Kornimate/medical-research-clean huggingface dataset:
the clinical significance of portal hypertension after cardiac surgery: a multicenter prospective observational study

Conditions: Surgery--Complications; Congestive Heart Failure; Right Heart Failure; Anesthesia; Venous Congestion

Summary: portal flow pulsatility detected by doppler ultrasound is an echographic marker of cardiogenic portal hypertension from right ventricular failure and is associated with adverse outcomes based on previous studies performed at the montreal heart institute. this multicenter prospective cohort study aims to determine if portal flow pulsatility after cardiopulmonary bypass separation is associated with a longer requirement of life support after cardiac surgery.

hypothesis: portal flow pulsatility detected by doppler ultrasound during cardiac surgery is an echographic marker of cardiogenic portal hypertension from right ventricular failure and is associated with adverse clinical outcomes. background: peri-operative right ventricular failure is associated with a high mortality rate. in this context, organ perfusion is hampered by both the reduction of cardiac output and venous congestion from the elevation of central venous pressure. the clinician's objective is to appreciate the hemodynamic impact on end-organs in an effort to adjust the therapy accordingly since the ultimate goal is to optimize their perfusion. based on this rationale, organ specific blood flow assessment using doppler ultrasound could be used to personalize management. in order to non-invasively assess the presence of cardiogenic portal hypertension, doppler ultrasound can be used to detect portal flow pulsatility, an abnormal variation in the velocity of blood flow within the main portal vein. in two single-center cohort studies, the presence of portal flow pulsatility after cardiac surgery was independently associated with post-operative complications such as major bleeding, acute kidney injury (aki) and delirium as well as increased length of intensive care unit (icu) stay. specific objectives: this multi-center cohort study aim to determine whether the association between portal flow pulsatility and organ dysfunction seen in previous studies is present across multiple cardiac surgery centers.

Eligibility criteria:
inclusion criteria: * adult patients (≥18 years old) and able to give informed consent undergoing cardiac surgery with the use of cpb for whom peri-operative tee is planned. * high surgical risk defined as at least one of the following: 1. multiple surgical procedures planned 2. euroscore ii ≥ 5% 3. known pulmonary hypertension (mpap\>25mmhg or spap\>40mmhg). exclusion criteria: * patient with a critical pre-operative state defined as vasopressor requirement, mechanical circulatory support, dialysis, mechanical ventilation or cardiac arrest necessitating resuscitation. * patient with known condition that could interfere with portal flow assessment or interpretation (liver cirrhosis, portal vein thrombosis) * planned cardiac transplantation * planned ventricular assist device implantation

Keywords: echocardiography portal doppler cardiac surgery
capecitabine versus s-1 in elderly advanced gastric cancer (agc): randomized trial

Conditions: Gastric Cancer

Summary: a significant proportion of advanced gastric cancer (agc) occurs in individuals 65 years of age and older. in addition, patient delay in seeking care for symptoms results in diagnosis at a more advanced stage than that seen in younger individuals. however, clinical trials on gastric cancer rarely have been available to the elderly. recently oral 5-fu pro-drugs, which have been reported to have clinically significant response rates and survival with mild or negligible toxicities, have been widely used for the patients with agc. however, few studies have been conducted in elderly patients.


Eligibility criteria:
inclusion criteria: * pathologically proven gastric or gastroesophageal junction adenocarcinoma * metastatic or recurrent unresectable disease * measurable lesions (according to response evaluation criteria in solid tumors \[recist\]) * age: 65-85 years old * performance status: eastern cooperative oncology group (ecog) 0-2 * adequate bone marrow function: absolute neutrophile counts(anc) ≥ 1,500/ul, platelet count ≥ 100,000/ul, hemoglobin ≥ 9 g/dl) * adequate renal function (serum creatinine≤ 1.5) * adequate liver function (serum bilirubin ≤ 2 x upper limits of normal \[unl\], aspartate aminotransferase (ast)/alanine aminotransferase (alt) ≤ 3 x unl) * no prior chemotherapy (but adjuvant chemotherapy completed at least 1 year prior to study treatment is allowed with the exception of capecitabine or s-1) written informed consent was signed by the patient exclusion criteria: * previous palliative chemotherapy * known allergy to study drugs * cns metastasis * significant medical comorbidities * active ongoing infection which antibiotic treatment is needed. * previous ( within 5 years) history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ.

Keywords: stomach cancer palliative chemotherapy capecitabine s-1
sequential segmental treatment of emphysema with upper lobe predominance (step-up) study

Conditions: Emphysema

Summary: this study is designed to demonstrate safety and efficacy in patients with severe upper lobe predominant emphysema. for validity of the study, the results will be compared to patients that receive optimal medical therapy.


Eligibility criteria:
inclusion criteria: * heterogeneous emphysema with upper lobe predominance in both lungs * fev1 between 20% and 45% predicted * residual volume (rv) \> 150% predicted * post-rehabilitation 6-minute walk test \> 140 meters exclusion criteria: * more than 3 copd related hospitalizations requiring antibiotics in past 12 months * fev1 \< 20% predicted * dlco \< 20% predicted or immeasurable dlco * body mass index (bmi) \ 32 kg/m2 * history of any of the following: * left ventricular ejection fraction (ef) ≤ 40% * stroke * myocardial infarction or acute coronary syndrome in previous year * hospitalization due to left ventricular failure in previous 3 years

Keywords: emphysema intervapor treatments pulmonary rehabilitation lung volume reduction endoscopic lung volume reduction
prevalence of sleep apnea/hypopnea syndrome in obese children

Conditions: Sleep Apnea; Children; Obesity

Summary: principal aim: to determine the prevalence of sleep apnea- hypopnea syndrome in obese children. secondary aim: 1. to fix the implication of the adenotonsillar hypertrophy, the obesity and the hormonal factors in the pathogeny of sahs in children. 2. to determinate of clinical and neurophysiologic characteristics of childhood sahs associated with obesity. design: a prospective transversal study.

the population of study will be make for children of both sex, between 3 and 14 years old and with body mass index (bmi) ≥ 95 percentile and with informed consent. methods: in all children included in the study, the investigators will carry out: previous history, history of snoring and chervin´s screening questionnaire of sahs, general physical and otorhinolaryngologic examination with nasopharyngoscopy, blood test with determination of glucose, lipids, insulin, leptin, adiponectin, and ghrelin, polysomnography (psg) with transcutaneous co2. the diagnosis of sahs will be made if on psg the respiratory disturbance index (rdi) is ≥ 3 and/or obstructive hypoventilation is present.

Eligibility criteria:
inclusion criteria: * children of both sex, between 3 and 14 years old * body mass index (bmi) ≥ 95 percentile * with informed consent. exclusion criteria: * without informed consent
interview of patients with hr+/her2- metastatic breast cancer who received capivasertib + fulvestrant

Conditions: Metastatic Breast Cancer

Summary: a cross-sectional, non-interventional, observational study using qualitative patient interviews to explore patient experiences and attitudes toward taking capivasertib + fulvestrant as directed


Eligibility criteria:
inclusion criteria (self-reported): * adult (over the age of 18 years) * diagnosed with hr+/her2- metastatic breast cancer * received at least 1 week of capivasertib + fulvestrant (patients will be invited to provide documents demonstrating the use of capivasertib. patients will be able to participate even if unable to obtain such documentation) exclusion criteria (self-reported): * patients who had discontinued capivasertib for more than 6 months before the date of the interview * unable or unwilling to follow study procedures (including providing informed consent) * not proficient in spoken english, as assessed by the moderator * receiving capivasertib in a clinical trial setting * patients who are not able to recall instruction for administration of capivasertib in a manner consistent with the labeling (e.g. 4 days on followed by 3 days off)
modification of scleral suture fixation of dislocated iol

Conditions: Dislocated Intraocular Lens

Summary: a prospective randomized study on patients with late in the bag intraocular lens (iol) dislocation after cataract surgery. two surgical techniques of suturing of iol to the sclera will be compared in the study. iol position will be compared between those two groups, as well to a control group consisting of ordinary pseudophakia where only measurement of iol position will be performed.

in this prospective randomized study 60 patients will be included with late intraocular lens (iol) dislocation and 60 patients in a control group with ordinary pseudophakia. traditional surgery includes a capsular-iol complex fixation to sclera by looping a prolene suture not only around haptics but also through capsular tissue. such a suture may cut through the bag, which may result in a decentered iol. a modification of "the traditional" method was created at s:t eriks eye hospital in order to achieve better centration of the iol. the study will evaluate the efficacy of these two methods. additionally, the impact of fibrosis of capsular bag on iol stability postoperatively will be evaluated.

Eligibility criteria:
inclusion criteria: * patients with in-the-bag dislocated iol who agree to participate in the study * inclusion criteria for the control group: pseudophakic eyes 7-10 years after uneventful cataract surgery. exclusion criteria: * patients with dislocated iol that is not visible in the pupillary plane * iol design not suitable for suturing using capsular bag * patients who are not able to cooperate under measurements * patients with marfan syndrome and ectopia lentis * exclusion criterion for the control group: other eye surgery.

Keywords: intraocular lens, dislocation
can acupoint low intensity shockwave therapy improve bladder voiding efficiency

Conditions: Detrusor Underactivity

Summary: with the increasing of the elderly population, patients with urinary dysfunction caused by inefficiency of bladder emptying becomes much often than before. however, the current treatments for this kind of bladder dysfunction are limited and unsatisfactory. low-intensity extracorporeal shockwave therapy (lieswt) is a very popular emerging treatment in recent years, and abundant of literatures have confirmed that this treatment is safe and effective in myofascial pain and male erectile dysfunction. recently, many animal experiments have showed that lieswt could improve urinary dysfunction caused by bladder dysfunction. taiwan based studies also reported that lieswt could improve symptoms of overactive bladder. lieswt is a non-drug, low-invasive and high-safety treatment, which is very suitable for elderly patients. in this study investigator combine the lieswt and acupuncture to treat the patients with underactive bladder. investigator hypothesize that lieswt could improve bladder voiding efficiency.

this is a randomized controlled trial, the inclusion criteria are the patients more than 20 years old and bladder voiding efficiency less than 70%, this trial will enroll 60 male and 40 female , total 100 patients. the male will be randomly assigned into three groups(group-1, group-2, group-3) by ratio 1:1:1, and the female will be randomly assigned into two groups (group-1, group-2) by ratio 1:1. group-1: lieswt on acupoint cv-4, and bilateral st-28 once a week for 8 weeks, group-2: lieswt on acupoint cv-4 and bilateral acupoint sp-6 once a week for 8 weeks, group-3: treatment with oral tamsulosin 0.2mg per-day for 8 weeks. the primary outcome is the improvement of bladder voiding efficiency. the secondary outcomes are global response assessment scale, the improvement of maximum uroflow rate, post-voiding residual urine amount, total score of international prostate symptom score.

Eligibility criteria:
inclusion criteria: 1.bladder voiding efficiency is less than 70%. exclusion criteria: 1. patient who has history active pelvic malignancy without treatment. 2. acute urinary tract infection. 3. pregnancy 4. active infective lesion on treatment site. 5. open wound on treatment site.

Keywords: detrusor underactivity acupoint voiding dysfunction bladder voiding efficiency low-intensity extracorporeal shockwave therapy
the study of spectrum of sleep disorders in cirrhotic patients and the efficacy of zolpidem in cirrhotic patients with insomnia

Conditions: Cirrhosis

Summary: all cirrhosis liver patients (child a/b/c) presenting to institute of liver and biliary sciences will be screened for sleep disturbance and excessive daytime sleepiness with epworth sleep score/ pittsburgh sleep quality index. 52 patients of clinical/ radiological/ biopsy proven cirrhosis (child a/b) will be enrolled after ruling out possibility of psychiatric illnesses like depression and anxiety with the help of phq-9 / gad-7 questionnares. patients who are suffering with sleep disturbance as evaluated with pittsburgh sleep quality index will undergo polysomnography and will be randomised to two groups after fulfilling all inclusion criterias. patients in group (group 1) will receive zolpidem 5mg at bed time daily and patients in control group will receive placebo at bed time daily. the treatment will be continued for 4 weeks. after 4 weeks enrolled patients will be reassessed with psqi and polysomnography. all patients will be advised regarding sleep hygiene.


Eligibility criteria:
inclusion criteria: * age 18 to 70 years * clinical, biochemical, radiological ,histological evidence of cirrhosis of all etiology * child a and b cirrhosis (for intervention part) * cirrhosis patients giving h/o persistent sleep disturbances (psqi≥5) * child a, b and c cirrhosis (for observational part) exclusion criteria: * active alcohol intake or intake within 1 month of enrollment * active substance abuse or intake within 1 month of enrollment * known psychiatric and neurological disorders * patient using antidepressant, anticonvulsants, other hypnotics * pregnancy or lactation * overt hepatic encephalopathy (grade 2,3,4) * child c cirrhosis (for intervention part) * acute decompensated state of cld (chronic liver disease) - gastrointestinal bleed, increased jaundice, he (hepatic encepahlopahty) , sbp (spontaneous bacterial peritonitis). * hcc (hepatocellular carcinoma) with portal vein thrombosis * acute febrile illness/ acute infection * post tips (transjugular intrahepatic portosystemic shunt)patient
fetoscopic tracheal balloon occlusion in unborns with severe congenital diaphragmatic hernia - eurotrial i

Conditions: Diaphragmatic Hernia

Summary: diaphragmatic hernia detected in fetal life carries a high risk for postnatal demise due to lung underdevelopment. clinical experience from prospective controlled non-randomized case series with fetoscopic tracheal balloon occlusion has seen improved survival rates in contrast to untreated controls. therefore, the purpose of this randomized clinical trial is to provide further evidence about the efficacy and safety of the prenatal interventional approach. primary outcome measure is postnatal survival to discharge from hospital treatment.


Eligibility criteria:
inclusion criteria: * pregnant women from european countries carrying fetuses with congenital right or left diaphragmatic hernias * normal karyotype, no further severe anomalies on prenatal ultrasound study * fetal liver herniation into the chest, lung-to-head ratio of ≥0,40 ≤0,84 between 30+0 - 33+5 weeks+days of gestation exclusion criteria: * any maternal disease or condition that would result in an increased risk to her personal health from the experimental procedure * abnormal fetal karyotype * further severe fetal anomalies on prenatal ultrasound

Keywords: congenital diaphragmatic hernia tracheal occlusion fetus fetal surgery fetoscopy
efficacy and safety of low-concentration atropine for myopia control in chinese children and adolescents

Conditions: Myopia, Progressive

Summary: to investigate the efficacy and safety of three low-concentration atropine sulfate eye drops (0.01%, 0.025% and 0.05%) in controlling the progression of myopia in chinese children and adolescents through a two-year clinical trial.


Eligibility criteria:
inclusion criteria: 1. the age of the screening stage is 3-15 years, both sexes; 2. one eye met the diagnosis of myopic refractive error, the spherical equivalent was between -0.50d and -8.00d, the astigmatism was ≥-3.00d, and the best corrected far vision was at least 0.8; 3. have normal thinking and language communication ability, and can actively cooperate with treatment and follow-up as required; 4. informed consent from the guardian and the child. exclusion criteria: 1. strabismus, amblyopia or other ocular abnormalities; 2. the presence of systemic disease abnormalities; 3. have taken myopia control treatment in the past month; 4. allergic to low concentration atropine or sulfuric acid drugs.
teen marijuana check-up

Conditions: Cannabis Use Disorder

Summary: this study will test a behavioral intervention tailored for adolescents who smoke marijuana and have concerns about their use. the study's purpose is to determine whether this intervention (two-sessions of motivational enhancement intervention followed by 12 months of optional skills training) will be more effective in reducing the use of this drug if augmented by three periodic motivational enhancement treatment check-in sessions as compared to three periodic computer-based check-in sessions. hypotheses: (1) participants in the motivational enhancement treatment check-ins (mci) condition will reduce their use of marijuana more than participants in the computer based (comp) condition and report fewer negative consequences. these differences are expected to be greater at later follow-ups (i.e, 9, 12, and 15 months) after repeated check-ins exert a cumulative effect. (2)engagement in cbt sessions will be greater for those in the mci condition and will partially mediate the effect on marijuana related outcome indices. (3) the mci intervention will lead to increased self-efficacy, and decreased normative perceptions of marijuana use by other teens that will also partially mediate the effect of the intervention.

the goal of this trial is to evaluate the efficacy of an enhanced teen marijuana check-up protocol to reach and intervene with non-treatment seeking adolescents who use marijuana heavily. two hundred fifty adolescents who use marijuana heavily will receive a 2-session individual motivational enhancement therapy. all participants will also be offered the opportunity, over a 12-month period, to repeatedly re-initiate marijuana counseling. participants will be randomly assigned to receive one of two types of periodic follow-up contacts: motivational interviewing-based marijuana check-ins (mci) or computer based control (comp) sessions. all participants will be reassessed at the 6, 9, 12, and 15-month anniversaries of enrollment. following their initial motivational enhancement therapy, the 125 experimental condition participants will additionally have a motivational enhancement treatment "check-in" session with their counselor at the 4, 7, and 10-month anniversaries of enrollment intended to reinforce the maintenance of treatment gains and motivate continued success, increase motivation to change for participants who did not meet their marijuana use goals, and/or prompt utilization of cognitive-behavioral treatment (cbt) sessions as needed. the 125 comparison participants will complete a computer based questionnaire at the same time intervals to serve as an attentional control.

Eligibility criteria:
inclusion criteria: 1. age (14-19 years old), 2. grade level (9th through 11th) and 3. marijuana use. exclusion criteria: individuals will be excluded if: 1. they are not fluent in english, 2. they have a thought disorder that precludes full participation, 3. they refuse to accept randomization to condition, 4. they are high school seniors.

Keywords: cannabis use disorder marijuana motivational enhancement treatment cognitive behavioral treatment continuing care
study of ssp-004184 (spd602) in healthy adults and subjects with impaired liver function

Conditions: Hepatic Impairment; Healthy

Summary: the purpose of this study is to evaluate how much of the study drug ssp-004184 (spd602) is absorbed by the body and how long it takes to be eliminated from the body in healthy subjects and subjects with mild, moderate, and severe hepatic (liver) impairment compared with subjects with healthy normal liver function.


Eligibility criteria:
inclusion criteria: * age 18-65 years inclusive at the time of consent. * willingness to comply with any applicable contraceptive requirements of the protocol and is: * male, or * non pregnant, non lactating female * females must be at least 90 days post partum or nulliparous. subjects who do not have hepatic impairment (healthy subjects) * normal renal function. subjects with hepatic impairment * subjects must provide a letter of evaluation from a hepatologist or copy of supporting documents confirming the subject's hepatic impairment (a liver biopsy is preferable but not mandatory). * hepatic impairment should be primary and must not be a complication of an underlying primary systemic disease (eg, patients with metastatic cancer and cancer cachexia) * documented chronic stable liver impairment exclusion criteria subjects who do not have hepatic impairment (healthy subjects) * a positive hiv antibody screen, hepatitis b surface antigen, or hepatitis c virus antibody screen. subjects with hepatic impairment * presence of a hepatocellular carcinoma, or an acute hepatic disease caused by an infection or drug toxicity. * presence of surgically created or transjugular intrahepatic portal systemic shunts. * a positive hiv antibody screen. * renal insufficiency. all subjects * subject has a history of thyroid disorder. * history of nephrotic syndrome. * history of alcohol or other substance abuse within the last year. * a positive screen for alcohol or drugs of abuse. * male subjects who consume more than 3 units of alcohol per day. female subjects who consume more than 2 units of alcohol per day. (1 alcohol unit = 1 beer \[12 oz/355 ml\] = 1 wine \[5 oz/150 ml\] = 1 liquor \[1.5 oz/40 ml\] = 0.75 oz/20 ml alcohol.) * caffeine consumption: for healthy subjects: routine consumption of more than 2 units of caffeine per day or subjects who experience caffeine withdrawal headaches or have a history of caffeine withdrawal headaches. (one caffeine unit is contained in the following items: one 6 oz/180 ml cup of coffee, two 12 oz/355 ml (ie, 24 oz/710 ml cola) cans of cola, one 12 oz/355 ml cup of tea, three 1 oz/28 g chocolate bars (ie, 3 oz/85 g chocolate). decaffeinated coffee, tea, or cola are not considered to contain caffeine.) * donation of blood or blood products within 60 days. * substantial changes in eating habits within 30 days.