cyrilzakka/clinical-trials huggingface dataset:
Benefit of Permanent Stimulation of the Left Branch of the His Bundle Versus Right Ventricular Stimulation After Atrioventricular Node Ablation for Rapid Atrial Fibrillation

The objective of the study is to evaluate the functional benefit of left bundle branch of His pacing compared to right ventricular pacing in patients implanted with a pacemaker prior to a atrioventricular node ablation procedure for rapid atrial fibrillation


Eligibility Criteria:
Inclusion Criteria:

1/ Pacemaker implanted patient with LBTP lead and back-up right ventricular lead who subsequently underwent successful atrioventricular node ablation for rapid AF 2) NAV ablation procedure performed less than 15 days ago 3) Age ≥ 18 years 4) Woman of childbearing age with effective contraception (estrogen-progestin or intrauterine device or tubal ligation) for at least 1 month and for the duration of the study, and a negative urine pregnancy test by B-HCG at inclusion Or, Postmenopausal woman: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit).

5) Membership of a social security scheme 6) Patient follow-up feasible 7) Patient has read and understood the information leaflet and signed the informed consent form

Exclusion Criteria:

1. Impairment of autonomy such that a maximal cardiorespiratory effort test (VO2 Max test) cannot be performed under good conditions (ADL scale \< 5).
2. LVEF \< 40% at inclusion
3. Person deprived of liberty by an administrative or judicial decision, or person under court protection, sub-guardianship or curatorship.
4. Patient participating in another interventional trial
5. Any history of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol, or from giving informed consent.
6. Pregnant, parturient or breast-feeding women, or those without proven contraception
DECIdE, Shared DECIsion in hEalth : the Real-life Impact Study

The aim of the DECIdE study is to evaluate the effect of a decision aid (the DECIdE tool) for shared decision making concerning optional prescription drugs on the level of uncertainty-certainty or comfort-inconfort (= decisional conflict) experienced by patients, compared with a condition of routine care without the use of a decision aid.

General practitionners and pharmacists will propose to their patients, complaining of a common symptom for which a drug is usually prescribed or dispensed, to discuss this drug and the symptom in order to reach a shared decision on whether to take it or choose another alternative.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 consulting a general practitioner or community pharmacy
* Patient complaining of a symptom or requesting a optional prescription drug (clinical situations and medicines pre-defined by expert consensus)
* First use of DECIdE with the healthcare professional for this situation
* Agreeing to take part in the study and to sign the written consent form
* Speaks and understands French

Exclusion Criteria:

* minor patients
* Patients under guardianship, curatorship or safeguard of justice
* Pregnant or breast-feeding women
* Second use of the DECIdE tool in the same situation / for the same drug
* Refusal to take part in the study
* Patient not affiliated to a medical insurance
Clinical Benefit of Cognitive Behaviour Therapy (CBT) for Insomnia in Cancer Patients

The purpose of this study is to conduct a formal controlled evaluation of the potential benefits of CBT for insomnia in cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Meets clinical criteria for insomnia.
* Diagnosis of breast, prostate, colorectal or gynaecological cancer.
* In follow-up phase with no further anti-cancer therapy planned.

Exclusion Criteria:

* Anti-cancer chemotherapy or radiotherapy within 4 weeks of trial entry.
* Evidence of sleep apnoea or other sleep disorder.
* Evidence of untreated major depressive disorder.
Effects of Receptive Language Intervention vs Individual Therapy for Preschool Children With Autism Spectrum Disorder.

Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by deficits in social communication and social interaction and the presence of restricted, repetitive behaviors. Atypical behaviors, conditioning, and difficulties interacting with others are emblems of Autism spectrum disorder (ASD). Autism spectrum disorder (ASD) frequently affects receptive language skills essential for comprehension and communication. Early intervention is crucial for optimizing language outcomes. This randomized controlled trial (RCT) investigates the comparative efficacy of receptive language intervention (RLI) in group versus individual therapy settings for preschool children with ASD.

This study aims to investigate the efficacy of receptive language intervention (RLI) in group versus individual therapy settings for preschool children with Autism Spectrum Disorder (ASD) aged 3-5 years. The study aims to address the knowledge gap regarding optimal delivery methods for receptive language interventions. Twenty preschool children (ages 3-5) with ASD will be randomly assigned to either group (n=10) or individual (n=10) therapy conditions. Outcome measures will assess by Laura Mize Teach Me To Talk receptive language checklist, noted before therapy and after completing 20 sessions post-therapy (after 7 weeks). Statistical analysis was done using SPSS 20. An Independent t-test was utilized to see any difference between groups. The study's findings will inform evidence-based practice, enhancing receptive language skills in preschool children with ASD. The study could give precious perceptivity to clinicians, preceptors, and policymakers, helping them make informed, substantiation-based opinions about the most effective and doable intervention strategies. The expected outcomes include comparable receptive language outcomes between group and individual therapy, identification of setting-specific benefits and challenges, and child characteristics influencing treatment response.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 3 to 5 years diagnosed with ASD.
* Children who are able to attend regular therapy sessions as scheduled in the study (either group or individual therapy).
* Both male and female will be included.

Exclusion Criteria:

* Children with co-occurring severe medical conditions.
* Children who have already received intensive speech and language therapy for receptive language skills within the last 6 months.
* Children with behavioral issues so severe (e.g., aggression, extreme hyperactivity) that they might disrupt group therapy sessions or be unable to focus in individual therapy.
Palliative Primary Tumor Resection in Minimally Symptomatic Patients With Colorectal Cancer and Synchronous Unresectable Metastases

Currently, the question remains whether palliative primary tumor resection could improve overall survival of minimally symptomatic patients with colorectal cancer and synchronous unresectable metastases. The aim of this study is to determine if there is an improvement in overall survival of palliative primary tumor resection followed by chemotherapy in minimally symptomatic patients with colorectal cancer and synchronous unresectable metastases compared to those of upfront chemotherapy/radiotherapy alone.

The present study is a single-center retrospective observational cohort study with a propensity score matching. Between 2016 and 2022 from our institutional database minimally symptomatic patients with colorectal cancer and synchronous unresectable metastases will be selected. Patients will be divided into two groups:

1. Surgical resection of the primary tumour before to systemic therapy
2. Systemic therapy without previous resection of the primary tumour. Propensity score matching (PSM) will be performed, to minimize the selection bias by adjusting variables that may affect the survival of patients. Categorical variables will be compared using the chi-square test or Fisher's exact test. Continuous variables will be compared using the Student's t-test or Mann-Whitney U test. Survival rate will be determined by using Kaplan-Meier analysis with a log-rank test. Univariate and multivariate analyses for survival will be conducted using Cox proportional hazard models. Statistical results will be considered significant at p values less than 0.05.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed colorectal adenocarcinoma
2. Resectable minimally symptomatic primary tumor with unresectable synchronous metastasis
3. Age ≥ 18 years
4. Informed consent

Exclusion Criteria:

1. Synchronous cancers
2. Carcinomatosis
3. Prior surgery, chemotherapy, radiation therapy for the primary tumor or distant metastases
Study of Genetic Alzheimer's Disease Mutation Carriers in Preclinical Stages of the Disease 18F-Florbetaben Positron Emission Tomography Study

The main purpose of the study is to assess safety of a single dose of FBB followed by PET scan in individuals at risk of genetic Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Adult children (\> 18 yo) of genetic Alzheimer?s disease patients with a known mutation in PSEN1, APP o PSEN2 genes and who are either cognitively normal (CDR=0) or have mild symptoms of cognitive decline (CDR 0.5 or 1)
* According to the principal investigator, participants must be committed to participate and complete all study procedures.
* Has signed the Informed Consent Form voluntarily to participate in the study

Exclusion Criteria:

* Subjects that are not able to complete the study.
* Any major disease or history of a major disease, especially hepatobilliar disease (AST /ALT ? 5 x ULN) or advanced renal insufficiency (creatinine ? 2 x ULN)
* Current or previous history of alcohol abuse or epilepsy
* Allergic to Florbetaben or any of its constituents
* Multiple drug allergies and/or previous history of contrast allergy.
* Pregnancy or breast feeding or planned pregnancy during the study period
* Any disease or history of disease which, in the opinion of the investigator, can cause disturbance of brain function (e.g. vitamin B12 or folic acid deficiency, disturbed thyroid function)
* Evidence for any other neurological or psychiatric disease
Emergency Department Ultrasound in Renal Colic

Renal colic is a common (1300 visits per year at our institution) and painful condition caused by stones in the kidney and ureter, and can be mimicked by life threatening conditions such as a ruptured abdominal aortic aneurysm (AAA). This can create clinical uncertainty. Emergency department targeted ultrasound (EDTU) is performed by an emergency physician at the patient's bedside, and has been shown to be accurate, safe, and efficient. We have shown that EDTU can accurately identify hydronephrosis, which is a predictor of complications of kidney stones. A normal formal ultrasound (US) predicts an uncomplicated clinical course. We will assess the accuracy of EDTU for the diagnosis of hydronephrosis, and when normal, whether patients can be safely discharged.


Eligibility Criteria:
Inclusion Criteria:

* Age 16 - 65 years
* Symptoms suggestive of renal colic
* EDTU performed within one hour (before or after) of formal imaging
* Imaging study arranged during this ED visit (includes next morning)

Exclusion Criteria:

* Hemodynamic instability (Pulse \> 120 or SBP \< 90 or requiring vasopressors)
* Fever (\>38 degrees C)
* Leukocytes and nitrites on dipstick urinalysis (evidence of urinary tract infection)
* Pregnancy
* Inmate
* Renal transplant or single functioning kidney
CD19+Targeted CAR-T Cell Therapy for Relapsed/Refractory CD19+ B Cell Leukemia and Lymphoma

This is a single arm study to evaluate the efficacy and safety of CD19-targeted CAR-T cells therapy for patients with relapsed/refractory CD19+ B Cell Leukemia and Lymphoma.

There are limited options for treatment of relapse/refractory B Cell Leukemia and Lymphoma.CD19 is expressed on most B Cell Leukemia and Lymphoma cells so it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of CAR-T targeting CD19 in patients with elapsed/refractory CD19+ B Cell Leukemia and Lymphoma. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent；
2. Diagnose as relapsed/refractory B Cell Leukemia and Lymphoma, and meet one of the following conditions:

   1. Failed to standard chemotherapy regimens;
   2. Relapse after complete remission, high-risk and / or refractory patients ;
   3. Relapse after hematopoietic stem cell transplantation;
3. For patients with Ph + ALL, the following conditions must be met: those who have received a standard induction chemotherapy regimen and who have not achieved complete remission after TKI treatment or have relapsed after remission (cannot tolerate TKI treatment or have contraindications to TKI treatment or the presence of TKI class) Except for drug resistant patients)；
4. Evidence for cell membrane CD19 expression；
5. All genders ，ages: 2 to 75 years；
6. The expect time of survive is above 3 months;
7. KPS\>60；
8. No serious mental disorders ;
9. Left ventricular ejection fraction ≥50%
10. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
11. Sufficient renal function defined by creatinine clearance≤2 x ULN;
12. Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
13. With single or venous blood collection standards, and no other cell collection contraindications;
14. Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Exclusion Criteria:

1. Previous history of other malignancy;
2. Presence of uncontrolled active infection;
3. Evidence of disorder that need the treatment by glucocorticoids;
4. Active or chronic GVHD；
5. The patients treatment by inhibitor of T cell；
6. Pregnant or breasting-feeding women;
7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.
Comparison of Double Lumen Tube Placement Techniques

The purpose of this study is to compare three different standard of care methods of double-lumen endobronchial tube (DLT) placement in patients who are scheduled to have thoracic surgery in which lung isolation is required.

The purpose of this study is to compare three different standard of care methods of double-lumen endobronchial tube (DLT) placement in patients who are scheduled to have thoracic surgery in which lung isolation is required. The investigators want to evaluate the technique of placement of the double-lumen endobronchial tube (DLT) using an included stylet that has been radically bent (ZU-bend) as compared to a commercial GlideRite stylet with the GlideScope and direct laryngoscopy using the Macintosh laryngoscope. A double-lumen endobronchial tube (DLT) is a breathing tube utilized to manage the airway when lung separation is needed for a surgical procedure. The investigator wants to evaluate how long it takes for successful placement of the double-lumen endobronchial tube (DLT) and assess the difficulty of the procedure experienced by the physician performing the intubation.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients requiring a double-lumen endobronchial tube placement for surgery at Emory University Hospital or Emory University Hospital Midtown
2. Patients willing and able to provide written informed consent

Exclusion Criteria:

1. Patients in whom a previously difficult airway manipulation was recorded on an anesthetic record
2. Lung transplantation procedures, as underlying pulmonary disorder that will confound the SpO2 (peripheral capillary oxygen saturation) metric
3. Any patient who is receiving anticoagulants in excess of a daily aspirin, patients with an International Normalized Ratio or INR \>1
4. Patients in whom one lung ventilation or placement of a double-lumen endobronchial tube is contraindicated
5. Patients who require a rapid-sequence intubation
6. Patients undergoing emergency procedures
Comparison of Efficacy in Removal of Advanced Glycation End Products (AGEs) Between Super High-flux Hemodialysis and Postdilution Online Hemodiafiltration: A Single-center, Prospective, Open-label, Crossover Randomized Controlled Trial

The goal of this clinical trial is to compare efficacy in advanced glycation end products removal between Super high-flux Hemodialysis and high-volume post-dilution online hemodiafiltration. The main question it aims to answer are

* Efficacy : endothelial dysfunction biomarker (AGEs) in super high-flux hemodialysis compared to online HDF
* Safety profile : Dialysate albumin loss, Intradialytic complication

Participants will be asked to randomized in 2 groups : Super high-flux HD or post dilution ol-HDF Researchers will compare SHF-HD and ol-HDF to see whether SHF-HD could remove AGEs better than ol-HDF


Eligibility Criteria:
Inclusion Criteria:

* Chronic HD \> 3 months
* Adequate small molecule uremic toxins removal
* Kt/v \> 1.8 in HD 2 times/week
* Kt/v \> 1.2 in HD 3 times/week
* BFR \> 300 mL/min
* RKF \< 100 ml/day
* Hemodynamically stable for \> 2 weeks

Exclusion Criteria:

* contraindicated to anticoagulant
* active malignancy
* advanced liver disease
Research on the Clinical Characteristics and Key Diagnosis and Treatment Technology of Genetic and Metabolic Liver Disease

1. Establish a follow-up cohort of genetic and metabolic liver disease in The Chinese population, and carry out research on disease spectrum, clinical characteristics and personalized diagnosis and treatment to improve the level of diagnosis and treatment.
2. Establish a multidisciplinary collaborative diagnosis and treatment model of genetic metabolic liver disease, develop and promote diagnosis and treatment paths, and improve the diagnosis and treatment ability of genetic metabolic liver disease in Beijing and even the whole country.
3. Establish a new CRISPR gene diagnosis technology to realize fast and low-cost genetic testing.
4. Elucidating the genetic mutation spectrum of common genetic and metabolic liver disease in China is helpful to accurate gene diagnosis and functional research.
5. Study the genotype-phenotype, mutation and clinical outcome relationship and influencing factors of the common genetic and metabolic liver disease population in China, to guide the early diagnosis, early treatment and improve the prognosis.


Eligibility Criteria:
Inclusion Criteria:

Meet the diagnostic criteria of each disease.

Exclusion Criteria:

1. Co-infected with hepatitis B virus, hepatitis C virus and HIV;
2. Patients with liver fibrosis and cirrhosis caused by other causes;
3. Patients with alcoholic liver disease and autoimmune liver disease;
4. Liver malignancy has been suggested or confirmed by evidence;
5. Combined with other serious systemic diseases.
Indigenous Recovery Planning for American Indians

This research project uses a Community-Based Participatory Research (CBPR) framework to test the efficacy of a culturally adapted relapse prevention intervention developed collaboratively by community partners from the Fort Peck Indian Reservation in northeastern Montana and research partners from Montana State University. The Indigenous Recovery Planning intervention employs trained Fort Peck community members to deliver manualized intervention content to American Indian adults with substance use disorder (SUD). By increasing access to culturally responsive evidence-based treatment, this research aims to decrease SUD-related health disparities and improve public health outcomes for underserved Native communities locally and nationally.


Eligibility Criteria:
Inclusion Criteria:

* American Indian, 18 years of age or older, living on the Fort Peck reservation, meeting diagnostic criteria for Substance Use Disorder, wanting treatment/help with recovery.

Exclusion Criteria:

* Not meeting inclusion criteria.
Prolonged Cardiopulmonary Bypass Time as Predictive Factor for in Hospital Infection

This study is to analyse the demographics and microbiological factors concerning patients undergoing cardio surgical intervention using CPB complicated with bloodstream infection (BSI) postoperatively.

Infectious complications after cardiovascular surgery, especially in operations that use cardiopulmonary bypass (CPB), is associated with significant morbidity and increase in peri-operative mortality. Prolonged CPB usage could be predictive for early bloodstream infection following cardia surgery. This study is to analyse the demographics and microbiological factors concerning patients undergoing cardio surgical intervention using CPB complicated with bloodstream infection (BSI) postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing cardiac surgery

Exclusion Criteria:

* patients having active or previous endocarditis
* patients whose causative microorganism of postoperative BSI was identical to that isolated from preoperative or intraoperative samples
* patients with common skin colonized microorganisms, such as coagulase-negative Staphylococci, Viridans group Streptococci, Corynebacterium species, Bacillus species, Propionibacterium species, and Aerococcus species or Micrococcus species, which were isolated from only a single blood sample and without evidence of clinical sepsis, because contamination was considered.
Obtaining and Storing Human Blood, Urine, and Fecal Samples for Spirochete-Related Epidemiological Research

Current spirochaete infection identification and diagnostic strategies have important limitations. Recent development may allow for an improvement in diagnostic, screening and survey capabilities. The goal of this study is to evaluate blood, urine and fecal samples from a variety of sources and generate information on the occurrence and epidemiology of spirochetes in the general and at risk populations.

The intent of this protocol is to obtain blood, feces and urine samples from subjects with or without a suspected spirochaete infection, so these samples can be used in spirochaete-related scientific studies.

Eligibility Criteria:
Inclusion Criteria:

1. The subject must be able to be fully consented to the study.
2. The subject must be 18 years of age or older.
3. The subject must be mentally competent as determined by the Investigator.

Exclusion Criteria:

1. The subject must not be currently incarcerated or pregnant.
2. The subject must not weigh less than 110lbs.
3. If the subject will be contributing more that 60 ml of blood during an 8 (eight) week period, then the subject must not have donated red blood cells within the last 8 (eight) weeks.
4. If the Subject's health would be compromised by contributing up to 30ml of peripheral blood.
5. If in the opinion of the Investigator, the subject has any clinically significant medical diagnosis/conditions which would prevent participation.
Comparison Between Melatonin and Diazepam for Prevention of Recurrent Simple Febrile Seizures

To evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of recurrent simple febrile seizures.

To evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of recurrence of simple febrile seizures in children aged 6 months to 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 months to 5 yrs .
* Simple febrile seizures

Exclusion Criteria:

* Complex febrile seizures
* Child with history of neonatal seizure.
* Afebrile seizures.
* History of anticonvulsive therapy.
* Children suffering from epilepsy.
* Children with abnormal EEG.
* Children with abnormal neurological examination.
* Positive family history of epilepsy.