Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of atiprimod treatment for patients with low to intermediate grade neuroendocrine carcinoma

Conditions: Neuroendocrine Carcinoma

Summary: this study will evaluate the safety and efficacy of atiprimod treatment in patients with low to intermediate grade neuroendocrine carcinoma who have metastatic or unresectable local-regional cancer and who have either symptoms (diarrhea, flushing and/or wheezing) despite standard therapy (octreotide) or progression of neuroendocrine tumor(s).

for carcinoid, despite the many cytotoxic chemotherapy trials that have been conducted, no regimen has demonstrated a response rate of more than 20% using the criterion of a 50% reduction of bidimensionally measurable disease. in the more recently reported ecog phase iii study of chemotherapy in carcinoid tumors (e1281), patients were randomly assigned to treatment with 5-fluorouracil (5fu) plus doxorubicin or 5fu plus streptozocin. the median progression free survival durations were disappointing. they were 4.5 months in the 5fu plus doxorubicin arm and 5.3 months in the 5fu plus streptozocin arm. overall survival durations recorded in the trial were also suboptimal at 15 and 24 months respectively. there is no clear survival benefit for cytotoxic chemotherapy. this is a phase ii, multi-center, open-label study of the safety and efficacy of atiprimod treatment in patients with low to intermediate grade neuroendocrine carcinoma who have metastatic or unresectable local-regional cancer and who have either symptoms (diarrhea, flushing and/or wheezing) despite standard therapy (octreotide) or progression of neuroendocrine tumor(s) (defined as the appearance of one or more new lesions or a 20% increase in the sum of the longest diameter of target lesions during the 6 months prior to enrollment). a maximum of 40 evaluable patients will be enrolled in this study. atiprimod will be administered orally as a single daily dose of 120 mg/day for 14 days, followed by a 14-day treatment-free period (i.e., 1 treatment cycle = 28 days).

Eligibility criteria:
inclusion criteria: * patient must have documented histologic proof of low or intermediate grade neuroendocrine carcinoma. both carcinoid (any site; atypical/intermediate grade carcinoid is allowed) and islet cell (pancreatic endocrine tumor) will be eligible. patient with neuroendocrine tumors associated with men1 syndrome will be eligible. * patients must have either metastatic or unresectable local-regional cancer. patients with brain metastases are allowed on study, but they must have evaluable target lesions elsewhere. * patients must have measurable disease, as defined by recist. * patients must have either symptoms (diarrhea, flushing and/or wheezing) despite standard therapy (octreotide) or progression of neuroendocrine tumor(s) (defined as the appearance of one or more new lesions or a 20% increase in the sum of the longest diameter of target lesions during the 6 months prior to enrollment).

Keywords: neuroendocrine carcinoma atiprimod carcinoid
evaluation of the severity of right to left shunt in pfo patients after systemic embolism

Conditions: Patent Foramen Ovale; Embolism

Summary: the aim of the project is to identify new risk indicators of pfo. the evaluation of the r-l shunt is based on the newly developed precise measurement technique. moreover, this measurement of r-l shunt is feasible in a case when r-l shunt is present only intermittently. multicentric study with 150 patients.

the aim of the proposed project is to identify new risk indicators of pfo. the evaluation of the r-l shunt is based on the newly developed precise measurement technique. moreover, this measurement of r-l shunt is feasible in a case when r-l shunt is present only intermittently. detection and quantification of r-l shunt will be realized by the original inntherm® ® system (innova medical s.r.o., velká dobrá). this system is based on the principle of thermodilution. the basic assumption of our study is the hypothesis, that the size of the r-l shunt (and especially its maximum size during intra-abdominal pressure increase) is a risk factor for the development of paradoxical embolism (from pulmonary to systemic circulation). the most critical consequence of paradoxical embolism is the development of ischemic stroke. such measurement with an unequivocal accuracy has never been done so far, due a lack of technology precise enough. precise quantification of r-l shunt will allow a more accurate prediction of high-risk patients, especially after correlation with commonly used methods. pfo is now an indication for implantation of percutaneous occlusion device only in case of secondary prevention of stroke, i.e. in a group of patients who have had an ischemic stroke. prospectively, precise and better identification of a risk group of these patients could lead to cost reduction of treatment. this cost reduction is crucial for young working-age patients who can be treated before a major irreversible brain injury occurs. a parameter applicable in primary prevention saves the cost of ischemic stroke treatment and other systemic embolism; additionally it will contribute to cost reduction during aftercare treatment.

Eligibility criteria:
inclusion criteria: 1. male and female patients aged ≥18 and \< 60 years 2. cryptogenic stroke or systemic embolization due to paradoxical embolization via patent foramen ovale 3. the patient indicated for occlusion of pfo with catheter occluder exclusion criteria: 1. inability to perform spiroergometry 2. inability to perform transesophageal echocardiography (tee) 3. inability to perform proper valsalva maneuver 4. inability to understand and/or signed informed consent form 5. contraindication of patent foramen ovale occlusion by any medical reason or patient refusal

Keywords: patent foramen ovale systemic embolism cardiac shunt right to left shunt hemodynamics
evaluation of the safety profile, quit and reduction rate after nicorette® gum and patch treatment

Conditions: Tobacco Dependence

Summary: to evaluate the safety, smoking cessation and reduction rate during 3 months of active nicotine replacement therapy (nrt) and a follow-up period of 3 months in smoking hospital physicians and staff who are motivated to quit

using nicorette® gum 2 mg, 4 mg and nicorette® patch 5 mg/16 h, 10 mg/16 h, 15 mg/16 h to alleviate nicotine cravings and withdrawal symptoms and assist smoking cessation in smoking hospital physicians and staff who are motivated to quit. during the study, brief telephone consultation and sms are provided as behavioral supports.

Eligibility criteria:
inclusion criteria: * healthy males and females, aged 18 years or older * normal dental status and chewing ability for nicotine gum users; normal skin without excessive hair growth on tested areas for nicotine patch users * current daily smoker for at least two years * have a carbon monoxide (co) level of at least 10 parts per million (ppm) after at least 15 smoke-free minutes * be motivated to stop smoking with the help of nicotine gum or patch treatment. * evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the trial * be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures. exclusion criteria: * current use of other tobacco-containing products e.g. snuff, chewing tobacco, cigars, or pipes. * use of any other stop-smoking products (nicotine or non-nicotine) or treatment (hypnosis, acupuncture, etc) during the study i.e. during the last 6-month period. * unstable angina pectoris or myocardial infarction during the previous 3 months. * pregnancy, lactation or intended pregnancy. * any major metabolic disease, clinically important renal, hepatic disease. * suspected alcohol or drug abuse. * participation in other clinical trials in the previous three months, or during study participation. * other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.

Keywords: nicotine dependence, smoking cessation, nrt
a study of ruxolitinib in pancreatic cancer patients

Conditions: Pancreatic Cancer

Summary: this was to determine the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of metastatic pancreatic cancer.

this was a randomized, double-blinded, placebo-controlled, phase 3 study, in which approximately 270 participants with advanced or metastatic adenocarcinoma of the pancreas who had failed or were intolerant to first-line chemotherapy were to be randomized (1:1) to one of the following treatment groups: * treatment a (n = 135): capecitabine + ruxolitinib * treatment b (n = 135): capecitabine + placebo treatment consisted of repeating 21-day cycles. capecitabine was self-administered for the first 14 days of each cycle, and ruxolitinib/placebo was self-administered during the entire cycle. treatment for all participants was to continue as long as the regimen was tolerated, and the participant did not meet discontinuation criteria. participants who discontinued treatment continued to be followed for subsequent anticancer treatments and survival.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the pancreas. * advanced adenocarcinoma of the pancreas that is inoperable or metastatic. * eastern cooperative oncology group (ecog) performance status 0 to 2 * received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy). * ≥ 2 weeks elapsed from the completion of previous treatment regimen and participants must have recovered or be at a new stable baseline from any related toxicities. * radiographically measurable or evaluable disease * an modified glasgow prognostic score (mgps) of 1 or 2 as defined below: * criteria: 1. mgps of 1: c-reactive protein (crp) \> 10 mg/l and albumin ≥ 35 g/l 2. mgps of 2: crp \> 10 mg/l and albumin \< 35 g/l exclusion criteria: * received more than 1 prior regimen for advanced or metastatic disease. * ongoing radiation therapy, radiation therapy administered within 30 days of enrollment * concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization). * current or previous other malignancy within 2 years of study entry without sponsor approval * prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase deficiency (dpd), or other known hypersensitivity to active substances, including fluorouracil (5-fu), ruxolitinib, or any of their excipients. * prior treatment with a jak inhibitor for any indication.

Keywords: metastatic pancreatic cancer
open label study evaluating the use of combination therapy of ezetimibe and statins in patients with dyslipidemia in colombia (0653-141)(completed)

Conditions: Lipid Metabolism Disorder

Summary: gather additional efficacy and safety (pharmacovigilance) information in the usual daily care in patients with dyslipidemia on ezetimibe under real conditions in colombia associated with statins.


Eligibility criteria:
inclusion criteria: * \> 18 years old * lipid metabolic disorder as per atp iii who have not reached the goals and who are on statins for at least 4 weeks or those who require ldl reductions over 50% to reach the atp iii goals or who need statins in accordance their risk score exclusion criteria: * pregnancy, breast feeding * moderate/sever liver disease: child score \> or = to 7 * fibrates terminal disease * contraindications to receive ezetimibe * contraindications to receive statins * mental disability * hypersensitivity to ezetimibe * on another clinical research trial
frequency specific microcurrent for the treatment of diastasis recti

Conditions: Diastasis Recti

Summary: determine if frequency specific microcurrent therapy improves pain management of dra by 30% or greater.

females aged 18 years or older who are postpartum from a singleton gestation status post vaginal and with diastasis recti will be recruited. the aim of this study is to determine if frequency specific microcurrent therapy improves pain management of dra by 30% or greater improving dra after microcurrent therapy in post-partum females may allow a faster, more effective return to activity thereby improving the return-to-duty transition and establishing personal readiness by meeting military fitness standards.

Eligibility criteria:
\*\*patients must be able to get care at nellis air force base (a military installation) in order to participate in this study\*\* inclusion criteria: * active duty and dod beneficiary postpartum females (12 hours to 24 hours) with diastasis rectus abdominus (dra) pain * aged 18 years or older * singleton gestation/delivered (one baby carried and born) * vaginal delivery * nulliparous (first pregnancy) or multiparous (more than one pregnancy in the past) exclusion criteria: * less than 18 years of age * females greater than 24 hours post-partum * medical history to include pacemaker * history of arrhythmia * transplant status * insulin pump * pain pump * active cancer * inability to measure ird * delivery via caesarean section * operative vaginal delivery (vacuum or forceps) * 3rd or 4th degree vaginal laceration

Keywords: diastasis recti postpartum family medicine microcurrent
validation and field test for risk appraisal instruments

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Heart Disease Risk Reduction

Summary: to field test the validity, reliability, cost, and cost-benefit of health risk appraisal (hra) instruments.

background: health risk appraisals instruments have provided the field of health promotion with an imaginative motivational and instructional tool to foster personal behavioral change. a hra typically asked questions about smoking, blood pressure, exercise, medical history, diet and other life style variables. these risk indicators were then compared to epidemiological and mortality data to yield an estimate of an individual or group's risk for disease. they were widely regarded as the most promising new addition to the health promotion armamentarium. the national health information clearinghouse divided them into the following three categories: computer-scored hras, which were mailed to a central computer facility for batch processing and were usually the more complex and detailed appraisals; microcomputer-based hras, which c;ould be processed by a microcomputer at home, in schools or at the worksite; and self-scored hras, which were usually brief, did not involve a computer, and were scored by the user. although hras were a burgeoning industry in health education, no properly designed and conducted scientific evaluation of them on a sufficiently large and representative sample of the general population had been undertaken in the united states or elsewhere. design narrative: in the first stage, fourteen hras were evaluated by determining the validity of the scoring system for estimating cardiovascular risk as employed in the framingham heart study data base, the accuracy of the reported risk factor scores as measured by physiological values, and the understandability and social acceptability of the instrument format. the second stage of the project was a field test to determine reliability and cost-effectiveness. ten groups of respondents were formed by randomly assigning eligible adults to one of the five hra groups and then to reliability and validity status. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
risk factors of relapse in esophageal squamous cell cancers who achieve pcr to neoadjuvant chemoradiotherapy

Conditions: Esophageal Cancer

Summary: it has been reported that patients with esophageal squamous cell carcinoma who achieved pathological complete response (pcr) to neoadjuvant chemoradiotherapy have better survival than those with non-pcr. howeve, there is still recurrent diseases developed in pcr patients after esophagectomy. herein, we aimed to investgate the risk factors of recurrence in pcr patients.

between january 2008 and december 2018, a total of 96 patients with pathological complete response were enrolled in this study. sterilized lymph nodes (sln) were defined as those lymph nodes without residual tumor but with the presence of treatment response to neoadjuvant chemoradiotherapy. prognostic factors for recurrence-free survival (rfs) were analyzed with univariate and multivariate analyses.

Eligibility criteria:
inclusion criteria: (1) patients with histopathologically confirmed escc;(2) patients received ncrt and radical esophagectomy in our hospital;(3) patients received the cisplabin plus or cisplain plus as the preoperative chemotherapy regimen; (4) those patients achieved pcr in the postoperative specimens (both primary tumor and resected lymph nodes). exclusion criteria: (1) patients who did not receive preoperative treatment or received preoperative chemotherapy alone;(2) patients who underwent ivor-lewis esophagectomy or sweet esophagectomy;(3) patients who received preoperative chemotherapy other than np or dp regimens;(4) patients with non-pcr to ncrt.

Keywords: risk factor
the nordic consensus study

Conditions: Stoma Site Leakage; Quality of Life; Nurse's Role; Stoma Ileostomy; Colostomy Stoma

Summary: a body assessment tool was developed to provide nurses with a more structured approach when choosing ostomy products. the body assessment tool will to be evaluated in clinical settings.

the primary objective is to evaluate the usability of the body assessment tool for the nurse. the secondary objectives are to explore if the use of body assessment tool has an impact on the leakage associated quality of life and leakage incidences for individuals living with ostomies. forty to fifty ostomates will be enrolled from each nordic country (i.e. denmark, sweden, norway and finland). the users will be recruited from 5-10 clinics in each country. the evaluation will include 1 visit at the clinic and at least 1 phone call visit to the user (end-of study phone visit). the usability of the body assessment tool will be evaluated by the nurses. the user's leakage and qol will be evaluated by the end-users.

Eligibility criteria:
inclusion criteria: * ostomates * male or female ≥18years * leakage issues exclusion criteria: * requires a caretaker or is unable to participate in the study * is pregnant or lactating
the combination of atra and danazol as second-line treatment in adult immune thrombocytopenia

Conditions: Autoimmune Thrombocytopenia

Summary: randomized, open-label, multicentre study to compare the efficacy and safety of atra plus danazol with danazol monotherapy in patients with corticosteroid-resistant/relapsed itp.

immune thrombocytopenia (itp) is a severe bleeding disorder. approximately 2/3 of patients achieve remission from first-line therapies. however, the underlying mechanism of corticosteroid-resistant or relapsed itp is not well understood; thus, treatment remains a great challenge. all-trans retinoic acid (atra) has an immunomodulatory effect on haematopoiesis, making it a possible treatment option. a multicentre prospective study was performed in non-splenectomized itp patients who were either resistant to a standard dose of corticosteroids or had relapsed. patients were randomized to atra+danazol and danazol monotherapy group. platelet count, bleeding and other symptoms were evaluated before and after treatment. adverse events are also recorded throughout the study, in order to compare the efficacy and safety of atra plus danazol with danazol monotherapy in patients with corticosteroid-resistant/relapsed itp.

Eligibility criteria:
inclusion criteria: * primary immune thrombocytopenia (itp) confirmed by excluding other supervened causes of thrombocytopenia; * platelet count of less than 30×109/l at enrolment * patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation. * 18 years older. exclusion criteria: * secondary immune thrombocytopenia (e.g., patients with hiv, hcv, helicobacter pylori infection or patients with systemic lupus erythematosus) * congestive heart failure * severe arrhythmia * nursing or pregnant women * aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria * creatinine or serum bilirubin levels each 1•5 times or more than the normal range * active or previous malignancy * unable to do blood routine test for the sake of time, distance, economic issues or other reasons.

Keywords: all-trans retinoic acid primary immune thrombocytopenia corticosteroid-resistant refractory danazol
study of safety and preliminary efficacy for ldk378 in japanese patients with genetic alterations in anaplastic lymphoma kinase (alk)

Conditions: Tumors Characterized by Genetic Alterations in Anaplastic Lymphoma Kinase (ALK)

Summary: estimation of the maximum tolerated dose (mtd) and/or recommended dose (rd) of ldk378 as a single agent when administered orally to japanese patients with tumors characterized by genetic alterations in anaplastic lymphoma kinase (alk)


Eligibility criteria:
inclusion criteria: * patients with a locally advanced or metastatic malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists * only patients with tumors characterized by genetic alterations in alk. for non-small cell lung cancer (nsclc), an alk translocation must be detected by fluorescent in situ hybridization (fish) in ≥15% of tumor cells. local site documented results on alk alteration are acceptable for enrollment of the patients. central confirmation of local results is not required. --eastern cooperative oncology group (ecog) performance status grade ≤ 2 * adequate organ function * dose-expansion part: patients must have nsclc that has progressed since prior therapy with alectinib. alectinib must have been the only prior alk inhibitor received by the patient prior to trial entry. exclusion criteria: * patients with symptomatic central nerve system (cns) metastases who are neurologically unstable or require increasing doses of steroids to control their cns disease * patients with unresolved nausea, vomiting or diarrhea \> common terminology criteria for adverse events (ctcae) grade 1 * other concurrent severe and/or uncontrolled medical conditions * patients who have been treated with chemotherapy or biologic therapy or other investigational agent \< 2 weeks prior to starting the daily dosing of the study drug for compounds with a half-life ≤ 3 days, and \< 4 weeks prior to starting the daily dosing of the study drug for compounds with a prolonged half-life (\< 6 weeks for patients that received nitrosoureas or mitomycin-c) * unresolved toxicity greater than ctcae grade 1 or unstable toxicity from previous anti-cancer therapy or radiotherapy (excluding neurotoxicity, alopecia, ototoxicity, lymphopenia), or incomplete recovery from previous surgery, unless agreed by novartis and the principal investigator and documented * patients who have received radiotherapy to lung within 4 weeks prior to starting the daily dosing of the study drug or patients who have not recovered from radiotherapy-related toxicities. for all other anatomic sites radiotherapy to a large volume (including whole brain radiotherapy) \< 2 weeks prior to starting the daily dosing of the study drug, and patients who have received radiotherapy to a small volume (including stereotactic radiotherapy to the cns) \< 3 days prior to starting the study drug. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: phase i, open-label, dose escalation, oral ldk378, japanese patients with tumors characterized by alk genetic alterations