Kornimate/medical-research-clean huggingface dataset:
lifestyle intervention for patients with impaired glucose regulation

Conditions: Overweight and Obesity

Summary: impaired glucose regulation (igr) is closely related to overweight/obesity. by studying different dietary patterns (energy-limited diet vs. low-carbohydrate diet) and intensive lifestyle interventions combined with blood glucose monitoring, glucose regulation of overweight/obesity is affected. to improve the blood glucose and related metabolic indexes of patients with impaired (igr), establish 1-2 clinical intervention programs for impaired glucose regulation.


Eligibility criteria:
inclusion criteria: * age 18-65 years old ② fasting blood glucose is between 5.6-6.9 mmol/l (100-125mg/dl) or oral glucose tolerance test (ogtt) 2h plasma glucose (2h-pg) is 7.8-11.1 mmol/l (140-200 mg/dl) * 24 kg/m2 ≤ bmi ≤ 35 kg/m2 * those who are willing to accept assessment and sign informed consent. exclusion criteria: * patients diagnosed with diabetes or undergoing diabetes treatment; * receiving drugs or surgery for weight loss at present or in the past 3 months; * receiving corticosteroid or thyroid hormone treatment; * secondary obesity caused by endocrine, genetic, metabolic and central nervous system diseases; * patients with abnormal liver function (alanine aminotransferase or/and aspartate aminotransferase exceeding the upper limit of normal value 3 times); patients with abnormal renal function (serum creatinine exceeding the upper limit of normal value); suffering from kidney disease and other diseases that need to control protein intake; * diseases affecting the digestion and absorption of food (such as chronic diarrhea, constipation, severe gastrointestinal inflammation, active gastrointestinal ulcer, gastrointestinal resection, cholecystitis/cholecystectomy, etc.); ⑦ suffering from cardiovascular and cerebrovascular diseases, grade 3 hypertension, chronic hepatitis, malignant tumors, anemia, mental illness and memory disorders, epilepsy and other diseases; ⑧ suffering from infectious diseases such as active tuberculosis and aids; ⑨ during pregnancy or lactation; ⑩patients with physical disabilities and clinicians think it is not suitable to participate in the study (for example, have a serious disease not included in the discharge criteria) or are unwilling to participate in this study.
neuroscience-informed treatment development for adolescent alcohol use

Conditions: Alcohol Drinking; Control

Summary: this study will examine the effect of n-acetylcysteine (nac), an over-the-counter antioxidant supplement, on brains of youth (ages 15-19) using magnetic resonance imaging (mri).

55 adolescents will receive, in a counterbalanced order, a 10-day course of nac 1200 mg twice daily and a subsequent 10-day course of matched placebo twice daily, separated by 11 days. urine and blood samples will be collected at baseline and urine samples again before and after each course of medication treatment. participants will receive a 1- hour mri scan at baseline and after each treatment trial.

Eligibility criteria:
inclusion criteria: participants were between the ages of 15-19 and may or may not have used alcohol. all participants in the alcohol-using group met criteria for heavy drinking, based on quantity and frequency of drinking (squeglia et al. 2011; squeglia et al. 2012) (see figure 2). exclusionary criteria: not having a parent to consent (for those under age 18); history of alcohol treatment or treatment-seeking; current dsm-5 diagnosis of moderate or severe substance use disorder other than alcohol or cannabis (american psychiatric association 2013); positive urine toxicology screen for narcotics, amphetamines, sedatives, hypnotics, or opiates (not prescribed by a doctor); alcohol withdrawal (\> 10 on the clinical institute withdrawal assessment for alcohol (sullivan et al. 1989); medical conditions or medications that contraindicate taking nac; current use of n-acetylcysteine or any supplement containing n-acetylcysteine (must agree not to take any such supplement throughout study participation); medical history of severe asthma (uncontrolled with medication); history of a serious medical, psychiatric, or neurological problem that could affect neural response, brain development, or study participation, including diabetes, seizure disorder, and severe head injury with loss of consciousness; history of learning disability, pervasive developmental disorder, or other condition requiring special education; current use of psychoactive medications that affect cerebral blood flow; non-correctable visual or hearing problems; non-fluent in english; mri contraindications (e.g., braces, claustrophobia, irremovable metal implants or piercings); (for females) pregnancy or refusal to use reliable methods of birth control; refusal of blood draw, abstinence from alcohol for \>14 days before participation, and use of alcohol \<12 hours before scanning (confirmed with breathalyzer). while cigarette and marijuana use will not be exclusionary, we will exclude any participants who are daily users of cannabis or tobacco.

Keywords: adolescent
low dose tamoxifen for mammographic density reduction

Conditions: Risk Reduction; Mammographic Density Reduction

Summary: karisma2 is a randomized, double-blinded, six-armed placebo controlled study to identify a low dose of tamoxifen, with less side-effects and a density reduction non-inferior to the standard dose of 20 mg.

this is a dose determination study aiming to identify the optimal tamoxifen dose for reducing the risk of breast cancer. the change in mammographic density is a very good marker of therapy response. investigators will test if 1 mg, 2.5 mg, 5 mg and 10 mg reduce the mammographic density to the same extent as 20 mg. 1440 healthy women 40-74 yrs were included when adhering the national swedish mammography screening program between 2016- 2019. women were randomized and treated daily for 6 months. mammograms were taken at baseline and at end of treatment and side effects were measured throughout the study trough schedueled questionnaires and spontaneous ae-reporting.

Eligibility criteria:
inclusion criteria: * attending the national mammography screening program, i.e. aged 40-74 and has performed a screening mammogram maximum 3 months prior to study inclusion * having a measurable mammographic density, i.e. ≥4.5 % density (volumetric) measured by volpara * informed consent must be signed before any study specific assessments have been performed exclusion criteria: * pregnancy at start, during time of study medication and up to 3 months after quitting study medication * breast feeding at start, during time of study medication and up to 3 months after quitting study medication * any previous or current diagnosis of breast cancer (including carcinoma in situ) * mammographic bi-rads code 3 or above at baseline mammography, or at a diagnostic mammography during time of treatment (the first 6 months of the study) * any previous diagnosis of cancer with the exception of non-melanoma skin cancer and in situ cancer of the cervix * currently using oral oestrogen and progesterone based hormone replacement therapy * current use of hormone contraceptive with hormones, e.g. hormonal contraceptive pills, or progesterone implants. hormonal intrauterine devices are accepted. * a history of thrombo-embolic disease such as embolies, deep vein thrombosis, stroke, tia or cardiac arrest. * known apc (activated protein c )- resistance, an inherited hemostatic disorder * a history of major surgery of the breast, e.g. reduction or enlargement, which might affect density measurements * women who have an increased risk of venous thrombosis due to immobilization, e.g. using wheelchair * known uncontrolled diabetes * hypertension at baseline, defined as systolic pressure higher than 140 mm hg and diastolic higher than 90 mm hg * use of drugs that interfere with cyp2d6 expression such as seroxat (paroxetine), fontex (fluoxetin) and zyban / voxra (bupropion) * use of waran (warfarin) * non-medical approved drugs against hot-flashes including phytooestrogen * not able to understand study information and/or informed consent

Keywords: breast cancer prevention tamoxifen
study of heat shock protein-peptide complex (hsppc-96) versus il-2/dtic for stage iv melanoma

Conditions: Malignant Melanoma

Summary: the primary goal of this study is to determine if people with metastatic melanoma who receive heat shock protein-peptide complex - 96 (hsppc-96 or oncophage) after surgery live longer than people who may or may not have surgery but who receive conventional chemotherapy including il-2/dtic. a second goal is to determine the safety and frequency of side effects in subjects who receive therapy with hsppc-96.

primary objective: * to determine whether subjects with stage iv melanoma randomized to hsppc-96 have longer survival than subjects randomized to physician's choice including interleukin-2 and/or dacarbazine/temozolomide and/or complete tumor resection. secondary objective: * to determine frequency of adverse events in subjects randomized to hsppc-96.

Eligibility criteria:
eligibility assessment: (the following assessments must be obtained within three weeks prior to randomization into the study) * medical history and physical examination (including egog score, evidence of immunosuppression); * ct/mri of the chest, abdomen and pelvis; * clinical examination; * ct/mri of the brain; * complete blood count with differential including platelets; * electrolytes (na, cl, k, hco3, ca, mg, po4); * renal function tests (bun and creatinine); * liver function tests (bilirubin, ast, alt); * serum pregnancy test for all women of childbearing potential. inclusion criteria: * stage iv melanoma (ajcc); * no prior therapy for stage iv melanoma; * no prior therapy with interleukin-2 and/or dacarbazine/temozolomide within the past 12 months prior to study entry; * candidate for surgical resection of some/all sites of melanoma and expected to obtain greater tan or equal to 7 grams of viable cancer tissue (in aggregate), which is equivalent to a greater than or equal to 2 cm lesion on ct/mri or clinical examination; * no brain metastases; * ecog score 0 or 1; * adequate cardiac function; * adequate hematopoietic, liver and renal function; * female subjects of child-bearing potential must agree to use contraception during the study * signed written informed consent. exclusion criteria: * mucosal or ocular melanomas; * other malignancies treated within the last five years, except in situ cervix carcinoma or non-melanoma skin cancer; * primary or secondary immunodeficiency, in the opinion of the investigator (including immunosuppressive disease, or use of systemic corticosteroids or other immunosuppressive medications); * prior splenectomy; * uncontrolled infection or other serious medical illnesses; * women who are pregnant or breast-feeding; * subjects participating in any other studies requiring administration of an investigational drug/biologic agent.

Keywords: immunotherapy, cancer, melanoma, skin cancer, tumor
shave margins in breast conservation therapy

Conditions: Breast Cancer; Cancer of Breast; Cancer of the Breast

Summary: the investigators propose a randomized controlled superiority trial of standard breast-conserving surgery (bcs) versus bcs with cavity shave margins (csm). the main objectives of this trial will be to evaluate prospectively the impact of routine standardized csm on margin status following primary surgery for early stage breast cancer (stage 0 - ii), on post-operative patient satisfaction and cosmetic outcomes, and on general intraoperative time and operative costs. a parallel group format will be implemented to compare this modified surgical therapy - bcs with csm - with bcs alone, which is the current standard of care.


Eligibility criteria:
inclusion criteria: * newly diagnosed, biopsy-proven stage 0-ii breast cancer. * planning to undergo breast-conserving surgery. * at least 18 years of age and no more than 85 years of age. * female. * able to understand and willing to sign an irb-approved written informed consent document. exclusion criteria: * prior surgical treatment for this diagnosis. * undergone neoadjuvant chemotherapy. * history of prior chest radiation therapy. * known metastatic disease. * pregnant. * preference for mastectomy instead of breast-conserving surgery. * history of ipsilateral breast cancer. * goggle assessment substudy: iodine or seafood allergies.
modifying the home television watching environment

Conditions: Obesity; Body Weight Changes

Summary: the purpose of this study is to determine if limiting television (tv) and computer time will result in a stabilization or smaller increase in body mass index (bmi), lower energy intake, and increased physical activity in 4-7 year old obese (\>85th bmi percentile) children over two years.

there is a positive correlation between obesity and television watching in adults and children. and, television watching, controlling for current obesity, is a predictor of future obesity. almost half of all children watch 3 or more hours of television each day. the american academy of pediatrics recommends that children watch no more than 1-2 hours each day. families will be randomized to one of two conditions. half the families will be taught to use the tv allowance to reduce their child's tv and computer use by one-half over a six month period and the other half will use the device to monitor tv watching (control group). this study uses tv allowance units to monitor home television watching, video game playing, and computer use. the tv allowance can also be used to limit the amount of tv and computer use by programming it to allow a specific number of hours for each family member. heights, weights, food intake, and physical activity will be measured at baseline and every six months. the purpose of this study is to determine if limiting television and computer time will result in a stabilization or smaller increase in bmi, lower energy intake, and increased physical activity in 4-7 year old obese (\>85th bmi percentile) children over two years.

Eligibility criteria:
* greater than the 85th bmi percentile * minimum of 15 hours of tv watching, computer use, and video game playing per week * no medical conditions that may affect the child's ability to safely participate in physical activity

Keywords: physical activity television child obesity reduce tv usual control
intracardiac t-wave alternans and ischemia

Conditions: Ischemia

Summary: t-wave alternans is a test that looks at microvolt changes in the t-wave on a beat to beat basis. the presence or absence of such changes has been shown to predict or exclude future arrhythmic events. the mechanism of t-wave alternans is unclear, but may relate to calcium metabolism in the heart, and may be affected by conditions such as ischemia or heart failure. the purpose of this study is to determine whether t-wave alternans, as measured through the lead of an implantable defibrillator, is produced by acute ischemia induced by occlusion during percutaneous coronary interventions.


Eligibility criteria:
inclusion criteria: * patient with cad undergoing pci with appropriate medtronic implantable defibrillator. exclusion criteria: * non-elective procedure * non-qualifying defibrillator type.
intravenous antibiotic treatment at home

Conditions: Infection

Summary: the purpose of the study is to develop and evaluate a new model for across services interaction with the use of welfare technology and telemedicine. the model includes innovative and new routines for the exchange of patient information, quality systems and procedures between the municipality and the hospital. this model will first be tested for use in intravenous antibiotic therapy. the results of the study will be used to further develop the service. in the larger context, it is desirable to provide knowledge that is transferable to other diagnostic groups, treatment methods and geographical areas.

this research-based innovation study has an evaluation approach with follow-up evaluation as the overall approach. the pre-project was carried out with a qualitative approach under the auspices of sintef 2018/2019. the main project consists of sub-study 1 and sub-study 2 (2020/2022). sub-study 1: the project use an iterative, user-centered service methodology with a qualitative approach. here, sintef has the main responsibility for a qualitative summary after conducting interviews, observations and group discussions with patients, next of kins and health professionals regarding the development and testing / quality assurance of the new concept / service course for home treatment. sub-study 2: the approach here is quantitative. descriptive data must be obtained from the hospital and municipal patient records, patient administration system (pas) at kristiansund hospital, alarm data from the regional response center and pump log from the individual patient's infusion pump after home treatment.

Eligibility criteria:
inclusion criteria: * main or bi-diagnosis during stay: a692 borreliosis g00 - g009 central nervous system inflammatory disorders i33 endocarditis j86 empyema d46.3 spondylodiscitis m86 osteomyelitis t84 prosthesis / osteosynthesis infections m00.0-m00.9 pyogen / septic arthritis j40-j47 chronic diseases of the lower respiratory tract * competent to give consent * the infection can not be treated with oral antibiotics in monotherapy * selected iv antibiotics must be suitable for administration via selected pumps * the patient's condition is stable and does not require frequent observation by health care professionals * the patient is motivated and willing to participate in intravenous treatment in home hospitals * must, after training, demonstrate mastery of practical procedures related to pump handling and any other procedures described in the patient's treatment plan * the home must be suitable for intravenous antibiotic treatment; access to refrigerators, hygienic conditions, social conditions * the patient must have a mobile phone and be able to handle the system for fast and secure communication with the regional response center (rro) exclusion criteria: * consent not given

Keywords: home care services, hospital-based telemedicine home infusion therapy hospital at home antibiotics
efficacy of methimazole dosing algorithm

Conditions: Graves Disease

Summary: to prospectively study the efficacy and safety of the cook county health (cch) methimazole (mmi) dosing algorithm in the setting of new onset graves' disease.

to conduct a prospective observational study in 60 patients with newly diagnosed graves' disease who are either methimazole naive or who have been initiated on mmi within previous 4-6 weeks per cch algorithm and assess for efficacy and safety of mmi dosing administered. study group size is based on 90% power and projected efficacy of 70% patients reaching target.

Eligibility criteria:
inclusion criteria: * non-pregnant adults (\>18 years of age) with new diagnosis of graves' disease (elevated free t4, free t3, low or suppressed tsh, positive tsi and or thyroid eye disease) and * either drug naïve or who have been initiated on mmi within previous 4-6 weeks per cch algorithm. exclusion criteria: * pregnant patients * hyperthyroidism due to other causes, example - toxic multinodular goiter, iodine induced thyrotoxicosis, etc. * graves patients who present with atrial fibrillation, chf or other end organ damage
acute health effects of high temperature exposure

Conditions: Cardiovascular System; Respiratory System; Cognitive Function

Summary: this is a randomized controlled human exposure crossover study. investigators aims to assess the acute effects of high temperature exposure and the underlying mechanisms.

the investigators will conduct a randomized controlled human exposure crossover study among about 30 healthy young adults in shanghai, china. each subject will be exposed twice: once to the high temperature (32℃) and once to moderate temperature (22℃) in a chamber for about 2 hours. during the exposure session, each subject will be requested to rest. health examinations will be conducted immediately prior to exposure, during the period of exposure and after exposure. health examinations include symptom questionnaire, blood pressure tests, cognitive function tests, magnetic resonance imaging, skin tests, spirometry, and holter monitoring. investigators plan to collect blood, urine and oropharyngeal swabs samples.

Eligibility criteria:
inclusion criteria: * living in shanghai during the study period; * body mass index \> 18.5 and ≤ 28; * right-handed; * receiving or having received higher education; * with ability to read and understand chinese smoothly. exclusion criteria: * smoking and alcohol abuse; * current drug and dietary supplements intake; * subjects with allergic diseases, such as allergic rhinitis, allergic asthma, and atopy; * subjects with cardiovascular diseases, such as congenital heart disease, pulmonary heart disease, and hypertension; * subjects with respiratory diseases, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease; * subjects with chronic diseases, such as diabetes, chronic hepatitis, and kidney disease; * subjects who have a history of major surgery due to the cardiovascular, cerebrovascular, respiratory, or neurological diseases; * subjects with neurologic disorders, such as stroke, traumatic brain injury, epilepsy, and schizophrenia; * abnormal spirometry (fev1 and fvc ≤ 75% of predicted and fev1/fvc ≤ 0.65); * subjects with color vision disabilities.

Keywords: high temperature randomized controlled trial cardiovascular effects cognitive function
hyaluronic acid gels for lower lid retraction

Conditions: Ectropion

Summary: lid retraction is a difficult problem encountered in oculofacial plastic surgery. it can result from previous surgery, radiotherapy or cicatrizing disease or it may be idiopathic. whatever the aetiology, the cosmetic appearance is troublesome to patients and, can be damaging to the cornea. the definitive therapy for lid retraction is surgical, and often involves complicated procedures including tissue grafting. hyaluronic acid gels (hag) have been fda approved for the treatment of facial rhytids by subcutaneous injection and volume addition. these gels have gained wide popularity in for cosmetic applications in filling volume deficit areas. functional applications in the periorbital area have also been described including the filling of volume deficit anophthalmic orbits, ectropion and loagophthalmos. additionally, pilot studies have found hag to be useful in correcting both upper and lower eyelid retraction, with good effect. the purpose of this investigation is to define the clinical utility of hag correction of lower eyelid retraction in terms of anatomic (lid position), quantitative (dry eye signs on cornea) and qualitative effects (symptom severity). our hypothesis is that hag correction of lower eyelid retraction will improve patient comfort, clinical signs of dry eye and aesthetic self image.


Eligibility criteria:
inclusion criteria: 1. lower eyelid retraction of \>1mm in one or both eyes. 2. complaints of either significant ocular symptoms (osdi\>13) or cosmetic deformity associated with the eyelid retraction. exclusion criteria: 1. age less than 21 years: due to lack of data on safety for hag fillers in pediatric population 2. age over 65 years of age: as hag filler effect may be different in this population 3. are pregnant or nursing: as there is little safety data on potential teratogenicity of hag fillers 4. have a demonstrated allergy to hag fillers or lidocaine 5. have a current infection, skin sore, pimple, rash, hive or cyst over the injection site: to avoid worsening the infection or transmitting it 6. have a bleeding disorder or currently taking blood-thinning medications such as coumadin or heparin on a daily basis. 7. currently active stage thyroid eye disease

Keywords: ectropion hyaluronic acid keratoconjunctivitis sicca lower eyelid retraction