Kornimate/medical-research-clean huggingface dataset:
development and validation of a scale to measure fear of activity in patients with coronary artery disease

Conditions: Coronary Artery Disease

Summary: low motivation to exercise is one of the barriers to participation in cardiac rehabilitation. fear of activity after a cardiac event is associated with low levels of physical activity. this study aimed to develop and validate a scale to measure fear of activity in patients with coronary artery disease.

low motivation to exercise is one of the barriers to participation in cardiac rehabilitation. fear of activity after a cardiac event is associated with low levels of physical activity. this study aimed to develop and validate a scale to measure fear of activity in patients with coronary artery disease. a scale for fear of activity in patients with cad (fact-cad) was created through semi-structured focus group interviews with patients. face and content validity of fact-cad was verified. the scale was applied to 250 patients who had myocardial infarction, coronary artery bypass grafting or percutaneous coronary intervention within the last 12 months. psychometric analysis included model fit, unidimensionality, reliability, local dependency, differential item functioning and external construct validity. analyses were performed using the rasch analysis model.

Eligibility criteria:
inclusion criteria: * subject has had myocardial infarction, coronary artery bypass grafting or percutaneous coronary intervention within the last 12 months. exclusion criteria: * acute cardiac event within the last month * attendance to cardiac rehabilitation * i̇nability to read and understand, * i̇nability to ambulate or unwillingness to participate

Keywords: coronary artery disease physical activity cardiac rehabilitation validation studies psychometrics
the acute effect of 2 different serving regimens of theobromine on physiological effects

Conditions: Cardiovascular Diseases

Summary: the main aim of this study is to determine whether there is a difference in the physiological effects of theobromine when provided via a single serving compared to multiple servings adding up to the same amount of theobromine provided on a day. this study also aims to study the pharmacokinetics of theobromine after administration once per day versus administration 4 times per day. hypothesis: the effects on heart rate are less pronounced when a high dose of theobromine is given in 4 smaller doses.


Eligibility criteria:
inclusion criteria: * apparently healthy men and post-menopausal women: no medical conditions which might affect study measurements (judged by study physician) * age 40-70 years * bmi ≥ 18 and ≤ 30 kg/m2 * blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged non clinically significant by research physician * written informed consent exclusion criteria: * previous cardiovascular event(s) (stroke, tia, angina, myocardial infarction, heart failure) * diabetes mellitus * reported weight loss or gain of 10% body weight or more during a period of 6 months prior to screening * reported intense sporting activities \> 10 h/week * use of over-the -counter prescribed medication which may interfere with study measurements, as judged by the physician * use of antibiotics in the three months before screening or during the run-in period. * currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months preceding the study and during the study itself * high caffeine consumption: reported consumption of more than 8 cups/cans of caffeine-containing drinks per day, i.e. coffee, black or green tea and cola (also cola light, diet \& zero) or consumption of more than 1 energy drink per day

Keywords: theobromine heart rate blood lipids
impact of diet and exercise activity on pregnancy outcomes

Conditions: Obesity; Gestational Diabetes; Type 2 Diabetes

Summary: the general goal of the present study is to assess the impact of a community-based exercise and dietary intervention in pregnant women living in urban areas during and after their pregnancy on the reduction of the risks of both diabetes and obesity in mothers and their offspring. we hypothesize that a community-based lifestyle intervention program during and after gestation may improve pregnancy outcomes in terms of reducing the risk of developing obesity or type 2 dm in mothers and their children.

impact of lifestyle intervention on excessive gestational weight gain

Eligibility criteria:
inclusion criteria: * pregnancy \< 20 weeks. * expressed interest in study and willingness to consent to participate in the study. exclusion criteria: * obstetric or medical contraindications for exercise according to 2002 socg guideline (ruptured membranes, preterm labor, incompetent cervix, hypertensive disorders of pregnancy, growth restricted fetus, placenta previa, persistent bleeding in 2nd or 3rd trimester, significant metabolic, cardiovascular, respiratory or systemic disorder) (5, 6). * pre-existing diabetes (except a history of gdm, but not in current pregnancy). * multiple gestations.

Keywords: exercise diet pregnancy obesity macrosomia
spinal cord stimulation frequency study

Conditions: Failed Back Surgery Syndrome

Summary: the purpose of this study is to evaluate the role of frequency settings on spinal cord stimulation in the management of failed back surgery syndrome (scs frequency study).

prospective, single-center, double-blinded, randomized crossover of 4 different stimulation frequencies: sham, 1200 hz, 3030 hz, and 5882 hz.

Eligibility criteria:
inclusion criteria: * at least 18 years old at the time of informed consent * willing and able to provide a signed and dated informed consent * capable of comprehending and consenting in english * willing and able to comply with all study procedures, study visits, and be available for the duration of the study * on a stable dose (no new, discontinued or changes in) of all prescribed pain medications and willing/able to maintain or only decrease the dose of all prescribed pain medications * tried appropriate conventional medical management for their pain * not indicated for additional surgical treatment in the opinion of the referring physician or spinal surgeon * undergone previous spinal surgery * diagnosed with fbss with appropriate pain score * primary pain at appropriate spinal level exclusion criteria: * has an active implanted device, whether turned on or off * displays current signs of a systemic infection * pregnant or lactating, inadequate birth control, or the possibility of pregnancy during the study * has untreated major psychiatric comorbidity * has serious drug-related behavioral issues * has neurological abnormalities unrelated to failed back surgery syndrome * diagnosed with raynaud disease * diagnosed with fibromyalgia * has any active malignancy or has been diagnosed with cancer and has not been in remission for at least 1 year prior to screening * has secondary gains which, in the opinion of the investigator, are likely to interfere with the study * participating or planning to participate in another clinical trial * has characteristics/limits of household or close contacts involved in study (eg, family member already a study participant where blind could be broken)
a study of ly3872386 in healthy participants and participants with atopic dermatitis

Conditions: Healthy; Atopic Dermatitis

Summary: the main purpose of this study is to evaluate the safety and tolerability of ly3872386 in healthy participants and participants with atopic dermatitis. the safety of prednisone is also evaluated in healthy participants. blood tests will be performed to investigate how the body processes the ly3872386 following single and multiple dosing in healthy participants and participants with atopic dermatitis. blood tests will also be performed to investigate how the body processes the prednisone in healthy participants. the study is conducted in three parts (part a, b and c). the study will last up to approximately 85, 183 and 44 days for parts a, b, and c, respectively.


Eligibility criteria:
inclusion criteria: part a and c: * overtly healthy as determined by medical evaluation 1. to qualify as japanese for the purpose of this study, the participant must be first generation japanese, defined as the participant's biological parents and all of the participant's biological grandparents must be of exclusive japanese descent, and must have been born in japan 2. to qualify as chinese for the purpose of this study, the participant must be, at a minimum, third-generation chinese, defined as all 4 of the participant's biological grandparents must be of exclusive chinese descent and born in china * have a body mass index of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive * male participants who agree to use highly effective or effective methods of contraception and women not of childbearing potential may participate in part a and c part b: * participants who have a diagnosis of atopic dermatitis at least 12 months prior to screening as defined by the american academy of dermatology * have a history, documented by a physician and/or investigator, of inadequate response to existing topical medications within 6 months preceding screening, or participants who failed systemic therapies intended to treat atopic dermatitis or a history of intolerance to topical therapy * have a body mass index of 18.0 to 38.0 kilograms per square meter (kg/m²), inclusive * male participants who agree to use highly effective or effective methods of contraception, women not of childbearing potential and women of childbearing potential may participate in part b exclusion criteria: * women who are pregnant and/or lactating * participants who have received live vaccine(s) (including attenuated live vaccines) or bacillus calmette- guérin within 35 days of screening * have a history or presence of multiple or severe allergies or an anaphylactic reaction to prescription or nonprescription drugs * have a known history of diabetes * have fasting glucose level of ≥126 milligrams per deciliter (mg/dl) and glycated hemoglobin ≥6.5 percent (%) and/or taking anti-diabetes medications at screening * have known history of osteoporosis
efficacy and safety study of sh t 586 in combination with rituximab to treat low-grade nhl

Conditions: Lymphoma, Low-Grade

Summary: the purpose of this study is to assess the antitumor effect and safety of fludarabine phosphate tablet in combination with rituximab in patient with indolent lymphoma.

as of 29 may 2009, the clinical trial sponsor is genzyme corporation. note: this study was originally posted by sponsor schering ag, germany, which was subsequently renamed to bayer schering pharma ag, germany.

Eligibility criteria:
inclusion criteria: * patients with cd 20 positive, relapsed/refractory indolent lymphoma. (regimens of prior chemotherapy are limited to 2; prior rituximab treatments up to 16 times are allowed.) * patients with measurable lesions (\> 1.5 cm). * patients who have not received any treatment for more than 4 weeks after completing previous therapies (6 months in the case of antibody therapies). * ecog performance status: 0 - 1 * patients with adequately maintained organ functions. exclusion criteria: * patients with infectious disease, serious complications, serious gastrointestinal symptoms, serious bleeding tendency, serious cns symptoms, fever \</=38 °c, interstitial pneumonia or pulmonary fibrosis, active other malignancies, autoimmune hemolytic anemia or the history of the disease, or glaucoma. * patients who are positive for hbs antigen, hcv antibody, or hiv antibody. * patients who received g-csf or transfusion within 1 week before the registration. * patients with the history of allergies to purine nucleoside analogue. * patients who experienced serious hypersensitivity or anaphylaxis to rituximab or mouse protein-derived products. * patients who had ever received prior therapy with fludarabine phosphate injection, pentostatin, cladribine, sh t 586, blood stem cell transplant, or monoclonal antibody therapy other than rituximab to nhl (including radioimmunotherapy). * patients who had progressive disease within 6 months of receiving therapy including rituximab. * women who are pregnant, of childbearing potential, or lactating. * patients who do not agree to practice contraception.
dana compared to mace in evaluation of suspected acute concussion

Conditions: Brain Concussion; Traumatic Brain Injury

Summary: the purpose of this study is to compare the sensitivity of the dana rapid exam with the mace cognitive score. the primary hypothesis is that the dana rapid exam will be more sensitive for detecting impaired cognitive performance than the mace cognitive score in the setting of a clinical diagnosis of concussion at the point of injury in the combat setting. a secondary purpose of this study is to examine a serial performance on the dana rapid exam in those subjects diagnosed with a concussion. the secondary hypothesis is that the dana rapid exam will show improvements in performance during the recovery period after concussion.

in operations iraqi freedom and enduring freedom (oif/oef), over 60% of combat casualties have been the result of explosive blasts, and many of these critical injuries involve trauma to the head. as a result, traumatic brain injury (tbi) has been deemed a "signature wound" of oif and oef. the symptoms of head injuries, particularly of concussion/mild tbi (mtbi), can be sever but subtle, suggesting that early and accurate diagnosis is paramount to a wounded warrior's appropriate medical care. most first providers in the war theater are medics who could benefit from an improved diagnostic test to better identify service members with concussion/mtbi. the mace cognitive test is heavily weighted towards memory, is not 100% specific, and does not preclude a diagnosis of concussion being rendered despite a score in the normal range. thus, an objective test of neurocognitive function, such as the dana rapid, that can be rapidly administered in theater by a combat medic would be highly beneficial to accurate clinical diagnosis and timely treatment. the results of the present study will provide information on the predictive value of the newly developed dana handheld computer in assisting in the diagnosis of concussion in service members who have been blast exposed. if the dana rapid exam proves to be equally or more accurate than the mace in detecting cognitive deficits, these tests and the handheld computer will also contribute to improved health care for service members by minimizing the time between injury and diagnosis.

Eligibility criteria:
inclusion criteria: * active duty military personnel * glasgow coma scale (gcs)score of 15, as assessed by the study member at the time of clinical evaluation following involvement in a mandatory event. * willingness to participate in the study, ability to communicate and comply with the study protocol and ability to provide informed consent exclusion criteria: * gcs score of less than 15

Keywords: concussion mild traumatic brain injury dana mace
the effect of n-3 fatty acids and fish on glucose and lipid metabolism in subjects with impaired glucose metabolism

Conditions: Hyperglycemia

Summary: the aim of the project is to examine whether the sources of n-3 fatty acids and fish itself differ in their effects on glucose metabolism, lipid metabolism, blood pressure, and serum inflammatory markers. lipidomic profiles and gene expression will be used for thorough assessment of the possible clinical changes. the study will compare the effects of alpha-linolenic acid containing vegetable oil, fatty fish, lean fish and control diet. the results of this project will help to identify the optimal source of n-3 fatty acids, and reveal the significance of the components of fish other than fatty acids. these data will be useful both nationally and internationally, since highly controlled dietary interventions utilizing new methodology are scarce.


Eligibility criteria:
inclusion criteria: * age 40-70 years * bmi 25-32 kg/m2 * fasting plasma glucose 5.6-7.0 mmol/l * 2 h plasma glucose in oral glucose tolerance test \<=11 mmol/l * fasting serum total cholesterol \<=7 mmol/l * fasting serum ldl cholesterol \<=5 mmol/l * fasting serum triglycerides \<=4 mmol/l exclusion criteria: * any chronic disease or condition that hamper the ability to follow dietary intervention * chronic liver, thyroid or kidney disease * alcohol abuse * diabetes * recent weight loss * recent myocardial infarction * corticosteroid therapy * psychiatric disorders which need drug treatment * cancer under treatment * fish allergy or other extensive food allergies * exceptional diets (like atkin's or vegan diet)
the national ct colonography trial

Conditions: Colorectal Cancer

Summary: rationale: new diagnostic procedures such as computed tomographic colonography may improve the ability to detect colorectal cancer and may provide a less invasive method of detection. purpose: this clinical trial is studying how well computed tomographic colonography works in screening healthy participants for colorectal cancer.

objectives: primary * compare the sensitivity of computed tomographic colonography (ctc) vs colonoscopy for detecting significantly large lesions (≥ 10 mm in diameter) in asymptomatic participants, in terms of specificity, area under the roc curve, and predictive values for detecting clinically significant colorectal neoplasia. secondary * determine the interobserver variation in accuracy of interpreting ctc examinations of these participants, including any benefits of a primary 3-dimensional read and/or independent second interpretations. * determine the effects of different colon preparations on the accuracy of ctc in these participants. * compare participant acceptance and willingness to have a repeat examination by ctc vs colonoscopy. * determine the accuracy of ctc in detecting flat lesions in the colon of these participants. outline: this is a multicenter study. participants receive an oral laxative, oral bisacodyl, and three doses of oral barium sulphate 24 hours before imaging. after cathartic cleansing, participants undergo computed tomographic colonography followed by colonoscopy. participants are followed up for approximately 4 weeks. projected accrual: a total of 2,607 participants will be accrued for this study.

Eligibility criteria:
1. inclusion criteria * male or female outpatients * aged 50 years or older * scheduled for screening colonoscopy * participant's signed informed consent 2. exclusion criteria * symptoms of disease of the lower gastrointestinal tract, including * melanotic stools or/and hematochezia on more than one occasion in the previous six months * lower abdominal pain that would normally require a medical evaluation * inflammatory bowel disease and/or familial polyposis syndrome * serious medical conditions that would increase the risk associated with colonoscopy or are so severe that screening would have no benefit * pregnancy * previous colonoscopy within the past five years * anemia (hemoglobin less than 10 gm/dl) * positive fecal occult blood test (fobt)

Keywords: colon cancer rectal cancer
the experiences of women with spinal cord injury regarding fertility, contraception and pregnancy

Conditions: Spinal Cord Injury

Summary: the aim of this study was to investigate the experiences of women with spinal cord injury regarding fertility, contraception and pregnancy.

although some studies exist in the literature on contraception and pregnancy in women with spinal cord injury, the data still remain insufficient. the aim of this study was to investigate the experiences of women with spinal cord injury regarding fertility, contraception and pregnancy.

Eligibility criteria:
inclusion criteria: * ages 18-55 * post-spinal cord injury period \> 1 year exclusion criteria: * having cognitive impairment

Keywords: fertility contraception pregnancy
correlation between headaches and septum and nasal mucosa contact

Conditions: Nasal Septum Deviation; Headache

Summary: headache is the most common complaint to neurologists. in the 80´s and 90's few papers, with limited number of patients, have proposed the association between nasal septum contact and headache. the international classification of headaches disorders proposed specific diagnostic criteria for this entity. with the major use of ct scans, the contact between nasal mucosa and septum is daily observed in many patients without complaint of headache. the purpose of this study is to determine if there is any correlation between nasal and septum mucosa contact and the prevalence of headache. the investigators hypothesized that no correlation will be found using ct scans in a large series of patients.

every patient older than 18 years old whom underwent sinuses or facial computed tomography will be asked to answer a questionnaire, where he will be able to describe his headache features (if present) . this information will be correlated with patient images findings, which are going to be evaluated by head and neck radiologists blinded for clinical information. logistic regression model will be used to verify this association; the presence of sinusitis and fever will used be as covariates.

Eligibility criteria:
inclusion criteria: * all patients older than 18 years whom underwent sinuses or facial tomography. exclusion criteria: * patients with clinical history of trauma

Keywords: nasal septum headache mucosa contact point headache
a prospective study for the early diagnosis of lung cancer in korean females

Conditions: Health Risk Behaviors

Summary: this is a single-arm prospective pilot study in a single institution. the target accrual is 200 participants of korean, female sex, never smoker status, and family history of lung cancer. the study will aim to enroll 200 participants in two years.

interested individuals will contact a research coordinator who will help to assess for study eligibility. individuals who are eligible and able to sign informed consent will then proceed to have a ldct screening exam with a result reported by a radiologist approved to read lung cancer screening scans. results of this screening test will be discussed with the subject and further recommendations will be given. negative results will proceed to have repeat ldct exams for two additional years. positive results will be recommended to have further diagnostic work-up, and possible treatment. those with positive findings may be recommended to repeat a ldct at varied intervals (e.g. at 3 months, at 6 months, etc.) per lung-rads recommendations which can be conducted as a research ldct or as standard-of-care. in addition, blood draw collection for a plasma-based assay will be collected at baseline, first year and second year for all patients along with the repeated ldct scans. a medical history questionnaire containing questions regarding ethnicity, family history of lung cancer, environmental exposures including secondhand smoke exposure, and a residential district to estimate the exposure of pm2.5 or pm10 will be given to the patient at the initial visit after informed consent has been obtained (appendix a). questionnaire can be collected within 1 month from the baseline consent.

Eligibility criteria:
inclusion criteria: 1. age 45-74 years old 2. korean female 3. never smoker defined as a lifetime exposure of less than 100 cigarettes 4. family history of lung cancer at first degree relatives (parents, siblings, or children) exclusion criteria: 1. prior history of lung cancer. 2. diagnosis of any cancer within the past five years 3. participation in a cancer prevention trial. 4. present symptoms suggestive of current lung cancer, including: unexplained weight loss of over 5 kilograms within the last 12 months or unexplained hemoptysis. 5. medical or psychiatric condition precluding informed medical consent. 6. history of ldct screening, chest ct, pet or pet/ct scan within 10 years