Kornimate/medical-research-clean huggingface dataset:
pericardial resection to treat heart failure

Conditions: Heart Failure

Summary: the researchers are doing this study to find out whether there will be less increase in cardiac filling pressure after the surgeon opens the pericardium (the membrane around the heart) than when the pericardium is intact. the researchers want to see whether opening the pericardium is an effective way to reduce the blood filling pressures in the heart.

this study will enroll patients with risk factors for lv diastolic dysfunction, either coronary artery disease or aortic stenosis, who are already undergoing cardiac surgery for clinical purposes (e.g. coronary artery bypass grafting or valvular heart disease). hemodynamic tests will be performed using standard clinical resources used as part of routine care in this setting, including pulmonary artery (pa) catheterization. after obtaining written informed consent, patients will undergo induction with general anesthesia as per clinical practice. the chest will be open but pericardium left intact. cardiac hemodynamics (pa wedge pressure, pawp; pa pressure, pap, right atrial pressure, rap) will be measured using pa catheter already in place at rest, and then during conditions of increased cardiac preload, induced by passive leg elevation and saline bolus (300 ml administered over 1-2 minutes). the surgical team will then perform anterior pericardiotomy, with removal of pericardial restraint similar to our percutaneous approach but using currently-available surgical tools. this will not be a complete pericardiectomy but rather a limited anterior incision to gain access to the heart for surgical exposure (standard care). the surgical team will then repeat hemodynamic assessments at rest and with acute volume loading (leg raise + saline) in exactly the same manner as with the pericardium intact. our hypothesis is that as compared to pericardium intact, the increase in pawp with volume loading will be reduced following opening of the pericardium.

Eligibility criteria:
inclusion * \>17 years old * subjects having open sternotomy for either aortic valve stenosis or coronary artery bypass grafting (or both) * provide informed consent exclusion * \<18 years old
the effect of thoracal paravertebral block on seroma reduction in breast surgery

Conditions: Seroma; Breast Cancer

Summary: thoracal paravertebral block (tpvb) is a commonly prefferred regional anesthesia technique to provide postoperative analgesia. in addition, the successful use of tpvb is reported for some seroma related pain cases. postoperative analgesia in breast surgery is a difficult and overworked issue due to etensive surgery and complex innervation of the breast and in addition to this complex mechanisms, seroma accumulation has a negative effect for patients postoperatively. with this study, the investigators aimed to study the effect of tpvb on seroma reduction for breast cancer surgery.


Eligibility criteria:
inclusion criteria: * 18-70 years of agge * asa i-ii * undergoing elective breast cancer surgery exclusion criteria: * obesity (body mass index \>35 kg/m2) * infection of the skin at the site of needle puncture area * patients with known allergies to any of the study drugs * coagulopathy

Keywords: thoracal paravertebral block breast surgery seroma reduction
study of nivolumab in combination with gm.cd40l vaccine in adenocarcinoma of the lung

Conditions: Lung Cancer; Adenocarcinoma of the Lung

Summary: the purpose of this study is to find out what effects (good and bad) a tumor vaccine (gm.cd40l) used in combination with nivolumab will have on participants and their cancer. another purpose of the study is to find out the maximum tolerated dose of nivolumab in combination with gm.cd40l vaccine. investigators also want to find out if the combination of gm.cd40l and nivolumab can boost the immune system of participants like you, and how their immune system reacts, both before and after the treatment.

this study has two parts and participants may be involved in either phase i part or phase ii. phase i: investigators plan to enroll participants in cohorts of 6 and monitor side effects over a 21 day period to determine the maximum tolerated dose (mtd) of nivolumab, which will be given in combination with gm.cd40l. this is being done since this study involves a combination of treatments that have not been studied in humans before and to find the best dose for the phase ii part of the study. phase ii: investigators plan to compare any clinical benefit in the participants who receive the combination of gm.cd40l vaccine with nivolumab, to participants that receive only nivolumab.

Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis of advanced/metastatic adenocarcinoma of the lung * eastern cooperative oncology group (ecog) performance status of 0/1 * chemotherapy naïve or have completed adjuvant chemotherapy for non-small cell lung cancer (nsclc) \>6 months prior * adequate bone marrow, renal and hepatic function * must have measurable metastatic disease according to response evaluation criteria in solid tumors (recist) v1.1 criteria * mandatory archival tissue or willingness to undergo a fresh biopsy * life expectancy of greater than 6 months exclusion criteria: * symptomatic brain metastasis or uncontrolled central nervous system (cns) metastasis * pregnancy or breast feeding * serious uncontrolled medical disorder or active infection that would impair the participant's ability to receive study treatment * prior use of a pd1 or pdl1 inhibitor * concurrent use of other anticancer approved or investigational agents is not allowed * autoimmune disorders * prior malignancy in past 2 years * systemic steroids at doses greater than 10 mg/day of prednisone or the equivalent * any other pre-existing immunodeficiency condition (including known hiv infection)

Keywords: advanced metastatic lung disease adenocarcinoma non-small cell lung cancer (nsclc)
study on enzalutamide and flutamide in patients with castration resistant prostate cancer

Conditions: Prostate Cancer

Summary: the objective of this study was to compare the efficacy and safety of the combination therapy with enzalutamide + androgen deprivation therapy (adt) and the combination therapy with flutamide + adt in patients with castration resistant prostate cancer who had relapsed during combined androgen blockade (cab) therapy with bicalutamide and adt. this study also investigated the order of alternative antiandrogen therapy (aat) by changing the 1st line medication after relapse of prostate-specific antigen (psa).


Eligibility criteria:
inclusion criteria: * subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small-cell histology. * subject on continuous adt with gonadotropin releasing hormone (gnrh) agonist/antagonist or bilateral orchiectomy. * serum testosterone level below the target level at screening visit. * subject with asymptomatic or mildly symptomatic prostate cancer. * subject has an eastern cooperative oncology group (ecog) performance status of 0 or 1. * subject has progression of the disease as defined by rising psa levels or progressive soft tissue or bony disease during cab therapy in combination of bicalutamide and adt. * a sexually active male subject and the subject's female partner who is of childbearing potential must use 2 acceptable birth control methods from screening to 3 months after the last dose of the study drug. * subject must agree not to donate sperm from screening to 3 months after the last dose of the study drug. exclusion criteria: * subject with severe concurrent diseases, infections, or complications. * subject with confirmed or suspected brain metastasis or active leptomeningeal metastasis. * subject with a history of malignant tumor other than prostate cancer in the past 5 years. * subject hypersensitive to the ingredients of enzalutamide capsules or flutamide tablets. * subject with a history of convulsive attack, or prone to convulsive attack. * subject with liver disorder such as viral hepatitis and hepatic cirrhosis, or subject with aspartate aminotransferase (ast) and alanine aminotransferase (alt) at screening visit higher than the upper limit of normal. * subject received treatment for prostate cancer with cytocidal chemotherapy that includes anti androgenic agents other than bicalutamide, abiraterone, or estramustine.

Keywords: enzalutamide xtandi prostate cancer
effect of preoperative chemotherapy on short-term outcome after pancreatic resection

Conditions: Locally Advanced Pancreatic Adenocarcinoma

Summary: no comparative trial investigating the effect of preoperative chemotherapy for locally advanced pancreatic cancer on short-term postoperative outcome has been published so far. the aim of the present study is to assess the potential impact of preoperative chemotherapy on short-term postoperative outcome after pancreatic resection in a case-matched series of cancer patients.

between 2003 and 2011, patients with locally advanced (stage iii) pancreatic cancer who were treated with preoperative chemotherapy (pcht) underwent surgical resection. each patient was matched with the closest two patients with pancreatic cancer ( control group ) selected from our prospective electronic database who met the following match criteria: age (+/- 3 years), gender, asa score, type of resection, pancreatic duct diameter (+/- 1 mm), and tumour size (+/- 5 mm).

Eligibility criteria:
inclusion criteria: * diagnosis of pancreatic cancer * preoperative chemotherapy * pancreatic resection exclusion criteria: * metastatic disease * asa score 4

Keywords: pancreatic cancer, neoadjuvant chemotherapy
a study of disease progression and anti-hiv treatments

Conditions: HIV Infections

Summary: to determine the influence of virus load, cd4 count, biologic phenotype, and presence of symptomatic disease on the response of hiv-infected patients to a new therapeutic regimen. per amendment 8/27/96: to extend the availability of currently assigned actg 303 treatment for 6 months.


Eligibility criteria:
inclusion criteria patients must have: * prior participation on protocol actg 175. per amendment 8/27/96: * patients must be on study/on treatment at the time the protocol study treatment is extended.

Keywords: zalcitabine didanosine drug therapy, combination aids-related complex antiviral agents zidovudine lamivudine
study of letrozole with or without byl719 or buparlisib, for the neoadjuvant treatment of postmenopausal women

Conditions: Breast Cancer

Summary: the purpose of the study was to determine whether treatment with a pi3k inhibitor plus letrozole led to an increase in pathologic clinical response and objective response rate compared to treatment with placebo plus letrozole in patients with breast cancer.


Eligibility criteria:
inclusion criteria: 1. patient is an adult, female ≥ 18 years old at the time of informed consent 2. patient has a histologically and/or cytologically confirmed diagnosis of breast cancer 3. patient is postmenopausal. 4. patient has t1c-t3, any n, m0, operable breast cancer 5. patients must have measurable disease 6. patient has diagnostic biopsy available for the analysis of pik3ca mutation and ki67 level. 7. patient has estrogen-receptor and/or progesterone positive breast cancer as per local laboratory testing 8. patient has her2 negative breast cancer defined as a negative in situ hybridization test or an ihc status of 0 or 1+ as per local laboratory testing exclusion criteria: 1. patient has locally recurrent or metastatic disease 2. patient has received any systemic therapy (e.g. chemotherapy, targeted therapy, immunotherapy) or radiotherapy for current breast cancer disease before randomization. 3. patient with type 1 diabetes mellitus or not adequately controlled type 2 diabetes mellitus 4. history of acute pancreatitis within 1 year of study entry 5. uncontrolled hypertension

Keywords: byl719 alpelisib breast cancer bkm120 buparlisib pathological complete response neoadjuvant hormone receptor-positive her2 negative objective response rate
nutritional supplementation in children at risk of undernutrition

Conditions: Malnutrition, Child

Summary: this is a prospective, multicenter, single-arm intervention study. the expected duration of study participation for each participant is approximately 120 days. the current study aims to investigate the effectiveness of an ons formula in children at risk or with undernutrition in thailand.


Eligibility criteria:
inclusion criteria: child is between 1 year 0 days to 5 years 364 days old at enrolment undernourished or at risk of undernutrition, defined as: * whz \<- 1 and haz \<-1 for children up to 4 years 364 days, according to the who growth standards; or * bmiaz \<-1 and haz \<-1 for children 5 years 0 days and older, according to the who growth reference standards child is not currently breastfed child's parent(s)/lg is willing to abstain from giving additional non-study oral nutritional supplement (ons) other than the study product during the study intervention period child is a singleton child's parent(s)/lg is able and willing to follow study procedures and record data in parent diary and complete any forms or assessments needed throughout the study child's parent(s)/lg is not planning to relocate during the study period child's parent(s)/lg has voluntarily signed and dated an informed consent form (icf), approved by an independent ethics committee/institutional review board (iec/irb) or other applicable privacy regulation authorization prior to any participation in the study exclusion criteria: child participates in another study that has not been approved as a concomitant study child is known to have galactosemia, be allergic or intolerant to any ingredient found in the study product child had a history of preterm delivery, defined as a birth before 37 completed weeks of gestation as reported by parent(s)/lg child had birth weight \ 4000 g child whose either parent has bmi ≥ 27.5 kg/m2 child has current acute or chronic infections including but not restricted to respiratory infections, diarrhea, acute and chronic hepatitis b or c, hiv infection or tuberculosis child has been diagnosed with the following: * severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis * neoplastic, renal, hepatic or cardiovascular, hormonal or metabolic disorders, congenital disease or genetic disorders such as atrial or ventricular wall defects, down's syndrome, or thalassemia * infantile anorexia nervosa, developmental disability, including physical disorders such as cerebral palsy, or developmental delay * disorders of hemoglobin structure, function or synthesis clinically significant nutritional deficiency requiring specific treatment with another nutritional supplement (other than the study product) any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study
study to compare pharmacokinetics & pharmacodynamics of warfarin & esmolol in the absence & presence of medi0382

Conditions: Healthy Volunteers

Summary: a phase 1 study to evaluate the effect of medi0382 on pk and pd of warfarin and esmolol in healthy subjects.

this is a phase 1 open label, one-sequence, crossover study to evaluate the effect of medi0382 on pk and pd of warfarin and esmolol in healthy subjects. the safety and tolerability of medi0382 in combination with warfarin and esmolol will also be evaluated. following screening, the study consists of 2 5-day inpatient stays followed by outpatient visits.

Eligibility criteria:
inclusion criteria:. * healthy volunteers aged ≥ 18 to 45 years * bmi between 18 -30 kg/m2 * females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception exclusion criteria: * any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product * receipt of investigational product as part of a clinical study or a glp-1 analogue containing preparation within the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening. * concurrent participation in another study of any kind * severe allergy/hypersensitivity to any of the proposed study treatments or excipients. * history or presence of gastrointestinal (gi), hepatic, or renal disease or any other conditions known to interfere with absorption, distribution, metabolism or excretion of drugs. * impaired renal function is defined as estimated glomerular filtration rate (egfr) \< 60 ml/minute/1.73 m2 at screening. * any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of screening. * history of hemophilia, von willebrand's disease, lupus anticoagulant, or other diseases/syndromes that can either alter or increase the propensity for bleeding.

Keywords: type 2 diabetes mellitus, medi0382
volatile organic compounds (vocs) in active inflammatory bowel disease

Conditions: IBD; Crohn Disease; Ulcerative Colitis

Summary: inflammatory bowel disease (ibd) are chronic diseases of the gut comprising crohn's disease (cd) and ulcerative colitis (uc). the symptoms of ibd consist of diarrhea, abdominal discomfort, weight loss, fatigue and rectal bleeding. however, symptoms and treatment vary between patients. early management of ibd can lead to better response rates and decrease the risk of irreversible bowel damage and future disease complications such as surgeries. current clinical tools for diagnosis and or assessing progression of ibd are either invasive (colonoscopy), have low patient acceptance (fecal calprotectin) or low accuracy (c-reactive protein). the purpose of this study is to collect clinical data and samples (including blood, breath and stool) donated by patients with ibd and patients with no ibd (controls) to facilitate research that may result in the development of new non-invasive methods of diagnosing ibd and understand the progression of the disease over time in order to better manage ibd patients.


Eligibility criteria:
inclusion criteria: * diagnosed as having crohn's disease or ulcerative colitis * aged 18-70 years. * understands the language and signs an informed consent form. * any disease location, except isolated upper gi crohn's disease only * any cd or uc disease activity. * outpatients and inpatients * patients will be recruited, and samples obtained at least one day, and no more than one week, prior to out/inpatient colonoscopy preparation to allow objective assessment of disease activity. exclusion criteria: * status post colectomy * status post diverting loop ileostomy or end ileostomy or colostomy * on antibiotics in the past 3 months or currently * women (pregnant or breast feeding) * subjects with concurrent chronic liver, renal, lung or metabolic disorders * active malignancy * bowel preparation at day of sample procurement * isolated upper gi crohn's disease only * active disease on colonoscopy, but normal fecal calprotectin at inclusion * c diff. positive at time of inclusion (test to be obtained in routine clinical care).

Keywords: ibd, voc
transanual tube placement in low anterior resection (lar) for rectal cancer

Conditions: Rectal Cancer

Summary: the purpose of this study is to evaluate the effectiveness of transanual tube placement in low anterior resection (lar) for rectal cancer in preventing anastomotic leakage.

transanual tube placement after anastomosis in low anterior resection for rectal cancer.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 and ≤ 75 years; 2. primary tumor has undergone histologically confirmed rectal adenocarcinoma; low rectal cancer was defined by the presence of the inferior pole of the tumor below the peritoneal reflection (in 11 cm from the anal margin). 3. together with clinical or radiological evidence of stage ii (t3-4, n0, m0) or stage iii (t1-4, n1-2, m0) disease (according to the 2010 revision of the international union against cancer primary tumor, regional nodes, metastasis (tnm) staging system). 4. performance status (ecog) 0\~1 5. adequate hematological function: neutrophils≥1.5 x109/l and platelet count≥100 x109/l; hemoglobin (hb) ≥9g/dl (within 1 week prior to randomization) 6. adequate hepatic and renal function: serum bilirubin≤1.5 x upper limit of normal (uln), alkaline phosphatase ≤5x uln, and serum transaminase (either primary tumor, regional nodes, metastasis (ast) or alt) ≤ 5 x uln(within 1 week prior to randomization); 7. written informed consent for participation in the trial. exclusion criteria: 1. body mass index (bmi) more than 30 kg/m2. 2. serious pre-operative comorbidity, including cardiovascular disease (coronary arteriosclerosis, arrhythmia, heart failure), pulmonary dysfunction (lung emphysema, obstructive lung disease), liver insufficiency (child-pugh b or c), renal insufficiency (serum creatinine \>2.0 mg/dl), and arterial circulation disturbance (occlusion of arterial vessels of limb in patient's history. 3. history of accepting abdominal surgery.

Keywords: anastomotic leak low rectal cancer
study of the cd40 agonistic monoclonal antibody apx005m

Conditions: Cancer; NSCLC; Melanoma; Urothelial Carcinoma; MSI-H; Head and Neck Cancer

Summary: this study is a phase 1 open-label dose escalation study of the immuno-activating monoclonal antibody apx005m in adults with solid tumors. study is intended to establish the maximum tolerated dose and the overall safety and tolerability of apx005m in 3 different administration schedules.

apx005m-001 is an open-label study and comprises a dose-escalation portion of approximately 8 dose level cohorts, plus an expansion cohort. eligible subjects with solid tumors will receive intravenous apx005m every 3 week, every 2 week or every 1 week until disease progression, unacceptable toxicity or death, whichever occurs first. study objectives include: * evaluate safety of apx005m * determine the maximum tolerated dose of apx005m * determine the pharmacokinetic parameters of apx005m: the maximal drug concentration (cmax), area under the curve of serum concentration over time (area under the curve/ auc), and half-life (t½). * preliminary assessment of clinical response

Eligibility criteria:
key inclusion criteria: * histologically documented diagnosis of solid tumor * for subjects in the every 2 week and every 1 week dosing cohorts histologically or cytologically documented diagnosis of urothelial carcinoma, melanoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, or any solid tumor with high microsatellite instability status (msi-high) * no known effective therapy options are available * measurable disease by recist 1.1 * ecog performance status of 0 or 1 * adequate bone marrow, liver and kidney function * no toxicities related to prior treatment related toxicities with the exception of alopecia and neuropathy * negative pregnancy test for women of child bearing potential key exclusion criteria: * any history of or current hematologic malignancy * major surgery or treatment with any other investigational agent within 4 weeks * uncontrolled diabetes or hypertension * history of arterial thromboembolic event * history of congestive heart failure, symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction * active known clinically serious infections

Keywords: immunotherapy cd40