cyrilzakka/clinical-trials huggingface dataset:
Astral VAPS AutoEPAP Clinical Trial

Patients with chronic respiratory failure such as those associated with Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS), Obstructive Sleep Apnea (OSA) or Neuromuscular Disease (NMD) are increasingly managed with domiciliary non-invasive positive pressure ventilation (NIPPV). The aim of this study is to now compare the Automatic Expiratory Positive Airway Pressure (AutoEPAP) algorithm with a fixed manual EPAP in iVAPS mode on an Astral mixed mode ventilator. It is proposed that the automatic settings of AutoEPAP will be as effective at managing respiratory failure and upper airway obstruction (UAO) as manual EPAP on the Astral device. Specifically demonstrating that the AutoEPAP function is as effective at treating UAO as manual EPAP.


Eligibility Criteria:
Inclusion criteria for the study are:

1. Participant has ability to provide written informed consent
2. Participants aged ≥18 years old
3. Participant has documented respiratory failure (e.g. sleep hypoventilation with historical PtCO2 increase ≥ 10mmHg) and/or daytime hypercapnia (\>45 mmHg)
4. Participant is currently using non-invasive positive pressure ventilation in ST or VAPS mode for ≥ 3 months
5. Participants with a previously documented AHI ≥ 5/hr
6. Participants with a recently (≤ 12 months ago) reviewed EPAP setting

Exclusion criteria for the study are:

1. Participants are not compliant on NIPPV (e.g. \< 4 hr/night)
2. Participants who are pregnant
3. Participants on oxygen therapy ≥5 L/min
4. Participants with an invasive interface (e.g. tracheostomy)
5. Participants who have had an acute exacerbation within the last 3 months that resulted in a hospitalisation
6. Participants who are acutely ill, medically complicated or who are medically unstable
7. Participants in whom NIPPV therapy is otherwise medically contraindicated
8. Participants who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
9. Participants with untreated, non-OSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome.
10. Participants who have the following pre-existing conditions: severe bullous lung disease, recurrent pneumothorax or pneumomediastinum, cerebrospinal fluid leak, recent cranial surgery or trauma.
11. Participant does not comprehend English
12. Participant is unable or unwilling to provide written informed consent
13. Participant is physically and/or mentally unable to comply with the protocol
14. Participant is not suitable to participate in the trial for any other reason in the opinion of the investigator
Comparing Vasopressin and Adrenaline in Patients With Cardiac Arrest

The effectiveness of medications in cardiac arrest has been greatly debated and questioned. Historically intravenous adrenaline has been the drug of choice since 1906. There have been few formal evaluations to determine the value of adrenaline for cardiac arrest, and clinical trials have not been able to show any benefit with intravenous adrenaline (compared to placebo or no treatment) in the field.

Thus the purpose of this study is to compare vasopressin and adrenaline in the treatment of cardiac arrest to answer the question whether there is an improvement in survival between vasopressin and adrenaline.

The effectiveness of medications in cardiac arrest has been greatly debated and questioned. Historically intravenous adrenaline has been the recommended drug of choice since 1906. There have been few formal evaluations to determine the value of adrenaline for cardiac arrest, and clinical trials have not been able to show any benefit with intravenous adrenaline (compared to placebo or no treatment) in the field.

More recently, vasopressin has been used in patients with cardiac arrest. In human studies on vasopressin, clinical trials have produced conflicting results.

The current study compared vasopressin and adrenaline in the treatment of cardiac arrest in patients presenting to the Emergency Department (ED). Specific outcomes included return of spontaneous circulation (ROSC) (as measured by the presence of a palpable pulse at any time during resuscitation), survival to hospital admission, survival to discharge from hospital, and functional status at discharge and at one year (as measured by the Glasgow-Pittsburgh outcome categories).

Eligibility Criteria:
Inclusion Criteria:

* Patient with cardiac arrest as confirmed by the absence of a pulse, unresponsiveness and apnea
* Age above 16 (Age 21 and above for CGH only)

Exclusion Criteria:

* Traumatic cardiac arrest
* Age 16 and below (Age 20 and below for CGH only)
* CPR is contraindicated
Colonoscopic Adenoma and Advanced Neoplasia Detection Rates According to Age

Current recommendations for colonoscopy screening programs usually involve patients older than 50 years of age. However, little is known about polyp or adenoma detection rates under 50. We compared these detection rates according to age in a large series of patients in common practice.

Methods: All colonoscopies performed in 2016 in our unit were prospectively recorded. We determined adenoma detection rate (ADR), polyp detection rate (PDR), mean number of polyps (MNP), and advanced neoplasia detection rate (ANDR).

Patients All consecutive patients who were scheduled for colonoscopy were included. Exclusion criteria were: patients scheduled for partial colonoscopy, interventional colonoscopy (for stent insertion, stenosis dilation).

Data collection The following data have been prospectively collected: age, gender, indication for colonoscopy, preparation procedure and quality of the preparation (assessed by the Boston Bowel Preparation Scale; BBPS) \[19-20\], caecal intubation (yes/no), withdrawal time, number and size of polyps and polyp histopathology.

All clinical data were collected during the procedure by a nurse and an endoscopist on a dedicated software. The database was then supplemented by the Clinical Research Associate for histopathological data.

We determined adenoma detection rate (ADR; percentage of colonoscopies with at least one adenoma), polyp detection rate (PDR: percentage of colonoscopies with at least one polyp), mean number of polyps per colonoscopy (MNP), large polyp detection rate (LPDR; percentage of colonoscopies with at least one polyp of 1 cm or more) and advanced neoplasia detection rate (ANDR: percentage of colonoscopies with at least one advanced neoplastic lesion as defined below).

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients who were scheduled for colonoscopy were included.

Exclusion Criteria:

* patients scheduled for partial colonoscopy, interventional colonoscopy (for stent insertion, stenosis dilation).
Rectus Muscle Re-approximation at Cesarean Delivery

We include in our study 200 pregnant women, primigravidas, at term who underwent elective lower segment Cesarean section for the first time among the age group of 20 - 35 years.

The patients are divided randomly into two groups as follows:

* Group (A): undergoing rectus muscle re-approximation
* Group (B): not undergoing rectus muscle re-approximation

We include in our study 200 pregnant women, primigravidas, at term who underwent elective lower segment Cesarean section for the first time among the age group of 20 - 35 years.

The patients are divided randomly into two groups as follows:

* Group (A): undergoing rectus muscle re-approximation
* Group (B): not undergoing rectus muscle re-approximation
* Examination for diastasis recti abdominis is done for all included patients before delivery, at 6 weeks, and 6 months postpartum. The women are tested in a standardized supine position with arms crossed over the chest. They are instructed to perform an abdominal crunch till the shoulder blades are off the bench. Then we measure the inter-recti distance. If there is no separation or separation ˂ 2 finger breadths so, there is no diastasis recti abdominis. But if the separation is more than 2 finger breadths or more than 4.5 cm so, this is considered diastasis recti abdominis.

The same surgical techniques are used for both groups. All women underwent Pfnannenstiel incision under general or spinal anaesthesia, with a combination of sharp and blunt dissection to open the abdomen. The rectus muscles are dissected off the fascia, and the muscles are separated in the midline by pulling. Then the uterus is opened followed by fetal and placental extraction. The transverse lower uterine segment incision is closed in two layers of continuous Vicryl number 1 suture. The parietal peritoneum is closed using a continuous absorbable suture. In group (A): rectus muscle re-approximation is done by 3 interrupted sutures, but muscle is not closed in the other group. The rectus sheath is sutured using continuous absorbable sutures. Finally, skin is sutured with subcuticular sutures with Vicryl Rapide.

Eligibility Criteria:
Inclusion Criteria:

* primigravida
* undergoing elective Cesarean section

Exclusion Criteria:

* Patients with history of any pelvic or abdominal surgery those having any medical disorder with pregnancy patients with BMI ≥ 40 chronic analgesia use multiple pregnancies
Impact of Sleep Restriction on Performance in Adults

The overall goal of this project is to look at the effects of long-term, sustained sleep restriction (SR) in adults, and assess the effects on mood and cognitive and physical performance.

Chronic Sleep Restriction (SR) is highly prevalent in today's modern society. Artificial light, portable electronic devices, and 24-h services have allowed individuals to remain active throughout the night, leading to reductions in sleep duration. SSD has been linked to obesity and our laboratory has been interested in establishing whether sleep could be a causal factor in the etiology of obesity. Given the increasing prevalence of obesity over the past 5 decades, coinciding with the marked reduction in sleep duration, further exploration into the role of sleep as a risk factor for obesity could provide additional ammunition in the fight to prevent further increases in the incidence of obesity.

This study will be a randomized, crossover, outpatient SR study with 2 phases of 6 weeks each, with a 6 week wash-out period between the phases. Sleep duration in each phase will be the participant's regular bed- and wake times during the habitual sleep (HS) phase and HS minus 1.5 hours in the SR phase. During the HS phase, participants will be asked to follow a fixed bedtime routine based on their screening sleep schedule. During the SR phase, participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time.

Eligibility Criteria:
Inclusion Criteria:

* BMI 25-29.9 kg/m2
* Have at least one obese parent
* Habitually sleep 7-9 hours a night
* Free of any current and past sleep and psychiatric disorders, including eating disorders, diabetes or Cardiovascular disease (CVD) (i.e., normal scores on: Pittsburgh Quality of Sleep Questionnaire Epworth Sleepiness Scale, Berlin Questionnaire, Sleep Disorders Inventory Questionnaire, Beck Depression Inventory, Composite Scale of Morningness/Eveningness, Three Factor Eating Questionnaire)
* All racial/ethnic groups

Exclusion Criteria:

* Smokers (any cigarettes or ex-smoker \< 3 years)
* Neurological, medical or psychiatric disorder
* Diabetics
* Eating and/or sleep disorders
* Contraindications for MRI scanning
* Travel across time zones within 4 weeks
* History of drug and alcohol abuse
* Shift worker (or rotating shift worker)
* Caffeine intake \> 300 mg/d
* Heavy equipment operators
* Commercial long-distance drivers
Interest of a Skin Transilluminator (Such as the VeinViewer®Vision Device) for Peripheral Venous Catheter Placement in the Obese Patient

Placement of a peripheral venous catheter (PVC) is the most common invasive procedure in anaesthesia and perhaps even in the field of medicine as a whole.

Placement of a peripheral venous catheter (PVC) is the most common invasive procedure in anaesthesia and perhaps even in the field of medicine as a whole. This procedure may be challenging in the obese patient - even for the most experienced healthcare professionals.

In a study, PVC placement was considered to be difficult in 46% of obese patients but only 13% of non-obese patients.

Placement of a central venous catheter is an option when PVC placement is impossible, although central access is associated with a non-negligible risk of complications (pneumothorax, infection, arterial puncture, etc.).

Facilitating peripheral venous access in obese patients should shorten the time required for PVC placement, decrease the number of perfusion attempts (a source of dissatisfaction and discomfort for the patients) and limit the use of a central venous catheter.

Although a number of novel vein visualisation devices (such as the VeinViewer®Vision from Christie Medical) have been developed to guide PVC placement, there are no literature data on the value of these devices in the management of difficult venous access in obese patients.

Eligibility Criteria:
Inclusion Criteria:

* All obese adult patients scheduled for surgery.
* Social security coverage

Exclusion Criteria:

* Age \<18.
* Contra-indication to PVC placement.
* Legal guardianship.
Physical Exercise as a Sustainability Tool in Men With Dysmetabolic Hypogonadism

Aim of this project is to delineate sustainable physical exercise programs and to assess the effects of such programs mainly on endocrine-metabolic and neurovegetative outcomes in a cohort of men with metabolic syndrome-related late-onset central hypogonadism.

Participants will undergo a personalised exercise program. After 6 months they will be subdivided into two groups, according to the weekly physical activity volume actually performed (above or below 600 MET·minutes/week). Changes in endocrine-metabolic and neurovegetative outcomes will be compared between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of late-onset central hypogonadism: total T levels \< 8 nmol/L (or \< 12 nmol/L in the presence of calculated free T \< 225 pmol/L) combined with sexual symptoms (erectile dysfunction, low libido and loss of waking erections) \[12\];
* diagnosis of metabolic syndrome, defined as association of waist circumference (WC) \> 94 cm and at least two among the following criteria: triglycerides ≥ 150 mg/dl, HDL-C \< 40 mg/dl, glucose \> 100 mg/dl, blood pressure (BP) ≥ 130/85 mmHg \[33\];
* ability to give informed consent, in accordance with good clinical practice rules and applicable national laws.

Exclusion Criteria:

* History of hypothalamus-pituitary organic disorders and/or testicular diseases;
* impossibility to assess cardiac autonomic regulation due to arrhythmias and/or current treatment for heart rate (HR) control (e.g., beta-blockers, antiarrhythmics);
* impossibility to undergo clinical assessment;
* impossibility or contraindications to perform exercise program (for instance, psychiatric disorders, severe musculoskeletal diseases, arrhythmias);
* inability to give informed consent or unwillingness to be enrolled in the study.
Magnetic Resonance Imaging of Injectate in Thoracic 2 Paravertebral Block

The purpose of this study is to analyze the spread of local anesthetic using magnetic resonance imaging after thoracic 2 paravertebral block in patients with cervical radiculopathy.

1. Ultrasound guided thoracic 2 paravertebral block will be done using sagittal scan or transverse scan.
2. Clinical parameters will be monitored (temperature, perfusion index, assessment of sensory block and analgesic effect, vital sign, adverse events) after the nerve block.
3. Cervical MRI will be taken 1 hour after the nerve block.
4. Follow up 7 days and 28 days after the MRI at outpatient clinic (numeric rating scale, medication quantification scale)

Eligibility Criteria:
Inclusion Criteria:

1. Patients with unilateral radiating pain in the upper extremity whose pain persists for more than 3 months despite conservative treatment
2. Diagnosis: cervical degenerative disc disease, cervical foraminal stenosis, cervical stenosis with/without myelopathy
3. Numeric rating score ≥ 4
4. 19 years or older

Exclusion Criteria:

1. Cervical or upper thoracic spine surgical history
2. If the body mass index is 35 kg/m2 or more
3. If you have an allergy or hypersensitivity reaction to a local anesthetic
4. coagulation disorders
5. Local infection at the injection site
6. claustrophobia
7. If you have a metal insert such as a pacemaker
8. pregnancy
9. Patients who are unable to communicate and have cognitive impairment
10. If a person who cannot read the consent form is included among the subjects (e.g., illiterate, foreigners, etc.)
Efficacy of Tazarotene in Treatment of Verruca Plana

Verruca plana is a common skin infection with worldwide distribution. Approximately 10% of general population is infected with flat warts and it represents up to 18 % of the patients seeking treatment for warts. Verruca plana is not merely an infectious disease but also affects the quality of patients' life. Verruca plana causes major cosmetic and social concerns. Lesions' persistence and recurrence cause frustrations and psychological distress which motivate patients to seek different treatment strategies. Verruca plana commonly affects the school aged children which augments its effect on the psychological and social development of children with stigmatization and bullying are great risks. The available treatment strategies neither ensured complete clearance of the disease nor were free of side effects. Frequently used physical removal methods are operator dependent and commonly lead to irritation, local inflammation, scars, dyspigmentation, and disfigurement. In this study we evaluate the efficacy and the safety of tazarotene gel 0.1% in the treatment of verruca plana compared to imiquimod or 5-fluorouracil

Patients will be assigned randomly into one of 4 groups as 1:1:1:1 using randomization.com with the seed number 7607

* Group (A): Patients will be treated with topical tazarotene gel 0.1%with a cotton tipped applicator on every lesion once daily at night.
* Group (B): Patients will be treated with topical 5- fluorouracil 5% cream applied once daily at night.
* Group (C): Patients will be treated with imiquimod cream 5% applied once daily at night.
* Group (D): Patients will be treated with petroleum jelly once daily at night.

Eligibility Criteria:
Inclusion Criteria:

* All participants must be willing to sign informed consent; for patients younger than 18 years old, parents or guardians will sign an informed consent

  * Age \> 4 years.
  * Both sexes.
  * Patients with clinically and dermoscopically diagnosed plane warts.
  * Subject is willing and able to follow all study instructions and to attend all study visits

Exclusion Criteria:

* • History of hypersensitivity to any of the drugs used.

  * Pregnancy and lactation.
  * Patients with epidermodysplasia verruciformis syndrome.
  * Patients with eczematous skin disorders.
  * Presence of any active infections e.g. herpes, tuberculosis.
  * History of topical anti wart treatment within 4 weeks of recruitment to the study, and a 12-week period for systemic anti-wart treatment, or immunotherapy, or HPV vaccine in the last 24 weeks.
Indexed Aortic Area in Bicuspid Aortic Valve Aortopathy

This study aims to determine the relationship between the cross-sectional aortic area/patient height ratio (indexed aortic area) and absolute aortic diameter in proximal thoracic aortic aneurysms associated with a bicuspid valve. This will shed light on whether aneurysms with smaller diameters than those recommended for surgical intervention by guidelines are still at risk of aortic complications attending an abnormally high indexed aortic area.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* First-time surgery
* Bicuspid aortic valve confirmed
* Thoracic aortic aneurysm involving aortic root or ascending aorta

Exclusion Criteria:

* No available pre-operative cross-sectional imaging
* Re-do surgery
Efficacy and Safety of Celecoxib Versus Placebo in the Treatment of Patients With Osteoarthritis of the Knee Who Were Unresponsive to Naproxen and Ibuprofen

To compare the safety and efficacy of celecoxib versus placebo in the treatment of patients with knee osteoarthritis who were unresponsive to treatment with prescription strength naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen


Eligibility Criteria:
Inclusion criteria:

* OA of the knee in flare state at baseline visit and functional capacity class of I-III
* Failed adequate trials of both naproxen and ibuprofen (prescription strength) within the past 5 years due to lack of efficacy, tolerability or both; duration of prescription strength ibuprofen and naproxen must have been a minimum of 2 weeks for each drug at the respective recommended doses if failure was due to lack of efficacy, and for any duration if failure was due to lack of tolerability

Exclusion criteria:

* Inflammatory arthritis or gout/pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
* Received acetaminophen within 24 hours of baseline visit
* Use of mobility assisting device for less than six weeks prior to study screening or use of a walker
* History of gastrointestinal (GI) perforation, obstruction, or bleeding
* Diagnosed or treated for GI ulcer within 60 days prior to first dose of study medication
* Recieved corticosteroids or hyaluronic acid within certain timeframe before study
An Imaging Study to Investigate the Distribution of GW842166X in the Brain.

GW842166X is being developed for the treatment and management of inflammatory pain. GW842166X is a CB2 receptor agonist and the mechanism is not fully understood, although it is thought that for the anti-inflammatory action the drug is required to cross inot the brain from the blood. This study aims to look at if the drug crosses into the brain once given orally using an imaging technique called positron emission tomography.


Eligibility Criteria:
Inclusion Criteria:

* Male aged 50 to 80yrs inclusive at the screening visit.
* subjects with negative HIV and hepatitis B and C test results within 3 months of study start.

Exclusion Criteria:

* A negative Allens test on arm to be used for arterial cannulation.
* Any contraindications to MRI scanning.
* History or presence of hepatic or renal disease.
* Previous involvement in PET or radiological investigations.
* Family history of cancer.
* History of claustrophobia
* Presence of a cardiac pacemaker or any other electronic device or ferromagnetic metal
Weekly Vaccination With Copaxone as a Potential Therapy for Dry Age-related Macular Degeneration

The purpose of the project is to investigate in eyes with dry AMD, the efficacy and safety as preventive therapy of the immunomodulatory substance named copaxone which had been proven as safe and effective agent for a neurodegenerative disease, in arresting the progression as well as the conversion of dry AMD to wet AMD. The hypothesis that the immunomodulatory agent copaxone proven for a neurodegenerative disease may work in the eye is revolutionary and may open a new avenue of preventive treatment for the disease which is the major cause of legal blindness in the industrial world


Eligibility Criteria:
Inclusion Criteria:

1. Dry AMD in one or both eyes
2. Age 50 or above of either gender
3. Signed informed consent.

Exclusion Criteria:

1. Known sensitivity to Mannitol or Copaxone.
2. Skin disease or active infection of skin.
3. Active fever or active treatment for infection.
4. History of other uncontrolled systemic active disease.
5. Premenopausal females not using reliable birth control.
6. Sensitivity to fluorescein or iodine.
7. Inability to comply with study procedures.