Kornimate/medical-research-clean huggingface dataset:
dermacyd tina gel sweet flower - photo evaluation

Conditions: Healthy

Summary: the purpose of this study is to prove the absence of photo irritation and photo sensitivity potential of the product dermacyd tina gel sweet flower.


Eligibility criteria:
inclusion criteria: * phototype skin ii and iii * integral skin test in the region exclusion criteria: * lactation or gestation * use of antiinflammatory and/or immunosuppression drugs 15 days before the selection * diseases which can cause immunity decrease, such as hiv, diabetes * use of drug photosensitizer * history of sensitivity or irritation for topic products * active cutaneous disease which can change the study results * history or photodermatosis active * family or personal antecedent of cutaneous photoinduced neoplasias * presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium * intense solar exposure in the study area * use of new drugs or cosmetics during the study the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: hygiene
canvas - canagliflozin cardiovascular assessment study

Conditions: Diabetes Mellitus, Type 2; Cardiovascular Diseases; Risk Factors

Summary: the study will assess canagliflozin (jnj-28431754) in the treatment of patients with type 2 diabetes mellitus (t2dm) with regard to cardiovascular (cv) risk for major adverse cardiac events (mace). other objectives include evaluating the overall safety, tolerability, and effectiveness of canagliflozin. the data from this study will be combined with the data from canvas-r study (study of the effects of canagliflozin on renal endpoints in adult subjects with t2dm, nct01989754) in a pre-specified integrated analysis of cv safety outcomes to satisfy us fda post-marketing requirements for canagliflozin.

the study will evaluate canagliflozin compared to placebo on cv events including cv death, heart attack, and stroke in patients with t2dm, whose diabetes is not well controlled at the beginning of the study and who have a history of cv events or have a high risk for cv events. the study includes 3 substudies which will compare the effectiveness of lowering blood glucose and assess the safety of canagliflozin relative to placebo in patients receiving specific commonly-used diabetes agents. 4,330 participants will be randomly assigned to treatment with 1 of 2 doses of canagliflozin (100 or 300 mg) or placebo, in a 1:1:1 ratio. this study was originally designed to last for up to 9 years. as per fda post-marketing requirements for canagliflozin, the study's last subject last visit will now occur when enough mace events (ie, cv death, nonfatal myocardial infarction, nonfatal stroke) are accumulated between the canvas (this study) and canvas-r studies. the completion target was reached in february 2017.

Eligibility criteria:
inclusion criteria: * patients must have a diagnosis of type 2 diabetes mellitus and greater than or equal to (\>=) 30 yrs old with history of cardiovascular (cv) event, or \>= 50 yrs old with high risk of cv events * patients must have inadequate diabetes control (as defined by glycosylated hemoglobin greater than or equal to 7.0% to less than or equal to 10.5% at screening) and be either (1) not currently on diabetes drug therapy or (2) on therapy with any approved class of diabetes drugs exclusion criteria: * a history of diabetic ketoacidosis, type 1 diabetes mellitus, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy * history of one or more severe hypoglycemic (ie, very low blood sugar) episode within 6 months before screening

Keywords: diabetes type 2 diabetes mellitus cardiovascular risk cardiovascular outcomes canagliflozin (jnj-28431754) placebo
a multicenter observational study on the development and health effects of premature ovarian insufficiency

Conditions: Premature Ovarian Insufficiency

Summary: premature ovarian insufficiency (poi) refers to the occurrence of ovarian hypofunction in women before the age of 40, which seriously affects women's overall health and quality of life. however, there is currently insufficient understanding of the risk factors, pathogenesis, short-term and long-term health effects of poi, and the health effects of the disease, and there is a lack of high-quality evidence to support clinical diagnosis and treatment decisions. this study intends to construct a hospital-based multi-center poi case-control and prospective special disease cohort, after baseline assessment and follow-up monitoring, collect disease characteristics, lifestyle, social psychology, environmental and occupational exposure, biological samples and other data, aiming to observe poi the natural occurrence, progression and health impact of poi, clarify the risk factors of poi, evaluate the impact of poi on women's health and disease risk, and discuss the benefits, risks and options of hrt for poi patients. the results of this study will deepen and expand the understanding of the occurrence and development of poi and its short-term and long-term health effects, provide high-level evidence for optimizing poi prevention, diagnosis and treatment strategies, and establish a long-term management system, laying the foundation for interventional research.


Eligibility criteria:
inclusion criteria: * age 18-39 years old * meet poi diagnostic criteria * volunteer to participate in this study and willing to cooperate with the investigation exclusion criteria: * reproductive endocrine disease * those receiving hormone supplementation and other steroid-containing drug therapy now or within half a year * chromosomal abnormalities * pregnancy and breastfeeding women * uncontrolled endocrine system diseases * uncontrolled cardiovascular system diseases * uncontrolled autoimmune related diseases * abnormal liver function * abnormal kidney function * abnormal coagulation function * severe anemia * history of malignant tumors * history of radiotherapy * history of chemotherapy * mental impairment * cognitive impairment

Keywords: premature ovarian insufficiency
benefits of a bolus calculator in pediatric patients on multiple daily insulin injections

Conditions: Poor Glycemic Control; Quality of Life

Summary: it it hypothesized that children and adolescents with type 1 diabetes, who are counting carbohydrates can achieve better metabolic control by concurrent use of the accu-chek aviva expert. additionally, it is proposed that carbohydrate counting in combination with the the accu-chek aviva expert will lead to better quality of life as a result of fewer restrictions when eating and less variation in blood glucose.

carbohydrate (carb) counting is a meal planning approach for patients with diabetes mellitus that focuses on carbohydrate as the primary nutrient affecting postprandial glycaemic response. in the early 1990's the diabetes control and complications trial (dcct) used carb counting as one of its education tools. more recently, short acting insulin analogues and insulin pumps have made the role of carb counting important and popular. carb counting can be used to estimate carbohydrate intake and adjust insulin around mixed meals and snacks using insulin to carbohydrate ratio. this effectively addresses the variable eating habits of most children and adolescents. carb counting can make food planning more flexible and thus more acceptable for young patients with diabetes. roche has recently launched the accu-chek aviva expert recently preliminary tested in adults4, being a blood glucose meter with integrated bolus calculator and memory function. this bolus calculator estimates the dose of insulin to be administrated on the basis of the following parameters: current blood glucose, grams of carbohydrate, carbohydrate to insulin ratio, insulin sensitivity, target blood glucose and insulin action time. hypothesis: it is hypothesized that paediatric patients in mdi therapy with suboptimal regulated diabetes will achieve better glycemic control by using accu-chek aviva expert rather than carbohydrate counting alone without the use of an external calculator.

Eligibility criteria:
inclusion criteria: * - patients with type 1 diabetes (n=120) age \> 1 year and \< 18 years * diabetes duration \>12 months * mdi therapy (fast acting analog for meals; long acting analog as basal) * hba1c \> 7.0% and \<11% exclusion criteria: * insulin pump therapy * missing consent declaration

Keywords: metabolic control quality of life
safety and efficacy of bendamustine, gemcitabine, rituximab, nivolumab (begern) in patients with r/r dlbcl

Conditions: Diffuse Large B Cell Lymphoma

Summary: despite the current advances in clinical oncology, the prognosis of patients with resistant diffuse large b cell lymphoma or relapse after high dose chemotherapy is dismal. therefore there is a need for the introduction of novel treatment regimens. this phase i/ii trial evaluates the safety and efficacy of combination bendamustine, gemcitabine, nivolumab and rituximab in patients with relapsed or refractory diffuse large b-cell lymphoma. the safety of combination treatment will be evaluated with the determination of recommended dose schedule prior to expansion of enrollment to evaluate the antitumor activity of bendamustine, gemcitabine, rituximab, and nivolumab.


Eligibility criteria:
inclusion criteria: * diagnosis: histologically confirmed diffuse large b-cell lymphoma * refractory or relapsed after at least two prior lines of treatment (i.e. induction and salvage regimen) for diffuse large b-cell lymphoma. * age 18-70 years old * eastern cooperative oncology group (ecog) performance status (ps) 0-2 * signed informed consent * no severe concurrent illness exclusion criteria: * uncontrolled bacterial or fungal infection at the time of enrollment * requirement for vasopressor support at the time of enrollment * karnofsky index \<30% * pregnancy * somatic or psychiatric disorder making the patient unable to sign informed consent * active or prior documented autoimmune disease requiring systemic treatment.

Keywords: diffuse large b-cell lymphoma nivolumab bendamustine hydrochloride gemcitabine rituximab
assessing the sensitivity of "suretouch™" in women undergoing diagnostic and screening mammography

Conditions: Breast Cancer

Summary: prospective, case-control study being conducted to determine the sensitivity of the suretouch device in detecting known masses at a pre-determined level of specificity.

this is a single-center, prospective, case-control study being conducted to determine the sensitivity of the suretouch device in detecting known masses at a pre-determined level of specificity. results of the mammography will be compared to the suretouch examination results. subjects will have between 1 and 3 research visits and 3 follow-up surveys, up to two years from the initial visit. the number of visits will be based upon comparison of the suretouch examination to conventional breast screening techniques (mammogram and ultrasound).

Eligibility criteria:
inclusion criteria: arm 1: * female subject presenting for screening mammography * 30-80 years of age, inclusive * able to provide written informed consent arm 2: * female subject presenting for diagnostic appointment and/or biopsy * 30-80 years of age, inclusive * 1-3 masses per breast * masses between 0.5 cm and 3.5 cm only exclusion criteria: * individuals who are unable to comprehend or unwilling to sign an informed consent form * women younger than 30 or older than 80 * pregnant women * women who have undergone bilateral mastectomies * males * prisoners * masses which are larger than 3.5 cm or smaller than 0.5 cm in size * individuals with more than 3 masses per breast will be excluded due to the complexity of these cases

Keywords: breast screening elastography
clinical study of high-intensity focused ultrasound tumor treatment system(super knife) in the treatment of breast cancer

Conditions: Breast Cancer

Summary: breast cancer is the most common cancer diagnosed among women and is the second leading cause of cancer death among women after lung cancer. the treatment methods of breast cancer include surgery, chemotherapy, radiotherapy and so on. the investigators discover a high-intensity focused ultrasound therapy to treat breast tumor, which is a non-invasive method.


Eligibility criteria:
inclusion criteria: ecog performance status of 0-1; histological confirmed invasive breast cancer; breast cancer tumor measuring ≥2 cm in maximal diameter and a single lesion as measured by mammogram, breast ultrasound, or breast mri; breast tumor's borders from the skin are greater than 1 cm; no lymph node or distant metastasis; absolute neutrophil count (anc) ≥ 1.5 × 109/l, platelets ≥ 50 × 109/l, hemoglobin ≥ 9.0 g/dl iv; serum creatinine ≤1.5 x upper limit of normal (uln); ast ≤ 2.5 x uln, alt ≤ 2.5 x uln; left ventricular ejection fraction ≥ 50%. exclusion criteria: inflammatory breast cancer, bilateral breast cancer, or occult breast cancer; any kind of prior treatment for breast cancer, including chemotherapy, radiotherapy, endocrine therapy and so on; pregnant and lactating women; patients who have participated in other clinical trials.

Keywords: breast cancer
discussion on the association model of traditional chinese medi-cine body constitution and female infertility

Conditions: Association Model; Chinese Medicine Physique Types; Health Care Base on Traditional Chinese Medicine; Women Infertility

Summary: abstract background: infertility may cause physiological and psychological distress. the health promotion administration in taiwan has listed infertility improvement under the "reproductive health and prevention section" in the whole person wellness policy. methods: this study was based on an exploratory research design. it used artificial intelligence algorithms such as logistic regression and association rules, and constructed the association model between the physique literature of traditional chinese medicine and common demographic variables. results: the participants showed three types of constitutions in traditional chinese medicine, namely yin deficiency, yang deficiency, and phlegm stasis. infertile women who prefer to eat heavy or sour-tasting foods were 2.8 times more likely to have ovarian factors than those who do not like to eat those foods. conclusions: based on the correction between physique type and the demographic variables of infertile women, care based on traditional chinese medicine should be pro-vided to improve the body constitutions of infertile women.

abstract background: infertility may cause physiological and psychological distress. the health promotion administration in taiwan has listed infertility improvement under the "reproductive health and prevention section" in the whole person wellness policy. methods: this study was based on an exploratory research design. it used artificial intelligence algorithms such as logistic regression and association rules, and constructed the association model between the physique literature of traditional chinese medicine and common demographic variables. results: the participants showed three types of constitutions in traditional chinese medicine, namely yin deficiency, yang deficiency, and phlegm stasis. infertile women who prefer to eat heavy or sour-tasting foods were 2.8 times more likely to have ovarian factors than those who do not like to eat those foods. conclusions: based on the correction between physique type and the demographic variables of infertile women, care based on traditional chinese medicine should be pro-vided to improve the body constitutions of infertile women.

Eligibility criteria:
inclusion criteria: * female exclusion criteria: * male
prolonged gadolinium retention after mri imaging

Conditions: Heavy Metal Toxicity

Summary: the researchers propose to investigate the prevalence of gadolinium in the urine of patients with a prior gadolinium-enhanced mri before and after a edetate calcium disodium challenge. moreover, will investigate if there is any correlation of gadolinium urine levels with levels of endogenous (e.g zinc) and xenobiotic metals.

the investigators propose to enroll 20 volunteers in this pilot study, including males older than 20 years and postmenopausal women in two groups: group 1: individuals who had a gadolinium-enhanced mri study within 1-4 weeks before participation and group 2: individuals who had gadolinium-enhanced mri study within 3-6 months before enrollment. the results will inform future analyses of gadolinium retention, excretion, and potential symptoms associated with same. thus, the specific aims of this cross sectional study are to: 1. evaluate levels of gadolinium in the urine of adults with normal kidney function and a prior mri performed within 6 months at baseline, and after a single dose of edetate calcium disodium . 2. evaluate levels of endogenous and xenobiotic metal levels and their relationship with gadolinium levels. 3. evaluate for symptoms of gadolinium toxicity.

Eligibility criteria:
inclusion criteria: • subjects who had a contrast enhanced mri for any indication within 1-4 weeks or 3-6 months, and normal renal function assessed by normal glomerular filtration rate (gfr) \>60 ml/min/1.73 m2 at the time of the gadolinium-enhanced mri study. exclusion criteria: * allergy to edetate calcium disodium * prior chelation therapy with edetate disodium since the administration of gadolinium * blood pressure \>160/100 * no venous access * platelet count \<100,000/mm3 * liver disease or alanine transaminase (alt) or aspartate transaminase (ast) \>2.0 times the upper limit of normal * diseases of copper, iron, or calcium metabolism * women of child-bearing potential * history of lead intoxication; lead encephalopathy; cerebral edema.

Keywords: gadolinium calcium disodium ethylenediaminetetraacetic acid (edta) heavy metal toxicity
effectiveness of home based occupational therapy for dementia.

Conditions: Dementia

Summary: the purpose of this study is to determine if a home based occupational therapy is effective in the treatment of dementia.


Eligibility criteria:
inclusion criteria: 1. dementia (according to dsm-iv tr) 2. a score 26 to 12 on the mmse 3. must be 55 or older 4. patient is living at home or therapeutical flat sharing 5. primary care giver at least 2 days / week available at home 6. written informed consent from patient and care giver 7. german as dominant language exclusion criteria: 1. other dementia (p.e. frontotemporal dementia, dementia with lewy bodies, creutzfeldt-jakob disease, parkinson's disease or atypical parkinson's syndromes 2. dementia with relevant displaying behavioural problems (neuropsychiatric inventory; npi, subscore ≥ 8) 3. depressive episodes (geriatric depression scale, gds (short version) ≥ 6) 4. mental disability 5. home based occupational therapy for dementia within the last 6 months 6. impairment of visual and/or acoustic cognition which does not allow occupational therapy 7. apoplexy with movement disorders which does not allow occupational therapy 8. severe physical/systemic illnesses (cardio-pulmonal, hematological or metabolic) which do not allow participating 9. recent history of addictive disorder 10. intermittent intake of depressant medication, that likely causes an impairment of cognitive performance during the trial 11. participation in another clinical trial
the role of wb-mri in the evaluation of prostate cancer patients treated with lutetium - prostate specific membrane antigen (lu-psma)

Conditions: Metastatic Castration Resistant Prostate Cancer (mCRPC)

Summary: the role of wb-mri in the evaluation of prostate cancer patients treated with lu-psma

multicentric, observational, single arm, prospective, study. all patients will undergo imaging assessments according to clinical practice or to lu-psma tumor institute of romagna (irst) 185.03 protocol, as follows: * baseline, before the treatment with lu-psma, ct and wb-mri will be performed * at the end of treatment with lu-psma, ct and wb-mri will be performed * in post-treatment follow-up every 4 months, until progression or for 1 year, ct and wb-mri will be performed. patients participating in this observational study will not be subjected to any additional procedure that falls outside the clinical practice or the study 185.03 lu-psma trial at irst.

Eligibility criteria:
inclusion criteria: - patients with mcrpc enrolled in the tumor institute of romagna (irst) 185.03 lu-psma protocol, performing baseline ct and wb-mri examinations and at least one ct and wb-mri re-evaluation. exclusion criteria: * no exclusion criteria

Keywords: wb-mri (whole body- magnetic resonance imaging) 177lu-psma 617 metastatic castration resistant prostate cancer (mcrpc) radio metabolic therapy (rmt)
brighter bites - access, continuity and education with fruits and vegetables

Conditions: Childhood Obesity

Summary: the purpose of the research is to find out how well a new nutrition program works for elementary school students and their families. this program is called brighter bites. brighter bites is a school-based program that teaches students and their parents about the importance of eating fresh fruits and vegetables and how to prepare them in tasty, healthy ways. this project is being carried out at six elementary schools in houston, texas. up to 600 first grade students and their parents/guardians are expected to join this project.


Eligibility criteria:
inclusion criteria: * child is in enrolled in the 1st grade in the participating school exclusion criteria: * none
comparison of 2 hyperglycemia-correction scales in hospitalized patients

Conditions: Diabete Type 2; Hyperglycemia

Summary: hyperglycemia in the hospital is associated with multiple adverse outcomes. previously, the mobile insulin scheme was used for its control. however, in the last decade, several studies have shown that the insulin basal-bolus (basal plus) regimen is associated with better glycemic control and a lower risk of hypoglycemia.

introduction: hyperglycemia in the hospital is associated with multiple adverse outcomes. previously, the mobile insulin scheme was used for its control. however, in the last decade, several studies have shown that the insulin basal-bolus (basal plus) regimen is associated with better glycemic control and a lower risk of hypoglycemia. objective: to compare the sensitive scheme of umpierrez and the correction factor suggested by davidson (1700/total dose of insulin) for the correction of hyperglycemia in patients with type 1 diabetes mellitus. methods: unblinded, randomized, controlled clinical trial in patients with hyperglycemia and type 2 diabetes mellitus hospitalized at a hospital in bogotá, colombia, between 2016 and 2018. a probabilistic sampling with randomly permuted blocks was performed. the umpierrez sensitive correction scheme and the davidson correction factor were compared by evaluating glycemic control at 2 and 5 hours, and the presence of hypoglycemia.

Eligibility criteria:
inclusion criteria: * patients with diabetes mellitus who presented hyperglycemia (above 140 mg/dl) located in the general ward, emergency room or hospitalization and who received a basal or basal bolus insulin scheme. exclusion criteria: * pregnancy, with acute decompensation of diabetes (diabetic ketoacidosis-hyperosmolar state) or type 1 diabetes

Keywords: diabetes mellitus hyperglycemia hospitalization treatment hypoglycemia