Kornimate/medical-research-clean huggingface dataset:
evaluation of empagliflozin vs standard care in veterans with prediabetes

Conditions: Prediabetes

Summary: prediabetes effects 96 million people 18 years of age or older. it is important to identify treatment options to slow or prevent progression to diabetes. it is also critical to assess the potential of medications like sodium glucose transporter 2 inhibitors to reduce the risk of cardiovascular events and kidney complications, both common and costly complications of diabetes. this is a 12-week, open-label pilot feasibility study assessing the use of empagliflozin in prediabetes.


Eligibility criteria:
inclusion criteria: diagnosis of prediabetes defined by hba1c \>5.7% and \<6.5% or fasting glucose 100-125 mg/dl with documentation of diagnosis (icd-10 code) within electronic health record at time of enrollment * age 35 to 60 years at time of enrollment * able to read and speak english exclusion criteria: * diagnosis of diabetes (type 2 or type 1) * contraindication to sglt2i medication per medication labeling, prior adverse reaction to sglt2i medication, or received sglt2i medication within the 6 months prior to enrollment * currently prescribed an antihyperglycemic agent approved for treatment of type 2 diabetes or taking any fda-approved weight loss agent or over-the-counter supplement promoted for weight loss * veterans unable to complete informed consent process (veterans with impaired decision-making ability or who require use of a legally authorized representative) * women who are pregnant or may become pregnant * veterans with neurogenic bladder, indwelling catheter, or urinary tract infection within the previous 12 months requiring hospitalization or emergency department visit
systemic inflammatory biomarkers in ovarian cancer

Conditions: Ovarian Cancer

Summary: in cancer patients, prognostic markers are needed to improve the management and clinical course of both the cancer itself and surgery therefor. elevated systemic inflammatory markers are associated with morbidity and mortality in most cancer types. in this study, the investigators aimed to determine the prognostic value of inflammatory markers such as neutrophil to lymphocyte ratio (nlr), platelet to lymphocyte ratio (plr), and lymphocyte to monocyte ratio (lmr) in patients undergoing cytoreductive surgery for ovarian cancer.

major gynaecological cancer surgery is a procedure with high complication rates and mortality risk due to both the patient' s old age and comorbidities and the extent of the surgery. among such surgeries, ovarian cancer-related surgery has the highest mortality rate. despite advances in early drug therapy and improvements in the cytotoxicity of drugs, ovarian cancer is frequently diagnosed at advanced stages, which further increases morbidity and mortality rates. although many years have passed, the prognostic role of cytoreductive surgery on survival in ovarian cancers continues to be important. predicting postoperative outcomes in these surgeries may reduce the length of hospital stay, need for stay in the intensive care unit, complications, and mortality. therefore, the role of systemic inflammatory biomarkers needs to be comprehensively investigated to understand the carcinogenic mechanisms better. for this purpose, the investigators planned to evaluate the prognostic effect of systemic inflammatory biomarkers on postoperative complications.

Eligibility criteria:
inclusion criteria: * patients older than 18 years of age exclusion criteria: * patients with acute or inflammatory diseases * patients with hematological malignancies * patients with autoimmune diseases patients who underwent intraoperative hyperchemotherapy (hipec)

Keywords: systemic inflammatory markers ovarian cancer cytoreductive surgery
effect of risk factors likely to influence immuno of combined hepatitis a & b vacc vs monovalent hepatitis a & b vacc

Conditions: Hepatitis B; Hepatitis A

Summary: the focus of this study is to evaluate how risk factors like age, gender, body mass index, smoking, alcohol consumption, etc. can influence immune response when subjects are vaccinated with gsk biologicals' combined hepatitis a/hepatitis b vaccine or monovalent hepatitis a and b vaccines (from gsk biologicals' or different manufacturers). the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

the study will also evaluate the persistence of hepatitis a and hepatitis b antibodies at months 12, 24 and 36 after the first dose of primary vaccination course.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * healthy and non-healthy male or female aged 41 years or older at the time of the first vaccination. * written informed consent obtained from the subject. * no serological signs of hepatitis a or b infection at screening. * if the subject is female, she must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * history of any hepatitis a or hepatitis b vaccination or infection, since the primary vaccination study 100382. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * acute disease at the time of enrolment. . * pregnant or lactating female. * female planning to become pregnant or planning to discontinue contraceptive precautions during the primary vaccination period.

Keywords: combined hepatitis a and hepatitis b vaccine hepatitis b hepatitis a monovalent hepatitis a and hepatitis b vaccines
accessing innovative mental health services for depression in vietnam

Conditions: Depression; Anxiety Disorders

Summary: this stepped wedge, randomized controlled trial (rct) will test the effectiveness of a digital mental health intervention (vmood) adapted from an evidence-based in-person intervention. the in-person intervention is based on principles of cognitive behavioural therapy and uses a supported self-management approach consisting of a patient skills workbook and supportive coaching by a non-specialist provider. it was developed in canada and shown to be effective in the vietnamese context in a previous rct conducted by the research team. the digital adaptation (vmood) is delivered via a smartphone app the research team developed in vietnam, in close collaboration with the institute of population, health and development (phad) in vietnam. the digital intervention will be delivered at the community level in 8 vietnamese provinces, with remote coaching provided via the app by social workers. the primary outcome measure for the study is the patient health questionnaire (phq-9), which screens for depression caseness. the investigators will also include the generalized anxiety disorder(gad-7) measure, as symptoms of anxiety commonly co-occur with depression. secondary outcome measures will include the who quality of life-brief (whoqual-brev), fast alcohol screening test (fast), the alcohol, smoking and substance involvement screening test (assist) adapted to assess tobacco use only. the investigators will also conduct a cost-effectiveness analysis (cea) using the 5-level eq-5d (eq-5d-5l), the health economic assessment (hea) adapted for the vietnamese health context, and work productivity and activity impairment questionnaire: depression (wpaid:d). finally, the system usability scale (sus) will be used to assess vmood usability.


Eligibility criteria:
inclusion criteria: * score of \>4 on phq-9 indicating depression caseness * consent to participate and complete all measures exclusion criteria: * cognitive disturbance * psychotic symptoms
a single-centre research study to evaluate the care4today® heart failure platform.

Conditions: Heart Failure With Reduced Ejection Fraction

Summary: a research study to evaluate the impact of a novel care pathway for patients diagnosed with heart failure within chiltern ccg, supported by an integrated clinical patient record. assessment of patient outcomes following implementation of care4today(r) heart failure platform.

this is an exploratory study to evaluate the impact of the novel care4today hf platform on a set of outcomes including hospital admission rate (primary diagnosis), 30 days post discharge readmission rate, length of hospital stay for patients with hf (primary and secondary diagnosis), patient quality of life, and patient clinical metrics. the study design includes comparison of two parallel cohorts: one where patients will be managed via the care4today hf platform (active cohort) and a second, where patients will be managed as per existing standards of care (control cohort). evaluation phase: the evaluation phase will be set up to assess the potential benefits of the care4today hf platform. this will be implemented across 10 gp practices who will be part of the active cohort, within the chiltern ccg region. the outcomes for these patients will be compared with the outcomes of patients in the control cohort over a one year period. patients pathway (for the active cohort): once the diagnosis of hf is confirmed, a hf specialist project nurse will register the patient on the care4today platform and provide the patient with instructions on how to use the patient portal, where patients can input various clinical measures, communicate with hcps and track their condition. complex patients, and/or patients that are deteriorating are referred to the community hf specialist nurse team where they will be monitored and managed.

Eligibility criteria:
inclusion criteria: * adults 18 years of age or older with the primary diagnosis of heart failure * must have moderate to severe lvsd (ejection fraction \<= 40%) confirmed by an echocardiogram and/or other cardiac imaging exclusion criteria: * patients with right heart failure as a consequence of respiratory disease * patients with heart failure with preserved ejection fraction * patients with significant learning disability, or severe mental health conditions * patients with metabolic heart disease e.g. amyloid * patients with severe non-operable valve disease
acceptance and commitment group therapy for unaccompanied minors

Conditions: Post Traumatic Stress Disorder; Depression; Anxiety Disorders

Summary: unaccompanied minors (um) are considered to be a highly vulnerable refugee subgroup. research has indicated that um experience traumatic events and consequently develop high levels of psychopathology. post-traumatic stress disorder is the most prevalent diagnosis, followed by depression, anxiety disorders as well as traumatic grief and conduct problems. acceptance and commitment therapy (act) may be particularly suited to the treatment of survivors of trauma and with vulnerable refugee groups such as um. a 5-week act group intervention will be carried out and its feasibility in um will be explored along with its effect on mental health. the act group intervention will be based on a self-help booklet by the world health organization "doing what matters in times of stress: an illustrated guide". following the 5-week act group intervention, focus groups with participants will be carried out to examine its acceptability and will be analysed qualitatively, using thematic analysis.

the hypotheses of the study are as follows: 1. the act group intervention will lead to increases in um psychological well-being and quality of life compared to a waiting-list (wl) control group. this includes improvements in post-traumatic stress symptoms, depression, anxiety, stress, and sleep difficulties. (primary outcomes). 2. the um receiving the act group intervention will demonstrate improvements in their prosocial behaviour compared to the wl control group. (primary outcomes). 3. at post-intervention, um receiving the act group intervention will have enhanced psychological flexibility compared to the wl control group. it is predicted that there will be decreased experiential avoidance and cognitive fusion, coupled with increases in values-driven committed action, present moment awareness and self-as-context. (secondary outcomes). 4. at the 1-month and 3-month follow-up time points, the um receiving the act group intervention will have retained the improvements from the treatment (i.e., increased psychological wellbeing, enhanced psychological flexibility, augmented prosocial behaviour) compared to the wl control group. additionally, it is predicted that um who completed the act group intervention will not only have sustained the benefits observed directly post-intervention but will in fact keep making progress at follow-up time points compared to the wl control group. from the qualitative analysis, the investigators presume to provide critical insights as to what is perceived acceptable and culturally appropriate treatment for this population.

Eligibility criteria:
inclusion criteria: * unaccompanied refugee minors living in sheltered accommodation in cyprus. * no specific diagnosis required to take part in the study. * no specific cultural background required. * minors who provide consent. exclusion criteria: - presence of active psychosis.

Keywords: unaccompanied refugee minors acceptance and commitment therapy child/adolescent mental health quality of life
g-ivf and sperm parameters

Conditions: Infertility, Male

Summary: the aim of this study is to investigate if adding a fixed volume of a physiological solution to a freshly produced sperm sample will affect sperm characteristics.


Eligibility criteria:
inclusion criteria: * patients producing a pre-clinical semen sample at the clinic exclusion criteria: * patients with known azoospermia * patients who have had a vasectomy

Keywords: sperm motility sperm preparation osmolarity
rada16 for aquablation day case

Conditions: Hematuria; Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Summary: this is a pilot proof of concept single-arm study using purastat following aquablation procedure to assess reduction of hematuria to allow for same day discharge. the primary objective is to assess how purastat affects post-operative hematuria following aquablation. the secondary objective is to assess the number of patients discharged on the same day based on the hematuria criteria (grade 0 and grade i).


Eligibility criteria:
inclusion criteria: • any man undergoing aquablation for luts due to bph exclusion criteria: • unwilling to sign consent
prospective randomized clinical trial comparing outcomes of secondary intention wound care methods

Conditions: Wound Surgical; Wound Heal

Summary: this is a randomized controlled trial which is designed to determine whether aggressive and frequent debridement of an acute post-surgical wound shortens healing time.

secondary intention is an established method of allowing post-surgical defects to heal. previous studies have shown a positive association between the frequency of debridement and healing rates in chronic wounds. however, the effect of debridement on acute, post-surgical wounds is not well-described in the literature. this randomized controlled trial is designed to determine whether aggressive and frequent debridement of an acute post-surgical wound shortens healing time.

Eligibility criteria:
inclusion criteria: 1. dermatology patients at lahey clinic: 2. who have undergone mohs surgery or excision 3. who are older than 18 years 4. who are able to give consent 5. who had postoperative defects allowed to heal by secondary intention on the a) head and neck, b) trunk and upper extremities, c) lower extremities 6. who are willing and able to return to clinic in peabody, ma, for all wound care visits exclusion criteria: 1. unable to consent (due to language barrier or mental status) 2. unable to perform daily wound care 3. unwilling or unable to return for follow-up 4. have baseline venous stasis or pitting edema of the affected limb 5. wear compression stockings or require use of a compressive bandage (such as an unna boot) at baseline.

Keywords: secondary intention wound care methods
radiation therapy in preventing metastatic cancer in patients who have diagnostic procedures to identify malignant mesothelioma

Conditions: Malignant Mesothelioma; Perioperative/Postoperative Complications

Summary: rationale: radiation therapy uses high-energy x-rays to damage tumor cells. it is not yet known if radiation therapy is effective in preventing metastatic cancer following surgery. purpose: randomized phase iii trial to determine the effectiveness of radiation therapy in preventing metastatic cancer in patients who have undergone diagnostic procedures to identify malignant mesothelioma.

objectives: * determine the efficacy of radiotherapy in the prevention of metastatic skin nodules or tumor seeding following invasive diagnostic procedures, such as chest drain insertion, pleural aspiration, pleural biopsy, and thoracoscopy, in patients with malignant mesothelioma. * determine whether the nodules that develop after radiotherapy are symptomatic in these patients. * compare the quality of life of patients treated with radiotherapy vs standard care alone. outline: this is a randomized study. patients are randomized to 1 of 2 treatment arms. * arm i: patients receive radiotherapy on 3 consecutive days beginning within 3 weeks after chest drain insertion, pleural aspiration, pleural biopsy, or thoracoscopy and once the wounds have healed. * arm ii: patients receive standard supportive care alone. quality of life is assessed at baseline, and then at 1, 2, 4, 6, 9, and 12 months. patients are followed at 1, 2, 4, 6, 9, and 12 months. projected accrual: a total of 44 patients (22 per arm) will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: * histologically proven malignant pleural mesothelioma by chest drain insertion, pleural aspiration, pleural biopsy, and/or thoracoscopy within the past 3 weeks patient characteristics: age: * not specified performance status: * not specified life expectancy: * at least 3 months hematopoietic: * not specified hepatic: * not specified renal: * not specified prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior systemic chemotherapy for malignant mesothelioma endocrine therapy: * not specified radiotherapy: * no prior local radiotherapy for malignant mesothelioma surgery: * see disease characteristics * no other invasive procedures to the same chest site during and for 1 year after study

Keywords: localized malignant mesothelioma advanced malignant mesothelioma perioperative/postoperative complications
biodegradable pancreatic stents for the prevention of postoperative pancreatic fistula after cephalic pancreaticoduodenectomy

Conditions: Pancreatic Fistula; Pancreas Neoplasm; Stent Disintegration; Pancreatic Cancer; Pancreatic Anastomotic Leak

Summary: background: postoperative pancreatic fistula (popf) remains the most important morbidity after pancreaticoduodenectomy (pd). there is no consensual technique for pancreatic reconstruction and many surgeons use a transanastomotic drain. currently, the stents used are not degradable and they can cause obstruction, stricture and pancreatitis. the use of biodegradable stents that disappear a few months after the intervention could have a role in the prevention of pancreaticojejunostomy complications. material and method: a single-center prospective randomized study was planned with patients undergoing pd. a duct-to-mucosa end-to-side anastomosis is performed for the pancreaticojejunal anastomosis and the stent is placed from the pancreatic duct to the jejunum. the primary outcome of the study is the evaluation of the presence of popf (drainage fluid amylase value of \> 5000 u/l on the first day).


Eligibility criteria:
inclusion criteria: * patients undergoing cephalic pancreaticoduodenectomy (whipple procedure). exclusion criteria: * patients with soft pancreas or chronic pancreatitis.

Keywords: pancreaticoduodenectomy pancreaticojejunostomy pancreatic stent pancreatic fistula
precision medicine for children with cancer

Conditions: Childhood Cancer; Childhood Solid Tumor; Childhood Brain Tumor; Childhood Leukemia; Refractory Cancer; Relapsed Cancer

Summary: this is a multicentre prospective study of the feasibility and clinical value of a diagnostic service for identifying therapeutic targets and recommending personalised treatment for children and adolescents with high-risk cancer.

this is a multicentre study conducted under the zero childhood cancer program. the study will be enrolling patients under the age of 21 with high-risk cancer over 3 years from cancer centres in australia. patient's cancer cells will be tested for genetic abnormalities (mutations) and undergoing drug testing in highly specialised laboratories. a multidisciplinary tumour board comprising of oncologists, clinical geneticists and scientists will then discuss the results of each case and determine whether a personalised medicine recommendation can be made. a report describing the results and tumour board recommendation (if any) will be provided to the patient's treating doctor. it is always at the discretion of the treating doctor whether to alter the patient's management based on the information arising from this research project.

Eligibility criteria:
inclusion criteria (all must be met) 1. age ≤ 21 years 2. histologic diagnosis of high-risk malignancy defined as expected overall survival \< 30% or where standard therapy would result in unacceptable and severe morbidity 3. appropriate tissue samples are available for analysis 4. life expectancy \> 6 weeks 5. written informed consent

Keywords: children precision medicine personalised medicine high-risk cancer refractory recurrent sequencing patient derived xenograft molecular profiling paediatric