cyrilzakka/clinical-trials huggingface dataset:
Postoperative Pain Control in AIS Using Liposomal Bupivacaine vs. 0.25% Bupivacaine With Epinephrine

A randomized controlled trial (RCT) investigating whether the local anesthetic injection of liposomal bupivacaine during posterior spinal fusion (PSF) for AIS is more effective in reducing acute postoperative opioid consumption compared to an equal volume injection of 0.25% bupivacaine with epinephrine for patients aged 10 to 17, with 128 patients randomly assigned to one of two arms: liposomal bupivacaine or 0.25% bupivacaine with epinephrine.


Eligibility Criteria:
Inclusion Criteria:

* ≥10 years old and ≤17 years old at assessment
* Diagnosis of Adolescent Idiopathic Scoliosis
* Planned surgical treatment of progressive spinal deformity with posterior spinal fusion

Exclusion Criteria:

* Diagnosis of neuromuscular, syndromic, or congenital scoliosis
* History of known allergy to local anesthesia
* Chronic pre-operative opioid consumptions
* Any other analgesic treatment for chronic pain before surgery
* Psychiatric or neurological disorders
* Cannot fluently read or speak English
Adjunctive Lisdexamfetamine (LDX) in Bipolar Depression

The specific aim of this study is to evaluate the efficacy and tolerability of lisdexamfetamine in the adjunctive treatment of bipolar disorder.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will meet DSM-IV-TR criteria bipolar I or II disorder,

Exclusion Criteria:

* Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures.
* Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease. Subjects should be biochemically euthyroid to enter the study.
Comparison of Upper Extremity and Lower Extremity Function and Quick DASH

Patient reported outcome measure (PROM) are a method by which to assess outcomes from a patient perspective. The QuickDASH is a commonly used PROM. QDASH was validated against grip strength and ability work, however not against its ability to actually measure what it sets forth to measure (ie: patient's ability to use a hammer, carry a shopping bag, wash a wall, etc). The purpose of this study is to correlate the self-reported QDASH with patients' ability to perform the functions on the QDASH and compare to a control group who completes the task on a lower extremity PROM, KOOS JR.


Eligibility Criteria:
Inclusion Criteria:

* new patient
* stanford hand surgery clinic patient

Exclusion Criteria:

-
Influence of Smoking on Clinical, Microbiological and Immunologic Parameters in Patients With Aggressive Periodontitis.

Treatment of smoker patients with AgP is considered a challenge to periodontists. To date, only one controlled clinical study (De Genaro Modanese et al., 2016) evaluated the effect of full mouth ultrasonic debridment (FMUD) on smokers with aggressive periodontitis. Its results showed significant improvements in clinical parameters (plaque index PI, bleeding on probing- BoP and probing depth-PD), and immunologic (reductions in interleukin 6- IL-6, tumor necrosis factor- α TNF-α levels), although the results were more favorable for non-smoking patients. Antimicrobials associated to mechanical therapy has been extensively studied (Hafajee et al., 2003, Heitz-Mayfield, 2006). The association of Amoxicillin and Metronidazole have had good clinical and microbiological results in randomized clinical trials in the treatment of AgP (Casarin et al., 2012, Sgolastra et al., 2012, Keestra et al., 2015).

Thus, this study investigates clinical, microbiological and immunological influence of smoking in the periodontal debridement associated to Amoxiciclin and Metronidazole of young individuals with pronounced periodontal destruction, compared with non-smokers individuals.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of generalized aggressive periodontitis, according to the American Academy of Periodontology-AAP, 1999;
* presence of at least 15 teeth;
* presence of at least 6 teeth containing 6 deep sites (≥ 7 mm), which are not located in bifurcation areas and
* present less than 20% of plaque index (PI) and bleeding on probing (BoP).

Exclusion Criteria:

* presence of periapical or pulpar alteration;
* presence of systemic alteration or use of medications (6 months prior to the study) that may influence the response to periodontal treatment;
* pregnant and lactating women;
* performing periodontal treatment including subgingival instrumentation in the 6 weeks preceding the study;
* teeth with bifurcation involvement;
* teeth with marked mobility;
* oral pathology;
* history of allergy to any component of the study, and
* previous periodontal surgery in the region of interest.
Unsupervised Therapy After Stroke in the Home Setting with a Hand Rehabilitation Device (ReHandyBot)

The ReHandyBot is a robot for hand rehabilitation after stroke. The aims of this study are (1) to investigate the feasibility of unsupervised therapy with the ReHandyBot with stroke inpatients, first in a rehabilitation clinic and then at participants' home, (2) to evaluate the usability of the ReHandyBot (user interface, implemented exercises, and gaming environment, which were adapted for independent usage), and (3) to quantify the dose of additional robotic therapy that patients perform without supervision.

The study consists of two primary phases. The first is a familiarization phase performed at the clinic, where therapists teach to the participants how to perform the exercises with the robot. Then, if capable of training with the robot safely, after discharge from the clinic participants can bring the robot home and autonomously train with it. The hypothesis is that unsupervised therapy might be a possible way to increase therapy dose for stroke patients, with the potential to further improve recovery of hand function, with minimal additional burden for therapists and for the healthcare system.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent signed by the subject;
* female and male patients between 18 and 90 years old;
* acute/subacute stroke (recruitment within 12 weeks from stroke onset);
* pre-stroke modified Rankin score ≤ 1;
* National Institutes of Health Stroke Scale (NIHSS) ≥ 1 in at least one of the items regarding motor functions, sensory functions and ataxia;
* possibility (e.g., enough space) to set up the ReHandyBot at home.

Exclusion Criteria:

* modified Ashworth Scale \> 2 for one or more of the following muscles: shoulder adductors, forearm pronator and supinator, flexors and extensors of elbow, wrist and fingers;
* moderate to severe aphasia: Goodglass-Kaplan's scale \< 3;
* moderate to severe cognitive deficits: levels of cognitive functioning-revised (LCF-R) \< 9;
* functional impairment of the upper limb due to other pathologies;
* severe pain in the affected arm: visual analogue scale for pain (VASp) ≥ 5;
* other pathologies which may interfere with the study;
* pacemakers and other active implants;
* after discharge the patient will go to an assisted living facility (e.g., care home).
Use of Ultrasound for Early Identification of Patients at Risk of Swallowing Disorders Acquired in the ICU

Swallowing disorders (SD) are particularly common after extubation in the ICU and may be associated with an increased risk of lung disease, increased length of hospital stay, and a higher risk of early reintubation. In contrast, early detection of SDs has been shown to be associated with a decrease in these complications. Thus, there is a need for rapid and reliable assessment of SDs in ICU patients before the withdrawal of mechanical ventilation.

Videofluoroscopy (VFS) and nasofibroscopy (NF) are the gold standard examinations for diagnosing SD. However, these two examinations are not feasible in intubated patients.

In this context, ultrasound appears to be a promising alternative to identify patients at risk of SD after extubation. This examination can be performed at the intubated patient's bedside and can be used evaluate the mobility of the structures involved in swallowing. Many studies have already shown the interest of ultrasound in the evaluation of SD but none has focused on intubated patients under respiratory assistance.

The objective of the present study is to evaluate the value of ultrasound in identifying patients at risk of presenting SD after extubation.

This monocentric study will take place in the Intensive Care Unit (ICU) of the Dijon University Hospital. The duration of participation in this research will be equal to the length of stay in the ICU. During their stay, patients will undergo ultrasound and nasofibroscopy. Information on the characteristics of the ICU stay will be collected at discharge.


Eligibility Criteria:
Inclusion Criteria:

Patient:

* Major
* On mechanical ventilation for at least 48 hours
* Affiliated to national health insurance

Exclusion Criteria:

Patient:

* Under legal protection (curatorship, guardianship, safeguard of justice)
* Pregnant, parturient or breastfeeding woman
* Refusal to participate by the patient or their proxy (or an immediate family member)
* Cognitive disorders incompatible with the understanding of instructions
* Previously diagnosed swallowing disorders
* With a neurological condition at the origin of the SD (stroke, ALS...)
* Treated for a lesion of the aerodigestive tract (by surgery, radiotherapy or radio-chemotherapy)
* presence of wounds or dressings on the areas to be evaluated that prevent ultrasound measurements
* Patient for whom a decision to limit or stop life support treatments has been taken collegially within the intensive care unit
* With one or more contraindications to performing NF:

  * Anatomical features not compatible with NF: mainly deviation of the nasal septum.
  * Risk of significant otorhinolaryngological bleeding
NEXAGON for the Treatment of Corneal Persistent Epithelial Defects Following Severe Ocular Injuries

This study will enroll participants with a non-infected, corneal persistent epithelial defect (PED) resulting from an ocular chemical and/or thermal ocular injury which is non-responsive or refractory to current standard of care for at least 14 days. It will assess the efficacy and safety of Nexagon® (lufepirsen) plus standard of care versus NEXAGON-vehicle (placebo) plus standard of care. The recovery of the corneal epithelium will be the primary outcome measure, defined as a cornea that re-epithelializes by Day 28 of treatment and remains re-epithelialized for at least a further 28 days.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female of any age.
2. The presence of a non-infected, corneal persistent epithelial defect (PED) which has resulted from a severe chemical and/or thermal (burn) injury to one or both eyes.
3. The PED is non-responsive to current standard of care for at least 14 days from injury.
4. The PED measures at least 2 mm along the largest diameter at Day 1 of the Treatment Period.
5. Providing written informed consent and ability to comply with the visit and dosing schedule.

Exclusion Criteria:

1. Have active ocular infection.
2. Subjects with corneal perforation or impending corneal perforation.
3. Subjects with any other past or present ophthalmic disease or medical condition that, in the Investigator's opinion, may affect the safety of the subject or the outcome of the study.
4. Subjects with severe lid abnormalities or ocular conditions that contribute to the persistence of the epithelial defect.
5. Female subjects of childbearing potential who are pregnant, nursing, planning a pregnancy or not using an adequate and medically acceptable form of birth control.
6. Subjects who have participated in an interventional clinical trial within 30 days prior to Day 1.
Diagnosing Respiratory Disease in Children Using Cough Sounds

The purpose of this prospective study is to evaluate the efficacy of the ResAppDx software application in diagnosis of pneumonia and other respiratory conditions (bronchiolitis, asthma/reactive airway disease, croup, upper or lower respiratory tract infections) in infants and children. Patient's cough sounds will be recorded using a smartphone and analysed using the ResAppDx software. The ResAppDx diagnosis will be compared to radiologic diagnosis and/or clinical diagnosis. The ResAppDx diagnosis will not be provided to the clinician or patient.


Eligibility Criteria:
Inclusion Criteria:

* Infant or child aged 29 days - 12 years
* Presenting to the study site with signs or symptoms of respiratory disease including cough, wheezing, stridor, chest in-drawing/retractions, difficulty breathing, fast breathing, abnormal lung sounds on exam, cyanosis/hypoxemia.
* Coughing spontaneously or able to cough voluntarily

Exclusion Criteria:

* Lack of a signed consent form from parent or legal guardian
* Lack of signed assent form for children aged 7 years or older who, in the opinion of the investigator, is able to provide assent based on their age, maturity or psychological state.
* Need for mechanical ventilatory support (including invasive, continuous positive airway pressure, or bilevel positive airway pressure) or high flow nasal cannula
* Any medical contraindication to voluntary cough, including (only enrolled if coughing spontaneously): severe respiratory distress, history of pneumothorax, eye/chest/abdominal surgery in past 3 months, hemoptysis in the past month, or too medically unstable to participate in study per treating clinician.
* Subject previously enrolled
* Tracheostomy present or tube placed
Red Blood Cells as a Reflection of Endothelial Function in Old Age

The aim of this study is to find out, how far red blood cells reflect age-depended changes in endothelial function.

It will be investigated with determination of endothelial function (measured as flow-mediated vasodilation) and of circulated nitric oxid-pool in red blood cells and in blood plasma, how far red blood cells reflect age-depended changes in endothelial function.

Eligibility Criteria:
Groups 1-3:

Inclusion Criteria:

* healthy subjects
* informed consent

Exclusion Criteria:

* hypertension (blood pressure ≥140/90 mmHg),
* hypercholesterolemia (LDL ≥250 mg/dl, HDL ≤45 mg/dl),
* diabetes mellitus (fasting plasma glucose ≥128 mg/dl)
* acute inflammation (CRP \>0.5 mg/dl)
* malignant diseases
* heart failure (NYHA III-IV)
* arrhythmia of high degree
* acute or terminated kidney disease
* cardiovascular diseases ( cardiac artery disease, peripheral vascular disease and cerebrovascular diseases)
* anemia
* pregnancy

Group 4 :

Inclusion Criteria:

* angiographical signs of apparent atherosclerosis (cardiac artery disease or peripheral vascular disease or degenerative valvular heart disease)
* informed consent

Exclusion Criteria:

* Hypertension (blood pressure ≥140/90 mmHg),
* Hypercholesterolemia (LDL ≥250 mg/dl, HDL ≤45 mg/dl),
* Diabetes mellitus (fasting plasma glucose ≥128 mg/dl)
* acute inflammation (CRP \>0.5 mg/dl)
* malignant diseases
* heart failure (NYHA III-IV)
* arrhythmia of high degree
* acute or terminated kidney disease
* cardiovascular diseases ( cardiac artery disease, peripheral vascular disease and cerebrovascular diseases)
* anemia
* pregnancy
Snacks, Smiles and Taste Preferences

The research study is designed is to determine whether children's acceptance of low sugar snacks, most preferred level of sweet and salty taste, and dietary intake of added sugars changes after repeated exposure to snacks lower in sweetness when compared to the control group.

This is a longitudinal, randomized, within- and between- subject study of children and their mothers to determine whether children's repeated exposure to snacks lower in sweetness and mothers' educational lessons about dental health and nutrition (intervention group) affects children's acceptance of low sugar snacks, most preferred level of sweet and salty taste, and dietary intake of added sugars when compared to the control group.

Eligibility Criteria:
Inclusion Criteria:

* English speaking mother 18 years or older
* Mother has primary responsibility for the eligible child's care
* Mother has primary responsibility for feeding the eligible child
* Mother is responsible for purchasing food for the family
* Mother must be willing to refrain from eating food and beverages high in added sugars in the eligible child's presence for the duration of the study

Exclusion Criteria:

* Child is in full-day daycare or school
* Child is currently on a special diet (e.g. weight management programs)
* Child has severe food allergies (e.g. gluten, peanuts)
* Child has medical conditions know to affect growth or eating (e.g. diabetes, cystic fibrosis)
* Mother is a current smoker
Impact of Antioxidant Agents on the Number of DNA Double-strand Breaks After Radiation-based Cardiac Examinations

Trial with medicinal products

Recent studies revealed that radiation-based procedures in patients may lead to DNA double-strand breaks in human blood lymphocytes. Additionally, ex vivo studies with human blood lymphocytes have shown a protective effect of antioxidant agents which have been described to decrease the number of DNA double-strand breaks.

This study represents a prospective, double-blinded, randomized, single center, and placebo-controlled phase II clinical trial which analyzes the capability of antioxidant agents to decrease the number of DNA double-strand breaks in human blood lymphocytes in patients undergoing radiation-based cardiac examinations (30 patients with high-dose radiation exposure, 30 patients with low-dose radiation exposure, and 30 subjects without radiation exposure).

A protective effect of antioxidant drugs in patients undergoing radiation-based examinations could therefore change patient management and would provide an important clinical impact.


Eligibility Criteria:
Inclusion criteria:

* Male or Female
* 18-70 years of age
* European origin
* Non-smoker
* 30 patients with high-dose radiation exposure from a cardiac examination
* 30 patients with low-dose radiation exposure from a cardiac examination
* 30 subjects without radiation exposure
* Given written informed consent
* Ability to participate in the study

Exclusion criteria:

* no known intolerance against one of the applied study drugs or against substances used for formulation of one of the study drugs or against other drugs with similar chemical structures as one of the study drugs
* Leukemia
* Lymphoma
* Radio- or chemotherapy
* Severe renal failure (GFR\<30 ml/min)
* Positive pregnancy test or lactation
* Radiation-based examination within the last 3 days
* Known glucose-6-phosphate-dehydrogenase deficiency
* Known nephrolithiasis (calciumoxalate calculus)
* Intake of barbiturates, tetracyclines, corticosteroids within the last 4 weeks
Study to Establish Whether the Use of T-Tube in Bile Duct Anastomosis in Liver Transplantation Decreases Morbidity

The purpose of this study was to compare the incidence and severity of biliary complications due to liver transplantation after choledochocholedochostomy with or without a T-tube. A per-protocol analysis was designed for recipients of orthotopic liver transplantation in a single center, who were randomly assigned to choledochocholedochostomy with or without a T-tube. It is a prospective and randomized study.


Eligibility Criteria:
Inclusion Criteria:

* Recipients of a deceased full-size liver graft
* Aged \> 18 years

Exclusion Criteria:

* Age \< 18 years
* Retransplantation
* Primary sclerosing cholangitis
* Fulminant hepatic failure
* Technical need for a hepaticojejunostomy
* Splitted graft
* Reduced-size graft
* More than one organ transplantation
* Living donation
* Finding of a large difference (twice the size) in common bile duct diameters between the graft and the recipient
Zanamivir Versus Trivalent Split Virus Influenza Vaccine

This unblinded pilot study is intended to assess the feasibility of a larger double-blind, randomized control trial. For the larger trial the investigators are interested in understanding the relative benefits of vaccine and antiviral prophylaxis, the risk factors for influenza infection in healthy adults, and in assessing the safety and tolerability of seasonal antiviral prophylaxis in healthcare workers.

The pilot study will be assessing the rate of infection with influenza and the rate of adherence to long-term zanamivir in 60 healthy volunteers.

Several studies have demonstrated that zanamivir and oseltamivir are effective in preventing influenza infection and illness when used either as prophylaxis after exposure to a household contact with influenza or when taken for several weeks at the height of influenza activity in the general community. However, the longest duration of prophylaxis with neuraminidase inhibitors in two clinical trials, to date, has been six weeks.

Antiviral medication will likely have an important role in the response to the next influenza pandemic. Additionally, there may be indications for use during seasons when the major infecting strain of influenza in not one whose antigen is well covered by the vaccine.

Eligibility Criteria:
Inclusion Criteria:

* 18-69 years old as of 01/Nov/2008
* have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry
* available for follow-up during the study period
* if a women of child-bearing years, must meet criteria to prevent pregnancy

Exclusion Criteria:

* allergy to any component of influenza vaccine or zanamivir
* previous serious adverse event associated with influenza vaccination
* receipt of influenza vaccine between 01/Mar/2008 and start of study
* previous adverse event associated with the use of antiviral medications
* expecting to be unable to take zanamivir for more than 72 hours during study period
* planning to spend more than 2 consecutive weeks outside Canada or more than 100 km from the study site during study period
* pregnant, or planning to become pregnant, during study period
* breastfeeding, or planning to breastfeed, a child under 12 months of age during study period
* receipt of immunoglobulin within six months of study entry
* immunocompromising condition or therapy that would be expected to reduce the efficacy of vaccination
* plans to receive cytotoxic or radiation therapy during study period
* history of cardiovascular or pulmonary disease that has required hospital admission within the past year
* history of asthma or other chronic respiratory disease
* participating in a trial that will result in the receipt of an investigational medication during the period that zanamivir may be taken (15/Nov/2008 to 30/Apr/2009)
Clinical Outcome of Dentsply Sirona EV Implants

Retrospective observational study of 500 implants placed between 2014 and 2020 of the same dental implant system (AstraTech Implant System EV, Dentsply Implants, Mölndal, Sweden).

The purpose of this study is to assess the cumulative survival, success and complications rates obtained with the use of AstraTech Implant System EV in one clinical center from market launch to 2020

All clinical records of patients with this implant system will be collected and the following data will be recorded:

Patient gender Date of placement Dimensions and location of implant(s) placed Type of implantation Design of the implant-supported dental prosthesis, single or partial, screw-retained or cemented Date of last radiographic control Type of biological and/or mechanical complications that occurred In biological complications, presence or absence of inflammatory signs and presence or absence of peri-implant bone loss.

For mechanical complications, screw loosening, porcelain fracture, fracture of the prosthetic abutment or fracture of the implant.

Date of explantation if present

The mean, standard deviation (SD), and percentage will be calculated for all recorded parameters.

A life table will be made with cumulative survival and success rate (CSR), according to Kaplan-Meier analysis. Correlations and regression analysis will be performed to assess the influence of the variables on the outcomes

Conclusions will be drawn based on the results obtained.

Eligibility Criteria:
Inclusion Criteria:

All patients who receive Astra Tech EV dental implant system placement.

Exclusion Criteria:

None