Kornimate/medical-research-clean huggingface dataset:
the actuate-cbc study

Conditions: Telemedicine

Summary: the study team will use implementation science to accelerate the uptake of teleconsultationfor burn patients by 1) examining the relationships between clinician perceptions of acceptability, feasibility, intention to use, and actual use of burn teleconsultation 2) identifying the optimal process for burn teleconsultation and the barriers and facilitators for its use during a crisis or prolonged care situation, and 3) designing and testing the effectiveness of a specific, tailored burn teleconsultation toolkit intervention to increase burn teleconsultation use.

the principal investigator's central hypothesis is that a tailored implementation intervention (toolkit) that integrates the known advantages of using telemedicine for burn consultation with new knowledge regarding clinician perceptions and the setting in which they work will improve the feasibility, acceptance, intention to use, and uptake of burn teleconsultation. the implementation intervention will enable rapid burn teleconsultation implementation under crisis circumstances and assist clinicians to virtually connect the person caring for a burn patient anywhere to the entire burn team's expertise. the study results will lead to more robust national crisis, wartime, and disaster response plans, improve quality of burn care, and decrease morbidity and mortality from serious burn injury, regardless of injury location.

Eligibility criteria:
inclusion criteria: * 18 years of age or older and * are providing burn care to patients at the 4 burn centers and the non-burnhospitals are eligible for inclusion. exclusion criteria: * do not meet inclusion criteria, * decline to participate or do not give consent to participate in the study, • * directly express uneasiness about the participation
evaluation of initial high risk human papillomavirus (hr-hpv) viral load as predictive marker for cervical intraepithelial neoplasia grade 1 (cin1) persistence

Conditions: Cervical Intraepithelial Neoplasia

Summary: relationship between hpv infection and cervical cancer is well established. among the hpv types identified to date, 15 are classified as high risk hpv (hr-hpv). detection of hr-hpv has been proposed to optimize cervical cancer screening.

a prospective detection and quantification of hr-hpv in patients with proven cin1 will be performed. relationship between hr-hpv initial viral load and the cin1 persistence will be evaluated.

Eligibility criteria:
inclusion criteria: * the women whose last one fcv of screening put in evidence a liebg of the neck of the womb having been confirmed by the colposcopie. * the inclusive patients will be of more than 18 years old. all the patients will be profitable of a regime of social security. exclusion criteria: * the patients whose result of the colposcopie is clashing with that of the fcv of initial screening (normal collar, liehg or the other one). * the patients having an antecedent of dregs of the neck of the womb, that this one was or not handled * the patients having had a hysterectomy. * the patients incapable to receive the information enlightened on the progress and the objectives of the study * the patients not having signed enlightened assent
a study to determine the effect of welchol tablets on cholesterol in patients who have been taking pravastatin for at least 4 weeks.

Conditions: Hypercholesterolemia

Summary: determine the effect of welchol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on pravastatin therapy for at least 4 weeks.


Eligibility criteria:
inclusion criteria: * male or female \> or = to 18 years of age * on a stable dose of pravastatin * ldl-c \> or = to 100 mg/dl and \< or = 250 mg/dl * triglycerides \< or = to 300 mg/dl * women are not pregnant or breast-feeding or planning to become pregnant * women have had a hysterectomy or tubal ligation, or who are post-menopausal or who practice an accepted method of birth control as specified in the protocol exclusion criteria: * bmi \> 40 kg/m2 * history of allergic or toxic reaction to colesevelam hcl * history of swallowing disorder * any serious condition that would interfere with the conduct of the study
effectiveness of internet-based depression treatment

Conditions: Mild to Moderate Depressive Symptoms

Summary: care for people suffering from depressive symptoms should be given in a step-wise approach. one first step can be the provision of self-help material. online self-help is an innovative way of providing self-help. the investigators want to study the effect of an interactive online self-help-program (deprexis) in the treatment of mild to moderate depressive symptoms. participants will be randomised to either twelve weeks of online-self help or a waiting-list control. symptoms of depression and other aspects will be assessed over a one year period. thereafter the controls will also receive online-self help. the investigators hypothesise that online self-help is superior to the control condition in alleviating depressive symptoms and preventing full blown depression.

this study is supported by the german ministry of health (bmg) and is a collaborative project of universität bern (pd dr. thomas berger), charité berlin (pd dr. matthias rose), universität bielefeld (prof. dr. wolfgang greiner), universität hamburg (prof. dr. steffen moritz, prof. dr. bernd löwe), gaia ag hamburg (dr. björn meyer), universität tübingen (prof. dr. martin hautzinger) and universität trier (prof. dr. wolfgang lutz).

Eligibility criteria:
inclusion criteria: * phq\>4 and \<15 exclusion criteria: * acute suicidality * psychotic d/o, bipolar d/o or other severe psychiatric d/o
ceus vs. amri for hcc detection in patients with indeterminate liver nodules

Conditions: HCC; Hepatocellular Carcinoma

Summary: the study will be conducted at the following locations: 1. ut southwestern medical center 2. parkland health and hospital system 3. university of michigan investigators will prospectively compare the performance of dynamic contrast enhanced abbreviated mri (amri) and contrast-enhanced ultrasound for early-stage hcc detection in patients with indeterminate liver nodules.

investigators will prospectively perform both abbreviated mri and contrast-enhanced ultrasound in enrolled patients every 3-6 months. contrast-enhanced ultrasound and abbreviated mri will preferably be done the same day, although will be permitted to be completed within 30 days of each other. abbreviated mri and contrast-enhanced ultrasound will be performed every 3-6 months until hcc development, regression to lr-1 or lr-2 (i.e., definitely or likely benign, respectively), or end of follow-up at 24 months post-enrollment.

Eligibility criteria:
inclusion criteria: * child a or b cirrhosis from any etiology with at least one iln on 4-phase ct, contrast- enhanced mri, or contrast enhanced us but without hcc at baseline. * adults 18 years old and above exclusion criteria: * patients post liver transplantation * patients with concurrent or prior hcc (lr-5 or biopsy proven) * other liver cancer including cholangiocarcinoma * patients with any active extra-hepatic malignancy * patients with significant comorbidity and limited life expectancy, e.g., stage d congestive heart failure, in whom surveillance is not warranted are also excluded given unlikely clinical benefit * patients with contraindication to contrast-enhanced mri or ceus, including implanted medical devices that are considered mr unsafe and severe claustrophobia

Keywords: lr3 lr4 hcc surveillance
effects of herbal products on metabolism and hunger

Conditions: Obesity; Metabolism

Summary: to test safety and efficacy on metabolism, heart rate, blood pressure, tsh (and other blood)and hunger/caloric compensation on ephedra versus placebo


Eligibility criteria:
inclusion criteria: age 18-50, non-smoking, not pregnant (serum), beck \<15, physician permission exclusion criteria: pregnant, lactating, smoker, use of appetite-affecting medications
leveraging artificial intelligence to prevent vision loss from diabetes among socioeconomically disadvantaged communities

Conditions: Vision; Diabetes

Summary: this study aims to investigate whether a novel artificial intelligence based screening strategy (ai-based point of care, incorporating diagnosis, scheduling, and education or ai-bridge), which allows primary care providers to screen patients for vision-threatening diabetic eye disease in the primary care clinic, improves screening and follow-up care rates across race/ethnicity groups and reduces racial/ethnic disparities in screening.

this is a multicenter clinical trial and university of wisconsin is the coordinating center of the study. a stepped-wedge cluster randomized clinical trial will be conducted. the investigators will evaluate the effectiveness of two standard diabetic retinopathy screening strategies at primary care clinics; (1) ai-based eye screening program called ai-bridge, eye photos of the patients will be obtained in the primary care clinic by trained clinic staff. images will be reviewed using autonomous artificial-intelligence (ai) algorithm (digital diagnostics). patients with referrable diabetic retinopathy are detected within minutes and patients with referrable disease will be assisted with scheduling an in-person follow-up eye care visit (2) usual care screening, primary care providers refer patients with diabetes to an eye care provider for an in-person dilated eye exam. after adapting ai-bridge protocols to clinics and training of clinic personnel, stepped wedge randomized clinical trial begins with sites transitioning from usual-care to ai-bridge in 4 steps. primary objective: * compare the proportion of patients, by race and ethnicity, who follow-up with recommended eye care in the ai-bridge and usual-care arms within 6 months of the recommendation. secondary objectives: * compare the difference in proportion of white vs hispanic and white vs black patients who get screening in the ai-bridge and usual-care arms within 6 months of the recommendation. * compare proportion of patients, by race and ethnicity, who receive eye screening in the ai-bridge and usual-care arms within 6 months of the recommendation.

Eligibility criteria:
inclusion criteria: * eligible patients include patients older than 21 years * diagnosed with type 1 or 2 diabetes * no known diabetic eye disease * medicaid as their primary insurance * not had an eye exam in the prior year exclusion criteria: -

Keywords: artificial intelligence ai diabetic eye disease cluster randomized trial pragmatic trial
pet and ct scans to evaluate patients with stage iii or stage iv melanoma

Conditions: Melanoma (Skin)

Summary: rationale: diagnostic procedures may improve the ability to detect metastatic melanoma and to determine the extent of disease. purpose: phase ii trial to evaluate the effectiveness of pet and ct scans to detect metastatic disease in patients who have stage iii or stage iv melanoma.

objectives: i. evaluate the sensitivity, specificity, and accuracy of fludeoxyglucose f 18 (fdg) positron emission tomography (pet) imaging in detecting metastatic disease in patients with stage iii or iv melanoma considered for operative management based on the currently accepted diagnostic work up including ct imaging. ii. determine how often the clinical management of these patients is altered based on fdg pet imaging findings in addition to ct scan results. outline: patients are required to fast for a minimum of 6 hours prior to positron emission tomography (pet) imaging. fludeoxyglucose f 18 (fdg) is administered iv over 15 minutes followed 50-60 minutes later by whole body pet imaging. iodinated contrast dye is administered by iv injection and by mouth followed by ct imaging of the chest, abdomen, and pelvis within 2 weeks of pet imaging. whole body fdg pet imaging and ct imaging of the chest, abdomen, and pelvis are repeated at 6 months. initial positive pet or ct imaging results are verified based on surgical and/or biopsy findings or clinical follow-up. projected accrual: a total of 100 patients will be accrued for this study within 2.5 years.

Eligibility criteria:
disease characteristics: histologically proven melanoma considered for operative management with 1 of the following: deep primary melanoma (greater than 4 mm, stage iiia) regional nodal disease (stage iiib) locally or regionally recurrent disease of an extremity considered for operative resection or isolated limb perfusion with curative intent systemic disease considered for curative resection (stage iv) patient characteristics: age: 18 and over performance status: not specified life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified other: not pregnant or nursing fertile patients must use effective contraception able to fast for 6 hours able to lie still for positron emission tomography imaging no second malignancy except previously treated nonmelanomatous skin cancer or carcinoma in situ of the cervix no active infection no inflammatory disease (sarcoidosis or rheumatoid arthritis) no allergy to shellfish or contrast dye used for ct imaging prior concurrent therapy: see disease characteristics

Keywords: stage iii melanoma stage iv melanoma recurrent melanoma
effects of a short-term exercise intervention on sleep in women exposed to trauma: a randomized controlled trial

Conditions: Traumatic Stress Disorder; Post Traumatic Stress Disorder; Trauma and Stressor Related Disorders; Mental Disorders; Exercise

Summary: this study aims to test whether sleep improvements, following 6 weeks of high-intensity interval training exercise among adult women exposed to a traumatic event, are mediated by improvements in heart rate variability or decreased anxiety and hyperarousal symptoms.

a total of 60 women with below-average sleep quality and physical activity levels who also screen positive for ptsd on the post-traumatic diagnostic scale (pds-5) will be randomized to either six weeks of exercise training or a waitlist control. twenty minutes of high intensity interval training will be performed three times per week for six-weeks. heart rate variability will be measured at rest, during, and following a cognitive task. psychometric measures supported by strong validity evidence will assess self-reported anxiety and ptsd symptoms, and sleep quality.

Eligibility criteria:
inclusion criteria: * self-reported exposure to a traumatic event * persistent (\> 1 month) ptsd-related symptoms adequate to screen positive for ptsd or self-reported history of a prior ptsd diagnosed by a health care professional. * poor sleep quality (pittsburgh sleep quality index \>5) * failure to meet recommended level of aerobic or resistance training during leisure time. physical activity for u.s. adults (\<150-mins of moderate or 75-mins of vigorous physical activity \[or a combination\] per week and/or \< 2 days a week of resistance training targeting the major muscle groups). * able to safely perform high-intensity exercise * aged 18-39 years * non-smoker * willing to avoid alcohol and vigorous physical activity 24 hours before visiting the lab * willing to avoid caffeine for 12 hours before visiting the lab exclusion criteria: * pregnant, lactating, or plans to become pregnant over the next 2 months. * individuals who started taking medication for anxiety or depression-related symptoms within the last month. * individuals currently taking beta-blockers or other medications/substances (marijuana and other illegal drugs) that impact heart rate. * history of reproductive disorders (e.g., premenstrual dysphoric disorder or polycystic ovary syndrome), cardiovascular (e.g., cardiac arrhythmia), or pulmonary disorders (e.g., asthma). * pain intensity of 8 or greater in the thigh or foot in the past month * probable alcohol use disorder
anterior gastropexy vs. no anterior gastropexy for paraesophageal hernia repair

Conditions: Paraesophageal Hernia; Hiatal Hernia Large

Summary: this study evaluates the effect of anterior gastropexy (one or more sutures fixing the stomach to the inner abdominal wall) on improving durability of paraesophageal hernia repair. half of participants will receive anterior gastropexy, while the other half will not. the hypothesis is that anterior gastropexy will help to prevent paraesophageal hernias from recurring.

paraesophageal hernias are hernias in which the stomach and/or other abdominal organs herniate through the diaphragm into the chest. this abnormal anatomy can lead to acid reflux, trouble swallowing, and shortness of breath, and can also be a risk factor for surgical emergencies involving the stomach. for these reasons, the society of american gastrointestinal and endoscopic surgeons has strongly recommended that all symptomatic paraesophageal hernias be repaired. these repairs are technically challenging, and the best available evidence suggests that more than half of patients undergoing repair will have radiographic hernia recurrence at 5 years after surgery. there has been suggestion that use of anterior gastropexy - in which suture is used to affix the stomach to the anterior abdomen - may reduce recurrence rates. however, it is uncertain whether this data is reliable. while some surgeons use anterior gastropexy routinely because they believe it reduces recurrence, other surgeons do not use anterior gastropexy due to the concern that patients will have short-term pain at the suture site. this study aims to evaluate the effect of using anterior gastropexy on recurrence rates after paraesophageal hernia repair, compared to not using anterior gastropexy.

Eligibility criteria:
inclusion criteria: * age 18+ * able to participate in follow-up * symptomatic paraesophageal hernia * paraesophageal hernia is at least 5 centimeters in height on upper gi study or endoscopy * elective laparoscopic paraesophageal hernia repair (must begin laparoscopic, but may convert to open surgery if needed) * crura must be reapproximated at time of surgery exclusion criteria: * previous operations of the esophagus or stomach * emergent operation for acute gastric volvulus * paraesophageal hernia repair with concurrent bariatric procedure or procedure to reduce stomach volume * placement of gastrostomy tube

Keywords: paraesophageal hernia gastropexy minimally invasive surgery
a study to evaluate the efficacy and safety of faricimab in patients with choroidal neovascularization secondary to pathologic myopia

Conditions: Choroidal Neovascularization Secondary to Pathologic Myopia

Summary: this is a phase iii, multicenter, randomized, double-masked, active comparator-controlled study evaluating the efficacy and safety of faricimab in patients with myopic choroidal neovascularization (cnv). this non-inferiority study will compare 6.0 mg faricimab versus 0.5 mg ranibizumab administered at a pro-re-nata (prn) dosing regimen after an initial active ivt treatment administration at randomization (day 1).


Eligibility criteria:
inclusion criteria: 1. treatment-naïve choroidal neovascularization (cnv) secondary to myopia 2. diagnosis of active myopic cnv in the study eye: 1. presence of high myopia, worse than -6 diopters of spherical equivalence 2. antero-posterior elongation measurement greater than or equal to 26.0 mm 3. presence of posterior changes compatible with pathologic myopia (e.g., tessellated fundus, lacquer cracks, etc.) 4. presence of active leakage from cnv on ffa (determined by central reading centre \[crc\]) 5. presence of intraretinal or subretinal fluid or increase of cst on oct (determined by crc) 3. bcva of 78 to 24 letters, inclusive (20/32 to 20/320 approximate snellen equivalent), using the early treatment diabetic retinopathy study (etdrs) protocol on day 1 4. overtly healthy as determined by medical evaluation that includes medical history, physical examination, and laboratory tests 5. ability to comply with the study protocol, in the investigator's judgment 6. other protocol-defined inclusion criteria apply exclusion criteria: 1. any major illness or major surgical procedure within 1 month before screening 2. pregnancy or breastfeeding, or intention to become pregnant during the study or within 3 months after the final study treatment administration 3. uncontrolled blood pressure (systolic \>180 millimetres of mercury \[mmhg\], diastolic \>100 mmhg) 4. stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to day 1 5. history of systemic or ocular disease that would contraindicate treatment with the investigational drug or comparator 6. uncontrolled glaucoma in study eye 7. any prior or concomitant treatment for cnv or vitreomacular-interface abnormalities, including, but not restricted to, intravitreal, periocular or laser interventions in study eye 8. prior or concomitant periocular or intravitreal pharmacological treatment, including anti-vegf medication, for other retinal diseases (e.g. geography atrophy, namd, dme etc.) in study eye 9. other protocol-defined exclusion criteria apply
bloom forward: investigating weight loss impact on tjac patients

Conditions: Obesity; Knee Osteoarthritis; Hip Osteoarthritis; Arthroplasty Complications

Summary: the goal of this clinical trial is to prospectively assess the efficacy of the bloom program, a comprehensive weight loss dietary and lifestyle program, in a population of patients living with obesity and awaiting hip or knee surgery. the main questions it seeks to answer are: 1. can the bloom program support these patients to lose up to 10% of their initial body weight? 2. will patients continue to lose weight for the next six months after completing the program? 3. does the bloom program help patients to improve their overall quality of life? study participants will undergo the bloom program, a virtual pre-operative weight management program that spans 24 weeks and is carefully supervised by medical professionals. they will be recruited at the leaf clinic after being referred by their primary care physician. during the bloom program, they will meet with a physician (initially, then once monthly) and a dietitian (initially, and then biweekly as part of virtual group coaching). they will have access to leaf's online learning portal. these are normal elements of the bloom program. furthermore, as part of their participation in the research study, participants will be asked to complete the following questionnaires: the mediterranean dietary score, the oxford hip and knee questionnaire and the eq-d5-5l quality of life assessment. they will complete these initially, and then at completion of the program and 3 and 6 months post-program. we will also collect their height and weight at these intervals.


Eligibility criteria:
inclusion criteria: * to be eligible for the study, subjects must meet all the following criteria: 1. age ≥ 18 years old 2. body mass index (bmi) ≥ 35 kg/m2 3. have being identified as a potential orthopedic surgery candidate by the total joint assessment clinic (tjac) 4. have a referral by their primary care practitioner 5. ready to participate actively in the program (i.e., readiness to change scale score ≥7) 6. acquisition of the required technology tools and skills to use the virtual platform (the bloom program will be conducted via virtual video conference) 7. english comprehension at a level that allows for active participation in the program exclusion criteria: * subjects who meet any of the following criteria are not eligible for the study: 1. active eating disorder 2. active substance use disorder 3. active smoking 4. currently or past enrollment in another weight loss program in the previous year prior to enrollment in the study 5. ongoing pregnancy or breastfeeding

Keywords: obesity body mass index weight loss noncommunicable diseases surveys and questionnaires metabolic disease arthroplasty osteoarthritis joint diseases