cyrilzakka/clinical-trials huggingface dataset:
Individualized Nutrition to Optimize Preterm Infant Growth and Neurodevelopment

Human milk has several well-established benefits but does not adequately meet the increased nutritional demands of the growing preterm infant, necessitating additional nutrient supplementation in a process known as fortification. In U.S. neonatal intensive care units (NICUs), human milk is primarily supplemented using standardized fortification, in which a multicomponent fortifier is added to human milk to achieve assumed nutrient content based on standard milk reference values. However, this method does not account for the significant variability in human milk composition or in preterm infant metabolism, and up to half of all very premature infants experience poor growth and malnutrition using current nutritional practices. Poor postnatal growth has adverse implications for the developing preterm brain and long-term neurodevelopment.

Recent advances allow for individualized methods of human milk fortification, including adjustable and targeted fortification. Adjustable fortification uses laboratory markers of protein metabolism (BUN level) to estimate an infant's protein requirements. In targeted fortification, a milk sample is analyzed to determine its specific macronutrient and energy content, with additional macronutrient supplementation provided as needed to achieve goal values. Emerging data suggest that both methods are safe and effective for improving growth, however information on their comparable efficacy and neurodevelopmental implications are lacking, particularly using advanced quantitative brain MRI (qMRI) techniques.

Through this prospective, randomized-controlled trial, the investigators will compare the impact of individualized human milk fortification on somatic growth and neurodevelopment in preterm infants. Infants will be randomized to receive one of three nutritional interventions: standardized (control group), adjustable, or targeted human milk fortification. Infants will undergo their assigned nutritional intervention until term-equivalent age or discharge home, whichever is achieved first. Brain qMRI will be performed at term-corrected age, and neurodevelopmental follow-up will be performed through 5 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Birth gestational age (GA) of ≤32 weeks
* Postnatal age ≤4 weeks at time of enrollment
* Maternal plan to provide human milk to infant, and consent to providing donor human milk if insufficient maternal milk supply
* Maternal age \> 18 years old

Exclusion Criteria:

* Formula feeding prior to 36 weeks PMA or discharge home (whichever achieved first), either secondary to parental preference or medical necessity
* Dysmorphic features or congenital anomalies suggestive of a genetic syndrome, metabolic disorder, chromosomal abnormality, or congenital infection
* Dysgenetic or major destructive brain lesions detected by head ultrasound before enrollment
The Use of Transcranial Focused Ultrasound for the Treatment of Neurodegenerative Dementias

The purpose of this open label study is to evaluate longer term tolerability and early efficacy of transcranial ultrasound in the treatment of patients with mild cognitive impairment or dementia.

The present study is designed as an open label study of patients with mild cognitive impairment (MCI) or dementia to evaluate longer term tolerability and early efficacy of transcranial ultrasound treatment.

Baseline and outcome measures in this study utilize validated tests that are appropriate for repeated measures which are not affected by practice effects. For patients with amnestic predominant cognitive change, the target will be the mesial temporal lobe through a trans temporal scalp window. Targeting will include reference to scalp fiducials based on the obtained MRI and Transcranial Doppler (TCD) waveform confirmation will be obtained because of the ability of TCD to record Doppler signal from the posterior cerebral artery that runs medial to the mesial temporal lobe.

On the day of the ultrasound appointment, patients will undergo ten to thirty minutes of transcranial ultrasound treatment. The sonification device will be aimed at the hippocampus or the putamen and substantia nigra, depending on the predetermined condition. Targeting will include reference to scalp fiducials based on the obtained MRI; confirmation of target accuracy will either be obtained by Doppler waveform confirmation or optical tracking technology which co-registers patient neuroimaging with real space. Patients will undergo 8 total sessions of focused ultrasound. Patients will be evaluated at baseline and upon final ultrasound treatment using the same measures obtained upon entry. Safety and any adverse events will be monitored closely.

Eligibility Criteria:
Inclusion Criteria:

* CDR stage of at least 0.5 (mild cognitive impairment)
* At least one pathognomic imaging biomarker of a neurodegenerative process.

Exclusion Criteria:

* Cognitive decline clearly related to an acute illness
* Subjects unable to give informed consent
* Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)
* Advanced terminal illness
* Advanced kidney, pulmonary, cardiac or liver failure
* Subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep
* Subjects with major depressive disorder
* Subjects with vascular causes of dementia
Study of Pulse Pressure During Tilttable and Erigo® in Adult Patients With Acquired Brain Injury

The purpose of this study is to determine if the pulse pressure changes are different whether patients are training in a traditional tilt table as compared to a robotic assisted tilt table, which induces leg movement.

The trial takes place in a non private hospital in Denmark. Patients are recruited from two wards treating patients with severe brain injury, and all patients admitted in the study period are considered in regards to inclusion or exclusion. Patients are included via closest relatives accept, and the patients GP(General Practitioner). Any adverse effect or event will be reported to the local ethics committee. All data will be collected simultaneously with the interventions. Some data will be directly recorded via monitor output, and some data will be directly inputted in Epidata, while trial takes place.

Sample size has been calculated to be between 10 and 60 individuals depending on the actual difference. Beyond 60 included individuals the clinical relevance of a statistical significant result is no longer apparent. If any individual variables are noncomplete, an analysis of the subjects with missing data, will be undertaken.

The statistical analyses planned follows the general crossover design using an approach considering 2 treatment and 2 periods. Patients are cluster randomized in clusters of 4, to be treated with one or the other intervention first.

Intervention A:

Traditional tilt table. measurements at 0 degrees 30 deg. 60. deg. and at return to 0 deg.

Intervention B:

Erigo® tilttable, with measurements as in intervention A. During the intervention the step frequency of the Erigo® i set at 48 steps/min.

Between the two periods a wash out period of at least ½ hour and maximum 2 hours are planned.

Primary outcome is derived from noninvasive BP measurements.

Eligibility Criteria:
Inclusion Criteria:

* Already being treated with traditional tilttable and must be able to benefit from Erigo® treatment from a clinicians view
* Acquired brain injury as primary diagnose
* Must have Rancho Los Amigo Scale score of minimum 1 to maximum 6 on the day of inclusion

Exclusion Criteria:

* Not on mechanical ventilation
* New cerebral, cardiological or other medical problems/emergencies between the 2 interventions
* Change in cardiac medications between interventions
* Patient must not have independent gait function immediately before trial
* must not have EFA(Early Functional abilities) part score \> 4 in the section "Standing", assessed by the treating physiotherapist.
The IBD&me Randomized Controlled Trial

Navigating the risk-benefit profiles of the various biologic options approved for inflammatory bowel disease (IBD) can be challenging for patients who are considering biologic therapies as a treatment option. Thus, there is a need for simple and efficient tools that elicit individual preferences and support the patient-provider interaction.

The principal objective of this study is to assess the impact of an online decision aid called IBD\&me on patient perceptions of shared-decision making as compared to a standardized education arm.

Context: Navigating the risk-benefit profiles of the various biologic options approved for inflammatory bowel disease (IBD) can be challenging for patients who are considering biologic therapies as a treatment option. Thus, there is a need for simple and efficient tools that elicit individual preferences and support the patient-provider interaction.

Objective: The principal objective of this study is to assess the impact of an online decision aid called IBD\&me on patient perceptions of shared-decision making as compared to a standardized education arm.

Hypothesis: IBD\&me, through optimizing shared-decision making (SDM) and improving the patient-provider interaction, will provide incremental benefits beyond those provided by high-quality educational material without an SDM tool.

Design: Pragmatic multicenter randomized controlled trial in IBD outpatient care

1. Intervention: IBD\&me is an online, freely available tool that allows patients to explore decision-making around biologic therapies for IBD at their own pace
2. Control arm: Standardized, high-quality educational material from the Crohn's \& Colitis Foundation

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Have ulcerative colitis (UC), Crohn's disease (CD), indeterminate colitis, or inflammatory bowel disease unclassified (IBD-U)
* Have experienced IBD related symptoms in the 30 days before screening
* Considering discussing biologic therapies for controlling his or her IBD at the next clinic visit
* Have an IBD-related visit scheduled at least 7 days and no later than 3 months following screening

Exclusion Criteria:

* Does not speak English
* Does not have access to the Internet
Sibutramine Versus Continuous Positive Airway Pressure (CPAP)in Obstructive Sleep Apnea (OSA) Patients

The primary objective of this study is to observe if Sibutramine is effective in improving the symptoms and signs of sleep apnea in obese patients. The secondary objectives are to document the effects of Sibutramine on heart rate variability and 24-h arterial pressure values. We hypothesized that sibutramine will improve sleep disordered breathing, cardiac autonomic function and systemic blood pressure in obese patients with obstructive sleep apnea (OSA).


Eligibility Criteria:
Inclusion Criteria:

* Eligible participants with non-treated OSA syndrome were aged between 18 to 65 years, with a body-mass index (BMI) ≥ 30 kg/m2 or ≥ 27 kg/m2 in the presence of other risk factors such as controlled systemic hypertension, type 2 diabetes, dyslipidemia and/or visceral obesity (as defined by a waist circumference ≥ 102 cm in men and ≥ 88 cm in women).

Exclusion Criteria:

* Exclusion criteria were uncontrolled systemic hypertension defined as blood pressure \> 145/90 mm Hg, previous pharmacological or surgical treatment for weight loss, had already used CPAP or had severe diurnal hyper somnolence requiring immediate treatment.
Effect of Systemic Antibiotic Therapy on Postoperative Complications in Patients Undergoing Wisdom Teeth Removal Surgery.

59 medically healthy patients, who are scheduled for third molar extraction surgery and give informed consent for the trial, are operated using a split-mouth technique.

One group of patients will be assigned to the test group (Amoxilan) for the first surgery and to the control group (placebo) for the second surgery, and vice versa, according to randomisation.

Patients receive 8 capsules Amoxilan or placebo (according to randomisation) perioperatively, and 6 capsules Amoxilan/placebo per day for 3 days postoperativeley.


Eligibility Criteria:
Inclusion Criteria:

* Symptom-free, bilaterally located third molars
* Medically healthy patient ≥ 16 years
* No allergies/intolerances against the investigational product/placebo
* Informed consent

Exclusion Criteria:

* General contraindications to wisdom tooth extraction surgery
* (Former) heavy smoking
* Use of antibiotics within the last three months or patients requiring antibiotic treatment prior to surgery
* (Planned) Pregnancy/lactating
The "Great Live and Move Challenge" Among Children Aged 7-11 Years

The Great Live and Move Challenge (GLMC) study is a 2-year cluster-randomized controlled trial designed to evaluate a multilevel and theory-based intervention to promote PA practice in children aged 7-11 years from French primary schools.

Recent population-based surveys have reported that a large majority of children were not active enough to meet the physical activity (PA) international guidelines in France, Europe and in the US. Therefore, there is a need to find efficient programs to improve PA habits in children from early age. The Great Live and Move Challenge (GLMC) study is a 2-year cluster-randomized controlled trial designed to evaluate a multilevel and theory-based intervention to promote PA practice in children aged 7-11 years from French primary schools. The aim of this paper is to describe the GLMC study protocol. The primary hypothesis is that the GLMC intervention will increase by 15% the proportion of children meeting the World Health Organization recommendations of 60 minutes/day of moderate to vigorous PA. Study recruitment goal is 5000 children . The GLMC is implemented on children and their parents and involves multiple local grass-roots partners, such as school teachers and municipal officials, as well as policy stakeholders. The Theory of Planned Behavior (TPB) constitutes the foundations of the intervention conception. The total duration of the intervention is 3.5 months each year, for two years. Children and parents are evaluated at pre- and post-intervention every year regarding PA practice (self-reported and objectively measured in a subsample of 400 children), TPB variables (i.e., intentions, attitudes, subjective norms, perceived behavioral control) and other psychosocial variables (e.g., perceptions of active opportunities). This study will evaluate the effectiveness of a multilevel and theory-based primary school PA program and potentially provide valuable information for schools and public health policers looking for innovative PA programs.

Eligibility Criteria:
Inclusion Criteria:

* All the children (and their parents) schooled in a primary school (year 3 or year 4) from Hérault, Gard, and Aude French departments

Exclusion Criteria:

* none
Single Dose Study of N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery

To evaluate the safety and efficacy of single IV doses of N1539 after dental impaction surgery.

This is a randomized, double-blind, placebo-controlled, single center study in subjects who have undergone third molar extraction surgery. Eligible subjects will have surgical removal of \>2 third molars, of which at least 1 must be a complete or partial mandibular impaction. Each subject's study participation will consist of a screening visit (1-21 days prior to surgery), an inpatient evaluation period of 24 hours following dosing, and a follow-up phone call 3-5 days postdose.

Eligibility Criteria:
Inclusion Criteria:

* surgical extraction of \> 2 third molars with at least 1 complete or partial mandibular bony extraction

Exclusion Criteria:

* allergic response to aspirin, NSAIDs, acetaminophen or hydrocodone
* use of aspirin or other analgesics within 48 hours prior to surgery
* current or recent history of drug or alcohol abuse
* any medication for treatment of chronic pain
* clinically significant abnormality on screening laboratory test active or recent history of peptic ulcer disease or GI bleeding
* prior abdominal surgery, except uncomplicated appendectomy
* any other surgical procedure within 30 days before administration of study drug
* pregnancy or breastfeeding
* untreated hypertension; SBP \> 140 mmHg or DBP \> 95 mmHg
The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Two-Week Treatment Period

The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus placebo over a two-week treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Have best corrected visual acuity in both eyes of at least +0.7 or better
* If female, are non-pregnant or non-lactating
* Have a current diagnosis of blepharitis in one or both eyes

Exclusion Criteria:

* Have lid structural abnormalities
* Have suspected ocular fungal or viral infection
* Have practiced warm compress therapy within 14 days prior to Visit 2
* Unable to withhold the use of contact lenses during the treatment or follow-up periods
* Unable to withhold the use of ocular cosmetic products within 24 hours prior to study visits
* Have had penetrating intraocular surgery within 90 days prior to Visit 2
* Have had ocular surface surgery within the past year prior to Visit 2
* Have a serious medical condition which could confound study assessments
The Utility of Timed Segmental Withdrawal During Screening Colonoscopy

The purpose of colonoscopy (colon examination with flexible tube and a camera) is to find early precancerous growth in the colon (polyps) and remove them before they turn into cancer. The doctor performing the procedure will first advance the colonoscope to the end of the colon (cecum) and then he will examine the colon for polyps while he is withdrawing the colonoscope. The period of time that the doctor spent examining the colon called "withdrawal time". Usually doctors will spend at least 6 minutes examining the colon after he reached the cecum. The investigators are proposing that dedicating half of the withdrawal time during colonoscopy in examining the right side of the colon, will increase the detection of polyps in the right side of the colon.

Research design: This is a prospective, randomized trial comparing the ADR between patients undergoing a screening colonoscopy in four different groups: 1) at least 3 minutes from the total withdrawal time dedicated to the right side of the colon, 2) at least 4 minutes from the total withdrawal time dedicated to the right side of the colon, 3) 6 minutes total withdrawal time regardless of time spent in any segment, 4) 8 minutes total withdrawal time regardless of the time spent in any segment. Randomization will be done in blocks after stratification. Four gastroenterologists and two fellows matched base on similar ADR and stratified on each arm of the study (segmental versus non-segmental withdrawal) will be performing the procedures. The estimated sample size of the four arms of the study is 400 patients.

Eligibility Criteria:
Inclusion Criteria:

* adults undergoing colonoscopy for screening or surveillance purposes

Exclusion Criteria:

* prior history of colonic surgeries
* Crohn's colitis or ulcerative colitis
* prior history of colon cancer
* poor bowel preparation
* pregnancy
Opioid Reduction Program for Total Knee Replacement Patients

In the context of prescribed opioids, research suggests that increased exposure is associated with long-term opioid use. Orthopedic surgeries are associated with the prescribing of more opioid narcotics than any other surgical specialty, particularly for Total Knee Replacement surgery, which is associated with severe post-operative pain. The proposed project is a randomized clinical trial to explore the efficacy of our Total Knee Replacement Opioid Reduction Program (ORP) vs. Treatment As Usual (TAU) in the reduction of opioid use following total knee replacement surgery.

The purpose of the study is to build upon our existing research to: (1) explore the efficacy of a disseminable Opioid Reduction Program (ORP) to reduce long-term use of prescribed opioids following TKR surgery, (2) assess whether lower opioid use following surgery is related to better functional recovery, and (3) model opioid use trajectories following TKR surgery (i.e., MMEs/week for 12 weeks), which will allow us to examine the factors that characterize at-risk groups.

There will be one control arm (Treatment as Usual or TAU) and one experimental arm (Opioid Reduction Program or ORP). The experimental arm will receive the intervention material twice. The first session is pre-surgery, and the second session is a shortened "booster" session approximately 2-weeks post-op.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older.
* Presenting for a total knee replacement (TKR) surgery at Campbell Clinic which will result in an opioid prescription.
* Access to a telephone.
* Able to consent in English.

Exclusion Criteria:

* Under the age of 18.
* Contraindications to use of opioid medication.
* No access to a telephone.
* Unable to understand consent materials in English.
Analysis of Volatile Organic Compounds in the Exhaled Air in Inflammatory Bowel Disease

The availability of noninvasive biomarkers for diagnosis and stratification of inflammatory bowel disease (IBD) courses is lacking. Thus, the aim of this study is to evaluated the accuracy of exhaled breath volatile metabolite analysis on diagnosis and stratification of patients with inflammatory bowel disease.

Background: The diagnosis and differentiation of inflammatory bowel diseases (IBD) is challenging due to the absence of a gold standard diagnostic modality for confirmation. Exhaled breath volatile metabolite analysis focusing on diagnosis and differentiation of IBD is a promising approach. Thus, the aim of this study is to evaluated the accuracy of exhaled breath volatile metabolite analysis for patients with inflammatory bowel disease.

Method: A single center, prospective study of diagnostic testing will be conducted, recruiting crohn's disease (CD), ulcerative colitis (UC), and healthy controls (HC). The exhaled breath volatile metabolite will be analyzed using gas chromatography/mass spectrometry (GC-MS). The informations of patient's disease location, disease activity, laboratory parameters and current medications will be collected to determine the feasibility of exhaled breath volatile metabolite analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis)
* Healthy controls who do not have any gastrointestinal disease or symptom

Exclusion Criteria:

* Pregnant or lactating woman
* Subjects who diagnosed liver cirrhosis, severe congestive heart failure, severe renal insufficiency, uncontrolled hypertension, endocrine disorder, metabolic disorder, prior malignancy, immune deficiency
* Subjects with mental retardation and cognitive impairment