cyrilzakka/clinical-trials huggingface dataset:
Urodynamics of Suprasacral Spinal Cord Injury Patients

The medical records of 215 patients with spinal cord injury(SCI) at the Department of Rehabilitation Medicine of the 2nd Affiliated Hospital of Wenzhou Medical University, Wenzhou, China were evaluated between January 1, 2016 and December 20, 2019. According to the inclusion criteria and exclusion criteria, 101 patients were included. The patients were dichotomized into two groups: complete SCI group and incomplete SCI group, based on the American Spinal Injury Association Guidelines Impairment Scale (AIS) .The investigators retrospectively collected records of urodynamic evaluations of this patients and then analyze the urodynamic parameters,including detrusor overactivity (DO), bladder compliance (BC), bladder-filling sensation, maximum cystometric capacity (MCC), detrusor external sphincter dyssynergia (DESD), maximum urinary flow rate (Qmax), detrusor pressure at a maximum urinary flow rate(PdetQmax).


Eligibility Criteria:
Inclusion criteria were:

1. the period of the spinal shock has passed.
2. patients diagnosed with traumatic suprasacral SCI, based on AIS.
3. urodynamic investigations were performed by the same urologist.
4. patients with voiding dysfunction.

Exclusion Criteria:

The patient with voiding dysfunction before the injury were excluded.
A Study of S5G4T-1 in the Treatment of Papulopustular Rosacea

To assess the efficacy and safety of S5G4T-1 compared to its vehicle when applied once daily for 12 weeks in participants with papulopustular rosacea.

In this Phase 3, double-blind, vehicle-controlled, parallel-group pivotal study, participants will be admitted only after a written informed consent has been obtained and after all inclusion/exclusion criteria have been met. Male and female participants at least 18 years of age with moderate or severe papulopustular rosacea will be eligible for enrollment for daily treatment with S5G4T-1 or its vehicle for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must sign an Institutional Review Board (IRB) approved written informed consent for this study.
2. Male and female 18 years of age and older.
3. Participants must have clinical diagnosis of moderate to severe rosacea.
4. Have a minimum total of 15 and a maximum of 70 total inflammatory lesions (papules and/or pustules) including those present on the nose.
5. Have 2 nodules or less.

Exclusion Criteria:

1. Females, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation or were found to have positive pregnancy test at Baseline or screening visits.
2. Presence of more than 2 facial nodules or any nodule greater than 1 centimeter (cm).
3. Current or past ocular rosacea (for example, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.
Beta Blockade in in Traumatic Brain Injury

The purpose of this study is test the effect of beta-adrenergic blockade on mortality in patients with traumatic brain injury with the hypothesis being that the addition of beta blockade to the treatment regime of this patient population will lower mortality and supress the catecholamine surge that accompanies traumatic brain injury as compared to those who do not receive beta blockade.

Half the patients will be randomized to receive propranolol and half will be randomized to receive no beta blocker.

The use of Beta-adrenergic blockade is not currently the standard of care of patients with traumatic brain injury. Traumatic brain injury is a common problem in our society with greater than 1.5 million cases occurring annually and over 50,000 deaths per year in the civilian population in the United States. Medical therapy has long consisted of monitoring intracranial pressure and supportive measures designed to limit intracranial pressure. Two retrospective observational studies completed at the University of Tennessee demonstrate that the addition of beta-adrenergic blockage to the treatment of the traumatic brain injury lessens mortality. The basis for conducting this study was established by retrospective data showing no harm to patients receiving Inderal and potential benefit. Available data, including data from the University of Tennessee, are retrospective and are limited to simple exposure to the drug. The proposed study will attempt to further quantify the effect by dosing with the drug to actual beta-blockade instead of simple exposure to the drug.

The effect of propranolol at the dosing levels used in this research will be determined by measurement of urinary catecholamines in both study arms and comparison of the actual effect of the drug on the catecholamine surge that occurs following traumatic brain injury will be determined.

Additionally, the effect of healthcare disparities on outcomes in patients with traumatic brain injury will be measured. Outcomes will be stratified by payer status and ethnicity to determine the effect each of these variables has on outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Subjects ages 18 and older with isolated traumatic brain injury as defined by Glasgow Coma Scale score 12 or less with documented injury on head CT and limited injury to the rest of the body. (Abbreviated Injury Scale (AIS) must be \< or = 3 from other body areas.)

Exclusion Criteria:

* Subjects \<18 years of age, prisoners, those on beta-blockers as home medication, those who are pregnant, those with severe liver disease, those taking vasopressors, those with acute coronary syndrome, and those with severe injury to another body region (AIS \>3).
* Subjects who cannot be enrolled within 48 hours of admission following acute resuscitation will not be enrolled into this study.
4 Pillars Toolkit for Adolescent Vaccination

The purpose of this study is to test whether or not the 4 Pillars Immunization Toolkit increases adolescent vaccination rates, particularly influenza and human papillomavirus (HPV) but also tetanus, diphtheria and pertussis (Tdap), and meningococcal conjugate (MCV) vaccination rates. The vaccines are all FDA licensed vaccines and to be used according to national guidelines. The investigators will conduct a randomized cluster trial of this toolkit in diverse primary care practices with electronic medical records (EMRs).

This intervention is a stratified randomized cluster trial in about 22 diverse primary care practices. These practices will be randomly assigned to be intervention or control sites to test this 4 Pillars Immunization Toolkit intervention package of evidence-based techniques tailored to their practice structure and culture; the specialties are split between pediatric and family medicine practices.

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Eligibility Criteria:
Inclusion Criteria:

* For clinical sites: inclusion criterion includes

  1. an appropriate adolescent population: e.g., adolescents aged 11 to 17 years
  2. currently using an EMR
  3. having and keeping immunization data within a EMR or registry.

Exclusion Criteria:

* For clinical sites: the exclusion criteria is consistent SOP use for the vaccines being studied or known much higher than average immunization rates.
Probiotics/TPN in the NICU

The purpose of this study is to evaluate the effect of probiotic administration on TPN dependence in infants \< 32 weeks GA and BW 1500 grams or less in the Banner - University Medical Center Phoenix and Banner Children's at Desert Neonatal Intensive Care Units (NICU). The primary endpoint of capturing the number of days of TPN administration can reflect that an infant is progressing towards readiness for the initiation or advancement of enteral feedings at an earlier interval. The relationship between probiotic administration and the incidence of NEC, culture positive sepsis, and mortality is of interest to us and will be captured. Finally, the assessment of the tolerance of probiotic administration and the potential positive impact on growth and development in these premature infants may validate our current practices.


Eligibility Criteria:
Inclusion Criteria:

* Birth weight \< 1500 grams or GA \< 32 weeks

Exclusion Criteria:

* Life threatening congenital anomalies
* Transfers to another facility prior to discharge home
* Investigator discretion to exclude if deemed necessary
New Treatment for Nocturnal Enuresis in Children

The aim of the study is to evaluate the role of sulbutiamine in treatment of monosymptomatic nocturnal enuresis in children by using it alone or as a combination therapy with tricyclic antidepressants (imipramine+sulbutiamine).


Eligibility Criteria:
Inclusion Criteria:

* Age : 6 - 18 years old.
* All children diagnosed by Primary monosymptomatic nocturnal enuresis in this age group.

Exclusion Criteria:

* Secondary nocturnal enuresis (child who has been continent for at least 6 months before the onset of bedwetting ).
* congenital anomalies (Posterior urethral valve , ectopic ureter , ectopia vesica ,...)
* history of previous lower urinary tract surgery (Multiple hypospadias surgeries ,..., )
* neurogenic bladder (as underactive bladder ).and urge incontinence.
* presence of post-void residual urine greater than 20% of functional bladder capacity.
* history or evidence of disorders in other organs such as (cardiovascular system disease), liver , psychological problems , evident allergic reaction to both medication.
Comparison Between a Standard Tube and the Ultra-thin Tritube for Intubation of the Trachea and for Maintaining Access to the Trachea After Anaesthesia, in Patients With an Expected Difficult Direct Laryngoscopy

The investigators compare the ease of intubation between a new ultra-thin endotracheal tube, "Tritube", and a standard endotracheal tube in patients with predictors of difficult laryngoscopy. Furthermore the investigators compare the acceptance of leaving the Tritube in trachea after end of anaesthesia, with the use of a tube exchange catheter.

In patients scheduled for surgery and anaesthesia in the Head-/neck/ear/nose/throat -region the investigators compare the ease of tracheal intubation between a new ultra-thin endotracheal tube, "Tritube", and a standard endotracheal tube in patients with predictors of difficult laryngoscopy. The intubation is performed with an angulated video laryngoscope.

Furthermore the investigators compare the acceptance of leaving the Tritube in trachea after end of anaesthesia, with the use of a tube exchange catheter. The latter continues into the post-operative recovery-ward.

Eligibility Criteria:
Inclusion Criteria:

* Patients for anaesthesia for surgery in the Head-/neck/ear/nose/throat
* planned for oral intubation with video-laryngoscopy
* with risk factors for difficult direct laryngoscopy

Exclusion Criteria:

* Patient with increased secretions in the airway (Pneumonia, bronchitis, productive cough)
* Patients planned for awake intubation
* Patients where mask-ventilation is judged to could become impossible
* Patients where access to the cricothyroid membrane is judged to be difficult or impossible
* Patients in ASA (american Society of Anaesthesiologists) physical classification status \>3
* Patients who are scheduled for rapid sequence induction (RSI) due to risk of aspiration
* Patients with stridor
* Patients with hypoxemia (Saturation \< 90 % in room air)
* Operation duration planned to \> 2.5 hours
* Patients with the need for a nerve-stimulation-tube during surgery
A DirEct to PatieNt Study in Chronic Pain

To compile real-world, direct from patient clinical outcomes and objective metrics in patients who have received or plan to receive a commercially approved interventional medical device therapy/procedure for chronic pain in routine clinical practice.


Eligibility Criteria:
Key Inclusion Criteria:

* Patient is planning to receive or has received a commercially approved interventional medical device therapy/procedure to treat chronic pain, ascertained from self-reporting
* Age ≥ 22 years at time of eligibility screening, ascertained by self-reported age at time of eligibility screening
* Proficient in written and spoken English, defined by self-reporting of comfort reading, writing and speaking English

Key Exclusion Criteria:

* Requires a legal representative to sign the ICF ascertained from self-reporting
The Approach of Biliary Drainage in Hepatolithiasis Patients With Sphincter of Oddi Laxity

Residual and recurrent stones remain one of the most important challenges of hepatolithiasis which is reported in 20% to 50% of patients treated with these therapies. Up to now the most two common surgical procedures performed were choledochojejunostomy and T tube drainage as biliary drainage in hepatolithiasis. The goal of the present study was to evaluate the therapeutic safety, and perioperative and long-term outcomes of choledochojejunostomy versus T tube drainage for hepatolithiasis with sphincter of Oddi laxity.

Background: SOL results in reflux of duodenal fluid and enteric bacteria infection, which lead to the formation of stones in the biliary tract. Roux-en-Y hepaticojejunostomy (HJ) shows considerable advantage for prevention of reflux of intestinal content into the bile duct. As a result, A randomized controlled trial (RCT) evaluate the therapeutic safety, and perioperative and long-term outcomes of HJ versus T tube drainage for hepatolithiasis with SOL.

Intervention: In total, 210 patients who met the following eligibly criteria were included and were randomized to choledochojejunostomy arm or T tube drainage in a 1:1 ratio.

Clinical data include: the incidence of biliary complications (stone recurrence; biliary stricture; cholangitis); sphincter of oddi function; biliary leakage; mortality; hepatic injury; quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Age age between 18 and 70 years
2. Diagnosed as hepatolithiasis with sphincter of oddi laxity during operation
3. Achieved removing the focus, extraction of stones and correction of stricture during the operation
4. Written Informed consent
5. Willingness for complete 3-year follow-up.

Exclusion Criteria:

1. Participation in concurrent intervention trials with interference of outcome of this study
2. Associated tumor
3. Diagnosed as sphincter of oddi complete loss of function or normal
4. Underwent choledochojejunostomy at past
5. Lack of compliance
Epidemiological Study on the Vaccination Coverage of the Population Aged 75 Years and Over in Picardy. According to the Study of 200 Patients Followed by General Practitioners of the Somme in 2016.

In France, the vaccination coverage of seniors is clearly deficient. It seems to be a cultural specificity, dating back more than 100 years, and which does not exist in Scandinavia, nor in much of the Anglo-Saxon world. Only influenza vaccination is a success for seniors. The high public health council sets the objective of immunization coverage in patients over 65 years of age to 80% whether or not the patient is benefiting from an exonerative ALD. The data collections carried out with the various pension funds objective have a lower immunization coverage with a rate ranging from 48.8 to 64%. Thus any medical consultation should be an opportunity to update the vaccination schedule of adults and the elderly.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman,\> 75 years old.
* Seen in consultation at the doctor's office
* In 2016.

Exclusion Criteria:

* Patient seen during a home visit.
* Patient resident in EHPAD.
Phase II Study of Whole or Partial Parotid Sparing Intensity Modulated Radiotherapy in Patients With Head and Neck Cancers

Phase II and III studies have demonstrated IMRT to be safe and standard practice for head and neck cancers treated with radiotherapy. This study will be an extension to an earlier, in-house, trial to allow continued recording of toxicities and outcomes in patients receiving IMRT for head and neck cancers. This study will allow us to examine radiobiological modelling for normal tissue complication probability and in particular, determining the dose threshold for parotid glands. Our primary objective is to assess the potential effectiveness of intensity-modulated radiotherapy (IMRT) in reducing xerostomia in head and neck cancer patients and determining threshold dose for whole parotid gland and superficial lobes of parotid glands


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed squamous cell cancer or undifferentiated cancer of nasopharynx, oropharynx, larynx and hypopharynx and squamous cell carcinoma unknown primary.
* TNM Stage: T1-4, N0-3 M0
* Patients requiring primary or postoperative radiotherapy to the primary site and bilateral neck irradiation requiring IMRT
* Parotid sparing IMRT feasible (parotids clear of malignant disease)
* WHO Performance status 0-1 (Karnofsky \>80)
* Aged 18 or older
* Induction chemotherapy and concomitant platinum based chemotherapy is permitted
* Concomitant cetuximab is permitted where platinum chemotherapy is contraindicated
* All patients must be suitable to attend regular follow-up and salivary flow measurements and be available for long term follow up.
* All patients must be able to complete self-assessed quality of life questionnaire
* Be able to provide written informed consent

Exclusion Criteria:

* Previous radiotherapy to the parotid gland/s
* Pre-existing salivary gland pathology interfering with saliva production
* Previous or concurrent illness which in the investigator's opinion which will interfere with either completion of therapy or follow up
* Brachytherapy is not allowed as part of the treatment
* Presence of lymphadenopathy adjacent to or involving both parotid glands making whole parotid sparing or superficial parotid sparing impossible
* Prophylactic use of amifostine or pilocarpine is not allowed
Testosterone Replacement for Male Opioid Agonist Maintained Patients

This study is designed to develop an effective treatment intervention for chronic pain, symptomatic hypogonadism, and opioid addiction

This study aims to assess the initial efficacy of testosterone replacement in male opioid agonist patients with symptomatic hypogonadism and chronic pain.

The study has two specific aims:

1. To estimate, in male opioid agonist maintained patients, the prevalence of (a)symptomatic hypogonadism and (b) co-occurring symptomatic hypogonadism and chronic pain.
2. To conduct a pilot randomized clinical trial to obtain data regarding the feasibility, acceptability, and efficacy (compared to waitlist control) of testosterone replacement for male patients with chronic pain and opioid dependence, and symptomatic hypogonadism treated with opioid agonist maintenance treatment (N=40).

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 50 years of age
* Male buprenorphine- or methadone-maintained patients at the APT Foundation
* Moderate to severe chronic pain
* Meet criteria for symptomatic hypogonadism
* Understand English
* Interested in receiving testosterone replacement

Exclusion Criteria:

* Current suicide or homicide risk
* Life-threatening or unstable medical condition
* Known or suspected prostate or chest cancer or history of polycythemia
Sterilizing Effects of the Erbium:YAG Laser Upon Metal Implants

Background:

Even today, postoperative infection is the commonest complications after surgery although all aseptic precautions are taken and causes significant postoperative morbidity, mortality, prolongs hospital stay, and increases costs. Infections that are related to orthopaedic procedures are considered particularly severe when implantation materials are used which further increases the risk of infection and holds the risk of biofilm formation. This is of particular concern since biofilm-mediated infections are difficult to diagnose and effective treatments are lacking. Therefore, new strategies for implant infection are currently being researched worldwide. In this study the relatively new approach for infection control by using an Er:YAG laser was adapted to an orthopaedic and traumatologic setting. This laser vaporizes all water containing cells in a very effective, precise and predictable manner and shows only a minimal thermal damage.

Methods:

For preliminary testing 42 steel pins and 42 plates were cultivated with cocultures for 2 weeks. The minimally necessary laser energy for biofilm removal was determined. We subsequently compared the effectiveness of biofilm removal with the Er:YAG laser and a cleansing of the metal implants with Octenidine soaked gauze. The temperature rise within the metal during the laser procedure was also measured.

In order to achieve an approximation to a clinical setting we want to compared the same effectiveness of biofilm removal similarly on steel pins directly after explantation from patients treated with external fixators for at least 2 weeks. Sonication and SEM will be used for analysis.

Preliminary Results Laser fluences exceeding 2.8J/cm2 caused a complete extinction of all living cells by a single laser impulse. Temperature rise within the implant is dependent on repetition frequency but overall negligible.

The effectiveness of biofilm removal after cleansing with Octenidine soaked gauze and irradiation with the Er:YAG laser will be evaluated on cultivated and extracted pins.

Conclusions We want to compare the effectiveness of the Er:YAG laser and Octenidine in the removal of biofilms from half-pins. We hypothesize that thee Er:YAG laser offers a secure, complete and non toxic removal of all kinds of pathogens from steel implants without damaging the implant or possible development of resistances. The precise non-contact removal of adjacent tissue could be an advantage over other disinfectants.

Level of Evidence (II-a)

Clinical Relevance:

Having one more arrow in the quiver for disinfection of percutaneous implants or for septic revision surgery when osteosynthesis equipment or arthroplasties are meant to be left in place would be extremely desirable.


Eligibility Criteria:
Inclusion Criteria:

All patients that are treated with external fixators for at least 2 weeks and patients whose implants have to be removed during septic revision surgery.

Exclusion Criteria:

-
Marginal Evaluation of Zirconia Reinforced Lithium Disilicate Partial Coverage Restoration of Egyptian Posterior Teeth.

Objective: To evaluate the marginal adaptation of the zirconia reinforced lithium disilicate (VITA AMBRIA) glass ceramic Inlay/Onlay compared with lithium disilicate(IPS emax Press) glass ceramic Inlay/Onlay in decayed posterior teeth.

A randomized controlled clinical trial, a double-blind (patient and examiner) is conducted by one trained and calibrated operators who perform all restorative procedures. The restorations will be evaluated by a blind and calibrated two examiner using the FDI (World Dental Federation) criteria. A total of 25 subject will be randomly assigned to each group for a total of 50 subject. The randomization sequence will be generated (www.randomlists.com/team-generator) and to ensure the confidentiality of the allocation, this will be used opaque, sealed and numbered envelopes in series. These will be kept with an independent researcher for the moment of inclusion of the subjects.

Both groups will receive Inlay/Onlay preparation . Digital impression will be taken, wax pattern for the Inlay/Onlay restoration will be designed and milled using CAD/CAM(computer-aided design/computer-aided manufacturing) software. After that, the wax pattern will be invested and final Inlay/Onlay restoration will be constructed from VITA AMBRIA and IPS e.max press ingots according to manufacturing instructions.

Eligibility Criteria:
Inclusion Criteria:

* The patient is healthy.
* 18-50 years old.
* Normal occlusion.
* Good oral hygiene.
* Tooth with complete root apex.
* Tooth with moderate coronal decay.

Exclusion Criteria:

* Patient Incapable of self-care, mental illness, undergoing radiotherapy, diabetic patient, allergy to one of the materials used, pregnancy, smoker, parafunctional habits, poor oral hygiene, severe periodontitis, tooth need vital pulp therapy or surgical crown lengthening or marginal elevation, tooth with enamel or dentin hypoplasia or hypocalcification, Mallaligned or malformed teeth and adjacent or opposing teeth are missed.