cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Probiotic Products for Digestive Health

The objective of this study is to evaluate the efficacy and safety of the probiotic product as an everyday gut health product in supporting digestive environment and homeostasis of gut microbiota.


Eligibility Criteria:
Inclusion Criteria:

1. Male or Female subject age 18-60 years at screening
2. Healthy subject according to investigator judgement based on screening data
3. Subjects must be either of non-childbearing potential, or if of childbearing potential, they must be abstinent or have practiced adequate contraception for the entire study
4. Subjects who have not smoked in the past 1 month prior to screening
5. Subjects with a healthy and balanced diet, including adequate fiber intake in their food consumption
6. Subject or subject's legally acceptable representatives have the ability to comply with the trial protocol
7. Signed informed consent from the subjects or subject's legally acceptable representatives (must be obtained before any trial related activities)

Exclusion Criteria:

1. History of presence of diabetes, immunodeficiency disorders, or chronic illness
2. Regular use of medications known to affect the gastrointestinal system or alter gut microbiota composition, including but not limited to antibiotics, and immunosuppressants
3. Have continuous, daily use of probiotic or probiotic containing products within 1 month prior to randomization
4. Pregnant, planning a pregnancy or lactating female (urinary pregnancy test will be applied to female subjects at screening)
5. Change type of diet during study
6. Any known allergy or intolerance to any of the ingredients in the formulation of the product under study
7. History of drug, alcohol or other substance abuse, or other factors that limit their ability to cooperate during the study
8. History of or presence of eating disorder
9. Subject whose condition does not make them eligible to the study, according to the investigator
The BONES Project: Building Healthy Bones in Children

The Beat Osteoporosis: Nourish and Exercise Skeletons (BONES) Project is an after-school program that includes weight loading physical activity, nutrition and bone health education, and calcium-rich snacks. The program is designed to improve bone health in early elementary school children.

Osteoporosis is a serious public health concern expected to threaten 52 million Americans by the year 2010. This debilitating disease comes at an annual cost of $17 billion. By optimizing bone development during the growing years, individuals can lower their risk of osteoporosis by building an adequate reserve of bone. This study will implement and evaluate an after-school program with exercise, education, and diet components designed to improve bone quality and muscle strength in early elementary school children.

First and second grade children from 84 after school programs in 33 diverse communities throughout Massachusetts and Rhode Island will be enrolled in the study. After-school programs will be randomized to either the BONES Project, to the BONES Project plus a parent/caregiver component, or to a no-intervention control group. The BONES curriculum will be implemented 4 days per week over a 20- to 25-week period; each after-school program will implement the program for 2 years. Participants will be followed for an additional year, assuming they remain in the after-school program or do not withdraw for some other reason. All parents will be asked to complete a Child Medical History survey and a Parent Health Survey at baseline, during the 2-year intervention, and at the end of the follow-up year. Parents in the BONES Project plus parent/caregiver component will receive a newsletter and worksheet 5 times per year.

Participants will be assessed by quantitative ultrasound, height, weight, and body composition measurements, muscular strength, self competence, physical activity level, food knowledge and preference, calcium intake, perceived parental support, and sleep habits.

Eligibility Criteria:
Inclusion Criteria

* Enrolled in participating after-school program
* Live in Massachusetts or Rhode Island
Investigating the Role of ATP Production by Airway Epithelium in Patients with Refractory and Unexplained Chronic Cough (RCC/UCC).

Chronic cough is a common troublesome symptom which has a global prevalence of approximately 10%, but with wide variations across continents. Patients with refractory and unexplained chronic cough (RCC/UCC) often exhibit dysregulated vagal pathways, necessitating a neuronal biomarker for targeted treatment. ATP, involved in the ATP/P2X3 pathway, may serve as a potential biomarker due to its role in the cough reflex. The study aims to discover if ATP production by the airway epithelium is greater in RCC/UCC patients compared with healthy controls, if the epithelium is a source of ATP, whether gene and protein expression related to ATP production differs between these groups and whether ATP release is triggered by mechanical and chemical stimulation. Additionally, the study seeks to determine if biomarker gene expression signatures can differentiate RCC/UCC patients from healthy controls.


Eligibility Criteria:
Inclusion Criteria for RCC/UCC:

* Patients with a history of RCC/UCC.
* Normal Chest X-ray in the last 5 years.
* No Evidence of Airflow Obstruction (FEV1/FVC ratio above LLN)
* Cough Severity VAS ≥ 40 mm at screening.

Inclusion Criteria for Healthy Controls:

* No history of chronic cough, asthma, COPD, or clinical history of bronchiectasis or interstitial lung disease
* No current smokers or those with \&amp;amp;gt;10 pack year history.
* No evidence of airflow obstruction ( FEV1/FVC ratio above LLN).
* Able to understand and give written informed consent.

Exclusion Criteria:

* Participants who are currently established on treatment and their chronic cough is well controlled.
* Unable to perform acceptable and reproducible spirometry.
* Participants with a positive covid-19 test within 2 weeks of screening.
* Current smoker or ex-smoker with ≥20 pack year smoking history and abstinence of ≤6 months
* Symptoms of upper respiratory tract infection in the last 1 month which have not resolved
* Lower respiratory tract infection or pneumonia in the last 1 month
* Asthma exacerbation in the previous month requiring an increase or start of an inhaled corticosteroid (ICS) or oral corticosteroid (OCS)
* Significant other primary pulmonary disorders in particular; pulmonary embolism, pulmonary hypertension, lung cancer, cystic fibrosis, significant radiologically proven emphysema, interstitial lung disease or bronchiectasis.
* History of psychiatric illness, drug or alcohol abuse which may interfere in the participation of the trial.
* Allergy or intolerance to sedation medication including fentanyl and midazolam, or a history of complications during procedural sedation
* Severe coagulopathy, bleeding disorder, or medical need for anti- coagulation that would increase the risk of endobronchial biopsy as determined by the investigator
The PhOCus Trial: Implementation of Pharmacogenomic Testing in Oncology Care

Doctors leading this study hope to find out if giving study participants' genetic information to cancer care providers will help personalize chemotherapy dosing decisions and decrease common chemotherapy side effects. Doctors leading the study will collect genetic information from study participants using pharmacogenomics/genotyping. Pharmacogenomics is the study of how the differences in our genes can affect our unique response to medications.

This is a randomized study, which means that participants in this study will be randomly assigned (as if "by flip of a coin") to one of two different groups: a "pharmacogenomics group" or "control group".


Eligibility Criteria:
Inclusion Criteria Adult patients receiving oncology care at The University of Chicago Medical Center, and for whom treatment with a fluoropyrimidine and/or irinotecan is planned are eligible.

Individuals of all genders, races and ethnic groups are eligible for this trial. There is no bias towards race, sex, or gender in the clinical trial outlined.

Exclusion Criteria

1. Subjects who have previously been exposed to the planned chemotherapy agent at any time (fluoropyrimidine and/or irinotecan).
2. Subjects enrolled in an investigational trial which would preclude dose modifications of fluoropyrimidine and/or irinotecan chemotherapies.
3. Subjects who have undergone, or are being actively considered for, bone marrow, liver or kidney transplantation.
4. Subjects with a history of or active blood cancer (e.g., leukemia).
5. Chronic kidney disease, as defined by glomerular filtration rate (GFR) \< 30/mL/min/1.73m2, due to the risk of decreased drug excretion.
6. Liver dysfunction, as defined by the following laboratory values, due to the risk of decreased drug metabolism: Total bilirubin more than 1.5 mg/dL, aspartate Aminotransferase (AST) and alanine transaminase (ALT) more than 2.5 X upper limit of normal\*. (\*AST and ALT more than 5 X upper limit of normal if hepatic metastases are present).
7. Subjects who have previously or are currently enrolled in another institutional pharmacogenomic genotyping study, or are known to have previously undergone pharmacogenomic genotyping for the gene(s) of interest via another commercial or other means.
8. Inability to understand and give informed consent to participate.
Socio-psychological Factors Involved in the Hematopoietic Stem Cell Transplantation Process in People With Hemopathies

Identify the psychological factors (i.e. personality and transactional factors), beneficial and deleterious, at different phases of the transplant process, on the patient's mental health (quality of life, short and long-term post-transplant recovery) and physical health (e.g. infections, relapse, length of hospitalization or even death).

To reach the research purposes, questionnaires will be given to patients at different times during the transplant process :

1. Pre-admission transplant questionnaire: given and collected by the transplant physician during the pre-graft consultation before entering hospitalization (approximatively 15 days before). To be completed by the patient on site (approximately 45 minutes to complete the questionnaire)
2. Transplant admission questionnaire: given during the first days of hospitalization. To be completed within 6 days and returned to the transplant physician (approximately 30 minutes to complete the questionnaire)
3. Post-transplant follow-up questionnaire: given in consultation at 6 months by the transplant physician (between 30 and 45 minutes to complete the questionnaire in consultation)

The questionnaires include validated and standardized scales.

The first questionnaire contains scales on dispositional factors (i.e. personality factors) . The second one is on the so-called transactional adjustment factors. And the third is on post-transplant factors (e. g. post-traumatic growth). Scales from the first and second questionnaire will be used to obtain a longitudinal view.

The study population concerns all patients going to receive an allograft transplantation, aged over 18 years, who have consented to answer the various questionnaires over a period of approximately 7 months . The participants come from the hematology departments of the Saint-Louis Hospital in Paris, the Estaing University Hospital in Clermont-Ferrand and the Brabois Hospital in Nancy.

Eligibility Criteria:
Inclusion Criteria:

* patient with hematopathy with allograft HSC indication
* allograft protocol
* patient over 18 years of age
* patient who has read and understood the information note and who has consented has not objected to participating in the research
* patient affiliated to a social security system (beneficiary )

Exclusion Criteria:

* patients receiving autograft
* patient under 18 years of age
* patient under guardianship or curatorship
Merci Registry - Real World Use of the Merci Retrieval System in Acute Ischemic Stroke

Post-Market Registry on Use of Merci Retrieval System. Primary data to be collected will include:

* Post-procedure revascularization success
* 90-day mRS 0-2
* 90-day mortality

The Merci Registry is a prospective multicenter registry with up to 3000 patients enrolled at a maximum of 100 sites.

The registry requires use (at least one pass in the intracranial vasculature) of any Merci Retriever device (X Series, L Series, V Series) in the setting of acute ischemic stroke due to large vessel intracranial occlusion.

Eligibility Criteria:
Inclusion Criteria:

* Patient with ischemic stroke is treated with a Merci Retriever that is indicated for thrombus removal in ischemic stroke. "Treated" is defined as being when a Merci Retriever is deployed in the neurovasculature of a patient with an ischemic stroke
* Patient/patient's surrogate provides informed consent and is willing to comply with the protocol requirements and complete required clinical evaluations, or in the absence of informed consent, an IRB/EC approved waiver of consent and executed data use agreement are in place

Exclusion Criteria:

-There are no exclusion criteria for this protocol
A Pilot Study of Prophylactic Management of Lamotrigine in Pregnant Women

Pregnant women who are taking lamotrigine will be evaluated monthly during pregnancy including a clinical evaluation and a blood draw for lamotrigine levels at each visit. Based on the Therapeutic Drug Monitoring protocol, participant's lamotrigine dosing will be adjusted as needed based on participant's blood levels compared to the reference concentration that was obtained prior to pregnancy or early in pregnancy while clinically stable. After delivery participant and participant's infants will be assessed for mood and functioning at 1, 2, 4, and 6 weeks postpartum.

Studies have demonstrated that at least 80% of women who stop mood stabilizing medications for pregnancy relapse psychiatrically. However, relapse is also quite common in women who continue taking mood stabilizing medication with studies demonstrating approximately a 30-37% relapse rate-most with depressive episodes. One likely explanation for the high relapse rate of Bipolar Disorder during pregnancy despite continued mood stabilizing medication is decreasing blood levels of mood stabilizing medications during the course of pregnancy. Pregnancy induces both pharmacokinetic and pharmacodynamic changes, which can result in decreased serum blood levels and decreased treatment efficacy. Therapeutic drug monitoring is considered standard of care for a number of psychiatric medications. Therapeutic drug monitoring can be an especially crucial guide to clinical treatment during pregnancy, but remarkably, there are no established protocols for the monitoring of levels and dosing of psychiatric medications in pregnancy. Most pregnant psychiatric patients are therefore managed based on symptom recurrence. In contrast, there are established protocols for monitoring blood levels and prophylactic management of antiepileptic medications for epilepsy, including lamotrigine which is also a mood stabilizing medication. The investigators will collect pilot data on the psychiatric outcomes, adverse events, and obstetrical and infant outcomes of pregnant women with Bipolar Disorder who undergo prophylactic therapeutic drug monitoring for a commonly used mood stabilizing medication during pregnancy- lamotrigine. In the epilepsy literature, there is a published protocol for lamotrigine management before, during, and after pregnancy for seizure control; the investigators will use this protocol as a guide.

Eligibility Criteria:
Inclusion Criteria:

* pregnant, prior or 20 weeks
* currently taking Lamotrigine and plan to continue throughout pregnancy
* history of Bipolar Disorder, Major Depressive Disorder, Schizoaffective Disorder or other psychiatric illness, currently stable
* may be taking other psychiatric medications

Exclusion Criteria:

* suicidal/clinically unstable
* alcohol, marijuana, or other drug dependence in last 90 days
Effect of Scalp Nerve Block on the Recovery Quality of Parkinson's Patients After Deep Brain Stimulation

Patients diagnosed with Parkinson's disease (PD) undergoing deep Brain Stimulation (DBS) have a higher risk of perioperative complications and postoperative pain will affect quality of recovery (QoR) resulting in longer hospitalization time and higher hospital costs. Scalp nerve block (SNB) combined with intercostal nerve block (ICNB)can alleviate postoperative pain while effect of them on postoperative recovery quality of patients diagnosed with PD was unclear. Therefore, the investigators conducted a randomized controlled trails to provide a novel method for enhanced recovery and early prevention and treatment of acute pain after DBS surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients with PD who receive elective deep brain stimulation (DBS) surgery
* Aged ≥ 18
* American Society of Anesthesiologists (ASA) physical status of I-III
* Able to communicate normally

Exclusion Criteria:

* Allergy to local anesthetics
* Pre-existing infection at block site
* Severe coagulopathy
* Pre-existing neuropathic pain condition
* Previous history of DBS surgery
* unwilling to provide informed consent or poor compliance
Body Versus Machine: Deep Breathing Versus Vagus Stimulation for the Treatment of Fibromyalgia

This randomized controlled trial aims to compare the efficacy of two vagal nerve innervation treatments, motivational nondirective resonance breathing and transcutaneous vagus nerve stimulation, on heart rate variability and pain intensity in patients suffering from CWP. This project tests new and potentially effective means of treating a major global and public health concern where prevalence is high, disability is severe, and treatment options are limited.

The primary objective of this randomized controlled trial is to investigate the effects of motivational nondirective resonance breathing (MNRB) and transcutaneous vagus nerve stimulation (tVNS) on autonomic health and pain intensity in participants diagnosed with chronic widespread pain (CWP). Two versions of MNRB and two versions of tVNS will be delivered and practiced by participants at home for two weeks. The primary outcome is photoplethysmography (PPG) measured heart rate variability (HRV). Secondary outcomes are self report numeric rating scale (NRS) pain intensity, FM pain severity and associated parameters, computerized cuff pressure algometry, blood pressure, psychological distress and health related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Confirmatory diagnosis of chronic widespread pain, including fibromyalgia
* Widespread pain index (WPI) ≥ 7 and symptom severity scale (SSS) score ≥ 5 OR WPI of 4-6 and SSS score ≥ 9
* Generalized pain in at least 4 of 5 body regions must be present
* Pain symptoms have been generally present for at least 3 months
* Average pain intensity ≥ 6 on a 0-10 numerical rating scale, where 0 represents "no pain" and 10 represents the "worst pain imaginable"

Exclusion Criteria:

* History and/or presence of comorbid severe neurological or psychiatric disorders (e.g., mania, psychosis, suicidality, bipolar/schizophrenia/autism spectrum disorders)
* Neurodegenerative disorders (e.g., Parkinson´s, Alzheimer´s, Huntington´s disease)
* Pregnancy or planned pregnancy
* Planned surgery
* Eating disorder (e.g., obesity, anorexia nervosa, etc.)
* Head trauma
* Migraine
* Active heart implants (e.g., pacemaker)
* Active ear implants (e.g., cochlear implant)
* Individuals who have practiced meditation consistently (for more than 20 min/day) within the last 6 months
Stimulating the Cochlear Apex Without Longer Electrodes

The most common cochlear implant intervention provides an electrode array that stimulates less than half of the length of the cochlea, leaving the regions which represent lower frequencies in the normally functioning ear unstimulated. Providing stimulation over the entire cochlea has the potential to improve speech understanding, sound quality, as well as spectral and temporal representation. Increasing the length of the electrode array to cover a greater portion of the cochlea has many potential issues, including increased damage to the cochlea and probability of incomplete insertions. In this study, a new technique is being investigated that allows stimulation across the entire cochlear extent without increasing the length of the electrode array. The purpose of this study is to evaluate the benefit of the new technique on speech understanding outcomes. Additionally, the study will investigate the new configuration to explore how the auditory system encodes temporal and spectral information.


Eligibility Criteria:
Inclusion Criteria:

* Participants in this study must have already been evaluated at the NYU cochlear implant center as being eligible for a cochlear implant.
* They must have decided to receive a cochlear implant manufactured by Cochlear Limited and have been diagnosed with a moderate to profound sensorineural hearing loss in the ear to be implanted.
* Individuals who have already been implanted with a cochlear implant manufactured by Cochlear Limited with or without this new approach may also participate in this study.

Exclusion Criteria:

* They are under the age of 18
* They have not been diagnosed with a moderate to profound sensorineural hearing loss in the ear to be implanted
* Have \>15 years of profound deafness
* Have not chosen to receive a cochlear implant manufactured by Cochlear Limited
* Are pregnant or plan to conceive within 6 months of consenting
HOW DOES HEMODYNAMIC REGULATION AFFECTS GRAFT FUNCTIONS DURING RENAL TRANSPLANTATION?

The aim of the researchers was to evaluate the adequacy of graft function in the postoperative period of patients who underwent renal transplantation and encountered hypotension in the intraoperative period.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing renal transplantation

Exclusion Criteria:

* patient refusal
Multi-level Approach of Brain Activity Using Intracranial Electrodes in Epileptic Patients

The main goal of this project is to study the mechanisms of epileptic activities using intracranial macro and micro electrodes in epileptic patients undergoing pre-surgical investigation.

The recordings will also be used to study physiological mechanisms like sleep and different cognitive functions.


Eligibility Criteria:
Inclusion Criteria:

* Patients with focal drug-resistant epilepsy
* Patients who undergo a presurgical evaluation with intracranial electrodes in the videoEEG unit of the Neurology department at the Pitié-Salpêtrière hospital.
* Patients who have been informed and provided written informed consent to take part in the study

Exclusion Criteria:

* Contraindication for an intracranial investigation (with macro-electrodes) : intercurrent infectious syndrome, decompensated associated pathology (cardiac, pulmonary, renal, hepatic), patient with increased risk of infection (ex: under immunosuppressive therapy)
* Pregnant or parturient woman
* Breastfeeding woman
* Minor person or legally protected adult (tutelage, legal guardianship, maintenance of justice)