cyrilzakka/clinical-trials huggingface dataset:
Myocardial Injury Following Elective Direct Current Cardioversion for Atrial Arrhythmias

Researchers are trying to determine if heart injury occurs in subjects who undergo direct current cardioversion.

External transthoracic direct current (DC) cardioversion is a commonly used method of terminating cardiac arrhythmias. Conventional wisdom indicates that external DC cardioversion causes myocardial injury. Previous research has shown that DC cardioversion resulted in myocardial injury as evidenced by increased levels of cardiac troponin, even though those changes were modest. Many of these studies evaluated monophasic defibrillators and older, less sensitive cardiac troponin assays. The current standard is now to use modern biphasic defibrillators and new high sensitivity cardiac troponin assays (hs-cTnT). It is conceivable that the newer defibrillators may not cause myocardial injury. It would be important to understand if myocardial injury occurs in this setting and its approximate magnitude as it would the interpretation of hs-cTnT values in patients and therefore influenced diagnoses. It may be if a threshold energy level can be identified that is would also influence the choice of energy used to deliver the shock in this situation.

A previous preliminary study documented no evidence of myocardial injury after elective DC cardioversion with modern day defibrillators. We aim to validate and expand that study here at Mayo Clinic Rochester.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are undergoing elective direct current cardioversion, either externally or via the patient's internal cardioverter-defibrillator

Exclusion Criteria:

* Patients under age 18
* Patients with myocardial infarction, coronary artery bypass grafting or any invasive cardiac procedure in the previous six weeks
* Pregnant patients
* Patients who cannot provide informed consent because of cognitive dysfunction
Study Of CP-751,871 In Patients With Ewing's Sarcoma Family Of Tumors

Define the efficacy of CP-751,871 in patients with Ewing's sarcoma family of tumors


Eligibility Criteria:
Inclusion Criteria:

* Ewing's family of tumors
* Current disease state for which there is no curative therapy

Exclusion Criteria:

* Prior anti-IGF-1R therapy
* Concurrent treatment with other anti-cancer agents
The Impact of COVID-19 Infection on the Symptoms of Functional Dyspepsia

Although respiratory symptoms were predominant in patients infected with COVID-19, gastrointestinal symptoms were always reported in about 10% patients. Previous studies demonstrated that the SARS-CoV-2 virus still persists in stool samples for a long time after initial infection. Moreover, some patients had a longer duration of COVID-19-related gastrointestinal symptoms, which was defined as "post-acute COVID-19 syndrome".

Previous studies have shown that functional gastrointestinal disorders may occur after acute gastroenteritis. Functional dyspepsia (FD) is one of the most common functional gastrointestinal disorders. FD was reported to be correlated with multiple pathophysiological mechanisms, including GI bacterial imbalance, disordered gut microbiota, and disturbed barrier and immune function. It is unknown whether COVID-19 infection could exacerbate the symptoms of FD. Therefore, we followed up a group of FD patients before and after COVID-19 and investigate the impact of COVID-19 infection on the symptoms of FD.


Eligibility Criteria:
Inclusion Criteria:

1. aged ≥18 years old
2. Patients who met broad criteria of dyspepsia before infection

Exclusion Criteria:

1. organ failure defined by Marshall standard
2. severe psychiatric illnesses
3. suspected or identified bowel obstruction
4. known malignancy
5. pregnancy or lactation
6. unable to provide consent
MN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia

The design of the Phase 2 clinical trial includes the following elements:

* Multi-center, two-arm, randomized, double-blind, placebo-controlled trial to evaluate MN-001 (tipelukast) vs. placebo in approximately 40 patients in the U.S.
* Patients will be randomized 1:1 to receive either 500 mg/day of MN-001 (tipelukast) or placebo for 24 weeks.
* The co-primary endpoints are (1) change from baseline in liver fat content measured by controlled attenuation parameter (CAP) score at Week 24, and (2) change from baseline in fasting serum triglycerides at Week 24. FibroScan® is a non-invasive, quantitative, and accurate measure of liver fat content commonly used in early phase trials to measure treatment response.
* Secondary endpoints include safety and tolerability and changes in lipid profile (HDL-C, LDL-C, and total cholesterol).


Eligibility Criteria:
Inclusion Criteria:

* FibroScan® CAP score ≥ 248 dB/m within 8 weeks of randomization.
* Diagnosis or history of Type 2 Diabetes mellitus with hemoglobin A1c (HbA1c) \>6.5 and ≤10% at Screening.
* Fasting serum triglycerides (TG) at Screening \>150 mg/dL
* On a stable dose of oral antidiabetic therapy for a minimum of 3 months prior to Screening.

Exclusion Criteria:

* Other causes of chronic liver disease (autoimmune, primary biliary cholangitis, HBV, HCV, Wilson's, α-1-antitrypsin deficiency, hemochromatosis, biopsy-proven cirrhosis, hepatocellular carcinoma);
* Documented history of advanced liver fibrosis
* Evidence of cirrhosis, hepatic decompensation, portal hypertension including splenomegaly, ascites, encephalopathy and/or esophageal varices;
* Diagnosis or history of Diabetes mellitus type 1;
* Weight change \>5% within last 3 months of Screening visit;
* Active gastrointestinal disease or history of gastric bypass surgery which could interfere with the absorption of oral medication;
* History of clinically significant acute cardiac event within 6 months of Screening;
French Observatory Syndromes Tako-Tsubo

Tako Tsubo syndrome (TTS) is characterized by the occurrence in the context of mental or physical stress, a clinical and ECG of acute myocardial infarction without significant coronary artery stenosis, accompanied by a disorder Acute, reversible left ventricular who takes on a characteristic apical ballonnisation evoking the image of a Japanese octopus trap called Tako (octopus) tsubo (jar). Pathophysiology of unknown changes immediate life-threatening prognosis is often good in the longer term.


Eligibility Criteria:
Inclusion Criteria:

* over 18
* allowed for an array of myocardial necrosis on clinical and electro cardiographic
* having a left ventricular ballooning echo cardiography, MRI or ventriculographic with normal coronary angiogram.

Exclusion Criteria:

* Absence of left ventricular ballooning and / or presence of coronary lesions on angiography
* Refusal by the patient to participate in the observatory
A Study of Effects of Selpercatinib in Hepatically Impaired Participants and Healthy Participants

The main purpose of this study is to assess how selpercatinib gets into the blood stream and how long it takes the body to remove it when administered to participants with impaired hepatic function compared to healthy participants. Information about safety and tolerability will be collected. The study will last up to about 7 weeks, inclusive of screening period.


Eligibility Criteria:
Inclusion Criteria:

* Female participants of non-childbearing potential who are agreeable to take birth control measures until study completion
* Males who are capable of fathering a child must agree to use one of the following methods of contraception from the time of the dose administration through 6 months after dose administration:

  * Male sterilization, with documented confirmation of surgical success. Male subjects will be surgically sterile for at least 90 days prior to Check-in (Day -1). If documentation is not available, male subjects must follow one of the contraception methods below:
  * Male condom with spermicide, or
  * For a female partner of male study participant:
  * Intrauterine device (IUD) (hormonal IUD; eg, Mirena®). Copper IUDs are acceptable (eg, ParaGard®);
  * Established use of oral, implanted, transdermal, or hormonal method of contraception associated with inhibition of ovulation; or
  * Bilateral tubal ligation.
* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meter squared (kg/m²) and had a minimum weight of at least 50 kg at screening
* Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study

Exclusion Criteria:

* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Have previously participated or withdrawn from this study
* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Had blood loss of more than 500 milliliters (mL) within the previous 30 days of study screening
* Require treatment with inducers or inhibitors of cytochrome P450 (CYP) CYP3A within 14 days before the first dose of study drug through the end of treatment or early termination
Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV.

The Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living with HIV: A Prospective, Individual, Double-Blind, Randomized Controlled Study is evaluating immediate or delayed single-dose nonavalent HPV vaccination among women living with HIV who received one HPV vaccination prior to HIV diagnosis.

The HOPE II Study is an individual-level, randomized trial of immediate or delayed vaccination with a single-dose of the nonavalent HPV vaccine. The primary outcome is single-dose HPV 16/18/31/33/45/52/58 vaccine efficacy (VE). The study will provide evidence on the efficacy of single-dose HPV 16/18/31/33/45/52/58 vaccination among women living with HIV.

Participants will be randomized 1:1 into two different Groups.

* Group 1: Will receive nonavalent HPV vaccine at Day 0 and meningococcal vaccine at Month 18
* Group 2: Will receive the meningococcal vaccine at Day 0 and nonavalent HPV at Month 18

The meningococcal vaccine was chosen as the control vaccination because meningococcal vaccination has no activity against HPV infection. Further, the meningococcal vaccine has the potential to be of benefit in a meningitis outbreak context and could be beneficial for young persons in a congregate setting such as tertiary institutions.

Eligibility Criteria:
Inclusion Criteria:

1. Assigned female at birth
2. Age 16 years and above on the day of signing the informed consent form
3. Living with HIV with confirmed test results or clinic records
4. History of receiving a single dose of an HPV vaccine before HIV diagnosis
5. Self-reported sexually active in the last six months
6. Lives within the study area and willing to provide updated locator information over the course of the study
7. Does not have an autoimmune, degenerative, or genetic disease
8. Does not have known advanced HIV (as per stage IV World Health Organization clinical staging criteria for HIV)
9. No other Investigator-determined factor would limit participation in the trial
10. Has not and is not enrolled in a monoclonal, investigational vaccine, or a large quantity blood draw study
11. The participant has a cervix

Exclusion Criteria:

1. Anyone with cervical abnormality on examination
2. Anyone with an allergy to vaccine components or yeast
Myopia Progression With Freeform Myopia Control Spectacles

This is a prospective, randomized clinical trial. There will be a total of 180 participants randomized into three groups, Group 1 - 60 participants will wear the commercial peripheral plus myopia control lens (CML).

Group 2 - 60 participants will wear the Open Ring 1 (OR1) lens design. Group 3 - 60 participants will wear the Open Ring 2 (OR2) lens design. For each group, an equal balance of gender will be recruited and 50% of children will be aged between 6- 9 years old and 50% aged 10-12 years old.

All groups will be required to wear spectacles for all waking hours for 12 months. After 12 months, the control group participants wearing CML will be randomised to wear either OR1 or OR2 lens designs; the Group 2 participants will continue wearing the OR1 lens for a further 12 months. The Group 3 participants will wear OR2 or OR3 (a modified design of OR2) based on their risk of myopia progression for a further 12 months.


Eligibility Criteria:
Inclusion Criteria:

Participants enrolled in the trial must:

* be aged between 6 to 12 completed years (6 and 12 years inclusive), irrespective of gender.
* For each group, an equal balance of gender will be recruited and 50% of children will be aged between 6- 9 years old and 50% aged 10-12 years old.
* be cycloplegic autorefraction spherical component -0.50 D to -4.00D, cylinder no more than -1.50D
* be accompanied by parents/guardians who can read and comprehend Chinese and give informed consent as demonstrated by signing a record of informed consent.
* be willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
* have ocular health findings considered to be "normal".
* be correctable to at least 6/9.5 (20/30) or better in each eye with spectacles.
* be willing to wear the spectacles provided by the investigators for all waking hours.

Exclusion Criteria:

Participants enrolled in the trial must NOT have:

* a known allergy to, or a history of intolerance to tropicamide or topical anaesthetics.
* had strabismus and/or amblyopia.
* Anisometropia greater than 1.50D spherical equivalent
* had previous eye surgery (including strabismus surgery).
* any ocular, systemic or other condition or disease with possible associations with myopia or affecting refractive development e.g. Marfan syndrome, retinopathy of prematurity, diabetes.
* had any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids.
* current orthoptic treatment or vision training.
* any anatomical, skin or other condition that would impact on the wearing of spectacles.
* Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.
* Currently enrolled in another clinical trial.
* No previous myopia management intervention or treatment within 3 months of enrolment
Viral Clearance and Epidemiological Characteristics in Patients With Monkeypox

The present observational study has been designed to understand the dynamics of viral clearance amongst patients with confirmed monkeypox, by quantifying monkeypox viral load in different specimens trough time, to better inform decision-making about patient management and isolation guidelines. Also, an immune analysis will be performed in a subset of individuals to describe humoral and cellular responses to monkeypox.

Starting in early May 2022 a large number of cases of Monkeypox have been reported in non-endemic countries. Although initial cases appeared to be linked to travel, the majority of subsequent cases appear to have no travel associated risk factors and these cases have predominantly occurred amongst Men who have Sex with Men (MSM) suggesting autochthonous transmission associated with sexual networks.

Monkeypox is known to be transmitted by close contact with skin lesions of infected individuals and/or via droplets. It is known that the virus can be detected from skin lesions, in blood, in throat swabs and on occasion urine samples. There is limited information as to whether the virus can be detected or persist in other sites including semen. Serial virological monitoring has been conducted in a small number of individuals and demonstrates that prolonged shedding for at least 2-3 weeks appears to be relatively common. To help control the current outbreak health authorities have used a number of strategies including identifying and isolating cases of monkeypox combined with contact tracing and limited use of ring-vaccination strategies. Because the number of cases seen outside of endemic areas has previously been limited, there is inadequate data to guide decision-making about the duration of isolation, but this is critical to the management of the current outbreak.

The present observational study has been designed to understand the dynamics of viral clearance amongst patients with confirmed monkeypox, by quantifying monkeypox viral load in different specimens trough time, to better inform decision-making about patient management and isolation guidelines. Also, an immune analysis will be performed in a subset of individuals to describe humoral and cellular responses to monkeypox.

Eligibility Criteria:
* Inclusion Criteria

  1. Adult male or female individuals of ≥18 years old.
  2. Examined by a specialist in sexually transmitted infections (STIs) and found to have lesions suggestive of monkeypox.
  3. Symptomatic with symptoms onset date ≤10 days prior to screening/baseline visit.
  4. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the trial.
  5. Has understood the information provided and capable of giving informed consent.
* Exclusion criteria:

  1. Severe disease - defined as requires admission to hospital
  2. Inability to consent and/or comply with trial protocol
  3. An alternative confirmed diagnosis that can fully explain the illness
Cortical Plasticity Assessment in Athletes With a History of Concussion

The purpose of this research is to determine whether athletes with concussion have changes in cortical excitability.

Single and paired transcranial magnetic stimulation (TMS) can be used as reliable neurophysiological marker of motor cortex reorganization in athletes with concussions.

This study also aims to determine whether modulation of cortical activity by a powerful technique of noninvasive brain stimulation (tDCS) results in a different cortical response as compared with sham tDCS.

This study is a multicenter study with investigators from other institutions (Dr. Alvaro Pascual-Leone and Dr. Hugo Theoret).

Eligibility Criteria:
Inclusion Criteria:

* Student-athletes at risk for traumatic brain injury (collegiate football, ice hockey)
* Age between 18 and 30 yr.
* Concussion as defined by the American Academy of Neurology: trauma-induced alteration in mental status that may or may not involve loss of consciousness (confusion and amnesia are the hallmarks of concussion)
* Concussion that occurred \> 6 months
* All head injuries classified as minor with a Glasgow Coma Scale of 13 to 15 at the time of the trauma
* Participants are cleared for full sport participation based upon neurological and neuropsychological (NS) assessments Classified as symptomatic based on Post-concussion Symptom List

Exclusion Criteria:

* Previous significant neurological history
* Use of tricyclic anti-depressants such as amitriptyline, nortriptyline and imipramine within the past six months.
* Use of anticonvulsants such as carbamazepine, phenytoin, valproic acid and gabapentin within the past six months
* History of seizures, depression or PTSD
* Presence of post-concussion symptoms such as complaints of loss of concentration, dizziness, fatigue, headache, irritability, visual disturbances, and light sensitivity.
* Contraindications to single pulse TMS (TMS will be used to measure cortical excitability) such as metal head implants
* history of seizures
* unexplained loss of consciousness
* metal in the head
* frequent or severe headaches or neck pain
* implanted brain medical devices.
* Contraindications to tDCS:
* metal in the head
* implanted brain medical devices

For the control group (subjects with no concussion) we will select subjects according to the previously stated list of exclusions as well as the following criteria: Subjects who are athletes (similar to the concussed group) with the same age range and also similar level of education; however these subjects will have no prior history of concussion or neurological insult as self reported. They should also have no contraindications to TMS or tDCS.
The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B

The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.

Cohort B was a 1:1 randomized, controlled study independently powered to compare transcatheter heart valve therapy with the first generation (SAPIEN™ THV) system to transcatheter heart valve therapy with the second generation (SAPIEN XT THV) system in patients who could not undergo surgery (inoperable).

Patients in the control arm of Cohort B received an Edwards SAPIEN THV with the associated delivery system while patients in the treatment arm of Cohort B received an Edwards SAPIEN XT THV with the associated delivery system.

Eligibility Criteria:
Inclusion Criteria

1. Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
2. The probability of death or serious, irreversible morbidity is greater than or equal to 50%.
3. The heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient.
4. The study patient or the study patient's legal representative was informed of the nature of the study, agreed to its provisions and had provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
5. The study patient agreed to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which was conducted as a phone follow-up.

Exclusion Criteria

1. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
2. Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma \[especially if thick (\> 5 mm), protruding or ulcerated\] or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta. (Transfemoral)
3. Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
4. It is known that the patient is currently enrolled in the PARTNER I Trial or was withdrawn from the PARTNER I Trial prior to endpoint analysis.
5. Active bacterial endocarditis within 6 months (180 days) of procedure.