cyrilzakka/clinical-trials huggingface dataset:
Comparison of Operator-guided and Automatic Algorithm-guided Atrial Fibrillation Ablation

Catheter ablation in the treatment of atrial fibrillation (i.e. pulmonary vein isolation) is now the most effective method of prevention of arrhythmia recurrence. Use of 3D electroanatomical system is now a golden standard.

Background hypothesis is that automatic algorithm collecting ablation points during pulmonary vein isolation (with certain catheter stability time, range of motion, and catheter-tissue contact force) prevents forming the gaps in the ablation line, thus preventing pulmonary vein reconnection and AF recurrence. The aim of the trial will be 1:1 comparison of the two methods of pulmonary vein isolation: with manual vs. automatic collection of ablation points using CARTO system and contact force catheter.

Atrial fibrillation (AF) is the most common sustained supraventricular arrhythmia. It increases the risk of hospitalization and all-cause mortality. AF causes about 5-fold increase in the risk of stroke and 3-fold increase in the risk of heart failure.

Catheter ablation in the treatment of AF (i.e. pulmonary vein isolation) is now the most effective method of prevention of arrhythmia recurrence, especially in paroxysmal AF. Still, efficacy of one procedure in a 1-year follow-up is between 20 and 80%, depending on demographic and clinical factors (concomitant diseases), and on the form of the arrhythmia (paroxysmal-persistent), it also depends on the method of ablation used and the experience of the centre. In a big European registry including over 1,300 patients antiarrhythmic drugs-free efficacy of catheter ablation in AF in 1-year follow-up was about 40%. Major finding in patients with AF recurrence after catheter ablation is pulmonary vein reconnection, so decreasing the risk of pulmonary vein reconnections seems crucial to diminish the risk of AF recurrence. Several novel technologies have been proposed lately to improve efficacy of AF ablation, their real importance needs validation in a clinical trial.

Current standard is radiofrequency (RF) ablation with manual collection of ablation points (by operator or assistant). Automatic algorithm collect ablation points with additional criteria: catheter stability time, range of motion, and catheter-tissue contact force. The operator can see more precisely where the RF current has been applied and where are the gaps in the line.

Background hypothesis is that automatic algorithm collecting ablation points (with certain catheter stability time, range of motion, and catheter-tissue contact force) prevents forming the gaps in the ablation line, thus preventing pulmonary vein reconnection and AF recurrence. The aim of the trial will be 1:1 comparison of the two methods of pulmonary vein isolation: with manual vs. automatic collection of ablation points using CARTO system and contact force catheter.

Eligibility Criteria:
Inclusion Criteria:

* patients with symptomatic atrial fibrillation qualified to catheter ablation according to current standards

Exclusion Criteria:

* lack of informed consent
* two previous pulmonary vein isolations
Personal Activity Intelligence in the Treatment of High Blood Pressure

Personal Activity Intelligence (PAI) is a novel metric developed to quantify the amount of routine physical activity (PA) needed to improve health and reduce cardiovascular (CV) mortality. The PAI metric can be integrated in PA monitors to promote and track PA. The present pilot study is a 12-week randomized controlled trial designed to test the efficacy of PAI in the treatment of high blood pressure. The primary aim is to investigate how routine PA (expressed as PAI level) affect ambulatory blood pressure by comparing the effect of the intervention (≥100 PAI per week) with a control recommended to follow national PA guidelines. The secondary aims are to investigate the effect on a comprehensive CV risk profile, and to model the effect of PAI level on multiple CV parameters. The CV risk profile includes office BP, arterial stiffness, stroke volume, heart rate, cardiac output, systemic vascular resistance, cardiorespiratory fitness, body composition, blood lipid profile and serum markers of glucose metabolism, kidney failure and systemic inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Systolic blood pressure (SBP) 130-179 mmHg and/or diastolic blood pressure (DBP) 80-109 mmHg at first clinical visit (screening). Note, this criteria was updated after the inclusion of three participants. The initial inclusion criteria were SBP 140-179 mmHg and/or DBP 90-109 mmHg.
* Not currently engaged in regular physical activity (\< 50 PAI per week based on self-reported PA)

Exclusion Criteria:

* Usage of blood pressure medication
* Usage of lipid modifying agents
* Diabetes
* Cardiovascular disease
* Diagnosed secondary hypertension
* Disease or disability that prevent exercise or participation in testing
Food Intake and Blue Dishware in Residents Living With Dementia

Blue dishware was alternated with white dishware for lunch and dinner for residents living with dementia. Food consumption occurred in the home dining room and food was weighed before and after consumption to determine proportion consumed. Eating challenges were also noted. Within-participant comparisons were made to determine if food intake and eating challenges improved with the blue dishware condition.


Eligibility Criteria:
Inclusion Criteria:

* living in a residential care environment with dementia
* informed consent of POA and assent of person living with dementia

Exclusion Criteria:

* did not come to the dining room to eat
* required eating assistance
* did not live on the study unit
Serplulimab Combined With Chemotherapy in Patients With Resectable Non-small-cell Lung Cancer

China with high incidence of non-small cell lung cancer. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of lung cancer patients was not significantly decreased. For patients with locally advanced lung cancer, direct surgery is not effective. It is difficult to achieve radical resection by surgery merely, and even if many patients receive surgery, they may eventually have tumor recurrence and poor survival rate. Therefore, it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients. According to the reports, PD-1/ PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of lung cancer. Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect. Multiple clinical results showed that serplulimab provided higher overall response rate for advanced lung cancer. However, in patients with locally advanced lung cancer, the efficacy of serplulimab combined with chemotherapy for sequential radical surgery is still unclear. The purpose of this study is to observe and evaluate the efficacy and safety of serplulimab combined with chemotherapy in the neoadjuvant therapy of resectable non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

1. signed informed consent;
2. patients age 18 to 75 years old
3. primary resectable, histologically confirmed non small cell lung cancer;
4. non small cell lung cancer the clinical stage was IIA-IIIB (no N3 patient) (according to AJCC TNM stage, 8th edition).
5. ECOG PS 0-1.
6. the diseases could be resectable assessed by thoracic oncologist

Exclusion Criteria:

1. with significant cardiovascular disease;
2. current treatment with anti-viral therapy or HBV;
3. Female patients who are pregnant or lactating;
4. history of malignancy within 5 years prior to screening;
5. active or history of autoimmune disease or immune deficiency;
6. signs of distant metastases.
AVAPERL1 Study: A Study of Avastin (Bevacizumab) With or Without Pemetrexed as Maintenance Therapy After Avastin in First Line in Patients With Non-Squamous Non-Small Cell Lung Cancer

This open-label study will assess the efficacy and safety of Avastin with or without pemetrexed as maintenance therapy in patients with advanced, metastatic or recurrent non-small cell lung cancer. In Part 1, patients will receive 4 cycles of treatment with Avastin (7.5mg/kg iv) plus cisplatin (75mg/m2 iv) plus pemetrexed (500mg/m2 iv) on day 1 of each 3-week cycle. In Part 2, patients responding to treatment will be randomized to receive further treatment cycles of Avastin (7.5mg/kg iv every 3 weeks) with or without pemetrexed (500mg/m2 iv every 3 weeks). Anticipated time on study treatment is until disease progression. Target sample size is \<500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adults \>/=18 years of age
* inoperable, locally advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC)
* at least 1 measurable lesion meeting RECIST criteria
* ECOG performance status 0-2
* adequate hematological, liver and renal function

Exclusion Criteria:

* prior chemotherapy or treatment with another systemic anti-cancer agent
* malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer or DCIS
* evidence of tumor invading major blood vessels
* current or recent use of aspirin (\>325mg/day) or full-dose anticoagulants or thrombolytic agents for therapeutic purposes
* history of haemoptysis \>/=grade 2
* clinically significant cardiovascular disease
Parenting Videos In Primary Care

The purpose of this study is to test the effectiveness of a video-based parent education intervention delivered in the primary care setting on parents and other caregivers discipline attitudes and practices.


Eligibility Criteria:
Inclusion Criteria:

* Adult caregivers of children ages 12 to 36 months with a scheduled well-child visit.
* Caregivers must be older than 18 years of age, must be considered a consistent caregiver for the child, must be the primary caregiver at least 2 days per week, and must live with the child.

Exclusion Criteria:

* Caregivers previously enrolled in the study.
* Caregivers who do not speak or read English,
* Caregivers not able to give contact information for follow-up,
* Caregivers of a child who has a severe behavioral problem or developmental delay as reported by the parent during the initial recruitment phone call.
Calcium Over Postprandial Effects of Fatty Meal on Metabolism, Blood Pressure, Oxidative Stress, Endothelial Function.

The purpose of the study is to investigate calcium acute influence over the postprandial effects of a fatty meal on serum calcium, plasma glucose and triglycerides, blood pressure, oxidative stress, and endothelial function in obese women.

Studies suggest that dietary calcium intake is inversely associated with cardiovascular disease, but supplementary calcium appears to be associated with raised risk of cardiovascular events. Fatty meals lead to oxidative and inflammation which seems to interfere in postprandial dismetabolism, a predictor of cardiovascular events. To investigate calcium acute influence over the postprandial effects of a fatty meal a crossover, controlled, and randomized clinical trial will be conducted with obese adult women who will be randomized into one of the three interventions, characterized by a fatty meal with different contents of calcium: low calcium (40 mg), high dietary calcium (540 mg from non-fat milk), and high supplementary calcium (540 mg from calcium carbonate). Each participant will receive all three meals and one of them every week. Before meals' intake blood sample will be collected and endothelial function assess will be performed. Participants will eat the specific meal and endothelial function will be assessed again after 120 minutes. Blood sample collections will be repeated every 60 minutes after meal's intake to perform latter biochemical analyzes to determine: 8-isoprostane levels, to assess oxidative stress status; triglycerides; glucose; insulin; and serum calcium. Blood pressure will be continuously assessed during 25 minutes before meals' intake and during 2 hours after it.

Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) greater than or equal to 30 kg/m2 and below 40 kg/m2
* habitual dietary calcium intake below 500 mg per day

Exclusion Criteria:

* smoking
* dietary supplements or drugs that could interfere with body weight, metabolic profile and blood pressure
* diabetes
* thyroid dysfunction
* hypertension
* angina pectoris
* heart kidney or liver failure
* intestinal malabsorption
* acute or chronic inflammation
* HIV infection
* autoimmune diseases
* cancer
* chronic obstructive pulmonary disease
* dyslipidemia with indication for drug treatment
* history of myocardial infarction or stroke
* pregnancy and lactation
* menopause
Cisplatin Induced Kidney Toxicity

Cisplatin (CisP) is a chemotherapeutic agent used to treat head and neck and lung cancer in adults and over 15 different pediatric cancers. Despite its known toxicity, CisP is still widely used as a first line chemotherapy as it is so effective. Nephrotoxicity is one of the most common adverse effects of CisP, occurring in 20-50% of patients. It manifests as acute kidney injury (AKI) typically within the first few days of exposure and is associated with short and long-term morbidity. Furthermore, AKI diagnosis is only possible once kidney damage has progressed to functional impairment, when mitigation strategies are ineffective. Tests that could predict AKI risk pre-emptively or diagnose early-stage AKI before functional loss would be very impactful, affording opportunities for prevention or early intervention to mitigate CisP nephrotoxicity, reduce morbidity and improve health outcomes.

The field of metabolomics seeks to identify patterns of small molecules (metabolites) involved in cell or tissue metabolism related to disease states, or patient factors like lifestyle and genetics. Plasma and urine are ideal for sampling the metabolome, which can identify at-risk patients and reveal disease-related changes earlier than existing diagnostic methods do.

In CisP-treated children and adults from across Canada, we will identify urine and plasma metabolite profiles a) prior to CisP dosing that predict CisP AKI risk, and b) shortly after dosing to identify early-stage nephrotoxicity, before clinical signs of AKI are detectable. Our identified biomarkers will allow individualization of CisP treatment based on the level of nephrotoxicity risk and the design of trials to mitigate the progression and complications of CisP nephrotoxicity.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants: Initiating treatment with CisP (≥75 mg/m2) for head/neck or lung cancers at one of the Adult participating sites; 18 years of age or older.
* Paediatric participants: Initiating treatment with CisP for any cancer diagnosis at one of the Pediatric participating sites; greater than 3 months of age.
* All participants: Consent to participate in the study.

Exclusion Criteria:

* Diagnosis of chronic kidney disease (CKD) at baseline (glomerular filtration rate \<60 mL/min/1.73m2, determined by chart review of either formal glomerular filtration rate testing, 24 hour creatinine creatinine clearance of age-appropriate serum creatinine-based estimated glomerular filtration rate equations; past kidney transplant)
* Previous use of any nephrotoxic drugs included on the provided Excluded Nephrotoxic Medications list in the two weeks prior to initiation of CisP treatment
* Previous use of CisP
* Previous radiotherapy (total body irradiation or abdominal radiation only) in the last 1 month prior to study
* Previous hematopoietic stem cell transplant
* Any chronic or acute health condition that the investigator feels would render the patient inappropriate for this study, including but not limited to significant uncontrolled cardiorespiratory, hepatic, infectious, or renal disease at the discretion of the investigator
Food as Medicine: A Quasi-Randomized Control Trial of Healthy Foods for Chronic Disease Management

The purpose of this study is to investigate the effect of providing healthy foods and nutrition education on participants' body weight, blood pressure, and average blood sugar level.

The healthy food offerings tested in this study will help determine which option is best to improve health outcomes among Cleveland Clinic Akron General patients with chronic conditions. Findings from this study could guide doctors in deciding on appropriate nutrition and dietitian services for Cleveland Clinic patients.

Participants will receive healthy food items for 15 weeks and nutrition counseling and education to support chronic disease management at no cost. The healthy food items will consist of either medically-tailored pre-prepared meals, or a weekly produce box with recipes depending on the study arm. Participants must complete a baseline study visit, one nutritional counseling session via phone, 2 to 4 nutrition education videos, and a 16-week post-intervention study visit.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age or older who are patients at Akron General Center for Family Medicine
* Have body mass index (BMI) equal to or greater that 30kg/m2 AND
* Have at least one of the following diagnoses determined based on patients' problem list in the electronic medical record (EMR) and the international classification of diseases, 10th revision (ICD-10) codes:

  1. Pre-type 2 diabetes mellitus
  2. Type 2 diabetes mellitus
  3. Hypertension
* Have NOT participated in nutrition counseling at the University of Akron Nutrition Center within the past 6 months

Exclusion Criteria:

* Food allergies
* Pregnant
* No access to internet
* Need English language interpretation
* Currently participating in a structured weight loss program or using weight loss medications
* Any condition that, in the Investigator's judgement, interferes with the ability to adhere to study requirements.
Skeletal Muscle Protein Synthetic Response to Amino Acid and Peptides

Skeletal muscle quality is an important determinant of exercise performance and overall health. It is vital for not just movement, but also metabolizing nutrients. Protein from the diet can promote muscle protein synthesis for muscle recovery and growth. More importantly, doing so shifts net protein balance positively (e.g. protein synthesis is greater than protein breakdown) and promotes greater rates of muscle protein turnover. Leucine is an amino acid required to build muscle, but it also acts as a signaling molecule informing the muscle to start protein synthesis. Before reaching skeletal muscle, dietary protein is digested into small peptides and free amino acids. Rate of absorption from the intestine to the blood stream is significantly faster for peptides compared to amino acids. As amino acid availability in the blood is a precursor for muscle protein synthesis, our objective is to determine if the different absorption rates between free amino acid and peptides influence muscle protein synthetic and breakdown rates.


Eligibility Criteria:
Inclusion Criteria:

* Recreationally-active adults: ≥ 30 min of physical activity at moderate intensity ≥ 3 times per week
* Ages: 18-35 years old
* English fluency

Exclusion Criteria:

* Tobacco, nicotine (patch/gum) use (previous 6 mo)
* Alcohol consumption \>10 drinks per week
* Metabolic disorders (e.g., Metabolic Syndrome, Diabetes, thyroid diseases)
* Cardiovascular disease, arrhythmias
* Hypogonadism
* Asthma
* History of uncontrolled hypertension
* Orthopedic injury/surgery (within 1 yr)
* Hepatorenal, musculoskeletal, autoimmune, or neurological disease
* History of neuromuscular problems
* Previous participation in amino acid tracer studies
* Predisposition to hypertrophic scarring or keloid formation
* Consumption of ergogenic-levels of dietary supplements that may affect muscle mass (e.g., creatine, HMB), insulin-like substances, or anabolic/catabolic pro-hormones (e.g., DHEA) within 6 weeks prior to participation
* Consumption of thyroid, androgenic, or other medications known to affect endocrine function
* Consumption of medications known to affect protein metabolism (e.g., prescription-strength corticosteroids, non-steroidal anti-inflammatories, or acne medication)
* Currently pregnant
Non-invasive Vagal Neurostimulation (nVNS) in Adolescents With Postural Orthostatic Tachycardia Syndrome (POTS)

The purpose of this study is to determine if nVNS will decrease autonomic symptom intensity (COMPASS-31 and Child Functional Disability Inventory) in adolescent patients with postural orthostatic tachycardia syndrome (POTS) in comparison to standard recovery STEPS management.

Project purpose: The investigators will study the use of non invasive vagal nerve stimulation in newly diagnosed adolescent patients with POTS to see if symptom management improves over 2 months. Surveys will include COMPASS-31. Child Functional Disability Inventory, and PHQ-9. Patient logs will evaluate headache frequency, exercise duration and VNS use.

Research objectives: The investigators hypothesize that:

Primary Aim 1. Use of noninvasive vagal nerve stimulation will decrease autonomic symptom intensity compared to control group.

Primary Aim 2. Use of noninvasive vagal nerve stimulator will improve child function.

Primary Aim 3. Heart rate elevation measured by head up tilt table test will decrease in the treatment group compared to the control group.

Secondary goals include:

Secondary Aim 1: To determine if utilization of noninvasive vagal nerve stimulation influences headache frequency Secondary Aim 2: Determine if utilization of noninvasive vagal nerve stimulation will influence weekly duration of aerobic exercise.

Secondary Aim 3: Determine if utilization of noninvasive vagal nerve stimulator results in significant side effects, particularly depression, in adolescent patients.

Eligibility Criteria:
Inclusion criteria:

1. Patient's age 12-19 years of age
2. Newly diagnosed POTS at Mayo Clinic in Rochester
3. Head up tilt table test results in a heart rate increase of 40 or more bpm
4. Consent is able to be obtained appropriately per age

Exclusion criteria:

1. POTS patients with orthostatic hypotension
2. POTS patients with vasovagal syncope
3. Use of medications other than midodrine or metoprolol
4. Inability to independently utilize the GammaCore device
5. Inability to independently complete surveys or patient logs
6. Patients receiving hormonal therapy other than birth control
7. Pregnancy
8. Prior neck surgery
9. Metallic implant present
10. Cardiac disorder
11. Presence of an eating disorder
12. Use of a feeding tube
Enthesis Differences in Rheumatoid Arthritis and Axial Spondyloarthropathy

The aim of this study is to investigate the sonographic differences in entheses in patients with Rheumatoid arthritis and Axial Spondyloarthropathy.

After recording the demographic data of the patients; 5 enthesis regions 5 enthesis sites were evaluated bilaterally as ''tricipital tendon (TT), quadricipital tendon (QT), proximal patellar tendon (PPT), distal patellar tendon (DPT), achilles tendon (AT)'' will be sonographically evaluated and the presence of hypoechogenicity , tendon thickness increase, power Doppler activity, erosion, presence of entezophyte/calcification will be investigated. The differences between the groups will then be compared.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis patients identified according to the 2010 American College of Rheumatology /Europan Leage Against Rheumatism classification criteria,
* axial Spondyloarthrtis patients identified according to the Assessment of Spondyloarthritis classification criteria
* healthy controls with no history of rheumatic diseases.

Exclusion Criteria:

* history of limb trauma and surgery in the last 3 months,
* metabolic disease (diabetes mellitus, hypothyroidism),
* malignant neoplasm,
* limitation of range of motion in the extremity,
* those who have received corticosteroid injections in the last 3 months,
* uncontrollable fibromyalgia.