cyrilzakka/clinical-trials huggingface dataset:
Stereotactic Ablative Radiotherapy (SAbR) for Treatment of Ventricular Tachycardia (VT) Refractory Standard Invasive Ablation Techniques

The purpose of this study is to evaluate the clinical efficacy and safety of stereotactic ablative radiotherapy (SAbR), also known as stereotactic body radiation therapy (SBRT), for treatment of ventricular tachycardia (VT) requiring implantable cardioverter defibrillator (ICD) treatments in patients with VT refractory to standard invasive ablation techniques. We hypothesized that SAbR is effective in suppressing sustained VT and reducing ICD treatments in this group of patients and is associated with acceptably low risk of serious complications.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Have an ICD implanted \> 6 months and all VT episodes in the past 6 months are available in device memory.
* Within the past 3 months, the patient has at least one episode of symptomatic monomorphic VT that requires ICD treatment (anti-tachycardia pacing and/or ICD shock) or was sustained/incessant but falls under ICD treatment zone. These VT episodes must occur after at least one standard invasive VT ablation or occur in a patient that is clinically deemed not eligible to the standard VT ablation procedure.
* Two independent cardiac electrophysiologists reviewed the case and agreed that the patient would benefit from suppression of these VT episodes but there is no optimal invasive VT ablation or antiarrhythmic drug options.

Exclusion Criteria:

* Has contraindication to receive SAbR or VT clinically deemed not suitable for SAbR.
* Is pregnant
* Has severe co-morbid medical condition or terminal illness and is unlikely to survive more than 6 months regardless of VT status based on clinical judgement by treating or enrolling physicians.
* On potent immunosuppressive therapy (e.g., post organ transplant)
* Has severe collagen vascular disorder with organ involvement
* Not willing or not able to consent to participate in the study
RAPID: a Comparison Study of a Novel Ultrasound Device of Automated Congenital Heart Imaging

The RAPID ultrasound is a portable imaging device that captures a one point image from the subcostal region of the heart. The device is set on the patient's chest and captures the image in \&lt;1 minute. It uses ultrasound imaging energy that is similar to commercialized devices and safe for patients of all ages and sizes. The device is a non-significant risk and therefore will not require an IDE. Images from RAPID will be taken directly before or after the standard clinical PCU. Images taken from both the RAPID device and the standard PCU will be de-identified and stored securely in BOX for review by two independent cardiologists. Image reviews will be conducted within Box.


Eligibility Criteria:
Inclusion Criteria:

* \<1 years old
* Be a patient at Masonic Children's Hospital or Masonic Children's Heart Center clinic undergoing PCU

Exclusion Criteria:

* Open Chest
* On ECMO
* Deemed medically unstable by care team
* Cardiology, ICU, hospitalist or bedside nurse concerns
Researching the Effects of Airway Clearance Therapies in Cystic Fibrosis

This is a pilot study investigating the effectiveness and clinical efficacy of airway clearance therapy (ACT) in cystic fibrosis (CF). Enrolled subjects will undergo measurements of mucociliary clearance (MCC) and exhaled biomarkers at baseline and after 3 different forms of ACT: high frequency chest wall oscillatory vest, oscillatory positive expiratory pressure device, and whole-body vibration.


Eligibility Criteria:
Inclusion Criteria:

* Adults with confirmed diagnosis of cystic fibrosis aged 18 years and older.

Exclusion Criteria:

* Pregnant or lactating women,
* Individuals with severe lung disease (FEV1 \<30%), or with exacerbations of lung disease requiring antibiotics or medication change within four weeks prior to enrolment.
* Individuals unable to use vest-based HFCWO, OPEP device, or who require oxygen supplementation at rest.
* Individuals with significant balance or gait impairment preventing them from tolerating being positioned on a vibrating platform.
Gait Speed at Discharge as a Marker for Readmission

The principal aim is to assess if a simple test, the time it takes to walk 10 meters for a patient about to be discharged after a hospital stay for an acute illness, is related to the risk of readmission.


Eligibility Criteria:
Inclusion Criteria:

* \>50 years of age Patient discharged to home, or temporary short stay nursing home Expected survival \>90 days The ability to read or understand the instructions and to give informed consent.

Exclusion Criteria:

* Planned hospital stay, i.e. the patient was admitted electively The including investigator is directly involved in the care of the patient
Effect of 2.5 Years of Rasagiline Therapy on Progression of Cognitive Biomarkers Assessed by MRI in Parkinson's Disease.

In this investigator-initiated study, we will compare changes in brain cognitive biomarkers assessed by diffusion tensor imaging over 2.5 years among 12 patients with Idiopathic Parkinson's disease (IPD) receiving rasagiline, 20 IPD patients not receiving MAO-B inhibitors and 25 age-matched healthy controls. Will also compare the changes in Mini-Mental State Exam (MMSE) and Montreal Cognitive Assessment (MoCA) scores and plasma brain-derived neurotrophic factor (BDNF) with changes in brain cognitive biomarkers in all IPD patients and HC over 2.5 years.


Eligibility Criteria:
IPD or HC subjects who were enrolled in a similar study about 2.5 years ago and for whom Baseline DTI data are available.
Nanofat on Wound Healing and Scar Formation

This study will evaluate the effectiveness and safety of intradermal injection of Nanofat on wound healing and scar formation.

In this monocentric, randomized, controlled, double-blinded prospective interventional study, twenty patients will be included. Each patient will be his/her own control.

Patients undergoing DIEPflap breast reconstruction will be included in this study. During the surgery, the abdominal incision will be divided in two equal sides with the umbilicus as midline reference. The sides will be randomized in a treatment side and control side. The treatment side will receive intradermal nanofat injections after the subcutaneous and right before the intradermal sutures.

The patient and investigators will be blinded for the treatment protocol. The effects on wound healing, adverse events, scar formation and pigmentation will be evaluated up to one year after the surgery.

Eligibility Criteria:
Inclusion Criteria:

- scheduled for DIEP-flap breast reconstruction surgery at our department

Exclusion Criteria:

* smokers
* use of cortisone or other immunsuppressants
* diabetes mellitus type 1 or 2
* age
* connective tissue disease
AtriCure Bipolar Radiofrequency Ablation of Persistent Atrial Fibrillation

ABLATE Persistent is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating persistent atrial fibrillation during concomitant on-pump cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is greater than or equal to 18 years of age
2. Subject has history of persistent atrial fibrillation as defined by the ACC/AHA/ESC Guidelines
3. Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following:

   * Mitral valve repair or replacement
   * Aortic valve repair or replacement
   * Tricuspid valve repair or replacement
   * Coronary Artery Bypass procedures
4. Subject's Left Ventricular Ejection Fraction ≥ 30%
5. Subject is able and willing to provide written informed consent and comply with study requirements
6. Subject has life expectancy of at least 1 year

Exclusion Criteria:

1. Patients with longstanding and continuous AF in which cardioversion has failed or has not been attempted
2. Previous cardiac ablation including catheter ablation, AV-nodal ablation, or surgical Maze procedure
3. Wolff-Parkinson-White syndrome
4. Prior cardiac surgery (Redo)
5. Class IV NYHA heart failure symptoms
6. Prior history of cerebrovascular accidents within 6 months or at any time if there is residual neurological deficit
7. Documented MI within 6 weeks prior to study enrollment
8. Need for emergent cardiac surgery (i.e. cardiogenic shock)
9. Known carotid artery stenosis greater than 80%
10. LA size greater than or equal to 8 cm
11. Current diagnosis of active systemic infection
12. Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
13. Pregnancy or desire to get pregnant within 12-months of the study enrollment
14. Preoperative need for an intra-aortic balloon pump or intravenous inotropes
15. Renal failure requiring dialysis or hepatic failure
16. Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
17. Therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders
Low-volume Polyethylene Glycol Bowel Preparation for Colonoscopy

the efficacy and tolerability of a low-volume (2 L) PEG regimen for colonoscopy compared to single (4 L) or split-dose (2 L + 2 L) treatments are not different.

In-hospital patients were randomly assigned to one of three groups: group 1 single dose (PEG-3350; PEG-4 L the day previous of the study, starting at 17:00 and finishing at 21:00 h); group 2: split-dose (PEG-3350; 2 L the day before 17:00-19:00 h and 2 L same day of the procedure 06:00-08:00 am); group 3: low-volume 2 L PEG-solution (same day of the procedure 06:00-08:00 am).

The quality of colonic preparation was assessed by the Boston bowel preparation scale (13); tolerability (nausea, vomiting, and abdominal pain), compliance, sleep disturbance and adverse effects in group 3 were compared with those in groups 1 and 2. The time since the last dose of bowel-preparation agent, the time since the last solid food was consumed, the approximate amount of bowel preparation taken (0%, 25%, 75%, or 100%), and the start time of the colonoscopy were recorded.

Satisfactory colon preparation was considered when scores of the Boston bowel preparation scale were 2/3; otherwise, the procedure was considered unsatisfactory preparation.

Eligibility Criteria:
Inclusion Criteria:

* In-hospital patients with an indication for colonoscopy

Exclusion Criteria:

* patients under 18 years of age
* the presence of a severe illness (cardiac, renal, or metabolic)
* major psychiatric illness
* known allergies to PEG-3350
* refusal to consent to the study
Phase 2b Open-label Study of Inaxaplin in Participants With Proteinuric APOL1 Mediated Kidney Disease

The purpose of the study is to evaluate the efficacy, safety, and tolerability of Inaxaplin (IXP) in participants with proteinuric APOL1- mediated kidney disease (AMKD).


Eligibility Criteria:
Key Inclusion Criteria:

* Participant has an APOL1 genotype of G1/G1, G2/G2, or G1/G2 obtained with a Vertex designated investigational clinical study assay
* Estimated Glomerular Filtration Rate (eGFR) of greater than or equal to (≥) 25 milliliter per minute (mL/min)/1.73m\^2 at screening

Key Exclusion Criteria:

* Evidence of Focal Segmental Glomerulosclerosis (FSGS) with a known cause other than due to APOL1 risk variants
* Uncontrolled hypertension

Other protocol defined Inclusion/Exclusion criteria may apply.
Comparision of the Use in Marcaine and Chloroprocaine in Rachianesthesia for the Surgical Correction of Inguinal Hernia.

Comparison the use of marcaine and chloroprocaine in rachianesthesia for a surgical correction of inguinal hernia. Comparision between acute and chronic (3 months and 6 months) pain.


Eligibility Criteria:
Inclusion Criteria:

* Adults under rachianesthesia

Exclusion Criteria:

* Personal history of gastric ulcus
* ASA 4
* Emergency
* Combined surgery
hUC Mesenchymal Stem Cells (19#iSCLife®-CSD) Therapy for Patients With Healing Poor After Uterus Injury

The purpose of this study is verify the efficacy and safety of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) therapy for patients with Healing Poor after Uterus Injury, and exploring the possible mechanisms of umbilical cord mesenchymal stem cell therapy in Healing Poor After Uterus Injury disease

This is a random, open label, and self-control experiment. 10 patients are selected and sign consent forms, then divided into one group. Doctors collect the basic information of patient (including age,height, mental condition, vital sign, history of disease, pharmaco-history, and so on.), evaluate the symptom of healing Poor after Uterus Injury (Menstrual conditions, Visual analogue scale, pregnancies).

All patients receive laboratory and image examination as baseline. Then, cell treatment will be given based on the clinical protocol. Doctors have follow-up visit on 3 and 6 month after treatment, and do efficacy evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Female, with BMI 18-24 kg/m\^2
* Meet the clinical standard of Healing Poor After Uterus Injury
* Non smoker
* Do not accept stem cells treatment in 6 months
* Participants or their family members sign the consent form of this study

Exclusion Criteria:

* Pregnant or breast feeding women
* Age \<18 or \>40
* Refuse to sign the consent form
* Patients with underlying risk of medical disease history: history of diabetes, serious cardiovascular disease, severe infection, alimentary tract hemorrhage, etc.
* Serum with HIV, syphilis antibody positive
* Severe mental disease, cognitive disorder patients
* Other severe system or organ organic disease
* Participate other clinical experiments in 3 months
* Ovarian and pituitary dysfunction diseases
* With some other conditions that doctor propose not to participate
The Role of Personal Experience for the Therapeutic Attitude in the Context of Substance-assisted Therapy Training

The study investigates two groups of participants of the SÄPT therapist's training starting in October 2022. The overall objective is to investigate the risks and benefits of personal experience (PE) with substance-induced altered states of consciousness for physicians or psychotherapists in the context of a training course for substance-assisted therapy. Specifically, the study aims to assess changes in therapeutic attitude and other factors important in interactions between patients and therapists (such as empathy and cognitive flexibility).


Eligibility Criteria:
Inclusion Criteria:

* Participation in the SÄPT therapist training (medical doctors and psychologists)
* Age 27 years or older
* Sufficient understanding of the German language
* Understanding of procedures and risks associated with the study
* Willing to adhere to the protocol and signing of the consent form
* Willing not to operate heavy machinery (including driving cars) within 24 hours after substance administration
* Woman of childbearing potential are required to use effective, established contraception, such as oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository at least one month before and after each study substance intervention, and are willing to take a urine pregnancy test at the medical screening and before every study substance intervention.
* Men are required to use contraceptive methods in the month after each study substance intervention and are required to inform their partner(s) about their study participation.

Exclusion Criteria:

* Previous significant adverse response to a hallucinogenic drug
* Significant medical condition rendering volunteers unsuitable for participation (such as impaired kidney or liver function, or heart disease incl. uncontrolled hypertension or hypotension)
* Strong underweight (\<45kg)
* Current major psychiatric disorder (including personality disorder, including suicidality) and / or previous psychotic or bipolar disorder.
* Psychotic disorder or bipolar disorder in first-degree relatives
* Use of medication that may interfere with the effects of the study medication. Patients must be willing to discontinue medications in cases where drug-related interactions are possible (the washout phase will be at least 5 times the particular drug's half-life \[typically 3-7 days\] prior to the respective study session). Discontinuation of medication must be judged to be acceptable by the responsible investigator.
* Women are excluded from substance intervention during pregnancy or breastfeeding.
* nParticipation in another clinical trial (currently or within the last 30 days)
Alpha-linolenic Acid and the Risk of ASCVD

Background: The plant-derived omega-3 fatty acid alpha-linolenic acid (ALA, 18:3-n-3) may reduce the risk of atherosclerotic cardiovascular disease, including incident myocardial infarction, ischemic stroke and peripheral artery disease. However, the results of previous studies have been inconsistent.

Objectives: To investigate the associations between dietary intake of ALA, adipose tissue content of ALA, and the risk of the major atherosclerotic cardiovascular diseases incident myocardial infarction, ischemic stroke and subtypes, and peripheral artery disease.

Methods: This project will be based on data from the Danish cohort study Diet, Cancer and Health which consisted of 57,053 men and women at recruitment between 1993 and 1997. Dietary intake of ALA will be assessed using a validated semiquantitative food-frequency questionnaire and adipose tissue content will be determined with the use of gas chromatography analyses of adipose tissue biopsies collected at baseline. Also, detailed information on lifestyle factors, medical history and anthropometri was collected at baseline.

Incident cases have been identified through national registries and the diagnoses have previously been validated.

Analyses of dietary intake of ALA will be analysed using a traditional cohort design, whereas analyses on adipose tissue content of ALA will be analysed based on a case-cohort design. Hazard ratioes with 95% confidence intervals will be used to describe the associations between the exposure variables and the outcome variables of interest.


Eligibility Criteria:
Inclusion Criteria:

* Born in Denmark
* Age between 50 and 64 years
* Living in the areas of Copenhagen and Aarhus

Exclusion Criteria:

* Previous cancer
Assessing the Impact of VR-Based Observational Mindfulness Meditation on Stress Reduction in Adults

This study investigates the impact of a mindfulness-based intervention using virtual reality (VR) and artificial intelligence (AI) coaching on stress reduction. Participants will engage in VR-based observation mindfulness activities guided by an AI coach. The study aims to evaluate the effectiveness of this intervention compared to a standard relaxation process by measuring self-reported stress levels, physiological biomarkers (e.g., heart rate), and participant satisfaction. The research could inform the development of future digital mental health interventions.

This study employs a randomized controlled design to assess the effectiveness of a VR-based mindfulness intervention for stress reduction. Participants are randomly assigned to either the experimental group, which undergoes VR-based observation mindfulness activities guided by an AI coach, or the control group, which experiences standard relaxation exercises. Pre-intervention data, including self-reported stress levels (measured via PSS-10, DASS-21, and STAI) and baseline heart rate, are collected. Following the intervention, participants complete post-intervention measurements to evaluate changes in stress levels, physiological responses, and satisfaction with the VR program.

The experimental group participates in mindfulness activities designed to enhance attention to detail and present-moment awareness through object observation within the VR environment. The AI coach facilitates the session by prompting reflective and observational questions, fostering deeper engagement. The control group undergoes relaxation exercises with no active mindfulness engagement. All procedures are conducted in a controlled laboratory setting, ensuring consistency and minimizing external variables.

The study collects objective (heart rate and heart rate variability) and subjective (self-reported stress and satisfaction) data to evaluate the intervention's efficacy. The findings aim to provide insights into the feasibility and benefits of integrating VR and AI technologies in stress reduction interventions. The results will also contribute to the development of more engaging and accessible digital mindfulness practices for diverse populations.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years and older.

Exclusion Criteria:

* Those with visual or hearing impairments that prevent interaction with VR content.
Simple Once Daily Triple Regimen Including Tenofovir, Emtricitabine and Efavirenz in HIV-1 Infected Patients (ANRS 1207)

In the context of Sub-saharian Africa, this trial evaluate one of the most simple treatment available for HIV-1 infected patients. The combination proposed is a triple antiretroviral therapy with only one intake of 3 pills per day. This combination has already been studied in the North countries.

Here in Senegal, the efficacy and the compliance to treatment will be evaluated after 24, 48 and 96 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Documented infection with HIV-1 (ELISA- Western Blot)
* Outpatient of masculine or feminine gender
* In female patients any risk of pregnancy must be avoid: women at least 1 year past menopause or being confirmed sterile or having an effective contraceptive device
* No previous treatment with antiretroviral therapy
* CDC group C (except tuberculosis if CD4 count is over 350 /ml), CDC group B with CD4+ count under 350/ml and CDC group A with CD4 count under 200/ml.
* Patient has provided informed written consent
* Patient must agree not to take any concomitant medication throughout the duration of the study without first informing the investigator

Exclusion Criteria:

* Deficiency of the patient rendering participation in the study or understanding of the information imparted difficult or even impossible
* Patient participating in a different clinical study
* Presence of serious or developing pathology
* Severe liver failure (TP under 50% et bilirubinemia over 3 LSN)
* Thrombocytopenia with platelet level under 50 000 cells /ml
* Known severe renal pathology (creatinine clearance under 50 ml/min)
* Clinical or biological problem corresponding to indications of grade over or equal 3 of WHO classification
* Karnofsky under 70 percent
* Opportunistic infections
* Patients taking medications not recommended in the context of the protocol
Niacin and Endothelial Function in Early CKD

The purpose of this study is to obtain information on whether raising levels of HDL-cholesterol (the "good" cholesterol) can improve how blood vessels work in kidney disease. This may help us understand the causes leading to high rates of heart disease in kidney disease and also ways to reduce this risk.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CKD Stage 2 (GFR \>60 and microalbuminuria/proteinuria) and Stage 3-4 (GFR 15-30)
* HDL-cholesterol \<50 for men and \<55 for women
* If taking a statin, stable dose for past one month
* Glucose \<200 mg/dL and HbA1c \<9%
* Transplant recipients who are in stage 2-3 CKD; 1-year post transplant; and have had no rejection episodes in the 6-months prior to study entry

Exclusion Criteria:

* Hospitalization within prior 3 months
* Any of the following conditions:

  * uncontrolled peptic ulcer disease
  * active liver disease OR abnormal SGOT/SGPT
  * history of adverse reaction to niacin
  * contra-indication to aspirin
  * concurrent fibrate therapy
  * history of gout
  * serum phosphorus levels below 2.7mg/dl
* Nursing
* Pregnancy