cyrilzakka/clinical-trials huggingface dataset:
Diclofenac for Prevention of Post-ERC Pancreatitis

The study aims at assessing the effectiveness of Diclofenac for prevention of post-ERCP pancreatitis. It will be undertaken embedded in the Swedish national register for Gallstone surgery and ERCP (GallRiks). Patients are randomised to Diclofenac prior to the ERCP or no prophylaxis. GallRiks is used to identify which patients fulfill the eligibility criteria and which patients develop pancreatitis after the ERCP.

Endoscopic Retrograde Cholangiopancreatography (ERCP) is a procedure commonly performed for diagnosing changes in the bile ducts or managing outflow obstruction. Although ERCP may in most cases be performed safely, there is a risk of developing acute pancreatitis following the procedure. The risk has been estimated to 5-10%, with an increased risk in women, younger patients and in case the cannulation is difficult.

Phospholipase 2 is crucial in the pathogenesis of acute pancreatitis. As Diclofenac is a potent inhibitor of Phospholipase 2, it has been suggested that it may be used for prevention of post-ERCP pancreatitis. There is some evidence for the effectiveness of Diclofenac, but more studies are needed to confirm that it reduces the risk of post-ERCP pancreatitis.

In order to test whether Diclofenac reduces the risk for post-ERCP pancreatitis, a register-based randomized controlled study is planned. The study will be conducted embedded in the Swedish Register for Gallstone Surgery and ERCP (GallRiks). GallRiks includes data corresponding to the eligibility criteria as well as outcome measures. GallRiks will also be used to record which patients have been screened for inclusion.

Patients who meet the eligibility criteria are invited to the study. If they accept inclusion, they are randomized to 100 mg Diclofenac prior to the ERCP or np prophylaxis. No blinding is done.

The aim is to include 1000 patients. When 500 patients have been included, an interim analysis will be performed, comparing the incidence of pancreatitis and mortality in the two groups. A retrospective review of the patient records will be performed for those who develop pancreatitis.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing ERCP

Exclusion Criteria:

* Decision to perform ERCP taken intraoperatively
* Intolerance/allergy against NSAID
* Patients taking NSAID daily
* Severe cardiac fail (ASA\>4)
* Kidney failure (GFR\<30 ml/min)
* Coagulation disorder
* History of peptic ulcer bleeding
* History of abdominoperineal resection
* Pregnancy
* Patients who do not understand Swedish
Project COPE (Coping Options for Parent Empowerment)

The purpose of this research study is to collect information to better understand caregiver responses to COVID-19 stress and to help caregivers of children with Autism Spectrum Disorder (ASD) cope with these stressors.


Eligibility Criteria:
Inclusion Criteria:

1. Must be willing to consent to participate via RedCap
2. Indicate a mild or greater elevation on screening measures of anxiety and/or depression
3. Not meet any exclusion criteria.
4. Lives in Florida
5. Has a child between the ages of 4-13 years who has been diagnosed with ASD
6. Speaks either English or Spanish primarily
7. Has technical capacity to participate in Zoom sessions on a mobile device or preferably a computer

Exclusion Criteria:

1. Severe mental illness (e.g., bipolar disorder, schizophrenia, an intellectual disability, psychosis, alcohol use disorder, substance use disorder) or hospitalization for mental health concerns or suicide attempt. Parents may receive concurrent psychiatric or psychological intervention services but may be excluded if the severity of current mental illness is such that outpatient, weekly group treatment would be considered inappropriate.
2. Parents who report any prior arrest for child endangerment, child abuse or child neglect may also be excluded.
3. Parents who have Moderate or greater risk of suicidal ideation.
Endobronchial Ultrasound Strain Elastography in Sarcoidosis

Strain elastography (SE) is an imaging method used for the measurement of relative tissue elasticity through qualitative (color pattern) or semi-quantitative methods (strain ratio or strain histogram). Very recently, the first pilot study has provided preliminary evidence that EBUS-SE elastography may help identify fibrotic lymph nodes in sarcoidosis and that sampling lymph nodes characterized by low strain elastography, that is "stiff" nodes, is associated with an increased risk of retrieving an inadequate sample (i.e. a sample which is not representative of the lymph node tissue). The investigators hypothesize that an EBUS-SE pattern indicative of lymph node stiffness will be associated with less granulomas and more fibrosis.

In the last decade, the possibility to sample under ultrasound guidance (endosonography) the intrathoracic lymph nodes through the airways (endobronchial ultrasound guided, EBUS-TBNA) or through the oesophagus (endoscopic ultrasound-guided fine needle aspiration, EUS-FNA/EUS-b-FNA) has revolutionized the diagnostic approach to sarcoidosis. Individual studies and meta-analyses performed in selected and unselected patient populations have shown that EBUS and EUS both have overall diagnostic accuracy exceeding 80%. In addition, endosonography provides useful information about lymph node density; indeed, the presence of inhomogeneity in the lymph node texture on B-mode during endosonography represents the most important factor favouring infection over sarcoidosis in patients with lymphadenopathy.

Although the diagnostic success rate of EBUS-TBNA in detecting granulomas in lymph nodes of patients with suspected sarcoidosis is very high, the procedure is not foolproof and tends to have a lower yield in stages II/III as compared to stage I disease. Clinical experience suggests that at least some of the false-negative EBUS-TBNA results in sarcoidosis patients may be caused by the presence of lymph nodes with extensive fibrosis. We aim to evaluate whether EBUS-SE may help identify fibrotic lymph nodes in sarcoidosis and if the outcome of EBUS-TBNA is different in lymph nodes for which EBUS-SE suggest high fibrotic content.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* ASA physical status I-III.
* Clinical/radiological (computed tomography) suspicion of sarcoidosis (Stages I to III)

Exclusion Criteria:

* Inability or unwillingness to consent.
* Severe bleeding disorders
* Contraindication for temporary interruption of the use of anticoagulant or antiplatelet therapy different from aspirin.
* Recent and/or uncontrolled cardiac disease, uncontrolled pulmonary hypertension.
* Compromised upper airway (eg, concomitant head and neck cancer or central airway stenosis for any reason).
* Pregnancy
Effects of Monopolar Electrocautery Use During Surgery on Implanted Cardiac Defibrillators

This observational protocol will evaluate the effects of monopolar electrocautery (ME) on implantable cardioverter defibrillators (ICDs) in patients undergoing surgery. ME can cause electromagnetic interference (EMI) leading to ICD damage or inadvertent ICD discharge (shocks). Recommended practice calls for the preoperative reprogramming of ICDs when ME will be used to prevent patients from receiving inadvertent shocks. This requires the presence of someone trained in ICD programming, but a trained person is not always readily available.

In this study the investigators will reprogram ICDs prior to surgery according to current practice, but will also record what would have happened had the ICD reprogramming not occurred ("detection on" but "therapy off"). In addition, the investigators will evaluate the effect of the location of the electrosurgery unit (ESU) return pad on the incidence of EMI. The investigators hypothesize that directing the current return path away from the ICD will result in lower EMI rates than previously described.


Eligibility Criteria:
Inclusion Criteria:

* Adult individuals of both genders, 18 years of age and older
* For patients undergoing surgery about the waist, previous implantation of a functioning Boston Scientific or Medtronic ICD
* For patients undergoing surgery below the waist, previous implantation of a functioning Boston Scientific, Medtronic, St. Jude Medical, or Biotronik ICD
* Signed informed consent

Exclusion Criteria:

* Surgery involving the ICD pocket (generator change out procedure)
* Surgery or procedures exclusively involving bipolar electrocautery (such as ophthalmic surgery)
* Patients undergoing surgery above the waist with ICDs not manufactured by Medtronic or Boston Scientific (other ICDs do not allow reprogramming to allow EMI detection without the potential for inadvertent ICD discharge)
Effect of Sleep Deprivation on Sensory Integration of Balance, Fall Risk and Postural Stability

Sleepiness caused by sleep deprivation may increase the risk of injuries and damages during physical activity. Individual data so far indicates worsening of postural stability and control with females exhibiting better static postural stability regardless of sleeping conditions in comparison to men. However, the literature is deficient in terms of postural stability conditions with eyes open and eyes closed states, as well as fall risk and sensory integration of balance.


Eligibility Criteria:
Inclusion Criteria:

* Age 19 to 24
* Healthy young adults from Rawalpindi/Islamabad.
* Both males and females
* Participants should have normal sleep patterns without any signs or symptoms of insomnia or hypersomnia.
* Persons without any sleep disorders.
* Persons without any neurological disease.

Exclusion Criteria:

* Persons with sleep disorders such as hypersomnia, insomnia, parasomnia etc.
* Elderly population.
* Persons with any sort of neurological deficits.
* COVID positive and those with any suspected signs and symptoms of COVID-19.
* Alcoholics
* Pregnant females
* A participant with the history of or active diagnosed conditions of any of the following, which renders individual's performance will be excluded:

  * Neurological.
  * Musculoskeletal.
  * Cardiopulmonary.
  * Any congenital disorder or limb deformities.
A Comparative Study Between Mechanical and a Viscoelastic Disc Prosthesis in the Lumbar Spine

TDR implants for the lumbar spine are currently most 2- or 3-piece devices with a purely mechanical function that provide/restore mobility. Lately interest is growing on non-mechanical implants that could possibly provide/restore mobility, but also produce counterforces on mobility as in healthy discs. No previous comparison between these two concepts has been performed, neither on clinical outcome, neither on specific differences on facet-joint load and wear.

A total of 250 patients are to be enrolled and treated. Inclusion criteria is unbearable pain and dysfunction from degenerative disc disease (DDD) that at one or two segments in the lover lumbar spine, that has not responded positively from at least one year of conservative treatment (that is combination of intense physical training and drugs).

Patients with DDD below L3 vertebra are divided I three groups:

1. One segment DDD appropriate for treatment with TDR.
2. Two segments DDD appropriate for treatment with TDR.
3. One segment DDD appropriate for treatment with TDR and one segment DDD not appropriate for treatment with TDR, that will be treated with anterior fusion (ALIF) at the same surgical procedure, called "hybrids". Within all three groups there will be an equal randomization between the two prosthesis types.

Clinical outcome will be evaluated from questionnaires sent out to patients after 12- and 24 months and 5- and 10 years after surgery. The questionnaire are the currently used ones from the Swedish Spine Registry (SweSpine) including VAS leg/back, EuroQol ,GA and ODI. Complications will be registered continuously and facet-joint load/health will be examined from flex-ext x-rays at 1 and 2 years. At the 2-year check up a 3D-CT will be performed to further evaluate the facet joints and their load under flex-ext.

Eligibility Criteria:
Inclusion Criteria:

* Incapacitating pain from DDD (both clinical and radiological) in one or two segments below the L3 vertebra, were at least one segment is suitable for TDR treatment.
* Patient with more than one year of pain, that has during this period made a prolonged and adequate conservative program.

-Patient between 20 and 55 years of age. -

-Patient able to understand written and spoken Swedish.

Exclusion Criteria:

* Patient does not accept to be part of the study.
* Three or more segments suspected to be symptomatic.
* Earlier vertebral fracture, tumour, infection or fusion in the lumbar spine. -Substantial scoliosis/deformity.
* Need for posterior decompression.
* Pregnancy, psychiatric illness or drug abuse. -Patient does not understand written and spoken Swedish and can thus not take part in information and answer questionnaires.

-Patient residing outside Sweden and thus is not covered with SweSpine. -
Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Patients With Diabetic Macular Edema

The purpose of this study is to determine the efficacy of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) on the best corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in patients with diabetic macular edema (DME) with central involvement.


Eligibility Criteria:
Inclusion Criteria:

The following is an abbreviated list of inclusion criteria:

* Adults ≥ 18 years with type 1 or 2 diabetes mellitus
* Decrease in vision determined to be primarily the result of DME in the study eye
* BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye

Exclusion Criteria:

The following is an abbreviated list of exclusion criteria:

* Laser photocoagulation (panretinal or macular) in the study eye within 90 days of day 1
* Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of day 1
* Previous treatment with anti-angiogenic drugs in the study eye (pegaptanib sodium, bevacizumab, ranibizumab, etc.) within 90 days of day 1
* Active proliferative diabetic retinopathy (PDR) in the study eye
* Uncontrolled diabetes mellitus
* Only 1 functional eye even if that eye is otherwise eligible for the study
Effectiveness of Interpersonal Psychotherapy (IPT) for Men and Women Prisoners With Major Depression

This study will examine the effects of a first-line treatment for major depressive disorder (MDD), interpersonal psychotherapy (IPT), among men and women prisoners.

The purpose of this 3-year randomized trial is to promote uptake of evidence-based treatment in criminal justice settings by conducting a fully-powered randomized effectiveness study that collects pilot implementation data, including cost-effectiveness data. Group IPT will be compared to treatment as usual (TAU) in a sample of 90 male and 90 female prisoners with MDD from 4 institutions, allowing us to explore gender effects.

Eligibility Criteria:
Inclusion Criteria:

* Meet all DSM-IV criteria for primary (non-substance induced) major depressive disorder
* Expectation of at least 6 months of incarceration at baseline interview
* Incarcerated for at least 4 weeks

Exclusion Criteria:

* Lifetime:

  * Bipolar disorder
  * Psychotic disorder
* Are imminently suicidal
* Cannot understand English well enough to understand the consent form or assessment instruments when read aloud
A Twelve Week Safety and Efficacy Study in Rosacea

The purpose of this study is to evaluate th safety and efficacy of one-daily topical application of CLS001 low, mid and high dose compared to vehicle gel in subjects with papulopustular rosacea.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of papulopustular rosacea (at least 15 lesions)

Exclusion Criteria:

* nodular rosacea or subtype 3
* clinically significant abnormal findings that would interfere with study objectives
Comparison of MRI Versus Three Dimensional Ultrasound in the Diagnosis of Mullerian Duct Anomalies

Mullerian duct anomalies (MDAs) are relatively common disorders, with a prevalence estimated to be around 2% in the general population, and 6% to 7% in women with a history of recurrent pregnancy loss. Mullerian duct anomalies are associated with recurrent pregnancy loss, intra uterine growth retardation, and preterm labor and birth. The prevalence of preterm birth and pregnancy loss varies with the type of MDA. Patients can benefit from surgery or hysteroscopic interventions like metroplasty based on the type of MDA. Therefore, to optimize patient outcomes, accurate diagnosis and description of MDAs is essential.

Magnetic resonance imaging (MRI) is an excellent way of evaluating the uterus for MDAs. MRI, although costly, is less expensive than laparoscopy and hysteroscopy and is non-invasive. Pellerito et all evaluated 26 women with surgically proven MDAs and found that in 24 cases MRI was able to correctly diagnose the MDAs. Therefore MRI is generally considered as a reference standard for uterine evaluation. In a study comparing MRI and endovaginal Two-Dimensional Ultrasound (2DUS), MRI appeared to be more accurate than 2DUS with a sensitivity of 77%, specificity of 33%, and a positive predictive value of 83%.

Endovaginal Three-Dimensional Ultrasound (3DUS) is a relatively new technology that creates three-dimensional volumes from a series of two-dimensional images. This technique allows the user to acquire coronal or face-on-view of the uterus which is essential in evaluating the uterus for the presence of MDAs. Kupesic and Kurjak used 3DUS to evaluate 86 patients and found that it had sensitivity of 98.38%, specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 96% in the diagnosis of septate uteri \[7\]. Endovaginal 3DUS is less expensive, less invasive, and less-time consuming than hysteroscopy or MRI and appears to be a very promising technology for the evaluation of MDAs. 3DUS appears to be at least as accurate as MRI in the diagnosis of MDAs. In addition, 3DUS is less expensive than MRI and in some patients better tolerated. If validated using prospective studies, 3DUS has the potential to become the reference standard for the diagnosis of MDAs.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 16
2. Patients with suspected Mullerian Duct Anomalies (history of recurrent miscarriage or history of primary or secondary infertility).
3. Patients scheduled to undergo routine endovaginal or transabdominal Ultrasonography and pelvic MRI to evaluate possible MDAs

Exclusion Criteria:

1. Age \< 16
2. General contraindications to MRI such as pacemaker etc.
Ampicillin/Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section

The efficacy and safety of a single dose of ampicillin/sulbactam compared to a single dose of cefuroxime at cord clamp for prevention of postcesarean infectious morbidity has not been assessed.

Women scheduled for cesarean delivery were randomized to receive a single dose of either 3g of ampicillin-sulbactam or 1.5g of cefuroxime intravenously, after umbilical cord clamping. An evaluation for development of postoperative infections and risk factor analysis was performed.

The efficacy and safety of a single dose of ampicillin/sulbactam compared to a single dose of cefuroxime at cord clamp for prevention of postcesarean infectious morbidity has not been assessed.

The investigation was designed to evaluate the efficacy and safety of a single dose of ampicillin/sulbactam 3g compared to a single dose of cefuroxime 1.5g in preventing postoperative morbidity. The primary outcome was development of an infection either at the surgical site or elsewhere e.g. urinary tract infection.

A prospective randomized controlled study was performed from July 2004 to December 2008 in one major tertiary care hospital in Athens Greece. All patients undergoing a cesarean delivery were eligible.Patients were randomly assigned to receive either 1.5g of cefuroxime, or 3g of ampicillin/ sulbactam intravenously after the time the umbilical cord was clamped.

Eligibility Criteria:
Inclusion Criteria:

- All patients undergoing a cesarean delivery were eligible.

Exclusion Criteria:

* Patients with known hypersensitivity to penicillin or cephalosporins.
* Patients who required concomitant antibiotic therapy during surgery.
* Patients who have received antibiotics during the 72 hours immediately preceding their enrollment.
* Patients whose postpartum fever was clearly associated with other known causes.
Comparison of Different Tools to Facilitate Nasotracheal Tube Placement Under Video-laryngoscope Use

to investigate the effectiveness of techniques of either using Magill forceps or cuff inflation in facilitation of nasotracheal tube advancement into trachea

Patients who undergo oxo-maxillofacial surgery need naso-tracheal intubation to present good surgical view-field. but, sometimes, the naso-tracheal tube is unable to advance from nasopharynx, oropharynx, into trachea without assistance. Using techniques of either Magill forceps or cuff inflation is advantageous is not determined.

Eligibility Criteria:
Inclusion Criteria:

1. patients with American Society of Anesthesiologists physical status I-III
2. aged 20-65 years
3. Requiring Nasotracheal Intubation under general anesthesia
4. unlimited mouth open
5. unlimited neck motion

Exclusion Criteria:

1. mouth open \< 3 cm
2. Ankylosing arthritis patients.
3. BMI≧35 kg/m2
Mind Body Program for Fear of Recurrence

This is a pilot feasibility study of a group-based, mind body intervention for managing stress and fear of recurrence and promoting resiliency among adult cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must have a history of breast, lung, colorectal, hematologic, prostate, melanoma, or gynecological cancer (by medical record and/or self-report)
2. Completion of primary cancer treatment (radiation, surgery, and/or chemotherapy) between 3 to 30 months ago
3. Ages 18 and older (by medical record and/or self-report)

Exclusion Criteria:

1. Self-reported inability to speak and write in English
2. Concurrent participation in weekly, group-based psychosocial or mind-body programs
3. Serious mental illness (by medical record and/or self-report) as defined by history of suicidality, psychosis, and/or psychiatric hospitalization in the past year.
4. Inability to travel to necessary study visits
5. No e-mail address to access online assessments