cyrilzakka/clinical-trials huggingface dataset:
Promotora-Led Intervention for Metabolic and Mental Health

Evidence-based programs to prevent diabetes among high-risk individuals are less effective among those who also have mental health needs. This study involves developing and pilot testing the first adaptation of the landmark Diabetes Prevention Program lifestyle intervention to simultaneously treat prediabetes and elevated mental health symptoms. This project has large potential to impact public health, given that more than half of the U.S. adult population has either of these conditions, and is at risk for developing comorbid diabetes and mental illness.

The overall goal of this study is to develop an effective and potentially scalable intervention to prevent diabetes in people with elevated mental health symptoms (EMS) and prediabetes. This study focuses on Latinos, a demographic group at particularly high risk for these related conditions. Experience from the Diabetes Prevention Program (DPP), and related translational studies, suggests that the evidence-based DPP lifestyle intervention is less effective among depressed individuals. The proposed Promotora Intervention for Metabolic and Mental Health (PRIME2) will be the first adaptation of the DPP lifestyle intervention to simultaneously address mental health and prediabetes in a program delivered by promotoras, or community health workers.

Eligibility Criteria:
Inclusion Criteria:

* Latino ethnicity
* Spanish fluency
* Age ≥18 years
* BMI ≥25 kg/m2
* And "increased risk of diabetes" (ADA Diabetes Risk Score ≥5 as determined by 7-item questionnaire and/or hemoglobin A1C ≥ 5.7%)

Exclusion Criteria:

* Hemoglobin A1C ≥ 6.5%
* Current or planned pregnancy during the study period
* Chronic conditions that could affect potential participants' ability to participate (osteoarthritis, heart disease, pulmonary disease requiring oxygen or daily bronchodilator use, and severe psychiatric disease)
* Medical comorbidities that could influence weight loss or weight gain (thyroid disease, cancer, and HIV)
* Medications that could affect weight or glucose metabolism (thiazide diuretics, β-blockers, and systemic glucocorticoids).
Rapid Diagnosis of Antibiotic Resistance in Gonorrhoea

The purpose of this study is to develop a laboratory-based assay that will be a real-time PCR test to detect the organism N. gonorrhoeae and its most important genetic markers of antimicrobial resistance. This study will also determine factors associated with gonorrhoea and describe sexual behaviours of men who have sex with men, to inform parameters for a mathematical model of gonorrhoea transmission and antimicrobial resistant gonorrhoea.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or female, aged 18 years or above.
* Participant is literate in German, French, English or Hungarian.
* Participant is at risk for a N. gonorrhoeae infection. This is defined as:

  1. exhibiting signs/symptoms of a N. gonorrhoeae infection.
  2. having a sexual partner who has been diagnosed with a N. gonorrhoeae infection.
  3. participating in high-risk activities for a N. gonorrhoeae infection.

     Exclusion Criteria:
* Subject does not agree to undergo diagnostic test for gonorrhoea.
Application of Transcutaneous Electrical Acupoint Stimulation in Laparoscopic Cholecystectomy

To explore the application of transcutaneous electrical acupoint stimulation combined with transverse abdominis plane block in Laparoscopic cholecystectomy, in order to reduce postoperative pain and promote postoperative recovery.

Percutaneous electrical acupoint stimulation has been applied in preoperative prophylaxis, intraoperative anesthesia and postoperative rehabilitation, and can reduce perioperative anxiety, improve the efficacy of preoperative smoking cessation and alcohol abstinence, and shorten the preoperative fasting time. During surgery, it can reduce the amount of anesthetic drugs, anti-inflammatory and anti-stress effects, stabilize circulation, and protect important organs; After surgery, improve the speed and quality of wake-up of patients, promote the recovery of maintenance function, regulate immune function, and reduce postoperative adverse reactions such as postoperative pain, postoperative nausea and vomiting, postoperative urinary retention, etc. As one of the common nerve blocks, transverse abdominis block is used clinically, and its main function is to relieve perioperative pain and reduce the amount of traumatic stress and analgesic drugs

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) class I and II
* Age 18-65 years
* Laparoscopic cholecystectomy for the first time
* There is no rupture, infection in the acupoint pasting site
* The patient knows and signs the informed consent form

Exclusion Criteria:

* People with visual impairment, hearing impairment and alcoholism
* History of diabetes, myocardial infarction or cerebrovascular accident, liver and kidney dysfunction
* Those who are allergic to non-steroidal drugs, anticholinergic drugs, and anesthetic drugs
* Those who are unable to cooperate or refuse to participate in the research or request to withdraw during the research process
* Those with contraindications to percutaneous electrical stimulation, including local skin damage, infection or implantation of electrophysiological devices in the body
A Study to Describe the Persistence With Ozanimod Treatment in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants

The purpose of the study is to collect clinical data on the persistence with ozanimod treatment, as well as to describe its effects on participant-relevant outcome parameters in treatment-naïve participants with RRMS.


Eligibility Criteria:
Inclusion Criteria:

* Relapsing-remitting multiple sclerosis (RRMS) diagnosis by 2017 revised McDonald criteria at the treatment start

  * Participant who started treatment with ozanimod for the first time 3 months (+/- 2 weeks) before inclusion, according to European Union (EU) Summary of Product Characteristics (SmPC) and/or Spanish therapeutic positioning report (TPR) recommendation and following routine clinical practice of the participating hospital
  * Low-to-moderate activity, defined as less than 2 relapses in the previous year before starting the treatment with ozanimod

Exclusion Criteria:

* Prior exposure to ozanimod or any other disease modifier treatment (DMT) for RRMS before starting treatment with ozanimod subject of this study
* Participant who has started ozanimod within a clinical trial

Note: Other protocol-defined inclusion/exclusion criteria apply
Using EEG to Study Coma in the Neurocritical Care Unit

Despite its clinical significance, the pathophysiology of coma is still under investigation and the physiology of emergence from coma remains a mystery. Furthermore, predictors of emergence from coma, despite their obvious clinical value, remain un-established. Because of its low arousal state and hypothesized parallel neurophysiological mechanisms, sleep has been studied as both an animal and human model of coma, and awakening from sleep has likewise been studied as a surrogate of coma emergence. In this study, we will determine whether certain electrographic patterns, known as spectral shifts, which have correlates in normal sleep, are predictive of eventual awakening from coma and the time course of this emergence. To detect spectral shifts in comatose patients, EEG monitoring must be performed for several days. Quick, simple, and reliable EEG recording in the ICU will be enhanced by a small device that can be easily and properly positioned on the head by hospital personnel and which lacks cumbersome cables or receivers. Traditional EEG monitoring requires placement of up to 25 wires, which can impede efficient intensive patient care. Our hypothesis is that we can detect a difference in spectral shifts in comatose patients who will eventually emerge from coma as compared to comatose patients who do not wake up and that a wireless EEG patch-type device can effectively make this distinction.


Eligibility Criteria:
Inclusion Criteria: All patients with brain injuries admitted to the neurocritical care unit will be screened for enrollment. The estimated enrollment will be for 100 patients. 90 patients will be comatose with Glascow Coma Scale \< 9. The other 10 patients will be control, non-comatose patients for quality control of the device. Consent for inclusion will be obtained from the patient or next of kin for all enrolled patients.

Exclusion Criteria: None
Videogame-based Tool for Job Search and Executive Function Improvement in Adults With ASD

This study aims to assess the efficacy of Identifor, a strength- based, person-centered, vocational assessment tool to develop a more effective way to identify individual abilities, skills, and interests. Identifor uses computer games specifically designed for young adults with ASD.


Eligibility Criteria:
Inclusion Criteria:

* IQ above 60
* Diagnosis of ASD as confirmed by qualified clinician (including Dr. Fung), and if necessary the administration of Autism Diagnostic Interview-Revised (ADI-R) and/or Autism Diagnostic Observation Schedule-Generic (ADOS-G)
* Age 18 to 55
* Adults who are physically healthy
* able to travel to work independently

Exclusion Criteria:

* DSM-5 diagnosis of other severe psychiatric disorder such as schizophrenia
Positions and Peripheral Oxygen Saturation

The subjects were placed consecutively in random order in the five different positions by drawing lots. Oxygen saturation (SaO2) and vital signs (pulse rate, respiratory rate, systolic blood pressure, diastolic blood pressure and body temperature) were measured in each position at 10, 25 and 40 minutes.

The semi-seated position in bed at 45°: SSPB-45° The semi-seated position in bed at 60° :SSPB-60° Seated position in bed at 90°: SPB-90° Lying on the right side of the body at 45°: LRSB-45° , Lying on the left side of the body at 45°: LLSB-45°

A questionnaire which consisted of a Subjects' Introduction Form and a Vital Signs-SaO2 Record Form was used in collecting the data.

The subjects were placed consecutively in random order in the five different positions, SSPB-45°, SSPB-60°, SPB-90°, LRSB-45°, and LLSB-45°, by drawing lots. Oxygen saturation (SaO2) and vital signs (pulse rate, respiratory rate, systolic blood pressure, diastolic blood pressure and body temperature) were measured in each position at 10, 25 and 40 minutes. Oxygen saturation and vital signs were measured with a finger pulse oximeter (Nellcor N-560). Nail polish was removed before measurement of oxygen saturation, and if there was any physical restraint on subjects it was removed. Body temperature was measured via the ear with a tympanic membrane thermometer (Covidiev Genius 2). Systolic and diastolic blood pressure were measured with a calibrated sphygmomanometer from the left arm with the same sphygmomanometer (Erka aneroid sphygmomanometer®) and stethoscope. Pulse rate and respiratory rate were manually monitored for a period of one minute by the researcher using a wristwatch. Verbal and written informed consent was obtained from the subjects or from their closest relatives.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who were over 18 years of age and who are able to lie in all positions, and who had unilateral/or bilateral lung disease documented by medical diagnosis by a physician were included in this study.
* Patients who accepted to participated to the study.

Exclusion Criteria:

* Patients who have not accepted to participate.
In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome

Muscular compartment syndrome (MCS) is consecutive to an increase in intramuscular compartment pressures, and is a rare but serious postoperative complication.

The INVOS (In Vivo Optical Spectroscopy) monitors tissular oxygenation continuously and non-invasively.

The objective is to develop a model mimicking the physiopathology of MCS to assess the interest of the INVOS in this case.

After inflation of a tourniquet (pressure equal to the mean arterial pressure, we will obtain a model of slight venous congestion and arterial hypoperfusion. A comparison will be made between INVOS monitoring, sensory deficits, pain, electromyography and invasive pressure.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* \>18yr
* Informed consent
* Male

Exclusion Criteria:

* Neuropathies
* Vascular pathology
* Actual pain
* Anti-platelet or anticoagulant therapy
* Ipsilateral history of fracture
Validation of a Delirium Monitor

Delirium is a common disorder in hospitalized patients, nevertheless it is poorly recognized by physicians and nurses, even when screening instruments are used. Electroencephalography (EEG) appears to be a sensitive tool for the diagnosis of delirium. However, standard EEG recording with 25 electrodes is labor intensive. We have previously showed that a brief EEG registration with three electrodes and automatic processing can distinguish patients with delirium from patients without delirium very well. However, these findings need to be validated in an unselected population.

The primary objective of this validation study is to investigate the sensitivity, specificity, and predictive values of the EEG-based delirium monitor (including three electrodes and a reference electrode) compared to delirium quantification in frail elderly patients after surgery.

In an international multicenter study, 154 frail elderly patients will be included who will undergo elective surgery and are expected to remain admitted for at least two postoperative days. Patients are excluded if communication is not possible or admitted for neurological surgery.

A five minute EEG registration with the delirium monitor with four electrodes will be performed prior surgery and three consecutive days after surgery or until discharge. Within one hour of the EEG recording, the delirium assessment will be performed and recorded on video, which will be evaluated by delirium experts. The relative delta power (calculated from one minute of artifact-free EEG segment) will be compared with the conclusion of the delirium experts.


Eligibility Criteria:
Inclusion Criteria:

* 60 years and older
* Frail
* Undergoing elective surgery
* Expected to remain admitted for at least 2 postoperative days

Exclusion Criteria:

* No communication possible due to a language barrier or deafness
* Admission for neurological surgery
* Participation in this study during a previous hospital admission
* Practical or logistical reasons hampering the use of the delirium monitor, such as technical failure of the monitor
* Isolation because of known carrier ship of a resistant bacterium
Remote Game-based Exercise Program for Cognitive and Motor Function Improvement

As our population ages, more older adults face motor-cognitive declines, increasing their risk of falls and fear of falling. Exercise is an effective way to maintain cognitive function, as supported by recent studies. However, those with poor motor and cognitive abilities often struggle to visit rehabilitation centers, leading to high dropout rates and low adherence to unsupervised programs. A remote exercise program tailored for individuals with cognitive impairments is urgently needed to preserve cognitive function, promote independent living, and reduce related costs. Researchers aim to develop an in-home system for adults with mild cognitive issues or dementia, designed to improve balance and cognition while being remotely supervised through telemedicine.

This study aims to develop and validate a remote exercise intervention for individuals at risk of or experiencing dementia using a wearable sensor-enabled platform, called Tele-Exergame. This approach could preserve cognitive function, promote independent living, reduce costs related to cognitive-motor decline, and advance remote technology use for screening cognitive and motor performance in older adults. The findings are crucial for healthcare providers, clinicians, seniors, and caregivers.

100 participants will be randomly assigned to either the intervention or control group, both undergoing a 12-week daily home exercise program for at least cumulative active exercise of 30 minutes per week twice weekly. The intervention group will complete sessions remotely using Tele-exergame, while the control group will participate in home-based exercise without technology.

Eligibility Criteria:
Inclusion Criteria:

* Adults with diagnosed with dementia or cognitive impairment
* Living independently in a residential home with a caregiver/informant
* Able to walk at least 30 feet with or without assistance

Exclusion Criteria:

* Immobility or major mobility disorder or inability to engage safely in the proposed weight-bearing exercise program
* Diagnosed with severe cognitive impairment (MoCA score \< 16)
* Subjects with major hearing/visual impairment
Profile and Regulatory Network of Exercise in Improving Metabolic Phenotypes of Patients with Prediabetes

This study is a single-arm, self-control, single-center study to investigate the molecular mechanism under exercise improving metabolism of patients with prediabetes. 40 overweight/obese patients with prediabetes will be recruited in this study and instructed to participate in an 8-week exercise program. We aim to investigate 1) the changes of clinical phenotypes such as body weight, body fat, laboratory values, and resting energy expenditure before and after exercise 2) the changes of peripheral blood mononuclear cell by single cell sequencing 3) search for potential biomarkers of exercise in improving metabolism through multi-omics integrated analysis of single-cell transcriptome, phenomics, metabolomics, etc.


Eligibility Criteria:
Inclusion Criteria:

1. Han Chinese
2. 5.6 mmol/L≤fasting blood glucose\<7 mmol/L, and/or 7.8 mmol/L≤2h-postload glucose\<11.1mmol/L, and/or 5.7% ≤HbA1c\<6.5% without anti-hyperglycemic medicine treatment
3. Voluntary participation and provide informed consent

Exclusion Criteria:

1. Participated in any clinical study in relation to weight-loss in the past 1 year
2. Had a weight change of more than 10% present weight in the past 1 year
3. Had a drug usage not suitable for this study in the past 3 months, such as hormone drug, orlistat, metformin, GLP-1 receptor agonists, lipid-lowering agents, liver protection drug, etc
4. Presence of diseases influencing glucose and lipid metabolism ,such as hyperthyroidism, hypothyroidism, Cushing syndrome, etc
5. Poorly controlled blood pressure: systolic blood pressure≥180mmHg, and/or diastolic blood pressure≥100mmHg
6. Presence of serious heart, liver, kidney or systemic diseases
7. Presence of skeletal and muscular diseases which make it difficult to exercise
8. Received any kind of surgery in the past 1 year
9. COVID-19 positive or recovery from COVID-19 within 4 weeks
10. Presence of eating disorders or have a history of eating disorders
11. Presence of sleep disorders
12. Work in disrupted circadian rhythms
13. Pregnancy and breastfeeding women
Vascular Dysfunction in Offspring of Assisted Reproduction Technologies

The prevalence of infertility has been estimated at 9% worldwide. The steadily increasing use of assisted reproductive technologies (ART) has allowed millions of infertile couples to have children. These children make up for 1 to 4% of the population in developed countries. ART involves the manipulation of early embryos at a time when they may be particularly vulnerable to external disturbances. In line with this concept, studies in mice suggest that ART alters the activity of enzymes involved in the regulation of metabolic and cardiovascular homeostasis. Alternatively, infertility itself or the drugs used to stimulate ovulation may have adverse effects on the outcome of the offspring. The safety of ART for long-term health is, therefore, of utmost importance. Among the potential long-term consequences of ART, cardiovascular disease may represent an important candidate, but there is no information.

Investigators show that, children born after in vitro fertilization (IVF) present systemic and pulmonary vascular dysfunction at high-altitude when compared to age- and sex-matched control subjects. A 5 years follow-up study shows that premature vascular aegieng persist and evolve to arterial hypertension. Arterial hypertension may induce cardiac dysfunction.

Therefore, the major goal of this proposal is to assess cardiac function in apparently healthy participants born after ART.


Eligibility Criteria:
Inclusion Criteria:

* Offspring of ART
* Healthy
* Born at term

Exclusion Criteria:

* Cardio-pulmonary malformations
* Neuro-muscular malformations
Pilot Trial for WounDx™ Clinical Decision Support Tool

The purpose of this research is to evaluate the overall use of the WounDx medical device in a clinical setting, such as a hospital. The WounDx device is experimental and not yet approved by the United States Food and Drug Administration (FDA). WounDx uses information about a patient's wound to generate a report that a surgeon may use to help determine when to close or not close the wound. The final decision to close the wound remains with the surgeon. The results from this pilot trial will inform a larger pivotal trial.

Determining if a large, traumatic extremity wound is ready for successful delayed closure remains a challenge, as approximately 23%-25% of these wounds fail to heal after delayed closure is attempted, even when treated with aggressive surgical interventions, including debridement every 2-3 days. This pilot trial uses WounDx™, a device that aids clinicians in identifying extremity wounds that are likely to heal after surgical closure. The device is a Clinical Decision Support Tool (CDST) and consists of two main components: an immunoassay to obtain the expression of inflammatory biomarkers and, together with clinical data input, an interpretative algorithm. The purpose of the device is to identify wounds likely to proceed through normal phases of wound healing and, as a result, provide the clinician with a wound-specific prediction that an open traumatic extremity wound will heal successfully and remain closed if delayed closure is performed. The pilot trial serves as a proof of concept (POC) trial and establishes the overall feasibility of clinical operations (including recruitment, randomization, implementation of the intervention, and data collection). Trial enrollment is planned only for adults (≥18 to ≤65 years) with at least one traumatic extremity wound ≥75cm 2 , being treated with Negative Wound Pressure Therapy (NPWT), and delayed primary closure including split thickness skin grafting and rotational or free flaps. Local and systemic inflammatory biomarker expression will be assessed in wound effluent samples collected during subject treatment. These results will be input with other associated clinical data to WounDx™ to allow the device to provide a report including a recommendation on whether a specific wound should be closed within 48-72h of the previous debridement surgery, which is consistent with the current clinical practice guidelines. This pilot trial will inform the conduct of a larger, pivotal clinical trial to evaluate the safety and efficacy of WounDx™ in aiding clinicians identify traumatic extremity wounds ready for surgical closure.

Eligibility Criteria:
Inclusion Criteria:

* Wound surface area ≥75cm 2
* Extremity injury (including shoulder and buttock - without visceral communication)
* Wound amenable to Negative Pressure Wound Therapy using 3M™ V.A.C. ® canisters without gel pack

Exclusion Criteria:

* Insulin Dependent Diabetes
* Peripheral Vascular Disease
* Connective Tissue Disorders
* Preexisting immunosuppressive conditions or immunosuppression therapy
* Pregnancy
* Prisoners