cyrilzakka/clinical-trials huggingface dataset:
Imaging of Lungs With a New Type of Magnetic Resonance Imaging (MRI) Called UTE (Ultrashort Echo Time)

This research study has 2 purposes:

1. To learn about new ways to use Magnetic Resonance Imaging (MRI) to take clearer pictures of the lungs. A type of MRI called Ultra Short Echo Time (UTE) will be used as well as traditional MRI.
2. To collect images and health information about lungs that have different kinds of lung diseases to compare to healthy lungs. This collection will help researchers and clinicians to better understand lung variations in health and disease.

This study will involve one MRI session that will take about 10 to 30 minutes and for some participants a breathing test that measures how well the lungs are working. This test is called spirometry.

Interstitial, obstructive, and rare lung diseases are pulmonary disorders that comprise more than 300 disease entities that are poorly understood, diagnosed, and treated. X-ray computed tomography (CT) is the imaging gold standard and the current clinical practice for imaging lung structure and function of patients. Recent advances in magnetic resonance imaging (MRI) pulse sequences and hardware with ultra short echo times (UTE) have enabled MRI of lung anatomy nearly comparable to CT without the risk of ionizing radiation.

The overreaching goals of this study are:

1. to allow for technical development and validation of UTE MRI sequences as an imaging alternative to CT as well as a future diagnostic tool, and
2. to allow for preliminary UTE data generation for healthy and various disease populations. We anticipate this as being particularly important for data on children where variability is greater due to normal variations in size, age and maturity as well as distinctive differences in expression of lung diseases in pediatrics versus adult populations.

This is a prospective, controlled study for technical development and validation of UTE MRI techniques with normal and disease cohorts. This study will use the standard MRI hardware (FDA approved coils and magnet) but will be developing and refining techniques used in the MRI sequences to obtain UTE images. This refinement includes varying the MRI settings to maximize image signal, to control image contrast, and to develop the software needed to acquire more specialized images for the purpose of improved imaging of the lungs. The data will also be used to collect normative data for comparison with lung pathologies.

Subjects may enroll more than once (with separate consent). For these subjects the MRI information may be used to generate data for in-subject temporal variability in both healthy controls and disease groups.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent or Parental Permission
* Age ≥ 5 years
* Willing and able to comply with MRI instructions

Exclusion Criteria:

* History of any comorbidity reviewed at the Screening Visit that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the subject.
* Standard MRI exclusion criteria as set forth by the Cincinnati Children's Hospital Radiology Department and Imaging Research Center.
* Pregnancy
The Efficacy and Safety of Zhigancao Tang Granule for HFpEF of Qi-Yin Dificiency

This study was designed as a randomized, double blinded and placebo-controlled clinical trial. The aim of the study is to evaluate the efficacy and safety of Zhigancao Tang granule in patients with HFpEF of Qi-Yin dificiency.

Heart failure with preserved ejection fraction (HFPEF) is a clinical syndrome characterized by diastolic dysfunction.The incidence of HFpEF is increasing in recent years. Standard treatment of heart failure does not improve the prognosis of HFPEF patients. Zhigancao Tang was used to improve the symptoms of chronic heart failure in China.This randomized,double-blinded and placebo-controlled trial will objectively and standardly evaluate the effectiveness and safety of Zhigancao Tang granule.After 12 weeks of treatment, 122 HFpEF patients with deficiency of Qi and Yin were observed and evaluated in terms of heart function, clinical symptoms,exercise tolerance and quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Comply with the diagnostic criteria of Western medicine for HFpEF and the diagnostic criteria for TCM syndromes of Qi-Yin deficiency;
2. Cardiac function classification by NYHA: grade I to III;
3. Age between 30 and 80 years old;
4. Those who volunteer to participate in clinical trial observation, sign informed consent and indicate date;
5. During the observation period, those who do not take other drugs other than those specified and can insist on completing the treatment and observation.

Exclusion Criteria:

1. Valvular heart disease, restrictive cardiomyopathy, pericardial disease;
2. Decompensated heart failure is unstable after treatment;
3. Combined with atrial fibrillation;
4. Patients with severe lung, liver, endocrine system and kidney dysfunction;
5. Patients with cancer and other common malignant diseases reducing life expectancy;
6. Pregnant or lactating women;
7. Allergic constitution or allergic history to common drugs;
8. Patients with mental illness or poor compliance of traditional Chinese medicine treatment.
Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking

The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have stable, documented cardiovascular disease (including at least one of the following diagnosed \> 2 months prior to the Screening visit - angina, myocardial infarction (MI), revascularization, transient ischemic attack (TIA), and peripheral vascular disease (PVD).
* Participants that smoke \> 10 cigarettes / day.

Exclusion Criteria:

* Participants with unstable cardiovascular disease
* Cardiovascular events in the past 2 months
* Moderate or severe chronic obstructive pulmonary disease (COPD)
Workload Evaluation (Via NASA Task Load Index) of Robotic Assisted and Laparoscopic Surgery

workload evaluation (via NASA Task Load Index) of robotic- assisted and laparoscopic surgery

evaluation of individual and overall workload during robotic visceral surgeries using NASA Task Load Index and one additional question referring to difficulty level of the operation in comparison with laparoscopic procedures

Eligibility Criteria:
Inclusion Criteria:

* robotic and laparoscopic procedures

Exclusion Criteria:

* decline of participation (patients, medical stuff)
* paparoscopic appendectomies, laparoscopic cholecystectomies
Social Skills in Children With Developmental Coordination Disorder (DCD)

In this study we will examine the social-communicative skills of children with Developmental Coordination Disorder (DCD) by using online parental questionnaires in children aged 5 to 15y.

Developmental Coordination Disorder (DCD) is a neurodevelopmental disorder described in the DSM-V characterized by motor coordination problems which significantly interfere with daily living activities and participation. The problems cannot be explained by another disorder and are already present in early life.

Although DCD is a 'motor' disorder, other domains may equally be affected. Children with DCD show lower health-related quality of life, more socio-emotional problems, and experience more academic difficulties. It has been proposed that social skills may mediate the emergence of socio-emotional problems at a later age. Previous research has suggested that socials skills of children with DCD may be altered. However, the process remains unclear. One possible hypothesis is that early motor coordination problems leads to avoiding or inhibits age-appropriate physical and social activities, which may reduce the opportunities to develop adequate socials skills and/or may impact negatively on a child's developing self-esteem and create a sense of isolation and exclusion.

Indeed, it has been reported that these children spend more time playing alone and are often onlookers instead of actively engaging in play. In general they exhibit a lower participation rate which may contribute to the reported poorer peer relations, less (deep) friendships, and a tendency for more bullying and loneliness. They also feel less competent in peer and social relations. Poorer social interaction skills and more social communication problems have been recognized in these children even interfering in non-verbal skills such as poorer recognizing of facial expressions and emotions and a reduced tendency to follow gaze which may be similar to children with ASD.

It can be debated if these social problems are comorbid or rather a secondary consequence.

With this study the investigators aim to map social responsiveness problems in children with Developmental Coordination Disorder and clarify if and which domains are most affected. The investigators defined the following research question: "Do children with Developmental Coordination Disorder experience social responsiveness problems compared to typically developing children? If so, which domains are most affected?".

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of DCD
* Comorbidities are allowed (f.e. ASD, ADHD, ADD,...)

Exclusion Criteria:

- Any other neurodevelopmental disorder which might affect motor development (f.e. CP).
Oncologic Safety of Sentinel Lymph Node Biopsy in Clinically Palpable Axillary Lymph Node in Breast Cancer Patients

Evaluation patients with palpable lymph node with breast cancer by sentinel lymph node biopsy and how to affect on the management of breast cancer.

Breast cancer is the most common type of cancer in females and the 3rd leading cause of cancer mortality. One of the important aspects of breast cancer management is axillary staging and the status of axillary lymph nodes is an important prognosticator that affects adjuvant treatment decisions in patients with early breast carcinoma. Sentinel lymph node biopsy (SLNB), is considered to be the standard of care for node negative breast cancer, as it can save patients from the complications of axillary lymph node dissection (ALND). These complications include lymphedema, arm stiffness, and neuralgia, all of which significantly affect the patient's quality of life and raise healthcare costs. It also allows accurate axillary staging with minimal morbidity. Oncologic outcomes in terms of disease-free survival, overall survival, and locoregional recurrence rate were similar in the SLNB alone versus the ALND group in patients with clinically node-negative axilla. In doing the SLNB, a combination of radioactive technetium-99m and blue bye technique is preferred to increase the SLN identification rate than using one technique in isolation. The rationale for performing upfront SLNB as routine for patients being treated for breast cancer should be challenged, for this our study aiming for evaluation of the role of sentinel lymph node biopsy in management of breast cancer.

Eligibility Criteria:
Inclusion Criteria:

1. age more than 18 years.
2. fit for surgery.
3. Patients with no previous breast surgery. .

Exclusion Criteria:

1. patients less than 18 years.
2. patients unfit for surgery .
3. patients with advanced breast cancer.
4. Patients with previous breast surgery.
Muscle Soreness and Stiffness in Patients With Chronic or Frequent Episodic Tension Type Headache.

The aim is to investigate muscle soreness and stiffness in patients with Chronic or Frequent Episodic Tension Type Headache before and after treatment with amitriptyline - and to compare the results with healthy individuals.

The muscle stiffness is measured with ultrasonic shear wave elastography in m. masseter, m. sternocleidomastoid and m. Trapezius.

The muscle soreness is measured by palpation of the muscles aided by a so called palpometer.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Tension type headache or frequent episodic tension type headache with at least ten episodes or more per month throughout three months or more.
* Pericranial muscle tenderness

Exclusion Criteria:

* Other primary headache disorder (with the exception of episodic migraine.)
* Pregnancy or ongoing breastfeeding
* Heart disease that contradicts treatment with amitriptyline
* Drug or substance abuse
Virtual Advisors for Physical Activity Promotion in Underserved Communities

The primary aim of this research study is to evaluate the effectiveness of a computer-based 'virtual lay advisor' intervention relative to a proven human lay advisor/promotore intervention to promote regular walking among inactive midlife and older Latino adults. The primary analysis is a non-inferiority analysis comparing these two interventions.

COMPASS (Computerized Physical Activity Support for Seniors) was a single-blind, cluster-randomized noninferiority parallel trial conducted by investigators from Stanford University School of Medicine and Northeastern University. Participants were recruited from community centers in Santa Clara and San Mateo Counties, CA which had been randomized in pairs based on locale to either Virtual or Human advisors. Allocation concealment was accomplished by utilizing staff not directly involved in study enrollment, assessment, or intervention procedures. Both arms received a similar 12-month behavioral PA instruction/support program at their designated community center based on Active Choices-an individually-tailored PA intervention with demonstrated effectiveness and translatability across diverse adult populations. The primary outcome was change in 12-month weekly walking minutes.

In addition to the major trial and primary investigation described above, an exploratory Substudy was conducted separately to begin to evaluate the initial "proof of concept" of a food literacy curriculum in 2 separate community centers that were not part of the major trial. This first-generation exploratory Substudy is not part of the major trial and therefore is not included in this protocol and trial description.

Eligibility Criteria:
Inclusion Criteria:

* Spanish or English-speaking primarily Latino men or women
* Aged greater than or equal to 50 years
* No plans to move within the next year
* Inactive (have not engaged in moderate-intensity or more vigorous physical activity
* \> 3 days per week for at least 20 min per day) within last 6 months
* Able to participate in study intervention and assessments at their local neighborhood senior center

Exclusion Criteria:

1. Any medical condition or disorder that would limit participation in moderate intensity physical activity (such as sustained walking), including life-threatening disorders, myocardial ischemia, major functional disabilities in the orthopedic area, or inability to complete baseline assessments for any reason (including psychological, cognitive);
2. Not stable on their medications, including hormone replacement therapy, for ≥ 3 months (given that changes in medications can create additional stress and burden over and above attempts to change lifestyle behaviors);
3. Inability to complete a face-to-face training session with a computer-based program
Enhancing Sleep Quality for Nursing Home Residents With Dementia

This was a pilot study (R61) to prepare for a full clinical trial (R33) aiming to improve clinical outcomes for an important, growing, and vulnerable population-nursing home (NH) residents with Alzheimer's disease or related dementias (ADRDs). The goal was to pilot and refine the research methods and intervention that would be subsequently evaluated in a full implementation trial (hybrid type III). The goal of the evidence-based intervention (LOCK) that was refined in this pilot study and will be evaluated in the subsequent full clinical trial is to improve the sleep of NH residents with ADRD.

In community (non-VA) NHs \[one from each of 3 national NH corporations\], the multi-disciplinary research team achieved two aims: (1) refined the LOCK program to focus on sleep for residents with ADRD during this pilot (R61) phase, (2) which prepared the team for the second phase of this two-part NIA-funded grant (the R33 phase) to test the impact and sustainability of this intervention for NH residents with ADRD in an incomplete stepped-wedge randomized controlled trial.

THIS PILOT STUDY R61 PHASE (1 YEAR; N = 3 NHS; 1 NH PER CORPORATION) HAD THE FOLLOWING SPECIFIC AIMS:

1. Refine the LOCK sleep program train-the-trainer protocol by implementing and pilot-testing in three NHs.
2. Test and refine the research methods to: effectively identify eligible NHs and residents; obtain consent; collect primary data from residents and staff (sleep time via actigraph); explore staff impressions of additional sleep measurement devices (Fitbits); transfer primary and secondary data to our data center; and merge all data.

Eligibility Criteria:
Inclusion Criteria:

* Nursing home residents aged \>=50 years with an Alzheimer disease or related dementia (ADRD) diagnosis, identified by nursing home staff participating in frontline LOCK sleep huddles as having sleep problems

Exclusion Criteria:

* residents with a high risk of OSA who are not being treated for OSA because actigraph measurements are inaccurate in that population.
* residents who have a persistent bilateral resting tremor or paralysis in both arms (a subset of persons with Parkinson's disease and related significant tremor-causing diagnoses), due to actigraph measurement inaccuracies
To Evaluate the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple Sclerosis

Primary Objective:

To describe the safety of teriflunomide in patients with relapsing forms of multiple sclerosis.

Secondary Objective:

To describe the efficacy of teriflunomide in patients with relapsing forms of multiple sclerosis.

The study duration is one year; post treatment safety follow up visit will be conducted 4 weeks after the patient takes the last dose of teriflunomide

Eligibility Criteria:
Inclusion criteria:

* Age of patients ≥ 18 years
* Patients with relapsing form of multiple sclerosis at time of screening visit.
* Signed written informed consent.

Exclusion criteria:

* Patients with hypersensitivity to teriflunomide, leflunomide, or to any excipients in the tablets.
* Liver function impairment or persisting elevations of serum glutamic pyruvic transaminase (SGPT/ALT), serum glutamic oxaloacetic transaminase (SGOT/AST), greater than two times the upper limit of normal (ULN) during screening visit.
* Known history of pre-existing acute or chronic liver disease.
* Patients with significantly (as per Investigator's discretion) impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia.
* Known history of severe immunodeficiency, acute or severe active infections.
* Female patients with a positive pregnancy test at screening or women of child-bearing potential who do not agree to use effective methods of contraception throughout the course of the study.
* Male patients unwilling to use reliable contraception during the course of the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Management of Traumatic Bone Defects in Tibial Plateau Fractures With Antibiotic-Impregnated Biodegradable Calcium Sulfate Beads: A Prospective Clinical Trial

This is a prospective clinical trial of tibial plateau fractures treated with internal fixation and a calcium sulfate graft which can be mixed with antibiotics and molded into various bead sizes for implantation into bone defects. The graft material chosen for this study is STIMULAN Rapid Cure (Biocomposites, UK), which is approved for use as a bone void filler and may be mixed with a variety of antibiotics. The combination of STIMULAN + antibiotic in bead form is the "study device".

Our primary study aim is to look at resorption and remodeling of the study device into bone. Another important aim of the study is to look at subsidence, or collapse, of the joint surface.


Eligibility Criteria:
Inclusion Criteria:

* Adult (skeletally mature) men or women;
* Acute, closed, tibial plateau fractures, Schatzker grade 1 through 5;
* Internal fixation and use of study device per protocol;
* Fracture repair within 30 days of injury;
* Signed informed consent to participate in study.

Exclusion Criteria:

* Uncontrolled diabetes;
* Severe degenerative or metabolic bone disease;
* Malignancy;
* Severe vascular or neurologic disease;
* Alcoholism;
* Substance abuse;
* Use of systemic steroids;
* Immunosuppressive therapy;
* Hypercalcaemia;
* Renal-compromised patients;
* Osteomyelitis or chronic infection in the study limb;
* Women who are pregnant or breast-feeding.
Volociximab in Combination With DTIC in Patients With Metastatic Melanoma Not Previously Treated With Chemotherapy

This clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) that is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.


Eligibility Criteria:
Inclusion Criteria:

* Males and females of at least 18 years of age with stage IV or unresectable stage III non-ocular melanoma who may have received 0 to 2 prior regimens for metastatic disease with a biological therapy or immunotherapy (e.g., IL-2 or interferon-alfa).
* Measurable disease according to Response Criteria for Solid Tumors (RECIST).
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1.
* Estimated survival is greater or equal to 4 months.
* Negative pregnancy test (women of childbearing potential only).
* Pretreatment laboratory levels that meet specific criteria.
* Signed informed consent, including permission to use protected health information.

Exclusion Criteria:

* Prior treatment with M200 or a5b1 inhibitors and murine or chimeric monoclonal antibodies.
* Prior treatment with DTIC, temozolomide, or other chemotherapeutic regimens.
* Known sensitivity to murine proteins or chimeric antibodies or other components of the product.
* Use of any investigational drug within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer).
* Systemic biologic, immunotherapy, and/or radiation therapy within 4 weeks of the first dose of M200.
* Documented central nervous system (CNS) tumor or CNS metastasis.
* History of thromboembolic events and bleeding disorders within the past year.
* Medical conditions that may be exacerbated by bleeding.