Kornimate/medical-research-clean huggingface dataset:
randomized trial of follow-up to mailed fit kits

Conditions: Colorectal Cancer Screening

Summary: this study aims to assess whether follow-up calls can increase the return rate of mailed fit kits. to assess this, a randomly selected half of eligible patients were randomized to receive a follow-up call reminding the patient to return the fit kit.

this study aims to assess whether follow-up calls can increase the return rate of mailed fit kits. patients ages 45 to 59 due for colorectal cancer screening, who had not received a fit kit in the previous 3 months but had completed one sometime in the past and had an assigned primary care provider, were sent a fit kit in october of 2024. half of patients were randomized to receive a follow-up call reminding the patient to return the fit kit. this work analyzes the return rate of the mailed fit kit, with or without phone call follow-up.

Eligibility criteria:
inclusion criteria: * age 45-59 * due for colorectal cancer screening * not sent a fit kit in the past 3-months * previously returned a fit kit. exclusion criteria: * under age 45 or over age 59; * incarcerated; * not due for colorectal cancer screening * sent a fit kit in the past 3-months

Keywords: fecal immunochemical tests (fit) cancer screening nurse follow-up
evaluation of trc101 in subjects with chronic kidney disease and metabolic acidosis

Conditions: Acidosis

Summary: this was a double-blind, placebo-controlled, parallel-design, 6-arm, fixed dose study. the study enrolled 135 adult male and female subjects with stage 3 or 4 chronic kidney disease and low serum bicarbonate levels. the study was conducted in two parts. in part 1 study drug dosing (trc101 or placebo) continued for 14 days twice daily (bid). in part 2 study drug dosing (trc101 or placebo) continued for 14 days once daily (qd). the maximum study duration per subject was anticipated to be up to 42 days.


Eligibility criteria:
inclusion criteria: * estimated glomerular filtration rate (egfr) of 20 to \<60 ml/min/1.73m2 * serum bicarbonate level of 12 to 20 meq/l exclusion criteria: * any level of low serum bicarbonate that, in the opinion of the investigator, requires emergency intervention. * severe comorbid conditions other than chronic kidney disease. * chronic obstructive pulmonary disease. * anticipated changes in doses of any of the following drugs or drug classes: diuretics, non-ophthalmic carbonic anhydrase inhibitors, oral diabetes drugs, antihypertensive drugs, antacids, h2-blockers, or proton pump inhibitors. * excluded drugs or drug classes: insulin, non-daily or "as needed" diuretics, herbal products, dietary supplements, multivitamins, naturopathic remedies, sodium bicarbonate, potassium citrate, sodium citrate or other alkali therapy, non-steroidal anti-inflammatory drugs (nsaids), fiber supplements, laxatives, calcium and magnesium supplements, or electrolyte binders and other binder drugs.

Keywords: metabolic acidosis serum bicarbonate kidney disease
bmi and its relationship to hypoglycemic seizures in children with insulin-requiring diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: the landmark study diabetes control and complication trial (dcct) clearly showed that intensive insulin management delays the onset and progression of longterm complications in adolescents with type 1 diabetes mellitus (t1dm). the same clinic trial also showed increased rate of severe hypoglycemia which required assistance. the risks of severe hypoglycemia, defined as loss of consciousness or seizure associated with hypoglycemia, include lower hba1c, younger age, higher insulin dose, male sex, lower parental socioeconomic status, non-hispanic white ethnicity, longer duration of disease, the presence of psychiatric disorders, and underinsurance. the purpose of this protocol is to explore the relationship between hypoglycemic seizures and bmi.

this is a retrospective study using questionnaire/survey/interview. we will give subjects a letter stating the purpose and describing the study. we will answer all questions they have about the study. once the parents and patient verbally agree to participate in the study, we will proceed with the survey.

Eligibility criteria:
inclusion criteria: * t1dm * 2-17 years old exclusion criteria: * t2dm * known seizure disorder
a study of liocyx in patient with recurrent hbv-related hcc post liver transplantation

Conditions: Recurrent Hepatocellular Carcinoma

Summary: hepatocellular carcinoma (hcc) represent approximately 70-85% of liver cancer, in which hepatitis b virus (hbv) is the major etiologic agent accounting for at least 80% of hcc in asian countries. overall, transplantation remains the best option however, hcc recurrence rate is high among liver transplant patients. while there are limited treatment measures for hbv-related hcc recurrences, the study hypothesized that liocyx is capable of lysing target liver cells expressing the hbv cognate antigens and provide clinical benefit to patients with hbv-related hcc.

the study is a phase i/ii, open label, single-arm, multicenter study of liocyx. subjects with recurrent hepatitis b virus-related hepatocellular carcinoma who undergone liver transplantation will be enrolled. approximately 6-12 subjects will be enrolled in phase 1 dose regimen exploration, and approximately 60 subjects will be enrolled to characterize the safety and evaluate the efficacy of liocyx" all subjects will be followed up for survival until death.

Eligibility criteria:
inclusion criteria: * recurrent locally advanced and/or metastatic hepatocellular carcinoma (hcc) post liver transplantation * life expectancy of 3 months or greater * have measurable disease by the revised response evaluation criteria in solid tumors (mrecist) * history of positive test for hepatitis b virus surface antigen (hbsag) * expression of liocyxtm target epitopes within specific human leukocyte antigen (hla) class i profile * had received treatment with at least one standard therapy or refused, appropriate approved therapy for their disease * 21 years of age or older * eastern cooperative oncology group (ecog) performance status ≤1 * willing and able to comply with all study procedures exclusion criteria: * known, clinically suspected or has history of central nervous system (cns) and bone metastasis * tumor burden in the liver exceeding 70% * significant ongoing immunologic rejection based on pathology and clinical diagnosis * evidence or history of significant bleeding diathesis or coagulopathy * prior exposure to any cell therapy such as, but not limited to nk, cik, dc, ctl, stem cells therapy * known history of testing positive for human immunodeficiency virus (hiv) 1 or 2 or known acquired immunodeficiency syndrome (aids) * lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples * women who are pregnant or breast-feeding

Keywords: recurrent hepatocellular carcinoma hepatitis b virus-related post liver transplantation hcc
seasonal influenza vaccination reminders for children with high-risk conditions

Conditions: Seasonal Influenza Vaccination

Summary: the objective of this study was to assess the feasibility and effectiveness of using a statewide immunization information system (iis) to send seasonal influenza vaccine reminders from local health departments (lhds), targeting children with high-risk conditions.


Eligibility criteria:
inclusion criteria: * children, 24-60 months * current or previous enrollment in medicaid (michigan) * presence of at least 1 chronic condition, as indicated by the michigan care improvement registry (mcir) * resident of kalamazoo, ottawa, or kent counties (michigan) exclusion criteria: * receipt of influenza prior to notification date * ineligible for reminder/recall notification in the michigan care improvement registry (mcir)

Keywords: influenza vaccine reminder / recall immunization registry immunization information systems
adjuvant acupuncture care for breast cancer patients experiencing side effects from chemotherapy

Conditions: Breast Cancer

Summary: breast cancer patients report many symptoms while undergoing conventional care, including nausea/vomiting, fatigue, pain, depression and anxiety. existing interventions to address these common side effects of treatment are limited. patients diagnosed with cancer frequently seek complementary medicine (cam), and there is a need to investigate potential effects of cam therapies. this phased pilot and feasibility study has two aims: 1. develop an acupuncture treatment protocol for adjuvant acupuncture care for breast cancer patients undergoing chemotherapy using structured interviews with established acupuncture teams in norway. 2. implement the treatment protocol in a pilot study to evaluate outcome measures, effect sizes and acceptability of acupuncture care delivered alongside conventional care. study results will support the design of future research; including a phase iii randomised controlled trial.


Eligibility criteria:
inclusion criteria: * females, 18 years or older with early stage breast cancer, no previous chemotherapy and no metastatic disease exclusion criteria: * needle phobia, use of anticoagulant drugs, inability to comply with study regimen

Keywords: breast cancer chemotherapy adjuvant therapy acupuncture fatigue early stage breast cancer patients
the energy balance study

Conditions: Obesity

Summary: very low carbohydrate diets and high-complex carbohydrate, low-fat diets are popular weight-loss methods in the united states. the purpose of the energy balance study is to explore how extreme differences in diet affect eating behaviors, activity and calorie-use, and body composition. we will conduct a controlled feeding study (all food will be provided for the duration of the study) in which obese adults will be randomly assigned to one of three dietary groups: a low-carbohydrate-eat as much as you like diet, a high-carbohydrate-eat as much as you like diet, or a high-carbohydrate-calorie-restricted diet. the low-carbohydrate diet will be modeled after the induction phase of the atkins diet. the high carbohydrate diet will be based on the "dietary approaches to stop hypertension (dash)" diet. during the first 3 weeks, participants will eat a typical diet adjusted so that they neither gain or lose weight. then, for 6 weeks, they will eat their assigned research diet. resting calorie use and body composition measurements will be taken at the end of week 2 and week 9. frequent blood sampling for 24 hours will be done through a catheter (tube) placed in an arm vein at the end of weeks 2 and week 9 and for 12 hours at the end of week 3. change in body composition, activity and energy expenditure, and blood components known to influence eating behavior will be measured under typical diet conditions and after one-day and 6 weeks of the research diet.


Eligibility criteria:
inclusion criteria: * bmi; 30-50 kg/m2 * age at least 21 years * relative good health exclusion criteria: * major debilitating mental or physical illness that would interfere with participation * renal or hepatic disease, diabetes * history of gallbladder disease/removal * hyper-or hypothyroidism * poorly controlled hypertension * use of lipid lowering medications * pregnancy or lactation * current excessive use of alcohol * current/recent chronic use of tobacco

Keywords: obesity weight loss low carbohydrate diets high complex carbohydrate diets healthy adults body composition energy expenditure
population study of the prevalence of celiac disease and other gluten-dependent disorders in children and adolescents

Conditions: Celiac Disease in Children

Summary: to study the prevalence and clinical features of celiac disease in children to develop new treatment approaches and rehabilitation strategies.

the purpose of this screening program is to identify people at high risk for developing celiac disease, which is due to the genetic intolerance of gluten - a protein found in wheat, rye and barley. when a person with celiac disease consumes gluten-containing foods, his immune system damages the mucous membrane of the small intestine. inflammation develops and, as a result, the absorption of vitamins, minerals and other vital nutrients is disrupted. studies have shown that timely diagnosis of celiac disease is important for the treatment or prevention of its complications. left untreated, the disease can lead to impaired growth and development, diabetes, cancer, or other diseases. in europe and the usa, celiac disease is a chronic disease that occurs in approximately one in 100 and one in 22 who have risk factors. there are frequent cases of an erased or low-symptom course of celiac disease. unfortunately, ninety-seven percent of cases remain undiagnosed and, accordingly, do not receive proper treatment. a screening program will increase knowledge about the disease and contribute to the early detection of the disease.

Eligibility criteria:
inclusion criteria: * schoolchildren from various districts of moscow selected as a result of questioning in the risk group for the development of celiac disease * availability of written informed consent of the child over 14 years of age to participate in the study; * availability of written informed consent of the parent of the child to participate in the study; * age from 7 to 18 years; * male and female gender; * the number of points according to the results of the survey is more than 25. exclusion criteria: * age up to 7 years and over 18 years. * the lack of written informed consent of the child over 14 years of age to participate in the study; * the lack of written informed consent of the parent / guardian of the child to participate in the study; * the number of points on the results of the survey from 0 to 24
phase i, healthy subject, safety, tolerability and pharmacokinetic study of an m1 agonist to treat cognitive impairment

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics in young and elderly healthy volunteers of htl9936, a selective m1 receptor agonist intended for the treatment of cognitive disorders.

the purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics in young and elderly healthy volunteers of htl9936, a selective m1 receptor agonist intended for the treatment of cognitive disorders. this study is a single ascending dose study.

Eligibility criteria:
inclusion criteria: * body mass index of ≥19 and ≤ 30kg/m² * healthy subject free from any clinically significant illness or disease * female subjects must be ≥65 years exclusion criteria: * subject who is predicted to be a cyp2d6 poor or ultra rapid metabolizer * history of hypersensitivity to study drug * history of epilepsy or seizures * subject with previous history of suicidal behavior * subjects with significant hearing impairment * subjects with an abnormal eeg
measuring various variables in obstructive sleep apnea

Conditions: Obstructive Sleep Apnea-hypopnea Syndrome

Summary: this study included 90 volunteer obstructive sleep apnea syndrome patients. only 7 ml blood samples collected from patients. some biochemicals parameters analyzed in blood serum/plasma.

this study included 90 volunteer patients diagnosed with osas, and they were divided into three groups according to the apnea-hypopnea index (ahi) score: mild osas (n=30;5≤ ahi ≤13.70), moderate (n=30;15.80≤ahi≤26.60) and severe (n=30;34.10≤ahi≤86.30). demographic data, as well as biochemical parameters, nocturnal oxygen saturation percentage (spo2), and body mass index (bmi) were measured. plasma agmatine levels were measured by ultra-high-pressure liquid chromatography (uhplc), plasma trace elements (cu, co, mg, mo, zn, se) levels were determind by inductively coupled plasma mass spectrometer (icp-ms) and serum telomerase levels were measured by enzyme-linked immunosorbent assay (elisa) method. analyzes were carried out at the cumhuriyet university advanced technology research and application center.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of obstructive sleep apnea disease * apnea-hypopnea index (ahi) score between 5-87 exclusion criteria: * asthma * chronic obstructive pulmonary disease * pneumonia * psychiatric * diabetes * heart failure * who work at night work

Keywords: sleep apnea agmatine telomerase trace elements
the effect on glycemic responses and subjective ratings of satiety of a snack with or without ingredients to slow carbohydrate digestion

Conditions: Glycemic Response; Satiety

Summary: the objective of this trial is to compare a snack with ingredients (whole grains and dietary fiber) to slow carbohydrate digestion to a similar control snack without such ingredients and evaluate the effect of the snack on glycemic response and subjective satiety. the test product will be compared with a control product as well as white bread in a randomized, controlled, crossover trial including 20 healthy males or females between the ages of 18 and 70 and having a body mass index (bmi) between 25 and 30 kg/m2. following an overnight fast, participants will be given each of the study products in a random order at least a week apart. glucose and insulin will be measured before product consumption and over a period of four hours. visual analog scales to measure subjective satiety will also be administered over a period of four hours.


Eligibility criteria:
inclusion criteria: 1. healthy males or females between the ages of 18 and 70 inclusive 2. no chronic medications other than oral contraceptives 3. body mass index (bmi) between 25 and 30 kg/m2 inclusive. 4. body weight stable in a 5 kg range in the 3 months prior to study entry exclusion criteria: 1. pregnant or nursing a baby 2. women with child-bearing potential who are unwilling to use an effective means of contraception during the study which could include abstinence. 3. adults unable to consent and prisoners
an extension study to evaluate the efficacy and safety of horizant in adolescents with moderate-to-severe primary rls

Conditions: RLS

Summary: the objectives of the trial are to evaluate the long-term efficacy and safety of horizant (gabapentin enacarbil) 600 mg daily, for the treatment of rls in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe primary rls.

patients who complete the 12-week daily dosing efficacy and safety study (xp109) will be allowed to enroll in the open-label extension (ole) study (xp110), thereby providing exposure to horizant for up to 48 weeks. enrolled patients will take open-label horizant 600 mg tablets once a day at approximately 5 pm with food, beginning at week 0 of the ole study up to and including week 36. after the end of the treatment period, a follow-up visit will be included 14 days (± 3 days) after the last dose of horizant. patients will visit the clinical site on 6 different occasions, including a follow-up visit 14 days (± 3 days) after the last dose of study drug.

Eligibility criteria:
inclusion criteria: patients who completed participation in horizant study xp109. * negative pregnancy test for females of childbearing potential. male patients able to father a child must agree to use a barrier method (male condom, female condom, diaphragm, or cervical cap) with spermicide for at least 30 days prior to dosing and throughout the study. fertile, sexually active patients must agree to use 2 medically accepted methods of contraception * patients must be willing to refrain from using any drugs that are likely to affect rls or sleep assessments for the duration of the study. * signed patient and parent (or legal guardian) institutional review board (irb)-approved assent and consent forms before any study procedures are carried out exclusion criteria: * patients who, in the opinion of the investigator, would be noncompliant with the study visit schedule, procedures, or medication administration * patients who have developed clinically significant or unstable medical conditions, or who would otherwise be unsuitable for participation in a continuation study with gabapentin enacarbil

Keywords: restless legs syndrome rls
gs-5885, gs-9451 with peginterferon alfa 2a (peg) and ribavirin in treatment-naïve subjects with chronic genotype 1 hep c virus infection and il28b cc genotype

Conditions: Chronic Hepatitis C

Summary: this is a phase 2, randomized, open-label exploratory study that will examine the antiviral efficacy, safety, and tolerability of response guided treatment (rgt) with gs-5885 + gs-9451 + peg/rbv (6 or 12 weeks), or peginterferon alfa 2a (peg)/ribavirin (rbv)alone (24 weeks) in treatment naïve subjects with chronic hep c (hcv) infection with genotype (gt) 1 and il28b cc genotype.


Eligibility criteria:
inclusion criteria: * males and females 18-70 years of age * chronic hcv infection * subjects must have liver biopsy results (≤ 3 years prior to screening) indicating the absence of cirrhosis. alternatively a non-invasive alternative to liver biopsy (such as fibrotest, fibroscan, or acoustic radiation force impulse imaging) within 6 months of screening in countries where allowed * monoinfection with hcv genotype 1a or 1b * hcv rna \> 10\^4 iu/ml at screening * il28b cc genotype * hcv treatment naïve * candidate for peg/rbv therapy * body mass index (bmi) between 18 and 36 kg/m2 * creatinine clearance \>= 50 ml/min * agree to use two forms of highly effective contraception methods for the duration of the study and for 7 months after the last dose study medication. females of childbearing potential must have negative pregnancy test at screening and baseline exclusion criteria: * exceed defined thresholds for key laboratory parameters at screening * diagnosis of autoimmune disease, decompensated liver disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (copd), hiv, hepatitis b virus (hbv), hepatocellular carcinoma or other malignancy (with exception of certain skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed * subjects with current use of amphetamines, cocaine, opiates (e.g., morphine, heroin), or ongoing alcohol abuse are excluded. subjects on stable methadone maintenance treatment for at least 6 months prior to screening may be included into the study * use of prohibited concomitant medications two weeks prior to baseline through the end of treatment

Keywords: chronic hepatitis c il28b cc genotype treatment naive peginterferon α-2a (peg) genotype 1a/b gs 9451 gs 5885 ribavirin (rbv) hcv ns5a inhibitor hcv ns3 protease inhibitor
using the active breathing control device to reduce radiation side effects to critical structures in breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate the use of a device that helps coordinate the breathing cycle in the radiation treatment of the breast in order to minimize the radiation dose to the normal structures around the breast.

the active breathing coordinator (abc) allows for temporary and reproducible immobilization of internal thoracic structures by monitoring the patient's breathing cycle and implementing a breath hold at a predefined lung volume level. while abc is fda approved and commercially available, only preliminary dosimetric data is available on a small number of patients with breast cancer. there is some data using abc for intrathoracic malignancies, which shows that it is feasible and safe to use. abc can be used to optimize the distance between chest wall, heart and liver. this allows adequate treatment of the breast and underlying chest wall while minimizing irradiated cardiac and liver volume.

Eligibility criteria:
inclusion criteria: * requiring adjuvant or post mastectomy radiation therapy with tangential fields or 3-fields * adequate pulmonary function * presence of 5 cc of the heart or liver with the simulation fields * karnofsky performance status (kps) equal to or greater than 70 exclusion criteria: * pregnant women * patients who have had previous ipsilateral breast or thoracic radiation therapy

Keywords: breast cancer active breathing control active breathing coordinator abc