cyrilzakka/clinical-trials huggingface dataset:
A Single Arm Trial With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)

The purpose of this trial is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.


Eligibility Criteria:
Inclusion Criteria:

To qualify as high-bleeding risk and/or a candidate for 1-month DAPT, subject had to meet at least one of the criteria detailed below:

* Adjunctive chronic oral anticoagulation treatment planned to continue after PCI
* Age ≥ 75 years old
* Baseline Hgb \<11 g/dl (or anemia requiring transfusion during the 4 weeks prior to procedure)
* Any prior documented intracerebral bleed
* Any documented stroke in the last 12 months
* Hospital admission for bleeding during the prior 12 months
* Active non-skin cancer currently undergoing treatment or surveillance (in lieu of treatment)
* Planned daily NSAID (other than aspirin) or steroids for ≥30 days after PCI
* Planned surgery that would require interruption of DAPT (within the next 12 months)
* Renal failure defined as: Creatinine clearance \<40 ml/min
* Thrombocytopenia (PLT \<100,000/mm3)
* Severe chronic liver disease defined as: subjects who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
* Expected non-compliance for at least 6 months DAPT for other medical reasons

Exclusion Criteria:

* Pregnant and breastfeeding women
* Subjects requiring a planned PCI procedure after 1 month of index procedure
* Procedure planned to require non-trial stents, stand-alone POBA, or stand-alone atherectomy
* Active bleeding at the time of inclusion
* Cardiogenic shock
* Subject with planned surgery or procedure necessitating discontinuation of DAPT within one month following index procedure
* Subject not expected to comply with long-term single antiplatelet therapy
* A known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, Biolimus A9 (or its derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (eg, BioLinx™), stainless steel (or other metal ions found in 316L stainless steel), zinc, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
* PCI during the previous 6 months for a lesion other than the target lesion of the index procedure
* Participation in another clinical study within 12 months after index procedure
* Subjects with life expectancy of less than 2 years
Study of CM512 in Patients With Moderate-to-Severe Atopic Dermatitis

A Phase 2 study designed to evaluate the efficacy and safety of CM512 in adult patients with moderate-to-severe Atopic Dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of moderate-to-severe AD for at least 1 year according to the American Academy of Dermatology's consensus criteria prior to the screening visit meeting all of the following criteria:
* EASI≥16 at Screening and Baseline visits;
* Investigator's Global Assessment (IGA) score of≥3 at Screening and Baseline visits;

  * 10% Body Surface Area (BSA) of AD involvement at Screening and Baseline visits;
* Mean of weekly Pruritus Numeric Rating Scale (NRS) severity score≥4 at Baseline;

Exclusion Criteria:

* Not enough washing-out period for previous therapy.
* Concurrent disease/status which may potentially affect the efficacy/safety judgement.
* Organ dysfunction.
* pregnancy.
* Other.
Enhancing Vaccination Uptake Through Points Redemption Based Financial Incentives and Digital Platforms: an Open-label Cluster Randomized Controlled Trial Utilizing Community Mobilization and Empowerment Strategies

The overall goal is to develop and optimize a health digital platform and points redemption-based financial incentive interventions for the promotion of non-National Immunization Program (non-NIP) vaccination uptake and related preventative behaviors in China, and formulate a low-cost, labor-saving and replicable pattern. The primary objective is to develop and optimize a digital platform-based point-redemption and financial incentive system and evaluate the effectiveness of the interventions for improving non-NIP vaccines coverage and related preventive behaviors.The main questions it aims to answer are:

H1: Participants allocated to the intervention group will demonstrate a 3% increase in vaccine doses of targeted non-NIP vaccines, including HPV vaccines, influenza vaccines, pneumonia vaccines, rotavirus vaccines, varicella vaccines, and haemophilus Influenza Type B polysaccharide conjugate (Hib) vaccines, compared to those in the control group at the 12-month follow-up.

H2: Participants allocated to the intervention group will exhibit a 5% increase in the prevalence of related preventive behaviors compared to those in the control group at the 12-month follow-up.

Researchers will compare the financial incentive intervention to the routine activities to see if the intervention works to improve the vacciantion rate of non-NIP vaccines.

Participants will:

1. Participants can automatically input their health behaviors through the digital platform, and the back-end will verify the information with data provided by the township hospitals or community health centers.
2. A QR code will be implemented at each township hospital or community health center. Participants will scan the QR code after completing vaccination or other related preventive behaviors. The digital platform will automatically record points for each completed behavior.
3. Use accumulated points to redeem gifts on the system, including household goods, electronic products, and free or discounted health services.


Eligibility Criteria:
Inclusion Criteria:

* Do not move from the original research and implementation site within the next year;
* Voluntarily participate in the study and sign the informed consent;
* No mental disorder or cognitive impairment, able to understand and cooperate with research requirements.

Exclusion Criteria:

* Have contraindications related to vaccination;
* The state of the body during the intervention period is not suitable for vaccination.
Retrospective Evaluation of Athens Complete Health Improvement Program (CHIP) Database

Data from participants in Athens CHIP classes from May 2011 to present will be analyzed to evaluate the differences in outcomes based on: 1) gender, 2) age, 3) whether a household member participated in the class with them.

Participants had health screens before and after completing the class. The data from the health screens that will be utilized for comparison will include: body mass index (BMI), blood pressure, and fasting blood sugar and lipid levels.

Identified data will be provided to the PI from Live Healthy Appalachia/CHIP on a flash drive. This data will be password protected by the research team. The data will consist of two different databases, 1) identifiers with health screen results, 2) identifiers with demographics (age, gender, household member in class). The researchers need data from both databases for this study. Each participant has been assigned a unique participant number by CHIP.

The databases will be combined by the research team, allowing the demographics to be matched to the biomarkers. The unique CHIP identifier will be maintained as a participant ID, while all other identifying data will then be deleted from the database.

The data will then be analyzed for relationships by a statistician.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in The Complete Health Improvement Program
* Signed the CHIP Request to Participate consent form, which includes the statement: "I understand that my test results are confidential but may be used for statistical analysis and group summaries."
* Completed both health screens

Exclusion Criteria: none
A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease

Primary Objective:

To compare the pharmacokinetics (PK) of single and multiple doses of IPX203 with Immediate release carbidopa-levodopa (IR CD-LD) in subjects with advanced Parkinson's disease (PD).

Secondary Objectives:

To compare the pharmacodynamics of single and multiple doses of IPX203 with IR CD-LD.

To compare the efficacy of IPX203 with IR CD-LD following multiple doses.

To evaluate the safety of IPX203.

IPX203 is an investigational product containing CD-LD.

IPX203-B16-01 Study Design:

A randomized, open-label, rater-blinded, multicenter, 2-treatment, 2-period, multiple-dose crossover study.

Approximately 30 qualified IR CD-LD-experienced advanced PD subjects will be randomized.

The study duration will be approximately 8 weeks, including the screening period.

Eligibility Criteria:
Eligibility will be determined at screening and Visit 1 of the study.

Inclusion Criteria:

* Diagnosed with idiopathic PD at age ≥ 40 years who are being chronically treated with stable regimens of CD-LD but experiencing motor complications.
* Hoehn and Yahr Stages 2, 3, or 4
* Montreal Cognitive Assessment (MoCA) score ≥ 24 at Screening Visit in "on" state.
* For the 4 weeks prior to the Screening, the subject experiences daily "wearing-off" episodes with periods of bradykinesia and rigidity and experiences an "off" state upon awakening on most mornings by history.
* Responsive to CD-LD therapy and currently being treated on a stable regimen with CD-LD for at least 4 weeks prior to Visit 1
* Typically experiences an "on" response with the first dose of IR CD-LD of the day (by subject history).
* By history, efficacy of the first morning dose of IR CD-LD lasts less than 4 hours

Exclusion Criteria:

* History of medical conditions or of a prior surgical procedure that would interfere with LD absorption, such as gastrectomy or proximal small-bowel resection.
* Liver enzyme values ≥ 2.5 x the upper limit of normal; or history of severe hepatic impairment.
* History of drug or alcohol abuse within the 12 months prior to Screening.
* Received within 4 weeks of Visit 1 or planning to take during participation in the clinical study: any doses of a controlled-release (CR) LD apart from a single daily bedtime dose or any doses of Rytary, additional CD (eg, Lodosyn) or benserazide (eg, Serazide), or catechol-O-methyl transferase inhibitors (entacapone or tolcapone) or medications containing these inhibitors (Stalevo). Received within 4 weeks of Visit 1 or planning to take during participation in the clinical study: nonselective monoamine oxidase (MAO) inhibitors, apomorphine, or dopaminergic blocking agents including antiemetics.
* History of psychosis within the past 10 years.
* Treatment with any dopamine antagonist antipsychotics for the purposes of psychosis or bipolar disorder within the last 2 years.
* Based on clinical assessment, subject does not adequately comprehend the terminology needed to complete the PD Diary.
The Effect of a Web-Based Behavioral Intervention on Physical Activity Levels in Adolescents

The primary purpose of this study is to test whether rewarding physical activity with a motivational website will increase physical activity levels in middle school-aged children over six months. As a secondary outcome, the study also tests the intervention's impact on biological measures of inflammation and metabolic function in a sub-set of study participants who agree to provide blood samples.

Physical activity is associated with a variety of positive health outcomes, as well as improved metabolic profiles and reduced inflammation. However, levels of moderate to vigorous physical activity (MVPA) diminish dramatically as children move into the middle school years. To address this problem, this study tests a behavioral intervention, called "Zamzee," designed to motivate middle school-aged children to increase their levels of MVPA. The Zamzee intervention consists of a 3-axis accelerometer that tracks individual physical activity rates over time and a website that displays individual physical activity rates and provides rewards for maintaining or improving physical activity rates. The primary aim of this randomized, controlled trial is to test whether middle school-aged children randomly assigned to the Zamzee intervention will show significantly greater levels of physical activity levels over six months, compared with control group participants who wear the accelerometer but have no access to the rewards website. A secondary aim is to test the intervention's impact on biological parameters that may contribute to the long-term health effects of inactivity (including C-reactive protein as a measure of inflammation, and hemoglobin-A1C as a measure of metabolic status) in a sub-set of study participants who agree to provide blood samples.

Eligibility Criteria:
Inclusion Criteria:

* Middle-school-aged students aged 11 to 14

Exclusion Criteria:

* Previously participation in a Zamzee pilot study
* Existing medical conditions or health complications that will interfere with the ability to be physically active
* Inability to read and write English
Breathing for Adolescent Stress Reduction Feasibility RCT

The purpose of this study was to test a simple slow breathing curriculum for reducing stress among high school students. The curriculum was developed by the Health and Human Performance Foundation and implemented for this study at a public high school in Colorado, United States.

Nearly 1 in 3 US adolescents meet the criteria for anxiety, an issue worsened by the COVID-19 pandemic. Untreated adolescent stress and anxiety can adversely affect teenagers' development, education, and physical and mental health. Although stress-management strategies may seem abundant, many are unscalable or inaccessible for today's youth. Slow diaphragmatic breathing reduces stress and anxiety by downregulating the body's stress response, and is a recommended adolescent stress management strategy. Schools are under pressure to support students in reducing stress, yet diaphragmatic breathing practices are rarely used in school settings. The investigators developed and implemented a 5-week curriculum during COVID-era hybrid learning to conduct the first randomized controlled trial of slow diaphragmatic breathing for stress reduction in a US high school setting.

Eligibility Criteria:
Inclusion Criteria: Students were eligible to participate in this study if they:

1. Were enrolled at study start (baseline period) in one of four senior (12th grade) English classes taught by the teacher who was recruited for the study;
2. Accepted participation in the study, including willingness to abide by the randomization process, by signing student assent on the consent form;
3. Had parental permission to participate in the study, indicated by their signing their consent on the consent form.

Exclusion Criteria: Students were excluded from the study and data collection, but not from class, if they:

1. Chose not to participate; or,
2. Did not receive parental permission.
Statin Therapy to Reduce Progression in Women with Platinum Sensitive Ovarian Cancer

This is a single arm pilot trial to evaluate the feasibility of using a simvastatin intervention, and to evaluate its effects on cancer progression, among 20 patients with platinum-sensitive ovarian cancer, treated with carboplatin and liposomal doxorubicin at Cedars-Sinai Medical Center.

This is a pilot study of statin therapy to examine the feasibility of simvastatin use to reduce disease progression in 20 patients with platinum-sensitive ovarian cancer at Cedars-Sinai Medical Center. This study will focus on patients with recurrent platinum sensitive ovarian cancer to increase the likelihood that this population will experience recurrent disease during the 6-month intervention and follow-up. In addition, this population of patients has a narrow range of standard of care carboplatin doublet combinations that are prescribed, enabling the investigators to create a more homogenous study population. Given their high risk of developing recurrent disease, women with platinum sensitive ovarian cancer, have the potential to derive the maximum benefit from an intervention that could delay disease progression and enhance survival.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent platinum sensitive ovarian cancer, all histologies (serous, endometrioid, mucinous, clear cell). Platinum sensitivity defined as ≥ 6 months since last platinum treatment.
* No contraindication to carboplatin and/or liposomal doxorubicin or simvastatin.

Exclusion Criteria:

* Prior or current use of any statin medication
* Current systemic use of medications known to interact with statins
* Current use of any other investigational agents
* Liver disease, active cirrhosis
* Uncontrolled intercurrent illness
* History of chronic myopathy
* Prior cancer other than ovarian cancer or non-melanomatous skin cancers
* Known active infection with HIV
* Current excessive alcohol consumption (average alcohol consumption of more than 5 drinks per day)
* Prior exposure to doxorubicin or liposomal doxorubicin
* Hemoglobin A1C \>8.0%
MSK Validation Study

Spinal posture and imbalance are known to be related to increased muscle expenditure, with narrow "cone of economy" of muscle effort defining the most comfortable postures. Therefore, it is hypothesized that predicting the posture of the lowest muscle effort available for a patient with a given spinal alignment and body properties will correspond to the posture the patient will most likely assume. Based on established musculoskeletal models, a model application was configured to allow prediction of this optimal posture. This study aims to assess the validity of this approach and the value of using biomechanical modeling for pre-operative planning.

The objective of this study is to validate a novel method of post-operative posture prediction - a full-body biomechanical model based on an established technology and physiological reasoning. Specifically, the model ability to predict postoperative global sagittal alignment, including compensatory and reciprocal changes, from pre-operative radiographic imaging and the information about planned posture correction will be evaluated. This will be realized by comparing model-predicted radiographic measures and overall balance to follow-up patient radiographs.

Having demonstrated model validity to predict postoperative posture will allow to use this method for simulating various "what-if" scenarios to empower surgical planning by predicting expected outcomes. This can be used to optimizing preoperative planning, which has a potential to substantially improved surgery predictability and patient outcomes.

Furthermore, validated model will allow scientific investigation of the principles governing human posture and biomechanics of the pathological spine. Generated scientific knowledge of biomechanical factors influencing sagittal posture and surgery outcomes (e.g. number of levels fused, amount and distribution of posture correction, etc.) can lead to improvements in clinical management of spinal disorders.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients
2. Any ethnicity
3. At least 18 years of age
4. Has undergone a thoracolumbar spinal fusion procedure

Exclusion Criteria:

1. Patient has had a prior spinal surgery in the thoracic and/or lumbar spine;
2. Patient presents scoliosis greater or equal to 20° T4-T12 Cobb angle;
3. Patient has been diagnosed with idiopathic adolescent scoliosis (treated or untreated);
4. Patient has other implants that obstruct the spine and/or pelvis in the lateral view;
5. Patient presents any of the following complications: pseudoarthrosis, instrumentation failure, instrumentation pull-out and/or requires a revision surgery at any time following the primary surgery and prior to 3 months post-op;
6. Patient is a prisoner.
Hemodynamic Effects During Land vs Water Exercise for Older Adults With Orthostatic Hypotension

The purpose of the study is to understand how blood pressure, heart rate, and symptoms of low blood pressure (such as dizziness or nausea) are affected by positional changes and exercise when on land or in the water for people who tend to experience orthostatic hypotension.


Eligibility Criteria:
Inclusion Criteria:

* Self-report of dizziness upon standing (from sit or supine position) or known diagnosis of orthostatic hypotension
* Able to stand independently for 3-5 consecutive minutes
* Able to walk independently (with or without an assistive devise)
* Medically stable for last month
* Score of 3 or greater on Mini-Cog (standardized outcome measure to detect dementia)
* Full coronavirus vaccination

Exclusion Criteria:

* Diagnosis of dementia
* Contraindication for pool exercise (such as infected open wounds, fecal incontinence, diarrhea.)
Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics

This study will evaluate the effects of mild and moderate impairment of hepatic function on the single-dose pharmacokinetics, safety and tolerability of AG-013736.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of reduced hepatic function (Child Pugh Classification A or B)
* Body Mass Index of 18-32 kg/m2

Exclusion Criteria:

* History of febrile illness within 5 days prior to first dose
* Any condition possibly affecting drug absorption (e.g. gastrectomy)
* Positive urine drug screen
Pulmonary Diffusing Capacity During Postural Postural Changes and Acute Exercise

The combined measurement of the pulmonary diffusing capacity to carbon monoxide (CO) and nitric oxide (NO) (DLCO/NO) has recently been standardised and validated for clinical use. It involves a very short breath-hold time (≤5 seconds), and it may be repeated up to 12 times without affecting measurements, and it is thus ideal for assessing acute changes in pulmonary diffusing capacity and its components during various physiological manoeuvres. The aim of the present study is to compare the test-retest reliability of pulmonary diffusing capacity measurements during postural changes (sitting vs. supine) vs. rest-to-exercise. DLCO/NO will either be measured in the sitting position during rest vs. exercise or in the sitting and supine posture, and this will be repeated within 1-7 days in 20 healthy individuals that will be randomised to one of the two interventions. Statistically,the test-retest relaibility of sitting-to-supine vs. rest-to-exercise changes in DLCO/NO will be compared by parametric methods.


Eligibility Criteria:
Inclusion Criteria:

• Regular exercise (1-3 timer per week)

Exclusion Criteria:

* Any known medical condition that requires regular medication or any known lung condition
* Smoking
* Symptoms of disease within 2 weeks prior to the study
* Abnormal lung function test
* Pregnancy