Kornimate/medical-research-clean huggingface dataset:
a study into the future cardiovascular disease (cvd) risk of phenylketonuria (pku) patients on a low phenylalanine treatment diet (lpd).

Conditions: Phenylketonurias; Cardiovascular Diseases

Summary: this study will assess the cardiovascular disease (cvd) risk in phenylketonuria (pku) patients on a low-phenylalanine diet (lpd). ultrasound tests, diet information and routine blood samples will be collected once per patient at their next outpatient appointment. 32 adults with pku will be studied and compared to reference data for healthy people. the results will show if the pku cvd risk differs from healthy people, and if cvd risk varies within people with pku.

cardiovascular disease (cvd) is the largest cause of deaths worldwide each year. many factors affect cvd including diet, genetics, exercise and smoking. it is unclear if phenylketonuria (pku) and the low-phenylalanine diet (lpd) affect cvd risk. cvd risk can be predicted by measuring the thickness of the artery wall in the neck which supplies blood to the head. thickness is measured using a non-invasive, safe ultrasound test (similar to pregnancy jelly scans). a wall thicker than normal indicates an increased cvd risk. a wall thinner than normal indicates a lower cvd risk.

Eligibility criteria:
inclusion criteria: * phenylketonuria patients at guys and st thomas' centre for inherited metabolic diseases, who have a diagnosis of phenylketonuria at birth (following the introduction of the newborn screening programme), and who are over the age of 18 will be invited to take part in the study. * the study will only include patients diagnosed at birth, which will allow a better assessment of the effects of the diet, which are not influenced by a late diagnosis and a prior diet which is not low-phenylalanine. exclusion criteria: * phenylketonuria patients at guys and st thomas' centre for inherited metabolic diseases, who have a diagnosis of phenylketonuria after birth (not diagnosed during newborn screening), will be excluded from taking part in the study. * if patients are pregnant, or plan to be pregnant during the study they will also be excluded. * patients with a previous history of cardiovascular disease, and/or a history of cardiovascular disease in their immediate family will also be excluded. * patients that are unable to understand and consent to the study (i.e. due to language issues or lacking capacity) will also be excluded.

Keywords: pku cvd cardiovascular disease risk
phase ii study of medi4736 monotherapy or in combinations with tremelimumab in metastatic pancreatic ductal carcinoma

Conditions: Metastatic Pancreatic Ductal Adenocarcinoma

Summary: a phase ii open-label, multi-center study of medi4736 evaluated as single agent or in combination with tremelimumab in patients with metastatic pancreatic ductal adenocarcinoma.

this is a phase ii, open-label, multi-center study to determine the efficacy and safety of medi4736 evaluated as single agent or in combination with tremelimumab in patients with metastatic pancreatic ductal adenocarcinoma (pdac) whose disease has progressed on fluoropyrimidine containing or gemcitabine-containing first-line chemotherapy.this study will consist of part a, lead-in, as well as a possible expansion part b.

Eligibility criteria:
inclusion criteria: - 1. histologically or cytologically confirmed metastatic pdac, no more than 1 prior chemotherapy regimen 2. eastern cooperative oncology group 0 or 1 3. at least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with computed tomography (ct) or magnetic resonance imaging (mri) scan and that is suitable for accurate repeated measurements exclusion criteria: 1. any concurrent chemotherapy, investigational product , biologic, or hormonal therapy for cancer treatment. 2. history of leptomeningeal carcinomatosis 3. ascites requiring intervention 4. brain metastases or spinal cord compression.

Keywords: pancreatic ductal adenocarcinoma, pdac
effects of a zumba dance program for postmenopausal women with metabolic syndrome

Conditions: Metabolic Syndrome

Summary: the aim of this study is to examine the effects of a 12-week zumba dance intervention on fitness, anthropometric and psychometric parameters and eating behavior.


Eligibility criteria:
inclusion criteria: * postmenopausal women (age 45-65) * waist of \>94 cm or bmi \> 30kg/m2 * not physically active \>1x/week for 20 minutes * written consent before the start of the study exclusion criteria: * involvement in other clinical studies * unable to participate at the dance lessons * medical contraindications for the intervention or increased risk for exercise participation

Keywords: cardiorespiratory fitness weight quality of life depression menopausal symptoms exercise barriers executive functions
a study of hrs-9057 in patients with heart failure and volume overload

Conditions: Heart Failure With Volume Overload

Summary: the study is an open-label, tolvaptan-controlled phase i study to evaluate the safety, tolerability, pk/pd profile and efficacy of hrs-9057 in the treatment of heart failure with volume overload. a total of 24 subjects who experience volume overload due to heart failure despite diuretic treatment will be enrolled in the study and receive hrs-9057 injection or tolvaptan tablets.


Eligibility criteria:
inclusion criteria: 1. male or female, age 18-70 years at the time of signing informed consent. 2. diagnosed as chronic heart failure at least 1 month prior to screening. 3. patients with chf in whom lower limb edema, pulmonary congestion, jugular venous distension or hepatomegaly due to volume overload is present despite diuretics treatment. exclusion criteria: 1. medical history of myocardial infarction, acute decompensated heart failure, stroke, or transient ischemic attack within 30 days prior to or at screening; 2. hypovolemic hyponatremia.
communityrx for hunger: a hospital-based intervention

Conditions: Food Insecurity; Caregivers; Clinical Trial; Hunger; Health-Related Quality of Life; Patient Satisfaction

Summary: the goal of this research program is to reduce health disparities by deploying an information-based intervention to increase caregiver utilization of community-based food supports and satisfaction with care among food insecure caregivers of hospitalized children. we will conduct a randomized controlled trial to evaluate, versus usual care, the effects of the communityrx-h intervention on caregiver use of food resources (primary), caregiver patient satisfaction with care (primary), caregiver mental health-related quality of life (secondary), and caregiver household food security (secondary). the proposed research will yield an understanding of how to leverage a child's hospitalization to effectively intervene on the problem of food insecurity. findings will inform the rapidly growing field of healthcare-based interventions to address health-related social needs.


Eligibility criteria:
inclusion criteria: * at least 18 years old * english-speaking * living in 1 of the 16 zip code target regions * self-identify as a primary caregiver of a child \<18 years old hospitalized in cch's general, intensive care or transplant units exclusion criteria: * recollection of previous receipt of a healtherx
accuracy of babysat v3 with profound hypoxia and motion

Conditions: Hypoxia

Summary: performance testing of pulse oximeters. the protocol involves brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained and during different motion scenarios. the blood sample is analyzed for oxygen saturation with a gold standard bench co-oximeter. this protocol is aligned with the latest iso and fda guidance documents for pulse oximeter testing.


Eligibility criteria:
inclusion criteria: * the subject is male or female, aged ≥18 and \<50 * the subject is in good general health with no evidence of any medical problems * the subject is fluent in both written and spoken english * the subject has provided informed consent and is willing to comply with the study procedures exclusion criteria: * the subject is obese (bmi\>30). * the subject has a known history of heart disease, lung disease, kidney or liver disease. * diagnosis of asthma, sleep apnea, or use of cpap. * subject has diabetes. * subject has a clotting disorder. * the subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation. * the subject has any other serious systemic illness. * the subject is a current smoker. * any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly. * the subject has a history of fainting or vasovagal response. * the subject has a history of sensitivity to local anesthesia. * the subject has a diagnosis of raynaud's disease. * the subject has unacceptable collateral circulation based on exam by the investigator (allen's test). * the subject is pregnant, lactating or trying to get pregnant. * the subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures. * the subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.
comparison of two techniques in gingival recession treatment. one-year clinical follow-up study

Conditions: Gingival Recession

Summary: 42 patients were treated either with e-ctg (n=20) or scaf (n=22). the recordings included clinician-based (recession depth, recession width, probing depth, clinical attachment level, keratinized tissue width, tissue thickness, clinical attachment gain (cag), root coverage (rc), keratinized tissue change (ktc)) and patient-based (wound healing index (whi), dentine hypersensitivity (dh), tissue appearance, patient expectations and aesthetics) parameters that were taken at baseline, t1 (sixth week), t2 (sixth month) and t3 (first year).


Eligibility criteria:
inclusion criteria: * single miller i gr defects ≤3mm at upper anterior or premolar teeth * systemically healthy * identifiable cemento-enamel junction (cej) * pd ≤3 mm exclusion criteria: * periodontal surgery experience in the past two years * excessive contacts * mobility * caries * loss of vitality * smoking * pregnancy
left atrial function analysis for patients with persistent atrial fibrillation undergoing pulmonary vein isolation

Conditions: Persistent Atrial Fibrillation; Catheter Ablation

Summary: this prospective observational study is designed to describe the factors determining the success of pulmonary vein isolation (pvi) for patients with persistent atrial fibrillation (af). these factors - described as left atrial (la) function - are simultaneously studied by multi-modal techniques in patients undergoing radiofrequency ablation. the simultaneous measurements are conducted before the pvi in af and after the sinus rhythm converted due to pvi. these measurements include invasive la pressure monitoring, la voltage map creation, la strain evaluation by transthoracal echocardiography, la scar-mapping by cardiac mri, defining biomarkers from blood samples. during the one year follow-up period rhythm monitoring is conducted by regular holter-monitoring. our aim is to define the predictive values of the above mentioned factors and to create a new score system for predicting pvi success in persistent af population.


Eligibility criteria:
inclusion criteria: * documented, symptomatic persistent atrial fibrillation (af) * catheter ablation is indicated * aged 18-75 years * signed patient informed consent form * able and willing to comply with all pre-, post-, and follow-up testing and requirements exclusion criteria: * secondary af * paroxysmal, long-standing persistent or permanent af * ejection fraction \< 30% * gfr \<30 ml/min/1.73m2 * unstable angina pectoris or myocardial infarction within the past 2 months * severe heart failure (nyha iv) * severe copd (gold iii-iv) * previous left atrial catheter ablation * previous transthoracic cardiac surgery * implanted cardiac device (pacemaker, icd, crt, vad) * awaiting cardiac transplantation or other cardiac surgery within the next 12 months * any contraindication for pulmonary vein isolation, mri or anticoagulation * coagulopathy * active malignancy, left atrial myxoma * autoimmune disorder, chronic inflammatory disease * acute illness, active systemic infection, sepsis * women who are pregnant, breast feeding, or planning to become pregnant in the next 12 months * aged under 18 years or above 75 years * enrollment in other studies, which exclude participation in other studies * patient not willing or not able to sign the informed consent form

Keywords: persistent atrial fibrillation pulmonary vein isolation catheter ablation left atrial function left atrial pressure voltage map strain scar success biomarker
web system for engaging families & doctors in continuous asthma quality improvement

Conditions: Asthma

Summary: asthma, one of the most common pediatric illnesses, is optimally managed according to national heart lung and blood institute (nhlbi) guidelines yet this is not often done in primary care. this project is to develop and test the effects of using a module for guideline based care in the child health and development interactive system (chadis) online system by prompting and incorporating patient symptom/control and adherence data from standard questionnaires to inform visits and providing automated patient specific education and asthma action plans in individual care portals.

we will complete the formative work collecting professional opinion to create and pilot the initial chadis asthma intervention module (chadis-ai), an innovative decision support system. chadis-ai content will be assembled and vetted by asthma experts and primary care providers (pcps). parent and teen focus groups will vet the content and language of the adherence materials and care portal. a system will also be established for points for patient participation, to give clinicians maintenance of certification (moc) credit, and ongoing run chart reports of their patients' asthma status for continual quality improvement (qi) feedback. the resulting system will be pilot tested and refined by clinician feedback. practices will be randomly assigned to intervention vs control. control practices will use chadis for asthma care without the a-i module. intervention practices will be further randomized to have remote coach support for patients or not. outcomes will be examined of asthma severity/control, match of severity with guideline based medication management, numbers of emergency department (ed) visits, hospitalizations and oral steroid use. effect of remote coaching will also be assessed.

Eligibility criteria:
inclusion criteria: * asthma diagnosis exclusion criteria: * not english or spanish speaking
evaluation of a medication health center to promote opioid safety

Conditions: Overdose

Summary: this study will assess the impact of an opioid safety clinic intervention for patients prescribed chronic opioid therapy. outcomes are visits to the clinic, naloxone dispensings, prescription drug monitoring reviews, and urine drug screens conducted

given ongoing concerns about the risk of opioid overdose among people taking chronic opioid therapy for pain, kaiser permanente colorado (kpco) sought to develop a standardized approach to promote opioid safety. operational stakeholders adapted an existing opioid safety clinic model, tailored it for kpco's context, and implemented it in three geographically dispersed kpco clinics with leadership support. the approach was a multidisciplinary "medication health center" to assess patients, educate them about overdose risk, provide naloxone, and ensure adherence to standard monitoring. operations and the research team then collaborated to assess the effectiveness of the program to inform decisions to scale the program to other regions.

Eligibility criteria:
evaluation population: 1. eligible clinics 2. patients prescribed chronic opioid therapy eligibility criteria for clinics: 1. clinic leadership willing to be randomized to order of implementation 2. not a pilot location eligibility for an mhc visit included the following: 1. patients in the kpco chronic opioid registry 2. no primary care physician (pcp) or mhc visit in the past 6 months 3. not managed by the integrated pain service, a specialty pain service that takes care of the highest risk and most complex pain patients patients enter the chronic opioid registry if they fulfill any of the following criteria: * 2 opioid fills in the last 90 days; fills should be separated by 27 days, or * 1 opioid fill with pill number ≥100 pills in the last 90 days, or * 1 long-acting/extended-release opioid fill in the last 90 days

Keywords: naloxone opioids safety
patient education in preventing nausea and vomiting in cancer patients receiving chemotherapy

Conditions: Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: patient education may improve the effectiveness of ondansetron in preventing nausea and vomiting in patients receiving chemotherapy. purpose: this randomized clinical trial is studying how well patient education works in preventing nausea and vomiting in cancer patients receiving chemotherapy.

objectives: i. determine whether an educational intervention to enhance the effectiveness of ondansetron can prevent acute postchemotherapy nausea and emesis in cancer patients. ii. assess any potential effectiveness of the intervention on delayed postchemotherapy nausea and emesis in these patients. iii. examine the effect of the intervention on patient expectations. outline: this is a randomized, double blind, multicenter study. patients are stratified by center and chemotherapy agent (cisplatin vs carboplatin vs doxorubicin). patients are randomized to one of two treatment arms. arm i: patients receive standard educational materials. arm ii: patients receive specific intervention material in addition to standard educational materials. patients then complete a patient information questionnaire. patients receive ondansetron orally or iv over 10-15 minutes in addition to the first 2 courses of chemotherapy. patients complete a nausea and emesis questionnaire after each of their first 2 chemotherapy treatments. projected accrual: a total of 300 patients (150 per treatment arm) will be accrued for this study.

Eligibility criteria:
disease characteristics: chemotherapy naive with diagnosis of any cancer scheduled to receive chemotherapy containing cisplatin, carboplatin, or doxorubicin patient characteristics: age: 18 and over performance status: not specified life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified prior concurrent therapy: see disease characteristics

Keywords: nausea and vomiting unspecified adult solid tumor, protocol specific
effects of kinesiotaping with and without pelvic tilts in dysmenorrhea

Conditions: Dysmenorrhea

Summary: this study aims to determine the effects of kinesiotaping with \& without pelvic tilts on pain \& menstrual distress in females with dysmenorrhea. this study will be a randomized controlled trial to compare the effectiveness of kinesiotaping with and without pelvic tilts in subjects with primary dysmenorrhea.

this study will be a randomized controlled trial to compare the effectiveness of kinesiotaping with and without pelvic tilts in subjects with primary dysmenorrhea. subjects with primary dysmenorrhea meeting the predetermined eligibility criteria will be divided into two groups using the random sequence generation method. pre-intervention responses shall be taken during the first menstrual cycle using the numeric pain rating scale, wallid tool \& menstrual distress questionnaire. subjects in group a shall be treated with kinesiotaping and pelvic tilts while subjects in group b shall be treated with kinesiotaping only. each subject will receive 02 treatment sessions during the second \& third menstrual cycles. post-intervention responses shall be recorded in the fourth menstrual cycle using the numeric pain rating scale, wallid tool \& menstrual distress questionnaire.

Eligibility criteria:
inclusion criteria: * age 18-30 years * nulliparous * regular menstrual cycles * primary dysmenorrhea (diagnosed via wallid tool) exclusion criteria: * allergic to kinesiotape * skin disorders * uterine fibroids * endometriosis * polycystic ovarian syndrome

Keywords: dysmenorrhea active stretching kinesiotape
retinal imaging with oblique illumination

Conditions: Retinal Disease

Summary: retinal diseases are the major cause of blindness in industrialized countries and while tremendous effort is made to develop novel therapeutic strategies to rescue retinal cells, optimal means to evaluate the effects of such treatments is still missing. nowadays, diseases diagnosis and treatment monitoring are performed thanks to imaging devices and functional measurements (visual acuity of visual field tests). these eye examinations lead to the detection of large scale damages of the retinal tissue, i.e. the diagnosis is made too late or the treatments cannot be adapted in time. with the developed technology, the goal is to provide a tool to the ophthalmologists that allow for better treatment monitoring and early diagnosis. indeed, the technology is able to image the retinal tissues with a ten times more detailed visualization as compared to the standard of care (oct instruments, slo instruments or eye fundus cameras). towards this goal, we designed the present protocol in order to test the technology with a clinical prototype (cellularis version 1) in a clinical environment. the objective is to describe and quantify at the cellular level the retina of patient affected by different retinal diseases as well as the healthy retina of people with different ages. we will assess the repeatability of the instrument and compare the results of the measurements with images obtained with the standard of care (oct and slo images).


Eligibility criteria:
inclusion criteria: group 1 * individuals, 18 to 50 yo, with normal eye fundus. * emmetropic or ametropic between +3d and -3d group 2 * individuals, 18 to 50 yo, with normal eye fundus. * myopic between -6d and -12d. group 3 * individuals over the age of 50 and age-matched to patients with amd. * with nwith normal eye fundus. * astigmatic, myopic (\<-12d) or presbyopic participants may be included group 4 * patient over 50 yo, with early or intermediate amd, including extrafoveolar geographic atrophy * with visual acuity ≥ 0.6 and clinical judgment of good central fixation. group 5 * patient over 18, with other retinopathy than amd, * with visual acuity ≥ 0.6 and nd clinical judgment of good fixation exclusion criteria: eye with * rpe detachment * a clinically unclear situation * abnormality preventing good visualization of the fundus * less than 3 months post-surgery of the anterior segment * less than 6 months post-surgery of the posterior segment * active uveitis - myopia ≥12d, hyperopia \> +5d, astigmatism \> 4d * contraindication to dilatation * a palpebral opening that is less than 6 mm in height individual: * albino - unable to fix a target at least 10 seconds * who does not tolerate being in the dark for 30 minutes * unable to follow the procedures of the study * refusing to be informed of the incidental discovery of a clinically significant pathology investigators of the study, their family members, collaborators and students