cyrilzakka/clinical-trials huggingface dataset:
A Multicentre Retrospective Study on Bicuspid Aortic Valve

Bicuspid Aortic Valve (BAV) is a common congenital heart disease with an incidence ranging from 0.16% in Asians to 2% in Westerners. Asian populations with BAV have different morphological characteristics from those of the Western populations, and further elucidation of these differences will serve as a guide for the treatment and follow-up of Asian patients. Therefore, we conducted this multicentre retrospective study to analysis the clinical features, long-term development and surgical prognosis of BAV .

Bicuspid Aortic Valve (BAV) is a common congenital heart disease with an incidence ranging from 0.16% in Asians to 2% in Westerners, and more than one half of patients require medical or surgical treatment within 20 years of diagnosis. Therefore, early diagnosis and effective treatment can help to reduce the incidence of irreversible cardiac impairment and adverse outcomes such as sudden death. Asian populations with BAV have morphological characteristics that differ from those of the Western populations, and further elucidation of these differences could serve as a guide for the treatment and follow-up of Chinese patients. Based on the above background, We conducted this multicentre retrospective study. We will search for patients diagnosed with BAV by echocardiography or other imaging examinations from December 2021 to October 2022 at Nanjing Gulou Hospital, Jiangsu Provincial Hospital and Nanjing Children's Hospital; collect clinical symptoms, signs and examination results of them; find out the specific surgical plan and time of surgery if they have undergone surgery; follow up for symptoms, medication and reexamin Echocardiography to confirm any endpoint events.

Eligibility Criteria:
Inclusion Criteria:

* All patients with a suspected diagnosis of Bicuspid Aortic Valve by echocardiogram from December 2021 to October 2022

Exclusion Criteria:

* Patients with suspected Bicuspid Aortic Valve not clearly diagnosed by echocardiography and not confirmed by cardiac surgery
Impact of Two Recall Intervals on Dental Caries Incidence, Anxiety and Quality of Life of Preschool Children

Objectives: To assess the effectiveness of two recall intervals on dental caries incidence (primary outcome) in preschool children with low and moderate caries risk. The level of anxiety, oral health related quality of life (OHRQoL), time and cost (secondary outcomes) according to each interval will also be assessed. Methods: The sample will consist of 224 children between 3-5 years of age, of both genders, with low and moderate caries risk according to the clinical criteria adapted from the Secretary of Health of São Paulo. Children will be randomly allocated into two study groups: Group 1 (G1) - oral clinical examination + orientation for oral health and diet on the recall of 12 months; and Group 2 (G2) - oral clinical examination + orientation for oral health and diet on the recall of 18 months.

An examiner calibrated and blinded to the study groups and the secondary outcomes will perform the clinical examinations, which consist of: the gingival bleeding index, dental plaque index, detection of caries and its activity according to the ICDAS (International Caries Detection and Assessment System) and the clinical features of active and inactive caries lesions will be associated with the criteria discribed in ICDAS Commitee manual. An external dentist will conduct the assessment of the anxiety levels assessed by the Facial Image Scale, the OHRQoL measured by B-ECOHIS (Brazilian Early Childhood Oral Health Impact Scale), the time and costs. All groups will be followed for a period of 36 months. All analyzes will be performed with the intention of treatment (ITT) and considering the sensitivity analyzes to assess the differences between the ITT analyzes and the complete cases analyzes.

Eligibility Criteria:
Inclusion Criteria:

* Children between 3-5 years of age, of both genders, with low and moderate caries risk according to the clinical criteria adapted from the Secretary of Health of São Paulo.
* Guardians who have signed the informed consent confirming their participation and their child in research.

Exclusion Criteria:

* Children showing visible dental plaque and gingivitis in baseline.
* Children showing more than 08 active and/or inactive caries cavitated surfaces, and who show fistula and/or dental abscess.
* Special patients.
* Children who received professional application of fluoride in the 6 months prior to the survey.
Multiparametric MRI for Assessing Breast Cancer Response to Anti-HER2 Therapy

This is a single institution, observational research study in which patients are observed using DWI/DCE MRI imaging before and after receiving neoadjuvant anti-HER2 therapy.

This is not a treatment trial. Patients will be treated according to the plan developed by their medical oncologists. Only patients planning to receive anti-HER2 therapy as part of planned systemic therapy will be eligible for this imaging study. Patients and their referring oncologist will be asked to start the anti-HER2 therapy 2-3 weeks prior to surgery and after the pre-therapy MRI.

Eligibility Criteria:
Inclusion Criteria:

* Subjects at least 18 years of age.
* Have a new diagnosis of invasive breast cancer, clinical stage I - III, HER2 positive.
* Planning to undergo surgical resection plus adjuvant therapy to include an anti-HER2 agent.
* Have tissue block available for review of experimental markers.
* Be a candidate for MRI imaging.
* Be willing to comply with scheduled visits required for the trial.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Recent therapy for breast cancer prior to baseline MRI.
* Subjects may not receive other investigational agents during the study window for imaging.
* Contraindications for MRI or MRI contrast including severe claustrophobia, history of previous reaction to MRI contrast, renal disease, congestive heart failure, other significant systemic diseases or any metal in their body, including but not limited to: a brain aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or defibrillator, cochlear implant, ocular foreign body (e.g. metal shavings), other implanted medical devices: (e.g. Swan Ganz catheter), insulin pump, metal shrapnel or bullet.
* Pregnant or nursing.
Active Surveillance of the Small Renal Mass

Active surveillance in kidney cancer involves closely observing the tumor with periodic imaging studies rather than immediately proceeding to an invasive treatment. This does not mean that the tumor is ignored or that future treatment is not necessary, rather it means the tumor does not require treatment at this time. On active surveillance, a tumor is closely monitored without treatment, however if the tumor changes and reaches a predefined threshold that your physician no longer considers safe, your physician will strongly encourage treatment.

While some patients with small kidney tumors may require eventual treatment, most do not. Therefore, the American Urologic Association considers active surveillance an acceptable treatment strategy. This protocol is a prospective study of active surveillance for small clear cell kidney tumors (the most common type of kidney tumor) and is designed to identify if there are predictive markers that may help identify which patients are unlikely to require surgical treatment. Predictive markers are measurable characteristics that may predict the future behavior of a tumor. There are currently no available predictive markers that can help identify which tumors are not destined to require treatment. Such a marker may be useful to increase the use of active surveillance by informing patients with small renal tumors that immediate treatment may be considered overtreatment.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Life expectancy \>3 years (by physician estimate)
* Measurable, solid renal neoplasm, 1.0 -2.7 cm in size and visible on ultrasound
* Clear cell renal cell carcinoma histology
* Renal tumor diagnosed within 6 months
* Recent biopsy (\<6 weeks) performed, if performed at an outside institution, there must be sufficient material for biomarker analysis
* No evidence of vascular invasion or regional nodal/distant disease
* Renal tumor that is able to be managed with upfront surgery
* Adequate organ function (Hemoglobin \> 9, Absolute neutrophil count (ANC) ≥ 1500/μL Platelets ≥ 100,000/μL, AST and ALT ≤3.0 upper limit of normal (ULN), total bilirubin ≤ ULN, eGFR ≥ 30
* Good Performance status (ECOG ≤2)
* Understanding and willingness to provide consent

Exclusion Criteria:

* History of a hereditary renal cancer syndrome
* Tumor \>2.7 cm, stages T1b-T4
* Life expectancy \<3 years
* Presence of an active, untreated, metastatic non-renal malignancy
* Uncontrolled medical illness including infections, hypertension, arrhythmias, heart failure, or myocardial infarction within 6 months that would predispose to immediate surgical therapy
* Medical contraindication to upfront surgical management of renal mass
* History of bleeding diathesis or recent bleeding episode that would prevent surgical resection
* Unwillingness to undergo monitoring and imaging studies
A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults With Obesity or Overweight

The main purpose of this study is to evaluate the efficacy and safety of Bimagrumab and Tirzepatide, alone or in combination, in adults with obesity or overweight, with at least one obesity related comorbidity, without Type 2 Diabetes. The study will last about 70 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have a BMI of

  * ≥30 kilograms per square meter (kg/m2) or
  * ≥27 kg/m2 and \<30 kg/m2, with at least one of the following weight-related comorbidities:

    * Hypertension
    * Dyslipidemia
    * Cardiovascular disease
    * Obstructive sleep apnea
* Have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss)

Exclusion Criteria:

* Have a prior or planned surgical treatment for obesity
* Have at least one laboratory value suggestive of diabetes during screening
* Use of metformin, or any other glucose-lowering medications
* Have Type 1 Diabetes, latent autoimmune diabetes, been diagnosed with any form of diabetes mellitus except for a prior diagnosis of gestational diabetes mellitus, or history of ketoacidosis or hyperosmolar coma
* Have poorly controlled hypertension
* Have any of the following cardiovascular conditions within 3 months prior to screening:

  * acute myocardial infarction
  * cerebrovascular accident (stroke)
  * unstable angina, or
  * hospitalization due to congestive heart failure
* Have ongoing or a history of frequent intermittent or chronic tachyarrhythmia syndromes
* Have ongoing or a history of bradyarrhythmias other than sinus bradycardia
* Have a history of New York Heart Association (NYHA) Functional Classification III or IV congestive heart failure
* Have a history of symptomatic gallbladder disease within the past 2 years
* Have signs and symptoms of any liver disease
* Have a disease or condition known to cause gastrointestinal malabsorption or a known clinically significant gastric emptying abnormality
* Have a history of acute or chronic pancreatitis
* Have renal impairment, measured as estimated glomerular filtration rate \<30 mL/minute/1.73 m2
* Currently taking or have taken medications that may cause significant weight gain or promote weight loss within 3 months prior to screening
Improving Inpatient Screening for Hepatitis C

This study will use a stepped-wedge cluster randomized clinical trial to evaluate a health system initiative to set defaults in the electronic health record admission order set to nudge inpatient hepatitis C (HCV) screening.

The hepatitis C virus (HCV) is the leading cause of liver transplant and hepatocellular carcinoma in the United States, but direct-acting antiviral medications are now available and can cure the disease in over 95% of those that are treated. The Centers for Disease Control and Prevention (CDC) estimate that 75% of all chronic HCV infections in the United States are among adults born between 1945 and 1965. The CDC and US Preventive Services Task Force (USPTF) therefore recommends birth cohort screening for all adults born in this time period. In 2016, the Commonwealth of Pennsylvania signed into law a requirement that all hospitalized patients born during this time period be offered HCV screening. In this study, a stepped-wedge cluster randomized clinical trial will be conducted to test the effect of defaulting HCV screening into the admission order set to improve screening rates.

Eligibility Criteria:
Inclusion Criteria:

* Be admitted to the Hospital of the University of Pennsylvania (HUP) or Penn Presbyterian Medical Center (PPMC)
* Born between 1945 and 1965

Exclusion Criteria:

* Patients will be excluded if they have already received Hepatitis C screening or have been previously diagnosed with Hepatitis C.
The Safety and Efficacy of Low and High Carbohydrate Diets

This study will compare the safety and effectiveness of a low carbohydrate diet (Atkins Diet) with a high carbohydrate diet (conventional USDA diet).

Despite the considerable mass appeal of popular diet books, such diet approaches lack data to support their efficacy and safety. Despite its widespread use for more than 30 years, the Atkins diet has never been evaluated in a large, randomized, controlled trial. This study will assess the short-term and long-term clinical effects of a low-carbohydrate diet and a high-carbohydrate diet in overweight and obese men and women.

Participants in this study will be randomly assigned to the Atkins diet (low-carbohydrate, unlimited fat and protein) or a conventional USDA diet (high-carbohydrate, low fat). The study will evaluate the effects of each dietary approach on changes in: 1) weight and body composition, 2) metabolic and organ function, 3) exercise tolerance. Each participant will be enrolled in the study for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 30 and 40
* Live and work within 1 hour of the study site
* Stable psychological status

Exclusion Criteria:

* History of heart disease, heart attack, or stroke
* Blood pressure \> 140/90 mmHG
* Abnormal cholesterol levels
* Significant psychiatric illness
* Any medication that affects weight or metabolic rate
* Presence or history of a chronic disease that is known to affect appettite, food intake, or metabolism (i.e. diabetes, thyroid disease or cancer).
* Currently using antidepressants, steroids, tobacco or illegal drugs
* Pregnant, breastfeeding, or planning pregnancy
* 10 lb change in weight within 6 months of study entry
* History of malignant arrhythmias or cerebrovascular, renal, or hepatic disease
* History of protein wasting diseases or gout
* Severe arthritis
* Osteoperosis
* Certain types of hormone replacement therapy
* Currently following a vegetarian diet
Effect of High-Dose B-Complex Vitamins on the Symptoms of Schizophrenia

The purpose of this study is to determine whether individuals with schizophrenia who will take a high dose of the B-vitamins folate, B12 and pyridoxine, may experience improvement in their symptoms.

Individuals with schizophrenia often experience disturbing residual symptoms, even with the best available current treatments. Homocysteine, normally found in the body, can interfere with NMDA-glutamate receptor function, and this might be responsible for some of the symptoms of schizophrenia. This double-blind protocol will have study participants who suffer from schizophrenia take either a high-dose combination of folate, B12 and pyridoxine (a combination that can lower homocysteine in the body) or placebo for three months. Clinical measures (e.g., PANSS, CGI) will be taken to determine whether those taking the vitamin combination experience clinical benefit.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Schizophrenia or Schizoaffective Disorder
* Ages 18-65, male or female
* Treatment regimen includes a new-generation antipsychotic (clozapine, olanzapine,risperidone, quetiapine, ziprasidone or aripiprazole)
* Stable medication for 4 weeks prior to screening visit

Exclusion Criteria:

* Diagnosis of active substance use disorder within the last month
* Already taking vitamin supplements totaling \> 400 mcg folic acid per day, or regular B12 injections
* Pregnant or breastfeeding
* Seizure disorder
* Non-English speaking
* Without capacity to give informed consent
A Comparative Analysis of Portable Bladder Scanner to Determine Age/ Volume Specific Accuracy in 0-6 Years of Children

As a part of the urodynamic studies, urinary catheterization is inserted to measure residual urine, however, it has shown to be an invasive procedure, cause urinary tract infection, and traumatic experience. Bladder scan has been introduced as an alternative and non-invasive method to measure urine residual in the bladder.

Functional urinary disorders are common as more than 15% of children are diagnosed. During the normal course of urinary tract development, bladder and urinary sphincter develop by 2 to 4 years old, and by five years old, the tract is completely developed. The underdevelopment of the urinary tract may lead to complications of the bladder and kidneys along with social impairment. Therefore, the diagnosis is critical as an early diagnosis can prevent long term complications. To diagnose, newborns undergo basic urinalysis, urine culture examination, blood creatinine analysis, and kidney and bladder ultrasound. If any abnormalities are present at the under the age of five, it is recommended that they are followed up on a regular basis. Also, urodynamic studies should be performed every year along with others for early identification and intervention. Studies have shown that UDS (urodynamic studies) significantly reduce the deterioration of the bladder and kidney and the need for operation such as bladder dilation.

As a part of the urodynamic studies, urinary catheterization is inserted to measure residual urine, however, it has shown to be an invasive procedure, which can cause urinary tract infection. The bladder scanner is an ultrasonic imaging device that has been developed for non-invasive measurement of residual volume in the bladder. The images and measurements are obtained by applying a probe onto the abdomen. It constructs 12 cross-sectional images at 15 degree interval using the reflection signals from urine in the bladder and extracts the position of the bladder wall.

The objective of the study is to assess the validity of existing pediatric algorithms for diagnosing neurogenic bladder and evaluate the accuracy of measuring the post-void residual volume between the ages of 0 to 6 years old.

It hypothesizes that when the portable bladder scanner (Bladder Scanner, Biocon-900) is used in pediatric population between the ages of 0 to 3 years old will show greater difference in infused and scanned volume than 4 to 6 years old.

Eligibility Criteria:
Inclusion Criteria:

* Under the age of 6 years old.
* Urodynamic study is scheduled to due to suspected changes in the bladder function or shape.
* Those who understand and sign the informed consent form.

Exclusion Criteria:

* Subjects with surgical history of the bladder.
* Constant leaking of the urine due to bladder neck contracture.
* Any congenital abnormalities that induce changes in the shape of the bladder.
* Unsuitable to participate in the study at the discretion of the principal investigator.
Continuous Local-anesthetic Wound Infusion for Neck Dissection

The goal of this study is to assess the efficacy of continuous local anesthetic wound infusion to improve quality of recovery following ablative surgery and neck dissection.

Bilateral cervical plexus catheters are convenient and safe to place under the direct vision of the surgeons during ablative and neck dissection. The investigators hypothesize that continuous local anesthetic wound infusion to block bilateral cervical plexus will improve quality of recovery following ablative surgery and neck dissection. The primary endpoint is the quality of recovery, which will be assessed using the 15-item quality of recovery questionnaire (QoR-15). Secondary endpoints include numeric pain scale, number and proportion of patients on salvage analgesics, Incidence of phrenic nerve block, Incidence of recurrent laryngeal nerve block, length of post-anesthesia care unit (PACU) stay, length of post-operative hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Over age 18;
* patients with head and neck cancer Undergoing ablative surgery and neck dissection.

Exclusion Criteria:

* Patient refuse;
* Relatively contraindications: severe heart, liver, or kidney dysfunction, coagulation dysfunction, and local anesthetic allergy history;
* Intervention unlikely to be effective: drug abuse history, receiving other types of nerve block treatment;
* Unlikely to complete the follow-up: alcoholism, planned to replace WeChat and phone within three months; the expected life span less than three months;
* Unable to cooperate with the questionnaire and use the patient-controlled analgesia pump.
Armenian National Registry of Myocardial Infarction

This is a national, multicenter prospective observational study of patients presenting to hospitals in Armenia with STEMI diagnosis.

The main questions it aims to answer are:

* Determine the rate of in-hospital mortality for the patients with STEMI admitted to the participating hospitals.
* Compare short and long-term CV and all-cause mortality and hospitalization.
* Determine how professional guidelines are followed in real-world situations.

Although the state program on primary percutaneous coronary intervention in ST elevated myocardial infarction, which was launched in 2015 helped to drastically decrease STEMI mortality rates, patients who had survived usually develop heart failure (HF) which leads to increased economic burden for the Armenian healthcare system.

The total duration of the study will be 24 months. The target number of the inclusion is 2500 patients. The follow-up period for enrolled patients will be 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patient (≥ 18 years of age),
2. Admitted to the participating centers for a STEMI within 48 hours of symptom onset: characterized by a rise and fall of cardiac markers (troponins) together with ST elevation in at least two contagious leads or LBBB.
3. Have given signed informed consent to participate in the study.

Non-Inclusion Criteria:

1. MI occurring ≤ 48 hours after PCI or CABG
2. The patient or the legal representative refused to sign the informed consent

Exclusion Criteria:

Withdrawal of the informed consent