Kornimate/medical-research-clean huggingface dataset:
defining the clinical role of topiramate in the treatment of alcohol dependence in australia

Conditions: Alcohol Dependence

Summary: to compare the clinical effectiveness, tolerability, and cost-effectiveness of topiramate to active control (naltrexone) on treatment outcomes for alcohol dependence in a double-blind randomised controlled trial.

clinicians urgently require new treatment strategies for the treatment of alcohol dependence. although alcohol use disorders are a leading cause of preventable death in australia, their treatment is generally not evidence based. the medications currently approved for use in australia for the management of alcohol dependence have limited efficacy, and existing research does not address the heterogeneity of treatment response. targeted personalised medicine addresses this heterogeneity with better medicine selection for patients based on their genotype and clinical comorbidities. members of our research team have recently demonstrated findings that support the use of topiramate (top) 200 mg/day to reduce heavy drinking and pharmacogenetic findings that implicate the gluk1 receptor subunit in the mechanism of these effects. this project will evaluate the clinical effectiveness and tolerability of topiramate relative to the active control naltrexone (ntx) in heavy drinkers. investigators hypothesise that topiramate treated patients will be better able to achieve a reduction in heavy drinking and predict that, based on prior research, that the effects would be moderated by a single nucleotide polymorphism (rs2832407) in grik1. research personnel will utilise an innovative prospective pharmacogenetic randomisation approach to a double-blind, randomised, controlled trial. individuals will receive 12 weeks of titrated treatment with topiramate (200 mg/day) or naltrexone (50mg/day) and medical management.

Eligibility criteria:
inclusion criteria: * alcohol use disorder according to the diagnostic and statistical manual of mental disorders version v criteria * age 18-70 * average weekly alcohol consumption of \>30 standard drinks for men and \>25 standard drinks for women, with a weekly average of \> 2 heavy drinking days during the month before screening * adequate cognition and english language skills to give valid consent and complete research interviews * willingness to give written informed consent * willingness to provide a blood sample for genotyping * written informed consent exclusion criteria: * active major psychological disorder associated with psychosis, significant suicide risk, and signs of impaired cognitive functioning * pregnancy or lactation * concurrent use of any psychotropic medication other than antidepressants * currently taking any tricyclic antidepressant * use of antiretroviral dolutegravir * any substance dependence other than nicotine * opioid abuse, opioid dependence, or on opioid maintenance treatment * clinically significant liver disease * history of nephrolithiasis * history of glaucoma * lack of stable housing and/or contact phone number * previous hypersensitivity to top or ntx * any alcohol pharmacotherapy within the past month
evaluation of implantable tibial neuromodulation pivotal study (titan 2)

Conditions: Overactive Bladder

Summary: the purpose of this prospective, multicenter study is to assess the safety and efficacy of tibial neuromodulation using the medtronic tibial neuromodulation (tnm) system.


Eligibility criteria:
inclusion criteria: 1. subjects 18 years of age or older 2. qualifying voiding diary 3. have a diagnosis of uui for at least 6 months 4. failed and/or are not a candidate for conservative therapies. 5. willing and able to accurately complete study diaries, questionnaires, attend visits, operate the system, and comply with the study protocol 6. willing and able to provide signed and dated informed consent exclusion criteria: 1. have primary stress incontinence 2. history of a prior implantable tibial neuromodulation system 3. anatomical defects, clinically significant edema or previous surgeries which precludes use of the device 4. previous pelvic floor surgery in the last 6 months 5. women who are pregnant or planning to become pregnant during the course of the study 6. characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements. 7. concurrent participation in another clinical study that may add additional safety risks and/or confound study results.
comparison between endovascular and bronchoscopic tumor marker insertion for real-time stereotactic-guided radiotherapy in lung cancer

Conditions: Lung Cancer; Lung Metastases; Radiotherapy

Summary: the role of radiotherapy is well established in the management of early stage lung cancer or as part of a multidisciplinary approach of locally advanced lung cancer (1). recent advances in cyberknife© technology, which is a robotic system of stereotactic irradiation including localisation and real time lesion-tracking, has led to an increase in accuracy and potentially in efficiency of the irradiation of tumor field (2)(3). according to several studies, promising results in local control and survival rates have been achieved in patients suffering from primary lung cancer or peripheral lung metastasis treated with cyberknife© (4)(5)(6)(7)(8). fiducial markers are implanted in or near a tumor in a configuration defining a com (center of mass) guiding the cyberknife for tumor localization. tumor movement is then synchronized to respiratory cycle motion during treatment which reduces toxicity of non target lung tissue irradiation. change in marker positioning leads to com alterations, thus limiting detection by the tracking system. percutaneous (9)(10)(11) (12), endovascular (12)(13) fiducial implantation or by means of bronchoscopic devices (14)(15)(16)(17)(18) are three techniques that have been validated in previous studies as feasible and safe procedures, providing accurate tracking. few studies are currently available in the litterature comparing these modalities (19)(20). the percutaneous implantation technique will not be considered for this study because this technique is associated with a high risk of pneumothorax (9). both the endobronchial and endovascular technique have been described in the literature with equivalent success rate (87-90%) in intention to treat (21)(22). one of the endpoints of this study is to verify that these results are reproducible in our institution where both techniques are currently available and to investigate other secondary endpoints such as fiducial marker migration after placement, complications rates and procedure time.


Eligibility criteria:
inclusion criteria: * lung cancer (primary or secondary, any histological type) * early stage lung cancer: patients diagnosed with stage i for which operation is contra-indicated, for example because of cardiac or pulmonary comorbidities. * locally advanced lung cancer stages ii - iiib * metastatic lung cancer stage iv (palliative care) * 18 y ≤ age ≤ 85 y exclusion criteria: * age \<18y * incapacity of judgment * absence of a signed consent form

Keywords: fiducial marker placement stereotactic body radiotherapy interventional radiology
candesartan effectiveness study in pro-b type natriuretic peptides (bnp)

Conditions: Hypertension; Left Ventricular Hypertrophy

Summary: the purpose of this study is to investigate effect of candesartan based therapy on percent change of b type natriuretic peptides(bnp) level in the subjects with hypertension and left ventricular hypertrophy.


Eligibility criteria:
inclusion criteria: * hypertension with diastolic blood pressure within 95-115 mm/hg or/and systolic blood pressure within 160-200 mm/hg * patients diagnosed as left ventricular hypertrophy by electrocardiogram exclusion criteria: * secondary hypertension * history of myocardial infarction * stroke within the previous 6 months

Keywords: lvh
empowerment and burnout of midwives at the end of health emergency from covid-19

Conditions: COVID-19

Summary: as the fifth wave of covid-19 comes to an end and the pandemic's countermeasures expire, there is a need to assess the impact of the pandemic on health care providers, especially midwives, as the professionals deputed to promote and protect women's holistic health, in all phases, physiological and otherwise, of the life cycle. the midwife considers the person as a whole, in which the mind-body-culture components interact profoundly. prevention and containment measures have impacted on midwifery clinical and nursing practices with the mandatory continuous use of personal protective equipments (ppe) and social distancing to protect the patient and the practitioner, effectively hindering the intimacy of the woman-midwife relationship. the impact assessment focuses on two dimensions: learning, investigated as perceived empowerment, and perceived malaise, investigated as burnout. empowerment has a positive connotation, which can offset burnout, a syndrome that affects the physical, psychological and emotional health of midwives and can have significant negative implications on midwife turnover, patient safety and outcomes, and the efficiency of healthcare organisations.


Eligibility criteria:
inclusion criteria: 1. midwives registered in the orders of friuli venezia giulia (fvg) region 2. midwives in practice for at least one year 3. midwives practicing in fvg region exclusion criteria: 1. consent not granted 2. midwives in retirement for more than a year

Keywords: midwifery empowerment burnout
treatment of anemia in patients with cancer who are not currently receiving chemotherapy or radiotherapy

Conditions: Anemia

Summary: the purpose of this study is to determine the effectiveness of different doses of epoetin alfa for treating anemia in patients who have cancer; or patients who no longer have any signs of cancer, but remain anemic as a result of their treatment. these patients should not be currently receiving chemotherapy or radiotherapy. a subject's participation in the study will last approximately 6 months. subjects will receive weekly doses of epoetin alfa or placebo. their hemoglobin will be tested every week.


Eligibility criteria:
inclusion criteria: * body weight \>/=99 lbs * ecog 0-2 * anemia results from cancer, chemotherapy, radiotherapy or an association with hormonal therapy or immunotherapy * screening hemoglobin level of \</=11.0 g/dl for men or \</=10.0 for women
role of bp1.3656 on alcohol responses

Conditions: Alcohol Use Disorder

Summary: the current study will determine whether a novel pharmacotherapy, bp1. 3656, affects laboratory alcohol self-administration in participants with alcohol use disorder (aud).

the current study employs bp1.3656, a novel investigational compound with a track record for safety and tolerability in phase i clinical trials. when administered to mice, bp1.3656 was associated with increased metabolism of histamine and elevated brain dopamine and acetylcholine, suggestive of utility in psychiatric disorders including alcohol use disorder (aud). this study is a phase ii laboratory-based trial of bp1 .3656 for aud. 40 non-treatment seeking participants with aud will be recruited. participants will be randomly assigned to intervention with bp1 .3656 or placebo in a within-subject, crossover design. during each intervention period, outcome measures relating to alcohol motivation and self-administration will be assessed in the laboratory. it is hypothesized that relative to placebo, alcohol self-administration will be decreased by bp1 .3656.

Eligibility criteria:
inclusion criteria: * fulfilling diagnostic and statistical manual (dsm)-5 criteria for aud with endorsement of 4-8 symptoms * average weekly consumption ≥ 14 standard drinks for women and ≥ 21 standard drinks for men over the past 3 months * willingness to take study medication and participate in laboratory sessions requiring alcohol administration * able to give written informed consent * certified as healthy by a comprehensive clinical assessment. alanine transaminase (alt) and aspartate aminotransferase (ast) levels should not be more than 1.2 times normal exclusion criteria: * seeking treatment for alcohol use (or current efforts to cut down or seek treatment) * a clinical institute withdrawal assessment (ciwa) score of 8+ upon initial assessment * current medical conditions or medications that contraindicate receiving the study drug (based on the study physician's assessment) * meeting criteria for a current substance use disorder aside from alcohol or nicotine * recent recreational drug use (assessed via urine toxicology screen) * history of gross psychiatric or neurological impairment (e.g., schizophrenia, bipolar disorder, neurological disorders) * reported difficulty with intravenous procedures * self-report of significant alcohol-induced flushing after 1-2 drinks (a proxy for aldehyde dehydrogenase deficiency) * currently nursing or pregnant (females) * serious unstable medical condition * current use of medication that could increase the risk of bp1.3656b administration * having any clinical condition, drug sensitivity, or prior therapy which, in the investigator's opinion, makes the participant unsuitable for the study * any history of seizures

Keywords: ethanol alcohol self administration bp1.3656b alcohol use disorder alcoholism alcohol drinking drinking behavior alcohol-related disorders substance-related disorders chemically-induced disorders mental disorders
the effect of lactobacillus delbrueckii subsp. bulgaricus on human's weight reduction

Conditions: Overweight and Obesity

Summary: to evaluate the improvement in weight, body fat, and bmi after adding probiotics as a once-daily therapy for 84 days in overweight individuals.

the study product contains lactobacillus delbrueckii subsp. bulgaricus at a concentration of 1x10\^8 cfu in each 100 mg. the objective of this study is to evaluate the benefits of probiotics as an add-on therapy in overweight individuals by assessing the improvements in weight, body fat, and bmi after adding probiotics as a once-daily therapy for 84 days. a randomized, two-regimen, placebo-controlled, parallel design is employed in this study, where each subject will receive either probiotics or a placebo. the add-on study product will be administered once daily for 84 days. the benefits will be assessed at baseline and subsequently on study days 28, 56, and 84, focusing on parameters such as weight, body fat, and bmi.

Eligibility criteria:
inclusion criteria: * age ≥ 20 years old * overweight (bmi ≥ 23) or body fat percentage ≥ 25% for males and ≥ 30% for females * having any of the following risk factors: atherosclerotic cardiovascular disease, type 2 diabetes, age ≥ 45 years for males, ≥ 55 years for females or postmenopausal, hypertension, dyslipidemia (total cholesterol \> 200 mg/dl or low-density lipoprotein cholesterol \> 130 mg/dl or triglycerides \> 130 mg/dl), high-density lipoprotein cholesterol \< 40 mg/dl * if routinely taking medication for lowering blood glucose, blood pressure, or lipid levels, there should not be significant dosage changes within the past three months * being willing to participate after receiving an explanation from the physician, completing the trial plan, and signing the consent form exclusion criteria: * history of diabetic ketoacidosis * medical records indicating the occurrence of cerebrovascular disease, acute myocardial infarction, coronary artery bypass surgery, placement of coronary artery stents, or peripheral vascular disease within the last 6 months * occurrence of acute infectious diseases within the last month and antibiotic use for \> 7 days * short-term use of steroids, nsaids, immunosuppressive drugs, interferons, immunomodulators, or any changes in the dose of long-term medications within the last month * use of any weight-loss drugs in the last three months (including orlistat, lorcaserin, and liraglutide) * history of any cancer or undergoing cancer treatment in the past 5 years * abnormal liver function (got or gpt greater than 3 times the normal upper limit) or liver cirrhosis * impaired kidney function (egfr \< 30 ml/min/1.73 m2) * history of alcohol abuse * participation in any other interventional clinical research within the last month * pregnant and breastfeeding women * history of allergy to the investigational product * participants deemed unsuitable for inclusion by the principal investigator

Keywords: lactobacillus delbrueckii subsp. bulgaricus weight reduction health care
korean cohort study for outcome in patients with chronic kidney disease : a 10-year longitudinal cohort study of the chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: the goals of the know-ckd (korean cohort study for outcome in patients with chronic kidney disease) study are 1) to establish a ckd cohort representing korean ckd population for up to 10-year follow-up, and 2) to investigate the renal progression, mortality, complications, risk factors, role of biochemical parameters and the genetic influence. know-ckd research group comprises nephrologists, pediatric nephrologists, epidemiologists and statisticians from eleven centers in korea. know-ckd will enroll 2,850 individuals with ckd stage from 1 to 5 between 2011 and 2015 and follow them up to 10 years. dialyzed patients or those with allograft kidney are excluded. at enrollment and at pre-specified intervals, laboratory tests will be conducted on the kidney function, biochemical profiles, anemia, cardiovascular complication (echocardiography, coronary ct, arterial stiffness), and mineral bone disorder. a biobank is also established for the dna, serum and urine at regular interval. information on the medical history, health questionnaires, qol will also be collected. web-based case-report forms (crf) is developed for the systemic management of the patient data.


Eligibility criteria:
inclusion criteria: * age: \>20 and \<75 yr, * ckd stage 1 through 5 * predialysis exclusion criteria: * unable or unwilling to give consent * previously received chronic dialysis * previous any organ transplant * heart failure * known liver cirrhosis * past or current cancer * pregnant women * single kidney due to trauma or donation

Keywords: renal progression mortality complications risk factors role of biochemical parameters genetic influence
graft versus flap in management of proximal penile hypospadias

Conditions: Proximal Penile Hypospadias

Summary: proximal hypospadias (penoscrotal, scrotal, and perineal types) account for approximately 20% of all cases . the management of hypospadias has greatly improved over the past two decades since the introduction of tubularized incisized plate urethroplasty. however, obtaining a favorable cosmetic outcome and functional straight penis is a major surgical challenge for such patients, and the ideal repair of proximal hypospadias remains the holy grail for hypospadias specialists.

the surgical plan for proximal hypospadias can be divided into single and staged operations. single stage operations are often associated with high rates of complications and reoperations. reportedly, complications occur in 20-50% of patients. therefore, many pediatric surgeons are selecting staged procedures. staged surgical repair of proximal forms of hypospadias has been proven to achieve successful both functional and cosmetic results. although staged repair with inner preputial layer graft has regained popularity in the repair of proximal hypospadias; but choosing between flaps or grafts to substitute the urethral plate in 2-stage hypospadias repair has been a matter of debate with no consensus in the literature. flaps have reliable blood supply that may be theoretically less liable for strictures or contractures. grafts are more versatile, which can be used in primary and recurrent cases when healthy local skin is deficient. in this study, our aim is to compare outcomes of grafts and flaps when used to substitute the urethral plate in two-stage repair of primary proximal penile hypospadias (penoscrotal and scrotal types).

Eligibility criteria:
inclusion criteria: * age: more than 6 months. * type of hypospadias: proximal penile hypospadias (scrotal and penoscrotal variants) exclusion criteria: * age: less than 6 months. * perineal hypospadias. * circumcised patients. * previous hypospadias repair * raised serum creatinine, coagulopathy.
greater omentum binding to the pancreatic stump to prevent pancreatic fistula following distal pancreatectomy

Conditions: Pancreatic Fistula; Pancreatic Neoplasms

Summary: background and aim: distal pancreatectomy (dp) is often performed for primary benign or malignant lesions occurred in the body or tail of the pancreas. the occurrence of pancreatic fistula (pf) after dp remains high, ranging from 5% to 60%, despite in high-volume centers. management of pancreatic stump to prevent pf has been a long-standing issue in pancreatic surgery. our group has proposed greater omentum binding as a novel approach to secure pancreatic stump with the purpose of reducing pf. with respect to the previous preliminary data which demonstrated greater omentum binding of pancreatic stump significantly reduced the occurrence of pf based on a small prospective cohort, we therefore aimed to verify the safety and effectiveness of this novel approach in a large prospective randomized cohort. method: tjbdps06 is a prospective, randomized controlled, parallel-group, superiority trial in a single high-volume pancreatic center. a total of 200 patients who will receive dp and fulfill the inclusion criteria will be randomly allocated to the greater omentum binding group or the group without this step in an enhanced recovery after surgery (eras) setting. the trial hypothesize that greater omentum binding of pancreatic stump could safely and effectively secure pancreatic stump following dp, therefore reducing the occurrence of pf. the primary outcome is pf within 90 days after dp. the secondary outcomes are overall morbidly, mortality, and major complications (clavien-dindo ≥iii) within 90 days following dp. the duration of entire trial is presumably three years, including prearrangement, two-year inclusion period, and data analysis. discussion: the current trial will be the first in demonstrating safety and effectiveness of greater omentum binding of pancreatic stump following dp in a large high-volume pancreatic center. this approach will offer an inexpensive, technically easy, and secure coverage technique for the pancreatic stump in dp and may be particularly useful for patients with a soft pancreas which is a markedly risk factor of pf.


Eligibility criteria:
inclusion criteria: * all patients who undergo dp whether made by open or laparoscopic surgery; * patients age 18 to 75 years; * patients benefit from distal pancreatectomy according to nccn guidelines; * the subject understands the nature of this trial and willing to comply, and ability to provide written informed consent. exclusion criteria: * distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs; * history of abdominal disease or surgery which may results in obvious omentum adhesion; * synchronous malignancy in other organs; * patients with high operative risk as defined by the american society of anesthesiologists (asa) score \>4; * pregnant women.