Kornimate/medical-research-clean huggingface dataset:
smartwatch ecg evaluation trial i

Conditions: Atrial Fibrillation

Summary: this is a single-center, non-randomized study to collect validation data for submission to the food and drug administration (fda) to support a 510(k) device clearance for a smartwatch ecg.

1. obtain a simultaneous recording of a lead i (ra-la) ecg from the smartwatch and a clinical standard device (ge cardiosoft ecg). subsequent recordings will be acquired from the other models of the smartwatch as well as a recording utilizing the fda-cleared kardiamobile. 2. compare the ecg waveforms from the smartwatch to the ge and kardiamobile devices to demonstrate equivalence in terms of cross correlation (correlation coefficient \>.95) and rms difference (\<10 microvolts). 3. compare the algorithmic determination from the smartwatch ecg to those of the ge and kardiamobile to demonstrate equivalence.

Eligibility criteria:
inclusion criteria: * male or female \> 18 years of age. * ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures. * being seen in the ou cardiac electrophysiology outpatient clinic. exclusion criteria: * inability or refusal of the patient and/or the patient's legally acceptable representative to provide written informed consent for any reason. * other conditions that in the opinion of the lead investigator may increase risk to the subject and/or compromise the quality of the clinical trial.
renal function in adults with congenital heart disease.

Conditions: Cardiovascular Abnormalities; Kidney Failure

Summary: impaired kidney function is associated with a poor outcome in patients with heart failure but it is not known of this is the case for patients who have been born with their heart condition (congenital heart disease). this study aims to investigate how frequently patients with congenital heart disease have kidney disease and whither this does have an impact on their outcome. the hypothesis is that kidney dysfunction will be common in these patients and may have an impact on long-term health and life-expectancy.

renal dysfunction is a recognised independent prognosticator in patients with chronic heart failure. indeed it has been suggested that the clinical impact of renal dysfunction may be greater than that of left ventricular ejection fraction per se. the role of renal function has also been investigated in small sub-groups of patients with adult congenital heart disease (achd) for example peri-operatively. it is not however known if renal dysfunction has the same prevalence and significance as when present to patient with acquired heart failure. the hypothesis of the study is that renal dysfunction, both overt and sub-clinical, will be commonly detected in patients with congenital heart disease. the study proposes that renal dysfunction will be associated with hospitalisation for heart failure and fluid overload and will also identify patients at an increased risk of worsening clinical status. comparisons: baseline renal function (creatinine, glomerular filtration rate by equation and clearance testing), quantification of urinalysis, baseline neurohormones. follow-up data regarding clinical endpoints including new arrhythmia, functional deterioration, and hospitalisation.

Eligibility criteria:
inclusion criteria: * the ability to give informed consent * age \>18 years * congenital heart disease being treated as an outpatient exclusion criteria: * pregnancy * renal failure requiring renal-replacement therapy * known diabetes * shellfish, iodine, or significant drug allergy (sub-study only).

Keywords: adult congenital heart disease heart failure renal failure proteinuria
a case management study targeted to reduce health care utilization for frequent emergency department visitors

Conditions: The Focus is to Investigate Effect of a Case Management Interventions in Frequent Visitors to Emergency Departments

Summary: the aim of the study is to determine whether a nurse-managed telephone-based case-management intervention can reduce healthcare utilization and improve self-assessed health status in frequent emergency department users.

the study tests a nurse-run case-management intervention targeted towards frequent emergency department visitors. the aim is to reduce visits to emergency departments as well as to improve quality of life by facilitating coping mechanisms as well as redirecting these patients to more suitable health care facilities.

Eligibility criteria:
inclusion criteria: * recent history of frequent visits to emergency department * anticipated sustained high visit frequency * living in one of five swedish counties where trial is ongoing exclusion criteria: * moribund patients * psychosis * severe hearing impairment or language difficulties * other factors that may make it impossible or impractical for a patient to participate in the study

Keywords: case management, disease management, emergency department
a computational approach to optimal deactivation of cochlear implant electrodes

Conditions: Hearing Loss

Summary: the goal of the present study is to use computationally driven models of speech understanding in ci users to guide the search for which combination of active electrodes can yield the best speech understanding for a specific patient. it is hypothesized that model-recommended settings will result in significantly better speech understanding than standard-of-care settings.

aim 1 is to quantify speech understanding and sound quality with model-recommended combinations of active electrodes compared to standard settings, and compared to two control active electrode combinations. aim 2 is to translate the model-driven recommendations from aim 1 into practical guidance about how many (and possibly which) ci electrodes to deactivate.

Eligibility criteria:
inclusion criteria: cochlear implant subjects * must be older than the age of 18 * implanted unilaterally with ci with at least 1 year of experience * no diagnosis of any other communicative or cognitive disorder. * english-speaking * willingness and ability to provide informed consent normal hearing subjects * must be older than age of 18 * no diagnosis of any other communicative or cognitive disorder. * english-speaking * willingness and ability to provide informed consent exclusion criteria: not meeting the inclusion criteria above
the effect of high reality simulation environment on the skills of midwifery students, in newborn heel blood collection

Conditions: Students; Educational Problems; Anxiety

Summary: the researchers gave midwifery students theoretical training on how to take heel blood on a newborn model. students were asked to take heel blood on the model in the high-reality simulation environment and simulation room. the student's ability to take heel blood before and after taking heel blood in a high-reality simulation environment or on a newborn model in a simulation environment, satisfaction with learning, anxiety and self-efficacy levels were compared.

the population of the research consisted of 4th grade midwifery students studying in the fall semester of the 2022-2023 academic year (n = 98). 6 students could not continue studying. no sample selection was made and an attempt was made to reach the entire universe. the sample of the research consisted of a total of 92 midwifery students, n=46 in the control group and n=46 in the experimental group. verbal and written permission was obtained from the students included in the research. both the experimental and control groups were given theoretical training on heel blood collection on a model using the show-and-tell technique.then, those in the experimental group were asked to take heel blood on a newborn model in a high-reality simulation environment. the control group was asked to take heel blood on a newborn model in the simulation laboratory. self-efficacy-efficacy scale for both the experimental group and the control group. state and trait anxiety scale was applied as pre-test and post-test. student satisfaction and self-confidence in learning scale was applied only as a posttest. the heel prick skill evaluation form was filled out by a researcher. pre-test and post-test results, student tudent satisfaction and self-confidence in learning scores , and heel blood skill scores were compared between the experimental and control groups.

Eligibility criteria:
inclusion criteria: * 4th grade students (n=49) who took the maternal and child health practice course of the midwifery department and agreed to participate in the study voluntarily were included in the study. exclusion criteria: * students in younger grades who did not take the maternal and child health practice course were excluded.

Keywords: skills training high reality simulation environment skills laboratory midwifery training.
topical asc-j9 cream for acne

Conditions: Acne

Summary: to evaluate the safety and efficacy of topical 0.1% and 0.025% asc-j9 creams applied twice daily for facial acne compared to vehicle control.

approximately 180 patients at least 12 years of age with facial acne will be randomized to twice daily topical treatment with 0.1% or 0.025% asc-j9 cream or vehicle control for 12 weeks. patients will return to the clinic at weeks 2, 4, 8 and 12 and again 4 weeks after the last dose of study drug for evaluation of acne status and safety parameters.

Eligibility criteria:
key inclusion criteria: * at least 12 years of age at the time of enrollment * facial acne, with: 1. 20-60 inflammatory facial lesions (papules/pustules/nodules/cysts); 2. 20-100 noninflammatory facial lesions (open and closed comedones); 3. no more than 2 nodules/cysts on the face (defined as an inflammatory lesion greater than or equal to 5 mm in diameter); 4. investigator's global assessment (iga) acne score of 3 or 4. key exclusion criteria: * females who are pregnant or breast-feeding * skin diseases other than acne vulgaris * use of other topical or systemic treatments for acne * other significant medical conditions or clinically significant abnormal laboratory test results.

Keywords: androgen receptor degradation enhancer
prophet study: ctdna-guided personalized induction immunochemotherapy for nsclc

Conditions: Non-small Cell Lung Cancer (NSCLC)

Summary: the goal of this clinical trial is to evaluate the clinical value of ctdna testing in guiding the optimization of immunochemotherapy cycles during induction treatment for resectable patients with nsclc. the main questions it aims to answer are: * does ctdna clearance indicate pathological complete response? * are additional cycles of immunochemotherapy necessary for patients who have ctdna clearance after initial cycles of treatment? researchers will use ctdna dynamics to guide the cycles of induction treatment to see if some patients can avoid excessive cycles of treatment.

advances in precision medicine have highlighted the potential of circulating tumor dna (ctdna) detection in nsclc diagnosis, treatment efficacy monitoring, and prognosis evaluation. induction immunotherapy combined with chemotherapy is now a standard treatment for patients with resectable nsclc, but optimizing the number of immunochemotherapy cycles to enhance efficacy and reduce toxicity remains a critical clinical challenge. in this phase ii, proof-of-concept trial, around 83 patients with ajcc stage iia-iiib nsclcs who are deemed resectable by an mdt team will participate to evaluate the potential role of dynamic ctdna changes in guiding the cycle reduction of induction immunotherapy combined with chemotherapy while maintaining overall efficacy. eligible patients will receive 2 cycles (21-day intervals) of pd-1 inhibitor + platinum-based chemotherapy. subsequent cycles (1-2 additional cycles) are determined by ctdna status via tumour-agnostic strategies: 1. for patients with ctdna clearance: randomized (1:1) to surgery or continued therapy. 2. for patients with ctdna persistence: sequential 1-2 additional cycles. for all patients who are available to undergo surgery, the operation will be performed 4-6 weeks following the last cycle of treatment.

Eligibility criteria:
inclusion criteria: 1. histologically/cytologically confirmed, untreated stage iia-iiib nsclc (iaslc 8th edition). 2. deemed resectable by mdt. 3. egfr/alk wild-type (non-squamous patients; squamous patients exempt). 4. ecog ps 0-1. 5. adequate organ function (neutrophils ≥1.5×10⁹/l, platelets ≥100×10⁹/l, hb \>9 g/dl, cr ≤1.5×uln, ast/alt ≤3×uln). 6. measurable lesions (recist 1.1). exclusion criteria: 1. active autoimmune diseases (exceptions: vitiligo, type i diabetes, stable hypothyroidism). 2. systemic corticosteroids (\>10 mg prednisone equivalent/day) within 14 days. 3. grade 3-4 interstitial lung disease. 4. concurrent malignancies requiring treatment. 5. prior anti-pd-1/pd-l1/ctla-4 therapy. 6. active hbv/hcv, hiv/aids, or pregnancy.

Keywords: non-small cell lung cancer ctdna induction therapy immunochemotherapy
flupenthixol and haloperidol for treating cocaine abuse schizophrenics - 9

Conditions: Cocaine-Related Disorders; Substance-Related Disorders

Summary: the purpose of this study is to evaluate the safety and efficacy of flupenthixol and haloperidol for cocaine dependence in individuals with schizophrenia/schizoaffective illness.


Eligibility criteria:
please contact site for information.

Keywords: cocaine dependence
pet-ct in the initial staging of breast cancer and in the early assessment of response to neoadjuvant chemotherapy

Conditions: Breast Cancer; Positron-Emission Tomography

Summary: the two main objectives of this prospective study are: * to identify those patients for whom pre-treatment fdg (fluorodeoxyglucose) pet (positron emission tomography) ct-scan (computed tomography scan) provides useful information for the treatment of breast cancer (asaint 1), * to improve fdg pet-ct-scan imaging criteria for assessing response to neoadjuvant therapy early, in m0-patients (asaint 2). the secondary objective is to better understand the interactions between the imaging parameters of fdg pet-ct-scan and biological and histological features of breast cancer . this is a non-interventional study. two pet-ct-scans are performed, one before starting treatment, and the other after 2 cycles of neoadjuvant chemotherapy. the two pet-ct-scans are prescribed by oncologists from the center of breast diseases unit at st. louis hospital, in paris, france. oncologists provide clear information to the patients on the purpose of the examination. the examinations are performed in the nuclear medicine department at st. louis hospital. pet-ct-scans data, tumor characteristics, results of other imaging and biological tests, results of surgery and patient's follow-up are summarized in a "de-identified" file. this file has been declared to the national commission on informatics and liberties (cnil). the data in this file are established prospectively and secondary analyzed to assess the precise role of pet-ct-scans in the initial staging of breast cancer and to determine the optimal pet-ct-scans criteria to evaluate response to neoadjuvant treatment early.


Eligibility criteria:
inclusion criteria : * histologically confirmed breast cancer * stage ii and iii breast cancer * neo-adjuvant chemotherapy * baseline pet-ct-scan (asaint 1 and 2) * pet-ct-scans after second cycle of neo-adjuvant chemotherapy (asaint 2) * tumor biopsy for diagnosis and biological analysis with hormone receptors and human epidermal growth factor receptor-2 (her2) available * surgical intervention after completion of neo-adjuvant chemotherapy * evaluable pathological response exclusion criteria : * other tumor localization * non controlled diabetes mellitus * pregnancy
china healthy aging cohort study

Conditions: Age Problem; Disability; Dementia; Death

Summary: this is a community-based prospective cohort study in china. the study has been initialized in 2024 and included older residents. the goal of this observational study is to explore the risk factors related to disability and dementia in the elderly chinese community population, and develop a risk prediction model for disability and dementia.

this is a community-based prospective cohort study in china. individuals who were aged 60 years or older, had lived in the communities for more than 1 year, and had signed the informed consent form were enrolled in the present study. the study has been initiated in 2024 and aimed to explore the risk factors related to disability and dementia in the elderly chinese population, and develop a risk prediction model for disability and dementia. this work consists of three steps as follows. first, by integrating the data of the elderly cohort of 4 communities in beijing, shenzhen, haikou and hangzhou, we plan to establish a chinese elderly database. second, to explore the risk factors of disability and dementia in elderly chinese. third, to construct risk prediction models of disability and dementia in chinese elderly.

Eligibility criteria:
inclusion criteria: * aged 60 years or older * lived in the community for more than 1 year * signed the informed consent form exclusion criteria: * cannot complete the survey

Keywords: disability, dementia, ageing, cohort
post-operative pain management in children with supracondylar humerus fractures

Conditions: Supracondylar Humerus Fracture

Summary: there are two common and concurrently used strategies for pain management following surgical treatment of supracondylar humerus (elbow) fractures in children: opioids vs over the counter pain medications. the purpose of this study is to determine if ibuprofen and acetaminophen can provide similar or better pain relief compared to ibuprofen and hydrocodone/acetaminophen (also known as hycet) for this population of children after they have been discharged. if over the counter medications can provide adequate pain relief, then fewer opioid prescriptions would be necessary. this reduces early opioid exposure and decreases unnecessary opioids in circulation.

prior to surgery, participants will be randomly assigned to a group that will determine whether they are prescribed an opioid vs non-opioid pain management plan at discharge. each participants' parent or guardian will be given a journal to keep track of their child's pain severity and the pain medications taken. the journal will updated daily until participants no longer require pain medication. participants will follow up with their surgeon per usual at their post-operative visits.

Eligibility criteria:
inclusion criteria: * closed, gartland type iii supracondylar humerus fracture * fractures treated with closed reduction and percutaneous pinning (crpp) * patients expected to follow up at texas children's hospital * patients/guardians must speak english or spanish exclusion criteria: * fractures associated with open skin wounds, polytrauma, neurologic deficit, or vascular deficit * patients who have impaired ability to report pain severity such as intellectual delay. * patients who have a problem with bone healing such as osteogenesis imperfecta. * patients who are unable to take the standard dose of acetaminophen, ibuprofen, or hydrocodone (allergy, severe kidney disease, etc). * patients who are on chronic nsaid or opioid medication prior to injury. * patients with injury from suspected non-accidental trauma.
multicenter randomized trial of 68ga-psma-11 pet/ct based srt after radical prostatectomy

Conditions: Recurrent Prostate Carcinoma

Summary: this phase iii trial studies how well gallium ga 68-labeled psma-11 (68ga-psma-11) positron emission tomography (pet)/computed tomography (ct) works in diagnosing participants with prostate cancer that has come back after surgery. 68ga-psma-11 are taken up by cancer cells. diagnostic procedures, such as pet/ct scans, may help find and diagnose prostate cancer and find out how far the disease has spread. giving 68ga-psma-11 with pet/ct may help doctors plan better for salvage radiation therapy in participants with recurrent prostate cancer.

primary objective: i. success rate of salvage radiation therapy (srt) measured as biochemical progression-free survival after initiation of srt. secondary objectives: i. sub-group analysis of the primary endpoint (success rate of srt) within the subgroup with baseline psa ≥ 0.5 ng/ml ii. 5-year biochemical progression-free survival rate (from date of randomization). iii. metastasis free survival. iv. initiation of additional salvage therapy after completion of srt. v. change in initial treatment intent. outline: participants are randomized to 1 of 2 arms. arm i: participants receive standard of care srt. arm ii: participants receive 68ga-psma-11 intravenously (iv) and 50-100 minutes later undergo whole-body (skull base to mid-thighs) pet/ct. participants then undergo srt per the discretion of the treating radiation oncologist. after conclusion of pet/ct, participants are followed up periodically for up to 5 years.

Eligibility criteria:
inclusion criteria: * histopathology proven prostate cancer. * planned srt for recurrence after primary prostatectomy. * prostate-specific antigen (psa) \>= 0.1 ng/ml at time of enrollment. * willingness to undergo radiotherapy. * treating radiation oncologist intends to incorporate 68ga-psma-11 pet/ct findings into the radiotherapy plan if patient undergoes 68ga-psma-11 pet/ct. exclusion criteria: * extra-pelvic metastasis on any imaging or biopsy. * androgen deprivation therapy (adt) within 3 months before 68ga-psma-11 pet/ct. * contraindications to radiotherapy (including active inflammatory bowel disease). * concurrent systemic therapy for prostate cancer with investigational agents.

Keywords: psma pet/ct salvage radiation therapy randomized trial
adult pulmonary langerhans cell histiocytosis: a national registry-based prospective cohort study

Conditions: Histiocytosis; Histiocytosis, Langerhans-Cell; Histiocytosis Pulmonary

Summary: the long-term outcomes of adult patients with pulmonary langerhans cell histiocytosis (plch), particularly survival, is largely unknown. this is the first prospective study in the field evaluating the long-term outcomes of plch patients. this french countrywide registry-based study included a large cohort of plch patients followed for a sufficiently long period to address risk factors of long-term outcomes of plch patients.


Eligibility criteria:
inclusion criteria: * age \>= 18 years * diagnosis of plch was either histologically confirmed on a biopsy of an involved tissue, or based on the combination of the following criteria: 1) an appropriate clinical picture; 2) a typical nodulo-cystic pattern on lung high-resolution computed tomography (hrct) and 3) exclusion of alternative diagnoses exclusion criteria: -
right ventricular septal pacing for the prevention of left ventricular dysfunction in patients with atrio-ventricular block

Conditions: Atrio-Ventricular Block

Summary: the aim of this study is to investigate the effects of the right ventricular septal pacing on left ventricular function compared with right ventricular apical pacing.


Eligibility criteria:
inclusion criteria: * the patients who need pacemaker implantation for atrio-ventricular block exclusion criteria: * pregnancy, left ventricular dysfunction at the time of implantation