Kornimate/medical-research-clean huggingface dataset:
a study to evaluate camrelizumab plus rivoceranib (apatinib) as adjuvant therapy in patients with hepatocellular carcinoma (hcc) at high risk of recurrence after curative resection or ablation

Conditions: Hepatocellular Carcinoma (HCC)

Summary: a trial to evaluate the efficacy and safety of camrelizumab plus rivoceranib (apatinib) versus active surveillance as adjuvant therapy in patients with hepatocellular carcinoma (hcc) at high risk of recurrence after curative resection or ablation.


Eligibility criteria:
inclusion criteria: * subjects with a histopathological diagnosis of hcc * subjects who have undergone a curative resection or ablation (radiofrequency ablation \[rfa\] or microwave ablation \[mva\] only) * no previous systematic treatment and locoregional therapy for hcc prior to randomization * absence of major macrovascular invasion * no extrahepatic spread * full recovery from curative resection or ablation within 4 weeks prior to randomization * high risk for hcc recurrence after resection or ablation * for patients who received post-operative transarterial chemoembolization: full recovery from the procedure within 4 weeks prior to randomization * child-pugh class: grade a * ecog-ps score: 0 or 1 * subjects with hcv- rna (+) must receive antiviral therapy * adequate organ function exclusion criteria: * known hepatocholangiocarcinoma, sarcomatoid hcc, mixed cell carcinoma and fibrolamellar hcc; other active malignant tumor except hcc within 5 years or simultaneously * evidence of residual lesion, recurrence, and metastasis at randomization; * moderate-to-severe ascites with clinical symptoms * history of hepatic encephalopathy * history of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal haemorrhage * active or history of autoimmune disease * interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity * cardiac clinical symptom or cardiovascular disease that is not well controlled * severe infection within 4 weeks prior to the start of study treatment * hiv infection * known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug * subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy * thrombosis or thromboembolic event within 6 months prior to the start of study treatment * known genetic or acquired hemorrhage or thrombotic tendency * abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment * serious non-healing or dehiscing wound * major curative procedure within four weeks * factors to affect oral administration * previous or current presence of metastasis to central nervous system
clinical study for the treatment with interferon-ß-1a (ifnß-1a) of covid-19 patients

Conditions: COVID-19 Virus Infection

Summary: pharmacological therapies of proven efficacy in coronavirus disease 2019 (covid-19) are still lacking. since two clinical stages of covid-19 are emerging, an early one with typical clinical characteristics of a viral infection (fever, malaise, cough) and a later one with pneumonia leading to progressive respiratory failure, associated with heavy, cytokine-mediated, inflammation, an intervention by a compound possessing both antiviral activity and immunomodulatory effects would be most effective at the earliest possible stage. the purpose of this clinical trial is to test the efficacy of interferon-β-1a (ifnβ-1a), in covid-19 patients in an open label, randomized clinical trial. the design of the study is to test ifnβ-1a in addition to standard of care compared with standard of care alone. the primary outcome is the time to negative conversion of severe acute respiratory syndrome-coronavirus-2 (sars-cov-2) nasopharyngeal swabs.


Eligibility criteria:
inclusion criteria: 1. informed consent signed 2. patients hospitalized with confirmed swab rt-pcr detection of sars-cov-2 3. x-ray and/or ct diagnosed pneumonia 4. age \>=18 years 5. clinical status defined as 3, 4 or 5 on the 7-point ordinal scale exclusion criteria: 1. known allergy or hypersensitivity to ifnß-1a or ifnß-1b 2. presence of severe concomitant illnesses/medical conditions that in the physician opinion do not allow participation to the study 3. pregnant or lactating females 4. history of major depression disorder or suicidal attempt or suicidal ideation 5. spontaneous blood alanine aminotransferase/aspartate aminotransferase (alt/ast) levels \> 5 times the upper limit of normal 6. clinical status defined as 1, 2, or 6 on the 7-point ordinal scale
yoga and aerobic exercise in epilepsy

Conditions: Epilepsy; Epilepsy; Seizure; Epilepsy Idiopathic

Summary: in recent years, there is growing interest in illustrating the health benefits of exercise among epilepsy. although exercise is recommended for patients with epilepsy, there is uncertainty concerning the effects of yoga and aerobic exercise on multiple health outcomes in epilepsy. the aim of this trial is to examine the effects of yoga and aerobic exercise training on physical activity, health-related physical fitness, mental, emotional, and psychological health status, seizure frequency and quality of life.


Eligibility criteria:
inclusion criteria: * patients with epilepsy diagnosed by a neurologist using the international league against epilepsy (ilae) criteria, * having access to the internet at least three per week. exclusion criteria: * any history of neurological disorders other than epilepsy, * significant physical and cognitive impairments, * musculoskeletal comorbid conditions, * contraindications for an exercise intervention including diagnosed cardiovascular, pulmonary, or endocrine diseases, * pregnancy, * mental deficiency or low education level to understand the questionnaires, * currently participating in an exercise program, * volunteers who miss 3 consecutive intervention sessions, and do not participate in 10% of sessions.

Keywords: epilepsy yoga aerobic exercise
efficacy of nice classification in the histological evaluation of colorectal lesions

Conditions: Colorectal Polyps

Summary: recently, a new category classification (nice classification) using non-magnified nbi has been proposed. we design this multicenter study to evaluate the reliability and validity of the nice classification in diagnosing colorectal polyps by chinese endoscopists during both image and real-time process.

many reports have demonstrated the efficacy of narrow band imaging (nbi) with magnification in predicting the histology and invasion depth of colorectal polyps. in china, however, the magnifying endoscope is not used in some medical centers. even in centers equipped with this technique, the magnifying colonoscope is not sufficiently used in daily practice. recently, a simple category classification (nice classification) using non-magnified nbi has been proposed, which classifies colorectal tumors into types 1-3 based on different characteristics of color, surface pattern, and microvessels. type-1 is considered an index for hyperplastic lesions, type-2 is an index for adenoma or mucosal/sm scanty invasive carcinoma and type-3 is an index for deep sm invasive carcinoma. the new classification has soon arouse attention and been validated in some centers on the efficacy of differentiating adenomatous and hyperplastic polyps. however, most studies enrolled diminutive polyps less than 5mm and the efficacy of non-magnified nbi in differentiating type-2 and type-3 lesions has not been reported. to promote this simple classification, we design this multicenter study to evaluate the predictive validity and performance characteristics of the non-magnified nbi in diagnosing polyps during both image and real-time process.

Eligibility criteria:
inclusion criteria: * patients with colorectal lesions during colonoscopy examination * informed consent available exclusion criteria: * suspect of advanced colorectal cancer * history of colorectal surgery, familial adenomatous polyposis or inflammatory bowel disease * poor bowel preparation * patients under unsuitable conditions for examination or treatment, such as acute upper gastrointestinal bleeding, noncorrectable coagulopathy, severe systemic disease, etc

Keywords: narrow band imaging(nbi) nice classification colorectal lesions predicting histology
randomized study of cisplatin-etoposide versus an etoposide regimen without cisplatin in extensive small-cell lung cancer

Conditions: Small Cell Lung Carcinoma, Extensive Disease

Summary: the purpose of this study is to determine if a cisplatin-etoposide regimen improves survival in comparison to a regimen containing etoposide and without platinum derivative.


Eligibility criteria:
inclusion criteria: * histological or cytological diagnosis of small-cell lung cancer * extensive disease (i.e. a disease with distant metastases or that cannot be included in a single irradiation field incorporating primary tumour, mediastinum and supraclavicular lymph node(s)) * availability for participating in the detailed follow-up of the protocol * presence of an evaluable or measurable lesion * informed consent exclusion criteria: * prior treatment with chemotherapy, radiotherapy or surgery * performance status \< 60 on the karnofsky scale * a history of prior malignant tumor, except non-melanoma skin cancer or in situ carcinoma of the cervix or a cured cancer (defined as a disease-free interval \> 5 years) * white blood cells \< 4000/mm3 * platelets \< 100000/mm3 * serum bilirubin \> 1.5 mg/100 ml * serum creatinine \> 1.3 mg/100 ml and creatinine clearance \<60 ml/min * recent myocardial infarction (less than 3 months prior to date of diagnosis) * congestive cardiac failure or cardiac arrhythmia uncontrolled by medical treatment * uncontrolled infectious disease * serious medical or psychological factors which may prevent adherence to the treatment schedule

Keywords: small cell lung carcinoma chemotherapy phase iii randomised study
special investigation in patients with ankylosing spondylitis (all patients investigation)

Conditions: Ankylosing Spondylitis

Summary: this study of adalimumab (humira) will be conducted to clarify the following with regard to the treatment of ankylosing spondylitis with this drug: * unknown adverse drug reactions (especially important adverse drug reactions) * incidence and conditions of occurrence of adverse reactions in the clinical setting * factors that may affect the safety and effectiveness of humira


Eligibility criteria:
inclusion criteria: * patients with ankylosing spondylitis who are not responding well to conventional therapy and receive adalimumab will be enrolled in the survey exclusion criteria: * contraindications according to the package insert * patients who have serious infections * patients who have tuberculosis * patients with a history of hypersensitivity to any ingredient of humira * patients who have demyelinating disease or with a history of demyelinating disease * patients who have congestive cardiac failure

Keywords: ankylosing spondylitis
deep brain stimulation for severe self-injurious behaviour in children

Conditions: Self-Injurious Behavior; Autism Spectrum Disorder

Summary: deep brain stimulation for the treatment of severe refractory self-injurious behaviour in children with autism spectrum disorder: a randomized trial to evaluate the effectiveness of deep brain stimulation (dbs) of the nucleus accumbens for the treatment of severe refractory, repetitive self-injurious behavior (sib) in children with autism spectrum disorder. secondary objectives are to examine the effects of dbs on subtypes of sib through functional analysis.

the proposed study is a single-center, double-blinded, block-randomized crossover trial. twenty-five (25) participants will be recruited and enrolled in this trial to undergo bilateral nucleus accumbens dbs. after recovery, participants will be randomized to a 3 month block of active stimulation or the dbs will remain off. after a two week washout period, the participants will cross over to the other group. at the end of the second block, all patients will have their dbs devices activated during an open label period. all participants will have baseline assessments that will be repeated at the end of each block. expected study duration is 24 months.

Eligibility criteria:
inclusion criteria: * age 5-17 at the time of enrollment * dsm-5 diagnosis of autism spectrum disorder * history of repetitive self-injurious behaviour, as reported by parents and documented on clinical assessment, either at the time of enrollment into the study or in prior medical records. the definition of self-injury is contextual, but requires ongoing, intermittent or continuous manifestation of self-mediated physical injury to the child. * foreseeable risk of serious future self-harm. * screening by study team for presence automatically reinforced self-injurious behaviour (asib) subtype 2 or subtype 3 based on caregiver history. * failure or non-eligibility of medical therapy with ongoing repetitive self-injurious behaviours, at 6 months or more after initiation of therapy. * parents or legal guardians, including caregivers, informed and able to provide written consent. * able to comply with all testing, follow-up visits, and study appointments and protocols for 12 months following the end of the duration of the study. exclusion criteria: * substance dependence or abuse in the last 6 months, excluding caffeine and nicotine. * any contraindication to mri scanning. * presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions that may incur significant risk from a surgical procedure. * pregnancy.

Keywords: deep brain stimulation dbs asd sib nucleus accumbens
efficacy of an advanced care planning program in advanced heart failure

Conditions: Heart Failure

Summary: an "advanced planning program of health decisions" (apphd) is a process of reflection and relationship between the patient, their relatives and health professionals. it is based on respect for patient's autonomy, to engage patients in making decisions about their disease so that the process is shared between the medical team, the patient and their relatives. until now, it has not been measured whether the apphd is effective and, therefore, really fulfills its purpose

background: an advanced care planning (acp) program of health decisions is the result of a process of reflection and relationship-building between the patient, their relatives and health professionals. it is based on respect for patients' autonomy, involving them in making decisions about their disease in a way that is shared between the medical team, the patient and their relatives. up until now, the efficacy of an acp has not been measured in the existing literature, and therefore it is unknown if these programs reach their goal. objetives: the main objective of our study is to evaluate the efficacy of an acp program for decision-making in patients with advanced heart failure (hf) in comparison to usual follow up and care. this objective will be evaluated by the patient activation measure test, which measures the participation and self-management of the patient in decision-making. secondary objectives: to evaluate the effect of the program on quality of life, to know if the patients wishes expressed through the acp program are fulfilled, to measure the impact of the program on patients' caregivers, to determine the satisfaction of patients included in the program and to evaluate the effect on quality of death. methods: randomized multicentre clinical trial at four hospitals in madrid. once they are included in the study, patients' allocation to groups (control vs intervention) will be made by alternative sampling. acp will be applied to the intervention group, whereas in the control group usual follow-up will be carried out in hf units. all patients will fulfil questionnaires and tests related to the objectives of the study again after a 12-month follow-up period in order to gauge the effect of acp in patients with advanced hf.

Eligibility criteria:
inclusion criteria: * patients with hf defined by framingham diagnostic criteria. * stage c or d of the accf / aha classification. * full capacity to decide. * signing of informed consent. exclusion criteria: * cognitive impairment, measured by mini-mental status examination (\< 27). * presence of another disease other than hf that may severely affect the quality of life: stroke with significant residual deficit, end-stage renal failure, child c cirrhosis, extreme obesity, haemoglobin \<8 g / dl, advanced peripheral artery disease (stage iii-iv), severe thyroid or adrenal disease, neoplastic with estimated survival of less than 2 years. * patients who do not sign the informed consent.
clinical prediction model of obstructive sleep apnea at mansoura university hospitals

Conditions: Osa Syndrome

Summary: obstructive sleep apnea syndrome (osas)is a sleep breathing disorder manifested by complete apnea or partial hypopnea obstruction of the upper airway, which often remains undiagnosed and untreated (kuczynski, w., 2019). these episodes, which should be more than 5 per hour and last at least 10 s, can lead to a sleep fragmentation and hypoxia (huon, l.-k.a., 2017). osas predominantly affects 26% of individuals between 30 and 70 years in the u.s (apnea hypopnea index ≥5 events per hour) (schwartz, m., 2018). obstructive sleep apnea it is increasingly recognized as an independent risk factor for cardiac, neurologic, and perioperative morbidities. yet this disorder remains undiagnosed in a substantial portion of our population. it is imperative for all physicians to remain vigilant in identifying patients with signs and symptoms consistent with osa (park, j. g., 2011). the test of hypothesis is to design a clinical prediction model of obstructive sleep apnea from collected data of the patients having symptoms of obstructive sleep apnea and the results of their sleep study

aim of study: to identify standard clinical parameters that may predict the presence of obstructive sleep apnea (osa) among egyptian patients in sleep study unit, chestdepartment mansoura university hospital, egypt study design :retrospective study the study will include the patients who visited sleep outpatient clinic of sleep disordered breathing unit of chest department, mansoura university from 2004 to 2022 inclusion criteria 1. patients aged \>18 years old 2. presented with symptoms suggestive of osa like excessive daytime sleepiness, snoring, nocturnal chocking and witnessed apnea exclusion criteria :patients with long-term use of medications known to affect sleep integrity,current alcohol or drug abuse, history of psychosis ,central sleep apnea syndromes ,previous osa surgery ,other sleep disorders methods: study design: this is retrospective study the recorded data of all patients which include all their symptoms and comorbidities as well as their use of any regular medications will be collected. 1. physical examination: * all recorded vital data, height, weight, and body mass index (bmi) of the patients will be collected * the probability of osa using the stop-bang and berlinequestionnaire in all the patients will be collected * the calculated epworth sleepiness scale (ess) for each patient will be assessed. 2. sleep study (psg) diagnostic polysomnogram that had been done for all the patients for diagnostic purpose will be assessed.

Eligibility criteria:
inclusion criteria: 1. patients aged \>18 years old 2. presented with symptoms suggestive of osa like excessive daytime sleepiness, snoring, nocturnal chocking and witnessed apnea exclusion criteria: 1. patients with long-term use of medications known to affect sleep integrity current 2. alcohol or drug abuse 3. history of psychosis 4. central sleep apnea syndromes 5. previous osa surgery 6. other sleep disorders
induction of labor in term premature rupture of membranes: a comparison between oxytocin and dinoprostone followed six hours later by oxytocin

Conditions: Labor; Induction; PROM (Pregnancy)

Summary: prelabor rupture of membranes (prom) is most commonly defined as rupture of membranes before the onset of labor and occurs in 8% of term pregnancies. a prolonged interval from rupture of membranes to delivery is associated with an increase in the incidence of chorioamnionitis and neonatal sepsis. the management of the term patients with prom, especially those with an unfavorable cervix, remains controversial. management options to choose from are immediate induction of labor versus delayed induction or expectant management. several reports have detailed an increase in maternal and neonatal morbidity with expectant management, whereas active management leads to a shorter interval from prom to delivery, reducing the risk of postnatal infections. in addition, active management is preferred by patients. the investigators know that, neonatal intensive care admission, variable decelerations, and primary cesarean delivery rates are positively correlated with a longer admission-to-labor-onset interval in women with prom . so, to reduce the induction to delivery times, concurrent oxytocin infusion with dinoprostone vaginal pessary use for labor induction in women with prom may be beneficial. several studies have shown shorter induction-to-delivery interval with concurrent oxytocin infusion with prostaglandin agent at initiation of labor . however, in these studies, there is a a paucity information in prom labor induction. only one randomized control trial have compared the efficacy of concurrent dinoprostone and oxytocin and oxytocin alone in women with term prom . this study indicated that concurrent vaginal dinoprostone and intravenous oxytocin conferred no advantage over intravenous oxytocin alone for the outcomes of interest, including length of labor patient satisfaction or risk for cesarean delivery. unfortunately, this study was limited by small sample size. the aims of this randomized study was to compare two protocols (oxytocin vs. sustained-release dinoprostone followed six hours later by oxytocin) for induction of labour in women with prom at term and an unfavorable cervix.


Eligibility criteria:
inclusion criteria: * women with a live singleton fetus at term \[37-42 weeks of gestation in cephalic presentation * reactive nonstress test (nst) * presenting with prom * a bishop score of 5 or less before the onset of labor * an absence of spontaneous contractions exclusion criteria: * women in active labor * previous uterine surgery, * antepartum hemorrhage, * chorioamnionitis, * contraindication to prostaglandin use (bronchial asthma, glaucoma), \*contraindication to vaginal delivery, * multiple pregnancy, * non-vertex presentation * major fetal anomalies

Keywords: induction of labor in term premature rupture of membranes dinoprostone oxytocin