Kornimate/medical-research-clean huggingface dataset:
a pilot study of the effects of diet and behavioral interventions on health in diabetics

Conditions: Diabetes Type II

Summary: the study is a small pilot, designed to provide data regarding the feasibility and acceptability of conducting such a study on a larger scale. the present study is a randomized controlled clinical trial comparing two mindfulness-based lifestyle modification programs to help people manage diabetes and lose weight, one using on a low-carbohydrate diet (lc) and the other using a moderate-carbohydrate diet promoted by the american diabetes association (ada). intervention content will include information about nutrition (carbohydrate restriction or american diabetes association recommended diet) and emotion regulation and mindful eating strategies.

approximately 40 individuals with type ii diabetes or prediabetes will be randomized in a 1:1 ratio to treatment groups. groups will meet for 12 weekly sessions, then approximately biweekly for 3 sessions, for a total of 15 1.5-2 hour sessions over 4.5 months. participants will be evaluated at 0, 1 month, 3 months, and 6 months. our outcome of interest is hba1c (glycated hemoglobin, a measure indicative of blood glucose levels and tied to diabetes severity).

Eligibility criteria:
inclusion criteria: * diabetes mellitus, type 2. * hgba1c \> 6.0% at screening. this is to confirm the diabetes diagnosis. * aged 18 years old and older * bmi 25 and above. exclusion criteria: * condition that will make it difficult for participation. such as: * cancer * liver failure * unstable coronary artery disease * severe emphysema * bulimia or strong history of bulimia * vegan * laboratory evidence of organ dysfunction * abnormal kidney function (serum creatinine) * thyroid stimulating hormone out of normal range * previous use or new changes in medications that can interfere with the measures used in the study: * current use of insulin and no immediate plans to start or increase diabetic mediations. * more than 3 oral hypoglycemic medications. * use of systemic (oral or iv) corticosteroids in the 6 months prior * severe autoimmune disorders * initiation of psychiatric medications in past 2 months. * weight loss confounds * current use of weight loss medications or supplements. * history of or planned weight loss surgery. * other * pregnant or planning to get pregnant in the next year, breastfeeding, less than 6 months post-partum. * unable or unwilling to do home glucose monitoring.

Keywords: diabetes obesity mindful eating positive affect low carbohydrate diet
a study of the safety of imovax polio™ in china

Conditions: Poliomyelitis; Polio

Summary: this study is designed to obtain post-marketing safety data on imovax polio™ vaccine in china. primary objective: to describe the safety profile after each dose of imovax polio™ administered at 2, 3, and 4 months of age in population aged over 2 months old living in the study city china.

study participants will receive a single dose of imovax polio™ vaccine at 2, 3, and 4 months of age, respectively. each participant will make a total of 7 visits. safety will be monitored at each visit and up to 30 days after each vaccination.

Eligibility criteria:
inclusion criteria : * subject is more than 2 months (60-89 days) old when receiving the first dose of polio vaccine. * subject's parents/legal representative showed willingness to complete the 3 primary doses fully using imovax polio™ according to the schedule: one injection at 2, 3, 4 months old, respectively. * informed consent form obtained from the subject's parent/legal representative. * subject plan to live in the selected study sites for at least three months after inclusion. exclusion criteria : * subject with a history of serious illness (e.g., hypersensitivity, seizure, convulsion, encephalopathy diseases) * known or suspected impairment of immunologic function * acute medical illness with or without fever within the last 72 hours * subject plan to leave the study sites for at least three months after inclusion * administration of immune globulin or other blood products within the last three months * participation in another clinical trial at the same time * contraindication to vaccination according to imovax polio™ leaflet.

Keywords: poliomyelitis imovax polio™ polio
diabetes strengths study - pilot of provider-delivered strengths-based intervention

Conditions: Type 1 Diabetes

Summary: the purpose of this study is to determine whether a newly developed intervention is feasible and acceptable to adolescents with type 1 diabetes and their families and diabetes care providers, and to evaluate trends in whether the intervention impacts important diabetes outcomes. the intervention involves diabetes care providers discussing and reinforcing individuals' and families' diabetes management strengths during routine, outpatient diabetes care appointments.

the purpose of this study is to pilot test a newly developed strengths-based clinical intervention delivered by diabetes care providers in the context of routine ambulatory diabetes care, designed to promote resilience and support diabetes management among adolescents with type 1 diabetes and their families. the emphasis of the intervention is shifting the tone of clinical encounters for diabetes care to emphasize and reinforce youths' and families' current diabetes strengths and positive diabetes management behaviors. youth with type 1 diabetes are seen routinely in clinic every 3-4 months, and this intervention will occur at two consecutive clinic visits. the intervention consists of (a) assessing youth and family diabetes strengths and adherence prior to each visit, and (b) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique "diabetes strengths profile" generated from the strengths and adherence assessments. outcome assessments are conducted at baseline (prior to the start of the intervention) and immediately following the conclusion of the intervention (approximately 6-8 months later). the primary outcome is feasibility and acceptability, measured by qualitative feedback from participants and providers, as well as quantification of recruitment and enrollment, provider adherence to intervention protocol, and time to completion. secondary (exploratory) outcomes include diabetes regimen adherence, glycemic control, family conflict, diabetes burden, diabetes strengths, and satisfaction with the diabetes care provider relationship. strengths and adherence assessments are also completed prior to the second clinic visit to generate the diabetes strengths profile.

Eligibility criteria:
inclusion criteria: 1. at least one parent of each adolescent, self-identified as the primary caregiver most involved in diabetes care, will also be enrolled with each adolescent participant. when present, secondary caregivers involved in diabetes management will be invited (not required) to participate. 2. youth type 1 diabetes diagnosis for at least 12 months, to allow ample opportunity for adjustment to diabetes management 3. youth and parent fluency in written and spoken english because assessment measures are not available in other languages. exclusion criteria: (1) presence of a serious mental illness or developmental disability in youth or parent that would impede participation would exclude eligibility.

Keywords: adolescence adherence
behavioral cvd prevention using informatics

Conditions: Health Behavior

Summary: overweight/obesity is strongly linked to mortality from multiple chronic diseases, including cardiovascular disease, diabetes, and obesity-related cancers.the successful management of overweight/obesity requires management of nutrition and physical activity over time. for racial/ethnic minority and low-income populations, who face both higher prevalence of obesity and chronic diseases compared to others, interventions promoting behavioral change are a national health priority. from the available range of behavioral change intervention strategies, there is a growing knowledge base that documents the efficacy of peer support interventions for improving self-care, quality of life, and behavioral change. in this study, the investigators will examine the following research question: what is the preliminary efficacy and degree of implementation and acceptability of an intervention approach in which peer counselors provide evidenced-based counseling about nutrition and physical activity behaviors for weight management to public housing residents using a computer-assisted program called cuesweight?


Eligibility criteria:
inclusion criteria: * willing to wear an accelerometer * 18-65 years old * public housing resident with no plans to move in next 6 months * body mass index ≥25 * open to making changes to diet \& physical activity habits exclusion criteria: * currently enrolled in a comprehensive weight loss program or a research study whose primary outcome is weight loss * primary language spoken is a language other than spanish or english * not willing to participate in study protocols, including wearing the accelerometer, not willing to have study staff send text messages

Keywords: weight loss health status disparities
infiltration effect on suv

Conditions: Dose Response Relationship, Drug

Summary: a widely used semi-quantitative parameter to assess tumor status is the standardized uptake value (suv). suv estimation accuracy can be impacted by many variables. today there still exists a significant amount of variability in pet/ct results in test and re-test studies. this variability can be introduced by instrumentation and subject-specific factors. variability reduces image quality and increases the required changes in tumor quantification to reflect real tumor response or progression. pet/ct scanning process requires that the entire net injected dose of radiolabeled tracer is administered intravenously as a bolus. the quality and quantification of a pet/ct image is highly dependent on the uptake of radiolabeled tracer. boellaard et al. have indicated infiltrations could potentially underestimate suv measurements by as much as 50%. infiltrations and obstructions are not uncommon. recent studies using a novel qa/qc tool (laratm system) for the radiotracer injection process revealed that current means to detect infiltration do not completely identify all infiltrations/obstructions. since infiltrations may not be visible in the standard field of view (fov) and since the impact of a peripheral circulatory obstruction may not be visible even if an injection site is in the fov, it is possible for reading and treating physicians to be unaware that a patient's image and quantification has been impacted. additionally, when current means do detect an infiltration, they under-represent the severity because they are not capturing that infiltrations often resolve during the uptake period. as a result, infiltrations or obstructions may cause suv inaccuracy and could adversely impact staging and tumor assessments. the purpose of this study will be to characterize the impact of moderate or greater infiltrations on standardized uptake values. patients experiencing a moderate or greater infiltration on a routine clinical pet scan will be invited to return for a repeat scan with injection performed by specially trained personnel to reduce the risk of repeat infiltration. the two scans will be compared to assess for changes in tumor uptake intensity.


Eligibility criteria:
inclusion criteria: * subjects with solid tumors undergoing pet/ct scan who have at least one measurable target lesion and sustain a moderate or greater infiltration. exclusion criteria: * subjects unwilling or unable to tolerate a repeat pet/ct scan. * subjects with meaningful medical intervention between pet/ct scans that would likely impact suv. * subjects with follow up injection infiltrations that would likely impact the suv. * pregnant patients.

Keywords: injections, intravenous fluorodeoxyglucose f-18
latin america hip fracture mortality study

Conditions: Hip Fractures

Summary: the purpose of this study is to estimate the survival proportion one year after surgery for intertrochanteric fracture in older adults in latin america.

this is a multi-center, prospective, observational clinical study to evaluate mortality in patients with surgically-treated hip fracture in latin america, and investigate associated prognostic factors. patients will be followed for 12 months.

Eligibility criteria:
inclusion criteria: * adults 60 years and older * diagnosis of an isolated intertrochanteric fracture (ao 31-a) confirmed by radiographic evaluation * primary surgical fracture treatment within 10 days after trauma * no prior treatment for the fracture * ability to understand the content of the patient information / informed consent form * willingness and ability to participate in the clinical investigation according to the cip * signed and dated irb/ec-approved written informed consent exclusion criteria: * polytrauma (ie, multiple injuries, whereof one or the combination of several injuries is life threatening) * pathologic fracture due to a disease other than osteoporosis (eg, tumor, metastasis) * active malignancy * class 5 and 6 of the american society of anesthesiologists (asa) physical status classification (appendix 2) * neurological and/or psychiatric disorders that would preclude reliable assessment (eg, parkinson's disease, multiple sclerosis, severe depression) * recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment * prisoner * participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study * noncompletion of patient baseline questionnaires * prior implant on the fractured hip

Keywords: hip fracture mortality
a pilot study of immunization with hiv-1 antigen pulsed allogenic dendritic cells in hiv-infected asymptomatic patients with cd4+ t cells > 350 cells/mm3

Conditions: HIV Infections

Summary: to define the safety and efficacy of sibling-supplied, hiv antigen-pulsed dendritic cells in increasing the immune response in hiv-infected patients. dendritic cells are a type of white blood cell used by the body to fight infection. they are instrumental in presenting antigens (such as hiv antigens) to the body's immune system. since dendritic cells are not functioning maximally in hiv-infected patients, infusion of dendritic cells from an hiv-negative sibling may enable the affected sibling's immune system to recognize foreign particles more readily and increase immune response against the virus.

dendritic cells are a type of white blood cell used by the body to fight infection. they are instrumental in presenting antigens (such as hiv antigens) to the body's immune system. since dendritic cells are not functioning maximally in hiv-infected patients, infusion of dendritic cells from an hiv-negative sibling may enable the affected sibling's immune system to recognize foreign particles more readily and increase immune response against the virus. dendritic cells from an hiv-negative sibling are obtained and treated with various viral proteins (hiv vaccines) or immunomodulators. the treated dendritic cells are infused into the hiv-infected patient monthly for 6 months. siblings must be able to donate on multiple occasions, and patients are followed every 2-4 weeks during the study. patients are screened over 3 months prior to study entry.

Eligibility criteria:
inclusion criteria patients must have: * hla a2+. * same cell type as donor sibling. * cd4 count \> 350 cells/mm3. * hiv asymptomatic status. * no hiv antivirals during study. * normal labs and chest x-ray. donor siblings must have: * hla a2+. * hiv negativity. * ability to donate cells on multiple occasions. * negative status for hepatitis b and c. exclusion criteria concurrent medication: excluded: * antiviral therapy (unless cd4 count declines to \< 350 cells/mm3). prior medication: excluded: * antiviral therapy within 90 days prior to study entry.

Keywords: hiv antigens immunotherapy, adoptive dendritic cells
assessment of the impact of an add-on and its smartphone application on the daily management of glaucoma

Conditions: Glaucoma

Summary: glaucoma is one of the most common chronic pathologies and affects several millions patients. among these, many have a poorly controlled glaucoma, damaging vision and leading to blindness. one between principal reasons for poor glaucoma medication adherence is forgetfulness. to improve this issue, digital tools may benefit both ophthalmologists and patients by monitoring eye drop administration.


Eligibility criteria:
inclusion criteria: 1. patient \> 18 years old, both genders 2. diagnosed with glaucoma, with controlled iop (\<18mmhg) 3. currently receiving a topical glaucoma treatment 4. receiving a multitherapy a fixed combination of dorzolamide-timolol, preservative-free. 5. patient willing to participate in the study. 6. patient familiar with a smartphone and its applications exclusion criteria: 1. patient with any eye condition in addition to glaucoma requiring expected additional treatment 2. patient with an ongoing or known history of ocular allergy and/or uveitis and/or viral infection and or ocular infection. 3. patient who underwent intraocular surgery within the past 3 months or scheduled to undergo intraocular surgery within the next 3 months 4. patient with best-correct visual acuity \<20/70 in the better seeing eye 5. patient whose drop administration is performed by someone else 6. alcohol addiction and/or heavy smoker, according to the investigator's judgement. 7. patient inability to understand the study procedures or to give informed consent. 8. non-compliant patient (e.g., not willing to attend a visit; way of life interfering with compliance). 9. participation in this study at the same time as in another clinical study. 10. patient being institutionalized because of legal or regulatory order, inmate of psychiatric wards, prison or state institutions, or employee of the study sites or of the sponsor's company. 11. patient not covered by the government health care scheme of the country in which he/she is living (if applicable). 12. women of childbearing potential, pregnant or breastfeeding: childbearing potential is defined as a woman who is not using a reliable method of contraception (oral contraceptive, intrauterine device, subcutaneous contraceptive implant, vaginal ring, patch) or is not surgically sterilized.
a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ves001 in healthy participants

Conditions: Dementia, Frontotemporal

Summary: this is a phase 1, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of single and multiple doses of ves001 in a two part followed by a multicenter, open-label phase 1b study in asymptomatic grn mutation carriers. part a will evaluate the safety, tolerability, pk, and pd of single doses of ves001 in healthy volunteers. part b will evaluate the safety, tolerability, pk, and pd of multiple doses of ves001 in healthy volunteers.

part a will include six cohorts, with eight participants per cohort. participants in each cohort will be randomised in a 6:2 ratio (ves001 vs. placebo). part b will include three cohorts, with ten participants per cohort. participants in each cohort will be randomised in a 8:2 ratio (ves001 vs. placebo).

Eligibility criteria:
inclusion criteria part a \& b: 1. healthy men or women aged 18 to 55 years. 2. body mass index between 18 and 32 kg/m2, with a minimum weight of 50 kg. 3. effective contraception required during the study and for at least 90 days after their last dose. 4. participants in group 3, where the food effect is being investigated, must be able to eat a high-fat meal within 30 minutes for breakfast. exclusion criteria part a \& b: 1. medical conditions or treatments that could interfere with the study. 2. history of any known neurologic disease, cognitive impairment, or a history of seizure, (significant) head trauma, or loss of consciousness. 3. history of active malignancy (active cancer cells or tumors) within the last 5 years. 4. abnormal laboratory test results or infectious diseases (hepatitis b, hepatitis c, and/or hiv). 5. recent medication or supplement use, unless allowed by the investigator. 6. participation in other research studies involving study treatment or devices. 7. positive tests for illegal drugs or alcohol at screening. 8. heavy smoking or inability to abstain from smoking during the study. 9. excessive consumption of caffeine (more than 8 cups per day). 10. history of severe allergic reactions to medication 11. recent blood donation or significant blood loss. 12. pregnancy, breastfeeding, or plans to become pregnant (for women).
a randomized trial to improve quality of life outcomes in asthma patients

Conditions: Asthma

Summary: among 180 patients with moderate asthma, the specific aim of this randomized trial is to assess the effectiveness of an intervention involving education, enhancement of self-efficacy, and asthma social support in preventing deterioration in functional status over two years.

the goals of this study are to develop and implement a multi-component intervention to improve quality of life and decrease urgent resource utilization in adult asthma patients followed in a primary care practice. specifically, the intervention involves a two-component self-directed self-management workbook. the first component focuses on increasing knowledge by providing patients with factual information about asthma and self-management. the second component focuses on asthma self-efficacy using case vignettes and making a contract to adopt a behavior to improve asthma. asthma-related social support is achieved through interval telephone contact.

Eligibility criteria:
inclusion criteria: * patients will be eligible for this study if they are 18 years of age or older and have moderate asthma based on the nhlbi asthma expert panel's classification which rates symptoms, frequency of exacerbations, nocturnal attacks, activity restriction, use of medications, and pulmonary function. exclusion criteria: * patients will be excluded from this study for the following reasons: if they are have other pulmonary diseases; if they are unable to provide informed consent because of cognitive deficits; if they are not fluent in english; if they refuse to participate.

Keywords: self-management self-efficacy quality of life resource utilization