Kornimate/medical-research-clean huggingface dataset:
habit building software application to increase engagement of vulnerable populations in the national diabetes prevention program (ndpp) lifestyle change program (lcp)

Conditions: Prediabetes

Summary: the goal of this clinical trial is to learn whether a companion software application can improve program engagement in the national diabetes prevention program in adults with prediabetes. the main question\[s\] it aims to answer \[is/are\]: do participants using the software application (the intervention group) have better engagement with the diabetes prevention program than those who do not use the companion software application (the control group)? are participants using the software application (the intervention group) more likely to stay in the diabetes prevention program longer than those who do not use the companion software application (the control group)? participants are those who have signed up for their local diabetes prevention program and agree to be in the study.


Eligibility criteria:
inclusion criteria: * is eligible for and enrolls in a live or distance lcp at a designated study site during the enrollment period of the study * has a smartphone or other device able to engage with the ft lcp app * can read basic 5th grade english, as used in the ft lcp app exclusion criteria: * cohorts and sites enrolled in concurrent, similar health app-based studies
feasibility testing of decision support for patients who are candidates for an implantable defibrillator

Conditions: Cardiovascular Disease; Sudden Cardiac Death

Summary: sudden cardiac death (scd) due to a ventricular arrhythmia is a serious cause of cardiovascular death in canada. the implantable cardioverter defibrillator (icd) offers high-risk patients a treatment option to reduce the incidence of scd by delivering an internal shock to restore a normal rhythm, if needed. definitive evidence has established the effectiveness of the icd for reducing mortality when used as prophylaxis for scd (a primary prevention indication). approximately 3,700 new candidates accrue annually. practice guidelines define the criteria to determine patient icd candidacy for primary prevention. however, in addition to scd risk, icd candidates may have chronic diseases such as diabetes, renal insufficiency, hypertension, and atrial fibrillation. thus, balancing the benefits and risks of an icd can become complex, particularly when competing mortality risks are present. research has recognized human costs associated with device complications and shocks affecting psychological, health related quality of life (hrql), and morbidity outcomes. the complexities surrounding the long-term benefits/risks, complications, replacements, and shocks, warrant decision support to prepare patients to make decisions. in canada, there is no clear framework to support patients' decision-making in the context of icd treatment options. decision support, using a decision aid, could moderate treatment related uncertainty and prepare patients to make active, informed, quality decisions. objectives: 1) develop a decision aid for icd candidates to support quality decision-making (informed, deliberate, values-based choices), 2) to evaluate the decision aid, and 3) to determine the feasibility of conducting a trial.


Eligibility criteria:
inclusion criteria: * referred for consideration of an icd(non-crt)for a primary prevention indication * english speaking * able to provide informed consent exclusion criteria: * unable to understand the decision aid due to a language barrier or visual impairment * referred for secondary prevention indication

Keywords: sudden cardiac death implantable cardioverter defibrillator decision aid
gabapentin for relief of immediate postoperative pain

Conditions: Postoperative Pain

Summary: the purpose of this study is to use gabapentin as an additional or alternative treatment for short term pain control following cesarean delivery in order to reduce the use of opioid pain medication and improve overall pain control following surgery.

this is a randomized, placebo controlled, double blind study. after consent, the subject will complete a depression screening to establish a baseline score. within 2 hours following completion of a cesarean section, the subject will be given the study drug (600mg gabapentin) or placebo. she will be given this every 8 hours for 48 hours scheduled. she will also have the option to take routine opioid pain medication if her pain is uncontrolled. she will be asked to rate her postoperative pain on a visual analog scale prior to receiving the study drug, 2-4 hours after each dose, and at 24, 36, and 48 hours postoperatively. for breastfeeding infants, data will be collected regarding overall feeding quality, somnolence levels, gestational age at birth, infant weight at birth and discharge, the highest bilirubin level while inpatient and any treatment for this as applicable. the subject will complete the depression scale again at 48 hours following delivery. at one week postpartum, they will receive a phone call and the following will be addressed: a final pain survey, a depression survey, nausea level, number of pain pills left in their prescription, adverse events, whether or not they would take the study drug again if they should happen to have another cesarean section, and infant well-being if breastfeeding.

Eligibility criteria:
inclusion criteria: 1. pregnant women at least 18 years of age 2. gestational age \> or = to 30 weeks 3. singleton gestation 4. women undergoing a non-emergent cesarean delivery 5. spinal anesthesia or combined spinal-epidural anesthesia utilized during cesarean 6. ability to undergo the informed consent process in english exclusion criteria: 1. vertical skin incision 2. general anesthesia for cesarean 3. history of major depression or postpartum depression requiring medication 4. chronic opiate use during pregnancy, defined as anyone who has taken an opioid or opioid replacement therapy in the 3 days prior to admission for delivery. this does not include opioids given for labor anesthesia. 5. magnesium sulfate treatment postpartum 6. preexisting fibromyalgia, chronic pain syndrome, or rheumatologic disorder
tailored approaches to improve medication adherence

Conditions: Hypertension

Summary: the purpose of this study is to to culturally tailor a technology-based individualized adherence intervention for black and latino patients with uncontrolled htn or t2dm, who are non-adherent to their medications, and determine its acceptability.

using a randomized controlled trial design, this study will compare the efficacy of a tailored adherence intervention (tai) to a single patient education (pe) session, on medication adherence among 40 high-risk black and latino patients with uncontrolled hypertension (htn) who are non-adherent to their prescribed antihypertensive medications. patients randomized to the pe group will receive a single tablet delivered patient education session at the baseline visit. patients randomized to the tai group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. following completion of the tailoring survey, patients will collaborate with the ra to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles.

Eligibility criteria:
inclusion criteria: * have uncontrolled hypertension defined as bp\>140/90 mmhg on at least two consecutive visits in the past year (or bp\>130/80 mmhg for those with diabetes or kidney disease) and framingham risk scores (frs) \>20% (or at least one cvd risk factor including hyperlipidemia or diabetes); * have been prescribed at least one antihypertensive or oral anti-diabetic medication; * self-identify as latino or african american/black * be \> 18 years of age exclusion criteria: * refuse or are unable to provide informed consent; * currently participate in another hypertension study; or 2 diabetes study * have significant psychiatric comorbidity * plan to discontinue care at the clinic within the next 3 months vulnerable populations including adults unable to provide informed consent, pregnant women, and prisoners will be excluded from this study.

Keywords: hypertension latinos medication adherence blood pressure control patient-centered black
physical activity and fatigue in myasthenia gravis

Conditions: Myasthenia Gravis

Summary: danish patients with myasthenia gravis are asked to answer a validated and international questionnaire about physical activity. also background questions about their disease and comorbidity are asked. to validate the data about physical activity from the questionnaires 69 patients are asked to wear an accelerometer for 7 days to measure activity level.

secure digital mails are sent to around1500 patients qua their civil registration number (cpr number) (each resident of denmark has a permanent unique civil registration number that is provided at birth or immigration to denmark). the mail contains a link for the software redcap (© 2018 vanderbilt university), recommended by rigshospitalet. redcap is a secure web application for building and managing online surveys and databases. patients are, in redcap, informed about the project, and if interested, asked to sign the included informed content and answer six validated and translated questionnaires.

Eligibility criteria:
inclusion criteria: * danish resident. * alive. * minimum age 18 years. * registered in the danish patient register with diagnosis code 70.0 (icd-10) or 733.09 (icd 8). * subscribing e-boks (the danish system for receiving secure digital emails). exclusion criteria: * i fulfilling the inclusion criteria, then no exclusion criteria

Keywords: survey physical activity fatigue
efficacy and safety of multimodal ablation combined with pd-1 monoclonal antibody, lenvatinib and tace in the treatment of unresectable primary hepatocellular carcinoma: a single-arm, single-center clinical study

Conditions: Carcinoma, Hepatocellular; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Digestive System Neoplasms; Liver Neoplasms

Summary: this study is a prospective, single-arm, single-center trial evaluating the efficacy of tace combined with multimodal ablation, tislelizumab, and lenvatinib in the treatment of unresectable primary liver cancer.

this study aims to evaluate the efficacy and safety of multimodal ablation combined with tislelizumab, lenvatinib, and tace in the treatment of primary liver cancer. by comparing preoperative and postoperative immune markers, the study seeks to clarify the clinical value of multimodal ablation combined with systemic therapy and tace in the management of primary liver cancer.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 80 years, no gender restriction. 2. clinically or pathologically confirmed hepatocellular carcinoma (hcc). 3. cnlc stage iib-iiia with tumors deemed unresectable after multidisciplinary discussion. 4. no prior systemic chemotherapy, targeted therapy, or immunotherapy for hepatocellular carcinoma. 5. presence of an ablation-eligible lesion with imaging-evaluable target tumor(s), with the maximum diameter of the target lesion \>5 cm. 6. ecog performance status (ps) of 0-1 and an expected survival of more than 3 months. liver function child-pugh score ≤7. exclusion criteria: 1. liver function classified as child-pugh grade c. 2. presence of tumor thrombus in the main portal vein or hepatic vein. 3. extensive systemic metastases with an expected survival of \<3 months. 4. severe failure of major organs, including liver, kidney, heart, lungs, or brain. 5. recent esophageal (or gastric fundus) variceal rupture and bleeding within the past month. 6. history of other malignancies. 7. concurrent use of other antitumor therapies, such as radiotherapy or systemic chemotherapy. 8. active infection, including:hbv infection with hbv dna \<2000 iu/ml (\<10⁴ copies/ml) or reduced by one log after antiviral therapy.hcv infection requiring antiviral treatment per clinical guidelines.hiv infection or biliary system inflammation. 9. history of organ transplantation or hepatic encephalopathy. 10. uncorrectable coagulation disorders. 11. refractory massive ascites, pleural effusion, or cachexia. 12. pregnancy, altered consciousness, or inability to cooperate with treatment. 13. interval of less than one month since the last local therapy. 14. any other factors deemed by investigators to contraindicate study participation or significantly impact the patient's involvement in the study.

Keywords: multimodal tislelizumab lenvatinib tace unresectable primary liver cancer
online platform for self-service of patients with chronic cardiovascular diseases

Conditions: Cardiovascular Diseases

Summary: the purpose of this study is to define the requirements and characteristics of the software that will be developed for the project "creation of a platform for self-service of people living with chronic cardiovascular diseases in an understandable, clear, complete, consistent and verifiable manner. the project concerns the design and implementation of a long-term program of therapeutic exercise and evaluation, by exercise and health professionals, of the anatomical and functional adaptations of exercise in patients and athletes with cardiovascular diseases. essentially, it is a program of recording and monitoring cardiovascular rehabilitation in the form of systematic exercise of the patient both at home and in sports venues, which will contribute to the prevention of cardiovascular events in conditions of fatigue and at rest as well as to the gradual rehabilitation of the patient who performs a physical activity. depending on the individual's functional capacity and health issues, combined with monitoring the patient's vital signs (such as blood pressure, heart rate, oxygen saturation, body temperature) the exercise professional will create an individualized, targeted exercise program with ultimate aiming at its rehabilitation with the help of physical activity and the improvement of its functional performance and by extension the quality of life of the individual. at the same time, the project will seek to motivate patients to remain committed to the physical activity program, with the aim of faster reintegration into their daily life.


Eligibility criteria:
inclusion criteria: * patients with cardiovascular disease and recent myocardial infarction (\>4weeks) * patients shall be in a clinical stable condition. exclusion criteria: * uncontrolled t1 or t2 diabetes mellitus. * comorbidities precluding exercise training (e.g., orthopaedic/neurological conditions). * uncontrolled arrhythmias
comparison of tetracaine 0.5% and lidocaine 2% jelly for topical phacoemulsification cataract surgery

Conditions: Cataracts

Summary: the purpose of this study is to determine if there is a difference on the penetration of betadine 5% when using lidocaine 2% jelly versus topical tetracaine 0.5% in topical cataract surgery. this will be assessed comparing bacterial colony count and species by taking swabs from the eye surface before and after the topical anesthesia has been administered.

the purpose of this research study is to show that using lidocaine2% jelly before surgery as an anesthetic (keep you from feeling touch or pain) for cataract surgery does not block the antiseptic (cleans and kills germs) effect of betadine5%.

Eligibility criteria:
inclusion criteria: * greater or equal to 18 years old * uni- or bi-lateral visually significant cataracts exclusion criteria: * hypersensitivity to betadine5%, topical tetracaine0.5%, or lidocaine2% jelly * pregnancy
the effect of alginate supplementation on weight management

Conditions: Overweight and Obesity

Summary: this project will assess the effect of the alginate (in a capsules) on the weight of generally healthy volunteers over a 12 week period. to achieve this, will recruit 150 (non-smoking) generally healthy volunteers to attend the study centre on four separate occasions. volunteers will be randomly allocated into active or placebo arm of the trial, both will receive capsules with the same appearance. the volunteers will have their height, weight, waist circumference, body composition, and fasting levels of circulating glucose, triacylglycerol and cholesterol measured at each for the four visits.

the study will last approximately 12 weeks depending on your availability. volunteers will be asked to come to the research facility in newcastle university, before they have had any breakfast, on four separate occasions. the volunteers must not eat or drink anything (except water) after 8 pm the evening before they come in. this includes not drinking any alcohol, tea or coffee. each time the volunteers come in, their height (first assessment only), weight, waist circumference and body composition will be measured. body composition is measured using scales which can determine the percentage of their body is fat or bone or muscle. this is done using a small harmless electrical current passing through their body, they will not detect or feel this at all. their height will also be measured at the first visit. cholesterol, triglyceride and glucose levels in the blood will also be measured at each visit. this will be done through a single finger prick blood sample. enough capsules will be given to the volunteers to last you four weeks at the first three visits. the capsules will be filled with either alginate or another dietary fibre believed to have no effect on weight management. volunteers will be asked to take four of these capsules with their three main meals per day over the 12 week study.

Eligibility criteria:
inclusion criteria: * generally healthy * bmi over 20 exclusion criteria: * pregnant, lactating, * bmi under 20

Keywords: obesity overweight
a study of mk-0822 in postmenopausal women with osteoporosis to assess fracture risk (mk-0822-018)

Conditions: Postmenopausal Osteoporosis

Summary: the purpose of the event-driven base study is to determine the safety and efficacy, especially fracture risk reduction, of odanacatib in postmenopausal women diagnosed with osteoporosis. in a placebo-controlled extension of the base study, participants continued to receive the same blinded study medication for a total of up to 5 years of blinded study medication combined between the base study and the extension. after participants received 5 years of blinded study medication, they received open-label odanacatib through the end of the first extension. participants were then invited to enroll in a second extension study in which they received open-label odanacatib for an additional 5 years. two imaging substudies (pn032-base/extension and pn035) were conducted for participants in the mk-0822-018 study. additional safety information was collected for participants who discontinued from the base study or the blinded first extension in an observational follow-up study, mk-0822-083 (eudract number: 2007-002693-66) .


Eligibility criteria:
inclusion criteria: * postmenopausal women (for at least 5 years) who are ≥65 years of age and have low bone mineral density * ambulatory (able to walk) exclusion criteria: * must not be taking osteoporosis therapy or have a metabolic bone disorder other than osteoporosis * has or has had a hip fracture * currently participating in another drug study
efficacy of acupuncture as an adjunct to methadone treatment services for heroin addicts

Conditions: Opiate Withdrawal Syndrome

Summary: this is an open-label, randomized, 2-sequence, cross-over study evaluating the difference of efficacy between ear acupressure alone and ear acupressure plus electroacupuncture therapy both combined with methadone treatment services for heroin addicts.

methadone substitution therapy has been the treatment of first choice for opiate dependence, but patient on methadone substitution therapy report a wide side effects, and relapse rate is up to two third of methadone treatment patients between one to two years. therefore, adjuvant therapeutic interventions for heroin addiction patients are needed. since 1996, the world health organization (who) has classified acupuncture treatment indications, including drug abuse. the purpose of this study is to compare the difference of efficacy between ear acupressure alone and ear acupressure plus electrical acupuncture therapy both combined with standard methadone maintenance therapy to the heroin addicts. patients who receive methadone were randomly assigned to sequence a and b. sequence a(n=20) receive ear acupressure combined with electroacupuncture for four weeks, followed by one week wash-out period. then ear acupressure alone for another four weeks. sequence b(n=20) receive ear acupressure alone for four weeks first, and followed by one week wash-out period, then ear acupressure combined with electroacupuncture for another four weeks. measures of methadone dosage and using the craving visual analog scale (vas) to assess the craving severity for 8 weeks. using the short form health survey (sf-36) and the pittsburgh sleep quality index (psqi) to assess improvement of life quality and sleep quality. using beck anxiety and depression inventory to evaluate emotional problems. urine opiate screenings are provided after 4 weeks , 8 weeks treatment and 1 month after end of treatment, to screen opiate reuse. the study hypothesis was acupuncture had more clinical efficacy than ear acupressure upon craving severity, life quality, mood stability ,reduced methadone dosage and sleep quality when provided as an adjunct to a standard methadone maintenance treatment.

Eligibility criteria:
inclusion criteria: fulfilled diagnostic and statistical manual of mental disorders, 5th edition criteria for opioid use disorder and had been received methadone maintenance treatment for more then one month. exclusion criteria: 1. had taking acupuncture treatment in past 30 days 2. had severe adverse effects or events history from receiving acupuncture treatment 3. had any serious physical illness 4. had a significant risk of suicide 5. ear infection 6. were pregnant or or a woman plan to pregnant 7. had bleeding disorders or were taking anticoagulant drugs 8. had epilepsy, cerebral vascular disease and brain injured history.

Keywords: methadone heroin acupuncture
a phase 1 study of the hsp90 inhibitor, sta-9090 in subjects with acute myeloid leukemia, acute lymphoblastic leukemia and blast-phase chronic myelogenous leukemia

Conditions: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Blast-phase Chronic Myelogenous Leukemia; AML; ALL; CML

Summary: an open-label phase 1 study to assess safety and efficacy of once-weekly sta-9090 (ganetespib) in subjects with aml, all and blast-phase cml.


Eligibility criteria:
inclusion criteria: * subjects with a pathologic confirmation of the diagnosis of aml, all, or blast-phase cml * ecog performance status 0-2 * adequate organ function as defined in the protocol. * ability to understand and willingness to sign a written informed consent document. exclusion criteria: * hyperleukocytosis * acute promyelocytic leukemia (fab-m3) subtype * uncontrolled disseminated intravascular coagulation (dic) * active central nervous system leukemia * concomitant radiation therapy, chemotherapy, or immunotherapy * women who are pregnant or lactating * neuropathy ≥ grade 2 (nci ctcae) at time of enrollment * chemotherapy (with the exception of hydroxyurea) or radiotherapy within two weeks or within six times the agent's half life * require ongoing therapy with either g- or gm-csf, or long-acting versions of these molecules * use of any investigational agents within two weeks or within six times the agent's half life --treatment with chronic immunosuppressants * other medical/psychiatric condition that may increase the risk associated with study participation as defined by the protocol.

Keywords: synta sta-9090 ganetespib hematologic cancers acute myeloid leukemia acute lymphoblastic leukemia blast-phase chronic myelogenous leukemia aml all cml hsp90 inhibitor