cyrilzakka/clinical-trials huggingface dataset:
Fulfilling Care Needs of Adolescents With Cancer

The aim of phase 1 of this study is to develop a care need scale (CNS) for adolescents with cancer. The aim of phase 2 is to examine the mediating role of care needs between physical and psychosocial dysfunction and QoL, and to explore the recovery trajectory and its predictors regarding the care needs, physical and psychosocial factors, and the QoL of adolescents with cancer at the first, second, and third 3-month periods after initiating on-treatment and off-treatment. The aim of phase 3 is to examine the effectiveness of the computerized assessment with graphic outcome (CAGO) for fulfilling the care needs of adolescents with cancer, its acceptability for adolescents with cancer, and its usability for clinicians in pediatric oncology units.


Eligibility Criteria:
The inclusion criteria for adolescents with cancer are

1. 13-20 years of age
2. previously or currently treated for cancer
3. able to communicate in Chinese
4. able to comprehend the study information
Adenovirus (RGDCRAdCOX2F)

This is a single center, Phase I dose finding study of a single direct tumor injection of an RGD modified conditionally replicative adenovirus (RGDCRAdcox2F) in persons with adenocarcinoma of the pancreas. The study is designed to determine the MTD of RGDCRAdCOX2F that corresponds to the maximum desired toxicity of ≤ 20%.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented pancreatic adenocarcinoma that is confined to the pancreas and regional lymph nodes after staging by CT or MRI and endoscopic ultrasound.
* One prior line of therapy is permitted (i.e. neo-adjuvant therapy); however, at least 4 weeks must have elapsed between the last dose of drug and the injection of RGDCRAdCOX2F.
* Must be able to tolerate esophagogastroduodenoscopy (EGD) and the tumor must be accessible by endoscopic ultra sound. Participants will be excluded if obtaining biopsies are deemed unsafe or not feasible.
* Age 18 years of age or older at the time of consent
* Normal cardiac and pulmonary function based on history and physical exam
* Participants with partners of childbearing potential must be willing to use at least two forms of effective birth control (one form must be a barrier method) for at least 1 month after Day 1.

Exclusion Criteria:

* Pregnant or breastfeeding. Persons of child-bearing potential must have a negative pregnancy test (serum or urine) with 14 days of study enrollment.
* Other pancreatic malignancies (e.g., neuroendocrine tumors and mucinous cystic) and adenocarcinomas of the ampulla, bile ducts, and duodenum.
* Tumors in mucosal regions or close to an airway, major blood vessel, or spinal cord that in the opinion of the enrolling investigator could cause occlusion or compression in the case of tumor swelling or erosion into a major vessel in the case of necrosis.
* Known history of human immunodeficiency virus (HIV) infection
* Known history of or active acute or chronic active hepatitis B or C infection
* Serious concurrent infection or medical illness, which in the enrolling investigator's opinion would jeopardize the ability of the participant to receive the treatment outlined in this protocol with reasonable safety.
* Requires immunosuppression ≥10mg/day of prednisone for more than

  1 week.
* History of or active known or suspected autoimmune disease, or a syndrome that requires systemic or immunosuppressive agents.
* Disease beyond the regional lymph nodes
* Active diffuse pancreatitis
* Active inflammatory conditions
* Prior gastrojejunostomy
Utilization of Fixed Combination (Budesonide/Formoterol and Salmeterol/Fluticasone and Beclomethasone/Formoterol) in Treatment of Asthma Patients

Moderate and severe asthma bronchiale is treated by fixed combination (budesonide/formoterol or salmeterol/fluticasone) in the Czech Republic.

There is a hypothesis that doctors should prescribe to each patients per year: six units of fixed combination budesonide/formoterol, or seven units of fixed combination budesonide/formoterol in approach SMART, or twelve units of fixed combination salmeterol/fluticasone. With regard to current prices the treatment by fixed combination budesonide/formoterol should cost less.

The investigators do not have any data about real life utilization of fixed combination in asthma treatment in Czech Republic The investigators propose to conduct a non-interventional multicentric retrospective epidemiological study looking into the patients records kept by specialist - allergists and pulmologists.

Retrospective data for eligible patients will be reviewed by participating investigators, physicians taking care of their patients, and recorded in the electronic CRF. Only patients who have been treated for asthma bronchiale (classification of severity - moderate or severe persistent asthma) with fixed combination for at least one year could be included into the study. There are no scheduled visits for any patient participating in the study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 6 years or over
* Asthma bronchiale, classification of severity - moderate or severe persistent
* Documented fixed combination (budesonide/formoterol or salmeterol/fluticasone) therapy for at least 18 months
A Phase II Study of CPC-201 to Treat Alzheimer's Disease Type Dementia

This is a Phase II, Single-Blind, Placebo-Controlled, Sequential Treatment, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of CPC-201 in Patients with Alzheimer's Disease Type Dementia.


Eligibility Criteria:
Inclusion Criteria:

* Aged 50 - 79 years inclusive.
* Meeting the diagnosis of probable Alzheimer's Disease
* Of moderate severity (Mini-Mental Status Exam \[MMSE\] score 10 - 20 inclusive).
* Patients must be in generally good health as indicated by their medical history and physical examination, vital signs, electrocardiogram (ECG), and standard laboratory tests.

Exclusion Criteria:

* Women of child bearing potential.
* History or presence of a seizure disorder.
* History of peptic ulcer disease, urinary or gastric retention; asthma or obstructive pulmonary disease.
* History or presence of bladder outflow obstruction, gastrointestinal obstructive disorder or reduced GI motility, or narrow-angle glaucoma.
* History or presence of gastrointestinal, hepatic, or renal disease, or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
* History or presence of myasthenia.
* Known hypersensitivity to donepezil, solifenacin or related drugs.
* Any other clinically relevant acute or chronic diseases which could interfere with patients' safety during the trial, or expose them to undue risk, or which could interfere with study objectives.
* Patients who have participated in another clinical trial with an investigational drug within previous 30 days.
ECA-enhanced Document Explanation RCT

The investigators will evaluate a computer-animated character that explains medical illustrations to people, comparing the character to having people understand the illustrations on their own, and also comparing the computer character on a computer display to one in immersive virtual reality. The investigators will determine which method leads to the best understanding and lowest anxiety.

The investigators are developing a new approach to explaining patient education documents and illustrations to patients with varying levels of health literacy, involving the use of Embodied Conversational Agents (ECAs). The investigators will evaluate our ECA-augmented Document Explanation tool to determine whether it improves patient learning relative to traditional static patient education documents. The investigators will conduct a 3-arm randomized between-subjects experiment, in which participants read a patient education document with embedded medical illustration, either unaided (CONTROL), with the assistance of an ECA rendered in 2D on a standard computer monitor (ECA-2D), or with the assistance of an ECA in immersive Virtual Reality (ECA-3D).

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Speaks English or Spanish ﬂuently
* Is able to independently consent
* Has adequate corrected vision to read patient education documents

Exclusion Criteria:

\* None
Remote Preconditioning and Myocardial Protection

Remote ischemic preconditioning (RIPC) of the myocardium by limb ischemia/reperfusion may mitigate cardiac damage, but its interaction with the anesthetic regimen is unknown.

The investigators will test if RIPC will be associated with differential effects depending on background anesthesia. Specifically, the investigators hypothesized that RIPC during sevoflurane anesthesia attenuates myocardial injury in patients undergoing congenital cardiac defects repair surgery and that effects may be different during propofol anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric scheduled for cardiac surgery requiring the cardioplegic arrest and cardiopulmonary bypass

Exclusion Criteria:

* Previous cardiac surgery
* Urgent or emergent cases
* Patient with the following diseases diabetes mellitus ,hypertension ,renal failure, hepatic and pulmonary diseases
ATRX/DAXX in EUS-FNB Specimens of Pan-NETs

P-NENs are classified as functional (F-) or non-functional (NF-) depending on the presence or absence of a clinical hormonal hypersecretion syndrome. Moreover, the WHO 2017 classification of pNENs distinguishes between well-differentiated pancreatic neuroendocrine tumors (pNETs) and poorly differentiated pancreatic neuroendocrine carcinomas (pNECs). pNETs are then divided according to a grading scheme based on Ki67 index in pNETs-G1 (Ki67 index ≤3%) and pNETs-G2 (Ki67 index between 4% and 20%). pNECs are all G3, with a Ki67 index \>20%. Endoscopic ultrasound with fine-needle biopsy (EUS-FNB) demonstrated safe and effective preoperative grading based on the Ki-67 proliferative index. However, downstaging rate is not neglectable, reaching 15% in a recent metanalysis. Moreover, recent whole-exome and whole genome sequencing studies revealed that the mutually exclusive inactivating mutations in death domain-associated protein (DAXX) and/or in α-thalassemia/mental retardation X-linked (ATRX) chromatin remodeling genes are associated with more aggressive disease. In a retrospective study, the investigators recently evaluated the correspondence of DAXX/ATRX expression on 41 EUS-FNB samples with corresponding surgical specimens demonstrating a 95.1% (almost perfect agreement, κ = 0.828; p \< 0.001) and 92.7% (substantial agreement, κ = 0.626; p \< 0.001) concordance for DAXX and ATRX expression, respectively. This study aims to evaluate the potential clinical/prognostic role of DAXX/ATRX expression as implementation of the currently used Ki67-based grading, evaluated on EUS-FNB samples in a prospective cohort of patients with NF-pNETs


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Cyto/histologic diagnosis of pNETs
* Signed informed consent

Exclusion Criteria:

* Functional pNETs
* Multiple pancreatic nodules
* Diagnosis of MEN-1 or Von-Hippel Lindau
* Mixed types (e.g., mixed neuroendocrine-acinar/adenocarcinoma) or neuroendocrine carcinomas
* Predominantly cystic lesions (more than 50% of the volume).
* Metastatic tumors at the time of diagnosis
* Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma
* Use of anticoagulants that cannot be discontinued
* INR \>1.5 or platelet count \<50.000
* Pregnancy or breastfeeding
* Failure to sign the patient's or closest relative's informed consent
Treatment of Heart Failure and Associated Functional Mitral Valve Regurgitation

The objective of the study is to evaluate the safety and performance of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).


Eligibility Criteria:
Inclusion Criteria:

1. Is ambulatory, able and willing to comply with the study protocol and has provided written informed consent
2. Age ≥ 18
3. Trans-septal catheterization is determined to be feasible by the treating physician
4. NYHA class II-IV heart failure of any etiology
5. Symptomatic with MR grade ≥ 2+
6. LVEF ≥20% ≤ 50%
7. LVEDD \> 50 mm and ≤ 70 mm
8. No anticipated change in patient's cardiac medication regimen anticipated throughout the course of the study.
9. • In the opinion of the investigator and heart surgery team, the patient is not a candidate for surgery, and the use of the ARTO™ System is technically feasible.

Exclusion Criteria:

1. In the opinion of the Investigator, the femoral vein and internal jugular vein cannot accommodate a 16 F catheter or the presence of an inferior vena cava (IVC) filter would interfere with advancement of the catheter or ipsilateral DVT is present
2. Significant structural abnormality of the mitral valve (e.g., flail, prolapse, leaflet calcification)
3. Significant mitral annular calcification
4. Hemodynamic instability (systolic pressure \< 90 mmHg without afterload reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump)
5. Prior mitral valve surgery or valvuloplasty or any currently implanted prosthetic valve or VAD
6. History of, or active, rheumatic heart disease
7. History of Atrial Septal Defects (ASD), whether repaired or not
8. History of previously repaired PFO or PFO associated with clinical symptoms (e.g., cerebral ischemia) within 6 months of the planned investigational procedure
9. In the opinion of the investigator, an atrial septal aneurysm is present that may interfere with transseptal crossing
10. Biventricular pacing initiated or anticipated within 6 months of the planned investigational procedure
Conjugated Linoleic Acid on Body Weight and Body Fat Mass for 12 Weeks

This study has purpose to assess the effect of conjugated linoleic acid (CLA)-fortified milk powder with nutrition counseling and nutrition module in body weight and body fat mass among overweight and obese adult in Indonesia

After being informed of the potential benefits and risks regarding the study, the respondents were asked to sign the consent. The respondents who met the criteria of overweight/ obese without any historical diseases will be randomized into intervention or placebo groups. The intervention will be given for 12 weeks (CLA-fortified milk powder 3.4 gram, once-daily consumption). Both the intervention and placebo groups will also receive nutrition counseling and nutrition module.

Eligibility Criteria:
Inclusion Criteria:

1. Body mass index (BMI) 23 - 24.9 kg/m2 for overweight and ≥ 25 kg/m2 for obese
2. Fat mass percentage (FM%) of ≥ 20% for men and ≥ 30% for women
3. Agree to follow the study

Exclusion Criteria:

1. Lactose intolerance
2. Undergoing treatment (e.g., antibiotics and/or anti-inflammatory or immunosuppressant drugs and weight loss)
3. Any physical condition that might be contraindicated to dietary restrictions
4. Any non-communicable disease (e.g., Diabetes Mellitus, Chronic Kidney Disease, Cancer, Hypertension)
5. Pregnant
A Novel Clinically Usable Point Score To Prejudge The Complexity Of Colonoscopy

Colonoscopy is the current common method for management of colorectal diseases, and effectiveness of colonoscopy associate with complication rate. A lot of patients were failed because of technical difficulty, those required more than 10 min to intubate the cecum are consider as difficult colonoscopy, in such condition, specialized equipment or maneuvers may be required for a successful colonoscopy. Thus, it is important to set up a clinical model to predict the technical difficulty of the examination in preoperational stage.


Eligibility Criteria:
Inclusion Criteria:

* patients aged 18-90 years old who undergoing colonoscopy without sedation

Exclusion Criteria:

* no bowel preparation or colon cleansing by enema only
* no need to reach cecum
* prior finding of severe colon stenosis or obstructing tumour
* history of colectomy
* unstable hemodynamics
* pregnant
* unable to give informed consent
The Assessment of Right Ventricular Contractility in Response to Sildenafil

The primary objective of this study is to examine the effects of Sildenafil, administered during cardiac catheterization, on right ventricular contractility in children with pulmonary arterial hypertension.

The effectiveness of Sildenafil as a pulmonary vasodilator in children with heart disease was first reported in detail during cardiac catheterization and postoperatively in 2003. It is now used frequently for long-term treatment of children with pulmonary arterial hypertension at The Hospital for Sick Children and it is now a routine part of the hospital's testing protocol for all patients being evaluated for pulmonary hypertension in the cardiac catheterization laboratory.

The beneficial effects of Sildenafil in pulmonary hypertension are thought to result predominantly from relative vasodilatory and antiproliferative effects on the pulmonary vasculature. On the basis of early data showing lack of significant PDE5 expression in the normal heart, PDE5 was thought to be expressed in the coronary vessels but not in the human myocardium. Very recently, it was reported for the first time that PDE5 is markedly upregulated in hypertrophied right ventricular myocardium in humans and that in the rat PDE5 inhibition with Sildenafil increases contractility in hypertrophied right ventricular myocardium but not in normal right ventricle, which lacks PDE5 expression. The assessment of right ventricular contractility in humans is a challenge, but we have developed several techniques that are recognized as 'state of the art' assessment of right ventricular function.

The purpose of this study is to examine the effects of Sildenafil, which is routinely administered during cardiac catheterization to assess pulmonary vascular resistance, on right ventricular contractility in children with pulmonary arterial hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Significant pulmonary arterial hypertension (mean pulmonary artery pressure \> 25 mm Hg)
* Patients aged 4-18 years
* Routine cardiac catheterization clinically indicated for deciding therapeutic treatment
* Informed assent/consent from patient/parent

Exclusion Criteria:

* Suprasystemic pulmonary artery pressures
* Evidence of right heart failure
* History of ventricular arrhythmia
* Known vascular access arrhythmia
* Contraindication to Sildenafil
* Concurrent inotropic / PDE administration
* Other medical, psychological or social circumstances which complicate a regular participation in the study, and/or increase the risk for the patients themselves
* No consent/assent
* Pregnancy or unwillingness to comply with contraceptive advice
A Combined Transvenous and Epicardial Lead Placement Procedure for Implantation of Cardiac Resynchronization Devices: a Feasibility Study.

Cardiac resynchronization therapy has become one of the cornerstones of the treatment of heart failure. However, a large proportion of patients still fails to this type of therapy. This may be due to a suboptimal position of the left ventricular pacing lead, which may be caused by unfavorable cardiac venous anatomy. Implantation of the pacing lead using video assisted thoracic surgery is more flexible and evades the venous system altogether, resulting in a much more favorable position of the pacing lead, with better treatment results as e consequence.


Eligibility Criteria:
Inclusion criteria

* NYHA class II-III.
* Left ventricular ejection fraction ≤ 35%.
* QRS-duration of ≥ 120 ms (NYHA III) or ≥ 130 ms (NYHA II) and left bundle branch block morphology.
* No sidebranch of the coronary sinus near the posterolateral wall of the left ventricle and/or presence of a Thebesian valve which reduces coronary sinus diameter 50% or more (corresponding to a decrease in cross sectional area of 75% or more).
* On optimal medical therapy for heart failure, including beta-blockers, ACE-inhibitors, AT2-antagonists and aldosteron antagonists.
* Age ≥ 18 years.
* Signed informed consent.

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Coronary ischemia or a recent myocardial infarction (\< 6 months).
* Allready a CRT-device implanted.
* Venous thrombosis without options to reach the right heart.
* Presence of any other condition than HF with a life expectancy of \< 1 year.
* History of intrathoracic surgery.
* Presence or suspected presence of a noncompliant left lung.
* Participation in another intervention trial.
* Unable to understand Dutch language.
* Pregnant women.
A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis

This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab (RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis who are intolerant of methotrexate or where continued treatment with methotrexate was considered inappropriate. Patients were randomized to receive either tocilizumab 8 mg/kg intravenously (iv) every 4 weeks plus placebo subcutaneously (sc) every 2 weeks, or adalimumab 40 mg sc every 2 weeks plus placebo iv every 4 weeks. Treatment was anticipated to last 24 weeks. With regard to the blind, the study nurse was unblinded due to the nature of the treatment administration, but the investigator and the patient remained blinded.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, ≥ 18 years of age.
* Rheumatoid arthritis of \> 6 months duration.
* Intolerant of methotrexate or continued treatment with methotrexate is considered inappropriate.
* All disease-modifying anti-rheumatic drugs (DMARD) are to be withdrawn prior to receiving study drug.
* Weight ≤ 150 kg.

Exclusion Criteria:

* Major surgery (including joint surgery) within 12 weeks prior to baseline or planned major surgery within 6 months after baseline.
* History of or current inflammatory joint disease other than rheumatoid arthritis (RA).
* Treatment with a biologic agent at any time prior to baseline.
* Intra-articular or parenteral corticosteroids ≤ 4 weeks prior to baseline.
* Active current infection or history of recurrent bacterial, viral, fungal or mycobacterial infection.