cyrilzakka/clinical-trials huggingface dataset:
A Study of Total Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer

A Phase II Study of Total Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer

Recommended treatment of patients with locally advanced rectal cancer (LARC) includes preoperative chemoradiation (CRT), total mesorectal excision (TME) and postoperative adjuvant chemotherapy (ACT). However, treatments fail to show an improved therapeutic effect on high-risk patients now. Total neoadjuvant therapy (TNT) is a new try for rectal cancer treatment,and this trial aims to identify and select the more promising TNT sequence.

This trail is a multicenter, randomized, phase II trial . Eligible patients age from 18 to 75 years with histologically confirmed rectal adenocarcinoma. MRI is mandatory, and patients of stage II or III rectal cancer are eligible if any of the following criteria are fulﬁlled: Categories T4,Categories N2, MRF involvement, EMVI positive, and lateral lymph node involvement. Patients are randomly assigned to 3 groups, group 1: concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group);or group 2: concurrent chemoradiotherapy → consolidation chemotherapy → TME (CNCT group);Or group 3: induction chemotherapy → concurrent chemoradiotherapy →TME ( INCT group).The primary end point is the rate of tumor down-staging, which is deﬁned as stage yp0-II after surgery,and watch-and-wait strategy after complete clinical response (cCR) was allowed. Secondary end points include acute toxicity, compliance with TNT, surgical complications, 3-year overall survival (3yOS),3-year disease free survival (3yDFS),3-year distant metastatic free survival(3yDMFS),3-year locoregional recurrence-free survival(3yLRRFS) and quality of life.

Eligibility Criteria:
Inclusion criteria:

1. 18-75 years old, regardless of gender
2. Histologically confirmed rectal adenocarcinoma;
3. Up to 12 cm above the anal verge on the basis of rigid rectoscopy.
4. MRI of the rectum is acceptable;
5. Patients in stage II or III rectal cancer are eligible if any of the following criteria are fulﬁlled: Categories T4,Categories N2, MRF involvement, EMVI positive, and lateral lymph node involvement.
6. ECOG score 0-1 or KPS score ≥80.

Exclusion Criteria:

1. History of malignant tumor in other parts;
2. Cannot complete MRI; Allergic to 5-fu drugs; Allergic to platinum drugs;
3. During thrombolytic and anticoagulant therapy, the patient has bleeding diathesis or coagulation dysfunction; Or aneurysm, stroke, transient ischemic attack, arteriovenous malformation in the past year;
4. History of kidney, urine test found proteinuria or clinical renal function was significantly abnormal;
5. History of digestive tract fistula, perforation or severe ulcer;
6. Active infection is present; Clinically obvious heart disease; New York heart association (NYHA) of Ⅱ level or congestive heart failure; Unstable symptomatic arrhythmia or peripheral vascular disease ≥ grade II; Myocardial infarction and cerebrovascular accident occurred within 6 months before enrollment.
Maximal Exercise Capacity and Extra-pulmonary Characteristics in Patients With Lung Cancer With Complete Remission .

While lung cancer are rare disease in the early 20th century, its incidence increased in parallel with the increase in smoking habits. It is the most common type of cancer in the world. Despite advances in the efficacy of chemotherapy and radiotherapy regimens, surgical resection is the most effective curative treatment modality to improve survival in non-small cell lung cancer. Pulmonary resection candidates are selected according to not only tumor type and stage, but also functional status, exercise capacity, underlying lung disorders and health-related quality of life assessments. Patients with lung cancer often have lung and heart comorbidities that affect the outcome of the outcome measures and restricts cancer treatment options. In patients with lung cancer, shortness of breath, physical inactivity, weakness in peripheral muscles and exercise intolerance are described. Pulmonary rehabilitation is a multidisciplinary treatment designed to improve exercise capacity, functional status, health-related quality of life and to reduce the attenuation of chronic shortness of breath and fatigue in patients with chronic lung problems.

In literature, the effect of surgery in patients with lung cancer on postoperative respiratory muscle strength is not clear. There is no study investigating the effect of chemotherapy and radiotherapy on respiratory muscle strength. For these reasons, the aim of the study was to evaluate the curative period of non-small cell lung cancer patients with reliability and validity assessment methods. The hypothesis of our study was; when compared with patients with lung cancer and healthy individuals, exercise capacity, respiratory and peripheral muscle strength, physical activity levels, sleep and quality of life of lung cancer patients are reduced; dyspnoea, fatigue, depression, cough and pain levels increase.

According to sample size calculation 20 lung with complete remission cancer patients and 20 healthy individuals were included in the study. Cross-sectional observational research. The demographic, physical and physiological characteristics were recorded from the patient files. Exercise capacity (using cardiopulmonary exercise testing), physical activity, pulmonary functions, respiratory and peripheral muscle strength, dyspnea and fatigue perception, depression, cough, pain and quality of life were evaluated. Primary outcome measurement is maximal exercise capacity. Secondary outcomes are respiratory and peripheral muscle strength, pulmonary functions, physical activity, dyspnea and fatigue perception, depression, cough, pain and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients with; Diagnosed with lung cancer Stage 1, stage 2 and stage 3 patients in lung cancer patients Clinically stable and Under standard medication patients were included.

Exclusion Criteria:

* Patients with Metastasis Orthopedic and neurological problems Acute infection Non-co-operable
* Healthy Subjects with Any diagnosed disease were excluded.
The Effect of Dapagliflozin on the Short-term Prognosis of Patients With Acute Myocardial Infarction

Dapagliflozin is one of the SGLT-2 inhibiters. Recent clinical trials have demonstrated that SGLT-2 inhibitors are effective for treating heart failure. The DAPA-HF clinical trial has demonstrated that the effects of empagliflozin and dapagliflozin improve renal outcomes and reduce all-cause and cardiovascular death in patients with HFrEF\[1\]. However, its effect on myocardial infarction, the most common disease leading to death in the population, has not been evaluated sufficiently. A meta-analysis has demonstrated that compared with the control, SGLT2 inhibitor is associated with a reduction in the incidence of major adverse cardiovascular events (MACEs), myocardial infarction, cardiovascular mortality and all-cause mortality\[2\]. It seems that dapagliflozin might be effective for patients with acute myocardial infarction based on these studies. Thus, this study aims to evaluate the effect of dapagliflozin on short-term prognosis in patients with acute myocardial infarction compared to placebo.

1. Faiez Zannad, João Pedro Ferreira, Stuart J Pocock et el. SGLT2 inhibitors in patients with heart failure with reduced ejection fraction: a meta-analysis of the EMPEROR-Reduced and DAPA-HF trials. Lancet. 2020 Sep 19;396(10254):819-829.
2. Cai-Yan Zou, Xue-Kui Liu, Yi-Quan Sang et el. Effects of SGLT2 inhibitors on cardiovascular outcomes and mortality in type 2 diabetes: A meta-analysis. Medicine (Baltimore). 2019 Dec;98(49):e18245.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with acute MI, either STEMI or NSTEMI, according to the fourth universal definition of MI (Thygesen et al. 2019), disease onset within 7 days.
2. Previously diagnosed with type2 diabetes mellitus, newly diagnosed type2 diabetes according to ADA criteria or glucose intolerance.
3. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and the protocol.

Exclusion Criteria:

1. Patients diagnosed with Type 1 Diabetes Mellitus.
2. Patients with renal dysfunction. (GFR\<90mmol/L).
3. Patients who have recently undergone immunosuppressive therapy.
4. Patients with a history of recurrent urinary tract infections.
5. Patients who are known to be allergic to SGLT-2 inhibitors.
6. Patients who are hemodynamically unstable.
7. Chronic symptomatic heart failure within the last year and known reduced ejection fraction (LVEF≤40 %), documented before the current MI hospitalization.
8. Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial.
9. Any other non cardiovascular diseases, such as active malignancy requiring treatment at the time of screening or with a life expectancy of fewer than two years based on the investigator´s clinical judgment.
10. Currently on treatment with a sodium-glucose co-transporter 2 inhibitor (SGLT2-inhibitor).
The PICM Risk Prediction Study - Application of AI to Pacing

Development of pacing induced cardiomyopathy (PICM) is correlated to a high morbidity as signified by an increase in heart failure admissions and mortality. At present a lack of data leads to a failure to identify patients who are at risk of PICM and would benefit from pre-selection to physiological pacing. In the light of the foregoing, there is an urgent need for novel non-invasive detection techniques which would aid risk stratification, offer a better understanding of the prevalence and incidence of PICM in individuals with pacing devices and the contribution of additional risk factors.

Retrospective review of patient characteristics including 12 lead resting electrocardiograms and imaging data (CMR, CT, echo, CXR and fluoroscopy of pacing leads) of patients with right sided ventricular pacing lead due to symptomatic bradycardia, who developed pacing induced cardiomyopathy (or need for CRT upgrade) versus patients who did not using supervised machine learning methods. Development of personalised predictive pacing algorithm to improve right ventricular lead placement, such as conduction system pacing or pre-emptive implantation of an additional left ventricular lead to prevent left ventricular dilatation and pacemaker-induced cardiomyopathy (PICM) with heart failure (left ventricular ejection fraction \<50% by Simpson method), hospitalisation or death with the use of the retrospective patient data through machine learning.

Eligibility Criteria:
Inclusion Criteria:

* All patients who received a pacing device (VVI, DDD, ICD, leadless pacemaker) from the GSTT/RBH/KCH/ICH database in the last 10 years (from 01/01/2014)
* All patients who are \>18 years old.
* Male and Female

Exclusion Criteria:

* Patients who did not receive a pacing device (VVI, DDD, ICD, leadless pacemaker)
* All patients \<18 years old
* Patients with congenital heart disease
* Patients who have received artificial heart valves or underwent cardiac bypass surgery
* Patients who did not have an echocardiogram after receiving a pacing device
Safety Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder

This study will evaluate the long-term safety and tolerability of escitalopram (Lexapro) in children 7 to 11 years of age with major depressive disorder (MDD).


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients 7 to 11 years of age, inclusive
* Current diagnosis of MDD based on DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) criteria as confirmed by K-SADS-PL (Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime) with a minimum duration of 6 weeks
* Patient's parent(s), guardian(s), or LAR(s) is capable of providing information about his or her condition, provides informed consent, and agrees to accompany the patient to all study visits. (Preferably the same parent, guardian, or LAR will accompany the patient to all study visits)
* Patient's family is sufficiently organized and stable to guarantee adequate safety monitoring

Exclusion Criteria:

* Current principal DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that was the primary focus of treatment
* Patients with a diagnosis of conduct disorder will not be allowed to participate in this study
* Current diagnosis of mental retardation, dementia, or amnestic or other cognitive disorders based on DSM-IV-TR criteria
* History of allergy, intolerance, or hypersensitivity to escitalopram, citalopram, or other drugs of the same class
* Imminent risk of injuring self or others or causing significant damage to property, as judged by the PI
* Suicide risk as determined by meeting any of the following criteria:

  * Any suicide attempt
  * Significant risk, as judged by the PI, based on the psychiatric interview or information collected in the Columbia-Suicide Severity Rating Scale (C-SSRS)
Hangover and Residual Zopiclone Effect on Spatial Perception

Hangover after recreational alcohol use, residual effect of zopiclone and placebo compared in terms of spatial perception, psychomotor tests and simulated driving ability. Three recording visits plus screening included.


Eligibility Criteria:
Inclusion Criteria:

* weight \>45 kg
* likely to experience and predict alcohol hangover within the next five weeks
* no childbearing potential of negative pregnancy test at screening
* a valid driving license

Exclusion Criteria:

* breastfeeding
* infection with HCV, HBV or HIV
* a medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
* suspected or current drug or alcohol abuse
Prescription Patterns, Resource Utilization & Costs - Add-on Therapy With Anti Dipeptidyl Peptidase-IVs vs Rosiglitazone

This retrospective database study analyzed resource utilization and costs associated with sitagliptin (STG) in comparison with rosiglitazone (RSG) added to metformin (MET) monotherapy among adults with a diagnosis of diabetes who were continuously enrolled in a large US healthcare plan.


Eligibility Criteria:
Inclusion Criteria:

* Continuously enrolled in the health insurance plan to ensure complete claims coverage
* At least 1 claim with a diagnosis of diabetes (ICD-9 250.xx)
* Aged 18 years or older at the index date
* At least 6 months of baseline period prior to the index date
* At least 1 claim for MET during the baseline period
* At least 180 days of continuous therapy with RSG+MET or STG+MET after the index date

Exclusion Criteria:

* At least 1 claim for insulin or sulfonylurea in the baseline period
* At least 1 claim with a diagnosis of congestive heart failure in the baseline period
EGFR Mutation Targeting Molecular Probe for PET Imaging

In this project, investigators plan to develop a F-18 labeled molecular probe in order to detect the EGFR mutation tumor lessions in patients to identify patients benefiting fromTKIs treatment, and evaluate its efficacy in detecting EGFR Del 19 mutant lung cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female, aged 18-75 years old (including 18 and 75 years old), ECOG score 0 or 1.
2. Patients could understand and sign the informed consent form voluntarily with good compliance.
3. Patients with histologically or cytologically or clinically confirmed lung cancer with measurable disease.
4. Women had to be using an effective contraceptive method (effective contraceptive means sterilisation, intrauterine hormonal devices, condoms, contraceptives/pills, sexual abstinence, or partner's removal of the vas deferens) during the study and for 6 months after the study. Men should consent to subjects who must use contraception during the study period and for 6 months after the end of the study period.
5. Predicted survival greater than 3 months;

Exclusion Criteria:

1. Severe hepatic or renal dysfunction;
2. Pregnant or nursing;
3. Known allergy to the investigational drug or its excipients in study;
4. Unable to comply with the PET/CT imaging procedures;
5. Claustrophobia or other psychiatric disorders;
6. Other conditions deemed unsuitable for participation in the trial;
The Calmer Project

The purpose of this study is to see if the Calmer is more effective at managing acute pain in preterm infants in the neonatal intensive care than the current standard of care in the unit.

Hypothesis: While receiving treatment with Calmer, infants will show lower behavioral pain scores and lower heart rates, and more stable autonomic regulation as measured by heart rate variability indices, than infants given a soother plus facilitated tucking (standard of care) during routine blood collection.

60 infants will be randomized to either receive the standard of care or the Calmer during a routine blood collection.

Eligibility Criteria:
Inclusion Criteria:

* Stable infants admitted to the Neonatal Intensive Care Unit at Children's and Women's Health Centre of British Columbia (C\&W)
* Preterm infants born at 27 to 36+6 completed weeks gestational age (GA) will be included
* GA is determined on the basis of the first day of the last menstrual period, early gestation ultrasonogram (in most cases) or best estimate based on neonatal examination
* Mothers must speak enough English to provide consent

Exclusion Criteria:

* Infants who have congenital anomalies, active, ongoing infection, or have undergone surgery
* Infants who have received pharmacological analgesics or sedatives within 72 hours of the assessment
* History of maternal abuse of controlled drugs and substances; blood collection that occurs beyond the 35th completed week (35 weeks + 6 days) GA
* Small for GA defined as a birth weight at least 2 standard deviations below mean for GA
* Higher order multiples (e.g. triplets)
* Infants in a cot
The Real-world Firebird 2 Versus Cypher Sirolimus-eluting Stent in Treating Patients With Coronary Artery Disease

Sirolimus-eluting stent (SES) has been world-widely used in clinical practice in treating patients with coronary artery disease (CAD). The efficacy and safety of Cypher SES (Cordis, MA) has been proved by several randomized clinical trials. Here the investigators design a prospective, multicenter, randomized clinical study in purpose of identifying the non-inferiority in the efficacy and safety in treating CAD patients by Firebird 2 SES (Microport, Shanghai), comparing with Cypher SES.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* male or un-preganant female
* stenosis \> 70% in one of major the epicardial coronary arteries
* no contra-indications of stent implantation
* singed the informed consent

Exclusion Criteria:

* acute myocardial infarction within one week
* have contra-indications of stent implantation or can not tolerate dual antiplatelet therapy
* no history of stent implantation within last one-year
* received other brand coronary stent during index procedure
* with no achievement of informed consent
Relationship Between Erythropoietin Administration and Stress Responses in Trauma Patients

The purpose of this study is to determine whether Erythropoietin decrease stress responses and inflammation in trauma patient.

Transfusion of blood products has many disadvantages. Erythropoietin is used to increase red blood cells production and decrease such disadvantages.In some studies anti inflammatory effects is shown for Erythropoietin.

One of the most problems in the intensive care unit is stress response. we are going to evaluate effects of erythropoietin on oxidative stress and inflammation in trauma patient in intensive care unit.

Eligibility Criteria:
Inclusion Criteria:

* All multiple trauma patients\>16 years with informed consent

Exclusion Criteria:

* Hypertension
* Allergy
* Erythroid leukemia
* Pregnancy and breast feeding
* Pre operative patient
* Severe cardiovascular and cerebrovascular diseases
* Thromboembolic disorders
Efficacy and Safety of Parecoxib on Morphine Patient-controlled Epidural Analgesia (PCEA) After Gynecologic Surgery

The purpose of this study is to determine the effects of parecoxib in combination with epidural morphine in providing analgesia for patients undergoing gynecological surgery.

Researches have showed that the use of epidural and spinal block resulted in significant reduction in morbidity and mortality after surgery. Moreover, appropriate pain management results in better outcomes. Opioids therapy is recommended as the first choice medication for the management of postoperative pain but is associated with a number of undesirable adverse effects. A multimodal therapy for providing postoperative analgesia has advantages over the use of opioids alone. The use of NSAIDs and opioids together often improves analgesia and reduces the need for opioids in the postoperative period. Often, the combination of COX-2 inhibitors with epidural analgesia is preferred. With epidural analgesia, addition of COX-2 inhibitors may improve the analgesia and decrease the undesirable side effects.

Eligibility Criteria:
Inclusion Criteria:

* women scheduled for elective gynecological surgery under combined spinal-epidural anesthesia

Exclusion Criteria:

* contraindications for CSE placement
* known allergy, sensitivity, or contraindication to opioid and nonopioid analgesic drugs
* history of bleeding disorders, peptic ulceration, or anticoagulant use within the past month
* current pregnancy or breastfeeding
* history of known or suspected drug abuse
* unable to understand the use of pain assessment scales and the PCA device
* Patient with asthma or bronchospasm, requiring treatment with glucocorticoids
* poorly controlled hypertension or diabetes, a chronic or acute renal or hepatic disorder, or inflammatory bowel disease
* patients had taken antidepressants, narcotic analgesics, antihistamines, anxiolytics, hypnotics, sedatives, NSAIDs, or corticosteroids up to 24 h before receipt of the study medication