Kornimate/medical-research-clean huggingface dataset:
prospective evaluation of self-testing to increase screening (prestis) asian/asian american women supplement

Conditions: Cervical Cancer; Human Papillomavirus Infection

Summary: regularly attending for pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women and persons with a cervix. this study is a supplement to increase representation of asian and asian american women in a pragmatic clinical trial that evaluates if mailing and testing self-sampled kits for high-risk human papillomavirus (hpv) can cost-effectively increase screening participation among underserved minority women in a safety-net health system.

regularly attending for pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women and persons with a cervix. using mailed self-sampling kits to test for high-risk human papillomavirus (hpv), the virus that causes cervical cancer, may overcome multiple barriers to clinic-based screening. the parent study (nct03898167) is a randomized controlled trial to compare the effectiveness of three outreach interventions to increase primary screening participation and clinical follow-up among underscreened women a in a safety net health system. the three strategies that will be evaluated are: 1) telephone recall; 2) telephone recall with mailed self-sample hpv testing kits; and 3) telephone recall with mailed self-sample hpv testing kits and patient navigation. a supplemental accrual of asian/asian american persons (target n=240) was added to increase representation of this subpopulation in the parent trial.

Eligibility criteria:
inclusion criteria: * asian ethnicity reported in the electronic health record * no history of hysterectomy or cervical cancer * no pap test in the past 3.5 years or pap/hpv co-test in the past 5.5 years * patient of harris health system in harris county (houston), texas * have at least 2 visits to ambulatory care within harris health system in the past 5 years * be currently enrolled in a healthcare coverage or financial assistance plan accepted by harris health system or have been enrolled in a harris health coverage plan in the past 12 months exclusion criteria: * no valid telephone contact information * unable to communicate in english, vietnamese or spanish * currently pregnant * history of cervical dysplasia in the past 3.5 years

Keywords: screening human papillomavirus infection self-testing
multicenter study on rehabilitation medical data for pediatric big brain development

Conditions: Pediatric ALL; Healthy

Summary: retrospective study for development of imaging-genetics (brain imaging/genome big data) models and algorithms that are clinically explainable and have high predictive performance in brain research on pediatric developmental disorders

retrospective study for development of imaging-genetics (brain imaging/genome big data) models and algorithms that are clinically explainable and have high predictive performance in brain research on pediatric developmental disorders

Eligibility criteria:
inclusion criteria: * healthy subjects and patients 20 years old or younger who underwent imaging examinations performed at the department of rehabilitation medicine at our hospital from january 2010 to december 2023 (patients who underwent brain mri tests to determine the cause of developmental delay) exclusion criteria: * none
efficacy and cost-effectiveness of orthodontic retention protocols

Conditions: Orthodontic Relapse

Summary: objective is to assess changes of dentition and periodontium, and hygiene in retention after the end of the active phase of orthodontic treatment, and relationship with gender, type of retention appliance, pre-therapeutic condition of dentition and duration of active phase of treatment.

a total of 152 subjects will be recruited and randomly assigned into three groups. first group will have a square 8-stranded 0.673x0.268 mm retainer wire bonded in mandibular teeth after completing the active phase of comprehensive orthodontic treatment with fixed appliances. retainer will be bonded on lingual site canine to canine on each tooth. second group will have a round 6-stranded 0.40 mm retainer in mandible. third group will be without fixed retainer, only with thermoplastic vacuum-formed removable essix retainer in mandible. subjects will be examined before orthodontic treatment (t0), upon completion of treatment (t1), six months in retention (t2), two years (t3) and three years in retention (t4). changes in intercanine width, relapse (unexpected tooth movements), retainer failure, accumulation of biofilm, calculus and gingivitis will be assessed.

Eligibility criteria:
inclusion criteria: finished orthodontic treatment, participants must have all permanent teeth exclusion criteria: hypodontia, missing teeth

Keywords: retention wire fixed retainer orthodontic therapy
individually tailored web-based cbt for eating disorders and the role of knowledge acquisition

Conditions: Eating Disorders; Bulimia

Summary: background: previous studies on internet-based treatment with eating disorders have shown promising results. objective: the first aim of this study was to investigate the effects of a tailored therapist guided internet-based treatment for individuals with eating disorders. the second aim was to examine the role of knowledge acquisition. method: 138 participants were recruited. screening consisted of online questionnaires followed by a telephone interview. a total of 92 participants were included after a semi-structured diagnostic interview and randomized to an 8 week treatment program (n=46) or to a control condition (n=46). treatment consisted of individually prescribed cognitive behaviour therapy text modules in conjunction with online therapist guidance. the control group consisted of a waitlist who later received treatment.

as above

Eligibility criteria:
inclusion criteria: * have reoccurring eating disorder uns or bulimia * bmi above 17,5 exclusion criteria: * suicide prone * ongoing psychological treatment

Keywords: emotional eating restrictive eating body dissatisfaction
a novel, regulated gene therapy (ngn-401) study for females with rett syndrome

Conditions: Rett Syndrome

Summary: this study will evaluate the safety profile of the investigational gene therapy, ngn-401, in females with typical rett syndrome.

the study is a phase 1/2, open-label study designed to assess the safety, tolerability, and efficacy of administration of an adeno-associated viral vector serotype 9 (aav9), using neurogene's proprietary transgene regulation technology. ngn-401 contains a full-length human mecp2 gene which is designed to express therapeutic levels of the mecp2 protein while avoiding overexpression. the study treatment will be given as a single administration under general anesthesia via intracerebroventricular (icv) delivery. each participant will be followed for safety and preliminary efficacy for 5 years after treatment and is expected to enroll in a long-term follow-up study for 10 years.

Eligibility criteria:
inclusion criteria: * diagnosis of typical rett syndrome with a documented disease-causing mutation in the methyl-cpg-binding protein 2 (mecp2) gene * current anti-epileptic drug regimen has been stable for at least 12 weeks * participant and caregiver should reside within a 2-hour drive of the study center for at least 3 months following treatment * participant must have never taken trofinetide or have taken trofinetide and discontinued due to lack of tolerability, lack of efficacy, or other reasons. following ngn-401 dosing, trofinetide may be initiated after a specified time period and with the support of the treating clinician exclusion criteria: * normal or near normal hand function * has a current clinically significant condition other than rett syndrome * presence of a concomitant medical condition that precludes intracerebroventricular administration, or use of anesthetics or immune suppression needed for study related procedures * grossly abnormal psychomotor development in the first 6 months of life * a history of other genetic disorders or neurological conditions, such as stroke, brain tumor, or autoimmune processes affecting the central nervous system other inclusion and exclusion criteria apply.

Keywords: typical rett syndrome mecp2 rett disorder genetic diseases, inborn genetic diseases, x-linked neurodevelopmental disorders neurobehavioral manifestations neurologic manifestations intellectual disability nervous system diseases heredodegenerative disorders, nervous system pathologic processes rtt
tailored internet-delivered cognitive behaviour therapy in primary care

Conditions: Depression; Anxiety Disorders

Summary: a tailored internet-based cognitive-behavioural intervention is tested within a primary care clinic. weekly measures of symptoms of depression and anxiety are obtained. significant within-group effects are expected.

this internet-based cognitive-behavioural therapy intervention contains 8-10 text-based self-help modules in which 4 modules are fixed (the first three and the last) and the rest are "prescribed" following the diagnostic interview. these modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things. the intervention is tested within a primary care clinic. weekly measures of symptoms of depression and anxiety are obtained.

Eligibility criteria:
inclusion criteria: * symptoms of depression and anxiety exclusion criteria: * severe depression (based on interview) * severe psychiatric condition (e.g. psychosis or bipolar disorder) * suicidal (measured in diagnostic interview)
clinical approaches to correcting vitamin d inadequacy and maintaining adequacy

Conditions: Vitamin D Inadequacy; Vitamin D Deficiency

Summary: vitamin d is available in two forms, vitamin d2 and vitamin d3. it has previously been assumed that these two forms maintain blood vitamin d equally. however, this may not be the case. this study will evaluate whether d2 and d3 produce equal elevation of blood vitamin d. additionally, it will evaluate whether once per month vitamin d dosing is as effective in maintaining blood vitamin d levels as daily dosing.


Eligibility criteria:
inclusion criteria: 1. community dwelling men and women age ≥ 65 years. 2. able and willing to sign informed consent. 3. serum 25ohd concentration ≥ 10 and less than 60 ng/ml by hplc. 4. willing to avoid use of cod-liver oil and non-study vitamin d supplementation; standard multiple vitamins containing ≤ 400 iu used no more than once daily will be allowed exclusion criteria: 1. current hypercalcemia (serum calcium \> 10.5 mg/dl) or untreated primary hyperparathyroidism. 2. history of nephrolithiasis. 3. screening 25ohd concentration ≥ 60 ng/ml. 4. baseline 24-hour urine calcium \> 250 mg if female, \> 300 mg if male. 5. known risk factors for hypercalcemia, e.g., malignancy, tuberculosis, sarcoidosis, paget's disease 6. history of any form of cancer within the past five years with the exception of adequately treated squamous cell or basal cell skin cancer. 7. renal failure defined as a calculated creatinine clearance (cockroft-gault method) ≤ 25 ml/minute 8. severe end-organ disease, e.g., cardiovascular, hepatic, hematologic, pulmonary, etc., which may limit ability to complete the study 9. known malabsorption syndromes, e.g., celiac disease, radiation enteritis, active inflammatory bowel disease, etc. 10. use of medications known to alter bone turnover including bisphosphonates, estrogen, selective estrogen receptor modulators, pth, testosterone or calcitonin 11. vitamin d intake greater than 5,000 iu daily 12. treatment with any active metabolites of vitamin d within six months of screening 13. treatment with any drug which may interfere with vitamin d metabolism, e.g., phenobarbital, phenytoin.
bio|stream.icm obesity

Conditions: Tachycardia Atrial; Atrial Fibrillation; Syncope; Bradycardia; Cryptogenic Stroke

Summary: the aim of the submodule study is to assess whether a high bmi may influence the sensing performance and the secg quality of the biomonitor.

this submodule of the bio\|stream.icm registry specifically investigates the performance of the biomonitor in a subset of obese patients with a bmi \>30 kg/m2 in order to exclude any concerns regarding impaired icm sensing performance. these concerns are founded in the increased distance between heart and device electrodes due to fat layers that may attenuate signal detection and therefore sensing performances of the icm.

Eligibility criteria:
inclusion criteria: * patient is already enrolled in the bio\|stream.icm registry * patient bmi \> 30 exclusion criteria: * patient clinically indicated for or already implanted with another cardiac active device

Keywords: obesity biomonitor biomonitor iii syncope cryptogenic stroke atrial fibrillation
evaluation study of tides depression care quality improvement intervention

Conditions: Major Depression; PTSD

Summary: in spite of the impact on veteran�s health status and treatment cost, depression is under-diagnosed and under-treated. the goal of this study is to learn how to implement a previously tested, effective collaborative care model for improving the quality of depression care across multiple veterans integrated service networks (visns). to achieve this goal, we are conducting a randomized controlled trial of evidence-based quality improvement (ebqi), a dissemination method that relies on expert design and local implementation of evidence-based practice interventions. we hypothesize that ebqi will result in increased rates of assessment and appropriate management of depression. results will be useful in designing realistic chronic care programs and performance measures for continuing care improvement.

objectives: our primary objective is to evaluate whether collaborative care ebqi results in increased rates of assessment and appropriate management of depression and decreased depressive symptomatology for veterans. our secondary objective is to evaluate the effect of ebqi on organizational outcomes. methods: three visns, 10, 16 and 23, are participating. three primary care clinics within each visn are randomized, two to the intervention and one to usual care, for a total of nine study sites. in the intervention clinics, va leadership, assisted by study staff, tailor and implement a depression care program for patient assessment, patient self-management support, provider education, primary and mental health collaboration, and care management. the usual care clinics participate only in the evaluation. patient recruitment is through a telephone interview. patients who are at risk for major depression are recruited, 67 from each site. patient outcomes including depression symptom severity on the phq-9 and the va sf-12 are being assessed by telephone at six months post enrollment. other outcome variables are adequacy of antidepressant trials, psychotherapy and specialty care visits, and treatment adherence. a utilization and cost analysis will be conducted. visn and vamc leadership are surveyed to assess organizational outcomes. data is being collected through va administrative databases, patient and staff interviews, and study records. power calculations and data analysis planning reflect the clustered sample design.

Eligibility criteria:
inclusion criteria: * enrolled as a pt in the va healthcare system * screens positive for major depression * has a scheduled visit at a primary care site taking part in the study exclusion criteria: * severe alcohol abuse * psychosis * dementia * acutely suicidal (at screening) * lack of access to or ability to use a phone

Keywords: evaluation quality improvement cluster randomized trial care model collaborative care informatics
study of cemiplimab alone or in combination with fianlimab and/or other experimental agents in adult participants with peri-operative stage iii/iv cutaneous squamous cell carcinoma (cscc)

Conditions: Cutaneous Squamous Cell Carcinoma

Summary: this study is researching an investigational drug called regn2810, also known as cemiplimab, and when combined with another investigational drug called regn3767, also known as fianlimab (each individually called a "study drug" or called "study drugs" when combined). the study is focused on a type of skin cancer known as cutaneous squamous cell carcinoma (cscc). the aim of the study is to see if cemiplimab or cemiplimab in combination with fianlimab can eliminate or reduce the number of living cancer cells in tumor(s) if taken before surgery. the study is looking at several other research questions, including: * whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make it possible to have a less extensive surgery or a different treatment plan after surgery * whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make the cancer less likely to come back after surgery * what side effects may happen from taking the cemiplimab or cemiplimab in combination with fianlimab * how much of the cemiplimab or cemiplimab in combination with fianlimab is in the blood at different times * whether the body makes antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects)


Eligibility criteria:
key inclusion criteria: 1. stage iii/iv (m0) cscc, for which surgery would be recommended in routine clinical practice 2. tumor biopsy is required during screening period as described in the protocol 3. participant is willing to undergo delayed surgery 4. at least 1 lesion that is measurable by response evaluation criteria in solid tumors (recist) v1.1 5. eastern cooperative oncology group (ecog) performance status of 0 or 1 6. adequate organ and bone marrow function as described in the protocol key exclusion criteria: 1. stage i or ii cscc 2. anogenital, penile, vermilion lip cscc 3. cscc bone invasion 4. solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy as described in the protocol 5. prior radiation therapy for cscc 6. myocardial infarction within 6 months of enrollment, or history of myocarditis. 7. prior treatment with anti-cancer systemic therapy within the last 3 years prior to projected enrollment date as described in the protocol note: other protocol-defined inclusion/exclusion criteria apply

Keywords: neoadjuvant adjuvant surgery
gemcitabine and oxaliplatin (gem-ox) plus glivec in gemcitabine-refractory pancreatic cancer

Conditions: Advanced Pancreatic Cancer

Summary: the main research objective is to work out the optimal doses of the novel combination of gemcitabine, oxaliplatin and imatinib mesylate (glivec) in patients with advanced pancreatic cancer that has progressed during or after treatment with first-line gemcitabine.

using the phase i study design, the dose of gemcitabine will be escalated in several steps to identify the highest tolerable dose that can be given safely. based on pre-defined dose-limiting toxicity, the maximum tolerated dose of the combination will be identified and a safer dose for further evaluation of this regimen in pancreatic cancer selected. the primary objectives are therefore based around safety of the drug combination.

Eligibility criteria:
inclusion criteria: * age \> 18 years * gemcitabine-refractory, histologically confirmed pancreatic cancer (progression during or within 6 months of first-line treatment) * locally advanced or metastatic disease with measurable or non-measurable disease * life expectancy of greater than 10 weeks * prior treatment with investigational therapies including egfr and vegf antagonists is allowed when administered\>4 weeks prior to start of therapy exclusion criteria: * any serious uncontrolled medical condition * prior radiation treatment is not allowed * no prior chemotherapy within the previous 4 weeks * known peripheral neuropathy \> ctcae v 3.0 grade 1; absence of the deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible * known brain metastases * lack of physical integrity of the upper gi tract, malabsorption syndrome, or inability to take oral medication * fertile women (\<2 years after last menstruation) and men of childbearing potential not willing to use effective contraception * pregnancy or breast feeding

Keywords: pancreatic cancer toxicity chemotherapy dose finding
translation, cultural adaptation, reliability, and validity of the turkish version of the cervical radiculopathy impact scale

Conditions: Cervical Radiculopathy; Cervical Radicular Pain; Cervical Radiculitis; Cervical Root Syndrome

Summary: the purpose of this study was to investigate adaptation, validity, and reliability of the turkish version of the cervical radiculopathy impact scale (cris).

cervical radicular syndrome is a common health problem that causes pain in the arm and / or hand and is accompanied by motor and / or sensory defects. these symptoms often have an intensity that prevents normal function. for individuals with cervical radicular syndrome, there is a lack of a patient-reported outcome measurement tool to measure the impact of the disorder. the cervical radiculopathy impact scale (cris), which focuses on the symptoms and functionality of the arm and neck, was developed to improve the quality of studies on cervical radicular syndrome. cris is a newly developed self-report questionnaire that covers the measurement of symptoms and limitations in individuals with cervical radiculopathy due to pain, tingling sensation, and loss of sensation in the arm with neck discomfort. the cris consists of 21 items divided into three subscales: (i) symptoms, (ii) energy and postures, and (iii) actions and activities. each item contains a likert type answer and takes a value between 1 and 5. the study is planned with 105 individuals with hip disease. after questioning the sociodemographic characteristics of the individuals, the patients will be asked to fill in cris, eq-5d health-related quality of life questionnaire, neck disability index, quick disabilities of the arm shoulder and hand, brief illness perception questionnaire, short form-36 and visual analog scale. test-retest will be re-applied to those of the same individuals who can be reached after 1 week. the results will be analyzed using the spss version 22.0 computer package program.

Eligibility criteria:
inclusion criteria: * individuals with radiculopathy symptoms and diagnosis. exclusion criteria: * having another neck disorder other than radiculopathy, * history of cervical spine surgery, * corticosteroid injection to cervical spine in the past 3 months, * having neurological and cognitive disorders.

Keywords: cervical radiculopathy reliability validity cross-cultural adaptation