cyrilzakka/clinical-trials huggingface dataset:
Clinical Interest of a Genetic Diagnosis in Early Infant Epilepsy, Paraclinical and Therapeutic Management, and Psychological Impact of Families

To determine the paraclinical and therapeutic interest of genetic diagnosis in early onset epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Children aged ≤ 12 years,
* hospitalized or followed at the Hautepierre Hospital of the University Hospitals of Strasbourg for primary epilepsy having started in the first 5 months of life, from 2010 to 2021.

Exclusion Criteria:

- Children with secondary epilepsy (with infection trauma)
Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents

This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar disorder or symptoms of mania.

Patients are randomly assigned to receive lithium (Eskalith), valproate (Depakote), or risperidone (Risperdal) for 8 to 16 weeks. They will have weekly visits to monitor their response to the medication. When the study is complete, care will be transferred to the child's treating psychiatrist.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV criteria for bipolar I (manic or mixed) or mania for at least 4 weeks
* CGAS less than or equal to 60
* Good physical health

Exclusion Criteria:

* Schizophrenia or any pervasive developmental disorder
* Major medical or neurological disease
* History of addiction to illicit substances or alcohol or drug abuse within the last 4 weeks
* IQ less than 70
* Pregnancy or breast-feeding
* Unacceptable methods of contraception
* In-patient care at baseline
Comparison of Contact-force Monitoring Irrigated Tip Catheter and Mesh-like Irrigated Tip Catheter in Atrial Fibrillation Ablation: Prospective Randomized Trial (COMMIC Trial)

Mesh-type flexible tip (MFT) catheter is developed to generate bigger radiofrequency (RF) lesion, and contract force (CF) catheter improves the maintenance of catheter-tissue contact during atrial fibrillation catheter ablation (AFCA).

The investigators compared clinical outcome of AFCA conducted by MFT catheter and CF catheter in prospective randomized manner.

The investigators prospectively assigned 230 patients with AF in a 1:1 ratio to ablation by MFT catheter (FlexAbility™, Abbott Inc. USA) and CF catheter (TactiCath™, Abbott Inc. USA). The primary end point was AF recurrence after single procedure, and the secondary end point was response to antiarrhythmic drugs.

A. Study design

1. Prospective randomization (FlexAbility group vs. TactiCath group )
2. Target number of subjects: 360 (180 per group)
3. Rhythm follow-up : 2012 ACC/AHA/ESC guidelines (Holter monitoring at the baseline, 2 month, and thereafter every 6 months; ECG if the patient has any symptom)
4. Anticoagulant therapy followed by 2014 ACC/AHA/ESC guidelines
5. All complications in each group will be evaluated including the re-hospitalization rate, cardioversion frequency, major cardiovascular event, and mortality rate.

B. Progress and rhythm/ECG follow-up

1. To be performed in accordance with the 2012 ACC/AHA/HRS guidelines for AF management
2. Follow-up at 2 weeks, 2 months, and thereafter every 6-month.
3. Rhythm control at 2 months, and thereafter every 6-month follow-up with Holter
4. If the patient complains of symptoms, ECG will be performed at any time, and rhythm follow-up will be carried out with a Holter or event recorder.

Eligibility Criteria:
Inclusion Criteria:

* Appropriate indiction for AF catheter ablation (20\~80 years old)
* Echocardiographically measured left atrial size \< 55mm
* Anticoagulation eligible patients

Exclusion Criteria:

* AF associated with significant cardiac anomaly, structural heart disease affecting hemodynamics
* Ineligible to CT imaging due to significant renal disease
* Prior history of AF catheter ablation or cardiac surgery
* Active internal bleeding
* Anticoagulation ineligible patients
* Valvular AF
* Life expectancy \< 1year
* Drug or alcohol addicted patients
* Other unacceptable patients for clinical trial determined by investigators
Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's Patients

Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 3-arm safety and efficacy study (Part A) with an open-label phase (Part B).

During Part A, each patient will participate for up to 30 weeks, which includes a Screening Period of 1 to ≤ 6 weeks, followed by a Baseline Visit and 24 weeks of double-blind treatment:

* Screening Period: 1 - 6 weeks.
* Double-Blind Treatment Period: 24 weeks.

After completion of Part A, patients will continue in Part B for an additional 56 weeks:

* Open-Label Treatment Period: 52 weeks.
* Post-Treatment Safety Follow Up: 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patient understands study requirements and has given his/her written informed consent on an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved consent form.
* Parkinson's disease diagnosis consistent with UK Parkinson's Disease Society Brain Bank Diagnostic criteria
* Minimum of 3 years since diagnosis.
* Meet Hoehn and Yahr PD stage
* Good response to levodopa
* Stable regimen of anti-PD medications
* Patients must have been taking a levodopa-containing anti-PD medication continuously for at least the previous 12 months
* Patient has documented a minimum amount of Off time.
* If of childbearing potential (male and female) must use an acceptable method of contraception

Exclusion Criteria:

* Previous tozadenant study participation
* Current or recent participation in another study.
* Secondary or atypical parkinsonism
* Neurosurgical intervention for PD
* Patient is taking apomorphine, budipine, istradefylline, tolcapone, or DUOPA™/Duodopa®
* Treatment with excluded medications
* Untreated or uncontrolled hyperthyroidism or hypothyroidism
* Clinically significant out-of-range laboratory
* MMSE out of range
* Current episode of major depression (stable treatment for depression is permitted).
* Recent suicide attempt or suicidal ideation type 4 or type 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS)
* Women lactating or pregnant
* Hypersensitivity to any components of tozadenant or excipients
* Abnormal findings on the physical or neurological examination, or medical history that would make the patient unsuitable for the study
* History of hepatitis or cholangitis
OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages

The purpose of this observational study is to find the best measures to define how well a person with eosinophilic disorder is doing. People with EoE, EoG, EoN and EoC normally undergo endoscopy and/or colonoscopy where cells are collected for microscopic analysis. Treatments are then decided based on how the cells look. We are aiming to compare different tissue components such as inflammatory cell types with clinical symptoms. We want to see if scores on standard questionnaires can give us an idea how well the person is doing.

This is a longitudinal observational study in which individuals (males and females 3 years of age and greater) with EoE, EoG, EoN and EoC will be followed over the course of time to see if standard questionnaires can give us an idea of how well the person is doing.

Participants undergoing standard of care (normal, routine care) endoscopies and/or colonoscopies will have biopsies (small pieces of tissue from the GI tract normally collected during these procedures) collected and used for the research study. Participants will also complete questionnaires related to their symptoms and quality of life. Participants will be followed over the course of time and asked to complete the questionnaires at various time points throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Males or females 3 years of age and older
* Mucosal eosinophilia:

EoE ≥ 15 eosinophils/HPF in the distal or proximal esophagus EoG ≥ 30 eosinophils/HPF in 5 HPF\&#39;s in the body and/or antrum EoN ≥ 53 eosinophils/HPF in the duodenum and/or ≥ 56 eosinophils/HPF in the jejunum and/or ileum EoC ≥ 84 eosinophils/HPF from the transverse or descending colon and/or ≥ 32 eosinophils/HPF from the rectosigmoid colon or a biopsy from any colonic location with ≥ 100 eosinophils/HPF

- Presence of symptoms is required for patients who are newly diagnosed but not required for patients who were previously diagnosed.

Exclusion Criteria:

* History of intestinal surgery other than G tube placement
* Enrolled in a blinded investigational study at the time of the first study visit
* Have esophageal stricture (\&lt;3mm)
* Have other identifiable causes for eosinophilia (except Inflammatory Bowel Disease): infections, Gastrointestinal (GI) cancer, other GI inflammatory disease (e.g., Ulcerative Colitis or Crohn\&#39;s Disease)
The Effect of Online Sexual Health Training Given to Nursing Students on Knowledge, Attitude and Self-Efficacy

Nurses play an important role in providing sexual health care to individuals. In this study, online sexual health training will be implemented in an innovative way by supporting the use of models in the process of providing sexual counseling to the patients of nursing students. The most commonly used PLISSIT model will be taught to nursing students while providing sexual counseling to patients and its effectiveness will be determined.

Nurses play an important role in providing sexual health care to individuals. In this study, online sexual health training will be implemented in an innovative way by supporting the use of models in the process of providing sexual counseling to the patients of nursing students. The most commonly used PLISSIT model will be taught to nursing students while providing sexual counseling to patients and its effectiveness will be determined. The research is planned to be pre-test post-test comparative, randomized, with one experiment and one control group, ın order to determine the effect of online sexual health training given to nursing students with the PLISSIT model on the myths about sexuality, sexual health care knowledge, sexual health care attitude and sexual health care self-efficacy. This research will be carried out between November 2023 and December 2023 with the participation of fourth grade students studying at Marmara University Faculty of Health Sciences, Department of Nursing. Students who is suitable the inclusion criteria will be randomized to the experimental (n=30) and control groups (n=30). The data of the research will be obtained by using \&amp;#34;Student Information Form\&amp;#34;, Sexual Health Care Questionnaire, which includes 3 scales as \&amp;#34;Sexual Health Care Knowledge Scale\&amp;#34;, \&amp;#34;Sexual Health Care Attitude Scale\&amp;#34;, \&amp;#34;Sexual Health Care Self-Efficacy Scale\&amp;#34; and \&amp;#34;Sexual Myths Scale\&amp;#34; and \&amp;#34;Student Opinion Form on Sexual Health Education\&amp;#34;. Ethical permission and institutional permission were obtained.During the research, while the control group receives routine training, the experimental group will be given online sexual health training including 20 hours of PLISSIT model teaching by the researcher. The data of the research will be obtained by using the data collection form before the training, after the training.

Eligibility Criteria:
Inclusion Criteria:

* Being a senior nursing student,
* Having sufficient Turkish speaking and understanding skills,
* Agreeing to participate in sexuality education on the online platform,
* Sufficient or unlimited internet access,
* Having any computer, tablet or smart phone,
* Being willing to participate in the research

Exclusion Criteria:

* Desire to leave the research,
* Incomplete filling of data collection forms,
* Not attending the training given in the study.
Using the Canary Breathing System for Panic Disorder Patients

The purpose of this study is to test the effectiveness of the Canary Breathing System (CBS) in treating the symptoms of panic disorder.

Panic disorder (PD) is associated with hyperventilation. The efficacy of a brief respiratory feedback program for PD has been previously established. The aim of the present study was to expand these results by testing a similar program with more clinically representative patients and settings. The intervention is delivered via home use following initial training by a clinician and provides remote monitoring of client adherence and progress by the clinician. Outcomes were assessed post-treatment and at 2- and 12-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of Panic Disorder
* Subjects between 18 and 60 years of age (inclusive on day of enrollment)
* Subjects with a Clinician's Global Impression of \> or = to 4.
* If on psychotropic medication, on a stable dose for a minimum of 3 months prior to enrollment
* If on psychotropic medication, an agreement to stay on their stable dose from study entry until the 2-month follow-up.

Exclusion Criteria:

* Pregnancy
* Current enrollment in another drug or device study
* Current enrollment in another drug or device study that is not at least 30 days past the final follow-up
* Currently undergoing cognitive behavioral therapy (or equivalent)
* Refractory to either a breathing training program or cognitive behavioral therapy (or equivalent) in the 3 months prior to enrollment
* Evidence of organic mental disorder
* Severe suicidality
* Presence of any psychotic disorder
* Bipolar disorder that is present for \< 5 years; a major depressive, manic or hypomanic episode in the last 12 months; failure to take and maintain a stable dose of medication in treatment of bipolar disorder in the last 12 months
* Current alcohol or drug dependence
* Cardiovascular or pulmonary disease
* Epilepsy or seizures
* Undergoing additional psychologic treatment at any point from study enrollment to 2-month follow-up to treat panic disorder
Subcutaneous Closed-Suction Drainage Affects Surgical Wounds Healing in Lower Gastrointestinal Open Surgery: a Randomized Controlled Study

This is a single-center, randomized controlled trial to evaluate whether subcutaneous closed-suction drainage would decrease the incidence of poor surgical site healing in lower gastrointestinal open surgery. The independent risk factors of the incidence of poor surgical wounds healing in lower gastrointestinal open surgery will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* aged 18-85 years old, male or female
* all patients underwent lower gastrointestinal surgery: the digestive tract below Treitz ligament was called lower gastrointestinal tract, including jejunum, ileum, ileocecal part and colorectal
* open surgery (instead of laparoscopic) required
* willing participated in clinical verification and signed informed consent.

Exclusion Criteria:

* laparoscopic surgery
* upper gastrointestinal surgery (esophagus, stomach, duodenum and hepatobiliary pancreas)
* simple appendectomy / total appendectomy
* hernia surgery and intestinal obstruction surgery without intestinal resection
* infection of incision site before operation
* pregnant women
* expected death within 1 month after operation.
Neural Development of Deductive Reasoning

Children's understanding of linear-order (e.g., Dan is taller than Lisa, Lisa is taller than Jess) and set-inclusion (i.e., All tulips are flowers, All flowers are plants) relationships is critical for the acquisition of deductive reasoning, that is, the ability to reach logically valid conclusions from given premises. Behavioral and neuroimaging studies in adults suggest processing differences between these relations: While arguments that involve linear-orders may be preferentially associated with spatial processing, arguments that involve set-inclusions may be preferentially associated with verbal processing. In this study, we use functional magnetic resonance imaging to investigate how and when these processing differences appear in children from 8 to 14.


Eligibility Criteria:
Inclusion Criteria:

* Right-handed
* Affiliated to the French social security
* Whose parents gave informed consent

Exclusion Criteria:

* Neurological disorders
* Psychiatric disorders
* Birth complications requiring admission into neonatal intensive care unit
* Medication affecting central nervous system processing
* Significant hearing impairment
* Uncorrected visual impairment
* Non-native English speaker
* Contraindications for MRI
Effect of Consumption of Dairy Product on Upper Gastric Discomfort

The purpose of this study is to determine whether the consumption of test dairy products is effective in reducing upper gastric discomfort after 2 weeks of product consumption.


Eligibility Criteria:
Inclusion Criteria:

* Male and female
* 21 - 60 years old
* Experiencing upper gastric discomfort

Exclusion Criteria:

* Participants with alarm symptoms (dysphagia, bleeding, involuntary weight loss clinically significant \>10% of it habitual weight during the last 6 months).
* Participants with diagnosed severe organic esophageal medical history (endoscopic eosophagitis A, B, C or D of Los Angeles classification, peptic stenosis, Barrett oesophagus, huge hiatus hernia or para-esophageal) gastric or duodenal ulcer or high digestive haemorrhage clinical history.
Study to Investigate Safety and Tolerability of mRNA-0184 Administered Under Different Infusion Conditions in Healthy Participants

The purpose of this study is to evaluate the safety and tolerability of intravenously (IV) administered mRNA-0184 under different infusion conditions.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, electrocardiogram (ECG), and vital signs.
2. Participant who could become pregnant must meet conditions as defined in the protocol.

Exclusion Criteria:

1. History of any clinically significant disease or disorder which may either put the participant at risk because of participation in the study or influence the results or the participant's ability to participate in the study.
2. Any clinically significant illness, or medical/surgical procedure, within 4 weeks of the first administration of the study investigational product (IP) (mRNA-0184).
3. Any clinically significant abnormalities in clinical laboratory results at Screening. Repeat assessments are allowed at the Investigator's discretion if a false positive is suspected.
4. Clinically significant abnormal findings in vital signs at Screening.
5. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
6. Use of any prescribed medication during the 2 weeks or 5 half-lives of the medication, whichever is longer, prior to the first administration of the study IP. Hormonal contraception is permitted.
7. Has received another IP within 4 weeks of the first dosing of the study IP or within 5 terminal half-lives of the IP, whichever is longer.
Catheter Ablation of All Inducible AT Post AF Ablation

In the treatment of symptomatic drug resistant persistent atrial fibrillation (Ps AF), catheter ablation has a class IIA indication. During the follow-up, a significant amount of patients (\~50%) will experience atrial tachycardias (AT) recurrence. The endpoint of AT ablation during the second procedure has not been validated. At present, several strategies are considered as good clinical practice.

Main objective: To evaluate if ablation of all inducible AT post AF ablation (ATPAFA) offers as substantial benefit in comparison with ablation of the clinical ATPAF only during a redo procedure post initial persistent AF ablation.

Secondary objectives:

To evaluate the prognosis of non-inducibility during a redo procedure for ATPAFA


Eligibility Criteria:
Inclusion Criteria:

* Male or Female Adults (≥18 years old)
* Patients with stable ATPAF at least two months after the first AF ablation procedure.
* Consent signed by the patient after reading the information leaflet

Exclusion Criteria:

* Mental or physical inability to take part in the study
* Spontaneous AF in the EP lab
* Presence of any pulmonary vein stents
* Presence of any pre-existing pulmonary vein stenosis
* Presence of any cardiac valve prosthesis
* Clinically significant mitral valve regurgitation or stenosis
* Myocardial infarction, PCI / PTCA or coronary artery stenting within the last 3 months
* Unstable angina
* Any cardiac surgery within the last 3 months
* NYHA class III or IV congestive heart failure
* Uncontrolled hyperthyroidism
Role of MSCT Volumetry in Assessment of Brain Atrophy in Septic Patients

assessment of brain atrophy associated with septic ICU patients by using MSCT Volumetry

Sepsis is the leading cause of admission to ICU , the number of patients who survive and discharge from ICU has also increased due to technological advances in ICU however quality of life of these patients after ICU discharge is lower than that of healthy people of a similar age, in particular Sepsis associated encephalopathy associated with brain dysfunction.

We hypothesized that brain damage including brain volume reduction that ocurre in acute phase of Sepsis using CT scan and there finding " relationship to risk factor and outcome".

We compared head CT finding at time of admission with those obtained during the course of the treatment

Eligibility Criteria:
Inclusion Criteria:

* patients \>16years old with sepsis associated with disturbance in conscious level admitted to ICU

Exclusion Criteria:

* Age\< 16y Brain death Hematological disease Malignant disease Hypoxemia Error in automatic tissue classification Motion artifac
A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk

The purpose of the trial is to assess the efficacy and safety of tirzepatide taken once a week to insulin glargine taken once daily in participants with type 2 diabetes and increased cardiovascular risk. The study will last about 108 weeks and may include up to 30 visits.


Eligibility Criteria:
Inclusion Criteria:

Participants must:

* Have been diagnosed with type 2 diabetes mellitus (T2DM)
* Have HbA1c between ≥7.5% and ≤10.5%
* Be on stable treatment with unchanged dose of at least 1 and no more than 3 types of oral antihyperglycemic drugs, which may only include metformin, SGLT-2 inhibitors, and/or sulfonylureas for at least 3 months before screening
* Have increased risk for cardiovascular (CV) events
* Be of stable weight (± 5%)
* Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening

Exclusion Criteria

Participants must not:

* Have type 1 diabetes mellitus
* Have had chronic or acute pancreatitis any time prior to study entry
* Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring immediate or urgent treatment
* Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss
* Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level \>3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if there ALT level is ≤3.0 the ULN for the reference range
* Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months
* Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
* Have been taking any other diabetes medicines other than metformin, SGLT-2 inhibitors, and/or sulfonylureas during the last 3 months
* Have been taking weight loss drugs, including over-the-counter medications during the last 3 months