cyrilzakka/clinical-trials huggingface dataset:
Pentoxifylline and Late Onset Sepsis in Preterm Infants

* Hypothesis: The investigators hypothesized that Pentoxifylline has potent anti-inflammatory effect which can augment the antimicrobial effect of antibiotics in treatment of Late onset sepsis (LOS) in preterm infants thus decreasing neonatal mortality and morbidity.
* The purpose of this study: to assess the efficacy and safety of Pentoxifylline as an adjunct to antibiotic therapy on mortality and morbidity of preterm infants with LOS.

* Role of pentoxifylline, a phosphodiesterase inhibitor, in reducing mortality associated with neonatal sepsis is not well studied.
* Hypothesis: we hypothesized that Pentoxifylline has potent anti-inflammatory effect which can augment the antimicrobial effect of antibiotics in treatment of Late onset sepsis (LOS) in preterm infants thus decreasing neonatal mortality and morbidity.
* Purpose of the study: to assess the efficacy and safety of Pentoxifylline as an adjunct to antibiotic therapy on mortality and morbidity of preterm infants with LOS.
* Design: A prospective, randomized, double-blind clinical trial.
* Setting: Neonatal Intensive Care Unit, Mansoura University Children's Hospital.
* Patients: 120 preterm infants with suspected or confirmed LOS.
* Intervention: Enrolled infants were randomly assigned to receive intravenous Pentoxifylline (5 mg/kg/hr for 6 hours on 6 successive days) or placebo in addition to antibiotics.
* Primary outcome: Death before hospital discharge.
* Secondary outcomes: Length of hospital stay, duration of respiratory support, duration of antibiotics use, chronic lung disease, necrotizing enterocolitis, intraventricular hemorrhage, periventricular leukomalacia, retinopathy of prematurity, Serum levels of Tumor necrosis factor, C-Reactive protein levels, and adverse effects of Pentoxifylline.

Eligibility Criteria:
Inclusion Criteria:

- Appropriate for gestational age preterm infants with suspected or confirmed late onset sepsis

Exclusion Criteria:

* Preterm infants with major congenital malformations
* Preterm infants with chromosomal anomalies
* Preterm infants with inborn-errors of metabolism
* Preterm infants with congenital infection
Safety and Efficacy Study of a Fluoroquinolone to Treat Complicated Skin Infections

The purpose of this study is to assess the efficacy, safety and tolerability of RX-3341 (delafloxacin), a fluoroquinolone, versus tigecycline, a glycylcycline antibacterial drug, in the treatment of complicated skin and skin structure infections.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years of age) men or women with cSSSI
* Diagnosis of one of the following 3 types of cSSSI: wound infection that has developed within 30 days of surgery, trauma, or a bite injury; abscess that has developed in the 7 days before enrollment; or cellulitis that has developed in the 7 days before enrollment
* Sexually active men and women of childbearing potential must agree to use an acceptable form of contraception, as determined by the investigator, during participation in the study and for 30 days after the final dose of study drug
* The patient must be willing to comply with protocol requirements

Exclusion Criteria:

* Medical history of hypersensitivity or allergic reaction to quinolones, tetracycline or tetracycline derivatives
* Chronic or underlying skin condition at the site of infection
* Infection involving prosthetic materials or foreign bodies (unless prosthetic material will be removed within 24 hours), infection associated with a human bite, osteomyelitis, decubitus ulcer, diabetic foot ulcer, septic arthritis, mediastinitis, necrotizing fasciitis, myositis, tendinitis, endocarditis, toxic shock syndrome, gangrene or gas gangrene, burns covering ≥10% of body surface area, severely impaired arterial blood supply, current evidence of deep vein thrombosis or superficial thrombophlebitis
* An infection that would normally have a high cure rate after surgical incision alone
* Any infection expected to require other antimicrobial agents in addition to study drug
* Receipt of \>24 hours of systemic antibiotic therapy in the 7 days before enrollment
* A severely compromised immune system
* History of Child-Pugh Class B or C liver disease or severe renal impairment (creatinine clearance of \<30 mL/minute)
* Pregnancy or lactation
Applicaion of Mouth Opener Combined With Electronic Video Laryngoscope in Double-lumen Intubation of Patients With Difficult Airway

How to quickly expose glottis and accurately insert double luminal tracheal tube in patients with difficult airway in thoracoscopic surgery has become an urgent problem in anesthesia induction.This study through the double cavity bronchial tube visual laryngoscope intubation with open mouth and electronic video laryngoscope used in combination, to explore whether can shorten the glottis exposure, improve the success rate of the double lumen tube intubation will reduce pharyngeal damage, reduce intubation hemodynamic fluctuations, in order to improve the glottis appeared difficult patients with bronchial intubation success rate to provide the reference.

A total of 60 patients who needed double-lumen endobronchial catheterization in thoracic department and whose Arne o 'risk index score was at least 7 points were randomly divided into three groups.Group B was intubated with video laryngoscopy.Group C was intubated with a mouth opener for video laryngoscope combined with a double-lumen bronchial tube for video laryngoscope intubation (hereinafter referred to as the mouth opener).The glottis exposure time, bronchial intubation time, intubation times, success rate of one intubation, and NRS score of pharyngeal pain 8 hours after surgery were observed and recorded in the three groups, and the hemodynamic changes after intubation were observed and recorded.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of early lung cancer
* Ages ranged from 30 to 80

Exclusion Criteria:

* Pregnancy
* Prediction of difficulty in mask ventilation
* Chest X-ray examination of trachea, bronchial anatomical abnormalities or tumor compression caused by trachea/bronchial deformation
* Failure of assessing Arne risk index
Predictors of Recurrence in Bipolar Disorder in Spain

Observational, prospective (1 year follow up), multicenter, non-interventional open label study in order to assess the factors that predict onset of mood disorders episodes (depression, mania, hypomania and mixed) in stabilized patients with bipolar disorder I or II in Spain. Other objectives are

1. to describe the clinical course of illness in a cohort of patients with TB I or II: duration, severity, polarity and seasonality
2. to describe clinical and functional situation of patients during the different phases, evaluating prognostic meaning of subsyndromal symptoms
3. to evaluate the economical impact on health service of these patients (hospitalization, primary care, treatments...).

Target population is ambulatory bipolar I and II patients, clinically stabilized for at least the two months prior to recruitment and who had at least one acute episode (depressive, manic, hypomanic or mixed) within the year prior to recruitment. The primary endpoint is the onset of mood disorders episodes (depression, mania, hypomania and mixed) during the follow-up period and evaluation of which factors predict onset of mood episodes


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed of Bipolar Disorder I or II (DSM-IV-TR)
* Patients Stabilized from at least 2 months who had a mood disorder episode (depression, mania, hypomania or mixed) in the last year.
* To be attended by a psychiatric specialist

Exclusion Criteria:

* Inability to participate in the study
* To have taken part in other study in the last 6 months
Effect of Daily Nicotine Patch Application on Mechanical Ventilation Weaning in Smoking Patients

Nicotine patches are frequently used in smoking patients during their stay in the ICU in order to avoid tobacco's weaning symptoms which are likely to interfere with mechanical ventilation weaning.

Until now the effectiveness of this treatment has not been proven. The aim of this study (NICOREA study) is to determine if a difference exists on the duration of mechanical ventilation once patients receive or not a nicotine substitute.

Six hundred mechanically ventilated patients are going to be enrolled to receive nicotine or placebo during a 24 month period in 14 centers in France.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 et 80 yrs
* SOFA score below or equal to 16 at randomization time
* Patient expected to be mechanically ventilated for at least 24hrs
* Patient known to be usually smoking more than 10 cigarettes per day according to her/him or to a next of kin
* Consent obtained from the patient or a next of kin.

Exclusion Criteria:

* Patients having been in the ICU for more than 72 hours or mechanically ventilated since more than 48 hours
* Isolated brain trauma
* Patients weaned from tobacco since more than 21 days
* Patients smoking only pipe, cigars or cannabis
* Chronic skin diseases (psoriasis, dermatitis, etc)
* Patients receiving other products containing nicotine
* Patients not understanding French
* Patients with severe hearing deficiency
* Mechanical ventilation weaning using an expert system
* Disease with short term fatal issue
* Pregnancy
* Patient depending on other persons for most every day actions
* Myocardial infarction within 3 months, ventricular arrhythmia's
* Stroke during the 3 last months
* Known hypersensibility to nicotine or patches
COugh Among Hypertensive Patients Treated With Telmisartan, Who Had to Stop previoUs ACE-i Treatment Due to couGH in Slovakia

In the light of ONTARGET and TRANSCEND studies results, it would be interesting to investigate the real-life telmisartan treatment tolerability. It is well known and accepted that the Real-life setting is much more adequate to reflect the antihypertensive and safety properties of the drug in comparison to the organized and scheduled setting of the clinical trial. Because there are not much data on the cough in relation to telmisartan, therefore it would we worth to observe the cough frequency and general treatment tolerance in patients treated with telmisartan, who had to stop their previous ACE-I treatment due to cough.


Eligibility Criteria:
Inclusion Criteria:

* Hypertension
* Age \> 18
* ACE-I related cough

Exclusion Criteria:

* Current treatment with telmisartan
* Cholestatic disorders and severe hepatic failure
* Allergy to telmisartan
* Pregnancy and lactation period
Study of Co-administration of Olmesartan Medoxomil Plus Amlodipine in Patients With Mild to Severe Hypertension

This study assesses the efficacy and safety of co-administration of olmesartan medoxomil plus amlodipine in mild to severe hypertensive patients older than 18 years of age


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients
* 18 years of age or older (20% equal to or older than 65 years)
* With mild to severe hypertension defined as seated diastolic blood pressure of 95-120 mmHg while off any hypertensive medication

Exclusion Criteria:

* Patients should not have serious concomitant conditions that could interfere with the analysis of the results or that could interfere with the well-being of the patients
Effect of Neuromodulation on Pain Biomarkers and Functional Outcome in Patients With Fibromyalgia Syndrome

Fibromyalgia is the third most common musculoskeletal condition in terms of prevalence, after lumbar pain and osteoarthritis. Its prevalence is around 2-4 % and is more frequent in women than in men; the prevalence is highest in age the range of 40-60 years.

Group A (Control Group): Patients will receive exercises, and sham Non-Invasive Neuromodulation, 3 sessions per week (one hour for each session) for 4 weeks.

Group B (Study Group): Patients will receive exercises as in group (A) in addition to Non-Invasive Neuromodulation 3 sessions per week (one hour for each session) for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Patients fibromyalgia from both genders.
2. The duration of fibromyalgia is more than 6 month (all patients with history of cervical or lumbar pain) and following diagnosis of FM using the 2016 revised FM criteria, on the basis of the ACR-2010 criteria.
3. Their ages will be ranged from 25-35 years old.
4. They will be medically stable and have sufficient cognitive abilities that enable them to understand and follow instruction according to Montreal Cognitive Assessment (MoCA) \>26.

Exclusion Criteria:

1. Other Neurological diseases as stroke , multiple sclerosis, Parkinson's disease and motor neuron disease
2. Pacemaker
3. Spinal fusion-cervical or lumbar
4. Metal implants in the spine
5. Pregnancy
6. Epilepsy
7. Severe psychiatric disorder or alcohol and drug abuse.
8. Unstable medical condition which could compromise the participant's welfare or confound the study results.
9. Uncontrolled blood pressure or diabetes
10. Visual or auditory problems.
11. Active inflammatory conditions
Platelet-Rich Plasma (PRP) for Treatment of Symptomatic Lumbar Facet Syndrome of the Spine

The purpose of this study is to investigate the feasibility of standardized autologous platelet rich plasma injections into osteoarthritic lumbar facet joints to treat back pain and improve patient function.


Eligibility Criteria:
Inclusion Criteria:

* Suspicion of z-joint mediated low back pain
* Pain rating of ≥4/10 on a VAS scale
* Symptom duration of 3 or more months
* Failed conservative therapy (minimum of PT and pain medications)
* Have diagnosis of lumbar facet syndrome after MRI, X-ray, or CT imaging of any severity and a medial branch block with local anesthetic that confirms lumbar facet pathology.

Exclusion Criteria:

* Inability to undergo fluoroscopically guided procedures
* Current pregnancy
* Prior spinal surgery with hardware
* Intolerance to local anesthesia, contrast medium, or blood derivatives
* Local or systemic infection or spinal infection
* Irreversible coagulopathy
* Patients that require strict anticoagulation and cannot be off antiplatelet medication for at least a week
* Less than 18 years of age
* Corticosteroid shot within last 3 months into affected lumbar facet joint because of concern of damage to cartilage in the joint in that time period.
* Patients with workman compensation related back pain
* Patients with rheumatic cause of lumbar facet arthritis.
* Patients who have had a radiofrequency neurotomy of the nerves innervating their affected facet joints within the last year
Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy

Cardiac resynchronization therapy (CRT) is an effective therapeutic strategy in patients with symptomatic heart failure (HF) patients with LVEF of ≤35% and left bundle branch block (LBBB). However, approximately one-third of CRT-recipients do not improve after therapy (non-responders), despite meeting the required criteria.

Previous studies have documented that the positive respons to CRT is related to the delayed electrical activation of the left ventricle in patients with LBBB. It has also been illustrated that non-ischemic CRT-candidates with LBBB demonstrate lower regional myocardial blood flow and metabolism in the septum. Additionally, it has been suggested that LBBB can lead to impaired coronary blood flow in the left anterior descending artery (LAD). This observation is based on an echocardiography-based study, that showed that the percentage of diastolic flow duration (%DD) in LAD was shorter in patients with LBBB compared to the control-group and patients with right-ventricular pacing.

It has been demonstrated that CRT has positive effects on septal myocardial perfusion in patients with HF and LBBB. The dominant hypothesis explaining this phenomenon is built on improved septal myocardial work after CRT-implantation, which leads to increased myocardial energy and therefore increased myocardial perfusion. In contrast, it has been suggested that due to re-established synchronous left ventricular electrical activation, CRT reduces the septal intramyocardial pressure in early diastole, leading to a relatively longer antegrade flow duration in LAD. Therefore, the aim of the study is to evaluate the effect of CRT on coronary blood flow in LAD in patients with non-ischemic HF and LBBB.

The investigators hypothesize that increased LV-function after CRT not only is due to resynchronized LV ejection and filling, but also improved coronary flow.

The study aims to enroll 60 patients with heart failure due to non-ischemic dilated cardiomyopathy, LBBB, with or without CRT. All patients meeting the criteria will be recruited from the outpatient clinic at the Department of Cardiology, Aalborg University Hospital.

Invasive flow measurements in the LAD, including fractional flow reserve (FFR), absolute coronary flow and -reserve will be conducted with the CRT on and off, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* QRS ≥ 150 ms before implantation
* Heart failure because of dilated cardiomypathy
* Sinus rhythm
* Stable medical therapy
* LBBB
* CRT device

Exclusion Criteria:

* eGFR \< 30 ml/min
* Severe valvular heart disease
* Permanent atrial fibrillation or atrial flutter
* Prior PCI or CABG
* Prior myocardial infarction
* Heart failure due to ischemic heart disease
* Other type of device (pacemaker, ICD)
* Not able to give informed consent
* Does not understand Danish
Mechanical Stimulation in Preventing Bone Density Loss in Patients Undergoing Donor Stem Cell Transplant

This pilot clinical trial studies mechanical stimulation in preventing bone density loss in patients undergoing donor stem cell transplant. Mechanical stimulation may limit, prevent, or reverse bone loss, increase muscle and cardiac performance, and improve overall health

PRIMARY OBJECTIVES:

I. To determine the feasibility of a mechanical stimulation regimen in hematopoietic cell transplant (HCT) patients.

SECONDARY OBJECTIVES:

I. To evaluate the data collection tools to prepare for a larger phase II trial.

OUTLINE:

Patients undergo mechanical stimulation over 20 minutes once daily (QD) beginning on date of hospital admission and continuing through day 100 post-HCT, except for day 0 (date of transplant).

Eligibility Criteria:
Inclusion Criteria:

* Meet eligibility criteria for first allogeneic HCT, and are scheduled to undergo allogeneic HCT
* Pre-transplant Karnofsky Performance Status (KPS) \>= 70
* Patient or legal representative must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

* Any prior allogeneic HCT
* Pre-transplant weight \>= 280 lbs
* Body mass index (BMI) \< l8kg/m\^2
* Human leukocyte antigen (HLA)-mismatched HCT
* Cord blood transplant
* Osteopenia or osteoporosis (T-score =\< -1.0)
* Multiple myeloma diagnosis
* Any prior history of a central nervous system (CNS) hemorrhage
* Currently treated with a therapeutic dose of anti-coagulation for a recent pulmonary embolism or deep vein thrombosis
* Current or previous bisphosphonate use
* Prior history of non-traumatic fracture
* Any screws, pins, rods, or other metal objects in the body
* Total joint replacement
* History of kidney stones or gall stones
* Any artificial limbs
* Pregnant or nursing female patients
* Unwilling or unable to follow protocol requirements
* Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study intervention
De Novo Metabolic Syndrome in Liver Transplant Patients After Immunosuppression Withdrawal

Evaluate de novo onset of metabolic syndrome, NAFLD and NASH in liver transplant recipients who have discontinued immunosuppressive therapy ("tolerant") and in those taking immunosuppressive therapy ("non-tolerant").

A retrospective single-center study was conducted aiming to define the incidence of de novo Metabolic Syndrome (MS) in patients who withdraw Immunosoppression (IS) drugs after Liver Transplant (Tolerant-group) compared to these who couldn't wean IS drugs(non-TOL-group).

Eligibility Criteria:
Inclusion Criteria:

* single LT recipients with an attempt of IS withdrawal
* minimum 5 years follow-up

Exclusion Criteria:

* Liver transplant combined with other organs
* Presence of metabolic syndrome and/or NASH and/or NAFLD as an indication for liver transplantation
* Loss of patient to follow-up
Safety Study to Evaluate Intracranial Pressure During High Frequency Chest Wall Oscillation

The purpose of this study is to evaluate changes in intracranial pressure (ICP) during or immediately following high frequency chest wall oscillation (HFCWO) treatment with the Vest™ in neurosurgical subjects.

This study is a single site safety study to evaluate changes in intracranial pressure during or immediately following HFCWO treatment with the Vest™ in neurosurgical subjects with intracranial pressure monitors having normal opening pressures and ICP less than or equal to 20 mmHg. The secondary objective of this study is to evaluate changes in arterial blood gases that may result with Vest™ therapy in ventilated patients.

Eligibility Criteria:
Inclusion Criteria:

* ICP monitor with normal opening pressure (greater than or equal to 20 mmHg)
* On ventilator
* Arterial line in place
* Age equal to or greater than 18
* Admitted to neurotrauma intensive care unit (ICU)

Exclusion Criteria:

* Inability to obtain informed consent
* Unstable spinal cord injury
* ICP \> 20 mmHg sustained for \> 5 minutes
* Hemodynamic instability within the prior 12 hours
* Active hemoptysis
* Hemothorax
* New onset, unstable arrhythmia
* Enrollment in another interventional study
* Aneurysm that has not been clipped or coiled
* Coagulopathic head injury subjects
Clinical and Molecular Characterization of Cerebral Proliferative Vasculopathy

As principal objective, the study aims to:

1. Describe the spectrum and evaluate the frequency of angiodysplasia of the nevrax;
2. Establish the physiopathological basis of Fowler's syndrome;
3. Identify FLVCR2 partners and the signaling pathways involved;
4. Test new candidate genes: GPR124 and possible partners of FLVCR2.

As second objective, the study aims to:

* perform phenotype / genotype correlation if necessary;
* and propose a prenatal diagnosis in families with identified mutations.


Eligibility Criteria:
Inclusion Criteria:

* Angiodysplasia restricted to central nervous system with or without glomerular vasculopathy.
* Informed consent signed.

Exclusion Criteria:

* Vascular malformations not confined to the nevrax.
* No signature of consent.