cyrilzakka/clinical-trials huggingface dataset:
The Efficacy of Nurse-driven, Protocol Guided Ventilator Weaning in a Medical-Surgical Intensive Care Unit (ICU)

1. Mechanically ventilated patients weaned by nurse-driven ventilator weaning protocol will have a mean length of stay on ventilator at least one day shorter than patients weaned by physician-initiated, non-protocol methods
2. Mechanically ventilated patients weaned by nurse-driven ventilator weaning protocol will have al least similar Ventilator, ICU, and Hospital Length Of Stay (LOS) compared to patients weaned by physician-initiated, non-protocol method
3. Nurse-driven ventilator weaning protocol is well accepted by other services: physicians, nurses, and respiratory therapists.

Ventilatory support is one of the most common indications for admission to ICU (1).

The duration of mechanical ventilation is associated with several serious complications, increase mortality, prolong ICU stay, and increase hospital cost (7,8).

Traditionally, the process of ventilator weaning is initiated and carried out my physicians.

Recently, there have been few studies that supported the utility of protocol guided weaning algorithms. Its use have been associated with earlier initiation of weaning, leading to shorter ventilator time, and a trend for shorter ICU length-of-stay and lower hospital costs (1,2,4,9) Several studies have also shown the relative safety of utilizing nursing (3) and RT staff alone or in cooperation with medical staff in the weaning of patients from mechanical ventilation (1,2,6).

We recently developed a nurse-driven ventilator weaning protocol for all ICUs at St. Luke's and Roosevelt hospitals. The protocol was approved by the Critical Care Committee and is implemented as of May 2007. All ICU nurses, respiratory therapists, and ICU physicians have been educated on this protocol We plan to prospectively collect data to look at length of stay on mechanical ventilation in patients weaned by nurse-driven ventilator weaning protocol. We plan to compare such data to retrospectively collected ventilator LOS data in patients weaned by physician-initiated ventilator weaning method.

Eligibility Criteria:
Inclusion Criteria:

* Receiving MV for at least 24 hours in the ICU
* Meeting established protocol criteria for a vent wean trial

Exclusion Criteria:

* Patients in whom MV was actively withdrawn for terminal wean
* Brain dead patients on MV
* Age \<18 years old
* Transfers from other hospitals or health care facility who were ventilator dependent
Clinical Pharmacy Guided Patient Counselling and Adherence Support on Renal Transplant Recipients

As a result of the shortage of donor organs and the close relationship between allograft or even life loss and non-adherence after kidney transplantation, improvement of patient adherence appears essential. So the current study aimed to monitor adherence barriers of renal transplant recipients and evaluate possible consequences of nonadherence on recipients' clinical outcomes as well as to implement a structured adherence management program consisting of intensified patient counselling and adherence support by a dedicated clinical pharmacist as an adjunct to standard post-transplant patient education carried out by transplant physicians to investigate the efficacy of the implemented program on patients adherence and health outcomes as compared to standard physician patient care. The study is a prospective self-controlled interventional study that recruited 69 living donors-renal transplant Patients attending the transplant clinic of Nasser institute and satisfying the inclusion criteria. On enrolment, patient-related baseline data that could determine and affect patients' adherence as well as patients' clinical outcomes were recorded. After all patients received the adjuvant adherence management program by the clinical pharmacist for 6 month, patients' health outcomes were re-evaluated to compare them to baseline data


Eligibility Criteria:
Inclusion Criteria:

\>18 years at least 1 year post-transplant to allow for stabilization of the prescribed immunosuppressant therapy (IST) regimen Independent of others for medication management and willing as well as able to repetitively visit the outpatient clinic for educational training \& data collection.

Exclusion Criteria:

* Pediatric Older than 65 years. Multi-organ transplant. Pregnant or lactating. Cancer patients.
Molecular Imaging of FAP Expressing Cancer-associated Fibroblasts in NSCLC Treated With Immune-checkpoint Inhibitors

Evaluation of the relation between baseline fibroblast activation protein (FAP) expression based on Ga-FAPI uptake with patient outcome among NSCLC patients receiving immunotherapy for recurrent/metastatic disease.

Fibroblast activation protein (FAP), a type II membrane glycoprotein, is selectively expressed by cancer-associated fibroblasts (CAFs) in more than 90% of epithelial carcinomas. FAP also regulates antitumor immune response. For these reasons, FAP is an attractive target and molecular imaging biomarker to assess CAFs and the tumour's landscape before and during immunotherapy. The PET radiotracer 68Ga-FAPI (Fibroblast activation protein inhibitor) allows the visualisation and quantification of CAFs.This study will use a non-invasive technique to assess CAFs before and during immunotherapy and to evaluate diverse predictive biomarkers in a prospective setting studying simultaneously CAFs (using 68Ga-FAPI) and cfDNA.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years.
* Pathologically- proven non-small-cell lung cancer (NSCLC).
* Proposed for treatment with anti-PD-(L)1 alone or in combination with chemotherapy and/or anti-CTLA4 in the advanced setting.
* ECOG Performance status ≤2.
* Patient's written informed consent obtained prior to any study procedure.

Exclusion Criteria:

* Surgery and/or radiotherapy to thoracic region within the last 8 weeks or anti-cancer systemic therapy within the last 2 weeks.
* Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) and c-ros oncogene (ROS1) mutations.
* Pregnant and lactating women
* Previous or concurrent malignancy diagnosed within the last 2 years except adequately treated in situ carcinoma of the cervix uteri, localised (T1N0) low grade (Gleason score 6) prostate cancer undergoing active surveillance and basal or squamous cell skin cancer.
* Subjects with another significant medical condition which, in the investigator's opinion, may interfere with the completion of the study.
A Study to Evaluate How Well Single and Multiple Doses of GLPG3121-modified Release Formulation Are Tolerated in Healthy, Adult Subjects

The aim of the study is to examine the safety and tolerability of GLPG3121-modified release formulation when given to healthy male subjects once as a single dose or multiple times over a period of 14 days in fasting condition or after a standard breakfast.

The study will evaluate how the body absorbs and breaks down GLPG3121, and how GLPG3121 and the major breakdown product of GLPG3121 are eliminated from the body. In addition, the study will investigate the effect of food (high-fat) after a single oral dose of GLPG3121 as modified release tablet.


Eligibility Criteria:
Inclusion Criteria:

* Male between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF).
* A body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
* Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests, available at screening and prior to randomization. Hemoglobin, neutrophil, lymphocyte, and platelet counts must be above the lower limit of normal range. Total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and serum creatinine must be no greater than the upper limit of normal (ULN). Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator.
* Subject must be able and willing to comply with restrictions on prior and concomitant medication.
* Negative screen for drugs (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, tricyclic antidepressants) and alcohol.

This list only contains the key inclusion criteria.

Exclusion Criteria:

* Known hypersensitivity to investigational product (IP) ingredients or history of a significant allergic reaction to IP ingredients as determined by the investigator.
* Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or history of hepatitis from any cause with the exception of hepatitis A that was resolved at least 3 months prior to first dosing of the IP.
* History of or a current immunosuppressive condition (e.g. human immunodeficiency virus \[HIV\] infection).
* Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first dosing of the IP.
* Presence or sequelae of gastrointestinal, liver, kidney (estimated glomerular filtration rate \[eGFR\] \<=90 mL/min/1.73 m2, using the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.

This list only contains the key exclusion criteria.
Safety, Tolerability and Protective Efficacy of PfSPZ Vaccine in Gabonese Children

This study is a single site, randomized, double-blind, placebo-controlled trial. The trial will assess the safety, tolerability, immunogenicity and vaccine efficacy (VE) of PfSPZ Vaccine in Gabonese children that are naturally exposed to malaria parasites. Healthy children aged 1- 12 years living in the surrounding areas of Lambaréné and/or Fougamou Province in Gabon will be eligible for participation.

The trial will be performed in 200 healthy Gabonese children, recruited across three age-strata: 7-12, 3-6 and 1-2 years (12-35 months). Within each age-stratum, volunteers will be randomized in a 2:1 ratio to receive three doses via direct venous inoculation (DVI) of either PfSPZ Vaccine (0.9x10\^6) or normal saline (NS) on days 0, 7 and 28 respectively; a minimum of 40 and a maximum of 100 volunteers are included in each of these age-strata.

In total, approximately 133 children will receive PfSPZ Vaccine and approximately 67 children will receive placebo. Randomization will be stratified by age-stratum, using permuted blocks of randomized size (3, 6, or 9). The start of inclusion into each age-stratum will be staggered, such that immunization of the first 3-6-year-olds will not commence until two weeks after start of immunization in the first 7-12-year-olds, and immunizations in the first 1-2-year-olds will not commence until two weeks after start of immunization in the first 3-6-year-olds. All volunteers will receive presumptive treatment with artemether-lumefantrine two weeks prior to final immunization (day 14). All volunteers will receive presumptive treatment with age-standardized 3-day course of oral artemether-lumefantrine (AL) \~two weeks prior to first immunization and again two weeks prior to final immunization.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children aged 1 to 12 years
* Provision of written informed consent of a legal representative of age 18 or above and provision of informed assent by participants in concordance with Gabonese national guidelines.
* Able and willing to comply with all study requirements
* Residence in the area throughout the study period
* Household member reachable by mobile phone during the immunization phase

Exclusion Criteria:

* Receipt of an investigational product in the 30 days preceding enrollment
* Prior receipt of a malaria vaccine
* Immunization with more than 3 other vaccines or at least on elive vaccine within the past four weeks
* Use of immunoglobulins or blood products within 3 months prior to immunization with the investigational product
* Known or suspected HIV infection or any other immunosuppressive state
* Positive for hepatitis B surface antigen (HBs-antigen)
* Seropositive for hepatitis C virus (antibodies to HCV)
* A hemoglobin concentration \<9 g/dl (applies at enrollment only)
* History of non-febrile or atypical febrile seizures
* Pregnancy or lactation
* Any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the risk to the child because of participation in the study or impair interpretation of the study data
Role of Endoscopic Third Ventriculostomy in Management of Malfunctioning Ventriculoperitoneal Shunt

The aim of this study is to analyze our experience in management of malfunctioning ventriculoperitoneal shunt by using endoscopic third ventriculostomy (ETV).

Cerebrospinal fluid shunting remains the most common line of treatment for hydrocephalus. Endoscopic third ventriculostomy (ETV) is an alternative to cerebrospinal fluid (CSF) shunting that is potentially favorable due to the lack of implanted hardware. Most previous studies of ETV have focused on its role as an initial treatment for hydrocephalus and on comparing ETV with CSF shunting. However ,some patients who have previously been treated with a CSF shunt then developed malfunction are candidate for ETV.

The ETV Success Score (ETVSS) is the most widely used scale to estimate the likelihood of ETV success for a given patient .

Although the age of the patient is the most important component of the ETVSS, history of previous treatment with a shunt is also included in the model. According to the ETVSS, previous shunting reduces the likelihood of ETV success by approximately 10%.

There have been numerous previous studies of ETV in patients with a history of a CSF shunt (post shunt ETV), reporting success rates from 50% to 80% . Two review articles also covered this topic, one of which reported ETV success by meta-analysis in 68% of 519 pooled patients .

Most patients with shunt malfunction and or infection are treated with revision procedures, but ETV can be used as an alternative treatment in such cases .The role of endoscopic management of hydrocephalus in shunt malfunction was not investigated extensively so far.

There are several studies which have considered ETV as the main treatment of hydrocephalus inpatients with shunt failure.

Therefore, this is an attractive topic in neurosurgery especially in pediatric neurosurgery that can work and make a different kind of studies to explore the role of ETV for shunt failure.

The goal of the current study was to present our experience with endoscopic third ventriculostomy for management of shunt malfunction.

Eligibility Criteria:
Inclusion Criteria:

* • All patients with malfunctioning VP shunt will be included in this study.

Exclusion Criteria:

* Patients with contraindications for endoscopic procedure such as intracranial infection or bleeding disorders
* Previous unsuccessful attempts of endoscopic third ventriculostomy.
* Active infection or inflammation in the central nervous system.
* Recent history of intracranial hemorrhage.
* Medically unfit for surgery.
Effects of Exercise Interventions in Frail Middle-aged and Older Adults

This study aimed to determine the ideal parameters of exercise program for frail middle-aged and older adults on physical and mental functions.

Exercise has been suggested as a possible lifestyle intervention for improving physical and cognitive performance. Various training options depending on various physical circumstances will be presented. However, the ideal exercise protocol for frail middle-aged and older adults had the greater benefits remain unknown. In general, 3-6 months of frequent exercise can enhance physical and cognitive outcome.

The investigators conduct this multiple arm, prospective study to determine the ideal parameters of exercise program for frail middle-aged and older adults on physical and cognitive functions. This study designed to recruit 200 older adults with frailty. All the older adults will receive exercise training using either elastic band, dumbbells, machines, treadmill, cycling for 6 months. Outcome measures including a systematic evaluation for frail older persons using comprehensive geriatric assessment, as well as the assessments of physical and cognitive functions before and after interventions.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged above 50 years old with frailty syndrome

Exclusion Criteria:

* Acute illnesses, such as unstable cardiac dysrhythmia, sepsis, or unstable vital signs
* Physical or Cognitive issues that make it difficult for the patients to participate in our program
Effects of Health Belief Model Interventions on Preventive Beliefs in Secondhand Smoke Exposure

The aim of this study was to compare the effects of feedback, interactive education, and social media interventions based on the health belief model on protective beliefs in adults at risk of exposure to secondhand smoke at home.

Secondhand smoke (SHS) exposure, also known as environmental tobacco smoke, passive smoke or involuntary smoke, is caused by the burning of cigarettes and other tobacco products and the smoke exhaled by a smoker. Although Turkey is one of the best countries in combating SHS exposure, one in four adults is exposed to SHS at home. One of the most important reasons for this exposure is the lack of deterrent policies for the home environment, which is considered a private area. It is entirely possible for non-smoking individuals to be protected from SHS exposure at home through their own efforts. In this context, the knowledge, behaviors and perceptions of non-smoking adults about exposure are important in preventing or reducing SHS exposure at home. Interventions based on the behavior change model can be effective in developing protective behaviors in adults at risk of SHS exposure at home. Individual and group interventions using multiple educational materials and methods based on the Health Belief Model (HBM) (SHS exposure feedback, interactive group education and social media sharing) can develop protective behaviors in individuals at home.

Eligibility Criteria:
İnclusion Criteria

* Non-smokers aged 18-64 who live with at least one smoker,
* Literate individuals,
* Individuals who own a smartphone,
* Individuals who voluntarily agree to participate in the study.

Exclusion Criteria:

* Individuals who do not speak Turkish,
* Pregnant individuals,
* Participants who have been living apart from SHS exposure sources in the week leading up to data collection.
Trace Element Repletion Following Severe Burn Injury

Major burn patients are characterized by large exudative losses of Cu, Se and Zn. Trace element (TE) repletion has been shown to improve clinical outcome. The study aimed to check if our repletion protocols were achieving normalization of TE plasma concentrations of major burn patients and if the necessity for continuous renal replacement therapy (CRRT) might increase the needs.

Retrospective analysis of prospectively collected data in burn patients requiring intensive care (ICU) between 1999 and 2015. The cohort was divided into 4 groups according to the protocol changes. Period 1 (P1): 1999-2000, P2: 2001-2005, P3: 2006-2010, P4: 2011-2015. Changes consisted mainly in increasing TE repletion doses and duration. Demographic data, daily TE intakes and weekly plasma concentrations were retrieved for the first 21 ICU-days.

Eligibility Criteria:
Inclusion Criteria:

* Burn injury involving ≥20% body surface (TBSA) (i.e. the threshold for intravenous TE repletion prescription)
* At least one TE plasma concentration during the ICU stay

Exclusion Criteria:

* Comfort care
* Admission \>24h after burn injury
Acceptance and Commitment Therapy for Problematic Chemsex

Investigation of the efficacy of Acceptance and Commitment Therapy (ACT) for the psychological treatment of problematic chemsex. As a pilot study, the intervention will be tested in a small group.

After being informed about the study, all patients giving written informed consent will be assessed to determine eligibility for study entry.

Patients who meet eligibility requirements will receive psychological intervention consisting in an 8-session individual on line-delivered ACT-based treatment.

The participants will be assessed through self-report instruments before and after treatment and at 3 months follow-up.

The pilot study will not include a control group.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years-old
* Spanish speaking
* having used psychoactive substances to facilitate, maintain and/or improve sexual relations in the last year
* significant score on the HBI Inventory (of 53 or more)
* clinically significant discomfort related to sexual practices
* degree of interference in his/her life of sexual practices greater than or equal to 5 out of 10
* desire to improve/reduce excessive sexual behaviour

Exclusion Criteria:

* receiving psychological or psychopharmacological treatment
* intellectual disability
* substance dependence (use not associated with sex)
* personality disorder or other serious or chronic mental disorder diagnosed
Pleural Abrasion Plus Minocycline Versus Apical Pleurectomy for Primary Spontaneous Pneumothorax

Optimal surgical management of primary spontaneous pneumothorax has been a matter of devate, especially regarding the method of pleurodesis. Previous studies have shown that thoracoscopic apical pleurectomy is a reliable method with a very low incidence of recurrence. However, this procedure is more technical demanding and time consuming through thoracoscopy. In addition, a more extensive pleural injury may cause impaired pulmonary function and a higher risk of perioperative complication such as hemothorax. In our previous studies, we have shown that thoracoscopic pleural abrasion with minocycline instillation is an easy and convinent method of pleurodesis which decreases the rate of recurrence without affecting pulmonary function. In this study, we hypothesized that pleural abrasion with minocycline instillation is as effective as apical pleurectomy in preventing pneumothorax recurrence while the short-term and long-term complications are less.

Optimal surgical management of primary spontaneous pneumothorax has been a matter of devate, especially regarding the method of pleurodesis. Previous studies have shown that thoracoscopic apical pleurectomy is a reliable method with a very low incidence of recurrence. However, this procedure is more technical demanding and time consuming through thoracoscopy. In addition, a more extensive pleural injury may cause impaired pulmonary function and a higher risk of perioperative complication such as hemothorax. In our previous studies, we have shown that thoracoscopic pleural abrasion with minocycline instillation is an easy and convinent method of pleurodesis which decreases the rate of recurrence without affecting pulmonary function. In this study, we hypothesized that pleural abrasion with minocycline instillation is as effective as apical pleurectomy in preventing pneumothorax recurrence while the short-term and long-term complications are less.

Eligibility Criteria:
Inclusion Criteria:

* Age between 15 and 50 years old Undergoing thoracoscopic bullectomy Had multiple blebs or no identified blebs during the operation

Exclusion Criteria:

* With underlying pulmonary disease With major systemic disease or acute infection Underwent ipsilateral operation previously Bleb number = 1 or 2