Kornimate/medical-research-clean huggingface dataset:
a study of gb201 in combination with weekly paclitaxel and low-dose gemcitabine in patients with pancreatic cancer

Conditions: Metastatic Pancreatic Cancer

Summary: this is a phase ii/iii randomized, open-label clinical study of gb201 in combination with weekly paclitaxel and low-dose gemcitabine in patients with metastatic pancreatic cancer following chemotherapy failure


Eligibility criteria:
inclusion criteria 1. written, signed consent for trial participation in accordance with applicable ich guidelines. 2. must have histologically or cytologically confirmed advanced pancreatic adenocarcinoma that is metastatic. 3. patients who are candidates for and have access to gemcitabine-nab-paclitaxel or are candidates for folfirinox/mfolfirinox must have received these standard of care regimens before randomization. 4. must have one or more evaluable metastatic tumors by recist 1.1. 5. must have ecog performance status of 0 or 1. 6. must have life-expectancy of \> 12 weeks. 7. must be ≥ 18 years of age. 8. for male or female patients of child producing potential: must agree to use contraception or take measures to avoid pregnancy. 9. adequate biological parameters： * absolute neutrophil count (anc) ≥ 1.5 × 10\^9/l * platelet count ≥ 100,000/mm\^3 (100 × 10\^9/l). * hemoglobin (hgb) ≥ 9 g/dl. * ast (sgot) and alt (sgpt) ≤ 2.5 × institutional upper limit of normal (uln) \[5 ×uln in presence of liver metastases\] * total bilirubin ≤ 1.5 × institutional uln. if total bilirubin is \> uln, it must be non-rising for at least 3 days. * serum creatinine within normal limits or calculated clearance \> 60 ml/min/1.73 m\^2. 10. acceptable coagulation studies. 11. no clinically significant abnormalities on urinalysis. 12. patient must have adequate nutritional status. 13. pain symptoms should be stable (of tolerable grade 2 or less). 14. only patients with available archival tumor tissue must consent to submit block of tumor tissue. 15. the patient is not receiving therapy in a concurrent clinical study. exclusion criteria 1. anti-cancer chemotherapy, radiotherapy, biologic therapy or immunotherapy administered two weeks prior to the first planned dose of study medication. investigational agents administered within four weeks of first planned dose of study medication. 2. patients with any unresolved lingering toxicity \> grade 2 from prior treatment will be excluded. 3. patient who were intolerant to prior taxane treatment. 4. major surgery within 4 weeks prior to randomization. 5. patients with any known brain or leptomeningeal metastases are excluded, even if treated. 6. patients with clinically significant pleural effusion or ascites. 7. patient with gastrointestinal disorder(s) which could significantly impede the absorption of an oral agent. 8. prior treatment with napabucasin or participation in a clinical trial evaluating napabucasin. 9. uncontrolled inter-current illness. 10. known hypersensitivity to gemcitabine, taxanes or any of their excipients. 11. uncontrolled chronic diarrhea ≥ grade 2 at baseline. 12. patients being treated with any coumarins. 13. patients with a history of other malignancies.

Keywords: pancreatic cancer
cln-418 study on subjects with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: study to evaluate the safety and tolerability of the study drug cln-418, to determine the maximum tolerated dose and/or recommended phase 2 study dose of cln-418.

this is a study to evaluate the safety and tolerability of the study drug cln-418, and to determine the maximum tolerated dose and/or recommended phase 2 study dose of cln-418. the study will also look at the anti-tumor activity, pharmacokinetics and immunogenicity of cln-418.the study consists of 2 parts. in part 1, patients are enrolled into different cohort doses in order to identify the appropriate recommended phase 2 dose (rp2d) or maximum tolerated dose (mtd). in part 2, participants with metastatic / unresectable non small cell lung cancer (nsclc), triple negative breast cancer (tnbc) will receive the maximum tolerated dose (mtd) and/or recommended phase 2 dose (rp2d) established in part 1 of the study. in part 1 and part 2, participants will be administered treatment every 3 weeks.

Eligibility criteria:
inclusion criteria: 1. willingness to sign a written informed consent document. 2. male or female subject aged ≥18 years old at the time of screening. 3. histologically or cytologically confirmed advanced solid tumors (e.g., breast cancer, ovarian cancer, endometrial cancer, cervical cancer, squamous cell non-small cell lung cancer (snsclc), cholangiocarcinoma, esophagus cancer, urothelial carcinoma, head and neck squamous cell carcinoma (hnscc)), followed by dose-expansion cohorts (part 2) of subjects with advanced and/or metastatic non-small cell lung cancer (nsclc), triple-negative breast cancer (tnbc).or recurrent and progressed since last antitumor therapy for which no alternative, curative standard therapy exists. 4. adequate organ and bone marrow function. exclusion criteria: 1. prior used anti-b7h4 and/or anti-4-1bb antibody treatment. 2. immuno-oncology therapy or targeted anti-cancer therapy within 4 weeks prior to first dose of investigational product, any other anti-cancer therapy within 2 weeks prior to first dose of investigational product. 3. not yet recovered from surgery or (immune-related) toxicity related with previous treatment. 4. known history or active infection of hepatitis b or c. 5. history of cirrhosis or non-alcohol steatohepatitis, alcohol or drug-related, autoimmune hepatitis. 6. known brain metastases or other central nervous system metastases that are either symptomatic or untreated that require concurrent treatment. 7. active infection that requires treatment with antibiotics or antiviral treatment within 3 weeks prior to first dose of investigational product. 8. known history of infection with human immunodeficiency virus or known acquired immunodeficiency syndrome (aids). 9. known autoimmune disease. 10. clinically significant cardiac condition. 11. pregnant or breastfeeding women.

Keywords: advanced solid tumors
social media-based active self-report on incidence and outcomes of adverse events in nk/tcl patients

Conditions: Extranodal NK-T-Cell Lymphoma, Nasal Type

Summary: the purpose of this study is to collect data from patients by social media and self-report on the adverse events and outcomes happened with patients with extranodal natural killer/t-cell lymphoma, nasal type, who are treated outside of clinical trials in china.

extranodal natural killer/t-cell lymphoma, nasal type, is a rare subtype of non-hodgkin lymphoma with relatively high incidence in china. l-asparaginase based chemotherapy are widely used with chinese patients and has been reported to improve overall response and prolonged the long-term survival in some clinical trials with very limited patients. however, most patients were treated out of clinical trials in china. therefore the real incidence of adverse events and treatment outcomes are largely unknown. this study is designed to evaluate the incidence of adverse events and treatment outcomes by social media-based (www.house086.com, www.wechat.com) self-report from patients who are treated out of clinical trials.

Eligibility criteria:
inclusion criteria: * pathological diagnosis of extranodal natural killer/t-cell lymphoma, nasal type based on who 2008 classification of tumors of haematopoietic and lymphoid tissue. * treated with at least one cycle of l-asparaginas or pegaspargase based chemotherapy. * signed informed consent. exclusion criteria: * patients who are enrolled in any other clinical trials. * relapsed patients who were initially treated with non-l-asparaginas or non-pegaspargase based regimens.
living with multimorbidity: co-ordinate program

Conditions: Multimorbidity; Quality of Life; Symptom Management

Summary: multimorbidity is common and is the coexistence of two or more chronic conditions in the same individual. people with multimorbidity suffer from a high symptom burden, directly affecting quality of life (qol). hospitalization can be a window of opportunity to initiate interventions to promote recovery and resilience and enhance qol. however, interventions targeting the symptom trajectory and burden of patients with multimorbidity are lacking. thus, the investigators envisage a nurse-led pre-discharge intervention augmented by telephone support, focusing on care coordination and symptom management. this approach is anticipated to help reduce symptom burden and improve qol.

aim 1: describe the symptom trajectory and burden from the perspectives of patients, family caregivers, and health professionals and collectively develop a symptom management toolkit; and aim 2: refine and pilot test the nurse-driven symptom management toolkit/intervention to decrease the symptom burden and increase the qol of critically ill adults with multimorbidity. interventional study (aim 2): the study aims to test the feasibility of the care coordination and symptom management (coordinate) intervention developed from aim 1 using an experienced-based co-design methodology. a single-arm feasibility study will be implemented with assumptions on the effectiveness of the coordinate intervention on outcomes such as symptom burden and quality of life will be evaluated. sample and setting: individuals aged 55 years and older, living with two or more chronic health conditions, and willing to provide informed consent will be included in the study. the exclusion criteria include if participants cannot speak english or have a documented cognitive impairment that would prevent participation. patients will be approached in the intermediate care unit (imcu) of an academic teaching hospital while the participants are in-patient before discharge. intervention components and timing: the intervention consists of four components- i) needs assessment; ii) question prompt list; iii) goals discussion and; iv) symptom assessment and tracking. the intervention will start with the enrolment of a patient living with multimorbidity. the intervention consists of one in-person pre-discharge visit by the study team and four follow-up telephone calls (at 48 hours, 1 week, 4 weeks, and 6 weeks post-discharge). primary outcomes 1. symptom burden 2. quality of life

Eligibility criteria:
inclusion criteria: * english speakers who are planned for discharge from johns hopkins hospital (jhh) imcu * who meet the criteria for being admitted to imcu and planned discharge with multimorbidity as defined by two or more chronic conditions. exclusion criteria: * who can not provide informed consent or have documented cognitive impairment
effectiveness of an educational intervention aimed at increasing the emotional competencies of patients under surveillance after antineoplastic treatment of oesogastric or bronchopulmonary cancer

Conditions: Digestive System Neoplasms; Thoracic Neoplasms

Summary: emotional skills are the ability to use emotions cleverly in daily life. good emotional skills are associated with better mental and physical health in healthy and clinical populations. however, to our knowledge, cancer patients have never benefited from an intervention aiming at increasing their emotional skills. our goal was thus to design and test such an intervention. a prospective, multi-center, randomized controlled trial (rct) will be conducted in esogastric and lung cancer patients after antineoplastic treatments. forty-three patients are expected in each arm. the primary outcome is the change in emotional skills assessed using a patient-reported validated questionnaire between the start and two weeks after the end of the intervention and at 2-month follow-up. the experimental arm will have to follow three individual sessions on emotional skills (i.e. identification, understanding, expression and regulation of emotions) while the control arm will have to follow three sessions of relaxation. in each arm, the first session can be held face to face or over the phone and the last two sessions will be held over the phone. patients have exercises to practice in between sessions.it is hypothesised that the experimental group will experience a greater increase in emotional skills than the control group.


Eligibility criteria:
inclusion criteria: * patient under surveillance after curative or palliative antineoplastic treatment (surgery and/or chemoradiotherapy and/or radiotherapy alone and/or chemotherapy alone) of esogastric or bronchopulmonary cancer, * patients with a life expectancy estimated by their physician involved in the research to be greater than or equal to six months, * patient with a ≥ 4 score on the distress scale (scale from 0 to 10), * affiliation to a social security scheme, * mastery of the french language, * signing of informed consent to participate in this research. exclusion criteria: * cognitive disorders or unstabilized psychiatric disorders that may impair the ability of reasoning and thinking necessary to complete the questionnaires and attend workshops * difficulty or deficiency that prevent the patient from a good understanding of the imperatives of the research * any situation likely to significantly affect emotional competence during the study according to the investigator's judgment (in particular, ongoing psychotherapeutic follow-up)) * patients under judicial protection (guardianship or curators).

Keywords: emotional intelligence quality of life cancer survivors psychology supportive care
mass balance study of jtz-951 in subjects with end-stage renal disease on hemodialysis

Conditions: Anemia of Chronic Kidney Disease

Summary: a mass balance study to determine the routes and rates of elimination of radioactivity, to determine total radioactivity in plasma and whole blood over time and compare levels to jtz-951 and drug-derived entities in plasma and to determine pharmacokinetic (pk) parameters of jtz-951 and its metabolite(s).


Eligibility criteria:
inclusion criteria: * subjects with end stage renal disease on hemodialysis * post-dialysis body weight \>45.0 kg * bmi between 18.0 and 40.0 kg/m2 (inclusive) exclusion criteria: * subjects with aspartate aminotransferase (ast) or alanine aminotransferase (alt) \>2.0 × upper limit of normal (uln), or total bilirubin \>1.5 × uln at the screening visit * subjects who have hepatobiliary disease or condition (such as biliary cirrhosis) * subjects with positive test results for hbsag (hepatitis b surface antigen), hcv antibody or hiv antibody * subjects with known history of liver failure or liver surgery * subjects with a history or current clinically significant chronic or acute blood loss

Keywords: jtz-951 pharmacokinetics 14c-jtz-951 mass balance time course
two institutes experience in laparo-endoscopic rendezvous technique for gallbladder and bile duct stones

Conditions: Calculus; Gallbladder, With Cholecystitis

Summary: the management of gallbladder stones (lithiasis) concomitant with bile duct stones is controversial. the management of cbd stones has evolved considerably since the advent of laparoscopic surgery. the more frequent approach is a two-stage procedure, with endoscopic sphincterotomy and stone removal from the bile duct followed by laparoscopic cholecystectomy. the laparoscopic-endoscopic rendezvous combines the two techniques in a single-stage operation. so the aim of this study was was to evaluate one-stage lc with intra-operative endoscopic sphincterotomy (ioes) vs two-stage pre-operative endoscopic sphincterotomy (poes) followed by lc for the treatment of cholecystocholedocholithiasis.

this is two center study was carried out on 523 patients and completed in 436 patients with gall bladder stones and with suspected or confirmed cbds at two gastroenterology center at zagazig first 264 patients at the gastrointestinal surgery unit in the zagazig university hospitals and second 172 patients at gastroenterology unite at al ahrar hospital from january 2010 till april 2022. a single-step technique combining lc and io-ercp was used to treat them. to confirm the presence of cbds, a laparoscopic intraoperative cholangiography (ioc) was performed. a soft-tipped guidewire was inserted into the duodenum through the cystic duct and papilla. over the guide-wire, an endoscopic papillotomy was introduced. the stones were retrieved with a retrieval balloon after an io-ercp and endoscopic sphincterotomy. the length of the postoperative hospital stay, surgical operating time, surgical success rate, postoperative complications, and residual cbds were all evaluated. 77 patients excluded either incomplete data or didn't complete both steps within our centers.

Eligibility criteria:
inclusion criteria: 1. patients having stone in the gallbladder and concurrent cbd stone, as determined by mrcp or us. 2. patients with acute cholecystitis, acute cholangitis, obstructive jaundice, and those with highly suspicious criteria for cbd, stones such as dilated cbd on us examination more than7 mm in diameter without obvious cbd stones, high serum bilirubin level, and or high serum alkaline phosphatase level, were also included in this study. exclusion criteria: 1. patients with history of hepatobiliary surgery as choledocho-duodenal anastomosis. 2. patients with previous ercp attempt. 3. patients with previous upper abdominal surgery as total or partial gastric resection. 4. patients with morbid obesity. 5. patients with uncorrectable coagulopathy. 6. patients aged below 18 years or above 80 years. 7. patients within the american society of anesthesiology (asa) class 4 and 5 disease. 8. patients who refused to give consent or participate in the study.
anticoagulant and antiarrhythmic management based on continuous rhythm monitoring

Conditions: New Onset Atrial Fibrillation

Summary: this pilot study aims to assess the feasibility and safety of using an ilr to identify the incidence of recurrent af after an episode of newly diagnosed af. the study further aims to assess the risk of af recurrence in this low risk population based on left atrial and left atrial appendage anatomic and functional indices in addition to the standardized clinical cha2ds2-vasc score.

there is a significant incidence of recurrent af following initial diagnosis of af. inclusion of left atrial (la) and left atrial appendage (laa) abnormalities together with risk prediction of cva using cha2ds2-vasc score will identify patients at low or high risk for adverse cardiovascular events in patients with manifest and silent af. patients requiring cardioversion have higher risk of recurrent af in follow up.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. newly diagnosed af 3. patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule exclusion criteria: 1. patient is participating in or plans to participate in any other investigational drug or device clinical trial that has not reached its primary endpoint 2. patient received an organ transplant, or is on a waiting list. 3. patient is not able to follow instructions for remote monitoring 4 prior history of af
effect of diet on gulf war illness

Conditions: Irritable Bowel Syndrome

Summary: fermentable oligo-, di and mono-saccharides and polyols (fodmaps) are carbohydrates that are poorly digested in intestines. the undigested carbohydrates are fermented in the colon by gut bacteria. fermentation of these carbohydrates can lead to diarrhea, gas and distension of the colon. low fodmap diet effect may be mediated by changing the gut bacteria and/or by production of chemicals that influence veteran's intestines which then result in reduced disease symptoms. the goal of this study is to compare a low fodmap (modified healthy) diet to a high fodmap (typical healthy) diet for effect on veterans with ibs and symptoms of gulf war illness.

study design this will be a prospective, blinded randomized clinical trial with two parallel groups. there will be 1-week screening period, 3-week diet treatment and, follow-up one month later while veterans choose their own diet. veterans who were deployed and served in operation desert storm and desert shield will be recruited to participate. the two study diets to be provided to the veterans and compared are: low fodmap (modified healthy) diet: high fodmap (typical healthy) diet: the fodmap content of this diet will be higher than low fodmap diet. all questionnaires will be answered and measurements performed at baseline, end of treatment and at follow-up visits.

Eligibility criteria:
inclusion criteria: * gulf war veterans * men and women age 25-90 years * gulf war illness: veterans will have rome iii criteria for ibs and two or more of the non-intestinal symptom groups (chronic-once a week or more often-fatigue, insomnia, joint pains, general stiffness, and headache, neurological an mood, respirator and skin symptoms) * symptoms of \> 6 months duration * no significant findings on physical examination, complete blood count and clinical chemistry panel * normal gross appearance of the colonic mucosa (small colon polyps not an exclusion criteria) * veterans with psychological disorders will not be excluded but will be identified for sub-group analysis. exclusion criteria: * current evidence of any lower gastrointestinal disorder such as celiac disease or inflammatory bowel disease * clinically significant chronic disease: hiv, cardiac, pulmonary, hepatic or renal dysfunction * presence of giardia antigen, and clostridium difficile toxin in stool * current history of drug or alcohol abuse * investigator perception of patient's inability to comply with study protocol * recent change in gastrointestinal medications * subject is currently participating in another research protocol. these subjects will be allowed to enroll after a washout period of one month.

Keywords: gulf war illness diet ibs fodmap
rosiglitazone effect on mitochondria and lipoatrophy

Conditions: HIV Infections

Summary: the purpose of this study is to examine the effect of rosiglitazone on limb fat and mitochondrial indices in hiv-1-infected subjects receiving stable antiretroviral therapy that does not contain stavudine (d4t) or zidovudine (azt).

this is a phase ii, randomized, double-blind, placebo-controlled study of rosiglitazone for the treatment of hiv-associated lipoatrophy. subjects will receive blinded study treatment for 48 weeks. this study will examine the effect of rosiglitazone on limb fat and mitochondrial indices in hiv-1-infected subjects receiving stable antiretroviral therapy that does not contain d4t or azt. the study also will assess the safety and tolerability of rosiglitazone in this population, and its effect on carotid imt, prevalence of metabolic syndrome, lipid parameters and glucose metabolism.

Eligibility criteria:
inclusion criteria: * lipoatrophy * thymidine sparing arv for at least 24 weeks * prior thymidine nrtis for at least 12 months exclusion criteria: * diabetes * heart failure * liver disease * hormonal therapies

Keywords: mitochondria hiv lipoatrophy