Kornimate/medical-research-clean huggingface dataset:
open-label extension safety study of procrit in patients with anemia of chronic disease due to rheumatoid arthritis

Conditions: Anemia; Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the long-term safety profile of epoetin alfa in patients with anemia of chronic disease due to rheumatoid arthritis

epoetin alfa is an analogue of erythropoetin, a hormone secreted by kidneys known to stimulate red blood cell production. although epoetin alfa has been known to be effective in treatment of anemia associated with chronic kidney disease, information on its effectiveness and long-term safety for treatment of anemia associated with rheumatoid arthritis is limited. this 35-week safety study is an extension of a 20-week, prospective, randomized, double-blind, placebo-controlled, multi-center study that investigates effectiveness of epoetin alfa in patients with anemia of chronic disease due to rheumatoid arthritis. the study hypothesis is that there will be no long-term safety concerns of epoetin alfa administered once every two weeks in rheumatoid arthritis patients with anemia of chronic disease. patients will receive epoetin alfa injections (40,000 units) under their skin once every 2 weeks for up to 31 weeks. doses may be adjusted depending on the patients' hemoglobin level up to the maximum of 60,000 units once every 2 weeks or 40,000 units once weekly.

Eligibility criteria:
inclusion criteria: * patients must have signed an informed consent * women must be postmenopausal for at least one year, surgically sterile, or practicing an effective method of birth control, or have a negative serum pregnancy test at week 1 of the study * women must not be breast feeding during this study period * patients must have completed the double-blind (db) study (pr03-33-055) without missing more than 4 study visits and have hemoglobin level of less than or equal to 12.9 g/dl at week 20 of the db study exclusion criteria: * uncontrolled hypertension * elective surgery, including joint replacement, anticipated to require transfusion during the extension study period * thromboembolic event during the double-blind study including acute myocardial infarction, cerebrovascular accident and/or transient ischemic attack * deep vein thrombosis and/or pulmonary embolism * uncontrolled psychiatric disease or other co-morbid disease that have developed or worsened since enrollment to the double-blind study * planning to be enrolled in any other clinical trial during the course of this study

Keywords: anemia rheumatoid arthritis hemoglobin level
of 18f mel050 using pet/ct in metastatic melanoma

Conditions: Metastatic Melanoma

Summary: the purpose of this study is to investigate the safety and potential effectiveness of the imaging compound 18f mel050 for finding sites of melanoma.


Eligibility criteria:
inclusion criteria: * written informed consent obtained prior to any protocol-specific procedures * male and female patients with histologically confirmed melanoma * at least one site of metastatic disease, as demonstrated on the pre-study 18f fdg pet/ct scan performed as part of routine clinical care * age \>/= 18 years * life expectancy \>/=3 months * ecog performance score of 0-2 exclusion criteria: * pregnant or breastfeeding females * systemic anti-melanoma therapy within the 2 weeks prior to the pre-study 18f fdg pet/ct scan until after the 18f mel050 pet/ct scan * patients whose clinical care may be compromised because of the delay resulting from performance of the 18f mel050 pet/ct scan * patients whose only metastatic lesion is in the central nervous system * patients with urinary incontinence or patients who cannot comfortably hold their urine for more than 90 minutes * any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study * patients unwilling or unable to comply with protocol and patients with a history of non compliance or inability to grant informed consent.

Keywords: melanoma metastatic diagnosis
detection of ileoanal pouch/reservoir adenomas

Conditions: Adenomatous Polyps

Summary: the detection of adenomas is the basis for the follow-up of patients with familial adenomatous polyposis, after colectomy, with a remnant rectum or an ileal pouch. the optimal method for the adenomas detection is not defined yet. despite the proven effectiveness of indigo-carmine in different indications dye chromoendoscopy is not used in a consensual way at the international level. the situation of the ileal pouch is specific as adenomas have a usually flat shape and are much more difficult to identify than in the situation of a remnant rectum, even in the situation of \> 5 mm adenomas that should be resected. our hypothesis is that indigo-carmine can improve adenomas detection, including \> 5 mm adenomas, in patients with a an ileal pouch after colectomy improving the effectiveness of surveillance programs and potentially reducing the risk of cancer in this population.


Eligibility criteria:
inclusion criteria: * patients with familial adenomatous polyposis * ileo-anal anastomosis with pouch reservoir * quality of the final preparation = 3 (excellent) on the studied area * films made under optimal conditions for the 3 staining methods exclusion criteria: * patient with no familial adenomatous polyposis * patient without ileo-anal anastomosis reservoir * insufficient quality of the final preparation \<3 * absence of films made under optimal conditions for the 3 staining methods

Keywords: familial adenomatous polyposis ileoanal pouch/reservoir adenomas chromoendoscopy indigocarmine colectomy
decompressive craniectomy in patients with cerebellar infarction

Conditions: Cerebellar Stroke

Summary: the investigators aimed to evaluate the outcome in participants up to 80 years of age with space-occupying cerebellar infarction treated with suboccipital decompressive craniectomy (sdc) compared to medical therapy alone.

this trial is a prospective, randomized, controlled, clinical trial based on a stroke center. the primary end point was survival with favorable outcome, defined as a score of 0 to 3 on the mrs at 12 months (±30 days) after randomization (defined by a score of 0 to 3 on the modified rankin scale (mrs), which ranges from 0 \[no symptoms\] to 6 \[death\]). secondary outcomes included death, barthel index, baseline stroke severity nihss (national institute of health stroke scale), and sf-36 at 6 months and 1-year after randomization. the variables for subgroup analysis were age, sex, time to randomization, lesion volume, brainstem involvement, hemorrhagic transformation.

Eligibility criteria:
inclusion criteria: * the presence of cerebellar territory infarction with an nihss score ≥8. * initial glasgow coma scale (gcs) score \<9 on admission and clinical deterioration (a score of ≥ 1 decrease on gcs score) within 48 hours from onset. * decrease in the level of consciousness to a score of ≥ 1 on item 1a (level of consciousness) of the nihss, rapid deterioration to coma. exclusion criteria: * prestroke mrs score ≥2. * prestroke score on the barthel index \<95. * score on the glasgow coma scale ≤6. * both pupils fixed and dilated. * any other coincidental brain lesion that might affect outcome. * space-occupying hemorrhagic transformation of the infarct. * pregnancy. * life expectancy \<3 years.
changes in the bladder micro-environment following midurethral sling surgery for stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: this observational cohort study is aimed at determining changes in the cytokine expression profile as well as the urinary and vaginal microbiome of women undergoing midurethral sling placement for the treatment of stress urinary incontinence.

primary objectives: this is a pilot study to evaluate how midurethral sling (mus) placement for the treatment of stress urinary incontinence (sui) affects the bladder microenvironment, specifically the local microbial community or "microbiome" of the bladder and the cytokine expression profile. the investigators also aim to correlate any changes in the microbiome or cytokine expression profile with patient-reported urinary symptoms preoperatively and postoperatively. specific aim 1: assess the change in the urinary and vaginal microbiome (preoperatively to postoperatively) in women undergoing mus placement for the treatment of sui. the investigators hypothesize that the bladder environment will be disturbed by surgery involving the lower urinary tract and will show demonstrable changes in the urinary and vaginal microbiota. specific aim 2: characterize the cytokine profile of the bladder (preoperatively to postoperatively) in women undergoing mus placement for the treatment of sui. the investigators hypothesize that mus treatment will change the cytokine profile of the bladder and lead to alterations in the expression of pro-inflammatory cytokines.

Eligibility criteria:
inclusion criteria: * age \> 18 years old * planning to undergo retropubic midurethral sling placement exclusion criteria: * prior surgery for stress urinary incontinence * untreated pelvic organ prolapse \> stage ii based on pop-q assessment * concomitant surgery for prolapse * current use of anticholinergic medications * use of systemic or vaginal antibiotics in the last 2 months * active urinary tract infection * history of recurrent uti * pregnancy * history of pelvic radiation or bladder cancer

Keywords: microbiome cytokine
efficacy study of neoadjuvant chemotherapy to treat advanced ovarian cancer

Conditions: Advanced Ovarian Cancer

Summary: neoadjuvant chemotherapy is alternative treatment option to upfront cytoreductive surgery to treat advanced ovarian cancer. paclitaxel plus carboplatin is most frequently selected chemotherapeutic regimen for neoadjuvant chemotherapy. docetaxel had similar therapeutic efficacy compared to paclitaxel in adjuvant chemotherapy trials in ovarian cancer. however, docetaxel had more favorable toxicity profile. therefore, the investigators aimed to evaluate the efficacy of docetaxel plus carboplatin as neoadjuvant chemotherapy in patients with advanced ovarian cancer.


Eligibility criteria:
inclusion criteria: * advanced epithelial, tubal, or primary peritoneal cancer * cancer cells in paracentesis, thoracentesis, or laparoscopic surgery * less probability of complete cytoreduction * age: 20-80 years * gog performance status: 0-3 * adequate organ function bone marrow: anc ≥ 1,500mm3, platelet ≥ 100,000/mm3, hb ≥ 10.0 g/dl kidney: creatinine ≤ 1.25 × unl liver: ast, alt ≤ × 2.5 unl (in case of liver metastasis, ast, alt ≤ × 5 unl), alkaline phosphatase ≤ 5 x unl, bilirubin ≤ 1.5 mg/ mm3 exclusion criteria: * previous chemotherapy or pelvic radiation therapy * final diagnosis is other malignancies * coincidental other malignancies within 5 years except carcinoma in situ of uterine cervix * history of severe allergy * pregnancy, lactating woman * uncontrolled medial disease * bowel obstruction requiring immediate surgery * etc.
a clinical trial of 16 weeks of duration to evaluate retreatment with elbasvir/grazoprevir plus sofosbuvir and ribavirin in patients with chronic hepatitis c genotypes 1,4 who have failed to treat with a regime based on an inhibitor of the ns5a

Conditions: HCV

Summary: this is a phase 4 clinical trial to treat patients who have failed to treat with regimen based on an inhibitor of the ns5a

the duration of the treatment will be 16 weeks and then will be a security perid with 2 visits (week 12 post treatment and week 24 post treatment) the study in an open label study with a single arm .

Eligibility criteria:
inclusion criteria: * adults with chronic hcv genotype 1, 4 infection with or without hiv infection aged 18 years or above * hcv rna plasma concentration of at least 1000 iu / ml * subjects previously treated with ns5a-based regimens for at least 8 weeks. * patients with hcv relapse after receiving a complete treatment with ns5a-based aad regimen for at least 8 weeks and becoming undetectable at the end of treatment. relapse is defined as a confirmed hcv rna detectable upon completion of therapy of a5 based on ns5a against hcv. * subjects with compensated hepatic cirrhosis (child a) could be included. * for patients with hiv coinfection: * be infected with hiv-1, documented by any rapid hiv test with the corresponding license and confirmed by a western blot or second antibody test using a method other than the initial rapid hiv and / or i / cia method or by hiv-1 p24 antigen or viral load of hiv-1 rna plasma. * be on stable hiv antiretroviral therapy (art) for at least 4 weeks prior to entry into the study using a dual itn backbone of tenofovir or abacavir and emtricitabine or lamivudine plus raltegravir or dolutegravir or rilpivirine (with cd4 + t cell count\> 100 cells / mm 3 and undetectable hiv-1 rna at baseline. results from prior analysis will be accepted within 24 weeks prior to study entry). exclusion criteria: * subjects with hepatitis other than c or steatosis. * subjects previously treated less than 8 weeks with regimens based on ns5a. * evidence of previous hepatocellular carcinoma although it has criteria of cure * subjects with past or current decompensated liver disease; only decompensated patients who have received a liver transplant and have not decompensated after transplantation will be included. * subjects suspected of clinical or genotypic reinfection of hcv. * subject with hcv response regrowth while receiving ns5a-based ada therapy against hcv. said regrowth is defined as a confirmation of detectable hcv rna after achieving undetectable hcv rna during ns5a-based aads against hcv. * recent history of drug or alcohol abuse. * important comorbidities. * pregnant, lactating or non-lactating women contraceptives, if they are women of childbearing age. women of childbearing age are defined as those women who have not undergone permanent infertility procedures or who have been amenorrheic for less than 12 months. * subjects with a glomerular filtration rate of less than 30 ml / min.
study of safety and tolerability of dcr hbvs

Conditions: Hepatitis B, Chronic

Summary: dcr-hbvs will be evaluated for safety and efficacy in healthy volunteers and chronic hepatitis b patients.

dcr hbvs is being developed for the treatment of chronic hepatitis b (chb) in adults. the study will be conducted in 3 parts, a single ascending-dose (sad) phase in normal healthy volunteers (group a), a single-dose (sd) phase in patients with chb (group b), and a multiple ascending-dose (mad) phase in patients with chb (group 1c-3c). cohort 4c is a single ascending dose with a possible duration of up to 48 weeks. cohort 5c is a multiple dose cohort with a possible duration of up to 72 weeks.

Eligibility criteria:
inclusion criteria: * healthy at the time of screening as determined by medical evaluation. * capable of giving informed consent. * 12-lead ecg within normal limits or with no clinically significant abnormalities. * negative screen for alcohol or drugs of abuse. * non-smokers for at least 3 months with a negative urinary cotinine concentration at screening. * bmi within range 18.0 - 32.0 kg/m2 (inclusive). * female participants not pregnant, not breastfeeding, and not of childbearing potential or willing to follow contraceptive guidance. * chronic hepatitis b infection (group b and c only). * clinical history compatible with compensated liver disease with no evidence of cirrhosis (group b and c only). * continuously on nucleotides (nuc) therapy for at least 12 weeks prior to screening (group c only). exclusion criteria: * history of any medical condition that may interfere with the absorption, distribution, or elimination of study drug. * poorly controlled or unstable hypertension. * history of diabetes mellitus treated with insulin or hypoglycemic agents. * history of asthma requiring hospital admission within the preceding 12 months. * evidence of g-6-pd deficiency. * currently poorly controlled endocrine conditions, excluding thyroid conditions. * history of multiple drug allergies or history of allergic reaction to an oligonucleotide or galnac. * clinically relevant surgical history. * use of prescription medications (excluding contraception for women) within 4 weeks prior to the administration of study intervention. * use of clinically relevant over-the-counter medication or supplements (excluding routine vitamins) within 7 days of first dosing. * has received an investigational agent within the 3 months prior to dosing or is in follow-up of another study. * antiviral therapy (other than entecavir or tenofovir) within 3 months of screening or treatment with interferon in the last 3 years (group b and c only). * use within the last 6 months of anticoagulants or systemically administered corticosteroids, immunomodulators, or immunosuppressants (group b and c only).

Keywords: chronic hepatitis b dna virus infections chb hbsag liver disease rnai
proton radiation for unresectable, borderline resectable, or medically inoperable carcinoma of the pancreas

Conditions: Pancreatic Cancer

Summary: the prognosis for patients with localized pancreatic adenocarcinoma who are not surgical candidates is poor. patients characterized as having "borderline resectable" disease treated with preoperative chemo-radiotherapy fair somewhat better - although many of these patients are not converted to resectability. it may be argued that intensification of local and regional therapy might 1.) increase the share of patients able to undergo curative surgery and 2.) improve the local disease control interval and extend survival for patients who remain unresectable. therefore, the purpose of this research study is to determine if an increase in the number of surgical resection pancreatic adenocarcinoma is higher than historical data by using a combined treatment of proton radiation with capecitabine (oral chemotherapy).

participants as part of this research study will receive proton radiation over 6 weeks with oral chemotherapy (capecitabine) only taken on radiation days. in addition, if surgery is an option, then surgical resection will be performed at least 8 weeks after treatment with radiation and chemotherapy.

Eligibility criteria:
inclusion criteria: * biopsy proven unresectable adenocarcinoma of the pancreas. * have either unresectable, borderline resectable or medically inoperable carcinoma of the pancreas, or refusing surgery. * a biliary obstruction is able to participate as long as a drainage tube is in place prior to starting treatment with proton radiation, * participants of child-producing potential must be willing to use contraception while on treatment and for at least 12 months thereafter. * required pretreatment laboratory parameters: * absolute granulocyte count (agc/anc) ≥ 1.8 thou/mm3 * platelet count ≥ 100,000/mm3 * bilirubin \< 2 mg/dl * alt/sgpt \< 3x upper limit of normal * creatinine \< 3 mg/dl exclusion criteria: * evidence of distant metastasis. * prior surgical resection. * previous history of invasive malignancy (except non-melanoma skin cancer and low to intermediate risk prostate cancer) unless the participant has been disease free for 5 years prior to registration. * active or untreated infection, * pregnant or breastfeeding women or subjects of child producing potential not willing to use medically acceptable contraception while on treatment and for at least 12 months thereafter. * previous radiation to the abdomen.

Keywords: unresectable borderline resectable
evaluation of intestinal lesions and disease activity in inflammatory bowel disease based on 18f-fapi pet imaging

Conditions: Inflammatory Bowel Disease (IBD); Disease Activity; FAPI

Summary: the goal of this observational study is to evaluate the role and effect of 18f-fapi pet imaging in the identification of intestinal lesions and the assessment of disease activity in inflammatory bowel disease. the main question it aims to answer is: can 18f-fapi pet imaging effectively identify intestinal lesions in inflammatory bowel disease and accurately assess disease activity? colonoscopy, enhanced abdominal ct, and 18f-fapi intestinal imaging were completed within 1 week, and major adverse outcomes (mao) were followed up 12 months after enrollment. last updated on march 25, 2025


Eligibility criteria:
inclusion criteria: * patients diagnosed with ibd according to clinical, imaging, endoscopic, and histopathological criteria; * patients ≥18 years old; * 18f-fapi pet/ct intestinal imaging, conventional endoscopic and enhanced ct were performed within 1 week; * intestinal segment matching was evaluated by endoscopy and imaging; * patients voluntarily participate and sign informed consent. exclusion criteria: * pregnant or lactating patients; * imaging images are of poor quality and cannot be used for diagnosis and evaluation; * patients with contraindications for endoscopic or ct examination.

Keywords: inflammatory bowel disease 18f-fapi pet disease activity
evaluation of infectivity and illness of norwalk gi.1 virus lot 001-09nv in the human challenge model

Conditions: Norovirus Infection

Summary: there is a need for safe, highly infectious norovirus inocula for use in norovirus vaccine-challenge studies to assess the efficacy of norovirus vaccines and examine the immune response among vaccinated and unvaccinated subjects. the purpose of this study is to generate the infection and illness rate and immune response data necessary for the conduct of future investigation of norovirus vaccine studies.


Eligibility criteria:
inclusion criteria: * general good health, without significant medical illness, based on medical history, physical examination, vital signs, and clinical laboratories (cbc, chemistry, and urinalysis) as determined by the investigator in consultation with the research monitor and sponsor * available for all planned visits and to spend at least 5 days in confinement * confirmed blood type (a or o) * demonstrated to be h type-1 antigen secretor positive (by saliva test) * body mass index between 17 and 30 at screening * female subjects must have a negative pregnancy test and either use contraceptives or be sterile * available to return for follow-up visits following discharge from the inpatient unit and deliver stool specimens to the investigator promptly exclusion criteria: * presence of significant medical condition * donation or use of blood or blood products within 4 weeks prior to challenge * diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood draws problematic * abnormal stool pattern * any gastroenteritis within the past 2 weeks * occupational hazards, including having daily contact with children under the age of 5, women known to be pregnant, employment in the food service industry, health care workers, etc.