cyrilzakka/clinical-trials huggingface dataset:
Protective Ventilation With High Versus Low PEEP During One-lung Ventilation for Thoracic Surgery

One-lung ventilation (OLV) with resting of the contralateral lung may be required to allow or facilitate thoracic surgery. However, OLV can result in severe hypoxemia, requiring a mechanical ventilation approach that is able to maintain adequate gas exchange, while protecting the lungs against postoperative pulmonary complications (PPCs). During OLV, the use of lower tidal volumes is helpful to avoid over-distension, but can result in increased atelectasis and repetitive collapse-and-reopening of lung units, particularly at low levels of positive end-expiratory pressure (PEEP).

Anesthesiologists inconsistently use PEEP and recruitment maneuvers (RM) in the hope that this may improve oxygenation and protect against PPC. Up to now, it is not known whether high levels of PEEP combined with RM are superior to lower PEEP without RM for protection against PPCs during OLV.

Hypothesis: An intra-operative ventilation strategy using higher levels of PEEP and recruitment maneuvers, as compared to ventilation with lower levels of PEEP without recruitment maneuvers, prevents postoperative pulmonary complications in patients undergoing thoracic surgery under standardized one-lung ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring OLV (no emergency surgery)
* BMI \< 35 kg/m2
* age ≥ 18 years
* expected duration of surgery \> 60 min
* planned lung separation with double lumen tube (DLT, not for study purpose only)
* most of ventilation time during surgery expected to be in OLV

Exclusion Criteria:

* COPD GOLD grades III and IV, lung fibrosis, documented bullae, severe emphysema, pneumothorax
* uncontrolled asthma
* Heart failure NYHA Grade 3 and 4, Coronary Heart Disease CCS Grade 3 and 4
* previous lung surgery
* documented pulmonary arterial hypertension \>25mmHg MPAP at rest or \> 40 mmHg syst. (estimated by ultrasound)
* documented or suspected neuromuscular disease (thymoma, myasthenia, myopathies, muscular dystrophies, others)
* planned mechanical ventilation after surgery
* bilateral procedures
* lung separation with other method than DLT (e.g. difficult airway, tracheostomy)
* surgery in prone position
* persistent hemodynamic instability, intractable shock
* intracranial injury or tumor
* enrollment in other interventional study or refusal of informed consent
* pregnancy (excluded by anamnesis and/or laboratory analysis)
* esophagectomy, pleural surgery only, sympathectomy surgery only, chest wall surgery only, mediastinal surgery only, lung transplantation
* presence before induction of anaesthesia of one of the adverse events, listed as postoperative pulmonary complications (aspiration, moderate respiratory failure, infiltrates, pulmonary infection, atelectasis, cardiopulmonary edema, pleural effusion, pneumothorax, pulmonary embolism, purulent pleuritis, lung hemorrhage)
* documented preoperative hypercapnia \> 45mmHg (6kPa)
Immediate Mobilization After Plate Osteosynthesis of Proximal Tibial Fractures - A Cohort Study

The purpose of this study is to investigate if immediate mobilization with weight bearing as tolerated following surgery with plates and screws after a fracture of the shinbone near the knee is possible without increased risk.

The investigators hypothesize immediate weight bearing as tolerated following surgery with plates and screws of the above mentioned fracture, in cases deemed stable by the surgeon, will not lead to any loss of reduction.

The purpose of this study is to investigate immediate mobilization with weight bearing as tolerated following plate osteosynthesis after a proximal tibial plateau fracture is possible without increased risk of loss of reduction and/or failure of the osteosynthesis. Subsequently, this may lead to earlier recovery and less risk of thromboembolic complications.

The investigators hypothesize immediate weight bearing as tolerated (WBAT) following plate osteosynthesis after a proximal tibial plateau fracture, in cases deemed stable by the surgeon, will not lead to any loss of reduction.

Exposure will be defined as surgery with one or two angular stable plates (closed reduction, internal fixation) after a proximal tibial fracture. Patients will be allowed immediate weight bearing as tolerated in cases where the osteosynthesis is deemed stable. This represents the current practice at Slagelse Hospital. Typical, all lateral tibia plateau fractures (AO fracture classification 41B1-3) osteosynthesized will be allowed immediate WBAT after surgery. Other tibia plateau fractures will be allowed immediate WBAT if the osteosynthesis is deemed stable by the surgeon perioperatively.

Fractures are treated with one or several locking plates, and if needed after reduction of the tibial plateau, an impacted allogenic bone graft is used. The bone graft is applied through a cortical window osteotomy distal to the fracture.

Follow up will be performed at 2 weeks, 6 weeks, 3 months, 6 months and 1 year by any of the authors or a consultant in orthopedics. Follow up will be performed at the outpatient clinic.

Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized and osteosynthesized with one or several locking plates because of a proximal tibial fracture

Exclusion Criteria:

* Non-ambulatory patients,
* Patients diagnosed with dementia and
* Patients residing to another hospital
Nucleoside (Acid) Analogues Treatment in Patients With Normal ALT and Positive HBVDNA.

This study is to investigate the clinical efficacy and safety of Nucleoside (acid) analogues treatment in patients with normal Alanine Aminotransferase and positive Hepatitis B virus DNA.

Hepatitis b virus infection has always been a global public health problem that endangers national health. Current clinical guidelines do not recommend antiviral therapy for people with positive hepatitis b-DNA and normal Alanine Aminotransferase, but studies have found that viral replication is associated with an increased risk of cirrhosis and liver tumors. Nucleoside (acid) analogues can effectively inhibit viral reverse transcriptase, reduce HBV viral load in the blood, thereby reducing secondary inflammation, and contribute to liver cell regeneration and disease recovery. And its side effect is small, adverse reaction rate is low, use safety.

Eligibility Criteria:
Inclusion Criteria:

* Positive hepatitis b surface antigen and hepatitis b antibody \> 0.5 year;
* Age from 18 to 65 years old;
* Serum Alanine Aminotransferase(ALT) ≤1×ULN at least 12 weeks;
* Positive Hepatitis b virus(HBV);
* Do not receive nucleotide/nucleoside analogues or interferon treatment in the past half year.

Exclusion Criteria:

* Other active liver diseases;
* Hepatocellular carcinoma or other malignancy;
* Pregnancy or lactation;
* Human immunodeficiency virus infection or congenital immune deficiency diseases; 5.Severe diabetes, autoimmune diseases; 6.Other important organ dysfunctions; 7.Using glucocorticoid; 8.Patients can not follow-up; 9.Investigator considering inappropriate.
Adverse Effect of Prolonged Methylphenidate Treatment on Cardiac Functions

The purpose of this study is to find out whether prolonged treatment with methylphenidate has any adverse effect on cardiac functions and measurements.

Attention deficit hyperactivity disorder (ADHD) is the most common neurobehavioral condition of childhood, with symptoms consisting of inattentiveness, impulsivity and hyperactivity. The diagnosis relies on subjective criteria since there is no objective test for ADHD. Stimulants are the recommended treatment, during the last 2 decades both the rate of its use has increased, and the age for starting treatment has decreased. Adverse side effects have been few, none of which were serious.

Recently, regulators of the Food and Drug Administration (FDA) have been told on forty deaths among patients who took stimulants through 2003. Accordingly, a subcommittee of the FDA recommended that prescription drugs to treat ADHD should be accompanied by strong 'black-box' warnings that they may increase the risk of heart problems in some patients.

To date, there does not appear to have been any study that has evaluated cardiac functions in these patients. In this study we will evaluate the possible long term effect of methylphenidate on cardiac functions, as to provide more knowledgeable basis for decisions on the treatment of ADHD patients with methylphenidate.

Children age 8-18 years who were treated on methylphenidate for more then five years will be allocated in outpatient clinics. Complete EKG and echocardiographic examinations will be performed and cardiac functions, left ventricular mass and left ventricular muscle width will be compared to the normal range of values. The results will give us, for the first time, a basis to support or reject the causative relationship between these drugs and severe cardiac problems.

Eligibility Criteria:
Inclusion Criteria:

Children with ADHD aged 8-18 years who are taking methylphenydate (Ritalin©, Ritalin SR©, Ritalin LA©) for more than 5 years.

Exclusion Criteria:

Children with any known heart disease or anomaly. Children whose ADHD is part of a syndrome or are mentally retarded. Children that are on any other chronic medications.
A Comparative Study With Parenteral Oxycodone, Morphine and Dexamethasone in Postoperative Pain in Paediatric Patients

The aim of this randomized, double-blind study is to compare parenteral pre-emptive oxycodone, morphine and dexamethasone with placebo in the treatment of postoperative pain in paediatric patients 4 to 12 years of age. The investigators hope to find out whether there are any differences in postoperative pain and/or adverse effects among these groups.

After the induction of anaesthesia and before intubation the child receives one of the research drugs in a double-blind fashion: 0.1 mg/kg of oxycodone , 0.1 mg/kg of morphine, 0.5 mg/kg dexamethasone (max 24 mg), or placebo. All the research drugs are diluted into a dose of 10 ml with NaCl 0.9%, the placebo being solely the dilute.

The patients are followed minimum 4h postoperatively: first in the recovery room, and after the patient is stable enough the study is continued in the day-patient unit. Level of pain and adverse effects are registered all on same predetermined intervals being 15 min during the first postoperative hour, followed by interval of 30 min until the discharge.

The safety measurements noted include pulse, respiratory rate, non-invasive blood pressure and peripheral oxygen saturation are recorded on the same intervals The registering of pain, adverse effects and given medication continues at home for 48 hours post operatively with a questionnaire filled by the parents.

Eligibility Criteria:
Inclusion Criteria:

* 4 to 12 years of age
* Scheduled to tonsillectomy
* ASA class I or II
* Written informed consent is obtained from the parents and the child (when appropriate).

Exclusion Criteria:

* Allergy to morphine, oxycodone or dexamethasone
Mold Exposure and Impact on Asthma Control in French Asthmatic Children

Observational, multicenter, study conducted in 12 hospitals in the Nord and Pas-De-Calais departments. The aim of this study is to describe the relationship between reported exposure to molds and asthma control in a pediatric population.

Each patient followed by a specialized asthma pediatrician in one of the study center will be proposed to participate in the study.

Children aged 1 to \< 18 years, with asthma diagnosis, based on the assessment of a specialized physician after a follow-up of at least 6 months Inclusion, non-inclusion and exclusion criteria will be verified by the investigators. The questionnaires will be completed during the consultation, collected by the physician in charge of the consultation and sent to the principal investigator for data entry.

Inclusion will take place over a period of 12 consecutive months from the date of obtaining regulatory approval.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 1 to \< 18 years, with asthma diagnosis, based on the assessment of a specialized physician after a follow-up of at least 6 months, Follow-up in one of the study center in Nord and Pas de Calais departments (Lille, Lens, Tourcoing, Valenciennes, Arras, Roubaix, Seclin, Armentières, Calais, Boulogne/mer, Dunkerque, GHICL-Saint Vincent) over an inclusion period of 12 months

Exclusion Criteria:

* Children living ≤ 50% of the weekly time in their primary home (e.g., shared custody)
* Children whose living arrangement characteristics are difficult to analyze (e.g., child accompanied by grandparents or by the parent without primary custody)
* Children whose residence has recently changed, making it impossible to assess the impact of the living arrangement over the past year
* Children living outside of the Nord and Pas-de-Calais departments
* Children whose parents are unable to complete the questionnaire
The Changing Panorama in Risk Factors of Cerebral Palsy

The study will be carried of scanning the database of 296 individuals with cerebral palsy followed in the university pediatric rehabilitation clinic. Cerebral palsy risk factors and demographic information will be obtained from the database. The data will be classified according to date of birth, divided into 3 groups: those born before 2000, those born between 2000-2010, and those born after 2010.Changes in cerebral palsy risk factors will be investigated at 10-year intervals.

The study will be carried of scanning the database of 296 individuals with cerebral palsy followed in the university pediatric rehabilitation clinic. Cerebral palsy risk factors and demographic information will be obtained from the database.

Cerebral palsy subtypes classified according to The Surveillance for Cerebral Palsy in Europe (SCPE) classification into four groups: spastic (unilateral and bilateral), dyskinetic (dystonic and choreoathetoic), ataxic/hypotonic, non-classifiable. Cerebral palsy risk factors will be primarily divided into 4 as preconceptional, antenatal, intrapartum and neonatal risk factors. Then, risk factors in the data will be distributed to the appropriate risk factor group.

The data will be classified according to date of birth, divided into 3 groups: those born before 2000, those born between 2000-2010, and those born after 2010. Changes in cerebral palsy risk factors will be investigated at 10-year intervals.

Eligibility Criteria:
Inclusion Criteria:

* cerebral palsy patients

Exclusion Criteria:

* missing data on the cerebral palsy database
Correlation Hand Grip Strength and Walking Distance in Elderly

Elderly patient post coronary revascularization assessed hand grip strength and changes in six minute walking distance

Coronary artery disease causes muscle dysfunction which leads to decreased muscle fitness due to reduced cardiac output, resulting in reduced oxygen uptake from the blood, and further decreases functional capacity or maximum oxygen uptake. The elderly population is an age group at risk of developing coronary artery disease. Handgrip strength s a good predictor for assessing overall muscle fitness, where handgrip strength assessment with a dynamometer is one method of determining muscle fitness, one of the factors affecting cardiorespiratory fitness, which can be assessed by the 6-minute walk test. This study wants to determine the correlation between handgrip strength and changes in 6-minute walk test after undergoing phase 2 cardiac rehabilitation in the elderly after coronary revascularization and this study also wants to know the predictive value using the parameters studied.

Eligibility Criteria:
Inclusion Criteria:

* Post coronary revascularization
* MMSE \>= 26 BMI 18.5-25

Exclusion Criteria:

* Comorbid cardiovascular, lung, kidney and metabolic disease
* Frailty Syndrome
Coronary and Structural Interventions Ulm - Coronary Chronic Total Occlusions

To evaluate the long-term results after recanalization of coronary chronic total occlusions.

Patients with successful recanalization of coronary chronic total occlusions are followed during a period of 5 years to demonstrate safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* coronary artery disease
* chronic total occlusion

Exclusion Criteria:

* no written informed consent
Xanthine Oxidase and Uric Acid Origin in Preeclamptic Women

Findings regarding the presence of xanthine oxidase and uric acid in different blood locations is important in preeclamptic women. We aim to detecting Xanthine oxidase and uric acid levels in both umbilical cord artery and vein as well as maternal blood (3 "locations") in pregnant women with and without diagnosis of preeclampsia. The study population will be divided into groups matching the three "locations" in order to describe and compare outcome levels.

Significance - findings regarding the presence of xanthine oxidase and uric acid in different blood locations may provide a scientific basis for understanding the source of them in preeclamptic women. Aim - detecting Xanthine oxidase and uric acid levels in both umbilical cord artery and vein as well as maternal blood (3 "locations"). Methods - samples will be collected from pregnant women with and without diagnosis of preeclampsia with blood uric acid \> 6 mg/dL. Than the study population will be divided into groups matching the three "locations". The investigators will describe and compare outcome levels (including Xanthine oxidase, uric acid).

Eligibility Criteria:
Inclusion Criteria:

* preeclampsia and none-preeclampsia diagnosed pregnant women.

Exclusion Criteria:

* Known or reported kidney disease.
Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study

In this trial, the investigators will evaluate the effect of thrombus aspiration followed by stent implantation in improving myocardial blush grade in patients with acute non-ST-elevation myocardial infarction compared to conventional percutaneous coronary intervention (PCI).

The Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS) has shown that thrombus aspiration improves myocardial perfusion and clinical outcome compared to conventional primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction. Impaired myocardial perfusion due to spontaneous or angioplasty-induced embolization of atherothrombotic material also occurs in patients with Non-ST-elevation myocardial infarction (NSTEMI). The aim of this study is to determine whether thrombus aspiration before stent implantation will result in improved myocardial perfusion in patients with NSTEMI compared to conventional PCI.

The study is a single-centre, prospective, randomised trial with blinded evaluation of endpoints. The planned inclusion is 540 patients with acute NSTEMI who are candidates for urgent PCI.

If thrombus aspiration leads to significant improvement of myocardial perfusion in patients with acute NSTEMI it may become part of the standard interventional approach.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute NSTEMI defined by

  * Chest pain suggestive for myocardial ischemia for at least 30 minutes,
  * Time from onset of symptoms of less than 72 hours
  * ECG with ST-segment shifts (depression of \>0.1 mV in at least two contiguous leads or transient ST-segment elevation \>0.1 mV in at least two contiguous leads for less than 30 minutes) and/or T-wave changes (inversion of \>0.15 mV in at least two contiguous leads)
  * Positive cardiac troponin T \>0,01 μg/L.
* Clinical indication for urgent PCI of the ischemia-related target lesion as identified at coronary angiography

Exclusion Criteria:

* Persistent ST-elevation of more than 0.1 mV in 2 or more leads
* Presence of cardiogenic shock
* Inability to obtain informed consent
* Known existence of a life-threatening disease with a life expectancy of less than 6 months
Traditional Print Communication Methods, Simple Electronic Communication Methods, or Usual Care in Increasing How Often Older Women Undergo Colorectal Cancer Screening

RATIONALE: Finding out which communication method affects a participant's decision to undergo colorectal cancer screening may help increase the number of participants who undergo screening. It is not yet known which communication method is more effective in increasing how often participants undergo colorectal cancer screening.

PURPOSE: This randomized clinical trial is studying traditional print communication methods to see how well they work compared with simple electronic communication methods or usual care in increasing how often older women undergo colorectal cancer screening.

OBJECTIVES:

* Compare traditional print versus simple electronic communication versus usual care, in terms of increasing colorectal cancer (CRC) screening rates, in average-risk women attending a routine OB/Gyn visit.
* Explore the moderating role of attentional style and background variables on the impact of the interventions in these participants.
* Determine the mediating effect of potential cognitive-affective factors related to CRC screening in these participants.
* Investigate the comparative cost-effectiveness of these interventions to improve CRC screening adherence.

OUTLINE: This is a randomized study. Participants are randomized to 1 of 3 screening arms.

* Arm I: Participants are contacted by simple electronic communication methods by an email message linked to a personalized website.
* Arm II: Participants are contacted by traditional print communication methods.
* Arm III: Participants are observed (usual care). Participants in arms I and II are randomized a second time to receive messages about colorectal cancer screening that are matched or mismatched to their attentional style.

PROJECTED ACCRUAL: A total of 5,000 participants will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* At average risk for colorectal cancer (CRC) as defined by the following criteria:

  * Asymptomatic without a personal history of colorectal polyps or cancer
  * No inflammatory bowel disease
  * No family history of familial adenomatous polyposis or hereditary nonpolyposis CRC
  * No CRC in more than one first-degree relative
* Nonadherent with standard CRC screening recommendations at the time of index OB/Gyn appointment

PATIENT CHARACTERISTICS:

* Email accessible at home and/or work
* Able to communicate with ease in English

PRIOR CONCURRENT THERAPY:

* Not specified
Effect of Detrol LA on Overactive Bladder Symptoms, Sexual Quality of Life and Sexual Function in Women

The purpose of the study is to assess the impact of treatment with tolterodine ER versus placebo on Urgency Urinary Incontinence in sexually active women with OAB symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Female outpatients 18 years or older.
* Overactive bladder symptoms (subject-reported) for greater than or equal to 3 months.
* Currently sexually active with a male partner.

Exclusion Criteria:

* Diagnosed or suspected interstitial cystitis, uninvestigated hematuria, urogenital cancer, and interstitial or external radiation to the pelvis or external genitalia or clinically significant bladder outlet obstruction.
* Symptoms of incontinence being predominately stress urinary incontinence as determined by the investigator.
* Treated with antimuscarinic/ anticholinergic medication, for any reason including OAB, within the last 3 months or are expected to start therapy during the study treatment period.
* Any drug for urgency urinary incontinence (UUI) initiated within the past 3 months prior to Visit 1, with the exception of estrogen (topical or systemic) as long as treatment is not initiated within 4 weeks prior to Visit 1 (screening)