Kornimate/medical-research-clean huggingface dataset:
a phase 3 study comparing dinaciclib versus ofatumumab in patients with refractory chronic lymphocytic leukemia (p07714)

Conditions: Chronic Lymphocytic Leukemia (CLL)

Summary: this study is being conducted to demonstrate the superiority in progression-free survival (pfs) of dinaciclib compared to ofatumumab in chronic lymphocytic leukemia (cll) participants with del 17p or in the overall population who are refractory to either fludarabine treatment or chemoimmunotherapy.

dinaciclib is a cyclin-dependent kinase (cdk) inhibitor, specific for cdk 1, 2, 5 and 9.

Eligibility criteria:
inclusion criteria: * aged 18 years or older * confirmed diagnosis of chronic lymphocytic leukemia (cll) * fludarabine or chemoimmunotherapy refractory disease defined as: failing to respond to or relapsed within 6 months of completing fludarabine or another purine analog alone or in combination regimens, or failing to respond to chemoimmunotherapy or relapsed within 24 months of completing therapy with a combination of chemotherapy plus an anti-cd20 monoclonal antibody * eastern cooperative oncology group (ecog) performance status 0, 1, or 2 * adequate organ function and laboratory parameters * women of child-bearing potential who are not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study exclusion criteria: * symptomatic brain metastases or primary central nervous system malignancy * treatment with a cyp3a4 inhibitor or inducer within 1 week prior to randomization, or any chemotherapy or biologic therapy within 4 weeks prior to randomization * known human immunodeficiency virus (hiv) infection or a known hiv-related malignancy * participants with with clinically active hepatitis b or c defined as disease that requires therapy * positive test for glucose-6 phosphate dehydrogenase (g6pd) deficiency * prior allogeneic bone marrow transplant * presence of richter's transformation * indeterminate deletion 17p status * previous treatment with ofatumumab, dinaciclib, or other cdk inhibitors * active autoimmune anemia or thrombocytopenia unless stable, which is defined as being responsive to corticosteroids or other standard therapy
persistence and long-term protection of vi antibodies induced by vi-dt conjugate vaccines in indonesian

Conditions: Vaccine

Summary: vi-dt typhoid vaccine is a novel vaccine. this study will be done to know the long-term protection and persistent antibody by measured the antibody titer after 2,3,4 and 5 years after immunization.

this study will be done to know the long-term protection and persistent antibody, by measured the antibody titer after 2,3,4 and 5 years after immunization.

Eligibility criteria:
inclusion criteria: * healthy. * subject who completed the phase ii vi-dt study (typhoid 0218) * subjects/parents have been informed properly regarding the study and signed the informed consent form. * subject/parents/legal guardians will commit to comply with the instructions of the investigator and the schedule of the trial. exclusion criteria: * subject concomitantly enrolled or scheduled to be enrolled in another trial. * evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥ 37.5oc). * known history of allergy to any component of the vaccines. * history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection. * any abnormality or chronic disease which according to the investigator might be compromised by the vaccination and/or interfere with the assessment of the trial objectives.

Keywords: vi-dt typhoid conjugate vaccine
fluid management guided by bioimpedance analysis in peritoneal dialysis(pd) patients.

Conditions: End Stage Renal Disease

Summary: 1. purpose: to investigate the effect of bioimpedance analysis(bia) guided fluid management versus experiential way on clinical outcome in peritoneal dialysis patients. 2. design: prospective,randomized,controlled,single center study 3. study hypothesis: patients on peritoneal dialysis are frequently hypervolemic, which is associated with increasing hazard of death and cardiovascular events. bioimpedance analysis is a safe, and easy way, which appears to be more useful and sensitive than other techniques for assessing volume status in dialysis patients. therefore we hypothesize that more concise and strict fluid management guided by bia may help to improve patients' survival, decrease cardiovascular events and hospitalization rate. 4. objects: incident and prevalent patients with overhydration status. 1. anticipated cases:240 2. arms: all the patients are randomized into two arms.(bia group/clinical group) 3. observational time:12 months 5. primary outcome: all cause mortality. secondary outcomes: technique survival, cardiovascular events, peritonitis, residual renal function.


Eligibility criteria:
inclusion criteria: * patients who are undergoing peritoneal dialysis and clinically stable for at least 3 months; * 18 years and older; * ratio extracellular water (ecw)/total body water(tbw)≧0.4; * signed the informed consent exclusion criteria: * patients who have mental graft; * amputation; * patients who is unable to accomplish the bia measurement in standing position for 3 minutes; * patients whose heart function are class iv estimated by new york heart association (nyha) standard; * patients who have acute complications within 30 days prior to study enrollment; * patients whose life expectancy is within 6 months; * patients who are pregnant; * patients who are unable to give consent.

Keywords: peritoneal dialysis fluid overload bioimpedance analysis randomized controlled trial
insomnia in patients participating in interdisciplinary pain rehabilitation

Conditions: Musculoskeletal Pain; Insomnia

Summary: the main purpose of this project is to conduct a prospective cohort study in order to better understand the importance of insomnia symptoms in patients referred to interdisciplinary rehabilitation due to chronic pain. moreover, this project will also raise awareness on how insomnia symptoms, alone, and in interplay with factors such as function, psychological distress, physical activity, and fatigue impact on patient's prognosis and work ability. our aim is that this knowledge can be used to design new interventions and improve rehabilitation programs for this patient group.

insomnia is a vast problem among patients with chronic musculoskeletal pain. despite the close relation between pain and sleep, sleep quality has received little attention in rehabilitation programs for patients with pain. so far, there is a lack of studies investigating the association between insomnia and chronic pain in patients referred to interdisciplinary rehabilitation. identifying subgroups of the population with higher burden of poor sleep will aid clinicians to tailor treatment and prevention strategies. moreover, knowledge on how insomnia symptoms fluctuate throughout the rehabilitation program and how insomnia symptoms interact with factors such as mental distress, physical activity, and fatigue impact on patient's recovery (e.g., the prognosis of pain, quality of life, and work participation) can be used to develop and implement more successful rehabilitation programs. this is a cohort study primarily designed to address sleep problems in patients referred for pain rehabilitation by using questionnaire data from the rehabilitation centers linked to registry data. this study will constitute both a cross-sectional survey among patients referred to rehabilitation before they participate in rehabilitation. in addition to questionnaires, administrative data and clinical data, these data will be linked to national health registries on prescriptions, health care use and sickness absence. potential participants are patients referred to rehabilitation at five different unicare rehabilitation centers in norway (unicare helsefort, unicare coperio, unicare hokksund, unicare friskvern and unicare jeløy) due to long-term pain complaints.

Eligibility criteria:
inclusion criteria: * take part in rehabilitation for long-term pain complaints at one of the five centers * consented to research exclusion criteria: * none
pda post nicu discharge

Conditions: Patent Ductus Arteriosus

Summary: the purpose of this study is to track post-discharge outcomes on prematurely born infants who are discharged from the nicu with a patent ductus arteriosus (pda). investigators plan to report on the spontaneous closure rate as well as the incidence of pulmonary and/or cardiac events in these infants. the goal is to identify risk factors associated with adverse outcomes in prematurely born infants who are sent home with a pda.


Eligibility criteria:
inclusion criteria: * documentation of informed consent and authorization for participation. * estimated gestational age of 32 weeks or less. * active diagnosis of a pda at discharge. * at least one echocardiogram obtained during hospital stay documenting/ confirming pda diagnosis. * parental agreement to provide follow-up information on their child. * cardiologist and/or pediatrician willing to provide follow-up information on enrolled infants. exclusion criteria: * no known major congenital anomalies (inborn error of metabolism, cyanotic congenital heart disease, gastroschisis, omphalocele, diaphragmatic hernia or other major gastrointestinal anomalies, major neurological injury or anomaly, multiple congenital anomalies). * chromosomal / genetic disorders - inherited metabolic disorders (aa, fat or carbohydrate), trisomies, turner's syndrome,vater's syndrome, charge, digeorge or other 22q11 deletions, major chromosomal duplications, deletions detectable on high resolution karyotype (not microarray). * parent(s) unwilling to participate in follow-up.
efficacy of å6 in ovarian cancer patients following first-line chemotherapy and a rising ca125 levels

Conditions: Ovarian Cancer; Primary Peritoneal Carcinoma

Summary: the purpose of this study is to determine whether injections of å6 are effective in treating ovarian cancer patients who have completed first-line therapy and currently have no detectable cancer but have experienced a doubling of ca 125 levels.


Eligibility criteria:
inclusion criteria: * females ≥18 years of age * histologically or cytologically documented primary epithelial ovarian carcinoma, cancer of the fallopian tube, or primary peritoneal carcinoma * completion of first-line chemotherapy * clinical remission as a result of chemotherapy * history of normal ca125 level after initial course of therapy * ca125 serum level has shown 2 consecutive rises based on 3 consecutive samples which are mutually \>= 28 days apart, provided that: 1. the 3rd sample is above the institution's uln, and 2. the 3rd sample is confirmed by a 4th sample which is likewise higher than the 2nd sample value and is above the institution's uln * no clinically evident disease progression, as assessed by history, physical examination, computed tomographic (ct) scan, or magnetic resonance imaging (mri) * ecog performance status of 0 or 1 * no clinically significantly abnormal clinical laboratory tests or concomitant illnesses * ability and willingness to self-administer subcutaneous injections * although pregnancy is extremely unlikely in this patient population because of the disease and prior treatment, patients who have the potential to become pregnant must have a negative pregnancy test and must agree to practice an effective method of contraception throughout the trial. exclusion criteria: * persistent adverse events due to agents administered more than 4 weeks earlier * more than 1 course of previous chemotherapy for the qualifying cancer * disease requiring chemotherapy or radiotherapy * ascites * recent history of active infection, gastrointestinal bleeding, thromboembolic disorders, or anticoagulation

Keywords: asymptomatic subcutaneous ca125 progression angstrom ångstrom ovarian cancer
do compression stockings used during cesarean sections affect intraoperative hypotension and nausea?

Conditions: Intraoperative Hypotension

Summary: the present study aimed to determine the effects of compression stockings used during cesarean section on intraoperative hypotension.

cesarean section is among the most common surgeries in young and healthy individuals. its frequency is increasing in our country and on a global scale. a total of 57% of all births in our country were performed by cesarean section between 2018 and 2023. spinal anesthesia is frequently used during cesarean sections with its advantages such as the patient being conscious, not having a risk of aspiration, not causing respiratory depression in the newborn, and the mother being able to breastfeed early. however, spinal anesthesia has complications such as hypotension and post-spinal headache, bradycardia and asystole, nausea, hypoventilation, total spinal block, urinary retention, spinal hematoma, back pain, infection, transient neurological symptoms, or cranial nerve paralysis. the present study aimed to determine the effects of compression stockings used during cesarean section on intraoperative hypotension.

Eligibility criteria:
inclusion criteria: 37-38 weeks pregnant women exclusion criteria: * chronic disease * women who developed complications during surgery * women with multiple pregnancies * women with pregnancies with known fetal anomalies

Keywords: hypotension vasopressor varicose veins
a study of a fimh blocker, eb8018, in crohn's disease patients

Conditions: Crohn Disease

Summary: enterome small molecule drug eb8018 is a first-in-class fimh blocker to be studied in crohn's disease patients. the proposed indication for eb8018, as an add-on therapy, will be the treatment of adult patients suffering from crohn's disease.

this open-label, multicenter study will enroll 8 evaluable patients with active crohn's disease and will consist of 2 parts. part 1 will include 2 sentinel patients with a single dosing period followed by a 13-day multiple dosing period. part 2 will include the 6 remaining patients with multiple dosing only. this phase 1b study will investigate the pk, safety, preliminary effects of the gut microbiome, and inflammatory biomarkers of eb8018 following 13 days of consecutive bid oral dosing in patients with crohn's disease. part 1 of this study will demonstrate a single oral dose of eb8018 that is safe and tolerable in patients with crohn's disease and part 2 of this study will characterize the pk profile when administered as multiple oral doses.

Eligibility criteria:
selection criteria: * male and female patients of nonchildbearing potential ≥18 years of age at screening and day -1 * active crohn's disease based on an elevated calprotectin at baseline.
cardiorespiratory effects of nasal high frequency ventilation in neonates

Conditions: Ventilator Lung; Newborn; Hemodynamic Instability; Echocardiography

Summary: the aim of the present work is to study the cardio-respiratory effects of non-invasive ventilation (nasal high-frequency ventilation and nasal cpap) as an initial therapy of respiratory distress in moderate and late preterm infants as regard: i. primary outcomes: * duration of the non- invasive respiratory support. * need of invasive ventilation in the first 72 hours. * short-term complications such as air leak syndromes, pulmonary hemorrhage, intraventricular hemorrhage, and nasal trauma. ii. secondary outcomes: * need for surfactant administration. * days on invasive mechanical ventilation. * days on supplemental oxygen. * duration of hospital stay. * mortality rate. iii. hemodynamic changes during the period of non-invasive ventilation.


Eligibility criteria:
inclusion criteria: moderate and late preterm infants born between 32+0 to 36+6 weeks gestation(according to who definitions of preterm birth) admitted to the neonatal intensive care unit with spontaneous breathing and clinical manifestations of rd (tachypnea, nasal flaring, intercostal and subcostal retraction and or grunting). exclusion criteria: * any baby intubated for resuscitation or for other reasons. * obvious major congenital malformations or known complex congenital heart disease. * pulmonary hemorrhage. * cardiopulmonary arrest needing prolonged resuscitation.

Keywords: premature infants echocardiography
pathophysiology of hypoventilation in obesity and effects of bariatric intervention

Conditions: Obesity Hypoventilation Syndrome (OHS)

Summary: breathing is impacted by obesity. early changes are characterised by significant breathing abnormalities during sleep (a condition called sleep disordered breathing, the most common of which is obstructive sleep apnoea). as the breathing changes worsen in severity, it may result in a rise in carbon dioxide levels during daytime causing a condition called obesity hypoventilation syndrome (ohs). the current treatment for obesity related breathing changes include supportive breathing therapy at night, optimisation of associated medical conditions and weight loss. weight management is an important part of obesity treatment. weight loss strategies such as life-style modification do not always work. weight loss surgery (bariatric surgery) has been shown to be an effective weight management intervention with long-term results. this study aims to understand breathing changes that occurs due to obesity and their resolution after weight loss surgery. the investigators are aiming to recruit participants with sleep disordered breathing who are currently awaiting bariatric surgery. in particular, the investigators are interested in comparing breathing changes in participants with ohs, who have abnormal regulation of their carbon dioxide levels, and participants with sleep disordered breathing with normal co2 regulation. participants will be recruited through outpatient clinics for sleep disordered breathing. the participants will undergo comprehensive breathing assessments on enrolment including an overnight sleep study. participants will undergo further daytime breathing assessments before and after their bariatric surgery. end of study will be 6 months after surgery - participants will have a final comprehensive breathing assessment including an overnight sleep study to review resolution of their breathing changes. depending on the wait list time for the bariatric surgery, it is anticipated that participants will be enrolled in the study for 2 years.


Eligibility criteria:
inclusion criteria: 1. patients 18 years or older 2. bmi \> 40 3. patients with significant sleep disordered breathing requiring treatment 4. patient is being assessed for bariatric surgery for either gastric sleeve or gastric bypass surgery exclusion criteria: 1. patients with decompensated hypercapnic respiratory failure (ph\< 7.3) 2. chronic hypercapnic respiratory failure due to a cause other than obesity such as neuromuscular, chest wall or airway disease 3. unstable cardiac disease including coronary artery disease and heart failure 4. significant co-morbid psychiatric disease requiring anti-psychotic medications 5. chronic pain syndrome on high dose opioid medications 6. treatment for drug or alcohol addiction 7. cognitive impairment that would prevent informed consent 8. pregnancy 9. need for long-term renal replacement therapy 10. patients who undergo bariatric intervention with gastric balloon or gastric band.
nt-probnp for evaluation of the dyspneic patient in the emergency room and the medical ward

Conditions: Shortness of Breath; Acute Exacerbation

Summary: the proposed study intends to evaluate the impact of the nt-probnp assay on the diagnosis of heart failure in patients with dyspnea of unknown etiology presenting to the emergency room and admitted to the medical wards.

the proposed study intends to evaluate the impact of the nt-probnp assay on the diagnosis of heart failure in patients with dyspnea of unknown etiology presenting to the emergency room and admitted to the medical wards. patients will be consented and randomized to open or blinded nt-probnp test performed within 90 minutes in a venous blood sample. evaluation of the er diagnosis and final discharge diagnosis in admitted patients will be carried out in light of the nt-probnp results.

Eligibility criteria:
inclusion criteria: 1. acute shortness of breath of unknown etiology as presentation to the emergency room 2. possible acute exacerbation of known heart failure exclusion criteria: none -

Keywords: nt-probnp heart failure dyspnea
sintilimab and chemotherapy sequential radiotherapy in advanced esophageal cancer

Conditions: Metastatic Esophageal Squamous Cell Carcinoma

Summary: this is an investigator-initiated, single-arm, exploratory clinical study.the study population consisted of treatment naive advanced esophageal squamous cell carcinoma patients. the purpose of this study was to evaluate the efficacy and safety of immunotherapy combined with chemotherapy and residual lesions irradiation of esophageal squamous cell carcinoma.


Eligibility criteria:
inclusion criteria: 1. diagnosed with stage iv esophagus squamous cell carcinoma. 2. expected survival time ≥3 months 3. enrolled patients must have at least one measurable lesion conforming to the recist v1.1 definition. 4. physical fitness ecog score of 0 or 1 5. organ function levels must meet the following requirements and meet the following standards: a) bone marrow function: absolute neutrophil count (anc) ≥1.5×10\^9/l, platelet count ≥90×10\^9/l, hemoglobin ≥90 g/l; b) liver function: total bilirubin tbil≤1.5×uln (total bilirubin ≤3×uln in subjects with gilbert's syndrome, liver cancer or liver metastasis), ast and alt ≤2.5×uln in patients without liver metastasis, ast and alt ≤5.0×uln in patients with liver metastasis; c) renal function: creatinine (cr) ≤1.5×uln, or creatinine clearance (ccr) ≥50 ml/min (according to cockcroft and gault formula); d) urine routine / 24-hour protein quantification: qualitative urine protein ≤1+ (if qualitative urine protein ≥2+, 24 hours \< 1g can be included); e) cardiac function: left ventricular ejection fraction ≥50%; f) coagulation function: international standardized ratio (inr) ≤1.5×uln, and activated partial thrombin time (aptt) ≤1.5×uln; exclusion criteria: 1. known or suspected history of active autoimmune diseases, autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes) 2. have a history of immunodeficiency, including hiv positive, or other acquired, congenital immunodeficiency disease, or history of organ transplantation and bone marrow transplantation；interstitial lung disease, drug-induced pneumonia,requiring steroid therapy or active pneumonia with clinical symptoms or severe pulmonary dysfunction； 3. there are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) heart failure of nyha class 2 or higher (2) unstable angina (3) myocardial infarction within 24 weeks (4) clinical need for treatment or interventional supraventricular or ventricular arrhythmia； 4. have a tendency to hereditary bleeding or coagulopathy. clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ and above； 5. allergic reactions to test drugs for this application； 6. pregnant or lactating women； those whom the investigator considered unsuitable for inclusion。