Kornimate/medical-research-clean huggingface dataset:
hyperthermic intraperitoneal chemoperfusion (hipec) in gastric cancer

Conditions: Gastric Neoplasms

Summary: this study investigates the effect of a combined therapy with gastrectomy and hipec in localized advanced gastric cancer.

an operation and the constant further development of the surgical techniques can not always prevent the recurrence of a tumor of the stomach or the transition from the esophagus to the stomach. as reason for this recurrence, the investigators assume that the tumor was already present at the time of the surgery and has crossed the boundaries of the stomach or free tumor cells are located in the peritoneal cavity, even if they can't be found with the bare eye or imaging methods. such free tumor cells have the possibility of developing metastases within the abdominal cavity. an innovative local treatment method is being tested in tübingen and applied to remove any remaining free tumor cells or very small and invisible residual tumors. these free tumor cells can be determined prior to the start of treatment by peritoneal endoscopy (diagnostic laparoscopy). if these can be identified by lavage of the abdominal cavity there is an increased risk for the development of peritoneal metastases. therefore, in patients with detected free tumor cells in the lavage water of the abdominal cavity, after the removal of the stomach, should be used once a chemotherapy in the abdominal cavity, which is warmer than the body (intraoperative hyperthermic chemotherapy, hipec). in this study the investigators want to demonstrate, that the single administration of intraoperative hipec with cisplatin and doxorubicin in addition to routine surgery delays the onset of peritoneal metastases and the additional therapy with its low risks is reasonable.

Eligibility criteria:
inclusion criteria: * written informed consent of the patient * positive lavage cytology in staging laparoscopy * intraoperative r0- or r1-gastrectomy (re-evaluation intraoperative) * histologically confirmed locally advanced, resectable adenocarcinomas of the stomach (incl. aeg ii-iii): \>ct3 and/or cn+ and cm0 (none existing solid peritoneal metastases, re-evaluation intraoperative) * neoadjuvant chemotherapy ≥ 2 cycles exclusion criteria: * \< 18 years * existence of contraindications or contraindications against the study medication * uncompensated heart failure (nyha iii and iv) * severe chd, medically insufficient treatable cardiac arrhythmias, uncontrolled arterial hypertension * serum creatinine ≥ 1.5 x the standard value or a creatinine clearance \< 60 ml/min/1.73 m2 * severe pulmonary dysfunction (copd, pah), pulmonary function test confirmed (ivc \< 55 %, dlco \< 40%) * malignant secondary tumor disease that persists for \< 5 years (exception: in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin) * participation in other interventional studies that at the time of the propec study inclusion, still are not finished * pregnancy or lactation
resveratrol and serum apo a-i

Conditions: Dyslipidemia

Summary: although much effort has been done to lower ldl-cholesterol concentrations, there is still a substantial risk for cardiovascular disease (cvd). another strategy to lower the risk for cvd is elevating the hdl-cholesterol (hdl-c). both in vitro and in vivo studies showed that elevating hdl-c or apolipoprotein a-i (apo a-i) levels protect against cvd. however, despite many initiatives, no new widely applicable intervention strategies with proven efficacy have been developed. epidemiologic studies have shown that a higher polyphenol intake is associated with a lower risk for cvd. resveratrol, a polyphenol, could, through several beneficial mechanisms, exert a positive effect on formation of atherosclerotic plaques and thus on developing cvd. it has been shown in animals that resveratrol elevates ppar-alpha activity. this may lead to elevated apo a-i and hdl-c levels in the blood. however, these effects are not shown in human intervention studies.


Eligibility criteria:
inclusion criteria: * aged between 45 and 70 years * hdl-c \<1.0 mmol/l (men) * hdl-c \<1.3 mmol/l (women) * serum total cholesterol \<8.0 mmol/l * plasma glucose \<7.0 mmol/l * bmi between 25 - 35 kg/m2 * non-smoking * willingness to abstain from resveratrol rich products from two weeks prior to the study and the duration of the study: * grapes and grape juice * wine (red and white) * all berries * peanuts * peanut butter * soy (products) * pomegranate exclusion criteria: * unstable body weight (weight gain or loss \>3 kg in the past 3 months) * indication for treatment with cholesterol-lowering drugs according to the dutch cholesterol consensus * use of medication or a medically-prescribed diet known to affect serum lipid or glucose metabolism * active cardiovascular disease (for instance congestive heart failure) or recent (\<6 months) event, such as acute myocardial infarction or cerebro-vascular accident * not willing to stop the consumption of vitamin supplements, fish oil capsules or products rich in plant stanol or sterol esters 3 weeks before the start of the study * men: consumption of \>21 glasses of alcohol-containing drinks per week women: consumption of \>14 glasses of alcohol-containing drinks per week * abuse of drugs * pregnant or breastfeeding women * participation in another biomedical study within 1 month prior to the screening visit * having donated blood (as blood donor) within 1 month prior to the screening visit or planning to do so during the study * impossible or difficult to puncture as evidenced during the screening visits

Keywords: resveratrol fmd pwv hdl-cholesterol macrovasculature microvasculature
ertugliflozin: cardioprotective effects on epicardial fat

Conditions: Cardiovascular Diseases; Atherosclerosis; Type 2 Diabetes; Insulin Resistance

Summary: the purpose of this study is to learn if sodium-glucose cotransporter 2 inhibitor (sglt2i) medications enhance beneficial properties of epicardial adipose tissue including metabolic flexibility, insulin sensitivity, decreased cell size and reduced inflammation.


Eligibility criteria:
inclusion criteria: * patient at stanford cardiovascular surgery clinic who is scheduled for cardiac bypass surgery or vascular surgery * history of diabetes mellitus type 2 currently diet controlled, or on metformin or dpp4 inhibitors exclusion criteria: * allergy or intolerance to interventional medication * currently taking insulin, glp-1 inhibitors, or sulfonylureas

Keywords: epicardial adipose tissue sglt2 inhibitor
percutaneous pinning vs orthosis and early mobilization

Conditions: Hand Injuries; Finger Fracture

Summary: this study aims at investigating if splinting and early mobilization is a better method, regarding range of motion, for treating fractures of the base phalanx of the fingers compared to surgery with pinning. this will be achieved through a randomised clinical trial comparing the two methods.

proximal phalangeal fractures of the hand are very common and affect patients of all ages. . most fractures heal without complications but these injuries can result in impaired hand function and prolonged inability to work and perform activities of daily living. if there is a dislocation that cannot easily be repositioned to a stable position, surgery might be required. surgery is often performed with percutaneous pinning and immobilisation in plaster for 4 weeks. good results of non-surgical treatment with a splint that allows immediate mobilization of the interphalangeal joints has been reported. this study will compare these two methods for treating fractures of the base phalanx of the fingers. recruited patients will be randomized to one of the two treatment arms: 1. surgery with pinning 2. conservative treatment with a splint. primary outcome is total active range of motion in the affected finger at 3, 6 months and 1 , 3 years. secondary outcomes are number of sick days and various patient related outcome measures.

Eligibility criteria:
inclusion criteria: -fractures of the base phalanx of digit 2-5 in the hand. exclusion criteria: * fracture older than 2 weeks. * more than 25° of sagittal plane and/or 10° lateral angulation after reposition. * intra-articular step \>1mm. * associated fractures in other bones (i e metacarpals, middle and distal phalanges) and/or tendon and nerve injuries in any finger. * open fractures. * patient age \<18 years. * inability to co-operate with the follow-up protocol (i.e. language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
acute renal failure post liver transplantation

Conditions: Acute Renal Failure

Summary: trial to test the effect of administering n-acetylcysteine on cytokines and markers of oxidant stress and the incidence of acute renal failure post liver tranplant

1. to determine levels of pro-inflammatory cytokines and oxidative stress markers in liver transplant patients during post-transplant period 2. to correlate changes in pro-inflammatory cytokines and markers of oxidative stress to acute renal failure and acute rejection 3. to determine the impact of using n-acetylcysteine on cytokines and markers of oxidative stress and the incidence of acute renal failure post liver transplantation

Eligibility criteria:
inclusion criteria: * first liver transplant * normal renal function before transplantation \[serum creatinine ≤ 1.5 mg / dl\] * no requirements for dialysis before transplantation * age greater than 18 years exclusion criteria: * re-transplant * renal dysfunction i.e. serum creatinine \> 1.5 mg/dl * need for dialysis before transplantation * presence of hepatorenal or hepatopulmonary syndrome\* * combined liver and kidney transplant * peptic ulcer disease * pregnancy

Keywords: acute renal failure post liver transplant
cardiopulmonary bypass prime solution in patients undergoing heart valve surgery

Conditions: Heart Valve Diseases

Summary: in this randomized clinical trial, patients with undergoing open heart valve surgery will be enrolled into the study. participants will be divided into two groups based on the priming solution type. the first group will receive hydroxyethyl starch (hes) 130/0.4 additive to ringer lactate (rl) and the second group will be given only rl as priming solution. all patients will be observed closely during postoperative days. through follow up, bleeding/coagulopathy, renal function, hepatic function, and cerebral oxygenation will be recorded in both groups.

cardiopulmonary bypass (cpb) pump is a device for circulating blood in the body while the heart is undergone surgery. for providing circulating volume in the body we need to add about 1.5 to 2 lit fluids as priming solution in the cpb pump. some fluids mainly included crystalloids, colloids, starch, and gelatin in an only fluid or in a combined formula. during cpb time, the blood dilution is caused by adding prime solution into the circulating volume, and consequently it decreases blood viscosity. moreover, in addition to a decrease in hematocrit level, coagulation factors and plasma proteins can dramatically decreased. these processes may lead to bleeding events and tissue hypoperfusion and organ damages. to decrease complications, some modalities such as adding colloids to crystalloids have been implemented. on the other hand, any regimen for priming solution has its shortcomings need to be considered based on patient condition and surgical issue. in this double blinded randomized clinical trial study, we aimed to compare the the effects of six percent hes 130/0.4 and rl as priming solutions on coagulation factors, renal function, hepatic function, and cerebral oxygenation in patients undergoing open heart valve surgery.

Eligibility criteria:
inclusion criteria: patients who provided written informed consent and had no heart failure (lvef \>55%), no hepatic failure (defined as aspartate aminotransferase (ast) \>40 mg/dl and/or alanine aminotransferase (alt) \>40 mg/dl), no prior history of cardiac surgery, serum creatinine \ 40 kg/m2, no heparin-induced thrombocytopenia, no cancer, no severe pulmonary valve insufficiency, no pulmonary function test \<65% before heart valve surgery exclusion criteria: included consent withdrawal by the patient or by his/her proxy, allergic reaction to the drugs, the aortic cross clamp time greater than 120 minutes, on-pump time greater than 150 minutes, the performance of the retrograde autologous priming.
effect of hepatic impairment on the pharmacokinetics, safety and tolerability of pf-06865571 in subjects with hepatic impairment and in healthy subjects

Conditions: Hepatic Impairment; Healthy Volunteers

Summary: the current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma pk of pf-06865571.


Eligibility criteria:
inclusion criteria: * participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * body mass index (bmi) of 17.5 to 35.4 kg/m2, inclusive; and a total body weight \>50 kg (110 lb), at the screening visit; with a single repeat assessment of total body weight (and hence bmi), on a separate day permitted to assess eligibility, if needed. * capable of giving signed informed consent. exclusion criteria * any condition possibly affecting drug absorption (eg, prior bariatric surgery,gastrectomy, ileal resection). * at screening, participants with a positive result for human immunodeficiency virus (hiv) antibodies, as assessed by sponsor-identified central laboratory, with a single repeat permitted to assess eligibility, if needed. * other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. * previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product used in this study (whichever is longer). * participants with known prior participation (ie, randomized and received at least 1 dose of investigational product) in a study involving pf-06865571. * a positive urine drug test, for illicit drugs on day -1, * at screening or day -1, a positive breath alcohol test. * male participants with partners who are currently pregnant. * blood donation (excluding plasma donations) of approximately 1 pint (500 ml) or more within 60 days prior to dosing and until the follow-up contact. * unwilling or unable to comply with the criteria in the lifestyle considerations. * investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or pfizer employees, including their family members, directly involved in the conduct of the study.

Keywords: non-alcoholic fatty liver disease non-alcoholic steatohepatitis
description of an immune activation profile linked to insulin resistance in subjects aged 55-69

Conditions: Insulin Resistance; Metabolic Syndrome X

Summary: the aim of the study is to describe an immune activation profile of people at risk of insulin resistance based on a wide range of markers which will allow easy identification of patients at risk.


Eligibility criteria:
inclusion criteria: * the patient has been informed of the study, its objectives, constraints and the patient rights * the patient must have given their free and informed consent and signed the consent form * the patient is aged 55-69 exclusion criteria: * the subject is participating in an interventional category 1 study * the patient has participated in another category 1 interventional study in the last 3 months * the patient is in a period of exclusion determined by a previous study * the patient is under safeguard of justice or state guardianship * the subject refuses to sign the consent * the subject does not understand the information
addressing heightened levels of aggression in traumatized offenders with psychotherapeutic means

Conditions: Appetitive Aggression

Summary: heightened levels of aggression are fuelling violent incidents at all levels, especially in post-war regions. narrative exposure therapy for forensic offender rehabilitation (fornet) aims to address trauma symptoms along with reactive and instrumental/appetitive aggression to encounter the downward cycle of perpetration and enforce a sustainable (re-)integration into civil life. in the present study, the investigators provide an adapted version of fornet to former combatants in the north kivu, eastern dr congo. structured baseline, 3 and 6 month follow up interviews will be administered to assess the main outcome measures recent violent acts and appetitive aggression.

participants will be recruited through local ngos and eligible clients randomized to the treatment or waitlist control group, respectively. the treatment will be provided by supervised local counsellors after a 4-week training. at baseline, 3-month and 6-month follow up, sociodemographic data, trauma exposure, perpetrated violent acts, ptsd, recent aggression, functionality and drug dependency will be assessed. the interviews will be conducted by blind congolese psychological interviewers after an intensive 3-weeks training and continuous supervision.

Eligibility criteria:
eligibility criteria * former participant of an armed group in dr congo * involvement in violent attacks inclusion criteria: * ptsd diagnosis or aas sum score of 22 or higher exclusion criteria: * acute intoxification (alcohol or other drugs) * acute psychotic symptoms * sign of cerebro-organic diseases

Keywords: aggression violence post-conflict reconstruction demobilization traumatized offenders
correlation between specific gene mutationand local immune microenvironment and immunotherapy efficacy in nsclc

Conditions: NSCLC

Summary: immunotherapy for pd-l1 positive patients is still ineffective in some patients，which may be related to the complex immune microenvironment.in view of this bottleneck, further refinement of immunotyping and in-depth study of drug resistance mechanism are the most important tasks. in this observational study, we evaluated the difference of gene mutation and immune microenvironment and therapeutic effect in primary nsclc.

there are still some patients with pd-l1 positive who are ineffective in immunotherapy, which may be related to the complex immune microenvironment. in view of this bottleneck, further refinement of immunotyping and in-depth study of drug resistance mechanism are the most important tasks. recently, studies have shown that the core elements of tumor microenvironment that have a significant impact on immunotherapy are:1. infiltration abundance of specific killer t cells; 2. pd-l1 expression dependent on ifn - γ pathway, down-regulation of various active molecules and up-regulation of inhibitory molecules; 3. activation and clearance of various inhibitory t cells. although the classification has achieved further refinement of immune cells and molecular level, there are still some problems to be solved urgently: first, the classification of til cells needs further refinement, and different types of til infiltration have different guiding significance for prognosis; second, the subjective second-order semi quantitative scoring is often used for til count scoring, with low repeatability and different centers it is not easy for different pathologists to reach an agreement on the results of reading and interpretation. thirdly, conventional methods are difficult to meet the requirements of tumor microenvironment analysis. in conclusion, it is urgent to develop a multi molecular marker landscape analysis system for tumor microenvironment, and establish a standardized detection process for each molecule to meet the needs of clinical positioning, quantitative and qualitative analysis for key molecular markers of immune microenvironment. in this observational study, we evaluated the difference of gene mutation and immune microenvironment and therapeutic effect in primary nsclc.

Eligibility criteria:
inclusion criteria: * non small cell lung cancer was diagnosed by cytology or histopathology; * patients to be treated with pd-1 / pd-l1 inhibitors; * who signed the informed consent for participating in the research plan exclusion criteria: * history of other malignancies * cancer meningitis in subjects * incomplete clinical follow-up data * failure to sign informed consent to participate in the research program

Keywords: pd-l1 nsclc biomarker mihc immune microenvironment mutation sequencing
an observational study of people who have recently been infected with hiv

Conditions: HIV Infections

Summary: this is a long-term follow-up study of people who are identified during acute or recent hiv infection and are being followed at clinical research sites associated with the acute hiv infection and early disease research program (aiedrp). the purpose of this study is to collect data on the immunological and virologic responses that occur early in the course of hiv infection in treatment-naive and treatment-experienced hiv infected adults. study hypothesis: this study will examine the immunological responses that occur early in the course of hiv infection in treated and untreated individuals. the long-term follow-up of these subjects will help identify host immunological and genetic factors along with therapeutic strategies associated with control of viremia and delayed disease progression. in addition, this cohort will provide the recruiting mechanism to support future trials of therapy to restore immune function. furthermore, this cohort will provide a population suitable to monitoring changing patterns in the transmission of drug resistant viral strains while also evaluating ongoing behavioral risk factors associated with hiv transmission.

this study will collect data on the immunological and virologic responses that occur early in the course of hiv infection in treated and untreated hiv infected adults to identify host immunological, virological, and therapeutic factors that influence disease progression. this study will also monitor changing patterns in the transmission of drug-resistant viral strains and evaluate ongoing behavioral risk factors associated with hiv infection. participants in this study will be followed for up to 10 years. during the first year of participation, study visits will occur approximately every 4 weeks for the first 12 weeks, then every 12 weeks thereafter, with a minimum of 8 study visits during the first year. participants will be asked to complete a behavioral questionnaire at week 8. after the first year of participation, there will be 4 visits per year. blood collection and vital sign measurement will occur at each study visit. participants enrolled in this study are strongly encouraged to also enroll in the aiedrp core01 study.

Eligibility criteria:
inclusion criteria: * documented acute or recent hiv infection as defined in the study protocol * willing to be followed longitudinally by this study

Keywords: acute infection hiv aids acute hiv early hiv