cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Thermocool SF Catheter on the Common Cavo-tricuspid Isthmus Dependent Atrial Flutter Ablation

The purpose of this study is to determine whether the Thermocool SF ® system is at least as effective and safe as regular 8mm catheters and irrigated tip catheters in the treatment of cavo-tricuspid isthmus dependent atrial flutter.

The catheter of Biosense Webster Thermocool SF® is characterized by a porous, thin-walled tip allowing a uniform cooling of the catheter tip and so, achieving increased efficiency in cooling. This allows to reduce the flow of irrigation and power output while achieving similar tissue temperatures as the conventional irrigated catheters. There is evidence of greater efficiency of Thermocool SF® catheter in causing tissue damage, but there are no clinical studies on the specific treatment of common atrial flutter.

Investigators hypothesize that the Thermocool SF® system is at least as effective and safe in the treatment of cavo-tricuspid isthmus dependent atrial flutter as conventional and 8 mm irrigated tip catheters.

150 patients with common atrial flutter were randomized to 3 groups of 50 patients and each group underwent ablation catheter ablation with CelsiusTMDS® 8 mm, 3.5 mm irrigated tip Thermocool® or Thermocool® SF respectively. After the procedure, patients are being followed by clinical reviews, electrocardiograms at the 3rd, 6th and 12th months, 24h ECG-Holter examination at the first and 6th month and monthly phone consultation. Rate of recurrence and presence of other supraventricular arrhythmias are being recorded during follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic common atrial flutter.
* Electrocardiographic documentation of common atrial flutter.

Exclusion Criteria:

* Refusal to give consent.
* Life expectancy less than 6 months.
* Contraindication for ablation.
* Previous cavo-tricuspid isthmus ablation.
Feasibility of Immediate Postpartum Long-acting Reversible Contraception Implementation

The objective of this study is to test and disseminate tools that drive successful immediate postpartum Long-Acting Reversible Contraception (LARC) implementation. The long-term goal is to reduce unintended pregnancy soon after childbirth by increasing access to immediate postpartum LARC for women who desire it.

Based on previous work, the investigators have generated a toolkit to guide the integration of immediate postpartum LARC services into widespread clinical practice. In the proposed work, this toolkit will be used to initiate immediate postpartum LARC services in a single site with low baseline immediate postpartum LARC uptake (Michigan Medicine). The investigators will conduct a feasibility study using mixed methods to assess acceptability and appropriateness of toolkit items; patient experience of care; immediate postpartum LARC utilization rate; and prenatal contraceptive counseling rate.

Eligibility Criteria:
Inclusion Criteria:

* Female (patients)
* Pregnant (patients)
* Receiving obstetrical care at Michigan Medicine (patients)
* L\&D provider at Michigan Medicine (providers)

Exclusion Criteria:

* non-English speaking
* unable to provide informed consent
Bifurcation Stenting Using 2 Link Stent Nobori Versus 3 Link Stent Xience

The primary objective of this study is to make a comparison of safety and efficacy of DESs with different link number (2-link Nobori and 3-link Xience) in patients with de novo true bifurcation lesions.

The minimum lumen diameter of the side branch ostium in bifurcation at 8 months and the MACE rate until one year after PCI will be assessed in both groups.


Eligibility Criteria:
Inclusion Criteria:

1. Patient eligible for percutaneous coronary intervention
2. Patient or substitute decision-maker willing to provide written informed consent, which is approved by the Institutional Review Board or its equivalence
3. De novo stenosis at coronary bifurcation with up to two vessels (visually estimated diameter stenosis ≥50%)
4. Second vessel at coronary bifurcation treatable with trial device during the procedure
5. True coronary bifurcation, ≥50% diameter stenosis in both the main and side branches, belonging to the Medina classes 1.1.1, 1.0.1, and 0.1.1,
6. Visually estimated target lesion reference vessel diameter, 2.5-5.0 mm in the main branch, ≥2.25 mm in the side branch
7. Target lesion treatable with one or two stents in both the main and side branches
8. Consensus of PCI after discussion between cardiologists and cardiac surgeons for the lesion in the left main coronary artery
9. Thrombolysis in Myocardial Infarction grade ≥1 flow in both the main and side branches

Exclusion Criteria:

A. General restrictions

1. Unable to be followed by the implementing medial institution
2. Life expectancy \<1 year
3. Acute myocardial infarction (\<1 week)
4. Left ventricular ejection fraction \<30%
5. Scheduled for elective treatment requiring antiplatelet drug Withdrawal
6. Deemed as unsuitable by the investigator or subinvestigator
7. Serum creatinine level ≥2.0 Mg/dl

B. Vascular morphological restrictions

1. Lesion proximal to coronary artery bypass graft anastomotic site (visual estimation ≤5.0 mm) or including a part of coronary artery bypass grafting
2. In-stent restenosis
3. Severe calcification
Study of HC-58 in Upper Limb Hemiplegic Patients After Stroke

The purpose of this study is to investigate the efficacy and safety of HC-58 in patients with severe upper limb hemiplegia following stroke.


Eligibility Criteria:
Inclusion Criteria:

* Patients with severe upper limb hemiplegia after stroke
* Within 28 days after stroke at enrollment

Exclusion Criteria:

* Patients with sensory loss between shoulder and hand on paralyzed side
* Patients with pain between shoulder and hand on paralysed side which affects medical rehabilitation
A Biotype Enhancing Strategy For The Patient Undergoing Accelerated Orthodontics

Numerous treatment protocols geared towards accelerating orthodontic treatment have emerged in the past few years as an appealing alternative for patients and practitioners. In the context of a thin biotype, these approaches pose a burden that could precipitate periodontal detrimental changes. Therefore, case selection and the implementation of periodontal biotype enhancing strategies become a relevant consideration to ensure long-term successful treatment outcomes. This study focuses on the biological and clinical value of the use of a porcine naturally cross-linked collagen matrix known as Mucograft®. Within the scope of Surgically Accelerated Orthodontic Treatment (SAOT) the structural and material features of Mucograft® provide: 1) A protective effect to the thin biotype upon rapid orthodontic protusive/proinclination movements and 2) Mucograft® enhances the therapeutic window effect that supports an increase on tooth movement rate. The designs of this randomized controlled clinical trial includes a cohort of 40 subjects distributed on the following groups I) Ortho tx, II) Ortho tx + Decortication, III) Ortho tx + Decortication + Mucograft®, and IV) Ortho tx + Mucograft®. Comparing clinical, tomographic and digital impression derived measurements will capture the clinical phenotype; while the biologic phenotype will be derived from evaluating crevicular fluid levels of tooth movement mediators such as Interleukin 1-β and Interleukin-1RA. The significance and innovative value of this proposal stems from the use of Mucograft® as an ideal collagen-based biotype enhancer when performed along with the corticotomy. This approach could prove to be effective to further increase the therapeutic window that allows accelerating orthodontic treatment and, at the same time, could decrease the recession risk in movements of proclination of antero-inferior incisors. Besides, the use of a collagen scaffold alone could potentially trigger a comparable orthodontic acceleratory outcome that could be evaluated as an alternative to decortication.


Eligibility Criteria:
Inclusion Criteria:

* Angle's class I malocclusion
* Little's grade II or III dental crowding
* Periodontally stable patients
* Patients with no more than 2 mm of keratinized gingiva in at least two sites of the antero-inferior region

Exclusion Criteria:

Patient with presence of marginal tissue recessions on inferior incisors

* Patients with a metabolic or neoplastic alteration
* History of orthopedic surgery in the last 6 months
* History of fractures in the last 6 months
* History of bisphosphonates use
* Patient with systemic compromise
Effectiveness of Exercise in the Treatment of Depression

The main objective is to test the non-inferiority of supervised exercise versus antidepressant treatment in reducing depressive symptoms in patients with clinical criteria for depression (according to ICD 10) over a period of 6 months follow-up.

This is a randomized clinical trial in primary care in which a total of 312 patients over 65 years with clinically significant depression will be randomly assigned to an exercise program supervised or receive treatment with antidepressant drugs commonly used in clinical practice. At baseline physical fitness of the participants will be checked, and assessments will be made after 15 days and 1, 3 and 6 months. The supervised exercise program will consist of 2 sessions per week in groups of 10-12 patients over a 6 month period in which a sports instructor will train patients to perform at least 30 minutes of regular, moderate-intensity activity with a frequency almost daily, including aerobic exercise and strength training, flexibility and balance. In both groups will be evaluated periodically, among other variables, the state of depressive symptoms, level of physical activity, self-rated health, occurrence of adverse effects and adherence to exercise program or antidepressant treatment. The main outcome measure is the reduction of the baseline score on the scales of depressive symptoms (Montgomery-Asberg Depression Rating Scale and Geriatric Depression Scale).

Eligibility Criteria:
Inclusion Criteria:

* People with depression

Exclusion Criteria:

* Contraindication to exercise
Medicines Reconciliation at an Intensive Care Unit

This study evaluates the effect of performing medicines reconciliation on patients admitted to an intensive care unit. Half of the patients will receive a medicines reconciliation at the intensive care unit. The other half will not. All included patients will receive medicines reconciliation after transfer to the ward.

Transfer of patients from one level of care to another is known to increase the risk of medication errors. Medication reconciliation is an accepted intervention to increase the knowledge on the patients medication use, thus reducing the risk of avoidable medication errors. For patients in the intensive care unit treatment of the imminent threat is obviously the most important. Nevertheless, knowledge about previous medications are important.

Eligibility Criteria:
Inclusion Criteria:

* belonging to the hospitals intake area
* written informed concent by the patient or his/her next to kin

Exclusion Criteria:

* Patients without next to kin
* Not Norwegian speaking, in need of a translator
* medication reconciliation performed earlier
* Patients with Guillain-Barre or Myasthenia Gravis, due to long expectancy of stay
* Short life expectancy, decided in cooperation with the physician
Feasibility of Doctors' Rooms-based Infusion of Zoledronic Acid

1. The study will assess the safety and tolerability of a single-infusion of zoledronic acid 5 mg administered in a private medical practice setting by a nurse provided by a nationwide infusion service. Safety data will largely be monitored by investigating changes in the patients' well-being during the study.
2. The study will pilot and test a Patient Registry and Infusion Service process, which will allow zoledronic acid to be administered to trial patients in the investigators' private rooms by a team of roving nurses.


Eligibility Criteria:
Inclusion Criteria:

1. Female after menopause with osteoporosis either: 70 years of age or older with a bone mineral density T-score of -3.0 or less OR with a fracture due to minimal trauma.

Exclusion Criteria:

1. Intravenous bisphosphonate within the past 12 months
2. Abnormal levels of protein in the urine via dipstick at screening if not caused by bacterial infection
3. Abnormal liver function tests greater than twice normal
4. Evidence of high bone turnover
5. Abnormal calcium blood levels
6. Low Vitamin D levels
7. Poor renal function
8. Abnormal parathyroid function or uncontrolled, abnormal thyroid function
9. History of eye inflammation
10. History of diabetes leading to kidney or eye problems
11. A history of cancer except some non-invasive cancers of skin, colon, breast and cervix
12. Patients with severe dental problems or current dental infections Or requiring dental surgery
13. Known sensitivity to zoledronic acid or bisphosphonates

Other protocol defined inclusion/exclusion criteria may apply
BIOlogics in Severe Nasal POlyposis SurvEy.: a French Registry

With a prevalence of 2-4% in western countries, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is of major concern regarding its substantial impact on the social and physical quality of life. So far, endoscopic sinus surgery remains the treatment of choice when the first line of medical treatment with corticosteroid has failed.

During the last 15 years, several studies have shown that CRSwNP is associated with a T helper 2 (T2) immune response leading to B cell release of IgE, mucosal recruitment of eosinophils from bone marrow via Interleukin (IL)-5, IL-4 and IL-13 mediated chemoattractant production.

New biologic agents capable of blocking T2 cytokines have been developed in the field of eosinophil-associated diseases, shifting the paradigm of treatment for patients with CRSwNP. In the near future, endotype profiling with accurate biomarkers will be mandatory to tailor the treatment of nasal polyposis with specific biologic therapies.

Herein the investigators propose a prospective study monitoring medical records of CRSwNP patients who undergo biologic treatments. The objectives are to assess treatment efficacy on quality of life, to report clinical and biological criteria for prescription and to measure tolerance and compliance.Patient-reported outcomes will be addressed according to their initial clinical profile (allergy, asthma, NSAID, gastroesophageal reflux disease, obstructive apnea, otologic disorder, smoke habit).


Eligibility Criteria:
Inclusion Criteria:

* Patients of over 18-year old requiring a biologic treatment for CRswNP in accordance with its marketing approval.
* The patients already treated according to this criteria since August 2021 will be followed and their previous clinical and biological data retrospectively collected

Exclusion Criteria:

* Oral corticotherapy in the previous month;
* Biologic treatment with anti-IgE (omalizumab), anti-IL-5/IL-5R (mepolizumab, benralizumab) or anti-IL-4/IL-13R (dupilumab) or any other biotherapy for inflammatory diseases in the previous 6 months of initiation of treatment apart from ongoing biotherapies for severe asthma or CRSwNP;
* Hypersensitivity to humanized antibodies ;
* Documented SARS-Cov2 infection in the last 3 months with persistent olfactory disorders related to COVID;
* Pregnant or breast-feeding women;
* Patient without social coverage.
Polish Nationwide Register of Hospitalized Patients in Cardiac Intensive Care Units

Cardiac Intensive Care Units (CICUs) provide care for a diverse patient population. Understanding the clinical characteristics, analysis of treatment modalities, and prognosis of patients hospitalized in the CICU are important to improve cardiovascular care. The purpose of this registry is to determine the demographics, clinical, treatment, and prognosis of patients hospitalized in the Polish CICUs. Data from this multicenter, prospective observational study will provide more robust data to facilitate quantitative characterization of cardiac care in contemporary Polish CICUs and enable the development of infrastructure for clinical trials in CICUs.


Eligibility Criteria:
All consecutive patients hospitalized at Polish CICUs.
Deep Learning Enhanced Detection of Aortic Stenosis - The DETECT-AS-Diagnostic Study

The DETECT-AS Diagnostic Study will assess the performance of artificial intelligence (AI) risk predictions to detect aortic stenosis using results from portable electrocardiogram (ECG) and cardiac ultrasound devices.


Eligibility Criteria:
Inclusion Criteria:

* Age 70 years or older
* Attending a routine outpatient primary care clinic at one of the three enrollment sites

Exclusion Criteria:

* Opted out of research studies
* Non-English speaking
* Urgent or emergent visits, defined as a visit for an illness or injury that needs attention quickly or is life-threatening
* Any echocardiogram within 12 months of clinic visit
* Prior history of moderate or severe AS
* Prior history of aortic valve replacement or repair, including transcatheter and surgical AVR with either a bioprosthetic or mechanical valve
* Presence of implantable cardiac devices, including permanent cardiac pacer, implantable cardioverter-defibrillator, or left ventricular assist device
* Prior heart transplant
* History of dementia
* Documented life expectancy of \<1 year or current participation in hospice services.
Expression of Steroid Receptors in Endometrium

Expression of steroid receptors in endometrium during ovarian stimulation.

The purpose of this study is to examine in stimulated cycles a) whether there is a difference in expression of steroid receptors in stroma and glands of endometrium between different days during the follicular phase b)whether there are secretory changes detected by endometrium histology before ovulation c)whether there is an association between expression of steroid receptors in endometrium and exposure to oestradiol and progesterone during the follicular phase.

Eligibility Criteria:
Inclusion Criteria:

* Treatment by IUI,
* BMI:18-29KGR/M2,
* No previous ovarian surgery,
* Normal hysterosalpingography,
* Estradiol \< 80pg/ml and progesterone \< 1.6ng/ml on day 2 of the cycle

Exclusion Criteria:

* Endometriosis,
* Severe male factor
Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic Valve Thrombosis and Its TrEatment With Anticoagulation

This is a prospective study designed to evaluate the structural and functional integrity of transcatheter or surgical bioprosthetic valves with multimodality imaging. The study further aims to confirm resolution of the early bioprosthetic valve thrombotic changes with anticoagulation.

Patients with a history of bioprosthetic valve replacement undergo cardiac contrast CT imaging and transthoracic echocardiography to evaluate structural and functional integrity of the aortic valves. The imaging studies will be performed at least 48-hours after bioprosthetic valve replacement. Patients with prosthetic valve abnormalities suggestive of thrombus will be administered anticoagulation therapy, followed by repeat contrast CT of the chest and transthoracic imaging. Repeat imaging following 3 months of anticoagulation therapy is performed to evaluate the response to anticoagulation therapy. I

Eligibility Criteria:
Inclusion Criteria:

* Presence of transcatheter or surgical bioprosthetic aortic valve implanted at least 48 hours prior to enrollment
* Age 18 years or older
* Ability to provide informed consent and follow-up with protocol procedures.

Exclusion Criteria:

* Renal insufficiency (creatinine \> 1.5 mg/dL)
* Known allergy to iodinated contrast agents
Epigenetics and Gut Microbiota in Children With Epilepsy

The ketogenic diet is a high-fat, low-carbohydrate diet used in the treatment of epilepsy. The diet can be an efficient treatment option in children with drug resistant epilepsy, with more than 50 % seizure reduction in about 40- 70 % of the patients. However, there is still a lack of knowledge regarding the mechanisms of action, how will respond to the treatment and potential adverse effects.

The ketogenic diet is a high-fat, moderate protein, low-carbohydrate diet. It is an internationally established treatment option in children with drug resistant epilepsy. About 40 -70 % of children with drug resistant epilepsy treated with the ketogenic diet achieve \> 50 % seizure reduction. However, even though the ketogenic diet has been used in the treatment of epilepsy for almost a Century, little is known about how the dietary treatment reduces seizures and which patients that will respond well. In addition, there is limited knowledge about potential adverse effects of the treatment. This is a prospective study following the patients from 4 weeks before initiating the ketogenic diet and during the treatment. The influence of the dietary treatment on the gut microbiota, epigenetics, quality of life, and adverse effects will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Drug resistant epilepsy
* Age 2- 17 years
* Two or more countable seizures/week
* Willing to try treatment with the ketogenic diet for at least 12 weeks

Exclusion Criteria:

* Glucose transporter protein 1 deficiency, pyruvate dehydrogenase deficiency, or pyruvate carboxylase deficiency
* Known or suspected disease in wich the diet is contraindicated
* Epilepsy surgery the last 6 months before diet initiation
* Steroid medications the last 2 months before diet initiation
* Breastfeeding
* Psychogenic non-epileptic seizures
* Eating disorder
* Pregnancy or planed pregnancy
* Feeding disabilities not compatible with dietary treatment
* Inability to follow study scheme
* Previous treatment with high-fat, low- carbohydrate diet
* Medical need to start dietary treatment immediately
Desipramine in Infantile Neuroaxonal Dystrophy (INAD).

This is a research study to find out if clinically prescribed desipramine is effective at improving the symptoms and slowing the progression of Infantile Neuroaxonal Dystrophy (INAD) in affected children.

Participants will receive an initial oral dose of study drug once a day. This dose may be changed depending on response to study drug Clinically collected data will be recorded for up to 5 years. Investigators will also ask for participant permission to obtain a sample of child's skin biopsy from unused clinical sample previously collected for standard of care.

To be eligible participants must be able to swallow tablets The study drug is to be taken once daily Schedule of events. Day 0 - ECG and blood tests (4 ml or ¾ teaspoon) Day 3 - ECG and blood tests (4 ml or ¾ teaspoon) Day 7 - ECG and blood tests (4 ml or ¾ teaspoon) Weeks 2, 3, 4, 8 \& 12. ECG and blood tests (4 ml or ¾ teaspoon) Every 3 months for up to 5 years.

.

Eligibility Criteria:
Inclusion Criteria:

* 03-17years.
* Any gender
* Confirmed homozygotes or compound heterozygotes of pathogenic mutation variant(s) in PLA2G6
* Confirmed homozygotes of pathogenic mutation in PLA2G6
* Documentation of clinical presentation (signs and symptoms of neurodegenerative process) of INAD

Exclusion Criteria:

* Patient has sign and symptom suggesting an ongoing acute or chronic illness such as fever of unknown origin or infection.
* Patient has a second genetic condition
* Parents are unable or unwilling to return for continued care for up to 12 months
High-intensity Training Safely Improves Exercise Capacity in Heart, Lung, Kidney, and Liver Transplant Recipients: a Comparative Study

The investigators will investigate whether high-intensity exercise training can safely improve physical performance in long-term stable heart, kidney, lung, and liver transplant recipients. Adult transplant recipients will participate in Transplantoux, a 6-month individualized home- and group-based training program, with the goal to cycle the Mont Ventoux in France. The investigators will do cardiopulmonary exercise testing : maximal oxygen consumption, maximal power and BMI.


Eligibility Criteria:
Inclusion Criteria:

* minimum post-transplant period of 6 months
* no acute rejection during the immediately preceding 6 months

Exclusion Criteria:

* patients with cardiovascular or orthopedic contra-indications for intensive physical exercise