cyrilzakka/clinical-trials huggingface dataset:
Awake Thoracic Epidural Anesthesia Versus General Anesthesia in Thoracotomy

This study aims to compare awake thoracic epidural anesthesia and general anesthesia in thoracotomy.

The severity of acute postoperative pain is a causative factor for chronic postsurgical pain, and it has been observed that the incidence of chronic postsurgical pain is very high after thoracotomy. Effective management of acute post-operative pain is a must in these patients.

Thoracic epidural analgesia (TEA) is used as an adjunct to general anesthesia (GA) in thoracic surgery. However, tthe horacic epidural blockade has been rarely utilized as a sole method to provide anesthesia for major thoracic procedures

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 75 years old.
* Both genders.
* American Society of Anesthesiologists (ASA) physical status classification II or III.
* Scheduled for thoracotomy.

Exclusion Criteria:

* Difficult airway management,
* Hemodynamically unstable patients, obesity (body mass index \>30).
* Absolute contraindication to thoracic epidural anesthesia such as (patient refusal, allergy to local anesthetics, coagulopathy, active neurologic disorders, skin infection at insertion site, uncooperative patients, uncontrolled cough, and unfavorable anatomy for thoracic epidural).
* Neurological disorders: risk of seizure, unable to cooperate, intracranial mass or brain edema, extensive pleural adhesions or previous pulmonary resections, hypoxemia (PaO2 \<60) or hypercarbia (PaCO2 \>50)
* Poor cardiac function (ejection fraction less than 50%).
* Patients with bad pulmonary function tests.
Accountability Support Through Peer-Inspired Relationships and Engagement (ASPIRE) Trial

This project aims to test the efficacy of a text message intervention, ASPIRE, designed to address cognitive and behavioral elements and modify exposure to peers that influence drinking behaviors. Young adults who are contemplating reducing their drinking will be recruited from a national sample and randomized to ASPIRE versus a text message intervention focused solely on cognitive and behavioral elements. We will measure effectiveness at 3, 6, and 12 months, study mechanisms driving behavior change, and identify which subgroups stand to benefit most.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-25 years (verified using date of birth)
* Lives in the U.S. (based on zip code)
* English reader (verified based on completing screen)
* 2+ days with ≧4 standard alcohol drinks for women or ≧5 standard alcohol drinks for men in past month
* Owns a mobile phone with SMS (verified by texting enrollment procedure)

Exclusion Criteria:

* Currently enrolled or past enrollment in a 4-year college
* Active military
* Pregnant or pregnancy plans in the next 12-months
* Prisoner status
* Current or planned treatment for alcohol or substance use disorder in next 12-months
Heparin-Binding Protein and Heparins

Heparin-Binding protein is a protein from primary and secretory granluae of white blood cells. It is released when white blood cells become activated and has been advocated as a biomarker for sepsis. The aim of this study is to find out if Heparins in clinical doses can change the level of Heparin-binding protein in plasma.

Blood samples are taken from patients before and after Heparins in clinical doses. The effects of heparins on Heparin-binding protein concentration in plasma is measured. This is a small observational study.

Eligibility Criteria:
Inclusion Criteria:

* Planned endovascular treatment of aortic aneurysm or peripheral vascular surgery where unfractionated heparin in \>3000 units are given perioperatively
* Planned subcutaneous low molecular weight heparin as a thromboprophylactic treatment after major surgery or on Intensive Care treated patients.
* Planned open heart surgery with cardiopulmonary bypass.

Exclusion Criteria:

* Under 18 years
* Unable to get informed consent from patient or relative
3D Printed Bolus in Post-mastectomy Radiotherapy

Recently, there is growing interest in the application of three-dimensional (3D) printed bolus to radiotherapy.At present, the researches on the application of 3D-printed bolus in breast cancer are mainly focused on air gap between skin and bolus or electron beam conformal therapy \[7,15\], there are no clinical experience with customized 3D-printed bolus for volumetric modulated arc therapy (VMAT) in daily practice has been published up to now. We aim to evaluate dosimetry and application of 3D-printed bolus for the post-mastectomy radiotherapy (PMRT) with Volumetric modulated arc therapy (VMAT). Seventy five patients with breast cancer receiving radiotherapy following post-mastectomy in our department were randomly selected in this study. The accuracy of fit of the 3D-Printed bolus to the chest wall was improved significantly relative to conventional bolus.This study demonstrates customized 3D-printed bolus in post-mastectomy radiation therapy improves fit of the bolus compared to conventional bolus. Furthermore, VMAT based on 3D-printed bolus significantly improves the chest wall target coverage and the conformity of plan, and reduces the dose of ipsilateral lung and heart, compared to conventional bolus.


Eligibility Criteria:
Inclusion Criteria:

* breast cancer patients with post-mastectomy treatment

Exclusion Criteria:

* NA
Pre-procedural 3DCT Versus Angiography Guided PCI for Ostial Right Coronary Artery Lesions

Even with second generation drug eluting stents, rates of target lesion failure (TLF) for aorto-ostial RCA lesions remain high \[3yrs TLF 14.2%\]. Retrospective studies show that stent underexpansion and geographical stent-ostium mismatch are the main predictors for TLF. Geographical mismatch means that the stent is implanted either too distal (thereby not fully covering the lesion) or too proximal (thereby protruding too much in the aorta and hampering future engagement with guiding catheters). The investigators hypothesize that, pre-procedural 3D CT coronarography to determine the optimal C-arm angle of the X-ray system with the most accurate visualization of the aorto-ostial angle and determination of localization of calcium, could prevent geographical mismatch.


Eligibility Criteria:
Inclusion Criteria:

* Clinically indicated non-emergent PCI for an aorta-ostial-RCA lesion defined as a significant de novo lesion \[by angiography or by physiological assessment\] for which the operator intends to fully cover the ostial RCA with stent struts
* Willing to provide informed consent

Exclusion Criteria:

* Emergent PCI indication: if the ostial RCA lesion is the culprit lesion of an acute coronary syndrome \[of note: if the ostial RCA lesion is a non-culprit lesion, patient can be included in the trial\]
* In-stent restenosis or thrombosis in the ostial RCA
* Renal insufficiency \[eGFR\<30 ml/min\]
* Known allergic reaction to contrast medium
The Effect of Walking in Kidney Transplant Patients

Cardiovascular diseases are among the most common causes of death in kidney transplant patients. Physical activity is of great importance in preventing cardiovascular diseases after transplantation. Although regular physical activity is recommended in international guidelines to prevent post-transplant mortality and morbidity in kidney transplant patients, studies have shown that patients do not follow regular physical activity instructions.The aim of our project is to examine the effect of pedometer-assisted physical activity on metabolic parameters after kidney transplantation.

Patients with kidney transplant surgery will be randomized to the intervention (n: 34) and control groups (n: 34), respectively, according to the transplant surgery date. Intervention and Control groups will be given the same training on the importance of physical activity during discharge training. The pedometer will be given to the intervention group to evaluate the activity level, and it will be said that their goal is to take 2000 steps in 20 minutes a day after discharge. Patients will be asked to carry the pedometer during physical activity, and to write down the number of steps they take in 20 minutes on the form given to them for 90 days. Patients in the control group will only be advised to do physical activity every day and will be asked to record the minutes of physical activity they do for 90 days. Metabolic parameters of the patients in the intervention and control groups will be examined at the end of the 4th and 12th months. These parameters are blood pressure, body mass index, complete blood count (hemoglobin, leukocyte, thrombocyte), blood glucose, sodium, potassium, calcium, liver enzymes, serum creatinine, total and indirect bilirubin, albumin and total cholesterol levels.

Eligibility Criteria:
Inclusion Criteria: • Over the age of 18 and under the age of 65,

* Kidney transplantation at the center where the study was conducted between the research dates,
* There is no activity restriction recommendation by the physician,
* Patients who agree to participate in the study.

Exclusion Criteria:

* Multiple organ transplantation at the same time,
* Death or graft loss/rejection in the hospital before discharge,
* Patients with physical activity restrictions by the physician,
* Patients who are re-hospitalized within the first 3 months after discharge
Inferior Turbinate Reduction in Pediatric Population Failing Surgery for Sleep Disordered Breathing

This study will examine whether treatment of inferior turbinates in patients with continued symptoms of obstructive sleep apnea, sleep related breathing disorder, snoring, disturbed sleeping, open mouth breathing, and upper airway resistance syndrome after tonsillectomy and adenoidectomy will improve these symptoms and should be included in the treatment paradigm for treatment of sleep related breathing disorders in infants, children, and adolescents.

The question proposed by this study is one of treatment: To what extent does treatment of nasal obstruction from enlarged inferior turbinates with cold ablation inferior turbinate reduction in infants, children, and adolescents improve symptoms of obstructive sleep apnea, sleep related breathing disorder, snoring, disturbed sleeping, open mouth breathing, and upper airway resistance syndrome in patients that continue to have symptoms after tonsillectomy and adenoidectomy.

The trial seeks to provide evidence that the treatment of inferior turbinates in patients with continued symptoms of obstructive sleep apnea, sleep related breathing disorder, snoring, disturbed sleeping, open mouth breathing, and upper airway resistance syndrome after tonsillectomy and adenoidectomy will improve these symptoms and should be included in the treatment paradigm for treatment of sleep related breathing disorders in infants, children, and adolescents.

Eligibility Criteria:
Inclusion Criteria:

1. Patients that underwent tonsillectomy and adenoidectomy for obstructive sleep apnea, sleep related breathing disorder, snoring, disturbed sleeping, open mouth breathing, and upper airway resistance syndrome with persistent symptomatology.
2. Enlarged inferior turbinates with nasal obstruction (\>25%).
3. Age 0-18 years.
4. Lack of improvement of obstructive sleep apnea symptoms after maximal medical treatment with intranasal steroids in patients with symptoms of ARS and H2 blocker medication in patients with symptoms of LPR.

Exclusion Criteria:

1. Previous adenotonsillar surgery or placement of tympanostomy tubes for recurrent otitis media, tonsillitis, or sinusitis.
2. Patients with BMI \> 97% for age and sex.
3. Patients with craniofacial abnormalities.
4. Patients with previous airway issues, anatomic variance from normal, mallampati class III or IV, septal deviation, choanal stenosis, and nasal stenosis.
Influence of Injectable Platelet Rich Fibrin on Different Orthodontic Tooth Movements During Clear Aligner Therapy

The aim of this prospective clinical project will be to assess the effect of platelet rich fibrin on the rate of different orthodontic tooth movements during clear aligner therapy.

The aim of this prospective clinical project will be to assess the effect of platelet rich fibrin on the rate of different orthodontic tooth movements during clear aligner therapy.specifically canine retraction,incisors leveling and alignment,maxillary molar distalization and incisors intrusion

Eligibility Criteria:
Inclusion Criteria:A- leveling and alignment Eligibility criteria

1. Age ranges from 15 to 22 years. 2. Bilateral Class II molar relationship. 3. Skeletal Class I or mild Class II relationship. 4. Normal or decreased vertical height. 5. No posterior crowding or spaces. 6. Fully erupted maxillary first and second molars. 7. Congenitally missing or extracted third molars. 8. Good oral hygiene. 9. Absence of any periodontal disease and alveolar bone loss. 10. Absence of medications that may inhibit orthodontic movement

Lower incisor leveling and alignment Inclusion criteria Complete permanent dentition (third molars not included); Moderate mandibular anterior crowding (with little's irregularity index score greater than 4 mm) who required non-extraction approach in the mandibular arch; No tooth size, shape or root abnormalities visible on the patient's radiographic records; No spaces in the mandibular arch; No blocked out tooth that did not allow for placement of the bracket at the

initial bonding appointment; 6. No required management with interproximal stripping, inter-maxillary elastics, open NiTi springs, and removable or extra-oral devices. Canine retraction Eligibility criteria

Age, 15 to 25 years; Class ii division 1 malocclusion with mild or no crowding; No previous orthodontic treatment; No systemic disease that might have affected bone formation or density, such as osteoporosis, hyperparathyroidism, or vitamin d deficiency; Adequate oral hygiene; Probing depth values not exceeding 3 mm across the Entire dentition; Adequate thickness of the attached gingiva (1-2 mm); No radiographic evidence of bone loss

Exclusion Criteria:Patients who required surgery to correct skeletal discrepancies. Patients with congenital dentoskeletal disorders. Missed or mutilated teeth in maxillary arch. Patients with poor oral hygiene and/or periodontally compromised patients Severe dental crowding that necessitates an extraction approach 2. Abnormal anteroposterior and vertical relationships; 3. Patients with cleft lip and palate, anomalies, and syndromes; 4. Previous orthodontic 5. Treatment; 6. Regular medications intake that could interfere with otm. -

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Multimodal Magnetic Resonance Imaging Study on the Neural Mechanisms of Remission in Children With ADHD

Attention-deficit/hyperactivity disorder(ADHD) is highly prevalent among children and adolescents and often associated with poor long-term outcomes in adulthood. it is thus a serious public health problem. Methylphenidate(MPH) and Atomoxetine(ATX) are most frequently used for treating ADHD in many countries but the individual treatment response varies. Some patients present good response to either MPH or ATX with minimal or no symptoms left and optimal functioning(remission) after treatment, while others are poor responders to one of the two or even both. The underlying mechanism for the heterogenous responsiveness remains unknown. Thus we proposed to use multimodule magnetic resonance imaging(MRI) technology to explore the neural mechanisms of remission in children with ADHD treated with MPH or ATX.

the main aim of the current study is to explore the mechanism of remission in children with ADHD treated by MPH or ATX. Baseline information including demographic information, clinical features including ADHD symptoms, cognitive assessments such as executive function, MRI scans including resting state functional MRI, structural MRI, and DTI would be acquired in each participant. after 8-12 weeks of treating with MPH or ATX, patients would be classified into subgroups of remitted and unremitted groups. all baseline tests would be acquired again at the end of the study. comparisons would be done to explore the remission mechanism induced by MPH or ATX

Eligibility Criteria:
Inclusion Criteria:

- clinical diagnosis of ADHD, based on K-SADS-PL medication naive aged 6-16

Exclusion Criteria:

- history of severe head injury (with coma) other severe physical problem or disease in nervous system intelligence quotient (IQ) \< 80
Memory and Scoliosis Spinal Exercises

This is a behavioral observational study aimed at evaluating the impact that spinal exercises exert on memory of young people. It consists of a short self-administered questionnaire which will be given to adolescents with scoliosis to complete. Relationships between young individuals' answers and health-related quality of life will be evaluated.

This is a behavioral observational study aimed at evaluating the impact that spinal exercises exert on memory of young people. Literature found out that a memory-experience difference exists between pleasant and unpleasant situations and young people are expected to capture memories more accurately when these, as voiced for instance by outcome measures of health-related quality of life, are at their worst- rather than at their best-perceived level.

In Literature there are not studies which investigate the relationships between the memory of spinal exercises as for adolescents with idiopathic scoliosis and health-related quality of life.

The study consists of a short self-administered questionnaire which will be given to young persons to complete. In more details, the survey is made of four questions collecting information on time to learn an exercise, time to perform an exercise, difficulty to do the exercise, commitment to perform the exercise. Further, participants will have to complete a self-administered health-related quality of life questionnaire, and namely the Scoliosis Research Society-22 patients questionnaire.

Descriptive statistics will be presented by taking into account the socio-demographic characteristics of the sample being investigated. Statistical correlations between adolescents' answers and health-related quality of life questionnaire will be also evaluated.

This study's usefulness relies on understanding which spinal exercises impact more on memory in order to increase a young persons' positive routines and improve their performance with rehabilitative programs, with the ultimate goal of growing their adherence to and satisfaction with treatment.

Eligibility Criteria:
Inclusion Criteria:

* a primary diagnosis of Adolescent Idiopathic Scoliosis determined by expert clinicians
* ability to read and understand the Italian language

Exclusion Criteria:

* any diagnosable cause of scoliosis
* leg-length discrepancy of \> 1 cm
* lower limb deformities interfering with spinal posture,
* cardiac and/or respiratory dysfunction
* systemic illness
* previous spinal surgery,
* cognitive impairment
* refusal to adhere to the study
Study to Evaluate Safety and Efficacy of VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation With an Open-Label Expansion

The objective of this study was to evaluate the safety and efficacy of VX-661in combination with ivacaftor in participants with cystic fibrosis (CF) who are homozygous for F508del cystic fibrosis transmembrane conductance regulator (CFTR) mutation


Eligibility Criteria:
Inclusion Criteria:

* Homozygous for the F508del CFTR mutation
* FEV1 ≥40% and ≤90% of predicted normal for age, sex, and height
* Stable CF disease as judged by the investigator

Exclusion Criteria:

* History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant
* Pregnant and nursing females: Females of childbearing potential must have a negative pregnancy test at screening and Day 1 of the PC Phase and Day -7 or Day 1 of the OLE Phase (whichever was applicable)
* Sexually active participants of reproductive potential who are not willing to follow the contraception requirements
* The participant or a close relative of the participant is the investigator or sub investigator, research assistant, pharmacist, study coordinator, or other staff directly involved with the conduct of the study.
High Flow Nasal Oxygen for Children With Cystic Fibrosis Presenting With Respiratory Failure - a Randomized Controlled Study

Respiratory exacerbations are frequent among cystic fibrosis patients and supplemental oxygen is usually required. We will compare a new high flow nasal cannula system with Venturi masks for oxygen supplementation to patients with CF hospitalized for respiratory exacerbation.

Introduction: Cystic fibrosis (CF) is a genetic disease that leads to chronic lung infections and recurrent respiratory exacerbations. Supplemental oxygen is usually required during respiratory exacerbations. Recently, a new high flow nasal cannula system that provides flows up to 40l/min at 100% humidification was developed and tested in neonates and children, providing greater comfort to the patient. The main hypothesis of the study is that this method has advantages for oxygen supplementation to patients with CF hospitalized for respiratory exacerbation. Methods: 40 patients with CF aged 6 to 18 years will be randomized to receive supplemental oxygen via nasal cannula or Venturi masks during hospitalization for respiratory exacerbation. Main outcomes will be the duration of hospitalization and oxygen supplementation, viscosity and transportability of sputum and personal impressions of patients regarding the method of oxygen administration (questionnaire). Spirometry and venous blood gas analysis will be performed after the second hospital day, and sputum samples will be obtained in the first and third day of hospitalization. Clinical treatment (antibiotics, etc) will be defined by the medical team of the institution, not involved in the study. Expected Results: The use of high flow nasal cannula will result in significantly less time of supplemental oxygen, with increased comfort for patients, without significant differences in the levels of PaCO2. Sputum samples obtained from the patients treated with the high flow nasal cannula will have lower viscosity and higher transportability as compared to those obtained from patients treated with Venturi mask.

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of cystic fibrosis
* Age between 6 and 17 years
* Ability to perform lung function testing
* Hospital admission due to acute pulmonary exacerbation in the last 12h
* Regular use of Pulmozyme
* Need for high FiO2 defined as more than 2 liters per minute in the nasal cannula or need of a Venturi mask

Exclusion Criteria:

* Recent admission (less than 30 days)
* Recent or current atelectasis (less than 3 months)
* Hemoptysis or pneumothorax
* Need for a bronchoscopy during admission
* Need for non-invasive ventilation for more than 2 hours/day