cyrilzakka/clinical-trials huggingface dataset:
Effects of Time-restricted Eating Supported by Mobile Technology in Patients With Non-alcoholic Fatty Liver Disease: Randomized Controlled Trial

In non-alcoholic fatty liver disease (NAFLD), it is established that calorie restriction is the most essential dietary modification. The time-restricted diet is successful lowering total calorie consumption and insulin resistance, and is anticipated to be beneficial for patients with NAFLD. Therefore, this study aims to conduct a prospective study to determine the effect of time-restricted diet via a mobile application on the amount of intrahepatic fat and 10-year cardiovascular disease risk in patients with NAFLD.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 19 years who are willing and able to complete all procedures
* Hepatic steatosis by imaging (ultrasound, computed tomography, magnetic resonance imaging, and controlled attenuation parameter (≥260 dB/m))

Exclusion Criteria:

* Body mass index (BMI) \<23
* Other causes of chronic liver disease (HBV, HCV), autoimmune diseases or chronic cholestatic liver disease
* Medications which cause liver disease or secondary hepatic steatosis (Tamoxifen, systemic corticosteroids, methotrexate, tetracycline, estrogens, valproic acid, and statin (registration is possible if statin is delivered in a consistent dosage within 12 weeks)
* Significant alcohol intake (\>210g/week for men, \>140g/week for women)
* Severe medical comorbidities (ischemic heart disease, 3rd degree atrioventricular block, chronic obstructive pulmonary disease, severe hypertension (blood pressure \> 200/120 mmHg)
* Psychiatric illnesses which limit ability to exercise safely
* Diagnosed with diabetes on medication or insulin
* Participation in a weight-loss program within 12 weeks
* MRI contraindications
Florida Community-Engaged Research Alliance (FL-CEAL) in Communities Disproportionately Affected by Health Inequities

The purpose of the study is learn more about ways to help people with non-medical issues that can affect participant health. The study team will examine if Community Health Workers, members of a community who provide basic health and medical care within communities, are more helpful to people with non-medical issues than simple reading materials on how participants can do it.


Eligibility Criteria:
Inclusion Criteria:

* Individuals living within the target community who do not plan to move out of the community within the next six months
* Having two un-met SDOH needs

Site Specific Inclusion Criteria:

University of Miami/ Healthy Little Havana Inclusion Criteria

* Age 18 and over

Health Choice Network/ Broward Community Health Center/ Genesis Community Health Center Inclusion Criteria

* Age 18 and over

Florida International University Inclusion Criteria

* Age 50 and over
* Individuals who identify as Lesbian, Gay, Bisexual, Transsexual (LGBT)

Mayo Clinic Florida Inclusion Criteria

* Age 21 and over
* Black/African American; Hispanic or Non-Hispanic ethnicity

Florida A\&M University/ Mother Care Network Inclusion Criteria

* Women between the ages 13-19 years
* Black/African American; Hispanic or Non-Hispanic ethnicity

University of Florida Inclusion Criteria

* Women aged 18 and over
* Pregnant and recently post-partum minority women
* Black/African American or Caucasian race; Hispanic or Non-Hispanic ethnicity
* Are uninsured or underinsured

Exclusion Criteria:

* Are unable or unwilling to consent
* Plans to move out of the community during the next six months
* Enrollment in a research study addressing Social Determinants Determinants Of Health (SDOH) in the last three years.
* Prisoners
Remote Evaluation of the Naída CI M90 (Marvel) Sound Processor

Within-subject comparison. Remotely Evaluating latest Advanced Bionics Marvel Sound Processor for cochlear implants, from two adult groups.

Within-subject comparison, standard of care CE marked Advanced Bionics device. Remote Evaluation of new CI Naida M sound processor through speech understanding in quiet and noise using standard clinical tests, subjective feedback on sound quality for a set of listening situations reflecting everyday use and a ease of use questionnaire. Two adult groups, one CI users and the other bimodal users. All tests completed remotely.

Eligibility Criteria:
Inclusion Criteria:

* CI users with a CI, HiRes90K (Advantage) or HiRes Ultra cochlear implant system
* Unilaterally implanted recipients using only a Naída Q sound processor
* Bimodal users: additionally using hearing aid on their contralateral ear

  * Minimum of 18 years of age
  * Minimum of five years' experience with their Naída Q sound processor
  * Minimum of six months experience with their contralateral hearing aid (if applicable)
  * Ability to give feedback on sound quality
  * Speech intelligibility with the BKB sentence test in noise at a +10 dB SNR \> 10% as obtained during previous visits in the clinical routine or BKB \>50% in quiet conditions if noise has previously not been tested
  * Fluent in English language

Exclusion Criteria:

* Difficulties additional to hearing impairment that would interfere with the study procedures
* Concurrent participation in any other clinical hearing study
* Not due to have their sound processor upgraded in line with normal clinical procedures
Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy

Acute facial nerve palsy occur in 10-20/100 000 children/year in Sweden. About 20 % of these children will have persistent symptoms with excessive tear secretion, drooling and social problems due to asymmetry in the face. Studies on cortisone treatment to adult patients with acute facial nerve palsy have shown beneficial effects, but no studies with strong quality have been performed in children.

Investigators will perform a double-blind randomized placebo-controlled multicenter trial on children with acute facial nerve palsy. Participants will be recruited consecutively at 9-12 study centers in Sweden during 2019-2020. Oral cortisone (prednisolone) 1 mg/kg x 1 in 10 days (or placebo) will be started on admission. Clinical data, including recovery will be followed-up until 12 months.

The primary outcome is defined as total recovery of the facial nerve palsy, measured with the House-Brackmann scale (grade 1) at 12-months follow-up.

The overall purpose is to assess the utility of cortisone treatment given to children with acute facial nerve palsy in this study. If the total recovery rate is significantly improved in the prednisolone group as compared to the placebo group, prednisolone treatment will be introduced in clinical practice for children with acute facial nerve palsy in order to reduce the risk of persistent symptoms.


Eligibility Criteria:
Inclusion Criteria:

1. 1-17 years of age
2. Acute peripheral unilateral facial nerve palsy
3. Less than 72 hours since debut of symptoms
4. Signed informed consent

Exclusion Criteria:

1. Head trauma \<1 month
2. Central or bilateral facial nerve palsy
3. Malformations in head and neck
4. Conditions not compatible with cortisone treatment (arterial hypertension, diabetes mellitus, psychiatric disorder, active or latent tuberculosis, intolerance of lactose)
5. Current or past oncological diagnosis
6. Other serious medical conditions (meningitis, encephalitis, stroke)
7. Acute otitis media
8. Signs of herpes simplex or varicella zoster infection (vesicles in the ear region)
9. Pregnancy or breastfeeding
10. Use of any systemic or inhaled steroids within 2 weeks prior onset of symptoms
11. Immunization with live vaccine 1 month prior onset of symptoms
12. Requirement of live vaccine within 2 months from start of experimental treatment (prednisolone or placebo)
13. Evaluation of primary endpoint at 12 months not feasible for any reason
14. Previously included into the FACE study
The Effect of Norepinephrine on the Development of Pressure Injury

Norepinephrine mainly increases mean arterial pressure among intensive care patients. It may be an essential risk factor in developing pressure injuries. However, there are still conflicting findings in the literature.

This study aimed to examine the effect of norepinephrine infusion on the development of pressure injuries among patients in adult intensive care.

This retrospective and correlational study was conducted between March 2021- May 2022. The electronic patient data were obtained from 289 adult patients (Case group n=149; control group n=149) treated with and without norepinephrine in the intensive care unit, respectively. The demographic and clinical characteristics were evaluated using descriptive statistical methods (number, percentage, mean, standard deviation). A logistic regression model was established to estimate the dependent variable (development of pressure injury) with the independent variables.


Eligibility Criteria:
Inclusion Criteria:

The sample consisted of all patients

* over 18 years old
* who did not have pressure injuries upon admission to the intensive care unit. Patients who received norepinephrine and received norepinephrine infusion for at least 48 hours during their stay in ICU were included in the case group (n=149), and patients who did not receive an infusion were included in the control group (n=140).

Exclusion Criteria:

The sample excluded of all patients

* less than 18
* who have pressure injuries during admission
* who had norepinephrine infusion less than48 hours during their stay in the intensive care unit.
A Trial of TD0019 in Treatment of Cervical Scapulohumeral Syndrome

Cervical scapulohumeral syndrome, which is also called scapulohumeral syndrome or cervical radiculopathy is a group of syndromes related to cervical spine disorders with disfunctional nerves and without inflamation. The physical syndromes vary from neck pain, Sensory Processing Disorder/Movenment Disorder of areas dominated by injured nerves.

The hard capsule TD0019 is a product based on the traditional prescription named "Độc hoạt tang ký sinh thang" combined with Nattokinase and the extraction of Salix alba Cortex

.

Cervical scapulohumeral syndrome, which is also called scapulohumeral syndrome or cervical radiculopathy is a group of syndromes related to cervical spine disorders with disfunctional nerves and without inflamation. The physical syndromes vary from neck pain, hands, accompanied by a Sensory Processing Disorder/Movenment Disorder of areas dominated by injured nerves. The most common reason is Cervical spondylosis The hard capsule TD0019 is a product based on the traditional prescription named "Độc hoạt tang ký sinh thang" combined with Nattokinase and the extraction of Salix alba Cortex.

The trial lasts for 24 months with 4 subject visits (from T0 to T3) and is conducted in National Hospital of Traditional Medicine (Hanoi, Vietnam).

Screening procedure occurs at T0 visit, followed by T1 (15+-3 days) and T2 (30+-3 days).

There are 2 levels of dosages: basic dose (arm 1) and 1.5x (arm 2) of basic dose.

There is also another arm using placebo, thus the trial have 3 arms in total.

Eligibility Criteria:
Inclusion Criteria:

Subject must meet all below criteria to be enrolled:

* Subjects diagnosed with cervical scapulohumeral syndrome according to the Guideline of Vietnam MOH 2014
* Age \> 18 at time of signing ICF, male or female.
* No contraindications with oral NSAIDs.
* Agree and and sign in the ICF

Exclusion Criteria:

Subjects will be excluded in the trial if any of the below are met:

* Hypersensitivity to any subtances of TD0019 or any NSAIDs.
* Pregnant or lactating.
* Currently having surgical indications.
* Movement disorders, diabetes, myasthenia, alcoholism
* Other conditions asseted by the investigator that are not eligible to be enrolled.
* Cervical scapulohumeral syndrome caused by tumor, infection, hypertension, physical injured.
* Arrhythmia, hypertension.
* Hypertensitivity to meloxicam or its excipients.
* Cross - hypertensitivity to aspirin or other NSAIDs.
* Peptic ulcer
* Severe liver failure
* Severe renal failure without dialysis.
* Gastrointestinal hemorrhage, recent brain hemorrhage.
* Uncontrolled heart failure.
* Alcoholism, movement disorders, diabetes, muscular dystrophy.
Screening for Malnutrition in Obese Patients

More than half of the Dutch population is overweight or obese, which is associated with an increased risk of COVID-19 and worse outcomes during a COVID-19 infection. In addition, malnutrition and loss of muscle mass are often reported with COVID-19, as well as with cancer and other diseases. Malnutrition and overweight or obesity can coexist, even within the same individual. It is still unclear which mechanisms contribute to the worse outcomes of COVID-19 and other diseases in case of overweight, malnutrition, and a combination of both. The aim of this study is to identify which parameters are associated with worse disease outcomes through literature research and database research (COVID-19 and cancer, more than 150.000 participants). In addition, a clinical study will be conducted aiming to develop a simple screening tool for the recognition of the coexistence of malnutrition and overweight or obesity in clinical practice.

Overweight and malnutrition are both common and have a significant societal impact as well as a negative effect on healthcare. They can also coexist, and may potentially reinforce each other. How the combination of both influences the course of COVID-19 and other diseases is still largely unknown. There is no simple set of parameters yet available to screen for the simultaneous occurrence of overweight and malnutrition.

This project has the following objectives:

* To evaluate the nutritional status (malnutrition, overweight, and the combination of both) and the (dietary) treatment of patients with COVID-19 in primary care (WP1).
* To assess the influence of various parameters of malnutrition and overweight and their effects on the outcomes of COVID-19 and cancer based on literature and data from existing Dutch cohorts (WP2 and WP3).

Based on this, to develop a screening tool for malnutrition in overweight; (WP4).

- Dissemination of the results (WP5).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Overweight (BMI of 25 kg/m² or higher)

Exclusion Criteria:

* Physically or mentally unable to participate.
* Severe cognitive disorder or severe emotional instability, as assessed by the attending nurse or physician.
* Insufficient proficiency in the Dutch language to express themselves properly and no interpreter or assistant to help.
* Patient resides in a nursing or care home.
An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis

The purpose of this study is to describe the long-term safety risks in adult participants with moderate-to-severe ulcerative colitis who are treated with Simponi.


Eligibility Criteria:
Inclusion Criteria:

* Have moderate-to-severe ulcerative colitis of at least 3 months' duration prior to enrollment, confirmed by endoscopy at any time in the past
* For enrollment into the Simponi-exposed cohort meets one of the following:

  1. The participant is currently receiving Simponi ,or
  2. The participant is continuing to receive Simponi after participation in an ulcerative colitis study, or
  3. The participant is scheduled to receive Simponi within 30 days after enrollment
* For Thiopurine cohort:

  1. The participant is currently receiving thiopurines, having received at least 12 consecutive weeks of therapy prior to registry entry
  2. Participant must not be receiving other approved biologic agents, including Simponi, or any investigational agents at enrollment
  3. Participant may have received biologics other than Simponi or investigational agents prior to enrollment

Exclusion Criteria:

* Participants who cannot be treated with Simponi or thiopurines
* Participants with a previous diagnosis of lymphoma or hematologic malignancy at any time prior to enrollment
* Participants currently receiving an investigational or biologic agent other than Simponi
* Participants with any condition for which, in the opinion of the investigator, participation in the registry would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments
Transgender Post-reassignment Urogynecologic Measures and Perceptions

The intent of this mixed methods study for transgender women after gender confirmation surgery is to characterize and subsequently create a validated screening questionnaire for postoperative urologic and pelvic floor symptoms. For individuals who seek gender-confirming treatment, about 13% undergo genital surgery for cosmetic purposes with or without gonadectomy, and this number is increasing. Patient satisfaction following surgery is high, particularly regarding sexual and cosmetic outcomes; however, unexpected negative functional outcomes such as bowel and bladder dysfunction and pelvic organ prolapse impact overall patient satisfaction. The available information suggests that 16-33% of patients experience incontinence postoperatively, with stress predominance, 32-47% experience abnormal voiding, and 24-66% experience overactive bladder symptoms. Outside of the typically assessed voiding symptoms, unique complaints of MTF postoperative patients include obstructive voiding symptoms due to urethral stenosis, persistent perimeatal erectile tissue, prostatic hypertrophy, and irritation from neovaginal tissue. Additionally, may of these patients develop symptomatic neovaginal prolapse, requiring re-suspension. We suggest that further clarification regarding MTF postoperative urologic and pelvic floor complaints can be achieved via a mixed methods approach. By using focus group interviews to create specific evaluative questions for this unique population, we can then prospectively assess patients undergoing surgery via a national multicenter sampling strategy. The goal of the study is to better understand the unique symptoms these women experience and create a validated, reliable screening questionnaire to monitor patients after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Stage 1 -- Male-to-female transgender women who are at least 4 weeks postoperative following genital surgery for gender confirmation
* Stage 2 -- Male-to-female transgender women who are scheduled to undergo surgery or are within 4 weeks postoperative
* Both stages -- Minimum age 18 years old
* Both stages -- English fluency
* Both stages -- Reliable contact information and/or permanent residence

Exclusion Criteria:

* Preexisting pelvic pathology, including abnormal anatomy or baseline voiding dysfunction
* Urinary or intestinal problems prior to surgery lasting greater than 6 weeks
Teleoperation Experimental Comparison With Able-bodied Subjects

To compare the use of the semi-autonomous control algorithm (condition 1) with the standard of care myoelectric system used with the TASKA prosthetic hand (condition 2). Able bodied subjects will enroll in a laboratory based experimental session at the University of Colorado at Boulder. Subjects will be fitted with a by-pass prosthesis which enables the able-bodied subject to control the prosthetic hand using the myoelectric signals on their able limb. A TASKA prosthetic hand will be sensorized using the Point Touch technology. In a randomized order, the subjects will perform functional tasks evaluating dexterity and assistance with prolonged gross motor movement using each experimental condition. Then, a direct comparison can be made across subjects for the semi-autonomous control algorithm and the standard of care myoelectric system used in the TASKA prosthetic hand.


Eligibility Criteria:
Inclusion Criteria:

* Able-bodied subject
* Fluent in English
* Age of 18 years or greater

Exclusion Criteria:

* Significant cognitive deficits as determined upon clinical evaluation
* Significant neurological deficits as determined upon clinical evaluation
* Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
Cardiac Rehabilitation in Patients With Continuous Flow Left Ventricular Assist Devices:Rehab VAD Trial

Cardiac rehabilitation programs improve mortality, functional capacity, and quality of life, for a variety of patients with heart disease. It stands to reason that patients with LVADs might therefore also benefit from the same structured exercise training, education, and clinical surveillance. One potential benefit of cardiac rehabilitation in this patient population is reversal of the skeletal muscle atrophy that occurs due to extended periods of poor peripheral perfusion (i.e. before implantation) and prolonged sedentary behavior.

Purpose: The purpose of this proposed study is to examine the effects of a 6-week exercise program on cardiorespiratory fitness, quality of life, and device flow rate in patients with recently implanted LVADs.

Methods: 30 patients with recently implanted LVADs will be referred by the Henry Ford Hospital Advanced Heart Failure Program once the patient is deemed appropriate for exercise. Before enrollment into cardiac rehabilitation patients will undergo a six minute walk test and graded exercise stress test on a treadmill to determine exercise capacity. Additionally, a quality of life questionnaire will be given.

Following the stress test, patients will be randomized (2 to 1 ratio) into either cardiac rehabilitation or control. Those chosen to be in the control group will be encouraged to maintain daily activities; those in the rehabilitation group will partake in 6 weeks of a standard cardiac rehabilitation program. This will consist of 3 days a week of supervised exercise as well as education regarding diet and lifestyle modifications.

At 6 weeks after randomization both groups will again undergo fitness assessments and retake the quality of life questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Continuous flow left ventricular assist device
* Implanted within the past six months
* Approval from cardiologist to participate in cardiac rehabilitation
* Age greater or equal to 18 years
* No history of cardiac rehabilitation participation since receiving a LVAD

Exclusion Criteria:

* Orthopedic limitations to perform exercise
* Current infection related to LVAD
* Severe anemia
* Recent CVA related to LVAD implant that affects ability to exercise
* Unable to attend cardiac rehabilitation at Henry Ford Hospital
* Uncontrolled metabolic disorders
Calcium Retention as Influenced by Dietary Components That Induce an Acid Load

The impact of protein sources such as beef as part of Western diet on calcium retention remains controversial. We propose to test the hypothesis that the positive effect of high protein intake (especially from meat protein) can offset the negative effect of protein-induced net acid load on bone metabolism and the retention of body calcium. Healthy postmenopausal women recruited from the community will consume two diets differing in meat protein and acid load for 7 weeks. Calcium retention from diets will be determined using a highly sensitive measurement of whole body retention of a calcium isotope added to the diet.


Eligibility Criteria:
Inclusion Criteria:

* Average body mass index
* Normal blood work
* Normal bone density

Exclusion Criteria:

* Chronic disorder
* Non-traumatic bone fractures