cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Subjective Well-being and Tolerability of Quetiapine XR to Risperidone

The trial is designed to assess the long term subjective well-being in schizophrenic outpatients treated with quetiapine XR (extended release) or oral risperidone at flexible dose in a naturalistic setting over a period of one year. Secondary outcome measures have been selected for helping in the differentiation of the compared atypical antipsychotics. The primary objective of this study is to demonstrate the non-inferiority of quetiapine XR to risperidone assessed at month 6 in terms of responder rate using the self-report instrument SWN-K


Eligibility Criteria:
Inclusion Criteria:

* Treated for symptomatic schizophrenia (DSM-IV-TR codes: 295.10, 295.20, 295.30,295.60, 295.90) or schizoaffective disorder (DSM-IV-TR code:295.70) or schizophreniform disorder (DSM-IV-TR code: 295.40). Patients with co-morbid depressive symptoms may be enrolled
* Patient with first episode of the above mentioned disease (item 3) or patient requiring a medication change for clinical reasons (effectiveness, tolerability, compliance, patient preference), i.e. switch from typical to atypical neuroleptics, switch from other atypical neuroleptics, excluding patients treated with risperidone or quetiapine at the time of enrolment.

Exclusion Criteria:

* Patients with a baseline SWN-K total score of \>75
* Patients with previous treatment with risperidone or quetiapine may be enrolled if change of treatment has not been dictated by major lack of tolerability and efficacy and if date of last dose has been at least 3 months prior to enrolment.
Alternate Day Micafungin: A PK Study in Pediatric Patients

The purpose of this study is to examine the pharmacokinetics of micafungin when it is given on an every other day schedule. The study will determine if every other day micafungin will provide drug exposure equivalent to daily dosing while reducing administration costs and improving patient convenience. Fifteen patients will be enrolled on this study. Blood samples for PK measurements will be obtained for 48 hours following a single dose of micafungin (3 mg/kg).

Disseminated fungal infection is a major cause of morbidity and mortality in immunocompromised children. Many of the drugs used for fungal prophylaxis have been associated with kidney and liver toxicity. Also, breakthrough infections have been reported with the use of some of the oral agents due to poor oral absorption. An alternative approach is the use of intravenous micafungin for fungal prophylaxis. Micafungin has a distinct advantage due to its better safety profile, specifically in terms of liver and kidney toxicity. Currently, children who receive micafungin are given daily dosing. This study will examine the pharmacokinetics of micafungin when it is given on an every other day schedule. It will examine whether every other day micafungin will provide drug exposure equivalent to daily dosing while reducing administration costs and improving patient convenience. Both animal and adult human data support the use of this approach. Fifteen patients will be enrolled on this study and will be given a single dose of micafungin (3 mg/kg). Blood samples will be drawn for pharmacokinetic measurements after administration of micafungin.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients who are at risk for fungal infection and require prophylaxis.
* Age ≤ 10 years excluding neonates
* Children must have an indwelling venous access device
* Patients with adequate organ function (documented within 2 weeks prior to start of micafungin): creatinine \< 2 times upper limit normal; ALT, AST and total bilirubin ≤ 3 times upper limit normal

Exclusion Criteria:

* Patients who are \< 28 days old (neonates) or \> 10 years of age
* Patients who have history of past or evidence of active fungal disease (by either radiological studies or biopsy proven) or are being treated for presumed fungal infection.
* Patients who have history of allergy to micafungin or other echinocandin preparations, such as Caspofungin or Anidulafungin.
* Patients who have received micafungin or other echinocandin preparations in the previous two weeks.
* Patients receiving antifungal prophylaxis other than Fluconazole at the time of enrollment.
* Failure to sign informed consent, or inability to undergo informed consent process.
* Not medically advisable to obtain the specimens necessary.
HA Residents With PVD, 6MWD Assessed at HA (2840m) vs LA (Sea Level)

To study the effect of relocation from 2840m (Quito) to sea level (Pedernales) in patients with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (PH) who permanently live \>2500m on 6-minute walk distance (6MWD)

This research in patients with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who permanently live at HA \>2500 (PVDHA) will have 6-minute walk distance near their living altitude in Quito at 2840m and at sea level in Pedernales the day after the first and the second night after relocation.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18-80 years old of both genders,
* Residence \> 2500m of altitude
* diagnosed with precapillary PH (mean pulmonary artery pressure (mPAP) \>20 mmHg, pulmonary artery wedge pressure (PAWP) ≤15 mmHg and pulmonary vascular resistance (PVR) ≥2 WU (wood units) by right heart catheterization) with PH being classified as PAH or CTEPH according to guidelines
* Patients stable on therapy
* NYHA (new york heart association) functional class I-III
* Provided written informed consent to participate in the study.

Exclusion Criteria:

* Age \<18 years or \>80 years
* unstable condition
* Patients who cannot follow the study investigations, patient permanently living \< 2500m.
* Patients with moderate to severe concomitant lung disease (FEV1\<70% or forced vital capacity \<70%), severe parenchymal lung disease, severe smokers (\>20 igarettes/day)
* Severely hypoxemic patients at Quito permanently have persistent SpO2 (oxygen saturation by pulseoximetry) \<80% on ambient air.
* Patients with chronic mountain sickness (Hemoglobin \> 19 g/dl in women, \>21 g/dl in men)
* Patient with a non-corrected ventricular septum defect
* Relevant concomitant other disease of the heart, kidney, liver, blood (anemia hemoglobin\<11 g/dl)
Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild Alzheimer's Patients

This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with mid Alzheimer's disease


Eligibility Criteria:
Inclusion Criteria:

* Male and/or female patients between 40 and 85 years of age (both inclusive)
* Diagnosis of mild Alzheimer's Disease (AD)
* Mini-Mental State Examination (MMSE) 20 to 26 at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 6 weeks.

Exclusion Criteria:

* Previously participated in an AD vaccine study and received active treatment.
* History or presence of an active autoimmune and/or with an acute or chronic inflammation, and/or clinically relevant atopic condition.
* History or presence of seizures and/or cerebrovascular disease.
* Presence of other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)
* Advanced, severe, progressive or unstable disease that might interfere with the safety of the patient.

Other protocol-defined inclusion/exclusion criteria may apply
RONICICLIB / Placebo in Combination With Chemotherapy in Small Cell Lung Cancer

This is a study to investigate the potential clinical benefit of roniciclib when given in combination with chemotherapy Carboplatin / Etoposide or Cisplatin / Etoposide as first line treatment in patients with extensive disease small cell lung cancer. Approximately 140 patients will be randomized (1:1) to receive treatment with either roniciclib or placebo in combination with chemotherapy.

Roniciclib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. The growth of the tumor may be decreased by preventing these specific proteins from functioning. By specifically targeting these proteins, roniciclib in combination with chemotherapy may stop cancer growth.

The primary endpoint (the most meaningful result to be tracked) of this study is based on the progression free survival, i.e. the time the disease is not worsening. The aim is to show that the therapy with roniciclib in combination with chemotherapy prolongs the time the disease is not worsening in this patient population compared to patients receiving placebo in combination with chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged ≥18 years (or country-specific legal age of maturity, if \>18 years)
* Histologically or cytologically confirmed (extensive-stage disease) ED SCLC (small cell lung cancer)
* At least 1 solid tumor lesion measurable by computer tomography (CT) scan or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1

Exclusion Criteria:

* Prior systemic anticancer therapy for SCLC (including previous therapy with a cyclin-dependent kinase \[CDK\] inhibitor)
Ventilatory Strategy for the Prevention of Atelectasis During Bronchoscopy Under General Anesthesia, VESPA Trial

This trial compares two different types of ventilation for the prevention of partial or complete collapsed lung (atelectasis) in patients undergoing bronchoscopy under general anesthesia. Ventilatory strategy to prevent atelectasis (VESPA) may work better than standard of care mechanical ventilation to reduce the intra-procedural development of atelectasis during bronchoscopy under general anesthesia.

PRIMARY OBJECTIVE:

I. To determine if our ventilatory strategy to prevent atelectasis (VESPA) can reduce the intra-procedural development of atelectasis during bronchoscopy under general anesthesia when compared with conventional mechanical ventilation.

SECONDARY OBJECTIVES:

I. To describe proportion of VESPA-induced complications. II. To describe and compare proportion of bronchoscopy-induced complications in VESPA and control arms.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive anesthesia using a standard short breathing tube called laryngeal mask airway (LMA) and then undergo standard of care bronchoscopy.

GROUP II: Patients receive anesthesia using a longer breathing tube called an endotracheal tube and then undergo standard of care bronchoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing bronchoscopy with radial probe endobronchial ultrasound (RP-EBUS) for peripheral lung lesions
* Recent (\< 4 weeks) chest computed tomography (CT) performed prior to the bronchoscopy
* Voluntary informed consent to participate in the study

Exclusion Criteria:

* Patients with baseline lung consolidation, interstitial changes or lung masses (\> 3 cm in diameter) in dependent areas of the lung (right/left \[R/L\] B6, 9, or 10 bronchial segments) as seen on most recent CT
* Pregnancy
* Ascites
* Known diaphragmatic paralysis
* Air-trapping with residual volume \> 150% of predicted
* History of primary or secondary spontaneous pneumothorax
* Lung bullae \> 5 cm
Lumen Apposing Metal Stents With and Without a Double Pigtail Stent in Pancreatic Collections

The study evaluates the security of LAMS with ando without a coaxial double pigtail plastic stent in the management of pancreatic fuid collections.

The introduction of lumen-apposing metal stents (LAMS) represented a great improvement in the EUS-guided transmural drainage of pancreatic fluid collections (PFCs). It is postulated safer than other types of stents due to the presence of bilateral anchoring flanges, designed to appose the stomach or duodenum to the PFC wall minimizing the risk of perforation or peritoneal leakage. In addition, the larger lumen diameter facilitates the drainage of PFC, specially the walled-off pancreatic necrosis (WOPN). However, secondary adverse effects such as infection due to complete or partial stent obstruction, migration, bleeding or buried LAMS syndrome have also been related . The placement of a coaxial double pigtail plastic within the LAMS has been reported beneficial in order to avoid external migration or the lumen obstruction and to the prevention of bleeding and other adverse events. The aim of this study was to evaluate the efficacy and safety of LAMS with and without a coaxial double pigtail plastic stent in the EUS-guided transmural drainage of PFCs.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pancreatic fluid collections and indication of drainage.
* EUS-guided trasmural drainage wiht lumen apposing metal stents.
* Criteria for drainage were as specified by the Working Group of the International Association of Pancreatology.

Exclusion Criteria:

* Other types of collections and stents
* Severe coagulopathy (protombin time \> 1,5) or thrombocytopenia (platelet count \< 50 x 109/L)
* PFCs with a previous attempt failed of EUS-guided transmural drainage
* Age younger than 18 years
Withholding of Life-sustaining Treatment and Quality of Life After Severe Acute Brain Injury: Qualitative Analysis and Ethical Issues

Withdrawal of life-sustaining treatment affects 10-15% of ICU patients, including those with severe acute brain injury, whose care appears futile in terms of prognosis based on clinical and paraclinical data, expected quality of life, patient preferences, age, or reduced quality of life.

There are few studies on withholding treatment compared with withdrawing treatment, and even fewer on survivors after a decision to withhold treatment.

Quality of life is defined by WHO as "an individual's perception of his or her position in life in the context of the culture and value systems in which he or she lives and in relation to his or her goals, expectations, standards and concerns". The relationship between quality of life and neurological outcome after severe acute brain injury is controversial and therefore difficult to predict.

That's why the investigators question the legitimacy of making decisions to withhold treatment from patients with severe acute brain injury based on their expected quality of life, when this prediction is uncertain.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* with severe acute brain injury (TBI, stroke, central nervous system infection).
* admitted in the neurocritical care unit in 2022.
* followed up 24 months after ICU between 15th April 2024 and 31st August 2024.

Exclusion Criteria:

Patients:

* death in 2024,
* refusal by patient or relative.
R115777 in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have recurrent or metastatic non-small cell lung cancer.

OBJECTIVES:

* Assess the response rate of patients with recurrent or metastatic non-small cell lung cancer when treated with tipifarnib.
* Determine the clinical toxicities of this treatment in these patients.
* Assess the overall survival and time to progression of this patient population when treated with this regimen.
* Evaluate the inhibition of protein farnesylation in vivo and correlate such inhibition to plasma levels of tipifarnib.
* Evaluate the occurrence of CYP450 polymorphisms and relate these to drug toxicity, pharmacokinetics, and response to this treatment in this patient population.

OUTLINE: This is a multicenter study.

Patients receive oral tipifarnib twice daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 12 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed recurrent or metastatic non-small cell lung cancer (NSCLC)
* Measurable disease

  * At least 20 mm in at least one dimension
  * Nonmeasurable is defined as any of the following:

    * Bone lesions
    * Leptomeningeal disease
    * Ascites
    * Pleural/pericardial effusion
    * Inflammatory breast disease
    * Lymphangitis cutis/pulmonis
    * Abdominal masses not confirmed and followed by imaging techniques
    * Cystic lesions
* No CNS metastases

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-2

Life expectancy

* At least 12 weeks

Hematopoietic

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic

* Bilirubin no greater than 2 times upper limit of normal (ULN)
* AST no greater than 3 times ULN (no greater than 5 times ULN in case of hepatic metastases)

Renal

* Creatinine no greater than 2 times ULN

Cardiovascular

* No New York Heart Association class III or IV heart disease

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No uncontrolled infection
* No other prior malignancy in past 5 years except adequately treated basal cell or squamous cell skin cancer or other adequately treated noninvasive carcinomas
* No other concurrent severe underlying disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No prior biologic, gene, or immunotherapy

Chemotherapy

* No prior chemotherapy for NSCLC except low dose cisplatin as radiosensitizer

Endocrine therapy

* Not specified

Radiotherapy

* Prior radiotherapy to less than 25% of bone marrow allowed

Surgery

* Not specified
Development and Evaluation of the ICP Waveform Tracing Capabilities and Safety of HS-1000 Device

Invasive intracranial pressure (ICP) monitoring, using modalities such as parenchymal pressure transducer or external ventricular drain (EVD), provides an ICP waveform that encapsulates valuable diagnostic and monitoring clinical information.

HS-1000 device, a proprietary new non-invasive ICP monitor, is expected to display an ICP waveform safely and accurately with minimal discomfort to patients, compared to standard invasive ICP monitoring procedures used at the participating institutions.

A study will be conducted on 100 patients who undergo invasive ICP measurement due to suspected ICP elevation, regardless to etiology. Each enrolled patient will be monitored with the HS-1000 device and data will be collected throughout the entire procedure. Once the data collection is done, results of the non-invasive measurements will be analyzed accordingly. The end-point of the study is to collect at least half an hour of measurements for each participant.

Eligibility Criteria:
Inclusion Criteria:

* Adult men and women subjects, aged 18 years old and over at screening visit
* Subjects with neuropathology that the principal investigator considers including in this study.
* Survival expectancy greater than 72 hours
* Subject or legal authorized representative (per local regulation) is able and willing to comply with the requirements of the protocol
* Subject or legal authorized representative (per local regulation) is able to understand and sign written informed consent to participate in the study

Exclusion Criteria:

* Local ear infection
* Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
* For women of childbearing potential: pregnancy (positive pregnancy test) or breast-feeding
* Subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s)
* Any condition that may jeopardize study participation (e.g., abnormal clinical or laboratory finding) or interpretation of study results, or may impede the ability to obtain informed consent (e.g., mental condition)
Acute Impact of Cardiac Resynchronization on Vascular Function (RVA-CRT)

Evaluation of the effect of short term activation/deactivation of biventricular pacing (BivP) of the CRT (during routine CRT interrogation) on vascular function as assessed via retinal vessel analysis (RVA), in patients treated with CRT.

Heart failure is a condition in which the heart becomes unable to maintain the body's need of blood supply. Congestive heart failure can be considered a syndrome but the final common path of many cardiovascular diseases. Recently, the investigators of this study confirmed an increased impairment in retinal microvascular function in patients with ischemic heart failure compared to patients with stable coronary disease.

If medication fails to improve ejection fraction, cardiac resynchronization therapy (CRT) is the guideline-recommended treatment for patients with advanced heart failure and bundle branch block.

The question remains if CRT changes purely hemodynamics by synchronizing the heart or has potential impact on the microvasculature to cause reverse remodeling of the failing heart. Measuring retinal vascular function might increase knowledge on the effects of cardiac resynchronization therapy.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* Patients ≥ 18 years of age, male or female, diagnosed with advanced heart failure
* Implanted as well as activated CRT device for at least 3 months prior to Visit 1

Exclusion Criteria:

* Current acute decompensated HF
* Documented pacing dependency
* Documented AV-Block II (Mobitz Typ 2) or III in patient's history
* History of hypersensitivity or allergy to Tropicamide
* Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular (CV) surgery, percutaneous coronary intervention (PCI) or carotid angioplasty within 3 months prior to Visit 1.
* History of heart transplant, on a transplant list or with ventricular assistance device (VAD).
* Presence of any other disease with a life expectancy of \< 6 months
* Presence of significant endocrine diseases, including primary hyperparathyroidism, Cushing's disease, adrenal insufficiency, pituitary tumors, primary hyperaldosteronism, manifest hyperthyroidism or genetic endocrine disorders
* Presence of active acute infectious diseases.
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc
* Women who are pregnant or breast feeding
* Known narrow-angle glaucoma
* Known epilepsy (flicker-light could trigger a seizure)