cyrilzakka/clinical-trials huggingface dataset:
DNA Methylation Trajectories in Aging

The goal of this observational study is to profile changes in DNA methylation of circulating CD4+ T and CD8+ T cells from healthy young to aged with diagnosis of HFpEF, a particular phenotype of HF which is highly prevalent in aging.

The main question it aims to answer is:

-Do DNA methylation biomarkers help us to understand the role of inflammation in HFpEF during aging?

Our goal is to provide a simple large-scale panel of epigenetic-sensitive biomarkers useful in aged patients with HF in the early natural history of the disease (HFpEF).


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects aged between 18 and 40 years
* Aged subjects (≥65) without signs and symptoms of heart failure
* Aged subjects (≥65) with diagnosis of heart failure with preserved ejection fraction (EF major than 50%)

Exclusion Criteria:

* Heart failure with reduced ejection fraction (EF minor than 40%)
* Heart failure with mildly reduced EF (HFmrEF) (EF 41-49%)
* History or diagnosis of cancer and inflammatory diseases
Relation Between Complication in Repeated Cesarean Sections, Newborn Outcome and Surgical Characteristics and Maternal Information

To examine the relation between complication in Repeated Cesarean Sections and Newborn Outcome compared to number of repeated cesarean section and reasonf or surgery and personal medical information to the mother


Eligibility Criteria:
Inclusion Criteria:

women who had at least one cesarean section -

Exclusion Criteria:

women that this was their first cesarean section

-
Bikes For Life: Measuring the Effects of a Bicycle Distribution Program on Pediatric Obesity

The investigators propose a study to evaluate the success of a bicycle distribution program in increasing physical activity level, decreasing sedentary activity levels and positively affecting body-mass index (BMI) in participants aged 6 to 12 years old with overweight or obesity, who do not already own a bicycle, and are patients at the Children's Hospital Colorado Child Health Clinic (CHC), Lifestyle Medicine Clinic, or Rocky Mountain Youth Clinics. The investigators anticipate that the receipt of a bicycle will increase physical activity level, decrease sedentary activity time and decrease or stabilize patients' BMI. The investigators will answer this research question by distributing bicycles to 525 children and conducting follow up visits over the course of a year to measure the outcomes of interest.


Eligibility Criteria:
Inclusion Criteria:

* Ages 6-12 years
* Do not own a bicycle
* BMI over 85% for age (overweight or obese)

Exclusion Criteria:

* Outside of state age range
* Not overweight or obese
* Already own a bicycle.
My MediHealth: A Paradigm for Children-centered Medication Management

The last mile of the medication use system requires tools to help patients comply with medication administration rules and monitor for side effects. Personal health records (PHR) and emerging user-adopted communication tools promise to change the landscape of medication management. The overarching goal of the MyMediHealth project is to investigate ways in which PHRs and supported applications can improve the safety and quality of medication delivery. Preliminary work in this area by a team of parents, patients and school/clinic health providers created a vision for MyMediHealth, a next-generation medication management system. MyMediHealth was envisioned to allow home-based, school-based, and other caregivers to ensure safe and effective medication delivery. This vision featured just-in-time medication reminders to children with special health care needs, two-way communication to log when doses have been administered or when side effects have occurred, and mechanisms to warn caregivers about side effects and drug interactions. However, much of this work was done using prototypes, storyboards, and vision videos. Recognizing that this vision cannot be carried out without significant changes in processes and policies, the purpose of this proposed study is to evaluate the impact of medication management tools such as MyMediHealth on medication adherence for children with chronic illnesses. Specifically, the investigators hypothesize that compared with usual practice, children using mymedihealth will have improved medication adherence and will report improved (decreased) asthma symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Access to the internet Caregiver agrees to let child use the Internet for the project Internet service working properly Legal guardian approves of study Child with her or his own cell phone

Exclusion Criteria:

* non English or spanish speaking family
A Follow-up Study to Evaluate the Efficacy and Safety of Novomax in Posterior Lumbar Interbody Fusion

This is a long-term follow-up study for more than 3 years to evaluate the efficacy and safety of bioactive glass-ceramic intervertebral spacer (Novomax) in posterior lumbar interbody fusion.

During one-level PLIF, bioactive glass-ceramic intervertebral spacer (Novomax) and titanium cage were inserted in the experimental group and control group, respectively. Bone fusion by simple radiography had angular deformity of less than 3 degrees and a potential of less than 3 mm in flexion extension radiographs, and thin-section CT (\<2 mm) was used to determine the combination between the vertebral endplate and the autogenous bone or bioactive glass-ceramic intervertebral spacer (Novomax) in the cage without any gaps or the part connected to bony trabecula as fusion, and both groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

\[In Interventional Study\]

* Subjects who required between L1 and S1 among those who required an extensive laminectomy or facetectomy to correct severe disc extrusion or severe spinal stenosis or those who required PLIF due to grade I or II spondylolisthesis

\[In Long-term Follow-up Study\]

* Subjects who are treated with bioactive glass ceramic intervertebral spacer or titanium cage in one-level PLIF surgery

Exclusion Criteria:

\[In Interventional Study\]

* Subjects with average T-scores of L1-L4 at \<-3.0 in DEXA bone density tests
* Subjects who are pregnant or breast-feeding
* Subjects with a history of malignant tumor or malignant diseases (but the cases of cured disease with no relapse for the past 5 years were included in the present study)
* Subjects with abnormal blood potassium and phosphorus levels
* Subjects who are considered not suitable for the study by significant disease(liver disease, kidney disease, respiratory disease, metabolic disease, or psychological disease)
* Subjects who are not able to comply with the study requirements
* Subjects who are considered not suitable for the study by the investigator

\[In Long-term Follow-up Study\]

* Subjects who are not able to comply with the study requirements
* Subjects who are considered not suitable for the study by the investigator
Effect of Tadalafil on the Quality of Life and Sexual Life in Erectile Dysfunction

Study is a clinical study assessing the effect of oral tadalafil 10mg or 20 mg on psychosocial aspects and quality of life of erectile dysfunction patients and to compare tadalafil with previous oral erectile dysfunction medication. Study period is 13 weeks. Study patients fill in quality of life questionnaires and treatment satisfaction questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* have a history of erectile dysfunction (defined as a consistent change in the quality of erection that adversely affects the patient's satisfaction with sexual intercourse)of at least 3 months duration
* have been using any oral prescription medication,but not tadalafil, for erectile dysfunction for a minimum period of 3 months before visit 1
* have responded to previous erectile dysfunction medication as assessed by the investigator

Exclusion Criteria:

* exhibit evidence of clinically significant hepatobiliary disease (including jaundice) at visit 1
* cardiovascular exclusion criteria: history of chronic stable angina treated with nitrates, recent acute cardiovascular events or procedures (myocardial infarction, coronary interventions, stroke, etc.), history of other serious cardiovascular events (e.g. arrhythmias, sudden cardiac arrest, congestive heart failure, etc.), systolic blood pressure \<90mmHg or diastolic blood pressure \<50mmHg at screening
* receiving treatment with cancer chemotherapy
The Influence of Oxytocin on Automatic Imitation Behaviour in Healthy Adults

In this study, the influence of oxytocin on automatic imitation behaviour is investigated. Healthy adults will be administered with either oxytocin or a placebo, and will perform an imitation-inhibition task (as a measure of automatic imitation behaviour). To determine the specificity of the oxytocin effect, an unrelated cognitive task (Stroop task) will also be presented.


Eligibility Criteria:
Inclusion Criteria:

* Male
* non-smoker

Exclusion Criteria:

* no pacemaker, deep brain stimulation electrodes or other stimulation devices
* normal neurological history (no brain operations, migraine, epilepsy, alcoholism
* no epilepsy in family
* no chronic disease(s) that require constant medication (asthma, hypertension, diabetes)
* no medication 24h prior to experiment
* no alcohol or caffeine 2h prior to experiment
* no sleep deprivation 24h prior to experiment
Sphenopalatine Block Vs Dexmedetomidine Infusion in Trans Nasal Endoscopic Pituitary Surgery

Improving pain and surgical field by using sphenopalatine ganglion block and dexmedetomidine in trans-nasal endoscopic pituitary surgery.

Pituitary neoplasm is one of the most common sellar pathology. Trans-nasal endoscopic pituitary surgery (TEPS) evolved rapidly, almost replacing the craniotomy approach. TEPS, a surgical instrument, is primarily executed through a minimally invasive approach through the nostril to access a pituitary tumor.

That is why the anesthetic plan must ensure the best possible surgical field visualization and the most adequate analgesia.

Multimodal anesthesia including regional and general anesthesia are obtained to optimize surgical field by decreasing bleeding, reduce pain, promote rapid recovery and potential economic gains for the hospital.

The sphenopalatine ganglion block (SPGB) is considered one of the regional anesthetic techniques that is safe and easy anesthetic procedure used to control bleeding and for postoperative analgesia.

Dexmedetomidine (DEX) has become popular for induced hypotension. It is an α2-adrenoceptor agonist with a sympatholytic and analgesic effect. It provides a unique conscious sedation without respiratory depression. It is used effectively in optimizing surgical field through its hemodynamic stability effect.

Eligibility Criteria:
Inclusion Criteria:

* Age: between 21-64 years old.
* sex: males and females.
* Body mass index: 35 kg/m2.
* ASA Physical status: grade Ⅰ-Ⅱ.

Exclusion Criteria:

* patients receiving beta blockers, anti-coagulants and antihypertensive medications also patients receiving clonidine or benzodiazepines, neuroleptics or antidepressants two weeks prior to the study.
* Any contraindication for regional anesthesia e.g. coagulopathy, infection at site of block and hypersensitivity to any drug used in this study.
* Patients who are known to be drug addict.
Study to Compare the Safety and Pharmacokinetic Characteristics of LBEC0101 25 mg With Those of Enbrel®

To compare the pharmacokinetic characteristic of LBEC0101 25mg with the active comparator, Enbrel® 25 mg.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males, 20 to 45 years of age the moment of screening
* Body mass index is between 18.0 and 30.0 kg/m

Exclusion Criteria:

* The tuberculosis patient or latent tuberculosis patient
* Hypersensitivity response to the test and comparator drugs
Comparison of Remnant Preserving Versus Remnant Resecting Anterior Cruciate Ligament Reconstruction

Anterior cruciate ligament injury is very common knee injury. Especially Anterior cruciate ligament complete rupture leads to knee joint instability and degenerative change of the knee. Anterior cruciate ligament reconstruction is performed for resolving these problems and it gives excellent results. For leading to successful result of anterior cruciate ligament reconstruction, selecting of appropriate femoral tunnel and tibial tunnel is necessary. If selecting inappropriate tibial tunnel location makes pain, synovitis, impingement of transplanted tendon, loss of range of motion, instability, failure of transplantation and risk of arthritis. It is known that selection of inappropriate tibial tunnel location is the most common cause of anterior cruciate ligament reconstruction failure.

Recently many studies reconstructed at anatomical lesion instead of isometric point. And some cadaver studies reported that tibial insertion of anterior cruciate ligament has "C" shape. There are two methods for anterior cruciate ligament reconstruction. One is preserving remnant and the other is removing remnant.

This study aims to compare the tibia and femoral tunnel location of remnant preserving and remnant resecting anterior cruciate ligament reconstruction.

The study design is a double-blind randomized controlled trial. Randomly, twenty patients planed to undergo anterior cruciate ligament reconstruction using autograft by remnant preserving and other twenty patients undergo anterior cruciate ligament reconstruction using autograft by resecting anterior cruciate ligament. The clinical outcome is comparative preoperative, postoperative 6weeks, 3months, 6months and 1years. And clinical score consists of Visual Analog Score, lachman test, anterior laxity, Lysholm knee score, international knee documentation committee score. Femoral and tibial tunnel location will be analyzed by three-dimensional computed tomography using Bernard quadrant method after surgery.

The present study aimed to determine and compare (1) the accuracy of tibia and femoral tunnel location and (2) postoperative functional outcome after anterior cruciate ligament reconstruction between remnant preserving group versus remnant resecting group.

Eligibility Criteria:
Inclusion Criteria:

* over 19 years old
* patients for ACL reconstruction having medicare insurance

Exclusion Criteria:

* infection
* previous surgery experience
* progressive osteoarthritis
Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression

The protocol involves functional Magnetic Resonance Imaging acquisitions immediately before and after Low Field Magnetic Stimulation treatment on two separate days in a sham controlled, randomized trial, in order to assess the physiologic effects of Low Field Magnetic Stimulation on brain function in a geriatric population with bipolar depression.

In this study, the investigators will examine changes in brain activity from Low Field Magnetic Stimulation in subjects over the age of 50 with bipolar disorder who are currently depressed using functional Magnetic Resonance Imaging. Following screening visits, study procedures include two visits, at least two weeks apart, during which subjects will complete brief mood scales, undergo up to 15 minutes of imaging, receive 20 minutes of Low Field Magnetic Stimulation treatment, and then return to the scanner to undergo up to 15 minutes of imaging procedures. Due to the crossover design, subjects receiving active treatment during the first visit will receive sham treatment during the second visit; subjects receiving sham treatment during the first visit will receive active treatment during the second visit. A follow-up phone call will occur at least two days after each imaging/treatment visit. The main endpoint of this study is the observation of changes in resting state functional Magnetic Resonance Imaging activity in post-treatment acquisitions as compared to pre-treatment acquisitions.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects will have a diagnosis of Bipolar Disorder Type I or II, current episode depressed as measure by a MADRS ≥ 20.
2. Subjects must be maintained on a stable dose of all psychotropic medications for a period of at least two weeks prior to screening.
3. Subjects must be capable of providing informed consent.
4. Subjects must permanently reside within a 2-hour drive of McLean Hospital.
5. Subjects must be currently seen by a provider (psychiatrist, therapist, PCP) whose practice is within a 2-hour drive of McLean Hospital.

Exclusion Criteria:

1. Dangerous or active suicidal ideation, as measured by the C-SSRS (see "Safety Measures" section), and physician evaluation.
2. Subjects meeting DSM-5 criteria for schizophrenia, schizoaffective disorder, or other psychotic disorders, or dementia.
3. Current mania as defined by a score of ≥ 10 on the Young Mania Rating Scale at screening.
4. Subject has an MMSE score ≤ 24.
5. Subject is pregnant or plans on becoming pregnant.
6. Subject has recent history (within 7 days of screening) of ECT or TMS treatment.
7. Subject has recent history of substance abuse (cannot meet DSM-5 criteria for substance abuse, no significant drug abuse within last 3 months, no history of dependence in last year, no drug use within last month, other than marijuana use).
8. Subject has any contraindication for MRI (i.e. Presence of a pacemaker, neurostimulator, or metal in head or neck).
the Change of CEM and the Prognosis of Coronary Artery Disease in Real Clinical Practice

The purpose of this study is to investigate the change of total cholesterol content of erythrocyte membranes (CEM) in patients with coronary artery disease treated with secondary prevention drugs, and the correlation with the prognosis.

In this clinical trial, plasma samples, the red cells and associated clinical data of patients with coronary artery disease were collected from Department of Cardiology of Lu'an Shili Hospital and the First Affiliated Hospital of Jinan University. Blood samples collected from all the participants at baseline (prior to the follow-up) and the time points of follow-up were placed into ordinary test tubes and stored at 4°C for less than 4 hours. After centrifuged, plasma and erythrocyte membranes was separated and stored at -80°C. The change of total cholesterol content of erythrocyte membranes (CEM) was measured. A follow-up form was designed according to the research purpose and discussed among the team members. The follow-up was performed through telephone by the trained investigators with good communication skills and knowledge on the diagnosis and treatment of coronary artery disease. Patients were followed up every six months from the day of discharge. The results of the follow-up were entered into the database, a process that was carried out by a designated person and double-checked by an independent person. The primary clinical endpoints were composite atherosclerotic cardiovascular disease outcomes, defined as nonfatal myocardial infarction, nonfatal stroke, or cardiovascular mortality. Secondary clinical endpoints were revascularization, including percutaneous coronary intervention and coronary artery bypass grafting, and Class IV heart failure requiring hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent;
* First diagnosis of CAD through CAG;
* Aged 45-70.

Exclusion Criteria:

* Patients with severe liver or kidney damage;
* Taking statins within the last 3 months;
* Patients who had been diagnosed with CAD and treated with oral medication;
* Chronic diseases of the blood system;
* Familial hyperlipidemia patients;
* Patients combining autoimmune disease;
* Patients combining acute infectious disease;
* Patients who undertaken surgery or injury;
* Patients who combining cancer;
* Patients who taking glucocorticoid replacement therapy;
* Abnormal red blood cell (RBC) count (M: \<4.0 or \>5.5 × 1012/L; F: \<3.5 or \>5.0 × 1012/L) or abnormal hemoglobin (M: \<120 or \>160 g/L; F: \<110 or \>150 g/L).
Virtual Reality Prolonged Exposure (PE) for Bus Bomb Survivors

This study will examine whether the use of a Virtual World will be effective in helping treat Posttraumatic Stress Disorder (PTSD). This is a pilot study, with five victims of bus bombings who have developed PTSD. The study will examine pre- and post-treatment levels of PTSD, anxiety, depression and day-to-day functioning.

PTSD can be a long-term debilitating psychiatric problem, occurring following exposure to a traumatic event. Recent studies have shown that Cognitive Behavioral Therapy is effective in the treatment of PTSD. More specifically, a protocol called Prolonged Exposure, where the patient is gradually exposed to feared stimuli, along with building a narrative of the traumatic event, has been shown to reduce PTSD and depression symptoms, both at the end of therapy (9-12 weeks) and at long term follow up.

Despite this success, some patients do not show symptom reduction with this therapy. Virtual Reality, where a real-time virtual world is created, has been successfully used to treat a variety of fears, from pain management to fear of flying. This technique has also been successfully used with patients who have not benefited from Prolonged Exposure for their PTSD, following 9/11.

This study will examine the use of a virtual reality world that involves a bus bombing. It has been created using different levels of exposure to distressing detail, such that the therapist can control the amount of exposure. The protocol is based on Prolonged Exposure, with the Virtual Reality being used to help the patient build a narrative of the event.

Five patients with PTSD following a bus bombing will be treated. They will be assessed pre and post-treatment for symptoms levels of PTSD, depression, anxiety and daily functioning. The treatment consists of 9 sessions, each lasting 90 minutes. Therapy will be supervised, and protocol adherence will be checked by an external therapist. All therapists are trained as supervisors in Prolonged Exposure.

Eligibility Criteria:
Inclusion Criteria:

* PTSD following a bus bombing
* Hebrew speaking

Exclusion Criteria:

* Other psychiatric illness
* Other concurrent intervention
A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of Clavicle Plates

The objective of the registry is to evaluate the continued safety and performance of Arthrex Clavicle Plates used to treat clavicle fractures.

To assess safety, device-related adverse events will be reported and evaluated over the course of the study. To evaluate the performance imaging of the target area will be evaluated at three months postoperative. Additionally, patient-reported outcomes will be evaluated at three months postoperative, 6 months postoperative, and one year postoperative using the Visual Analogue Scale (VAS), Veterans Rand 12-Item Health Survey (VR-12), and American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES).

Eligibility Criteria:
Inclusion Criteria:

1. The subject requires surgery using the Arthrex Clavicle Plate for clavicle fracture.
2. The subject is 18 years of age or over.
3. The subject is not considered a vulnerable subject (i.e., child, pregnant, nursing, prisoner, or ward of the state).
4. Subject signed informed consent and is willing and able to comply with all study requirements

Exclusion Criteria:

1. Insufficient quantity or quality of bone.
2. Blood supply limitations and previous infections, which may retard healing.
3. Foreign-body sensitivity.
4. Any active infection or blood supply limitations.
5. Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
6. Subjects that are skeletally immature.