cyrilzakka/clinical-trials huggingface dataset:
Study Comparing Pulmonary Vein Isolation With the Cryoballoon, Radiofrequency Energy, or Both in the Treatment of Atrial Fibrillation (AF)

The purpose of this study is to perform a prospective, randomised study investigating the safety and efficacy of cryoballoon catheter ablation compared with radiofrequency ablation, or both together in the treatment of paroxysmal AF.

The hypotheses for this study are (1) that cryothermal energy is as effective and safe as using radiofrequency energy in the treatment of paroxysmal AF and is associated with a better long term outcome, and (2) that use of both cryothermy and RF in combination is as effective and safe as using either radiofrequency energy or cryothermy alone and is associated with a better long term outcome.

Pulmonary vein isolation is an important treatment for patients with atrial fibrillation (AF), particularly those in whom antiarrhythmic drugs are ineffective or cannot be tolerated. One method involves the use of radiofrequency energy and 3-D mapping system to produce a series of lesions (small burn areas) within the heart. Another method involves passing a balloon (called a cryoballoon) into the heart and freezing the parts of the heart muscle that the veins drain into. Both methods appear to be effective from known data. However, it is not known if use of either method alone or both together is the most effective. We aim to perform a prospective, randomized clinical trial comparing these three strategies.

Substudy 1: Use of cardiac MRI to evaluate ablation lesions. Some patients will also be asked to undergo an MRI scan of the heart before the ablation procedure, and again at three months and one year following the procedure. This will allow us to examine the potential role for MRI in imaging scar tissue formed by the ablation, and help us understand the time course of scar formation and changes to that part of the heart following the ablation.

Substudy 2: Platelet reactivity and activation in AF, and the impact of curative ablation. Blood and urine samples will be taken pre- and 3 months post ablation to see if platelet reactivity and activation are affected by AF compared to established normal ranges, and whether curative ablation impacts on this.

Eligibility Criteria:
Inclusion Criteria:

* Patients with documented paroxysmal AF on at least 2 occasions and accepted for catheter ablation.

Exclusion Criteria

* Significant valvular disease
* Previous left atrial ablation
Minto Model in Effect Site Mode for Target-Controlled Infusion of Remifentanil During Cardiopulmonary Bypass

Target controlled infusion with remifentanil is widely used during cardiac surgery, wich is performed using the Minto model. It was derived from patients undergoing general surgery. However, pharmacokinetics of remifentanil can be changed during cardiopulmonary bypass. The investigators tested whether Minto model for target controlled infusion produces constant plasma remifentanil concentration during the cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with the ASA class I\~III undergoing elective cardiac surgery using cardiopulmonary bypass

Exclusion Criteria:

* Patients not using target controlled infusion during the operation
* Patients with drug/substance abuse
* Patients using analgesics before this study starts
* Pregnant women
* Patients who rejected study participation
Environmental Toxicants Avoidance Study

This study is designed to test whether non-persistent environmental chemicals (PECs) are elevated in people with glucose dysregulation. The primary aim is to measure whether this toxicant burden can be reduced using a dietary and lifestyle modification intervention. The secondary aim is to observe any changes in glucose response pre and post-intervention.

The primary aim will be measured using a commercially-available screening test for urinary toxicant metabolites. The toxicant burden will be measured by a percentile score of each metabolite and summing all percentile values. A risk level of each metabolite will be normalized by the percentile score in order to calculate the total toxic burden for an individual. Wilcoxon-ranked sum non-parametric calculations will be used to evaluate whether pre and post-intervention reduction has occurred. Because this is a single-arm trial, any reduction in the toxicant burden will be correlated with the relative improvement of the secondary endpoint and will be measured using Kendall's tau-beta ranked correlation.

The secondary aim will assess each participant's fasting and post-prandial glucose response measured daily for throughout the 3-week trial. Because this study is not powered, the estimated man reduction from baseline cannot be estimated. Any reduction in blood glucose mean values will allow us to calculate an effect size for future investigation. The ranking of the improvement in glucose response (AUC) will be tested by ranking the reduction of the toxic burden by a correlation analysis using Kendall's tau-beta ranked correlation described above.

Each participant is provided with a baseline in-person assessment, one midpoint education session and a final assessment session. Each participant will receive a standardized packet of information regarding dietary and lifestyle interventions which reduce toxicant exposures along with a water filter for home use and gift card to support the purchase of organic food during the trial. Questionnaires including a Medical Symptom Questionnaire, Weekly Stress Inventory and Knowledge Attitudes and Behavior Questionnaire will be administered pre and post-intervention.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years old or older
2. Able to complete the remote informed consent process.
3. Glucose dysregulation with HbA1c \>= 5.7% at baseline
4. If hemoglobin A1c (HgA1c) is greater than 6.5% and the potential participant is not already receiving standard care for diabetes from a physician, participants must see their primary care provider for diabetes standard care before enrollment in the study.
5. Those not already eating a majority organic-food diet and drinking filtered water (\>50% by self-disclosure)

Exclusion Criteria

1. Use of insulin or insulin analog medications
2. Planning to have elective surgery, diagnostic procedures, dental, or cosmetic procedures during the study period
3. Unable or unwilling to modify dietary and lifestyle behaviors
4. Those already eating a majority organic-food diet and drinking filtered water (\>50% by self-disclosure)
Active and Healthy Brotherhood: A Program for Chronic Disease Self-Management for Black Men

This study will test ways to improve health behaviors using an intervention that has been specially designed for African-American men. The program, called Active \& Healthy Brotherhood (AHB), will provide information on basic health, and healthy eating, physical activity, stress management, and how to get medical care when needed.The AHB intervention will be compared to a control group that will receive basic health information in videos and brochures.


Eligibility Criteria:
Inclusion Criteria:

1. AA (based on self-report)
2. self-reported male
3. aged at least 21 years
4. non-institutionalized (i.e., community-dwelling, not living in assisted living facilities, nursing homes, etc.)
5. at high risk for developing chronic disease (e.g., not meeting current guidelines for PA and/or F\&V intake; current smoker; diagnosed with high cholesterol) or
6. currently diagnosed with diabetes, hypertension, or cardiovascular disease
7. residents of Forsyth County, NC (or surrounding areas and able to attend group sessions in Forsyth County).

Exclusion Criteria:

1. have had a cardiovascular procedure (e.g., heart surgery), heart attack, heart failure, stroke in the last 6 months
2. have cognitive, visual, auditory, physical functional (e.g., unable to walk unassisted), or language impairment precluding participation in group discussion, learning activities, or data collection.
3. currently achieve \>150 min/wk of moderate intensity PA or \>75 min/wk of vigorous intensity PA AND currently consume \> 9 servings of F\&V daily.
4. are currently enrolled in a chronic disease management program.
5. are unwilling to accept randomization assignment or planning to move from local area in \<2 years.
6. are currently receiving chemotherapy/radiation treatments.

Participants will be required to obtain approval from a health care provider prior to participation in the study if they:

1. are unable to participate in moderate PA due to physical limitations as indicated by positive (risk) responses on the PA Readiness Questionnaire (PAR-Q) and/or physician disapproval on the PAR Medical Examination.
2. have BP\>180/\>110 and/or HbA1C\>12 and/or triglycerides \>500.
3. have health conditions that could preclude changes to diet (e.g., irritable bowel syndrome, celiac disease)
Ramipril in Pediatric Patients on Hemodialysis

The aim of the study is to evaluate the effect of Ramipril in pediatric patients on regular hemodilaysis

Evaluate the effect of Ramipril on blood pressure, heart rate, Endothelial dysfunction and inflammatory markers in pediatric patients on regular hemodilaysis and the correlation of response with ACE I/D polymorphisms.

Eligibility Criteria:
Inclusion Criteria:

* Patients \< 16 years old
* Patients who have been on regular HD for 6 months or longer
* Hypertension at enrollment

Exclusion Criteria:

* History of active connective tissue disease
* Acute infection within 1 month prior to the study
* Advanced liver disease
* Gastrointestinal dysfunction requiring parental nutrition or active malignancy
* Use of medications such as immunosuppressive drugs within 1 month prior to the study
* Use of anti-inflammatory medications
* Use of vitamin E at a dose higher than 60 IU per day or vitamin C higher than 500 mg per day
* History of myocardial infarction or cerebrovascular event within 3 months prior to the study
* History of ACE inhibitor-associated angioedema
* Inability to discontinue ACE inhibitors or ARBs
Improving Antihypertensive Medication Adherence

Poor adherence to antihypertensive medications is associated with morbidity, and data suggest that substance abuse may contribute to poor adherence. Contingency management (CM), an intervention highly efficacious for improving outcomes of substance abusers, shows promise in improving medication adherence in a handful of small trials. CM involves providing tangible reinforcement each time the behavior (medication ingestion) is exhibited. Thus far, studies evaluating CM for increasing medication adherence have utilized MEMS caps, but reinforcement of adherence via MEMS caps is done relatively infrequently and with delay, hindering its efficacy. A widely utilized technology that may be more appropriate for reinforcing medication adherence is cell phones, which can record the process of pill ingestion through video functions. As regular monitoring and feedback is important in the efficacy of CM, patients can be provided with daily messages regarding adherence and CM earnings. In this pilot study, we propose to randomize 40 hypertensive substance abusing patients with suboptimal adherence to antihypertensive medications to one of two 12-week treatment conditions: (1) usual care, or (2) usual care with cell phone monitoring and CM. In the CM condition, patients will carry a cell phone and record and send in time- and date-stamped self videos of medication ingestion. These patients will receive congratulatory messages or reminders about adherence, and they will earn vouchers each time medication ingestion occurs at the appropriate time, along with bonuses for sustained adherence. We hypothesize that the CM condition will improve self report and pill count measurements of medication adherence and that it will result in decreased blood pressure. Results from this study may have widespread implications for the use of cell phones as a novel technology to improve medication adherence.


Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* have been prescribed one or more antihypertensive medications
* blood pressure of \>120 mmHg systolic or \>80 mmHg diastolic
* substance use problem
* willing to use a cell phone to record medication ingestion for three months
* have a valid photo ID (driver's license, passport, state ID) and are willing to sign an off-campus property transfer form and return study equipment at the end of study participation

Exclusion Criteria:

* uncontrolled psychiatric disorders
* significant cognitive impairment
* non-English speaking
Bariatric Surgery and COVID-19

The National Bariatric Surgical Registry (NBSR) is a prospectively collected database for all patients undergoing elective bariatric surgery in the UK. It was used to identify patients that underwent elective bariatric surgery during the pandemic (one year from 1st April 2020). Characteristics of this group were compared with a pre-pandemic cohort (one year from 1st September 2018).


Eligibility Criteria:
Inclusion Criteria:

All patients listed on National Bariatric Surgical Registry (NBSR) that underwent elective bariatric surgery during the pandemic (one year from 1st April 2020) or prior to the pandemic (one year from 1st September 2018) -

Exclusion Criteria:

- Where a variable was 'not recorded' this point was excluded from analysis. For age, gender, procedure type and provider the records were 100% complete, for BMI at time of surgery there was 5% missing data and for other variables the missing value rate was 2% or lower.
European Clinical Evaluation of the BD HPV Assay on the BD Viper LT System

The purpose of the study is to compare the results of the Becton Dickinson (BD) Human Papilloma Virus (HPV) Assay on the Viper LT instrument from SurePath media diluted in HPV diluent (pre-quot and/or residual), PreservCyt media diluted in HPV diluent (pre-quot and/or residual) and a BD cervical brush in BD transport medium to reference histology results from biopsy.

This is a multicenter study consisting of 2-3 European clinical trial sites, and up to 2 BD Viper LT Systems.

The BD HPV Diluent tube will be run on the BD HPV assay with the Viper LT instrument and compared to histology, Digene hybrid capture 2 (HC2), and Roche LINEAR ARRAY HPV Genotyping Test results.

Eligibility Criteria:
Inclusion Criteria:

* Referred to follow up due to one or more abnormal Pap or an HPV infection
* Subjects who have provided informed consent
* Subjects who meet the minimum age set forth by the ethics committee (EC) and/or national screening guidelines.

Exclusion Criteria:

* Known to be pregnant
* With prior complete or partial hysterectomy involving removal of cervix
* Subjects with an application of chemical compounds to the cervical area 24 hour prior to study entry- this includes acetic acid, iodine, spermicide, douche, anti-fungal meds.
* Subjects on who conization, Loop electrosurgical excision procedure (LEEP), laser surgery or cryosurgery has been performed.
Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease

The overall objective of this project is to study the influence of modern anti-inflammatory treatments in established inflammatory rheumatic diseases (IRD) on antibody response elicited by pneumococcal vaccination using 13-valent conjugate vaccine in combined schedules with 23-valent polysaccharide vaccine. In addition, the aim is to study the clinical aspects of vaccination regarding: tolerability in immunosuppressed patients with IRD, impact on existing rheumatic disease, possible association with onset of new autoimmune diseases, long-term immunity following pneumococcal vaccination and efficacy in preventing invasive pneumococcal disease. Results from this study are expected to bridge the existing knowledge gap and contribute to body of evidence needed for recommendations and implementation of vaccination program in IRD patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with IRD receiving active anti-rheumatic treatments with DMARDs or biological remedies are offered to participate in the study. The protocol permits stratification for prednisolone usage.

Exclusion Criteria:

* known allergy/intolerance of pneumococcal vaccine
* pregnancy
* active infection
Synthetic Metabolic and Genetic Networks for Medical Diagnosics

This is a category 3 human study, prospective, comparative, in parallel groups. A comparative qualitative and quantitative analysis of several markers in 250 samples is proposed.

The assumption is that researchers can engineer synthetic metabolic and genetic networks to expand the panel of molecules that are currently known to be detected by natural systems. The investigators also hypothesize synthetic metabolic and genetic networks can be tuned for decisions making and in particular to diagnose diseases from biomarkers detections.

This project proposes for the first time a hybrid analogue / digital solution for the multiplexed detection of biomarkers using bacterial and paper-based biosensors. Biosensors can be designed using analog or digital devices. Digital devices in synthetic and natural systems are noise-resistant and useful for decision-making. Analog devices are useful for signal transmission and processing. Here the investigators take advantage of signal transmission and processing via analog transducers and adders, and then decision-making via genetic switches. Such a hybrid analogue / digital approach has not yet been developed for biosensing. Another novelty of the project is to use synthetic metabolic pathways to develop analog devices. The advantage in term of treatment, for example, consists in the fact that the speed of enzymatic reactions in an analog adder far exceeds the speed of gene expression required to create a genetic logic matrix; it becomes even more pronounced when the devices are connected in series. The methodology will be illustrated for the detection of biomarkers of prostate tumors, but it is broad enough to be applicable to other diagnoses. The choice to develop biosensors for prostate disease is of practical relevance since the current screening strategy (based on PSA measurement) can lead to overdiagnosis and cannot differentiate between patients with aggressive tumors and those with an indolent illness.This study propose to mainly develop a bacterial and paper-based biosensor system

Eligibility Criteria:
Inclusion Criteria:

* Men aged over 18
* Informed, written consent of the patient for the biological collection
* Subject affiliated to a French social security scheme or beneficiary of such a scheme

Patients specific inclusion criteria :

- Admitted to care prostate disease or suspicion of prostate cancer and with a positive or negative PSA blood result

Controls specific inclusion criteria :

- Man free from all prostate or bladder pathologies

Exclusion Criteria:

* Patient under legal protection
* Persons deprived of their liberty, protected adults or vulnerable persons
* Participants may withdraw their consent at any time and for any reason whatsoever without incurring any negative consequences without change in their usual care

Controls specific non-inclusion criteria :

* Patient with current prostatic or urinary infection
* History of treatment for prostate cancer other than surveillance management
Pharmacogenetics Associated With IV Ketamine

The Canadian Rapid Treatment Center of Excellence (CRTCE) is a healthcare facility principally focused on providing best practices of intravenous ketamine treatment to adult patients suffering from treatment resistant depression. Patients who have received IV ketamine at the clinic are eligible to participate in this study where genetic biomarkers are correlated with response to IV ketamine.


Eligibility Criteria:
Inclusion Criteria:

1. Must have received IV ketamine previously to treat Treatment-Resistant Depression
2. Between the ages of 18-65 years old.
3. Clinical diagnosis of MDD
4. Individuals may have had comorbid psychiatric conditions (e.g., anxiety), but the comorbid psychiatric condition cannot be the primary clinical concern.
5. Ability to provide informed consent

Exclusion Criteria:

1. Individuals who meet DSM 5 criteria for a substance use and/or alcohol use disorder in the past 3 months.
2. Individuals who are currently experiencing psychotic symptoms as part of an MDE (mood congruent/mood incongruent).
3. Individuals who are unable to consent to the procedure.
4. Individuals who are unable to adhere to the protocol in its totality
Antiretroviral Therapy for Acute and Chronic HIV Infection

This is a protocol designed to randomize subjects with acute HIV infection to receive standard HAART or mega-HAART for subject who are enrolled in SEARCH 010 study (protocol title: Establish and characterize an acute HIV infection cohort in a Thai high risk population.

To describe the impact of standard HAART versus mega-HAART initiated during the acute HIV infection period on immunological and virological outcomes.

HIV-1 plasma viral RNA measurements and CD4 counts during follow-up and after therapy

Number of HIV and non-HIV related clinical events Adverse events related to HAART Adherence to HAART Resistance to antiretroviral medications

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. Enrolled in SEARCH 010 protocol and have protocol-defined acute HIV-1 infection (Tested 4th generation HIV EIA negative and NAT positive or tested 4th generation HIV EIA positive, negative by less sensitive EIA and NAT positive)
3. Choose to start HAART according to protocol
4. Understand the study and sign informed consent form. Persons who cannot read will have the consent form read to them by a study staff and they can give informed consent by using thumb print.
5. Availability for follow-up for the planned study duration

Exclusion Criteria:

1. Persons who have a history of a medical or psychiatric disorder by investigator's interview and physical examination according to standard practices, that in the judgment of the investigator(s), would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent.