cyrilzakka/clinical-trials huggingface dataset:
Establishment of NAFLD Cohort and Development of Fibrosis Markers

This study is designed for establishment of non-alcoholic fatty liver disease patients cohort to development of markers to predict histologic progression of liver fibrosis.

* Acoustic radiation force impulse elastography and transient elastography
* Liver tissue (frozen tissue, paraffin block)
* Whole blood, Serum
* Fat amount ratio CT (Visceral adipose tissue, Subcutaneous adipose tissue amount)
* Body composition analyzer (InBody scale):Total fat/muscle mass and appendicular skeletal muscle mass
* Pulmonary function test with post-bronchodilator response and DLCo
* EKG, EchoCG, Heart CT (Coronary calcium score), and Pusle wave velocity (AI index, arterial stiffness)
* Brain MRI or CT
* Upper esophagogastroscopy and colonoscopy
* Berlin score questionnaire and Polysomnography

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed fatty liver disease
* Patients with radiologically confirmed fatty liver disease

Exclusion Criteria:

* History of significant alcohol consumption
* Viral hepatitis
* Autoimmune hepatitis
* Metabolic diseases (e.g. hemochromatosis, M. Wilson, alpha 1-antitrypsin deficiency)
* Hepatotoxic medication (e.g. amiodarone)
Alpena Otago Telehealth Program

This project is to analyze the outcomes of the Alpena Otago Telehealth Program. The Alpena Senior Citizens Center is implementing the Otago program, an evidence-based, 6-month, home exercise program using live video chats in combination with an online exercise app, Blue Marble. We will recruit seniors who are participants of the Alpena Otago Telehealth Program to allow the study team to analyze their outcomes. The goal of the study is to examine the feasibility and efficacy of a 6-month, home-based, Otago Telehealth program for seniors in Alpena.


Eligibility Criteria:
Inclusion Criteria:

* participating in Alpena Otago telehealth program
* age \>= 60 years
* ability to use a tablet
* ability to walk at home with or without a cane or walker
* ability to exercise like moving arms or legs while standing
* ability to communicate in English and follow instructions
* ability to provide the consent

Exclusion Criteria:

* advanced neurologic condition
* severe visual impairments
* falls due to syncope or dizziness
Initiation of Oral Feeding at 30 Versus 33 Weeks Postmenstrual Age

The purpose of the study is to determine if earlier initiation of oral (by mouth as opposed to tube) feedings in premature infants results in earlier attainment of full oral feedings and/or discharge.

Infants will be enrolled and randomized at 30 0/7 weeks postmenstrual age. The Earlier Oral Feeding group will initiate oral feedings at 30 0/7 weeks postmenstrual age. The Later Oral Feeding group will initiate oral feedings at 33 0/7 weeks postmenstrual age. The number of oral feeding attempts will be advanced according to a feeding progression protocol for both groups. Successful completion of a feeding is defined as oral completion of the full volume of a feeding within 30 minutes, without a bradycardic episode (heart rate \<100 beats per minute) or desaturation (oxygen saturation decrease \>5% from baseline values). If infant does not successfully complete \>95% of the total prescribed volume of a feeding, the remainder of the volume will be supplied via gastric tube. All oral feedings will be performed by bedside nurses, or by a parent with observation by the nursing staff, with continuous cardiorespiratory and pulse oximetry monitoring. Individual oral feeding attempts for both groups will continue until one of the following occurs despite appropriate pacing of the feeding: 1) the feeding is completed 2) feeding duration of 30 minutes 3) adverse event during a feeding \[multiple bradycardic episodes (3 episodes of heart rate \<100 beats per minute), bradycardia with choking episode, single severe bradycardia (heart rate \<60)\]. If the infant experiences an adverse event during an oral feeding attempt, oral feeding attempts will be held for 2 days.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age \<= 29 weeks at birth
* Tolerating enteral feedings for at least 3 days before 30 weeks postmenstrual age

Exclusion Criteria:

* Neurologic, cardiac, respiratory, or gastrointestinal disorders that interfere with oral feeding
BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity

This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric lower limb spasticity.


Eligibility Criteria:
Inclusion Criteria:

* Minimum weight of 10 kilograms (kg)/22 pounds (lb)
* Cerebral palsy with dynamic muscle contracture of the ankle

Exclusion Criteria:

* Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or mitochondrial disease
* Uncontrolled epilepsy
* Botulinum Toxin therapy of any serotype for any condition within the last 3 months
* History of surgical intervention of the lower study leg within 1 year, or planned surgery of any limb during the study
A Study to Learn About Abrocitinib in Adult Patients With Moderate to Severe Atopic Dermatitis

The purpose of this non-interventional observational study is to learn about the safety and effects of the medicinal product (called Abrocitinib) for the potential treatment of moderate to severe atopic dermatitis (AD). AD is a long-lasting disease that causes redness and irritation of the skin. This non-interventional study is seeking participants who is eligible for Abrocitinib treatment according to the summary of product characteristics (SmPC):

* Are aged at least 18 years old
* Have a confirmed diagnosis of AD by a skin doctor
* Decide to start treatment with Abrocitinib as part of routine clinical practice
* Have a personally signed and dated informed consent document. This is used to indicate that the patient has been informed of all pertinent aspects of the study and data privacy aspects

Participants will take the medicinal product as prescribed in the real-world setting. We will examine the experiences of people receiving Abrocitinib. This will help us determine if the medicinal product is effective and safe. Participants will take part in this study for 3 months. During this time, participants will be followed up from the date of their first Abrocitinib prescription for 12 months. During this non-interventional study, some participants may switch to other therapies after their initial Abrocitinib therapy. We will follow these participants further when they switch therapy to monitor their experiences. Participant documentation is expected quarterly as per standard clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years
* Confirmed diagnosis of AD by dermatologist prior to study inclusion
* Patient for whom the decision to initiate treatment with abrocitinib was made as part of routine clinical practice irrespective of the patients being

  1. abrocitinib naive or,
  2. patients who reinitialize treatment with abrocitinib after being off treatment for ≥28 days prior to study inclusion
* Patient is eligible for abrocitinib treatment according to Summary of Product Characteristics (SmPC)
* Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the non-interventional study

Exclusion Criteria:

* Contraindications according to SmPC
* Receipt of any investigational drug within 3 months or longer if required according to wash-out period prior to inclusion or participation in a clinical trial during observation period
* Patients being treated with abrocitinib within a time period of \<28 days prior to the timepoint of study inclusion
* Patients who are investigational site staff members or patients who are Pfizer employees directly involved in the conduct of the non-interventional study
* Patients who are unable to consent
Digital Reminiscence Therapy for Alzheimer's in Institutionalized People

Digital reminiscence therapy (DRT) is an innovative intervention designed to enhance the psychological health of institutionalized seniors with Alzheimer's disease. This approach utilizes digital tools to facilitate the sharing of personal memories and experiences, fostering social interaction and emotional engagement. By combining technology with therapeutic reminiscence techniques, DRT aims to stimulate cognitive function and improve mood, potentially alleviating symptoms of anxiety and depression commonly observed in this population.

Research indicates that reminiscence therapy can lead to improvements in quality of life and overall well-being for individuals with dementia. The interactive nature of digital platforms encourages participation and allows caregivers to customize content based on the individual's preferences and history. As such, DRT not only serves to strengthen the connections between seniors and their pasts but also enhances their current social interactions, promoting a sense of identity and belonging. Overall, DRT represents a promising avenue for addressing the psychological needs of older adults with Alzheimer's in institutional settings, highlighting the potential benefits of integrating technology into therapeutic practices.


Eligibility Criteria:
Inclusion Criteria:

* People over 60 years of age.
* Confirmed diagnosis of mild or moderate Alzheimer's, where the patient still retains a certain degree of autobiographical memory.
* People institutionalized in a geriatric care center or similar.
* Level of cognitive impairment that allows understanding and basic interaction with digital tools.
* Approval and signature of informed consent by the participant or his/her legal representative, demonstrating agreement to participate in the study.
* Availability or access to devices (tablets or computers) provided by the study program or the care center.

Exclusion Criteria:

* Diagnosis of other neurological or psychiatric conditions (such as vascular dementia, Parkinson's, or psychotic disorders) that may significantly interfere with the program's results.
* Patients in advanced stages of Alzheimer's with severe limitations in remembering autobiographical events or interacting with digital devices.
* Vision, hearing, or fine motor problems that prevent the use of electronic devices in an appropriate manner, without the possibility of adaptation or assistance.
* Individuals or legal representatives who are unable or unwilling to give informed consent.
* Behaviors that may put the participant, staff, or other residents at risk when carrying out program activities.
Stem Cell Therapy to Improve the Muscle Function of Patients With Partly Denervated Muscles of the Arm

The purpose of this study is to assess muscle improvement after stem cell injection in the biceps muscle of patients with a brachial plexus injury.

Brachial plexus injuries can cause severe disabilities and often affect young adults and newborn children. When initial conservative treatment or nerve surgery fails, muscle/tendon transfers are the only current treatment options available to regain a functional arm. During this extensive surgery a healthy donor muscle is transposed to exert a different function. After long-term denervation the muscle is irreversibly changed. Muscle atrophy, fattening, fibrosis, decrease in capillary to muscle fiber ratio and decline in the number of satellite cells, which are responsible for post-natal muscle repair, is seen. For neuromuscular diseases, cell therapy aiming at rescuing muscle damage by delivery of cells that can differentiate into skeletal muscle, might be a promising approach. Safety questions remain whether stem cell injection results in non-muscle tissue formation like inflammatory cells or connective tissue formation in the transplanted muscles. Furthermore, it remains to be determined whether these stem cells undergo functional integration and enhance muscle function. The objective of this pilot study is to assess functional and morphological improvement of the m. biceps brachii after autologous bone marrow-derived mononuclear cell injection.

Eligibility Criteria:
Inclusion Criteria:

* BP patients with paresis of m. biceps brachii (MRC 1,2,3), either after conservative treatment or at least two years after nerve surgery with partial recovery of the elbow flexor
* Patients capable and willing to give informed consent

Exclusion Criteria:

* Function recovery of the elbow flexor (m. biceps brachii) to a MRC motor scale of 0
* EMG activity: no motor unit potentials
* Medical history of other central of peripheral neurological disorders
* Inability to undergo BM harvesting
* Bleeding diathesis, INR \> 2
Safety and Pharmacokinetics of Tucatinib (MK-7119) in Chinese Participants With Cancer (MK-7119-002)

The primary purpose of this study is to characterize the safety and tolerability of tucatinib (MK-7119) in Chinese participants with human epidermal growth factor receptor 2 positive (HER2+) advanced breast cancer, gastric or gastroesophageal junction adenocarcinoma (GEC), and colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed HER2+ advanced breast cancer, gastric or GEC, and colorectal cancer
* Have progressed at least one previous therapeutic regimen and either no longer are candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance within 7 days prior to allocation
* Has life expectancy \>6 months in the opinion of the investigator
* Have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as assessed by the local site investigator/radiologist
* Must test negative for hepatitis B surface antigen (HBsAg)
* If there is a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load at screening
* For males, agree to be abstinent from heterosexual intercourse, or agree to use acceptable contraception, for the duration of study and 1 week after
* For females, is not pregnant or breastfeeding AND one of the following applies:
* Is not a woman of childbearing potential (WOCBP)
* Is a WOCBP and uses highly effective contraception and is not pregnant

Exclusion Criteria:

* History of prior cancer within \<3 year, except for adequately treated basal cell or squamous cell carcinoma of the skin, cervical cancer in situ, or other in situ carcinomas which needs discussion between the investigator and the Sponsor
* Participants with leptomeningeal disease are excluded
* Has symptomatic central nervous system (CNS) metastases
* Has active human immunodeficiency virus (HIV), hepatitis B virus, or HCV infection
* Has had chemotherapy, immunotherapy, radioimmunotherapy, definitive radiation, or biological cancer therapy or treatment with an investigational product within 4 weeks (2 weeks for palliative radiation) before the first dose of study intervention
* Has an active infection requiring therapy
* Has refractory nausea/vomiting, chronic gastrointestinal disease, or significant bowel resection
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study
* Has a QTc prolongation
* Has uncontrolled illness including but not limited to ongoing symptomatic congestive heart failure (New York Heart Association \[NYHA\] Class III or IV heart failure), unstable angina pectoris, cardiac arrhythmia, and psychiatric illness that would limit compliance with study requirements
* Has had major surgery within 4 weeks prior to first dose of study intervention
* Is currently participating in another clinical trial
* Has psychiatric or substance abuse disorder
The Optimizing Treatment of PegIFN Alfa in HBeAg-negative CHB Patients With Low Level HBsAg

As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with sequential treatment of pegylated interferon alpha and NAs.

In order to optimize HBsAg clearance in CHB patients with low level HBsAg, the investigators enrolled patients who had received, and responded to, NAs for more than 12 months(see the inclusion criteria), and patients are switched to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. The longest course of treatment is 96 weeks. After treatment, patients will be followed up for 24 weeks. During the 96 weeks course of treatment, HBsAg level will be monitored. When HBsAg level is less than 0.05 IU/mL, peginterferon treatment will be stopped and patients will receive 24 weeks follow up.

Eligibility Criteria:
Inclusion Criteria:

1. CHB patients who had received single NAs for more than 12 months.
2. Hepatitis B e antigen (HBeAg)-negative.
3. Hepatitis B surface antigen (HBsAg) positive and \<1000 IU/mL.
4. Hepatitis B virus DNA \<100 IU/mL.

Exclusion Criteria:

1. Patients with liver cirrhosis, Hepatocellular Carcinoma or AFP \>2 ULN or other malignancies.
2. Patients with other factors causing liver diseases.
3. Pregnant and lactating women.
4. Patients with concomitant HIV infection or congenital immune deficiency diseases.
5. Patients with diabetes, autoimmune diseases.
6. Patients with important organ dysfunctions.
7. Patients with serious complications (e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding.)
8. Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months.
9. Patients with a previous use of IFN anti hepatitis B virus treatment or have NAs drug resistance.
10. Patients who can't come back to clinic for follow-up on schedule.
Glutamate Reducing Interventions in Schizophrenia

Participants will be administered several doses of pomaglumetad (POMA) (low and high doses) over 14 days to individuals at clinical high risk for developing psychosis and use magnetic resonance imaging (MRI) brain imaging to determine whether these doses of POMA are affecting glutamate levels.

A double-blind, randomized, phase 1b, multiple dose trial of 14 days of treatment with POMA (80 mg, 160 mg, 240 mg, 320 mg) in clinical high risk patients to determine which dose, if any, reduces glutamate and metabolism using MRI techniques. The GO NO-GO decision will be whether or not any dose tested in the R61 phase of the trial decreases left hippocampal CA1 region cerebral blood volume (CBV).

Eligibility Criteria:
Inclusion Criteria:

* Capacity to provide informed consent
* Currently using a reliable form of birth control

Exclusion Criteria:

* Metal implants in body or a history of metal working
* Lifetime diagnosis of asthmatic symptoms within the past 3 years or known sensitivity to contrast agents
* Lifetime diagnosis of renal failure/disease
* Acute neurological, neuroendocrine, or medical disorder including renal insufficiency (CrCl\<40 mL/min/1.73m2)
* Lifetime diagnosis of hypertension or diabetes or seizure disorder
* IQ\<70
* Acute risk for suicide and/or violence
* Pregnant lactating
* Current abuse of substances (alcohol, cocaine, stimulants, cannabis, opiates, sedative hypnotics)
* Current use or anticipated need for antipsychotics or mood stabilizers (all antipsychotics, also depakote, lithium, lamotrogine, pregabalin or any med with a mechanism of action like gabapentin), probenecid, selective serotonin reuptake inhibitors, tricyclic antidepressants, and monoamine oxidase inhibitors
* More than one previous gadolinium scan
Treatment of Androgenetic Alopecia in Females, 9 Beam

The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 9 beam model in promoting hair growth in females diagnosed with androgenetic alopecia when treatment is applied as directed.

This is a randomized double-blind, control device clinical study across 5 sites, evaluating changes in terminal hair count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).

The trial with 60 female subjects who have been diagnosed with androgenetic alopecia, who are between 25 and 60 years of age, have Fitzpatrick Skin Types I-IV, with classifications of Ludwig I-4, II-1, II-2, or frontal, have active hair loss within the last 12 months.

Subjects will use the device on three non-concurring days a week as directed per device for 26 weeks duration.

Initial efficacy endpoint for each subject will be assess at visit 4 (week 16).

Safety analysis will be assessed based on the reports of adverse events during study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of androgenetic alopecia
* Fitzpatrick Skin Types I-IV
* Ludwig I-4, II-1, II-2, or frontal
* Active hair loss within last 12 months

Exclusion Criteria:

* Photosensitivity to laser light
* Malignancy in the target area
* Pregnancy
* Lactating females
Feasibility Trial of a Multi-level Media Production and Social Marketing Campaign to Reduce HPV Vaccine Hesitancy

Since 2019, the HPV working group of the University of Virginia Cancer Center's Southwest Virginia Community Advisory Board has developed and executed strategies to increase regional HPV vaccination rates. Members collaboratively developed Appalachian Voices for Health, a multi-level media production and social marketing intervention. This novel intervention builds on the past efforts of the working group and the engaged organizations; takes into account the impact of vaccine hesitancy on HPV vaccination uptake; and incorporates best practices. Through the intervention, Nursing and Dental Assistant students from Mountain Empire Community College will develop PSAs after receiving training about HPV vaccination and health communication. These PSAs will be used in a social marketing campaign executed through a regional transportation system managed by Mountain Empire Older Citizens. Specifically, the trial's aims are three-fold: assess the intervention's impact on community members' and students' HPV vaccine hesitancy (Aim 1) and perceptions and actions related to HPV vaccination (Aim 2) and evaluate other feasibility indicators at the community-, student-, organizational-, and process levels (Aim 3). The research team will use a concurrent mix-methods approach to assess feasibility indicators. Aims will be assessed using surveys, focus groups, meeting minutes, and implementation records. Data will be analyzed using descriptive and inferential statistics and content coding. Determination of the intervention's feasibility will consider the achievement benchmarks for feasibility indicators individually and collectively. Data will be used to inform refinement and future testing of Appalachian Voices for Health.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* enrolled as a student in one of the regional community college's health sciences programs (Phase 1 only)
* ride the regional health services focused non-profit's rideshare buses or view their social media during one or more of the three survey periods (Phase 2 only)
* work for either the regional community college or non-profit AND were involved in supporting the execution of the study components within their organization.

Exclusion Criteria:

* Under 18