Kornimate/medical-research-clean huggingface dataset:
model 4396 left ventricular (lv) lead study

Conditions: Heart Failure

Summary: this study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe and effective. using a lead on the left side of the heart has been shown to potentially improve heart failure symptoms. the shape and size of this new lead may make it a good choice for patients or physicians.

this study is a prospective, multi-center, non-randomized design. all consented patients who meet all inclusion and no exclusion criteria may receive the investigational lead. the study design has statistical power to show safety at one-month after implant. it also has statistical power to show effectiveness at one-month and three-months after implant.

Eligibility criteria:
inclusion criteria: * crt/cardiac resynchronization therapy-defibrillator (crt-d) indications, new york heart association (nyha) iii and iv, indicated for implantable cardiac defibrillator (icd) if crt-d is implanted, patient consent, geographically stable exclusion criteria: * lv lead implant attempt in last 30 days, unstable angina or acute myocardial infarction (mi) in past 30 days, coronary artery bypass graft (cabg) or percutaneous transluminal coronary angioplasty (ptca) in past 3 months, contraindicated for transvenous pacing, heart transplant

Keywords: heart failure cardiac pacing cardiac resynchronization therapy left ventricular lead
effect of novel nasoalveolar molding techniques on parents' satisfaction and short term treatment outcomes in unilateral cleft lip and palate infants: a randomized controlled trial

Conditions: Cleft Lip and Palate

Summary: the aim of this trial is to figure out the efficiency of modified grayson nam on parents' satisfaction, nasal esthetics, interlabial gap and maxillary arch changes. nam might improve and facilitate the surgical procedure after lip closure. this might decrease the need of further interventions to improve esthetics and function of clp patients. this trial will help the patients and practitioners in taking the decision of inclusion of nam in the clp treatment protocol as a mandatory step or skip a useless procedure with all of its burden.

in this randomized trial, 4 groups will be included. the first group will receive a modified nasoalveolar molding appliance in addition to taping. in the second group, the patient will receive the cad/nam. the third group is tape only, while the fourth group remain untreated. the follow-up period will be 3 months till surgical lip closure. the assessment will be through a questionnaire for the parents' satisfaction outcome, photographs for nasal esthetics and interlabial gap outcome and maxillary models for the maxillary dimension change outcome.

Eligibility criteria:
inclusion criteria: 1. infants with age range from 7 - 30 days. 2. unilateral complete cleft lip and alveolus. 3. presence of unilateral cleft palate. 4. medically free subjects. 5. both males and females. exclusion criteria: 1. patients older than 30 days. 2. syndromic patients with other defects in addition to cleft lip and palate. 3. patients with bilateral cleft lip and palate. 4. incomplete cleft lip. 5. medically compromised patients.
evaluation of niche programme activities in kenya

Conditions: Growth Disorders; Malnutrition

Summary: this study evaluates the impact of additional cash and nutritional counselling on nutrition outcomes in pregnant women and children up to the age of two years in ct-ovc (cash transfer- orphan and vulnerable children) households in kitui and machakos counties of kenya. the control arm households will receive their normal ct-ovc cash payment and the intervention arm will receive an additional cash payment and nutritional counselling.


Eligibility criteria:
inclusion criteria: * pregnant women and children aged up to 23 months of age in households receiving ct-ovc cash transfers in kitui and machakos counties of kenya exclusion criteria: * not residing in ct-ovc households
study on nutrition and cardiovascular risk in spain.

Conditions: Cardiovascular Disease

Summary: the purpose of this study is to assess the distribution, awareness and control of main cardiovascular risk factors in the spanish population. the main study variables are: * lifestyles (tobacco, alcohol, nutrition, physical activity) * biological risk factors either well-established (blood lipids, glucose, insulin and blood pressure) or emergent (leptin, c-reactive protein and other markers of inflammation)

data collection comprised 3 sequential stages: 1. computer-assisted telephone interview to obtain information on lifestyle, knowledge and attitudes about cardiovascular disease risk factors, and the signs and symptoms of heart attack and stroke, subjective health, and morbidity; 2. first homevisit, to collect blood and urine samples for analysis by a central laboratory; 3. second home visit, to measure anthropometric variables and blood pressure and to administer a computer-assisted dietary history; data on functional limitations are also collected from participants aged 65 years and older.

Eligibility criteria:
inclusion criteria: * non-institutionalized spanish resident * 18 years and over exclusion criteria: * none

Keywords: cardiovascular risk factors nutritional assessment epidemiology
evaluation of efficiency of ritalin in multiple sclerosis (ms) patients

Conditions: Relapsing Remitting Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive

Summary: scientific background: growing awareness and accumulating data regarding the cognitive impairment and its progression in multiple sclerosis (ms) patients has received an important place in neurological research in the last decade.

scientific background: growing awareness and accumulating data regarding the cognitive impairment and its progression in multiple sclerosis (ms) patients has received an important place in neurological research in the last decade. cognitive impairments occur frequently (43 to 65%) in ms. moreover, in up to 50% of patients in whom no cognitive disturbances are found on routine neurological examination, cognitive impairments can be elicited using sensitive and disease specific neuropsychological tests. even in patients with short disease duration of less than two years, discrete impairment of cognitive function may be found in up to 60% on neuropsychological testing without impacting activities of daily living. we have recently reported that cognitive impairment occurred in 53.7% of patients with probable ms (evaluated within a mean of one month of the onset of new neurological symptoms). verbal abilities and attention span were most frequently affected (43.3 and 41.8% respectively). an additional study demonstrated that ms patients within the first 5 years of disease onset presented attentional dysfunction only when the cognitive load of the attention task was high and when controlled information processing was required. this high rate of attention impairment found in ms patients early in the disease process may have a significant impact on quality of life and activities of daily living as attention is one of the most fundamental cognitive functions essential for normal daily activities and a requisite step towards conscious perception. consequently, we suggest investigating whether treatment with ritalin (methylphenidate) has an effect on patients.

Eligibility criteria:
inclusion criteria: * diagnosis of definite ms according to poser criteria; * attention impairment defined as abnormal pasat score; * written and signed informed consent; exclusion criteria: * pregnancy or lactation; * steroid treatment; * persistent psychostimulant treatment; * ms relapse;

Keywords: ms ritalin pasat cognition attention relapsing remitting secondary progressive primary progressive
hscrp & ch indices in patients with coronary artery disease with and without apical periodontitis

Conditions: Apical Periodontitis; Coronary Artery Disease

Summary: endodontic treatment is done in patients with chronic pulp exposure in patients with coronary artery disease and systemic inflammatory markers recorded before and and after treatment and compared with patients with coronary artery disease without chronic pulp exposure.

endodontic treatment is done in patients with chronic pulp exposure in patients with coronary artery disease and systemic inflammatory markers recorded before and and after treatment and compared with patients with coronary artery disease without chronic pulp exposure. systemic inflammatory burden is assessed before and after endodontic treatment.

Eligibility criteria:
inclusion criteria: * coronary artery disease patients with and without chronic pulp exposure exclusion criteria: * other systemic diseases * antibiotics for more than 1 month * smoking * analgesics more than 1 week

Keywords: apical periodontitis coronary artery disease
food as medicine project

Conditions: Hypertension

Summary: causes' fresh produce program (fpp) in durham county has addressed barriers to food security related to transportation with an innovative delivery model, but lacks evidence regarding the impact of food supplementation on chronic diseases like hypertension, which is prevalent in historically excluded populations in durham county. the goal of this research study is to determine the efficacy of the modified dietary approach to stop hypertension (dash) diet in black/african american and hispanic/latinx participants with chronic hypertension who identify as food insecure using a randomized controlled trial. this research will leverage fpp's innovative distribution system to deliver medically-tailored produce bags and provide education workshops to the experimental participants relative to their experimental group. the study population group intends to include members of the durham community and surrounding areas that identify as members of either the black/african american or hispanic/latinx populations. success will be measured in pre- and post-intervention biomarkers and qualitative participant experience data. recognizing the risk of using protected health information of durham community members, many of whom are members of historically excluded populations that have been subjugated to harmful and extractive research practices, steps will be taken to ensure that collected information about research participants' personal and health information is protected and used only for the purposes of research. ultimately, this research aims to work directly with the community to address hypertension outside of the clinic using food and education delivered directly to participants. the success of such an intervention could lead to expansion of delivering medically and culturally tailored foods to the larger fpp population and beyond.


Eligibility criteria:
inclusion criteria: 1. adult parent/legal guardian (age 18 or older) 2. documented essential hypertension (systolic bp \>140 and/or diastolic bp \>90, at least two documented clinical measurements) 3. self-reported african american or latino exclusion criteria: 1. hypertension due to secondary cause (e.g. renovascular hypertension, hyperthyroidism, cushing's disease etc.) 2. homelessness or insecure/transitional housing 3. inability to prepare or cook food for themselves 4. participants not living in durham county, n.c. 5. pregnant women
delayed loading following repair of a ruptured achilles tendon

Conditions: Achilles Tendon Rupture

Summary: the purpose of the study is to investigate if delayed loading following surgical treated achilles tendon rupture influence the clinical outcome and muscle and tendon structure after one year. the investigators hypothesize that delaying the gradual introduction of loading in the initial 26 weeks may reduce the heel-rise deficit (primary outcome) and thus improve the clinical outcome one year after surgery (primary endpoint).


Eligibility criteria:
inclusion criteria: * diagnosed with a traumatic, complete mid-substance achilles tendon * no contraindications for mri * presented within 14 days from injury * adult (18 to 60 years) * understand danish * manage transport to/from the hospital on their own exclusion criteria: * other injuries affecting their lower limb functions * prior achilles tendon rupture * smoking * systemic diseases influencing tendon healing * anticoagulation treatment * inability to follow rehabilitation or complete follow-ups * immunosuppressive treatment including systematic corticosteroid treatment

Keywords: achilles tendon surgery
anti-mesothelin car t cells for patients with recurrent or metastatic malignant tumors

Conditions: Mesothelin Positive Tumors

Summary: this is a single-arm, open-label, one center, dose escalation clinical study, to determine the safety and efficacy of infusion of autologous t cells engineered to express chimeric antigen receptor targeting mesothelin in adult patients with mesothelin positive, recurrent or metastatic malignant tumors.


Eligibility criteria:
inclusion criteria: 1. patients with mesothelin positive, recurrent or metastatic malignant tumors , including but not limited to pancreatic adenocarcinoma, ovarian cancer, or pleural mesothelioma. 2. relapsed or metastatic after standard treatment 3. measurable tumors by recist1.1 standard 4. patients are 18 to 70 years old. 5. life expectancy \> 3months. 6. kps ≥70. 7. satisfactory major organ functions: adequate heart function with lvef≥50%; no obvious abnormities in ecg; pulse oximetry ≥ 90%; cockcroft-gault creatinine clearance≥40 ml/min; alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤3uln; bilirubin ≤2.0 mg/dl . 8. blood: hgb ≥ 80 g/l, anc ≥ 1×10\^9/l, plt ≥ 50×10\^9/l. 9. women of reproductive potential must have a negative pregnancy test. male and female of reproductive potential must agree to use birth control during the study and one year post study. exclusion criteria: 1. patients with a prior history of autoimmune disease or other diseases who need long-term use of systemic hormone drug or immunosuppressive therapy 2. active infection. 3. hiv positive. 4. active hepatitis b virus infection or hepatitis c virus infection. 5. currently enrolled in other study. 6. patients, in the opinion of investigators, may not be eligible or are not able to comply with the study. 7. patients who have allergic disease, or are allergic to t cell products or other biological agents used in the study. 8. patients whose tumors have metastasized to bone marrow, or have clinical signs of bone metastasis, such as bone and joint pain . 9. patients who have brain metastasis or signs of brain metastasis, such as loss of self-consciousness.
quality improvement strategies to increase human papillomavirus (hpv) vaccination in integrated healthcare delivery systems

Conditions: Human Papillomavirus Infection

Summary: hpv vaccination coverage is at lower levels than the national goal. this study will evaluate the effectiveness of quality improvement strategies for increasing hpv vaccination coverage among adolescent within the context of large integrated health care delivery systems.

the university of north carolina (unc) will evaluate the impact of a quality improvement (qi) model for increasing hpv vaccination coverage among adolescents in primary care settings. unc will partner with the american cancer society (acs) to evaluate the effectiveness of their vaccinate adolescents against cancer (vacs) model for hpv vaccine qi within the context of integrated healthcare delivery systems (idss). the vacs model includes the development of a qi action plan and a qi team. the qi team is made up of health care providers from participating clinics within the idss. the team then helps implement specific qi activities in participating primary care clinics. the model also includes vaccination coverage assessments in participating clinics at multiple time points to assess the impact of qi activities. specific qi activities that will be offered to participating clinics will be chosen from a menu of options that will include the center for disease control and prevention's afix model and physician-to-physician engagement. afix (assessment, feedback, incentives and exchange) consists of brief quality improvement consultations that immunization specialists from state health departments deliver to vaccine providers in primary care settings. using immunization registry data, the specialist evaluates the clinic's vaccination coverage and delivers education on best practices to improve coverage. physician-to-physician (p2p) engagement consists of an in-depth training about how to make strong and effective hpv vaccination recommendations to primary care providers. the investigators will compare changes in hpv vaccination coverage between the quality improvement arm or wait list control arm.

Eligibility criteria:
inclusion criteria: * integrated healthcare delivery systems headquartered in new york state or wisconsin with at least 4 pediatric or internal medicine practices within the system. * all clinics within the integrated healthcare delivery system must participate in the state immunization registry. exclusion criteria: * integrated healthcare delivery systems headquartered outside of new york state or wisconsin.

Keywords: quality improvement hpv vaccine integrated healthcare delivery systems
effect of food insulin index on metabolic parameters in obese adolescents

Conditions: Pediatric Obesity

Summary: the aim of this study was to determine the effect of food insulin index (fii) on metabolic parameters and appetite in obese adolescents with insulin resistance. a randomized, single-blind and crossover trial included 15 obese adolescents aged 12-18 years with insulin resistance. all participants were submitted two different breakfasts: low glycemic index, low insulin index (lgi-lii) and low glycemic index, high insulin index (lgi-hii), with a 1-week washout period between meals. at time 0 (just before breakfast), 15, 30, 45, 60, 90, 120, 180 and 240 minutes after the meal, serum glucose, insulin and c-peptide levels were measured and appetite was evaluated by visual analog scale. at the end of four hours, participants were served ad libitum lunch meal. then, the foods eaten at lunch were recorded and their energy and nutrient analysis was calculated.


Eligibility criteria:
inclusion criteria: * aged 12-18 years * age- and sex-specific body mass index (bmi) ≥95th percentile of the world health organization (who) growth-reference data * new diagnosis and not receiving any treatment * homeostatic model assessment for insulin resistance (homa-ir) \>3.16 exclusion criteria: * hypertension, cardiovascular disease, diabetes mellitus or any other significant metabolic, endocrine or gastrointestinal disease * use of tobacco or alcohol * taking any medications * having difficulties for physical activity

Keywords: pediatric obesity insulin resistance diet
the detection of barrett's esophagus by gastrointestinal endoscopy prevents esophageal carcinoma in morbid obese after sleeve gastrectomy

Conditions: Gastroesophageal Reflux

Summary: severe gastroesophageal reflux disease (gerd) leading to a chronic aggression of esophagus mucosa, called barrett's esophagus is a main complication of sleeve gastrectomy for morbid obesity. barrett's esophagus is considered as a early stage of neoplastic transformation to adenocarcinoma. since this last years, six european bariatric centers have adopted the policy to realize endoscopy before and five years or more after sleeve gastrectomy. investigators worked out a database comprizing the endoscopic features and patient characteristics. refleeve projet aim to analyse the long term follow-up datas of 100 patients, evaluate the prevalence of barret's esophagus and investigate the advantage of the systemetic detection to prevent esophagus adenocarcinomas.


Eligibility criteria:
inclusion criteria: * patients who had had sg with a minimum follow-up of 5 years, without signs of barrett's esophagus before sg; * an upper gi endoscopy before the sg; * an upper gi endoscopy indicating that no barrett's esophagus was present at the time of the sg; * an upper gi endoscopy done with the scope of searching for the endoscopic anomalies of the barrett's esophagus according to the international guidelines for the diagnosis of barrett's esophagus 9. * endoscopic biopsies according to the international guidelines for the diagnosis of barrett's esophagus 9. exclusion criteria: * sg as a conversional procedure from another bariatric procedure such as the gastric banding; * no upper gi endoscopy before the sg * barrett's esophagus before the sg; * a second procedure after the sg such as the conversion to roux-en-y gastric bypass or duodenal switch; * an upper gi endoscopy done not following the international guidelines for the diagnosis of barrett's esophagus9.
the role of surgical resection and stereotactic radiosurgery in primary central nervous system -diffuse large b cell lymphoma

Conditions: Primary Central Nervous System Diffusing Large Cell Lymphoma

Summary: the objective of this observational study is to understand the long-term impact of surgery and gamma knife treatment on primary central diffuse large b-cell lymphoma. the main questions it aims to answer are: can surgery and gamma knife prolong the survival period of patients with primary central diffuse large b-cell lymphoma? participants who have already incorporated surgery and gamma knife as part of the routine medical care for patients with primary central diffuse large b-cell lymphoma will answer questions about survival period within 5 years.


Eligibility criteria:
inclusion criteria: pathologically confirmed pcns-dlbcl complete clinical records detailing treatment methods and surgical approaches. exclusion criteria: incomplete systemic treatment data loss to follow-up after initial contact prior receipt of whole-brain radiotherapy.