Kornimate/medical-research-clean huggingface dataset:
canadian adult congenital heart disease intervention registry

Conditions: Atrial Septal Defect; Patent Foramen Ovale; Tetralogy of Fallot; Fontan; Coarctation of Aorta; Transposition of Great Vessels; Percutaneous Pulmonary Valve Implantation

Summary: the achdi registry study will create a foundational database for adult congenital heart disease interventions. this pan-canadian registry will collect clinical and patient-reported information that will enable the evaluation of care processes and outcomes in five most common achdi interventions by enabling prospective and retrospective registry-based studies to answer important clinical practice and policy-relevant questions.

the goal of this study is to establish a rigorously developed registry to enable an impactful research agenda in adults with congenital heart disease interventions (achdi). the clinical and patient-reported information captured in the registry will allow researchers to evaluate care processes and outcomes in five most common achdi interventions including transcatheter closure of atrial septal defects, closure of patent foramen ovale, coarctation of aorta stenting, percutaneous pulmonary valve implantation, and complex catheterization. in 2019, we established the canadian research network for achd interventions (crn-achdi), a national achd research network bringing together researchers, providers, patients, and policymakers from 4 provinces (alberta, british columbia, ontario and quebec) to improve patient experiences and outcomes through i) a national registry with modern data platform; ii) a rigorously established national research priorities agenda; and iii) a strong collaborative and multidisciplinary research environment. the c-achdi registry will provide opportunities for researchers to ask clinical practice and policy-relevant research questions that are supported by high quality data. in addition, it will provide an opportunity for patients to contribute data for meaningful and high quality clinical and translational research. the c-achdi registry will provide a base for conducting registry-based studies (e.g., prospective experimental, prospective and retrospective observational) in the future as well as a foundation for benchmark and quality improvement activities.

Eligibility criteria:
inclusion criteria: * participants must be 18 years or older referred for intervention for one of five achd conditions including diagnostic catheterization for complex achd patients (tetralogy of fallot, fontan, and transposition of the great vessels, single ventricle, truncus arteriosus); transcatheter closure of atrial septal defects; transcatheter closure of patent foramen ovale; coarctation of aorta stenting, and percutaneous pulmonary valve implantation. exclusion criteria: * participants below the age of 18 * participants residing outside of canada
evaluating the effects of tasimelteon vs. placebo in delayed sleep-wake phase disorder (dswpd) and the cry1δ11 variant

Conditions: Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm; Chronobiology Disorders; Gene Mutations and Other Alterations Nec

Summary: this is a double-blind, randomized, two-period crossover study to evaluate the efficacy and safety of a single oral dose of tasimelteon and matching placebo in male and female subjects with dswpd and the cry1δ11 variant.


Eligibility criteria:
inclusion criteria: * ability and acceptance to provide written informed consent. * a confirmed clinical diagnosis of delayed sleep-wake phase disorder (dswpd). * carrier of cry1δ11 variant. * men or women between 18 - 75 years, inclusive. * body mass index (bmi) of ≥ 18 and ≤ 40 kg/m\^2. exclusion criteria: * major surgery, trauma, illness, general anesthesia, or immobility for 3 or more days within the last 30 days. * pregnancy, recent pregnancy (within 6 weeks), or women who are breastfeeding. * a positive test for substances of abuse. * current tobacco user.
a study to assess the effect of diets with different protein composition - mainly coming from lean red meat - in body weight and lipid profile in overweight and obese women

Conditions: Weight Loss; Obesity; Overweight; Diet, Reducing; Lipids

Summary: the objective of the study is to assess the effect of diets with different protein composition (20%, 27% and 35%), mainly coming from animal proteins such as lean red meat, on body weight and lipid profile in overweight and obese women. a dietary intervention is carried out during 3 months in 90 women who are individually randomized to an hypocaloric diet with three types of macronutrient composition: 1) 35% proteins, 30% fat and 35% carbohydrates; 2) 27% proteins, 30% fat and 43% carbohydrates and 3) 20% proteins, 30% fat and 50% carbohydrates. around 50% of total proteins in diet come from lean red meat (leg or shoulder of lamb) by providing up to 15 different recipes to participants to use them as part of the diet. at the beginning of the study, after 6 weeks and at the end of the intervention, the following parameters are determined: anthropometric (weight, waist circumference, body mass index and body composition), blood pressure, dietary (72-hours dietary registry) and exercise assessments and biochemical analysis (total cholesterol, triglycerides, hdl cholesterol, ldl cholesterol, apolipoprotein a1, apolipoprotein b, iron, transferrin, ferritin, uric acid, glucose, hba1c, insulin and adipokines). in 3-months visit, participants will be advised to follow the prescribed diets during the next 3 months. monitoring visits with the nutritionist will not be performed. a follow-up visit will be done after 3-months of end of intervention (at 6-months after beginning the study) to assess the long-time efficacy on main endpoint of each diet. in this visit only anthropometric parameters (weight, waist circumference, body mass index and body composition) will be determined.


Eligibility criteria:
inclusion criteria: * age: 18-80 years old. * body mass index between 27.5 - 40. * steady weight in last 3 months (±3 kg). * informed consent provided. exclusion criteria: * presence of uncontrolled endocrinological pathology (including hypothyroidism). * type 2 diabetes mellitus with bad metabolic control (hba1c \> 8%). * lipid-lowering drugs in the last 3 months. * intake of functional foods with plant sterols in the past 6 weeks. * vitamin supplements intake. * hormone replacement therapy. * consumption of orlistat in the last 2 months * high intake of alcohol (\> 30 gr./day). * any serious disease which involves less than 1 year life expectancy or, in investigators judgment, limit the follow-up of an homogeneous diet throughout the study. * pregnancy or intention of pregnancy during the study.

Keywords: weight loss obesity overweight diet, reducing lipids
promoting healthier food purchases by leveraging the online-grocery environment

Conditions: Obesity

Summary: rationale: online-grocery shopping is predicted to be one of the "hottest" food trends of 2014, as national retailers such as amazon, as well as start-up companies, venture into the e- commerce grocery sector. importantly, the online-grocery environment could be uniquely manipulated to promote healthier food purchasing and help with weight control. since consumers tend to choose items listed first on menus and buffet lines, the order of food products displayed on the grocer's website may impact purchasing. furthermore, it's possible that in an online-grocery environment, nutrition information could be made more salient to consumers. for example, previous research has demonstrated that label color influences perceptions of the healthfulness of foods. the fda also recently proposed a redesign of foods' nutrition facts panels, which would highlight calorie content in a larger font. although implementing this label change on all food labels could take years, e-commerce sites could change the format of the nutritional information they display much more quickly. objectives: the proposed study intends to nudge consumers to make healthier grocery purchases through three distinct interventions: 1.) manipulating the order of food items within grocery categories; 2.) displaying product nutrition information in red or green; and 3.) presenting calorie information in a larger font size. we propose to examine these concepts in adult consumers using a grocery e-commerce platform servicing socioeconomically and racially diverse communities in the northeastern u.s.


Eligibility criteria:
inclusion criteria: * shopping on a rosie grocery site exclusion criteria: * no exclusion criteria, all orders will be eligible
pilot study to evaluate the effectiveness and safety of axiom worldwide drx9000™ spinal decompression system

Conditions: Low Back Pain

Summary: this pilot study will evaluate the effectiveness and safety of the axiom worldwide drx9000 for active treatment of chronic low back pain.

currently, there are no prospective safety and/or outcomes studies utilizing the drx9000™ in the peer-reviewed medical literature. there are published trials utilizing similar machines which provided evidence in support of the fda granted indications for use spinal decompression and of the drx9000™. axiom worldwide has determined it will be of benefit to the continuing medical care of patients and a furthering of the scientific knowledge of the treatment of lbp to complete such a prospective evaluation using a standardized treatment protocol. this study will therefore attempt to establish and validate the safety and efficacy of this computerized spinal decompression system in the treatment of lbp and sciatica.

Eligibility criteria:
inclusion criteria: * male or female, greater than 18 years of age * able to understand possible risks and benefits and provide written informed consent (icf) to the irb approved clinical multimodal protocol * lbp with an intensity level of greater than 4 on an eleven point numerical pain rating scale (vrs) of 0-10 (with 0 - no pain and 10 - worst possible pain) * completed the necessary diagnostic and medical history evaluations as described in the protocol to confirm the patient's diagnosis and eligibility for the study and drx9000 treatment protocol. * willing and able to complete a six week 20 session of drx9000 outpatient treatments and a minimum of 6 months follow-up exclusion criteria: * pregnancy * evidence of neurological motor deficits on clinical examination * evidence of spinal cord compression, metastatic cancer, tumor, hematoma, infection or compression fracture * evidence of severe central stenosis with neurological deficits or nerve root entrapment * litigation for health-related claim (in process or pending), worker's compensation, or personal injury * previous spine fusion surgery, insertion of hardware or artificial disc * hemiplegia or paraplegia * history of severe cardiovascular or metabolic disease, or abdominal aortic aneurysm * unwillingness to postpone other types of therapy for lbp during the 6 week treatment sessions * known alcohol abuse or drug abuse * height less than 4 feet 10 inches (147 cm) or greater than 6 feet 8 inches (203 cm) * body weight greater than 300 pounds (136 kg)
study of cp-751,871 in combination with exemestane in postmenopausal women with hormone receptor positive advanced breast cancer

Conditions: Breast Neoplasms

Summary: to test the efficacy of cp-751,871 combined with exemestane in the treatment of postmenopausal patients with hormone positive advanced breast cancer


Eligibility criteria:
inclusion criteria: * postmenopausal women with a diagnosis of hormone receptor positive advanced breast cancer * hba1c \<5.7% exclusion criteria: * previous treatment for advanced disease
platelet drug trial in coronary disease progression

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia

Summary: to determine the effectiveness of the platelet inhibitor drugs dipyridamole and aspirin in reducing the angiographic progression of coronary artery disease over a five-year period and to test the predictive value of the platelet survival half-life in identifying patients with more rapid progression of coronary disease and development of its complications.

background: coronary atherosclerosis is the leading cause of death in this country and the developed countries of the world. although modern coronary care units have resulted in a markedly decreased hospital mortality from acute myocardial infarction, especially in those patients who enter the hospital early, its overall impact is limited since two-thirds of patients who die from coronary disease do not reach the hospital. when the trial was initiated in 1979, new approaches to the medical treatment of coronary disease and its complications were needed with an effort directed towards prevention of its progression and prevention of its complications through medical therapy. this prevention could save significant health care dollars over the long-term especially if the need for aortocoronary bypass graft surgery and the incidence of myocardial infarction could be reduced. early identification of the patient at risk of developing coronary disease or of those with early coronary artery lesions would allow a greater impact of any successful intervention therapy. design narrative: randomized, double-blind. the patients in the experimental group were treated with dipyridamole and aspirin for five years. patients in the control group received a lactose placebo. the primary endpoint was angiographic evidence of progression of coronary artery disease and development of new coronary disease. secondary endpoints included total mortality, cardiac mortality, mortality due to myocardial infarction, and incidence of new myocardial infarction. recruitment ended in december 1982. the study completion date listed in this record was obtained from the statement immediately above ("recruitment ended in december 1982") and was confirmed from the query/view/report (qvr) system.

Eligibility criteria:
patients aged 65 or less. angiographically identified coronary heart disease
study of pemetrexed in the treatment of patients with ovarian cancer who have failed prior platinum-based chemotherapy

Conditions: Ovarian Neoplasms; Primary Peritoneal Cancer

Summary: the purposes of this study are to determine: - whether standard or higher doses of pemetrexed should be given to patients with ovarian or primary peritoneal cancer that has recurred; - the safety and side effects of standard and higher doses of pemetrexed given to patients with ovarian or primary peritoneal cancer that has recurred; - whether standard or higher doses of pemetrexed can help patients with ovarian or primary peritoneal cancer that has recurred.


Eligibility criteria:
inclusion criteria: * patient must have been diagnosed with ovarian or primary peritoneal cancer * patient must have had 1 or 2 prior platinum-based chemotherapeutic regimens. * patient must have adequate health status. * patient compliance and geographic proximity that allow for adequate follow up is required. * signed informed consent from the patient or legal representative is required. exclusion criteria: * patient is pregnant or breast-feeding * patient has received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. * patient has previously participated in another study investigating pemetrexed. * patient is unable or unwilling to take folic acid, vitamin b12 supplementation, and corticosteroids. * patient cannot be taking nonsteroidal anti-inflammatory drugs around the time of administration of study drug.
case collection study to support digital mammography image software change

Conditions: Breast Cancer

Summary: the primary objective of this study is to compare image processing software to support a new image processing software application for a full-field digital mammography (ffdm) system.


Eligibility criteria:
inclusion criteria: * female * \> 40 years exclusion criteria: * pregnant women, or women who may become pregnant * mammographic evidence of breast surgery, prior radiation to the breast, needle projection or pre-biopsy markings are evident in the mammogram (but may include breast implants) * palpable lesion or one that is visible by another modality * inmates
melatonin for prevention of kidney injury

Conditions: Acute Kidney Injury; Adverse Drug Event

Summary: this study will evaluate the safety and effectiveness of melatonin for the prevention of antibiotic associated acute kidney injury in hospitalized patients.

consenting subjects meeting inclusion and exclusion will be randomized to receive melatonin 5 mg daily or a matching placebo. study subjects will be followed for the duration of hospitalization or discontinuation of broad spectrum antibiotics (vancomycin plus piperacillin/tazobactam). the primary outcome and secondary outcomes will be evaluated by the study team.

Eligibility criteria:
inclusion criteria: * aged 18 to 75 years * currently prescribed vancomycin with the presumption that therapy will be continued for at least 3 days based on a review of subject status. because of the critical nature of starting empiric broad-spectrum antibiotics, we will allow one dose of the antibiotic combination before consent and enrollment. this strategy is necessary for the ethical conduct of the study. exclusion criteria: * estimated creatinine clearance \< 30 ml/min * liver impairment (liver enzymes \> 3 times upper limit) * any history of allergy or contraindication to melatonin * pregnancy or breastfeeding * autoimmune disease * requiring vasopressors * requiring mechanical ventilation * history of acute kidney injury in the past 30 days * inability to take oral medications * clinical evidence of significant unstable or uncontrolled illness which, in the opinion of the research team, could confound the results of the study or put the patient at undue risk.
effects of dynamic surface exercise training on trunk control and gross motor functions in children with diplegic cerebral palsy

Conditions: Cerebral Palsy Spastic Diplegia

Summary: the purpose of this study was to determine the effect of dynamic surface exercise treatment on trunk control and gross motor abilities in children with spastic diplegic cerebral palsy.

a clinical trial was conducted to assess the impact dynamic surface exercise training on gross motor and trunk control of children with spastic diplegic cerebral palsy. the trial enrolled 38 children with spastic diplegic cerebral palsy of gmfcs levels 3 and 4. children were randomly assigned to either the dset or conventional physiotherapy training groups. both groups underwent 60-minute vigorous exercise program four days a week for two months. the trunk control measurement scale was used to assess trunk control, while the gmfm-88 was used to assess gross motor function. trunk control and gross motor function scores were obtained at the beginning, the fourth week, and the eighth week.

Eligibility criteria:
inclusion criteria * diplegic children having cerebral palsy * children of age 5 - 12 years * children of gmfcs- e \&r level iii and iv * children who can follow verbal commands exclusion criteria: * children with epileptic fits * children presenting with lower limb muscular contractures * children with scoliosis

Keywords: trunk control dynamic surface exercise therapy gross motor
human papillomavirus screening and vaccine readiness program

Conditions: Human Papilloma Virus-Related Carcinoma

Summary: public health research institute (phri) is carrying out a 15 month research and advocacy project with the goals of generating critical data on acceptability, identifying determinants and facilitators of hpv vaccine uptake in adolescent girls; and investigating physicians' attitudes to identify predictors of intention to recommend immunization in mysore, india.

discovery of the viral etiology of cervical cancer has opened up the possibility of primary prevention through vaccination. high-risk sexually transmitted types of human papillomavirus (hpv) have been identified as a necessary agent in cervical carcinogenesis, and work on vaccine development has progressed rapidly. vaccines for hpv types 16 and 18, which are implicated in \~70% of cervical cancers, as well as types 6 and 11, which cause genital warts, have been shown to be effective and have been licensed in the last year. modeling studies have indicated that an hpv vaccine could be cost-effective even alongside existing screening programs. ideally, girls should be vaccinated before the onset of sexual activity, and estimates suggest that introduction of an hpv vaccination at age 12 could reduce lifetime cervical cancer incidence by up to 94%. as with any new technology, the success of hpv vaccination will be dependent on levels of acceptability and uptake. given the need for parental consent in india, research into parental acceptance is of vital importance. although parental acceptance of vaccination against sexually transmitted infections (sti) including hpv, appears high in other parts of the world, there is little data in india. in previous research from other parts of the world, the biggest concern identified was that vaccinations may disinhibit risky sexual activity among adolescents. other attitudes and beliefs that may influence parental uptake of an hpv vaccine include fear of potential side effects, concern about giving children too many vaccinations, the belief that vaccinations may cause disease, and religious and cultural taboos against vaccination. there is a critical need to develop data and experience that will provide the information needed by policymakers prior to the introduction of a cervical cancer vaccine in india. the present research will be guided by the ecological framework and identify where the locus of hpv vaccine decision-making lies in an indian setting. this project will explore household, peer and authority figure influencers in vaccine uptake. this process will include qualitative research methods such as focus group discussions and one-on-one interviews..

Eligibility criteria:
inclusion criteria * potential participants must have at least one daughter between 8 and 14 years of age * be a decision maker for the welfare of a girl aged 8-14 years * be able to understand and give informed consent * be able to speak kannada

Keywords: hpv acceptability