cyrilzakka/clinical-trials huggingface dataset:
Study of ANA773 in Healthy Volunteers and Patients With Hepatitis C Virus (HCV) to Assess Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD)

The overall study design includes two parts, Part A and Part B.

Part A evaluated ANA773 following oral administration to healthy volunteers. A total of 40 evaluable healthy volunteers were enrolled in Part A of the study.

Part B evaluated ANA773 following oral administration to patients with chronic HCV infection. A total of 34 evaluable patients were enrolled in Part B of this study in 2 study centers.

Study Design:

Part A evaluated ANA773 following oral administration to healthy volunteers. A total of 40 evaluable healthy volunteers were enrolled in Part A of the study.

Part B evaluated ANA773 following oral administration to patients with chronic HCV infection. A total of 34 evaluable patients were enrolled in Part B of this study in 2 study centers.

Eligibility Criteria:
Part A Inclusion:

* Male or female, ages 18 to 65 years
* No clinically significant abnormalities
* No serious or severe chronic conditions
* Non-smokers

Part A Exclusion:

* Female subjects who are pregnant or breast-feeding
* History of significant medical condition that could interfere with study medication or associated study assessments
* History of or current drug or alcohol abuse

Part B Inclusion Criteria:

* Male or female, ages 18 to 65 years
* Diagnosed with chronic liver disease consistent with chronic hepatitis C infection for at least 6 months
* Screening HCV RNA ≥ 375,000 copies/mL or ≥ 75,000 IU/mL
* Naïve to or have relapsed from prior IFN-alpha based therapy

Part B Exclusion Criteria:

* Female subjects who are pregnant or breast-feeding
* Received anti-viral therapy or immunomodulatory therapy within 90 days prior to administration of the first dose of study medication
* Use of an investigational drug or participation in an investigational study with a licensed drug within 30 days
* History of significant medical condition that could interfere with study medication or associated study assessments
* History of or current drug or alcohol abuse
Virtual Reality and Active Video Games to Improve Balance in Children With Brain Injury

The purpose of this pilot feasibility study is to assess the feasibility of using the Playstation Xbox 360 and Rutgers V-step via a Kinect Sensor with active video game software as a part of a physical therapy intervention to improve obstacle negotiation, gait speed, and stair negotiation in ambulatory children with Cerebral Palsy (CP) hemiparesis or spastic diplegia, or non-progressive brain injury (BI). Children will be assessed using perceptual, balance, functional and gait assessments.


Eligibility Criteria:
Inclusion Criteria:

* Age 7-17
* Diagnosis of Cerebral Palsy or Diagnosis of Acquired Brain Injury
* Ambulatory with or without an assistive device x 150 feet
* Cognition and attention ability sufficient to be successful in video game play and to follow instructions of the investigator.
* Able to complete testing process.
* Current patient at Blythedale Children's Hospital program (Expected Length of Stay/availability for study of approximately 8 weeks)

Exclusion Criteria:

* Any history of photosensitive epilepsy or seizures triggered by exposure to flashing lights, television or video games
* Attention or behavior problems that prevent the successful completion of game play
* Any acute musculoskeletal injury that limits weight bearing on one lower extremity (due to orthopedist concerns for fracture or injury)
* Any medical condition that prevents the child from tolerating exercise due to cardiovascular conditions
Magnesium Supplementation for Primary Prevention of Heart Failure in Obesity

The objective of this study is to investigate whether nutritional supplementation with magnesium can improve cardiovascular structure and function in participants with obesity - with a long-term goal of preventing clinical heart failure. Specifically, in a randomized open-label pilot study, we will assess whether dietary Magnesium (Mg) supplementation (versus no supplementation) for 24 weeks in obese patients will improve left ventricular (LV) mass.

The investigators propose a 24-week therapeutic trial involving 40 participants with obesity from the Providence VA Medical Center without clinical heart failure. 20 participants will be treated with 400 mg of Magnesium Oxide twice daily, while 20 participants will receive no treatment. The trial tests the hypothesis that oral Mg supplementation will improve: LV structure (by LV mass, steatosis, and ECV), LV function (systolic and diastolic), vascular health (systolic blood pressure and aortic pulse wave velocity) and visceral adiposity.

Eligibility Criteria:
Inclusion Criteria:

Body mass index greater than 30 kg/m2

Exclusion Criteria:

1. History of hospitalization for heart failure (systolic or diastolic);
2. Unstable angina or prior myocardial infarction;
3. LV ejection fraction \<50% on imaging study;
4. Valvular heart disease (stenosis or insufficiency) greater than moderate degree;
5. Renal dysfunction, serum creatinine \>2.5 mg/dL or estimated creatinine clearance \<30 mL/min/1.73 m2 (30),
6. Pregnant women or actively breastfeeding women
7. History of drug supplementation within the last 6 months in which more than 50 miliequivalents per day of supplemental magnesium is contained
VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia

The purpose of this study is to determine the safety and efficacy of VEC-162 compared to placebo to improve sleep parameters in a model of insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects with no medical, psychiatric or current sleep disorders.
* Subject must sign a written consent form.

Exclusion Criteria:

* Recent history of night shift work or jet lag.
* Prior experience sleeping in a sleep lab environment.
* History of sleep disorders.
Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)

The purpose of this study is to determine the safety and efficacy of Rabeprazole extended release (ER) 50 mg versus Esomeprazole 40 mg for healing and symptomatic relief among subjects with erosive gastroesophageal reflux disease (GERD).

This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all the inclusion/exclusion criteria will be randomly assigned to 1 of 2 treatment groups, Rabeprazole ER 50 mg or Esomeprazole 40 mg for the treatment of moderate to severe erosive GERD.

Eligibility Criteria:
KEY INCLUSION CRITERIA:

1. Male or female, ages 18 to 75 years.
2. History of GERD symptoms for at least 3 months immediately before screening.
3. Heartburn for at least 2 days a week for at least 1 month before screening.
4. Esophageal erosions of Los Angeles (LA) grades C or D based on EGD taken within 14 days prior to enrollment.
5. Subjects who are H. pylori negative based on a screening test.
6. Females should be either of non-childbearing potential or of childbearing potential. Females of childbearing potential must have negative pregnancy tests prior to randomization. Female subjects of childbearing potential must agree to use medically acceptable methods of contraception.
7. Subjects must be able to read, write, and understand the language of the symptom diary.

KEY EXCLUSION CRITERIA:

1. Current or a history of esophageal motility disorders.
2. Current or a history of Barrett's esophagus. Current esophageal strictures or esophagitis (known or suspected to be due to etiology other than GERD such as infection or medications).
3. Current or a history of Zollinger-Ellison syndrome and other acid hypersecretory conditions, or current gastric or duodenal ulcer.
4. Current or a history of cancer, with the exception of fully excised skin basal cell carcinoma.
5. Inflammatory bowel disease.
6. Unstable diabetes mellitus.
7. History of esophageal, gastric and duodenal surgery except simple suturing of an ulcer.
8. Subjects who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (-\>;= 20 mg/day prednisone or equivalent), or aspirin (-\>; 325 mg/day).
Prognostic Value of Right Ventricular Myocardial Strain in Patients With Acute Myocardial Infarction

For a long time, the right ventricle has been the "forgotten chamber", but with the deepening of people's understanding of the disease, right ventricular dysfunction has become an important factor to evaluate the disease progression and late prognosis of patients with AMI. Right ventricular myocardial strain derived from two-dimensional speckle tracking echocardiography is a new method for early evaluation of regional and global right ventricular systolic function, and its repeatability is much higher than that of LVEF. Acute inferior myocardial infarction is often caused by occlusion of the proximal middle segment of the right coronary artery. Many studies have confirmed that RVMS is an independent predictor of poor prognosis in patients with AIMI. However, 60% of the right ventricular systolic function is contributed by the left ventricle and interventricular septum, and the left anterior descending branch and the left circumflex branch are the main sources of blood supply to the left ventricle and interventricular septum, so in theory, non-RCA occlusion can also lead to varying degrees of right ventricular dysfunction. However, there are few studies on the role of RVMS in predicting the prognosis of AMI patients caused by non-RCA occlusion. Therefore, the purpose of this study is to prospectively study the value of dynamic changes of RVMS in predicting the prognosis of patients with acute myocardial infarction with different infarct-related vessels, in order to provide more clinical reference information for the diagnosis and treatment of AMI.

In this study, 200 patients with acute myocardial infarction treated in Peking University Third Hospital from March 2022 to March 2024 were enrolled in this study. the parameters of myocardial enzymes, blood lipids and echocardiography were collected at the acute stage, 2 weeks and 6 months after discharge, and were followed up for two year. The echocardiographic parameters and MACE of patients with acute myocardial infarction with different infarction related vessels were compared. This shows the significance of right ventricular myocardial strain in predicting the prognosis of patients with acute myocardial infarction.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females were between 35 and 85 years old;
2. coronary artery disease underwent emergency PCI for NSTEMI or primary PCI for STEMI;
3. coronary artery type was right coronary dominance;
4. regular follow-up for 2 year.

Exclusion Criteria:

1. Patients who cannot complete 2D speckle tracking imaging;
2. patients with severe valvular disease, cardiomyopathy, or congenital heart disease; severe liver and kidney insufficiency or chronic respiratory disease;
3. previous PCI or CABG;
4. coronary artery type: Left crown dominance.
A Clinical Effectiveness Trial in Post-Operative Pterional Craniotomy Drain Placement

This is a clinical trial where patients who present to the neurosurgery service in need of a procedure that requires a pterional craniotomy will be screened, and if eligible, enrolled for the randomization in the placement of a drain at the surgical site. At present, there is not a protocol for whether or not to use a drain following this procedure. There is some debate on whether it serves any real benefit for the patient or if it may actually be detrimental in cases where infection occurs. This study aims to answer this question by randomizing patients to drain placement and then comparing patient outcomes between the two groups. These include the following: infection rate, length of hospital stay, self-reported patient pain and discomfort, the amount of time before patients are able to open their eye ipsilateral to the side of operation, change in forehead circumference post-op days 1-3, and any unforeseen post-operative complications. This will be accomplished through using a patient-administered survey, recording physical measurements, and a patient chart review. Statistical analysis will then be used to identify any differences that may exist.


Eligibility Criteria:
Inclusion Criteria:

* Patients that have been scheduled for surgery requiring the use of a pterional craniotomy approach

Exclusion Criteria:

* Patients in need of a surgical intervention requiring a pterional craniotomy due to reasons of physical injury
* Patients who need a pterional craniotomy with a orbitozygomatic approach
* Patients who have noticeable physical injury to their skull
* Patients with a prior surgical history of a craniotomy
* Patients with a pathological condition deemed severe enough by the screening physician to possibly influence the healing process of the procedure (blood clot disorder, cirrhosis, severe nutrient depletion, congestive heart failure etc.)
Prone Breath Hold Technique to Decrease Cardiac and Pulmonary Doses in Women Receiving Left Breast Radiotherapy

This is a pilot study to determine whether the addition of inspiratory hold (breath holding) can decrease the radiation dose that the heart and lung receive for patients being treated for left sided breast cancer.

Subjects have a standard of care CT simulation, which includes an additional breath hold CT. Inspiratory gated breath-hold will be used. Two radiation plans will be generated: one for the CT scan performed free breathing, and one for the CT scan performed with inspiratory gated breath hold. The cardiac and lung doses will be determined. At the discretion of the treating physician, the plan with the lower cardiac and lung dose may be used to treat the patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients of Dr. Gonzalez
* ≥18 years of age
* Node-negative left breast cancer
* Invasive or DCIS breast cancer
* Prior lumpectomy
* Deemed appropriate for treatment in the prone position by the treating physician
* Able to tolerate prone position and breath hold during CT simulation

Exclusion Criteria:

* \<18 years of age
* Patients requiring treatment in supine position
Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia

This study is being done to evaluate the long-term safety of tegaserod in women with symptoms of dyspepsia who have completed the core study. Tegaserod will be evaluated at 6 mg twice daily.


Eligibility Criteria:
Inclusion Criteria:

* Female, 18 years and older
* Fulfilled eligibility criteria in CHTF919D2301 (double blind study) and successfully completed the double-blind study

Exclusion Criteria:

- Early discontinuation from the double-blind study

Other protocol-defined inclusion/exclusion criteria may apply
Under-Resourced Adults with Chronic Pain EHealth Study

The purpose of this study is to examine the feasibility of the dissemination of a cognitive-behavioral eHealth application (app) for pain self-management with Black and LGBTQ+ adults with high-impact chronic pain lasting at least 3 months and disrupting daily functioning (Implementation aim).


Eligibility Criteria:
Inclusion Criteria:

* Identify as Black or LGBTQ+.
* Reside in MN, WI, or IA.
* Chronic pain diagnosis for at least 3 months.
* Experience chronic pain that makes it harder to do their day-to-day activities
* Have daily access to a smart mobile device (smartphone or table) and are willing to use the EPIO app.

Exclusion Criteria:

* Unable or unwilling to use the digital app for the study
* Do not have daily access to a smart mobile device (smartphone or tablet)
* Self-report cancer related pain, or severe untreated psychological illness (e.g., psychosis); and/or do not fit into one of the demographic categories listed in #1-3 for inclusion criteria.
EVA Nexus Vitrectomy Device Field Observation Study

determine the safety and effectiveness of the device.

To perform a field observation study using the newly developed EVA Nexus vitrectomy device.

Patients that are scheduled for intra-ocular surgery regardless of the indication:

* Vitrectomy surgery
* Cataract surgery
* Vitrectomy combined with cataract surgery

Eligibility Criteria:
Inclusion Criteria:

* Patients that are scheduled for intra-ocular surgery regardless of the indication:
* Vitrectomy surgery
* Cataract surgery
* Vitrectomy combined with cataract surgery
* In case of (combined) vitrectomy: primary or repeat vitrectomy
* General or retrobulbar anesthesia, the latter can be combined with sedation
* Patients aged ≥ 18 years

Exclusion Criteria:

* Patients aged \< 18 years
Superiority of Epidural Placement Technique Using EpiFaith Syringe

The aim of this study is to evaluate the impact of EpiFaith® syringe on the establishment of successful epidural labor analgesia, change of elapsed time for identification of epidural space, and learning curve of CA-1 residents.

We hypothesize that EpiFaith® syringe, in comparison with conventional glass syringe, will result in a similar overall success rate for catheter placement, but with a larger reduction in change of elapsed time for identification of epidural space and catheter placement of each practitioner. Moreover, we hypothesize that the cumulative learning summary curve using EpiFaith® syringe will be higher than conventional glass syringe in resident trainees, which will show the possible value of EpiFaith® syringe for teaching and learning obstetric epidural anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Females 18 years of age and older at screening
* Request labor epidural analgesia
* Able to give informed consent to participate in the study
* American Society of Anesthesiologists (ASA) class Ⅰ to Ⅲ health status
* BMI ≤ 40 kg/m2

Exclusion Criteria:

* BMI \> 40 kg/m2; any contraindication to neuraxial anesthesia (coagulopathy, uncorrected hypovolemia, increased intracranial pressure, or local skin infection)
* Cardiac disease history, marked spinal deformity, previous spinal surgery, or impalpable anatomical landmarks
* Any allergy to bupivacaine or fentanyl
BioGlue or Vivostat in the Control of Air Leak in Thoracic Surgery

Following lung surgery air may continue to leak from the surface of the lung. Chest drains are placed to allow this air to be removed safely and prevent the lung from collapsing. Drains need to remain until the air leak from the lung has ceased.

Air which continues to leak results in longer chest drainage times which cause increased discomfort and immobility for patients. These patients are at risk of secondary complications such as infection. Longer hospital stays and increased costs ensue. A randomised controlled trial (RCT) conducted at The Royal Brompton Hospital has shown clear benefits in the management of difficult air leak with the use of BioGlue. BioGlue is a surgical sealant applied to the surface of the lung at the time of surgery.

BioGlue is of bovine origin. Concerns exist regarding the potential risk of transmission of blood borne diseases with bovine derived medical products. Should a surgical adhesive without these potential risks prove as effective as BioGlue then its use could be commended.

The Vivostat System is a medical system that derives a sealant from the patient's own blood. A small study has shown that it may also be of benefit in the management of difficult air leaks. The principal aim of our RCT is to compare the duration of air leak, length of chest drainage and hospital stay associated with BioGlue to that of Vivostat.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years and over)
* Males and females
* Patients undergoing any thoracic surgical procedure likely to result in alveolar air leak.
* Written informed consent

Exclusion Criteria:

* Age less than 18 years
* Pregnancy
* Breast feeding
* Previous treatment with BioGlue or Vivostat
* Inability to give informed consent
* Pneumonectomy
* Empyema
* Grade 0 air leak
Investigation of Sensory Processing Patterns of Elderly Individuals Who Have Had Hip Fracture Surgery

This study aims to evaluate the sensory processing processes of elderly adults who have undergone fall-related hip fracture surgery in the last 6 months, according to different patterns, and to examine the relationship between physical performance, fall risk, fear of falling, and depression parameters that may be related to sensory processing.


Eligibility Criteria:
Inclusion Criteria:

* Being 65 years or older
* Being able to stand independently for 30 seconds
* Being able to walk 3 m independently (with an assistive device if necessary)
* Getting a score of 24 or more on the Mini Mental Test

Exclusion Criteria:

* Hip fracture patients receiving medical treatment for pathological hip fractures, polytrauma, traffic accidents, bone tumors
* Having a history of diseases that may directly affect the evaluation process (neurological diseases such as Parkinson's, Alzheimer's and cancer)
* Having vision and hearing loss
* Having a psychiatric illness
Retrospective Study of Patients With Spasticity in the Spanish Population

This is a retrospective study of patients with spasticity in the Spanish population.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of spasticity

Exclusion Criteria:

* Current enrollment in a clinical trial
NAVAH Impact on Radiation Therapy Completion in Black Breast & Prostate Cancer Patients

African-Americans have disparately limited access to optimal cancer care. They have the highest overall cancer death rate and shortest survival time of any racial or ethnic group in the United States. Elucidation of disparities in access to cancer care are important since previous work has indicated that when equal access to RT in Radiation Therapy Oncology Group (RTOG) prospective randomized trials is granted, race does not independently affect outcomes, a finding similar to work conducted in Level I evidence-proven optimal management of curable neurologic conditions. Breast cancer is the most common cancer in African-American women and Prostate cancer is the most common cancer in African-American men. African-American breast \& prostate cancer participants are less likely to receive standard-of-care radiation therapy.

Previous work has identified that compared to Caucasian women with breast cancer, African-American women are 48% more likely to have RT omission during treatment, 167% less likely to receive timely completion of RT after breast-conserving surgery, 40% less likely to complete RT, and significantly more likely to experience RT treatment delays. Shorter course radiation therapy may reduce disparities in radiation therapy care facing African-American breast cancer participants.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have histologically or cytologically confirmed Breast or Prostate Cancer.
* Subjects must be Age \>18 years. This study requires informed consent by the subject; as children are not able to perform this without parental approval, subjects \< age 18 are excluded from this study.
* Subjects must be of African - American race.
* Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Subjects NOT of African - American ethnicity.
* Subjects WITHOUT histologically or cytologically confirmed Breast or Prostate Cancer.