Kornimate/medical-research-clean huggingface dataset:
treatment of nonalcoholic fatty liver disease with probiotics and prebiotics

Conditions: Nonalcoholic Fatty Liver Disease

Summary: the investigators' aim is to determine whether probiotic and prebiotic treatment plus lifestyle advice is more effective in reducing hepatic fat content than lifestyle advice alone in patients with nonalcoholic fatty liver disease (nafld).


Eligibility criteria:
inclusion criteria: * age 18 to 70 years * fatty liver identified by imaging studies including ultrasound, computer tomography or magnetic resonance imaging * elevated alanine aminotransferase (alt) according to prati's criteria (\>30 iu/l in men and \>19 iu/l in women)18 * written informed consent obtained exclusion criteria: * positive hepatitis b surface antigen, anti-hepatitis c virus antibody, or anti-nuclear antibody titer above 1/160 * alcohol consumption above 30 g per week in men or 20 g per week in women * alt above 10 times the upper limit of normal * liver decompensation, as evidenced by bilirubin above 50 µmol/l, platelet count below 100 × 109/l, prothrombin time above 1.3 times the upper limit of normal, albumin below 35 g/l, presence of ascites or varices * use of systemic corticosteroids and methotrexate in the last 6 months * evidence of hepatocellular carcinoma * terminal illness or cancer, unless in complete remission for more than 5 years
practices made by patients to avoid insulin injection pain

Conditions: Diabetes Mellitus

Summary: abstract objective: this study was conducted to determine the knowledge levels of dm patients about the disease and insulin use, and their practices to avoid insulin injection pain. methods: data were collected from 399 patients who administered insulin injections in the study. patient identification form, disease and treatment compliance form, morisky-8 treatment adherence scale (mmas-8), and visual analog scale were used for data collection. the data were collected by the same researcher by face-to-face interview technique.

the face-to-face interview technique was applied to all patients who met the inclusion criteria and accepted to participate in the study, in the waiting area of the internal medicine outpatient clinic. data were collected by the same researcher. questionnaire forms were filled in the form of questions and answers in 10-15 minutes.

Eligibility criteria:
inclusion criteria: * patients between the ages of 18-65, diagnosed with diabetes mellitus at least 1 year ago, injecting themselves with insulin. exclusion criteria: * having no communication problems, and having no mental illness were included in the study.

Keywords: insuline injection pain lipohypertrophy nursing care
a prospective study of a modified lumbar puncture (lp) procedure that reduces post-lumbar puncture headaches (plph) in patients

Conditions: Post-Lumbar Puncture Headache

Summary: the purpose of this study is to o determine whether the modified lp procedure reduces the incidence of plph to 5% or lower, to determine whether the modified lp procedure reduces the frequency of epidural blood patch (ebp) usage to 10% or lower of the plph population and to identify factors that may contribute to or reduce incidence of plph


Eligibility criteria:
inclusion criteria: * participants who can sign informed consent * participants who have stated willingness to comply with all study procedures and availability for the duration of the study * participants receiving a lp per standard of care (soc) need for diagnostic or therapeutic purposes only * participants with karnofsky performance scale (kps) ≥ 60 exclusion criteria: * participants with a past medical history of chronic headaches (≥15 days per month) or acute headaches * participants with recent neurosurgical device implants such as ventriculoperitoneal shunt * participants with more than one dural puncture during the same lp procedure * participants have chronic coagulopathy with elevated prothrombin time (pt), partial thromboplastin time (ptt), and international normalized ration (inr). * participants who are on active anticoagulant or antiplatelet therapy unless stopped such therapy prior to lp per soc guidance. * participants with suspicions of raised intracranial pressure by either clinical assessment or imaging assessment or both * participants with severe spinal column deformities, such as scoliosis. disc diseases are not exclusion criteria * participants with lp procedural complications that require a needle type or needle size change

Keywords: lumbar puncture headache
primary care treatment integrating motivation and exposure

Conditions: Stress Disorders, Post-Traumatic; Alcohol-Related Disorders

Summary: this project aims to develop and test an integrated brief intervention to reduce heavy alcohol use and ptsd severity in veterans receiving veterans affairs primary care. standard brief alcohol interventions have been unsuccessful in reducing heavy drinking in traumatized individuals and current integrated treatment for alcohol use disorder and ptsd are too long to be delivered in primary care. therefore, this application addresses this gap by developing an intervention tailored to the specific needs of heavy drinking veterans who have co- occurring ptsd. this study aims to incorporate two evidenced-based interventions: brief motivational interviewing (bmi) with prolonged exposure for primary care (pe-pc). this newly developed brief intervention will be piloted in an open trial to gather veteran participant feedback and develop clinician training and fidelity procedures.


Eligibility criteria:
inclusion criteria: * a score of 8-25 for men, 6-25 for women on the audit and have past month drinking (i.e., have not quit drinking over the last month) * score ≥30 on the ptsd checklist-5 (pcl-5) and report a traumatic event on the criterion a screener exclusion criteria: * score of a 26 or higher on the audit * gross cognitive impairment as assessed by the mini mental status exam * current symptoms of mania or psychosis * currently in need of detox services * have had a suicide attempt in the last two months or a current intent to commit suicide as assessed on the p4 screener. (patients with recent suicide attempts or intent may be enrolled following receipt of suicide prevention services) * are currently receiving psychotherapy for heavy drinking or ptsd outside of pc within the last 2 months * have started or changed the dose of a psychotropic medication for heavy drinking or ptsd in the last two months that was prescribed outside of va pc * have a preference to be directly referred to va specialty care for heavy drinking or ptsd.
endoscopic ultrasonographic staging and conventional endoscopic staging for depth of invasion for early gastric cancer

Conditions: Gastric Tumor; Early Gastric Cancer

Summary: the accurate prediction of depth of tumor invasion in early gastric cancer is essential for the proper selection of candidates for endoscopic resection. conventional endoscopy and endoscopic ultrasonography have been useful diagnostic method for depth of invasion in early gastric cancer. however, there has been no prospective comparative study on the accuracy between the 2 methods. therefore, the investigators prospectively compare the accuracy between the 2 methods regarding prediction of depth of invasion.


Eligibility criteria:
inclusion criteria: * patients with early gastric adenocarcinoma undergo both endoscopic staging and endoscopic ultrasonographic staging for depth of invasion exclusion criteria: * patients had previously received neoadjuvant chemotherapy or chemoradiotherapy * patients with obviously advanced gastric cancer by endoscopy * the evidence of distant metastasis or extensive adjacent organ invasion on abdominal ct scan

Keywords: endoscopy endosonography stomach cancer tumor staging
coaching and education for diabetes distress

Conditions: Diabetes Distress

Summary: diabetes distress (dd) is a negative emotional reaction to a diagnosis of diabetes and concerns about the burden of managing diabetes, the risk of complications, and inadequate support system. dd is common among people with diabetes and is strongly associated with poor diabetes self-care and poor diabetes control. reducing dd should thus be an important component of diabetes management. in line with the growing evidence, the american diabetes association now recommends that providers "routinely monitor people with diabetes for diabetes distress, particularly when treatment targets are not met". despite increased recognition of the need to manage dd, interventions that are both feasible and effective for reducing dd in routine care settings are not yet known. a pilot study showed that health coaching (hc) has some efficacy in addressing dd but no adequately powered study has implemented a pragmatic research design capable of assessing the real-world effectiveness of hc in reducing dd. this study seeks to assess whether hc effectively reduces dd among primary care patients with diabetes, and whether hc is more effective than an educational program targeting dd. the investigators hypothesize that over a 6-month period, patients with poorly controlled diabetes and dd who enroll in and complete at least five hc sessions will achieve higher and clinically significant reductions in dd and hba1c, and greater compliance with diabetes self-care recommendations than those who receive only an educational program targeting dd as part of usual diabetes care. the two-arm randomized controlled trial for patients with poorly-controlled diabetes is taking place at an academic family medicine practice in houston, texas. both arms will receive usual care, which includes education about dd. in addition, the intervention arm will receive eight hc sessions over a five-month period. the primary outcome measure is reduction in dd over a six month period. additional outcome measures include changes in glycemic control (hba1c) and self-care practices (medication adherence, dietary, and physical activity behaviors). the study will also measure satisfaction and willingness-to-pay for hc to determine the extent to which hc, if effective for reducing dd, can be operationalized in similar healthcare settings.


Eligibility criteria:
inclusion criteria: * has had a diagnosis of type 2 diabetes for at least 6 months * aged 18 to 75 years * most recent hba1c taken within 30 days was ≥ 8.0 * at least moderate diabetes distress (a mean score ≥ 2.0 on the 17-item diabetes distress scale). exclusion criteria: * moderately-severe to severe depression: patient health questionnaire (phq9) score ≥15 * other severe mental health disorder (e.g. alzheimer's, schizophrenia) * current pregnancy * severe diabetes complications or functional deficits (e.g. kidney failure requiring dialysis, amputation, blindness).

Keywords: diabetes distress diabetes mellitus diabetes control health coaching diabetes self-management
genomic risk in retroperitoneal sarcoma

Conditions: Retroperitoneal Liposarcoma; Soft Tissue Sarcoma

Summary: the protocol intends to explore the biology which may underlie recurrences of retroperitoneal liposarcoma. surgery remains the only curative intent intervention for this disease. often, tumors recur in locations within the retroperitoneum remote from the original primary tumor. this study hypothesizes that normal appearing retroperitoneal fat actually harbors underlying genetic changes which predispose to development of future liposarcoma. to accomplish this goal, retroperitoneal fat is sampled from quadrants within and remote from the primary tumor and is subsequently subjected to genetic analyses looking for such predisposing factors.


Eligibility criteria:
inclusion criteria: * adult patients (age ≥18 years). * histologically confirmed retroperitoneal liposarcoma via preoperative biopsy, or cross-sectional imaging suspicious for liposarcoma with planned surgical resection * will be undergoing surgical resection for treatment of primary or recurrent disease * have provided informed consent to participate in this study exclusion criteria: • prior surgical anatomy which makes sampling of remote areas of the retroperitoneum technically impossible or clinically undesirable for safety reasons
does high-dose vitamin b3 supplementation prevent major adverse kidney events during septic shock?

Conditions: Acute Kidney Injury; Septic Shock; Nicotinamide; Mortality

Summary: sepsis is the most common cause of acute kidney injury (aki) in critically ill patients and is associated with a high mortality rate. currently there is no available specific treatment to prevent or treat aki in this setting. many experimental and clinical data suggest that nicotinamide, a safe and inexpensive vitamin, could be effective to prevent major adverse kidney events during septic shock. the main objective of the study is to show the superiority of nicotinamide supplementation compared to the placebo group, in patients with septic shock admitted to intensive care. a 15% reduction in the incidence of major renal adverse events at day 30 is expected in the "nicotinamide" group.


Eligibility criteria:
inclusion criteria: * adult patients with septic shock defined as sepsis with persisting hypotension requiring vasopressors to maintain map ≥65 mm hg and having a serum lactate level \>2 mmol/l (18 mg/dl) despite adequate volume resuscitation. * written informed consent exclusion criteria: * presence of inclusion criteria for more than 24 hours * immediate indication to start renal replacement therapy at the time of randomization: hyperkalemia≥ 6.5 mmol /l, metabolic acidosis with ph \<7.15 not controlled by medical treatment, diuretic resistant acute pulmonary edema or accumulation of a toxic requiring dialysis. * formal indication of nicotinamide supplementation according to the attending physician (eg pellagra, undernutrition, severe alcoholism) * known severe chronic kidney disease (clearance \<30 ml /min) in the last 3 months preceding the setic shock or kidney transplant recipient. * moribund patient (estimated survival less than 24 hours) * patient who are not expected to survive to day 30 due to terminal-stage disease (terminal respiratory or heart failure, child c cirrhosis, uncontrolled cancer) * resuscitated cardiac arrest * pregnant or lactating * legal tutorship and guardianship * lack of social security coverage.

Keywords: acute kidney injury septic shock nicotinamide
research on circulation management strategy based on oxygen metabolism balance after chd surgery

Conditions: Congenital Heart Disease (CHD); Cardiopulmonary Bypass; Children; Oxygen Delivery; Oxygen Consumption; Oxygen Saturation; Goal-directed Therapy

Summary: the objective is to investigate a goal-oriented postoperative circulation management strategy centered on "oxygen metabolism balance". this strategy is independent of the absolute metrics of oxygen supply and consumption, and aims to enhance oxygen consumption and uptake within the critical "golden 8 hours" following pediatric cardiopulmonary bypass, thereby preventing severe hypotension, cardiopulmonary arrest, and other adverse events.

this study firstly offered a specialized treatment strategy for children, particularly those who have undergone cardiopulmonary bypass surgery, that uses tailored parallel control and is independent of absolute oxygen supply and consumption characteristics.in addition, this study seeks to investigate the correlation between oxygen supply and consumption following pediatric cardiopulmonary bypass surgery and to assess the clinical utility of a goal-directed strategy concerning cardiac function recovery (icon, echocardiography, myocardial markers) and outcomes (incidence of low cardiac output, duration of endotracheal intubation, length of ccu stay, and mortality). this strategy is of great significance to improve the surgical outcomes and prognoses for children.

Eligibility criteria:
inclusion criteria: * 1.body weight \> 2.5kg; * 2.preoperative oxygen saturation \>80%; * 3.biventricular radical surgery with cardiopulmonary bypass. exclusion criteria: * 1. complicated with functional single ventricle and atrial isomerism; * 2.complicated with liver, kidney, lung, brain and other vital organ diseases; * 3.history of rescue before operation; * 4.palliative surgery; * 5.residual deformities that significantly affected hemodynamics after operation; * 6.guardians did not provide the bundle of informed consent.
r-chop versus r-mini-ceop in elderly patients(>65)with dlbcl

Conditions: Elderly Patients (>65 Years); Diffuse Large B Cell Lymphoma (DLBCL)

Summary: the study has the purpose to compare r-chop versus r-mini-ceop in elderly patients (\>65 years) with diffuse large b cell lymphoma (dlbcl).


Eligibility criteria:
inclusion criteria: 1. patients with untreated dlbcl aged 66 to 80 years without major accompanying diseases and considered as "non frail". 2. patients were classified as "non frail" (fit) if they had * adl (activity of daily living) score of 6 * less than three grade 3 cumulative illness rating score for geriatrics (cirs-g) co-morbidities and no grade 4 co-morbidities * absence of geriatric syndrome 3. patients hiv negativity; 4. concurrent malignancy; 5. written informed consent. exclusion criteria: * all other patients were classified as "unfit", and were excluded from randomization

Keywords: dlbcl r-chop r-ceop elderly patients
a multi-center open-label evaluation of the safety of sarecycline tablets in the treatment of acne vulgaris

Conditions: Acne Vulgaris

Summary: open-label study will evaluate the safety of an approximate 1.5 mg/kg/day dose of oral sarecycline in the long-term treatment of participants with moderate to severe facial acne vulgaris.


Eligibility criteria:
inclusion criteria: * successfully completed participation in phase 3 study of sarecycline (sc1401 or sc1402) * signed informed consent or assent form * body weight between 33 kg and 136 kg, inclusive * negative urine pregnancy test for females of childbearing potential * agrees to use effective method of contraception throughout study, if applicable. * able to fulfill protocol requirements, indicated willingness to participate in study and agrees to all study procedures by providing written informed consent/assent and authorization to disclose (personal health information) exclusion criteria: * currently participating in another clinical study, unless it is a pharmacokinetic sarecycline study and participation approved by medical monitor; has received investigational medication (except sarecycline) within 30 days of enrollment. * discontinued participation in a phase 3 study with sarecycline for any reason * had poor compliance wtih study requirements/study drug dosing in a phase 3 study with sarecycline * is receiving/planning to receive any systemic acne medication, systemic retinoids, systemic corticosteroids or any androgen/anti-androgenic therapy (eg, testosterone, spironolactone) * is pregnant, lactating or planning a pregnancy during the study period * has a significant intercurrent illness (including clinically significant abnormality in clinical laboratory tests), psychiatric disorder, or other factors that, in the opinion of the investigator or medical monitor, precludes participation in the study * is judged by the investigator to be unsuitable for any reason
multimodal physiotherapy based on tele-rehabilitation in chronic pelvic pain associated with endometriosis

Conditions: Endometriosis; Chronic Pelvic Pain Syndrome

Summary: * objective: to determine if the tele-rehabilitation program for chronic pelvic pain associated with endometriosis composed of pain education, therapeutic exercise and respiratory control decreases pain according to the visual numerical scale (evn), catastrophizing with the pain catastrophizing scale (pcs), kinesiophobia with the tampa scale of kinesiophobia (tsk), improves sexual function according to the female sexual function index (fsfi) and qol compared to the control group with the health status questionnaire (sf-12). * follow-up: four evaluated questionnaires: preintervention; postintervention, 3 months postintervention, 6 months postintervention * participants: 66 women diagnosed with endometriosis with chronic pelvic pain in different spanish endometriosis associations. * randomization: women will be randomly assigned to two groups using the epidata 3.1 software * interventions: experimental group: therapeutic exercise + conscious breathing (16 sessions) and pain education (4 sessions) through the trak platform. control group: they will receive informative material in weeks 1, 3, 5 and 7 about their pathology and with recommendations for them to achieve healthy lifestyle habits that do not further damage their disease.


Eligibility criteria:
inclusion criteria: * women with a medical diagnosis of endometriosis. * age equal to or older than 18 years and up to 55 years. * who are or have received medical and/or surgical treatment and with controlled disease. * persistent pelvic pain for at least 3 months. * pain greater than 4 on the evn. * no cognitive limitation to understand the information sheet, instructions and freely sign the informed consent * have any electronic device available (tablet, computer, cell phone). * have a current email address. * have a valid e-mail address. exclusion criteria: * peri- and postmenopausal women. * women pregnant or desiring gestation during the study. * women with a history of gynecologic cancer and/or undergoing any systemic and/or localized oncologic treatment in the pelviperineal region * women with a diagnosis of chronic fatigue or fibromyalgia▪. * women concomitantly participating in another intervention study. * women undergoing surgery during the study.

Keywords: endometriosis chronic pelvic pain physical therapy pain education
study to allow for second treatment cycle of dcvac in patients with localized prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to assess the safety of the second cycle of dcvac/pca in patients who completed the first cycle of dcvac/pca in the clinical trial sp003 without an objective progression of the disease.

same as brief summary

Eligibility criteria:
inclusion criteria: * male 18 years and older * histologically confirmed prostate adenocarcinoma stage pathological tumor-2 (pt2) * post radical primary prostatectomy * completion of dcvac/pca arm in study sp003, without objective progression of the disease exclusion criteria: * prior androgen deprivation therapy for prostate cancer * peripheral neuropathy of common toxicity criteria (ctc) grade 2 or greater * other uncontrolled intercurrent illness * treatment with immunotherapy against pca * clinically significant cardiovascular disease * active autoimmune disease requiring treatment

Keywords: prostate cancer radical prostatectomy