cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) in the Treatment of Major Depressive Disorders

The purpose of this study is to demonstrate superior efficacy of Quetiapine fumarate sustained release (SEROQUEL) compared with placebo when used as a mono-therapy in the treatment of Major Depressive Disorders PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility Criteria:
Inclusion Criteria:

* Patient is able to provide written informed consent before beginning any study related procedures
* Patient has a documented clinical diagnosis of major depressive disorder
* Patient is able to understand and comply with the requirements of the study, as judged by a study investigator

Exclusion Criteria:

* Patients with a history of non-compliance as judged by the study investigator
* Patients with a known lack of response to previous treatment with quetiapine
* Patients who have participated in a clinical trial within 4 weeks of randomization
Early Medical Thoracoscopy Versus Simple Chest Tube Drainage in Complicated Parapneumonic Effusion and Pleural Empyema

Multicenter, randomized controlled study to compare early mini-invasive thoracoscopy to simple chest tube drainage in complicated parapneumonic effusions or pleural empyema. 100 patients will be recruited. Follow-up will be 3 months. It will be looked at the rate medical cure, the need for secondary interventions, death and duration of hospital stay. In a nested trial in 20 patients the intrapleural pharmacokinetics of linezolid (approved antibiotic agent) will be measured.

Background Pleural empyema has a high morbidity and mortality. Until now it is not clear which method is best to initially drain the pus, especially in complicated effusions with septa.

The objective of this study is to compare the standard treatment of simple chest tube drainage to early mini-invasive medical thoracoscopy. In earlier studies medical thoracoscopy has been a safe and effective method in pleural diseases. However there is no prospective data available.

Methods We conduct a prospective randomized controlled multicenter study on 100 patients with complicated parapneumonic effusions with septa or empyema with frank pus. Patients will be randomized to receive either simple chest tube drainage or early medical thoracoscopy. The latter will be performed in local anaesthesia and analgosedation according to the standards set by the European Study on Medical Video-Assisted Thoracoscopy (ESMEVAT)-group. Fibrinolysis will be used routinely. In 20 patients a nested study on the intrapleural pharmacokinetics of linezolid as antibiotic agent will be performed.

Follow-up will be structured on day 1, day 7, before discharge and after 3 months including chest radiographs and clinical and laboratory evaluations.

Outcome Primary outcome will be medical cure without the need of secondary intervention or death.

As secondary outcome we will measure duration of hospital stay, adverse events.

Provisional agenda Start of study: October 2005 End of study: October 2007

Potential outcome \& benefit The study should clarify the role of early medical thoracoscopy in patients with complicated parapneumonic effusions or pleural empyema. Different authors have speculated that early intervention could be preferable. On the other hand, in many centres worldwide patients are primarily treated by a simple chest tube with or without pleural fibrinolysis. In case of failure of simple drainage, but this means several "precious" days later, a more invasive procedure is needed. At that moment tight pleural septa have formed, and often a surgical VATS or thoracotomy in general anaesthesia becomes necessary. Therefore, this pivotal study could lead to changes in the management of patients with pleural empyema.

Eligibility Criteria:
Inclusion Criteria:

* Septated pleural effusion (ultrasonography) in the context of a lower respiratory tract infection
* Frank pleural empyema (pus)

Exclusion Criteria:

* Fibrothorax
* Tuberculous empyema
* Medical thoracoscopy cannot be performed within 24 hours
* Pregnancy
* Inability to give informed consent
IMPACT STUDY: Investigating Microbial Pathogen Activity of Copper Textiles

The purpose of this study is to assess the impact of copper linens on hospital acquired infections and drug resistant bacteria.

Healthcare-associated infections (HAIs), particularly those due to multidrug-resistant organisms (MDROs), are of great clinical and public health concern. Although evidence-based prevention strategies have resulted in some success in curtailing HAIs, novel approaches are needed to achieve further reductions. Efforts to curb the emergence of MDROs have been largely unsuccessful. Thus, new strategies to address MDROs are urgently needed. This grant is comprised of two complementary studies that focus on identifying innovative approaches to more effectively prevent HAIs and curtail further emergence of MDROs.

We will conduct a randomized controlled trial (RCT) to assess the efficacy of copper oxide-impregnated textiles in preventing HAIs and MDROs as well as in reducing environmental microbial contamination. We hope to provide critical information to inform the development of novel strategies, and enhance the impact of existing strategies, to successfully address HAIs and MDROs.

For approximately four months the hospital is conducting a research study to learn about the possible impact of copper linens in reducing hospital acquired infections. Some rooms will have copper linens (Group 1) and some rooms will have regular linens (Group 2). The linens will be comprised of the top and bottom sheets, pillowcase cover, and hospital gown.

Patients in both groups will be asked to provide samples during their stay in the ICU. For both study groups, the linens will be sampled twice after they are placed. This will occur on 2 consecutive days. At the same time, study staff will take samples from several areas of the room (the hand rails, overbed table, nurse call button).

Patients will also be asked to allow the research team to obtain swabs of the nose, per-rectal area, armpit and groin. These swabs will be performed on their first day enrolled into the study, then 4 days later, and every week until ICU discharge.

Eligibility Criteria:
Inclusion Criteria:

* Hospital inpatients
* Admission to intensive care unit
* Hospital Admission at least 48 hours

Exclusion Criteria:

* Hospital admission less than 48 hours
Comparison of Intranasal Oxytocin Effects Using Co-administration With a Vasoconstrictor

This study aims to dissociate direct from indirectly mediated effects of intranasal oxytocin administration by using treatment with or without prior intranasal administration of a vasoconstrictor to reduce peripheral increases in peptide concentrations. Primary outcomes of the randomized placebo-controlled double-blind experiment are blood oxytocin concentration and oxytocin-associated responses in central and peripheral systems.

Intranasal application of the neuropeptide oxytocin has been reported to produce a number of neural, physiological and behavior effects which may be of potential therapeutic relevance, but it is unclear the extent to which they are mediated directly via the peptide entering the brain or indirectly as a result of increased peripheral concentrations. In the current placebo-controlled, double blind experiment on healthy adult male subjects the investigators will measure the effects of a single dose of intranasal oxytocin (24IU) on brain activity (using electroencephaolography - EEG) as well as on cardiac (heart-rate and heart-rate variablility) and gastric (electrogastrogram - EGG) activity and physiological arousal (skin conductance response - SCR). The pattern of functional effects observed will be compared with subjects receiving intranasal pretreatment with a vasoconstrictor prior to oxytocin in order to reduce the amount of oxytocin entering the peripheral circulation. The investigators hypothesize that prior administration of the vasoconstrictor will greatly reduce blood oxytocin concentrations following intranasal oxytocin treatment. Where neural/physiological effects are also affected, this will indicate an indirectly mediated action of intranasally administered oxytocin whereas if they are not this will indicate a directly mediated action.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury
* medical or psychiatric illness.
Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice (Chicago)

A cross-sectional conductive study at the University of Chicago Medicine facilities (hospital and outreach clinics) to enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.

A cross-sectional conductive study at the University of Chicago Medicine facilities (hospital and outreach clinics) will be conducted to include a total of 250 newborns with a desired distribution of skin color according to Neomar's scale : skin color 1 and 2: 20%, skin color 3: 30% and skin color 4: 50%. Skin color may also be quantitatively assessed using a handheld spectrophotometer (CM-700d, Konica Minolta).

The Picterus Calibration Card will be placed on the chest of the newborn with the hole in the card placed over the infant's chest. A validated smartphone with Picterus JP will be used to collect digital images, which are analysed to calculate a Picterus bilirubin value.

Eligibility Criteria:
Inclusion Criteria:

* Infants born with gestational age \&amp;gt; 35 weeks.
* Birth weight ≥ 1800 grams
* Age 1 - 14 days
* Infants requiring a TSB blood sample for clinically suspected jaundice as part of standard care

Exclusion Criteria:

* Infants showing signs of inborn disease.
* Infants with skin rash or other skin disease that affects the skin where measurements are performed.
* Infants transferred to the pediatric ward for medical treatment.
* Infants that have received phototherapy in the last 24 hours
uPAR-PET/MRI in Glioblastoma Multiforme

The purpose of this study is to investigate the applicability of urokinase plasminogen activator receptor (uPAR) Positron Emission Tomography (PET) / MRI molecular imaging of glioblastoma.

68Ga-NOTA-AE105 is a radioligand targeting urokinase plasminogen activator receptor (uPAR), which is a promising imaging biomarker of tumor aggressiveness. 68Ga-NOTA-AE105 PET/MRI will be applied in patients suspected of glioblastoma multiforme. The uptake of the radioligand 68Ga-NOTA-AE105 will be compared and correlated with expression of the molecular target: uPAR using immunohistochemistry of tumor tissue samples obtained during routine stereotactic biopsies or operation. In addition, the semiquantitative uptake (standard uptake values, SUVs) of 68Ga-NOTA-AE105 in tumor tissue will be correlated with overall survival and progression free survival

Eligibility Criteria:
Inclusion Criteria:

* Patients where imaging with MRI or CT is suspicious of having glioblastoma multiforme, and patients, and who is referred for stereotactic biopsy, chemotherapy or surgery
* The participants must be capable of understanding and giving full informed written consent
* age above 18 years

Exclusion Criteria:

* Pregnancy
* Lactation/breast feeding
* Age above 85 years old
* Weight above 140 kg
* Known allergy towards 68Ga-NOTA-AE105
Evaluation of New or Worsening Lens Opacifications in Men With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss

This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate new or worsening lens opacifications in men with non-metastatic prostate cancer receiving denosumab for bone loss due to androgen deprivation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Men ≥ 30 years of age with non-metastatic prostate cancer, having undergone bilateral orchiectomy or initiated androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) agonists and is expected to continue on ADT for at least 12 months
* Adequate visual accuracy allowing eye testing
* Bone Mineral Density (BMD) requirements: Osteopenia if under 70 years of age; Osteopenia or normal BMD if over 70 years of age
* Signed informed consent

Exclusion Criteria:

* Previous surgery for cataracts in both eyes, current diagnosis of cataracts, cataracts surgery foreseen in the near future, or ocular disease leading to visual loss
* Diagnosis of osteoporosis
Liver Resection for Patients With Hepatocellular Carcinoma and Clinically Significant Portal Hypertension

Clinically significant portal hypertension limits the therapeutic options for hepatocellular carcinoma (HCC), which is closely associated with patient prognosis. HCC patients with CPSH are heterogeneous and treatment allocation remains controversial. The aim of this study was to compare the survival benefits of liver resection (LR) and transarterial chemoembolisation (TACE) in these populations.


Eligibility Criteria:
Inclusion Criteria:

* HCC patients treated conventional liver resection or transarterial chemoembolisation

Exclusion Criteria:

* (1) presence of types III/IV portal vein tumour thrombosis (PVTT), hepatic artery, biliary duct or inferior vena cava invasion; (2) presence of extrahepatic spread (EHS); (3) underwent previous treatments; (4) Eastern Cooperative Oncology Group Performance Status (ECOG-PS) \>1; (5) diffuse tumor nodules; (6) combined with other tumours or severe cardiac, cerebral, and renal insufficiency; (7) non-Clinically significant portal hypertension（CSPH）, and (8) absence of baseline information
Centralized Reading Assessment of Chronic CerebroSpinal Venous Insufficiency (CCSVI) in Patients With Multiple Sclerosis and Other Neurological Diseases

This a retrospective, blinded trial in which collaborators in Italy will review the doppler findings from the Combined Transcranial and Extracranial Venous Doppler (CTEVD) trial in an attempt to measure reproducibility.

This study will retrospectively investigate doppler images from the second phase of the CTEVD trial.

1. To determine the prevalence of CCSVI in patients with MS, compared with the prevalence observed in a control population consisting of Other Neurological Diseases (OND) patients and Healthy Controls (HC) by using blinded, controlled centralized ultrasound reading assessment of 5 Venous Haemodynamic (VH) CCSVI CCSVI Doppler UltraSound (CDUS) criteria.
2. To investigate whether prevalence of CCSVI is different between centralized and local CDUS reading of 5 VH CCSVI CDUS criteria.
3. To investigate the prevalence of CCSVI in patients with MS, compared with the prevalence observed in a control population consisting of OND patients and HC, when bidirectional flow in the intracranial veins and sinuses CDUS criterion is not considered as part of VH CCSVI CDUS criteria.
4. To determine whether prevalence of CCSVI in patients with MS, compared with the prevalence observed in a control population consisting of OND patients and HC differs when using CDUS velocity and flow parameters in the Internal Jugular Veins (IJVs) and Vertebral Veins (VVs).
5. To determine the reproducibility of VH criteria by using of centralized and local blinded, controlled CDUS reading assessment.

Eligibility Criteria:
Inclusion Criteria:

* Participation in the CTEVD Phase 2 study
* Available CDUS exam
* Diagnosed with CIS, MS, OND, or being a HC
* Fulfilling inclusion criteria from the CTEVD study

Exclusion Criteria:

* Not having an available CDUS exam
* Diagnosed with Radiologically Isolated Syndrome (RIS) or Neuromyelitis Optic (NMO)
* Fulfilling exclusion criteria from the CTEVD study
RC Repair Versus Subacromial Balloon Spacer in Older Adults

The purpose of this pilot study is to assess the feasibility of a full randomized trial design.

The feasibility objectives are:

1. Recruitment

   1. To establish an estimate of the proportion of patients screened who are eligible for inclusion, and of those, the proportion who consent.
   2. To establish an estimate of the proportion of eligible patients with medium/large tears versus massive tears.
2. Surgery -to confirm agreement among surgeons regarding the protocol's standardized surgical techniques of both groups.

Clinical objectives for observational purposes only are as follows:

1. Patient reported and clinical outcomes.
2. Number of "failures" in each group (defined as additional surgery and/or having \<12% improvement in SANE score from baseline).

Eligibility Criteria:
Inclusion Criteria:

* 70 years of age or older
* clinical and radiological diagnosis of a full thickness supraspinatus (or larger) RC tear \>2cm or more than 1 full tendon
* ongoing symptoms after 3 months of physiotherapy
* a tendon amenable to partial or complete repair (as determined by pre-operative MRI)
* absence glenohumeral arthritis (Hamada \< 3)
* absence of neoplastic diseases at treated site

Exclusion Criteria:

* previous surgery or pseudoparalysis on study shoulder
* complete subscapularis deficiency
* external rotation lag signs
* avascular necrosis
* post-infectious arthritis
* proximal humerus fracture
* inflammatory arithritis
* axillary nerve palsy
* concomitant tendon transfer
* neuromuscular disorder
* unable to speak/read English

Intra-operative Exclusion:

-tendon is NOT amenable to partial or complete repair
Complications of the Cephalic Route in Implantable Site Placement in Children

Totally implantable venous access devices (TIVADs) offer long-term central venous access for children requiring intravenous treatments. Their use is recommended in infants (31 days - 1 year old) for \>31 days of non-peripherally compatible therapy, and in children and adolescents (\>1 year old) for any intravenous therapy lasting more than 31 days. Indications include chemotherapy administration and chronic disease management, avoiding repeated peripheral venous punctures and causing less interference with the activities of the patients.

There are several methods for TIVAD placement, but the optimal evidence-based method remains unclear . The two main approaches for TIVAD placement are closed cannulation of a vein, followed by insertion of the catheter in Seldinger technique, and the surgical insertion of the catheter into a vein through an open cut-down technique 5-7. Different location of insertion are possible: by closed cannulation, the catheter is usually placed in subclavian vein, internal jugular vein, and brachiocephalic vein; by open cut-down it can be placed in external jugular vein, axillary vein, or cephalic vein.

Thanks to progress in medical and surgical care, children are nowadays surviving previously fatal illnesses, but with the need of long-term treatments. For this reason, it's essential to preserve their vessel health. With this objective, in the CHU of Angers, physicians prefer trying first the cephalic vein cutdown for TIVAD positioning in children, reserving the use of other venous accesses in case of failure of this procedure or the need for multiple devices implantations.

To date, few reports have been published about cephalic vein cutdown in children. It is a common opinion that this technique can't be successfully performed in patients under a certain limit of weight or age. In this context, the investigators conducted a retrospective single-centre study to analyse the results of cephalic vein cutdown in children. The primary aim was to describe the feasibility of this technique in paediatric population and identify the risks factors associated with its failure. In addition, this study describes indications, outcomes, and complications of TIVAD implantation.


Eligibility Criteria:
Inclusion Criteria:

* All patients under 18 years who underwent TIVAD implantation between 2012 and 2022.
* Patients for whom cephalic vein cutdown was the first attempted surgical technique for device placement.

Exclusion Criteria:

* Patients who previously had a central venous access
Preventing Obesity in the Worksite: A Multi-Message, Multi-"Step" Approach

The purpose of this research study is to develop, implement, and evaluate a multi-component obesity prevention program in a workplace setting. A quasi-experimental design will be utilized, with hospital employees receiving the intervention and clinic employees serving as the comparison group. It is hypothesized that the intervention group will see greater changes in healthier eating, increased participation in physical activity, and reduced risk for obesity (weight, BMI, waist circumference).

Over one-third of Americans are now considered obese. Efforts to prevent obesity involve changing the individual behaviors that contribute to obesity, mainly healthful eating and physical activity, as well as the social and physical context in which those behaviors take place. Due to their existing networks and available resources, worksites are a logical place to help individuals make healthy choices through health promotion efforts. The purpose of this project is to partner with a community hospital to plan, implement, and evaluate a multi-component obesity prevention program in their workplace. The prevention program will target individual and interpersonal determinants of eating behavior and physical activity, as well as the context in which these behaviors take place. This intervention will include four integrated components: (1) nutrition labeling (using stoplights, calories, and step equivalents) in the worksite cafeteria, and modifying the cafeteria environment, (2) distributing pedometers to employees, (3) persuasive media messaging, and (4) the use of "influentials" to address social norms around eating and physical activity behaviors. A quasi-experimental design will examine the effectiveness of this multi-component worksite obesity prevention program.

Eligibility Criteria:
Inclusion Criteria:

* Employee at one of the hospital/clinic locations participating in the study

Exclusion Criteria:

* none
Efficacy and Safety of Etomidate Sedation in Gastric Endoscopic Submucosal Dissection

During endoscopy, the patient is sedated to relieve pain and improve the ease of the procedure. Sedation endoscopy using propofol is effective, but has the disadvantage that cardiopulmonary side effects are frequently observed. However, etomidate is known to have hemodynamic and respiratory stability.The purpose of this study was to compare the efficacy and safety of etomidate and propofol in sedated gastric endoscopic submucosal dissection.


Eligibility Criteria:
Inclusion Criteria:

* Age 19-80
* American Society of Anesthesiologists Physical Status Classification System (ASA) score of I, II, III
* Scheduled endoscopy

Exclusion Criteria:

* Pregnancy
* Previous study History of hypersensitivity to drugs or substances containing soy or egg ingredients
* Those who think that tracheal intubation will be difficult
* Obstructive sleep apnea
* History of side effects from previous sedatives
* People with severe liver disease, kidney disease, or heart disease
* Those who want a non-sleeping endoscope
* A person who refuses to provide consent
* SBP \&lt; 80mmHg or SpO2 \&lt; 90%
* Patients with adrenocortical dysfunction, chronic steroid users