cyrilzakka/clinical-trials huggingface dataset:
Evaluate Safety and the Oncolitic Adenovirus VCN-01 Activity in Patients With Refractory Retinoblastoma

Phase I study, single site, open label with dose escalation, for evaluate safety and the oncolitic Adenovirus VCN-01 activity in patients with refractory retinoblastoma.

Phase I clinical trial, single-center, open-label, dose-escalation study, to evaluate the safety of the VCN-01 and, secondarily, its anti-tumoral activity. The trial sample consists of approximately 13 patients aged between 1 and 12 years old.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with retinoblastoma with a somatic mutation of the geneRB1 and active tumor in a single eye, or germinal mutation of RB1 with active tumor/s in an eye and the contralateral eye unaffected, enucleated or without tumor activity. In both cases, relapsed or refractory with the use of systemic, intraarterial or intravitreal chemotherapy or radiotherapy, in accordance with the availability at his/her referral site, in whom enucleation is the only recommended treatment under opinion of the medical team treating the case at the originating referral site.
2. Normal renal function: serum creatinine: \<45μmol/L (0-2 years); \<57μmol/L (3-6 years); \<60μmol/L (7-10 years); \<80μmol/L (11-13 years).
3. Normal Hepatic function: serum ALT: \<0,52μkat/L (de 9 months -12 years); serum AST: 61-80 g/L (8 months - 5 years); 63-83 g/L (5-9 years); 63-82 g/L (9-12 years).
4. Adequate marrow reserve manifested in an absolute neutrophil count\> 1000 / mm3, platelets\> 100,000 / mm3 and hemoglobin\> 8 g / dl, without transfusional or cytokine support at least one month prior to study entry.
5. Age greater than one year and less than 12 years at the time of inclusion in the study.
6. Informed consent form signed.

Exclusion Criteria:

1. Presence of factors that require immediate enucleation of the affected eye such as glaucoma, rubeosis iridis, anterior chamber involvement.
2. Comorbidities: Uncontrolled epilepsy with anticonvulsant treatment, cardiac disease not compensated by treatment.
3. Active Infections.
4. Other chronic or active acute diseases that under the criterion of the researcher were an exclusion criterion.
5. History of having received attenuated or live vaccines in the 30 days prior to inclusion in the study.
6. Any cause of Immunosuppression.
7. Trilateral Retinoblastoma.
8. Extraocular spread.
9. History of having received treatment for retinoblastoma with chemotherapy or radiation therapy by any means within 30 days prior to inclusion in the study.
10. Patients who can not complete the study procedures for reasons psychological or social.
11. Pregnancy. Female patients with procreative potential should be agree to undergo a blood or urine pregnancy test and the result should be negative to enter the study.
Quit & Fit 2.0: Feasibility and Usability Testing

Pilot randomized controlled trial to compare tobacco cessation rates of two arms: a 6-week culturally tailored tobacco cessation intervention versus a 6-week personalized culturally-tailored tobacco cessation intervention among African American women.


Eligibility Criteria:
Inclusion Criteria:

* Self-identify as an African American woman
* Currently smoke 5 cigarettes per day or more
* Has smoked daily for the past one year
* Able to provide informed consent
* Generally good health as determined by medical history

Exclusion Criteria:

* Currently pregnant
* Diagnosis of cardiovascular disease
* Diagnosis of lung disease
* Diagnosis of mental illness
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Prisoners
Pneumococcal Vaccines Early and in Combination

The purpose of this study is to determine whether an early schedule of a combination of three doses of PHiD-CV and one dose of PCV13, is superior to three doses of either PCV13 or PHiD-CV.

Aboriginal children in the Northern Territory (NT) have high rates of otitis media caused by non-capsular H. influenzae (NCHi) and pneumococci. Pneumococcal conjugate vaccine has effectively reduced disease caused by the 7 serotypes. Rates of non-vaccine serotype otitis media (OM), particularly 19A is increasing, and NCHi continues to be a major pathogen in perforations. Parallels with pneumonia are highly probable in this population. Vaccines with expanded and early age protection are needed.

In early 2009 GSK's pneumococcal H. influenzae protein D conjugate vaccine (PHiD-CV) was licensed in Australia. Compared to the current vaccine, 7PCV, this vaccine offers protection from pneumococcal serotypes 1, 5, 7F as well as NCHi (which is a primary pathogen of OM, and possibly pneumonia). However by 2010, a new generation of Wyeth's 7PCV, PCV13 will also be licensed in Australia. Compared to PHiD-CV this vaccine offers protection from additional serotypes 3, 6A and 19A, however it does not offer protection from NCHi infection. There is no empirical evidence to suggest that either vaccine will have superior clinical efficacy for otitis media or pneumonia in high-risk children. The novel combination strategy proposed for this trial has the potential to provide the best of both vaccines.

Eligibility Criteria:
Inclusion Criteria:

Indigenous infants

* 4 to 6 weeks of age
* Living in remote communities that have provided signed Expressions of Interest in participating in PREV-IX_COMBO trial
* Intend to remain in their community until their baby is 7 months of age
* Eligible for routine vaccinations.

Exclusion Criteria:

* Prior adverse reaction to pneumococcal conjugate vaccines according to Australian Immunization Handbook.
* Gestational age \< 32 weeks
A Study of LY3200882 and Pembrolizumab in Participants With Advanced Cancer

The main purpose of this study is to see if the drug LY3200882 which is an inhibitor of transforming growth factor-β (TGFβ) receptor 1 in combination with pembrolizumab is safe and effective in participants with cancer that has spread to other parts of the body.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have received a PD-1 PDLI therapy within 9 weeks of starting dosing on this study \[for example, nivolumab, pembrolizumab, atezolizumab\]
* Participants must be willing to have tumor biopsies
* Participants must have adequate organ function
* Participants must have Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
* Participants must be able to swallow tablets
* Participants with stable, previously treated brain metastases may participate if neurologic symptoms have resolved and participants have been off steroids for at least 14 days

Exclusion Criteria:

* Participants must not have moderate or severe cardiovascular disease
* Participants must not have active autoimmune disease (for example Crohn's disease, Hashimotos disease, etc)
* Participants must not have an active infection requiring treatment
Automated Control of End-tidal Volatile Anesthetic Concentration

The new MIRUS system as well as the established AnaConDa system uses a reflector to conserve volatile anaesthetics (VA). Both systems act with commercially available ICU ventilators. In contrast to AnaConDa the MIRUS includes an automated control of end-tidal VA concentrations. In this study the investigators compared feasibility, costs and recovery times after anaesthesia with isoflurane (ISO), sevoflurane (SEVO) or desflurane (DES) in ventilated and spontaneously breathing patients.

The study was approved by the appropriate Institutional Review Board. After written informed consent 63 ASA I-III patients undergoing elective hip or knee replacement surgery under general anesthesia were included. Patients were randomly organized into 3 groups (20-22 each). Anesthesia was induced with intravenous anaesthetics. After tracheal intubation MIRUS automatically adjusted the end-tidal VA concentration to 1.0 MAC. Patients were ventilated with the Puritan Bennett 840 ICU ventilator. After 1 h of anaesthesia with 1.0 MAC the ventilator mode was switched from SIMV V+ (totally controlled ventilation, "passive patient", with a tidal volume of 8 ml/IBW) to proportional assist ventilation (PAV) with 50% support ("active patient"). At the end of surgery the MIRUS system was stopped (MAC set to 0.0) and recovery times were measured.

Eligibility Criteria:
Inclusion Criteria:

* Signing of the informed consent document (patient or relatives).
* Patient age 18 years or older.
* ASA I-III

Exclusion Criteria:

* ASA IV patients
* Epidural or spinal analgesia
* Allergy or known hypersensitivity to any of the study drugs
* Patients with known or suspected genetic susceptibility to malignant hyperthermia
* Previous participation in this trial
* Participation in another clinical trial within 4 weeks prior to selection.
* Pregnant women
Risk of Acute Kidney Injury After Intravenous Contrast Computed Tomography Scans

Intravenous iodinated contrast media is commonly used to enhance diagnostic yield of computer tomography (CT) scans in clinical medicine. However, the perceived risk of contrast-induced nephropathy (CIN) frequently limits its use. While CIN is often self-limiting, it can cause significant morbidity by prolonging admissions and rendering an at-risk individual dialysis dependent. CIN has long been observed and described in clinical studies. There is ample data on CIN after administration of intraarterial contrast, but evidence is less compelling when it comes to intravenous contrast. Increasing studies have called into question the actual risk of intravenous contrast media. Expert panels are suggesting that the risk could have been overstated, leading to contrast being withheld when indicated. There is paucity of local data on this particular issue. More real world data on the actual incidence and risk factors of AKI will be helpful to clinicians.

The investigators plan to conduct a single center, retrospective study, to determine the incidence and risk factors of post contrast AKI in contrast enhanced CT scans.

A single center, retrospective study will be conducted, looking into all patients who had contrast-enhanced CT scans done in a specified time period. Serum creatinine at baseline and at 48-72 hours post-contrast of the participants will be compared to determine presence of post contrast AKI (PC-AKI). Data on the participants' demographics, comorbidities, laboratory results and use of nephrotoxins will also be captured and analysed.

The primary objective of this study is to determine the incidence of AKI after intravenous contrast administration for contrast enhanced CT scans (CECT). The secondary objective is to identify risk factors of PC-AKI and possibly come up with a risk stratification system that can be utilized in clinical practice. The investigators hypothesize that there is significant risk of acute kidney injury after intravenous contrast media administration, but it lower than that in the setting of intraarterial contrast; and that risk factors of AKI may include: pre existing chronic kidney disease, diabetes, hypertension, proteinuria, use of nephrotoxins, age, increased dose of contrast.

Eligibility Criteria:
Inclusion Criteria:

1. Underwent one or more CT scan in CGH in the stipulated study period
2. CT scan done as an inpatient or outpatient of CGH
3. Serum creatinine available less than 6 months before scan
4. Serum creatinine available within 1 week after scan

Exclusion Criteria:

1. Age 12 or below
2. Dialysis dependent before scan (dialysis related charge code applied 24 months before scan)
3. Baseline serum creatinine not available
4. Post scan serum creatinine not available
Low Level Laser Versus Neural Mobilization of Brachial Plexus on Shoulder Dysfunction Post Liver Donation

The purpose of the study will be to compare therapeutic effect of low level laser versus neural mobilization techniques on shoulder dysfunction post liver donation.

The need for this study develops from the lack of information in the published studies about the effectiveness of low level laser and neural mobilization of brachial plexus on shoulder dysfunction post liver donation.

Following liver donation and transplantation, shoulder dysfunction and discomfort occur in 20% to 60% of patients.

Low-level laser therapy (LLLT) has been used as a non-pharmacological alternative to treat painful musculoskeletal conditions. It is used in acute, chronic painful and inflammatory affections shows that low energy irradiation from lasers alters cellular processes, producing anti-inflammatory effects and increased collagen turnover.

Neural mobilization (NM) is an intervention aimed at restoring the homeostasis in and around the nervous system, by mobilization of the nervous system itself or the structures that surround the nervous system. Neural mobilization facilitates movement between neural structures and their surroundings (interface) through manual techniques or exercise. Human and animal studies revealed that NM reduces intraneural edema, improves intraneural fluid dispersion, reduces thermal and mechanical hyperalgesia and reverses the increased immune responses.

The present study is designed to investigate the effect of LLLT versus NMT on shoulder dysfunction post liver donation.

Eligibility Criteria:
Inclusion Criteria:

* Patients are both males and females.
* Their age will range from (20-50) years.
* Patients will suffer from unilateral shoulder pain(Rt shoulder).
* Patients will begin the training program one week post.operative.
* All patients will suffer from moderate to severe pain (VAS score \> 4).
* Patients will be given their informed consent.

Exclusion Criteria:

* Known history of high level Spinal cord injury and malignancy
* Metabolic disease with a neurological component such as diabetes.
* Orthopedic disorders such as fracture or dislocation.
* Musculoskeletal disorders that will impair performance during training and tests.
* Uncontrolled cardiovascular or pulmonary diseases .
* Circulatory disturbances of upper extremity
* Psychiatric illness, severe behavior or cognitive disorders.
* Uncooperative patients.
China STEMI-PCI Program

1. Registration
2. Performing in three stages
3. Major aim: Much more and standard reperfusion therapy in STEMI patients


Eligibility Criteria:
Inclusion Criteria:

* Onset of STEMI within 12h
* Onset of STEMI within 12-36h needing primary PCI

Exclusion Criteria:

-
Efficacy of Aclidinium Bromide Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

The main purpose of this study is to evaluate the efficacy, safety and tolerability of multiple doses of inhaled aclidinium bromide in moderate to severe COPD patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult male and female patients aged 40 with stable moderate to severe COPD (GOLD guidelines).
* Post-salbutamol (FEV1) \< 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/FVC \< 70%.
* Current or ex smokers of 10 pack-years.

Exclusion Criteria:

* Patients with no history or current diagnosis of asthma.
* No evidence of an exacerbation within 6 weeks prior to the screening visit.
* No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
* No contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
Case Method Education on COPD to General Practitioners

Background:

COPD is an inflammatory and chronic obstructive lung disease, mainly caused by smoking. Most patients with COPD are discovered and treated in primary health care. Co-morbidity with heart disease, hypertension, diabetes, osteoporosis and underweight is common. It is important to diagnose COPD at an early stage, primarily to motivate smoking cessation, which is the most important factor for decelerating the progress of COPD. In addition, medication and rehabilitation to reduce symptoms of COPD can be given. Previous studies in Sweden have shown poor quality of primary health care provided to patients with COPD.

As general practitioners often deal with multiple medical problems and patients' motivation when diagnosing and treating COPD we hypothesize that case method education (see description under "intervention") in COPD has better effect than traditional education (see description under "intervention").This study aims to examine the effect of case method education on (1) learning in COPD among general practitioners and on (2) health in their patients with COPD.

Method:

Primary health care centers (PHCC) in Stockholm will be recruited. The PHCCs will be randomized to either case method education (n=9 PHCCs) or traditional education (n=9 PHCCs) in COPD for their general practitioners. The educations will be held during two times (two hours each) within a time range of three months, covering examination and treatment of patients with COPD. At least 10.000 patients should be listed at PHCCs included. Random sampling of 45 patients with COPD at stage 2-3 will be done from each PHCC. The patients will fill in a self-assessment questionnaire including CCQ, CAT and LINQ (see outcome measures) as well as questions about medication, exacerbations and other chronic diseases. The questionnaire will be sent to the patients 1-2 months before the education and 18 months after the education. Differences in assessments in the questionnaire before and after the education will be compared between the patients listed at the PHCCs that have received case method education vs. traditional education. In addition, general practitioners (approximately, n=180) at the PHCCs will fill in a questionnaire, immediately before and 12 months after the education, covering the learning outcomes in order to study differences in learning between the two intervention groups.


Eligibility Criteria:
Inclusion Criteria:

* Primary Health Care Centers (PHCC): \>10.000 patients listed. \>70% permanent employed general practitioners
* Patients: Diagnosis of COPD registered at the COPD. Grade of COPD 2-3 (GOLD) at the latest spirometry completed since 2008.

Exclusion Criteria:

* None
Spinal Cord Compression Re-Treat Study

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Radiation therapy may be effective in treating malignant spinal cord compression in patients who have received previous radiation therapy to the spine.

PURPOSE: This phase II trial is studying radiation therapy in treating patients with malignant spinal cord compression.

OBJECTIVES:

Primary

* To determine the efficacy of a biologically effective dose-based re-irradiation strategy, in terms of the response rate (based on the mobility score using the Tomita scale where improvement in mobility or stable mobility score will be regarded as a response) in patients with malignant spinal cord compression.

Secondary

* To determine quality of life as assessed by the EORTC QLQ-C15 PAL version 1.0 questionnaire.
* To determine the non-spinal radiation-induced toxicity using standard RTOG criteria.
* To determine the rate of long-term spinal toxicity and radiation-induced myelopathy using the RTOG SOMA morbidity grading system.

OUTLINE: Patients are divided into 2 groups according to the interval since their most recent radiotherapy to the involved area of the spinal cord.

* Group 1 (\< 6 months since prior radiotherapy): Patients undergo radiotherapy for a cumulative biologically effective dose (BED) ≤ 100 Gy_2 in addition to receiving other current treatment.
* Group 2 (≥ 6 months since prior radiotherapy): Patients undergo radiotherapy for a cumulative BED ≤ 130 Gy_2 in addition to receiving other current treatment.

Mobility score is assessed and patients complete a quality-of-life assessment at baseline and at each follow-up visit starting at week 5.

After completion of study treatment, patients are followed up at 1 and 5 weeks, at 3 months, and then every 3 months thereafter.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* MRI-confirmed diagnosis of malignant spinal cord compression

  * MRI of the entire spine performed
* Histologically proven malignancy

  * No primary tumors of the spine or vertebral column
* Undergone previous radiotherapy to the involved area of the spinal cord (e.g., full segment and/or ≥ 2 cm in cranio-caudal of overlap between the 2 areas treated)

  * Maximum biologically effective dose received from previous irradiation ≤ 90 Gy_2
* Deemed not suitable for neurosurgical intervention at the time of initial assessment

  * Patients deemed inoperable are eligible

PATIENT CHARACTERISTICS:

* Karnofsky performance status 40-100%
* Short life expectancy
* No medical or psychiatric condition that, in the opinion of the investigator or research team, contraindicates participation in this study

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Correlation of Renal Mass Pathologic Grade and Contrast Enhanced Ultrasound (CEUS)

Patients with renal lesions suspicious for renal cell carcinoma (RCC) have a variety of different treatment pathways available to them. Imaging surveillance is being used frequently on smaller renal masses, and radiologists are being asked to biopsy more renal lesions to better guide decision making by urology. This is in large part due to the pathologic grade of renal masses having been shown to correlate with patient outcomes. The World Health Organization (WHO) or Fuhrman grade is the standard grading scale used by pathologists for RCC. The goal of this study will be to correlate contrast enhanced ultrasound findings with the pathologic grade of RCC. Specifically, the investigators hypothesize that tumors with different pathologic grades will show different patterns of qualitative enhancement, as well as different perfusion kinetics.

Renal malignancies are relatively common, with lifetime risk ranging from 1 in 48 in men to 1 in 83 in women, of which RCC is the most common. RCC comes in a variety of subtypes, and pathologic grade has been shown to be one factor that correlates with patient prognosis \[Novara et al\]. The most commonly used pathologic grading systems are the WHO or Fuhrman scale, which rely on histologic features of the tumor such as nuclear size, irregularity, and nucleolar prominence.

Care of patients with RCC depends on a number of factors, including size and pathologic grade. As such, radiologic surveillance with CT and MRI is common, and percutaneous biopsy of renal masses for the purpose of pathologic grading is also relatively common. While percutaneous biopsy of renal masses is the least invasive way to obtain tissue, these still carry risks, especially of hemorrhage give the vascular nature of the kidneys and RCC.

Contrast enhanced ultrasound has been shown to have the ability to differentiate renal masses from normal background renal parenchyma \[Barr et al\]. It has the unique ability to be used in patients with renal dysfunction as it is excreted by the liver and lungs. As such, it is well suited for use in patients with underlying renal pathology. This study will aim to use contrast enhanced ultrasound to evaluate the qualitative and quantitative features of renal masses prior to surgical removal, and then evaluate for correlation of these features with pathologic grading following surgery.

Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 18 years of age
* Previously identified renal mass with radiology and clinical features consistent with RCC
* Clinical care plan includes partial or total nephrectomy

Exclusion Criteria:

* Less than 18 years of age
* Currently pregnant
* Renal mass with clinical care plan that does not include nephrectomy
* Renal mass suspected to be non RCC neoplasm by imaging and clinical data
* Renal mass unable to be visualized by grayscale ultrasound
* Known renal vein thrombosis