cyrilzakka/clinical-trials huggingface dataset:
Effect of Prebiotic and PUFA on the Gut Microbiota and Metabolic Risk Markers

The main objective of this study is to investigate in detail how a high-(prebiotic)fibre diet and a high-PUFA diet affect the gut microbiota composition in a metabolic challenged population, and if the diet-induced modulation of the gut microbiota mediates changes in metabolic risk markers.

Intake of both experimental diets over 4 weeks are expected to induce beneficial changes in the gut microbiota composition and to affect markers for insulin sensitivity, lipid metabolism and inflammation. The investigators hypothesize that the effect of both interventions on the metabolic risk markers will be partly mediated by the diet-induced changes in the gut microbiota composition.


Eligibility Criteria:
Inclusion Criteria:

* BMI: 25-40 kg/m2
* Non-smoking
* Indices of the Metabolic Syndrome defined by the International Diabetes Federation (IDF 2006):

Central obesity (waist circumference; men: ≥94 cm and women: ≥80 cm) + any one of the following; raised triglyceride level (≥1.7 mmol/L), reduced HDL cholesterol (men: \<1.03 mmol/L, women: \<1.29 mmol/L), raised BP (systolic ≥130 mm Hg or diastolic ≥85 mm Hg) or raised fasting plasma glucose (≥5.6 mmol/L).

Exclusion Criteria:

* Use of antibiotics
* Weight change \>3 kg 2 months prior to study start
* Intensive physical training/ elite athlete
* Medication for dyslipidemia, type 2 diabetes or elevated blood pressure
* Dietary supplements with pro/prebiotics, dietary fibre or fish oil supplement
* Lactation, pregnancy or planning of pregnancy during the study
* Gastro intestinal and liver disorders
* Chronic inflammatory disorders
* Diagnosed psychiatric disorder including treatment required depression
* Surgical treatment of obesity and abdominal surgery
tDCS to Decrease Opioid Relapse (UH3)

Investigators will measure behavioral and brain responses following transcranial direct current stimulation (tDCS) to the dorsolateral prefrontal cortex (DLPFC) (anode on right DLPFC, cathode on the left DLPFC) delivered during cognitive control network (CCN) priming. In Phase I, the EEG provided validation of expected changes in these networks following tDCS stimulation of the DLPFC. In this current phase (II), the investigators will perform a larger randomized clinical trial (RCT) (active vs. sham control) to address long-term neurobehavioral outcomes, including opioid relapse, craving, and sustained EEG changes.

Investigators will perform an RCT in 100 opioid dependent participants who recently initiated buprenorphine or methadone. Participants will be randomized to receive five sessions of tDCS+CCN priming stimulation vs. sham tDCS+CCN priming. Participants will be assessed three times using electroencephalographic (EEG), once prior to tDCS+CCN priming, right after the completion of 5 sessions of tDCS+CCN priming (one week later), and again 10 weeks later.

This phase will address long-term (3- and 6-month) neurobehavioral outcomes, including opioid relapse, craving, and sustained EEG changes during a paradigm that challenges networks associated with craving (CR) and cognitive control (CCN). During the 24 weeks of buprenorphine or methadone maintenance treatment, the investigators will examine our primary clinical outcome, relapse (opioid use on \>4 days per month and having an opioid positive urine screen), as well as days of opioid use.

Eligibility Criteria:
Inclusion Criteria:

1. current opioid dependence
2. between 21-60 years of age
3. recent initiation of buprenorphine or methadone (≤30days)
4. enrolled in Butler Hospital's Alcohol and Drug Inpatient Unit, Alcohol and Drug Partial Hospital Treatment Program, Intensive Outpatient Services, or Outpatient Services at Butler Hospital OR receive opioid-treatment services in the community.

Exclusion Criteria:

1. current diagnosis of organic brain disorder (e.g., Parkinson's disease, Huntington's disease, multiple sclerosis, intracranial mass/infection, hydrocephalus)
2. bipolar, schizophrenia, schizoaffective, or schizophreniform disorder, or current psychosis associated with any disorder
3. current suicidality
4. evidence of significant neurocognitive dysfunction
5. conditions associated with heightened tDCS risks, e.g., seizure disorder, nonremovable intracranial metal objects (other than dental fillings and dental implants), skin disease or active lesions on the scalp, migraine/other headache disorder with significant active symptoms, traumatic brain injury or skull fracture within the past year, any implanted medical devices or device components that can interact with electromagnetic fields or are controlled by physiological signals
6. probation/parole requirements or an upcoming move that might interfere with protocol participation
7. planning to terminate buprenorphine or methadone in less than 3 months
8. current pregnancy or plan to become pregnant in the next month.
Enhancing Knowledge Translation in Nutrition Through a Healthy Eating Blog

The purpose of this study is to evaluate the effects of an evidence-based healthy eating blog on dietary behaviors of mothers

Mothers randomised to the experimental group were exposed to one weekly blog post for 6 months. Blog posts focus on the improvement of dairy products as well as vegetables and fruits consumption targeting five food skills categories: (1) knowledge about food, nutrition and cooking; (2) planning of healthy meals, and for including children to develop their food skills; (3) conceptualizing outcomes; (4) mechanical techniques for food preparation; (5) perception of food characteristics. Each post included a step-by-step recipe developed by the research team and featuring dairy products, vegetables and fruits. Recipes were described textually and also using pictures. Twenty-six posts were created over the six-month intervention. Participants randomised to the control group were not exposed to the healthy eating blog. The primary outcome is the daily intakes of dairy products, vegetables and fruits. The secondary outcomes are mothers' food skills and body weight.

Eligibility Criteria:
Inclusion Criteria:

* Have Internet access, have at least one child aged two to twelve years, are mostly in charge of the planning and preparation of family meals, consume less than two servings a day of dairy products and/or less than seven servings a day of vegetables and fruits.

Exclusion Criteria:

* Take medications that could affect food intake, have eating disorders, are dieting, are currently pregnant or lactating.
Characterizing the Use of Ofatumumab in a Real World Setting

This is a non-interventional primary use of data study utilizing de-identified patient-level onboarding and adherence data managed through the MSGo patient support service platform and includes a sub-study to explore the impact of ofatumumab on relevant patient reported outcomes (PROs) with respect to clinical outcomes.

This study will be run in two parts. Part I will operate as a Secondary Use of Data study and Part II will operate as a Non-Interventional primary use of data study.

Part I: This study is descriptive in nature without any key underlying hypothesis and will explore the onboarding and adherence of RMS patients in Australia to ofatumumab treatment. De-identified patient-level onboarding and adherence data will be primarily generated and managed through the MSGo platform which will function as a Patient Support Service.

Part II: This part of the study will operate as a non-interventional primary use of data study and will explore the impact of ofatumumab on relevant patient reported outcomes (PROs) with respect to clinical outcomes. This part of the study will only be conducted at a selection of participating clinics. Patients in this part of the study will also have data collected as part of Part I of the study.

The data for the PROs will be collected through a mobile based application .

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with relapsing forms of multiple sclerosis (RMS) to delay the progression of physical disability and reduce the frequency of relapse
* Expanded Disability Status Scale (EDSS) of 5.5 or lower (aligned with the plannedKEP criteria). Patients accessing ofatumumab through the PBS would have to meet the finalised restriction criteria (to be confirmed).
* Patients will provide consent to participate in Part I of the study through the MSGo experience program or patient support program onboarding process.
* Patients will need to provide additional consent to participate in Part II sub-study.

Exclusion Criteria:

* Patients diagnosed with Primary Progressive MS or Secondary Progressive MS without disease activity in line with the Australian Product Information\].
Single or Combined Protocols for NV-AMD

The present interventional study represents a Research Program for the Clinical Governance supported by supported by the Healthcare Fund of the Emilia-Romagna Region. It aims to evaluate, after 12 months of monitoring, clinical safety, therapeutic efficacy, number of intra-vitreous injections of bevacizumab (IVIB), compliance and quality of life correlated to the vision by comparing the data obtained in two groups of patients (group A and group B), affected by neovascular age-related macular degeneration (NV-AMD) never previously treated or already undergoing pro-re-nata (PRN) treatments with biological drugs inhibiting vascular endothelial growth factor (Vascular Endothelial Growth Factor, VEGF), i.e. anti-VEGF drugs. Participating patients are randomized to the following therapeutic regimens: i. group A, a single intra-vitreous injection of bevacizumab PRN repeated after monthly periodic monitoring of the patient (IVIBx1 regimen); ii. group B, two combined intra-vitreous injections of bevacizumab, spaced 30 ± 10 days apart and repeated as-needed after periodic monitoring of the patient (IVIBx2 regimen). Within the aforementioned regimens, the re-treatment (single or combined in patients undergoing IVIBx1 or IVIBx2, respectively) is performed when signs of persistent neovascular activity is present. The present trial consists of a randomized controlled open-label study with parallel arms to evaluate the non-inferiority of clinical safety and therapeutic efficacy of the IVIBx1 regimen compared to the IVIBx2 regimen (1: 1 allocation) administered in patients with NV-AMD. The number and type of tests, as well as the number of intra-vitreous injections of anti-VEGF drug performed in patients treated with the PRN regimens IVIBx1 or IVIBx2 do not differ from those performed during normal clinical practice at the Eye Clinic of the University Hospital of Ferrara. The intra-vitreous administration of bevacizumab is performed in accordance with the guidelines of the Italian Ophthalmology Society.


Eligibility Criteria:
Inclusion Criteria:

* age \> 50 years
* ability to comply with study procedures
* active NV-AMD in either treatment-naïve or previously treated patients
* BCVA \> 20/200 in the study eye

Exclusion Criteria:

* any other possible cause of choroidal neovascularization other than AMD
* ocular media opacities or other causes counteracting data collection
* presence or onset of contraindications to the use of bevacizumab
Long-term Paired Associative Stimulation as a Treatment for Incomplete Spinal Cord Injury of Non-traumatic Origin

The investigators have recently shown in incomplete SCI patients that long-term paired associative stimulation is capable of restoring voluntary control over some paralyzed muscles and enhancing motor output in the weak muscles (1). In this study, the investigators will administer long-term paired associative stimulation to patients with incomplete SCI of non-traumatic origin.


Eligibility Criteria:
Inclusion Criteria:

* incomplete SCI of non-traumatic origin

Exclusion Criteria:

* epilepsy
* metal inclusion in the head area
* pacemaker
* hearing device
* high intracranial pressure
Evaluation of L-alpha-acetylmethadol (LAAM) in Methadone Patients - 5

The purpose of this study is to determine the pharmacokinetics of L-alpha-acetylmethadol (LAAM) in adults transferred from methadone maintenance treatment for opiate dependence.


Eligibility Criteria:
Please contact site for information.
Comprehensive Oral Care Long-term Care Facilities

Oral care is a common way of caring for long-term care facility residents, particularly for those with swallowing difficulties, as oral health is closely related to eating function. Oral care includes general oral hygiene and comprehensive oral care (including cleaning, facial massage, oral muscle massage and stretching, and oral moisturizing). Regular oral care can reduce oral diseases, improve oral mucosa, increase appetite, and improve eating function. However, it is still unclear whether comprehensive oral care can improve eating function and aid in removing nasogastric tubes. Therefore, this study plans to recruit residents with dysphagia from multiple long-term care facilities nationwide to investigate the impact of comprehensive oral care on nasogastric tube removal. The study will collect basic information, disease diagnosis, and onset time and use random grouping to investigate the effects of general oral hygiene and oral care on nasogastric tube removal. The results of this study can provide guidance for clinical practitioners and researchers on oral care and eating function improvement for long-term care facility residents.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older, with swallowing disorders classified as grades 1-3 on the Functional Oral Intake Scale (FOIS).
* Conscious and alert.
* Able to follow simple one-step commands (e.g., raising a hand, opening the mouth).
* Able to maintain a seated position for more than 15 minutes.
* Has a swallowing reflex (able to swallow saliva on command).

Exclusion Criteria:

* Acute infection.
* Hypoxemia (SaO2 \< 90%) or requiring the use of a ventilator.
* Structural abnormalities of the oropharyngeal area that prevent oral feeding.
* Failing the water swallow test (coughing or wet voice in two or more out of three attempts, or no significant laryngeal elevation).
Insulin by Jet-injection for Hyperglycemia in Diabetes

The purpose of this study is to compare the pharmacokinetic and pharmacodynamic profile of the rapid-acting insulin analogue aspart (Novorapid®) injected subcutaneously by jet-injection to that of the same insulin injected with a conventional pen in the management of hyperglycemia in subjects with diabetes

Recently, we showed in both healthy, non-diabetic volunteers and in patients with type 1 (T1DM) and insulin-treated type 2 diabetes (T2DM) a 40-50% faster absorption of rapid-acting insulin analogues when administered by jet injection technology rather than by conventional insulin pen. The faster insulin action of insulin administration by jet injection may be especially advantageous for correction of hyperglycemia.

To investigate this, a open-label randomised controlled cross-over study will be performed in 20 adult patients (18-75 years) with T1DM or T2DM on basal-bolus insulin treatment.

The pharmacokinetic and pharmacodynamic profile of insulin aspart will be derived from the time-action profiles of insulin and glucose, respectively, in response to insulin (in a dose of 1.5 times the amount of insulin needed to reduce blood glucose to 6 mmol/l calculated by the insulin-sensitivity factor) after reaching hyperglycemia (18-23 mmol/l). All patients will be investigated twice, where on one occasion the jet-injector device will be used to inject insulin, and on the other occasion insulin will be injected with a conventional insulin pen. The order of these occasions will be randomised. Both devices will be operated by the patient after sufficient training. Ease of use will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* diabetes mellitus type 1 or 2
* Age 18-75 years
* Body-Mass Index ≥25 kg/m2 and ≤40 kg/m2
* Stable glycaemic control with HbA1c ≥48 (6.5%) and ≤86 mmol/mol (10%)
* Insulin treatment according to basal-bolus regimen, i.e. by multiple daily injections at least four times daily, or by subcutaneous insulin pump, for at least 12 months, use of metformin allowed

Exclusion Criteria:

* Inability to provide informed consent
* Insulin requirement of \<34 or \>200 units per day
* Treatment with systemic corticosteroids, immunosuppressive or cytostatic drugs
* Known allergy to aspart insulin
* Use of oral antidiabetic drugs other than metformin
* Symptomatic diabetic neuropathy
* History of a major cardiovascular disease event (myocardial infarction, stroke, symptomatic peripheral artery disease, coronary bypass surgery, percutaneous coronary or peripheral artery angioplasty) in the previous 6 months
* Pregnancy or the intention to become pregnant
* Renal disease (creatinine \>150 μmol/l or MDRD-GFR \<30 ml/min/1.73m2)
* Liver disease (aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range)
* Presence of any other medical condition that might interfere with the study protocol
* anemia
Complementary Interventions on Patients With Dementia: Comparative and Longitudinal Research

Cognitive function, behavioral and psychological symptoms, and quality of life will improve after administration of cognitive stimulation therapy, reminiscence therapy, and aroma-massage therapy in patients with dementia.

This study will base on the pattern of behavioral and psychological symptoms of dementia, to verify and compare the effectiveness of the three non-pharmacological complementary interventions, cognitive stimulation therapy, reminiscence therapy, and aroma-massage therapy on patients' cognitive function, behavior and psychological symptoms, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* been diagnosed with dementia (all stages) or MMSE below 23 for high school educated and 17 for less than high school education
* able to communicate verbally or nonverbally
* able to understand short sentences
* can sit for at least 50 mins.

Exclusion Criteria:

* no hospitalization within the past two weeks
* not under severe acute illness
* no psychiatric disorders.
Implementation of the NPMS Obstetric Hemorrhage Bundle at a Tertiary Center: Utilization of the Delphi Method

The National Partnership for Maternal Safety (NPMS) developed an obstetric hemorrhage consensus bundle to provide every United States birthing facility consistent, validated practice guidelines. To facilitate implementation of each element of this bundle at the participants large tertiary center, the investigators utilized the Delphi method to identify deficiencies, perceived barriers to implementation, and multidisciplinary consensus on changes with high feasibility and impact on patient care.


Eligibility Criteria:
Inclusion Criteria:

* ≥ five years of experience on the L\&D unit
* current employment on the L\&D unit \> 20h per week
* prior involvement in clinical obstetric hemorrhage situations

Exclusion Criteria:

* none
Improving Smoking Cessation Outcomes in Heavy Drinkers - 1

To test the effectiveness of an smoking cessation treatment for smokers who also drink alcohol heavily.

Heavy alcohol use frequently co-occurs with cigarette smoking and may impede smoking cessation. This clinical trial examined whether smoking cessation treatment that incorporates brief alcohol intervention can improve smoking cessation outcomes (7-day verified point prevalence abstinence) and reduce drinks consumed per week. Heavy drinkers seeking smoking cessation treatment were assigned by urn randomization to receive, along with 8-weeks of nicotine replacement therapy, either a 4-session standard smoking cessation treatment (ST, n = 119) or standard treatment of equal intensity that incorporated brief alcohol intervention (ST-BI, n = 117).

Eligibility Criteria:
Inclusion Criteria:

1. be at least 18 years of age
2. have smoked cigarettes regularly for at least one year
3. currently smoke at least 10 cigarettes a day
4. currently be using no other tobacco products or nicotine replacement therapy
5. currently drink heavily according to self-report (\>14 drinks per week or \>5 drinks per occasion at least once per month over the last 12 months for men; \>7 drinks per week or \>4 drinks per occasion at least once per month over the past 12 months for women)

Exclusion Criteria:

1. meet full DSM-IV criteria for alcohol dependence in the past 12 months
2. meet criteria for other current psychoactive substance abuse or dependence (excluding nicotine dependence and alcohol abuse) in the past 12 months \[this would also exclude individuals with lifetime substance dependence who continue to have some abuse/dependence symptoms in the past 12 months\]
3. meet criteria for current dysthymia, major depression, or manic episode \[past month\]
4. are currently psychotic \[past 12 months\] or suicidal \[suicidal ideation or intent in the past month\]
5. have an unstable medical condition that would suggest caution in the use of the nicotine patch (e.g., unstable angina pectoris, arrhythmia, recent congestive heart failure)
6. are currently pregnant or lactating or intend to become pregnant. We also will exclude participants who are not alcohol dependent but who have characteristics that might make supervised alcohol detoxification necessary (e.g., morning drinking to avoid withdrawal, daily drinking of \>12 drinks, recent withdrawal symptoms, history of severe withdrawal symptoms such as hallucinations, seizures, or delirium tremens).
Optimizing Diagnostics Of Syncope Events Using Intelligent Telemetric Solutions.

The purpose of this study is to assess efficacy of prolonged Full Disclosure electrocardiogram (ECG) monitoring and signal analysis using advanced telemetric technology to diagnose syncope in comparison with standard diagnostic procedure

Syncope can be caused by many conditions, often benign but in some cases syncope can be a symptom of severe arrhythmia. Early diagnosis of the underlying disease is very important to identify patients with severe cardiac arrhythmia to commence adequate treatment. Standard diagnostic methods such as 24 hours Holter electrocardiogram (ECG) monitoring or Event Holter do not guarantee early diagnosis of the arrhythmia. Prolonged heart rhythm recording and analysis using an automatic full disclosure telemetric device can increase probability of arrhythmia diagnosis and early administration of adequate treatment. Study patients will be diagnosed using standard Holter ECG monitoring, Event Holter or 30 days telemetric ECG monitoring. Efficacy of telemetric monitoring in diagnosis of cardiac arrhythmia will be assessed in comparison with the standard Holter monitoring and Event Holter.

Eligibility Criteria:
Inclusion Criteria:

* History of syncope
* Ability to operate the telemetric device at home
* Exclusion of underlying neurological disease
* informed consent undersigned by the parents
* informed consent undersigned by the child if over 16 years of age

Exclusion Criteria:

* Syncope with known underlying disease
* Inability to operate the telemetric device at home
* Complete Heart block
* QT\>500ms
* Implantation of ICD
* Inability to comply with the study protocol