Kornimate/medical-research-clean huggingface dataset:
hbv envelope proteins variability on hbs antigen clearance under nucleos(t)ide analogue therapy

Conditions: Hepatitis B, Chronic

Summary: hepatitis b virus (hbv) infection remains difficult to eradicate with about 240 million people living with hbv chronic infection. hbsag clearance, correlated with a good clinical prognosis, is difficult to achieve even with antiviral treatments (3-14 %). hbv envelope proteins are essential for entry into hepatocyte and are targeted by the immune system. molecular characteristics of hbv envelope proteins may favour better viral fitness at the entry step into hepatocytes and/or hbv escape from host immunity. here we investigated whether variability of hbv envelope proteins can contribute to the differential responses to anti-hbv treatment in patients with hbsag clearance or persistence.

our study is a retrospective study of patients with chronic hepatitis b virus, selected exclusively at the university hospital center of nancy in the department of hepato-gastroenterology (hge). the patient inclusion criteria were as follows: adult patients with chronic hepatitis b, treated with nucleos(t)ide analogues, mono-infected with hbv (without co-infection with hcv, hiv and hdv). for each patient included, biological, clinical and therapeutic data were collected retrospectively. patients with loss of viral load on treatment were included in this study. among them, patients showed either a clearance of hbsag on treatment ("responders") or the control patients showed a persistence of hbsag on treatment ("non-responders", control patients).

Eligibility criteria:
inclusion criteria: * adults * patients with chronic hepatitis b * treated with nucleos(t)ide analogues * mono-infected with hbv (without co-infection with hcv, hiv and hdv) exclusion criteria: * minor * pregnant women * patients with vhc or vhd

Keywords: hepatitis b virus pres/s variability anti-hbv treatment
sexual habits affect penis size in adulthood

Conditions: Observational Study

Summary: purpose: to assess in kazakh adult males erect penis sizes, and study an influence of their natural physiological events and behavioral habits during their growing ages on their penile sizes nowadays. study design: an observational cross-sectional survey pilot study using a correlational design with the intention-to-treat principle.

participants. a total of 282 adult kazakh males from the republic of kazakhstan and who have been visited at the urology units of three university centers in the biggest cities of the republic of kazakhstan (astana, almaty, and karaganda) were prospectively included in the study, which took place between january 2020 and january 2021. measurements of the penis erect length and girth were by two doctor-urologists according to the method of veale d et al. (2015). statistical analysis. two-tailed student's t-test, pearson correlation and multivariate tests of the manova and mancova (body height as covariate) were used. sample size estimation. in a cross-sectional observational study in assessment of erect penis size of kazakh adult males we supposed that the primary interest lies in assessment of erect penis sizes in the three cities (k=3). the investigators wish to be 95% sure of detecting when the mean erect penis sizes not exceed 1 mm (i.e., 1-β=0.95, and m1=1, m2=0). the standard deviation of erect penis size is likely to be 1.56 mm (i.e. sd=1.56) with a statistical power of 95% and significance level of 2.5% with the bonferroni correction based on one-sided hypothesis testing. at the 5% type i error rate (i.e., α=0.05), the sample size of the survey is 196.

Eligibility criteria:
inclusion criteria: * male gender aged from 23 to 35 years * fill out the questionnaire * bmi ≤ 29.9 kilogram per meter square * a male who has at least one healthy native child * no non-communicable chronic diseases. exclusion criteria: * female gender * bmi ≥ 30.0 kilogram per meter square * infertility * erectile dysfunction, previous pelvic surgery, suspected hypogonadism, penile disease, or deformity * specific treatment with androgens * alcohol or drug abuse * history of alcohol consumption ≥ 30 g/day within the past 5 years.

Keywords: penis size frequency of erection masturbation coitus sexual abstinence body growth
endoscopic therapy for laterally spreading tumors (lsts)

Conditions: To Compare the Efficacy and Safety of Hybrid ESD and ESD in the Treatment of Colorectal LST

Summary: this study will retrospectively include lst patients who were admitted to 6 medical centers (the second affiliated hospital, college of medicine, zhejiang university; the affiliated jinhua hospital, zhejiang university school of medicine; first affiliated hospital of huzhou university; the second hospital of jiaxing; jinhua people's hospital; lanxi people's hospital) from 2020.05.01 to 2023.04.30 with the purpose of comparing the efficacy and safety of hybrid esd and esd in the treatment of colorectal lst. the complete resection rate, operation time, operation cost, intraoperative and postoperative complications of hybrid esd and esd lst will be compared. to provide strong evidence for the selection of endoscopic treatment strategies for lst.


Eligibility criteria:
inclusion criteria: * age ≥18 years old; * lst lesion diameter \>1cm; * medical record data integrity exclusion criteria: * pedicle lesions; * resection of residual lesions after endoscopic treatment; * advanced endoscopic imaging showed submucosal infiltrating lesions. * the lesions are in patients with inflammatory bowel disease; * familial polyposis; * electrolyte abnormalities; * coagulation dysfunction; * pregnant or lactating patients; * taking nonsteroidal anti-inflammatory drugs or anticoagulants; * a history of alcoholism; * severe organ failure; * medical records are incomplete

Keywords: colorectal adenoma；laterally spreading tumors, endoscopic submucosal dissection, hybrid endoscopic submucosal dissection
oral contraceptives for treating premenstrual dysphoric disorder in bipolar disorder

Conditions: Premenstrual Dysphoric Disorder; Bipolar Disorder

Summary: this study is a pilot, randomized, placebo-controlled trial evaluating the treatment of premenstrual dysphoric disorder comorbid with bipolar disorder using combined oral contraceptives. lay summary: this study is being done with the hope of finding a safe and effective treatment for individuals who experience both bipolar disorder and severe premenstrual symptoms. as part of this clinical trial, participants will receive either a combined oral contraceptive (i.e. oral birth control pills) as a treatment for severe premenstrual symptoms or a placebo (a pill without any active components - similar to a sugar pill). people that are enrolled in this study will either receive the treatment or the placebo for a period of 90 days. during this time, people that are participating in the study will fill out some questionnaires, and their mental and physical health will be monitored by the study physicians. one of the goals of this study is to also understand whether it is feasible (practical) to do a larger clinical trial using this treatment in this group of people.


Eligibility criteria:
inclusion criteria: * 16-45 years of age * diagnosis of bd (clinically euthymic) according to the dsm-5 * diagnosis of pmdd according to the dsm-5 * regular menstrual cycles * no contraindication to use oral contraceptives * capable of consent for treatment exclusion criteria: * smoking and over the age of 35 * current or recent (last month) use of systemic estrogen or progesterone treatment * severe reactions to hormone treatment * pregnant or breastfeeding * current substance use disorder * oophorectomy or hysterectomy * current unstable medical conditions * history of current or past breast cancer, pancreatitis, migraines or blood clotting disorders.

Keywords: bipolar disorder premenstrual dysphoric disorder
traumacel fam trium in the post-market surveillance phase

Conditions: Bleeding; Surgical Wound

Summary: the investigational medical device traumacel fam trium is a sterile plant polysaccharide haemostatic agent based on the oxidized cellulose in the form of multilayer nonwoven fabric. it is used as an adjunct to stop capillary, venous, or small arterial bleeding, and also to prevent early postoperative bleeding. it can be used in all areas of stopping diffuse bleeding from resection surfaces such as parenchymatous organs, muscles or defined body cavities. the wide scope of application allows the use for classical, robotic surgery and endoscopic treatments (e.g. laparoscopic). the main objective of the study is to compare the efficacy and safety of traumacel fam trium and regenerated oxidized cellulose based fibrous haemostat when used in accordance with their intended purpose. the partial objectives are: identification of any previously unknown side-effects and monitoring of known side-effects; identification and analysis of potentially newly emerging risks; confirmation of the acceptability of the benefit-risk ratio; identification of any systematic misuse of the device or off-label use of the device in order to verify the correctness of its intended purpose.


Eligibility criteria:
inclusion criteria: * minimum age of 18. * surgical intervention. * negative pregnancy test of women in fertile age. * diffuse soft tissue, vascular or parenchymal haemorrhage after conventional surgical haemostatic methods have not worked or are impractical (e.g. ligation, suture, compression, cauterisation). * informed consent exclusion criteria: * hypersensitivity or a known reaction to oxidized cellulose. * age under 18 * a severe clinical condition of the patient (e.g. associated illness, mental disorder) which, according to the investigator, could adversely affect patient safety and/or compliance with the procedures used in the study. * the patient has participated in another clinical study involving a haemostatic product within 30 days prior to enrolment, or another such clinical study is planned during the subject's participation in the study. * pregnancy or lactation. * if during the procedure itself, there was no need to use the test agent * application of any other topical haemostatic product prior to application of the test agent to the same site.

Keywords: oxidized cellulose haemostatic agent
pain and symptom management in rural communities

Conditions: Chronic Pain; Palliative Care

Summary: patients in isolated rural settings often lack easy access to pain care and specialist services. yet rural residents are more likely than their urban counterparts to be older; be in poorer overall health; suffer from more chronic or serious illnesses and disabilities; be uninsured or underinsured; and live in poverty. telehealth is an emerging method of health care delivery that has been found useful and effective in many clinical settings and specialties. telehealth technologies can bridge geographic distance and increase access to specialist care in rural settings. the investigators propose a cluster randomized clinical trial design to test the effects of a telehealth-enhanced palliative care pain-management program for 240 patients and 40 providers in rural health care settings. the proposed program will provide services to both patients and providers: patients will conduct self-assessments and report pain and other symptoms via telehealth. health care providers will receive telehealth-delivered case consultations that will include case management, evidence-based practice resources, and peer support. providers and their patients will be randomly assigned to intervention groups, which receive the telehealth-enhanced palliative care pain-management intervention, or to control groups. the investigators primary aim is to compare patient self-reports of pain and quality of life in the intervention and control groups over 2 months. aim 2 is to examine, in the intervention and control groups over 2 months, providers' knowledge and attitudes regarding pain and perceived competence in treating pain. aim 3 is to evaluate the cost-effectiveness of the telehealth intervention. the investigators will use mixed effects models with patients nested within providers to evaluate the effect of the intervention on study outcomes. findings from this study will be instrumental in advancing telehealth and improving pain management and palliative care among underserved rural populations.


Eligibility criteria:
inclusion criteria: * over 18 years of age * diagnosed with pain * completion of an outpatient visit in the past 2 months * functional fluency in english * no cognitive impairment * no problems with regular phone lines exclusion criteria: -

Keywords: pain and symptom management
the hastiin bidziil (strong man) intervention

Conditions: Substance Use

Summary: the hastiin bidziil (strong man) intervention study is part of a larger project called, community-driven indigenous research, cultural strengths \& leadership to advance equity in substance use outcomes (circle) center of excellence. circle aims to address drug use related health problems in collaboration with diverse indigenous communities. this study is a randomized controlled trial study to measure the effectiveness of a secondary prevention program, called hastiin bidziil (strong man), aimed at reducing substance use among native american indian (ai) men ages 18-26.


Eligibility criteria:
inclusion criteria: * self-identify as american indian * self-identify as a man * age 18-26 years at time of enrollment * screen positive for at least moderate risk on any substance, except for tobacco use only * reside within \~60 miles of a study community (fort defiance, az; chinle, az) exclusion criteria: * any condition that would affect successful participation (e.g., planned move) * profound disability that limits the ability to participate in assessments or interventions * participated in the preliminary phase of this study to adapt ceta for this project

Keywords: young men common elements treatment approach (ceta)
debritom - micro water jet technology and wound healing

Conditions: Diabetic Foot Ulcer; Non-healing Wound; Non-Healing Ulcer of Skin; Venous Leg Ulcer; Venous Ulcer

Summary: this study will investigate the clinical efficacy of micro water jet technology in the debridement and healing of chronic lower extremity ulcers.

this is a prospective cohort, single-center, open-label study in subjects with chronic lower extremity wounds. the study will enroll up to 20 subjects. subjects will undergo screening evaluations to determine eligibility to enroll in the study. all study subjects will receive micro water jet technology debridement as opposed to other debridement methods as part of their wound care treatment. the other aspects of subjects wound care protocol will remain unchanged. in the case of bilateral limb ulcers, or multiple ulcers, subjects will have the option to receive micro water jet debridement on one or all of the ulcers.

Eligibility criteria:
inclusion criteria: * male or female age 18 or older * the ability and willingness to provide informed consent * presence of a chronic lower extremity ulcer * chronic ulcer is defined as that greater than 4 weeks in duration. * subject's informed consent for participation prior to proceeding with micro water jet technology debridement * patient's ulcer cannot exhibit any gross clinical signs of infection. * patient is willing to participate in all procedures and follow up evaluations necessary to complete the study. * patient willing and able to comply with having micro water jet technology debridement potentially weekly or biweekly as part of their wound care treatment plan for up to 20 weeks. exclusion criteria: * patients with active wound infection, or untreated osteomyelitis * patients with dementia, or impaired cognitive function * patients who are unable or unwilling to participate in all procedures and follow up evaluations * patient has active charcot foot * patient with malignant wounds
study of safety and efficacy of brolucizumab 6 mg drug product intended for commercialization in patients with namd

Conditions: Neovascular Age-related Macular Degeneration

Summary: the purpose of this extension study was to assess the safety and efficacy of the new formulation of brolucizumab 6 mg ophthalmic solution when given to the same patients who received brolucizumab in the core trial crth258a2301 (also known as crth258-c002). the medical condition treated in the core and extension trials was neo-vascular age-related macular degeneration (namd).

subjects in the united states who had completed the 96 week core trial, crth258a2301 (also referred as crth258-c002), were eligible to participate in the extension trial provided the core trial visit 26 at week 96, was less than or equal to 12 weeks from the baseline visit in the extension trial, crth258a2301e1. subjects who were treated with aflibercept during the core trial and met the eligibility requirements of this extension trial continued to receive aflibercept in this extension trial in order to maintain the masking during the extension trial. no hypothesis testing or descriptive analyses were planned. subjects who were treated in the core trial with brolucizumab 3mg or brolucizumab 6 mg, and met the eligibility requirements of this extension trial, received the new formulation of brolucizumab 6 mg solution in the extension trial. enrolled subjects were to receive three intravitreal (ivt) ophthalmic injections. the study eye was the same eye that received the treatment in the core study. the extension trial consisted of 7 study visits at 4 week intervals over a period of 24 weeks. assessment of the efficacy and safety of brolucizumab 6 mg was based on a within-patient comparison with the last 6 months of corresponding core-study efficacy and safety data serving as the reference. neither the patient selection process nor expected sample sizes supported a valid comparison between aflibercept and brolucizumab. the aflibercept arm was included only to maintain the masking in the extension trial. data was presented descriptively for only brolucizumab in line with the study objective. no formal hypothesis testing was planned.

Eligibility criteria:
inclusion criteria: * sign written informed consent * completed the core study, crth258a2301, also known as crth258-c002 as defined by assessments at visit 26/week 96 within ≤12 weeks of the baseline. exclusion criteria: * patient discontinued the treatment or the core study prematurely at any time * patient received standard of care treatment for namd after completion of the core study * pregnant or nursing women and women of child-bearing potential * stroke or mi (myocardial infarction) within 3 months of the baseline extension visit

Keywords: double-masked, extension study neovascular age-related macular degeneration intravitreal injection brolucizumab aflibercept
spironolactone against anthracycline-induced cardiomyopathy

Conditions: Anthracycline Induced Cardiotoxicity

Summary: this study sought to investigate the whether spironolactone protects the heart against anthracycline-induced cardiotoxicity.

anthracyclines are the cornerstone in the treatment of numerous hematological and solid cancers. the most common side effect of anthracycline is cardiotoxicity and this may limits its use and increases the rate of mortality and morbidity. cardiotoxicity is cumulative, dose dependent, and irreversible. improvements in protective mechanisms against the cardiotoxicity of anthracycline are important to prevent the discontinuance of these chemotherapeutics. spironolactone is an aldosterone antagonist which blocks the last step of the rennin angiotensin aldosterone system (raas). the raas is one of the most effective systems in remodeling of the myocardium in post-myocardial damage. according to the rales study, in patients with severe heart failure, 25 mg spironolactone per day in addition to the standard therapy has positive effects, particularly on cardiac fibrosis and on remodeling, and substantially reduces the risk of both morbidity and death. in the ephesus study, it has been shown that, after the myocardial damage due to infarction, the administration of aldosterone antagonists had positive effects on the remodeling process, left ventricular ejection fraction and primer end-points. in the present study, we tested the hypothesis that raas blockage with spironolactone may reduce the cardiotoxicity of anthracycline group chemotherapeutics.

Eligibility criteria:
inclusion criteria: * lvef \>50% * first diagnosed breast cancer * female sex exclusion criteria: * prior breast cancer and/or prior anthracycline exposure history * lvef \<50% * use of angiotensin converting enzyme inhibitors, angiotensin receptor blockers and beta blockers * creatinin value \>2 mg/dl * presence of chronic kidney failure * potassium value \>5.3 mg/dl * presence of adrenal gland diseases, * presence of severe liver failure * co-morbidities such as coronary heart disease, hypertension, atrial fibrillation, and valvular heart disease. * male patients were excluded for the homogenization of the study

Keywords: anthracycline spironolactone cardiotoxicity
efficacy of modified fut protocols in relation to cr protocol

Conditions: Stroke

Summary: there are some treatments after stroke. among these, use forced therapy (fut), which is based on overcoming learned disuse by reintroduction of the paretic upper limb in the performance of daily activities. there are different protocols fut to the daily time constraint, the number of days and even the type of constriction. researchers have developed a protocol using four weeks constriction, daily constriction 24 hours and with the free end of the weekends. because it is a restrictive therapy, which requires the use of one of the arms and on the other hand, this mode of treatment is open to criticism, however, despite the efficacy of the protocol, patients do not have good adhesion to the protocol for the constriction severe over time. the objective of this work is to verify the safety of the developed protocol and analyze the feasibility of reducing the daily time of constriction 12 hours, with a new protocol movement constriction, easier to perform and more patient acceptance. participate in this study 82 individuals hemiparetic post stroke, which will be recruited to neurovascular diseases clinic and will be registered at the rehabilitation center of integrated state hospital. participants will be randomly divided into three groups: the fut24 (non-paretic upper limb constriction 24 hours a day, five days a week for 4 weeks), the fut 12 (non-paretic upper limb constriction for 12 hours a day, five days a week for 4 weeks) and ck (classic kinesiotherapy, at least 2 times a week for 4 weeks). will be held weekly and after the end of the monthly monitoring reviews protocols. for the rating scales are use: national institute of health stroke scale, the ashworth scale, the wolf motor function test, the motor activity log, fugl-meyer assesment, dynamometry handgrip and surface electromyography (flexor and extensor muscles wrist). the researchers hope that this protocol does not bring damage to the upper limb in constriction and it is established a new protocol fut easier to perform and more acceptable to patients, allowing the use of this technique by health professionals.

the constriction of the non-paretic upper limb will be conducted through a tubular mesh with ul positioned in adduction and shoulder internal rotation and elbow flexion greater than 90º in fut 24 and fut 12 groups. daily, the mesh is withdrawn by the investigators made hygienic, and the new constraint is accomplished using a new tubular mesh.the classic kinesiotherapy group,which will receive as a treatment only kinesiotherapy.

Eligibility criteria:
inclusion criteria: 1. good cognition, 2. absence of joint blocks, 3. good range of motion in upper limb with at least 20º of active extension of the wrist and 10º in the metacarpal phalangeal, 4. joint and walking capacity without assistance. exclusion criteria: 1. heart arrhythmia, 2. hypertension, 3. severe cardiovascular and respiratory problems, 4. inability to attend the sessions.

Keywords: stroke hemiparesis upper limb