cyrilzakka/clinical-trials huggingface dataset:
Topical Pancreatic Duct Lidocaine for Prevention of Post-ERCP Pancreatitis

The purpose of this study is to determine if lidocaine is effective in reducing the incidence of post-ERCP pancreatitis.

Post endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis is a common cause of morbidity for which there is no known pharmacologic prophylaxis. Post-ERCP pancreatitis is thought to be caused by several factors, including intraductal pressure, multiple duct injections with contrast, and neural arc reflexes. Lidocaine is a safe, inexpensive class IV antiarrhythmic that has topical anesthetic effects, inhibits trypsin activity, and may potentially prevent post-ERCP pancreatitis by injection directly into the pancreatic duct at the time of ERCP. Lidocaine has been shown to inhibit phospholipase A2, a key pancreatic enzyme, interrupt local arc reflexes to stop neuronal transmission, and to dampen GI tract mucosal reflexes to prevent high ductal pressure.

The key objective of this study is to determine if injection of lidocaine is beneficial in preventing post-ERCP pancreatitis. Subjects will be randomized to study group or control group in an equal ratio. The physicians performing the ERCP will be unaware of the treatment group to which patients have been assigned. Study arm will receive contrast agent Diatrizoate 60% (5 ml) diluted with lidocaine 2% (5 ml) during ERCP. Control arm will receive contrast agent Diatrizoate 60% (5 ml) diluted with normal saline 0.9% (5 ml) during ERCP. Diatrizoate diluted with normal saline is the standard of care. Patients will be contacted 1 day and 1 week post-ERCP to assess for symptoms of pancreatitis.

Eligibility Criteria:
Inclusion Criteria:

* Patients included are \>18 years old, referred to Endoscopy Clinic for an ERCP for any well established indication such as: biliary strictures, benign and malignant hepato-pancreato-biliary tumors, chronic pancreatitis, and suspected sphincter of Oddi dysfunction

Exclusion Criteria:

* Known sensitivity to lidocaine or contrast agent
* History of seizure disorder
* History of cardiac arrhythmia (tachyarrhythmia, bradyarrhythmia, cardiac conduction defects, prolonged QT syndrome)
* History of congestive heart failure
* Active acute pancreatitis before procedure
* Planned biliary stent removal without pancreatogram
* Pregnancy
* Incarcerated individuals
* Less than 18 years of age
* Previous sphincterotomy
* Inability to give informed consent
A Study of Physical Activity paTTerns and Major Health Events in Older People With Implantable Cardiac Devices

An observational study of physical activity patterns in 150 older adults with cardiac implantable electronic devices (CIED)

Study Type: observational, investigator led Study Design: observational model: cohort (retrospective) Population: 150 people over 60 years of age with a Medtronic CareLink® compatible CIED in situ recruited from the Manchester University NHS Foundation Trust, England, UK Data collection: daily PA measures, demographic details, co-morbidity status, physical frailty assessment, functional status, quality of life (QOL) and NEHA data Consent: for participation in the study, physical frailty assessment, additional collection of retrospective CIED data, and access to electronic patient records Data sources: CIED downloads, self-report questionnaire, physical measurements (height, weight, hand grip strength, gait speed), electronic hospital records, HES (hospital episode statistics) data Results analysis: data will be analysed to investigate: daily PA variability; the association between PA and NEHAs, and the impact of frailty on PA patterns

Eligibility Criteria:
Inclusion Criteria:

1. Age 60+ years
2. Functioning CIED in situ for at least 6 months
3. Medtronic manufactured device compatible with CareLink® Cardiac Compass application (platform which measures and stores physiological parameters)
4. Lives in the Greater Manchester area
5. Able and willing to given written, informed consent to enter the study

Exclusion Criteria:

1. Faulty or incompatible device
2. Immobile (unable to walk in upright position)
3. Active participant in a clinical trial which does not allow concurrent recruitment into this study
4. People unable to consent in the English language (including the understanding of study literature which is published in English only)
Changes in Sensory Block Level During a Programmed Intermittent Epidural Bolus Regimen for Labor Analgesia: an Observational Cohort Study

Epidural analgesia is widely used for managing pain during labor. The programmed intermittent epidural bolus (PIEB) technique has been shown to produce less consumption of local anesthetics, better sensory block, less motor block, and increased maternal satisfaction than other epidural analgesia techniques. Despite all benefits from PIEB, such practice has been associated with high sensory block levels. Therefore, assessment of the sensory block level is an essential component of clinical safety. The lack of a standardized technique and timing to assess the sensory block level can lead to inappropriate management. The purpose of this study is to investigate the changes in block level over time, during cycles of a PIEB regimen. The investigators hypothesize that these levels will be highest soon after the PIEB bolus and lowest preceding the subsequent PIEB bolus. The investigators also want to investigate a possible correlation between these changes in sensory block levels and motor block, pain scores, and rescue bolus of local anesthetics.


Eligibility Criteria:
Inclusion Criteria:

* women admitted to the Labor and Delivery unit at Mount Sinai Hospital that request and have no contraindications to receive epidural analgesia
* 18 years old or more
* capable of understanding and signing the written informed consent
* have no language barrier to respond to the level of sensory block assessment
* and have no conditions that could compromise the body sensitivity to cold.

Exclusion Criteria:

* unintentional dural puncture during labour epidural placement
* do not achieve adequate pain control 20 minutes after the loading dose (numeric rating scale (NRS)\>1 on a 0-10 NRS),
* deliver before 160 minutes following the loading dose
* require rescue boluses in the first 80 minutes after initiation of PIEB (that is, before the 2nd PIEB bolus)
* withdraw their consent.
Alzer® and Diamel® to Prevent Severe Diabetes Macular Edema

Macular edema is the main cause of low vision in diabetics. They continue looking for new treatment alternatives. The nutritional supplement Alzer, is a powerful antioxidant that together with Diamel, a supplement that has shown efficacy in metabolic control, could be a therapeutic option. Objective: To evaluate the therapeutic efficacy of the Alzer Diamel combination in mild and moderate macular edema. Material and method: A randomized double-blind phase II clinical trial versus placebo will be conducted in 64 patients, who will be randomly assigned to two groups, one will receive Alzer + Diamel and another will receive placebo from Alzer and Diamel. All patients will undergo clinical, biochemical and ophthalmological evaluation during the study.


Eligibility Criteria:
Inclusion Criteria:

* Diabetics type 2 insulin treated.
* Age between 18 and 65 years.
* Glycosylated hemoglobin (HB A1c) \<8% at the beginning of the investigation.
* Patients who express written voluntariness to enter the study with their signature of the informed consent document.
* If woman of childbearing age, negative pregnancy test and use of barrier contraceptives.

Exclusion Criteria:

* Pregnancy and lactation.
* Age over 65 years.
* Macular edema with vitreous-retinal traction or other cause (renal, arterial hypertension, post-surgical).
* Opacity of the refractive media that hinders the ophthalmological examination.
* History of hypersensitivity to another similar product or one of its components.
* Patients at potential risk of not compliance the study (those who will travel during the period of the investigation or distance in their residence, outside the city).
* Subjects who are participating in another clinical trial Patients with cognitive disorders or a mental disorder that hinders their follow-up.
Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid Arthritis

The safety and immunogenicity of the TNF-Kinoid (TNF-K) have been evaluated in a phase II clinical study conducted in subjects with Rheumatoid arthritis. Preliminary results of clinical efficacy are promising.

The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in subjects with Rheumatoid arthritis in whom treatment with methotrexate is not working anymore. Subjects who have never been treated with anti-TNFα monoclonal antibodies will be enrolled in this trial. In addition, the immune responses and the safety elicited by TNF-K will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Has had a diagnosis of RA according to the revised ACR criteria (Aletaha et al. 2010) for at least 6 months.
* Has been treated with and tolerated MTX for at least 3 months prior to the first administration of study product, - Has at least four swollen joints/66 and/or four tender joints/68,
* Has CRP ≥ 10 mg/L at screening.
* Is positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptides (CCP) antibodies at screening.

Exclusion Criteria:

* Has inflammatory rheumatic disease other than RA
* Has been treated with non-biological DMARDs/systemic immunosuppressives
* Has been treated with leflunomide within 12 weeks prior to first administration of study product.
* Has received intra-articular, intramuscular (IM), or intravenous (IV) corticosteroids
* Has received infliximab, etanercept, adalimumab, certolizumab, golimumab; another TNFα antagonist; or rituximab prior to the study.
* Has been treated with any other biological DMARDs
A Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat Under Fed and Fasted Conditions

The purpose of this study is to evaluate the single-dose pharmacokinetics and bioequivalence of darunavir 800 mg when administered as a fixed dose combination relative to 2 x 400 mg tablets of the commercial tablet formulation, in the presence of 150 mg cobicistat, (under fed and fasted conditions) in healthy participants.

This is a randomized (the study drug is assigned by chance), open-label (all people know the identity of the intervention), 3-panel, single-center, single-dose, crossover (method used to switch patients from one treatment arm to another in a clinical trial) study in 134 healthy adult participants. The study consists of 3 phases including a screening phase of approximately 3 weeks (Days -21 to -1) followed by an open-label treatment phase consisting of 3 panels with 2 single-dose treatment sessions of 5 days each (Days -1 to 4) separated by a washout period of at least 7 days, and a follow-up period occurring 7 to 10 days after last intake of study drugs. The study consists of 3 panels. In each panel participants will be randomly be assigned to 1 of 2 treatment sequences (AB or BA for Panel 1; CD or DC for Panel 2; and EF or FE for Panel 3). Participants will receive either single-dose darunavir 800 mg as 2 x 400 mg tablets and cobicistat 150 mg tablet or single-dose darunavir/cobicistat 800/150 mg as tablet in each panel (under fed and fasted conditions).

Eligibility Criteria:
Inclusion Criteria:

* Participant should be healthy on the basis of physical examination, medical history, vital signs, and electrocardiogram and clinical laboratory tests performed at screening
* Have a Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.5 to 30.0 kg/m2, extremes included
* Men and women must agree to use a highly effective method of birth control

Exclusion Criteria:

* Has a positive HIV-1 or HIV-2 test at screening
* Has a Hepatitis A, B or C infection (confirmed by hepatitis A antibody immunoglobulin M (IgM), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody, respectively) at screening
* Has any history of renal insufficiency
* Has a history of significant skin reactions or any history of allergies to drugs
Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)

This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will be eligible to enroll in CN012-0028.

The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with psychosis associated with Alzheimer's Disease.


Eligibility Criteria:
Key Inclusion Criteria:

* Must have completed study CN012-0026, CN012-0027 or CN012-0056.
* Subject was aged 55 to 90 years, inclusive, at the time of enrollment into the parent CN012-0026, CN012-0027 or CN012-0056 study.
* Can understand the nature of the study and protocol requirements and provide a signed informed consent or, if deemed not competent to provide informed consent, the subject's legally acceptable representative must provide informed consent, and the subject must provide informed assent before any study assessments are performed.
* At entry into this study, or any time during the study, if a subject needs to relocate from home or residential assisted-living facility to a nursing home facility, the Sponsor/Medical Monitor must approve the subject's participation in the study.
* Have an identified or proxy caregiver (spends approximately 10 hours/week with the subject).

Key Exclusion Criteria:

* Significant or severe medical conditions that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results.
* Clinically significant abnormalities, including any finding(s) from the ECG, laboratory tests, physical examination, or vital signs, at the EOT visit of Study CN012-0026, CN012-0027 or CN012-0056 that the Investigator, in consultation with the Medical Monitor, are considered to jeopardize the safety of the subject.
* Subjects participating in another investigational drug or device study or planning on participating in another clinical study during the duration of CN012-0028.
HP Improves Sleep and Overall Survival Rate in Maintenance Hemodialysis Patients

Sleep disturbance has been long-standing torments in most of patients with maintenance hemodialysis (HD). In this study, we attempted to explore whether long-term hemoperfusion (HP) could improve sleep disorder and increase overall survival rate in HD patients.


Eligibility Criteria:
Inclusion Criteria:

1. duration of maintenance HD should be equal or more than 3 months,
2. patient's age should be equal or more than 18 years

   Exclusion Criteria:

   - i) he/she diagnosed with malignant tumors, an active rheumatism, infectious diseases, or a severe heart failure ii) he/she would disagree with the study
3. he/she has received a short-term poor prognosis
4. he/she would be more than 80 years old
Safety and Efficacy of the HA-based Dermal Fillers HYAPROF® SOFT and HYAPROF® BALANCE

Purpose of this study is the demonstration of safety and efficacy of the dermal fillers HYAPROF® SOFT and HYAPROF® BALANCE for restoration of the facial volume and contour.

This is a prospective, multicenter, observational, open label, two-arm, crossover, PMCF clinical trial for demonstration of the safety and efficacy of the HA-based dermal fillers HYAPROF® SOFT and HYAPROF® BALANCE for restoration of the facial volume and contour. Besides safety aspects, evaluated immediately after the treatment, 4 weeks, 3 and 6 months after the treatment, the performance of the demal fillers are evaluated in the 3 and 6 months follow-up by using GAIS and WSRS.

Eligibility Criteria:
Inclusion Criteria:

* subjects intended for the treatment with HYAPROF® SOFT and/or BALANCE according to the instructions for use of the product
* decision for the treatment with HYAPROF® SOFT and/or BALANCE was made before the subject was recruited for the clinical trial
* subjects signed written informed consent
* adult subjects at least 18 years old
* all Fitzpatrick skin types
* area treated either with HYAPROF® SOFT or HYAPROF® BALANCE - no combination of the products in one treated area

Exclusion Criteria:

* tendency to hypertrophic and keloid scarring
* intolerance to gram-positive bacteria
* prone to active inflammatory or infectious processes
* suffering from acute or chronic skin diseases
* undergoing anti-coagulant therapy
* known allergy to hyaluronic acid
* suffering from autoimmune diseases
* multiple allergies
* pregnancy or lactating women
* subjects unlikely to cooperate in the clinical investigation or to comply with the treatment or with the clinical investigation visits
Multicenter and Prospective Clinical Registry Study of Autoimmune Encephalitis in China

In recent years, more and more previously thought to be unknown encephalitis was found to be a specific antigen associated encephalitis，but because of the lack of recognition in the clinic, usually been misdiagnosed as other causes of encephalitis. Therefore, it is urgent to establish a database of autoimmune encephalitis in Chinese population. The prospective clinical trial of atutoimmune encephalitis in China, by screening the autoimmune encephalitis associated antibody and summarizing the cases analysis, in order to provide evidence for clinical diagnosis and treatment of autoimmune encephalitis.


Eligibility Criteria:
Inclusion Criteria:

1. Older than 6 months.
2. Encephalopathy symptoms (change of mental state and consciousness level) persist for more than 24 hours;
3. At least one or more clinical features of the followings: fever, epilepsy, focal neurological deficiency symptoms, changes in CSF(cerebrospinal fluid inflammatory), changes in EEG (electroencephalogram), radiographic abnormalities;
4. Clinical suspected encephalitis, but conventional detected methods cannot make etiology clear.
5. Signed the informed consent.

Exclusion Criteria:

1. Infants less than 6 months;
2. The metabolic encephalopathy;
3. Infectious encephalitis with clear pathogen clinically, referring the specific pathogenic microorganisms, including: bacteria, virus, fungus, parasite, spirochete and so on;
4. Non-infectious encephalitis with clear diagnosis clinically, including: multiple sclerosis, neuromyelitis optic, acute disseminated encephalomyelitis and so on.
Burnout Reduction and Engagement App-based Trial of Headspace (BREATHE)

The purpose of this research is to develop a mobile app-based intervention to reduce burnout and improve well-being using human-centered design principles and stakeholder feedback.

Recent studies of professional burnout among physicians have highlighted urology as a worrisome outlier: 39% of practicing urologists and 64% of urology residents reported high levels of depersonalization and emotional exhaustion. Despite the known association of burnout with adverse clinical outcomes, psychological distress, and career dissatisfaction, rigorous studies of physician-focused interventions remain limited.

Pilot studies of well-being mobile applications (e.g. headspace ®) have demonstrated better outcomes compared to traditionally delivered mindfulness interventions (e.g. in-person guided meditation). Nevertheless, a rigorous assessment of the impact of an app-based intervention on burnout is needed.

Therefore, the present study will assess the effectivity of a mobile app-based intervention to reduce burnout among healthcare professionals.

Eligibility Criteria:
Inclusion Criteria:

* Being a health-professional at the Urology Department of Mayo Clinic, RST
* Sign the informed consent and agreed to share data from the app to the research team.

Exclusion Criteria:

* Using an alternate app designed with the same purpose at the beginning, part and/or entire duration of the study.
* Not provide any data despite being included in the study
Rehabilitation for Improved Cognition

Many patients with exhaustion disorders continue to have significant difficulties with attention and memory function which reduce their work ability. This randomized study investigates whether the addition of a 12-week period of specific cognitive training or physical fitness training could further enhance cognitive function in patients with exhaustion disorder participating in a multimodal rehabilitation program.

This study was performed at The Stress Rehabilitation Clinic at the University hospital of Umeå. In total 161 patients with diagnosed exhaustion disorder were recruited consecutively to the study from March 2010 until June 2013. Participants were all in age span 18-60 years old, had an ongoing employment and were assessed as suitable for a 24-week multimodal rehabilitation, which consisted of cognitive behavioural therapy in group (maximum eight persons), prescription of physical activity/exercise (FaR©) and vocational measures with rehabilitation meetings. A randomization by group was performed after 12 weeks of multimodal rehabilitation to one of three conditions; A/ continued multimodal rehabilitation, B/ addition of a computer-based cognitive training, and C/ addition of physical fitness training. The added training was performed during the last 12 weeks of rehabilitation (week 12 to 24) and with three weekly training occasions. Primary endpoint was change in cognitive functioning, estimated as a global brain score. Secondary endpoints were changes in different specific neuropsychological tasks, estimated psychological wellbeing, physical capacity, work ability, health-related quality of life and cost-effectiveness. A long-term follow-up was performed one year after termination of the interventions (at week 76).

Eligibility Criteria:
Inclusion Criteria:

* Confirmed exhaustion disorder according to criteria established by the Swedish National Board of Health and Welfare
* 18 - 60 years of age
* Current employment
* Considered suitable for multimodal rehabilitation in group

Exclusion Criteria:

* Need of other treatment or rehabilitation
* Abuse of alcohol or drugs
* Participation in another intervention study
Effects of Brain Breaks on Educational Achievement in School Settings: The Break4Brain Project

A total of 600 children between 10 and 12 years of age will be randomized among two experimental conditions: physical activity interacting with a video (n = 300), and sedentary activity (n = 300). The experimental condition will take place in the school settings during the school day through a between-subject design with a total of two measurements, pre, and post-test. Using the latest advances, the transient effects of the experimental conditions on cognitive and academic performance will be measured. The experimental condition was crafted through a qualitative design involving semi-structured interviews with teachers (n = 41) and members of the management team (n = 16), along with questionnaires administered to students (n = 600). To enhance and ensure its sustainability, the same process will be replicated after the intervention. Interviews and questionnaires were meticulously crafted by the RE-AIM framework, and subsequently validated through a rigorous process involving an expert panel (n = 30) utilizing the Delphi methodology. This project has the potential to substantially contribute to the field of acute physical activity and could have a meaningful transference on the educational system. This method might be prescribed as an effective teaching strategy.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 10-12 years.

Exclusion Criteria:

* Children who have serious physical or mental disorders (autism spectrum disorder, intellectual disability, and cerebral palsy) that would impede participation in the experimental conditions.