Kornimate/medical-research-clean huggingface dataset:
cardiopulmonary outpatient rehabilitation using mobile technology

Conditions: Cardiac Disease; Pulmonary Disease; Cardiopulmonary Disease

Summary: this is a randomized controlled trial of the feasibility and utility of implementing a smartphone application (mvn) to maintain compliance with a heart healthy lifestyle after discharge from a cardiac outpatient rehabilitation program. patients will be randomized into one of two groups: usual care (control: uc) or movn mobile application (intervention: mvn). this study will improve and strengthen data collection from this at-risk patient population by recording baseline clinical and psycho social measures while gaining insight into self-reporting of physical activity and frequency between the uc and mvn groups.


Eligibility criteria:
inclusion criteria: * current participants in the joan and joel smilow cardiac rehabilitation and prevention center (jjcrpc) of rusk rehabilitation patient within two weeks of completing outpatient cardiac rehabilitation * clinically stable: moderate to low risk strata by standardized clinical assessment * clinically stable: moderate to low risk strata by standardized clinical assessment * no infections * no unstable arrhythmias, aortic stenosis, thrombophlebitis, dissecting aneurysm or symptomatic anemia * controlled blood pressure-resting diastolic \<100 mmhg, systolic \<180mmhg * no uncompensated heart failure nyha class 3-4 * stable angina (no chest pain for month) * no 2nd or 3rd degree heart block * no uncontrolled high grade exercise induced ventricular ectopy-hemodynamically stable * own an iphone (version 3 or above), an ipad, or an ipod touch (version 4 or higher) or android phone or tablet * ability to use and comfortable with using mobile health technology to monitor physical and psychosocial health * is comfortable using mobile applications * english language fluency * ability to provide informed consent exclusion criteria: * patients who do not fulfill all inclusion criteria stated above.
establishing the incidence of tako-tsubo cardiomyopathy in scotland

Conditions: Takotsubo Cardiomyopathy; Myocardial Infarction

Summary: acute stress-induced (takotsubo cardiomyopathy) presents like a heart attack and is triggered by intense emotional or physical stress. although coronary arteries are unobstructed, it has been suggested that the risk of death is similar to a myocardial infarction. the purpose of the starr study is to identify all cases of takotsubo in scotland since 2010 and assess its epidemiology and outcomes.

public health scotland will identify all patients centrally coded under codes i42.8 (other cardiomyopathies), i42.9 (cardiomyopathy, unspecified) and i51.8 (other ill-defined heart diseases), using the community health index (chi) numbers from january 2010. all identified chi numbers will be thereafter cross-checked with their clinical data at participating health boards to confirm a diagnosis of takotsubo cardiomyopathy and a registry of all confirmed takotsubo cases will be established. clinical data will be collected for all takotsubo patients retrospectively and prospectively. this will be compared to two contemporaneous gender and age matched control populations: 1. a cohort of randomly selected individuals from the scottish general population supplied by public health scotland 2. patients with myocardial infarction (extracted through collaboration with, the high-steacs investigators, nct01852123). electronic data linkage will be performed by public health scotland to assess outcomes, prescribing and scores of prediction.

Eligibility criteria:
inclusion criteria: * all patients diagnosed with takotsubo cardiomyopathy exclusion criteria: * na
acceptance and commitment therapy for informal caregivers of people with dementia

Conditions: No Specific Conditions

Summary: dementia has a major impact on people with dementia and their family. informal caregivers of people with dementia are at higher risk of developing depressive symptoms compared to informal caregivers of people with other chronic diseases. therefore, supporting this group of informal caregivers is particularly important. with an online program based on acceptance and commitment therapy (act), this study supports caregivers of people with dementia to lead a more meaningful and less stressful life. in addition to following the online program, caregivers are supported weekly by a coach, who helps to set goals, map important values in life, and take actions in relevant areas. the current study aims to examine the (1) feasibility and acceptability of the intervention and its procedure and; (2) preliminary effectiveness of the intervention on clinical outcomes (e.g. psychological flexibility and self-competence); and (3) maintenance of change after the intervention in short-and long-term follow-ups. this study includes a single-arm, non-randomized trial with a baseline assessment, a 9-week internet-based intervention period, a post-intervention assessment, and two follow-ups at 3 and 6 months. act is a promising form of therapy that has previously been shown to be effective in increasing the mental well-being of caregivers. however, this is the first study to combine online act modules, goal-setting, and weekly coaching for informal caregivers of people with dementia.


Eligibility criteria:
inclusion criteria: * adult informal caregivers (at least 18 years old) * access to the internet and having a tablet or computer * self-identified primary informal caregiver of a person diagnosed with dementia * taking care of the care recipient at least once a week for a period of at least three months * obtained informed consent \*general (psychological) support from case managers will not count as professional psychological support, and therefore, informal caregivers who receive support from the case managers will also be included. exclusion criteria: * caregivers who report having a cognitive disorder in their clinical record will be excluded (based on self-report). * caregivers who receive psychotherapy or psychopharmacological treatment within the last 3 months will be excluded (based on self-report).

Keywords: acceptance and commitment therapy informal caregivers internet-based intervention feasibility
open label, extension study of pro044 in duchenne muscular dystrophy (dmd)

Conditions: Duchenne Muscular Dystrophy

Summary: the purpose of this study is to see whether pro044 is safe and effective to use as medication for duchenne muscular dystrophy (dmd) patients with a mutation around location 44 in the dna for the dystrophin protein.

a phase ii, open-label, extesion study. following a screening period of up to one month, subjects previously treated with pro044, and eligible for enrolment in pro044-clin-02, will be allocated to one of three groups to receive either 6 mg/kg or 9 mg/kg pro044 weekly by iv infusion or 6 mg/kg weekly by sc injection for 48 weeks. safety and tolerability, pharmacokinetics (pk), pharmacodynamic (pd) and efficacy assessments will be conducted at regular intervals throughout the study.

Eligibility criteria:
inclusion criteria: 1. subjects previously treated with pro044. 2. continued use of glucocorticoids for a minimum of 60 days prior to study entry with a reasonable expectation that the subject will remain on steroids for the duration of the study. changes to the dose regimen or cessation of glucocorticoids will be at the discretion of the principle investigator (pi) in consultation with the subject/parent and the medical monitor. if the subject is not on steroids, involvement in the study needs to be discussed with the medical monitor exclusion criteria: 1. current, or history of, liver or renal disease. 2. acute illness within 4 weeks prior to the first dose of pro044 (week 1) which may interfere with the measurements. 3. severe cardiac myopathy which in the opinion of the investigator prohibits participation in this study 4. need for daytime mechanical ventilation. 5. screening aptt above the upper limit of normal (uln). 6. screening platelet count below the lower limit of normal (lln). 7. use of anticoagulants, antithrombotics or antiplatelet agents. 8. use of any investigational product within 6 months prior to the start of screening for the study. 9. current or history of drug and/or alcohol abuse.

Keywords: duchenne muscular dystrophy dmd biomarin pro044
tax preparation pilot

Conditions: Financial Stress; Maternal Distress

Summary: the goal of this study to understand what percentage of families in the pediatric clinic at boston medical center (bmc) currently file taxes and use free tax preparation and would accept and use referral to a free tax preparation service. the investigators specifically want to understand which of two methods of connecting to free tax preparation (referral versus navigated connection) is more effective. also studied will be the feasibility of using surveys on financial wellness and other health indicators to track participants' health. these pilot findings will be used to design a larger study that aims to assess whether integrating free tax preparation services into a pediatric clinic can increase tax filing rates and, as a result, the amount of money families receive in tax refunds. additionally, the investigators hope to understand whether receiving this service impacts parental stress as well as how parents and babies are using the healthcare system.


Eligibility criteria:
inclusion criteria: * guardian of a child 0-5 years * english, spanish, or haitian-creole -speaking * child is a boston medical center pediatric primary care patient exclusion criteria: * guardian not present at time of clinic visit * have no taxable income for the calendar year * not using bmc for pediatric primary care * have already filed their taxes for 2020

Keywords: tax preparation service tax filing earned income tax credit (eitc) child tax credit
drug-eluting registry: real-world treatment of lesions in the peripheral vasculature

Conditions: Peripheral Vascular Diseases

Summary: the elegance registry's objective is to collect real-world data (rwd), including populations previously not represented in peripheral vascular disease (pvd) trials, health economics data, and to support the safe use of commercially available boston scientific corporation (bsc) drug-eluting devices for the treatment of lesions located in the peripheral vasculature.

a global prospective, non-randomized, open-label, multi-center registry to collect real-world data, including health economic data, to support the use of commercially available drug-eluting bsc devices for the treatment of lesions located in the peripheral vasculature.

Eligibility criteria:
inclusion criteria: * patients 18 years and older * written informed consent (patient data release-form) * use of any commercially available boston scientific drug-eluting device marketed for treatment of lesions in the peripheral vasculature and specified in the registry enrollment guide exclusion criteria: * life expectancy of \<1 year
the prognosis of early pregnancy with post coital bleeding

Conditions: Vaginal Bleeding During Pregnancy; Postcoital Bleeding

Summary: this is a prospective study, where the investigators will monitor pregnant women at 4-23 weeks of pregnancy coming to the "women- e.r." at "meir" hospital due to spontaneous -or after intercourse- bleeding or bleeding secretions. the women will fill out questionnaires regarding past illness, vaginal bleeding, and gynecologic history. then they will undergo full examination including ultrasound. after discharge, the investigators will recommend to all the women who came due to bleeding or bleeding secretions to avoid intercourse for two weeks after the bleeding stops. afterwards they will be monitored until their delivery date (filling questionnaires a month after coming to the e.r. and at the end of the pregnancy). after they give birth the investigators will assess the rate of pregnancy, obstetric and embryonic complications in each of the study groups.

this is a prospective study, where the investigators will monitor pregnant women at 4-23 weeks of pregnancy coming to the "women e.r" at "meir" hospital due to spontaneous -or after intercourse bleeding - bleeding secretions. the women will be divided in to two groups 1. pregnant women (age 18-40) at 4-23 weeks of pregnancy with spontaneous bleeding or bleeding secretions 2. pregnant women (age 18-40) at 4-23 weeks of pregnancy that have appealed to the "women er" 24 hours after bleeding or bleeding secretions due to intercourse. the women will fill out questionnaires regarding past illness, vaginal bleeding, and gynecologic history. then they will undergo full examination including ultrasound. after discharge, the investigators will recommend to all the women who came due to bleeding or bleeding secretions to avoid intercourse for two weeks after the bleeding stops. afterwards they will be monitored until their delivery date (filling questionnaires a month after coming to the e.r. and at the end of the pregnancy) the doctor that had examined the women, will have to fill out questionnaires regarding the bleeding source, the time after intercourse, how long after the intercourse the bleeding had appeared and which kind of examination he had carried out. a month after their appeal to the e.r. and after they give birth ,the investigators will assess the rate of pregnancy, obstetric and embryonic complications in each of the study groups, by phone.

Eligibility criteria:
inclusion criteria: * women (age 18-40) with early pregnancy (4-23 weeks) with singleton or twins pregnancy that address to the "women e.r." due to vaginal bleeding. exclusion criteria: * age \>40 or \<18 * women with history of more then 3 abortions. * women with history of more then 2 pre term labor * ectopic pregnancy * placental previa * women who takes anticoagulation therapy * women with known pathology at cervix. * women with known uterus defect. pregnancies with chromosomal defects or birth defects that was discovered at the screening tests.

Keywords: post coital bleeding vaginal bleeding
neoadjuvant therapy for locally advanced rectal cancer

Conditions: Colorectal Cancer

Summary: this study aims to evaluate the clinical efficacy and safety of anlotinib in combination with penpulimab and conventional chemoradiotherapy for the neoadjuvant treatment of locally advanced rectal cancer

penpulimab 200mg iv d1 anlotinib 12mg p.o. qd d1-14 radiation therapy 1.8-2gy/50-55gy chemotherapy: capecitabine 800mg/m2 p.o. bid d1-d14, or capecitabine plus oxaliplatin 130mg/m2. every 21 days is 1 cycle in the above regimen, two cycles of targeted therapy (chemotherapy + immunotherapy + targeted therapy) are synchronized during radiotherapy; after the end of radiotherapy, two cycles of adjuvant chemo-immunotherapy (chemotherapy + immunotherapy) were continued.

Eligibility criteria:
inclusion criteria: -patient's age: 18 years old - 80 years old - * rectal cancer patients diagnosed with adenocarcinoma by pathological examination of primary biopsy * patients with no prior treatment, preoperative clinical stage: ct3-4n+m0 rectal cancer patients (ajcc 8th); * patients who agree to undergo radical surgical treatment and have no contraindications to surgery as judged by the surgeon; * no other multiple primary cancers; * at least 1 measurable or evaluable lesion according to the efficacy evaluation criteria for solid tumors version 1.1 (recist v1.1); * expected survival time≥ 3 months; * a score of 0-1 based on the united states eastern cooperative oncology group performance status score (ecog ps score); * the investigator plans to give pd-1 monoclonal antibody combined with chemotherapy treatment regimen after evaluation, and signs informed consent. exclusion criteria: * active, known or suspected autoimmune disease; * known history of primary immunodeficiency; * known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; * pregnant or lactating female patients; * patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc., requiring emergency surgery; * uncontrolled intercurrent illness including but not limited to: * people living with hiv (hiv antibody positive) * severe infections that are active or poorly clinically controlled * patients with active hepatitis * evidence of severe or uncontrolled systemic disease (e.g., severe psychiatric, neurological, epilepsy or dementia, unstable or incompensable respiratory, cardiovascular, hepatic or renal disease, uncontrolled hypertension \[i.e., greater than or equal to ctcae grade 2 hypertension despite medication\]). * patients with active bleeding or new thrombotic disease, taking therapeutic dose of anticoagulant drugs or bleeding tendency, abnormal coagulation function (inr\&gt;1.5×uln, aptt\&gt;1.5×uln); * those who are currently undergoing clinical trials of other drugs; * other patients who are considered by the investigator to be unsuitable for inclusion.
prostate cancer detection rate of targeted biopsies with pcavision

Conditions: Prostate Cancer

Summary: the primary objective is to demonstrate non-inferiority of the detection rate of clinically significant prostate cancer (cspca) in targeted biopsies based on pcavision imaging (pcavision pathway) in comparison with the detection rate of clinically significant cancer in targeted biopsies based on mri (mri pathway).

all patients will undergo imaging using mri and pcavision during which suspicious lesions will be identified based on each imaging technique independently with readers being blinded for the results of the other imaging technique. thereafter, a mri targeted 3-core biopsy per lesion (maximum of 2 lesions) and/ or a pcavision targeted 3-core biopsy (maximum of 2 lesions) will be performed by a one physician if suspicious lesions have been identified based on imaging. if lesions have been identified with both pcavision and mri in the same patient, the order of the targeted biopsies will be randomized. if the same lesion has been identified on both mri and pcavision, both a mri-targeted and a pcavision targeted biopsy will be separately performed. histological examination of the targeted biopsies will be performed to determine presence of clinically significant prostate cancer.

Eligibility criteria:
inclusion criteria: * be male * have an age of 18 years or older * be biopsy naïve * have a clinical suspicion of prostate cancer * be scheduled for evaluation by prostate mri based on a suspicious dre and/or elevated serum psa * have signed informed consent exclusion criteria: * active (urinary tract) infection or prostatitis * a patient history with a cardiac right-to-left shunt. * allergic to sulphur hexafluoride or any of the other ingredients of the ultrasound contrast agent sonovue * current treatment with dobutamine * known severe pulmonary hypertension (pulmonary artery pressure \>90 mmhg), uncontrolled systemic hypertension or respiratory distress syndrome * any (further) contraindication to undergo mri or 3d mpus imaging * incapable of understanding the language in which the patient information is given. * medical history of prostate surgery * treatment of 5 alpha-reductase inhibitors for at least 3 months

Keywords: contrast enhanced ultrasound ceus multiparametric ultrasound artificial intelligence mri
determination of the optimal spontaneous breathing trial during weaning of mechanical ventilation

Conditions: Intensive Care Unit; Invasive Mechanical Ventilation; Ready to Wean From Ventilation

Summary: assessment and comparison of three spontaneous breathing trials in five specific profiles of intensive care unit and perioperative patients. a physiological cross over study

mechanical ventilation is the most used organ replacement therapy in intensive care unit (icu). after resolution of acute illness, separating the ventilator from the patient may be specially challenging. before extubation, it is recommended to perform a spontaneous breathing trial (sbt) to evaluate the ability to sustain breathing with minimal or no support. the way to carry out this step of the weaning process present important variation across regions of the world. two techniques are preferentially used : the t-piece trial (oxygen supply without positive pressure) and low pressure support ventilation (psv) from 6 to 10 cmh2o according to the airway humidification device. the best strategy for successful weaning remains unknown, especially about specific subgroups of respiratory and neurological diseases. our aim is to assess which spontaneous breathing trial would best reproduce post-extubation inspiratory effort. we compare t-piece trial, psv 7 cmh2o without positive end expiratory pressure (peep) and psv 0 cmh2o without peep. five specific profiles are evaluated : chronic obstructive pulmonary disease (copd), severe brain injury, blunt thoracic trauma, post abdominal surgery and miscellaneous. the hypothesis is that t-piece trial and psv 0 cpap 0 trial are the best for mimic inspiratory effort after extubation. however, we could highlight various results according to different subgroups of icu patients. the final aim is to determine a personalized wean trial for each.

Eligibility criteria:
inclusion criteria: * icu patient with invasive mechanical ventilation for at least 24 hours * physician decision to extubate and all criteria for ventilatory weaning must be present * resolution of disease acute phase for which the patient was intubated * conscious patient (richmond agitation-sedation scale (rass) \> 0), no sedation * good coughing effort, good swallowing, positive leak test (\> 12% of tidal volume (vt)) * no important secretions * no respiratory acidosis, adequate oxygenation (pao2 / fio2 \> 150 mmhg and cpap ≤ 8) * adequate pulmonary function (respiratory rate (rr) ≤ 35, negative inspiratory force (nif) \> 20 cmh2o, rr/vt \< 105) * stable cardiovascular status (heart rate (hr) \ 90 mmhg, no or minimal vasopressors) * if severe brain injury, the visage score must be ≥ 3 (visual pursuit, good swallowing, gcs \> 10) exclusion criteria: * obese patients with bmi ≥ 35 kg/m2 * contraindication for nasogastric tube or esophageal manometric balloon placement * refusal of study participation or to pursue the study by the patient, no consent * pregnancy or breastfeeding * absence of coverage by the french statutory healthcare insurance system

Keywords: intensive care unit critical care mechanical ventilation weaning spontaneous breath trial rehabilitation