cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Bevacizumab Plus RAD001 Versus Interferon Alfa-2a and Bevacizumab for the First-line Treatment in Adult Patients With Kidney Cancer

To estimate the difference in efficacy and safety of bevacizumab and RAD001 compared to bevacizumab and interferon alfa-2a for first-line treatment of patients with metastatic carcinoma of the kidney.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with metastatic renal cell carcinoma
2. Patients with at least one measurable lesion
3. Patients with progressive metastatic renal cell carcinoma
4. Patients who had a prior partial or complete nephrectomy
5. Patients with a Karnofsky Performance Status ≥70%.
6. Adequate bone marrow function
7. Adequate liver function
8. Adequate renal function
9. Adequate coagulation profile

Exclusion Criteria:

1. 4 weeks post-major surgery
2. Patients who had radiation therapy within 28 days prior to start of study
3. Patients in need for major surgical procedure during the course of the study.
4. Patients with a serious non-healing wound, ulcer, or bone fracture.
5. Patients with a history of seizure(s) not controlled with standard medical therapy.
6. Patients who have received prior systemic treatment for their metastatic RCC.
7. Patients who received prior therapy with VEGF pathway inhibitor
8. Patients who have previously received systemic mTOR inhibitors
9. Patients with a known hypersensitivity RAD001 (everolimus) or other rapamycins or to its excipients.
10. Patients with history or current central nervous system (CNS) metastases or spinal cord compression.
11. Patients with a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment.
12. Patients with proteinuria at screening.
13. Patients with inadequately controlled hypertension
14. Patients receiving ongoing or with recent need for full therapeutic dose of oral or parenteral anticoagulants or chronic daily treatment with aspirin
15. Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent.
16. Patients with a known history of HIV
17. Patients with hypersensitivity to interferon alfa-2a or any component of the product.
18. Patients with an active, bleeding diathesis or coagulopathy or recurrent thromboembolism
19. Patients who have any severe and/or uncontrolled medical conditions or other conditions
20. Left Ventricular Ejection Fraction \< lower limit of institutional normal assessed by ECHO or MUGA
21. Patients who have a history of another primary malignancy ≤ 3 years
22. Female patients who are pregnant or breast feeding
23. Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start.
24. Patients unwilling to or unable to comply with the protocol

Other protocol-defined inclusion/exclusion criteria may apply
The Impact of Physical Training Under Normobaric Hypoxia on Oxidative Stress Level, Inflammatory State, Intestinal Damage, and Mitochondrial Metabolism in Young Males

* Cognitive assessment of the influence of a 4-week proprietary training program under normobaric hypoxia conditions on the levels of inflammatory markers, disturbances in prooxidant-antioxidant balance, degree of intestinal damage, and mitochondrial energy production rate in young sedentary males.
* Applied objective: Development of practical training guidelines utilizing training in normobaric hypoxia conditions to enhance mechanisms related to oxygen transport, adaptive changes within the immune system, body's antioxidant capacity, gut permeability, substrate utilization efficiency, and mitochondrial function for coaches and athletes.


Eligibility Criteria:
Inclusion Criteria:

* no known metabolic diseases, no contraindications to physical exercise and no history of high altitude sickness stated in interview. A medical examination (including ECG, blood and urine tests) is required.

Exclusion Criteria:

* changes in diet during the experiment, smoking and abuse of alcohol and/or other stimulants.
Effects of E-Cigarette Flavors on Adults TCORS 2.0

This study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers.

This study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers. Regular cigarette smokers who do not want to quit smoking will be asked to complete 3 lab sessions in which they will use an e-cigarette and complete questionnaires. This will be followed by a two-week period where participants are asked to stop using cigarettes and other tobacco products and to only use the e-cigarettes provided. Researchers will examine the influence of flavors (sweet, cool, tobacco) on reward (liking/wanting) from e-cigs containing one of two nicotine concentrations (6 mg/ml, 18 mg/ml) following acute tobacco abstinence.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-24 years or 35 -50 years
* Able to read and write
* Smoking \> 10 cigarettes or cigars/day
* Willing to abstain from regular smoking for 2 weeks and use only e-cigarettes
* Not seeking treatment to stop smoking
* No regular use of e-cigarettes

Exclusion Criteria:

* Daily use of other drugs including prescribed psychoactive drugs
* Any significant current medical or psychiatric condition
* Known hypersensitivity to propylene glycol
* Pregnant or lactating females
Depth of Anaesthesia and Postoperative Cognitive Decline in Patients Undergoing Heart Surgery

Post-Operative Cognitive Decline (POCD) is common after cardiac surgery and associated with increased morbidity and mortality. The pathophysiology of POCD is only poorly understood. Causes include hypoperfusion, microemboli and the systemic inflammatory response, which result in a reduction of cerebral oxygen delivery.

Cerebral oxygenation can be monitored non-invasively by measuring frontal lobe oxygen saturation (rSO2).

The bispectral index (BIS) of the electroencephalogram is widely known to measure depth of anaesthesia, and there is a high correlation between BIS, a dimensionless calculated number between 0 and 100, and clinical criteria of sedation. With BIS below 60 recall is extremely low.

The investigators demonstrated recently that inappropriately high levels of anaesthesia may be associated with poorer long-term outcomes in cognition after non-cardiac surgery (Ballard et al. 2012). Whether optimisation of the depth of anaesthesia and cerebral oxygenation has an effect on postoperative cognitive function in patients undergoing cardiac surgery is unknown.

The investigators hypothesize that the incidence of POCD in elderly patients (\> 65 years old) at 6 weeks is less with mildly deep anaesthesia (BIS 50 +- 10) and optimised rSO2 (interventions when rSO2 drops below 15% of baseline reading) when compared with current practice (BIS blinded anaesthesia, reflecting moderately to highly deep anaesthesia and blinded rSO2 measurements).


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective coronary artery bypass graft surgery
* patients at 65 years of age and older

Exclusion Criteria:

* diseases of the central nervous system including dementia
* inadequate knowledge of English
* a current or past psychiatric illness
* current use of tranquilizers or antidepressants
* severe visual, auditory, or motor handicap
The Doses of Systemic Steroid in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)

It is well established that steroid use is a benefit in the treatment of chronic obstructive pulmonary disease (COPD) with acute exacerbation (AE). But it is still debated about the regimen and dosage of steroid use. From this retrospective review of medical charts, the researchers investigated the therapeutic impact of various steroid dosages in COPD with AE.

Data collection from medical charts was conducted at Far Eastern Memorial Hospital, a tertiary-care hospital with around 900 beds. Patients who were admitted from January 2008 to December 2008 and diagnosed as having chronic obstructive pulmonary disease with acute exacerbation (code ICD-9: 491.21) were included in this study. The study was approved by the Institutional Review Board of the Far Eastern Memorial Hospital (FEMH:098097-3).

Demographic data, medical histories and medicine prescriptions at outpatient clinics, emergency and inpatient departments were collected. The initial presentations of acute exacerbation and laboratory data were also summarized from the records of the emergency department. The reports of pulmonary function tests within 6 months before or after the exacerbations were included while reviewing the charts. The probability of concomitant pneumonia (pAECOPD) was determined by attending physicians and reviewed by the investigator according to the radiologic findings. If there were incoherent opinions about the probability of pneumonia between the physicians and the investigator, it was determined by another independent pulmonologist. The highest daily doses and total doses of systemic steroids were calculated and recorded as the equivalent doses of prednisolone (1 mg methylprednisolone is equal to 1.25 mg prednisolone; 1 mg hydrocortisone is equal to 0.25 mg prednisolone). The subjects were divided into 3 groups according to the highest daily dose of steroids as follows: patients receiving more than 60 mg/day were designated to the HD group; those receiving less than or equal to 60 mg/day to the LD group; and those who did not receive any steroids during admission to the NIL group. The length of stay (LOS) was defined as the duration from admission to the emergency department to discharge. Hyperglycemia, psychosis, nosocomial infections and active peptic ulcer diseases were regarded as acute side effects of systemic steroids. Hyperglycemia was defined as a new blood sugar level of more than 200 mg/dl in patients without a history of diabetic mellitus, or an increment in diabetes medications. The relapse rate within 30 days was assessed by outpatient follow-up records.

Eligibility Criteria:
Inclusion Criteria:

* From January 2008 to December 2008, patients were admitted and diagnosed as having chronic obstructive pulmonary disease with acute exacerbation (code ICD-9: 491.21)

Exclusion Criteria:

-
Adjuvant Curcumin to Assess Recurrence Free Survival in Patients Who Have Had a Radical Prostatectomy

This is a prospective study to determine if the adjuvant use of Curcumin improves recurrence-free survival.

This is a prospective study to determine if the adjuvant use of Curcumin improves recurrence-free survival in patients after radical prostatectomy compared to placebo

Eligibility Criteria:
Inclusion Criteria:

* Status post radical prostatectomy for histologically confirmed adenocarcinoma of the prostate
* pathologically confirmed T1-T3 disease
* no sign of lymph node or metastatic disease
* pT1-pT3pNxMx patients in whom standard NCCN or AUA guidelines would suggest are at low risk for pelvic lymph node or metastatic disease and who would not require confirmatory imaging for metastatic disease. This includes patients with Gleason 6 or 7(T2 disease) and PSA less than 20.
* Eastern Cooperative Oncology Group(ECOG) status 0-2
* adequate renal and liver function as well as bone marrow reserve (measured serum creatinine \<2mg/dl, bilirubin ≤ 1.5 mg/dl, ANC ≥ 1.5 x 10 (3) uL, platelets ≥ 50 x K/uLL, and hemoglobin ≥ 10 g/dL)
* 30-80 y/o at time of diagnosis with a life expectancy of \>= 3 yrs
* focally positive surgical margins are permitted
* no plan to receive adjuvant hormone or radiation therapy
* PSA at the time of enrollment must be undetectable
* life expectancy of 3 years

Exclusion Criteria:

* must not have exceeded 3 months from time of surgery to enrollment into study
* T3b or T4 or node positive disease
* macroscopic residual disease after surgery
* hormone therapy before surgery
* history of gallbladder problems or gallstones, or biliary obstruction, unless patient had cholecystectomy
* radiation therapy as primary treatment after surgery
* INR value greater than 1.5
* AST/ALT are equal or greater than 2 times the upper limit of normal
* antiplatelet or anticoagulant agents- patients taking 81mg of Aspirin will be allowed with close observation
* history of gastric or duodenal ulcers or untreated hyperacidity syndromes
* patients who are currently taking curcumin and are unwilling to stop or plan to take curcumin during the study
Safety and Efficacy Study of Albiglutide in Type 2 Diabetes

The purpose of this study is to determine whether albiglutide is effective in the treament of patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* BMI 20-45kg/m2 inclusive

Exclusion Criteria:

* females who are pregnant, lactating, or \<6 weeks post-partum
* CHF NYHA class III-IV
Lung Screen Uptake Trial

This study tests the impact of a novel invitation strategy on attendance rates to a pre-lung cancer screening lung health check appointment. Patients will be individually randomised (1:1) to receive either control invitation materials or intervention invitation materials. Those who attend will undergo a "lung health check" and be invited to a baseline screening scan if eligibility criteria are fulfilled.

Lung cancer screening using low dose computed tomography (LDCT) scans has been shown to reduce lung cancer-specific and all-cause mortality in a large United States (US) trial, and screening is now being carried out in the US. Studies have shown that participation rates are invariably low, particularly by current smokers and those from socioeconomically deprived backgrounds; groups within which high risk candidates are overrepresented.

In this study the investigators aim to improve informed participation in screening and reduce socioeconomic and smoking-related biases in participation. The investigators will identify individuals at high risk of lung cancer; specifically adults aged 60-75 who are current or recent former smokers. Eligible individuals will be invited by their General Practitioner to a "lung health check appointment" via one of two randomly allocated invitation strategies. The control materials will be similar to those used by UK screening programmes for other cancer types. The intervention materials have been designed to reduce barriers to participation among smokers from low socioeconomic status backgrounds.

Those that attend will have a lung cancer risk assessment, and if confirmed to be eligible, will undergo a baseline LDCT scan. Data will be collected with respect to demographics, risk and various clinical and radiological outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Recorded as a current smoker during the year 2010 or in subsequent years since then.

Exclusion Criteria:

* Active diagnosis of lung cancer or metastases
* CT thorax within the past year
* Inability to consent to study
* Palliative care register
* GPs alert to co-morbidity that contraindicates screening or treatment for lung cancer
Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure

CO-CREATION-HF aims to evaluate the effectiveness of a comprehensive and hybrid cardiac rehabilitation model compared to supervised exercise alone.

Comprehensive, hybrid cardiac rehabilitation (CR) models have been scantly investigated in heart failure (HF) populations, particularly in low-resource settings.

A 2 parallel-arm, multi-center randomized clinical superiority trial will be conducted with blinded outcome assessment. 152 HF patients (NYHA class II or III) will be recruited consecutively, and randomly assigned. The experimental intervention will include evaluation, medical and nurse management, aerobic interval training, resistance exercise, psychosocial support, and education. These will initially be delivered in a center, transitioning to home in 4 stages. Participants in the control arm will receive face-to-face continuous aerobic exercise sessions and resistance exercises. The main outcomes are cardiorespiratory fitness, functional capacity, and quality of life. These will be measured at baseline, end of intervention, and 12-month follow-up.

The pragmatic, comprehensive hybrid CR model could be implemented more broadly if superiority is demonstrated.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with HF of New York Heart Association functional class II or III.
* Meets HF diagnostic criteria of Guidelines
* On optimal tolerated medical therapy.
* Deemed by the treating physician as stable for at least 1 month.
* Able to attend the health center three times a week for the first month, and twice a week for the 2nd and 3rd months
* Owns a mobile phone
* Patient consents to participate in the study by signing an informed consent form.

Exclusion Criteria:

* Chronic kidney disease with glomerular filtration rate \< 20 mL/min.
* Decompensated thyroid disease.
* End-stage liver failure or Child-Pugh C.
* Cardiac device or cardiac surgery in the previous month or planned in the next 3 months.
* Patients with dyspnea predominantly of non-cardiac cause (e.g. COPD).
* Atrial fibrillation with a heart rate greater than 90 beats per minute at rest.
* Active neoplasm with life expectancy \<2 years.
* Inclusion in another interventional study.
* Explicit contraindications to performing exercise.
* Comorbidities that preclude the patient from engaging in a CR program.
* Musculoskeletal or neurological disease that precludes the patient from performing exercise.
The Benefits of R Anastomotic Technique for Billroth-II Reconstruction With Braun Anastomosis During Totally Laparoscopic Distal Gastrectomy: a Propensity Score Matching Analysis

Between March 2019 and September 2022 in our centre, R anastomosis was performed on 123 patients undergoing TLDG for distal gastric cancer. A retrospective review of a prospectively collected database identified patients who underwent TLDG between January 2010 and September 2022. Patients who underwent R anastomosis were matched in a 1:1 ratio with patients who underwent conventional anastomosis using a propensity score based on age, sex, preoperative BMI, American Society of Anesthesiologists (ASA) score, and the history of abdominal surgery. Surgical and postoperative outcomes and clinicopathological data were analyzed for both groups.


Eligibility Criteria:
Inclusion Criteria:

1. elective surgery for endoscopic and pathological diagnosis of malignant tumour of the gastric antrum or body with no distant metastases confirmed by multilayer spiral computed tomography;
2. patients who underwent B-II-B anastomosis during TLDG; and (3) patients who could be followed up postoperatively.

Exclusion Criteria:

(1) patients who had received preoperative neoadjuvant radiotherapy or chemotherapy; (2) patients undergoing emergency surgery; (3) the presence of other malignant tumours concurrently; and (4) patients who were lost to follow-up.
AMIS Plus - National Registry of Acute Myocardial Infarction in Switzerland

The AMIS Plus national registry collects and analyzes data on patients with acute myocardial infarction in Switzerland in the pre-admission, hospital and follow-up phases. Emphasis is placed on the evaluation of risk factors, diagnostics, urgent therapy strategies and treatment of acute coronary syndrome. The AMIS Plus data gathered are important for assessing guidelines, improving compliance with guidelines in clinical practice, investigating patient groups not extensively studied in large randomized trials, quality assurance as well as the continuous improvement of therapeutic strategies based on a large database.

The AMIS Plus project has two main goals:

1. To Maintain a Nationwide Registry

   * An ongoing nationwide registry (databank) of acute coronary syndromes
   * Description of the patient population with acute coronary syndromes
   * Description of characteristics of treatment and hospitalization
   * Description of outcomes 3- and 12-months after admission for ACS
   * Epidemiological studies, e.g. definition of risk factors of patients with acute coronary syndromes, hospital mortality, time and cost-effective strategies as well as outcome measures
2. Quality Control

   * Evaluation of compliance with guidelines for the medical care of acute coronary syndromes
   * Internal quality control through regular feedback and benchmarking

Methods

All Swiss hospitals admitting patients with acute coronary syndrome are eligible. Data are collected on demographics, risk factors, symptoms, laboratory results, invasive therapy, complications and medication.

Since the start in January 1997, the method of data collection has continuously improved in order to suit the different needs and technological advancements of the participating hospitals. Participants can either complete paper questionnaires and send them directly to the AMIS Plus Data Center at the Institute of Social and Preventive Medicine in Zurich where these questionnaires are then checked and entered online or they can enter data directly online (AMIS online questionnaire). Data security has a high priority. Participant identification (code for hospital and physician) and a password are required to access the data entry form and send data.

Eligibility Criteria:
Inclusion Criteria: Patients who had symptoms within the last 48 hours at hospital admission with a discharge clinical diagnosis of acute myocardial infarction or patients who suffered an acute myocardial infarction in hospital during a hospitalization for other reasons.

Exclusion Criteria: Since January 2012, patients with unstable angina are no longer included.
Adverse Myocardial and Vascular Side Effects of Immune Checkpoint Inhibitors

Our knowledge on cardiovascular side effects of immune checkpoint inhibitors (ICIs) is restricted to this date to observational retrospective data (mainly case series and pharamcovigilance analysis). We aim at assessing the incidence of cardiovascular adverse side effects of ICIs by means of a prospective interventional single centre study using multiple biomarkers.

Immune checkpoint inhibitors (ICIs) are drastically improving cancer prognosis. Cardiovascular adverse side effects of ICIs are though to be rare but may be responsible for \~50% death rates.

Prospective screening for cardiovascular and muscular immune related side effects has not been undertaken independently from the industry.

The aim is to describe the incidence of these side effects by means of serial assessment in patients undergoing ICI therapy for cancer. Biomarkers as ECG, echocardiography, cardiac magnetic resonance imaging and long-term ECG monitoring will be undertaken at inclusion (before ICI therapy is started), and during the first cycle treatments and at 6 months follow-up.

Mean endpoint encompasses cardiovascular and muscular adverse side effects between the 2nd and the 3rd ICI cycle. Secondary endpoints include cardiovascular and muscular adverse side effects at 6 months follow-up, and the incidence of individual side effects.

4 ancillary studies based on patients' blood biobanking are also planned. Their objectives are:

* to assess sensitivity of heart failure biomarkers in predicting cardiovascular events under ICI,
* to assess sensitivity of cytokine biomarkers in predicting cardiovascular events under ICI,
* to bank cells to induce cardiomyocytes from stem cells
* to bank DNA to identify genetic factors related to occurrence of cardiovascular events under ICI

Eligibility Criteria:
Inclusion Criteria:

- prescribed treatment by immune checkpoint inhibitors (ICI) for cancer

Exclusion Criteria:

* previous treatment by any ICI
* any contraindication to cardiac resonance magnetic imaging
* contraindication to gadoteric acid, meglumin or any gadolinium-based contrast agent
* pace maker or automated implantable defibrilator
* pregnancy, breastfeeding
* women of childbearing potential who do not use one of the following methods of birth control: hormonal contraception or intrauterine device or bilateral tubal occlusion
* patient under legal protection
* renal failure defined by creatinine clearance \<30ml/min/m² (CKD-EPI)
* current participation or exclusion period of another interventional clinical study

Exclusion Criteria for ancillary studies:

- hemoglobinemia \< 9 g/dl