Kornimate/medical-research-clean huggingface dataset:
68ga psma-11 pet/ct in recurrent prostate cancer

Conditions: Prostate Cancer; Prostate Cancer Metastatic; Prostate Cancer Metastatic to Bone

Summary: the goal of this research is to examine the ability of gallium-68 (68ga) prostate-specific membrane antigen-11 (psma-11) positron emission tomography/computed tomography (pet/ct) to detect sites of recurrent prostate cancer in patients with biochemical recurrence previously treated with radical prostatectomy (rp) or external beam radiation (ebrt) and to assess treatment response to subsequent salvage therapy.

in developed countries, prostate cancer is the most common malignancy in men and the third leading cause of death in men. following primary therapy for prostate cancer, a substantial number of patients will recur either locally in the pelvis or in extra pelvic locations. approximately 20-30% of patients' status post rp will recur and up to 60% patients treated with ebrt will recur, as detected by rising serum levels of prostate specific antigen (psa) after original therapy. this phenomenon is referred to as biochemical recurrence (bcr), as the elevated psa usually occurs in advance of obvious clinical or radiologic evidence. this study is designed to evaluate the performance of 68ga psma-11 pet/ct in detecting the location (localized versus extra pelvic) of bcr and advanced metastatic prostate cancer compared to conventional imaging. in addition, we will evaluate its performance in assessing interim and post salvage therapy response compared to conventional imaging, including pelvic magnetic resonance imaging (mri), computed tomography (ct), and bone scintigraphy.

Eligibility criteria:
inclusion criteria: * patients with suspected bcr of prostate cancer following initial treatment with either prostatectomy or definitive ebrt of the prostate or patients with known metastatic prostate cancer who have failed systemic therapy. * patients being considered for salvage therapy. * patients must have an eastern cooperative oncology group (ecog) performance status of 0-3. * patients must be medically stable as judged by the patient's physician. * patients must be able to lie still for 20-40 minutes for the pet/ct scans. * ability to understand and the willingness to sign a written informed consent. * patients with bcr and no known lesions should not be on antiandrogen therapy at the time of scans. patients with known metastases who are currently being treated with anti-androgen therapy may remain on this medication. exclusion criteria: * patients who have or have had a biopsy proven concurrent other malignancy, excluding skin cancers. * patients may not weigh more than the maximum weight limit for the pet /ct scanner table (\> 200 kg or 440 pounds). * history of allergic reactions attributed to compounds of similar chemical or biologic composition to 68ga psma-11. furosemide will not be administered to patients with known allergy. * patients must not be claustrophobic.

Keywords: pet/ct prostate cancer gallium-68 psma-11
study of the aliviado dsd caregiving mastery program

Conditions: Delirium Superimposed on Dementia

Summary: delirium superimposed on dementia (dsd) is an acute and serious condition that is common in persons living with dementia (plwd). involvement of family caregivers may aid prevention, early detection, and management of dsd. the purpose of the proposed study is two-fold. first, the investigators will develop a family-centered, mhealth-enhanced dsd caregiving mastery program ("aliviado dsd caregiving mastery program") through a 5-week co-design workshop with 8 family caregivers (aim 1). the investigators will adapt/refine the existing clinician-centered dsd contents and an mhealth app from the evidence-based "aliviado dementia care" program for use by family caregivers to support their day-to-day implementation of dsd detection, prevention, and management tasks in the community. second, the investigators will pilot test the full aliviado dsd caregiving mastery program with 30 family caregivers of plwd at high risk for delirium, assessing feasibility, acceptability, app usability, and preliminary program impact (aim 2).


Eligibility criteria:
inclusion criteria: to be eligible as a "dementia caregiver" in the co-design workshop, an individual must: * be at least 18 years old, * be english-speaking, * provide at least 8 hours of unpaid care weekly or live with a community-dwelling plwd, * self-identify as unfamiliar with dsd, * have the capacity to consent, and * have internet access to be eligible as a "dsd caregiver" in the co-design workshop, an individual must: * be at least 18 years old, * be english-speaking, * be a current or past dementia caregiver with experience caring for a relative or friend during his/her dsd episode within the past 12 months, * have the capacity to consent, and * have internet access. to be eligible to participate in the feasibility trial, an individual must meet all of the following criteria: * being 18 years old or older, * english-speaking, * providing at least 8 hours of unpaid care per week to, or living with, a community dwelling plwd whose delirium risk assessment score \>=5, * having the capacity to give informed consent, and * having a smartphone with internet access. exclusion criteria: * individuals who are blind or deaf will be excluded.
milk volume outcomes following oral nicotinamide riboside supplementation in mothers of extremely preterm infants

Conditions: Preterm Birth; Inadequate Milk Production

Summary: breastfeeding has well-established immunity and developmental benefits for newborns, yet mothers of preterm infants often struggle to provide sufficient breast milk. the investigators hypothesize that supplementing mothers of preterm infants with nicotinamide riboside (nr) during early postpartum will result in increased milk production. nr is a unique precursor to nad+, which functions in whole-body metabolism, including that which supports the elevated energy demands of lactation. in lactating rats, nr supplementation improved milk quantity and quality, with metabolic benefits for the mother and lasting protective advantages for the offspring. no studies have been conducted to date that explore the short- or long-term use of nr for increasing milk supply in lactating women. this study will follow a small cohort of women and very preterm infants in the nicu throughout two intervention phases-- one in which each mother will randomly receive either nr or a placebo, then the opposite treatment-- to determine the effect of maternal nr supplementation on expressed milk volume and other markers of metabolism.


Eligibility criteria:
inclusion criteria: * informed consent for participation of both mother and baby * infant delivered at ≤28 weeks gestation * infant born at the uc davis medical center or transferred to the uc davis medical center nicu within the first 6 days of life. * mothers willing to express and measure milk volume exclusion criteria: * infant is participating in an intervention trial that could influence growth, development, or feeding tolerance * mother has previously undergone breast surgery or has experienced other breast trauma * mother is actively using narcotics or amphetamines * mothers is receiving cancer treatment * mothers is receiving lithium or gold therapies * mother plans to use any form of galactagogue (including fenugreek) * mother is taking any form of contraceptives or plans to resume use of contraceptive within four weeks of delivery * mother is involuntarily confined * mother is an adult unable to consent * mother resides \<50 miles from uc davis medical center * anyone deemed unfit for participation by investigator(s)
the efficacy of a transdiagnostic sleep and circadian intervention for patients with mental disorders and sleep problems

Conditions: Depression; Bipolar Affective Disorder; Attention Deficit Disorder

Summary: the aim of this study is to examine the effect of a non-pharmacological transdiagnostic sleep intervention as add on to standard treatment for bipolar disorder, depression and attention deficit disorder. our hypothesis is that the intervention will reduce the severity of the sleep problem and increase sleep quality compared to a control group receiving sleep hygiene education.

sleep problems include insomnia, circadian rhythm disorders, hypersomnia, and inadequate sleep hygiene. patients suffering from mental illness are more likely to suffer from sleep problems than the general population. sleep problems can aggravate the underlying disorder, cause relapse and suicidal ideation. sleep problems often persist after the mental disorder is successfully treated. sleep medication is often used but not recommended for long term use. non-pharmacological treatment of sleep problems is in demand by patients, but treatment options are few. the present intervention is based on a transdiagnostic manual combining cognitive behavioral therapy for insomnia with chronotherapy, but more research on the efficacy is warranted. the aim of this study is to investigate whether the intervention reduces the severity of the sleep problem, increases sleep quality, leads to increased sleep efficiency, reduces sleep latency and awakenings, provides better quality of life, increases personal recovery, provides greater readiness to take on a job or reduces consumption of sleep medication.

Eligibility criteria:
inclusion criteria: * age ≥18 years * f31 bipolar disorder, f32 unipolar depression or f90 attention deficit disorder * insomnia severity index (isi) ≥ 14 (exceeding the threshold for a sleep problem) * sleep problems for 3 months: 3 times a week at least one of the following: * sleep onset latency ≥ 30 minutes * wake after sleep onset ≥ 30 minutes * total sleep time ≥ 11 hours per day * displaced circadian rhythm; sleeps earlier than 8 p.m. or later than 02 a.m. * irregular circadian rhythm; bedtime varies ≥ 3 hours throughout the week exclusion criteria: * acutely increased suicide risk (central regions guideline for assessment of suicide risk) * active substance abuse (f10-19) * the sleep problem can be significantly explained by insufficient treatment of physical * disease affecting sleep (documented in patients electronic journal) * unstable social situation (does not have a permanent residence) * shift work (≥ 2 times a week for the last 2 months) * pregnancy and breast-feeding
safety and efficacy of topical nvc-422 gel in impetigo

Conditions: Impetigo

Summary: this is a randomized, double-blind study comparing 0.1% nvc-422, 0.5% nvc-422 and 1.5% nvc-422 topical gel in children with impetigo.

this study is a randomized, sequential group, double-blind study. the first 60 subjects enrolled will be randomized to either 0.1% nvc-422 or 0.5% nvc-422. randomization is 1:2 where 20 subjects will receive 0.1% nvc-422 and 40 subjects will receive 0.5% nvc-422. if there are no safety issues regarding the first 2 doses tested, the next 60 subjects will be randomized to either 0.1% or 1.5% nvc-422 with 20 subjects receiving 0.1% and 40 subjects receiving 1.5% nvc-422. the lesion most representative of the subject's infection will be identified as the target lesion. this target lesion will be photographed, graded clinically, and its location recorded. at visit 1, screening and/or baseline, a gram stain will be performed to assess presence of gram-positive cocci. if gram-positive cocci are present, a swab for culture and sensitivity will be obtained. treatment will began immediately after randomization. treatment will be 3 times per day (tid) for 7 consecutive days, following a morning, afternoon, and evening schedule. after the start of treatment (day 1), subjects will be assessed for safety on day 4 (± 1). clinical and bacteriological assessments of the target lesion will also occur on day 8 (+1) and follow-up on day 15 (± 2).

Eligibility criteria:
inclusion criteria: * subjects must be 2 - 12 years of age * parents or legal guardians must sign a written informed consent document * positive gram stain of target lesion showing gram-positive cocci; * clinical diagnosis of primary non-bullous impetigo as per the protocol * skin infection rating scale total score of at least 4, with at least three of the five primary signs and symptoms present at baseline including a score of 1 or greater for exudate/pus; * screening within one day of enrollment into the study. exclusion criteria: * presence of other skin diseases at or near the investigational target area to be treated; * disease is so widespread or severe that, in the opinion of the investigator, oral antibiotic treatment is needed * active impetigo lesions greater than 5 cm2 * signs and symptoms of a current infection requiring antibiotic treatment * use of systemic or topical antibiotics or steroids within 72 hours prior to study entry * females of childbearing potential
prediction of relapse risk in stable systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: whether and when systemic lupus erythematosus (sle) patients with stable disease should withdraw glucocorticoid (gc)? how about the relapse risk? what are the risk factors for disease flare? all the above are unclear. long-course gc treatment has a lot of side-effects even in a sustaining low dose. the aim of this study is to explore the relapse risk after gc withdrawal in sle patients with stable disease more than one year and to establish a predictive model for flare risk stratification.

systemic lupus erythematosus (sle) is a chronic autoimmune disease with a relapsing-remitting course. for patients in remission, glucocorticoid (gc) is used to be maintained in a low dose for a long time in fear of disease flare. long-term gc could bring a lot of side-effects even in a low dose. whether and when patients with stable disease should withdraw gc? how about the relapse risk? what are the risk factors for disease flare? all the above remain unclear. the aim of this study is to explore the relapse risk after gc withdrawal in sle patients with stable disease and to establish a predictive model for risk stratification. meanwhile the investigators aim to testify the effects of hydroxychloroquine in preventing sle relapse. this study is an open-labeled randomized controlled clinical trial.

Eligibility criteria:
inclusion criteria: * sle diagnosis fulfilled the systemic lupus international collaborating clinic revision of the american college of rheumatology classification criteria for sle * disease stabilized ≥ 1 year * selena-sledai ≤ 3 * anti-double strand dna negative by if measurement and ≤ 200iu/ml by elisa method * complement 3 (c3) ≥ 0.5\*lower limit of the normal range, and fluctuation of the c3 is less than 10% within the last year * 24 hour urine protein ≤ 0.5g * prednisone (or equivalent) ≤ 7.5mg/d for more than 6 months * no use of immunosuppressants including csa, mmf, ctx, fk506, lef, mtx in recent 6 months. but hydroxychloroquine (hcq) is permitted and should be in use * never use biologic agents including rituximab, belimumab, epratuzumab and so on * no severe organ involvement in recent 2 years including lupus encephalosis, diffused alveolar hemorrhage, thrombotic thrombocytopenia purpura, rapid progressive glomerulonephritis, severe thrombocytopenia, severe hemolytic anemia, myocardial involvement, myeleterosis or severe peripheral neuropathy exclusion criteria: * active sle * in pregnancy or breastfeeding, plan for pregnancy * plan or has been on a surgery in recent 6 months * current infection * history of malignancy * severe organ dysfunction or other complications * unable to follow up * inappropriate to be enrolled * psoriasis, porphyria, arrhythmia or eye diseases that contradict with hcq usage

Keywords: systemic lupus erythematosus stable relapse risk glucocorticoid withdrawal
gastric cancer survival without chemotherapy

Conditions: Gastric Cancer

Summary: this study is observational study to analyze the actual overall survival of the patients who did not receive adjuvant chemotherapy after curative gastrectomy for gastric cancer. the investigators developed prediction model for the overall survival of these patients and validated.

adjuvant chemotherapy (ac) after curative gastrectomy is the standard treatment for patients with locally advanced gastric adenocarcinoma in east asia; however, for various reasons, some patients do not receive this treatment. the aim of this study was to develop a system that reflects the survival rate of patients without ac. a survival prediction model was developed based on the modified staging system and risk factors for overall survival (os), which were examined using the cox proportional hazards regression model. the model was validated for the power of prediction and discrimination, compared with the american joint committee on cancer (ajcc) cancer staging manual 8th edition; it was externally validated using an independent dataset. the newly developed survival prediction model improves the accuracy of os prediction for stage ii and iii gastric cancer patients without ac after curative gastrectomy.

Eligibility criteria:
inclusion criteria: * histologically confirmed primary gastric adenocarcinoma * curative r0 resection with d2 lymph node dissection * pathologic stage ii or iii gastric cancer exclusion criteria: * patients who received neoadjuvant or ac treatment * follow-up loss or death within 30 days of surgery * completion of total gastrectomy * other malignancy within 5 years before gastrectomy

Keywords: gastric cancer adjuvant chemotherapy overall survival nomogram prediction
treatment response of maintenance dose of proton pump inhibitor in patients with nonerosive gatroesophageal reflux disease

Conditions: Non-erosive Gatroesophageal Reflux Disease

Summary: for erd(erosive reflux disease), which pathogenesis is mainly the acid reflux mechanism, primary treatment is therefore ppi. however, nerd(non-erosive reflux disease) is much more complex than erd and there are more factors causing the typical symptoms. as a result, there is no consensus for the treatment of nerd besides using ppi similar to gerd(gastroesophageal reflux diseas). this study intent to evaluate the effect of ppi(esomezol) on nerd patients and analyze the improvement of symptoms and the factors related to the result.

(1) among gerd patients, egd(esophagogastroduodenoscopy) must be done before 6 months and must prove there is no erosive lesion. (2) during egd, esophagus mucosa histology will be taken for evaluation. (3) for nerd patients, esomezol is given once a day (before breakfast meal), for whole 8 weeks. (4) pagi-sym and had-k is evaluated and score just before the administration of ppi, 4weeks after and 8weeks after the study initiation.

Eligibility criteria:
inclusion criteria: * patient over 19 years old * patient with typical gerd symptom (heartburn or acid reflux more than once a week) exclusion criteria: * patient who received egd since the past 6 months, and diagnosed as gerd endoscopically * patient with active gastric/duodenal ulcer * patient who received esophagus, stomach or duodenum surgery * patient with hypersensitivity to esomezol® * patient with no achieved agreement on the study from the guardian or patient himself.
an open-label, phase 1b study of acalabrutinib with and without dexamethasone in subjects with multiple myeloma

Conditions: Multiple Myeloma (MM)

Summary: to characterize the safety profile of acalabrutinib with and without dexamethasone in subjects with relapsed or refractory multiple myeloma (mm)


Eligibility criteria:
inclusion criteria: * men and women ≥ 18 years of age. * a confirmed diagnosis of mm, which has relapsed after, or been refractory to ≥ 1 prior therapy for mm, and is progressing at the time of study entry. * eastern cooperative oncology group (ecog) performance status of ≤ 2. * agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children. exclusion criteria: * a life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk * significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the new york heart association functional classification * malabsorption syndrome, disease significantly affecting gastrointestinal function, gastric bypass, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction. * breast feeding or pregnant

Keywords: bruton tyrosine kinase inhibitor btk multiple myeloma mm acp-196 acalabrutinib calquence
blood levels of tumor cells in predicting response in patients receiving first-line chemotherapy for stage iv breast cancer

Conditions: Breast Cancer

Summary: rationale: measuring blood levels of tumor cells in patients with breast cancer may help doctors predict how patients will respond to treatment. purpose: this laboratory study is looking at blood levels of tumor cells in predicting response in patients receiving first-line chemotherapy for stage iv breast cancer.

objectives: primary * predict the overall and progression-free survival of patients with stage iv breast cancer by measuring the rate of circulating tumor cells (ctc) before the second course of chemotherapy. secondary * predict overall and progression-free survival of these patients by measuring the rate of ctc before the start of chemotherapy, at the first tumor evaluation, and after 2-3 courses of chemotherapy. * correlate the detection of ctc with tumor markers, clinical response, and radiological response. * study the changing status of her-2 in ctc in patients receiving trastuzmab (herceptin®). outline: this is a multicenter study. blood samples are collected at baseline, before the second course of chemotherapy, before the third or fourth course of chemotherapy, and when progressive disease is diagnosed (before second-line treatment is initiated). circulating tumor cells from the blood samples are examined by immunofluorescence. patients are followed periodically for up to 3 months.

Eligibility criteria:
disease characteristics: * diagnosis of stage iv breast cancer * measurable or evaluable disease * scheduled to receive first-line chemotherapy with or without trastuzumab (herceptin®), depending on her-2 status * histologic block available for confirming pathologic diagnosis and measuring her-2 status via fish patient characteristics: * life expectancy \> 3 months * no other cancer in the past 5 years except for basal cell skin cancer or epithelial in situ cancer of the cervix * no geographic, social, or psychiatric reasons that would make treatment impossible prior concurrent therapy: * no prior chemotherapy for metastatic disease

Keywords: stage iv breast cancer