Kornimate/medical-research-clean huggingface dataset:
prediction of the cobrra af anticoagulant trial in healthcare claims data

Conditions: Atrial Fibrillation

Summary: investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. the investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

this is a non-randomized, non-interventional study that is part of the rct duplicate initiative (www.rctduplicate.org) of the brigham and women's hospital, harvard medical school. it is intended to replicate, as closely as possible in healthcare insurance claims data, the trial listed below/above. although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates through standard practice. investigators assume that the rct provides the reference standard treatment effect estimate and that failure to replicate rct findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original rct finding.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * non-valvular atrial fibrillation exclusion criteria: * prior anticoagulant use \[day -180, day 0\] * stage 4 or 5 chronic kidney disease or end-stage renal disease \[day -180, day 0\] * dialysis or renal transplant \[day -180, day 0\] * recent major or clinically relevant non-major bleeding \[day -180, day 0\] * other indications for anticoagulation (dvt, pe, or prosthetic heart valve) \[day -180, day 0\] * use of an antiplatelet \[day -180, day 0\] * significant liver disease and coagulopathy \[day -180, day 0\] * use of cyp3a4 or p-gp inhibitors or inducers \[day -180, day 0\] * pregnancy or breastfeeding \[day -180, day 0\] * cancer \[day -180, day 0\] * bypass surgery, obesity, or the use of a weight loss or appetite suppressor \[day -180, day 0\] * mitral stenosis with or without insufficiency, mitral rheumatic insufficiency, and other/unspecified mitral valve disorders \[day -180, day 0\]
online spanish cognitive intervention program for spanish-speaking latino/hispanic subarachnoid hemorrhage patients

Conditions: Subarachnoid Hemorrhage; Cognitive Impairment; Quality of Life; Depression, Anxiety

Summary: the purpose of this research study is to examine the effectiveness of an online spanish cognitive intervention program in latino/hispanic spanish-speaking subarachnoid hemorrhage patients. in particular, the researchers will examine whether cognitive impairments associated with a subarachnoid hemorrhagic event improve after completing the online cognitive intervention program. secondary outcomes of the research study include examining whether there is an improvement in research participants' quality of life and psychological functioning as a result of the online spanish cognitive intervention program.

40 spanish-speaking research participants who have sustained a subarachnoid hemorrhage in the last 6 months will participate in the current research study. participants will be randomly assigned to one of two groups: 1) cognitive intervention group (n = 20) or 2) control group (n = 20).

Eligibility criteria:
inclusion criteria: * history of a subarachnoid hemorrhage within the last 6-months. must be confirmed by medical records and/or neurointerventionist radiologist * 18 years and older * primarily spanish-speaking * able to read in spanish * able to use a computer exclusion criteria: * history of neurological conditions (e.g., alzheimer's disease, epilepsy, traumatic brain injury, brain tumor, encephalitis, meningitis, parkinson's disease) other than subarachnoid hemorrhage * history of neurodevelopment disorder (e.g., autism spectrum disorders, attention deficit-hyperactivity disorder) * history of learning disabilities * history of psychiatric illness (e.g., depression, anxiety, bipolar disorder, schizophrenia) * alcohol or illicit substance abuse or dependence * currently on medication(s) that may impact performance on the neuropsychological evaluation or online cognitive intervention program * severe expressive aphasia * upper extremities or vision problems that prevent participant from adequately using a computer or completing the neuropsychological evaluation * unable to commit to participate for the entire study including returning for one-year follow-up neuropsychological evaluation

Keywords: spanish-speakers subarachnoid hemorrhage cognitive intervention
antibiotic regimen for dental implants cases

Conditions: Dental Implant Infection

Summary: this study aims to: 1. to identify the most common organisms causing dental implant failure. 2. set an appropriate antibiotic regimen according to the causative organism to limit the antimicrobial resistance by limit the use of antibiotics.

dental implant surgery is a common treatment for replacing missing teeth and has a high success rate. implant failure is most likely the result of multiple factors as age, sex, smoking, maxillary implant site, quantity and quality of bone, implant surface treatments and features are some of the statistically examined parameters linked to implant failure. the most frequent and avoidable cause of dental implant failure is infection. a retrospective analysis demonstrated fewer numbers of early implant failures among those that were placed under antibiotic treatments. early implant failure is commonly associated with certain strains of bacteria. the most common bacteria involved are streptococci, anaerobic gram-positive cocci, and anaerobic gram-negative rods.porphyromonas gingivalis and fusobacterium nucleatum frequently colonize the implant in early and late losses and could therefore be characteristic for implant loss in general. thus, the antibiotic to prevent delayed healing of wound should be bactericidal and of low toxicity. systemic antibiotic prophylaxis has been used to reduce the risk of early implant failure and local infections around dental implants.antibiotics are one of the most cost-effective, life-saving medicines and contribute to an extended lifespan. access to antibiotics without a prescription is a driving factor for irrational antibiotic use due to a potential lack of access to proper diagnosis and diagnostic tools. this eventually leads to the development and spread of antibiotic resistance \&it is one of the increasing public health challenges worldwide.

Eligibility criteria:
inclusion criteria: saliva samples from patients seeking dental implant procedures - exclusion criteria: * immunodeficiency or immunosuppressing treatment * current antibiotic treatment * smoking * acute or chronic oral infection (including ongoing periodontal infection).
clinical relevance of small airways disease in severe asthma patients treated with anti-interleukin-5 therapy

Conditions: Asthma

Summary: the aim of this research is to investigate the extent and clinical relevance of small airways disease in severe eosinophilic asthma patients treated with anti-il5/5r therapy.


Eligibility criteria:
inclusion criteria: * severe asthma patients treated with anti-il5/5r therapy (i.e. mepolizumab, benralizumab, reslizumab) for at least 4 months. exclusion criteria: * no information about lung function at baseline, or after both 4 months and 12 months. * no information about clinical response (i.e. number of exacerbations, reduction of mocs/ maintenance oral corticosteroid dose, acq, aqlq) after both 4 months and 12 months. * treatment with another anti-il5/5r therapy before
alveolar microperforation for inflammation-enhanced tooth movement during orthodontic treatment

Conditions: Malocclusion

Summary: the purpose of this research study is to assess the clinical effectiveness of the procedure of a minimally invasive alveolar microperforation procedure to achieve accelerated tooth movement in patients undergoing orthodontic treatment. "accelerated tooth movement" means that using the propel™ device may help complete your treatment with braces on one side of your mouth sooner than would be expected if the device were not to be used.

following informed consent and satisfying the screening/enrollment assessments, a panoramic and periapical radiograph of the teeth designated for micro-osteoperforation treatment is to be taken. prior to the intervention the subjects will swish 5cc of chlorhexidine for one minute, twice. micro-osteoperforation, propel™, is conducted under local or topical anesthesia after the subject is banded and bonded. the procedure will be randomized to either the left or right side in each subject. following the procedure, chlorhexidine rinses are to begin twice a day for a week. the subjects will be advised to take tylenol only in case of significant pain. subjects will be seen four to six weeks after completion of treatment for the first follow-up. subjects will be followed up with a telephone consult 24 hours after micro-osteoperforation is performed. they will be asked if any pain medication was taken after being dismissed from the research center and if so, they will be asked the name and dose of medication taken. study will conclude at the 6 month follow up visit or when space on the treating side is closed.

Eligibility criteria:
inclusion criteria: * adolescent and adult subjects ages 18-55 years old, in good general health, with adult or mixed dentition, regardless of presence of third molars. * subjects are american society of anesthesiologists (asa) class i (asa class i - patients are considered to be normal and healthy). * periodontal or gingivitis diseases must be addressed prior to study enrollments: probing depth(pd)\<5mm,gingival index (gi)\<1,plaque index(pi)=1 * if any caries is present, patient will be referred to dentist for treatment and maintenance before beginning treatment * able to understand english, follow simple instructions and sign informed consent exclusion criteria: * subjects who have taken any local or systemic antibiotics, corticosteroids or periodontal medications in the previous six weeks. * subjects with extreme skeletal class ii malocclusion: overjet\>10mm, (pogonion to nasion perpendicular line)pg-nper\>18mm, a point nasion b point (anb)\>7, sella nasion line to gonion gnathion line (sn-gogn)\>38 * vulnerable subjects who unable to consent for themselves

Keywords: malocclusion accelerated tooth movement braces orthodontic treatment propel
hip muscle strength in fai versus normal controls

Conditions: Femoro-acetabular Impingement

Summary: hip muscle strength in femoro-acetabular impingement participants versus normal controls. to investigate the hip muscle strength in a normal control group and compare this to patients who have a diagnosis of femoro-acetabular impingement (diagnosed clinically and with confirmed radiological features).


Eligibility criteria:
inclusion criteria: * males and females. * aged 18-30. * control group - normal range of movement and no evidence of femoro-acetabular impingement on clinical examination (negative impingement test, no symptoms). * participants with femoro-acetabular impingement as diagnosed clinically and on radiological imaging for the comparison group (mri). exclusion criteria: * patients under the age of 18. * patients over the age of 30. * control group - evidence of underlying pathology affecting the hip, abnormal range of motion, evidence of femoro-acetabular impingement on clinical examination. * previous surgery of the hip joints. * medical history of arthritis (including rheumatoid and reactive). * family history of femoro-acetabular impingement (control arm participants). * patients who are currently experiencing or have experienced hip pain in the previous 1 year (control arm). * other conditions (e.g. neurological, muscular dystrophy etc) which may affect hip muscle strength.

Keywords: hip muscle strength fai
a study to examine the safety and toleration of pep005 topical gel in patients with actinic keratoses on the top of the hand

Conditions: Actinic Keratosis

Summary: the purpose of this study is to examine the safety and toleration of pep005 topical gel, administered on an actinic keratosis (ak) treatment area on the top of a hand.

actinic keratoses (ak) is a common skin condition characterized by rough, scaly patches or sores on the top layer of the skin which if left untreated can progress to skin cancer. current treatments can cause scarring and hypopigmentation, be inconvenient, or require long treatment duration. non-invasive alternative therapy for treatment of ak lesions is thus being researched.

Eligibility criteria:
inclusion criteria: * male patients at least 18 years of age. * post-menopausal female patients * 4 to 8 clinically typical, visible and discrete ak lesions within an area on the dorsum of one hand. * written informed consent has been obtained. * agreement from the patient to allow photographs of the selected ak treatment area to be taken and used as part of the study data package.

Keywords: actinic keratosis topical dermatology hand
study on umorestat hydrogen sulfate capsule in patients with locally advanced/metastatic pancreatic cancer

Conditions: Pharmacokinetics; Pancreatic Cancer; Gene Polymorphisms

Summary: based on the tolerability, safety and pharmacokinetics phase i/ii clinical trials of ulimostat hydrochloride capsules (lh011) combined with gemcitabine hydrochloride (gem) in locally advanced/metastatic pancreatic cancer patients, to determine pharmacokinetics, the biotransformation pathway and metabolite profile of ulimostat in patients with locally advanced/metastatic pancreatic cancer.

this study is a research on the pharmacokinetics and gene polymorphisms of ulimostat hydrochloride capsules in patients with locally advanced/metastatic pancreatic cancer. aims to collect the "phase i/ii clinical trials of the tolerability, safety and pharmacokinetics of ulimostat capsules (lh011) combined with gemcitabine hydrochloride (gem) in patients with locally advanced/metastatic pancreatic cancer" patient's peripheral blood sample to determine the structure of the metabolites of ulimostat in the biological samples and trough concentration and genotyping tests were performed on patients to investigate the correlation between gene polymorphisms of metabolic enzymes, transporters, target protein upa and proteins expressed in upstream and downstream signaling pathways and blood drug concentration, efficacy, safety and tolerance of ulimostat.

Eligibility criteria:
inclusion criteria: * successfully enrolled in a phase i/ii clinical study on the tolerability, safety and pharmacokinetics of umorestat hydrogen sulfate capsule (lh011) combined with gemcitabine hydrochloride (gem) for patients with locally advanced/metastatic pancreatic cancer. * fully understand the purpose and requirements of this study and sign a written informed consent. * willing to provide blood samples. exclusion criteria: * suffering from inflammatory bowel disease. * the researcher considers it unsuitable to participate in this study.

Keywords: pharmacokinetics gene polymorphisms pancreatic cancer
augmentative and alternative communication in games with virtual reality in intellectual disabilities

Conditions: Intellectual Disability

Summary: background: games using motion capture from webcam have become increasingly popular. a population that lacks much stimulus in the teaching-learning process has under-explored the benefits of this kind of games: the intellectually disabled. the aim of this study is to analyse the effectiveness of games with virtual reality in the total reaction time. method: a convenience sample of 165 intellectually disabled participants will have their performance measured using a virtual reality game. the intervention is to play two different games twice, in two sessions with an interval of, at least, seven days between the sessions. participants will be randomized between two raters, both master students.


Eligibility criteria:
inclusion criteria: * all the children that uses to go the institution where the data collection will be realised (apae). exclusion criteria: * those who decline to participate * those who are not present in the two days of evaluation.

Keywords: assitive technology virtual reality games intellectual disability augmentative and alternative communication
a study on immunity duration against polio over 18 months infants after 2 or 3 primary doses sabin ipv in china

Conditions: Poliomyelitis

Summary: in 2017, china cdc conducted a study titled "a study of immunogenicity and seroconversion with sabin ipv schedules in china". at present, all the infants in the monitoring cohort were over 18 months old and at least one year had elapsed since the last dose of sipv inoculation.since there is no any data about the protection duration of two-dose sabin ipv schedules, china cdc propose to follow up the study cohort to evaluate the proportion of seroprotection of antibody and measure neutralizing antibody titers against poliovirus at over 18 months of age infants after a 2-dose or a 3-dose primary schedule of sabin ipv in chinese children.

in 2017, china cdc conducted a study titled "a study of immunogenicity and seroconversion with sabin ipv schedules in china". this study offers evidence that two doses of sipv administered at 4 and 8-11 months of age and three doses of sipv administered at 2, 3, and 4 months of age both provide serological protection against poliomyelitis. at present, all the infants in the monitoring cohort were over 18 months old and at least one year had elapsed since the last dose of sipv inoculation. since there is no any data about the protection duration of two-dose sabin ipv schedules, china cdc propose to follow up the study cohort when all subjects are at least 18 months old to monitor persistence of antibody. so that, if the antibody levels are not high enough to protect children from the disease, remedial measures can be taken as soon as possible.so china cdc conduct this follow up study ,to 1. evaluate the proportion of seroprotection of antibody against poliovirus at over 18 months of age infants after a 2-dose or a 3-dose primary schedule of sabin ipv in chinese children. 2. measure neutralizing antibody titers against poliovirus type i, ii and iii at over 18 months of age infants after 2-dose sabin ipv schedule, compared with 3-dose sabin ipv schedule.

Eligibility criteria:
inclusion criteria: * parent or legal guardian agree to participate in the follow study. * the subject was vaccinated either two doses or three doses sabin ipv ,collected two blood samples and laboratory test results were available per protocol of pervious study * the subject is at least 18 months age. exclusion criteria: * parent or legal guardian does not agree to participate in the follow up study. * the subject has received any polio vaccine product beyond the protocol of previous study.

Keywords: inactivated poliovirus vaccine sabin strain
precision performance status assessment in breast cancer patients receiving neoadjuvant chemotherapy

Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8; Triple-Negative Breast Carcinoma

Summary: this study assesses the performance status in stage i-iii triple negative breast cancer patients who are receiving neoadjuvant chemotherapy. information collected in this study may help doctors learn if movement and fitness trackers can be used to predict side effects in cancer patients receiving chemotherapy.

primary objective: i. to determine if in-office movement trackers or baseline metabolic equivalents (mets) groups identify those patients who are at highest risk for severe adverse event (sae)s on neoadjuvant chemotherapy. secondary objectives: i. to determine the association between the occurrence of saes, unexpected healthcare encounters, depending on the change in activity level classification between the baseline mets group and mid-treatment mets group (at month 3). ii. explore association between patient reported outcome (pro) data and movement tracker data. outline: patients complete movement assessment 5-15 days prior to the initiation of neoadjuvant chemotherapy and at day 1 of neoadjuvant chemotherapy. patients' sae data is collected. patients are observed during their neoadjuvant chemotherapy for up to 6 months.

Eligibility criteria:
inclusion criteria: * patients with pathologically confirmed breast cancer with any receptor status, who will receive neoadjuvant chemotherapy. patients with denovo oligo-metastatic disease, where the intent of therapy is curative with incorporation of local therapy (surgery/radiation to the breast and/or metastatic sites) are also eligible. * age \>= 18 years * ability to understand and the willingness to sign a written informed consent * willingness to wear sensors to track physical activity, global positioning system (gps) location, and provide symptom ratings each night during the screening period of their clinical trial and 180 days after starting treatments * able to read english, spanish, or mandarin to complete patient reported outcomes * able to ambulate without an assistive device exclusion criteria: * missing lower limbs * known movement disorder such as parkinson's disease, choreo-athetoid movement disorders, essential tremor if that movement disorder is of sufficient severity to require drug therapy