cyrilzakka/clinical-trials huggingface dataset:
Ocrelizumab Effects on the Metabolome in MS

In this observational study, the investigators aim to recruit 50 patients over an 10-12 month period. The investigators will recruit patients with relapsing-remitting MS (based on 2017 McDonald Criteria) beginning treatment with ocrelizumab and fulfilling study inclusion and exclusion criteria. Participants recruited in this study will be participants in the Johns Hopkins MS Precision Medicine Center of Excellence bio-banking protocol which requires collection of serum and plasma at 6-monthly intervals and hence will have blood collection performed prior to Ocrevus start and then at 6, 12, 18 and 24 months following ocrelizumab initiation as part of the bio-banking protocol. All recruited participants will provide written informed consent.

The investigators will collect demographic and clinical characteristics at baseline and update these at follow-up visits. These will include disease duration, co-morbidities, relapses, treatment status and history. The investigators will also collect physiological variables - height and weight at each visit.

All recruited patients will return for follow up visits at 6,12, 18 and 24 months post-ocrelizumab initiation. At each visit patients will undergo the following evaluations - EDSS, MSFC, SDMT, fatigue scale (MFIS), quality of life measure (MS-QOL), depression scale (Beck depression inventory, 2nd version) and Block Food Frequency Questionnaire.

The investigators will then utilize plasma collected at the various time points to perform global metabolomics analysis. This will yield measures of various metabolites in the circulation, including amino acids and metabolites of the amino acids. The investigators will utilize this data to determine the change in the circulating metabolome produced by treatment with ocrelizumab.

Following this the investigators will assess changes in the various clinical measures collected - disability (EDSS, MSFC), cognition (SDMT), mood (BDI-II), fatigue (MFIS) and quality of life (MS-QOL) with Ocrelizumab treatment and correlate these with the changes noted in the metabolome. This approach will allow us to determine whether the metabolic changes are associated with/ could underlie the changes noted in clinical measures.


Eligibility Criteria:
Inclusion Criteria:

* Between 18-75 years of age
* Diagnosis of relapsing remitting multiple sclerosis (RRMS) based on 2017 McDonald Criteria
* Initiating treatment with Ocrelizumab based on decision of the treating physician
* Able to return for visits every 6 months to Johns Hopkins MS Center

Exclusion Criteria:

* Presence of additional neuroinflammatory or neurodegenerative disorder
* Steroids within the past 30 days
* Other significant metabolic comorbidity - eg: uncontrolled hypothyroidism or diabetes
* Likely to switch therapy in the following year
* Previous treatment with rituximab or other chemotherapy agents
Enhancing Referrals to Child and Adolescent Mental Health Services: EnCAMHS

Our aim is to find low-cost and widely reusable mechanisms to reduce inappropriate referrals. Our key objectives are:

Engage with key stakeholders to identify problems with making appropriate referrals Analyse CAMHS referral data to understand and identify problems (quantitatively) Identify requirements for sustainable solutions Explore with key stakeholders how we can improve the referral process Identify how the best proposed solutions could be embedded within routine CAMHS referral pathways

The Investigators shall conduct a series of focus groups with key stakeholders involved in the referral to CAMHS process; children and young people (CYP), parents/carers, key referrers, CAMHS professionals in order to better understand the challenges that exist with the current referral process. Following this, the Investigators will conduct further focus groups with the key stakeholders above, in which they will suggest sustainable solutions to the problems that have been identified.

The Investigators shall then identify how the propose solutions can be embedded into routine CAMHS referral pathways.

Eligibility Criteria:
Inclusion Criteria:

* Aged 16 years and above
* have experience of CAMHS referral pathway

Exclusion Criteria:

* younger than 16 years
Single Ascending Dose Study of TD-1439 in Healthy Subjects

Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-1439 in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) 18 to 32 kg/m2 inclusive
* Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use highly effective methods of birth control
* Women of non-childbearing potential are at least 2 years postmenopausal or are surgically sterile
* Males must abstain from sex or use highly effective methods of birth control
* Negative for HIV, and Hepatitis A, B, and C

Exclusion Criteria:

* Female subjects who are pregnant, lactating, breastfeeding or planning to become pregnant during the study.
* Subjects with a history of angioedema.
* Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
* Subject has acute illness (gastrointestinal, infection \[e.g., influenza\] or known inflammatory process)
* Subject bradycardia
* Subject has hypertension
* Subjects has orthostatic hypotension
* Subjects has orthostatic tachycardia
* Subject has a known personal or family history of congenital long QT syndrome or known family history of sudden death.
* Subject has donated blood or blood components or has had blood loss exceeding 400 mL within the 90 days prior to Screening.
* Additional exclusion criteria apply
Intravenous Lidocaine to Reduce Propofol Consumption During Gastroscopy.

The goal of this clinical trial is to assess if intravenous administration of linisol reduce the propofol consumption and the sides effects of sedation during gastroscopy in healthy patients (ASA 1 and 2 patients).

Prior to propofol sedation, participants will receive either an intravenous bolus of linisol (1.5 mg/kg) = treated group or placebo = control group.

After the gastroscopy, patients will be asked to complete a satisfaction questionnaire


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for gastroscopy under narcosis and who have signed the consent.
* ASA score: 1 and 2
* BMI between 18 and 30 kg/m2

Exclusion Criteria:

* Lidocaine allergy
* Anesthesia within the last 7 days
* Use of local anesthesia in the last 24 hours
* Rhythm disorder or HR \<50
* Pregnant women and breastfeeding
* Participation in another clinical study in the last months
* Cannot understand VAS score or French
* Severe central nervous disease and mental illness.
* obstructive sleep apnea (known or STOP BANG score \>5)
* Upper lung infection.
* Liver or kidney function disorder
Healthcare Renunciation During the Confinement Period in Connection With the COVID-19 Epidemic in Adult Emergency Departments

Healthcare renunciation is defined as: "Individuals give up care when they do not seek services and health care professionals when they experience a disorder, experience a physical or mental disorder, or when they do not access all of the prescribed care." In 2008, 16.5% of the general French population reported having renounced care. The causes mentioned of the renunciation are mainly the financial difficulties, the deadlines of appointments considered too long, the geographical remoteness. In the department of Sarthe, the rate of cessation of care is estimated at 27.6% over the period from 2014 to 2017.

In the context of the COVID-19 epidemic, containment was applied in France counted from 17 March 2020. The widespread message was "save lives, stay at home". The Ministry of Solidarity and Health has provided health professionals with a circular to adapt the management of patients with chronic disease, requiring elective surgical care and pregnant women.

The decline in activity of general practitioners is estimated at 44% and that of other specialists at 71%. In Paris, visits to the emergency room fell by 45% for adults and 70% for children.

The main risk is the deterioration of the health status of some patients with the worsening of chronic diseases, the discovery of pathologies during episodes of decompensation and the absence of management of serious acute pathologies.

The study aims to assess the importance of giving up care during this period of COVID-19 and in comparison with a study conducted at the University Hospital of Angers and the hospital of Le Mans in 2017.


Eligibility Criteria:
Inclusion Criteria:

* All adults patients consulting in the emergency department and agreeing to answer the questionnaire

Exclusion Criteria:

* Patient admitted in the emergency department in serious condition (life distress)
* Person unable to consent
Epiduroscopic Laser Discectomy Procedures

Epiduroscopy or spinal endoscopy is the imaging of the epidural space using a percutaneous and minimally invasive fiberoptic imaging device. The definitive diagnosis and treatment of chronic pain is increasingly prevalent with epiduroscopy. Recently, as a result of these studies it has been reported that laser therapy with epiduroscopy applied discectomy during multiple lesions. Investigators aimed to retrospectively investigate the efficacy of epiduroscopic discectomy procedures performed at the Algology Clinic.

In this study, epiduroscopic discectomy procedures performed between January 2012 and July 2016 at the Algology Clinic of the Department of Anesthesiology and Reanimation, Sakarya University Training and Research Hospital, were examined retrospectively. After approval was received from the Sakarya University Faculty of Medicine's Ethics Committee, patient information was obtained from the KarMed (Kardelen Software, Turkey) hospital information system. Files were scanned from the hospital archive. The age, gender, weight, lumbar disc herniation level, preoperative and postoperative surgical history, amount of physiological saline used during the procedure and duration of the procedure, whether a lumbar epidural steroid (LES) was used during the procedure, the amount of epiduroscopic laser use during the procedure, and complications after the procedure were examined. The Oswestry Disability Index (ODI) and Visual Analogue Scale (VAS) scores were recorded preoperatively, as well as after 2 weeks and 2, 6, and 12 months postoperatively from the patient files.

The 2007 Number Cruncher Statistical System (NCSS, Kaysville, Utah, USA) program was used for statistical analysis. The Student t-test and Mann-Whitney U test were used for descriptive statistical methods (mean, standard deviation, median, frequency, ratio, minimum, maximum) in two groups, as well as the normal distribution of quantitative data. The Kruskal-Wallis test and Mann-Whitney U test were used in the comparison of three groups with no normal distribution. The Pearson Chi-square test was used to evaluate qualitative data, and Spearman's correlation analysis was used to evaluate intervariable relationships. The Friedman and Wilcoxon signed ranks tests were used in the evaluation of three or more follow-up parameters without normal distribution. Diagnostic screening tests (sensitivity, specificity) and receiver operating characteristic (ROC) analysis were used to determine the cutoff value for age. Significance was evaluated at the level of p \< (0.01).

Eligibility Criteria:
Inclusion Criteria:

1. Patients with low back and / or leg pain for at least 3 months or more
2. Patients who do not benefit from conservative treatment
3. In patients who underwent Lumbar MRI examinations and had axial sheaths with a herniation of 3 mm or more

Exclusion Criteria:

1. Patients with bleeding diathesis in preoperative laboratory tests
2. Patients with any local or systemic infection
ImPACT Intervention for Children With ASD

This randomised-controlled trial will assess the effect of an early intervention on the social-communicative abilities and brain activity of preschoolers with autism spectrum disorder (ASD). The children´s social-communicative abilities and the related brain activity will be evaluated at three time points: before the start of the intervention (pre-intervention), immediately after its conclusion (post-intervention) and several weeks after its conclusion (follow-up).

Previous research has shown that parent-implemented interventions are effective in improving the social skills of children with autism spectrum disorder (ASD). The aim of the present project is to investigate the brain activity changes that are at the basis of the changes observed in the children's behaviour. More specifically, the investigators will assess the effect of Project ImPACT, a parent-implemented intervention, which teaches parents techniques to stimulate the social-communicative abilities of their children.

The intervention is suitable for preschoolers with a diagnosis of ASD and consists of 18 sessions of maximum 2 hours each, one session per week, delivered by trained therapists of the home guidance services in Flanders. Children with a diagnosis of ASD (or children who are suspected of ASD) between 1,5 and 4 years old and their parents will participate in the study. They will be randomly assigned to the ImPACT intervention or treatment as usual. The investigators will assess the effect of the intervention on the children's social-communicative abilities, and on the neural and biological correlates of these abilities.

The families will be invited to come to the Faculty of Psychology and Pedagogical Sciences at three time points: before the start of the intervention, immediately after the end of the intervention (which is expected to last 18 weeks) and 12 weeks after the end of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* A clinical or working diagnosis of ASD

Exclusion Criteria:

-
Bern, Get Ready (BEready) Cohort Study for Pandemic Preparedness

The BEready project aims to find out how people in the Canton of Bern can be helped to be more prepared for the next pandemic. BEready wants to understand how infections spread among people as well as between people and animals. BEready wants to find out how social and environmental factors can influence the transmission or catching of infectious diseases. BEready wants to better understand how households and their pets in the Canton of Bern were and continue to be affected by the coronavirus disease 2019 (COVID-19).

The overall aim is to establish BEready as a 'pandemic preparedness cohort', a cohort with a well-characterised study population of households, which has an infrastructure to conduct studies about infectious diseases, and which can be rapidly mobilised to respond to a new pandemic. BEready aims to understand the epidemiology and transmission of infectious diseases (particularly viral respiratory pathogens) in households including pets in the canton of Bern, and to engage diverse communities in efforts to strengthen pandemic preparedness.

The objectives are:

* to study the distribution and timing of infectious diseases and transmission patterns of circulating infectious diseases, both between individuals and at the human-animal interface (One Health)
* to study social (e.g. gender, affective polarisation) and environmental factors (e.g. climate change), which may affect transmission or acquisition of infectious diseases;
* to understand how households, including their pets, in the canton of Bern have been and will be affected by COVID-19; and
* to engage diverse communities in ongoing efforts to strengthen pandemic and public health literacy, and to prepare for the public health response to a new pandemic.

Eligibility Criteria:
Inclusion criteria for adults and children:

* Informed consent
* Residence (average of more than 3 days/week) in a private household in the canton of Bern where at least one member aged 18 agreed to take part.
* For adults, children aged 14 years or older, and parents/legal guardians: internet connection (Wi-Fi, fixed or on a mobile phone) and personal email address.
* For adults, children aged 11 years or older, and parents/legal guardians: able to understand, speak, read and write German, French and/or English.

Inclusion criteria for household pets: Pets of eligible household members with the consent of their owners.

Exclusion criteria for adults and children: Currently planned move outside the canton of Bern
The Impact of Low Glycemic Index Nutritional Shake on Glucose Regulation in Overweight and Obese Adults

Low glycemic index nutritional shakes have clinically shown to improve post-prandial glycemic responses in acute laboratory control studies. However, there is limited information on how replacing meals with low-glycemic index shake could impact glucose regulation in free-living adults consuming their own diets.

The present study aims to examine the impact of adding the SP Glucose-Assist shake to the breakfast of non-diabetic overweight and obese adults.

Subjects:

40 non-diabetic adults aged 25-65 years and body mass index ranging between 25-39 .

Protocol:

This is going to be a three-week study that will include a one-week self-selected diet, followed by two weeks of a breakfast supplement shake (standard process glucose assist) or control cereal oat breakfast.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index 25-40
* Eating pattern 3 meals a day
* stable weight for the last 2 months (\<5 pounds fluctuation)
* Willing to eat oat cereal for breakfast
* glycated hemoglobin \<7%

Exclusion Criteria:

* glycated hemoglobin \>7%
* Body mass index ≤25 or ≥ 40
* Night shifting work
* Atypical meal pattern (not three meals a day or intermittent fasting)
* Thyroid medication
* Bariatric surgery
* Habitual strenuous exercise
* Commuting by bicycle
* Eating disorders
* Use of aspirin during the duration of the study
* Intake of Vit C \>60 mg/day during the study
* cancer
* cardiovascular disease
* renal disease
* hepatic disease
* X-ray, MRI or CT appointment during the study duration
* Current infection requiring medication
* Chronic, contagious, infectious diseases such as tuberculosis, Hepatitis A, B, C, or HIV
* Medications of supplements that could affect body weight or appetite (i.e. Ozempic)
* Participating in another study at the same time
Residual Shunt After Patent Foramen Ovale Device Closure in Patients With Cryptogenic Stroke

Among consecutive 47 cryptogenic stroke patients who underwent PFO closure, a serial follow-up bubble contrast TEE at 3 and 9 months after the index procedure was completed in 38 patients (81%, 46±10 years, 19 men). To evaluate the efficacy of PFO closure, the incidence of any- and significant residual shunt (≥moderate) was assessed.

The current investigation analyzed the date from the Gachon University Gil Medical Center PFO registry. Between March 2014 to February 2017, all consecutive 47 patients with ischemic stroke and PFO documented by bubble contrast with no other identifiable cause of the ischemic event, such as, carotid or intracranial artery stenosis, atrial fibrillation, and thrombus, or atheromatous plaque at the aortic arch (i.e. CS), were analyzed. PFO closure was determined according to the heart-brain team's discretion (the team consisted of an interventional cardiologist, an echocardiographer cardiologist, a neurologist, and a radiologist) based on clinical data, echocardiographic findings, and patients' preference. The Gore® Septal Occluder (WL Gore \& Associates, Inc., Newark, DE, USA) (n=19) and the Amplatzer® PFO occluder (St. Jude Medical, Inc. St.Paul, MN, USA) (n=19) and were used. The Occlutec® PFO occluder was used in one patient who were excluded from the analysis. The Institutional Review Board of Gachon University Gil Medical Center approved this study and all patients provided written informed consent prior to enrollment.

Eligibility Criteria:
Inclusion Criteria:

patients with cryptogenic stroke and PFO documented by bubble contrast TEE

Exclusion Criteria:

patients with other identifiable cause of the ischemic event such as, carotid or intracranial artery stenosis, atrial fibrillation, and thrombus, or atheromatous plaque at the aortic arch
Nurturing Needs Study: Parenting Food Motivated Children

High food motivation among children is trait-like and increases risks of unhealthy dietary intake and obesity. Scientific knowledge of how parenting can best support healthy eating habits and growth among children who are predisposed to overeating is surprisingly limited. This investigation will identify supportive food parenting approaches for obesity prevention that address the needs of highly food motivated children.

High levels of food motivation among young children are heritable, track over time, and associated with elevated risks of unhealthy eating and obesity. Despite significant growth of family-based obesity prevention efforts, the evidence base is remarkably scant on parenting highly food motivated children to prevent obesity and poor dietary outcomes. The goal of this investigation is to generate a robust basic science evidence for parenting highly food motivated children to prevent excessive dietary intakes and body mass index (BMI) gains during the preschool years. Using a prospective cohort design, this investigation follow 300 caregiver/child dyads over 18 months as children transition from preschool to elementary school, when significant numbers of children begin to experience problems of poor diet quality and obesity. Children with varying food motivation will be recruited to understand whether highly food motivated children have different needs than other children. A multi-method approach will use state-of-the-art measures, including ecological momentary assessment, to comprehensively investigate the amount, types, and consistency of food parenting practices (i.e., specific, goal-oriented behaviors) needed to prevent food motivated behaviors, excessive dietary intake, and BMI gains in children. Specifically, the role of structure (i.e., theoretically supportive) and its differentiation from more coercive types of food parenting control will be comprehensively characterized.

Eligibility Criteria:
Inclusion Criteria:

1. Child ages 4 or 5 years at baseline;
2. Parent/ primary caregiver with legal representation (having 50% or more custody of child);
3. Parent/primary caregiver reporting primary responsibility for child feeding outside of childcare (being with child when they are eating at least two times daily);
4. Caregiver with a cell phone that can be used to send and receive text messages. If there is more than one age-eligible child in the family, we will ask the caregiver to pick the index child.

Exclusion Criteria:

1. Parent/primary caregiver \<18 years of age;
2. Child history of major food allergies (e.g., peanuts);
3. Child medication use (e.g., insulin), developmental disability (e.g., autism) or medical condition(s) (e.g., diabetes) known to affect food intake and growth;
4. Foster child.