Kornimate/medical-research-clean huggingface dataset:
real world study of lapatinib among metastatic breast cancer patients

Conditions: Breast Cancer

Summary: a multicenter, retrospective, real world study of lapatinib among metastatic breast cancer (mbc) patients in clinical practice.

this study collected patients used lapatinib-base therapy among mbc, and tried to figure out if there was difference between single anti-her2 treatment and dual anti-her2 treatment. furthermore, this study investigated the treatment after lapatinib.

Eligibility criteria:
inclusion criteria: * patients who were treated with lapatinib between june 2014 to june 2018. * patients experienced progression on prior trastuzumab-containing regimens and a taxane. * complete medical history was available. exclusion criteria: * medical history was incomplete.

Keywords: her2 lapatinib
3d interlocking miniplates in fixation of mandibular fractures in the mental foramen region: a split-mouth study

Conditions: Mandibular Fractures; Miniplate

Summary: the study aims to compare 3d interlocking miniplates with conventional miniplates in management of mandibular parasymphyseal fractures both clinically and radiographically.

a total of 12 patients with recent bilateral parasymphyseal mandibular fractures were treated with 3d interlocking miniplates on one side and with conventional two miniplates in the other side. clinical evaluations were carried at multiple intervals up to 6 weeks postoperatively, with radiographic assessments performed immediately after surgery and at 12 weeks to measure mean bone density at the fracture line

Eligibility criteria:
inclusion criteria: * patients with recent bilateral mandibular fracture located in the mental foramina region. * adults without gender predilection who agreed to follow-up, * fractures requiring open reduction and internal fixation, and * those medically fit for general anesthesia were included exclusion criteria: * medically compromised patients, * fractures with infection, * pathological or old fractures, * completely edentulous patients, * comminuted fractures

Keywords: mental nerve conventional miniplates 3d interlocking mandibular parasymphyseal fracture
tamoxifen therapy in amyotrophic lateral sclerosis [als]

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Summary: this is a single-center, phase 2 randomized clinical trial of tamoxifen on mean percent predicted isometric muscle strength in patients with amyotrophic lateral sclerosis (als). the purpose is to determine whether the triphenylethylenetamoxifen, used as adjuvant therapy in the treatment of breast cancer, can delay the loss of isometric muscle strength in als patients.


Eligibility criteria:
inclusion criteria: * clinically probable-laboratory supported, clinically probable, or clinically definite amyotrophic lateral sclerosis exclusion criteria: * allergic or idiosyncratic response to tamoxifen. * other active neurologic diseases that may produce weakness, sensory loss, or autonomic symptoms. * psychiatric, psychological, or behavioral symptoms that would interfere with the subject's ability to participate in the trial. * clinically significant cardiac, pulmonary, gastrointestinal, hematologic, or endocrine (poorly controlled insulin-dependent diabetes mellitus or hyperthyroidism) disease that may confound interpretation of the study results. * previous kidney or pancreas transplants. * significant hepatic or renal disease (ast \> 5 times normal, serum creatinine \> 2.0 mg/dl for males or \> 1.8 mg/dl for females).
remote dietary counseling to promote healthy diet and blood pressure

Conditions: Blood Pressure; High Blood Pressure; Dietary Modification; Overweight and Obesity

Summary: american college of cardiology/american heart association (acc/aha) hypertension guidelines recommend lifestyle modification for patients with elevated blood pressure. while eating a dietary approaches to stop hypertension (dash)-type diet, increasing physical activity, and weight loss have been shown to reduce blood pressure, limited resources are available in the primary care setting to help patients make these changes. in this study, the investigators will compare the efficacy of a self-guided vs. dietitian-led approach using web-based lifestyle modification tools to reduce weight, improve dietary quality, and lower blood pressure in overweight/obese adults with elevated blood pressure.

goals that all participants will be instructed to target include: 1) weight loss \>=3% at 3 months; 2) consume a healthier dietary pattern (high in fruits, vegetables, whole grains, low-fat dairy, vegetable/fish/poultry sources of protein, healthier sources of fat, and avoid sugar and salt); 3) reduce sodium intake to \<2300 mg/d; 4) at least 180 min/wk of moderate-intensity physical activity.

Eligibility criteria:
inclusion criteria: * 24-hour ambulatory sbp 120-160 mmhg * bmi ≥ 25 kg/m2 * access to a telephone * access to a computer or smartphone with internet access * complete dietary data entry for at least 5 out of 7 days during run-in period * enter weight into the platform during run-in period exclusion criteria: * inability to understand english * myocardial infarction, stroke, or atherosclerotic cardiovascular disease procedure within last 6 months. * current treatment for malignancy * planned or previous bariatric surgery * pregnant, breast-feeding, or planned pregnancy prior to the end of participation * self-reported average consumption of \> 21 alcoholic beverages per week or binge drinking. * psychiatric hospitalization in past year * current symptoms of angina * planning to leave the area prior to end of the study * current participation in another clinical trial * principal investigator discretion (i.e. concerns about safety, compliance)

Keywords: lifestyle modification dash diet weight loss exercise
transverse abdominal block for analgesia in casarean section

Conditions: Analgesia Disorder

Summary: in this study, the investigators will compare the analgesic effect of bupivacaine and bupivacaine-dexmetomedine after elective cesarean delivery by performing an bilateral tap block, on the patients for whom the operation will be performed under general anesthesia.

the investigators will study 60 asa \[american society of anesthesiologist\] physical status i and іі patients undergoing elective cesarean delivery at tanta university hospital, in a prospective, randomized, comparative, clinical trial. patients will be randomly allocated to two equal groups (n = 30) using closed envelopes labeled 1,and 2 reflecting group 1and 2 respectively. the drugs are prepared by the anesthesiologist who is not involved in the study or data collection. group i: (n=30) will receive pre-delivery bilateral tap block with 10 ml of bupivacaine 0.5 % mixed with 10 ml saline and 10 μg dexmetonedine in 20 ml syringe labeled g 2. group ii: (n=30) will receive post-delivery bilateral tap block with 10 ml of bupivacaine 0.5 % mixed with 10 ml saline in 20 ml syringe labeled g2.

Eligibility criteria:
inclusion criteria: 1. we will study 60 asa \[american society of anesthesiologist\] physical status i and іі patients undergoing elective cesarean delivery 2. age between 21-40 years old. exclusion criteria: 1. refusal of participation in the study 2. patients who have infection or tumor at the site of puncture for local anesthetic injection. 3. patients who have coagulopathy, platelet abnormalities, and concurrent treatment with anticoagulant drugs. 4. patients known to have allergy or sensitivity to dexmetomedine, and/or bupivacaine 5. severe hepatic and/or renal insufficiency 6. morbid obesity (body mass index (bmi) \>35) 7. psychological disease

Keywords: analgesia, casarean section, tap block
randomized phase iii study of sequential radiochemotherapy of anaplastic glioma with pcv or temozolomide

Conditions: Anaplastic Astrocytoma; Oligodendroglioma; Oligoastrocytoma

Summary: background: the optimal treatment of anaplastic gliomas is controversial. standard of care in most centers is still radiotherapy. this phase iii study compared the efficacy and safety of radiotherapy vs chemotherapy in patients (pts) with newly-diagnosed, supratentorial gliomas of who grade iii. methods: pts were randomized 2:1:1 between june 1999 and february 2005 in 34 german centers to receive (i) a 6-week course of radiotherapy (1,8-2 gy fractions, total dose 54-60 gy) or (ii) four 6-week cycles of ccnu at 110 mg mg/m2 on day 1, vincristine at 2 mg on days 8 and 29 and procarbazine at 60 mg/m2 on days 8-21 or eight 4-week cycles of 200 mg/m2 temozolomide on days 1-5. treatment was stopped prematurely at disease progression or occurrence of unacceptable toxicity. at this time or at disease progression, treatment in the radiotherapy group was continued with one of the chemotherapies (1:1 randomization) and with radiotherapy in both chemotherapy groups. the primary endpoint was time-to-treatment-failure (ttf) defined as progression after radiotherapy and one chemotherapy in either sequence, or any time before if further therapy could not be employed. assuming a 50% improvement in ttf of starting with chemotherapy, 318 pts were to be enrolled to provide 80% power to achieve statistical significance at a one-sided level of 0.05.


Eligibility criteria:
inclusion criteria: * written informed consent * centrally confirmed anaplastic glioma according to the who-classification 1998/2000 * age ≥ 18 years * karnofsky performance status (kps) of 70 or higher * no prior systemic chemotherapy or radiation therapy of the brain * no hiv infection * adequate bone marrow reserve, liver function, and renal function * patients on corticosteroids had to be on a stable or decreasing dosage within the 14 days prior to randomization exclusion criteria: * glioblastoma * infratentorial localization of the tumor * pregnancy or lactation period * serious medical or neurological comorbidity * additional malignancy requiring radio- or chemotherapy * known hypersensitivity against study drugs * inability to swallow * frequent emesis * psychological. familial, sociological or geographical situations impairing compliance with f/u examinations * parallel participation in other studies

Keywords: 1p/19q loss mgmt prognostic factors pcv temozolomide
flusafe: flu sms alerts to freeze exposure

Conditions: Influenza; Acute Respiratory Infection; Influenza-like Illness

Summary: influenza infection results in an estimated 31 million outpatient visits, 55,000 to 974,200 hospitalizations, and 3,000 to 49,000 deaths. membership in household in which someone else has influenza is the major risk factor for contracting influenza. the household secondary attack rate (sar) is as high as 19% based on laboratory-confirmed influenza and 30% based on symptoms. non-pharmaceutical preventive measures, including education, may play a role in decreasing transmission, but are only effective if started within 36 hours of symptom onset in index cases. yet, most interventions are delayed because they are not initiated until care is sought. the investigators have demonstrated in one primarily latino, urban community sample, that text messaging can be used to rapidly identify community members with influenza-like illness (ili) early in an illness. this early identification would enable implementation of an educational intervention in the optimal time frame to reduce influenza transmission. providing education within a text message is a proven successful strategy to influence behavior. text messaging itself is scalable, low-cost, and can be used in low literacy populations. however, using text-message based surveillance to trigger a real-time text-message behavioral educational intervention to decrease household influenza transmission has not been assessed.

the study will enroll approximately 400 households with ≥1 child recruited from four contiguous communities in new york city. households will be randomized, stratified by community 1:1 to receive surveillance-only (no text message education) vs. surveillance plus text message educational intervention. for symptom surveillance, households in both arms will receive text messages 3x/week during each influenza season and report if someone in the household has ili symptoms. for those in the educational intervention arm, when an ili/acute respiratory infections (ari) is reported, a series of educational text messages will be sent with information to decrease household transmission.

Eligibility criteria:
inclusion criteria: * ≥3 persons per household * at least one person who is less than 18 years old * english or spanish speaking * household reporter has cell phone with text messaging capabilities * household reporter willing to use text messages to report * reside within study neighborhoods in new york city exclusion criteria * intention to move away from new york city area in \<12 months * language other than english or spanish

Keywords: influenza text message influenza-like illness acute respiratory infection
eash dressing on chronic venous leg ulcers

Conditions: Leg Ulcer

Summary: the primary objective of this study is to evaluate the safety and preliminary performance of eash dressing for 4 weeks followed by aquacel® dressing for 4 weeks on venous leg ulcers.


Eligibility criteria:
inclusion criteria: * subjects over 18 years, willing and able to provide written informed consent. * subjects who have an ankle to brachial pressure index (abpi) of 0.8 or greater * subjects who have a venous leg ulcer (i.e. ceap classification of c6 1), with duration less than 24 months and size ranging between 5 cm2-40 cm2. * subjects' leg ulcers will meet at least 3 of the 5 following clinical signs of infection: pain between two dressing changes, peri-ulcer skin erythema/inflammation, oedema, malodour (foul odour), and heavy exudate. * subjects who agree to wear compression therapy daily in combination with the trial dressing. exclusion criteria: * subjects with a history of skin sensitivity to any of the components of the study product. * subjects who have had current local or systemic antibiotics in the week prior to inclusion with the exception of wounds that are considered to be clinically infected at baseline. * subjects whose leg ulcers are malignant, or who have had recent deep venous thrombosis or venous surgery within the last 3 months. * subjects who have progressive neoplastic lesion treated by radiotherapy or chemotherapy, or on-going treatment with immunosuppressive agents * subjects exhibiting any other medical condition which, according to the investigator, justifies the subject's exclusion from the study * subjects who have participated in a clinical study within the past month.
randomized trial of two analgesics in elderly ed patients

Conditions: Pain

Summary: the purpose of this study is to perform a randomized, double blind 2-arm clinical trial of the comparative efficacy of 2 oral analgesics in the the management of acute pain in elderly patients who present and then are discharged from the ed.

to perform a randomized, double blind 2-arm clinical trial of the comparative efficacy of 2 oral analgesics in the the management of acute pain in elderly patients who present and then are discharged from the ed.. the 2 groups are as follows: 1. oxycodone/acetaminophen (5/325) 2. ibuprofen/acetaminophen (400/500)

Eligibility criteria:
inclusion criteria: * complaint of acute pain of \< 7 days duration * ed attending plans to discharge patient home with an oral analgesic exclusion criteria: * inability to confirm reliable means of phone followup. * past use of methadone * chronic condition requiring frequent pain management such as sickle cell disease, fibromyalgia, or any neuropathy * history of an adverse reaction to any of the study medications * ibuprofen or acetaminophen or opioids taken in past 4 hours * history of peptic ulcer disease * report of any prior use of recreational narcotics * medical condition that might affect metabolism of opioid analgesics, acetaminophen, or ibuprofen such as hepatitis, renal insufficiency, hypo- or hyperthyroidism, addison's or cushing's disease

Keywords: pain elderly
pneumococcal vaccination of otitis-prone children

Conditions: Recurrent Acute Otitis Media

Summary: acute otitis media (aom) is a common childhood disease, which becomes recurrent in 15-20% of the cases. streptococcus pneumoniae is one of the leading causative agents, and a small reduction in the number of aom episodes has been noted in unselected child cohorts after vaccination with conjugate heptavalent pneumococcal vaccine. this study was performed in order to investigate whether vaccination could reduce the number of aom episodes in very young, otitis-prone children.

ninetysix children (46 vaccinated, 50 not) with an onset of aom before six months of age, implying a high risk for developing raom, were recruited between 2003 and 2007. they were closely followed with clinical visits and nasopharyngeal cultures until the age of two years.

Eligibility criteria:
inclusion criteria: first episode of acute otitis media before 6 months of age and verified by an otorhinolaryngologist. - exclusion criteria: allergy to the vaccine, anatomical abnormality (eg cleft palate), chromosomal abnormality, immune deficiency, prematurity, prior administration of gammaglobulin or pneumococcal vaccine and a history of idiopathic thrombocytopenic purpura. -

Keywords: recurrent acute otitis media conjugate pneumococcal vaccine ventilation tube treatment nasopharyngeal flora
assessment psychological distress for cancer heredity test

Conditions: Cancer; Psychological Distress; Hereditary Diseases; Genetic Counseling

Summary: the study of hereditary cancer related syndromes allows reducing the risk of suffering in cancer to patients and close relatives. the objective of this study will be to evaluate the prevelance of psychological morbidity in patients attended at cancer genetic counselling unit, and to determine the socio-demographic and clinical factors that influence it. a descriptive cross-sectional study will be carried out. patients attented at the cancer genetic counselling unit, who have criteria for conducting a genetic syndrome test related to hererditary cancer, will be consecutively evaluated. to knowing the psychological morbidity it is relevant to providing care for these patients.

nowadays several familial cancer syndromes that confer a high lifetime risk of cancer can be identified with genetic testing. the psychological impact of genetic testing and the rates of psychological distress in patients undergoing genetic testing vary between 6 to 65% depending on socio-demographic or clinical characteristics. the effect of baseline distress on post-testing assessments tended to decrease or show little change over time, it may be important to target patients with high baseline distress for additional counseling or intervention both pre-testing and over time.the most robust predictor of future distress is baseline distress, additional factors were associated with cancer risk perception considering family history of cancer, patient's affected or unaffected with cancer, etc... it is relevant to developing and providing care for these patients, it has been demonstrated that enhanced genetic counseling with clinical psychologist to facilitate decision-making process, managing family concerns promoting their communication with and involvement of family members, and attending their emotional distress, can be beneficial. also, cancer genetic counseling may promote patient use of personal resources and enhance patient health literacy about their syndrome.

Eligibility criteria:
inclusion criteria: * age between 18 and 80 years * factors presumed predictive for hereditary cáncer * they agreed to participate in the research. exclusion criteria: * patients with cognitive impairment * patients with difficulties to read and understand spanish language.
biomarker analysis of hipec combined with pd1/pdl1 inhibitor for gastric cancer with peritoneal metastasis

Conditions: Gastric Cancer

Summary: a single-center, observational study, integrated biomarker analysis of hipec combined programmed cell death 1 /programmed cell death 1 ligand 1(pd1/pdl1)inhibitor in previously treated patients of advanced gastric cancer with peritoneal metastasis. tests will be performed on tumor tissue and blood samples, and imaging assessments will be reviewed in order to monitor how well each patient responds to treatment. this is an observational study, so participants will not receive cancer treatment, other than the treatment received as standard of care.

to analyze the correlation between genomic alterations, gene expression characteristics and the efficacy of hipec combined with pd1/pdl1 inhibitor conversion therapy in patients with peritoneal metastasis of gastric cancer. circulating tumor dna(ctdna) in plasma samples and dna, rna in tumor tissue sample were obtained over the course of hipec combined pd1/pdl1 inhibitor conversion treatment will be assessed by high-intensity, next-generation sequencing(ngs) to identify genomic alterations. the assay will performed used amoydx® master panel(amoy diagnostics co., xiamen, china), which contains 559 genes for dna mutation detection and 1813 genes for rna expression and fusion detection. data acquired will be analyzed to characterize the association between these genetic elements, clinical response, and durability of responses. there will be prospective groups for the study. samples will be collected from patients in the prospective cohort who have been treated with hipec combined pd1/pdl1 inhibitor at affiliated cancer hospital \& institute of guangzhou medical university under standard of conversion treatment.

Eligibility criteria:
inclusion criteria: 1. advanced gastric (gastroesophageal junction) adenocarcinoma confirmed by histology; 2. age 18-75 years, male or non-pregnant female 3. eastern cooperative oncology group(ecog): 0\~1； 4. negative for human epidermal growth factor receptor 2(her-2) by immunocytochemistry or fluorescence in situ hybridization； 5. the presence of gastric cancer peritoneal metastasis is confirmed by laparoscopic exploration, and the pci≤20； 6. patients had received hipec combined with pd1/pdl1 inhibitor conversion therapy. 7. signed the informed consent form, and blood and tissue samples can be obtained; exclusion criteria: 1. other distal metastases besides peritoneal metastases (e.g., liver, lung, pleural, brain, bone metastases, etc.); 2. other patients who were considered unsuitable for inclusion by the researchers;

Keywords: biomarker