cyrilzakka/clinical-trials huggingface dataset:
Effect of Evolocumab on Carotid Plaque Composition in Asymptomatic Carotid Artery Stenosis (EVOCAR-1)

This is a phase IV, randomised, placebo-controlled, double-blind, parallel group study to determine the effect of Evolocumab treatment on carotid plaque morphology and composition in asymptomatic patients with \>50% carotid artery stenosis.

In this study patients will be randomised in a 1:1 ratio to receive Evolocumab 140 mg every two weeks or matching placebo, to be administered for 12 months. After 12 months of treatment, patients will remain in follow-up for a further 12 months.

High resolution magnetic resonance imaging (MRI) will be used to serially monitor the impact of Evolocumab on carotid plaque morphology and composition in patients with significant carotid stenosis who do not meet clinical criteria for carotid endarterectomy. This approach will reveal if clinically beneficial plaque regression occurs, without requiring the large patient cohorts or long follow-up needed for cardiovascular outcome trials.

Results from this study will establish whether treatment with Evolocumab is likely to be beneficial to patients with asymptomatic carotid stenosis.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Sufficient English language ability to adequately understand the study
* Able to give informed consent
* Significant carotid artery plaque with 50-70% stenosis on ultrasound or MRI performed prior to screening
* Significant asymptomatic carotid artery plaque with \>70% stenosis on ultrasound or MRI performed prior to screening, but carotid endarterectomy or carotid artery stenting has been deemed unsuitable by multidisciplinary team during routine clinical care
* Lipid-rich necrotic core (LRNC) on baseline MRI scan
* Adequate image quality for MRI analysis.
* LDL-C ≥2.6 mmol/L (100 mg/dL)
* On stable dose of maximally-tolerated lipid-lowering therapy in accordance with UK national clinical guidelines (NICE CG18120) for ≥2 months prior to screening. Acceptable non-statin lipid-lowering medications include ezetimibe or a fibrate.

Exclusion Criteria:

* Any medical condition which, in the opinion of the investigators, would present an unacceptable risk to the participant if they were to take part in the trial, or prevent them from following the trial protocol
* Current or previous treatment with a PCSK9 inhibitor
* Eligible for PCSK9 inhibitor treatment under current NICE guidelines
* Contra-indication to or inability to use Evolocumab treatment, including:

  * Sensitivity to Evolocumab or any associated excipients
  * Unable to tolerate or perform self-administration of Evolocumab by auto-injector
  * Lack of suitable refrigerated storage
* Contra-indication to or inability to tolerate MRI
* Estimated glomerular filtration rate (eGFR) ≤45 mL/min/1.73 m2 prior to MRI scan
* Pregnancy or breast-feeding
* Women of childbearing potential who are unwilling or unable to use a highly effective method of contraception
Wearable Devices for Patient Monitoring in Long QT Syndrome

The main research question of this study is whether wearable devices have utility in monitoring patients with Long QT syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Long QT Syndrome
* Aged 18 years or over
* Phone with iOS version 15 or Android OS 9.0 or higher
* Able and willing to provide informed consent

Exclusion Criteria:

* Unwilling or unable to give consent
* Ventricular pacing at recruitment
* Bundle branch block or pre-excitation at baseline
The Change of the Detrusor Thickness After Hypospadias Repair - Comparison With the Normal Control Group

Even successfully managed hypospadias without any complication, voiding problem could be developed due to the increased urethral resistance. The investigators are trying to analyze the effect of hypospadias operation on voiding function by checking the detrusor thickness and urinary nerve growth factor.


Eligibility Criteria:
Inclusion Criteria:

\<Group 1\>

1. 6Mo-2Yr old penile hypospadias patients before operation \<Group 2\>
2. 6Mo-2Yr old male patients without hypospadias \<Group 3\>
3. penile hypospadias patients under the age of 5 Yr who got tubularized incised plate operation at out institution at the age between 6Mo and 2Yr old and more than 1 Yr have passed \<Group 4\>
4. 2Yr-5Yr old male patients without hypospadias1. 0-3 year old children without any abnormality of urinary tract

Exclusion Criteria:

\<Group 1, 2, 4\>

1. patients with history of urethral operation, febrile urinary tract infection, neurogenic abnormality om operation \<Group 3\>

1. patients with history of urethral operation other than hypospadias repair, febrile urinary tract infection, neurogenic abnormality
2. patients with development urethra-cutaneous fistula
Topical Treatment of Acute Otitis Media Through Tympanostomy Tubes (AOMT) and Its Effect on Microbial Flora

The purpose of this observational study was to evaluate the effects of a topical fluoroquinolone (antibiotic) instilled into the otic (ear) canal to treat Acute Otitis Media through Tympanostomy Tubes (AOMT) on selected bacterial species on the skin near the ear, in the nose, and in the throat.

Pediatric patients with tympanostomy tubes were enrolled into one of two groups: 1) Treatment, i.e., patients with signs of otic infection, to be treated with CIPRODEX; or 2) Healthy, i.e., patients without signs of otic infection, to receive no treatment. Microbiological specimens were collected from four areas (ear canal, skin, nose, throat) during three study visits (Day 1, Day 8, and Day 42), and the specimens collected from the Healthy group served as a comparison (control) group for identifying fluoroquinolone (FQ) resistant bacterial strains.

Eligibility Criteria:
Inclusion Criteria:

* Six months to less than 5 years of age at time of enrollment;
* Presence of bilateral, patent tympanostomy tubes;
* Otorrhea-free for at least 7 days following tympanostomy tube surgery (healthy group);
* Otorrhea up to and including 21 days in duration in at least one ear at Visit 1 (treatment group);
* Willing to refrain from significant water immersion of both ears without the use of adequate ear protection during swimming, bathing, showering and other water-related activities;
* Read and sign informed consent (parent or guardian);
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Ongoing/current therapy as described in protocol;
* Has received any treatment for current AOMT episode (treatment group);
* Otorrhea greater than 21 days in duration immediately prior to Day 1 visit (treatment group);
* History of or current acute or chronic non-tube otorrhea (through existing perforation of the eardrum);
* Current acute otitis externa (AOE), or malignant otitis externa (MOE) or other conditions which could interfere with evaluation of the study drug;
* Known or suspected ear infection of fungal or mycobacterial origin (treatment group);
* History or active herpes simplex, vaccina or varicella infections or overt viral infection of the tympanic membrane or the external canal;
* Prior otologic surgery, except that confined to the tympanic membrane, within one year of study entry;
* Diabetes;
* Any current known or suspected infection (other than AOMT) requiring systemic antimicrobial therapy;
* Known or suspected allergy or hypersensitivity to quinolones;
* Other protocol-defined exclusion criteria may apply.
My Healthy Brain: Preserving and Promoting Brain Health Through Evidence-based Practices

The objective of this trial is to demonstrate early proof-of-concept for My Healthy Brain, an 8-week group program that directly targets multiple lifestyle factors associated with brain health and prevention of cognitive decline. The investigators will explore the feasibility, acceptability, and effect sizes of improvement in primary lifestyle outcomes as well as secondary outcomes of self-determination and subjective well-being.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years
* English fluency/literacy
* ≥1 modifiable brain disease risk factor (outlined by JAMA)
* Bluetooth 4.0 enabled smartphone

Exclusion Criteria:

* Diagnosis of dementia; Montreal Cognitive Assessment \< 18
* Serious medical illness expected to worsen in next 6 months
* Current suicidal ideation
* Substance abuse
* Untreated serious mental health conditions
* Current use of digital monitoring device (eg. Fitbit)
* Mindfulness practice (\> 45 minutes/week) in the last three months
9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer

This is a randomized, controlled, open-label, multicenter phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of 9MW2821 combined with Toripalimab versus standard chemotherapy in first-line locally advanced or metastatic urothelial cancer.

The study is planning to enroll approximately 460 participants with unresectable locally advanced or metastatic urothelial cancer who have not previously received systematic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Sign the informed consent form approved by IEC.
* Male or female subjects aged 18 to 80 years.
* ECOG status: 0 or 1.
* Histologically confirmed local advanced or metastatic urothelial cancer
* Previously untreated with local advanced or metastatic urothelial cancer
* At least one measurable lesion, according to RECIST V1.1.
* Adequate tumor tissues submitted for test
* Suitable for cisplatin/carboplatin-based chemotherapy assessed by investigator
* Life expectancy for more than 12 weeks.
* Adequate organ functions.
* Proper contraception methods.
* Willingness to follow the study procedures.

Exclusion Criteria:

* History of another malignancy within 3 years.
* History of autoimmune disease requiring systemic treatment within 2 years.
* History of clinically significant cardiac/cerebrovascular diseases or thrombosis within 6 months.
* Major surgery treated within 28 days; Any live vaccines got within 28 days; Radiotherapy or Intravesical therapy treated within 21 days; Traditional Chinese medicine or any potent CYP3A4 inducers/inhibitors taken within 14 days.
* Lots of pleural fluid and ascites, uncontrolled bone pain or spinal compression existed within 14 days; Systemic treatment with active infection within 7 days.
* Previously treated with PD-1, PD-L1, PD-L2, CTLA-4 inhibitors; Previously treated with ADCs which target Nectin-4 or are conjugated with payload MMAE; Organ transplantation or allogeneic hematopoietic stem cell transplantation in the past.
* Clinical significantly toxicity Grade ≥ 2 (except alopecia and pigmentation) related to previous treatment.
* Any situations adding the risk of severe dry eye, active keratitis or corneal ulcer, etc.
* Peripheral neuropathy Grade ≥ 2.
* Any other serious chronic or uncontrolled disease.
* Uncontrolled central nervous system metastases or carcinomatous meningitis.
* Active HBV/HCV/HIV infection, etc.
* Known allergic sensitivity to any of the ingredients of the study drug.
* History of drug abuse or mental illness.
* Other conditions unsuitable into the study.
Role of Intracoronary Imaging in Plaque Identification

NSTE-ACS patients are more likely to exhibit high-risk plaque characteristics in non-culprit lesions. Both IVUS and OCT imaging techniques interact in a complementary manner to provide morphological characterization of the atherosclerotic coronary plaques and help identification of high-risk vulnerable plaques. Using morphological parameters obtained from OCT and IVUS, a new plaque vulnerability score will be established for more precise definition of the most vulnerable plaques that carry the greatest risk of rupture and subsequent detrimental clinical outcomes in the future. Such score might help in targeting these plaques with certain therapeutic interventions aiming to their stabilization.

Patients with NSTE-ACS presented to the study site fulfilling the eligibility criteria during enrollment period of 1 year. The culprit lesion(s) being responsible for the acute event will be revascularized by percutaneous coronary intervention (PCI). Both OCT (OPTISTM, St. Jude Medical Inc., St. Paul, MN, USA) and IVUS (Boston Scientific iLabTM Ultrasound Imaging System, MA, USA) will be performed after PCI to examine the non-culprit lesion(s) for detection of atherosclerotic plaques with the morphological characteristics consistent with high-risk plaques, namely "Vulnerable plaques". Plaque characteristics from IVUS and OCT imaging will be merged to establish novel scores, which help improve diagnostic accuracy for detection of high-risk lesions. Correlations IVUS and OCT images will be performed to identify most reliable factors associated with plaque vulnerability.Patients will be followed up to 6 months after PCI for detection of major adverse cardiovascular outcomes (MACE) after ischaemia-driven revascularization of the culprit lesion(s).

Eligibility Criteria:
No formal inclusion or exclusion criteria
Dosimetric Comparison of Three Radiation Techniques for Hypofractionated Whole Breast Radiotherapy in Early Breast Cancer

We aim to compare three different radiation delivery techniques, namely three-dimensional conformal radiation therapy (3D-CRT), intensity modulated radiotherapy (IMRT) and volumetric modulated radiation therapy (VMAT) in left-sided early breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* left sided early breast cancer patients. Should have histopathological prove to have invasive breast cancer. Operated by breast conservative surgery. Have no associated comorbidities

Exclusion Criteria:

* locally advanced breast cancer. Patients who have total mastectomy. Patients who had previous chest irradiation or known comorbidities.
Study of Skin and Muscle Parameters Using a Skin Sensor

The aim of this study is to assess the role of skin sensors in obtaining reliable and accurate serial measurements of skin parameters in the context of cutaneous skin wound healing.


Eligibility Criteria:
Inclusion Criteria:

* Males and Females age 18 and over
* Recent (post-operative day 0-90) skin surgery of the trunk,extremities, head or neck for minor skin problems resulting in sutured wounds or open granulating wounds.
* Otherwise good general health as assessed by the investigator
* The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.

Exclusion Criteria:

* Under 18 years of age
* Pregnancy or Lactation
* Subjects who are unable to understand the protocol or to give informed consent
Buprenorphine Treatment for Opioid Dependence

Buprenorphine/naloxone (BUP/NLX) treatment is effective for the treatment of prescription opioid dependence, previous studies have not determined the optimum dose of BUP/NLX for this patient population. The goal of this study is to determine if there are differences in clinical efficacy of BUP/NLX tablet in low dose range (less than or equal to 8/2mg) vs. high dose range (greater than or equal to 16, range 16-24mg). The main outcomes of interest will be treatment retention, use of opioids, and the use of other drugs of abuse.

This is a randomized, open-label clinical trial with approximately 9 Veteran opioid dependent men and women. Veterans were randomized to one of two treatment groups: low dose range of buprenorphine (\<8mg) vs. high dose range of buprenorphine/naloxone (BUP/NLX (\<16mg). During induction into buprenorphine, all participants will be started at a dose of 2mg, and this dose will be increased as needed for stabilization of opioid withdrawal symptoms, up to 8mg for the low dose group, and up to 16mg for the high dose group, within a 5 day period. Participants will be seen on a daily basis (excluding weekends) for the initial 5 day induction. At the end of the 12-week study, participants will either be referred to a buprenorphine clinic if they wish to continue this medication, or if they wish to be drug free, will undergo detoxification from buprenorphine for up to a 4-week period. Follow-up visits, scheduled at 1, 3, and 6 months after study completion.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females between the ages of 18 to 65, current dependence on prescription opioids as evidenced by documented prior treatment for opioid dependence, signs of opiate withdrawal as evidenced by a Clinical Opiate Withdrawal Scale score of 7 or greater, self-reported history of opioid dependence, and a positive urine toxicology for opiates;
2. willingness to be detoxified from opioids for buprenorphine maintenance ;
3. for women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy, with monthly pregnancy tests obtained during study participation.

Exclusion Criteria:

1. use of heroin for more than 4 days in the past month;
2. lifetime history of opioid dependence due to heroin alone;
3. ever used heroin intravenously;
4. requirement for current ongoing opioid treatment for adequate pain management;
5. current alcohol, benzodiazepine, barbiturate use with physiologic dependence as determined during screening history and physical,
6. serious unstable medical illness including bradycardia or other arrhythmias, major cardiovascular, renal, endocrine, or hepatic disorders for which buprenorphine treatment is contraindicated or which at the determination of the MD is medically dangerous;
7. serious psychiatric illness including psychosis, bipolar disorder with psychosis:
8. or significant current suicidal or homicidal thoughts necessitating a higher level or care;
9. known allergy or intolerance to buprenorphine.
Tele-spirometry in Primary Care - Randomized Clinical Trial Cluster: the Effectiveness of Telemedicine in Asthma

The purpose of this study is to determine the effectiveness of telemedicine multifaceted intervention in symptoms patients with asthma.

This study is a randomized clinical trial for patients with asthma from a primary care. The purpose is to determine the effectiveness of telemedicine (teleconsultation and telemonitoring) in control of asthma symptoms.

Eligibility Criteria:
Inclusion Criteria:

* individual with diagnosis asthma, Asthma Control Test \<20, spirometry from TelessaudeRS-Universidade Federal do Rio Grande do Sul (from randomization cluster)

Exclusion Criteria:

-low quality spirometries (inadequate)
Acute Mechanical Response to Anti-arrhythmic Drug Therapy

The aim of this study is to determine if anti-arrhythmic drugs with a sodium channel-blocking mechanism exert a detrimental electromechanical effect on cardiac function in patients depending upon baseline intraventricular conduction and left ventricular function.

Amiodarone therapy is used frequently for control of ventricular arrhythmias in patients who receive painful shocks from an implantable cardioverter-defibrillator (ICD). Data in post-myocardial infarction (MI) patients and ICD patients suggest that amiodarone is mortality-neutral; it neither confers increased nor decreased mortality. However, these data are derived from patients largely with normal intraventricular conduction, manifesting as a QRS complex duration on the surface ECG \<120 ms. Amiodarone, in addition to potassium-channel blocking effects, is a sodium channel-blocker. Because sodium channels mediate cardiac depolarization, and a QRS complex \>120 ms is indicative of abnormal depolarization, amiodarone may not be benign in patients with such conduction defects. Patients with cardiac resynchronization therapy-defibrillators (CRT-D), who all have abnormal baseline intraventricular conduction, may therefore be adversely affected by amiodarone. Anecdotal clinical data suggest that this may be the case, but the question of amiodarone's cardiac safety profile in CRT patients has never been studied.

Eligibility Criteria:
Inclusion Criteria:

* Implanted cardiac device requiring generator change and a new device
* Able to give informed consent

Exclusion Criteria:

* Current membrane-active anti-arrhythmic
* Glomerular filtration rate (GRF)\<30 milliliters (mL)/min
* MAP\<60 mmHg
* Known intolerance to procainamide
* Pregnancy
* Age \<18 or \>85 years old
* Baseline QT interval \>480 ms (500 ms if paced)
Neoadjuvant Colorectal Cancer With Unresectable Liver Metastases

The study was terminated early due to low enrollment with only 2 subjects enrolled and treated after being open for enrollment for over a year. Therefore, no meaningful efficacy analyses could be performed.

This trial is studying the effects (good and bad) of a combination of drugs, Irinotecan in combination with infusional 5-FU, leucovorin (FOLFIFI) plus Bevacizumab, for cancer of the colon or rectum that has spread to the liver only and is currently not able to be removed by surgery. All of the drugs that will be received in this research study have been approved in the United States for colorectal cancer, that has spread to other areas of the body, including the liver. Another reason for doing this study is to see if the chemotherapy drugs FOLFIFI plus Bevacizumab can sufficiently decrease the size of the cancer in the liver so that any tumor remaining can be completely removed with surgery and, if it can be removed whether doing so will prolong the time it takes the cancer to return and/or prolong the life of these patients. This trial is also looking at the genes of people who take part in this study, to see if it is possible to find out characteristics that can help predict whose cancer will respond well or not so well, and who will have more or less side effects to this chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* ECOG performance status of 0 or 1
* Histological documentation of adenocarcinoma of the colon or rectum. The primary site must have been confirmed to be in the large bowel

Exclusion Criteria:

* Prior systemic anticancer therapy for mCRC
* Prior hepatic surgery, chemoembolization, hepatic artery infusion, radiofrequency ablation or cryotherapy for liver metastases