Kornimate/medical-research-clean huggingface dataset:
group interventions for breast cancer survivors

Conditions: Breast Cancer Survivor

Summary: the purpose of this study is to compare two types of groups for breast cancer survivors: a meaning-centered group and a discussion group. many breast cancer survivors seek help to deal with the emotional burden of having gone through the cancer experience. participation in groups offering support often helps cancer survivors cope with stressors of life after having had cancer by giving them a place to express their feelings. the "meaning-centered group" is intended to teach breast cancer survivors how to maintain or even increase a sense of meaning and purpose in their lives after treatment for cancer. the "discussion group" is intended to help breast cancer survivors cope by giving them a place to get support from other breast cancer survivors. the goal of this study is to compare the benefits of these two types of group approaches for breast cancer survivors. the study is also testing the benefits and feasibility of conducting the groups virtually using a telephone and computer.


Eligibility criteria:
inclusion criteria: * history of non-metastatic breast cancer (dcis or stage i, ii, or iii) as recorded in the medical record at mskcc by self-report, or by outside correspondence, including a study checklist signed by a physician for patients outside of mskcc * post completion of treatment (may be on hormone therapy, such as tamoxifen or monoclonal antibody, such as herceptin or pertuzumab)) for any type of cancer as confirmed by the medical record at mskcc, by self-report, or by outside correspondence, including a study checklist signed by a physician for patients outside of mskcc * age 18 or older * access to a telephone, computer (e.g. desktop, laptop, smartphone, tablet) and internet for phase 2 only: * a score of ≥ to 4 on the distress thermometer (dt) and indication that this distress is related in some way to the patient's breast cancer or survivorship * if taking medication for mood, anxiety, depression, thoughts, sensory experiences such as hallucinations, or sleep, stable and consistent enough in dosage and use of that medication so as to not result in a clinically significant change as determined by the study pi/co-pi or, confirmed by reports in the medical record at mskcc, by selfreport, or by outside correspondence, including a study checklist signed by a physician for patients outside of mskcc * did not participate in phase 1 exclusion criteria: * evidence of or treatment metastatic disease * significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent or participating in the groups (i.e., acute psychiatric symptoms which require individual treatment).

Keywords: interventions meaning-centered group (mcg) discussion group (dg) modules sessions 12-291
expanding comparative effectiveness research (cer) capability through complex patient relationship management

Conditions: Diabetes; Hyperlipidemia

Summary: the investigators are testing whether patients with diabetes can communicate with our health care system through text messaging. the investigators will look at how often they respond to prompts for blood pressures, blood sugars, and step counts. the investigators will also see if they come in for lab tests when prompted by text message. also, for patients overdue for medication refills, the investigators will ask them why they have not yet called for the refill.

patients will be sent text messages through a software interface, the patient relationship manager (prm). a registered nurse will also use prm to receive incoming responses. tasks will be created for her to outreach to patients who have out of range text responses or poor response rates. this intervention if a feasibility study to see if patients can communicate with the investigator's health care system and potentially utilize prm to better manage their diabetes.

Eligibility criteria:
inclusion criteria: * age 18-75 years * diabetes * own a cell phone * 2 primary care visits in last year * english or spanish speaking exclusion criteria: * end-stage disease with estimate of less than 6 months to live

Keywords: text sms diabetes self-monitoring self-management adherence
study of 18f-florastamin pet/ct imaging in patients with suspected recurrence of prostate cancer

Conditions: Prostate Cancer

Summary: in this study, 18f-florastamin pet/ct will be performed in patients with suspected recurrence of prostate cancer, to assess the diagnostic performance and safety of 18f-florastamin pet/ct imaging.


Eligibility criteria:
inclusion criteria: 1. subjects fully understood the content, process, and potential risks of the study and voluntarily signed an informed consent form (icf). 2. male ≥ 18 years of age. 3. histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy. 4. suspected recurrence or distant metastasis of prostate cancer based on any of the following conditions: 1. at least 6 weeks after radical prostatectomy (rp): psa ≥0.2 ng/ml followed by a subsequent confirmatory psa value ≥0.2 ng/ml.; or 2. post-radiation therapy, after radical radiotherapy (or cryoablation therapy): increase in psa level that is elevated by ≥ 2 ng/ml above the nadir . 5. subjects who are willing to undergo biopsy, salvage surgery, or radiation therapy based on the researcher's clinical judgment; 6. ecog score 0 or 2. 7. subjects who meet the following conditions in hematology, renal function, and liver function: platelet count\>50 \* 10\^9/l urea/urea nitrogen and creatinine\<1.5 times upper limits of normal ast and alt\<2.5 times upper limits of normal. 8. expected survival time ≥ 6 months. 9. subjects and their partners must use effective contraceptive measurements and avoid sperm donation from the date of signing icf to 3 months after administration. exclusion criteria: 1. subjects who have participated in other interventional clinical trials before signing icf and were within the 5 half-lives of the investigational drug, or who are currently participating in other interventional clinical trials or have participated in clinical trials of radioactive drugs before signing icf and have been discontinued for less than 3 months until the signing date of icf. 2. intravenous injection of iodinated contrast medium within 24 hours, or any high-density oral contrast medium (such as barium sulfate. oral water contrast is acceptable, such as compound meglumine diatrizoate oral liquid) within 5 days, prior to study drug administration. 3. subjects administered any high energy (\>300 kev) gamma-emitting radioisotope within five physical half-lives prior to study drug administration. 4. if previously taking adt, it should have been discontinued at least 16 weeks prior to study drug administration. 5. the investigator determines that there are any medical diseases or other conditions that affect the safety or compliance of the subjects.
bariatric surgery on nash

Conditions: Non-Alcoholic Fatty Liver Disease; Obesity

Summary: the study investigates non-alcoholic fatty liver disease from serial liver biopsies collected from participants referred for assessment of bariatric surgery, rygb or sg.

non-alcoholic fatty liver disease (nafld) is an increasing health care problem closely related to obesity and has become the most common cause of chronic liver disease in developed countries. today, bariatric surgery is the most efficient treatment of morbid obesity in terms of a rapid and sustained loss of weight. in addition, bariatric surgery is accompanied by improvement of weight-related comorbidities including features of the metabolic syndrome and possibly regression of the entire nafld spectrum. the study is designed as an observational study including 40 patients referred to laparoscopic bariatric surgery (either rygb or sg). the primary endpoint is change in nafld activity score (nas) in serial liver biopsies collected from participants. additional tests include blood samples, anthropometry measurements, fibroscan and full body dual-energy x-ray absorptiometry (dexa) scan performed together with each biopsy. this unique model of serial liver biopsies in morbidly obese patients referred to bariatric surgery (rygb or sg), combined with state-of-the-art technologies and bioinformatics, will provide important information about the effects of weight loss on nash. the results will improve our understanding of the underlying mechanisms with the potential of identifying new potential nash targets or diagnostic biomarkers.

Eligibility criteria:
inclusion criteria: * obese (bmi≥35 kg/m2) individuals referred for bariatric surgery, either rygb or sg * age between 18 and 60 years at the time of inclusion * evidence of potential nash with fibrosis * willing to give informed consent and comply with all study procedures exclusion criteria: * type 1 diabetes * alcohol consumption ≥20 g/day for women or ≥30 g/day for men over a two-year period prior to inclusion * clinically significant kidney function impairment or other laboratory findings at time of screening leading to the diagnosis of clinically relevant disorders * any physical or psychological condition that the investigator evaluates would interfere with trial participation * previous gastrointestinal surgery (excluding cholecystectomy and appendectomy) * planned elective surgery (other than bariatric surgery) during the study period with the exception of dermatosurgical, ent (ear, nose, throat) or dental procedures not requiring general anaesthesia and/or perioperative antibiotic treatment * pregnancy or desire to become pregnant during the study period * any ongoing medication that the investigator evaluates would interfere with trial participation including anticoagulant medication, and medication that could cause nafld * contraindications to liver biopsy * other causes of liver disease than nafld, including viral hepatitis, wilsons disease, cystic fibrosis, coeliac disease and alpha-1 antitrypsin deficiency.
national registry for ichthyosis and related disorders

Conditions: Darier Disease; Hailey-Hailey Disease; Hyperkeratosis, Epidermolytic; Ichthyosis; Ichthyosis, Lamellar; Ichthyosis, X-Linked; Keratoderma

Summary: the ichthyoses are a family of genetic skin diseases characterized by dry, thickened, scaling skin. dermatologists estimate that there are over twenty varieties of ichthyosis, with a wide range of severity and associated symptoms. this registry is designed to identify people in the united states with the ichthyoses and other related disorders and to collect information about their skin ailment and how it has affected them. the database is available for review by approved research applicants. the registry is confidential and provides investigators a way to share information about studies and trials with potential participants while maintaining participants' privacy. although the registry is closed to new enrollment, it is still maintained in order to provide information related to understanding the diagnosis, pathophysiology, and treatment of ichthyoses. support for studies continues and inquiries from investigators are welcomed.

the purpose of this registry is to support studies aimed at determining the cause of the ichthyoses and treating them more effectively. the registry offers blinded information about well-characterized groups of individuals with specific diagnoses for study by skin biologists, pharmacologists, and others. the registry also provides information about research projects to those that have enrolled in the registry and expressed an interest in participating in studies. participants enrolled in the registry by contacting the registry officials. all participants participated in a phone interview with the study research nurse. participants were asked about diagnostic testing, treatments, birth history, medical history, degree and type of involvement, current physical condition, and other family members with skin disorders. a quality of life index was embedded in the interview. participants also indicated whether they would like to be contacted about participating in clinical research. this information was complemented by an enrollment form from the enrollee's caregiver. diagnosis was confirmed by specific criteria based on clinical involvement, review of histology, and where appropriate, serum cholesterol sulfate determination or dna analysis.

Eligibility criteria:
note: accrual into this study has been discontinued as of 03/31/04. inclusion criteria: * diagnosis of one of the ichthyoses, erythrokeratodermas, darier disease, hailey-hailey disease, palmar-plantar keratodermas, pachyonychia congenita, extensive epidermal nevi, or related disorder exclusion criteria: * ichthyosis vulgaris

Keywords: congenital epidermal nevus erythroderma darier hailey-hailey harlequin ichthyosiform ichthyosiform erythroderma keratoderma keratosis pachyonychia sjogren-larsson
evaluation of the safety and biologic effects of an eicosapentaenoic (epa)-enriched oil

Conditions: Heart Disease

Summary: the goal is to test the safety and efficacy of an epa-enriched oil made by dupont. dupont wishes to corroborate the safety of its novel oil rich in epa in humans prior to placing such a dietary supplement on the market. the goal of this study is to test this oil at doses of 600 mg and 1800 mg of epa/day as compared to olive oil placebo and a comparator oil providing 600 mg of dha/day over a 6 wk period. in a parallel arm study design, 120 healthy adults will be randomized to one of four groups (30 in each group) and studied in both the fasting and post-prandial state.

the safety profile of omega-3 fatty acids is considered to be excellent, and has been recognized as safe (gras) by the us food and drug administration when epa and dha (docosahexanoic acid) are given together at a dose of 3 grams/day or less. safety will be monitored by assessing for adverse reactions, measuring vital signs and a variety of laboratory tests including a complete metabolic profile and complete blood count. efficacy will be assessed by measuring changes in fatty acid profile and or fatty acid ratios. the goal of this study is to test this epa oil at doses of 600 mg and 1800 mg of epa/day as compared to olive oil placebo and a comparator oil providing 600 mg of dha/day over a 6 wk period. in a parallel arm study design, 120 healthy adults will be randomized to one of four groups (30 in each group) and studied in both the fasting and post-prandial state.

Eligibility criteria:
inclusion criteria: * healthy male or surgically sterile females between ages 21-70. * bmi of 20-35. exclusion criteria: * competitive exerciser. * current smokers. * those already taking dietary supplements (epa, dha, flax seed oil, fish oil, cod liver oil, weight control products, or high doses of vitamin c (\> 500 mg/day) or vitamin e (\> 400 units/day). * those consuming more than 3 oily fish species/week. * those consuming \> 2 drinks/day. * those with a history of a bleeding disorder, or history of significant cardiac, renal, hepatic, gastro-intestinal, pulmonary, neoplastic, biliary or endocrine disorders such as uncontrolled thyroid disease, or uncontrolled hypertension or diabetes. * those taking medications affecting serum lipids, body weight, or blood clotting.

Keywords: heart disease risk reduction
verification of novel survival prediction algorithm for patients with nsclc spinal metastasis

Conditions: Spinal Metastases; Non-Small-Cell Lung Cancer Metastatic

Summary: the purpose of this study is to learn whether our own made predictive algorithm can be used as a clinical practical decision support for patients with nsclc spinal metastasis. the scoring system consists of the use of egfr-tki, kps, age, scc, ca125 and smoking history. by predicting survival doctors could determine which patients are suitable for palliative therapy.

investigators have performed a retrospective study on 176 patients with nsclc spinal metastasis under the oversight of hospital's ethics committee, and investigators found that the use of egfr-tki, kps, age, scc, ca125 and smoking history had significant association with survival. then investigators built a simple, easy to use scoring system based on the features mentioned above. the score was calculated as 1 (for patients didn't receive egfr-tki), +2 (for kps \ 60years), 2 (scc ≥1.5ng/ml), +3 (ca125 ≥35 u/ml), +1 (smoking history 1-10/day), +2 (smoking history \>10/day), and 0 otherwise. this algorithm was used to divide the patients into low risk (0-3), intermediate risk (4-6), high risk groups (7-10) to predict survival and determine which patients are suitable for palliative therapy. now investigators wish to register this study to do a further research, in order to verify the accuracy and sensitivity of this algorithm.

Eligibility criteria:
inclusion criteria: * diagnosis by biopsy: non-small-cell lung cancer, including non-squamous carcinoma and squamous cell carcinoma. * diagnosis through both nucleotide bone scan and mri or pet-ct: spinal metastasis. * age 18-75 years. * have been or is about to be treated according to nccn panel recommendation. exclusion criteria: * diagnosis by biopsy: other tumors. * irregular follow-up and lost follow-up * withdraw from the study for any reason

Keywords: survival prediction spinal metastases non small cell lung cancer metastatic
renal hemodynamics and tubular function in patients with obstructive sleep apnea and healthy controls

Conditions: Obstructive Sleep Apnea; Healthy

Summary: nitrogen-oxide (no) plays an important role for blood pressure regulation, renal hemodynamics, and the renal excretion of sodium. no is synthesized from l-arginine in the vascular endothelium and have a very short half-life in plasma and is therefore very difficult to measure directly. l-mono-methyl-l-arginine (l-nmma) is an analogue to l-arginine and a competitive inhibitor of no, and therefore can be used to study the effect of no on the circulation. in normal subjects, infusion of l-nmma will cause an increase in blood pressure, decreased renal plasma-flow, decreased glomerular filtration rate, and a decreased excretion of sodium. hypothesis: patients with obstructive sleep apnea has a decreased activity in the no-system. this is contributing to the hypertension often seen in these patients. decreased activity in the no-system can be revealed by diminished fall in renal hemodynamic and sodium excretion after infusion of l-nmma.


Eligibility criteria:
inclusion criteria: * obstructive sleep apnea exclusion criteria: * drug or alcohol abuse * pregnancy * disease of the heart, lungs, liver, kidney or endocrine organs * cerebral infarction * diabetes * gastrointestinal disease
a study to evaluate the effect of vildagliptin on the maximum insulin secretion in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: type 2 diabetes results when the body does not produce enough insulin to regulate blood sugar. this study is designed to measure the effect of vildagliptin on the maximum insulin secretion by the pancreas.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes for at least 6 months * patients whose diabetes is controlled by diet and exercise only or patients taking metformin * bmi in the range 22-45 * blood glucose criteria must be met exclusion criteria: * pregnancy or lactation * type 1 diabetes or diabetes resulting from pancreatic injury * cardiovascular complications as defined by the protocol * significant diabetic complications as defined by the protocol other protocol-defined inclusion/exclusion criteria may apply

Keywords: vildagliptin type 2 diabetes insulin secretion beta cell
generalized seizure detection and alerting in the emu with the empatica embrace watch and smartphone-based alert system

Conditions: Epilepsy

Summary: to demonstrate safety and effectiveness of the embrace device in identifying convulsive seizures (cs) and notifying a caregiver during patient hospitalization at an epilepsy monitoring unit (emu).

to demonstrate safety and effectiveness of the embrace device in identifying convulsive seizures (cs) and notifying a caregiver during patient hospitalization at an epilepsy monitoring unit (emu). subjects will be fit with an embrace device upon admittance into the emu. the embrace system will be used in conjunction with the emu standard care practices to monitor the subject during the subject's stay. emu standard care practices will not be impacted by the embrace system, but rather the embrace will be used to supplement the emu monitoring. the events detected by embrace will later be compared to the gold standard results of the video eeg. a convulsive seizure (cs) is defined for the purpose of this study as any seizure with non-facial motor activity involving one or both upper and/or lower extremities that has repetitive motor activity (rhythmic motor movements).

Eligibility criteria:
inclusion criteria: * male and female patients with a history of convulsive seizure (as defined above) who are admitted to a hospital for routine veeg monitoring related to seizures. patients who are expected to have a convulsive seizure during their monitoring based on interpretation of clinical history. exclusion criteria: * patients who are not expected to have their typical convulsive seizure during the course of their hospital admission (i.e. expected reduction due to anti-epileptic drugs during hospital admission). * women who are pregnant. * patients who are known or suspected to have a history of pnes only. * patients with known allergic reactions to nickel or stainless steel * infants who were born pre-term and may not have fully developed skin

Keywords: epilepsy epilepsy monitoring unit emu seizure seizure detection
computer-guided glucose management systems in treating patients with hyperglycemia who have undergone blood and bone marrow transplant

Conditions: Hyperglycemia; Malignant Neoplasm

Summary: this clinical trial studies computer-guided glucose management systems in treating patients with hyperglycemia who have undergone blood and bone marrow transplant. a computer-guided glucose management system may help manage glucose levels in patients who have undergone blood or bone marrow transplant.

primary objectives: i. to examine the ability of computer-guided glucose management system (cggms) algorithms to control glucose within or close to current university of washington medical center (uwmc) intensive care unit (icu) targets (100 to 140 mg/dl) in non-critically ill bone marrow transplant (bmt) adult (age \>= 18 years) patients. outline: patients receive blood glucose management with intravenous (iv) insulin using glucommander.

Eligibility criteria:
inclusion criteria: * post-transplant adult patients (age \>= 18 years) on the bmt service at uwmc * requiring insulin secondary to: * known history of (h/o) type 2 diabetes mellitus * two blood sugar values \> 180 (point of care and/or am lab glycemia) * one blood sugar value \> 250 (point of care or am lab glycemia) exclusion criteria: * critically ill patients (intensive care unit \[icu\] admissions) * terminally ill patients * eastern cooperative oncology group (ecog) performance status \> 3 * previous type 1 diabetes mellitus * cognitively impaired patients, unable to consent