cyrilzakka/clinical-trials huggingface dataset:
Retrospective Study on the Efficacy and Tolerability of Liposomal Irinotecan

The aim of this retrospective study is to confirm the efficacy and safety results obtained in the NAPOLI-1-study, when Onivyde® in combination with 5-FU/LV is used in real-life practice in Belgium. The data needed to do so will be obtained using information that is routinely collected as part of patient's medical care.

Patients with pancreatic cancer have a poor prognosis with a 5-years survival of only 1-2%. This arises from the fact that it is typically diagnosed late, when curative resection is impossible. These patients are thus restricted to chemotherapy, with gemcitabine-based therapies being the standard of care for patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (mPDAC). However, even after second or subsequent lines of therapy, disease progression is inevitable. Therefore, the need for new treatment options is high. Recently, the advantage of using nanoliposomal irinotecan (Onivyde®) in combination with 5-fluorouracil and leucovorin (5-FU/LV) over the use of 5-FU/LV alone was demonstrated in a phase-3 randomized clinical trial (NAPOLI-1 trial). As this study showed significant improvement on overall survival, progression-free survival, time to treatment failure, overall response rate and tumor marker CA19-9 response, on October 14 2016 this therapy was approved by the EMA to be used for patients with mPDAC previously treated with gemcitabine-based therapy.

While randomized clinical trials, like the NAPOLI-1 trial, are considered the reference standard for comparing the efficacy and safety of treatments, these studies do not always reflect the everyday clinical practice. Therefore, the aim of this study is to evaluate the efficacy and safety of Onivyde® in real-life practice in Belgium. This information would be very valuable to determine the value of the drug and improve the knowledge of the actual use of Onivyde® after marketing authorization.

Eligibility Criteria:
Inclusion Criteria:

* Patient has diagnosis of pancreatic adenocarcinoma with documented metastatic disease.
* Patient progressed after gemcitabine-based therapy.
* Patient received at least one treatment cycle with Onivyde® + 5-FU/LV 5FU in the context of post-gemcitabine based therapy of mPDAC.

Exclusion Criteria:

* Patient has not received at least one treatment cycle with Onivyde® + 5-FU/LV.
* Previous irinotecan-based therapy in metastatic setting.
* Patientstarted the treatment with Onivyde® + 5-FU/LV after 01/04/2021
18F-DCFPyL PET-CT Scan and Prostate Cancer

Primary Objective:

The primary objective of this study is to assess the efficacy of 18F-DCFPyL PET-CT for initial staging of prostate cancer in Veterans compared to conventional imaging (99mTc-MDP bone scan and Diagnostic CT or MRI). The primary clinical endpoint of our study is the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT identifies M1 disease at initial staging.

Secondary Objectives:

Frequency of the change in primary treatment plan after initial staging.

This is a single arm Phase II clinical trial in Veterans with prostate cancer, no prior local therapy, who are at risk of having metastatic disease (PSA greater than 10, or Gleason Score greater than or equal to 4+3, or clinical stage greater than or equal to T2c). Veterans who are planned to undergo or have recently undergone conventional, routine care initial staging scans for prostate cancer (99mTc-MDP or NaF PET bone scan and diagnostic CT or MRI of pelvis) will also receive a 18F-DCFPyL PET-CT scan. The primary endpoint is the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT scan identifies evidence of M1 disease at initial staging.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years and male.
2. Ability to understand the study and the willingness to sign a written informed consent document.
3. Histologically confirmed adenocarcinoma of the prostate.
4. PSA greater than 10, or Gleason ≥4+3, or clinical stage greater than or equal toT2c.
5. Plan to undergo (or have already undergone) routine care initial systemic staging with conventional imaging for prostate cancer.
6. Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
7. No prior local therapy for prostate cancer (i.e., prostatectomy, radiotherapy, etc.).
8. Willing to comply with the procedural requirements of this protocol.

Exclusion Criteria:

1. Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection.
2. The subject has a condition or situation that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study.
3. Primary small cell carcinoma of the prostate.
4. Participation in this study significantly delay the scheduled standard of care therapy.
5. Weighs greater than 350 lbs., or unable to fit within the imaging gantry.
6. The subject undergone prior local therapy for prostate cancer (i.e. prostatectomy, radiotherapy, etc.).
7. Currently receiving androgen deprivation therapy (ADT) or anti-androgen? Previous use of ADT is allowed IF the subject has been off ADT or anti-androgen for 3 months or more.
Depression and Suicide Prevention in Adolescents Attending Special Schools

Depression is a major public health concern. In Dutch adolescents, the prevalence of major depressive disorder is estimated at 3.8%, and one in five adolescents report depressive symptoms. Depression is a risk factor in adolescent suicide. School-based prevention programs, for example the STORM approach, are effective in decreasing depressive symptoms among adolescents with elevated depressive symptoms at screening. However, not all adolescents attend general education. In the Netherlands, 7% of all adolescents enters special education (voortgezet speciaal onderwijs and prakijkonderwijs). They form a vulnerable subgroup concerning developing depressive symptoms and suicidality. To adapt and implement programs for these students, is complex yet crucial. This study aims to screen adolescents, offer them a prevention program to prevent the onset or continuation of depression and evaluate the effectiveness of this program. It is a randomised controlled trial with two conditions. The main study parameter is depressive symptomatology. Secondary study parameters are suicidality, anxiety and somatic complaints.

Eligible students enter the second or third grade of special education, presenting elevated depressive symptoms. All adolescents will be screened for depressive and suicidal symptoms. Those reporting suicidality will be guided to specialised care, together with their parents. Adolescents with elevated depressive symptoms in the experimental condition will be offered the CBT-based preventive group training Op Volle Kracht in their school setting. The control condition consists of monitoring, and is offered the training if the intervention has shown to be effective. Participants will fill in longitudinal measurements. At all times, adolescents will be guided to mental health care if necessary. Furthermore, teachers in all participating schools will attend a training on how to detect and address depressive and suicidal symptoms among adolescents.

The potential value of the study is that we can offer adolescents in the special educational sector a prevention program that is proven to be effective. In order to achieve this goal we need to evaluate the effectiveness of this prevention program in this target group. We are of opinion, however, that the risks associated with participation can be considered negligible. It is specifically aimed at depressive symptoms, within a population which receives care for other problems.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents are in their second or third year of secondary education, ór adolescents will reach the age 14 or 15 in this academic year.
* Score above cut-off on depression symptom questionnaire (≥ 14 on the CDI-2; Bodden et al. (2016)).

Exclusion Criteria:

* Adolescents who score 2 on item 8 of the CDI-2 or ≥ 23 on the VOZZ-screen (Kerkhof et al., 2015).
* Clinical depression based on the clinical interview at baseline ADIS-C (Silverman \& Albano, 1996).
* Absence of parental permission.
* Adolescent already receiving treatment for depressive symptomatology.
* Insufficient knowledge of the Dutch language.
Lumbar Degenerative Disc Disease Treated With Anterior Tension Band System (ATB) With ALIF/FRA Spacer

Multi-center, prospective nonrandomized study of treatment for 1 and 2 level degenerative disc disease between L2 and S1. Patients will be followed for a minimum of 2 years.

The primary objective of this study to measure fusion success in patients with lumbar degenerative disc disease using the ATB and ALIF/FRA Spacer. The Secondary objective is evaluation of the patient's quality of life, pain and function.


Eligibility Criteria:
Inclusion Criteria:

1. One or Two level (consecutive) degenerative disc disease between L2 and S1. Degenerative disc disease is defined as follows:

   Chronic pain (confirmed by patient exams and history) of discogenic origin, confirmed by radiographic evidence (e.g. MRI, discogram) two or more of the following:
   * Modic type 2 endplate changes on T2 weighted MRI
   * high intensity zone signal on T2 weighted MRI
   * positive discogram with negative controls
   * dark disc (diminished T2 weighted signal)
   * decreased disc height
2. Has experienced pain, functional deficit and/or neurological deficit for a minimum six month period of time prior to enrollment
3. Has failed to respond to non-operative treatment modalities for a minimum three month period of time prior to enrollment
4. Skeletally mature and at least 18 years of age
5. Signs the approved Informed Consent Document
6. Is available for long term follow-up and interval visits

Exclusion Criteria:

1. Has more than 2 levels to be instrumented
2. Has had a previous fusion attempt at the involved level(s)
3. Has had more than two previous open, lumbar spine surgical procedures at the involved level(s)
4. Currently implanted with anterior instrumentation at the involved level(s)
5. Patient would be classified as morbidly obese BMI \> 35
6. Active localized or systemic infection
7. Presence of a disease entity or condition which significantly affects the possibility of bony fusion (e.g., osteoporosis, metastatic cancer, long-term use of steroids, etc.)
8. Has an immunosuppressive disorder
9. Pregnant or interested in becoming pregnant during the study.
10. Has a known sensitivity to device materials
11. Mentally incompetent or prisoner
12. Currently a participant in another study for the same indications.
Evaluation of the Effectiveness of Predicting the Integrity of Interlobar Fissures Based on Chest Image AI Technology

The goal of observational study is to evaluate effectiveness of predicting the integrity of interlobar fissures based on chest image AI technology in patients with Chronic Obstructive Pulmonary Disease who will undergo lung volume reduction surgery with endobronchial valve implantation. The main question it aims to answer is: evaluation of the effectiveness of predicting the integrity of interlobar fissures based on chest image AI technology.

Participants will be evaluated by lung CT (quantitative analysis based on chest image AI technology and artificial analysis) and imported Chartis detection system.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic obstructive pulmonary disease who meet the GOLD diagnostic criteria
* FEV1 ≤ 45% pred and FEV1/FVC\<70%
* TLC\>100% pred and RV\>175% pred
* CAT≥18
* \>50% of emphysema destruction
* Smoking prohibition\>6 months
* Sign the informed consent form

Exclusion Criteria:

* PaCO2\>8.0 kPa, or PaO2\<6.0 kPa
* 6-minute walking test\<160m
* Obvious chronic bronchitis, bronchiectasis or other infectious lung diseases
* Three hospitalizations due to pulmonary infection in the past 12 months before the baseline assessment
* Previous lobectomy, LVRS or lung transplantation
* LVEF\<45% and or RVSP\>50mmHg
* Anticoagulant therapy that cannot be stopped before surgery
* The patient has obvious immune deficiency
* Participated in other lung drug studies within 30 days before this study
* Pulmonary nodules requiring intervention
* Any disease or condition that interferes with the completion of the initial or subsequent assessment
Biomarkers of Muscle Anabolism (MK-0000-082)

This study will evaluate the ability of comparative proteomics to identify early biomarkers of muscle anabolism.


Eligibility Criteria:
Inclusion Criteria:

* subject is a healthy male between 18 and 40 years old
* subject's weight is stable over the past 3 months
* subject agrees to refrain from consuming alcohol during study
* subject agrees to consume no caffeine while in the CRU
* subject agrees to follow meat-free diet
* subject is willing to avoid strenuous activity
* subject has been a nonsmoker for at least 6 months

Exclusion Criteria:

* subject is a regular user of illicit drugs
* subject has taken androgenic steroids in the past 12 months
* subject has participated in sports events, resistance training, or moderate to heavy endurance training in the past month
* subject has prostate cancer
* subject has HIV and/or hepatitis B or C
The Role of Endothelium A and EGFR Receptor in Fibrocytes From Asthma With Obstructive Sleep Apnea

The investigators will compare the circulating fibrocyte proportion in asthmatic patients with obstructive sleep apnea (OSA) and not with OSA In addition, the investigators will compare the expression of epidermal growth factor receptor (EGFR), endothelin A receptor (ETAR) and connective tissue growth factor (CTGF) The association of those factors and annual decline of forced expiratory volume in 1 second (FEV1) will be performed

Asthma is characterized by airflow obstruction, chronic airway inflammation and remodeling. The investigators' report has shown directly the relationship between fibrocytes, and chronic airflow obstruction with rapid decline in FEV1 in asthma. Asthma concomitant of obstructive sleep apnea (OSA) may appear intermittent hypoxia and result in the frequent attack of asthma symptoms. In animal model, hypoxia may increase the circulating fibrocytes, thus play a role in pulmonary hypertension. The investigators' published paper also showed that an increased expression of EGFR, ETAR and Vascular endothelial growth factor receptor (VEGFR) in circulating fibrocytes in chronic obstructive asthmatics. It is unknown whether circulating fibrocytes from asthma with OSA have the higher expression of EGFR, connective tissue growth factor receptor, VEGFR and ETAR compared to asthma without OSA. The investigators are also interested in whether proliferation and differentiation of fibrocytes are different between asthmatics with or without concomitant of OSA. The investigators will study the correlation between the percentage of circulating fibrocytes and the oxygen desaturation index (ODI) and severity of sleep apnea to clarify the role of hypoxia, which contributing to chronic asthma.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of asthma

Exclusion Criteria:

* chronic obstructive pulmonary disease (COPD)
* bronchiectasis
* cystic fibrosis
An Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids

This study was designed to evaluate the efficacy and safety of zoledronic acid compared to placebo in osteoporotic children treated with glucocorticoids

In March 2017, Novartis stopped enrollment as the study was not feasible to be conducted due to low enrollment and other recruitment challenges. Patients receiving the treatment continued to receive the treatment per protocol.

Eligibility Criteria:
Key Inclusion Criteria:

* A diagnosis of chronic rheumatologic conditions or inflammatory bowel disease or Duchenne muscular dystrophy requiring systemic glucocorticoids (i.v. or oral) within 12 months prior to screening
* Lumbar Spine BMDZ-score of -0.5 or worse
* Evidence of at least at least 1 vertebral compression fracture of Genant Grade 1 or higher (or radiographic signs of vertebral fracture) within 1 month from Screening visit OR One or more, low-trauma, lower extremity long-bone fracture which occurred sometime within the 2 years PRECEDING enrollment in the study OR Two or more, low-trauma, upper extremity long-bone fractures which occurred sometime within the 2 years PRECEDING enrollment in the study
* Consent/assent to study participation

Key Exclusion Criteria:

* History of primary bone disease (OI, Idiopathic Juvenile Osteoporosis, Rickets/Osteomalacia)
* Any medical condition that might have interfered with the evaluation of lumbar spine BMD, such as severe scoliosis or spinal fusion. Patients with less than 3 evaluable vertebrae by Dual Energy X-ray Absorptiometry (DXA) evaluation in the region of interest lumbar 1 (L1) to lumbar 4 (L4),
* Hypocalcemia and hypophosphatemia
* Serum 25-hydroxy vitamin D concentrations of \<20 ng/mL or \<50 nmol/L
* estimated glomerular filtration rate (GFR) \<60 mL/min/1.73 m2
* serum creatinine increase between Visit 1 and Visit 2 \>0.5 mg/dL (44.2 μmol/L)
* Uncontrolled symptoms of cardiac failure or arrhythmia
* Any prior use of bisphosphonates, or high dose sodium fluoride
Characterizing Emmer Seeds and Flours, and Determining the Glycemic Effects of Emmer Breads

This study characterized emmer seeds, flours, and breads, and investigated the effects of emmer breads on the glycemic response

This study aimed to 1. describe the technological characteristics of emmer seeds, flours, and breads, 2. determine the glycemic index and glycemic load of two emmer breads, and 3. to investigate the effects of these breads on postprandial glycemic response in healthy subjects

Eligibility Criteria:
Inclusion Criteria:

* healthy
* non-smoking
* non-diabetic men and women
* body mass index (BMI) between 18 and 27 kg/m2

Exclusion Criteria:

* severe chronic disease (e.g. coronary heart disease, diabetes mellitus,kidney or liver conditions, endocrine conditions)
* gastrointestinal disorders
* pregnancy
* lactation
* competitive sports
* alcohol
* drug dependency
Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)

The purpose of this study is evaluate the outcome after posterior lamellar keratoplasty (DMEK and Ultra-thin DSAEK) for corneal transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 or older
* Scheduled to undergo endothelial keratoplasty
* Able to provide written informed consent.

Exclusion Criteria:

* Age less than 18 years
Effect of Nitrous Oxide on Cisatracurium Infusion Demands

Background: Recent studies have questioned our previous understanding on the effect of nitrous oxide on muscle relaxants, since nitrous oxide has been shown to potentiate the action of bolus doses of mivacurium, rocuronium and vecuronium. This study was aimed to investigate the possible effect of nitrous oxide on the infusion requirements of cisatracurium.

Methods: 70 ASA physical status I-III patients aged 18-75 years were enrolled in this randomized trial. The patients were undergoing elective surgery requiring general anesthesia with a duration of at least 90 minutes. Patients were randomized to receive propofol and remifentanil by target controlled infusion in combination with either a mixture of oxygen and nitrous oxide (Nitrous oxide/TIVA group) or oxygen in air (Air/TIVA group). A 0.1 mg/kg initial bolus of cisatracurium was administered before tracheal intubation, followed by a closed-loop computer controlled infusion of cisatracurium to produce and maintain a 90% neuromuscular block. Cumulative dose requirements of cisatracurium during the 90-min study period after bolus administration were measured and the asymptotic steady state rate of infusion to produce a constant 90% block was determined by applying nonlinear curve fitting to the data on the cumulative dose requirement during the study period.

Results: Controller performance, i.e. the ability of the controller to maintain neuromuscular block constant at the setpoint and patient characteristics were similar in both groups. The administration of nitrous oxide did not affect cisatracurium infusion requirements. The mean steady-state rates of infusion were 0.072 +/- 0.018 and 0.066 +/- 0.017 mg \* kg-1 \* h-1 in Air/TIVA and Nitrous oxide/TIVA groups, respectively.

Conclusions: Nitrous oxide does not affect the infusion requirements of cisatracurium.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-III patients

Exclusion Criteria:

* Patients with significant renal,
* Hepatic or cardiac disease
Development and Validation of an ADL-score Based on FIM and EBI

The aim of this mixed-methods-study is to develop and validate an algorithm to transform FIM (Functional Independence Measure) and EBI (Extended Barthel Index) into an ADL score (Activities of Daily Life) that can be used to compare outcome quality of rehabilitation clinics.

The following steps are performed:

1. Development of an ADL-algorithms by experts
2. Validation of the ADL-algorithms in a quantitative approach
3. Finalization of the ADL-algorithms by experts based on study results


Eligibility Criteria:
Inclusion Criteria:

* Admission to in-patient neurologic rehabilitation clinic

Exclusion Criteria:

* No sufficient language skills (German, French or Italian)
Additional Effect of Visual Feedback Along With AOT on Balance,Mobility and Cognition in CP

the study aims to find the effectiveness of visual feedback along with action observation therapy in cerebral palsy. the effect of AOT on mobility, cognition and balance of the targeted population will be the intrest of the researcher


Eligibility Criteria:
Inclusion Criteria:

* Without visual impairment and visual field defects
* Mini-Mental state examination for Children (MMC) score \>25
* GMFCS (gross motor function classification system) I-III
* Children with Modified Ashworth Scale (MAS) less than 2

Exclusion Criteria:

* Unable to walk
* Children with severe co-morbidities