cyrilzakka/clinical-trials huggingface dataset:
Radiation Exposure Reduction in Supraventricular Tachycardia Ablation

Radiofrequency catheter ablation (RFCA) is the mainstay of therapy for supraventricular tachyarrhythmias, providing cure in a high percentage of cases. Conventional ablation techniques require the use of fluoroscopy to place and navigate catheters in the heart, thus exposing patients to ionizing radiations with an additional risk of cancer. The feasibility and safety of a non-fluoroscopic RFCA of a wide range of supraventricular arrhythmias using the EnSite NavX mapping system have been recently reported. The NO-PARTY is a multicenter, randomized-controlled trial designed to test the hypothesis that supraventricular arrhythmias RFCA through the non-fluoroscopic EnSite NavX mapping system results in a clinically significant reduction of the exposure to ionizing radiations compared with conventional ablation techniques.

NO-PARTY trial will determine whether supraventricular tachyarrhythmia RFCA through a non-fluoroscopic EnSite NavX mapping system is a suitable and cost-effective approach to achieve a clinically significant reduction of ionizing radiation exposure for both the patient and the operator.


Eligibility Criteria:
Inclusion Criteria:

* male and female patients between 14 and 50 years of age who have received an indication to radiofrequency catheter ablation of supraventricular arrhythmias according to current guidelines.

Exclusion Criteria:

* atrial fibrillation or non isthmus-dependent atrial flutter
* pregnancy
* hematological contraindications to ionizing radiation exposure
* presence of complex congenital heart disease, and cardiac surgery within 1 month from enrollment
DAA Therapy in Pediatric Patients With Chronic Hepatitis C

The Mukh-Mantri Punjab Hepatitis C Relief Fund (MMPHCRF) is a public health initiative for prevention and control of hepatitis C in the Punjab state, India. The efficacy of decentralised public health services and safety of 12- or 24-weeks of sofosbuvir (SOF) + ledipasvir (LDV) or SOF + daclatasvir (DCV) with or without ribavirin (RBV) in the treatment of pediatric chronic hepatitis C will be assessed

Consecutive chronic hepatitis C (HCV) infected children \[age: ≥12 to \<18 years; both treatment-naïve (TN) and treatment-experienced, (TE)\] are being enrolled.

Genotyping is not recommended for non-cirrhotic or TN patients and are treated with SOF+DCV for 12-weeks, while genotyping is recommended for patients with cirrhosis and TE patients.

Patients with liver cirrhosis or TE and genotype (GT)-3 are being treated with SOF+DCV for 24 weeks,

while non-GT-3 patients are being treated with SOF+LDV for 24-weeks. Patients \< 35 kg are being given half doses of medications and patients ≥35 kg are being given adult dosages of SOF (400 mg), LDV (90 mg) and DCV (60 mg) per day.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C, all genotypes
* Ages eligible for study: ≥12 to \<18 years (Child)
* Gender eligible for study: either
* Treatment-naive or treatment-experienced: either

Exclusion Criteria:

* Chronic liver disease of a non-HCV etiology
* serum creatinine \>1.5 mg/dL
* Evidence of hepatocellular carcinoma or other malignancy
* Co-infection with hepatitis B virus, or HIV
* Significant cardiovascular, pulmonary, or neurological disease
* Evidence of a malabsorption syndrome that could interfere with absorption of orally administered medications
* History of solid organ or bone marrow transplantation.
Long-term Durability Study of Collagenase Clostridium Histolyticum (CCH)

This study will evaluate the long-term safety and duration of efficacy of CCH in the treatment of women with cellulite. This study will be a single day evaluation, approximately 48 months after the first dose of study drug was received in the EN3835-201.


Eligibility Criteria:
Inclusion Criteria:

1. Have participated in and completed studies EN3835-201, EN3835-202 and EN3835-219 and had composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in study EN3835-201.
2. Be willing and able to cooperate with the requirements of the study.

Exclusion Criteria:

1. Has had retreatment with CCH in the area initially treated during the EN3835-201 study since the completion of study EN3835-219.
2. Has received collagenase treatments (eg, Santyl® Ointment and/or Xiaflex®/Xiapex®) since the completion of study EN3835-219.
3. Has had liposuction on the body region treated during the EN3835-201 study since the completion of that study.
4. Has had any surgery, invasive procedure (eg, liposuction), injectable treatment (eg, KYBELLA®) or any similar treatment in the area treated during the EN3835-201 study since the completion of that study.
5. Has any other condition(s) that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.
The Impact of Nutritional Service in the Stone Clinic on the Patient Urine Collection Results

Kidney stone disease has become a common phenomenon in the US and Europe with a growing incidence of about 10%. Life style and dietary changes have a cardinal part in kidney stone prevention. Therefore it was only natural to determine the impact of the addition of a nutritionist to a stone clinic run by a urologist and a nephrologist.

Kidney stone disease has become a common phenomenon in the US and Europe with a growing incidence of about 10%. A history of kidney stone disease has also been connected to cardiovascular and renal insufficiency events to a point that kidney stones is looked at today as a systemic predictor of hypertension, cardiovascular disease and more.

Seeing the importance of these risk factors we initiated a stone clinic for our kidney stone patients several years ago run jointly by a urologist and a nephrologist. Seeing that life style and dietary changes have a cardinal part in kidney stone prevention, it was only natural to determine the impact of the addition of a nutritionist to a stone clinic run by a urologist and a nephrologist on our patient parameters.

Eligibility Criteria:
Inclusion Criteria:

* 18 yo and older
* 2 kidneys
* Kidney or ureteric stone treated surgically or conservatively

Exclusion Criteria:

* Single kidney
* Aberrant kidney anatomy
The Study of Chest Infections in Infants Living in a Refugee Camp on the Thai-Burmese Border

This study will follow 1000 refugee infants from birth for two years. The aim of the study is to better understand why some children develop infections caused by the bacterium Streptococcus pneumoniae whilst others merely carry this organism asymptomatically at the back of the nose (in the nasopharynx). The investigators will also define which micro-organisms cause lower respiratory tract infections (e.g., pneumonia) in this population in order to implement appropriate interventions (e.g., vaccines). Infants will be reviewed monthly and a nasopharyngeal swab will be taken. A group of 250 mother-infant pairs will be studied in greater detail, to improve our understanding of the frequency and outcomes of nasopharyngeal carriage of Streptococcus pneumoniae. Monthly nasopharyngeal swabs will be collected from mothers and infants. The investigators will measure the infant immune response to Streptococcus pneumoniae carriage or disease by taking monthly blood samples. The investigators will make an assessment of the protective effect of antibodies acquired from the mother during pregnancy by taking blood from the mother and placenta at birth. An assessment of pneumococcal carriage in mothers will also be made to determine how frequently the bacterium is transmitted between family members. All lower respiratory tract infections will be documented, and the causative micro-organisms identified.

This project's central hypothesis is that acute lower respiratory infections (ALRI) are a common and significant cause of morbidity and mortality in young children living in Maela refugee camp on the Thai-Burmese border, and that this is reflective of the general situation in the developing world. Therefore, we aim to define the incidence, aetiology, and outcome of acute lower respiratory infections in this population. This will focus on Streptococcus pneumoniae and the factors associated with colonisation and invasive disease.

Additional objectives are to:

1. Characterise the interaction between bacterial and viral pathogens and disease.
2. Examine the dynamics of pneumococcal nasopharyngeal carriage, including transmission of strains between infants and their mothers.
3. Determine the effect of the non-pathogenic members of the nasopharyngeal flora on colonisation with potential pathogens.
4. Examine the role of passively transferred maternal pneumococcal antibodies in subsequent pneumococcal colonisation and disease in the infant.
5. Document the development of pneumococcal antibodies in the infants over time and correlate these with pneumococcal carriage and infection episodes.
6. Determine the risk factors associated with respiratory infection.
7. Characterise the bacteria causing invasive non-respiratory infections.
8. Conduct surveillance for influenza and in particular avian influenza A (H5N1) infection.

Eligibility Criteria:
Inclusion Criteria:

1. Infants born in SMRU antenatal clinic, Maela camp
2. Written informed consent from the mother
Subcutaneous Apomorphine in the Treatment of Progressive Supranuclear Palsy and Cortico Basal Degeneration (APOPARKA)

Treatment of tauopathies such as Progressive Supranuclear Palsy (PSP) and Cortico Basal Degeneration (CBD) remains a major challenge. These rare severe neurodegenerative extrapyramidal movement disorders share phenotypic overlap and are usually painful. Parkinson disease (PD) is a common extrapyramidal movement disorder and continuous subcutaneous apomorphine infusion (CSAI) is commonly used in advanced PD patients to alleviate motor and non-motor fluctuations. Effects of subcutaneous apomorphine were investigated especially on pain and, on quality of life in 7 patients with PSD or CBD.This is an observational "real life" surveillance-based study.The Verbal Rating Scale for Pain (VRS) was used to assess changes in pain level and the clinical global impression-improvement scale (CGI-I) was used to assess changes in patient's illness before and during six months of treatment. Detailed report of the symptoms and side effects has been recorded by home nurses throughout the study period.


Eligibility Criteria:
Inclusion Criteria:

* PSP or CBD patients for whom a treatment with subcutaneaous apomorphine is indicated

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patient under a legal protection procedure
* Patient denying to participated to the study
* Lack of affiliation to a social security system
Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus

The purpose of this study is to compare the novel oral anticoagulant apixaban with the standard therapy of warfarin on the size reduction or resolution of left ventricular thrombus over 3 months.

Current treatment for left ventricular thrombus is anti-coagulant or blood thinning agent known as warfarin. Recently at least three novel oral anticoagulant agents were used in the treatment of atrial fibrillation, pulmonary embolism and deep vein thrombosis (DVT).

Novel oral anticoagulant drugs will require no blood taking for INR monitoring, hence less visit and more convenience to patients. Latest studies also showed lesser rate of bleeding as compared to warfarin and hence relatively safer.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 - 80 years old
2. Presence of LV thrombus or spontaneous echo contrast (SEC) grade 3 or 4 (Patel VG 1996), with regional wall motion abnormalities
3. HASBLED score less than 3
4. No episodes of major bleeding in the past 6 months a) Major bleeding defined as i. episodes of bleeding with significant drop in haemoglobin(Hb)level of at least 2gm/dL - Includes upper and lower gastrointestinal bleed ii. The need for blood transfusion (pack cell) of at least 2 unit iii. Recent surgery with bleeding complications and lost of Hb as in (i) or (ii) iv. Any intracranial bleeds with neurological deficits

Exclusion Criteria:

1. Patient with unstable arrhythmias and/or recurrent cardiogenic shock
2. Patient with large ischemic stroke on recruitment-defined as involving \>1/3 of cerebral hemisphere or deemed to have high chance of haemorrhagic transformation
3. Patient with permanent pacemaker
4. Patient who is post valve replacement therapy
5. Patient who is pregnant.
6. Patient with advanced kidney disease at stage V and not on dialysis (CrCl \<15 mL/min)
7. Patient with advanced liver disease with coagulopathy
8. Patient with organized and old left ventricular thrombus
ReAl-life Multicentre Survey Evaluating Stroke Prevention Strategies (RAMSES)

The aim of this study is to evaluate the present status of stroke prevention strategies in patients with non-valvular atrial fibrillation (NVAF). Vitamin K antagonists (VKAs) have been the only available oral anticoagulant therapy for decades. Recently novel oral anticoagulants have emerged as an alternative for VKAs. This study is planned to evaluate the epidemiological characteristics, thromboembolic and bleeding risks, stroke prevention strategies and appropriateness of oral anticoagulant use in NVAF patients. Time in therapeutic range (TTR) is going to be calculated as the percent of visits in range (2-3) for warfarin patients. This is a national multicenter observational study in which Turkey is divided into seven regions. A proportional number of patients to the population of every region is planned to be included.

Atrial fibrillation (AF), classified as nonvalvular (NVAF) in the absence of rheumatic mitral stenosis or valvular prosthesis,is the most common arrhythmia, with an estimated prevalence of 1.5-2%. AF is associated with a greater risk of arterial thromboembolic events, especially cerebrovascular, whose incidence is 5-7 times higher. The risk of death is also doubled, and AF has a greater degree of disability and probability of recurrence than stroke due to other causes. To prevent stroke in patients with NVAF, antithrombotic treatments are employed with oral anticoagulants such as vitamin K antagonists (VKA) and, in a number of circumstances, antiplatelet agents. Although VKA (mainly warfarin) are highly effective to reduce the risk of stroke, and have been the sole choice for stroke prevention during the last 50 years, their use is limited for a number of reasons: narrow therapeutic range, drug and food interactions, need for monitoring, and risk of bleeding. Recently, new oral anticoagulants (NOACs) have been marketed for this indication. The aim of this study was to determine the standard clinical practice followed in the treatment to prevent stroke in patients with NVAF in Turkey. The purpose of this study is to demonstrate the current status of the clinical background of AF patients and to follow, analyze and evaluate patients with AF in a large multicenter nation-wide trial. The primary inclusion criteria will be age ≥18 years and with electrocardiographically confirmed NVAF (eg, by electrocardiogram, Holter monitoring, etc). The enrollment of patients will be started in February 2014. All the participating institutions will enroll all consecutive patients with NVAF under regular outpatient care or under admission.

Eligibility Criteria:
Inclusion Criteria:

* Atrial fibrillation

Exclusion Criteria:

* Valvular heart disease (mitral stenosis, prosthetic heart valves, heart valve surgery)
Early Occupational Therapy for Delirium Prevention in Older Patients Admitted to Critical Care Unit

This is a randomized, controlled trial to compare the efficacy of two strategies of non-pharmacological prevention of delirium in critically non-ventilated older patients:

* standard non-pharmacological prevention
* intensive nonpharmacological prevention (standard non-pharmacological prevention plus early and intensive occupational therapy).

Delirium is a complication in older, with incidences 70-87% in CCU. This increases mortality, hospital stay, hospital cost, and cognitive impairment. Occupational Therapy (OT) improves independence at discharge, and reduction in delirium in patients undergoing mechanical ventilation. This study compares the efficacy of non pharmacological standard prevention (control group) versus intensive nonpharmacological prevention (experimental group) in the delirium duration in older admitted CCU.

Eligibility Criteria:
Inclusion Criteria:

* Age over 60 years.
* Admission to CCU for monitoring by acute or chronic illness, expected more than 24 hours
* Informed consent of patient or family related.

Exclusion Criteria:

* Cognitive impairment before to admission (measured by Test Reporter-TIN).
* Severe disorder of communication and cultural constraint of language (inhability of properly communicating in Spanish)
* Delirium at CCU admission or at the beginning of the intervention
* Need for mechanical ventilation
* Early limitation of therapeutic efforts and greater comorbidity with expected mortality within 90 days (in the opinion of the treating team).
Immune Ablation and Stem Cell Support for Crohn's Disease

The investigators anticipate that this study will also form the basis to clarify further the role of the immune system in Crohn's disease.

This study is designed to ablate an aberrant immune system and then, similar to the use of marrow transplants for immunodeficient patients, reconstitute a new immune system with lymphocyte depleted stem cells. Subsequent disease activity will be followed by (1) Crohn's disease activity index (CDAI), (2) quality of life instrument (IBDQ), (3) type and amount of therapy for CD, and (4) flow cytometry of peripheral blood lymphocyte subsets. In addition, the subjects will undergo periodic absorption function testing, to assess small intestinal function. We anticipate that this study will also form the basis to clarify further the role of the immune system in Crohn's disease.

Eligibility Criteria:
Inclusion Criteria:

* Less than physiologic age 60 at time of pretransplant evaluation.
* An established clinical diagnosis of severe CD that has failed therapy with prednisone, azathioprine, 5 ASA products and metronidazole, and has failed to have a sustained decrement of 70 points in the CDAI after one course of anti-TNF alpha, Infliximad. The patient is being considered for therapy with cyclosporin A (CSA) or surgical resection. The CDAI (appendix A) is 250-400.
* Pre-study peripheral blood counts must include a platelet count greater than 100,000/ul and an absolute neutrophil count greater than 1500/ul.
* Stem cell harvest greater than 1.4 x 106 CD34 cells/kg after CD34+ selection (to continue to transplant.)

Exclusion Criteria:

* HIV positive
* History of coronary artery disease, or congestive heart failure.
* Uncontrolled diabetes mellitus, or any other illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive chemotherapy
* Prior history of malignancy except localized basal cell or squamous skin cancer. Other malignancies for which the patient is judged to be cured by local surgical therapy, such as head and neck cancer, or stage I breast cancer will be considered on an individual basis.
* Positive pregnancy test, lactation, inability or unwillingness to pursue effective means of birth control, failure to accept or comprehend irreversible sterility as a side effect of therapy.
* Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible.
* FEV I/FVC \< 50% of predicted, DLCO \< 50% of predicted.
* Resting LVEF \< 40%
* Bilirubin \> 2.0 mg/dl, transferase (AST) \> 2x upper limit of normal, unless the abnormalities are secondary to Crohn's disease.
* Serum creatinine \> 2.0 mg/dl.
* Platelet count less than 100,000/ul, ANC less than 1500/ul.
* Patients presenting with intestinal perforation or toxic megacolon, or a suppurative problem that will require urgent surgery. In addition, the patient may not have any active infection. The presence of intestinal stomas does not exclude the patient from study.
Efficacy, Safety, and Dose-response of a Live Biotherapeutic Product in Women With Acute Vaginal Infection

The purpose of this clinical trial is to investigate the clinical efficacy and safety of a Live Biotherapeutic Product (BGY-1601-VT) intended as a first line of treatment in cases of acute vaginal infection without upfront microbiological confirmed diagnosis


Eligibility Criteria:
Inclusion Criteria:

* Post-menarche woman aged 18 to 50 years old (inclusive),
* With suspected Bacterial Vaginosis (BV) and/or Vulvovaginal Candidiasis (VVC), presenting symptoms of acute vaginal infection
* No clinically significant and relevant abnormalities of medical history (including mental disorders) or physical examination,
* Able and willing to participate to the trial by complying with the protocol procedures as evidenced by her dated and signed informed consent form,

Exclusion Criteria:

* Other already diagnosed or suspected infectious causes of bacterial vaginal infection (e.g., Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae) within 1 month
* Current herpes simplex flare-up in the genital area,
* Vulvar condyloma due to the human papilloma virus;
* Vulvar dermatoses (e.g.: psoriasis or lichenification);
* Clinical diagnosis of BV or VVC within 4 months;
* Treatment with any antibiotic or antifungal therapy (local or systemic) within 2 months, regardless of the indication;
* Treatment with any local treatment (probiotics, antiseptic, etc.) within 1 month, regardless of the indication;
* Participant using any intravaginal product (local contraceptive \[spermicide, hormonal ring\], moisturizer, tampon, intimate hygiene product, etc.);
* Participant with a chronic disease or condition or treatment known to impact the immune system, including auto-immune disease, diabetes, cancer, renal failure, etc.
* Pregnant or breastfeeding patient or intending to become pregnant within 1 month ahead, or having given birth within 3 months;
* Participant in perimenopause, i.e. aged 45 years or more, with irregular menstrual cycles that could lead to a suspicion of menopause;
* With a known or suspected food allergy or intolerance or hypersensitivity to any of the trial intervention ingredient;
Physiological Effects of APRVplus and TCAV in ARDS

In previous studies, airway pressure release ventilation (APRV) has been proven to be an important respiratory support method for ARDS patients, and various APRV ventilation strategies have been proposed. This study aims to compare the physiological effects of two types of APRV ventilation strategy, Early Pathophysiology-driven APRV (APRVplus) and Time-Controlled Adaptive Ventilation (TCAV), through randomized crossover trials, providing evidence for clinical application and further research on APRV.


Eligibility Criteria:
Inclusion Criteria:

* intubated and mechanically ventilated patients
* meet the 2023 global new definition of ARDS

Exclusion Criteria:

* Pregnancy
* The expected duration of mechanical ventilation was less than 48 hours
* Intracranial hypertension (suspected or confirmed)
* Neuromuscular disorders that are known to prolong the need for mechanical ventilation
* Known or suspected chronic obstructive pulmonary disease(COPD)
* Terminal stage of disease
* Pneumothorax (drained or not)at enrollment
* Treatment with extracorporeal support (ECMO) at enrollment
* There was a lack of commitment to life support