cyrilzakka/clinical-trials huggingface dataset:
CPX in Paradoxical Low Flow Aortic Stenosis

Severe aortic stenosis is a condition with poor life expectancy once it becomes symptomatic. There are no prospective studies illustrating the utility of cardiopulmonary stress (CPX) testing in diagnosing and prognosticating patients with paradoxically low gradient and low flow severe aortic stenosis. We aim to prospectively investigate the utility of CPX in this patient population with the hypothesis that utilizing CPX parameters would better identify higher risk patients warranting further evaluation and possibly intervention sooner.

This will be a prospective crossectional, longitudinal study recruiting patients by invitation with paradoxical low flow low gradient severe aortic stenosis. Patients with PLFLG AS will have been identified in other studies and these patients will be approached for enrollment in the study. Patients deemed appropriate for enrollment will undergo recumbent bicycle stress testing with concomitant measure of gas exchange. The bicycle will be at 30 degrees with initiation of minimal resistance for 3 minutes, followed by an increase in work-rate of 25 watts every two minutes until the patient reaches a sign/symptom-limited maximum exertion or test limiting symptoms develop. Charts will be reviewed for baseline medical conditions and demographics. CPX protocol will be standard HFH protocol supervised by exercise physiologist. The first phase of the study will be investigating if these asymptomatic patients will be reclassified to symptomatic as defined by reduced V02 Max. The second phase will be following these patients for long term adverse events and if V02 max correlates with a higher risk.

Eligibility Criteria:
Inclusion Criteria:

* Aortic valve area \<1 cm2
* Mean aortic pressure gradient \<40 mmHg,
* Left ventricular ejection fraction \>50% by 2D transthoracic echocardiography

Exclusion Criteria:

* Ischemic heart disease
* Severe mitral valve disease (regurgitation or stenosis)
* Moderate or severe aortic regurgitation
* Pulmonary hypertension (PA pressure \>50 mmHg)
* COPD
* Uncontrolled hypertension (Systolic BP or Diastolic BP greater than 150/90)
* Inability or unwillingness to exercise.
Study of Muraglitazar Versus Pioglitazone in Type 2 Diabetes

The purpose of this study is to compare Muraglitazar and Pioglitazone in patients with Type 2 Diabetes. Both the safety and blood sugar lowering effects of these treatments will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes
* HbA1c \> = 8.0% and \< = 12.0%
* Serum triglyceride concentration \< = 600 mg/dL
* Fasting c-peptide \> = 1.0 ng/ml
* Body mass index \< = 41 kg/m2
* Drug naive patients

Exclusion Criteria:

* History of MI (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (TIA), cerebrovascular accidents, accelerated/malignant hypertension, or hypertension related CHF (congestive heart failure) within six months prior to screening and during the Lead-In Phase.
* Women of child Bearing Potential
* Uncontrolled hypertension, CHF defined as New York Heart Association (NYHA) Class II, III and IV, exacerbation of previously stable CHF (any NYHA class) or uncontrolled cardiac arrhythmia in the 30 days prior to screening and during the Lead-In Phase.
* History of renal disease, bladder cancer, pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.
Investigation of LBX1, TIMP2, GPR126 and CHD7 Gene Polymorphisms in Adolescent Idiopathic Scoliosis Patients

Adolescent Idiopathic Scoliosis (AIS) is a common disease of the spine observed in individuals aged 10-18 who typically do not have any other health issues. Despite numerous genetic studies conducted across different ethnic groups worldwide, the specific genes contributing to the development of scoliosis have not yet been definitively identified. Therefore, the aim of our study is to investigate whether there is an etiological relationship between AIS and the polymorphisms of the LBX1 (rs11190870, rs625039, rs11598564), TIMP2 (rs8179090), GPR126 (rs6570507), and CHD7 (rs121434341) genes in the Turkish population and to determine the relationship of these polymorphisms with gender, age, age at diagnosis and Cobb angle in these patients.

This prospective genetic research was conducted Bursa Uludag University Faculty of Medicine, Department of Orthopedics and Traumatology. A total of 301 individuals were included in the study, comprising 201 patients aged 10-18 years diagnosed with AIS and Cobb angle of 10 degrees or more on direct radiography, no known genetic disorders and no diseases known to play a role in the etiology of scoliosis and 100 healthy controls aged 10-18 years without a diagnosis of scoliosis based on physical examination and/or imaging. In the study, the LBX1, TIMP2, GPR126 and CHD7 gene polymorphisms in AIS patients and the control group were analyzed using real-time PCR with TaqMan probe SNP (single nucleotide polymorphism) primers (rs625039, rs11598564, rs6570507, rs121434341, rs11190870, rs8179090). Subsequently, the SNP regions were confirmed by DNA sequence analysis. The obtained findings were statistically analyzed.

Eligibility Criteria:
Inclusion Criteria:

Study group

* Being diagnosed with Adolescent Idiopathic Scoliosis (AIS) between the ages of 10 and 18.
* Having a Cobb angle of 10 degrees or greater on a plain radiograph.
* Not having any known genetic disorders.
* Not having any diseases known to play a role in the etiology of scoliosis (degenerative, neuromuscular, congenital scoliosis, etc., are excluded).

Control group

* Healthy individuals who have not been diagnosed with scoliosis by physical examination and/or imaging.
* Being between the ages of 10-18

Exclusion Criteria:

Study group

* Those diagnosed with non-idiopathic scoliosis.
* Individuals who develop scoliosis after the age of 18.
* Individuals with scoliosis under the age of 10.
* Those diagnosed with a genetic disease.
* Those diagnosed with any disease known to play a role in the etiology of scoliosis.

Control group

* Those who have physical examination suspicion of scoliosis.
* Those with a Cobb angle of 10 degrees or more on plain radiographs.
Anesthetic Cost Analysis With Desflurane in Automated Gas Control Mode

Inhalation agents constitute the major part of anesthetic drug costs (20% - 25%) and a significant portion of the applied inhalation agents are thrown into the atmosphere through the waste gas system without being absorbed by the patient. The amount of waste gas is directly correlated to the fresh gas flow (FGF). Reducing the TGA during general anesthesia reduces the consumption of inhalant agents and contributes to the reduction of greenhouse gas pollution. Risks such as hypoxia, hypercapnia, inadequate depth of anesthesia and potential toxic gas accumulation were associated with low flow anesthesia, but the patient was provided with adequate safety by following pulse oximetry, capnography, FiO2 and anesthetic gas analysis. We aimed to perform anesthetic cost analysis and patient security in automated gas control mode (AGC).

After the ethical approvel 60 adult patients scheduled for hepatectomy will be taken to study. Patients will be monitored after they are taken to the operating room (ECG, NIBP, SpO2, Body Temp, BIS, NIRS, PVI, PI, ORI). After the anesthesia induction and tarakeal entubation, first twenty patient will take 300 mL fresh gas flow with AGC mode (group 1), Second twenty patient will take 600 mL fresh gas flow with AGC mode (group 2), third twenty patient will take 600 mL fresh gas flow with manually. Hemodynamic and gas consumption data will be recorded. An operating room will be reserved for this study.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing hepatectomy with general anesthesia

Exclusion Criteria:

* Essential data missing
* Patient participating in other research projects
* Drug allergy
* Anesthetic complication story
Effect of Vitis Vinifera Extract on Oxidative Stress, Inflamatory Biomarkers and Hormones in High Trained Subjects

There is evidence that intense physical activity has a potential effect on thrombotic events due to catecholamine release. The hormones leptin and adiponectin have been used as markers of cardiovascular risk, but they are few and contradictory studies that relate physical training intensity and duration of high plasma concentrations of these hormones. The use of antioxidants, such as proanthocyanidins present in grapes, may help in reducing the undesirable effects of intense training.

Fifty four Brazilian healthy military without hyperglycemia, diabetes mellitus and endocrine disease were enrolled in this study. All subjects were high physically military trained. The Ethical Committee of the Universidade do Estado do Rio de Janeiro in Brazil (COEP008/2011) approved the study protocol. Informed consent was obtained from each subject after explanation of purpose and risks of all procedures used.

Eligibility Criteria:
Inclusion Criteria:

* Healthy physically active men

Exclusion Criteria:

* Diabetes, hypertension, obesity subjects, drug use
Resilience Curriculum for Novice Physicians-in-training

To determine the feasibility of delivering a structured resilience curriculum to novice physicians-in-training, we propose a pilot study to evaluate recruitment rates, course attendance and compliance with follow-up surveys. If our study can demonstrate feasibility in course delivery, further engagement of postgraduate specialty programs will facilitate conduct of an appropriately powered randomised controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* All first and second year medical residents enrolled in the Schulich School of Medicine \& Dentistry Anesthesia \& Emergency Medicine postgraduate residency programs.

Exclusion Criteria:

* None
Total Knee Replacement Study Using Standard Cutting Guide vs Otismed MRI Generated Cutting Guide

Patients are referred to the VA orthopedic surgical clinic because of osteoarthritis and are requesting consideration for a total knee replacement. Those who qualify for the knee replacement are informed about the study. Those who consent to participate are randomly assigned to either the standard cutting guide or to the new method which is a MRI generated cutting guide called Otismed. All patients have an MRI so both groups will be unaware of which surgical technique is used. All patients receive the usual pre-op care and same type of replacement knee. Follow-up research visits are scheduled at 4 weeks, 3 and 6 months, and 1 and 2 years. Patients will be informed of which surgical technique they were randomized to at the conclusion of the study.

Objective(s):

Primary:

Compare the surgical and clinical outcomes between patients receiving total knee replacement after random assignment to one of two groups:

1. surgical procedure with the standard knee cutting guide and
2. surgical procedure with the Otismed MRI generated cutting guide

Secondary:

Evaluate the cost benefit ratio related to the two different cutting guide uses.

Research Plan: All patients that are referred to orthopedics, are eligible for a total knee replacement for osteoarthritis and meet study criteria will be invited to participate. Patients will be randomly assigned to either the standard or the Otismed group. All patients will have a MRI of the knee. Patients and the research staff conducting measurements will be blinded to the type of cutting guide used for the surgery.

Methods: The study will be a randomized trial with the patient and data collector blinded to type of cutting guide used for the surgical procedure. The study will be conducted at one site and enrollment goal is 100 patients. Data collection will be done preoperatively and at 4 wks, 3 months, 6 months, one year and two year. Established instruments, the (Western Ontario and McMaster Universities Osteoarthritis Index) Womac and Oxford Knee Score, will be used. Measurements will be done to evaluate ROM (Range Of Motion) and assess post-op recovery. Surgical data and hospitalization data will be used for analysis of costs. Statistical analysis will be used for comparison of the two groups.

Eligibility Criteria:
Inclusion Criteria:

* All Veterans that are referred to orthopedics surgical clinic for a total knee replacement for osteoarthritis and meet study criteria will be invited to participate.

Exclusion Criteria:

* Patients who have undergone osteotomy, had previous healed tibia or femur fractures, previous joint replacement surgery or cannot have an MRI will be excluded.
A Randomized Controlled Trial of Inhaled Amphotericin B for Maintaining Remission in Allergic Bronchopulmonary Aspergillosis

Inhaled amphotericin, a antifungal drug would decrease Aspergillus colonization and decrease the occurrence of exacerbations of Allergic Bronchopulmonary Aspergillosis (ABPA).


Eligibility Criteria:
Inclusion Criteria: ABPA in remission defined as follows:

1. Age 12-65 years
2. Diagnosis of ABPA in the Chest Clinic
3. Received glucocorticoids for management of ABPA according to the Chest clinic protocol (0.5 mg/kg/day for 4 weeks, 0.25 mg/kg/day for 4 weeks, 0.125 mg/kg/day for 4 weeks, subsequently taper and stop steroids over the next 4 weeks).
4. Clinicoradiologic improvement with decline in IgE levels. The chest radiograph and IgE levels after four months of steroid therapy would serve as the baseline

Exclusion Criteria:

1. Failure to provide informed consent
2. Pregnancy
3. Involved in any other research protocol
ALK21-025: Vivitrol's Cost and Treatment Outcomes Registry

The objective of the VIVITROL Registry is to gather real world data on opioid dependence and to provide understanding of the health economics of opioid dependence.

The VIVITROL Registry is an observational, open-label, single-arm, multi-center registry of patients who have initiated treatment with VIVITROL for prevention of relapse to opioid dependence, following opioid detoxification.

The objectives of the VIVITROL Registry are:

* To describe characteristics of patients receiving VIVITROL for opioid dependence in real-world clinical practice.
* To assess clinical, health economic, and health-related quality of life (HRQOL) outcomes in a broad population of patients receiving VIVITROL in real-world clinical practice.
* To provide additional data to inform future research on VIVITROL.

Patients 18 years of age or older who have been determined by their participating prescriber to be an appropriate candidate for VIVITROL treatment may be offered enrollment into the registry. The decision to treat a patient with VIVITROL will be made by the patient's participating prescriber independent of the registry. VIVITROL will not be provided to patients enrolled in the registry in exchange for their participation; patients will receive commercially available VIVITROL via a standard prescription that will be filled through standard commercial channels.

Patients will be observed while receiving VIVITROL and for six months after they discontinue VIVITROL use. The registry is non-interventional; it will neither direct the treatment plan for enrolled patients nor define the frequency of follow-up visits of each patient. A patient's participation in the registry will not influence or direct patient treatment procedures or follow-up care. It is expected that patients will be seen at least once per month during active VIVITROL treatment to receive their monthly injection.

During the standard monthly injection visits, patients will be asked to provide detailed health economics information using a variety of questionnaires, including the EQ-5D and SF-12v2.

Eligibility Criteria:
Inclusion Criteria:

* Patient is aged 18 years or older
* Patient is diagnosed with a current opioid dependence for which treatment with VIVITROL is being initiated
* Patient has provided written informed consent
* Patient is willing and able to provide the information to be collected via the registry's interviews and questionnaires
* Patient expects to be available for ongoing registry participation

Exclusion Criteria:

* Prior use of VIVITROL
Endothelial Vasomotor Function in the Framingham Study

To determine whether the presence of endothelial dysfunction is an independent risk factor for cardiovascular disease events.

BACKGROUND:

Current research suggests that loss of the vasodilator, anti-thrombotic, and anti-inflammatory properties of the vascular endothelium plays a dynamic role in the pathogenesis of cardiovascular disease. Impaired endothelial function, including impaired nitric oxide-dependent vasodilation is associated with cardiovascular disease risk factors. Further, there is growing evidence that endothelial function can be improved by risk modification. However, the available studies have not definitively resolved the issue of the cross-sectional correlates of endothelial dysfunction because they have been limited to small samples of highly selected patients. For example, it remains unclear whether hypercholesterolemia, hypertension, or elevated glucose levels are independent determinants of endothelial dysfunction. Most importantly, no study has shown a relation between endothelial dysfunction and increased cardiovascular risk. Such a demonstration would increase our understanding of the pathogenesis of cardiovascular disease and aid clinicians in identifying high risk individuals who would benefit most from intervention.

DESIGN NARRATIVE:

Using non-invasive brachial artery ultrasound, endothelial function was examined in about 3,800 men and women of the Framingham Heart Study. The cross-sectional correlates of endothelial function with known coronary risk factors were examined and cross-sectional analyses were performed on the relation of endothelial function to prevalent cardiovascular disease. Observations were made of the adjusted relation of endothelial function to incident and recurrent cardiovascular events. The central hypothesis was that the presence of endothelial dysfunction was an independent risk factor for cardiovascular disease events.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - PDE5 Inhibitors vs Endothelin Receptor Antagonist

This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.

This is a non-randomized, non-interventional study that is part of the DREAM Study of Brigham and Women's Hospital. DREAM is led by Dr. Madhav Thambisetty, MD, PhD, Chief of the Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging (NIA) intramural research program. This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.

Eligibility Criteria:
Please see https://docs.google.com/spreadsheets/d/19NwmDi8xwWjzXqhSLPDTg4CKHt5UDQXuwCnZwY8jCS8/edit?usp=sharing or Appendix A for full code and algorithm definitions.

Medicare timeframe: 2008 to 2018 (end of data availability).

Inclusion Criteria:

* 1. Aged \> 65 years on the index date
* 2. No prior use of PDE5 inhibitors (sildenafil, tadalafil) and endothelin receptor antagonists (bosentan, ambrisentan, macitentan) anytime prior to cohort entry date
* 3. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date

Exclusion Criteria:

* 1. Prior history of dementia measured anytime prior to cohort entry date
* 2. No prior history of pulmonary arterial hypertension recorded in the 365 days prior to cohort entry date
* 3. Prior history of nursing home admission in the 365 days prior to the cohort entry date
Effect of Blood Pressure on Cardiovascular Outcomes and Recurrence After Catheter Ablation in Patients With Atrial Fibrillation

Effect of blood pressure on cardiovascular outcomes and recurrence after catheter ablation in patients with atrial fibrillation


Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria were age \&gt;18 years and a diagnosis of AF by electrocardiogram during the preceding six months or on admission

Exclusion Criteria:

No follow-up
A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)

This is a sub-study of Study RM-493-040 (NCT05774756).

The goal of this sub-study is to learn how well Setmelanotide works to improve weight reduction, hunger, and quality of life in patients 4 years of age and older with congenital Hypothalamic Obesity (cHO). To determine how well setmelanotide works and how safe it is, patients with cHO will take a daily injection of either setmelanotide or placebo and complete trial assessments for up to 26 weeks on a therapeutic regimen.


Eligibility Criteria:
Key Inclusion Criteria:

1. Diagnosis of multiple pituitary hormone deficiency (MPHD), or septo-optic dysplasia (SOD), or optic nerve hypoplasia (ONH), or Childhood-onset combined pituitary hormone deficiency (CPHD), or Pituitary Stalk Interruption Syndrome (PSIS) with at least one pituitary deficiency AND a body mass index (BMI) of ≥30 kg/m2 for patients ≥18 years of age, or BMI ≥95th percentile for age and sex for patients 4 to \<18 years
2. Age 4 years and older
3. Weight gain associated with the hypothalamic injury and a BMI of ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th percentile for age and sex for patients 4 to \<18 years of age
4. Agree to use a highly effective form of contraception throughout the study and for 90 days after the study

Key Exclusion Criteria:

1. Diagnosis of Prader-Willi syndrome (PWS) or Rapid-onset obesity with hypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumor syndrome (ROHHADNET)
2. Weight loss \>2% in the previous 3 months for patients aged ≥18 years or \>2% reduction in BMI for patients aged 4 to \<18 years
3. Bariatric surgery or procedure within last 2 years
4. Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior
5. Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease
6. Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion)
7. History or close family history of skin cancer or melanoma
8. Participation in any clinical trial with an investigational drug/device within 3 months prior to the first trial dose
9. Previously enrolled in a clinical trial involving setmelanotide or any previous exposure to setmelanotide
10. Inability to comply with once daily (QD) injection regimen
11. If female, pregnant and/or breastfeeding.
12. If receiving hormone replacement therapy, dose has remained stable for at least 2 months before Screening

Other protocol defined Inclusion/Exclusion criteria may apply.