Kornimate/medical-research-clean huggingface dataset:
human albumin infusion in liver cirrhosis and overt hepatic encephalopathy (hache)

Conditions: Overt Hepatic Encephalopathy

Summary: hepatic encephalopathy (he), a severe complication of decompensated cirrhosis, is characterized as neurocognitive dysfunction. emerging evidence suggests the potential role of human albumin infusion for the treatment of he, but its optimal dosage remains undefined. therefore, the investigators planned a randomized controlled trial (rct) to compare the efficacy of human albumin infusion at different dosages in in patients with liver cirrhosis and overt he.

overall, 174 patients with a diagnosis of liver cirrhosis, overt he, and a serum albumin level of 23-30g/l will be enrolled. they will be stratified according to the severity of overt he and randomly assigned at a ratio of 1:1 into the groups of human albumin infusion at a modified dosage and a routine dosage. the primary endpoint is the improvement of overt he within 3-5 days after treatment. the secondary endpoints include recurrence of overt he, survival, and adverse events.

Eligibility criteria:
inclusion criteria: * a definite diagnosis of liver cirrhosis and overt he * a serum albumin level of 23-30g/l * age ≥18 years old * sign the informed consent exclusion criteria: * contraindications to human albumin infusion * a history of transjugular intrahepatic portosystemic shunt * a diagnosis of acute liver failure * severe heart and/or lung diseases * psychiatric or nervous diseases * pregnant or lactating

Keywords: hepatic encephalopathy liver cirrhosis human albumin inflammation oxidative stress survival
effects of stress on exposure therapy

Conditions: Specific Phobia

Summary: this study investigates whether stress can augment exposure therapy outcome in patients with specific phobia (spider phobia).

stress has been shown to modulate fear extinction. the present study is aimed at investigating whether stress (administered prior to exposure with the socially evaluated cold pressor test) augments exposure therapy outcome in patients with specific phobia (spider phobia). furthermore, the effects of stress on the generalization of exposure-induced symptom reduction towards untreated fear stimuli (i.e. cockroaches) will be explored. participants are randomly assigned to the cold or warm water condition of the socially evaluated cold pressor test (secpt; schwabe et al., 2008). thereafter, participants of both conditions receive 45 minutes of in-vivo exposure to spiders. the effects of stress on exposure-based anxiety reductions toward spiders (treated fear stimulus) and cockroaches (untreated fear stimulus to assess generalization of treatment outcome) are assessed on the behavioral, subjective and physiological level at pretreatment, posttreatment (24 hours after exposure) and follow-up (4 weeks after exposure).

Eligibility criteria:
inclusion criteria: * women using oral contraceptives (oc) * specific phobia (spider phobia) exclusion criteria: * body mass index (bmi) \ 27 * pregnancy * any acute or chronic mental, somatic, endocrine, or metabolic disease * psychological, psychiatric, neurological or pharmacological treatment * shift work * smoking more than 5 cigarettes per month * vaccination in the past 2 month * drug or alcohol abuse

Keywords: anxiety disorders spider phobia stress exposure therapy generalization
feasibility and safety of high-intensity exercise training in patients surviving covid-19

Conditions: COVID-19

Summary: this current protocol encompasses an investigator-blinded randomized exercise intervention in 10 covid-19 survivors that have been discharged from hospital. the subjects will be randomized to perform three different exercise training protocols in a random order. the aim is to clarify the feasibility and safety of three training protocols in covid-19 survivors. the hypothesis is that patients surviving covid-19 will be able to comply to all training protocols.

the study is a randomized crossover trial testing the feasibility and safety of three different training protocols in 10 covid-19 survivors that have been discharged from hospital. the subjects will be randomized to perform three different exercise training protocols in a random order. the aim is to clarify the feasibility and safety of three training protocols in covid-19 survivors. the hypothesis is that patients surviving covid-19 will be able to comply to all training protocols. the study consists of 4 visits with 1 baseline session (a medical screening and fitness test) and 3 different training sessions. each training is separated by 1-week washout, to account for potential confounding by leisure activity performed just before the training, patients will be wearing activity watches (polar). feasibility and safety evaluation will be based on 1) how tolerable and enjoyable the training was based on a subjective questionnaire (likert scale) 2) compliance to the prescribed exercise protocol with regard to duration and intensity and 3) experienced side effects.

Eligibility criteria:
inclusion criteria: * age ≥ 40 years * a laboratory-confirmed initial positive test followed by one negative tests of severe acute respiratory syndrome coronavirus 2 (sars-cov-2) ≤ 6 months after hospital discharge * ≤10 l oxygen requirement during hospitalization exclusion criteria: * present atrial fibrillation * diagnosed with acute myocarditis * health conditions that prevent participating in the exercise intervention * patients who cannot undergo mr scans (e.g. kidney disease or metallic implants) * treatment with il-6 receptor antagonists (tocilizumab, kevzara) within the last month due to drug interference with the cardiopulmonary exercise adaptations.
an exploratory study of focal pulse ablation system in the treatment of atrial arrhythmia

Conditions: Typical Atrial Flutter; Atrial Fibrillation (AF)

Summary: this is a prospective, single-group clinical study. the objective is to evaluate the safety and efficacy of focal pulse ablation system in the treatment of typical atrial flutter.


Eligibility criteria:
inclusion criteria: * subjects aged at least 18; * subjects with at least one typical atrial flutter attack recorded by ecg or holter in the 180 days prior to enrollment, and the ecg of other hospitals could be accepted; * subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program. exclusion criteria: * any prior cavo-tricuspid isthmus ablation; * unstable angina; * atrial flutter secondary to electrolyte disorder, thyroid disease or other reversible causes; * myocardial infarction or coronary artery bypass grafting (cabg) or percutaneous coronary intervention (pci) within the prior three months; * at baseline, new york college of cardiology (nyha) heart function grades iii and iv; * implantable devices such as icds, crts and pacemakers in the body; * atrial or ventricular tumors, blood clots, thrombus, or known clotting disorders were recorded within the prior 90 days; * severe structural heart disease, including tricuspid stenosis, tricuspid malformation, or other congenital heart disease that prevents ablation surgery; * previously received tricuspid metal valve replacement; * thromboembolic events (including transient ischemic attacks) within the past 6 months; * mural thrombosis, tumor, or other abnormality that interferes with vascular puncture or catheter operation; * severe lung disease, pulmonary hypertension or any lung disease involving abnormal blood gas or severe breathing difficulties; * anticoagulation contraindications and a history of blood clotting or abnormal bleeding; * acute systemic infection; * serum creatinine greater than twice the upper limit of normal, or any history of renal dialysis; * women who are pregnant or breastfeeding or who cannot use contraception during the study period; * enrollment in another clinical trial evaluating other devices or drugs during the same period; * life expectancy less than 12 months (e.g. advanced malignancy); * abnormalities or diseases considered by the investigator to be excluded from inclusion in this study.
leveraging mhealth and peers to engage african- americans and latinxs in hiv care (lean)

Conditions: HIV/AIDS

Summary: this is a pragmatic randomized controlled study comparing existing linkage to care and retention (ltcr) services to an mhealth-enhanced linkage to care and retention (mltcr) protocol.

baltimore's hiv prevalence rate (586/100,000) is among the top 5 in metropolitan areas in the us, and disparities are profound. african americans have an hiv prevalence that is 5 times higher than among whites, and account for 78% of all hiv cases. latinxs also have a higher prevalence of hiv than whites and are at the highest risk for late hiv diagnosis among all racial/ethnic groups. in addition, hiv viral load suppression, which is the best predictor of long-term survival among hiv-infected patients, is substantially lower among minority populations in baltimore. the overall goal of this proposal is to evaluate whether mhealth-enhanced linkage to care and retention (mltcr) can improve hiv outcomes among hiv-infected african americans and latinos compared to standard linkage to care and retention (ltcr) programs. the mhealth-enhancement consists of two smartphone applications (app), one for patients and one for patient supporters (e.g. linkage officers, patient navigators, nurses, etc.), to help facilitate communication. communication will focus on issues related to hiv care (e.g. appointment scheduling, transportation), as well as patient-directed requests. using hiv surveillance data (e.g. unsuppressed hiv viral load), patient supporters will be automatically alerted if a patient has a high viral load and prompted to contact the patient. in addition to appointment reminders, patients will receive positive reinforcement behavioral text messages.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * ability to provide consent * identified by bchd linkage protocol to be a new hiv diagnosis or hiv-infected and "out of care" * identified by participating clinics as needing patient support services exclusion criteria: * not able to provide consent.
a study to establish a new onset hyperglycemia and diabetes cohort

Conditions: Diabetes; Type2 Diabetes; Diabetes Mellitus

Summary: create a large biobank of blood samples and data from subjects with new onset hyperglycemia and diabetes (nod).

a prospective nod cohort of 10,000 eligible, enrolled subjects will be assembled over the next 5 years, with each patient participating for up to 3 years from the date they meet biochemical (glycemic) criteria for diabetes. sites electronic medical record databases or other avenues for recruitment, such as physician and self referral, will be utilized to identify subjects meeting criteria for nod.

Eligibility criteria:
inclusion criteria: * subject is able and willing to provide informed consent and sign an informed consent form. * subject must sign an authorization for the release of their protected health information. * subject must be ≥50 and ≤85 years of age at the time of enrollment. * subject must have hyperglycemia and/or diabetes as one of the following within 90 days prior to enrollment: * all glycemic parameters must be measured in an outpatient setting a. (1) hemoglobin a1c (hba1c) ≥ 6.5% present, or b. any (2) pdms present on consecutive or simultaneous testing: * fasting blood glucose (fbg) ≥126 mg/dl * hemoglobin a1c (hba1c) ≥ 6.5% * random blood glucose (rbg) ≥200 mg/dl * 2h post glucose (pg) ≥200mg (11.1 mmol/l) during ogtt (oral glucose tolerance test), or c. any (1) pdm present followed by an anti-diabetes medication * subject must have \>1 glycemic parameter measured in the 18 months prior to the elevated index lab without meeting inclusion criteria a, b, or c. * subject must be willing to provide blood samples (fasting) at baseline, 6, 12, and 24 months post-enrollment. * subject or authorized representative must be willing to complete a detailed questionnaire. exclusion criteria: * subject must not have any past history of hyperglycemia and/or diabetes as defined by inclusion criteria a, b, or c * transient diabetes (e.g. gestational and steroid-induced) is not an exclusion. * subject must not be on active treatment for cancer, carry a current diagnosis of any cancer, and/or investigated for suspicion of recurrence of past cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix). * ongoing work up for suspicion of pancreatic cancer is not an exclusion. * subject must not have any past history of pancreatic cancer. * subject must not be on anti-diabetes medications prior to the elevated index lab. * subject must not be on chronic or acute use of steroid medications within 90 days of the elevated index lab. * allowed: nasal, topical steroids, oral budesonide, ophthalmic * subject must not have had a recent (within 1 week of the elevated index lab) intra-articular steroid injection. * in the physician's and/or investigator's judgement, subject does not have any co-morbidities that limit the subject's participation in the study.

Keywords: new onset diabetes diabetes type 2 diabetes
study of vaniprevir plus pegintron®/ribavirin in japanese participants with chronic hepatitis c who relapsed after treatment (mk-7009-044)

Conditions: Hepatitis C, Chronic

Summary: the purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir given in combination with pegylated interferon alfa-2b (pegintron®/peg-ifn) and ribavirin (rbv) in chronic hepatitis c (chc) genotype i (gt 1) participants who relapsed after previous therapy with interferon-based therapy. the primary efficacy hypothesis is that the percentage of participants achieving sustained virologic response 24 weeks after completion of all study therapy (svr24) in at least one of the vaniprevir 300 mg twice daily treatment regimens is greater than 20% (historical data of standard of care treatment).


Eligibility criteria:
inclusion criteria: * japanese participant diagnosed with compensated chc gt 1 * absence of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease * has received and tolerated treatment with ifn-based therapy (ifn α, ifn β, or peg-ifn) with or without use of ribavirin, but failed to respond to the prior treatment (relapse or breakthrough) * no evidence of cirrhosis exclusion criteria: * co-infection with human immunodeficiency virus (hiv) * positive hepatitis b surface antigen or other evidence of active hepatitis b infection * any other condition that is contraindicated or for which caution is required for treatment with peg-ifn or rbv * any condition or pre-study laboratory abnormality, or history of any illness, that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs, peg-ifn and rbv, to the participant
different limb lengths in gastric bypass surgery (slim) - part 3: metabolism and inflammation

Conditions: Obesity, Morbid

Summary: investigation of underlying metabolic mechanisms and impact on the two surgical procedures on inflammatory factors.

the aim of this project is to investigate underlying metabolic mechanisms in a subpopulation of patients of the slim trial, where a laparoscopic proximal roux-en-y gastric bypass (lrygb) with a longer biliopancreatic limb (bpl) is compared to a standard lrygb. for this purpose, the aim is to examine differences in number of intestinal enteroendocrine cells, subpopulations of intestinal macrophages, and gene expression or dna-methylation in tissue samples obtained by colonoscopy from the ileum and transverse colon. in addition, gut microbiota (from colon biopsy and fecal samples), meal-stimulated gut hormone profiles, glycemic control, and metabolite patterns (metabolomics; in blood, urine, stool and breath) including plasma bile acid concentrations preoperatively and 6 months post-surgery will be examined. body composition (fat mass and lean mass) will be measured by means of bia (bioimpedance analysis; biacorpus).

Eligibility criteria:
inclusion criteria: * 2 x 25 patients with morbid obestiy (bmi of 35 kg/m2 or higher) who comply with the regulatory rules for bariatric surgery in switzerland (smob guidelines) and participate in the slim trial * 15 healthy lean controls exclusion criteria: * general contraindications to kind of surgery * known or suspected non-compliance * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders etc. of the participant * participation in another interventional study * bmi \> 60 kg/m2 * height \< 145 cm * cl length of \< 180 cm as measured intraoperatively * asa physical status classification \> iii * inflammatory bowel disease * diabetes * intake of corticosteroids, anti-inflammatory/ immunosuppressive drugs potentially altering immune cells * clinical signs of current infection * known anemia (e.g. hemoglobin \< 110g/l for males, \< 100g/l for females) * known neutropenia (e.g. leucocyte count \< 1.5 x 10\^9/l or anc \< 0.5 x 10\^9/l) * known immunodeficiency, e.g. hiv * known vasculitis, collagenosis * known adrenal insufficiency and/or substitution with glucocorticoids * risky daily alcohol consumption (\> 24g/d for males, \> 12g/d for females) * drug abuse * known liver cirrhosis child b or c * known uncontrolled congestive heart failure * known uncontrolled malignant disease * currently pregnant or breastfeeding
quantifying congestion by ultrasound

Conditions: Heart Failure

Summary: the investigators will determine the feasibility of identifying and quantifying changes in interstitial and intravascular congestion by imaging in participants with heart failure. the investigators will either continue or temporarily suspend both loop diuretics and mineralo-corticoid antagonists (mra) for 48 hours in participants with heart failure that is both stable and mild and compare measurements of interstitial (b-lines) and intra-vascular fluids (ivc and jv diameter and renal venous flow) by ultrasound and, in a subset of participants without contra-indications, by cardiac mri.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of heart failure * plasma nt-probnp \>125ng/l or bnp \>35 ng/l * left ventricular ejection fraction (lvef) \<50% on prior imaging test * treated routinely with a daily dose of loop diuretic * receiving other guideline-indicated therapy for heart failure * willing to sign the informed consent form * greater than 18 years of age exclusion criteria: * chronic kidney disease stage 4 or worse (egfr \<30 ml/min/1.73 m²) * atrial fibrillation * significant valve disease (investigators opinion) * breathlessness or chest pain at rest or minor exertion * patients unable to lie flat * patients deemed too unstable to miss treatment with diuretics for 48 hours * patients taking part in another interventional trial * any other concomitant condition that in the opinion of the investigator would not allow a safe participation in the study (ie:-pregnancy, significant frailty) * patients unwilling or unable to consent * for patients willing to undergo mri; contraindication to mri including claustrophobia, metalworkers, and intra-orbital or intracranial metal (eg:- stents), and non-mri compliant device.
a first-in-human study using bdc-4182 as a single agent in advanced gastric and gastroesophageal cancer

Conditions: Gastric Cancer Adenocarcinoma Metastatic; Gastroesophageal Adenocarcinoma

Summary: a first-in-human study using bdc-4182 as a single agent in gastric and gastroesophageal cancers

this is a dose escalation study designed to evaluate the safety and tolerability of bdc-4182 to establish the recommended phase 2 dose (rp2d). participants will be enrolled in each dose cohort until the maximum tolerated dose (mtd) is reached. additional participants may be enrolled into backfill cohorts at dose levels that have been cleared to collect additional safety and tolerability data. additional participants may be enrolled at the determined rp2d in an expansion portion of the study.

Eligibility criteria:
key inclusion criteria: * has disease that is measurable by response evaluation criteria in solid tumors (recist) v.1.1. * subjects must have histologically/cytologically confirmed gastric or gastroesophageal cancer that is metastatic (stage 4) or unresectable (stage 3). * subjects must have received at least 1-2 prior lines of locally available standard therapies or must be intolerant of standard therapies. * for subjects in escalation: if prior claudin 18 ihc expression is known, the subject must have some degree of claudin 18 expression as defined as positive or have expression ≥ 1% of tumor cells ihc ≥ 2+. consult with medical monitor as needed. * adequate organ function * agree to have a biopsy prior to enrollment, at acceptable risk in the judgement of the investigator. if a biopsy is not safely accessible or clinically feasible, an adequate archival tumor sample must be submitted. key exclusion criteria: * known central nervous system (cns) metastases except for disease that is asymptomatic, clinically stable, and has not required steroids for at least 14 days before starting study treatment. * cardiac disease, pulmonary disease, or hepatic disease * active infection * history of inflammatory eye disease * residual toxicity from a previous treatment * any investigational agent or standard anti-cancer therapies within 28 days before starting study treatment or within 5 estimated elimination half-lives, whichever is shorter.

Keywords: gastric cancer gastroesophageal cancer
effects of targeted lower extremity joint training on multiple sclerosis (ms) gait abnormalities

Conditions: Multiple Sclerosis

Summary: this study is being done to test the possible benefits of task-specific focused ankle training using the ankle-bot on subjects with multiple sclerosis who have "foot-drop." the study also compares the effectiveness of task-specific focused ankle training using the ankle-bot with conventional focused ankle therapy in improving the gait of subjects with ms.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of ms * edss level between 3.5 - 6.0 * unilateral foot-drop * able to ambulate 25 ft. with no more than a unilateral assistive device exclusion criteria: * lower extremity injuries that limit range of motion or function * unable to demonstrate an understanding of the process of the study and/or fully understand instructions in order to safely participate in the study and use study equipment * unable to fit safely and properly into the ankle-bot device

Keywords: multiple sclerosis gait foot-drop ankle-bot physical therapy gait abnormalities
periodontal profile of hypogonadic men

Conditions: Periodontitis; Hypogonadism, Male

Summary: the aim of this study is to assess if hypogonadic men with periodontitis benefit from testosterone replacement therapy before being submitted to periodontal treatment. fifty hypogonadic men (total testosterone \<200ng/dl) will be recruited from the clinics hospital at federal university of paraná and subjected to periodontal evaluation by a trained and calibrated researcher. the subjects presenting with periodontitis (assessed by clinical parameters) will be randomly allocated to "testosterone replacement therapy" (trt) group or "placebo" for 3 months. after that time, all patients will receive nonsurgical periodontal treatment, which will be reassessed after 45 days. clinical parameters (such as probing depth, gingival and plaque index, clinical attachment loss, bleeding on probing), sub gingival plaque and gingival crevicular fluid will be collected at baseline, just before therapy and 45 days after therapy.


Eligibility criteria:
inclusion criteria: total testosterone \<200ng/dl in two assessments; at least 20 teeth present. - exclusion criteria: systemic diseases such as hormonal, inflammatory and immune alterations. -