Kornimate/medical-research-clean huggingface dataset:
treatment of relapsed or refractory natural killer/t cell lymphoma

Conditions: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type

Summary: the purpose of this study is to evaluate the efficacy and safety of pd-1 blockade pembrolizumab for patients with relapsed or refractory natural killer(nk)/t cell lymphoma.

patients with relapsed or refractory nk/t cell lymphoma usually have a bad prognosis. these patients cannot be treated successfully with the conventional chemotherapy. the investigators have been proceeding this trial to evaluate the efficacy and safety of the immune checkpoint inhibitor pd-1 blockade, pembrolizumab in the patients with relapsed or refractory nk/t cell lymphoma.

Eligibility criteria:
inclusion criteria: * age range 14-70 years old; ecog performance status 0-2; estimated survival time \> 3 months * histological confirmed evidence of relapsed or refractory nk/t cell lymphoma * before enrollment, representative formalin-fixed paraffin-embedded tumor samples (or 15 tissue sections at least) and related pathological reports are needed * previous treatment with at least one chemotherapy regimen * at least one measurable lesion * none of other serious diseases, cardiopulmonary function is normal * pregnancy test of women at reproductive age must be negative * patients could be followed up * none of other relative treatments including the traditional chinese medicine, immunotherapy, biotherapy except anti-bone metastasis therapy and other symptomatic treatments. * volunteers who signed informed consent. * no anti-pd1 antibody contraindication (all of the following tests are required to be finished within 14 days prior to the first research): 2.5×109/l\<wbc\<15×109/l, hemoglobin ≥ 90 g/l, neutrophil≥ 1.5×109/l, lymphocyte≥0.5×109/l, platelet ≥ 100×109/l, serum albumin≥2.5g/dl, alt and ast ≤ 2×uln, serum bilirubin≤ 1.5×uln, serum creatine ≤ 1.5×uln, serum albumin ≥ 30g/l, serum plasminogen is normal, creatinine clearance rate≥30 ml/min, inr≤1.5×uln, aptt≤1.5×uln exclusion criteria: * disagreement on blood sample collection * patients allergic of chimeric or humanized antibody * pregnant or lactating women * serious medical illness likely to interfere with participation * serious infection * primitive or secondary tumors of central nervous system * the evidence of cns metastasis * history of peripheral nervous disorder or dysphrenia * history of active autoimmune disease and a concomitant second cancer * patients participating in other clinical trials * patients taking other antitumor drugs * patients estimated to be unsuitable by investigator

Keywords: nk/t cell lymphoma immunotherapy clinical trial rr pfs os
early prediction of oral cancer by s100a7 immunohistochemistry signature-based assessment

Conditions: Oral Neoplasm

Summary: the purpose of this observational study is to evaluate the utility of the s100a7 immunohistochemistry signature-based assessment - straticyte - in determining the risk of progression to cancer of clinically suspicious oral lesions.

background: the standard of care for potentially premalignant oral epithelial lesion (ppoel) risk assessment for progression to cancer is dysplasia grading by histopathology. with significant overlap between dysplasia grades and high inter- and intra-observer variations, dysplasia grading alone has been shown to be inadequate as a prognostic tool. to investigate the utility of the s100a7 immunohistochemistry signature-based assessment - straticyte - in the early diagnosis of invasive oral cancer, a prospective multi-center observational study was designed with specimens obtained from community-based practices. methods: patients that qualify to enroll in the study will be assessed for both standard of care histopathological assessment for dysplasia grade and straticyte risk assessment, and followed for up to 60 months (from initial biopsy) to determine the outcome of their oral lesion(s).

Eligibility criteria:
inclusion criteria: * any clinically suspicious lesion biopsied to rule-out oral epithelial dysplasia/oral squamous cell carcinoma exclusion criteria: * biopsied lesion with or without dysplasia concomitant with oral squamous cell carcinoma at initial biopsy

Keywords: leukoplakia erythroplakia erythroleukoplakia lesion oral epithelial dysplasia s100a7 biomarker s100a7 immunohistochemistry signature-based early diagnosis straticyte oral neoplasia oral epithelial atypia hyperplasia hyperkeratosis oral squamous cell carcinoma oral cancer potentially premalignant oral epithelial lesion opmd mild dysplasia moderate dysplasia severe dysplasia low-grade dysplasia high-grade dysplasia personalized medicine predictive assay whole slide imaging computational pathology digital pathology artificial intelligence machine learning opml oral potentially malignant disorder oral potentially malignant lesion
biomarker identification for bladder cancer patients

Conditions: Bladder Cancer

Summary: to develop a simple blood and urine test that we would perform before patients start their treatment to predict the risk that their bladder cancer might come back. to develop this test the investigators plan to analyze blood, urine and cancer tissue from bladder cancer patients and follow them closely during and after treatment. this will include looking for changes in proteins and genes that might play a role in bladder cancer biology. the investigators will then compare the information obtained from the studies of blood, urine and cancer tissue between patients that are cured and those whose cancer comes back. the knowledge about these differences between patients can then potentially be used to develop a blood or urine test to tell us who has a high risk for having bladder cancer come back.


Eligibility criteria:
inclusion criteria: * adult patients ≥18 years old. * patients suspected, clinically diagnosed, or histologically diagnosed bladder cancer. * patients undergoing cystoscopy without cancer suspicion. * ability to give an informed consent. exclusion criteria: * patients receiving concurrent therapy for a second malignancy. * \< 18 years old. * inability to give an informed consent.

Keywords: bladder cancer
gsk bhr study (sont - second study)

Conditions: Asthma

Summary: the purpose of this study was to determine whether asthma control and reduced bronchial responsiveness could be achieved and maintained at a lower dose of inhaled corticosteroids with advair diskus bid or fp bid in adult and adolescent patients with persistent asthma


Eligibility criteria:
inclusion criteria: * diagnosis of asthma * controller asthma medication or medium dose ics * current or historical reversibility exclusion criteria: * life-threatening asthma * asthma instability * concurrent respiratory disease * drug allergies * respiratory tract infection * systemic corticosteroid use * immunosuppressive medication use * postive pregnancy test * tobacco use * investigation medication use * site affiliation

Keywords: fp asthma sont fsc bhr
a feasibility study of the automated fluid shunt (afs) for automated ascites removal

Conditions: Refractory Ascites

Summary: the purpose of this study is to determine whether the automatic fluid shunt (afs) can reduce the number of paracentesis procedures in patients with refractory ascites.


Eligibility criteria:
inclusion criteria: * female or male patients ≥ 18 years of age * removal of at least 10 l of ascites in the preceding 2 months for symptom relief * failure to respond to a maximum of 160 mg/d of furosemide and 400 mg/d of spironolactone (or equivalent doses of loop-acting and distal-acting diuretics), or intolerance to high dose diuretics because of hyponatremia, hyperkalemia, or other side-effects * dietary sodium restriction \<90 mcg/d. * serum creatinine levels of less than 1.8 mg/dl for at least 7 days before study entry. * total bilirubin levels of less than 3 mg/dl. * expected survival of greater than 6 months * written informed consent exclusion criteria: * presence of recurring systemic or local infection, such as peritonitis, urinary tract infection, or abdominal skin infection. * presence of peritoneal carcinomatosis * evidence of extensive ascites loculation * obstructive uropathy * coagulopathy that could not be corrected to a prothrombin time inr \<1.8, * thrombocytopenia that could not be corrected to a platelet count greater than 60,000/mm3 * any other clinically significant disease that could be adversely affected by study participation judged by the investigator * any condition requiring emergency treatment * pregnancy * inability to obtain informed consent
vasculera in participants with lipedema

Conditions: Lipedema

Summary: this study is designed to gain preliminary information via a uniform protocol regarding the clinical effects of vasculera in participants with lipedema and the possible role of the glycocalyx as a physiological target for vasculera activity. it is anticipated that the results of this case study will inform the development of a formal randomized, double-blind, placebo controlled trial.

the goal of this type of clinical trial is to compare the measurement of participants legs before treatment and after using the treatment for approximately 3 months in clinic patients 20 to 70 years old with lipedema. the main questions it aims to answer are: does the leg circumference decrease and does the participants' overall wellbeing improve? participants will: * have physical examinations and measurements at baseline and 3 month visit * complete wellbeing self-assessments at baseline and 3 month visit * have blood drawn for chemical markers at baseline and 3 month visit * complete four visits total

Eligibility criteria:
inclusion criteria: 1. established diagnosis of lipedema for at least one (1) year 2. women, ages 20 to 70 years 3. score of at least 4 out of 10 on self-assessment on a 0-10 scale (10=worst) for overall sense of well being 4. be willing to stop compression therapy for one week prior to each visit exclusion criteria: 1. other forms of leg enlargement, including lymphedema 2. any primary systemic vasculopathy 3. history of exposure to vasculera or other diosmin containing medication within one (1) year of the screening visit 4. concomitant use of warfarin, platelet inhibitors, factor xa inhibitors or any medication intended to reduce blood coagulability 5. concomitant use of diclofenac, metronidazole or chlorzoxazone 6. uncontrolled hypertension (bp\>170/110), unstable cardiac disease, active skin ulceration 7. any other disease or condition that, in the opinion of the investigator, might put the 8. subject at risk by participation in this study or confound evaluation of response to vasculera 9. history of substance abuse within one (1) year of the screening visit or of current alcohol consumption more than one (1) unit daily. for purposes of this study, a unit of alcohol will be considered to be 12 oz of beer, 6 oz of wine or 1 oz of hard spirits.
fih study of rgt-419b alone and with endocrine therapy in hr-positive, her2-negative advanced/metastatic breast cancer

Conditions: Breast Cancer

Summary: this is a phase i, first-in-human (fih), open-label study to evaluate the safety, tolerability, pharmacokinetic (pk) profile, and preliminary efficacy of rgt-419b administered orally as monotherapy or in combination with hormonal therapy in subjects with hr+, her2- locally advanced and unresectable (stage iii) or metastatic (stage iv) breast cancer whose disease has progressed during prior therapy with an approved cdk4/6i plus hormonal therapy.


Eligibility criteria:
inclusion criteria: 1. male or female \>/= 18 years old 2. ecog performance status 0 to 1 3. subjects must have histologically or cytologically confirmed diagnosis of er+, her2- abc consistent with asco cap guidelines that is locally advanced and unresectable (stage iii) or metastatic (stage iv) bc. 4. measurable and evaluable lesions at baseline per recist v1.1. 5. eligible subjects must meet all of the following criteria: * progression after receiving 1 line of prior cyclin-dependent kinase 4 and 6 inhibitor (cdk4/6i) therapy combined with ht in the mbc setting (up to 1 additional line of cdk4/6i is permitted in the post-surgical adjuvant setting); * subjects must have received therapy for ≥3 months in the mbc setting, or for ≥6 months in the adjuvant setting, prior to progression * progression after ≤3 lines of prior ht therapy (regardless of whether it is ht alone or in combination with other therapies) * prior ht combination agents, including serd, serm or ai, must have received formal approval by regulatory agency. * ≤ 1 prior line of chemotherapy in the metastatic setting 6. adequate organ function 7. ability to understand and the willingness to sign a written informed consent document exclusion criteria: 1. presence of visceral metastases with severe organ dysfunction as evidence by signs and symptoms, laboratory studies, lymphangitic spread and/or rapid progression of disease 2. pregnant or planning to become pregnant 3. prior irradiation to \>25% of the bone marrow and/or inadequate bone marrow function or evidence of clinically significant end-organ damage 4. major surgery, chemotherapy, targeted therapy, experimental agents, or radiation within 14-28 days prior to cycle 1, day 1 5. active, serious medical condition that is not well controlled with locally approved medications allowed by the protocol 6. history of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs used in the study

Keywords: breast cancer
fbntp imaging of breast cancer

Conditions: Breast Cancer

Summary: our preclinical studies suggest the capacity of the positron emission tomography imaging agent 18f-fluorobenzyl triphenyl phosphonium (fbntp) to detects early-stage small breast tumors (e.g., dcis), and differentiates benign from malignant masses with better accuracy than that obtained by existing breast imaging tools.

breast cancer is the most widespread type of cancer among women in the usa, and the second leading cause of death. the national cancer institute estimates that in 2013, in the usa, 226,870 women will be diagnosed with breast cancer and 39,510 women will die of breast cancer, most of them of progressive metastatic disease. early detection and treatment of the disease, when the tumor is still localized and at a high curability state, is the outmost important determinant of disease-free survival of breast cancer patients. survival rate of women first diagnosed with pure early-stage noninvasive tumor (ductal carcinoma in situ- dcis) is nearly 98%, which drops to 48% in patients with advanced disease.yet, early detection of breast cancer is relatively poor. this is best exemplify by the astonishing percentage of benign biopsies; 80% of 1.7 million biopsies in the usa, at a cost of $3 billion; whereas, only small fraction (\~20%) of newly diagnosed women are found to have pure dcis. our preclinical studies suggest the capacity of the positron emission tomography (pet) imaging agent 18f-fluorobenzyl triphenyl phosphonium (fbntp) to detects early-stage small breast tumors (e.g., dcis), and differentiates benign from malignant masses with better accuracy than that obtained by existing breast imaging tools. accordingly, the present protocol is designed to extend the preclinical findings into clinical studies in breast cancer women, and to assess the effectiveness of 18f-fbntp in detecting breast malignant lesions, in comparison with magnetic resonance imaging and fluorodeoxyglucose pet imaging.

Eligibility criteria:
inclusion criteria: * female patients with newly-diagnosed invasive and/or intraductal breast cancer detected by core needle or vacuum-assisted biopsy (i.e., index cancer) * age \> 25 ability and willingness to sign informed consent prior to any study procedure. * positive indication of disease on mammogram or mri scan. * candidate for breast cancer surgery on the basis of recommendation of a breast cancer surgeon. * ability to undergo up to 90 minutes of pem imaging. exclusion criteria: * any active or chronic illness that, in the opinion of the investigators, would make the study unsafe or limit compliance with study procedures. * past or present history of active substance abuse (drug or alcohol). * inability to tolerate venous access. * pregnant females are excluded from this study. all females of child-bearing potential will undergo a serum pregnancy test within 48 hours prior to fbntp administration.

Keywords: pet positron emission tomography breast cancer imaging
acceptance and value based methods in increasing wellbeing of adolescents with type 1 diabetes

Conditions: Diabetes

Summary: the aim of the study is to study how using acceptance and value based group intervention helps the wellbeing of teenagers with type in diabetes. the investigators created an act-group intervention consisting of five sessions, based on earlier research. 12-16 years- old diabetics who are treated at ksshp pediatric policlinic are invited to join the groups. the participants are randomized to research and control groups. the hba1c-level is monitored for both groups as well as the psychological flexibility, diabetes related acceptance, depression and quality of life.


Eligibility criteria:
inclusion criteria: * type 1 diabetes exclusion criteria: * weekly psychiatric appointments

Keywords: type 1 diabetes act adolescents value based methods acceptance
medial fat pad preservation in upper eyelid blepharoplasty

Conditions: Eyelid Diseases

Summary: medial upper eyelid pad of fat bulge is a common problem. medial fat pad preservation might be a good adjutant to upper eyelid blepharoplasty

blepharoplasty with repositioning of the nasal fat pad to the central arcus marginalis of the superior orbital rim during surgery or orbitoglabellar groove

Eligibility criteria:
inclusion criteria: * upper eyelid medial pad of fat bulge exclusion criteria: * other eyelid diseases and previous eyelid surgery

Keywords: upper eyelid pad fat blepharoplasty
ps128 may improve off duration on parkinson's disease

Conditions: Parkinson Disease

Summary: the purpose of this study is to investigate the short term effects (12 weeks) of lactobacillus plantarum ps128 (ps128) on parkinson's disease (pd) symptoms.

this study is designed to examine the extent to which l. plantarum ps128 can improve symptoms in pd patients. l. plantarum ps128 is a psychobiotic that regulates the level of dopamine in specific brain regions. patients with pd will receive ps128 treatment for 12 weeks. symptoms of pd will be clinically evaluated before and after the treatment, and the results will be compared.

Eligibility criteria:
inclusion criteria: * patients diagnosed with idiopathic parkinson's disease * according to the record of on / off diary for 3 consecutive days, the patient's daily off periods must be more than 3 hours a day. * between ages of 40-80 years old. exclusion criteria: * patients on antibiotics within the preceding one month * patients using of other probiotic products (sachet, capsule or tablet) within the preceding two weeks * have undergone surgery of liver, bladder, or gastrointestinal tract * have current or history of inflammatory bowel disease * have history of cancer * known allergy to probiotics * patients with comorbid dementia (mini-mental state examination score ≤ 26) or major depression (the beck depression inventory-ii score ≥ 29) * have received deep brain stimulation * patients receiving artificial enteral or intravenous nutrition
spontaneous coronary artery dissection registry (dissezioni spontanee coronariche italian-spanish)

Conditions: Spontaneous Coronary Artery Dissection

Summary: the study will investigate the clinical features, acute management and follow up of patients affected by spontaneous coronary artery dissection

spontaneous coronary artery dissection is now being increasingly studied as it is getting more and more relevant as a cause of acs. its management is currently a matter of debate due to the absence of rct and even the trigger events related to this kind of infarction are still unclear. notably, the benefits from the use of the antiplatelet medications that prolong bleeding time for a condition whose primary pathophysiology may be an intramural bleed are under discussion. hence, the targets pursued by our study may be essentially distinguished in five main points: 1. to assess the characteristics of scad patients highlighting the predisposing and precipitating factors related to the acute event 2. to analyze clinical presentation and management of spontaneous coronary dissections in terms of therapeutic approach in the acute phase (conservative therapy vs revascularization) 3. to evaluate the incidence of scad recurrence and of major adverse cardiovascular events (maces) at follow-up 4. to analyze the impact of a single antiplatelet therapy (sapt) over the dual one (dapt) along with the impact of different p2y12i regimens on acute and long-term prognosis 5. to evaluate impact of different angiographic scad type on outcome

Eligibility criteria:
inclusion criteria: * consecutive patients with a novel diagnosis of spontaneous coronary artery dissection (scad) exclusion criteria: * age \<18 year old or inability to provide informed consent

Keywords: spontaneous coronary artery dissection scad
balloon assisted maceration versus rotational thrombectomy in dialysis access salvage

Conditions: Dialysis Access Malfunction; Dialysis; Complications

Summary: the purpose of this research study is to compare how well a wire like device disrupts and removes blood clot in your blocked dialysis graft/fistula in comparison to inflating a balloon in your access for the same purpose. the wire like device is called the cleaner xt and has already been approved by the government/food and drug administration (fda) for this purpose. blood clots in your dialysis access can be fairly common and prevent you from being able to get dialysis. procedures for opening this blockage must then be performed which is why you have been sent to the hospital today. there are different ways of opening up this blockage which can including blowing up a balloon in multiple areas of the graft/fistula to squeeze the blood clot to break up the blockage or using a wire like device to break up the clot in small pieces and try to remove all of the clot from the wall of the graft/fistula.


Eligibility criteria:
inclusion criteria: * end stage renal disease on hemodialysis * age greater than 18 * upper extremity dialysis graft/fistula exclusion criteria: * pregnant * incarcerated * age under 18 * inability to consent for self * graft/fistula in a location other than upper extremity * peritoneal dialysis * catheter dialysis

Keywords: thrombosis of dialysis access
promoting positive emotional functioning in police and military populations

Conditions: Anhedonia

Summary: this study will examine whether actively serving and veteran members of the canadian armed forces (caf) and royal canadian mounted police (rcmp) who complete a treatment targeting anhedonia symptoms and amplifying positive emotional processing: 1) experience significant symptom reductions in anxiety, trauma, and depressive symptoms; 2) report increased experience of positive emotions; 3) report improvements to broad functioning and quality of life; and 4) find the treatment to be highly tolerable.


Eligibility criteria:
inclusion criteria: * be an actively serving or veteran member of the caf and rcmp; * have been referred to receive the treatment protocol at the osic at deer lodge centre by a doctor or psychologist; * have previously participated in at least one evidence-based psychological treatment for depressive, anxiety, or trauma-and-stressor-related condition at osic but remain clinically symptomatic; * be able to speak, read, and write in english; * have no current psychosis, untreated bipolar disorder, or current suicidal ideation with plan and intent; * be on a stable medication regime and agree to not make changes for the duration of the treatment.