Kornimate/medical-research-clean huggingface dataset:
the brain health study: a pragmatic, patient-centered trial

Conditions: Dementia; Alzheimer Disease

Summary: the eradar brain health study seeks to refine and test a novel, low-cost strategy for increasing dementia detection within primary care.

detailed description: eradar stands for "electronic health record (ehr) risk of alzheimer's and dementia assessment rule." it is a low-cost tool or algorithm that uses readily available ehr data elements to identify high-risk patients. the investigators will conduct a pragmatic randomized controlled trial to assess the impact of implementing eradar as part of a supported outreach process on dementia detection rates. the investigators will also explore the impact of eradar implementation on healthcare utilization and patient experience.

Eligibility criteria:
inclusion criteria: * no prior diagnosis of dementia (defined from ehr diagnosis codes) and not receiving medications for dementia * active patient at participating clinic * adequate data to calculate eradar score exclusion criteria: - currently receiving hospice care
antibacterial prescribing & oral health practice

Conditions: Dental Anxiety; Tooth Loss

Summary: a study by allied health professionals to explore the experience of patients undergoing tooth extraction at leeds dental institute in relation to antibiotic medication, dental anxiety and oral health practices

consented patients attending the leeds dental institute for tooth extraction will be asked to complete 3 questionnaires in order for the researchers to understand more about the background of patients who have teeth extracted at the centre. the study will focus on the patient's previous experience of dentistry such as whether they have had antibiotics prescribed for toothache, whether they suffer from dental anxiety and how they regularly look after their oral health.

Eligibility criteria:
inclusion criteria: * adult patients undergoing extraction of one or more teet * parents/guardians of children aged 5-12 years old undergoing extraction of one or more teeth * patients aged 13-15 undergoing extraction of one or more teeth * patients and parents/guardians who are willing to give informed consent or assent to complete questionnaires exclusion criteria: * patients, parents/guardians unable or unwilling to provide informed consent * parents/guardians of patients aged less than 5 years old * patients or parents who are unable to communicate directly with the health person carrying out the treatment

Keywords: tooth extraction dental anxiety antibiotic oral health
ghrelin changes after roux-en-y gastric bypass

Conditions: Obesity; Insulin Resistance

Summary: the purpose of this study is to determine whether gastric division (via roux-en-y gastric bypass) with resultant fundic isolation will alter the pattern(s) of ghrelin secretion in the early post-operative period following feeding in morbidly obese subjects.


Eligibility criteria:
inclusion criteria: * serum creatinine and liver function tests \< upper limits of normal * stable body weights for the past three months * women will have a negative pregnancy test * patients who are already scheduled for rygb with gastrostomy tube placement exclusion criteria: * significant hepatic enzyme elevations (more than 100% of upper limits of normal) * serum creatinine \> 1.5 mg/dl * history of ketoacidosis or current metabolic acidosis * current use of oral anticoagulants * positive pregnancy test (beta-human chorionic gonadotrophin) for females * intercurrent infections * patients with prior gastric operations

Keywords: obesity insulin resistance gastric tube ghrelin
cingal study for knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to see if a single injection of cingal into the knee provides safe relief of pain caused by osteoarthritis.

this study compared three groups of subjects. group one received a single injection of cingal (hyaluronic acid plus triamcinolone hexacetonide). group two received a single injection of monovisc (hyaluronic acid). group three received a single injection of saline as a placebo.

Eligibility criteria:
inclusion criteria: * subject is 40 - 75 years old with a body mass index (bmi)≤ 40 kg/m2 * subject has kellgren-lawrence (k-l) severity grade i, ii, or iii in the index knee as determined by x-ray. contralateral knee: k-l severity grade 0, i, or ii. exclusion criteria: * subject received an intra-articular (ia) injection of hyaluronic acid (ha) and/or steroid in either knee within 6 months of signing the informed consent form (icf). * subject had an arthroscopy of either knee within 3 months of signing the informed consent form (icf).

Keywords: knee osteoarthritis hyaluronic acid ha injection steroid injection knee injection
prevalence of acromegaly in a diagnostic consultation for sleep apnea syndrome

Conditions: Sleep Apnea Syndrome

Summary: prevalence of sleep apnea syndrome in patients with acromegaly is about 70%. it seems that comorbidities of arterial hypertension or type 2 diabetes are more severe in patients with acromegaly and sleep apnea syndrome. besides sleep apnea syndrome associated to acromegaly gives rise to few symptoms, that explains it is under diagnosed. the mechanisms of the association are based on maxillofacial modifications linked to acromegaly, a thickening of soft tissues with deposits of glyco-aminoglycanes but probably also because of the associated obesity, of the potential existence of a goiter and a muscular dystrophy of the dilatative muscles of the pharynx. at present, no study clearly documented prevalence of acromegaly in a diagnostic consultation for sleep apnea syndrome.

60 investigators will participate to this study. they will be chosen among those participating to the sleep observatory of the federation of pneumology (www.osfp.fr). all participating pneumologists would have to fill in the questionnaire (co-morbidities, concomitant treatments, biological analysis) directly online and also clinical signs and symptoms of acromegaly. a blood test for the insulin-like growth factor (igf-1) dosage will be systematically prescribed to the patient. pneumologists will have to include all consecutive patients presenting with sleep apnea syndrome suspicion. according to first igf-1 results, patients may have to do a second blood test in a referenced laboratory to confirm the dosage.

Eligibility criteria:
inclusion criteria: * body mass index \< 40 kg/m2 * patient consulting for sleep breathing disorder * informed consent signed * patient covered by french health insurance exclusion criteria: * other sleep disorder already diagnosed * pregnant women * patients participating in an other study
influence of an asthma education programme on asthma control during pregnancy

Conditions: Asthma

Summary: asthma is the most frequent respiratory disease during pregnancy. in a third of cases, the level of asthma control can decrease during the pregnancy, especially between the 29th and the 36th week. the occurrence of such complications are linked with a high asthma severity level just before the conception and an history of respiratory complications in a previous pregnancy. many reviews and recommendations claim that pregnant women with asthma should be included in an educational progamme. however, this is poorly studied. the purpose of this study is to observe if an educational programme given before the 20th weeks of gestation has an effect on asthma control until the end of gestation.


Eligibility criteria:
inclusion criteria: * pregnant woman (less than 20 weeks of gestation at the inclusion time) * diagnosis of asthma before the pregnancy (clinical history and specific medications used) * agreement to enter into the study exclusion criteria: * pregnant woman (more than 20 weeks of gestation at the inclusion time) * history of major respiratory problems during previous pregnancy(ies) * refusal to enter into the study

Keywords: asthma health education pregnancy
clinical trial of the tqb2102 injection in patients with advanced cancers

Conditions: Advanced Cancer

Summary: tqb2102 is an antibody-drug conjugate comprised of a humanised antibody against human epidermal growth factor receptor 2 (her2), a enzyme-cleavable linker, and a topoisomerase i inhibitor payload, which combine the ability of antibodies to specifically target tumour cells with the highly potent killing activity of drugs with payloads too toxic for systemic administration. this is a phase i study to evaluate the safety, tolerability and effectiveness of tqb102 injection in subjects with advanced malignancies.


Eligibility criteria:
inclusion criteria: * evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study; * male or female patient 18 to 75 years of age, an eastern cooperative oncology group (ecog) performance status of 0 to 1, and life expectancy ≥12 weeks; * patients with advanced malignancies confirmed by cytology/histopathology, with priority given to those exhibiting her2 expression, amplification, or mutation; * malignant tumor that failed from standard treatment or had no standard treatment; * according to the recist 1.1 standard, patient with at least one evaluable lesion; * the main organs function well; * male or female patient had no plans to become pregnant and voluntarily took effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug. exclusion criteria: * concurrent secondary malignancy or other malignancy with no evidence of disease for more than 3 years; * history of uncontrolled intercurrent illness; * major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4 weeks prior to first dose; * patients with known symptomatic brain metastases; * receiving any other investigational agent within 4 weeks before first dose; * patients with severe hypersensitivity after the use of monoclonal antibodies * history of interstitial lung disease or pneumonia; * unstable or serious concurrent medical conditions, as assessed by the investigators, that would substantially increase the risk-benefit ratio of participating in the study.
inflammation, infection, and future cardiovascular risk

Conditions: Cardiovascular Diseases; Coronary Disease; Cerebrovascular Accident; Myocardial Infarction; Venous Thromboembolism; Heart Diseases; Infection; Chlamydia Infections; Cytomegalovirus Infections; Helicobacter Infections; Herpesviridae Infections; Inflammation

Summary: to examine markers of underlying chronic inflammation and infection as potential risk factors for future myocardial infarction (mi), stroke (cva), and venous thromboembolism (vte) in plasma samples collected at baseline from healthy participants in the physicians' health study (phs).

background: the phs is a cohort which included 14,916 men initially free of cardiovascular disease and cancer who provided plasma samples at study entry in 1982. these men were randomly assigned in a factorial design to aspirin or beta-carotene therapy, and have been followed prospectively for the occurrence of vascular disease. design narrative: employing a nested case-control design, baseline plasma samples are assayed for four markers of inflammation (interleukin-6, tnf-alpha, soluble icam, soluble vcam) and four markers of chronic infection (antibody titers directed against chlamydia pneumoniae, helicobacter pylori, herpes simplex virus, and cytomegalovirus). case subjects are those study participants who have subsequently developed mi (n=550), cva (n=400), or vte (n=200). control subjects are selected from those study participants who remained healthy during follow-up and are matched to the cases by age, smoking status, and follow-up time. data on usual cardiovascular risk factors, lipid parameters, and hemostatic markers of risk are already available in the phs and will be used to evaluate the results for potential confounding and effect modification. since the phs was a randomized trial of low-dose aspirin for its initial 5 years, this cohort also provides the unique opportunity to investigate whether the use of an agent with anti-inflammatory properties modifies the risk of subsequent thrombosis among those with underlying inflammation. indeed, this intriguing hypothesis has recently been raised regarding data relating another marker of inflammation, c-reactive protein, to future risks of myocardial infarction and stroke. these analyses will take advantage of an existing blood bank from a well-characterized large cohort with many years of follow-up and high quality end-point verification. thus, this study could provide an efficient and cost-effective mechanism to evaluate the posited, but unproven roles of inflammation and infection as risk factors for future cardiovascular disease. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
college student stress: transitions over time

Conditions: Depressive Symptoms

Summary: this research study is being conducted to better understand how college students develop and cope with stress and to identify opportunities to help students notice and respond to stress early before symptoms contribute to significant negative consequences. this project will be completed in two parts. in the first part (not a trial) participants will be asked to complete a screening survey to determine eligibility. eligible participants (i.e., those with mild-to-moderate depressive symptoms and not receiving mental health care) will continue into the clinical trial portion (part two). there were 120 students in the clinical trial phase of the study, where 30 were randomly assigned to "assessment only" and 90 to the "intervention" condition.


Eligibility criteria:
inclusion criteria: * first-year college students that are full-time or part-time students enrolled at the university of michigan, ann arbor or flint campuses * mild-to-moderate depressive symptoms, and are not receiving professional mental health services will be eligible exclusion criteria: * under the age of 17 * currently be receiving mental health therapy/counseling from a healthcare professional * experiencing minimal depressive symptoms (defined in protocol) * experiencing moderately severe to severe depressive symptoms (defined in protocol)

Keywords: first-year college student surveys supportive text messages stress personalized feedback
who contributes to the ordering of ct scans in emergency department patients?

Conditions: Emergency

Summary: the primary objectives are: 1. to investigate which healthcare workers and other individuals contribute to the decision to order computed tomography (ct) scans for emergency department (ed) patients. 2. to investigate the specific reasons healthcare workers and other individuals order or request ct scans for ed patients. 3. to determine the frequency of clinically important actions following ct scan results. once the drivers of ed ct utilization are identified, interventions including education, incentives for compliance with evidence-based best practices, and interventions for noncompliance could be targeted appropriately.


Eligibility criteria:
inclusion criteria: - patients from age 0 to \<17 years, and patients age 18 years and older with traumatic and non-traumatic presentations, who visit adult and pediatric eds and receive a ct scan during their ed visit exclusion criteria: * patients older than 17, yet younger then 18. * patients who are unable to consent and who do not have a legally authorized representative.

Keywords: computed tomography emergency ct scan ordering behavior diagnosis radiation
efficacy and safety of lonigutamab in subjects with thyroid eye disease (ted)

Conditions: Thyroid Eye Disease

Summary: phase 1/2, multicenter, multiple dose clinical study designed to evaluate lonigutamab in subjects with ted.


Eligibility criteria:
key inclusion criteria: * male or female, ≥18 and ≤75 years of age. * proptosis defined in the study eye as ≥3 mm above normal. * clinical activity score (cas) ≥4 (using a 7-item scale) for the most severely affected eye * onset of active ted symptoms prior to baseline * must agree to use highly effective contraception as specified in the protocol key exclusion criteria: * pathology related to inflammatory bowel disease or irritable bowel syndrome. * clinically significant pathology related to hearing or history of hearing impairment * optic neuropathy * corneal decompensation unresponsive to medical management. * previous orbital irradiation (for any cause) or any previous surgical treatment for ted. * subjects with diabetes or hemoglobin a1c \&gt;6.0% at screening * any steroid use (intravenous \[iv\] or oral) with a cumulative dose equivalent to \&gt;3 g of methylprednisolone for the treatment of ted within the last year. * previous steroid use (iv or oral) specifically for the treatment of ted not to exceed 1 g total dose in the 8 weeks prior to screening. * previous use of teprotumumab or any other igf-1 receptor (igf-1r) inhibitor. * any previous treatment with a biologic drug for the treatment of ted (eg, rituximab and tocilizumab) * any other immunosuppressive agent within 1 month of screening. * cohort 4 only: prior history of craniofacial surgery or medical conditions that could alter orbital or facial features.

Keywords: ted
melodi matrix™ in breast reconstruction

Conditions: Breast Reconstruction

Summary: prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.


Eligibility criteria:
inclusion criteria: * female. * age 22 or older at the time of enrollment. * is scheduled to undergo unilateral or bilateral mastectomy (including prophylactic) with immediate two-stage post-mastectomy alloplastic prepectoral breast reconstruction. * is able to and willing to comply with the study requirements and providing informed consent. exclusion criteria: * has prior history of neoadjuvant radiotherapy. * has had prior history of failed tissue expansion or breast implantation at the intended reconstruction site. * has an active abscess or infection requiring antibiotics anywhere in their body within 30 days. * has a body mass index (bmi) \ 40. * is pregnant or is nursing; or plans to become pregnant during the course of the study. * has any connective tissue/autoimmune disorder or rheumatoid disease. * has known allergies to study device materials. * is participating in another interventional research study that may interfere with study endpoints. * has limited life expectancy or co-morbid conditions, social/psychological problems, or cognitive impairments that precludes participation. * has a medical condition or is taking medications that would result in elevated risk and/or affect the validity of the study. * intraoperative assessment demonstrates unfavorable conditions (i.e., poor mastectomy skin flap thickness or viability) for immediate, two-stage post-mastectomy alloplastic prepectoral reconstruction in any breast.
the monitoring and intervention of refractive changes in children and teenagers in tianjin

Conditions: Myopia; High Myopia

Summary: the study aimed to collect multi-factor information on school-age children with pre-clinical myopia, and to identify the initial factors and warning signs of myopia.

the incidence of myopia is high in china. at present, the mechanism of myopia is unclear, and the main theories are genetic and environmental aspects. many factors may affect the occurrence and development of myopia in students, such as ocular biological parameters, peripheral refractive state, differences in binocular vision function, eye habits, and outdoor time. in this study, the multi-factor information on pre-clinical myopia in school-age children was collected to find out the initial factors and warning signals of myopia.

Eligibility criteria:
inclusion criteria: * all students in grades 1 to 4 * can cooperate with the examination of students exclusion criteria: * obvious strabismus and amblyopia * eye diseases that affect vision, such as congenital cataracts, glaucoma, and retinal diseases * history of ocular surgery
groningen early-pd ambroxol treatment

Conditions: Parkinson; Parkinson Disease

Summary: the most common genetic risk factor for parkinson's disease is a heterozygous mutation of the gba1 gene, encoding the lysosomal enzyme glucocerebrosidase (gcase). reduced gcase activity is associated with aggregation of the protein alpha synucleine (asyn) in the central nervous system, which is related to the pathological cause of pd. ambroxol is a mucolytic expectorant that appears to facilitate the refolding of the misfolded gba protein thats acts as a chaperone for gcase. this randomized placebo-controlled trial aims to investigate the disease-modifying properties of ambroxol in pd patients with a gba1-mutation. patients will undergo motor and cognitive tests, as well as imaging and blood tests.


Eligibility criteria:
inclusion criteria: * diagnosis of parkinson's disease, according to movement disorders society (mds) criteria (27) * disease duration of 10 years or less at time of inclusion * pd patients carrying a gba1 mutation * able to write written informed consent, understanding study protocol and perform protocol related actions * willing and able to self-administer oral ambroxol or placebo medication exclusion criteria: * the refusal to be informed about an unforeseen clinical finding * use of an implanted deep brain stimulation (dbs) system * confirmed dysphagia that would preclude self-administration of ambroxol or placebo tablets * history of known sensitivity to the study medication * pregnant or breastfeeding women * participants of childbearing potential that would not use adequate birth control, consisting of a negative pregnancy test at the screening visit and use of accepted contraceptive methods defined as highly effective while participating in the study * mri incompatible implants in the body * any clinically significant or unstable medical or surgical condition that in the opinion of the principal investigator may put the participant at risk when participating in the study or may influence the results of the study or affect the participant's ability to take part in the study, as determined by medical history, physical examinations, electrocardiogram (ecg), or laboratory tests. such conditions may include: 1. impaired renal function (a positive urine dipstick test, and laboratory values below or above: a egfr \<45 ml/min 1,73m2, sodium 135-145 mmol/l, potassium 3.5-5.0 mmol/l, urea 2.5-7.5mmol/l). 2. moderate/severe hepatic impairment (laboratory values below or above: asat 0- 80u/l, alat0-90 u/l, ggt \> 80 u/l, alkaline phosphatase 35-210 u/l).

Keywords: ambroxol gba1 gba