cyrilzakka/clinical-trials huggingface dataset:
Using Nicotine to Reverse Age-related Auditory Processing Deficits

The present study will evaluate the effects of both aging and nicotine on psychophysical tasks and electrophysiological measures. Nicotine will be administered to study participants in the form of gum that is available as an over-the-counter medication. The hypothesis is that nicotine will reverse the detrimental effects of aging on auditory processing. The proposed experiments will characterize the effects of nicotine and may eventually lead to improved treatments of hearing loss in a variety of patient populations and in healthy aging.

Study participants will be recruited in two age groups: young (18-28 years) and old (60-85). Each participant will participate in two psychophysical and electrophysiological test sessions. For each of the two sessions, the participant will be administered gum before the test. For one of these sessions, the gum will be polacrilex that contains 6-mg nicotine, and for the other session, the gum will be a placebo control. The study will be double-blind, meaning that neither the experimenter nor the participant will know whether the participant has received nicotine or placebo for a given session. The study has a cross-over design, meaning that all participants will receive both nicotine and placebo in separate sessions. Finally, the order of drug administration will be counterbalanced, meaning that equal numbers of participants will receive 1) nicotine in session one and placebo in session two, and 2) placebo in session one and nicotine in session two.

Eligibility Criteria:
Inclusion Criteria:

* between 18 and 85 years of age
* non-smokers with a score of 0-2 out of 10 maximum on the Fagerström index of smoking dependency
* cognitive performance within two standard deviations of the CERAD mean

Exclusion Criteria:

* less than 18 or greater than 85 years of age
* deafness or excessive hearing loss
* smokers with a score between 3 and 10 on the Fagerström index of smoking dependency
* history of psychiatric illness, neurological disorders, diabetes mellitus, renal failure, or cardiovascular disease
* regular use of prescription medications (excluding oral contraceptives)
* drug dependency
Neurofunctional Correlates of Intentional Actions Towards Food Stimuli

In this project, the investigators will explore the cognitive neuroscience of intentional action in relation to food behaviour. To unravel how the brain systems involved in intentional control of actions and how these interact with the reward system in different physiological conditions and in relation to lean-weight or obesity, the investigators will manipulate the degree of intentionality of the behaviours under examination and the level of satiety of the participants.


Eligibility Criteria:
Inclusion Criteria:

* Normal weight (normal BMI)
* No MRI controindications
* No neurological or cognitive problems

Exclusion Criteria:

* Underweight or overweight
* MRI controindications
* Neurological or cognitive problems
Shared Decision Making in Parents of Children With Head Trauma: Head CT Choice

The investigators will test the impact of a decision aid, Head CT Choice, to determine if its use improves parents' knowledge and engagement in decision making and safely decreases healthcare utilization in children presenting to the emergency department with blunt head trauma.

The investigators' long term goal is to promote evidence-based, patient-centered evaluation in the acute setting, to more closely tailor testing to disease risk. The investigators will compare the use of risk stratification tools with usual clinical approaches to treatment selection or administration through the following aim:

Test if the decision aid, Head CT Choice, improves validated patient-centered outcome measures and safely decreases healthcare utilization. The investigators will randomize at the clinician level. Through the use of the intervention, Head CT Choice, the investigators aim to significantly increase parents' knowledge, engagement, and satisfaction, decrease the rate of head CT use, and decrease 7-day total healthcare utilization, with no significant increase in adverse events.

Eligibility Criteria:
Inclusion Criteria:

Parents and their child, seeking care for a child who:

1. Is \< 18 years of age;
2. Had blunt trauma above the eyebrows (not isolated to face or eyes);
3. Is positive for at least 1 of the PECARN clinical prediction rule predictors described below:

PECARN Predictors for children \< 2 years of age:

Severe mechanism (PECARN definition)\* Loss of consciousness \> 5 seconds Acting abnormally per parent Initial ED GCS \< 15 by attending (or CT decision-maker) Other signs of altered mental status (PECARN definition) Presence of occipital, temporal or parietal scalp hematoma Palpable skull fracture or unclear if skull fracture

PECARN predictors for children 2-18 years of age:

Severe mechanism (PECARN definition)\* Any loss of consciousness Any vomiting since the injury Severe headache in ED Initial ED GCS \< 15 by attending (or CT decision-maker) Other signs of altered mental status (PECARN definition)\*\* Any sign of basilar skull fracture Clinicians include attending physicians and fellows or midlevel providers caring for children with head trauma

Exclusion Criteria:

Parents of children with:

1. GCS scores \< 15
2. Evidence of penetrating trauma, signs of basilar skull fracture, or depressed skull fracture on physical examination
3. Brain tumors
4. Ventricular shunts
5. Bleeding disorder
6. Pre-existing neurological disorders complicating assessment
7. Neuroimaging at an outside hospital before transfer
8. Signs of altered mental status (agitation, somnolence, repetitive questioning, or slow response to verbal communication)
9. Syncope or seizure disorder preceded (led to) head trauma or seizure post head trauma
10. Known to be pregnant
11. Communication barriers such as visual or hearing impairment that may preclude use of the decision aid.
12. Strong suspicion of abuse for this head injury
A Scaleable Video Coaching Intervention for Opioid-using Mothers

This study will adapt and evaluate a novel, innovative, and highly scalable parenting intervention that employs video coaching to target responsive parenting, Filming Interactions to Nurture Development (FIND), among women who have been referred to or are in treatment for opioid misuse/addiction.

The overall objective of this study is to conduct a randomized trial with a sample of opioid-using women who are in or have been referred for treatment through outpatient and inpatient services and have a child aged 0-36 months. We will use a longitudinal design with an active control condition to test the central hypothesis that associations between (a) increases in responsive caregiving and (b) subsequent caregiver opioid addiction recovery, psychological well-being, and child developmental and biobehavioral outcomes (secondary targets), will be partially mediated through (c) changes in caregiver executive functioning, reward responsiveness, and parent self-concept. The rationale for this work is that it simultaneously addresses the unmet needs of a large, significantly underserved population and allows for a rigorous test of our conceptual model, which specifies hypothesized underlying mechanisms and differential impact.

Eligibility Criteria:
Inclusion Criteria:

* Must be an adult (18-50 years of age)
* Must be the biological parent of a child between the ages of 0-48 months of age
* Must have received, or be currently receiving, treatment for a substance use disorder for any DSM-5 class of substance use disorder except caffeine or tobacco. This includes alcohol, cannabis, hallucinogens, inhalants, opioids, sedatives, hypnotics/anxiolytics, and stimulants.
* Must have their child at least two days each week at study entry

Exclusion Criteria:

* Metal implants, metal fragments, pacemakers, or other electronic medical implants
* Claustrophobic
* Weigh \> 550 lbs
* Women who are or think they may be pregnant
* History of neurological disorders
* Left-handed
Case-control Study of Mesh-infection After a Size Tailored Hernia Repair With C-Qur V-Patch

Ventral hernias, such as umbilical, epigastric and trocar-site hernias, are best repaired with abdominal wall reinforcement by mesh implantation. Mesh-devices using a dual-sided mesh technology have been developed for the specific indication of small ventral hernias; this technique is very attractive because the mesh can be introduced through a nearly invisible scar in the umbilicus. The dual layer of the mesh inhibits the formation of adhesions of the viscera to the mesh so, if wanted, it can be positioned in a intraperitoneal position. No literature is available on the adequate size of mesh needed to repair a hernia defect of an umbilical or epigastric hernia. Very small hernias are now often enlarged for repair with a large mesh device. Small hernias might benefit of repair with a small mesh device so no enlargement of the defect is necessary Larger hernias might benefit from a larger mesh size to have more overlap of the mesh beyond the hernia defect. The SITUP-trial was a prospective cohort study who was designed to explore the efficacy of C-QUR V-Patch of different sizes for the different sizes of hernia defects. The study was stopped prematurely because of the perception of an unacceptably high rate of mesh infection. This new study will retrospectively examine the incidence of mesh infection in all ventral hernias repaired with a C-QUR V-Patch. Collection of patient data was done using the Eura-HS registry.


Eligibility Criteria:
Inclusion Criteria:

all adult patients that are planned for surgical repair of a umbilical, epigastric or trocar-site hernia will be considered to enter the study.

Exclusion Criteria:

patients refusing to participate at the follow up visits pregnancy age \< 18 years life expectancy less than 12 months emergency operations liver cirrhosis or ascites cancer patients concomitant surgery other than hernia repair
Study of Carboplatin/Paclitaxel With or Without Investigational Drug (CS-7017) in Subjects With Metastatic Non-small Cell Lung Cancer

The study has a safety and a Phase 2 portion. In the safety portion of the study, subjects with metastatic non-small cell lung cancer will be treated with study drug (CS-7017) in combination with carboplatin and paclitaxel to evaluate safety. In the Phase 2 portion of the study, subjects will receive study drug (CS-7017) or placebo in combination with carboplatin and paclitaxel to evaluate effectiveness and safety. The study will find out if adding CS-7017 to carboplatin and paclitaxel will be safe and improve progression free survival in subjects with metastatic non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed metastatic (stage IV) NSCLC with no significant pleural effusion or pleural involvement from the tumor
* Age greater than or equal to 18 years
* Adequate organ and bone marrow function

Exclusion Criteria:

* Any prior systemic therapy for NSCLC
* Major surgical procedure or other investigational agents within 4 weeks before study enrollment
* Need for concomitant use of other thiazolidinediones during the study
* History of any of the following conditions within 6 months prior to initiating study treatment: Diabetes mellitus requiring treatment with insulin or sulfonylureas or thiazolidinediones (TZDs) agents; Myocardia infarction with significant impairment of cardia function; Malabsorption syndrome, chronic diarrhea, inflammatory bowel disease or partial bowel obstruction;
* Clinically active brain metastases, uncontrolled seizure disorder; spinal cord compression or carcinomatous meningitis
Interest of the Peak of Reticulocytes in Chronic Hemodialysis Patients Treated by Mircera Hemodialysis Population

Patients under hemodialysis treatment are mostly treated by erythropoietin (EPO) through erythropoiesis stimulating agents (ESA). The objective of ESA treatments is to maintain the hemoglobin level in a therapeutic target around 11g/dl. The EPO dose that is necessary to reach this target depends on numerous and imbricated factors such as age, associated pathologies, iron status, inflammation. As of today, there is no marker to predict the EPO response and Hemoglobin (Hb) level is currently the only and late tool to assess the efficacy.

Reticulocytes are immature red blood cells that are temporary present in the blood circulation. They are easily monitored on every automatic dosing machines. Nevertheless, among the dialysis population, they are seldom used and attempt to define a normal reticulocyte level, attesting a correct medullar response to the administrated EPO dose failed due to the timing of blood collection (corresponding to the Nadir day of reticulocytosis).

In a preliminary study, it has shown that reticulocyte count kinetics depends on ESA's type, dose and administration frequency. Reticulocyte kinetics were compared in three groups of stable dialysis patients, depending on their ESA treatment. Reticulocyte curves under a monthly Mircera® treatment were different from the other ESAs, showing a high reticulocyte peak (av. 80 000 reticulocyte/ml) occurring on Day (D)8-D10 after Mircera® administration. On the contrary, at nadir's point (D20-D30 after injection), reticulocyte levels are low for all the patients, preventing from any interpretation of the reticulocyte level at monthly routine assessment. It looks as though it is the peak level of reticulocytes that should be used as a marker of ESA response.

Therefore, monitoring of reticulocytes would support the therapeutic decision on the need to adapt the EPO dose.

The study is design to determinated the interest of the reticulocyte peak in the daily practice

Eligibility Criteria:
Inclusion Criteria:

* Age\> or equal to 18 years
* Patients on hemodialysis or hemodiafiltration for at least 3 months
* Patient treated monthly by Mircera® for at least one month
* Affiliate or enjoying a social security scheme
* Patients who received oral and written information about the study, with no objection to the use of personal data and having signed an informed consent form and written

Exclusion Criteria:

* Patient who refused to give his written consent to the study
* Patients treated with another Erythropoiesis stimulating agent
* Minor
* Pregnant or breastfeeding women
* Major under guardianship
Evaluation of the GORE TAG Thoracic Endoprosthesis in the Treatment of Aneurysms

The purpose of this post-approval study is to evaluate the long-term performance of the GORE TAG® Thoracic Endoprosthesis (TAG device) in the primary treatment of descending thoracic aortic (DTA) aneurysms


Eligibility Criteria:
Inclusion Criteria:

1. Descending thoracic aortic aneurysm deemed to warrant surgical repair:

   1. Fusiform aneurysm greater than or equal to 2 times diameter of normal adjacent aorta
   2. Saccular aneurysm
2. Anatomy meets GORE TAG Thoracic Endoprosthesis specification criteria as indicated in the Instructions for Use (Appendix A)
3. Minimum 2 cm non-aneurysmal segment proximal and distal to the aneurysm

   • \<60 degree angle in the aortic arch may require additional length of non-aneurysmal segment if the arch is included in the treatment segment
4. Life expectancy \> 2 years
5. Surgical Candidate

   * ASA Class I, II, III, or IV
   * NYHA Class I, II, III or no heart disease
6. Male or infertile female
7. Minimum 21 years of age
8. Able to comply with protocol requirements
9. Signed Informed Consent Form

Exclusion Criteria:

1. 4 mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta
2. Significant thrombus at the proximal or distal implantation zones
3. Mycotic aneurysm
4. Hemodynamically unstable aneurysm rupture (non-contained aneurysm rupture)
5. Acute or chronic aortic dissection
6. Planned occlusion of the left carotid or celiac arteries
7. "Planned" concomitant surgical procedure (other than left subclavian transposition) or previous major surgery within 30 days
8. Myocardial infarction or cerebral vascular accident within 6 weeks
9. Severe respiratory insufficiency sufficient that precludes open thoracotomy
10. Renal insufficiency (Creatinine \> 2.0 mg/dL) with or without dialysis
11. Degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
12. Participation in another investigational device or drug study within 1 year
13. Documented history of drug abuse within 6 months
HFNC Vs LFNC in Patients with AF Undergoing RFCA Under Deep Sedation.

Oxygen supplementation through high flow nasal cannula (HFNC) may reduce the incidence of desaturation and hypoxemia during deep sedation at radiofrequency catheter ablation (RFCA procedures).This study is designed to test the hypothesis that the incidence of hypoxemia and desaturation in patients with atrial fibrillation undergoing RFCA under deep sedation, is less when using HFNC as compared to use of standard low flow nasal cannula (LFNC).

Desaturation may occur in patients under deep sedation which results in an elevated risk for perioperative adverse events including hypoxemia (1-3). The incidence of hypoxemia was 168 per 1000 in a general procedural sedation and analgesia population (4). The clinical significance of transient episodes of hypoxemia remains debatable. However, many peri-operative incidents are often short-term and limited in nature, but a number of them are a predictor to a serious complication with a permanent injury (5).This study investigates if high flow nasal cannula (HFNC) as compared to low flow nasal cannula (LFNC) will result in a lower incidence of intra-procedural oxygen desaturation and hypoxemia in patients with atrial fibrillation undergoing deep sedation for radiofrequency catheter ablation (RFCA).

Eligibility Criteria:
Inclusion Criteria:

* Adults undergoing an elective RFCA for atrial fibrillation in the Maastricht UMC Cardiac Catheter Labs under deep sedation administered by a clinician anesthesiology

Exclusion Criteria:

* Age under 18 years
* Body Mass Index (BMI) \> 32 kg/m²
* Diagnosed Sleep Apnoea Syndrome (SAS)
* Chronic Pulmonary Obstructive Disease (COPD) gold IV and COPD gold III with frequent or recent exacerbation
* Diagnosed pulmonary or cardiac condition requiring chronic oxygen therapy
* Complete nasal obstruction
* Active nose bleeding
* Untreated pneumothorax (pre- existing)
* Recent upper airway surgery
* Recent base of skull fracture
* Expected difficult airway
Pierre Robin Sequence Outcome Assessment Multi Institutional Study

The purpose of this prospective, multi-center, longitudinal study is to assess clinical outcomes related to the surgical treatment of PRS ( Pierre Robin Sequence) by MDO (Mandibular distraction osteogenesis). This study aims to develop a scoring system to determine success and complication rate pre and post MDO.

The recruitment phase of this trial is 3 years. Duration of the trial is 19 years.

All study patients who undergo mandibular distraction will be indicated for surgery following published and accepted protocols of care for mandibular distraction in this specific patient population. There will be no experimental/treatment arms in this study. All patients will undergo standard of care interventions and assessments that would not change if the patient were not to participate in this study. The purpose of this study is to follow multiple surgical outcomes following these standard of care practices. The methods and procedures detailed below follow published and accepted standards of care.

Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent/Assent Form
2. All patients with PRS as defined by mandibular hypoplasia, glossoptosis causing airway obstruction, who undergo MDO prior to the age of 6 months, will be included in the study. This will include all infants regardless of syndromic diagnosis, other organ system abnormalities, cleft palate diagnosis or the presence of other concurrent craniofacial anomalies.

Exclusion Criteria:

1. Infants over the age of 6 months
2. patients who undergo mandibular distraction for conditions other than Pierre Robin sequence.
3. Patient who refuse to be included in this study
Investigation on the Effect of Carnitine Supplement on Gut Microbiota and TMAO Production Capacity

In this project, the investigators aim to explore the impact of dietary L-carnitine supplementation on the TMAO production capacity of gut microbiota.

Recent studies have established plasma trimethylamine N-oxide (TMAO) levels as a strong, independent risk factor for cardiovascular disease. TMAO is produced by the interaction between gut microflora and ingested L-carnitine from food. Research indicates that both plasma TMAO concentration and the TMAO production capacity of gut microbiota in vegetarians are significantly lower than in omnivores, likely due to the reduced L-carnitine intake in vegetarian diets. This study aims to explore the impact of L-carnitine supplementation on the TMAO production capacity of human gut microbiota and to identify TMAO-producing bacteria within the gut microflora. The study plans to recruit both omnivore and vegetarian volunteers to undergo a one-month L-carnitine supplementation, followed by an evaluation of changes in TMAO production using an oral L-carnitine challenge test, along with gut microbiota assessment. TMAO concentration will be measured using LC-MS/MS, and gut microbiome analysis will be conducted through shotgun metagenome sequencing. Bioinformatic analysis may reveal potential TMAO-producing bacteria. Understanding the changes in TMAO production and gut microbiota composition post-L-carnitine supplementation may enhance our knowledge of the interplay between L-carnitine supplements, TMAO, and gut microflora.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects aged 20 to 65 years old
* no usage of antibiotics within one month
* no use of carnitine supplement within one month

Exclusion Criteria:

* having serious GI disorder
* medical history of myasthenia gravis
* history of diabetes,
* history of hyperparathyroidism,
* history of chronic kidney disease
* history of epilepsy
* history of severe anemia