cyrilzakka/clinical-trials huggingface dataset:
Assessment of Pain Management in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patients Who Are About to be Treated With Adalimumab

The purpose of this study is to assess whether or not adalimumab (Humira®) can influence pain medication in participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) with or without comorbidities, which do not constitute a contraindication for adalimumab as stated in the released summary of product characteristics. Therefore it shall be evaluated if pain medication which is used in these participants is changed, reduced or stopped due to adalimumab treatment.

This is a non-interventional, observational study in which Humira (adalimumab) is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. The assignment of the patient to a Humira-containing regimen has to be decided in advance and has to be current practice. The prescription of Humira is clearly separated from the decision to include the participant in this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis
* Patients must fulfill international and national guidelines for the use of a biological disease modifying antirheumatic drug in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (chest x-ray and interferon gamma release assay or purified protein derivative-skin test negative for tuberculosis). In addition one of the following criteria must be fulfilled:

  * unsatisfactory disease modifying antirheumatic drug response defined as failure to treatment with at least two disease modifying antirheumatic drugs including Methotrexate in patients with rheumatoid arthritis or psoriatic arthritis
  * unsatisfactory non steroidal antiinflammatory drug response in patients with ankylosing spondylitis or unsatisfactory response to prior biological disease modifying antirheumatic drugs in patients with rheumatoid arthritis or psoriatic arthritis or ankylosing spondylitis

Exclusion Criteria:

* Patients who meet contraindications as outlined in the latest version of the Humira syringe® summary of product characteristics and Humira Pen® summary of product characteristics
* Patients participating in another study program or clinical trial
* Patients who have been treated with Humira before
Dietary Nitrate and Cardiovascular Health

An expanding number of studies suggest a therapeutic role for nitrate and nitrite, most notably in treatment and prevention of cardiovascular disease including ischemia-reperfusion (IR) injury and hypertension. The nutritional aspects of these cardioprotective effects are particularly intriguing since nitrate and nitrite are abundant in our everyday diet.

Whether increasing the circulating pool of nitric oxide and nitrite by dietary nitrate offers a novel mechanistic approach to regulate mobilization of circulating angiogenic cells and thus regenerative processes in cardiovascular medicine is not known. Thus, in the present study, we tested whether oral application of nitrate leads to an enhanced number of circulating angiogenic cells and whether this is associated with an improvement in endothelial function.

Administration of a single dose of nitrate intervention or water alone to healthy volunteers. Before and up to 4 hours (short-term)/6 days (long-term) after ingestion, marker of vascular function are measured in plasma and by using high-resolution ultrasound.

Measurements are taken before and up to 4 h after double blind cross-over per os administration of a single dose of nitrate intervention (150 ml tab water with 150 umol/kg sodium-nitrate) or water control (100 ml Chapelle mineral water) to healthy volunteers. Circulating angiogenic cells are measured as CD34+/KDR+ and CD133+/KDR+ mononuclear cells in blood by flow cytometry and plasma is analyzed for nitrate and nitrite, as well as mobilization markers and cytokines including stromal cell derived factor, vascular endothelial growth factor and stem cell factor. All measurements are performed after \>12h overnight fasting.

Eligibility Criteria:
Inclusion Criteria:

* age \> 20 years
* refrain from nitrate containing food ingestion during trial

Exclusion Criteria:

* \> 36 years
* poor endothelial function
* acute infection
* any chronic heart or pulmonary disease
* arrhythmias
* acute or chronic renal failure
* cardio-vascular risk factors: diabetes mellitus, hypertension, hyperlipidemia
* intake of nutrition supplements (l-arginine, creatinine)
Exercise Training in Pregnancy for Obese Mothers

Observational studies demonstrate that overweight in pregnancy is a risk factor for adverse pregnancy outcomes as fetal macrosomia, prolonged labor, low Apgar score, shoulder dystocia, nerve plexus injuries, increased proportion of instrumental deliveries and perineal ruptures. There is a 2.6 fold risk for gestational diabetes mellitus (fourfold in morbidly obese women) and a recent study has shown that fetuses of obese mothers develop insulin resistance in uterus.

Main aims of this study are to assess if regular exercise in pregnancy among obese women can prevent or influence weight gain; impaired cardiac function in mother and fetus/newborn; impaired vascular function in mother; insulin resistance/sensitivity; body composition in mother and offspring; lumbopelvic pain; urinary and/or fecal incontinence; prolonged labor

Women with a self-reported pre-pregnancy BMI of 28 or more will be eligible for our study. Woman are eligible if they are 18 years or older, with a singleton live fetus at an early (week 12-14) ultrasound scan. Exclusion criteria are pregnancy complications with high risk for preterm labour or diseases that could interfere with participation.

Primary outcome measure is weight increase based on weight measured at 14 weeks and immediately before labour. Assessments are done at baseline at 14 (12-18) weeks of pregnancy, and again in week 38, as well as 3 months postpartum. Some measurements are also done at other points in time. The maternal secondary outcome measurements include fasting glucose, glucose tolerance assessed by 2-h, 75 mg per-oral glucose tolerance test, insulin resistance assessed by HOMA-IR, weight, height, body composition estimated by skinfold measurements in pregnancy and by dual energy x-ray absorptiometry postpartum, blood markers, lumbopelvic pain, urin- and fecal incontinence, quality of life, psychological wellbeing, depression, and diet.

Eligibility Criteria:
Inclusion Criteria:

* Pre-pregnancy body mass index of 28 or more
* 18 years or more
* singleton live fetus at the routine ultrasound scan

Exclusion Criteria:

* high risk for preterm labor or diseases that could interfere with participation
Air Tamponade in Macular Hole Surgery

Macular hole is a hole formation which takes place in the center of the retina. Such a hole needs surgical steps in order to close. Closure of the macular hole will lead to a substantially improvement of vision in most cases. Following macular hole surgery a tamponade of intraocular gas is normally injected in order to keep the macula dry for the postoperative period. Postoperative face down position for a week was earlier standard. Several authors report of good closure rates with both air tamponade or lack of face down positioning. In this study standard pars plana vitrectomy with peeling of the internal limiting membrane (ILM) will be performed. The gas tamponade will be replaced by air. Postoperative face down positioning will not be used.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic stage 2 - 4 macular hole
* Duration of symptoms ≤ 36 months
* Informed consent

Exclusion Criteria:

* Previous vitreomacular surgery
* Myopia ≥ 6 diopters
* Ocular trauma
* Disease affecting visual function
Acute Exposure of Simulated Hypoxia on ECG and Non-invasive Blood Pressure

Randomized crossover trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to simulated altitude (FIO2: 15.1% = equivalent to 2500m above sea level) on ECG repolarizations and non-invasive blood pressure measurements by Finapres® NOVA Technology.

Low altitude baseline measurements will be performed in Zurich (469m asl) including Echocardiography, right heart catheterization, six Minute Walking test (6MWT), pulmonary function test, clinical assessment and blood gas analysis at rest and under exercise. Randomly assigned to the order of testing, the participants will e tested under simulated altitude (FiO2: 15.1% with the "AMC Altitrainer") and shamed altitude with the same device. During the exposure to simulated altitude (FiO2: 15.1%) and shamed altitude of 1 hour each, the participants' ECG and non-invasively assessed blood pressure by Finapres at rest and under exercise will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* PH diagnosed according to internation Guidelines: mean pulmonary artery pressure (mPAP) ≥ 25 mmHg along with a pulmonary artery wedge pressure (PAWP) ≤15 mmHg during right heart catheterization at the time of initial diagnosis
* PH class 1 (PAH) or 4 (CTEPH)
* Stable condition, on the same medication for \> 4 weeks
* Patient live permanently at an altitude \< 1000m asl.

Exclusion Criteria:

* Resting partial O2 pressure (PaO2) ≤7.3 kiloPascal (kPA) corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed)
* Severe daytime hypercapnia (pCO2 \> 6.5 kPa)
* Susceptibility to high altitude related diseases (AMS, High Altitude Pulmonary Edema (HAPE), etc.) based on previous experienced discomfort at altitudes.
* Exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation
* Residence \> 1000m above sea level
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with walking disability
* Women who are pregnant or breast feeding
Telemedicine Control Tower for the Post-Anesthesia Care Unit

A single center prospective before-and-after proof-of-concept study to evaluate a telemedicine center for the PACU.

A proof-of-concept study in perioperative telemedicine that aims to demonstrate the (i) acceptability and (ii) utility of integrating telemedicine into the PACU environment. This proof-of-concept study will be conducted in the PACU.

Eligibility Criteria:
Adults (age ≥ 18) undergoing elective surgery at Barnes Jewish Hospital in St. Louis, Missouri will be enrolled
Compare a New Method and Formula as a Guide for the Intubation of a Left-sided Double-lumen Tube

One-lung ventilation (OLV) is required for the most of thoracic surgery to facilitate surgical visualization by collapsing the lung. The double-lumen tube (DLT) is the commonly used device for OLV. The objective of this study was to compare the accuracy of the distances between vocal cords to carina of trachea and formula base on patient's height as a guide for the intubation of a Left-sided Double-lumen tube

In previous study, investigators found that the distances between vocal cords to carina of trachea was a useful predictive method for the intubation of a Left-sided Double-lumen tube. However in some hospitals preoperative chest CT scans not contain the vocal cords slice. So in this study investigators will compare the accuracy of the distances between the midpoint of the thyroid cartilage to suprasternal notch base on body surface measurement add the distance between suprasternal notch to carina of trachea according to chest CT and formula base on patient's height as a guide for the intubation of a Left-sided Double-lumen tube.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients undergoing elective left side thoracic surgery
2. Requiring a Uniblocker or DLT for one-lung ventilation
2 Year Follow up of COSGOD III

The COSGOD III trial performed follow up until term age or discharge from the neonatal intensive care unit, whatever came first. The first neonate was randomised in September 2017 and the last in October 2021. A prospective follow up of the included neonates until an age of two years was not feasible in the COSGOD III trial since funding for long-term follow-up was not available.

However, data on long-term outcome of the included neonates into COSGOD III trial are of high interest. In many centres, who participated in the COSGOD III trial neonates are assessed routinely for long term outcome in outpatient clinics with Bayleys III/IV test or PARCA-R (Parent Report of Children's Abilities) questionnaire.

Aim of the present study is therefore to analyse in neonates, who were included into the COSGOD III trial, in a retrospective observational study routinely performed long-term survival and neurodevelopmental outcome assessment at a corrected age of 2 years (18-30 months).


Eligibility Criteria:
Inclusion Criteria:

* \> 50% 2 year neurodevelopmental outcome assessment at 2 years (18 to 30 months)

Exclusion Criteria:

* \< 50% 2 year neurodevelopmental outcome assessment at 2 years (18 to 30 months)
Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry

Prospective data will be collected in approximately 200 patients treated with an TMJ replacement. Patients will be followed up according to the standard (routine) for up to 5 years after the treatment. Data collection will include underlying disease, treatment details, functional and patient reported outcomes (PRO)s and anticipated or procedure-related adverse events (i.e. complications).

This registry is designed to be able to assess the number of patients who refuse alloplastic total TMJ replacement. Therefore, the participating sites are asked to register all cases of refused TMJ replacements too.

More in detail this registry has the following objectives:

* To describe clinical indications for TMJ replacement, and treatment patterns (including differences among regions if feasible)
* To describe the clinical evolution and outcomes of patients treated with a TMJ replacement
* To explore the relationship(s) between treatment, outcome(s) and quality of life (QoL).
* To identify predictive factors for favorable outcomes (pain reduction, range of motion (ROM), occlusal status, QoL) in patients treated with TMJ replacement.
* To describe the reasons of patients who refused TMJ replacements

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and or older
* Patients requiring alloplastic total TMJ replacement
* Informed consent obtained, i.e.:

  * Ability to understand the content of the patient information/informed consent form (ICF)
  * Willingness and ability to participate in the registry according to the Registry Plan (RP)
  * Signed and dated ethics committee (EC) / Institutional review board (IRB) approved written informed consent

Exclusion Criteria:

* Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment
* Pregnancy or women planning to conceive within the study period
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Interest of Auriculotherapy in Prophylaxis of Migraine and Headache in Patients With Migraines

The aim of the study is to show that auriculotherapy decreases the number of days with painful episodes of migraine and headache after 3 months of treatment

Prospective, multicenter, controlled and randomized study.

At the inclusion:

* initial assessment of migraine and headache attacks of the last 3 months with the migraine/headache/treatment diary;
* quality of life assessment (MIDAS questionnaire).

Patients are randomized in 2 groups (distribution 2/3 AUR+, 1/3 AUR-):

* AUR+: experimental group "Auriculotherapy". Patients benefit from 3 sessions of auriculotherapy at one month intervals.
* AUR-: control group. Patients do not benefit from auriculotherapy.

After 3 months, a visit of Algology is carried out :

* final assessment of migraine and headache attacks of the last 3 months with the migraine/headache/treatment diary;
* quality of life assessment (MIDAS questionnaire).

Eligibility Criteria:
Inclusion Criteria:

* Woman;
* Aged from 18 to 80;
* Benefiting from social security scheme or legal successor;
* Having given their non-opposition to the study; ·
* Diagnosis of chronical migraine for more than 6 months;
* Without background treatment or with stable background therapy for more than 1 month;
* Presenting a calendar of migraines and headaches mentioning the number of days with pain, intensity of pain and treatments for at least 3 months.

Non inclusion Criteria:

* Man;
* Patient with less than 6 painful episodes in 3 months;
* History or actual mental health disorder;
* Dependence on opioids or tranquillizers;
* Secondary headaches;
* Incapacitated to keep a diary of the migraines / headaches / treatments;
* Contraindications for the use of auriculotherapy (scheduled Magnetic resonance imaging examination, declared pregnancy, breastfeeding, artificial heart valves, Haemophilia, effective anticoagulation treatment);
* Having received auriculotherapy treatment in the indication of the study in the last 12 months before inclusion;
* Scheduled to start a new drug or non-drug therapy which could interfere with the study (antidepressant, opioids, anticonvulsant psychological therapy, physiotherapy, deep brain stimulation, etc..);
* Modification of background treatment during the month before inclusion.

Exclusion criteria

* Allergy or infection of the auricle
* Pregnancy
Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen

Acetaminophen is frequently used as an adjunct for pain management in pediatric surgical patients. The drug is available in an over the counter, inexpensive oral form as well as a considerably more expensive intravenous form. This study will compare opioid requirements and acetaminophen plasma levels post operatively for two dosing regimens to compare oral versus intravenous routes given pre operatively.

The primary purpose of this study is to compare opioid utilization in post-operative patients undergoing tonsillectomy and adenoidectomy, between IV and PO acetaminophen. Secondarily, it will provide information regarding possible cost savings, pharmacokinetics and safety between these two regimens.

Eligibility Criteria:
Inclusion Criteria:

* Patients ages 3 years to 17 years scheduled for tonsillectomy and adenoidectomy for obstructive sleep apnea with or without additional minor procedures such as sleep endoscopy, unilateral or bilateral myringotomy, insertion of tympanostomy tubes and/or ear exam. ( Minor additional procedures that are frequently combined with tonsillectomy and adenoidectomy but are not commonly considered to have pain that is significantly greater than the tonsillectomy and adenoidectomy).

Exclusion Criteria:

* Patients who meet University of California Davis Children's Hospital (UCDCH) criteria for Pediatric Intensive Care Unit (PICU) admission: on home oxygen pre-operatively, exhibit airway obstruction when awake (stertor above larynx, stridor at larynx), sleep study with apnea hypoxia index greater than 25 or sleep oxygen saturation nadir \<80%, cardiac disease, difficult intubation.
* Patients with a known allergy to acetaminophen
* Patients with known hepatic insufficiency or severe hepatic disease
* Patients with known Glucose-6-phosphate dehydrogenase (G6PD) deficiency
* Patients who are malnourished (ie lower levels of glutathione)
* Patients with severe renal impairment as defined by calculated creatinine clearance \<20 ml/min (per modified Schwarz equation)
* Patients who are pregnant
Dose Titration of Propofol for Tracheal Intubation in Children With Sevoflurane Inhalation Induction

Dose titration of propofol for tracheal intubation in children with sevoflurane inhalation induction.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients scheduled for elective day case surgery were enrolled.

Exclusion Criteria:

* History of obstructive sleep apnea
* Evidence of cardiorespiratory disease
* Those who were obese or allergic to any of the anesthetic agents in this study
* Those with an anticipated difficult airway, full stomach
* History of malignant hyperthermia or other myopathy were excluded.
Reinnervated PAP Flap for Oral Cavity and Oropharyngeal Defect Reconstruction

The aim of this study is to investigate sensory recovery and functional outcomes following oral cavity and oropharyngeal defect reconstruction with reinnervated PAP (profunda artery perforator) flaps.

Tumor resections involving the oral cavity or oropharynx cause significant functional deficits in swallowing and speech and subsequently impair the patients' quality of life. The anterolateral thigh (ALT) flap is widely regarded as a workhorse flap to reconstruct such defects. Previous studies assessing recovery of reinnervated ALT flaps reported superior sensory recovery, improved swallow function, and improved overall patient satisfaction in patients with reinnervated flaps compared with patients who received ALT flap reconstruction without sensory reinnervation. Recently, the profunda artery perforator (PAP) flap has been proposed as an alternative donor site in malnourished patients with thin lateral thigh thickness. However, reinnervation of PAP flaps has not been described. The study assesses sensory recovery after defect reconstruction with the reinnervated profunda artery perforator flap using already approved, non-invasive testing (Semmes-Weinstein monofilament testing, two-point discrimination, temperature, pain perception)

Eligibility Criteria:
Inclusion Criteria:

- Patient with defect involving the oral cavity or oropharynx who undergo reconstruction with a free reinnervated profunda artery perforator flap

Exclusion Criteria:

* \<18 years old
* Defect localizations other than the oral cavity or oropharynx
* Not able to give informed consent
* Inability to follow the procedures of the study, e.g., due to psychological disorders, dementia
* Inability or contraindications to undergo the investigated intervention