cyrilzakka/clinical-trials huggingface dataset:
PCSK9 Polymorphism and Risk of Cardiac Rupture

Protein convertase subtilisin/kexin type 9 (PCSK9) plays a regulatory role in cholesterol homeostasis by promoting low-density lipoprotein receptor (LDLr) degradation. Although the vast majority of the studies have focused on the role of PCSK9 in LDLr expression in the liver, an increasing body of evidence suggests that PCSK9 gene is also present in extra-hepatic tissues. A recent publication showed for the first time that PCSK9 is expressed in the ischemic heart and the expression is highest in the zone bordering the infarcted areas. Furthermore, the expression of PCSK9 is maximal early, at 1 week of ischemia.

Mechanical complications (or cardiac ruptures) are uncommon but potentially lethal sequelae of acute myocardium infarction (AMI) and are commonly associated with early mortality without appropriate surgical intervention. It's unknown why some patients develop these devasting complications following AMI, while others not. Interestingly, studies have shown that post-infarction cardiac rupture affect the border zone between the ischemic and normal area and occur within the first 3 to 5 days after AMI.

Based on the aforementioned observations, it's likely to assume a relationship between PCSK9 expression and the development of post-AMI cardiac rupture. Therefore, the main purpose of the this project is to study the PCSK9 gene polymorphism and its association with cardiac rupture. Investigators hypothesize that PCSK9 expression/secretion and development of post-AMI cardiac rupture may be a part of the dynamic changes at cellular levels occurring in the ischemic heart of genetically predisposed patients.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of acute myocardial infarction with ST sopra-elevation (control group)
* clinical diagnosis of acute myocardial infarction complicated by cardiac rupture

Exclusion Criteria:

* absence of coronary artery disease
Development of a Hospital Service That Uses Critical Pathway (Protocolized) Care Plans to Provide High-Quality, High-Reliability, Evidence-Based Medical Care

Our broad, long-term objective is to create a new non-resident (non-teaching) hospital service that uses patient-centered critical pathway care plans for treating patients in St. Marys Hospital. This innovative service, the Hospital Medicine (HOME) Team, will integrate three timely, high-priority concepts in healthcare: patient-centered quality care, evidence-based medicine, and principles that define high reliability organizations. The target populations for the new model of service are patients hospitalized with pre-defined admission diagnoses who are expected to require only a brief, focused hospital stay of four days or less. Specifically, we will 1) Design the prototypical approach to be used for developing all critical pathway care plans by integrating patient-centered quality care, evidence-based medicine, and principles that define high reliability organizations, 2) Systematically design the critical pathway care plans for two pre-defined admission diagnoses (community-acquired pneumonia and non-surgical low-back pain), and 3) Compare outcomes of this new service against respective historical patient cohorts for patients admitted with community-acquired pneumonia and non-surgical low-back pain. We anticipate that the prototypic methodology used to develop this patient-centered service will be replicated for other new hospital-service models. To our knowledge, there are currently no existing hospital services in the U.S. that have intentionally integrated principles of high reliability organizations into evidence-based critical pathways founded on patient-centered principles of uncompromising quality.


Eligibility Criteria:
1. Hospitalized patient with one of six medical diagnoses: community-acquired pneumonia, deep venous thrombosis or pulmonary embolism, cellulitis, alcohol withdrawal, pyelonephritis, low back pain.
2. Ability and agreement to consent.
An Efficacy, Safety, and Tolerability Study for TA-7284 in Patients With Type 2 Diabetes

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of TA-7284 compared with placebo in patients with type 2 diabetes.

Type 2 diabetes mellitus (T2DM) is well recognized as a major public health problem that presents patients with a significant risk of complications including heart disease, retinopathy, nephropathy, and neuropathy. Various classes of orally administered antihyperglycemic agents have been developed for the treatment of T2DM and although individual agents may be highly effective for some patients, it is still difficult to maintain optimal glycemic control in most patients, resulting in high rates of morbidity and mortality in the diabetic population. This is a randomized, double-blind, placebo-controlled, parallel-group study to demonstrate the efficacy, safety, and tolerability of TA-7284 compared with placebo in patients with T2DM, who are not optimally controlled on diet and exercise. The primary study hypothesis is that the study drug will be superior to placebo as assessed by the change in HbA1c from baseline. The patients will receive tablets of TA-7284, or placebo, once daily for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 20 to 80 years inclusive on the day of informed consent;
* Patients who was diagnosed with type 2 diabetes mellitus at least 3 months before the start of the run-in period;
* Patients with HbA1c of ≥6.5% and ≤9.5% (according to the Japan Diabetic Society \[JDS\] criteria) on the start day of the run-in period;

Exclusion Criteria:

* Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, Cushing's syndrome, etc.);
* Past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage III or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy);
* Fasting blood glucose of \>270 mg/dL on the start day of the run-in period or at Week 2 of the run-in period;
* eGFR of \<60 mL/min/1.73 m2 on the start day of the run-in period;
* Systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg on the start or end day of the run-in period;
* History of myocardial infarction, unstable angina, or cerebrovascular disorder within 3 months before the start of the run-in period;
* Concurrent serious (e.g., requiring inpatient hospitalization or surgical intervention) renal or hepatic disease;
* Past or current history of malignant tumor; however, this criterion shall not apply to those who have been free of relapse for at least 5 years even with a history of malignant tumor.
* Past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms;
* Pregnant women, lactating mothers, or women of childbearing potential;
* Any condition that subjects are assessed to be ineligible by the investigator (sub investigator).
Effects of Oriental Music on Preterm Infants

The goal of this study is to explore the effect of oriental music on premature infants' physiological and behavioral parameters during their hospital stay in the NICU.

Music exposure during care of preterm infants is the subject of increasing research. Many studies have shown positive impact of music exposure such as classical western music, lullabies or Quran on pain and physiological parameters of preterm infants in a neonatal intensive care unit (NICU) setting. No such study have explored the effect of oriental music which is the main popular music listened to in the Levant and Middle East and North Afrika (MENA) region.

We aim in this study to find out if the oriental music exposure in preterm infants improves babies' heart rate variability, physiological parameters and behavior state during their NICU stay.

Eligibility Criteria:
Inclusion Criteria:

* Clinically stable infants born between 28 and 366/7 weeks of gestation and ≥31 weeks Post Menstrual Age (PMA).
* Infants planned to stay in the NICU for at least 2 weeks at the time of enrollment.

Exclusion Criteria:

* Congenital anomaly affecting heart rate and hearing, significant brain insult (such as severe or moderate hypoxic ischemic encephalopathy, intraventricular hemorrhage (IVH) grade 3 or 4 or periventricular leukomalacia) that might affect the neurodevelopmental outcome.
* Receiving medications that might interfere with heart rate and reaction to music exposure such as midazolam or morphine.
Early Screening of Colorectal Cancer Based on Plasma Multi-omics Combining With Artificial Intelligence

To evaluate the accuracy and effectiveness of a novel screening method based on plasma multi-omics combining with artificial intelligence in a large prospective cohort for the detection of colorectal cancer and advanced adenomas.

Minimally invasive detection of circulating tumor DNA (ctDNA) in peripheral blood of patients with colorectal malignancies via liquid biopsy has emerged as a promising biomarker. This is urgently needed, as conventional imaging and plasma protein-derived biomarkers lack sensitivity and specificity.The goal of this observational study is to evaluate the effectiveness and accuracy of a novel screening method based on plasma multi-omics combining with artificial intelligence in five hospitals around China for the detection of colorectal cancer and advanced adenomas.

Eligibility Criteria:
Inclusion Criteria:

1. Inclusion criteria for colorectal cancer/advanced adenoma 1) Voluntarily participate and sign the informed consent form, and be able to cooperate with the entire research process 2) Be able to provide sufficient and qualified blood samples for this study 3) Patients with pathological diagnosis of colorectal cancer stage I-III (TNM staging according to AJCC 8th edition colorectal cancer staging system) 4) No previous cancer treatment, including chemotherapy, radiotherapy, targeted or immunotherapy, and any surgery treat 5) Advanced adenoma should at least meet one of the following conditions: ① Diameter \>10mm ② Villus-tubiform adenoma ③ More than 25% of villi structure in mixed adenoma ④High-grade intraepithelial neoplasia
2. Inclusion criteria for healthy people 1) Voluntarily participate and sign the informed consent form, and be able to cooperate with the entire research process 2) Diagnosed without colorectal adenoma or cancer by colonoscopy within 12 months

Exclusion Criteria:

1. Exclusion criteria for colorectal cancer/advanced adenoma 1) Women who are pregnant or breastfeeding 2) Currently diagnosed with another cancer or have a history cancer 3) Persistent fever or receiving anti-inflammatory treatment within 14 days before blood samples are taken in this study 4) Receiving blood transfusion within 30 days 5) Receiving organ transplantation or previous non-autologous (allogeneic) bone marrow or stem cell transplantation 6) Digestive tract bleeding, obstruction, perforation and any trauma or surgery within 3 months 7) Poor physical condition, not suitable for extraction blood samples 8) Subjects who are judged by the investigator to be unsuitable to participate in this study for other reasons;
2. Exclusion criteria for healthy people 1) Women who are pregnant or breastfeeding 2) Receiving organ transplantation or previous non-autologous (allogeneic) bone marrow or stem cell transplantation 3) Have a history cancer 4) Receiving blood transfusion within 30 days 5) Poor physical condition, not suitable for extraction Blood samples 6) Diagnosed with precancerous lesions by colonoscopy.
Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor

RATIONALE: Donepezil and EGb761 may be effective in improving neurocognitive function (such as thinking, attention, concentration, and memory) and may improve quality of life in patients who have undergone radiation therapy to the brain.

PURPOSE: This phase II trial is studying how well donepezil or EGb761 works in improving neurocognitive function in patients who have undergone radiation therapy for primary brain tumor or brain metastases.

OBJECTIVES:

Primary

* Determine the effect of donepezil or EGb761 on neurocognitive function in patients who underwent radiotherapy for a primary brain tumor or brain metastases at least 6 months before study registration.

Secondary

* Determine the toxicity of these drugs in these patients.
* Determine the quality of life of patients treated with these drugs.
* Quantify the extent of radiation-induced white matter disease and temporal lobe atrophy in patients treated with these drugs.

OUTLINE: This is an open-label, multicenter study.

* Group 1 (closed to accrual 10/09/03): Patients receive oral donepezil once daily for 24 weeks.
* Group 2: Patients receive oral EGb761 three times daily for 24 weeks. In both groups (group 1 closed to accrual 10/09/03), treatment continues in the absence of unacceptable toxicity.

In both groups (group 1 closed to accrual 10/09/03), quality of life and neurocognitive assessment is performed at baseline and at weeks 6 (group 1 only), 12, 24, and 30.

Patients are followed at 6 weeks.

PROJECTED ACCRUAL: A total of 70 patients (35 per treatment group) will be accrued for this study within 9.5 months. (Group 1 closed to accrual 10/09/03)

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of primary brain tumor or brain metastases, meeting 1 of the following criteria:

  * No radiographic evidence of disease
  * Stable disease, defined as no tumor progression within the past 3 months
* Previously treated with 1 course of localized or whole brain radiotherapy of at least 3,000 cGy at least 6 months before study registration

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Karnofsky 70-100%

Life expectancy

* At least 30 weeks

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Not pregnant or nursing
* Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No concurrent chemotherapy

Endocrine therapy

* Concurrent steroid therapy allowed if on stable or decreasing dose

Radiotherapy

* See Disease Characteristics
* No concurrent cranial radiotherapy

Surgery

* No concurrent surgery

Other

* More than 3 months since prior donepezil or EGb761
* No concurrent donepezil (group 2 only)
* No concurrent EGb761 (group 1 only) (closed to accrual 10/09/03)
* No concurrent anticoagulants (e.g., aspirin, dipyridamole, heparin, warfarin, or enoxaparin) (group 2 only)
* No concurrent monoamine oxidase inhibitors (e.g., phenelzine or tranylcypromine)
* No other concurrent therapy
Oral Pyridoxal 5'-Phosphate for the Treatment of Patients With PNPO Deficiency

The proposed clinical study is intended to evaluate oral P5P for the treatment of patients confirmed to have Pyridox(am)ine 5'-Phosphate Oxidase (PNPO) deficiency via genetic analysis. There is an unmet clinical need for pharmaceutical grade P5P, as to date none has been made commercially available. Patients will receive pharmaceutical grade P5P according to their normal oral P5P dosing regimen, as previously established by their physicians.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with confirmed PNPO deficiency via genetic analysis, whose seizures are typically controlled on P5P (oral) therapy.

   a. Typically controlled is defined as receiving multiple doses of P5P daily to control seizures. Receiving P5P for a minimum of 30 days.
2. Male and/or female patients.
3. Patients with previous failed treatment on pyridoxine are eligible for the study (patient should be off pyridoxine for at least 24 hours).
4. Written informed consent (by parent or guardian if under the age of 18).

Exclusion Criteria:

1. The patient has any condition or abnormality which may, in the opinion of the Investigator, compromise the safety of the patient, or influence their ability to comply with study procedures.
2. Known or suspected allergy to the trial drug or the relevant drugs given in the trial.
3. Involvement in a clinical research study within 4 weeks prior to screening and/or prior enrollment in the study. Participation in observational registry studies is permitted.
Safety and Efficacy Study to Treat Bacterial Vaginosis

The purpose of this study is to determine if product 55394 is safe and efficacious for the treatment of bacterial vaginosis.


Eligibility Criteria:
Inclusion Criteria:

* Have a clinical diagnosis of bacterial vaginosis as determined by the investigator.
* Other items as identified in the protocol.

Exclusion Criteria:

* Have a known or suspected other infectious cause of vulvovaginitis.
* Other items as identified in the protocol.
Epsilon Aminocaproic Acid (EACA) for the Reduction of Blood Loss in Total Hip Arthroplasty (THA)

You are being asked to take part in this research study because you are scheduled to have total hip replacement (arthroplasty) surgery. The goal of this study is to evaluate the effectiveness of the drug, epsilon Aminocaproic Acid (EACA), in decreasing the need for patients to receive blood after surgery. Currently, EACA is approved by the Federal Drug Administration (FDA) to treat a patient who is bleeding. The investigators plan to use EACA to prevent bleeding during and after surgery; use of this drug as a means of preventing bleeding is not currently approved by the FDA.

The goal of this prospective randomized study is to evaluate the effectiveness of a drug, epsilon aminocaproic acid (EACA), in reducing the frequency of postoperative blood transfusion following primary total hip arthroplasty. In our institution, up to 40% of patients with a preoperative of 13.5 g/dl or less undergoing total hip arthroplasty will require a blood transfusion. Fibrinolytic drugs such as EACA and tranexamic acid (TA) have been shown to decrease blood loss during surgery and decrease the likelihood of blood transfusion during postoperative hospitalization.. Both drugs decrease the body's ability to break down a blood clot, thus pushing the balance of blood clot formation and breakdown towards clot formation. This mechanism can decrease the amount of blood loss during and after a surgical procedure. The haemostatic effect of EACA has been investigated in multiple studies with the majority showing a positive effect on postoperative hemoglobin levels and decreased blood transfusion rates. Though several studies exist revealing the effective and safe use of perioperative TA, a similar drug to EACA, there is a paucity of information on the use of EACA in total joint arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

1. Scheduled for a primary total hip arthroplasty to be performed at the Mayo Clinic
2. A preoperative hemoglobin between 10.0 and 13.5

Exclusion Criteria:

1. A preoperative hemoglobin less than 10.0 or greater than 13.5
2. Revision arthroplasty;
3. Arthroplasty performed for acute fracture
4. Inability to obtain informed consent;
5. Allergy to EACA
6. Pregnancy
7. History of coronary stenting \< 6 months
8. Heart valve replacement;
9. Renal disease,
10. Coagulopathy, DIC,
11. embolic stroke
Safety of Capsule Endoscopy in Patients With Implantable Cardiac Devices

This is a prospective study designed to assess safety and potential influence of the MiroCam on cardiac pacemaker and implantable cardiac defibrillator.

MiroCam (IntroMedic, Ltd, Seoul, Korea) is a small bowel capsule endoscope using human body communication for data transmission. There is a concern of potential interactions between cardiac devices and capsule endoscope. This clinical study was designed to evaluate the potential influence of the MiroCam on cardiac pacemaker and implantable cardiac defibrillator.

Eligibility Criteria:
Inclusion Criteria:

1. age 20 years or older
2. cardiac pacemaker or implantable cardiac defibrillator
3. gastrointestinal disease

Exclusion Criteria:

1. previous GI perforation or obstruction history
2. known or suspected GI stricture
3. marked GI dysmotility
4. uncompensated heart failure (EF ≤30% or Killip's classification class ≥ III)
5. pregnancy
Cognitive Motor Therapy Applications Using Videogame Platform

This study designs and develops an evidence-based game approach that will enhance the investigators understanding and usability of electronic tools to measure cognitive and sensorimotor abilities in an inpatient rehabilitation stroke population.

The rehabilitation industry is the incipient stages of developing and using electronic based assessment and intervention tools. With the growing understanding of cognitive recovery following stroke, rehabilitation specialists are optimistic that appropriate rehabilitation interventions may optimize and enhance functional outcomes. The use of technology based assessments via video games may assist in a patient's cognitive recovery. Design and development of an evidence-based game approach will enhance the investigators understanding and usability of electronic tools to measure cognitive and sensorimotor abilities. There is no intervention only an assessment for usability.

Eligibility Criteria:
Inclusion Criteria:

* New onset stroke
* Ability to follow one-step commands

  * All participants must be admitted to the inpatient rehabilitation unit at Cedars-Sinai Medical Center
  * Scores needed for Participation in Study on the Complex Ideational Material-Short Form from the Boston Diagnostic Aphasia Examination and the Montreal Cognitive Assessment:
* Complex Ideational Material-Short Form from the Boston Diagnostic Aphasia Examination-Participants must obtain a total score of at least 5/6 item pairs to participate
* Montreal Cognitive Assessment-Participants must obtain a total score of 16 or greater and obtain a score of 6/6 on the orientation subtest
* In order to participate, participants must meet both of the above criteria

Exclusion Criteria:

* Patients who do not meet inclusion criteria as noted above.
Reducing Symptoms of Multiple Sclerosis Using Non-invasive Neuromodulation

This study sought to examine the effect of targeted physical therapy with and without cranial nerve non-invasive neuromodulation (CN-NINM), on the walking ability of people with MS who exhibited a dysfunctional gait.

Background: This study sought to examine the effect of targeted physical therapy with and without cranial nerve non-invasive neuromodulation (CN-NINM), on the walking ability of people with MS who exhibited a dysfunctional gait. The investigators hypothesized that subjects who received electrical stimulation would have greater improvement than those who had a control device after a 14-week intervention. Gait disturbance is a common problem for people with multiple sclerosis (MS). The investigators have developed an effective rehabilitative strategy using neuromodulation of the cranial nerves via electrical stimulation of the tongue to enhance the plasticity of the brain.

Methods: The study is a within-subject blinded randomized control design. Twenty chronic MS subjects with an identified gait disturbance were assigned to either an active or control group. Both groups completed a 14-week intervention program using a standardized combination of exercise and a device that provided electrical stimulation to the tongue. Those in the active group received electrical stimulation on the tongue that they could perceive. Those in the control group used a device that did not provide a physiologically significant stimulus and was not perceivable. Subjects were assessed with the Dynamic Gait Index (DGI).

Eligibility Criteria:
All subjects are initially evaluated for inclusion/exclusion on the Kurtzke Expanded Disability Status Scale (EDSS), a test typically administered by their healthcare provider as an ongoing part of standard therapy for M.S

Inclusion Criteria:

* Relapsing remitting MS ("RRMS"), primary progressive MS ("PPMS"), or secondary progressive MS ("SPMS") without relapse within 6 months of enrollment;
* EDSS score of 3.0 - 6.0 ;
* No changes in medication within 3 months of enrollment;
* Ability to walk 20 minutes on a treadmill (with handrail support as needed) without rest;
* Provided informed consent and willing to participate.

Exclusion Criteria:

• Major co-morbidities, especially other neurological disorders, uncontrolled pain, hypertension, diabetes, or oral health problems