Kornimate/medical-research-clean huggingface dataset:
fresh frozen plasma as a substitute for albumin in patients receiving a large volume paracentesis

Conditions: Liver Cirrhosis; Ascites Hepatic

Summary: large volume paracentesis with albumin administration is the standard of care for patients with refractory ascites complicating end-stage liver disease. however, the use of albumin is frequently limited due to expense and occasional short supply. the goal of this study is to demonstrate if the administration of fresh frozen plasma (ffp) is as effective as albumin for volume expansion at the time of a large volume paracentesis.


Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. cirrhosis of the liver based on biopsy or clinical and radiographic criteria 3. ability to provide informed consent (grade 0 to 1 he) 4. grade 3 ascites or refractory ascites 5. ascites requiring frequent large volume paracentesis of at least 5 liters at least once a month 6. no diuretic use exclusion criteria: 1. inability to obtain informed consent 2. age less than 18 3. hepatic encephalopathy grade \> 1 4. septic shock 5. active infection 6. respiratory failure 7. heart failure with reduced ejection fraction of ≤ 50% 8. moderate or severe pulmonary hypertension 9. history of stroke 10. unstable coronary artery disease 11. chronic kidney disease (gfr \<60) 12. gi bleed within 2 weeks 13. any licorice within 2 weeks of starting the study 14. any beta blocker use within the last 2 weeks 15. any diuretic use within 2 weeks 16. absence of paracentesis within 2 weeks 17. absence of volume expanders within 2 weeks 18. inr \> 1.7

Keywords: paracentesis albumin plasma
strocare - optimised cross-sectoral,coordinated treatment of stroke patients with patient-orientated outcome measurement

Conditions: Stroke

Summary: the trial is a multi-centred controlled interventional study with a pre-post design. the primary aim of the study is the evaluation of the effectiveness and cost-effectiveness of the strocare treatment.

stroke is the second most common cause of death in germany and the most common cause for life-long disability in adulthood. after stroke, patients often experience incisive changes in their health, daily routine and quality of life. the developed model of care (strocare treatment) forms a cross--sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation. it aims to optimize the transition from acute inpatient treatment after an acute stroke to the ambulant neurological rehabilitation treatment. this is done firstly by creating an electronic portal solution for a safe and coordinated transmission of clinical data between the three participating hospitals and five stroke-specialized ambulant rehabilitation clinics and secondly by introducing a case-manager provided by the participating health insurance agency for patient support and aftercare coordination. the presented study is a multi-centred controlled interventional study with a pre-post design. stroke patients in both groups are assessed after the index ischemic event and 12 months thereafter. further sources of information are the medical record, the electronic portal (only intervention group), and routine data provided by the collaborating barmer health insurance agency (for the intervention and control group and additionally for a historic control). the main hypotheses are : (1) the strocare treatment is more effective than the routine aftercare treatment (primary outcome: patient-reported physical quality of life) and (2) the strocare treatment reduces costs for care and in the inpatient sector by providing more coordinated and thorough rehabilitation and outpatient aftercare.

Eligibility criteria:
inclusion criteria: * patients in inpatient care in the stroke unit of one of the participating acute clinics who are insured at the barmer health insurance agency with the following diagnosis (icd-10): * ischemic attack (i63) * transient ischemic attack and related syndromes (g45) * intracerebral haermorrhage (i64) * written informed consent * sufficient mastery of german language exclusion criteria: * substantially impaired communication capacity due to aphasia or dementia * patients with artificial respiration * insufficient adherence * premorbid score of mrs≥4 * patients with artificial respiration (z99.1) * dementia (f00.x., f01.x. or g30.x) or aphasia (r47) * death during inpatient treatment or the admission to a nursing home following the acute treatment

Keywords: stroke patient-reported outcomes (pros) cross-sectoral care stroke aftercare aftercare coordination post-rehabilitation support evidence based treatment patient-centred care quality of life morbidity mortality functional status feasibility acceptance process evaluation health economics
teriflunomide tecfidera lmce

Conditions: Tecfidera; Teriflunomide

Summary: this study will investigate the effect of teriflunomide in reducing cortical gray matter (cgm) atrophy and leptomeningeal (lm) inflammation over 24 months compared to dimethyl fumarate (tecfidera®)


Eligibility criteria:
inclusion criteria: * diagnosed with ms according to mcdonald criteria * age 18-65 years * relapsing disease course * expanded disability status scale (edss) score of ≤ 5.5 * mri obtained at baseline (medication start date), 12 months, and 24 months * treated with 14mg of teriflunomide ≥ 3 months or with 240mg of dimethyl fumarate ≥ 3 months to meet inclusion, reflective of recommended dosing on the package label * clinical information available over the 24 month follow-up * none of the exclusion criteria exclusion criteria: * diagnosis of non-relapsing ms * use of experimental drug or investigational procedure during the study period * pregnancy during study period * severe hepatic impairment * relapse within 30 days prior to any of the 3 mris * corticosteroid use within 30 days prior to the mris * teriflunomide patients who have used leflunomide * pre-baseline use of alemtuzumab, cladribine, rituximab, or mitoxantrone * any other factor that, in the opinion of the investigator, would make the subject unsuitable for participation
toripalimab combine with rituximab for treatment of relapsed refractory cd20 positive diffuse large b-cell lymphoma

Conditions: Diffuse Large B-cell Lymphoma; Rituximab; Toripalimab

Summary: exploring the efficacy and safety of toripalimab with rituximab for treatment of relapsed refractory cd20 positive diffuse large b-cell lymphoma.

toripalimab is a recombinant, humanized programmed death receptor-1 (pd-1) monoclonal antibody that binds to pd-1 and prevents binding of pd-1 with programmed death ligands 1 (pd-l1) and 2 (pd-l2). rituximab is an antibody to cd20 molecules. one of the mechanisms of killing tumor cells is through antibody-dependent cell-mediated cytotoxicity (adcc). these two drugs may have a synergistic effect on anti-tumor. the purpose of this study is to determine whether toripalimab with rituximab is effective and safe for treatment of relapsed refractory cd20 positive diffuse large b-cell lymphoma. this is an exploratory small sample, phase ii, single-center clinical trial, which is going to enroll 20 participants.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old; 2. according to the who 2016 classification criteria, the cd20 positive diffuse large b-cell lymphoma (dlbcl) diagnosed by pathology should include the indicators of immunohistochemistry: cd10, bcl-2, mum-1, bcl-6 and c-myc; 3. relapsed or refractory dlbcl.patients younger than 65 years should relapse or progress after receiving at least second-line treatment, and patients 65 years of age and older could be intolerant to second-line treatment, and they who relapse or progress after receiving first-line treatment; 4. there is at least one measurable lesion, defined as measurable dual-diameter, intra-lymph node lesion, short diameter\> 1.5cm, extra-lymph node lesion short diameter\> 1.0cm; 5. recurrence confirmed by pathological biopsy and cd20 positive; 6. ecog score 0-2 points; 7. no autoimmune diseases; 8. blood routine examination meets the following criteria: 1. neutrophil count ≥ 1.5 x 109 / l,; 2. platelet ≥ 75 x 109 / l,; 3. hemoglobin ≥ 10.0 g / dl; 9. the main organ function meets the following criteria: 1. aspartate aminotransferase and alanine aminotransferase ≤ 2.0 times the upper limit of normal value; 2. bilirubin ≤ 2.0 mg / dl; 3. creatinine clearance rate ≥ 60 ml / min; 10. patients must agree to take effective contraceptive measures during the study according to the investigator's request; 11. understand and voluntarily sign written informed consent. exclusion criteria: 1. diagnosed as transformed diffuse large b-cell lymphoma; 2. diagnosed as double-hit diffuse large b-cell lymphoma (dhl); 3. diagnosed as primary or secondary central nervous system lymphoma; 4. hbv dna positive or hcv rna positive patients; 5. left ventricular ejection fraction \<50%; 6. patients with history of autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, sjogren's syndrome, ankylosing spondylitis 7. patients are using or have been used immunosuppressive drugs 8. patients with ≥2 grade peripheral neuropathy

Keywords: dlbcl cd20 toripalimab rituximab
study of the efficacy of sbrt on unresectable peripheral primary tumor

Conditions: Non-small-cell Lung Carcinoma

Summary: the purpose of this study is to evaluate the efficacy of stereotactic lung radiation therapy after concomitant radiochemotherapy for unresectable stage iii non-small cell lung carcinoma (nsclc) with peripheral primary tumor. evaluate in terms of local control rate at 6 months the addition of stereotactic radiotherapy after concurrent chemoradiotherapy in the treatment of mediastinal non-resectable stage iii nsclc having a peripheral primary tumor. the number of patients required in this multicenter prospective study is 70. this is a prospective, multicenter, non comparative and non randomized study.

stereotactic radiotherapy or sbrt (body stereotactic radiation therapy) allows to irradiate with high dose limited lesions size with a local control surrounding of 80-98% and with a low level of toxicity. we propose to realize a classic concomitant rt-ct for mediastinal irradiation and combine this treatment with stereotactic rt for peripheral primary tumor. the estimated inclusion period is approximately 3 years. follow-up duration for each patient is 2 years. the duration of the research is 5 years.

Eligibility criteria:
inclusion criteria: * 18 years ≤ age ≤ 75 years * ps ecog 0 or 1 * histologically proven nsclc * unresectable stage iii: t1 or t2 or t3 ≤ 5 cm and n2 or n3 (only contralateral mediastinum or homolateral supraclavicular). * peripheral primary tumor ≥ 1 cm and ≤ 5 cm * possible concomitant chemoradiotherapy : 1 cure induction and 3 concomitant cycles of chemotherapy with cisplatin and navelbine ® and 3d conformal radiotherapy delivering 66 gy in 33 fractions to the mediastinal lymph node involvement without treating the peripheral tumor. * adequate biological parameters * forced expiratory volume (fev) ≥1 liter or ≥ 30% of the theoretical value * patient covered by a health insurance scheme * signed informed consent exclusion criteria: * sclc or large cell neuroendocrine carcinoma * metastatic disease * stage iva * pregnant or breast-feeding women

Keywords: stereotactic lung radiation therapy radiochemotherapy unresectable stage iii non-small cell lung carcinoma peripheral primary tumor
transcranial ultrasound stimulation as a neuromodulation therapy for craving and relapse behaviors in alcohol use disorder.

Conditions: Alcohol Use Disorder (AUD); Transcranial Ultrasound Stimulation

Summary: this study aims to evaluate the efficacy of transcranial ultrasound stimulation in reducing cravings and preventing relapse in individuals with alcohol use disorders. utilizing a double-blind design, participants will be randomly assigned to receive either active accelerated transcranial ultrasound stimulation or a sham treatment.

as a major global public health issue, the core therapeutic goal of alcohol use disorder (aud) is to reduce alcohol craving and prevent relapse. in recent years, transcranial ultrasound stimulation (tus) has emerged as a reliable non-invasive neuromodulation technique. studies have shown that abnormalities in neural activity and structure in the ventromedial prefrontal cortex (vmpfc) of aud are closely associated with alcohol craving and dysregulation of the reward system. however, existing research on non-invasive neuromodulation techniques for aud has primarily focused on other brain regions, with limited exploration of interventions targeting the vmpfc. this study aims to evaluate the efficacy of a tus intervention targeting the vmpfc through a randomized controlled trial, assessing its potential to reduce alcohol craving and prevent relapse, thereby providing a theoretical foundation for clinical translation.

Eligibility criteria:
inclusion criteria: * education level of junior high school or above, capable of completing questionnaires and behavioral tests; * aged 18-60 years; * meet dsm-5 diagnostic criteria for alcohol use disorder; * no abnormal findings on physical examination; * agree to participate in follow-up assessments; * no contraindications for mri scanning. exclusion criteria: * have impaired intelligence (intelligence quotient\<70); * prior tdcs or tms treatment within the past 3 months; * contraindications for tms therapy (e.g., intracranial metal implants, history of traumatic brain injury, skull defects, cardiac pacemakers, cardiovascular diseases, or epilepsy); * severe somatic diseases or major organ dysfunction; * psychiatric disorders per dsm-5 criteria (e.g., schizophrenia, schizoaffective disorder, intellectual disability, autism spectrum disorder, dementia, memory impairment, or other cognitive disorders);
influence of sleep quality in patients with periorbicular hyperchromia

Conditions: Periorbital Disorder

Summary: periorbital hyperchromia (poh) or periorbital hyperpigmentation, commonly known as "dark circles", is a relatively common condition and a frequent reason for dermatological consultation. it is defined as brown-colored pigmentation, ranging from light to dark, which mainly involves the lower eyelids. poh affects individuals over a wide age range, including both sexes and all ethnicities, and is associated with a tired and aged facial appearance. the most commonly affected people are those with the highest skin phototypes. although the prevalence is similar between sexes and age groups, poh is a more frequent complaint in women. the dark circles characteristic of poh can negatively impact patients' quality of life, although it is not a condition associated with morbidity. popularly it is believed that the poor quality of sleep is a factor responsible for its appearance, but there is no consistent data in the literature that prove this.

we aim to compare the quality of sleep through the pittsburgh sleep quality index (psqi-br) already translated and validated in portuguese for patients with periorbicular hyperchromia (cases) with patients without this complaint (controls) and to compare dermatological quality of life through the quality of life in dermatology index (dlqi) already translated and validated for portuguese patients with periorbicular hyperchromia (cases) with patients without this complaint (controls). patients and / or family members who consult in the dermatology of the hospital de clínicas of porto alegre (preferably), but also other patients and / or relatives with outpatient care in this institution will be invited to participate in the control group. the winpepi program, version 11.32, was used to calculate the sample size. this objective predicts a pareto control case study by age, with a ratio of 1: 1. the sample size was 252 subjects, 126 cases and 126 controls. adding 10% to possible losses and refusals the sample size should be 280 subjects, with 140 cases and 140 controls. this value was stipulated taking into account the mean of 5.9 in the psqi-br of the cases already collected (n = 148 subjects) and corresponds to a difference of almost 3 points in the index ranging from zero to 21, corresponding to approximately 15% difference between groups. for this calculation was considered 80% power and significance level of 5%.

Eligibility criteria:
inclusion criteria: * cases: patients with periocular hyperchromia diagnosed by clinical examination. * controls: patients without periocular hyperchromia diagnosed by clinical examination. exclusion criteria: * pregnant patients * active collagenase patients * patients with bacterial or viral infections on the periorbicular area * patients undergoing any treatment modality for periocular hyperpigmentation in the last 3 months.

Keywords: dark circles periorbital hyperchromia sleep quality facial aesthetics
enhancing linkage to hiv care for newly detected hiv-positive persons in ukraine

Conditions: HIV

Summary: this study proposes to assess whether a modified antiretroviral treatment access study intervention, proved to be effective in the u.s. and based on the nurse case management approach, can impact the enrollment in hiv care of recently detected hiv-positive patients in specialized health care clinics in three regions in ukraine, using the existing local infrastructure. the proposed study addresses a significant public health issue of non-/late enrollment of hiv-positive persons in hiv care and treatment.

individual, parallel, two-arm, 1:1 rct. the study participants were recruited between october 2015 and december 2016 at 9 clinics located in dnipropetrovsk region (dnipropetrovsk regional narcological dispensary; dnipropetrovsk regional dermatovenereologic dispensary; kryvyi rih infectious disease clinic no. 1), mykolaiv region (mykolaiv regional narcological dispensary; mykolaiv regional dermatovenereologic dispensary; mykolaiv regional infectious disease clinic), and odesa region (odesa regional dermatovenereologic dispensary; odesa infectious disease clinic; odesa regional center of mental health). these three types of clinical sites (treating addiction, sexually transmitted infections \[stis\], and infectious diseases \[ids\]) were located in the regions with the highest hiv prevalence in ukraine, but were not co-located with hiv care facilities. participants assigned to the standard of care (soc) arm and the martas arm received referrals to the local aids centers (dnipropetrovsk regional aids center, kryvyi rih aids center, mykolaiv regional center for palliative care and integrated services (former mykolaiv aids center), and odesa regional aids center) or their departments ("trust" offices) located in each study region. investigators affiliated with the ukrainian institute on public health policy (uiphp) were responsible for all aspects of study design, management, and analysis.

Eligibility criteria:
inclusion criteria: * age 18+ years; * tested hiv-positive * fluent in russian or ukrainian; * able to read/understand and sign an informed consent exclusion criteria: * enrolled in hiv care; * plan to move out of the study region before the end of their follow-up period * cognitive impairment * have pending legal issues, independent of their lifetime history of incarceration * subject is a part of another intervention or/and research study with similar linkage-to-care objectives

Keywords: enrollment in hiv care recently detected hiv-positive specialized health care clinics ukraine
phase iii trial of high dose vs. standard dose vit d2 with docetaxel in met breast ca

Conditions: Breast Cancer

Summary: randomized phase iii trial to determine the effectiveness of high dose versus standard dose of vitamin d2 (ergocalciferol) given with docetaxel in patients with metastatic breast cancer

2 arms randomization in patients with metastatic breast cancer. arm a = docetaxel + high dose vitamin d2 arm b = docetaxel + standard dose vitamin d2

Eligibility criteria:
inclusion criteria: * histologically proven metastatic adenocarcinoma of the breast. * gender: female. * age ≥18 years. * ecog performance status ≤ 2.(see appendix i) * 25 (oh) vitamin d level ≤ 100nmol/l (40ng/l). * no more than 1 prior chemotherapy regimen not including docetaxel or paclitaxel for metastatic breast cancer. * patients progressed on doxorubicin or epirubicin as first line for metastatic breast cancer is eligible. * concurrent bisphosphonate therapy allowed. * life expectancy more than 6 months * at least 12 months since prior adjuvant or neo-adjuvant chemotherapy including taxanes regimens. * adequate hematologic, hepatic and renal function. * written informed consent. exclusion criteria: * pregnant or lactating women. * male breast cancer. * women of childbearing potential unless surgically sterile or using adequate measures of contraception. * metastatic inflammatory breast cancer. * cns metastasis. * leptomeningeal carcinomatosis. * malignant hypercalcemia. * history of kidney stones. * history of active primary hyperparathyroidism. * normal 25 (oh) vitamin d level ≥100 nmol/l or ≥ 40 ng/l. * previous or concomitant malignancy of any type, except adequately treated basal cell carcinoma of the skin or in situ cervix cancer. * patient on any anti-psychotic medications or steroid therapy. * history of malabsorption syndrome (pancreatic insufficiency, celiac disease and tropical sprue). * any of the following abnormal baseline hematological values: * anc \< 1.0 x109/l, or platelets \< 100.000 x 109/l. * any of the following abnormal laboratory tests: total serum bilirubin \>2.00 x uln (upper limit of normal), ast, alt \> 2.5 x uln or alp \>2.50 x uln (upper limit of normal).

Keywords: vitamin d in patients with metastatic breast cancer