Kornimate/medical-research-clean huggingface dataset:
efficacy and safety study of a modified sox regimen in first-line treatment of unresectable gastric adenocarcinoma

Conditions: Gastric Adenocarcinoma

Summary: this is an open-label, phase ii study to evaluate the efficacy and safety of a modified regimen of oxaliplatin and s-1 on unresectable gastric adenocarcinoma in the first-line therapy.

primary endpoint: overall response rate secondary endpoint: time to progression, overall survival, safety data

Eligibility criteria:
inclusion criteria: * signed written informed consent; * patients with histologically or cytologically confirmed unresectable gastric adenocarcinoma whose ecog performance status are 0-2; * presence of measurable disease by radiographic study (including ct or mri scan, or chest x-ray) or physical examination; * at least 3 weeks since last major surgery; * at least 12 months since last adjuvant chemotherapy; * at least 6 weeks since prior radiotherapy providing that the extent and site of radiotherapy fields are such that marked bone marrow suppression is not expected; * patients who have received palliative radiotherapy must have recovered from any reversible toxic effects e.g. nausea and vomiting caused by radiation of fields; * patients with reproductive potential must use effective bc; * required screening laboratory criteria: * hemoglobin 90g/l * wbc 3.5 x 109/l * neutrophils 1.5 x 109/l * platelets 100 x 109/l * creatinine 133 umol/l and creatinine clearance 60 ml/min * a probable life expectancy of at least 6 months; exclusion criteria: * brain metastases; * female of childbearing potential, pregnancy test is positive; * concomitant malignancies or previous malignancies other than colorectal cancer within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or low grade prostate cancer; * active infection; * concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk; * sexually active patients refusing to practice adequate contraception; * patients with conditions which might affect absorption of an oral drug (for example intermittent obstruction) unless discussed and agreed with principal investigator; * history of grade 3 or 4 toxicity to fluoropyrimidines; * pre-existing neuropathy ≥ nci ctc grade 2.

Keywords: gastric cancer adenocarcinoma sox
detection of coronary stenosis with intravenous microbubbles

Conditions: Coronary Stenosis; Carotid Stenosis; Myocardial Reperfusion

Summary: to detect coronary artery disease by both coronary and carotid artery imaging and myocardial perfusion imaging using a new low mechanical index real time system.

the objective of this clinical study will be to visualize both coronary and carotid arteries as well as detect myocardial perfusion following a routine intravenous injection of definity (0.05-0.20 millimeters), optison (0.1-0.4 millimeters) or pesda (0.05-0.2 ml). following these injections , we will attempt to contrast pulse sequencing on the siemens acuson sequoia system to image both the coronary and carotid arteries, as well as the myocardial perfusion.

Eligibility criteria:
inclusion criteria: * subjects scheduled for routine echocardiogram to look for evidence of coronary artery disease or a stress echocardiogram * women of child-bearing potential must be taking a medically approved form of birth control with a negative urine pregnancy test * be conscious and coherent, and be able to communicate effectively with study personnel * last eight patients will be diabetics who smoke * provide informed consent after receiving a verbal and written explanation of the purpose and nature of the study exclusion criteria: * severe valvular heart disease by doppler echocardiography * females of child-bearing potential who are not taking a medically approved method of birth control will be excluded. if the patient is pregnant she will be excluded. * patients who are allergic to blood or blood products will be excluded * have contraindication to optison, definity, or pesda (pulmonary htn, cardiac shunt) * non diabetics, non smokers
impact of recurrence score on adjuvant treatment decisions in breast cancer patients

Conditions: Breast Cancer Female

Summary: irma is a prospective, monocenter, non-interventional investigator initiated (iit) registry that aims to investigate the use of the ce-marked oncotypedx and its impact on adjuvant therapy recommendations in the clinical routine. additionally, the proportion of patients with low, intermediate and high rs in predefined clinical subgroups will be determined. to evaluate the impact of the rs on tumor cell dissemination, these subgroups also include dtc-negative versus dtc-positive patients.


Eligibility criteria:
inclusion criteria: * women ≥ 18 years of age * histologically proven unilateral primary non-metastatic invasive breast cancer * er-/ or pr- positive and her2-negative * n0-n1 (0-3 involved lymph-nodes). the nodal status may be evaluated clinically. * surgery or planed surgery at the department of women's health, tuebingen * written informed consent into irma exclusion criteria: * er-negative * her2-positive * \> 3 involved lymph-nodes * bilateral breast cancer * preexisting cancer disease within the last 10 years * preexisting invasive ipsi- or contralateral breast cancer (non-invasive ipsi- or contralateral breast cancer is not regarded as an exclusion criteria) * primary systemic therapy * locally advanced, inoperable or metastatic breast cancer * pregnant or lactating patients * inadequate general condition (not fit for chemotherapy)
pharmacokinetics of valacyclovir oral solution in children

Conditions: Herpes Simplex Virus Infection; Varicella Zoster Virus Infection

Summary: valacyclovir has replaced acyclovir in many clinical scenarios. pharmacokinetic data support the use of oral valacyclovir in children, but practical problems exist in children having to take adult-dose tablets. a formulation with acceptable palatability, good pharmaceutical quality and possibility of flexible dosing is developed. pharmacokinetic data of this formulation is missing. the present study investigates the pharmacokinetics of valacyclovir oral solution in children by determine the area under the curve (auc0-12), time above critical concentration (ccrit), cmax and tmax of acyclovir. secondary, the safety profile of a single dose of valacyclovir oral solution will be determined.


Eligibility criteria:
inclusion criteria: * subject is in the age of 2-12 years. * subject has an indication for (val)acyclovir prophylaxis and are planned to receive valacyclovir oral solution. * subject is managed with a central venous catheter (cvc/port-a-cath). * subject's parents have signed the informed consent form prior to screening evaluations. * subject is willing to participate after study procedures are explained in comprehensible language for the child. exclusion criteria: * severe anemia (\<6.0 mmol/l). * full dose has not been taken.
vitamin d estimation with giardia lamblia infections

Conditions: Giardia Lamblia Infection

Summary: investigators will take stool and blood samples from two groups of humans :- 1-group a (healthy group negative giardia or control group),2-group b (positive giardia or case group)then investigators make estimation for vitamin d in both groups then investigators try to find if there is relation between vitamin d level and giardia lamblia infections

in this research a case- control study will be used) ,the percentage of case to control will be 1:1 the total number of samples 192 ,investigators will take stool and blood samples from two groups of humans :- 1-group a (healthy group negative giardia or control group),2-group b (positive giardia or case group)then investigators make estimation for vitamin d in both groups then investigators try to find if there is relation between vitamin d level and giardia lamblia infections

Eligibility criteria:
inclusion criteria: * patient infected with giardia lamblia. exclusion criteria: * patient takes vitamin d supplement - patient has kidney disease- patient has liver disease-patient has a debilitating disease disease such as cancer or diabetes.

Keywords: estimaion of vitamin d in humans infected with giardia lamblia
incidence oird medical and trauma patients

Conditions: Respiratory Depression; Sedation

Summary: the primary objective of this prospective, blinded observational study is to correlate assessment of sedation and respiratory status with capnography and pulse oximetry monitoring in hospitalized adult medical and trauma patients receiving patient-controlled analgesia (pca) or nurse administered intravenous opioids for acute pain. nursing assessment of respiratory status and sedation level will be correlated with capnography and pulse oximetry values as technology-supported monitoring to identify respiratory depression and opioid-induced sedation. the secondary objective is to identify capnography and pulse oximetry values that correlate with respiratory decompensation and opioid-induced sedation in medical and trauma patients on the general care floor.


Eligibility criteria:
inclusion criteria: 1. spontaneously breathing adults 18 to 89 years of age 2. receiving pca or nurse administered iv opioids for medical or trauma-related pain 3. admitted to the general care floor from the emergency department 4. able to provide written informed consent exclusion criteria: 1. age is less than 18 years or greater than 89 years 2. transfer to the general care floor from the icu 3. provider order for respiratory monitoring using continuous capnography 4. receiving intrathecal or epidural opioids 5. trauma patient with a nerve block 6. inability or unwillingness to wear the etco2 sampling line nasal cannula or pulse oximetry sensor 7. history or diagnosis of a sleep disordered breathing syndrome 8. use of cpap or bipap non-invasive ventilation as home regime 9. pre-existing co-morbidity that impacts respiration or ventilation (e.g. copd or pulmonary fibrosis) (for the purpose of this study a trauma patient with rib fractures is not considered having a pre-existing condition) 10. receiving non-invasive ventilation 11. unable or unwilling to participate 12. member of a vulnerable population such as pregnant women or prisoners
monocenter, open label clinical investigation on the treatment of radiation induced dermatitis with xonrid®

Conditions: Radiodermatitis; Quality of Life

Summary: to evaluate the performance of xonrid® in the prevention and treatment of g2 radiation dermatitis in breast and head \& neck cancer patients.

the aim of this clinical investigation is to evaluate if the use of xonrid® in the prevention and treatment of g2 radiation dermatitis in breast and head \& neck cancer patients can be a valid support, when compared to the standard of care as defined by mascc (multinational association for supportive care in cancer) guidelines.

Eligibility criteria:
inclusion criteria: 1. male and female which are 18 years of age or older 2. performance status \< 2 3. epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinus and salivary glands or breast cancer, planned to receive a total dose of at least 50 gy 4. postoperative or curative radiation treatment 5. concurrent chemotherapy is accepted, in head \& neck cancer patients 6. patients willing and able to give signed informed consent and, in the opinion of the investigator, to comply with the clinical investigation plan tests and procedures. exclusion criteria: 1. pregnant or lactating women 2. planned to receive concurrent cetuximab 3. previous radiation therapy on the head and neck area or breast and thorax areas 4. cutaneous and connective diseases (i.e. lupus erythematosus or scleroderma) 5. systemic diseases known to delay the skin healing process such as diabetes mellitus or severe renal failure 6. use of a tissue-equivalent bolus 7. use of over-the-counter topical medications containing steroids 8. presence of rashes or unhealed wounds in the radiation field 9. recent sun exposure 10. mental conditions that could adversely affect patients' adherence to the study.
treatment of clogged tympanostomy tubes: an off-label use of dornase alfa (pulmozyme®)

Conditions: Otitis Media

Summary: the purpose of this study is to evaluate pulmozyme® (dornase) as compared to a standard ear drop floxin® (ofloxicin) to dissolve clogged tubes. this study will monitor the use of the new drug for any problems related to the medication. patients are being asked to be in this study because they had tubes placed for the treatment of chronic ear infection and the tube(s) are now clogged. clogged tubes are a common problem found in children with tubes. this problem occasionally is improved with ear drops like floxin®. however, it is frequently not improved even after this standard ear drop treatment.

the success in treating blocked tubes may relate to the ability to dissolve the material clogging the tube as well as dealing with the thick fluid in the middle-ear. the reasoning behind this study is that the use of pulmozyme® may be able to treat both of these problems. pulmozyme® was approved by the fda in 1994 for the treatment of cystic fibrosis patients. infections present in airway (lung) secretions of cystic fibrosis patients and the material that plugs ear tubes are in some ways the same. "off-label" use of a drug is the practice by physicians to use a fda-approved drug in treating conditions other than what the original approval was intended for. pulmozyme® has been used to treat other lung diseases not related to cystic fibrosis. there has been no published report on the use of pulmozyme® to treat ear infections. this study is a clinical trial that compares two treatments and will last for 3 months.

Eligibility criteria:
inclusion criteria: * subjects from age 1 to 18 years who have undergone tube placement in the previous 9 months. * subjects with middle-ear fluid on entry into the study will be required to have had a prior normal hearing test. exclusion criteria: * subjects with symptoms of an acute otitis media (otalgia or otorrhea), sensorineural hearing loss,cranio-facial syndromes, cystic fibrosis, prior ear surgery except tube placement, sensitivity to fluoroquinolones and presence of granulation tissue in the lumen of the tympanostomy tubes will be excluded.

Keywords: clogged ear tubes
promoting breast cancer screening in women who survived childhood cancer

Conditions: Breast Neoplasms; Early Detection of Cancer

Summary: the primary purpose of this study is to determine the impact of maximizing patient and primary care provider (pcp) activation on breast cancer surveillance rates among women previously treated with chest radiotherapy (rt) for a childhood cancer. this is an 18-month, 3-arm randomized controlled trial using a smartphone intervention with data being collected at baseline and 18-months through patient and provider surveys and medical record review. eligible women treated for a childhood cancer with chest rt will be randomly sampled from the childhood cancer survivor study (ccss) and randomly selected to one of three groups: control, patient activation (pa) using a smartphone-based intervention, or patient activation + primary care provider activation (pa+pcp) which will include physician materials about breast cancer risk in this population along with guidelines for breast cancer surveillance. participants in all groups will receive mailed targeted print materials as an educational resource about their previous chest radiation and breast cancer screening recommendations. the primary outcome is a medical record confirmed breast mri and mammogram with the goal of increasing the rate of women completing the national guideline-based recommended combination of breast mri and mammogram. this study will test the hypothesis that women in the pa and pa+pcp groups will have significantly higher rates of breast cancer surveillance (breast mri and mammogram) than women in the control group. in addition, the hypothesis that women in the pa+pcp group will have significantly higher rates of breast cancer surveillance than women in the pa group will also be tested.


Eligibility criteria:
inclusion criteria: eligible participants will include women who: * were diagnosed with a childhood cancer prior to the age of 21 years; * were treated with ≥ 10 gy of chest rt (recent revision with a lower dose threshold);1 * do not have a history of breast cancer; * have not had both a breast mri and mammogram in the previous 24 months; * do not have a contraindication to mri (i.e., pacemaker); * are 25 years of age or older at time of enrollment; * have an interval from their chest rt to the time of enrollment of at least 8 years; * have a smartphone; * are english-speaking. participants will be selected from women in the childhood cancer survivor study (ccss) cohort.

Keywords: cancer survivors smartphone mobile applications
massage to increase well-being and immune function in dominican children infected with hiv

Conditions: HIV Infections; AIDS

Summary: the purpose of this study is to determine whether massage therapy can improve immune status and enhance well-being in children living in the dominican republic who are infected with hiv.

the incidence of pediatric hiv in the dominican republic has been rapidly rising, while antiretroviral therapies are not yet readily available to slow disease progression. there is compelling evidence that massage therapy may enhance immune status and alter the course of hiv disease. increased immune capacity and improvement in hiv disease progression markers have been demonstrated following massage therapy in hiv infected adolescents and adults, even in the absence of antiretroviral treatments. in studies with premature newborns, increased weight gain, decreased stress behavior, and more optimal cognitive and motor development have been reported following massage treatment. this study will examine the efficacy of massage therapy, an affordable and potentially beneficial complementary/alternative treatment, to promote health and enhance well-being in hiv infected children in the dominican republic. children will be randomly assigned to receive either massage therapy or standard care/friendly visits twice weekly for 12 weeks. data will be gathered to assess acceptance, safety, and compliance to massage therapy and to examine whether massage treatment has improved immune function, developmental performance, and behavioral function.

Eligibility criteria:
inclusion criteria: * hiv infection * parent/caregiver signature on consent form exclusion criteria: * unknown hiv status * fever, new opportunistic infection, or acute hospitalization within 30 days prior to study entry * massage therapy within 30 days prior to study entry * unable to have massage (e.g., extensive skin lesions) * symptoms of child abuse * child born drug-addicted

Keywords: complementary therapies
a home-based intervention to promote mindful breathing awareness through pursed-lip breathing training for copd patients

Conditions: COPD; Emphysema

Summary: in this study, a system will be developed to guide patients with chronic obstructive pulmonary disease (copd) to complete a mindful breathing practice at home. copd is the third leading cause of death in the united states and no cure exists. shortness of breath is the most common disabling symptom. pursed lips breathing is a type of breathing practice that has demonstrated effectiveness for patients with copd. it requires practice to maintain and there is currently no home system to provide the needed feedback and support to maintain plb. additionally, syncing breathing and heart rate variation offers patients additional benefits. the proposed project explores the use of biofeedback to guide copd patients in a breathing practice and to provide data for health coaching to monitor and support the practice.


Eligibility criteria:
patients eligible for pulmonary rehabilitation will be recruited for this study.
recorded maternal voice on the emergence of general anesthesia on pediatric patients

Conditions: Anesthesia, General

Summary: mother spend a large amount of time with their children. it is assumed that mother contributes to their neurological development not only with visual stimuli, but also with auditory stimuli. a recent study revealed that prefrontal cortex can be activated in response to the self-name being spoken by the mother than by a stranger. therefore, investigators suppose that recorded maternal voice can stimulate the pediatric patients and thereby fasten the emergence from general anesthesia.


Eligibility criteria:
inclusion criteria: * children aged between 2 and 8 years of american society of anesthesiologists physical status (asa ps) i or ii who are planned to receive ophthalmology or otorhinolaryngology surgery under general anesthesia exclusion criteria: * asa ps iii or iv * with developmental delay or neurological diseases associated with symptoms of agitation * refusal of consent * maternal mutism * absence of mother * with allergy or contraindication to use of ketamine (increased intracranial pressure, open-globe injury, and a psychiatric or seizure disorder)

Keywords: emergence delirium emergence time bispectral index
neoadjuvant ecs versus ecf in local advanced breast cancer

Conditions: Breast Neoplasms; Neoadjuvant Therapy

Summary: s-1 is a newly developed novel oral dihydrouracil dehydrogenase inhibiting fluoro-pyrimidine drug consisting of i m tegafur (ft), 0.4 m 5-chloro-2, 4-dihydroxypyrimidine (gimeracil), and 1 m potassium oxonate (oteracil), with efficient antitumor activity and low gastrointestinal toxicity. several studies have proved the safety and efficacy of single agent s-1 in metastatic breast cancer. this study is designed to further investigate and compare the efficacy and safety of epirubicin-cyclophosphamide-s-1(ecs) vs. epirubicin-cyclophosphamide-5-fluorouracil (ecf) as neoadjuvant chemotherapy in patients with local advanced breast cancer.


Eligibility criteria:
inclusion criteria: * disease characteristic: * histologically confirmed primary breast cancer by core biopsy (mammotome or bard needle) * disease stage appropriate for neoadjuvant chemotherapy (t≥3cm, n0 or t（2-3cm）n1 or any t, n2) * her-2(-); ki67≥14% * no previous treatment for breast cancer (chemotherapy, endocrinotherapy, radiotherapy) * patients characteristic: * female patients, age 18 to 70 years old * performance status- eastern cooperative oncology group (ecog) 0-2 * life expectancy of at least 12 weeks * willing to be kept follow-up * functions below are maintained in major organs: * cardiac status: lvef: 50% 45% • haematopoietic status: leukocyte count: ≥4.0×109/l neutrophil count: ≥2.0×109/l platelet count: ≥100×109/l hemoglobin: ≥80g/l • hepatic status: total bilirubin ≤ 1.5 x upper limit of normal (uln), ast and alt ≤ 2.5 times uln(no liver metastasis) bilirubin: • renal status: bun ≤ 1.5 x times uln creatinine ≤1.5 times uln or calculated creatinine clearance, using the cockcroft-gault formula, ≥50 ml/min; women's ccr = body weight x (140-age)/(72 x serum creatinine) x 0.85 • written informed consent (both biopsy and neoadjuvant chemotherapy) will be obtained for patients for entering this study exclusion criteria: * previous treatment for breast cancer (neither local nor systemic therapy) * known or suspected distant metastasis * potentially pregnant, pregnant, or breast-feeding * drug allergy * concurrent malignancy or history of other malignancy (except hodgkin lymphoma) * currently active severe infection (hepatitis included) * history of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures * known history of uncontrolled severe heart disease, myocardial infarction within 6 months, congestive heart failure, unstable angina pectoris, clinically significant hydropericardium or unstable arrhythmias

Keywords: local advanced breast neoplasms neoadjuvant chemotherapy s-1