Kornimate/medical-research-clean huggingface dataset:
pd-1 inhibitor tislelizumab maintenance therapy in newly diagnosed dlbcl patients after asct

Conditions: Lymphoma, Large B-Cell, Diffuse; Transplantation; Chemotherapy

Summary: this is a multicenter, randomized controlled, prospective clinical trial. the objective is to investigate the efficacy and safety of tislelizumab maintenance therapy in newly diagnosed diffuse large b-cell lymphoma (dlbcl) patients after autologous hematopoietic stem cell transplantation (asct).

this is a multicenter, randomized controlled, prospective clinical trial. the objective is to investigate the efficacy and safety of tislelizumab maintenance therapy in newly diagnosed diffuse large b-cell lymphoma (dlbcl) patients after autologous hematopoietic stem cell transplantation (asct). 94 patients were randomly divided into two groups according to the ratio of 1:1. the whole trial included screening period (day-28 to day-1), treatment period (tislelizumab, 200mg every 8 weeks, 12 times) and follow-up period (2 years after the enrollment).

Eligibility criteria:
inclusion criteria: 1. male and female, aged 18-65; 2. newly-diagnosed high risk (aaipi 2-3 and aaipi 1 with large mass) dlbcl patients after autologous stem cell transplantation; 3. laboratory tests (blood tests, liver and renal function) meet the following requirements: 1. blood tests: white blood cell count ≥ 3.0 × 109 / l, absolute neutrophil count ≥ 1.5 × 109 / l, hemoglobin ≥ 90g / l, platelet ≥ 75 × 109 / l 2. liver function: transaminase ≤ 2.5 × upper limit of normal value, bilirubin ≤ 1.5 × upper limit of normal value; 3. renal function: serum creatinine 44-133 mmol / l; 4. the score of ecog was 0-2; 5. the subject or his legal representative must provide written informed consent before the special examination or procedure of the study. exclusion criteria: 1. pregnant or lactating women; 2. severe complications or infection; 3. lymphoma involving central nervous system; 4. participate in other clinical trials at the same time; 5. according to the judgment of the researcher, the patients who are not suitable for this study were selected.
clinical trial to evaluate safety and efficacy of hyperthermic intra-peritoneal chemotherapy (hipec) with mitomycin c used during surgery for treatment of locally advanced colorectal carcinoma

Conditions: Colorectal Cancer

Summary: the purpose of this study is to determine whether hyperthermic intra-peritoneal chemotherapy (hipec) with mitomycin c used during surgery for treatment of locally advanced colorectal carcinoma is effective in the treatment of locally advanced colorectal carcinoma.

the purpose of this study is to determine whether hyperthermic intra-peritoneal chemotherapy (hipec) with mitomycin c used during surgery for treatment of locally advanced colorectal carcinoma is effective in the treatment of locally advanced colorectal carcinoma. the hyperthermic intra-peritoneal chemotherapy (hipec) is expected to be an effective treatment with minimal side effects, it has already provided clear benefits in terms of overall survival in patients with advanced cancer. this is an attractive option for the healthcare professionals who face daily to peritoneal recurrence after performing complex surgeries, however its application is difficult due to the cost and resources increase. this leads to the necessity of administering the treatment within a clinical trials and in order to obtain a significant power this clinical trials will be multicenter and it will be performed in several oncological surgery units highly specialised and with extensive experience in colorectal carcinoma.

Eligibility criteria:
inclusion criteria: 1. male and female patients between the ages of 18 and 75 years; 2. adenocarcinoma of the colon, sigma and colon-sigma joint which represent ct4a/b in line with the american joint committee on cancer: the 7th edition of the ajcc cancer staging manual; 3. lymph node involvement: n0, the presence of n1/2 according to the 7th edition of the ajcc is allowed, provided that they can be resectable; 4. metastatic extent: m0; 5. karnofsky index \>70 or performance status ≤2; 6. informed consent properly completed. exclusion criteria: 1. presence of metastases (m1), in case of liver or peritoneal metastases at the time of surgery, the patient will be excluded from the trial and treated according to their new stage. 2. presence of unresectability criteria; 3. urgent intervention due to obstruction or perforation if there is tumor removal, prior interventions will be accepted as referrals without primary tumor removal or drainage of collections prior to scheduled surgery. 4. extraperitoneal rectal cáncer (avoiding alterations for neoadyuvance); 5. coexistence of another malignant neoplastic disease (synchronous tumors of the colon and upper rectum are accepted as long as the stage is equal to or less than the treated tumor). 6. severely altered liver, kidney and cardiovascular function; 7. intolerance to treatment; 8. administration of chemotherapy before the trial (use of neoadyuvance is discarded); 9. pregnant or breastfeeding women.

Keywords: hipec
serum biomarker levels improvement in poly cystic ovarian syndrome: impact of metformin compared to healthy controls

Conditions: Polycystic Ovary Syndrome; Insulin Resistance

Summary: the goal of this interventional study is to assess the effect of drug metformin in improving the fertility hormones and reducing the inflammatory hormones in polycystic ovarian syndrome (pcos) patients. we wish to answer the question whether metformin is necessary to improve pcos symptoms versus simple lifestyle modification. participants once diagnosed with pcos will be given metformin to be sued for 8 weeks. they will be asked to provide blood samples on day 0 and after 8 weeks of metformin use. the blood sample will be used to measure the hormonal and inflammatory profile. in addition, they will be required to compete a questionnaire regarding symptoms such as decrease in facial hair growth, improvement in menstrual cycle etc.


Eligibility criteria:
inclusion criteria: a) patients falling into pcos as per rotterdam criteria exclusion criteria: 1. systemic diseases like atherosclerosis, 2. diabetes mellitus 3. hypertension 4. congenital adrenal hyperplasia, androgen secreting tumors
multicenter trial to evaluate the effect of dapagliflozin on the incidence of cardiovascular events

Conditions: Diabetes Mellitus, Non-Insulin-Dependent; High Risk for Cardiovascular Event

Summary: this study is being carried out to determine the effect of dapagliflozin on cardiovacular outcomes when added to current background therapy in patients with type 2 diabetes with either established cardiovacular disease or cardiovascular risk factors.


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures * female or male aged ≥40 years * diagnosed with type 2 diabetes * high risk for cardiovascular events exclusion criteria: * diagnosis of type 1 diabetes mellitus history of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time * chronic cystitis and/or recurrent urinary tract infections * pregnant or breast-feeding patients

Keywords: phase iiib t2dm cardiovascular events
multimodal deep learning model predicts pancreatic cancer prognosis

Conditions: Pancreatic Adenocarcinoma

Summary: this study describes the development and validation of a deep learning prediction model, which extracts deep learning features from preoperative enhanced ct scans and analyzes postoperative pathological specimens of pancreatic cancer patients. the aim is to predict patient prognosis and response to chemotherapy treatment.

this study retrospectively collected enhanced ct scan data, pathological paraffin blocks, and clinical data from pancreatic cancer patients who underwent surgery at multiple centers between march 2013 and may 2024. the pathological paraffin blocks were stained using immunohistochemistry for prognostic immune microenvironment markers, and patients were classified based on these results. subsequently, deep learning features were extracted from enhanced ct scans, and a multimodal prediction model was constructed using imaging features and clinical information. the model's performance was evaluated using metrics including area under the receiver operating characteristic curve (auc), accuracy, sensitivity, and specificity.

Eligibility criteria:
inclusion criteria: 1. patients with pancreatic cancer, diagnosed through pathology; 2. patients underwent surgery and received adjuvant chemotherapy after surgery. exclusion criteria: 1. missing or inadequate quality of ct, 2. incomplete clinical or pathological data. 3. multiple primary malignancies; 4. history of malignancy.

Keywords: deep learning model pancreatic adenocarcinoma prognosis
ketamine-ketorolac versus fentanyl- ketorolac i.m in children during bone marrow biopsy

Conditions: Hematological Malignancy (Leukemia- Lymphoma)

Summary: investigators aim to compare between anaesthetic regimens that included dual-agent (fentanyl and ketorolac) or (ketamine and ketorolac) analgesic therapy

regarding patient registry; a prior g power analysis was done. based on the assumption that the pain score in intramuscular ketamine group will be similar to similar to those in previously published data; forty children would be required per group to detect a difference of 30% in cheops pain scores with a power of 90% (α =0.05, β =0.1) - statistical analysis: data will be analyzed through spss (statistical package for social sciences), program version 22. distribution of data will be first tested by the shapiro test. data will be presented as the mean and standard deviation (sd), median and range or numbers and percentages. for normally distributed data, the unpaired t-test will be used to compare the mean values of both groups. for pain and emergence behaviour scores, mann whitney u test will be used. fisher's exact test will be used for comparison of categorical data. the p value ≤ 0.05 will be considered as the level of statistical significance.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status ii exclusion criteria: * any known allergy to the studied drugs. * congenital heart disease * any cardiac problems. * use of psychotropic medication * mental retardation * any organ dysfunction
bilateral training versus unilateral training in stroke

Conditions: Stroke; Hemiparesis

Summary: this randomized, single-blind study compares the effectiveness of bilateral training to unilateral training for individuals with moderate hemiparesis. we hypothesize that bilateral training will be superior to unilateral in the proximal extremity but not the distal one.

upper extremity hemiparesis is the most common post-stroke disability. longitudinal studies have indicated that 30 to 66 percent of stroke survivors do not have full arm function six months post-stroke. bilateral arm training has been investigated as a potential rehabilitation intervention for individuals not eligible for constraint induced movement therapy. this training study included 24 hours of treatment over eight weeks. the protocol consisted of reaching activities with rhythmic auditory cueing emphasizing the proximal arm. subjects assigned to the bilateral group performed bilateral symmetrical activities while subjects in the unilateral group performed the same activity with the affected arm only. the motor assessment scale-upper limb item and the motor status scale are used as primary outcome measures. the reaching performance scale and strength measures are secondary outcome measures. assessments are administered pre-/ and post-training by a blind rater.

Eligibility criteria:
inclusion criteria: * cortical or subcortical stroke * chronic condition (at least six months prior) * ability to follow 2-step commands * ability to give consent exclusion criteria: * lesion in brain stem or cerebellum * visual field cut * neglect * uncontrolled hypertension * angina * copd

Keywords: stroke upper extremity hemiparesis
testing the effectiveness of night shift, a theory-based customized video game

Conditions: Trauma Injury; Physician's Role

Summary: the goal of this clinical trial is to test the effect of a video game on the implementation of clinical practice guidelines in trauma triage. the main question it attempts to answer is whether exposure to the game improves compliance with guidelines by emergency medicine physicians working at non-trauma centers in the us. participants randomized to the intervention condition will be asked to play a customized, theory-based video game for 2 hours immediately after enrollment, and then return to the game for 20 minutes every three months for the next 9 months. participants in the control condition will receive usual care.

transfer of severely injured patients to trauma centers, either directly from the field or after evaluation at non-trauma centers, reduces preventable morbidity and mortality. failure to transfer these patients appropriately (i.e., under-triage) remains common, and occurs in part because physicians at non-trauma centers make diagnostic errors when evaluating the severity of patients' injuries. the study team developed night shift, a theory-based adventure video game, to recalibrate physician heuristics (intuitive judgments) in trauma triage and established its efficacy in the laboratory. the investigators plan a type 1 hybrid effectiveness-implementation trial to determine whether the game changes physician triage decisions in real-life, and hypothesize that it will reduce the proportion of patients under-triaged.

Eligibility criteria:
inclusion criteria: - board certified physicians who work exclusively in the emergency departments (eds) of non-trauma centers in the us and triage adult trauma patients exclusion criteria: * non-physician healthcare professionals who work in eds * physicians who work at trauma and non-trauma centers * physicians who work outside the continental us

Keywords: heuristics serious game guidelines
pexy versus non-pexy for full thickness rectal prolapse

Conditions: Rectal Prolapse

Summary: no randomized controlled trial (rct) has compared no rectopexy to rectopexy for external full-thickness rectal prolapse (ftrp). this study was performed to test the hypothesis that recurrence rates for ftrp following no rectopexy are not inferior to those for rectopexy. method: this is a multicenter randomized non-inferiority trial. eligible patients were randomized to no rectopexy or rectopexy. the no rectopexy arm was defined as abdominal surgery with rectal mobilization only. the rectopexy arm was defined as abdominal surgery with mobilization and pexy. sigmoid resection was not randomized and was added in the presence of constipation. the endpoint was recurrence rates defined as presence of external ftrp after surgery. a pre-rct meta-analysis suggested a sample size of 251 patients based on a 15% expected difference in the 5-year cumulative recurrence rate. recurrence-free curves will be generated and compared using the kaplan-meier method and log-rank test, respectively. a bonferroni adjustment was used. an adjusted p value of \<0.01 was considered significant.


Eligibility criteria:
inclusion criteria: * informed consent * mental ability to understand the procedure * age range 18 to 70 * both sex exclusion criteria: * patients with recurrent rectal prolapse * previous pelvic or colorectal surgery * previous operation for fecal incontinence * cancer * chronic intestinal inflammatory diseases

Keywords: rectal prolapse mesh recurrence
mental health e-screening in pregnant and postpartum women

Conditions: Depression; Anxiety

Summary: to compare e-screening versus usual screening on: 1) women's and healthcare providers' views on feasibility and acceptability; 2) rates of detection of prenatal and postpartum depression and anxiety; 3) perceived risk and benefit of disclosure; 4) cost-effectiveness; 5) psychometric properties. we also aim to identify factors associated with feasibility of e-screening.compared to usual screening:1) e-screening is as feasible; 2) e-screening yields similar rates of prenatal and postpartum depression and anxiety; 3) the mean score for risk of disclosure is significantly lower and benefit of disclosure is significantly higher in the e-screening group; 4) e-screening is as or more cost effective in detecting prenatal and postpartum depression and anxiety; 5) features of e-screening are significantly associated with feasibility and acceptability, whereas demographic factors are not; and 6) reliability and validity indices of alpha and epds are strongly correlated for both administration modes.

given that it is critical to conduct screening within a system that links referral and treatment, our impact pilot trial is evaluating integrated screening and care (see summary of progress) versus usual prenatal care. the proposed trial engages 2 unique clinics with experienced staff who conduct routine screening (with referrals and treatment in place) to evaluate different modalities of screening. since widespread screening is unlikely to be successfully implemented if it entails additional human resources, this trial assesses the potential for a sustainable, e-health alternative.

Eligibility criteria:
inclusion criteria: * pregnant and postpartum women will be eligible for this study if they: 1. receive care at the recruitment sites ; 2. can read/write english; and 3. are willing to complete e-screening exclusion criteria: 1. do not receive care at the recruitment site; 2. cannot read/write english; 3. are not willing to complete e-screening

Keywords: pregnancy mental health screening computer feasibility
a phase i study to assess safety, tolerability and pharmacokinetics of op0595

Conditions: Healthy Volunteers; Bacterial Infections

Summary: the objectives of this study are to assess the safety, tolerability and pharmacokinetic profile of op0595 administered intravenously to healthy male, caucasian, adult subjects at single escalating doses.


Eligibility criteria:
inclusion criteria: * caucasian males aged between 18 and 45 years (inclusive) at screening * a body mass index (bmi) between 18.0 and 30.0 kg/m² (inclusive) at screening * good general health as determined by the investigator based on medical history, physical examination, vital signs, 12-lead ecg and clinical laboratory tests * negative urine test for drugs of abuse and breath test for alcohol both at screening and day -1 exclusion criteria: * receipt of any investigational agent or drug within four months before screening * a history or current evidence of allergic symptoms such as bronchial asthma, drug-induced rash or urticaria * hypersensitivity and/or allergy to drugs * concurrent or history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, respiratory, psychiatric, neurologic and/or hematological disorders * a history of chronic or recurrent infections or current active infection * a recent history of surgery within three months prior to screening, determined by the investigator to be clinically relevant * a history or presence of malignancy * donation of blood (or loss of blood) greater than 400 ml within three months before screening * a history of smoking at any time within one year before screening
different insulin regimens and postprandial coagulation activation

Conditions: Type 2 Diabetes; Cardiovascular Risk; Hemostasis; Inflammation; Endothelial Function

Summary: the purpose of this study in patients with type 2 diabetes was to investigate the acute effect of postprandial blood glucose levels modified by two different insulin treatment regimens on coagulation activation, inflammation and endothelial cell function. the investigators hypothesized that the rapid-acting insulin analogue aspart has a beneficial postprandial effect on coagulation, endothelial dysfunction and inflammation compared with the intermediate-acting insulin nph due to its ability to lower postprandial glycaemia.


Eligibility criteria:
inclusion criteria: * age 30-75 years * bmi \> 25 kg/m2 * type 2 diabetes for more than 4 years * pharmacological anti-diabetic treatment with insulin nph at bedtime or insulin aspart at meals for more than 24 months * metformin with stable dose \>1000 mg/d for more than 12 weeks * acetylsalicylic acid (75 mg/d) for more than 2 weeks * no other anti-diabetic treatment 3 month previously * hba1c\<8.5% at recruitment. exclusion criteria: * creatinine \> 120 µmol/l * alat /asat \> 2.5 x upper reference limit * use of anticoagulants within 1 month previously * any changes in dose of statins within 1 month previously * night work * present or planned pregnancy * mental sickness or alcohol abuse * clinically relevant major organ or systemic illness * uncontrolled hypertension \>180/110 mmhg * steroid treatment * known or suspected allergy to trial medications.

Keywords: hyperglycaemia postprandial type 2 diabetes cardiovascular risk markers
lactated ringer versus albumin in early sepsis therapy

Conditions: Septic Shock; Severe Sepsis

Summary: the use of albumin in critical ill patients is a matter of controversy. a large randomized controlled trial reported that albumin was as safe and effective as crystalloid solution for fluid replacement in intensive care unit, although the last one was less expensive. in surviving sepsis campaign international guidelines there are no preference for crystalloids over colloids. but recently, a retrospective analysis of patients with severe sepsis from safe study reported that the use of albumin in these patients would be superior, regarding reduction of mortality. the aim of this study is determine whether the use of albumin improve clinical outcomes in patients with severe sepsis or septic shock.


Eligibility criteria:
inclusion criteria: * age equal or higher than 18 years-old * severe sepsis or septic shock into 6 hours of evolution * written informed consent exclusion criteria: * shock from other causes * adverse reactions to human albumin * previous fluid resuscitation during current disease * previous use of albumin in the last 72 hours * religion objection * enrollment in another study * traumatic brain injury * hepatic cirrhosis * end stage renal disease * plasmapheresis * end of life patients

Keywords: septic shock sepsis albumin lactated ringer
head-to-head comparison of [18f]alf-psma-n5 with [18f]f-dcfpyl pet/ct in pca diagnosis, recurrence, and metastasis

Conditions: Prostate Cancer; PET/CT

Summary: to prospectively evaluate the radiodrug biodistribution of a novel pet imaging agent \[18f\]alf-psma-n5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with \[18f\]f-dcfpyl.

\[18f\]alf-psma-n5 pet/ct was used for initial assessment of prostate cancer or detection of recurrence. the maximum standardized uptake value (suvmax) was used to evaluate tumor uptake. the sensitivity, specificity, the number and accuracy of lesions identified and the distribution of lesions in each organ were calculated and compared with those of \[18f\]f-dcfpyl pet/ct.

Eligibility criteria:
inclusion criteria: * aged from 18 to 90 years old; * complete mri images and clinical data (such as psa level, gleason grade, etc.); * prostate cancer detected by psa or imaging examination, or clinically suspected recurrence after standardized treatment; * simultaneous \[18f\]alf-psma-n5 and \[18f\]f-dcfpyl examinations within two weeks; * willing to undergo surgery or needle biopsy for pathological examination after examination, or confirmed as prostate cancer by histopathology before or after treatment; * sign informed consent. exclusion criteria: * patients who cannot cooperate with the examination; * concurrent malignant tumors; * previous alcohol allergy; * patients with liver and kidney dysfunction; * other circumstances deemed by the investigator to be inappropriate for trial participation.