cyrilzakka/clinical-trials huggingface dataset:
Angled-tip vs. Straight-tip Guidewire in Biliary Cannulation

The investigators aim is to compare outcomes between an angled-tip guidewire and a straight-tip guidewire in cannulation of the common bile duct during ERCP. This is a randomized, controlled, single-blinded study. The primary outcome is success of cannulation and secondary outcomes are incidence of post-ERCP pancreatitis, procedure duration, and rate of complication between the angled wire and straight wire.

Wire-guided cannulation of the common bile duct is a standard technique utilized during Endoscopic Retrograde Cholangio-Pancreatography (ERCP) to ensure safe and effective access to the common bile duct via the ampulla of Vater. Due to the anatomy of the ampulla, and the orientation of the biliary orifice, a guidewire with an angled tip may allow easier and safer access to the common bile duct without inadvertent manipulation of the pancreatic duct. The investigators aim to assess the technical and clinical outcomes between an angled-tip guidewire (GW) compared to a straight-tip guidewire in wire-guided cannulation of the common bile duct. The investigators hypothesize that an angled-tip GW is associated with increased rate of successful cannulation, decreased procedure time and decreased rate of post-ERCP pancreatitis in wire-guided biliary cannulation during ERCP.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing ERCP for cholangiography, bile or tissue sampling from the gallbladder or bile duct
* patients undergoing ERCP for treatment of biliary diseases (removal of common bile duct stones, biliary stent placement)

Exclusion Criteria:

* Patients who are less than 18 years old
* Pregnant patients
* Patients who have undergone previous bile duct cannulation or sphincterotomy
* Patients who have undergone prior endoscopic balloon dilation or needle-knife fistulotomy
* Patients who have undergone gastric surgery (Billroth gastrectomy II, Roux-en-Y gastric bypass)
* Patients with acute pancreatitis
* Patients who refuse endoscopic intervention
* Patients with ampullary tumor, duodenal stenosis, or pre-operatively proven pancreaticobiliary malunion
The Safety&Efficacy of Repetitive Transcranial Magnetic Stimulation for Post-Stroke Upper Extremity Function Improvement

A randomized, controlled, subject and rater-blind, exploratory clinical trial to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation for improvement of upper extremity function after stroke.

Some studies related to rTMS for the recovery of motor function (upper and lower extremity functions) after stroke are being conducted, and the clear mechanism has not been elucidated. It is known that function is restored through various neurophysiological changes.

However, there are not many studies on rTMS in the chronic stroke period, 3 months after the onset of stroke recovery, which is slow, and among them, there is no established standard for which part of the brain should be stimulated for treatment.

Recently, techniques for finding brain regions that are activated when performing a specific action through an imaging technique called fMRI (Functional Magnetic Resonance Imaging) are being used in various fields.

Based on the idea in this regard, recent studies have been conducted that the effect of rTMS treatment is better than the existing method when fMRI is used to identify the brain regions involved in the movement of the upper and lower extremities.

The purpose of this study is to evaluate the safety and efficacy on upper extremity function after stroke using fMRI and rTMS.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 20 years of age
* Patients 3 months or more after stroke onset
* Patients with NIHSS score of 1 or more to 20 or less
* After hearing and fully understanding the detailed explanation of this clinical trial, the subject or legal representative voluntarily decides to participate and agrees in writing to abide by the precautions

Exclusion Criteria: Patients who fall under one or more of the following conditions are not eligible to participate in the study.

* Patients with systemic infectious disease at the time of participation in the clinical trial
* In the case of a person with impaired consent (MMSE less than 10 points), if not accompanied by a guardian
* Those with severe medical conditions such as unstable conditions of the cardiovascular system, digestive system, respiratory system, endocrine system, etc., who are in poor general condition
* Other cases where the researcher determines that participation in this clinical trial is not appropriate
* Those who are contraindicated in repetitive transcranial magnetic stimulation A. When metal materials (deep brain stimulation electrode, brain aneurysm clip, cardiac pacemaker, etc.) are in the body B. Uncontrolled epilepsy (epilepsy), patients with psychiatric disorders
* Pregnant, lactating women and patients with potential for pregnancy
* Patients with contraindications for imaging tests
* Those who have undergone cerebral surgery due to past or current related medical history
Efficacy and Safety Study of Transdermal Therapeutic System (TTS) Fentanyl in Participants With Osteoarthritis Knee Pain

The purpose of this study is to evaluate the efficacy and safety of Transdermal therapeutic system (TTS) fentanyl patches (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) in knee osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stiff) participants with moderate to severe pain.

This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), single-arm, prospective study (study following participants forward in time) of TTS-fentanyl matrix form in knee osteoarthritis participants. The study consists of 3 phases: a screening phase, an open label treatment phase consisting of 2 periods, and an evaluation phase. The first patch will be applied on the first day of treatment phase by the investigator, and sufficient patches until Day 30 will be provided to the participant with the instructions to apply the patch. The TTS-fentanyl dose will normally be increased, if needed by 12.5 microgram per hour taking into account the daily dose of supplemental paracetamol required by the participant. Efficacy with regard to pain control will be recorded principally by the participant via questionnaires in a daily diary. This record will be used to support more detailed assessments at study visits on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. Participants' safety will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Chronic (lasting a long time) primary osteoarthritis knee pain, one or two side with stage II Kellgen-Lawrence, for more than 3 months with Visual Analogue Scale (VAS) more than 4
* Good knee deformity, no limit range of motion
* Participant who has signed the informed consent form

Exclusion Criteria:

* Skin disease that prevents the use of the transdermal system or which could affect the absorption of fentanyl or local tolerability
* History or suspicion of alcohol or drug abuse within the past 5 years
* History of cardiac, nervous system or respiratory disease which in the investigator's judgment prevents participation in the study because of the potential for respiratory depression
* Confusion, reduced level of consciousness, or concomitant psychiatric disorder which, in the opinion of the investigator, could prevent participation in the trial
* Participants who do not understand or speak Thai
Advanced Ultrasound Methods in the Assessment of Carotid Plaque Instability

The primary aim of this project is to assess if advanced ultrasound methods such as SMI (Superb microvascular Imaging) and SWE (Shear Wave Elastography) can identify intraplaque neovascularization and plaque tissue stiffness in carotid artery plaques and relate these results to ipsilateral cerebrovascular symptoms.

The secondary aim of this project is to assess the level of agreement between the structural plaque characteristics assessed by advanced ultrasound examinations such as SMI, SWE, CEUS (Contrast enhanced ultrasound), GSM (Plaque gray-scale-median) and carotid MRI, metabolic activity of plaque assessed by 18F-FDG PET/CT with histology as the gold standard. Findings from the methods mentioned above will be related to cerebrovascular symptoms, blood tests (cholesterol-tot, LDL, HDL, CRP, leukocytes, glucose, HbA1c) and other cardiovascular risk factors at inclusion and upon 1 year follow up.

The project will include 3 studies:

Study 1:

Analyse the correlation between SMI assessed neovascularization and degree of stenosis in symptomatic patients with high-grade (\>50%) carotid stenosis versus asymptomatic patients with high-grade (\>50%) carotid stenosis.

All patients upon inclusion will undergo:

* Clinical, neurological evaluation
* Blood tests
* SMI, CEUS and SWE ultrasound
* Carotid MRI
* PET (subgroup)
* DW-MRI
* Histological assessments after the removal of plaque at carotid endarterectomy (CEA).

Study 2:

SMI and vascular events. Asymptomatic patient's follow-up at 12 months:

* Clinical neurological evaluation
* Blood test
* SMI, CEUS, SWE ultrasound
* Carotid MRI
* PET (subgroup)

Study 3:

This study will use the same patient pool described in study 1 undergoing the previously described procedural examinations upon inclusion and at one year follow up. Quantification of stiffness/elasticity in the artery wall will be performed and compared to plaque echogenicity measured as GSM . These results will be correlated to histology of the carotid plaque after trombendarterectomy, risk markers in blood (lipids, HbA1c, CRP, leukocytes), other cardiovascular risk markers (hypertension, diabetes, nicotine) and cerebrovascular symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Atherosclerotic carotid stenosis \>50% with or without cerebrovascular symptoms.

Exclusion Criteria:

* Malignancies
* Inflammatory disease
Neural Interfaces to Monitor Fatigue and Sleepiness in the Cathlab

Improvement of patients' care and outcome is largely based on development and validation of drugs and technologies, especially in rapidly evolving fields as Interventional Cardiology. In fact, even though the optimal efficiency of a cathlab can be influenced by Interventional Cardiologist's mental workload, stress' accumulation and performance, little if any attention is paid to the monitoring and optimization of his/her mental status. Electroencephalogram (EEG)-based neural-interfaces are able to estimate workload, fatigue and the degree of sleepiness through spectral analysis techniques. In particular, the amplitude of alpha waves is a widely validated indicator of mental engagement's level.

Developing a low cost and highly feasible device to monitor and analyze operator's mental engagement level and performance could be extremely appealing, especially considering both the lack of data in literature for interventional disciplines and the recent technology developments.

The investigators will prospectively record and analyze Electroencephalogram (EEG) signals from 5 interventional cardiologists and 2 fellows in training in all consecutive procedures at Ferrara University Hospital. Considering the hypothesis of independence of the working shifts, given the heterogeneity of their structure in terms of procedures' number and type and their distance in time, it is then possible to assume that the same operator's psycho-physical state diverges between two different acquisition days. Muse S (InteraXon; Canada), a minimally invasive device paired via Bluetooth to a dedicated app, is used to record EEG signals. Neurometrics will be acquired during Alpha Attenuation Protocols (AAP), a sensitive test to quantify sleepiness which involves measuring alpha power during 2 cycle of eye opening/closing protocol, for a total amount of 4 minutes. AAP will be recorded at the beginning of the shift, before and after each procedure performed and allow to extrapolate waves' power measures obtained during resting condition (AA Coefficient-eyes open (AAC-eo), AAC-eyes closed (AAC-ec) and AAC-mean), related to fatigue, and AAC-ec/AAC-eo (AAC-ratio), related to sleepiness. In addition, alpha-prevalence (AP) during on-task will be measured. Alpha prevalence is an estimate of alpha-power. Investigators will also measure several validated psychometric questionnaires: Karolinska Sleepiness Scale (KSS), Sleep Quality Scale (SQS) and Profile of Mood States-Fatigue subscale (POMS-F). Heart rate variability (HRV) during tasks, related to psycho-physical stress, is assessed through the square root of the mean of the sum of squares of differences between adjacent normal R-R (rMSSD).

The Game-on project aims to describe workload, mental fatigue and sleepiness through variation of psychometric and neurometric measurements during a work shift with the intent of establishing determinants of error and lengthening of procedural times.

Eligibility Criteria:
Inclusion Criteria:

* indication to coronary artery angiography and/or percutaneous coronary intervention

Exclusion Criteria:

* none
SMOFLipid in Patients Who Are Intralipid Intolerant

Soybean oil based IV fat emulsion (IVFE) has been one of the sole sources of IVFE in the US. Soybean oil based IVFE has higher ratio of omega-6 to omega-3 fatty acids and can be associated with a number of complications including inflammation, abnormal liver function tests (reflecting steatosis, cholestasis, etc.), and metabolic abnormalities. Recently the FDA has approved SMOFlipid which contains a mixture of soybean oil, medium chain triglycerides, olive oil, and fish oil. It provides a more positive ratio of omega-3 to omega-6 fatty acids and has been shown in short term trials to be beneficial in cases of intolerance to soybean oil IVFE. This study is designed to investigate the impact of SMOFlipid in prolonged use.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* current Mayo Clinic HPN patient, able to provide informed consent, anticipated duration of HPN greater than 3 months
* infusion company is able to provide SMOFlipid
* no history of alcohol addiction
* noted to be intolerant to SO based IVFE as defined below.

Exclusion Criteria:

* Pregnant women
* failure to provide consent
* patients who are deemed to be on HPN for less than three months
* patients who have previous proven addiction and dependence to alcohol/ heavy alcohol consumption reported (during history or reported in the EMR), known hypersensitivity to fish, egg, or soy, patients who will not be managed by the Mayo Clinic HPN team and patients who have active infection (as determined by the clinician) at the time of enrollment.
Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project

The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for one year after birth. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects which are visible at birth, as well as more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.

The purpose of the Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project is to follow pregnant women or women who have delivered a baby, who have been treated with Stelara or Tremfya within 3 months of their last menstrual period (LMP) or during pregnancy to evaluate the possible effect of this medication on the pregnancy outcome including child development and growth up to one year of age.

Eligibility Criteria:
Inclusion Criteria:

* Documentation of an exposure to Stelara (ustekinumab) or Tremfya (guselkumab) during pregnancy or within 3 months prior to the first day of the last menstrual period (LMP) for any number of days, at any time, at any dose, and at any time until completion of pregnancy.
* Documentation of gestational timing of the exposure to Stelara (ustekinumab) or Tremfya (guselkumab)

Exclusion Criteria:

* Women who have not have an exposure to Stelara (ustekinumab) or Tremfya (guselkumab) during pregnancy or within 3 months of the first day of the last menstrual period.
Cervical Length on Pregnancy Termination

Cervical length is used as a parameter to predict cervical insufficiency and onset of labor. However, its role in predicting abortion induction is unclear.To investigate the impact of cervical length measurement and fetal viability on second trimester pregnancy termination duration in nulliparous pregnant women.

Cervical length and fetal viability were evaluated prior to second trimester pregnancy termination due to various indications. nulliparous pregnant women through 13 and 26 gestational weeks in whom pregnancy termination was conducted within 72 hours after admission were included in the study. The subjects were grouped into two groups according to fetal viability.

Eligibility Criteria:
Inclusion Criteria:

-Nulliparous pregnant women at 13-26 weeks of gestation

Exclusion Criteria:

* Patients with multiple gestations,
* multiparous patients or
* patients that had uterine gynecologic surgery
Comparison of Heart Rate Variability Among Tracheal Intubation Methods

60 patients, in three group of 20 patients each, scheduled for surgery needing general anesthesia will be researched. Group A: tracheal intubation of single lumen tube using laryngoscope. Group B: single lumen tube using lightwand. Group C: double lumen endobronchial cath. During general anesthesia, the spectral power of heart rate variability at three periods: (1) preoperation baseline (2) pre-intubation and (3) post-intubation will be calculated and compared to investigate the autonomic stimulation effect of different tracheal intubation methods.

Tracheal intubation is a common practice during general anesthesia. Laryngoscope and lightwand are two commonly used methods of tracheal intubation. The autonomic stimulation of tracheal intubation may have adverse effect to the patients and have been investigated since many years ago. Conventional methods for assessing autonomic activity include measurement of blood catecholamine levels or measuring changes of the hemodynamic variables such as heart rate and blood pressure. The former is invasive and noncontinuous, and the latter is nonspecific and not accurate. Heart rate variability, a parameter derived from the spectral power of RR interval sequence in the ECG, is a non-invasive but direct measurement of autonomic activity. It is ideal and we will use this in the current research for comparing the autonomic activation during tracheal intubation of the two different methods.

Totally 60 ASA class I-II patients aged 18-65 years will be recruited. 40 of these are scheduled for various kind of surgery needing general anesthesia with tracheal intubation of single lumen tube. These 40 patients will be randomly assigned into group A and B, each with 20 patients. In group A the tracheal intubation will be performed by laryngoscope, and in group B the intubation performed by lightwand. The other 20 patients of the study, the group C, are scheduled for operations needing intubation of double lumen endobronchial cath. The intubation will be performed by laryngoscope.

ECG wil be recorded from at least 5 minutes before induction of general anesthesia and continue to at least 10 minutes after tracheal intubation. The induction and maintenance of anesthesia will performed as routine practice. The ECG records wil be analyzed offline. Power spectrum wil be generated by time-frequency analysis and the heart rate variability parameters at three periods (1)preoperation baseline (2) pre-intubation and (3) immediately post-intubation will be calculated and compared among the three groups.

Eligibility Criteria:
Inclusion Criteria:

* ASA class I-II, age 18-65, scheduled for surgery needing general anesthesia with tracheal intubation

Exclusion Criteria:

* history of major systemic diseases such as cardiovascular, pulmonary, renal and other diseases which affect autonomic activity.
Safety of Single Rising Doses and Relative Bioavailability of BI 691751

To investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of single rising doses of BI 691751 in healthy male subjects (part I).

To investigate the relative bioavailability of BI 691751 given as tablet versus oral solution (part II)


Eligibility Criteria:
Inclusion criteria:

1. Healthy male subjects
2. Subjects must be able to understand and comply with study requirements
3. Age from 18 to 55 years
4. BMI range: from 18.5 to 29.9 kg/m2
5. Known genotype as specified in the study protocol

Exclusion criteria:

1. Any relevant deviation from healthy conditions
a Cohort Study of Ischemic Cerebrovascular Disease

This study aims to establish a multicenter, large-scale, prospective cohort of patients with ischemic stroke. Various biological samples such as blood, feces, and urine are collected to identify biomarkers associated with ischemic stroke. By integrating demographic information, clinical indicators, imaging parameters, and biomarker parameters, the study aims to develop risk assessment, early warning, and prognosis prediction models. Additionally, the study aims to identify key genes and explore relevant signaling pathways related to ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of ischemic stroke.
2. Age ≥ 18 years.
3. Signed informed consent form.

Exclusion Criteria:

1. Patients with moderate to severe mental disorders or dementia who cannot cooperate to complete the informed consent and follow-up procedures.
2. Patients with neurological functional impairment caused by conditions such as migraine aura, epilepsy, or other non-ischemic strokes.
3. Agitated patients who cannot cooperate with imaging examinations.
4. Pregnant or lactating patients, as well as those planning to become pregnant within 90 days.
5. Patients with concurrent malignant tumors or severe systemic diseases with an expected survival period of less than 90 days.
6. Patients who have participated in other clinical studies within 30 days prior to enrollment or are currently participating in other interventional clinical studies.
The Effect of the Use of Washing Solutions at Different Temperatures Used in Intra-arterial Cannulation

Nowadays, intraarterial catheterization is frequently used as an invasive method for intraoperative blood pressure monitoring and control.The radial artery is frequently used in this procedure and the cannula should be flushed with 2-3 ml of heparinized fluid intermittently to prevent occlusion. During the operation, the ambient temperature is approximately 22-24 C and the patient temperature can be 34-36 C. Since the flushing fluids are also in the environment, they are 22-24 C. The aim of this study is to determine whether the fluids at room temperature cause vasoconstriction in the vessel and cause a change in blood pressure arterial values.

The aim of this study is to determine whether room temperature fluids cause vasoconstriction or vasodilatation in the vessel and cause a change in blood pressure arterial values.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III risk class,
* Medically undergoing intra-arterial cannulation
* Being between the ages of 18-70

Exclusion Criteria:

* Diagnosis of DM
* Vascular disease,
* Bleeding diathesis,
* inotropic drug use