of quantative analysis. the qualitative method , semi-structural interview , also will be used to collect data regarding caregiver's perception of social support and adaptation at the same time of self-report of questionnaires survey .there are five points of time to collect data: baseline (a), 3 months(b) , 6 months(c), 9 months(d),1 year(e) and 1.5 year(f) after eligible subjects agree to participate in the study. subjects: the study will use a convenience sample. once the caregiver's child is on has been diagnosed with neuroblastoma will be recruited in this study. instruments: three chinese versions of mishel uncertainty in illness-parent form , the self-reported socio-demographic questionnaire will be used to collect data. process recording will be typed once finishing interview for further analysis. data analysis: quantitative data will be analyzed using spss 15.0 statistical software. the data will be analyzed using descriptive statistics and inferred statistics. content analysis and theme formation will be categorized to assist the interpretation of quantitative results. implication: the findings of this study will be expected of the effects of nurse care manager model on children with newoblastoma cancer survivors.


Eligibility criteria:
inclusion criteria: * care giver of neuroblastoma children exclusion criteria: * na

Keywords: primary caregiver neuroblastoma support group posttraumatic stress uncertainty
evaluation of treatment factors in the management of chronic iliotibial band syndrome in female distance runners

Conditions: Iliotibial Band Syndrome

Summary: the primary objective of this study is to determine if a more specific exercise routine that incorporates a progressive hip stability program will help to rehabilitate the hip and reduce symptoms of iliotibial band syndrome more than conventional hip exercises. three different exercises interventions will be compared to determine its effectiveness in reducing pain, improving function and returning subjects to running symptom free. secondary objective for this study is to establish an intervention program for female runners with this injury. there will be three treatment arms and participants will be randomly assigned to one of three groups: group a- control (stretching), group b (conventional hip exercises and group c (experimental treatment- specific progressive hip exercises).

the gluteus medius muscle is part of a muscle group called the hip abductor muscles. the gluteus medius originates at the dorsal ilium (uppermost, largest bone of the pelvis) below the iliac crest and inserts at the top outside surfaces of the greater trochanter (top of the thigh bone). it is the major abductor of the thigh (moves the leg away from the midline of the body). the anterior fibres rotate the hip internally and the posterior fibres rotate the hip externally. based on the anatomy and function of this muscle, the gluteus medius plays a major role in the mechanics of running. research has shown that runners with iliotibial band syndrome have been shown to have weakness in this muscle. most conventional exercises that have been research have been exercises that focus on only activation of this muscle in an unloaded position (non-weightbearing). group b of this study will focus on those exercises that have been researched. group c will be the experimental group in which we will begin with the conventional exercises and progress the exercises from a floor (unloaded) position to a more dynamic functional position (standing). this will be geared towards running specific exercises. we would like to know if there will be a difference in how fast symptoms reduce and strength gains occur and at what rate.

Eligibility criteria:
inclusion criteria: 1. female between the ages of 19-45 years; 2. have been diagnosed or been affected by itbs (pain on the outside of the knee) for no less than 3 months; 3. a distance runner averaging a minimum of 15 km per week of road running; exclusion criteria: 1. have previous history of knee surgery or knee trauma to the affected side; 2. have been diagnosed with any other knee pathology such as patellofemoral pain syndrome, degenerative joint disease, chondromalacia patella, tendinitis or tendinopathy in the affected knee;
early clinical study of utaa91 injection for the treatment of relapsed/refractory autoimmune diseases

Conditions: Systemic Lupus Erythematosus; Rheumatoid Arthritis; Dry Syndrome; Idiopathic Inflammatory Myopathies; Systemic Sclerosis

Summary: this clinical trial is designed as a single - arm, open - label, single - center, investigator - initiated early - phase clinical study. the primary objective is to evaluate the safety of utaa91 injection in treating subjects with relapsed/refractory autoimmune inflammatory diseases (aid).

following the signing of the informed consent form, eligible subjects will receive an infusion of utaa91 injection. blood samples will be collected from the subjects before and after the infusion for pharmacokinetic, pharmacodynamic, immunogenicity, and safety assessments. aside from the baseline period, efficacy evaluations will be conducted periodically during the treatment phase after cell reinfusion until the occurrence of one of the following events, with the earliest event taking precedence: disease progression, initiation of new anti - disease treatment, death, intolerable toxicity, the investigator's decision, or the subject's voluntary withdrawal.

Eligibility criteria:
inclusion criteria 1. age ≥ 18 years (including the cut - off value), with no restrictions on gender. 2. expected survival time ≥ 3 months. 3. subjects with relapsed/refractory autoimmune diseases who have failed standard treatment or lack effective treatment options, including but not limited to rheumatoid arthritis, systemic sclerosis, systemic lupus erythematosus, idiopathic inflammatory myopathies, sjögren's syndrome, connective tissue disease - related interstitial lung disease, immune thrombocytopenia, primary biliary cholangitis, etc. 4. liver and kidney functions and cardiopulmonary functions meet the requirements. 5. no severe mental disorders. 6. able to understand this trial and have signed the informed consent form. exclusion criteria 1. malignant tumors other than relapsed/refractory autoimmune diseases (r/r aid) within 5 years before screening. 2. subjects with positive virus and/or syphilis tests. 3. presence of severe heart disease or unstable systemic diseases. 5. presence of active or uncontrollable infections requiring systemic treatment. 6. pregnant or breastfeeding women, as well as female subjects who plan to become pregnant within 2 years after cell infusion or male subjects whose partners plan to become pregnant within 2 years after their cell infusion. 7. subjects who have received car - t therapy or other gene - modified cell therapies before screening.
the application of serum dna methylation for patients with hcc

Conditions: Hepatocellular Carcinoma

Summary: the goal of this single-arm prospective study is to evaluate the application of serum dna methylation for hcc patients with normal alpha-fetoprotein. the main question it aims to answer is . is the dynamic change of serum dna methylation correlated to recurrence or treatment response of hcc

the enrolled individuals with hcc and normal serum alpha-fetoprotein level would receive serum dna methylation test before their treatment (including all kinds of recommened hcc treatment). then regularly serum dna methylation test would be done at 4th\~8th weeks, 16th week, 32th week and 48th week. if the enrolled patients did not have hcc recurrence during at 48th week. the regular check of serum dna methylation would be canceled. the enrolled patients would be observed till 96th week. if there is any recurrence during 48\~96th week, one time of serum dna methylation would be checked at the time of recurrence. the observation and intervention would be completed at 96th week.

Eligibility criteria:
inclusion criteria: * age ≥ 20 years old * the diagnosis of hepatocellular carcinoma (hcc) according to aasld 2018 clinical guidelines or histology report * individuals with hcc and normal serum alpha-fetorpotein level (\<20 ng/ml) * individuals who could sign informed consent exclusion criteria: * the histology report revealed non-hcc, hcc mixed with cholangiocarcinoma or sarcomatoid hcc * individuals with hcc and other concurrent malignancies * individuals with chronic kidney disease who could not tolerate contrast-enhanced dynamic images * individuals ever receiving any organ transplantation * individuals with hiv infection * individuals who could not able to understand and sign informed consent

Keywords: dna methylation
search for genes influencing childhood absence epilepsy (cae) study

Conditions: Childhood Absence Epilepsy; Epilepsy; Seizures

Summary: the purpose of our study is to identify gene(s) involved in the cause of childhood absence epilepsy (cae).

a high familial predisposition for epilepsy in patients with childhood absence epilepsy (cae), also called petit mal epilepsy, suggests underlying genetic causes contributing to the disease. several areas harboring potential absence epilepsy genes have been identified in the genome. this study will further narrow down those areas and identify gene(s) involved in the cause of cae by taking several approaches: 1. comparing patients with cae to healthy individuals without epilepsy and 2. investigating whole families with many members affected with epilepsy). participation in this study requires an interview regarding medical and family history and saliva (spit) collection from all available family members of families with many epilepsy cases. for those families without a history of epilepsy, parents and children are asked to provide a small amount of saliva only. healthy volunteers without epilepsy or a family history of seizures are asked to fill out an anonymous questionnaire and provide a small amount of saliva as well. although the study is based at mount sinai school of medicine in new york, all study materials can be sent to your home at no cost to participants or their insurance. for the collection of saliva, special containers are provided and they can be shipped back to mount sinai in the pre-paid envelope provided. study materials can be completed at your convenience. results from this study may enable scientists to understand the cause of absence seizures and, perhaps, other types of seizures as well and with this laying the foundation for better diagnosis and treatment of epilepsy patients in the future.

Eligibility criteria:
patients and their families: inclusion criteria: * clinical diagnosis of classical (typical) childhood absence epilepsy * good seizure control * must be able to give saliva sample exclusion criteria: * history of non-febrile seizures prior to the onset of typical absence seizures * other neuropsychiatric or developmental disorders.

Keywords: childhood absence epilepsy cae petit mal epilepsy seizures genes inheritance genetics genetic linkage
noncoding rnas in covid-19 and covid-19 related kidney dysfunction

Conditions: COVID-19

Summary: in this study, critically ill patients with highly suspected or confirmed covid-19 will be included. main goal is the identification of noncoding rnas in covid-19 associated organ dysfunction with an emphasis on acute kidney injury.


Eligibility criteria:
inclusion criteria: * covid-19 exclusion criteria: * kidney transplantation * egfr \< 30 ml/min * dialysis within last 90 days * chronic dialysis * pregnancy

Keywords: acute kidney injury (aki) organ dysfunction
ideal marker for targeted axillary dissection

Conditions: Breast Cancer

Summary: a multicentre prospective comparative study, comparing the use of various markers (magnetic marker magseed, iodine seed 125i, carbon suspension) for marking a pathological lymph node in patients with breast carcinoma prior to neoadjuvant therapy and subsequent surgical treatment consisting of targeted axillary dissection.

there are two basic aims of the study 1. prospective comparison of the reliability and accuracy of individual markers used for marking of a pathological axillary lymph node with subsequent targeted axillary dissection. 2. comparison of the number of complications during localizing and detection of individual markers and postoperative complications. in individual collaborating centers, these markers are commonly used in clinical practice for marking of a pathological lymph node in patients with breast carcinoma. the usual standard of practice and treatment will not be changed in any way; the patients will only be prospectively followed. the study will bring an answer to the question of which marker is the best for marking lymph nodes. apart from the basic demographic and other data (patient age, side of the body, size and characteristics of the tumor (typing, grading, staging), type and time of surgery, the incidence of complications during implantation or detection of the marker, number of lymph nodes, complications after surgery, and the final histological findings, also the following outcome measures will be observed: * depth of marker implantation (measured in mm) * marker migration (measured in mm) * success-rate of resection of the marked lymph node - assessment, whether the lymph node was removed (yes/no) using the respective marker, expressed in percent of successful removal for the respective marker * time from localizing the pathological lymph node using the marker to surgery (measured n days)

Eligibility criteria:
inclusion criteria: * diagnosis of breast cancer, confirmed with a biopsy * indication of neoadjuvant therapy * biopsy of pathologically enlarged axillary lymph node and marking of the lymph node using one of the markers before neoadjuvant chemotherapy * surgical treatment after neoadjuvant chemotherapy (targeted axillary dissection) exclusion criteria: * refusal to participate in the study * another treatment protocol, which does not include targeted axillary dissection

Keywords: breast cancer axillary dissection magseed marker iodine seed carbon suspension axillary lymph node
invasive candidiasis in critical care

Conditions: Invasive Candidiasis

Summary: the combination of acute phase marker monitoring and the "t2candida" assay (name of the test) will represent an acceleration of the identification of the causative agent of mycotic infection, a significant improvement in the specificity and positive predictive value of this strategy in the diagnosis of invasive candidiasis and candidemia in icu patients, thereby improving the clinical condition of patients and reducing the cost of specific antifungal therapy.

speed of response in the treatment of sepsis is crucial for the patient. the time from the collection of a positive haemoculture to the identification of the causative agent of sepsis is around 2 days; therefore, physicians in intensive care units deploy combined empiric antibiotic and antifungal therapy immediately when acute phase markers such as procalcitonin, interleukin-6, presepsin, c-reactive protein are elevated. a new acute phase marker is lipopolysaccharide-binding protein, which, together with presepsin, appears to be a suitable marker to distinguish invasive candida infections from bacterial infections. but its kinetics needs to be further analyzed. at the same time, the causative agent of sepsis, g-/g+ bacteria or yeast, must be identified as soon as possible. haemoculture and culture of the established drain is the gold standard, but the disadvantage is the low sensitivity and the time delay to obtain the result. it is therefore advisable to combine haemoculture with molecular biology-based tests that can identify the causative organism within hours. conversely, the disadvantage of these tests is that they identify only the most common sepsis pathogens and do not determine susceptibility to antibiotics and antifungals, but the advantage is that with prophylaxis in place, these tests are often positive when haemoculture is negative. the t2candida test can detect candida albicans, candida tropicalis, candida glabrata, candida krusei and candida parapsilosis, which are the more common causative agents of mycotic bloodstream infections.

Eligibility criteria:
inclusion criteria: * critically ill patients * new onset sepsis * rise in body temperature \>38°c according to the third consensus definitions for sepsis and septic shock * colonization with candida spp. from more than 1 non-sterile site * body temperature \>38 °c despite 5 days of broad-spectrum antibiotic therapy with the presence of at least 1 of the following risk factors: abdominal surgery, secondary peritonitis, pancreatitis, central venous catheter (cvc) insertion, total parenteral nutrition (cpv), dialysis, steroid therapy, immunosuppressive therapy, or liver transplantation * microbiological test results will be reviewed and categorized based on whether candida sp. is isolated from at least 2 non-sterile sites (±3 days) and whether there is an alternative microbiological diagnosis. exclusion criteria: * not signing the informed consent with participation in the study * administration of antifungal therapy prior to collection of the biological material required for the study

Keywords: invasive candidiasis biomarkers candida sepsis
bioequivalency study of terbinafine tablets under fed conditions

Conditions: Onychomycosis

Summary: the objective of this study was the bioequivalence of a roxane laboratories' terbinafine tablets, 250 mg, to lamisil® tablets, 250 mg (novartis pharmaceutical corporation.) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to terbinafine or any comparable or similar product.
safety of tki258 in advanced/metastatic melanoma subjects

Conditions: Melanoma

Summary: this study is an open-label, dose-escalating study to delineate the safety, pharmacokinetics (pk), and pharmacodynamics (pd) of tki258. pharmacokinetics and pharmacodynamics will be performed on all subjects. the eligible subject population consists of subjects who have been diagnosed with locally advanced or metastatic melanoma that is refractory to standard therapy or for which no curative standard therapy exists.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of locally advanced or metastatic melanoma (american joint committee on cancer \[ajcc\] stage iiib, iiic or iv) that is refractory to standard therapy or for which no curative standard therapy exists. * measurable disease * must be eighteen years of age or older * must meet baseline laboratory requirements * ecog performance status 0 or 1 * adults of reproductive potential must agree to use effective contraception or be sterile exclusion criteria: * concurrent therapy with any other investigational agent * uncontrolled central nervous system metastases * impaired cardiac function or clinically significant cardiac disease * received * chemotherapy, targeted therapy or monoclonal antibody therapy ≤4 weeks * biological therapy or immunotherapy (therapeutic or diagnostic) ≤2 weeks * an investigational agent (therapeutic or diagnostic) ≤4 weeks prior to starting study drug or has not recovered from side effects of such therapy * received any hematopoietic colony-stimulating factor (e.g., g-csf, gm-csf) ≤ 2 weeks prior to starting study drug. erythropoietin is allowed. * has undergone major surgery ≤ 2 weeks prior to starting study drug or has not recovered from side effects of such surgery. * malabsorption syndrome or uncontrolled gastrointestinal symptoms such as nausea, diarrhea, vomiting * pregnant or breast feeding women * history of another primary malignancy that is currently clinically significant or currently requires active intervention. * chronic anticoagulation therapy with full strength aspirin, coumadin, or heparin. * history of thromboembolic or cerebrovascular events within the last 12 months. * history of rectal bleeding, bloody vomit, or spitting up blood within the last 3 months. * known diagnosis of hiv infection (hiv testing is not mandatory) * use of ketoconazole, erythromycin, carbamazepine, phenobarbital, phenytoin, rifampin, st. john's wort and quinidine is prohibited. * other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study-drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, make the patient inappropriate for this study

Keywords: locally advanced or metastatic melanoma