Kornimate/medical-research-clean huggingface dataset:
iterative beta testing of videos for the dipper academy

Conditions: Type1diabetes

Summary: the purpose of this research is to develop dipper academy, a parent-focused, mobile health (mhealth) behavioral intervention to promote glycemic control in young children.

because many young children with t1d have glucose levels that exceed targets, investigators need to develop efficacious, accessible, and readily disseminable interventions to help them to improve their glycemic control. to do this, the investigators need efficacious interventions that specifically address the challenges that parents of young children face in daily t1d management. providers need mhealth interventions that minimize barriers that parents experience when trying to access face-to-face or in clinic interventions. finally, interventions are needed that are packaged to be easily deployable by other diabetes centers. the investigator's proposed intervention, dipper academy, will include all of these recommended advancements.

Eligibility criteria:
inclusion criteria: * parents of a young child who is between 3-5.99 years old and at least 6 months post t1d diagnosis * parents who are english-speaking. exclusion criteria: * parents of young children with evidence of type 2 diabetes or monogenic diabetes. * parents with evidence of severe psychiatric disorder. * parents of young children with a comorbid chronic illness (e.g., renal disease) that requires ongoing care beyond t1d. * parents of young children with a history of anemia or medication use that may interact with glycemic control (e.g., systemic steroids).
a study of trastuzumab emtansine, paclitaxel, and pertuzumab in patients with her2-positive, locally advanced or metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: this phase ib-iia, multi-institutional, open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics and feasibility of trastuzumab emtansine (t-dm1) administered by intravenous (iv) infusion in combination with paclitaxel (and pertuzumab, if applicable) in patients with human epidermal growth factor receptor 2-positive (her2-positive), locally advanced or metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * histologically documented her2-positive locally advanced or metastatic breast cancer * tumor tissue blocks or 15-20 unstained tissue slides for confirmatory central laboratory her2 status testing and other exploratory assessments * prior trastuzumab in any line of therapy (phase ib patients only) * no prior t-dm1 or pertuzumab therapy * measurable or evaluable disease * cardiac ejection fraction \>=50% by either echocardiogram or multigated acquisition scan * life expectancy \>= 90 days as assessed by the investigator exclusion criteria: * fewer than 21 days since the last anti-tumor therapy, including chemotherapy, biologic, experimental, immune, hormonal or radiotherapy for the treatment of breast cancer, with the following exceptions: hormone-replacement therapy or oral contraceptives are allowed; palliative radiation therapy involving \ = 14 days prior to first study treatment * history of intolerance or hypersensitivity to trastuzumab and/or adverse events related to trastuzumab, murine proteins, or any of the excipients that resulted in trastuzumab being permanently discontinued * peripheral neuropathy of grade \>= 2 per nci ctcae, version 3.0, at the time of, or within 3 weeks prior to, the first study therapy (phase ib patients) * peripheral neuropathy of grade \>/=1 per nci ctcae, version 3.0, at the time of, or within 3 weeks prior to, the first study therapy (phase iia patients) * history of exposure to the following cumulative doses of anthracyclines: doxorubicin \> 500 mg/m\^2; liposomal doxorubicin \> 900 mg/m\^2; epirubicin \> 720 mg/m\^2 * history of clinically significant cardiac dysfunction * brain metastases that are untreated, or progressive, or have required any type of therapy (including radiation, surgery, or steroids) to control symptoms from brain metastases within 60 days prior to the first study treatment. * history of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, basal cell carcinoma, or synchronous or subsequent her2-positive breast cancer or other malignancy with a similar expected curative outcome

Keywords: trastuzumab dm1 (t-dm1) trastuzumab emtansine armed herceptin her2 her2+ her2 positive breast cancer
cystic fibrosis reproductive and sexual health collaborative: building online research partnerships

Conditions: Cystic Fibrosis; Patient Engagement

Summary: this is a patient-centered outcomes research institute engagement effort aimed at training researchers/providers and patients to work in research teams together online throughout the research process (including: development, design, and dissemination) to address critical gaps in their care. this is a change from the typical research done with people with cf as they are frequently isolated from other members of the cf community because of infection control guidelines that restrict in-person contact to avoid the spread of bacteria between patients. this project has four aims: 1. build capacity for pcor knowledge and skills applicable for longitudinal online engagement, 2. create and disseminate a best practices pcor user guide for populations that solely engage online, 3. to create an interactive web-based version of our user guide through a survey and three modified delphi rounds, and 4. to create a comprehensive training manual for conducting pcor online (step-by-step instructions), which will incorporate the aforementioned user guide.

the cf reproductive and sexual health collaborative (cfreshc) will introduce and support patient-centered outcomes research (pcor) to the greater cf community using existing pcor training products and adapt them so that they address key issues related to researcher-patient teams that solely engage online. we will create a best-practices user guide for online engagement by performing key-informant interviews with patient- or community-engaged teams and periodic assessments of day-to-day platform use with cfreshc members and other pcor teams. this project has four aims: 1. build capacity for pcor knowledge and skills applicable for longitudinal online engagement, 2. create and disseminate a best practices pcor user guide for populations that solely engage online, 3. to create an interactive web-based version of our user guide through a survey and three modified delphi rounds, and 4. to create a comprehensive training manual for conducting pcor online (step-by-step instructions), which will incorporate the aforementioned user guide.

Eligibility criteria:
inclusion criteria: * any interested adult cf patients, cf caregivers, researchers or healthcare providers can be included in the online patient-engagement training program. any interested patients/community members and researchers/providers involved in patient-centered outcomes reserach teams that engage online can be included for the online platform interviews. exclusion criteria: * persons less than 18 years of age

Keywords: cystic fibrosis education patient engaged research training evaluation patient
effect of the sensory integration approach on balance and motor coordination in children with down syndrome

Conditions: Down Syndrome

Summary: down syndrome can be characterized by global mental and physical dysfunction or isolated gait, cognition, growth, or sensory disturbances. this study was conducted to investigate the effect of the sensory integration approach on improving balance and motor coordination in children with down syndrome.

thirty children were enrolled in this study and randomly assigned to two groups: group a received (sensory integration therapy program and training in physical therapy) and received group b (physical therapy training program only). motor coordination and balance were assessed before and after exercise for all children using bruininks - oseretsky test of motor proficiency - 2nd edition.

Eligibility criteria:
inclusion criteria: * children with down syndrome * the ages of five and ten years who can walk * their iq is more than 75% exclusion criteria: * they had a serious neurological disorder (epilepsy), orthopedic problems, upper or lower limb surgery, vision or hearing problems, use of medications that impair behavior or attention, and suffered from advanced intellectual disability

Keywords: trisomy 21, neurodevelopmental disorder
extension study of nt-501 ciliary neurotrophic factor (cntf) implant for macular telangiectasia (mactel)

Conditions: MacTel (Macular Telangiectasia) Type 2

Summary: this was a prospective, multicenter, single-masked, sham-controlled extension study designed to provide long-term safety and efficacy follow-up data for subjects with mactel who had nt-501 implanted intraocularly and/or underwent sham surgery in the respective precursor study (ntmt-01 or ntmt-02). a substudy was conducted in which subjects enrolled in study (ntmt-02), who had 1 study-eligible eye that underwent sham surgery, were offered the option to have nt-501 implanted in the same study eye. of the 19 subjects who had 1 study-eligible eye and underwent sham surgery in the cohort 2 precursor study (ntmt-02), 16 subjects elected to have nt-501 implanted in the same study eye during the substudy


Eligibility criteria:
inclusion criteria: * previously enrolled in the ntmt-01 or ntmt-02 protocol and received the nt-501 implant and/or underwent a sham procedure * participant must be offered sufficient opportunity to review and to understand the informed consent form, agree to the form's contents, and provide written informed consent. exclusion criteria: * there are no exclusion criteria
impact of coronary sinus flow reducer on coronary microcirculation and myocardial ischemia

Conditions: Coronary Artery Disease; Angina Pectoris

Summary: the increasing number of coronary revascularization procedures, coupled with improvements in drug therapy, has significantly extended the lifespan of patients with coronary artery disease (cad). however, there remains a significant number of cad patients who experience disability due to chronic refractory angina pectoris. these patients typically have severe diffuse cad and are not candidates for further revascularization involving surgical coronary artery bypass grafting (cabg) or percutaneous coronary intervention (pci). the installation of a coronary sinus reducer (csr) represents a new option for percutaneous treatment of patients with refractory angina pectoris who are not suitable for surgical or percutaneous revascularization. the csr device is designed as an hourglass-shaped stent that is positioned transcatheterally in the distal part of the coronary sinus. this increases intramyocardial venous pressure, which is believed to lead to a more favorable perfusion ratio between the ischemic subendocardial and non-ischemic subepicardial myocardium. previous research has demonstrated that the implantation of csr is a safe and relatively straightforward procedure. however, broader implementation and better patient selection are still limited by the fact that the exact mechanism of action remains controversial. it has not been determined why some patients have better outcomes compared to others with seemingly similar coronary artery disease. it is known that patients with atherosclerotic changes in the epicardial coronary arteries also have a certain degree of coronary microcirculation disease (the coronary vascular bed encompassing vessels with a diameter \< 200 μm), which cannot be assessed through standard coronary angiography. this study aims to assess changes in coronary microcirculation after the implantation of csr by measuring coronary flow reserve (cfr) and index of microcirculatory resistance (imr) before and 6 months after the procedure. furthermore, our goal is to associate these changes with clinical symptoms and myocardial ischemia.


Eligibility criteria:
inclusion criteria: * patients with coronary artery disease and refractory angina pectoris who are ineligible for coronary revascularization * signed informed consent exclusion criteria: * severely reduced systolic ejection fraction of the left ventricle (ef \< 35 %) * severe renal impairment (egfr \< 30ml/min/1.73m2) * severe chronic obstructive pulmonary disease (gold d) * contraindication for application of papaverine or regadenoson

Keywords: coronary sinus reducer myocardial ischemia coronary microcirculation
effect of weight and/or obesity on caspofungin drug concentrations

Conditions: Obesity; Fungal Infection

Summary: this study will find how weight affects the dosing of a drug called caspofungin. currently, the amount of caspofungin a patient receives is the same regardless of the patient's weight.


Eligibility criteria:
inclusion criteria: * male and female subjects, age 18 years of age or older, of all racial and ethnic origins. english and/or spanish speaking volunteers are eligible to participate. exclusion criteria: * pregnant or nursing or unwilling to use a reliable contraception method during the study. the effects of caspofungin on pregnancy are unknown. in addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of caspofungin, so that the pregnancy and post-partum state would be a confounding variable. * abnormal liver function tests: transaminases\>10 times upper limit of normal, alkaline phosphatase\>5 times upper limit of normal, total bilirubin\>5 times upper limit of normal. * history of allergies to echinocandins. * echinocandins are contraindicated for any reason. * volunteers unwilling to comply with study procedures. * suspected or documented systemic fungal infection. * concomitant use of rifamycins, tacrolimus, or cyclosporine

Keywords: echinocandin obesity pharmacokinetics pharmacodynamics fungal infection
exercise in patients admitted with recently decompensated heart failure

Conditions: Decompensated Heart Failure; Functional Cardiac Disorder

Summary: an aerobic physical exercise protocol will be applied to patients admitted in ward due to decompensated heart failure, in order to validate the efficacy and safety of physical exercise in this phase of clinical stabilization, through the said training protocol - eric program.

with the objective of validating the efficacy and safety of physical exercise as a therapeutic resource in patients admitted for decompensated heart failure; will be applied, by rehabilitation nurses, a protocol of physical exercise, with increasing levels of intensity. patients who meet the inclusion criteria will be randomized through an online program (randomizer.org) and the eric protocol will be applied to the test group. the control group will be implemented the usual care of rehabilitation nursing. the eric protocol comprises 5 levels of intensity, as following shown: stage 1 - respiratory and calisthenic exercises (5-10 minutes) stage 2 - pedaler for 5-10 minutes stage 3 - aerobic training: walking on the corridor for 5-10 minutes stage 4 - aerobic training: walking on the corridor for 10-15 minutes stage 5 - aerobic training: walking on the corridor for 15 minutes + climbing stairs for 5 minutes all patients will be monitored and followed up by a rehabilitation nurse while they are doing the exercise. the investigator decides, depending on the patient's performance and clinical conditions, the form of progression in the program, but it is mandatory to follow the previously defined levels of intensity. patients in the test group may start the program only on stage i or ii according to clinical criteria. at admission of the patients (test group and control group) clinical and sociodemographic parameters are evaluated, as well as data related to barthel's indices and london chest of activities of daily living (lcadl). at the discharge date, the barthel index and the lcadl scale will also be evaluated, as well as the 6-minute walking test.

Eligibility criteria:
inclusion criteria: * admission diagnosis of decompensated heart failure * more than 18 years old * capacity to provide informed consent exclusion criteria: * osteoarticular pathology that impedes the performance of the exercise; * existence of inotropic infusions; * dysrhythmia or precordial pain in the last 24 hours, * acute pulmonary edema in the last 12 hours, * sbp greater than 180mmhg or less than 80 mmhg (except in cases where this is the baseline value for the patient), * need for oxygen at a rate greater than 3 l / min, * glycemic decompensation in the last 12 hours,

Keywords: exercise nursing rehabilitation functional capacity heart failure
a randomized, double blind trial of ldt (telbivudine) versus lamivudine in adults with compensated chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: this study is being conducted to compare the safety and effectiveness of the investigational medication, ldt (telbivudine) with lamivudine, a drug currently approved by the us, european and asian health authorities for the treatment of hepatitis b infection. the results for patients taking ldt will be compared to results for patients taking lamivudine.


Eligibility criteria:
inclusion criteria: * chronic hepatitis b, documented by clinical history compatible with chronic hbv other protocol-defined inclusion criteria may apply. exclusion criteria: * patient is pregnant or breastfeeding * patient is co infected with hepatitis c virus (hcv), hepatitis d virus (hdv), hiv-1 or hiv-2. * patient previously received lamivudine or an investigational anti-hbv nucleoside or nucleotide analog at any time * patient has received interferon or other immunomodulatory treatment for hbv infection in the 12 months before screening for this study other protocol defined exclusion criteria may apply.
clinical performance of the asqelio™ trifocal diffractive intraocular lens

Conditions: Cataract

Summary: the goal of this observational study is to evaluate whether the asqelio™ trifocal intraocular lens (iol) can improve refractive outcomes and optical quality in patients (aged ≥45 years) undergoing cataract surgery or clear lens exchange, including both male and female participants. the main questions it aims to answer are: * does the asqelio™ trifocal iol provide accurate refractive correction with minimal residual refractive error? * does the lens reduce light distortion and provide good visual acuity at multiple distances (far, intermediate, near)? researchers will not use a comparison group, as this is a post-marketing, single-arm observational study. participants will undergo bilateral implantation of the asqelio™ trifocal iol during cataract or lens replacement surgery and attend a study follow-up exam approximately 270±90 days post-surgery. complete evaluations including: * manifest refraction testing * uncorrected and corrected visual acuity at far, intermediate, and near distances * binocular defocus curve analysis * contrast sensitivity testing * light distortion analysis using a light distortion analyzer * patient-reported outcomes via the catquest-9sf and visual symptoms questionnaires.


Eligibility criteria:
inclusion criteria: * patients 50 years of age or older undergoing cataract surgery by phacoemulsification and binocular iol implant asqeliotm trifocal tflio130c * independence of use of glasses after surgery. * iol power between +5.0d and +34.0d * transparent intraocular media except for cataracts in both eyes. * potential postoperative visual acuity of 20/25 or better. exclusion criteria: * preoperative corneal astigmatism greater than 1.0d * previous corneal surgery or trauma. * irregular cornea (e.g. keratoconus) * choroidal hemorrhage * microphtalmos * severe corneal dystrophy * uncontrolled or medically controlled glaucoma * clinically significant macular changes * concomitant severe eye disease * non-age-related cataract * severe optic nerve atrophy * diabetic retinopathy * proliferative diabetic retinopathy * amblyopia * extremely shallow anterior camera * severe chronic uveitis * pregnant or nursing * rubella * mature/dense cataract that makes it difficult to examine the eye fundus preoperatively. * previous retinal detachment * concurrent participation in other research with drugs or clinical devices

Keywords: multifocal iol optical quality visual performance
clinical trial of lupeol for mild-moderate acne

Conditions: Acne

Summary: for the chemical lupeol isolated from eggplant, we applied it to one side of face, and applied vehicle control to another side for 8 -weeks. the study was performed in a 8-week, randomized controlled, split face fashion. investigators evaluated safety and efficacy during baseline, 2 weeks, 4weeks, and 8 weeks after beginning of study.


Eligibility criteria:
inclusion criteria: * patients over the age 15 who were clinically diagnosed with mild to moderate acne vulgaris exclusion criteria: * ; known pregnancy or lactation, any medical illness that might influence the results of the study, a previous history of oral acne medication or surgical procedures including laser treatment within 6 month and topical medication within 4 weeks of study enrollment.

Keywords: medication
a study to understand the treatment patterns in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension during a switch of treatment to adempas in real-life clinical practice

Conditions: Hypertension, Pulmonary

Summary: the aim of this study is to understand the treatment patterns in patients with pulmonary arterial hypertension (pah) or chronic thromboembolic pulmonary hypertension (cteph) during a switch of treatment to adempas in real-life clinical practice. in addition, this study will describe patient demographics and reason for switching


Eligibility criteria:
inclusion criteria: - female and male adult patients diagnosed with pah or inoperable/recurrent/persistent cteph who have been switched from a ph treatment (i.e. endothelin receptor antagonist(eras), phosphodiesterase-5 inhibitor(pde5i) or prostacyclin analog (pca) to adempas exclusion criteria: * patients participating in an investigational program with interventions outside of routine clinical practice * patients who have not switched their therapy from an endothelin receptor antagonist (era) or prostacyclin analog (pca) but received adempas purely as an add-on therapy

Keywords: pulmonary arterial hypertension inoperable chronic thromboembolic pulmonary hypertension persistent chronic thromboembolic pulmonary hypertension recurrent chronic thromboembolic pulmonary hypertension switch of therapy titration phase retrospective chart review