Kornimate/medical-research-clean huggingface dataset:
a trial of post-discharge transitional care for patients with chronic liver disease

Conditions: Liver Diseases

Summary: patients with complications of advanced liver disease often have difficulties after hospital discharge that result in early hospital readmission. poor outcomes for these patients during this transitional time could be improved through the use of innovative transitional care models. this proposal aims to examine the effect of a transitional care model, the transitional liver clinic (tlc), in reducing hospital re-admissions, improving quality of life, and improving patient experience.

this study is a stepped-wedge randomized trial of 1,000 patients with advanced liver disease at four high-volume centers over 45 months (250 participants/site; \<6 participants/site/month) to evaluate the efficacy of the transitional liver clinic (tlc) compared to control. in the stepped-wedge design, all sites provide usual care (control) during the initial 9-month enrollment interval. at each subsequent 9-month interval, one site is randomized via a computer-generated randomization scheme to crossover to implement the tlc, which will continue through the final interval where all sites will have implemented the tlc. all sites enroll for the entire 45 months and thus contribute patients to both the control and tlc groups. there are an equal number of tlc and control intervals; thus approximately 500 patients will be in each group. participant follow-up will occur by telephone at 30 and 90 days after discharge.

Eligibility criteria:
inclusion criteria: 1. male or female age ≥18 2. diagnosis of advanced liver disease, defined as either (must meet either a or b) 1. cirrhosis based on (either i or ii): * biopsy * characteristic clinical, laboratory, and imaging findings 2. acute alcoholic hepatitis, defined by niaaa alcoholic hepatitis consortia, as * onset of jaundice (serum bilirubin \>3.0 mg/dl) in prior 8 weeks * consumption of \>40 (female) or 60 (male) g alcohol/day for ≥6 months, with \<60 days abstinence before jaundice onset, * ast\>50 iu/l, ast/alt\>1.5, and both values \<400 iu/l * liver biopsy confirmation in patients with confounding factors 3. has at least one of the following complications due to advanced liver disease occurring during hospitalization: 1. ascites requiring diuretics or paracentesis 2. hepatic encephalopathy requiring lactulose or rifaximin 3. gastrointestinal bleeding due to portal hypertension 4. jaundice 4. has planned discharge alive to home or a facility within 72 hours of informed consent 5. able and willing to provide informed consent exclusion criteria: 1. discharge under hospice 2. listed for liver transplant with meld-na ≥ 35 3. unable or unwilling to participate in post-discharge follow-up either in-person or virtually 4. unable to speak or understand english and/or spanish 5. low hearing or communicative ability (examiner rated) that would interfere with interventions and outcome assessments 6. lack of access to a telephone 7. incarcerated 8. concurrent enrollment in an interventional research study
intra-abdominal view and inflammatory markers in secondary peritonitis - correlation to recovery

Conditions: Peritonitis

Summary: the purpose of this study is to analyze the correlation between intra-abdominal view and patient recovery in secondary peritonitis, and to create a new classification based on these results. additionally, a variety of inflammatory markers from blood samples will be collected in order to analyze their correlation with patient outcomes.


Eligibility criteria:
inclusion criteria: * adult patients \> 18 years old * operated for complicated intra-abdominal infection exclusion criteria: * another diagnosis requiring icu level care at the same time * acute pancreatitis * acute mesenteric ischaemia due to occlusion in superior mesenteric artery or vein * peritonitis due to timely diagnosed trauma * missing informed consent or inability to understand it

Keywords: peritonitis inflammatory markers patient outcome assessment classification multiple organ failure intraabdominal infections
impact of rosuvastatin on endothelial function and inflammation in patients with chronic heart failure

Conditions: Heart Failure

Summary: statin therapy has been shown to efficiently reduce mortality in patients with coronary artery disease and myocardial infarction, partially as a result of the lipid-lowering properties of statins. however, especially the pleiotropic effects of statins, e.g. their anti-inflammatory and anti-oxidative properties, might be of interest in the treatment of patients with chronic heart failure that are limited in their exercise capacity due to alterations of the skeletal muscle and peripheral endothelial dysfunction. aim of this trial is therefore to assess the effects of three months of rosuvastatin treatment on markers of inflammation and oxidative stress in the skeletal muscle and the blood, on postnatal vasculogenesis, and endothelial function of the radial artery in patients with severe chronic heart failure.

a total of 40 patients with severe chronic heart failure are prospectively randomized to either 3 months of rosuvastatin or placebo treatment. before and after the intervention period maximal exercise capacity is measured by ergospirometry and endothelial function is determined by high-resolution a-mode ultrasound. skeletal muscle biopsies are obtained at begin and after 3 months and are analyzed for inflammatory markers, measures of oxidative stress and vasculogenesis. blood samples are assessed with regard to markers of inflammation and oxidative stress as well.

Eligibility criteria:
inclusion criteria: * chronic heart failure (nyha class iii or iv) * peak oxygen uptake \<20 ml/min/kg body weight * left ventricular ejection fraction \<30 % * left ventricular end-diastolic diameter \>55 mm * stable medication within the last 4 weeks exclusion criteria: * elevated got and gpt levels as a sign of hepatic dysfunction * elevated creatinine levels as a sign of renal dysfunction * insulin-dependent diabetes mellitus * arterial hypertension * muscle disease or elevated ck levels * treatment with fibrates * co-treatment with drugs that are metabolized by cyp3a4 * diseases that disallow a participation in the study

Keywords: chronic heart failure rosuvastatin endothelial function skeletal muscle
comparison of comfilcon a toric contact lenses and samfilcon a toric contact lenses

Conditions: Astigmatism

Summary: the objective of this study is to evaluate the subjective acceptance of comfilcon a toric contact lens, compared to samfilcon a toric lens.


Eligibility criteria:
inclusion criteria: * is at least 17 years of age and has full legal capacity to volunteer; * has had a self-reported oculo-visual examination in the last two years. * has read and signed an information consent letter; * is willing and able to follow instructions and maintain the appointment schedule; * is an adapted soft contact lens wearer, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day and who anticipates no difficulty wearing cls for 6 days/week, 10 hours /day. * is willing to wear contact lens in both eyes for the duration of the study; * has a minimum astigmatism of - 0.75, determined by refraction; * can be fit with the two study contact lens types in the powers available; * has a distance visual acuity of 0.20 logmar (approx 20/30) or better, determined by refraction; * can achieve a distance visual acuity of 0.20 logmar (approx 20/30) or better in each eye with the study contact lenses. * has clear corneas and no active\* ocular disease exclusion criteria: * is participating in any concurrent clinical trial; * has any known active\* ocular disease and/or infection; * has a systemic condition that in the opinion of the investigator may affect a study measure; * is using any systemic or topical medications that in the opinion of the investigator may affect a study measure; * has known sensitivity to fluorescein dye or products to be used in the study; * appears to have any active\* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses; * is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit); * is aphakic; * has undergone refractive error surgery. * has participated in the piano (i.e. ex-mktg-83) study.
nicotine mouth film for craving relief.

Conditions: Smoking Cessation

Summary: nicotine mouth film is a new dosage form of nicotine replacement therapy. the purpose of this study is to investigate the craving relief efficacy of nicotine mouth film by comparing mint nicotine mouth film to nicotine lozenge in light smokers using the provoked craving model. the cues used to provoke a craving episode will be the sight and smell of a lit cigarette and the manipulations required to light a cigarette. the smokers will be denied access to cigarettes for 4 hours prior to the provoked craving session in order to precipitate nicotine withdrawal and an increase level of cigarette craving.


Eligibility criteria:
inclusion criteria: * bmi within the range of 19-35 kg/m2; * current cigarette smokers who have smoked regularly daily for at least a year, * participants who smoke their first cigarette more than 30 minutes after waking up exclusion criteria: * known or suspected intolerance or hypersensitivity to nicotine (or closely related compounds) or any of the stated ingredients in formulation. * any participant whose co level rises during the sequestration period (i.e., the subject's two expired co assessments immediately prior to the provoked craving paradigm are higher than the mean baseline co assessment) and, in the opinion of the investigator, may have smoked during that time.

Keywords: provoked craving
effects of cpap level on respiratory mechanics and central drive in patients with copd

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: chronic obstructive pulmonary disease (copd) is a common respiratory disease characterized by airflow limitation that is progressive and not fully reversible. expiratory flow limitation (efl) is the main mechanism leading to dynamic pulmonary hyperinflation (dph) and intrinsic positive end-expiratory pressure (peepi). dph and peepi lead to increased inspiratory muscle efforts and impaired central drive mechanical and ventilation coupling, which is an important mechanism of dyspnea. appropriate setting of extrinsic peep (peepe) can decrease inspiratory efforts and work of breathing, improve patient-ventilator synchrony in severe copd patients with peepi and treated with mechanical ventilation. nevertheless, the effects of cpap/peepe level on respiratory mechanics, especially on central drive mechanical and ventilation coupling, still need further investigations. in the present study, about 40 patients with copd will be recruited as research subjects. and the investigators aim to observe the changes in respiratory mechanics, central drive mechanics, central drive mechanical and ventilation coupling at different levels of cpap. contrast analysis will be conducted to evaluate the effects of cpap level on respiratory mechanics and central drive during dph, which may provide a reasonable basis for the clinical application of cpap to copd patients and the exploration of a new reasonable cpap setting method.

patients with copd are divided into two groups: moderate group and severe group, both of which are intervented by cpap level. the static pressure volume curves of the lung and chest wall (campbell diagram) were established with slow deep respiratory manoeuvre. before using cpap level, we will measure the relevant parameters of lung volume, respiratory flow, diaphragm electromyogram, central drive mechanical and ventilation coupling. then incremental cpap level will be applied to investigate the effects of cpap level on the above mentioned respiratory mechanics parameters.

Eligibility criteria:
inclusion criteria: * patients from zhu jiang hospital,southern medical university * patients aged 40-70 years old * patients with pulmonary function test of forced expiratory volume at one second (fev1)/forced vital capacity(fvc) \< 70% and 30% ≤ fev1%pred \< 80% * patients in a clinically stable state * patients who signed informed consent. exclusion criteria: * patients with signs of an airway infection * patients with an acute exacerbation during the previous 4 weeks * patients with giant bulla(≥3cm in diameter) * patients with recent upper abdominal surgery * patients with one or more of the following diseases: esophageal cancer, reflux esophagitis, severe obstructive sleep apnea (apnea hypopnea index\>15/hr), neuromuscular disease, or significant heart failure * patients with poor compliance.

Keywords: copd cpap central drive
phase 1 study of mrtx1719 in solid tumors with mtap deletion

Conditions: Mesothelioma; Non Small Cell Lung Cancer; Malignant Peripheral Nerve Sheath Tumors; Solid Tumor; Pancreatic Adenocarcinoma; Advanced Solid Tumor

Summary: this is a phase 1, open-label, multicenter, study of the safety, tolerability, pk, pd, and anti-tumor activity of mrtx1719 patients with advanced, unresectable or metastatic solid tumor malignancy with homozygous deletion of the mtap gene.

this first-in-human clinical trial will begin with an exploration of mrtx1719 dose and regimen. as potentially viable regimens are identified, phase 1b expansion cohorts may be implemented to ensure sufficient safety experience, pk information, compare food effect and relative bioavailability between capsules and tablets, and early evidence of clinical activity are available.

Eligibility criteria:
inclusion criteria * histologically confirmed diagnosis of a solid tumor malignancy with homozygous deletion of the mtap gene detected in tumor tissue. * unresectable or metastatic disease. * presence of a tumor lesion amenable to mandatory biopsy for pharmacodynamic evaluation at baseline and on-study unless sponsor-confirmed as medically unsafe or infeasible. * age ≥ 18 years. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * adequate organ function. exclusion criteria * prior treatment with a prmt5 or mat2a inhibitor therapy. * active brain metastases or carcinomatous meningitis. * history of significant hemoptysis or hemorrhage within 4 weeks of the first dose of study treatment. * major surgery within 4 weeks of first dose of study treatment. * history of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications. * cardiac abnormalities. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: mtap deletion mesothelioma non small cell lung cancer malignant peripheral nerve sheath tumors solid tumor mtap malignant pancreatic adenocarcinoma pancreas cancer prmt5 synthetic lethality advanced solid tumor nsclc
feeding trial in the obese critical care population

Conditions: Critical Illness; Obesity

Summary: this study will assess enteral feeding in an obese critically ill population with a higher protein whey based peptide formula.

assess enteral feeding goal with a higher protein whey based peptide formula in an obese critically ill population.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * surgical or medical intensive care unit (icu) patient * body mass index (bmi) ≥ 30 exclusion criteria: * pregnant or lactating * unable to access gastrointestinal (gi) tract for feeding via tube * other contraindication to tube feeding * admitted with burns * severe head trauma
core muscle strength in women with primary dysmenorrhoea

Conditions: Pelvic Floor Muscle Weakness; Dysmenorrhea; Posture

Summary: the aim of this study is to compare core muscle strength, core muscle activations, and pelvic tilt angles in women with and without primary dysmenorrhea (pd).

the study included 27 women with pd and 27 healthy women without primary dysmenorrhea. demographic and menstrual information of the participants was recorded. the "sport-specific core muscle strength \& stability plank test" protocol was applied to evaluate the core muscle strength of the participants. pelvic floor, transversus abdominis, and multifidus muscle activations were assessed using the neurotrac® myoplus 2 dual-channel emg ets device. pelvic tilt measurement was performed using the apecs-ai posture assessment and correction system®. menstrual pain and symptoms were evaluated using the menstrual symptom scale. this study found that women with pd had higher muscle activations, lower pelvic tilt angles, and more severe menstrual symptoms. we believe these results may contribute to the etiology of pd.

Eligibility criteria:
inclusion criteria: * participants must meet the following criteria to be included in the study: age between 18 and 35 years diagnosed with primary dysmenorrhea (pd) according to the pd consensus criteria, which include: presence of menstrual pain within the first few years after menarche a visual analog scale (vas) pain score of 4 or higher in the last six months no pelvic pathology having a regular menstrual cycle (21-35 days) no uterine disorders exclusion criteria: the sample size for the study was determined using the g\*power software (latest version 3.1.9.7; heinrich-heine-universität düsseldorf, düsseldorf, germany). since our study consists of two groups (participants with and without primary dysmenorrhea), the power analysis was conducted using the "means: difference between two independent means (two groups)" method. based on similar studies, an effect size of d = 0.726 was used for the calculation. with a statistical power of 80% and a significance level of 5% (α = 0.05), the minimum required sample size was determined to be at least 25 participants per group, totaling 50 participants.pregnancy or suspicion of pregnancy active sexual life history of childbirth use of an intrauterine device (iud) history of surgery involving the abdomen, spine, or pelvic region within the last year diagnosis of secondary dysmenorrhea body mass index (bmi) of 30 or higher

Keywords: pelvic floor dysmenorrhea posture core electromyography
timing of post-prostatectomy psma imaging

Conditions: Prostate Cancer; Prostatectomy

Summary: the investigators will randomize patients presenting with early bcr with a negative baseline psma pet/ct, to upfront srt or surveillance. early bcr is defined as a psa relapse of \>0.1 to \ 0.5 to \<1.0 ng/ml. both early radiation treatment and surveillance with repeat psma pet/ct imaging are within patterns of practice locally; therefore, the investigators believe that there is clinical equipoise on this subject.


Eligibility criteria:
inclusion criteria: * histologically-proven prostate cancer * pt1-t4 pn0/nx cm0 * psa at bcr \>0.1 - \<0.3 ng/ml post-radical prostatectomy * psma pet/ct negative at bcr post radical prostatectomy * planned srt to prostate bed +/- pelvic lymph nodes * ecog 0 or 1 * age ≥ 18 years * informed consent: all patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed. exclusion criteria: * active or post prostatectomy androgen deprivation use * previous pelvic radiotherapy * other contraindications to radiotherapy
technological intervention for reducing alcohol use among people living with hiv/aids

Conditions: Acquired Immunodeficiency Syndrome; HIV/AIDS; Alcohol Drinking

Summary: while advances in medication have led to greatly improved outcomes for people living with hiv/aids, less than one-third of all people living with the disease are adherent enough to their medication to achieve viral suppression. alcohol consumption has been shown to have a significant effect on hiv medication adherence, so the proposed research will aim to reduce alcohol use among people living with hiv/aids through a technology-driven intervention. this eight-session intervention will be delivered using a combination of videoconferencing, smart phones, and bluetooth-enabled breathalyzers for monitoring of alcohol consumption, with an overall goal of reducing alcohol use, mitigating adherence issues, and achieving optimal prevention and treatment responses for people living with hiv/aids.

the trac intervention focuses on increasing motivation and building skills for avoiding triggers and managing situations that encourage drinking. it requires eight 30-minute sessions with a counselor using videoconferencing and mobile phones. in addition to receiving the eight sessions of intervention content, participants will complete smartphone-based self-monitoring of medication adherence and alcohol consumption, which will be discussed during intervention sessions. each day, they will be texted at two random times to complete a breathalyzer reading using a bactrack mobile pro, which is sold by a company with fda clearance and utilizes law enforcement-grade sensors for determining blood alcohol level. it connects wirelessly to phones via bluetooth, automatically uploads readings, allows the user to view their current and past readings with a mobile app, and allows them to share their readings with counselors. at the time of the breathalyzer reading, participants will also be asked to indicate via survey how many drinks they have consumed and their medication use for the day. the surveys will be programmed using qualtrics and accessible via a link in the reminder text message. data analytic methods will be focused on examining effects on alcohol intake, haart adherence, and hiv-related medical outcomes (cd4 count and viral load).if shown to be feasible, acceptable, and potentially efficacious, this intervention could have a significant impact on improving the accessibility of alcohol reduction counseling among plwha.

Eligibility criteria:
inclusion criteria: * hiv-positive * 18 years or older * at-risk drinker * currently prescribed hiv medication * current patient at the study recruitment site(s) exclusion criteria: * less than 18 years old * non-english speaking

Keywords: hiv/aids alcohol drinking medication adherence