cyrilzakka/clinical-trials huggingface dataset:
Liveonline Training Course to Improve Food Habits and Enhance Physical Activity in Older Adults

Aim of the study is to find out if the live online course is effective with regard to health promotion. Older adults receive support to initiate a health behavior (i.e., to enhance physical activity or to improve food habits).

Motivation, confidence and self-management strategies are optimized to make sure participants are able to integrate the physical activity or healthy diet into their daily life.

Aim of the study is to support older adults to define a personal health behavior (to enhance physical activity, to improve food habits), to check and optimize this intention regarding self-efficacy and volitional competencies, such as action and coping planning, disability management to adopt and maintain their behavior successfully.

Research questions:

* What is the pathway from health information/intention to behavioural change (motivational and volitional processes)?
* Which are the crucial social-cognitive variables in educating/coaching adults with low health literacy in daily self-management?
* Which other resources (e.g. social support) should be targeted in interventions to empower people in health behaviour change and maintenance?

Eligibility Criteria:
Inclusion Criteria:

* internet access at home
* proficient language skills (German)

Exclusion Criteria:

* no internet access at home
* no proficient language skills (German)
* contra-indication for physical activity or a diet rich in fruit and vegetables
Oxygen Reserve Index and Prevention of Hyperoxemia

In patients under general anesthesia, the oxygen level (FiO2) used in inspiration is usually adjusted by monitoring the peripheral oxygen saturation level (SpO2). As a non-invasive method, SpO2 monitoring is known as one of the required methods that can be used to adjust FiO2 and detect and treat hypoxemia. While SpO2 approaching 100% matches the value of 128 mmHg in arterial partial oxygen pressure (PaO2), in cases where PaO2 increases more, the investigators cannot follow this situation with SpO2 and cannot prevent hyperoxemia.

As stated in the literature, hyperoxemia has positive effects in general anesthesia and intensive care, as well as negative effects such as increased inflammation, oxidative stress and ischemia-reperfusion. In addition, acute lung injury, development of atelectasis, increased mortality, and critical illness rates have been associated with hyperoxemia in many publications. The only way the investigators can use to measure the level of hyperoxemia seems to be arterial blood gas analysis, and this method limits the investigators use because it is invasive. The Oxygen Reserve Index (ORi™) (Masimo Corp., Irvine, CA, USA) is a variable related to real-time oxygenation reserve status in the mildly hyperoxemic range (approximately 100 - 200 mmHg PaO2). ORi can be defined as a multi-wavelength, noninvasive pulse co-oximetry sensor. ORi is a dimensionless index ranging from 0.00 (no reserve) to 1.00 (maximum reserve) depending on the oxygenation reserve status.

There are very few studies in the literature using ORi to detect hyperoxemia. The investigators thought that if FiO2 levels used in preoxygenation, anesthesia maintenance and recovery stages in day surgeries were correlated with ORi levels, a threshold value could be determined for FiO2 levels during anesthesia stages in cases where invasive arterial blood gas could not be followed.

This study aims to determine the relationship between SpO2, FiO2 and ORi during general anesthesia, to investigate the usefulness of ORi in determining the FiO2 threshold value during anesthesia stages as an indicator of hyperoxemia, and to investigate the effects of these values on the hemodynamics, recovery, agitation and nausea-vomiting states of the patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an American Society of Anesthesiologists (ASA) score of 1

Exclusion Criteria:

* Patients with an American Society of Anesthesiologists (ASA) score of 2 and above
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASC30 Injection in Participants With Obesity

This is a phase 1 randomized, double-blind, placebo-controlled single ascending dose (SAD) study designed to evaluate the safety and tolerability of ASC 30 injection, for subcutaneous use in participants with obesity.


Eligibility Criteria:
Inclusion Criteria:

1. Have provided informed consent before initiation of any study-specific procedures.
2. Male or female participants, non-smokers, between 18 and 65 years of age (both inclusive).
3. No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures.

Exclusion Criteria:

1. Have evidence of any clinically significant active or chronic disease.
2. Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), or rare forms of diabetes mellitus.
3. Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
4. Have a history of acute or chronic pancreatitis.
5. Participants with a known clinically significant gastric emptying abnormality.
6. Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy.
7. Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the Investigator, may preclude the participant from following and completing the protocol.
Psychic Stakes of Reconstructive Plastic Surgery in Children With Ear Aplasia

The objective of the study is to analyse :

* Psychic experience of ear aplasia in children ;
* the modalities of their psychic functioning ;
* and the psychological repercussions of the plastic reconstruction surgery

Children with an ear aplasia have various cares (ENT, speech therapy, hearing aids and tomodensiometry) up to the proposal of the plastic reconstruction surgery at 9/10 years old.

The surgical technique used and preferred within Necker Hospital for these children is that of Saturo Nagata (1994).

This surgical protocol takes place in two times, spaced by 9 months. This surgery does not allow hearing better since it targets is only a reconstruction of the pinna. To date, no research has highlighted the subjective experience of a child with an aplasia of ear and of what this surgery engages and demands on the side of psychological work.

The purpose of this research is to interrogate the children's subjective experience with an unilateral ear aplasia and who wishes a plastic reconstruction surgery for their aplase ear.

Eligibility Criteria:
Inclusion Criteria:

* Minors of 10 to 16 years old
* Unilateral ear aplasia with or without articulatory disorders, followed and engaged in reconstruction surgery procedure within the ENT service of cervico-facial surgery of the Necker Hospital
* Children wishing a plastic reconstruction surgery and having received the approval of the medical team
* Francophone children
* Holders of parental authority and child voluntary for the research

Exclusion Criteria:

* Illiterate children
* Severe intellectual deficit
* Bilateral aplasia
* Syndromic impairment
Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder

The primary objective of this trial is to measure changes in physiologic signals to quantify the status of the autonomic nervous system during opioid withdrawal and cravings.

This is a prospective observational clinical trial in which 20 participants with a history of dependence on prescription or non-prescription opioids will be recruited for collection of physiologic data via wearable sensors during a 14-day inpatient detoxification treatment. The EmbracePlus Smartwatch and Corti Sensor will be worn continuously throughout the 14-day treatment course to detect heart rate, heart rate variability, skin conductance, skin temperature, motion, and cortisol levels.

Eligibility Criteria:
Inclusion Criteria

1. Participant shows signs of current opioid dependence; prescription or non-prescription
2. Participant is seeking an induction to medications for opioid use disorder (MOUD)
3. Participant is between 18 and 50 years of age
4. Participant is English proficient
5. Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements
6. Participant is willing to wear wearable sensors for 14 days

Exclusion Criteria

1. Participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition
2. Participant has a history of epileptic seizures
3. Participant has a history of neurological diseases or traumatic brain injury
4. Participant has recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation
5. Subject has significant current suicidal ideation within 30 days prior to Screening as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) completed at Screening, that, in the opinion of the investigator, warrants exclusion from the trial
6. Females who are pregnant or lactating
7. Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
Effects of Hip Abductors Strengthening In Knee Osteoarthritis

The aim of my study is to determine the effects of hip abductors strengthening and quadriceps strengthening in comparison with quadriceps strengthening alone in patients with knee osteoarthritis.

As the quadriceps strengthening is a keystone of exercise therapy for knee osteoarthritis. Thus is the hip abductors strengthening along with quadriceps strengthening would be added to the treatment protocol of osteoarthritis it might give more positive results, decrease pain and increase the recovery rate as well as helpful to improve the functional outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of single or both knees
* Kellgren Lawrence scale between 2-4

Exclusion Criteria:

* Knee valgus or varus deformity
* Hip or knee joint replacement
* Tibial osteotomy
* Any other surgery of hip or knee joint
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Montelukast vs Fluticasone

This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.

This is a non-randomized, non-interventional study that is part of the DREAM Study of Brigham and Women's Hospital. DREAM is led by Dr. Madhav Thambisetty, MD, PhD, Chief of the Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging (NIA) intramural research program. This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.

Eligibility Criteria:
Please see https://docs.google.com/spreadsheets/d/1u8YFpnMHI5HprhyuY14tIgd1COZcsAWKFlbYCT7aL_A/edit?usp=sharing or Appendix A (https://drive.google.com/file/d/1uC_G8TJ1ujoJbas1p1gFaYFzY7Hw7xMq/view?usp=sharing) for full code and algorithm definitions.

Medicare timeframe: 2008 to 2018 (end of data availability).

Inclusion Criteria:

* 1. Aged \>/= 65 years on the index date
* 2. No prior use of Montelukast and Fluticasone anytime prior to cohort entry date
* 3. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
* 4. At least two claims with asthma diagnosis measured 365 days prior to drug init

Exclusion Criteria:

* 1. Prior history of dementia measured anytime prior to cohort entry date
* 2. Prior history of nursing home admission in the 365 days prior to the cohort entry date
Influence of Respiratory Rate Settings on CO2 Levels During Nasal Intermittent Positive Pressure Ventilation (NIPPV).

Infants will be monitored by TcCO2 during three consecutive time periods of one hour each on a high and low rate of NIPPV, when in a stable condition. NIPPV rate will start high/low, changed to low/high and switched back to starting rate.

This will be a prospective, crossover observational study that will be performed at Rambam NICU.

Infants will be monitored by TcCO2 during three consecutive time periods of one hour each on a high and low rate of NIPPV, when in a stable condition.

NIPPV rate will start high/low, changed to low/high and switched back to starting rate.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age 240 to 336.
* At least 6 hours of stabilized NIPPV settings, i.e. minor changes in settings (FiO2 ≤0.10, PIP≤ 2.0 cmH2O, RR≤ 5 brm).
* At least 6 hours of stabilized tcCO2, i.e. ≤5 mmHg variation.
* At least 6 hours from surfactant administration.
* Parental consent

Exclusion Criteria:

* If NIPPV set rate is 10 bpm and tcCO2 related pCO2 is\<40mmHg.
* If NIPPV set rate is 30 bpm and tcCO2 related pCO2 is\>60mmHg.
* Unstable infants due to acute conditions (sepsis. IVH), or congenital malformations.
Defining the Molecular Risk in Israeli Patients With Secondary Compared to Primary Myelofibrosis

The aim of the study is to determine the rate of HMR mutations in PMF and secondary MF (post PV/ET) subjects, and correlate the rate of mutations with clinical features as known prognostic scores.

Main inclusion criteria:

1. Diagnosis of PMF, post PV MF or post ET MF according to the WHO 2008 classification
2. Age ≥ 18 years
3. Concurrent participation in clinical trials will be allowed.

Efficacy assessments will be evaluated by: HMR mutations rate, specific HMR mutations, disease duration, presence of splenomegaly, cytogenetic risk, DIPPS, IPSS, ET survival score and PV survival score.

The primary efficacy parameter to be assessed will be HMR mutation rate.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of PMF, post PV MF or post ET MF according to the WHO 2008 classification
2. Age . 18 years
3. Patient is willing and capable of giving a written informed consent.
4. Concurrent participation in clinical trials will be allowed

Exclusion Criteria:

1. Unwilling or unable to provide informed consent
2. Prefibrotic MF
Reintegrating Children Living at Landfills in Burundi Into Society by Means of a Comprehensive Family Program Addressing Maltreatment and Mental Health Symptoms

Children living at the landfills of Bujumbura are often exposed to maltreatment, including emotional neglect and physical abuse, and traumatic experiences. Furthermore, they grow up in severe poverty. Addressing trauma-related mental health issues and aggressive behaviour by Narrative Exposure Therapy (FORNET), familial communication by family visits, interaction difficulties of children by a group intervention, poverty by financial support and economic training for mothers, medical problems by medical assistance, legal conflicts by legal advice, and providing access to school, we aimed at reintegrating those children within the Burundian school system and improving familial relationships.

The investigators want to provide evidence, that mental health interventions are an integral part of assisting children and families affected by poverty and violence.


Eligibility Criteria:
Inclusion Criteria:

* Spending days at the landfills of Bujumbura

Exclusion Criteria:

* Psychotic symptoms
Impact of Mixed Reality Training on Motor Skills in Children With Autistic Spectrum Disorder

People with autistic spectrum disorder frequently present impaired motricity, or at least different motricity from neurotypical subjects (walking; postural balance; fine motor skills; motor control, etc.). Motor impairment can have impact on the performance and learning of simple tasks (bathing, dressing, writing, using tools, etc.), especially in children and teenagers.

These last years, new therapeutics such as Virtual, Augmented and Mixed Reality technologies have developed. Their therapeutic interest has been identified in various pathologies like phobia. However, their influence on motor skills has been little studied. The first results obtained with disabled adults described a significant increase in walking speed after a 3-month Mixed Reality training.

The aim of the study is to assess the impact of Mixed Reality training on motor skills of children with autistic spectrum disorder.

Eligibility Criteria:
Inclusion Criteria:

* aged between 8 and 12 years old
* with autistic spectrum disorder
* male or female
* agreeing to participate in the study

Exclusion Criteria:

* Visually impaired or blind.
* Traumatism and physical injuries
* Epilepsy
Establishment and Clinical Application of Risk Classification Model Based on Molecular Typing of Medulloblastoma in Children

The purpose of this study:(1) Development of a new risk classification model for childhood medulloblastoma. (2) Evaluation and improvement of existing individualized treatment protocols.

Medulloblastoma (medulloblastoma, MB) is the most common intracranial malignant tumor in children, accounting for 20% of all central nervous system tumors in children, seriously affecting the quality of life and life span of children. Based on a retrospective analysis of previous MB cases in our center, we found that the clinical prognosis of previous MB patients in our center was worse than that in foreign countries, with an overall five-year survival rate of about 65%, and nearly 30% of the patients had tumor recurrence and metastasis within 2 years after the operation, and the prognosis was poor. We analyzed the possible reasons as follows: (1) the compliance to radiotherapy and chemotherapy in children with MB in our center was poor, and some of the patients only completed radiotherapy and had poor compliance with chemotherapy; (2) due to the lack of family doctor system, the tumor of the newly diagnosed patients was huge, which seriously affected the important brain function and clinical prognosis; (3) the patients were not followed up strictly and regularly after operation to monitor tumor recurrence, which led to poor treatment effect after recurrence.

(4) the unified treatment standard has not been formed yet, and the treatment mode for patients is complex.

As the largest neurosurgery and pediatric neurosurgery center in China, the center intends to prospectively establish a high-quality homogeneous MB observation cohort in children, make use of the center's case resources and biological sample processing advantages, and carry out accurate treatment research on children's MB through regular follow-up and systematic management of the clinical cohort.

Eligibility Criteria:
Inclusion Criteria:

* Age 0.5-18 years (except neonates).
* Pathologically confirmed medulloblastoma.
* Not having received any other relevant treatment before surgery.
* Completion of enhanced MRI of the head and spinal cord.
* Availability of tumor samples and determination of molecular typing.
* Postoperative KPS score ≥ 70.
* Voluntary enrollment in the group and the ability to receive long-term follow-up.
* The patient or the patient's family voluntarily signed the informed consent form.

Exclusion Criteria:

* Patients who have recently received other drugs or radiation therapy.
* Patients suffering from acute or chronic infectious diseases
* Patients suffering from neurological or psychiatric diseases or mental disorders that cannot be easily controlled, or poor compliance.
* Patients who cannot receive enhanced MRI scans.
* Other conditions that the investigator believes make the patient unfit to participate in this trial.
Infrared Imaging in Septic Illness

The application of infrared thermal imaging in the diagnosis and prognostication of septic illness in adults.

During times of severe infection (sepsis), the small blood vessels supplying oxygen and nutrients to the skin and other organs (called the microcirculation), become abnormal and do not function as they normally would in health. Monitoring these small blood vessels is difficult to do clinically and the investigators want to investigate a new way of doing this.

The aim of this study is to validate a novel method of assessing the function of the microcirculation in healthy volunteers and patients with sepsis, by measuring the skin temperature profile of the leg and face with a thermal imaging camera. Thermal imaging cameras measure the heat given off by all objects and represents this as a picture, with colour used to represent the different temperatures.

Patients will be recruited from the Emergency Department and Intensive Care Units at University Hospitals of Leicester in to one of two groups based on their illness severity; uncomplicated sepsis and severe sepsis. Healthy volunteers will be recruited in to a third group. Recruitment will take place over a 6-month period with follow-up lasting for 12-months following recruitment. 105 participants will be recruited in total.

Temperature patterns seen on the face and leg will be investigated between the different groups. Changes in these temperature patterns as patients recover from sepsis (or indeed become worse), will also be investigated. Information from the thermal images will be correlated to routinely measured markers of infection, including clinical measurements (blood pressure, pulse, etc) and routine blood investigations.


Eligibility Criteria:
Inclusion Criteria:

1. Male or Female, aged 18 years or above.
2. Healthy volunteers - free from acute illness; will include staff and students at the University of Leicester and UHL, and patient relatives.
3. Patient with septic illness will be recruited in to one of two groups depending on their disease severity - Sepsis (without evidence of organ dysfunction) or severe sepsis (with organ dysfunction).
4. Able (in the Investigators opinion) and willing to comply with all study requirements.

Exclusion Criteria:

1. Patient refusal
2. Inability to gain appropriate assent/consent
3. Children
4. Prisoners or in police custody
5. Skin marking likely to preclude image analysis (such as extensive tattoos).
Dysfunction of Olfaction After COVID-19 Infection: Morphological and Histomolecular Investigation

Investigation of the mechanisms of persistent SARS-CoV-2 associated olfactory dysfunction (OD) in patients with well-documented olfactory function. The investigators plan to collect olfactory cleft biopsies and cytobrushes in COVID-19 patients and controls.

An explorative prospective clinical study using human body materials of living post-COVID-19 patients with and without OD, to study the mechanisms of persisting olfactory dysfunction. Patients consult ENT specialist for medical purposes and undergo standard-of-care diagnostics and management. The collected tissues from the olfactory cleft mucosa will be analyzed using single cell RNA sequencing and RNAscope combined with immunohistochemistry.

Eligibility Criteria:
Inclusion Criteria:

* Olfactory Dysfunction group: Presence of evident OD (Parosmia, Threshold-Discrimination-Identification (TDI)-score ≤24, Subjective abnormal quantitative olfactory function; measured by a visual analogue score (VAS) of smell impairment ≥5/10
* Control group: No OD (TDI-score \&gt;30.5.)

Exclusion Criteria:

* Presence of concomitant nasal mucosal pathology that might affect olfactory function or bias the study investigations
* Use of anticoagulation therapy
* Allergy to local anesthetics