Kornimate/medical-research-clean huggingface dataset:
gemcitabine plus cisplatin versus gemcitabine plus carboplatin in triple negative breast cancer (tnbc)

Conditions: Breast Cancer

Summary: gemcitabine plus cisplatin versus gemcitabine plus carboplatin in triple negative breast cancer (tnbc)

a phase ii, single-center, open-label, randomized study of gemcitabine plus cisplatin (gp) versus gemcitabine plus carboplatin (gc) as first-line treatment in patients with advanced triple-negative breast cancer.

Eligibility criteria:
inclusion criteria: 1. histological proven unresectable recurrent or advanced breast cancer, including de novo stage iv disease. 2. triple-negative for estrogen receptor (er), progestogen receptor (pr), and human epithelial receptor-2 (her2) by immunohistochemistry (er \<1%, pr \<1% and her2 negative). a negative her2 gene amplification should be verified by fish test for those patients with her2 (2+). for those with her2 (1+), fish test might be considered by the investigator. 3. no prior chemotherapy for metastatic breast cancer is permitted. prior administration of chemotherapy in the adjuvant/neoadjuvant setting is acceptable if completed 6 months before the enrollment. 4. at least one measurable disease according to the response evaluation criteria in solid tumor (recist 1.1) 5. performance status no more than 1 6. all patients enrolled are required to have adequate hematologic, hepatic, and renal function 7. life expectancy longer than 12 weeks 8. no serious medical history of heart, lung, liver and kidney 9. be able to understand the study procedures and sign informed consent. 10. patients with good compliance exclusion criteria: 1. pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days before the first day of drug dosing, or, if positive, a pregnancy should be ruled out by ultrasound) 2. women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study 3. treatment with radiotherapy at the axial skeleton within 4 weeks before the first treatment or has not recovered from all toxicities of previous radiotherapy 4. treatment with an investigational product within 4 weeks before the first treatment 5. patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. radiotherapy should be completed within 4 weeks prior to the registration 6. other active malignancies (including other hematologic malignancies) or other malignancies within the last 5 years, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia. 7. patients having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions 8. uncontrolled serious infection

Keywords: triple negative breast cancer fine line chemotherapy
typical flutter ablation:a comparison of 4 mm versus 2 mm irrigated cathéters

Conditions: Typical Atrial Flutter; Radiofrequency Ablation; Irrigated Catheters

Summary: the purpose of this study is to compare the efficacy of 4 mm irrigated catheters with 2 mm irrigated catheters for ablation of typical flutter.it's a prospective randomised multicenter study.


Eligibility criteria:
inclusion criteria: * all patients above the age 18 years undergoing a first catheter ablation for typical atrial flutter exclusion criteria: * pregnancy * hemodynamic instability * a recurrence of previous ablated typical atrial flutter
chinese medicine treat for hypertensive renal injury

Conditions: Hypertension; Renal Injury

Summary: this study evaluates whether the traditional chinese medicine (qianyangyuyin formula) could prevent and treat early renal injury in patients with hypertension and microalbuminuria (defined as a urinary albumin to creatinine ratio between 30 and 300 mg/g) based on standard antihypertensive treatment.

hypertension is the main cardiovascular disease and the most important risk factor for severe lethal and disabling diseases such as stroke, myocardial infarction, heart failure, and chronic renal insufficiency. the higher the blood pressure level, the higher the risk of these diseases. antihypertensive drugs can control blood pressure, and effectively reduce the risk of these serious complications. a multi-center, randomized, parallel, placebo-controlled clinical study was designed to explore the effectiveness and safety of early intervention of chinese medicine (qianyanguuyin formula) in improving urinary albumin to creatinine ratio (acr), based on standard antihypertensive treatment (losartan 100mg qd, if necessary combined with calcium channel blockers). patients were recruited if they were (1) age between 35 and 55 years old, (2) primary hypertension (grades 2-3 ), (3) microalbuminuria (acr of 30-300 mg/g) and egfr of at least 60 ml / (min∙1.73m2), (4) ascendant hyperactivity of liver yang or yin deficiency in tcm syndrome. it's intented to form a standardized plan for the prevention and treatment of early renal injury in hypertensive patients.

Eligibility criteria:
inclusion criteria: * subject has primary hypertension(grades 2-3) * subject has microalbuminuria \[defined as a urinary albumin/creatinine ratio (uacr) between 30 and 300mg/g, and a egfr at least 60ml/(min∙1.73m2)\] * subject has ascendant hyperactivity of liver yang or yin deficiency in tcm syndrome * subject voluntarily participates in the trial and signs informed consent exclusion criteria: * subject has secondary hypertension * subject with pregnancy or lactating * subject has serious life-threatening diseases, such as acute myocardial infarction, stroke, heart failure (nyha iv), and malignant arrhythmia * subject's liver function (ast or alt) is 2 times greater than normal value * subject has history of mental illness * subject currently participates in other drug clinical trials

Keywords: hypertension chronic kidney disease traditional chinese medicine early renal injury albumin to creatinine ratio(uacr)
vitamin d deficiency in elderly african american women in central texas

Conditions: Vitamin D Deficiency; Osteoporosis; Osteopenia

Summary: in order to make bone health a reality for older adults, we need to consider the prevalence of vitamin d deficiency in relation to environment latitude as well as vitamin d supplementation. darker skin pigmentation and aging are known factors influencing the body's ability to synthesis adequate amounts of vitamin d. the aim of this project is to document vitamin d deficiency in elderly african american women living in a southern latitude.

summary: since darker skin pigmentation and aging are known factors influencing the body's ability to synthesis adequate amounts of vitamin d, we hypothesize that: 1) the usual sun exposure in the southern united states may not be sufficient to maintain adequate vitamin d levels in elderly african american women, 2) recommended supplementation of vitamin d 400 iu/d may not be adequate to prevent vitamin d deficiency which in turn could lead to calcium deficiency and possibly sub-clinical hyperparathyroidism. this study will enroll 60 african american women age 65 or older who do not have renal, hepatic or gastrointestinal disorders that could affect vitamin d and calcium absorption and metabolism. patients will have two scheduled office visits. demographic data will be collected with attention to dietary intake of calcium and vitamin d, and the patient's customary degree of sun exposure. ca, 25-hydroxyvitamin d, pth and serum ctx (a bone resorption marker) are measured on enrollment day and repeated 6 weeks later. all patients not already taking 1000 mg calcium with 400 iu of vitamin d orally daily were given samples of this supplement to last for 6 weeks without making any change in diet or sun exposure recommendations. the study period will extend april to june - a time when there should be ample sunlight but it is not so hot as to stop the elderly from going outdoors. statistical analysis will be performed as to the effect(s) of ethnic background, age, diet, and intensity of sun exposure as related to ca, 25-hydroxyvitamin d, pth and serum ctx.

Eligibility criteria:
inclusion criteria: 1. age 70 or older woman 2. african american ethnicity 3. non-institutionalized exclusion criteria: 1. de-compensated hepatic insufficiency 2. renal insufficiency with gfr estimated to be \< 30 ml/min 3. gastrointestinal disorders that might affect absorption such as known malabsorption, celiac sprue, short gut or blind loop syndrome. 4. institutionalized

Keywords: hyperparathyroidism hypoparathyroidism calcium vitamin d bone mineral density african american female elderly
mono: symbicort® single inhaler therapy and conventional best standard treatment for the treatment of persistent asthma in adolescents and adults

Conditions: Asthma

Summary: the purpose of the study is to compare the efficacy of a flexible dose of symbicort (budesonide/formoterol) with conventional stepwise best standard treatment in patients with persistent asthma.


Eligibility criteria:
inclusion criteria: * diagnosis of asthma \>= 3 months * prescribed daily use of glucocorticosteroids for at least 3 months prior to visit 1 exclusion criteria: * smoking history \> 10 pack-years * asthma exacerbation requiring change in asthma treatment during the last 14 days prior to inclusion * any significant disease or disorder that may jeopardize the safety of the patient. additional inclusion and exclusion criteria will be evaluated by the investigator.
concordance between etco2, ptco2 and paco2 in the home-ventilated neuromuscular patient

Conditions: Neuromuscular Disease; Chronic Respiratory Insufficiency; Intermittent Positive-pressure Ventilation

Summary: the purpose of this study is to compare the measure of the co2 obtained on the end-tidal expiratory gas (etco2) with the value of co2 obtained by transcutaneous measure (ptco2), in home-ventilated neuromuscular patients.

monitoring of the effectiveness of ventilation in patients with neuromuscular require to regularly measure blood gases and in particular carbon dioxide (co2). the reference technique is arterial puncture. in recent years, a non-invasive techniques measuring co2 by transcutaneous sensor (ptco2) was introduced among the tools regularly used for follow-up monitoring of home ventilated patients. another technique for monitoring co2, originally developed for anesthesia, is based on the measurement of exhaled co2 (etco2). this technique requires relatively simple equipment, and represents a potential alternative for monitoring home-ventilated patients. recently, sensors for etco2 were coupled to devices for home ventilation. to the best of our knowledge, the role of etco2 in monitoring long-term ventilated patients has not been investigated to date. the purpose of the study is to analyze the correlation between the two non-invasive methods for measuring co2: ptco2 and etco2, in a group of home-ventilated patients with neuromuscular disease. the patients will be recruited during a routine follow-up hospitalization for their home-ventilation, and the etco2 will be measured during one night, in addition to the routinely measured ptco2.

Eligibility criteria:
inclusion criteria: * patient with neuromuscular disease, treated with home invasive or non-invasive ventilation * male or female age higher or equal to 18 years * negative pregnancy test for women of childbearing age or having an effective contraception exclusion criteria: * acute respiratory failure * long-term oxygen therapy * refusal to participate in the study * plan of legal protection * pregnant women * failure to cooperate * no affiliation to a social security scheme

Keywords: neuromuscular disease home ventilation end tidal co2 transcutaneous co2 monitoring
invest1d: promoting adolescent investment in diabetes care

Conditions: Type 1 Diabetes

Summary: the goal of this clinical trial is to see if a financial incentives program called invest1d is helpful to support diabetes management in adolescents with type 1 diabetes. adolescent participants will be randomized to usual care or receive financial incentives for meeting diabetes self-management and clinical outcomes goals during the study. researchers will compare changes in glucose levels, as well as adolescent and caregiver person-reported outcomes between groups.

adolescents face many challenges as they transition from childhood to adulthood. for adolescents with type 1 diabetes, there are additional responsibilities that come with daily diabetes self-management. the goal of this study is to find out whether financial incentives can help adolescents with their daily self-management. adolescent participants will be assigned to one of 6 groups. some participants will be asked to choose diabetes self-management goals such as increasing daily bolus insulin administration or increasing their continuous glucose monitoring system wear time, and then will be provided with financial incentives (money) when they meet their selected goals. other participants will be asked to continue their diabetes management as usual. researchers will collect data from 96 adolescent participants and their caregivers to assess change in glucose levels, as well as adolescent and caregiver person-reported outcomes.

Eligibility criteria:
inclusion criteria: * diagnosed with type 1 diabetes ≥12 months * utilize a continuous glucose monitor (cgm) to support diabetes management * average daily cgm use is less than or equal to 70% of the time and/or their baseline average insulin bolus administration is less than or equal to 3 times a day * are using diabetes technology that allows for tracking of bolus insulin administration if participant wants to work on improving daily bolus insulin administration * cognitively able to participate in incentive program and complete surveys * have access to a mobile phone to receive information about goal attainment and incentive updates * have the ability to upload glucose and insulin administration data remotely per processes used by participant's diabetes care team * caregivers are willing to participate in study and complete surveys exclusion criteria: * at time of screening, average cgm wear is greater than 70% of the time or baseline average insulin bolus administration is greater than 3 times a day * adolescent is not interested in using diabetes technology that allows for tracking of bolus insulin administration if participant wants to work on improving daily bolus insulin administration * cognitively or physically unable to participate * adolescent is a ward of the state * severe comorbidities including other major chronic health conditions that significantly impact daily management demands or health outcomes * caregivers are not willing to participate in study and complete surveys
effectiveness of two therapeutic approaches in female teachers with voice disorders

Conditions: Voice Disorders

Summary: the study compares two different approaches of voice therapy. vocal functional exercises (stemple,1997) and voice amplification using a portable amplifier (tsi supervoz ii - tecnisystem do brasil tsi 1210).

both approaches combined with vocal hygiene program (behlau, 2007).the target population are female teachers because they have the highest risk for developing voice problems. for this study the investigators are primarily interested in seeing if vocal functional exercises and voice amplification are equally effective at improving vocal functioning in teachers with voice disorders. the fiberoptic endoscopic evaluation will be done before randomization. all the participants will complete before and after a 6-week treatment phase (a) voice activity and participation profile (ppav), an instrument designed to appraise the self-perceived psychosocial consequences of voice disorders to assess the impact of voice disorders on daily activities (b) audio voice recording for later acoustic analysis, through the kay elemetrics multi dimensional voice program (c) audio recording for later perceptual analysis through consensus auditory-perceptual evaluation of voice (cape_v). it is believed that the search for evidence in clinical studies like this can contribute to awareness programs and vocal training for teachers.

Eligibility criteria:
inclusion criteria: * female teacher * 21-50 years old. * full or part time elementary to middle school teacher ( prefeitura municipal de belo horizonte). * minimum 20 hour weekly workload. * medical reference to speech therapy due to behavioral dysphonia exclusion criteria: * physical education or daycare teachers. * professional singers. * neurological and/or psychiatric voice disorders

Keywords: voice disorders voice
a study of sleeve gastrectomy risks and benefits

Conditions: Renal Failure

Summary: this research study is being conducted to collect information to improve the outcomes of patients who have renal failure and are scheduled to have a sleeve gastrectomy.

we will collect information on changes in physical performance, activity, blood pressure and glucose metabolism, body composition, and the quality of life prior to and three months after sleeve gastrectomy.

Eligibility criteria:
inclusion criteria: * kidney transplant candidates with obesity. * accepted for sleeve gastrectomy (sg). * accepted for kidney transplantation if criteria are met after sg. exclusion criteria: * not undergoing sleeve gastrectomy. * unable to connect through telehealth technology. * history of medical non-adherence that can affect adherence to the protocol. * any other medical condition that in the opinion of the principal investigators warrants exclusion for safety reasons.

Keywords: sleeve gastrectomy
soluble neprilysin, nt-probnp, and growth-differentiation-factor-15 as biomarkers for heart failure in dialysis patients

Conditions: Heart Failure; End Stage Renal Disease

Summary: objectives: the aim of this study is to determine whether growth differentiation factor-15 (gdf15) and circulating neprilysin (cnep) improve the diagnosis of congestive heart failure (hf) in patients on dialysis. background: dialysis patients are at increased risk of hf. however, diagnostic utility of nt-probnp as a biomarker is decreased in patients on dialysis. gdf15 and cnep are biomarkers of distinct mechanisms that may contribute to hf pathophysiology in such cohorts. methods: we compare circulating concentrations of nt-probnp, gdf15, and cnep along with nep activity in patients on chronic dialysis without and with hf, as diagnosed by clinical parameters and post-dialysis echocardiography. we use correlation, linear and logistic regression as well as receiver operating characteristic (roc) analyses.


Eligibility criteria:
inclusion criteria: * esrd on either chronic hemodialysis (hd) or peritoneal dialysis (pd) for ≥3 months exclusion criteria: * previous switch of the type of renal replacement therapy from hd to pd or vice versa * age \<18 years * pregnancy * plasma exchange or apheresis in the past 6 months * unipolar pacemaker * history of whole extremity amputation

Keywords: congestive heart failure (hf) biomarker chronic kidney disease (ckd) hemodialysis (hd) peritoneal dialysis (pd) neprilysin (nep) growth differentiation factor-15 (gdf15)
normalization of dyrk1a and app function as an approach to improve cognitive performance and decelerate ad progression in ds subjects: epigallocatechin gallate as therapeutic tool

Conditions: Down Syndrome (DS)

Summary: epigallocatechin-3-gallate (egcg), the major catechin in green tea, is postulated to modulate dual specificity tyrosine-phosphorylation-regulated kinase 1a (dyrk1a) and amyloid beta precursor protein (app) gene overexpression in the brains of down syndrome mouse models. the clinical study is aimed at demonstrating that normalization of dyrk1a and app functions is a therapeutic approach to improve cognitive performance and decelerate ad (alzheimer's disease) like progression.


Eligibility criteria:
inclusion criteria: * have been diagnosed of ds neurological disease, aged between 14-29 years. * have given the consent to participate (official custody). exclusion criteria: * subjects with neurological disease other than ds, relevant medical disease, co-morbid mental disorder or currently taking any treatment that could interfere with cognitive function or alter any key biomarkers and biochemical parameters analyzed. * having suffered from any major illness or undergoing major surgery in the last three months before the study. * regular ingestion of medication in the month preceding the study (exceptions for single doses of symptomatic medication administered up to the week preceding the trial). * current ingestion of vitamin supplements or catechins or aine in the two weeks preceding the study. * history of gastrointestinal, hepatic or renal problems or any other cause that may alter processes of absorption, distribution, metabolism, or excretion of the drug, or that might suggest gastrointestinal irritation to drug. * subjects following a vegetarian diet. * practice of physical exercise for more than 2 hours per day or energy consume/consumption of more than 3000 kcal per week.

Keywords: app function (amyloid precursor protein, cognitive stimulation, alzheimer disease. program