Kornimate/medical-research-clean huggingface dataset:
better me within trial to improve lifestyle behaviors in african americans

Conditions: Obesity; Pre-diabetes

Summary: this study describes a community-based participatory research (cbpr) approach to design a novel faith-enhancement to the diabetes prevention program (dpp) for aa women. a long-standing cbpr partnership designed the faith-enhancement from focus group data. the faith components were specifically linked to weekly dpp learning objectives to strategically emphasize behavioral skills with religious principles. using a cbpr approach, the better me within trial was able to enroll 12 churches, screen 333 aa women, and randomize 221 after collection of objective eligibility measures. a prospective, randomized, nested by church, design was used to evaluate the faith-enhanced dpp as compared to a standard dpp on weight, diabetes and cardiovascular risk, over a 16-week intervention and 10-month follow up.

reducing obesity positively impacts diabetes and cardiovascular risk; however, evidence-based lifestyle programs, such as the diabetes prevention program (dpp), show reduced effectiveness in african american (aa) women. in addition to an attenuated response to lifestyle programs, aa women also demonstrate high rates of obesity, diabetes, and cardiovascular disease. to address these disparities, enhancements to evidence-based lifestyle programs for aa women need to be developed and evaluated with culturally relevant and rigorous study designs. this study describes a community-based participatory research (cbpr) approach to design a novel faith-enhancement to the dpp for aa women. a long-standing cbpr partnership designed the faith-enhancement from focus group data (n=64 aa adults) integrating five components: a brief pastor led sermon, memory verse, in class or take-home faith activity, promises to remember, and scripture and prayer integrated into participant curriculum and facilitator materials. the faith components were specifically linked to weekly dpp learning objectives to strategically emphasize behavioral skills with religious principles. using a cbpr approach, the better me within trial was able to enroll 12 churches, screen 333 aa women, and randomize 221 (mean age =48.8 ±11.2; mean bmi =36.7 ±8.4; 52% technical or high school) after collection of objective eligibility measures. a prospective, randomized, nested by church, design was used to evaluate the faith-enhanced dpp as compared to a standard dpp on weight, diabetes and cardiovascular risk, over a 16-week intervention and 10-month follow up. this study provides essential data to guide enhancements to evidence-based lifestyle programs for aa women who are at high risk for chronic disease.

Eligibility criteria:
inclusion criteria: * identify as african-american * female * 18 years of age or older * parishioner at enrolled church * overweight or obese * willingness to participate in a 10-month study. exclusion criteria: * currently attending a weight loss program * diagnosed with diabetes * medical condition that interfered with physical activity or dietary changes * plans to move in the next 10 months.

Keywords: cbpr dpp african-american women obesity pre-diabetes
a study to determine the effect and safety of an oral janus kinase 2 (jak2)-inhibitor (ruxolitinib; inbc018424) in patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study was to determine clinical efficacy and safety of ruxolitinib (incb018424), a small molecule janus kinase 2 (jak2)-inhibitor, in patients with refractory or relapsed multiple myeloma.

the protocol was originally designed as a simon two stage but after it was determined that the initial 13 patients enrolled did not meet the definition of a 'responder' according to the international uniform response criteria for multiple myeloma the protocol was amended to allow patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or had withdrawn consent to have 40 mg of dexamethasone added to their dose of ruxolitinib.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of multiple myeloma with evidence of measurable disease. * relapsed or refractory disease with at least one line of prior therapy. * adequate bone marrow reserve. exclusion criteria: * received anti-cancer medications or investigational therapy in the past 28 days. * intracranial disease or epidural disease.
epidemiology and treatment patterns of paediatric pah (pulmonary arterial hypertension)

Conditions: Hypertension, Pulmonary

Summary: to describe the prevalence, incidence and current treatment and procedures patterns in a us pediatric population with pah in marketscan database during the period 2010-2013


Eligibility criteria:
inclusion criteria: * all pah patients who were in the marketscan database and who were under age 18 at some time during the years 2010 through 2013 exclusion criteria: not applicable

Keywords: pulmonary arterial hypertension
instruction to compress chest approximately 6-7cm for healthcare provider in hospital

Conditions: Cardiac Arrest

Summary: unlikely the other element for high quality chest compression during cardiopulmonary resuscitation(i.e. compression rate, chest recoil, hand position), chest compression depth (ccd) is influenced by surface on which the patient is placed, especially in hospital. for solving this problem, to place the patient on rigid surface, use a backboard that might decrease the mattress compression, receive a feedback that reflects the mattress compression depth (mcd) using dual accelerometer or magnetic sensor have been proposed. as the other solution, we hypothesized that training of 6-7cm ccd for healthcare providers improve accurate ccd during cardiopulmonary resuscitation when manikin is placed on mattress in hospital.


Eligibility criteria:
inclusion criteria: * medical students, healthy exclusion criteria: * heart, wrist, and low back disease

Keywords: cardiopulmonary resuscitation
elranatamab post trial access study for participants with multiple myeloma (mm)

Conditions: Multiple Myeloma

Summary: this is a post-trial access (pta) open-label, single-arm study in multiple myeloma participants who continue to derive clinical benefit from elranatamab monotherapy in the pfizer-sponsored elranatamab parent studies.

this is a single-arm elranatamab post-trial access study. participants will receive elranatamab. all participants will receive elranatamab until disease progression, unacceptable toxicity, withdrawal of consent, study termination or, elranatamab becomes commercially accessible in the participant's country.

Eligibility criteria:
inclusion criteria: * participants must agree to follow the reproductive criteria as outlined in the protocol * participants have completed a qualifying parent study, were still receiving elranatamab when the parent study terminated or completed, and are deriving clinical benefit from elranatamab (as determined by the investigator). exclusion criteria: * any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * participants not previously enrolled or who have discontinued study treatment in a parent study are ineligible for participation in this study.

Keywords: multiple myeloma elranatamab post trial access roll-over study extension study mm-15 magnetismm15 bcma bcma antibody magnetism bispecific antibody elrexfio
differences of the postoperative outcome for carotid surgery patients treated by either male or female surgeons

Conditions: Carotid Stenosis

Summary: this research will focus on the differences of the postoperative outcome for carotid surgery patients treated by either male or female surgeons. since 2012, in germany, the surgical treatment of carotid stenosis has an established quality assurance, making the thematic especially suitable for testing the surgical results of either male or female surgeons.

data about physician gender having impact on the treatment quality of a patient first appeared in 1999, the publication being about patients with breast cancer. this discussion was resumed in 2016 when y. tsugawa et. al showed that female doctors have, in comparison to male doctors, better treatment results. primary outcomes for the study were mortality and readmissions, which were lower if the treatment has been done by a female doctor. until today, there are only a few reports about the role of physician gender, especially that of surgeons, in the treatment quality. studies like the ones from blohm et. al and wallis et. al show that female surgeons have a better outcome and a lower mortality, 30 days after the surgery. wallis et. al also showed that the correlation between male surgeons and female patients have the worst results\]. none of the studies that were written until today focussed on carotid surgery. since 2012, in germany, the surgical treatment of carotid stenosis has an established quality assurance, with specific documentation and a standard surgical course of action. this is why we consider that this surgery is especially suitable for comparison of results, depending on surgeon genders.

Eligibility criteria:
inclusion criteria: * age above 18 years * all the patients that had a carotid revascularisation between jan. 2012 and dec. 2023. exclusion criteria: - no quality assurance

Keywords: carotid artery apoplexy surgical outcome gender specific outcome surgeon gender
effect of exercise before gastric bypass

Conditions: Morbid Obesity

Summary: exercise training is proved to protect against premature cardiovascular mortality. additionally there is evidence that relatively high exercise intensity may be an important factor for improving aerobic capacity and endothelial function in patients with post-infarction heart failure, metabolic syndrome, coronary artery disease, as well as in overweight and obese individuals. the aims of this study is to investigate if high-intensity exercise before a gastric bypass operation will decrease hospitalization days and complications after the gastric bypass.


Eligibility criteria:
inclusion criteria: * age: \> 20 years * bmi: \> 40 or \> 35 with comorbidity * resident: sør trøndelag exclusion criteria: * unstable angina * resent cardiac infarction (within last year) * heart failure * uncontrolled hypertension * cardiomyopathy

Keywords: high intensity exercise morbid obesity gastric bypass
effects of cardiovascular training in individuals with ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: to test the effects of a cardiovascular training compared to attention control in a group of as-patients participating in classic spinal mobility exercise groups (randomized controlled trial)

ankylosing spondylitis (as) is a chronic inflammatory rheumatic disease, affecting primarily the spinal column and iliosacral joints. in addition, an increased risk for cardio-vascular disease and osteoporosis has been described in patients with as. patients with as may suffer from severe impairment in physical functioning, i.e. spinal stiffness, pain and fatigue, which reduces their daily activities, and quality of life. as as mainly affects young people, work capacity may be reduced, which, together with medical treatment costs, results in a considerable burden for the society. current treatment guidelines for as (asas/eular 2006) propose drug treatment, mainly non-steroidal anti-inflammatory drugs, and in severe cases inhibitors of tnf alpha. in addition, mobility exercise as the cornerstone of functional training is recommended in all patients with as. the efficacy of mobility exercise was confirmed by the third update (2007, unpublished) of the cochrane review regarding physiotherapy in as. however, the review also suggested that mobility exercises have no effect on important quality-of life related outcomes, such as pain, fatigue, or cardiovascular fitness. reduced physical activity due to pain, fatigue and reduced cardiovascular fitness may put patients with as at increased risk for immobility-induced bone loss and vitamin d deficiency due to limited outdoor activities. finally, both inactivity and vitamin d deficiency may contribute to the elevated risk for cardiovascular disease and osteoporosis in patients with as. cardiovascular training may increase cardiovascular fitness, reduce pain and fatigue, and decrease bone loss. the intervention may also enhance vitamin d status by increasing the amount of physical activity performed outside. vitamin d has been found to reduce bone loss and improve cardiovascular health.

Eligibility criteria:
inclusion criteria: * age 18-75 years * diagnosis of as following the modified new york criteria * ability to cycle on a training bicycle * sufficient german language ability (for questionnaires) * willingness to follow the study protocol / informed consent exclusion criteria: * chronic heart failure, functional nyha class iii and iv

Keywords: ankylosing spondylitis education physical fitness
early life interventions for childhood growth and development in tanzania

Conditions: Malnutrition; Stunting; Cognitive Development; Enteric Pathogens

Summary: this study aims to assess growth and cognitive effects of treatment with azithromycin and nitazoxanide and/or nicotinamide (vitamin b3) supplementation nicotinamide.

children living in rural sub-saharan africa experience massive challenges to child thriving, with poor linear growth and delays in child development. in a cohort of 211 children living in the rural haydom area of tanzania (participating in the interactions of malnutrition \& enteric infections: consequences for child health and development "mal-ed" study), 70.6% had stunted growth at 18 months. this rate of moderate and severe stunting (length-for-age z-score \[haz\] \<-2 standard deviations) was the highest of the 8 study sites in mal-ed. this enormous deficit is likely associated with high rates of enteric infections with campylobacter, e. coli pathotypes, cryptosporidium, and giardia, organisms susceptible to azithromycin and/or nitazoxanide. infections such as these occur frequently in developing areas and are often associated with environmental enteropathy, including ongoing enteric inflammation and loss of enterocyte integrity, leading to possible bacterial translocation and poorer absorption of ingested nutrients. the consequences of these infections, enteric dysfunction and poor nutrient absorption frequently include growth stunting, learning delays, and an overall loss of human capital. emerging evidence suggests a potential role for the tryptophan-niacin pathway (including the end-product nicotinamide, an isoform of vitamin b3) in decreasing mucosal inflammation and affecting enteral microbiota. at the tanzania site of mal-ed, serum levels of tryptophan were related to subsequent linear growth, further suggesting importance of the tryptophan-niacin pathway. what is not clear is whether early childhood growth and development could be improved by targeting enteric infection and the tryptophan-niacin pathway by 1) delivering antibiotics against specific bacteria and/or 2) providing vitamin b3 as nicotinamide/niacinamide. the main analysis will be intention-to-treat but a secondary analysis will be per protocol.

Eligibility criteria:
inclusion criteria: 1. maternal age ≥18 2. infant ≤ 14 days exclusion criteria: 1. maternal inability to adhere to protocol 2. multiple gestation 3. severe illness (significant birth defect, hospitalization, severe neonatal illness) 4. birth weight \<1500 g 5. lack of breastfeeding at enrollment (and lack of intention to continue breastfeeding at time of enrollment).
a study comparing trifarotene cream 0.005% to aklief® cream (us reference listed drug), aklief™ cream (canadian reference product) in the treatment of acne vulgaris

Conditions: Acne Vulgaris

Summary: to demonstrate the efficacy, therapeutic equivalence and safety of trifarotene cream 0.005% (taro pharmaceuticals u.s.a., inc.) and us reference listed drug, canadian reference product over the placebo control in the treatment of acne vulgaris.

a multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing comparing trifarotene cream 0.005% (taro pharmaceuticals u.s.a, inc.) to aklief® cream (us reference listed drug), aklief cream (reference product) and each active treatment to a placebo control in the treatment of acne vulgaris.

Eligibility criteria:
inclusion criteria: * healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris. * subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3 or 4 as per the investigator's global assessment (iga). * subjects must have ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) and ≥ 20 inflammatory lesions (i.e., papules and pustules) and ≤2 nodulocystic lesions (i.e., nodules and cysts), at baseline on the face. * subjects must be willing to refrain from using all other topical acne medications or antibiotics for acne vulgaris during the 12-week treatment period, other than the investigational product. exclusion criteria: * female subjects who are pregnant, nursing or planning to become pregnant during study participation. * subjects with a history of hypersensitivity or allergy to trifarotene, retinoids and/or any of the study medication ingredients. * subjects with excessive facial hair (e.g. beards, sideburns, mustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. * subjects with a baseline irritation score of 3 = severe (marked, intense).
intraoperative cholangio-ultrasound in resective liver surgery

Conditions: Liver Cancer

Summary: liver surgery should be considered an echo-guided procedure to guarantee conservative but radical resections. the investigators describe a further application of intraoperative ultrasonography (ious) for studying the biliary tree during liver surgery with no need for formal cholangiography.

intraoperative ultrasonography (ious) in liver surgery is widely accepted as a fundamental tool for radical and safe hepatectomy \[1\]. new technical improvements of ious have been reported in recent years both for tumor characterization and staging \[2\] and for resection guidance \[3-5\]. however, intraoperative cholangiography (ioc) still represents the gold standard for studying the biliary tract anatomy as well as for guiding reconstruction in case of bile duct resection and, moreover, with the advent of living donation it is the standard reference for validating preoperative imaging \[6\]. conversely, it could be affirmed that ious in this sense has no role, if not for guiding intraoperative dilated bile duct drainage \[7\]. nevertheless, ioc has not negligible costs, it implies the use of x-ray, iodated contrast agents and is time consuming. herein is proposed a technique for bile duct exploration by means of intraoperative cholangio-ultrasound (iocus) validated on a consecutive series of patients undergoing liver resection. 1. machi j, oishi aj, furumoto nl, oishi rh (2004). intraoperative ultrasound. surg clin north am, 84(4): 1085-111 2. minagawa m, makuuchi m, takayama t, ohtomo k (2001). selection criteria for hepatectomy in patients with hepatocellular carcinoma and portal vein tumor thrombus. ann surg, 233(3): 379-84 3. torzilli g, del fabbro d, olivari n, calliada f, montorsi m, makuuchi m (2004). contrast-enhanced intraoperative ultrasonography during liver surgery. br j surg, 91(9): 1165-7 4. torzilli g, makuuchi m. ultrasound-guided finger compression in liver subsegmentectomy for hepatocellular carcinoma (2004). surg endosc, 18(1):136-9 5. torzilli g, takayama t, hui am, kubota k, harihara y, makuuchi m (1999). a new technical aspect of ultrasound-guided liver surgery. am j surg, 178(4): 341-3 6. lee vs, krinsky ga, nazzaro ca, chang js, babb js, lin jc, morgan gr, teperman lw. defining intrahepatic biliary anatomy in living liver transplant donor candidates at mangafodipir trisodium-enhanced mr cholangiography versus conventional t2-weighted mr cholangiography. radiology, 2004; 233(3): 659-66 7. torzilli g, makuuchi m, komatsu y, noie t, abe h, kobayashi t, kubota k, takayama t. us guided biliary drainage during hepatopancreatico-jejunostomy for diffuse bile duct carcinoma. hepatogastroenterology. 1999; 46(26): 863-6.

Eligibility criteria:
inclusion criteria: patients who need: * clarification of the bile duct anatomy; * disclosure of eventual intrahepatic bile duct dilation; * verification of the patency of a sutured bile duct after tumor detachment from a glissonian sheath; * check of the drainage of a bile duct stump on the liver cut surface prior to bilio-enteric anastomoses.
cataract online refraction evaluation: a multi center randomized controlled trial

Conditions: Cataract

Summary: background of the study: cataract is widely prevalent in especially elderly and cataract extraction surgery has thus become one of the most performedsurgeries worldwide. in recent decades the safety of cataract surgery has greatly improved and it is considered one of the safestsurgeries to be performed. postoperative management consists of routine examinations within one week, to ascertain no adverseevents have occurred immediately after surgery, and between 4-6 weeks, to determine the refractive error. the incidence of seriousadverse events following cataract surgery is estimated to be 1%. as a result, the majority of patient visits after cataract surgery willbe uneventful. nonetheless valuable time and hospital resources are consumed. remote monitoring could replace clinicalexaminations in selected patient groups. however, this practice of digital remote monitoring which the patient can use independentlyhas not been clinically validated yet. objective of the study: to determine non-inferiority of the corrected distance visual acuity (cdva) with the prescription obtained through the web-basedmeasurement of refractive error, compared to usual care, in patients who underwent routine cataract surgery. study design: observational randomized trial without interventions study population: patients eligible for cataract surgery, without visual acuity influencing comorbidities or predisposing complicating factors. primary study parameters/outcome of the study: costeffectiveness secundary study parameters/outcome of the study (if applicable): corrected distance visual acuity at the final post-operative visit, uncorrected distance visual acuity, refractive error(sphere/cylinder/axes), patient reported outcome measurements, adverse events.


Eligibility criteria:
inclusion criteria: * planned for bilateral phacoemulsification cataract extraction and intra-ocular lens implantation (either sequentialor in one procedure) * ≥ 18 years of age * no other current ophthalmic conditions or history that negatively influence post-operative visual acuity * be able to fill out the health questionnaires (in dutch, german or english) and perform the web-based refractiveassessment (possibly with assistance of family member or other close relative). * specific digital requirements include access to a computer and a smartphone and knowledge how to log in to anonline patient portal. exclusion criteria: * cataract extraction surgery combined with other procedures, including: keratoplasty, vitrectomy, glaucoma filter implants * ocular comorbidities that negatively influence post-operative visual acuity * no access to the digital requirements to take the online health questionnaire and/or perform the online refraction. * insufficient command of the dutch, german or english language to understand the questionnaires andinstructions of the web-based refractive assessment or no family member / close relative to assist with this * inability of performing the web-based eye exam prior to cataract surgery.

Keywords: e-health digital remote monitoring