cyrilzakka/clinical-trials huggingface dataset:
Motivational Interviewing and Physical Activity Change in Parkinson's Disease

The purpose of this study is to test the efficacy of a 6-month telephone-based motivational interviewing intervention and a web-based application intervention to improve physical activity in participants with Parkinson's Disease.

Participants will be randomized into one of four groups to examine two separate interventions. The groups are: motivational interviewing (a counseling/coaching style), a web-based application for participants to keep track of their physical activity, a combination of the motivational interviewing and the web-based application, and an educational program on various issues related to Parkinson's Disease. The intervention will last 6 months with a follow-up appointment at 9 months. Participants will be asked to come to Galter Pavilion at Northwestern Memorial Hospital or Shirley Ryan AbilityLab a total of five times over the course of the nine months.

Eligibility Criteria:
Inclusion Criteria:

* Community dwelling
* Age 18 or older
* Physician confirmed diagnosis of PD with Hoehn and Yahr stage ≤3
* Ability to ambulate independently (walker is allowed) for distance of 50 feet or 10 minutes at a time
* Does not meet current CDC physical activity guidelines of 150 minutes of moderate to vigorous physical activity per week
* Currently and plans to have a smartphone, tablet, or computer and access to the internet for the next 9 months
* Willing to monitor activity on their smartphone, tablet, or computer via a web-based application during the 9-month program
* Currently uses the internet in a basic capacity

Exclusion Criteria:

* Inability to speak and understand English
* Has a cardiovascular disorder or other health condition that would make exercise unsafe according to their physician
* Patients who are currently receiving physical therapy or received physical therapy one month prior to study enrollment
* Cognitive impairment as defined by inability to provide informed consent and to self-report feelings and behaviors
* Montreal Cognition Scale (MOCA): rating of less than 24, indicative of cognitive dysfunction
* Patients who indicate it is not recommended they participate in increased physical activity as indicated by the Physical Activity Restriction Questionnaire (PAR-Q)
* Patients who are in other studies that monitor fitness or physical activity
Immunogenicity and Safety of Commercially Available Vaccines Against SARS-CoV-2 (COVID-19) in Patients With Hematologic Malignancies

D1. Primary Objective:

1. Determine the immunogenicity of FDA approved COVID-19 vaccination in patients with hematologic malignancies

D2. Secondary Objectives:

1. Assess the safety of FDA approved COVID-19 vaccination in patients with hematologic malignancies
2. Analyze the kinetics of immunogenic response over time after receipt of the COVID-19 vaccination
3. Compare the immunogenicity of different COVID-19 vaccinations that will be approved by the FDA
4. Analyze advanced flow immunophenotyping of innate and adaptive immune blood cells in all participants and correlate with response to vaccination


Eligibility Criteria:
Inclusion Criteria:

1. Patients must not have received any prior COVID-19 vaccination
2. Patients must have any one of the following diagnosis:

   a. Monoclonal B-cell lymphocytosis b. Chronic lymphocytic leukemia/small lymphocytic lymphoma c. B-cell Non-Hodgkin's lymphoma: i. Follicular lymphoma ii. Mantle cell lymphoma iii. Diffuse large B-cell lymphoma iv. Marginal zone lymphoma v. Burkitt lymphoma vi. Double hit/triple hit lymphoma vii. Lymphoplasmacytic lymphoma/Waldenstrom's macroglobulinemia d. Hodgkin lymphoma

Exclusion Criteria:

1. Receipt of any vaccination (e.g., influenza, recombinant zoster) 2 weeks prior to registration
2. Prior chemotherapy, immunotherapy or oral agent therapy that was completed \>12 months prior to enrollment. NOTE: patients who are on oral agents for the treatment of their underlying malignancy will be allowed. Some of these medication classes include Bruton tyrosine kinase inhibitor (BTKi), BCL2 antagonists, PI3 kinase inhibitors, immunomodulatory agents, among others. Please contact the Principal Investigator for any clarification about these medications.
Investigation of Specific Biomarkers in Patients With Atrial Fibrillation Who Undergo Interventional Treatment

The two main mechanisms for atrial fibrillation (AF) recurrence after cryoablation include Pulmonary vein (PV) reconnection and the presence of non-PV associated arrhythmic focuses. The aim of this study is to reveal the specific biomarkers by antibody microarrays.

One hundred twenty patients with atrial fibrillation will participate in the study.

They will be divided into three groups.

1. Patients with AF recurrence after the first procedure but with isolated pulmonary veins at the beginning of the second AF ablation b)patients with AF recurrence after repeat PV ablation.
2. Patients with PV-associated atrial fibrillation. The group will be included patients with freedom of atrial fibrillation after PV isolation (first or repeat procedure).
3. Healthy volunteers

Groups would be formed from patients who previously underwent atrial fibrillation ablations and whose blood samples have been taken and placed in a biobank before interventional treatment. The first step will include proteomic serum profiling using antibody microarrays in ten subjects will be split into 3 groups. The second step will include validation of selected protein biomarkers, in the total cohort (N=120).

Eligibility Criteria:
Inclusion Criteria:

• Patient with paroxysmal/persistent atrial fibrillation who underwent interventional treatment

Exclusion Criteria:

* permanent AF
* contraindications to oral anticoagulation or heparin
* chronic kidney disease requiring dialysis
* untreated hypo- or hyperthyroidism
* breast feeding
* pregnancy
* chronic kidney disease requiring dialysis
* decompensated heart failure
* stroke within the last 3 months
* myocardial infarction within the last 3 months
* Percutaneous coronary intervention or Coronary Artery Bypass Grafting within the last 3 months
* active myocarditis
* artificial valve replacement surgery
* severe mitral or aortic stenosis
* coronary artery disease requiring revascularization
* heart transplant
Feasibility and Acceptability of a Substance Use Screening and Brief Intervention for Youth Living With HIV in Kenya

Youth living with HIV in Kenya frequently use substances and this negatively affects their mental health as well as viral suppression.

The goal of this study is to evaluate the feasibility and acceptability of a peer-delivered substance use screening and brief intervention for these youth.

Globally, youth are disproportionately affected by substance use. In sub-Saharan Africa (SSA), an estimated 41% of youth have used at least one substance in their lifetime. Youth Living with HIV (YLH) have not been spared. In a study conducted in Kenya, 33% and 46% of youth attending a HIV clinic reported harmful patterns of alcohol and illicit substance use respectively. Substance use among YLH has been associated with negative outcomes including antiretroviral therapy (ART) non-adherence, neurocognitive deficits, poor virologic control and depression. Unfortunately, YLH in SSA lack access to substance use interventions. A study conducted by Parcesepe et al reported that only 37% of HIV adolescent sites in select LMICs offered any substance use screening and interventions.

The World Health Organization (WHO) recommends screening and brief intervention (SBI) in primary healthcare for identification and early intervention for substance use. Primary healthcare workers in LMICs are however often unable to implement SBI due to heavy workload. Peers represent a potential means through which SBI may be delivered in adolescent HIV settings and presents a number of advantages. First, peer support systems are well established in many adolescent HIV clinics in sub-Saharan Africa. Secondly, by drawing upon their shared experiences as youth living with HIV, the peers can provide empathic support to the adolescents.

Few studies have evaluated implementation of peer-delivered SBI for adolescents. Available studies have been conducted in high-income countries. To our knowledge, no study has evaluated implementation of peer-delivered SBI among YLH. Our project seeks to fill this gap by evaluating the feasibility and acceptability of a peer-delivered SBI for YLH in Kenya. This project is in line with: (i) Kenyan Ministry of Health guidelines for delivery of adolescent and youth friendly services which lists substance use counseling as an essential service, and (ii) United Nations Programme on HIV/AIDS (UNAIDS) Fast-track target 95-95-95, which requires that by 2030, 95% of people on ART be virally suppressed (12) as well as target 3.5 of the Sustainable Development Goals (SDGs) which requires that governments strengthen the treatment and prevention of substance abuse. Data from this study will set the stage for full-efficacy trials and ultimately to scale-up efforts to other LMICs.

Eligibility Criteria:
Inclusion criteria:

• Youth aged 15-24 years

Exclusion criteria

* those ill during the appointment
* those who decline to assent/consent
* youth unable to speak fluently in English.
Protein Nutrition for Muscle Hypertrophy in Older Adults

The primary objective is to determine the effect of reduced activity on the stimulation of myofibrillar FSR with protein feeding in the elderly.

The primary objective is to determine the effect of reduced activity on the stimulation of myofibrillar FSR with protein feeding in the elderly

Eligibility Criteria:
Inclusion Criteria:

* Must habitually complete a minimum of 5000 steps per day
* Having obtained informed consent
* Non-obese
* Non-smoker

Exclusion Criteria:

* Aged \>80 years
* Inability to comply with study procedures
* Currently participating or having participated in another infusion trial during last 12 months
* Any acute or chronic llness
* History of neuromuscular problems
* Medications known to affect protein metabolism
* Individuals who complete fewer than 5000 steps per day
* Individuals who have metal implants
Assessment and Management of Post-Stroke Spasticity With Botulinum Toxin-A

Within the first year after stroke, approximately 38% of stroke survivors experience an increased resistance to movement, also called spasticity. One type of treatment that is approved for stroke survivors in Canada that could reduce spasticity is the injection of Botulinum toxin (BTX) into the affected muscle. While BTX reduces spasticity, there is limited evidence to show that BTX administration leads to functional improvements. This may occur because the outcomes aren't sensitive enough to detect change, some people may have better responses to BTX, or because BTX hasn't been paired with the right exercises to improve function. The aims of this research are: i) to determine if there is a way of improving the markers that measure change in response to treatment; and ii) to identify the ideal type of exercise that should be paired with BTX to allow the drug to have it greatest effect.

There are two primary research questions: a) What are the measures that will indicate whether a person with post-stroke spasticity will benefit from BTX therapy? It is hypothesized that EMG latency and amplitude, for those who best respond to BTX, will differ from those who demonstrate a weaker response to BTX; b)What is the ideal training approach for improving muscle function in stroke survivors receiving BTX injections? It is hypothesized that a training protocol that focuses on optimizing specific muscle activation patterns will demonstrate better outcomes than a training program designed to improve function.


Eligibility Criteria:
Inclusion Criteria:

* \>120 days post first ischemic stroke
* Unilateral spasticity (MAS ≥ 1) of the wrist or elbow
* \>18 years of age
* Medical referral for focal BoNT-A injections
* Residual active control of the wrist or elbow

Exclusion Criteria:

* Underlying neuromuscular disorders (i.e. ALS, neuropathies, myasthenia gravis)
* Inability to provide informed consent or communicate in English
* Bilateral paresis/spasticity
* Contractures
* Prescribed anti-spastic medication
Preventing Impaired Driving Among Adolescents

The primary goal of this project is to evaluate the efficacy of webCHAT, a single-session web-intervention, on reducing impaired driving among adolescents receiving behind-the-wheel training at driver education programs.

Alcohol and marijuana (AM) are the most commonly used substances among adolescents in the U.S. The consequences of AM use are significantly higher relative to use of either substance alone. This study builds on effective interventions that have demonstrated reductions in alcohol and/or marijuana use and reduced consequences one year later, and proposes to adapt one of those interventions, CHAT, to the web (web-CHAT). The investigators will evaluate the efficacy of web-CHAT among 15.5-17-year-old adolescents (n=150) recruited when teen participants are attending behind-the-wheel training. The study has the potential to promote public welfare by improving adolescent health outcomes and reducing risky driving behaviors that can have substantial monetary and social costs, as well as by providing unique insight into what mediates reduced risky driving attitudes behaviors among those in the intervention. The study is innovative because it is for both youth who are at risk for substance use as well as those who are not, and it is delivered during a teachable moment when adolescents receive driver's education. Finally, this study can provide unique insights about the efficacy of web-CHAT to reduce marijuana initiation, use, and risky driving attitudes in the context of a changing marijuana policy climate. A 3-year study is proposed to test the feasibility of research procedures in a driver education setting and pilot the efficacy of web-CHAT. The investigators will test whether web-CHAT reduces alcohol and/or marijuana initiation or use compared to teens in UC, at three and six-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* 15.5-17 year olds enrolled in driver education school
* Access to a computer or smartphone
* Within one month of taking their driver's licensing exam

Exclusion Criteria:

* Under 15.5 or over 17 years old
* Not enrolled in one of the participating schools
* Non-English speaking
A Postmarket Clinical Trial for EXCROSSAL Stent in CAD Patients With 3-month DAPT or 12-month DAPT

1. Prospective, randomized, multicenter clinical study
2. This is a post-marketing clinical study to evaluate whether it will affect the safety event when it is used in different treatment ways. Adopting non - inferiority design, 2700 cases were enrolled.
3. EDC system (eCRF electronic data collection system)
4. Follow-up points: 30 days,3 months, 12 months, 24 months, 36 months, 48 months and 60 months after the operation;

1. Subjects are eligible for coronary intervention
2. The lesion needs to be pre-expanded or special circumstances should be carefully considered according to the clinical manifestations
3. The selection of target vessel is based on the criteria of a diameter between 2.25mm and 4.0mm
4. If a stent needs to be placed at the target vessel, it is recommended that there be at least 2mm overlap between the stents; if the stent expansion is not sufficient, post-dilatation treatment is required.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years and ≤75 years;
2. De novo coronary artery primary lesions;
3. Stable angina pectoris;
4. Patients with coronary artery disease with similar symptoms of myocardial ischemia or angina;
5. Suitable for PCI indication and suitable for the implant of EXCROSSAL stents.
6. Able to understand the purpose of the study, voluntarily participate and sign the informed consent form, and willing to accept the clinical follow-up; Imaging criteria The target lesion length≤ 60mm；Visual reference diameter of the vessel is 2.25-4.0mm;

Exclusion Criteria:

1. Patients with acute myocardial infarction (AMI) within 7 days; Non-ST elevated ACS patients
2. those who implanted any stent before;
3. Left ventricular ejection score(LVEF) 30 %
4. Patients with bleeding tendency or anticoagulation treatment contraindications and/or PCI contraindications or coagulopathy;
5. There are other diseases such as cancer, malignant tumor, congestive heart failure, organ transplant, or candidate) or has a history of abuse (alcohol, cocaine, heroin, etc.), plan adherence is poor, or the life expectancy of less than 1 year;
6. It is estimated that elective surgery patients within 12 months;
7. Other coronary lesions requiring staged intervention;
8. If there are branches of blood vessels that need to be treated, the diameter of blood vessels ≥ 2.5 mm;
9. The subject's compliance or the researcher's judgment was not suitable for the participants in the study;
10. Pregnant or lactating persons; Imaging criteria

1. Left main disease, transplanted vessel lesions, stent restenosis; 2. The balloon cannot be predilated or/or the severe calcification lesion of rotatory failure; 3. The distortion of the stent is difficult to pass;
Exogenous Oxidation of Fructose-glucose Mixtures During Running

The aim of this study is to characterise exogenous carbohydrate oxidation rates during exercise, when ingesting glucose (polymers) only, compared to glucose-fructose mixtures, and glucose-fructose mixtures ingested in hydrogel form.


Eligibility Criteria:
Inclusion Criteria:

* Maximal oxygen consumption \> 50 ml.kg-1.min-1
* \> 1 year training in endurance running or triathlon
* No current injury or injury within the last three months
* No history of cardiac or metabolic disease such as coronary heart disease or diabetes
* No current or history of gastrointestinal issues
* Successful completion of the physical activity readiness questionnaire (PAR-Q)

Exclusion Criteria:

* Female
* Untrained in endurance running
* Current injury or injury within the past three months
* History of cardiac or metabolic disease such as coronary heart disease or diabetes
* History of or current gastrointestinal issues such as irritable bowel syndrome
* Unable to replicate diet and training for 3 and 5 days respectively prior to each experimental visit.
Evaluating Parent Delivered Interventions for Children With Autism

The investigators will assess the efficacy of parent delivered interventions in the treatment of social and communication deficits in children with autism. By collecting information about parent and child functioning before and after intervention, the investigators will be able to determine whether the intervention is effective in improving child social communication and reducing parent stress.


Eligibility Criteria:
Inclusion Criteria for autism participants:

* Children between the ages of 1.6 and 17.11 years of age
* Males and females
* Diagnosis of autism based on DSM-IV-TR criteria, an expert clinical evaluation, and ADOS or ADI-R if needed
* Receiving or will receive a parent delivered intervention to alleviate symptoms related to their diagnosis of autistic disorder
* Have a care provider that will reliably bring subjects to their chosen intervention and clinic visits, and is trustworthy to provide accurate accounts of services provided to the subject

Inclusion Criteria for developmentally delayed participants:

* Will have an age range between 1.6 and 17.11 years of age
* Males or females
* Diagnosis of a developmental delay or disorder based on DSM-IV-TR, ICD-10, and an expert clinical evaluation
* Have historical evidence of significant abnormal developmental milestones as determined by neurological history
* Receiving or will receive a parent delivered intervention
* Have a care provider that will reliably bring subjects to their chosen intervention and clinic visits, and is trustworthy to provide accurate accounts of services provided to the subject

Exclusion Criteria for autism participants:

* Is medically unstable (e.g., more than one seizure a month)
* Have a medical diagnosis that causes autism like symptomology (e.g., Fragile X, Down syndrome, Angelman's syndrome, tuberous sclerosis, Rett's disorder)

Exclusion Criteria for developmentally delayed subjects:

* Is medically unstable (e.g., more than one seizure a month)
* Has a diagnosis of ASD
Fluid Management for Cesarean Section III

Regional anesthesia, including epidural, spinal and combined epidural spinal anesthesia (CSEA), is a pivotal part in modern anesthesiology. Previously, the investigators found that epidural and spinal anesthesia during cesarean section possesses different responsiveness to fluid (including crystalloid and colloid) management given prior or posterior to anesthesia. Although CSEA is also widely used as an alternative of single epidural or spinal anesthesia for its combined effect of fast onset of anesthesia of spinal anesthesia and the property of duration of epidural catheterization, the fluid resuscitation during CSEA is still unknown. The investigators hypothesized that fluid management during CSEA would produce different effect on hemodynamics in cesarean section compared with epidural and spinal anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* 21-40 yr
* First time of delivery
* ASA status I-II
* No premature
* No genetic and infectious diseases
* Chinese

Exclusion Criteria:

* \< 21 yr
* \> 40 yr
* Subjects with cardiac and pulmonary disorders
* Dislocation of placenta
* Pregnant hypertension
* Allergy to local anesthetics
* Unwilling to cooperation
* Need intraoperative administration of vascular active agents
* With significant delivery side effects
Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars in Subjects Undergoing Elective Abdominoplasty

This study will compare how well EXC 001 works versus placebo in reducing the appearance of scars in subjects undergoing elective abdominoplasty. The study will also evaluate the safety of EXC 001 in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have sufficient excess abdominal tissue to qualify for a standard elective abdominoplasty
* Subject has chosen to have an elective abdominoplasty
* Medically healthy with normal screening results
* Subjects must not be pregnant or lactating

Exclusion Criteria:

* Females who are currently pregnant or pregnant during the 12 months prior to inclusion in the study, or lactating
* Participation in another clinical trial within 30 days prior to the start of the study
* Any other condition or prior therapy, which, in the opinion of the PI, would make the subject unsuitable for this study