Kornimate/medical-research-clean huggingface dataset:
a study of tqb3473 tablets in subjects with relapsed or refractory hematological malignancies

Conditions: Relapsed/Refractory Hematological Malignancies

Summary: this is a study to evaluate the maximum tolerated dose (mtd), occurrence of all adverse events (ae) and serious adverse events (sae) , pharmacokinetic parameters and antitumor effect of tqb3473 tablets in chinese adult patients with relapsed or refractory hematological malignancies.


Eligibility criteria:
inclusion criteria: -1.understood and signed an informed consent form. 2. relapsed or refractory malignant hematological tumors. 3. eastern cooperative oncology group (ecog) performance status score of 0 to 1; life expectancy ≥12 weeks. 4. has at least one measurable lesion. 5. adequate organ system function. 6. patients need to adopt effective methods of contraception. exclusion criteria: * 1. severe hypersensitivity to the drug or ingredients. 2. has received chemotherapy, radiotherapy, immunotherapy or any other anti-tumor therapy within 14 days before the first dose. 3. has received spleen tyrosine kinase (syk) inhibitors. 4. has to use ≥ 10 mg/day glucocorticoid prednisone. 5. has received btk inhibitors and pi3k inhibitors before the first dose. 6. has received allogeneic hematopoietic stem cell transplantation. 7. has received autologous hematopoietic stem cell transplantation within 12 weeks before the first dose. 8. has any acute or chronic gastrointestinal diseases. 9. has primary central nervous system lymphoma, or brain metastases with clinical symptoms, spinal cord compression, cancerous meningitis. 10. intermediate-risk or high-risk myelodysplastic syndrome. 11. pregnancy and lactation women. 12. has any serious and/or uncontrollable disease. 13. has active autoimmune disease and received immunosuppressive therapy. 14. has a history of neurological or mental disorders. 15. has uncontrollable systemic bacterial, fungal or viral active infections 16. the toxicity of previous antitumor treatment is not recovered to ≤ grade 1. 17. has other malignancies. 18. has received surgery within 4 weeks before the first administration. 19. has participated in any other clinical trials. 20. according to the judgement of the investigators, there are other factors that may lead to the termination of the study.
pfmt educational intervention for patients with advancer breast cancer

Conditions: Advanced Breast Cancer

Summary: a pfmt educational intervention was designed for women with metastasic breast cancer. it consisted in a 120 min workshop and 8 weeks of non-supervised (but with follow-up) self-training. iciq, iqol and ad hoc questions were performed before the workshop and after the 8 weeks training to see the prevalence of ui, the impact in their quality of life and the empowerment of self-training.

urinary incontinence (ui) affects women of all ages and has a great impact on the quality of life. cancer treatments such as chemotherapy or hormone therapy may play an important rol in the development and worsening of pelvic floor disorders. little evidence on the prevalence and impact of ui in metastassis breast cancer women is known. a protocol was designed to analyze the effect of a pfmt educational intervention on the ui and the impact on the qol, as well as in the empowerment feeling of the participants. feasibility of the protocol will be analized to design an optimal rct for testing our hypothesis during the usual visits, oncologist wil recruit women with advanced breast cancer who meet the inclusion criteria for the participation.

Eligibility criteria:
inclusion criteria: * advanced breast cancer * over 18 years old * ecog≤2 * no inestable bone metastasis * life expentancy\>6 months * literate in spanish exclusion criteria: * physical exercise contraindications * intense pain * being pregnant

Keywords: pelvic floor muscle training urinary incontinence educational intervention
the effectiveness of tech: tablet enhancement of cognition and health

Conditions: Mild Cognitive Impairment

Summary: this study assess the effectiveness of novel cognitive intervention utilizing tablet apps (tech protocol: tablet enhancement of cognition and health) to improve cognitive abilities, daily function and health-related quality of life of older adults with mci. older adults with mci will be randomly allocated to the tech protocol (experimental group) or standard care (control group). assessments will be administered pre and post the 6-week tech protocol and at 6-month follow-up by assessors blind to group allocation.

a single-blind randomized controlled trial (rct) will be conducted, by assessors blind to group allocation. participants will be referred to the study from 'maccabi healthcare services' by family physicians and geriatric physician of 'maccabi healthcare services central district'. the majority of tech protocol training will take place in the participants' home as self-practice. the assessment and weekly group meetings will take place at clinics of maccabi healthcare services in the central district. a helsinki approval (#2016009) has already been obtained. participants will receive information regarding the study and if eligible will sign a consent form, undergo the screening and then the pre-intervention assessments. then they will be randomly allocated into experimental or control group by a computer program (stratification of the severity of the cognitive decline according to the montreal cognitive assessment (moca) scores of above or below 23 points). the experimental group participants will receive the tech protocol, while participants in the control group will continue to receive standard care. following the intervention a second assessment will be performed, as well as six-months follow-up assessment.

Eligibility criteria:
inclusion criteria: * aged 65 and above. * have mci (as determined by the following four criterions: a. a score of 19-25 on the moca, b. subjective memory complaints, and report from an informant of the same memory complains (the informant should be a person who interacts with the participant three or more times a week), c. informant report of the cognitive decline as newly acquired, d. independence in basic activities of daily living (badl) and instrumental activities of daily living (iadl), as reported by the participants and the informant, excluding motor difficulties which are not caused due to neurological conditions or lack of performance with no changes compared to the past. * have normal or corrected vision and hearing. * speak, write and read hebrew. * able to understand and follow use of the touchscreen of a tablet after initial demonstration. exclusion criteria: * experience severe depressive symptoms (10 points or more in the geriatric depression scale) * are diagnosed with dementia, or other neurological or psychiatric condition (such as stroke, parkinson's disease).

Keywords: cognitive training tablet computers
the effect of oral semaglutide on bone turnover in patients with t2d: a randomized placebo-controlled clinical trial

Conditions: Type 2 Diabetes; Osteopenia

Summary: the hypothesis for this study is that oral semaglutide, a glp-1ra, has a positive effect on the balance between build-up and degradation as well as the strength of the bones in men and women aged 50-85 years with type 2 diabetes and an increased risk of bone fractures. treatment involves once daily oral glp-1ra semaglutide or matching placebo for 52 weeks. the effect will be measured by bone markers in blood samples, bone scans, bone tissue and bone marrow tests (bone marrow aspiration and biopsy), physical activity assessed by a questionnaire, and direct bone strength measured by microindentation at the start and end of the study.


Eligibility criteria:
inclusion criteria * type 2 diabetes and glycosylated haemoglobin (hba1c) of 48-91 mmol/mol (6.5-10.5%) and * t-score \<-1 in hip or lower back, assessed by dxa scan and / or * low-energy fracture within the last 3 years exclusion criteria * t-score \<-2.5 in hip or lower back, assessed by dxa scan, although these individuals may be included if they are not candidates for conventional osteoporosis therapy, e.g., due to allergies and renal impairment, or if they prefer to participate in the trial. * type 1 diabetes mellitus * severe npdr (non-proliferative diabetic retinopathy) or pdr (proliferative diabetic retinopathy) assessed within the last year. if a recent assessment is unavailable, a new retinal photo test will be performed. * congestive heart failure (nyha class iv) * primary hyperparathyroidism * vitamin d deficiency (\<25 nm) (re-test after substitution acceptable) * known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, severe renal impairment (egfr \<30) or liver dysfunction (baseline phosphatase higher than twice upper limit (105 u/l)), rheumatism, celiac disease, hypogonadism, severe copd, hypopituitarism, cushing's disease * clinically significant concomitant diseases or disorders (e.g., cancer) or clinically significant abnormal values in laboratory screening tests, including increased choriogonadotropin (hcg) in women. * history of gastrointestinal surgery (except uncomplicated surgical procedures such as hernia surgery and appendectomy) * antiresorptive or bone anabolic drugs for the last 12 months * use of anabolic steroids in the previous year * use of glp-1ras within 90 days * stable therapy with dpp4 inhibitors (unless the patient is willing to discontinue the treatment) * history of pancreatitis * allergy or hypersensitivity to the active substance or to any of the ingredients * inability to give informed consent * previous bariatric surgery * bmi \ 37 kg/m2
pancreatico enteric anastomosis post pancreaticoduodenectomy

Conditions: Cancer of Pancreas

Summary: the aim of this study is to make a step for evaluation and presentation of a safe technique for pancreatico-jejunostomy that help in minimizing post-operative morbidity and mortality in pancreatic cancer patient by comparing blumgart anastomosis with cattell warren technique of anastomosis.

study design this study is a randomized prospective clinical trial. methods of randomization: randomized block design the objective of the study was to evaluate the effect of blumgart anastomosis versus cattell warren techniques for pancreatico-jejunostomy regarding * surgical technique * peri-operative outcome including 1. length of hospital stay 2. post-operative pancreatic fistula 3. icu admission and stay 4. operative time 5. other morbidity and mortality data collection: all data will be collected for each group and will be divided into patients' factors, intraoperative and postoperative factors. patients' factors include patients' demographics, co-morbidities, neoadjuvant treatment, pathology and biliary drainage. intra-operative factors include type of pancreaticoduodenectomy (pd) (whether classic or pppd), operative time in hours and estimated blood loss in ml, pancreatic duct and texture of pancreas. post-operative factors include the short term post-operative course which will be divided into specific complications (pancreatic leakage, biliary leakage, delayed gastric emptying, 2ry hemorrhage, intra-abdominal collection, deep wound infection, portal vein (pv) - superior mesenteric vein (smv) thrombosis and general surgical complications.

Eligibility criteria:
inclusion criteria: * known pancreatic head cancer diagnosed radiologically. * operable and borderline pancreatic cancer. * patients who will undergo upfront surgery and those who received neoadjuvant chemotherapy are included. exclusion criteria: * metastatic patients. * locally advanced cases. * patients with comorbidities who are unfit for major surgical procedures. * patients with very small pancreatic duct where the pancreatic duct can't be identified.

Keywords: cancer pancreas pancreatico-jejunostomy pancreatico-enteric anasomosis pancreatic anastomosis post-operative pancreatic fistula pancreaticoduodenectomy whipple's procedure
studying common genetic mutations related to mucositis in patients with multiple myeloma receiving high-dose melphalan

Conditions: Mucositis; Multiple Myeloma and Plasma Cell Neoplasm

Summary: rationale: studying blood or mouthwash samples in the laboratory from patients receiving melphalan for cancer may help doctors learn more about changes that occur in dna, identify biomarkers related to cancer, and help predict how patients will respond to treatment. purpose: this clinical trial is studying common genetic mutations related to mucositis in patients with multiple myeloma receiving high-dose melphalan.

objectives: * to determine whether single nucleotide polymorphisms (snps) in genes that encode the melphalan transporters are associated with the development and/or severity of mucositis in patients with multiple myeloma receiving high-dose melphalan. * to determine whether snps in genes that influence melphalan metabolism are associated with the development and/or severity of mucositis in these patients. outline: this is a multicenter study. blood or mouthwash samples are collected and dna isolated from these specimens is analyzed for single nucleotide polymorphisms (snps) in lat1 or other candidate genes. public databases (i.e., dbsnp and hapmap) are reviewed to select representative snps for genotype analysis.

Eligibility criteria:
disease characteristics: * diagnosis of multiple myeloma * receiving treatment with high-dose melphalan for an autologous stem cell transplantation at any of these facilities: * vanderbilt university medical center * nashville veteran's administration medical center (vamc) * seattle vamc * san antonio vamc patient characteristics: * not pregnant prior concurrent therapy: * see disease characteristics * no palifermin

Keywords: mucositis stage i multiple myeloma stage ii multiple myeloma stage iii multiple myeloma refractory multiple myeloma
spirulina platensis for ppi withdrawal

Conditions: Gastro Esophageal Reflux Disease; Dyspepsia; Rebound Acid Hypersecretion

Summary: background: rebound acid hypersecretion after proton pump inhibitors (ppis) discontinuation may be accompanied by dyspepsia. aim: to assess whether spirulina platensis, by its anti-inflammatory properties, could minimize rebound symptoms after ppis withdrawal.

forty-five regular users of ppis entered in a 28-day run-in phase of pantoprazole 40 mg/day, followed by clinical and endoscopic evaluation. in the absence of large hiatal hernia, peptic ulcer, or moderate to severe reflux esophagitis, patients stopped ppis and were randomly assigned to receive spirulina (1.6 g/day) or placebo for 2 months, when evaluation was repeated. primary outcomes were dyspepsia and typical reflux symptoms (either appearance or maintenance of symptoms \> 50% from baseline). intention-to-treat analysis was applied.

Eligibility criteria:
inclusion criteria: * chronic use of any ppis, either original brand or generic * absence of conditions that contraindicate the cessation of ppis, such as active or recent peptic ulcer, active or recent upper digestive bleeding, regular use of salicylates or non-steroidal anti-inflammatory drugs, moderate to severe reflux esophagitis, and sliding hiatal hernia greater than 3 cm * formal agreement to participate exclusion criteria: * uncompensated acute and chronic morbidities * gastroesophageal surgery * cognitive deficit

Keywords: gastroesophageal reflux disease dyspepsia proton pump inhibitors spirulina platensis
paclitaxel plus pembrolizumab vs. paclitaxel weekly in er+ luminal b metastatic breast cancer

Conditions: Breast Cancer

Summary: pelican is a randomised phase ii trial that aims to evaluate the efficacy and safety of paclitaxel plus pembrolizumab relative to paclitaxel alone, in patients with locally advanced or metastatic er-positive, her2-negative, luminal b breast cancer who have received no prior chemotherapy for advanced or metastatic disease. patients will be randomised (2:1) to one of the two treatment arms: * pembrolizumab plus paclitaxel * paclitaxel


Eligibility criteria:
inclusion criteria: 1. willing and able to provide written informed consent 2. ability to comply with the protocol 3. female ≥ 18 years of age 4. histologically confirmed metastatic or locally advanced breast cancer that is luminal b, er+ve, her2-ve. 5. patients must have measurable disease. 6. representative formalin-fixed paraffin embedded breast tumour samples from the primary or recurrent cancer. 7. ecog performance status 0-1 8. adequate haematologic and end-organ function within 28 days prior to the first study treatment 9. patients of childbearing potential are eligible provided they have a negative serum or urine pregnancy test on day 1 cycle 1 (within 72 hours) of study treatment, preferably as close to the first dose as possible. exclusion criteria: 1. luminal a breast cancer 2. prior chemotherapy for advanced or metastatic disease 3. prior treatment with paclitaxel in the (neo)adjuvant setting within 12 months from the end of paclitaxel treatment and randomisation into this study 4. patients with neuropathy ≥ grade 2 5. previous systemic treatment for other neoplasms within 5 years prior to randomisation. 6. patients with prior allogeneic stem cell or solid organ transplantation. 7. prior treatment with cd137 agonists, akt inhibitors, anti-ctla-4, anti-ox-40, anti-programmed death-1 (pd-1), or anti-pd-l1 therapeutic antibody or pathway-targeting agents. 8. patients must not have a diagnosis of immunodeficiency or receiving chronic systemic steroid therapy. 9. received therapeutic oral or intravenous antibiotics within 14 days prior to randomisation. 10. administration of a live vaccine within 30 days prior to the first dose of study drug. 11. treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin \[il\] -2) within 28days or five half-lives of the drug, whichever is shorter, prior to randomisation. 12. history of autoimmune disease. 13. history of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia requiring steroids, or evidence of active pneumonitis on screening chest ct scan. 14. active infection requiring systemic therapy. 15. history of hiv infection 16. known active hepatitis infection. 17. known history of active tuberculosis

Keywords: er-positive metastatic locally advanced ki67 pam50 pembrolizumab paclitaxel her2-negative
surgical wound infections after vascular surgery: prospective multicenter trial

Conditions: Surgical Wound Infection

Summary: the purpose of this multicentre prospective trial is to determine the incidence and risk factors for surgical wound infections. also the investigators will evaluate consequences of wound infections to the patients, and extra costs caused by wound infections.


Eligibility criteria:
inclusion criteria: * non-emergency infrarenal aortic or lower limb arterial surgery exclusion criteria: * patient's refusal to participate

Keywords: surgical wound infection risk factor
a study to evaluate the effects of azithromycin on mac disease prevention in hiv-positive patients

Conditions: Mycobacterium Avium-intracellulare Infection; HIV Infections

Summary: this study is designed to find out whether hiv-positive patients whose immune systems have improved after receiving anti-hiv treatment should take azithromycin to prevent mycobacterium avium complex (mac) disease. this study also examines the possibility of putting off mac prevention treatment in patients who respond well to anti-hiv drug therapy. azithromycin is approved for the prevention of mac disease in people with hiv and low cd4 cell counts. however, some people who have taken azithromycin have been found to carry antibiotic-resistant bacteria (germs that can grow despite the presence of drugs used to kill them). it is not known whether the risks associated with taking azithromycin outweigh the risk of getting mac disease.

the need for mac prophylaxis in advanced hiv disease is recognized. prophylactic therapy is complicated, however, due to drug toxicity, potential drug interactions, patient noncompliance with multiagent regimens, microbial drug resistance, and high treatment costs. this study assesses the feasibility of deferring mac prophylaxis in patients whose cd4+ cell counts rebound in response to antiretroviral therapy. in this double-blind, placebo-controlled trial, patients are randomized to receive azithromycin weekly or matching placebo. patients are switched to open-label azithromycin if they have an average cd4+ cell count less than 50 cells/mm3 on 2 consecutive counts obtained at least 48 hours apart (preferably no more than 60 days). \[as per amendment 10/23/97: substudy cpcra 054: a subset of participants of cpcra 048 have oropharyngeal swabs taken at baseline and 4 months after randomization. antibiotic susceptibility tests are then performed on isolates of s. pneumoniae.\] \[as per amendment 9/3/99: participants in protocol version 3.0 are followed for data collection purposes every 4 months for 18 months until january 31, 2001. data collection includes cd4 cell counts, viral rna measurements, macrolide susceptibility in mac isolates, and antibiotic susceptibility of isolates from bacterial pneumonia episodes.\]

Eligibility criteria:
inclusion criteria you may be eligible for this study if you: * are hiv-positive. * have 2 cd4 counts over 100 cells/mm3 at least 30 days apart. * have a history of cd4 counts under 50 cells/mm3. * are at least 13 years old (need consent if under 18). * are in reasonably good health. * are expected to live for at least 6 months. * are receiving anti-hiv medications at study entry. exclusion criteria you will not be eligible for this study if you: * have/had mac disease. * have been unable to take azithromycin in the past. * are on any medications that act against mac.

Keywords: aids-related opportunistic infections placebos mycobacterium avium-intracellulare infection acquired immunodeficiency syndrome antitubercular agents azithromycin drug resistance, microbial cd4 lymphocyte count antibiotics time factors anti-hiv agents pneumonia, bacterial streptococcus pneumoniae