cyrilzakka/clinical-trials huggingface dataset:
Fluid Challenge Impact in the Portal Vein Pulsatility Depending on the Fluid Responsivness Status

Portal vein pulsatility index is a marker of venous congestion evaluated by point of care ultrasound. It is associated with acute kidney injury, especially in critically ill patients. It may be considered as a dynamic marker. The investigators hypothesized that portal vein pulsatility index is higher after a fluid challenge only in patient without preload dependence in critically ill patients with cardiovascular insufficiency.


Eligibility Criteria:
Inclusion Criteria:

* vasopressor requirement to maintain mean arterial pressure \>65mmHg AND
* at least one of the following criteria:

  * arterial lactate \>2mmol/L;
  * capillary refill time \>3s;
  * mottling score \>1;
  * diuresis \<0,5mL/h for more than 6hours.

Exclusion Criteria:

* Diameter of vena cava \<20mm
* Cirrhosis
* Pregnancy
* Severe acute pulmonary edema
* Phototype 4 or 5
* Patient opposition to participate
Mindfulness Program for Adolescents With 22q11DS

The goal of this study is to evaluate the effectiveness of the Aware Program, an online mindfulness education program, with adolescents with 22q11DS and their parents.

Parent-adolescent pairs (N=60) will be recruited to participate in a randomized controlled trial. Consent, permission, and/or assent will be sought prior to participation in the study. Participant pairs will be randomized into one of two study arms: intervention and wait-list control. All participants will complete a web-based pre-test questionnaire. Adolescents and parents in the intervention group will then receive access to the Aware Program for four weeks. Approximately 4-5 weeks after completing the pre-test questionnaire, all participants will complete a web-based post-test questionnaire (the post-test for the intervention group will include Consumer Satisfaction questions about the program). Adolescents and parents in the wait-list control group will then have the option of reviewing the Aware Program and will receive access for four weeks. After approximately four weeks, they will have the opportunity to complete the Consumer Satisfaction Questionnaire about the program.

Eligibility Criteria:
Inclusion Criteria:

To be included in the study, youth must:

* Have received a diagnosis of 22Q11.DS (also known as VeloCardioFacial Syndrome or DiGeorge syndrome)
* Be between the ages of 12 and 19 years old
* Have an IQ of greater than or equal to 55
* Have regular internet and computer access
* Speak and read English (all study and program materials are in English)

To be included in the study, parents must:

* Have a participating youth in the study
* Read fluently in English (all study and program materials are in English)

Exclusion Criteria:

- Only one parent per youth may participate
Gait and Muscle Power Training for Children With Developmental Coordination Disorder

Objectives: To compare the effectiveness of RAS-MPT, RAS alone, MPT alone, and usual care (as a control) for improving the overall gait performance of and reducing falls in children with developmental coordination disorder (DCD) and to explore the relationship between gait performance and falls in this population.

Design: A randomized controlled trial. Sample: 76 children with DCD. Interventions: RAS-MPT, RAS alone, MPT alone, or usual care (12 weeks). Major outcomes: Outcomes will be evaluated at baseline, post-intervention, and a 6-month follow-up. Comprehensive gait analysis will produce spatiotemporal gait parameters (e.g., velocity and stride length), kinematic gait parameters (e.g., knee joint motions), and leg muscle EMG outcomes; an isokinetic test will quantify leg muscle strength and force production time; and fall histories will be obtained via interviews. Anticipated results and significance: The RAS-MPT group is predicted to display the best gait performance, which is associated with reduced fall incidents. This novel training regime can be readily adopted in school, clinical, or home settings to improve locomotor ability in children with DCD, an outcome with positive socioeconomic implications.


Eligibility Criteria:
Inclusion Criteria:

* 6 to 9 years old
* classified as DCD according to the Diagnostic and Statistical Manual of Mental Disorders V
* \< 5th percentile on the Movement Assessment Battery for Children-2 (MABC-2)
* a total score of \< 46 (for children aged 6 to 7 years 11 months) or \< 55 (for children aged 8 to 9 years) on the DCD questionnaire 2007 (Chinese version)
* attending a mainstream school (i.e., intelligence level within the normal range).

Exclusion Criteria:

* any congenital, cognitive, psychiatric (e.g., comorbid attention deficit hyperactivity disorder or autism spectrum disorder), neurological, sensory, hearing, visual, vestibular, musculoskeletal, or cardiopulmonary disorder that may affect test performance
* obesity (body mass index \[BMI\] \>95th percentile)
* receiving active treatment such as physiotherapy
* those unable to follow instructions.
Acetabular Labral Tear in Dysplastic Hips

A prospective case-control study of the clinical and radiographic outcome of periacetabular osteotomy in patients with and without preoperative acetabular labral tears.


Eligibility Criteria:
Inclusion Criteria:

* Developmental dysplasia of the hip

Exclusion Criteria:

* contraindication for magnetic resonance arthrography
* severe deformities of the femural head
CLEAR Clinical Study

Acute in-booth assessment of a new noise reduction algorithm with cochlear implant recipients.


Eligibility Criteria:
Inclusion Criteria:

1. Conventional CI subject aged twelve years of age or older, or Hybrid subject aged 18 years or older
2. Recipient of a CI500 Series (CI512 or CI522) or CI24RE Series (CI24REH or CI422) cochlear implant
3. At least three months CI experience in ear to be assessed
4. At least three months experience with the CP810,CP920 or CP910 sound processor
5. Fluent speaker in the local language used to assess clinical performance
6. Open-set speech perception ability
7. Use of or eligibility for hybrid acoustic component (hybrid population only)

Exclusion Criteria:

1. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the investigational device
2. Unwillingness or inability of the candidate to comply with all investigational requirements
3. Additional handicaps that would prevent or restrict participation in the audiological evaluations or that would affect the scientific integrity of the study.
Study of an Environmental Risk Factor in Crohn's Disease

Inflammatory bowel disease (IBD) are lifelong chronic diseases affecting the gastrointestinal tract. The precise etiology and the different actors participating to the pathophysiological process leading to the disease development are still not well understood. A complex interaction between genetics, gut microbiota and environmental factors is thought to trigger the inappropriate mucosal immune response observed in IBD patients. We hypothesize that DON might be an environmental risk factor for IBD.The focus on the human relevance of the gut effects of DON by studying its exposure, metabolism and adverse effects in health and disease focusing on IBD patients


Eligibility Criteria:
Inclusion Criteria:

* Group 1: patients with ileocolic Crohn's disease requiring surgery
* Group 2: Patients requiring ileal and / or colonic surgery for a reason other than Crohn's disease or ulcerative colitis (for example, cancer, polyp or diverticulum).

Exclusion Criteria:

* Vegetarian or vegan patients, celiac disease, gluten sensitivity, eating disorders, people with a particular diet or eating behavior or suffering from obesity or anorexia
* Surgical history: patient having undergone intestinal resection
* Current treatments: patient receiving antibiotic or probiotic treatment within 6 weeks prior to inclusion / patient having taken topical treatment (suppositories or enema of 5ASA or corticosteroids) within 6 weeks prior to inclusion
Role of Pre-operative Counseling in the Surgical Patient

The study will seek to determine if surgical patients do better or the same if participants undergo pre-operative counseling for elective laparoscopic same day surgery. The study hypothesizes that patients who receive a pre-operative education booklet and a phone call from a surgical registered nurse, compared to the current standard of care, will have higher satisfaction with regard to participants' surgical experience, decrease in the number of post-operative phone calls, decrease in the number of opioid medications, and decrease in the number of emergency department visits. The importance of this study is to understand what surgical clinical practices can do in the pre-operative setting to enhance a surgical patient's recovery.

In the last decade there has been an increasing focus on the patient's pre-operative, operative and post operative experience to help patient's in participants' recovery. For example, the surgical community has focused on pathways such as Enhanced Recovery After Surgery (ERAS), to improve patient's outcome and surgical experience. Despite this emphasis, little has been described in the literature as to how surgeons can improve a patient's experience by counseling participants on what participants can expect before, during, and after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* General surgical patients who will undergo same-day laparoscopic ventral hernia, inguinal hernia, and gallbladder surgery at Howard County General Hospital with the general surgery practice at Johns Hopkins Community Physicians.

Exclusion Criteria:

* Patients less than 18 years of age
* Adults who lack the capacity to consent
* Pregnant women
* Prisoners
* Non-English speakers.
INFINITY™Total Ankle Replacement Follow-up

Study Title INFINITY™Total Ankle Replacement Follow-up (ITAR) Study Design Prospective, multi-site, multi-year post-market clinical follow-up study Study Group Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY™ Total Ankle System Number of Subjects 150 with 9 sites

The primary outcome measure of this post-market clinical observational study is to collect data relating to the INFINITY™ Total Ankle System survivorship at 10 years. The secondary outcome measures are to characterize the improvements after implantation over a 10 year period using patient reported outcome measures related to quality of life, pain and functional improvements, safety of the implants, as well as radiographic assessments (X-Rays)

The outcome measures collected in this study will be analyzed and reported as required for local, regional, and country requirements (i.e., regulatory authorities and notified bodies).

Eligibility Criteria:
Inclusion Criteria:

* Be 21 years of age or older at the time of surgery;
* Diagnosed with unilateral and/or bilateral ankle joint disease;
* Diagnosed with ankle joint damage from rheumatoid arthritis, post-traumatic, or degenerative arthritis;
* Willing and able to consent to participate (written, informed consent;
* Willing and able to attend the requested follow-up visits;
* A clinical decision has been made to use INFINITY™ Total Ankle System replacement prior to enrollment in the research.

Exclusion Criteria:

* Subjects with an ankle condition, as determined by the investigator, to be an inappropriate candidate for a total ankle replacement;
* Subjects requiring revision total ankle replacement of the ankle being considered for study.
Development, Feasibility and Acceptability of an iCBT Intervention for Adolescents With Anxiety

The aim of the feasibility study is twofold: 1) to test the feasibility of the study design, and 2) to test the preliminary efficacy and the acceptability of a new iCBT intervention when delivered with different levels of therapist support. The feasibility trial will provide important information on the initial participant responses, and on how to properly collect data in the subsequent RCT.

The feasibility trial is conducted as a randomized study with 16 participants consisting of two conditions: 1) guided iCBT, and 2) on-demand iCBT, both to be completed over a 14-week period. Participants in the guided iCBT condition will receive the new iCBT intervention with planned feedback after each completed module. Participants in the on-demand iCBT condition will receive the intervention with on-demand feedback that is participant-initiated. In both conditions, the therapist may spend a max. of 15 minutes giving feedback per module. As there is no evidence on what amount of therapist support is sufficient for adolescents, the allowed time spent giving feedback will not differ between the two conditions in the feasibility trial. Thus, data on engagement will be collected to inform how the two treatment conditions differ. The trial includes data points at pre-treatment (T1) and post-treatment (T2) where the same measures will be administered as are planned in the RCT.

Acceptability of the intervention will be investigated by conducting semi-structured interviews with the participants. The interview will include an evaluation of the intervention, client satisfaction and potential reasons for drop out.

The results from the feasibility trial will be used to inform the subsequent RCT and to revise the intervention, procedures, and conditions if needed.


Eligibility Criteria:
Inclusion Criteria:

* Between 12 and 17 years of age
* Primary anxiety diagnosis
* Must have the ability to read and write Danish
* Must have Internet access
* Must have a parent able to participate in the treatment alongside the adolescent

Exclusion Criteria:

* Specific phobia of blood-injection-injury type
* An autism spectrum disorder
* Psychotic symptoms
* Bipolar disorder
* Current suicidal ideation or self-mutilating behavior
* Current alcohol or substance abuse
* Moderate to severe depression
* Current eating disorder
Maestro Handheld Cardiac Monitor Validation

The purpose of this study is to demonstrate that the Maestro hand held heart monitor can accurately diagnose Atrial Fibrillation, atrial flutter or normal sinus rhythm in patients.

The purpose of this study is to determine if Maestro can be used to detect heart arrhythmias, specifically atrial fibrillation in humans. Maestro will be used to measure heart rate and rhythm at the same time that patients are being monitored with a standard 3, 5, or 12 lead electrocardiogram (ECG) in a clinical setting. The recorded Maestro results will be compared to the ECG results to assess Maestro's accuracy.

Data will be analyzed by a pass/fail criterial. The data will be downloaded and printed for the investigators' interpretation who will first review and code the data from Meastro, blinded to the ECG findings. Then the investigators will interpret the ECG findings and the 2 sets of data will be compared. The ECG result is the true value with which to compare the Maestro result.

Eligibility Criteria:
Inclusion Criteria:

* ability to provide informed consent

Exclusion Criteria:

* implanted pacemakers
* open wounds or abrasions on their hands
* prior damage to hands or thumbs precluding obtaining an ECG tracing
Effect of Sleep Restriction on Decision Making and Inflammation

* hypothesis: sleep restriction in healthy subject trigger alteration of decision making associated with immuno-inflammatory changes
* inclusion criterias: healthy subjects, men, under 35 years, BMI\<26, no sleep troubles, intermediate chronotype
* design: 12 subjects, longitudinal study 2 days of baseline, 7 night of sleep restriction (4h sleep/night), recovery (1, 2, 3 and 9 normal sleep nights).
* parameters: decision making tests, reaction time, wakefulness test, biological parameters (cathecholamines, pro-inflammatory cytokines...), heart rate, blood pressure
* control of sleep restriction: continuous polysomnographic survey


Eligibility Criteria:
Inclusion Criteria:

* healthy men, \< 35 yr old, BMI\<26, intermediate chronotype

Exclusion Criteria:

* sleep trouble, acute or chronique disease (cardiological, neurological...), women
Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures

This trial will evaluate the efficacy and safety of ucb 44212 as add on therapy in subjects with focal epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Males/Females from 18 to 65 years of age (minimum body weight of 40 kg)
* Subjects with a confirmed diagnosis of epilepsy suffering from partial onset seizures whether or not secondarily generalized
* Subjects who have been treated for epilepsy for \>=6 months and are currently uncontrolled while being treated with 1-3 concomitant Antiepileptic Drug (AEDs)
* Female subjects without childbearing potential; Female subjects with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method

Exclusion Criteria:

* Seizures occurring in clusters.
* Status epilepticus within 6 months of Visit 1
* History of non-epileptic seizures
* Subjects on vigabatrin
* Subjects on felbamate, unless treatment has been continuous for \>2 years
* Ongoing psychiatric disease other than mild controlled disorders.
* Subjects with clinically significant organ dysfunction
* Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients
* Pregnant or lactating women
* Subjects currently taking levetiracetam (LEV)
* Use of benzodiazepines (for any indication) taken at a higher frequency than an average of once a week, unless counted as one of the concomitant Antiepileptic Drug (AEDs)
177Lu-labeled NY108 SPECT Imaging in Patients

This is a single arm study to evaluate the safety and biodistribution of 177Lu-labeled NY108 (177Lu-NY108) SPECT Imaging in patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients voluntarily signed informed consent;
2. Age 18-75, male;
3. Clinical diagnosis of prostate cancer with diagnostic criteria referencing biopsy and at least one metastasis;
4. Patients must be 68Ga-NY108 Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive;
5. Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone) and at least one paclitaxel regimen;
6. Progressive metastatic destructive resistant prostate cancer as determined by PCWG3 criteria;
7. An ECOG score of 0-2

Exclusion Criteria:

1. Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
2. Patients with severe systemic or localized infections or other serious coexisting diseases;
3. Patients with abnormal immune function or who have recently used immunosuppressive or booster agents including various vaccines, etc;
4. Patients with autoimmune diseases, including rheumatoid, etc;
5. Inadequately controlled arrhythmias, including atrial fibrillation:
6. Cardiac insufficiency (New York Heart Association (NYHA) work class criteria);
7. Uncontrolled hypertension;
8. Patients with a history of allergy or hypersensitivity to any component of the imaging agent, including antibodies;
9. Subjects positive for syphilis, HBV, HCV, FIIV;
10. Subjects of childbearing age who are unable to use effective contraceptive devices:
11. Patients with a history of mental illness or related medical conditions;
12. Patients who are unable or unavailable for SPECT/CT scanning;
13. Other subjects who, in the opinion of the investigator, are not suitable for enrollment.
Home Telemonitoring System for Patients With Heart Failure

This randomized controlled trial compares a home telemonitoring system (HTS) versus usual care during a 90 days follow-up of Heart Failure (HF) ambulatory patients, in order to evaluate if the use of the HTS improves self-care and treatment adherence. The study was reviewed and approved by the Methodological Committee and by the Research Ethics Committee from the Provincial Health System, according to the Declaration of Helsinki. Written informed consent was obtained before randomization.


Eligibility Criteria:
Inclusion Criteria:

* were over 18 years with a primary diagnosis of HF,
* had been hospitalized at least once time as a consequence of a HF decompensation,
* had a Smartphone,
* had access to WiFi,
* had access to a weight scale and to a blood-pressure monitor

Exclusion Criteria:

* illiterate patients,
* had learning difficulties,
* had a cognitive impairment sufficient to interfere with the use of the telemonitoring system, or had a severe depression that could interfere with their quality of life perception.
High Frequency Intraoral Ultrasound Probe for Early Diagnosis of Periodontal Diseases

The goal of this clinical investigation is evaluation the agreement between the periodontal pocket depth measurement obtained by periodontal probing (gold standard) and the measurement obtained by the ultrasound device

This is a single-center prospective Clinical Investigation in two steps:

Step 1 Preliminary phase : collection and assessment of ultrasonic images to visualize dental and periodontal tissues and structures in order to manually perform periodontal measurements and generate data required for the Artificial Intelligence module training Step 2 : Performance Evaluation : assessment of the ultrasonic probe performance for faster, automatic, accurate and repeatable periodontal measurements in more comfortable conditions for both operator and patient

Eligibility Criteria:
Patient Inclusion Criteria :

Age ≥ 18 years Affiliated to a social security scheme Free, informed and signed consent Ability for participant to comply with the requirements of the study

Exclusion Criteria (patient):

Surgical procedure performed in the area to be scanned Osteosynthesis material Under legal protection Pregnant women, breastfeeding Teeth Inclusion Criteria Minimum of 10 teeth One tooth from each sextant Presence of at least 1/3 of pathological sites (\>4mm and/or deep sites \>6mm)