cyrilzakka/clinical-trials huggingface dataset:
Multivitamin Support Following Bariatric Surgery

Bariatric surgery (BS), an effective treatment for severe obesity and its comorbidities, may result in micronutrient and vitamin deficiencies. This monocentric prospective observational study aimed at evaluating the efficacy of a specifically designed vitamin/mineral formula (Bariatrifast) for preventing and treating micronutrient deficiencies in patients submitted to BS.

Although BS effectively reduces body weight, improves metabolic alterations, and enhances overall health, it may also lead to micronutrients deficiency. This prospective observational study aimed at evaluating the effectiveness and safety of a specific FSMP (Food For Special Medical Purposes) in maintaining an adequate vitamin and micronutrient intake in patients with obesity submitted to VSG (Vertical Sleeve Gastrectomy) or RYGB (Roux-en-Y gastric bypass) . The included 20 consecutive patients with severe obesity who underwent BS (11 males, 9 females, all aged ≥18 years, with a BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with at least one obesity-related comorbidity, followed for one year after surgery.

Eligibility Criteria:
Inclusion Criteria:

* age \>18yrs
* Written Informed consent done
* Bariatric surgery done

Exclusion Criteria:

* alcool or drugs abuse
* psychiatric illness
* allergy
Activity and Balanced Eating to Reduce Comorbidities and Symptoms of MS

Multiple sclerosis (MS) is the leading cause of irreversible neurological disability among young women and the second leading cause of disability among young men in the U.S. Cardiometabolic risk factors including obesity and hyperlipidemia are common among people with MS, and these risk factors are associated with severity and frequency of MS relapses and disease progression. People with MS often experience symptoms of pain, fatigue, and depression, which make adhering to a healthy lifestyle difficult, as evidenced by the high rates of unhealthy behaviors including poor diet and physical inactivity among this group. Physical activity has reduced symptoms of MS and improved metabolic risk profiles, but little research has focused on the role of a dietary intervention combined with physical activity in this group. Therefore, the purpose of this study is to test the efficacy of a combined diet and physical activity intervention for reducing cardiometabolic risks and MS symptoms when compared to a physical activity intervention alone.


Eligibility Criteria:
Inclusion Criteria:

* Relapsing-Remitting MS
* On disease modifying treatment for 6 months
* No relapse within the previous 30 days
* BMI 25-55 kg/m2
* Self-identify as not currently meeting recommendations for healthy diet and physical activity
* Ambulatory with or without assistance
* Reliable access to the internet via computer or smartphone
* Responsible for their personal food preparation or have input into the food prepared for them
* Score indicating low cognitive functioning on the Telephone Interview for Cognitive Status assessment

Exclusion Criteria:

* Physician does not approve participation
* Use of the following diabetes medications: Acetohexamide, Chlorpropamide (Diabinese), Tolbutamide (Orinase, Tol-Tab), Tolazamide (Tolinase), Glipizide (Glucotrol, Glucotrol XL, Metaglip), Glyburide (Micronase, DiaBeta, Glynase, Glucovance), Glimepiride (Amaryl), Humalog or lispro, Novolog or aspart, Apidra or glulisine, Regular (R) humulin or novolin, Velosulin (for use in the insulin pump), NPH (N), Lente (L), Ultralente (U), Lantus, Levemir or detemir, Humulin 70/30, Novolin 70/30, Novolog 70/30, Humulin 50/50, or Humalog mix 75/25
* Already on a specific diet meant to improve health
* Heart attack, stroke, or heart bypass surgery less than 6 months ago
* Pulmonary disease, cardiovascular disease or renal failure less than 6 months ago
* Smoking
* Cancer, HIV or liver/kidney disease
* Inability to travel to Lakeshore for testing
Evaluation of Quality-of-Life Improvements Using UroShield Device

The goal of this pilot study is to test key elements of the full study that will follow, including recruitment and retention strategies, intervention delivery, laboratory testing, data collection methods, and adherence to study protocol.

The main questions the investigators aim to answer focus on implementation and practicality:

* Recruitment feasibility and time to recruit
* How well do participants adhere to device protocol?
* How often do device components (i.e., actuators and drivers) have to be replaced?
* How much time is required for data collection and what sources or methods for data collection are used?

Results of this pilot study will inform the investigators as to necessary protocol modifications and overall feasibility for the larger randomized clinical trial to follow.

The UroShield® device works by generating ultrasonic waves to interfere with attachment of bacteria inside the catheter, preventing biofilm formation and subsequent infections.

This double-blind pilot study aims to recruit 10-20 patients with urinary catheters (urethral or suprapubic catheters) living in nursing homes (NHs) in Michigan. Patients who consent to participate in the study will be randomized to either the treatment or control group and will have either an active treatment UroShield® device attached or a sham UroShield® device attached to the external tubing of their urinary catheter. Participants will wear the device continuously for a maximum of 90 days. Assessments of pain and quality-of-life will be conducted by study staff over a maximum of 6 study visits, along with clinical data collection via medical record review. A urine sample and catheter sample will also be collected by study staff at each catheter change (approximately every 30 days).

Eligibility Criteria:
Inclusion Criteria:

* Male or female age 18+
* Indwelling urinary catheter (urethral or suprapubic) in place
* Written informed consent (and assent, when applicable) obtained from participant or participant's legal representative
* Able to comply with the requirements of the study

Exclusion Criteria:

* Pregnant or breastfeeding women
* Antibiotic use in past 10 days
* Ineligible catheter type in place (e.g., antimicrobial coated, 3-way catheter, condom catheter, nephrostomy tube, wicking device)
* Participation in another drug or device study in past 30 days
* History of poor compliance to medical treatment regimens
* Conditions that may severely compromise their ability to complete the study
Crossover Trial of AD182 and AD504 in Obstructive Sleep Apnea

This is a randomized, 3-period, placebo-controlled, crossover study to examine the efficacy and safety of AD182 and AD504 versus placebo in patients with obstructive sleep apnea.

The study is designed to examine the efficacy and safety of AD182 to treat obstructive sleep apnea. The study is a three-period single-dose randomized crossover design in which patients will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 3 treatments: AD182, AD504, or Placebo. Participants will return 1 week after their final crossover PSG for an end of study (EOS) Visit.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between 25 and 65 years of age, inclusive, at the time of the screening visit
* AHI 10 to 55 events/h if meets other PSG criteria

Exclusion Criteria:

* History of narcolepsy.
* Clinically significant craniofacial malformation.
* Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. A medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication
* CPAP should not be used for at least 2 weeks prior to first study PSG
* History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.
Development and Testing of an Electronic Behavioral Health Record Specific to the Wraparound Care Coordination Process

The purpose of this Phase II Small Business Technology Transfer (STTR) project is to complete development and evaluate usability and effectiveness of the Wraparound Team Monitoring System (Wrap-TMS), a web-based, electronic behavioral health information system (EBHIS) for the most widely implemented care coordination model in children's behavioral health, the wraparound process. Though wraparound is now considered "evidence-based," implementation in the real world often fails to conform to standards of fidelity and/or use objective data to guide management, supervision, and clinical decision making. Availability of such a system will support efficiency, implementation quality and fidelity, and outcomes for youths enrolled in wraparound. Wrap-TMS features functionality for data entry, management, and basic reporting for the full array of data and information elements needed to manage an integrated care coordination initiative for youths with serious emotional and behavioral disorder (SEBD). In light of our success in Phase I, subsequent partnerships with federal agencies, and inquiries of interest from several states and over 20 provider and managed care organizations, in this Phase II STTR the investigators will complete development of Wrap-TMS, followed by a randomized controlled effectiveness study comparing n=25 wraparound facilitators who use Wrap-TMS serving n=100 families to 25 non-user facilitators serving 100 families on practitioner, implementation, and youth/family outcomes. The evaluation will test two primary hypotheses:

1. Compared to facilitators in the control group, wraparound facilitators trained to use Wrap-TMS will demonstrate (a) greater use of data and feedback in service delivery; (b) greater fidelity to the wraparound process; (c) higher self-reported teamwork, working alliance, and satisfaction with the intervention; and (d) more positive attitudes toward standardized assessment.
2. Compared to the control group, parents of youths receiving services from facilitators trained to use TMS will report (a) greater goal clarity, (b) more data collection and use (c) greater satisfaction with services and progress, (d) better fidelity to wraparound, (e) more effective team functioning, (f) greater treatment alliance, and (f) better youth outcomes including greater progress and improved symptoms and functioning.


Eligibility Criteria:
Inclusion Criteria:

* Parent or legal guardian of a youth aged 6-17 with SEBD (serious emotional and behavioral disorder): at least one MH (mental health) diagnosis that results in long-term (\>6 mos) impairment in home, school and/or community functioning).

Exclusion Criteria:

* Non English speaking parents
* Foster parents
Development of Clinical Database of Individuals With Smith-Magenis Syndrome and Sleep Disturbances

This database will be used to better understand the sleep problems of people with SMS. This clinical database will be a part of a larger Smith-Magenis Patient Registry used to create an awareness campaign around SMS and the sleep disturbances that are characteristic of the disorder.


Eligibility Criteria:
Inclusion Criteria:

* Parent or legal guardian of individual with Smith-Magenis Syndrome

Exclusion Criteria:

* Not legal guardian of individual with SMS
Regulation and Mechanism of New Compound Functional Ingredients in Infants

A prospective, multicentre, randomized, double-blind, parallel control study was conducted to analyze the changes in growth, intestinal flora, and immune function of infants with different feeding patterns from postnatal to 1 year of age.

Breast milk is the most beneficial and safe natural food for the growth and development of infants, but some mothers cannot complete breast feeding.For infants who cannot be breastfed, how to improve the composition of formula milk powder and improve the growth and development of infants is an important issue to be solved urgently in this field.It has been found that new compound functional ingredients oligosaccharides and sialic acid may be beneficial to the healthy growth and development of infants and young children, but the specific mechanism and significance are still unclear due to the lack of systematic research.Known as the "second Brain", the gut is connected to the Brain via the brain-gut-axis.Intestinal microecological status can significantly affect the development of infant nervous system and immune system, and then affect the occurrence of related diseases in adulthood.Oligosaccharides and sialic acid may affect the structure of intestinal microecology, protect the immune function of infants and promote the healthy development of infants.This project is based on the previous studies, using multicenter, prospective, randomized, double-blind, parallel-group trial, discussion of oligosaccharides and sialic acid in infants and young children the intestinal micro ecology and the regulation of immune function and the role mechanism, revealing the oligosaccharides and sialic acid in infants and young children the role of immediate and long-term growth, and the significance of these new type of composite function is added to the dairy ingredients, to research and development more accord with our country new dairy products provide theoretical basis for the healthy growth of infants and young children.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy infants;
2. Full-term (gestational age ≥37 weeks);
3. Birth weight 2500-4500g;
4. Mothers have no history of diabetes, hypertension, heart disease, and other diseases during pregnancy;
5. The guardian signed informed consent and voluntarily enrolled into the group and promised to complete systematic follow-up.

Exclusion Criteria:

1. Hospitalization with cognitive impairment or deformity ≥2 days
2. History of birth asphyxia (Apgar score \< 3)
3. Severe allergy to milk and serious medical conditions such as intracranial hemorrhage, chronic diarrhea, necrotizing colitis, or acute infection
4. The guardian refused to enroll or could not complete the system follow-up.
Study of Transcranial Direct Current Stimulation to Treat Epilepsy

The purpose of this research is to see to what extent electrical stimulation applied to the scalp (transcranial direct current stimulation or tDCS) can reduce the number and intensity of epileptic seizures.

tDCS for treatment of epilepsy has been studied previously with results suggesting that it can lead to a notable seizure reduction for a limited time period after the cessation of stimulation, e.g., about one month. Here, we assess further aspects of tDCS treatment protocols, including the feasibility and safety of at-home use.

Eligibility Criteria:
Inclusion Criteria

* Clinical diagnosis of generalized onset or focal epilepsy or sleep-related epileptic encephalopathy.
* Estimated to have at least 2 countable seizures per month or spike-wave index ≥50%.
* Has not had control with at least 2 anti-seizure medicines.
* Able to maintain a constant medication for duration of the study (rescue meds allowed).
* Subject or legally authorized representative is able to understand consent and keep a seizure diary in English.

Exclusion Criteria:

* A disease likely to progress over course of the study.
* Psychogenic non-epileptic seizures.
* Suicide attempt or psychiatric hospitalization past 2 years.
* A skin condition interfering with scalp electrodes or allergy to silver.
* Women will verify not pregnant, and if applicable, have a serum pregnancy test.
* Implanted devices (e.g. pacemakers)-except VNS, which is allowed.
Using Mobile Devices for Neurofeedback to Reduce Opioid Use in Chronic Pain

The purpose of this study is to develop and test the feasibility of a commercially-ready mobile neurofeedback app for individuals with chronic pain. Thirty (30) participants who are prescribed opioids for chronic pain will use the new mobile neurofeedback app and an EEG headset for 10 minutes at a time, 4 times a week for 12 weeks and provide feedback about using the app.

In this STTR Phase I project, CrossComm will collaborate with Duke University to develop a commercial-ready mobile neurofeedback technology and test its feasibility among patients using opioids to treat chronic pain. Specific Aim 1 is to develop a commercial-ready mobile neurofeedback app and will be built according to commercial standards of robustness and maintainability. Specific Aim 2 is to test feasibility of the commercially available mobile app in N=30 patients with chronic pain prescribed opioids. Participants will be recruited for a baseline interview with the Duke Behavioral Health \& Technology Lab after passing a preliminary telephone screen. After providing informed consent, participants will provide data on demographics, pain symptoms, and opioid consumption. Each participant will download the mobile neurofeedback app to their smartphone and be instructed to use the intervention for 10 minutes a day, 4 times a week for 12 weeks. Study coordinators will conduct four teleconference sessions (weeks 1, 3, 6 and 9) to reinforce training, troubleshoot difficulties, and support intervention utilization. After the 12-week mobile neurofeedback intervention, the investigators will collect follow-up data, including pain measures, mobile app (usage, satisfaction, \& usability), and user feedback on the human-computer interface. Data from these will inform further app refinement preparing for STTR Phase II.

Eligibility Criteria:
Inclusion Criteria:

* Reports chronic pain (≥4 on 0-10 Numeric Rating Scale (NRS) on most days during the past 3 months)
* Prescribed opioids for pain management

Exclusion Criteria:

* History of seizures
* Plans to have pain-related surgery in the next 3 months
* Has an implanted medical device that could experience interference during EEG, such as a spinal cord stimulator or pacemaker
Raltegravir in the Swiss HIV Cohort Study

Since June 2007, raltegravir has been available in Switzerland within a named patient program for patients who have virologic failure, triple class experience and resistance, and no other treatment options. This proposal has been designed to evaluate efficacy and safety data among patients who receive raltegravir within the routine clinical practice in Switzerland and who participate in the Swiss HIV Cohort Study. This is a combined retrospective analysis of patients who already received raltegravir and a prospective part of patients who enter the named patient program and will be followed up in a standardized way. In the prospective part, patients will also be able to receive raltegravir in case of intolerance to their current medication with virologic suppression.

The analysis will primarily use descriptive statistics. In addition, we will assess the duration of virologic response and focus on predictors of HIV RNA suppression during a follow-up of at least 6 months. In the prospective part, we will assess trough plasma levels of raltegravir and other antiretrovirals. In patients who will develop virologic failure, genotypic and phenotypic resistance to raltegravir (and other antiretrovirals) will be performed to characterize the evolution of resistance during the raltegravir-containing regimen.


Eligibility Criteria:
Inclusion Criteria:

* all patients treated with Raltegravir within the Swiss HIV Cohort Study

Exclusion Criteria:

* drop out of the Swiss HIV Cohort study
Self-consciousness in Dementia

The aim of this study is to characterize the deficit in critical components of personal identity (self-consciousness and social cognition) in patients with Alzheimer's disease (AD) and fronto-temporal lobar dementia (FTLD), compared to healthy elderly, combining a neuropsychology and multi-podal neuroimaging study.

We posit that the alteration of some aspects of self-consciousness (autobiographical memory, nosognosia, metacognition) and social cognition (theory of mind and facial) results in personality changes in the patients, primarily due to the alteration of self-consciousness in AD and to social cognition in FTLD.


Eligibility Criteria:
Inclusion Criteria:

* AD (McKhann et al, 1984 and Dubois et al, 2007) or FTLD (Neary et al, 1998 or Rascovsky et al, 2011)
* MMSE \> or = 18
* Relative avaible

Exclusion Criteria:

* Contraindication to MRI
* Major depression
* Other central neurological condition
Evaluation of Mass Balance and Absolute Bioavailability of GLPG3667

This is a study in healthy male volunteers to assess how a new test medicine is taken up and broken down by the body as well as its safety and tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Male between 30 and 64 years of age (extremes included), on the date of signing the informed consent form (ICF).
* A body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive.
* Has a regular daily defecation pattern (i.e. 1 to 3 times per day).
* Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests. Neutrophil, lymphocyte, and platelet counts must be above the lower limit of normal range. Total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be within normal range. Other clinical laboratory safety test results must be within the normal ranges or test results that are outside the normal ranges need to be considered not clinically significant in the opinion of the investigator.

This list only contains the key inclusion criteria.

Exclusion Criteria:

* Known hypersensitivity to GLPG3667 ingredients or history of a significant allergic reaction to GLPG3667 ingredients as determined by the investigator
* Treatment with any medication (including over-the-counter (OTC) and/or prescription medication, COVID-19 vaccines, dietary supplements, nutraceuticals, vitamins and/or herbal supplements), except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) in the last 2 weeks or 5 half-lives of the drug, whichever is longer, prior to the first dosing.
* Subject has participated in a \[14C\]-radiolabeled study within the past 12 months.
* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. Occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017 (UK, 2017), cannot participate in the study.

This list only contains the key exclusion criteria.