Kornimate/medical-research-clean huggingface dataset:
think health! a personal weight management program

Conditions: Obesity

Summary: think health! a personal weight management program, or "¡vive saludable! un programa personalizado de control de peso" aims to improve the treatment of obesity in adults in the general population, by conducting research with men and women recruited from primary care medical practices. the study has a particular focus on african americans and latino. the design is randomized trial of the effectiveness of two versions of a lifestyle weight loss program called delivered by primary care providers (pcp) and ancillary staff at 5 clinical practice sites to their own patients. the two versions of the lifestyle weight loss program are called basic (minimal counseling provided by pcp every four months) and basic plus (same pcp counseling plus additional counseling by specially trained ancillary practice staff acting as lifestyle coaches (lc), monthly for the first 12 months and then every other month for up to 2 years).


Eligibility criteria:
inclusion criteria: 1. women and men 2. ages 18 to 70 years 3. body mass index \> 25 kg/m2 but \< 55 kg/m2 or who weigh \<400 pounds. exclusion criteria: 1. pregnancy or lactation, since contraindicated for weight loss or affecting weight status 2. weight loss \> 10 pounds in the previous 3 months 3. current use of weight loss medications 4. use of medications known to result in significant weight gain (e.g., oral steroids or second generation anti-psychotics) 5. psychiatric disorders including untreated major depression, psychosis, bulimia nervosa, and substance abuse 6. active chemo- or radiation therapy 7. unstable renal, hepatic, or cardiovascular disease, including malignant arrhythmias 8. recent (past 3 months) history of myocardial infarction, stroke, or congestive heart failure 9. participants age \ 70 years will be excluded because our experience has been that a specially tailored program would be needed. as a design consideration, we wanted to decrease the heterogeneity of the program. 10. participants with a bmi \> 55 kg/m2 will be excluded because they are likely to require more extensive medical and behavioral care than can be provided in this study. 11. more than 1 participant residing in the same household will be excluded to avoid contamination across the treatment conditions. 12. final exclusion criteria will be determined in collaboration with participating primary care providers

Keywords: weight management in adults reducing health disparities
community health worker-led hypertension management

Conditions: Hypertension

Summary: this study is to determine if hypertension management by community health workers (chw) supported by a mobile health application and remote physician supervision is non-inferior to management by a physician for the primary outcome of improvement in systolic blood pressure. the target population is patients with hypertension in rural guatemala. study duration will be 12-24 months.

the investigators have developed an innovative system of care utilizing chws equipped with a mobile application and supported and supervised remotely by physicians. this model of care is adapted from a chw-led diabetes program enabled by a similar cds application which the investigators implemented in the same communities in rural guatemala where we will carry out this proposed study. this program safely led to significant improvements in glycemic control. the mobile application is built on the widely-used commcare platform and provides clinical decision support (cds) to chws based on protocols from the who and the international society of hypertension for antihypertensive medication initiation and titration, lifestyle counseling, and identification of patients requiring a higher level of care. the primary objective is to determine if hypertension management by chws is non-inferior to care provided directly by a physician. the secondary objective is to evaluate the safety, acceptability to patients, and cost of chw-led care compared to care provided directly by a physician.

Eligibility criteria:
inclusion criteria: * adults age 18 or greater with diagnosis of hypertension and blood pressure (bp) greater than or equal to 140/90 or currently taking antihypertensive medication. * ability to provide informed consent exclusion criteria: * pregnancy * severe comorbid condition(s) with life expectancy less than 1 year

Keywords: community health worker
muscle property, alignment and joint loading in people with knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: knee osteoarthritis (koa) is a common chronic painful musculoskeletal condition among older adults. it poses great challenge to the health care system due to its inability to be cured. understanding factors associated with disease progression in koa should assist the development of novel prevention/rehabilitation strategies. this study investigate factors including muscle properties, lower limb alignment and joint loading in patients with knee osteoarthritis before and after a six-week exercise program.


Eligibility criteria:
inclusion criteria: 1. age between 50-80 2. having radiographic tibiofemoral joint oa in the medial compartment defined as kellgren and lawrence grade = 2 to 3 3. having medial knee pain on most days of the month 4. having a minimum average pain score of 2 on an 11-point numerical rating scale in the past week while walking exclusion criteria: 1. having lateral tibiofemoral compartment osteophytes greater than the medial side. 2. having undergone intra-articular corticosteroid injection or knee surgery to either knee within the past 3 months 3. having a systemic arthritic condition (e.g., rheumatoid arthritis) 4. having a knee joint replacement or high tibial osteotomy in the past 5. having any other muscular, joint or neurological condition influencing lower limb function 6. unable to walk unaided 7. having low back, hip, ankle or foot pain \> 3 on numerical rating scale 8. having a body mass index (bmi) \>36 kg/ m2

Keywords: muscle tension alignment knee osteoarthritis loading
observational study of conjunctivitis in the setting of dupixent® treatment for atopic dermatitis

Conditions: Conjunctivitis; Atopic Dermatitis

Summary: the primary objective of the study is to characterize the clinical phenotype(s) of dupixent®-associated conjunctivitis events. the secondary objectives of the study are to characterize the course of conjunctivitis events during the observation period and collect and assess data on treatment for conjunctivitis events and its effectiveness.


Eligibility criteria:
key inclusion criteria: * treatment with dupixent® for ad (per the current us prescribing information) should be ongoing, and have been initiated at least 8 weeks prior to study enrollment. note: a single missed dose in the 8 weeks prior to enrollment is allowed. * patients with protocol-specified conjunctivitis events must present with active bilateral conjunctivitis (with or without cornea or eyelid involvement) diagnosed by the ophthalmologist (investigator) which meets all of the following criteria: * developed (or significantly worsened) while receiving treatment with dupixent® for ad * is clinically significant (eg, moderate-to-severe, extensive, persistent, etc) as determined by the investigator * there is a suspected causal relationship between dupixent® and conjunctivitis because: * conjunctivitis is a new-onset condition or an unusual worsening of a preexisting condition (eg, significantly more severe, more extensive, or more protracted than ever before) and * no alternative explanation is more plausible, in the opinion of the investigator * reference patients must have ad treated with current ongoing treatment with dupixent® for equal or longer duration as compared to group 1, with no clinical signs of ocular inflammation noted during the entire dupixent® treatment key exclusion criteria: * any known medical, social, or personal limitations that are likely to restrict the patient's ability to undergo study visits and complete study procedures (as assessed by the investigator), including hypersensitivity or other contraindications to the anesthetic eye drops used during the ophthalmological examination. note: other protocol defined inclusion/exclusion criteria apply.
safety and efficacy of iv infusion of investigational agent (tzp-101) in patients with diabetic gastroparesis

Conditions: Gastroparesis; Diabetes Mellitus

Summary: the purpose of this study is to determine whether tzp-101 is safe in people with diabetes. also to determine if tzp-101 is effective in increasing the gastric emptying rate in diabetic patients.


Eligibility criteria:
inclusion criteria: * subject has type 1 or type 2 diabetes mellitus * subject has documented diagnosis of gastroparesis by: * delayed gastric emptying (gastric retention ≥60% at 2h and ≥10% at 4 h; based on scintigraphy -4h standardized radionuclide solid meal) * a minimum 3 month history of chronic upper abdominal discomfort (two or more: chronic postprandial fullness, bloating, epigastric discomfort, early satiety, belching after meal, postprandial nausea, vomiting) * subject has normal upper endoscopy * if female, must be permanently sterilized or postmenopausa. exclusion criteria: * patient has received any investigational drug within the preceding 30 days * patient is taking unstable doses of medication that affects gastric motility * patient has co-morbid condition * patient has a positive laboratory test result for hepatitis b, hepatitis c, hiv, or controlled substances. * patient has a history of a psychiatric disorder (including drug or alcohol addiction) requiring care by a psychiatrist or psychologist within the preceding 12 months. * patient has a recent,adult history of clinically significanthypersensitivity reaction(s) to any drug. * patient has known history of alcoholism

Keywords: delayed gastric emptying symptomatic gastroparesis diabetes mellitus
feasibility of implementing time-restricted eating in women with mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: this study will investigate the feasibility of implementing a time-restricted eating intervention in females with mild cognitive impairment. targeted therapeutic interventions that improve cognitive impairment and delay onset of adrd are particularly important for females, who have twice the lifetime risk of developing ad, compared to males.

this study will investigate the feasibility of implementing a time-restricted eating (tre) intervention in females with mild cognitive impairment. data will be collected for 10 weeks. baseline food timing, activity/sleep, metabolic health (fasting labs and anthropometric measures), and cognitive testing will be collected in the first two weeks. subjects will then be invited to enroll in a tre intervention for 8 weeks. subjects will be educated about the potential health benefits of tre, and then each subject will self-select a 10-hr window and consume all daily calories during this time frame. subjects will text the time of their first and last daily calories for the duration of the study. at the end of the 8-week tre intervention, metabolic, anthropometric, activity/sleep, and cognitive measurements will be collected.

Eligibility criteria:
inclusion criteria: * postmenopausal women * age 45-95 * diagnosis of mild cognitive impairment exclusion criteria: * individuals prone to hypoglycemia * liver disease * taking medications that affect eating behaviors * alcohol consumption of \>2 drinks per day * significant circadian disruption * having care-taking responsibilities that significantly affect sleep * shift work or irregular lifestyle * diagnosed clinical eating disorder * participating in a formal weight loss program
rct for the chinese medicine in treating hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: this is a randomized, double-blind, placebo-controlled clinical trial. eligible subjects will randomized into a treatment group or placebo group. they will receive either chinese medicine granules or placebo granules for 8 weeks followed by a 4-week observation period. the primary outcome would be the percent change in low-density lipoprotein cholesterol levels (ldl-c) after treatment.

hypercholesterolemia refers to a metabolic disease caused by abnormal cholesterol metabolism in the blood cholesterol content exceeding the normal range, which can be mainly divided into total cholesterol (tc) in plasma and low-density lipoprotein cholesterol ldl-c) or a decrease in high-density lipoprotein cholesterol (hdl-c). uncontrolled hypercholesterolemia is considered an important risk factor for cardiovascular and cerebrovascular diseases. in recent years, there has been an increasing number of clinical studies of traditional chinese medicine combinations or single herbs for hypercholesterolemia, and some drugs do have cholesterol-lowering effects, but the clinical evidence is not high due to bias or other deficiencies in trial design. therefore, this clinical trial aim to evaluate the effectiveness of dachaihu decoction combined erzhiwan with variation to the treatment of patients with clinical hypercholesterolemia, and tried to reduce its adverse effects on liver function through reasonable compatibility.

Eligibility criteria:
inclusion criteria: * age 18-80 years old, any gender; * ldl-c level of 4.1 mmol/l or above (no statin therapy during the screening period); * be able to maintain a more consistent lifestyle and eating habits throughout the study; * have a fixed residence and are not expected to move or travel for 8 weeks; * voluntarily sign the informed consent form. exclusion criteria: * taking drugs that may affect lipid metabolism (such as steroids, sleeping pills, and psychotropic drugs); * alcohol or drug abuse within the last 3 months; * known liver function or renal dysfunction; * history of severe cardiovascular and cerebrovascular diseases; or history of psychiatric illness; * participate in other interventional clinical trials within 3 months before the study, including drugs, supplements, medical devices, etc.; * known pregnant or lactating women, allergies or allergies to traditional chinese medicine; * patients with known secondary hypercholesterolemia.
melatonin supplements for improving sleep in individuals with hypertension

Conditions: Sleep Disorders; Hypertension

Summary: this study will evaluate the effectiveness of treatment with melatonin supplements in improving sleep in individuals with high blood pressure who are taking beta-blockers.

hypertension, or high blood pressure, is a condition in which an individual's blood pressure is higher than the normal level. it is estimated that one in three individuals in the united states has high blood pressure, though many do not know it because there are usually no symptoms. uncontrolled hypertension may lead to stroke, heart attack, heart failure, or kidney failure. beta-blockers are one class of drugs that have been developed to help lower blood pressure, and thereby decrease the risk for these serious problems. beta-blockers also lower the levels of melatonin, a hormone that has a sleep-promoting effect. many individuals who take beta-blockers for hypertension complain that they have trouble sleeping, which may be related to the beta-blockers' effect on melatonin levels. this study will evaluate the effectiveness of treatment with melatonin supplements in improving sleep in individuals with high blood pressure who are taking beta-blockers. in addition, the study will examine whether the melatonin supplements aid in lowering blood pressure. participants in this double-blind study will be randomly assigned to receive either melatonin supplements or placebo for the duration of the study. participants will take part in two inpatient phases. each inpatient stay will last 4 days and will be separated by 3 to 4 weeks. while in the clinic, participants' sleep patterns and core temperature will be recorded and plasma, saliva, and urine samples will be collected. blood pressure will be measured before and after each inpatient stay, as well as at points during the stay. throughout the study, participants' activity will be monitored by an accelerometer worn around the wrist.

Eligibility criteria:
inclusion criteria: * diagnosed with uncomplicated hypertension * currently being treated with atenolol (a beta-blocker) exclusion criteria: * history of medical illness other than essential hypertension * personal or family history of psychiatric illness * current use of any medication other than anti-hypertensive drugs * any recent travel across time zones * history of working various shifts on an irregular basis

Keywords: sleep disorders high blood pressure
gurney journey: virtual reality distraction

Conditions: Dental Caries in Children; Dental Diseases

Summary: the aim of this study is to determine whether a software virtual reality (vr) program provided during transportation to anesthesia induction reduces anxiety before the procedure, and compliance in pediatric patients. this study aims to measure the anxiety of patients as they arrive before their procedure, when parting from their parents for transportation to the procedure room, and when anesthesia is provided. compliance during anesthesia induction will also be monitored. participants will be randomly placed into to one of two groups. group 1 will receive standard care from a certified child life specialist prior to their surgery. group 2 will receive standard care from a certified child life specialist and distraction with a novel virtual reality software program.

the aim of this study is to determine whether a novel software virtual reality (vr) program provided during transition from periop to the procedure room and anesthesia induction reduces preoperative anxiety, and induction compliance in pediatric patients. this study aims to specifically monitor and measure the anxiety of patients as they arrive at the preoperative suite, when parting from their parents for transportation to the procedure room, and at induction of anesthesia. compliance during anesthesia induction will also be monitored. participants will be randomized to one of two groups. group 1 will receive standard care during their surgery. group 2 will receive standard care and distraction with a novel virtual reality software program. we hypothesize that anxiety will be reduced, and anesthesia compliance will improve for participants in group 2.

Eligibility criteria:
inclusion criteria: * ages 5-17 years old. * patients undergoing general anesthesia with mask induction for dental procedures. exclusion criteria: * cognitive impairment that will impact the use of the vr headset or interaction with the game. * participants who cannot comfortably wear the vr headset. * visual impairment that would hinder use of software program. * patients receiving general anesthesia via iv. * parent accompanies patient back for anesthesia induction.

Keywords: pediatric induction
the effect of mk0859 on lipoprotein metabolism in patients with dyslipidemia (0859-026 am3)

Conditions: Dyslipidemia

Summary: this study will investigate the effect of mk0859 on lipoprotein metabolism in patients with dyslipidemia already on statin therapy.


Eligibility criteria:
inclusion criteria: * patient's weight has been stable for at least 6 weeks * patient is in good health based on medical history, physical exam, and laboratory tests * patient has dyslipidemia exclusion criteria : * patient has a history of stroke, seizures, or major neurological disorders * patient has a history of cancer * patient is currently taking any lipid-lowering medications or substances except for statins * patient consumes excessive amounts of alcohol or caffeine * patient has multiple and/or severe allergies to food or drugs
tomosynthesis as primary test for breast cancer screening

Conditions: Breast Cancer

Summary: randomized trial comparing tomosynthesis plus synthetic 2d mammography vs digital mammography in respect to incidence of advanced cancers (interval and following round) and interval cancers.

this is a companion study of the other italian studies on tomosyntesis as primary screening test for breast cancer: retomo (nct02698202), proteus (nct02590315), impeto (nct03587259). the investigators conduct a randomized trial in three centres with a protocol that is similar to that of the other three studies. as for impeto and differently from the retomo and proteus studies, the intervention will be tomosynthesis + synthetic 2d. in the three centres about 8000 women will be recruited (4000 in the experimental arm and 4000 in the control arm). the study will compare the performance of tomosynthesis plus synthetic 2d vs digital mammography in respect to incidence of advanced cancers (interval and following round) and interval cancers. women 50 to 65 years old will be screened once according to randomization arm for one round, then all will be screened with digital mammography after two years. the investigators also will measure detection rates, specificity, interval cancers, advanced cancers occurring as interval cancers or at subsequent screens and allowing to estimate excess overdiagnosis comparing overall cumulative incidence after two or three rounds of screening. women will be asked for informed consent when they attend the mammography. if they accept they will be randomised to one of the two arms. all examinations will be read by two independent radiologists, in case of discordance a third reading is asked.

Eligibility criteria:
inclusion criteria: * women scheduled for a new round of mammographic screening * resident in the province exclusion criteria: * previous breast cancer diagnosis * pregnancy or suspicion of pregnancy * presence of brca1/2 gene mutation * previous digital breast tomosynthesis performed * unable to understand informed consent * chemotherapy in progress * presence of breast implant

Keywords: breast cancer screening tomosynthesis
evaluation of rate of progression with perimetry in newly diagnosed open angle glaucoma

Conditions: Glaucoma, Open-Angle; Ocular Hypertension

Summary: the purpose of this study is to evaluate rate of progression in newly diagnosed open angle glaucoma with different types of perimetry. would it be possible to find the rapidly progressing individuals sooner by doing perimetry more often? is there a difference between different types of perimetry in early glaucoma? what would be the optimal timing of perimetry in newly diagnosed glaucoma? in addition the quality of life in glaucoma patients will be evaluated with two types of questionnaires in three different time points. the enrolled patients will receive appropriate treatment according to glaucoma management guidelines.


Eligibility criteria:
inclusion criteria: * recently diagnosed open angle glaucoma exclusion criteria: * significant visual impairment due to another disease (e.g. diabetic retinopathy or maculopathy, cataract, visual field defect after stroke) * inability to perform perimetry reliably

Keywords: visual field tests ocular hypertension glaucoma, open-angle quality of life glaucoma progression early glaucoma frequency doubling technology (fdt) rarebit octopus 900 perimetry
effects of wheat breads on symptoms of ibs, a pilot study

Conditions: Irritable Bowel Syndrome; Wheat Sensitivity

Summary: this is randomized pilot study comparing tolerability of yeast-baked wheat bread and sourdough wheat bread in irritable bowel syndrome.


Eligibility criteria:
inclusion criteria: * ibs \& subjective sensitivity to wheat exclusion criteria: * celiac disease, pregnancy, lactation, ibd, major gi operations

Keywords: wheat, ibs, gluten, ati