cyrilzakka/clinical-trials huggingface dataset:
Systemic Methylprednisolone in Chronic Rhinosinusitis

The place of systemic corticosteroids in the treatment of children with chronic rhinosinusitis (CRS) remains unclear. We aimed to assess the effectiveness and tolerability of oral methylprednisolone (MP) as an anti-inflammatory adjunct in the treatment of CRS in children.Forty-eight children (age 6-17 years) with clinically and radiologically proven CRS were included. Patients were randomly assigned to either oral amoxicillin/clavulanate (AMX/C) and MP or AMX/C and placebo (P) twice daily for 30 days. Oral MP was administered for the first 15 days with a tapering schedule. Primary parameters were mean change in symptom and sinus computed tomography (CT) scan scores after treatment. Secondary study parameters were mean changes in individual symptom scores after treatment, relapse rate and tolerability. Forty-five patients completed the study, 22 received AMX/C and MP, and 23 AMX/C and P. Both groups demonstrated significant improvements in symptom and sinus CT scores, comparing baseline to end of the treatment (p\<0.001). Methylprednisolone as an adjunct was significantly more effective than placebo in reducing CT scores (p=0.004), total rhinosinusitis symptoms (p=0.001) and individual symptoms of nasal obstruction (p=0.001), postnasal discharge (p=0.007), and cough (p=0.009). At the end of the treatment, 48% of the children in the P group still had abnormal findings in CT versus 14% in the MP group (p = 0.013). Therapy-related adverse events were not different between groups. Although insignificant, the incidence of clinical relapses was also less in the MP group (25%) compared to P group (43%) (p = 0.137). Oral MP is well tolerated and provides added benefit to treatment with antibiotics for children with CRS.


Eligibility Criteria:
Inclusion Criteria:All patients presented with nasal and/or postnasal purulence, and one or more of the following symptoms: nasal obstruction, cough, halitosis, headache, or facial pain/pressure. The diagnosis of CRS was made on the basis of sinonasal symptoms and signs present for a period of more than 3 months in the presence of abnormalities on coronal sinus CT scans.

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Exclusion Criteria:Patients were excluded if they had used systemic corticosteroids in the last 2 months prior to the study, systemic antibiotics and inhaler or intranasal corticosteroids in the last 4 weeks prior to the study or if they had other respiratory disorders (cystic fibrosis, ciliary dyskinesia, nasal polyps, large adenoids, asthma), immune deficiency, systemic disease, gastro-esophageal reflux, aspirin sensitivity, and acquired or congenital sinonasal abnormalities, or a contraindication to corticosteroid use.

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Statin Therapy In Cardiac Surgery

The purpose of STICS trial (Statin Therapy In Cardiac Surgery) is to test whether perioperative treatment with Rosuvastatin 20 mg once daily prevents post-operative atrial fibrillation and reduces perioperative irreversible myocardial damage in patients undergoing elective cardiac surgery.

Evidence that pre- or perioperative statin treatment may reduce the occurrence of post-operative atrial fibrillation and improve clinical outcome in patients undergoing coronary artery bypass graft (CABG) or major vascular surgery has been largely generated by observational studies. In a recent meta-analysis of 6 randomized trials (of which only 2 had postoperative atrial fibrillation (AF) as a predefined outcome) evaluating the use of perioperative statin treatment in patients undergoing cardiac surgery (n=651 patients in total - study size between 40 and 200 patients), statin use was found to reduce the patients' relative risk of developing postoperative AF by 43% (RR 0.57, 95%CI 0.45,0.72) and their absolute risk by 14% (95% CI 8%,20%). Although these findings would be consistent with a rapid and, possibly, lipid-independent antiarrhythmic effect of statins, they have important limitations (e.g., single-centre, small size, lack of continuous ECG monitoring, mostly "ancillary" findings") and less bearing on current clinical practice, as they mostly included statin-naïve patients. For these reasons, the recent guidelines for the management of AF have not given a strong recommendation for the use of statins in the prevention of postoperative AF. Thus, whether intensive statin treatment in the perioperative period is associated with prevention of AF, cardio protection, and improved clinical outcome remains to be demonstrated.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients awaiting elective cardiac surgery who are willing and able to give informed consent for participation in the study and who are in sinus rhythm and not taking any antiarrhythmic medication, other than beta-adrenergic blocking agents, at the time of surgery.

Exclusion Criteria:

* History of obstructive hepato-biliary disease or other serious hepatic disease
* Untreated hypothyroidism
* Creatinine \> 200 umol/L
* Personal and family history of hereditary muscle disorders
* Known intolerance to statins or history of muscle toxicity with fibrates or statins.
* On-going use of fibrates, niacin or of agents that are strong inhibitors of cytochrome P-450 or the P-glycoprotein within a month preceding randomization (cyclosporine, oral azole antifungals,macrolide antibiotics, protease inhibitors, nefazodone, amiodarone or ≥ 1L/day of grapefruit juice)
* Significant mitral valve disease (moderate or severe mitral regurgitation-eg. \> grade II and/or mitral stenosis \& mitral annular calcification).
* Patients treated with any anti-arrhythmic agent (other than beta-adrenergic receptor blockers).
Sustained Aeration of Infant Lungs Trial

This study is a 2-arm randomized, controlled, multi-center clinical trial to determine which of two strategies at birth are best to optimally aerate the lung of preterm infants. Specifically we will determine in 600 infants of 23-26 weeks gestational age (GA) requiring respiratory support at birth which of two lung opening strategies - either a standard PEEP/CPAP of 5-7 cm H2O in the delivery room (DR), as compared to early lung recruitment using Sustained Inflation (SI) in the DR, will result in a lower rate of the combined endpoint of death or bronchopulmonary dysplasia (BPD) at 36 weeks gestational age.

Hypotheses:

1. Early lung recruitment with SI superimposed upon standard PEEP/CPAP in the DR will reduce the need for mechanical ventilation in the first seven days of life, and reduce need for surfactant use; and
2. A policy of DR SI on standard PEEP/CPAP recruitment will confer better outcomes at 36 weeks post-menstrual age (PMA) than standard PEEP/CPAP

The SAIL trial aims to provide evidence for changing policy or standard of care. The context of this trial is an unacceptable rate of poor long-term outcomes of preterm infants born as Extremely Low Gestational Age Newborns (ELGAN) \<1000 g birthweight (BW), but especially for those born between 23-26 weeks' gestational age (GA). Such infants are the most vulnerable and immature in all organ systems, including the lungs and the brain. These infants are at high risk of death and bronchopulmonary dysplasia (BPD) during their initial hospitalization, neurodevelopmental impairment (NDI) and pulmonary problems in infancy and childhood.

The SAIL trial focuses on facilitating the difficult transition of these most vulnerable infants from a liquid filled in-utero lung to an ex-utero air-filled lung. Sustained Inflation (SI) is a promising delivery room (DR) intervention, with evidence of short-term efficacy with minimal risk of additional harm beyond current standard accepted Newborn Resuscitation Program (NRP) Guidelines. This protocol proposes a fully informed consenting procedure. We propose to evaluate the impact of a SI in the DR on the need for mechanical ventilation in the first week of life which would also impact mortality rates and the incidence and severity of BPD.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age (GA) at least 23 weeks but less than 27 completed weeks by best obstetrical estimate
* Requiring resuscitation/respiratory intervention at birth -"apneic, labored breathing, gasping" (as defined in NRP 2011 AAP 6th Edition p.45)

Exclusion Criteria:

* Considered non-viable by the attending neonatologist
* Refusal of antenatal informed consent
* Known major anomalies, pulmonary hypoplasia
* Mothers who are unable to consent for their medical care and who do not have a surrogate guardian will not be approached for consent
Single Cell Leukocyte Landscapes and Cardiovascular Risk in Children With Chronic Kidney Disease

Chronic kidney disease (CKD) is associated with an increased cardiovascular mortality. In particular children with early-onset CKD have a lifelong increased risk to suffer from cardiovascular disease (CVD). Therefore, children with CKD deserve our attention. The immune system in children with CKD is disturbed, exhibiting pro-inflammatory features. Therefore, we aim to learn more about the characteristics of the immune system in early-onset CKD. In this project PBMC of pediatric CKD patients and age-matched healthy controls will be analysed and compared using CITE-Seq as a multimodal scRNAseq phenotyping method. All patients will be clinically characterized to integrate cardiovascular and immunological data.


Eligibility Criteria:
Inclusion Criteria:

* matching to one of the following groups CKD G3-5: estimated eGFR according to Schwartz formula \<60ml/min\*1,73m2 (no ESKD) CKD G5 D: patients with ESKD treated with hemodialysis for at least 3 months normal kidney function: CKD G1 or no CKD with eGFR \> 90ml/min\*1,73m2
* informed consent to participate in this study

Exclusion Criteria:

* body weight of less than 15kg
* acute or chronic inflammatory diseases
* fever
* diabetes
* chronic liver disease
* inflammatory bowel disease or other gastrointestinal disorders (constipation, diarrhea, short bowel syndrome)
* antibiotic prophylaxis or treatment within four weeks prior to recruitment
Efficacy of a Dietary Supplement on Parameters of Skin Aging in Men and Women

As the body ages, the skin experiences natural changes in structure and composition. These changes may manifest visibly as increased skin dryness, wrinkling, and a loss of firmness/elasticity. In this double-blind, randomized, placebo-controlled trial, the investigators will recruit healthy men and women with mild to moderate signs of skin aging and randomly assign them to either receive a HyaCera™ or placebo for 12 weeks. The investigators will perform a series of objective and subjective measurements to assess changes in skin condition. The investigators hypothesize that consumption of HyaCera™ leads to improvements in the general condition of the skin including skin hydration, crow's feet wrinkling, and other skin aging parameters.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers, 25 - 70 years old with mild to moderate fine lines and wrinkles
* All ethnicities and skin types
* Willing to maintain current skincare regimen on face, arms, and legs and withhold all facial and body treatments throughout the course of the study

Exclusion Criteria:

* Self-reported pregnant or breastfeeding or planning to become pregnant during the course of the study
* Any conditions on the face, arms and legs that would interfere with evaluations
* Under treatment for any known health issues/medical conditions including chronic health conditions and skin diseases/conditions
TAP vs Caudal Block Using Dexmedetomidine/ Bupivacaine for Post Operative Analgesia

Caudal epidural block is a well-established and commonly performed regional neuraxial technique for providing intraoperative and postoperative analgesia in children scheduled for lower abdomen/perineal surgical interventions. Although the efficacy and safety of Caudal epidural block are fairly high, the associated complications, such as inadvertent dural puncture, unwarranted motor blockade of the lower limbs, and disturbance of bladder function, limit its use. Furthermore, a major limitation of an uncomplicated Caudal epidural block when administered as a "single-shot" technique is its brief duration of action (up to 6 hours), which makes administration of additional analgesics necessary .

Ultrasonography guidance, by virtue of real-time visualization of the muscle layers and fascial planes, has significantly facilitated practice of regional nerve blockade for it offers confirmation of the spread of the local anesthetic drug in the correct space. Interestingly, there has been a reinvigoration of interest in ultrasonography-guided transversus abdominis plane block in children since its emergence as a valid postoperative analgesia alternative in adults undergoing abdominal surgery. transversus abdominis plane block involves blockade of spinal afferent nerves in the neurofascial plane between the internal oblique and transversus abdominis muscle. Whereas the advantages (reduction in pain intensity/analgesic requirements) of ultrasonography-guided transversus abdominis plane block have been well documented in adults in the first 48 hours post surgery, in children, its use as a primary postoperative analgesia technique remains limited. Caudal anesthesia is easy to perform in younger children; however, its main disadvantage is the short duration of action. Even bupivacaine, along-acting local anesthetic drug, can provide only4-8 h of analgesia. Dexmedetomidine is a highly selective alfa2 agonist with sedative and analgesic properties. It has an alfa1/2 selectivity ratio of 1600 : 1, which is eight times more potent than clonidine (200 : 1)\[16\]. DEX has been used effectively in intensive care to aid weaning from mechanical ventilation and is being used increasingly in children

Eligibility Criteria:
Inclusion Criteria:

* patients 2-8 years

Exclusion Criteria:
A Multicenter Trial to Investigate Fesoterodine Sustained Release in Overactive Bladder Syndrome

The trial consisted of a 2 week Run-In period, 12 week double-blind Treatment period and 2 week Safety Follow-Up period. Subjects were randomized to one of 4 treatment arms receiving either fesoterodine (SPM 907) 4mg, fesoterodine 8mg, active control (tolterodine SR 4mg) or placebo during the Double-Blind Treatment Period.

Two primary efficacy variables will be assessed for submission in the United States: change in the average number of micturitions (frequency) per 24 hours and the change in the average number of urge incontinence episodes per 24 hours. For the submissions in the European Union, the first primary variable will be the change in the average number of micturitions (frequency) per 24 hours and the co-primary variable is the treatment response, based on a treatment benefit scale. All continuous variables will be measured as changes from baseline to value after 12 weeks of treatment.

The most important safety variables included the assessment of adverse events, laboratory parameters, changes in ECG, physical exams and measurement of residual urine.


Eligibility Criteria:
Inclusion Criteria:

* Overactive Bladder Syndrome

Exclusion Criteria:

* less than 8 micturitions in 24 hours
Pulse Oximetry- Performance During Severe Signal Interference

Determine accuracy specifications and labeling claims of a pulse oximeter in a diverse subject population during severe signal interference over a specified saturation range.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects between the ages of 18 to 50 years (inclusive).
2. Must undergo a physical examination by a licensed physician, advanced practice nurse or physician assistant, including a 12 lead ECG, a medical history, and a blood test checking complete blood count and screening for sickle cell trait or disease
3. All female volunteers must have a negative urine pregnancy test prior to participation.

Exclusion Criteria:

1. A room-air baseline % modulation \< 1.5% on all four fingers on the test hand
2. Pregnancy or lactating women
3. History of syncopal episodes
4. Hypertension (defined as a systolic pressure of \>145 mmHg or a diastolic pressure \>90 mm Hg on three consecutive readings)
5. Premature ventricular contractions (PVC's) that are symptomatic or occur at a rate of more than 5/minute
6. History of seizures (except childhood febrile seizures) or epilepsy
7. Routine use of tranquilizers and/or excessive anxiety
8. History of frequent headaches or migraines
9. History of stroke
10. Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test multiple sensors
11. History of "altitude sickness" defined as headaches, malaise or dizziness when in the mountains or in an aircraft at altitude significantly above sea level for a prolonged period of time (\> 1 hour)
12. History of significant respiratory disease, such as severe asthma, emphysema, etc.
13. Sickle cell disease or trait.
14. The use of medications, pre-existing medical conditions, treatment for a medical condition or any other reason deemed relevant by the clinician conducting the study.
15. A clinically significant abnormal finding on medical history, physical examination, clinical laboratory test or ECG. Clinical significance will be assessed by the principal investigator or designee.
16. Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain)
17. Prior or known allergies to heparin
18. History of transient ischemic attacks or carotid artery disease
19. History of myocardial ischemia, angina, myocardial infarction, congestive heart failure or cardiomyopathy
20. History of chronic renal impairment
21. History of recent arterial cannulation (less than 1 month prior to study)
22. History of complications from previous arterial cannulation
23. Current use of blood thinners
NOC2 Spine Registry

The primary objective of the Spine Registry is to enhance the understanding of spinal disease and treatment of spinal disease with the goal of guiding treatment options.

This study will enhance the understanding of the variability, progression and treatment of spinal disease with the ultimate goal of better guiding and assessing therapeutic intervention. Researchers will collect complications and safety following cervical and lumbar surgeries to determine best options for patients. Prospective reports will be collected on patients undergoing lumbar or cervical spinal surgery. Patients will be enrolled in registry after signing informed consent. Data will be collected at various time points. The registry will serve as a database of cervical and lumbar surgeries in which retrospective analysis and exploratory analysis of specific research questions can be answered.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing lumbar or cervical surgery
* Understand and sign informed consent

Exclusion Criteria:

* There are no specific exclusion criteria
A Safety, Tolerability and Efficacy Study With QBW251 in COPD Patients With QBW251

To evaluate the efficacy, safety and tolerability of multiple doses of QBW251 vs placebo administered orally, on airway function, lung volume, and quality of life in patients with chronic obstructive pulmonary disease (COPD)


Eligibility Criteria:
Inclusion Criteria: Must have a diagnosis of GOLD II-III chronic obstructive pulmonary disease (COPD); Must have clinical diagnosis of chronic bronchitis; Must be either a current smoker (smoked ≤ 1 pack per day on average for the last 3 months with at least a 10 pack year smoking history) OR an ex-smoker with at least a 10 pack year smoking history; Exclusion Criteria: Must not be receiving chronic, daily, systemic steroids; Must not have severe emphysema (determined by HRCT); Must not have had a COPD exacerbation or respiratory tract infection requiring antibiotics or oral steroids or hospitalization within 6 weeks of screening; Must not be pregnant or nursing or a woman of child bearing potential; Other protocol-defined inclusion/exclusion criteria may apply
Intra and Postoperative Outcomes With 3 Injectors

This randomized clinical trial compares subjective performance during Intraocular lens (IOL) implantation, as well as incision enlargement and anterior segment morphology on OCT when IOL implantation was performed during microcoaxial phacoemulsification through a 2.2mm incision using one of three injectors :

Manual screw type (Monarch III), Manual plunger type (Royale) and motorised injector (Autosert). Further, the investigators also looked at incision integrity by comparing ingress of trypan blue from the ocular surface into the anterior chamber.

In this randomized, clinical trial, three types of injectors were compared :

1. Manual, screw type injector (Monarch III)
2. Manual, plunger type injector (Royale, ASICO)
3. Motorized injector (Autosert, Alcon)

Having performed a phacoemulsification through 2.2mm incision, IOL implantation was performed using a D cartridge and one of three injectors which was decided in a randomized fashion.

The investigators evaluated incision enlargement at following points : at the end of phacoemulsification, and then, at the end of IOL implantation The investigators also looked at trypan blue ingress into the anterior chamber from the ocular surface. At 1 day, 1 week, and 1 month after surgery anterior segment OCT morphology was also studied.

further, the surgeon was asked to subjectively grade the ease of implantation with each injector

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing phacoemulsification for age-related uncomplicated cataracts through a 2.2mm incision.
* Nuclear or corticonuclear of grade 2 to 4 according to the Lens Opacities Classification System (LOCS III)

Exclusion Criteria:

* Glaucoma,
* uveitis,
* shallow anterior chamber (depth \<2.1mm),
* prior ocular trauma or surgery,
* maximal pupillary dilatation \<6mm,
* high myopia (axial length \>25mm),
* posterior polar cataracts,
* dense cataracts, and
* an IOL power \<19.0 D or \>25.0 D
The Effect of Zoledronic Acid to Bone Fusion and Bone Metabolism of Patients With Lumbar Degenerative Disease After Lumbar Interbody Fusion

Many patients who have lumbar degenerative disease suffer from osteoporosis or reduced bone mass or low bone mineral density. Among patients with lumbar degenerative disease, some need fusion surgery. But conditions of osteoporosis or low bone mineral density slow down the rate of bone fusion, reduce the success of bone fusion, and ultimately affect the overall effectiveness of surgery. Zoledronic acid is an effective anti-osteoporotic. Many researchers dispute if zoledronic acid can promote the healing of long bone fractures. But few researchers focus on the effect of zoledronic acid to lumbar fusion. In this study, we select patients with lumbar degenerative disease who have had lumbar interbody fusion surgery. Three days postoperatively, the patients were randomized to either one infusion of zoledronic acid or sodium chloride intravenously. We follow all these patients for 6 months. During this time, we detect bone metabolism and bone fusion of these patients. At last, we can tell if zoledronic acid can modify bone metabolism and promote bone fusion.


Eligibility Criteria:
Inclusion Criteria:

* Patients with lumbar degenerative disease who have had lumbar interbody fusion surgery
* Age 50-70 years old
* Willing to sign informed consent

Exclusion Criteria:

* Application of strontium ranelate, sodium fluoride or parathyroid hormone
* Application of bisphosphonates more than 8 weeks during 2 years preoperatively
* Suffering from bone fracture during 3 months preoperatively
* Urinary creatinine clearance rate less than 35mL/min
* Serum calcium concentrations greater than 2.75mmol/L or less than 2.00mmol/L
* Pregnancy or breast-feeding women
* Suffering from cancer or other diseases that may be expected to live less than a year