cyrilzakka/clinical-trials huggingface dataset:
Obesity, Insulin Resistance, and PASC: Persistent SARS-CoV-2

The investigators are studying the pathophysiologic links between obesity, insulin resistance (IR), adipose tissue infection, and post-acute sequelae of COVID-19 (PASC). This study looks at whether adipose (fat) tissue contributes to PASC by driving chronic inflammation or by serving as a reservoir for SARS-CoV-2 persistence. The results will not only determine whether obesity and IR are risk factors for PASC, but will also define fundamental biology that sets the stage for the investigation of novel or existing therapies that target the causal pathways identified.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 to 80
* BMI ≥ 25 kg/m2
* not currently pregnant

Exclusion Criteria:

Arm 2 (Adipose Tissue Biopsy) exclusions include

* pregnancy
* prior liposuction
* recent change in weight (\> 2 kg in one month)
* bleeding disorders
* anticoagulant use

Arm 3 (healthy controls only) exclusions include patients with

* major organ disease
* diabetes
* history of liposuction
* bariatric surgery
* eating disorders
* psychiatric disorders
* pregnancy or lactation
* recent change in weight (over the past 12 weeks),
* use of weight loss medication or oral steroids
* hematocrit \< 33%
* fasting glucose \>= 126 mg/dL
* blood pressure \>160/100 mmHg
Daily Chlorhexidine Care at the Exit Site in Peritoneal Dialysis Patients

Chlorhexidine is used in central line dressing changes and is effective in reducing line infections. It is unclear if daily chlorhexidine care at the exit site in peritoneal dialysis (PD) patients can reduce the risk of Staphylococcus aureus (SA) colonization or exit site infection.

There is no consensus on what regimen is optimal for topical care of the peritoneal dialysis (PD) catheter exit site. Several methods including soap and water, povidone-iodine, hydrogen peroxide, chlorhexidine, and topical antimicrobial agents such as gentamicin or mupirocin cream have been described for care of the exit site. However, many of these studies were small or short-term and lacked longitudinal evaluation of bacterial decolonization efficacy. Staphylococcus aureus (SA) is one of most common causes of peritonitis and exit-site infection and is associated with a high PD catheter removal rate. Carriers of SA had a higher rate of exit-site infection than non-carriers. In previous studies, staphylococcal carriage prophylaxis using either mupirocin or gentimicin ointment in the nares or exit site significantly reduced the rate of exit-site infection due to SA. However, emerging antibiotic resistance is a concern. In addition, MRSA infection in PD patients is more severe than other pathogens; therefore, choosing a good antiseptic for SA and/or MRSA decolonization is important.

In recent years, the use of chlorhexidine in bathing or central line dressing changes was implemented to prevent bacterial colonization and multidrug resistant bacterial infections and was also used in hemodialysis patients. Data regarding chlorhexidine used in the catheter care of PD patients are limited and it is unclear if the use of chlorhexidine for exit site care contributes to long-term bacterial decolonization and acts as a prophylaxis for exit site infections.

Eligibility Criteria:
Inclusion Criteria:

* patients \> 20 years old who received PD for more than 3 months

Exclusion Criteria:

* a history of psychological illness or condition that interferes with caring of a wound
* recent (within 1 month) exit-site infection, peritonitis, or tunnel infection
* recent treatment with an antibiotic administered by any route in the last month
* or known hypersensitivity to or intolerance of chlorhexidine or mupirocin
COLOMBES Project:Constitution of a Population-based Cohort of Obese Subjects With Longitudinal Long-term Follow-up

The objective of the project is the constitution of a population-based cohort of 500 persons with severe or morbid obesity (BMI over 35 kg/m2) with annual follow-up for 10 years. It aims to improve the physiopathological, epidemiological and prognostic knowledge of obesity and its consequences. Clinical data, biological material, exams and questionaires will be collected and stored, allowing the realisation of research works, initiated by research teams from our hospital or from other settings.

The objective of this observational study is the follow-up of a cohort of 500 adult persons with morbid obesity (BMI\>35 kg/m2).

Clinical and paraclinical data, and biological samples (plasma, serum, DNA, RNA, cell blood, for persons undergoing bariatric surgery (specific consent): samples of liver and adipocytes) will be collected and stored during the follow-up visits. These visits take place at inclusion, at 6 months, twelve months and every year for ten years. The collection of parental DNA will be proposed when feasable for genetic studies.

Persons will be recruited for four years, with an expected number of 350 persons included, in the clinical research unit of Louis MOURIER university hospital (AP-HP).

Each person included will participate in the study for ten years. When included, patients agree to come every year to follow-up visits. They are informed that data collected will be used only for research on obesity and its health consequences.

Eligibility Criteria:
Inclusion Criteria:

* BMI\>35

Exclusion Criteria:

* previous bariatric surgery
* pregnancy
Direct Assessment of Microcirculation In Shock (DAMIS)

Maintaining organ perfusion is the key to successful intensive care medicine. Shock is the most dangerous microcirculatory disorder and one of the most hazardous and lethal conditions of critically ill patients still showing high mortality rates. However, there are still ongoing controversies, how to assess microcirculation, how to predict outcome in time and how to guide specific therapy. Macrocirculation does not reflect microcirculation. Microcirculation reflects organ perfusion and correlates with the outcome. There is growing evidence that microcirculatory parameters are powerful tools to predict the outcome after cardiac arrest. Several guidelines use it as a target to guide therapy, but these recommendations base only on supporting evidence of low quality. Lactate is a late reflector of reduced organ perfusion and is of limited value for time-critical decision-making and their value as a therapeutic target. Sublingual sidestream dark-field (SDF) - measurement is a non-invasive method that reliably reflects organ perfusion. The last generation of microcirculation assessment tools are easy to use hand-held devices that use an automatic algorithm. In consequence, microcirculation has become a directly detectable physiological compartment. However, systematic investigations about this technology in shock are still lacking. DAMIS determines the value of directly assessed microcirculation on outcome in different types of shock. Therefore, this multicenter study will recruit up to 200 patients in shock. After the first measurement, patients will be randomized either to intervention or to control. The intervention consists in knowing microcirculatory parameters. A checklist will assist the treating physicians of the interventional group in explaining microcirculatory values and offering possible treatment options. Patients in the control group will be measured as well, but results will not be communicated to the treating physician.


Eligibility Criteria:
Inclusion Criteria:

1. Older than 18 years
2. Admitted to the ICU in state of shock at the time point of admission to ICU or in the first 3 hours defined as

   * the need to use vasopressors, -dilatators, fluids to maintain mean arterial pressure \> 65 mmHg
   * AND lactate \> 2 mmol/l

Exclusion Criteria:

1. Younger than 18 years
2. Anatomic reasons that inhibit sublingual measurement
3. Lack of informed consent
4. more than 4 hours after ICU admission
Using Saliva Stimulation to Immediately Improve Heart Failure Inpatient's Thirst Sensation

The purpose of this study is to Using saliva stimulation to immediately improve heart failure inpatient's thirst sensation.

After being informed about the study and potential risks, all patients giving written informed consent will screening period to determine eligibility for study entry. Patients who meet the eligibility requirements will be randomize in a double-blind manner (participant and researcher) in a 1:1 ratio to experimental group (lemonade ice cubes) or the control group (water ice cubes).

Eligibility Criteria:
Inclusion Criteria:

* 1. Hospital stay for more than 24 hours;
* 2. NYHA III-IV;
* 3. Oral mucosa is intact, without ulcers or wounds;
* 4. Consciousness and normal cognitive function;
* 5. Those who are more than 20 years old and can answer the questionnaire in Chinese or Taiwanese verbally or in writing;
* 6. Normal swallowing function;
* 7. Stable vital signs and maintain systolic blood pressure above 90mmHg;
* 8. Those who need to limit water according to doctor's advice

Exclusion Criteria:

* 1. Those with endotracheal tube and respirator;
* 2. Those with indwelling nasogastric tube;
* 3. Those who fasted according to the doctor's advice;
* 4. Those who were diagnosed with dry syndrome
Train Your Brain: Neurofeedback Intervention for PTSD

The investigator's aim is to evaluate the efficacy of two types of neurofeedback treatments for PTSD symptoms reduction. Half of the participants will receive the current standard for PTSD neurofeedback care undergoing alpha/theta neurofeedback regulation. The other half will receive the newly developed limbic modulation index neurofeedback.

Traumatic stress is commonly resistant to existing therapeutics, possibly due to high treatment dropout rates along with a failure to target the relevant underlying neural mechanisms. Neuromodulation of deep limbic areas such as the amygdala may play a critical role in the effective recovery from traumatic stress. Human studies have shown the importance of such modulation during the encoding of traumatic stimuli, showing greater amygdala activation for subsequently remembered traumatic stimuli. In addition, a prospective study among previously healthy soldiers showed that hyper-activation of the amygdala prior to military traumatic exposure corresponded with more severe post-traumatic symptoms following exposure.

Together these finding points to the amygdala as a plausible neuromodulation target for preventive or early interventions of post-traumatic disturbances. Local neuromodulation of the amygdala could improve treatment specificity and the overall intervention outcome.

The main goal of the suggested research is to further develop and implement a non-invasive, portable and cost-effective brain-imaging tool that will provide individual on-line guidance for amygdala modulation. This closed-loop brain training will enhance individual resilience to and coping with potentially traumatic stress as well as alleviate consequential psychopathologies.

Eligibility Criteria:
Inclusion Criteria:

* Previous diagnosis of PTSD
* PTSD symptoms within the last 30 days

Exclusion Criteria:

* Any active psychosis or suicidal intent
* A severe traumatic brain injury (one in which consciousness was lost for greater than 6 hours)
* Any of the following neurological disorders: Parkinson's, Alzheimer's, Brain Tumor, or Brain Lesion.
The National Musculoskeletal Audit and Research Database

Developing and testing a musculoskeletal national audit in community/primary care

This project aims to develop, setup and test an MSK national audit which will use patient and clinician inputted data to measure the quality of care for patients presenting in community MSK services and general practice with common MSK conditions. Secondly this project aims to use the national MSK audit information to understand and improve the quality and consistency of care for MSK patients.

Eligibility Criteria:
Inclusion Criteria:

(MSK Services)

* MSK service seeing adult (+18 years) set in community care
* MSK service with at least 10 WTE HCPs
* System in place for digital collection of PROM/PREM data

(FCP Services)

* FCP service seeing adult (+18 years) in primary care
* FCP service with at least 1 WTE FCP seeing MSK patients
* Use of EMIS or SYSTMONE
* Able to implement Midlands FCP template
* System in place for digital collection of PROM/PREM data

(For patients)

* +18 years
* Active phone number or verified email address to participate in the patient questionnaire
* Able to provide informed consent

Exclusion Criteria:

(MSK Services)

\* Secondary care MSK services

(For patients)

* Has declined for data to be part of research as part of consent process
* Unable to complete surveys due to health issues including severe or terminal illness, severe learning difficulties or psychological disorders
Efficacy and Safety of Broncho Muco Cleaner Balloon Dilation Therapy

In COPD patients with chronic bronchitis, it is aimed to determine whether the broncho muco cleaner balloon dilation method can provide clinical and functional benefit by causing destruction in hyperplasic goblet cells in the bronchial system. Although 2 studies have been published on this subject before, one of them is a retrospective design and the other is a pilot study consisting of only 10 patients . Therefore, it is clear that it should be supported by a controlled prospective study with more patients.

Within the scope of the research, broncho muco cleaner balloon dilatation treatment will be performed with fiberoptic bronchoscope under general anesthesia in chronic bronchitis-predominant COPD cases, and the effectiveness and reliability of the procedure will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Adults of both sexes aged 40-75 years
* Being diagnosed with stage II-IV chronic bronchitis-predominant COPD according to the GOLD guideline
* To have quit smoking for at least 6 months
* mMRC 2 and above
* Receiving optimal medical treatment for COPD
* Being stable for at least 3 weeks
* To have completed 6 weeks of pulmonary rehabilitation before the first procedure
* Having sufficient mental and physical capacity to sign the voluntary consent form for the procedure.

Exclusion Criteria:

* be under the age of 40 and over the age of 75
* pregnant patients
* breastfeeding a child
* Being an active smoker
* Concurrent asthma
* Chronic kidney disease with GFR \<30 ml/min
* Clinically significant arrhythmia, Left heart failure (EF\<45) or pulmonary hypertension (PABs\>45 mmHg)
* Liver cirrhosis
* Those who use anticoagulants or clopidogrel or equivalent drugs and cannot be stopped before and during the procedure, or the presence of bleeding diathesis
* 6 minutes walking test \<100 meters
* FEV1\<15%
* Those with positive early reversibility in pulmonary function tests
* Patients who do not regularly take 15lgu15in therapy for COPD
* Emphysema-predominant COPD patients
* Presence of active malignancy
* Partial CO2 pressure \> 55mmHg or pO2\<55 mmHg in room air
* Active pulmonary infection
* Pneumothorax or pulmonary surgery in the last 6 months
* Patients with other clinically significant lung disease other than COPD
* Those who have undergone a previous lung device procedure, including implanted emphysema stents, lung coil delivery, valves, lung denervation, or other devices for emphysema.
* Those taking \> 10 mg of prednisolone per day
* Those with a known sensitivity to the drug (such as lidocaine, 15lgu15ine and benzodiazepines) needed to perform bronchoscopy.
Skin Flap Visible Light Spectroscopy (VLS) Oximetry for Monitoring Free-Flap Ischemia During Breast Reconstruction and Recovery

The purpose of the study is to understand the relevance of tissue oximetry measures of tissue flaps during surgery and during recovery, and to determine if T-Stat is a reliable and early method of detecting compromised flaps.

The tissue saturation of free flaps will be measured before, during, and after surgery and during recovery.

Eligibility Criteria:
Inclusion Criteria:

* Under surgical breast reconstruction
* Informed consent

Exclusion Criteria:

* Failure to give consent
Effect of Cocoa Flavanols on Vascular Function

Endothelial dysfunction is associated with a higher incidence of adverse cardiovascular events in patients with coronary artery disease (CAD). CAD patients also show impaired function and number of endothelial progenitor cells (EPCs, adult stem cells) which circulate in adult blood and contribute to endothelial repair. Clinical studies suggest that endothelial function can be improved in CAD patients by consumption of flavanol-rich cocoa. Yet, the mechanism is not known. It is also not known whether flavanol-rich cocoa provides an additive, positive effect in patients who are already receiving the maximal recommended therapies for risk factor modification. Therefore, the researchers propose to perform an investigator-initiated, randomized controlled cross-over study administering flavanol-rich cocoa or a placebo for two months in CAD patients on optimal medical therapy. An improvement of endothelial function as measured by flow-mediated dilation (FMD) will be the primary endpoint of this study. The researchers propose to also measure determinants of FMD such as microvascular response, inflammatory markers, metabolites of nitric oxide, as well as the number and function of EPCs in the blood. Importantly, detailed food questionnaires and plasma flavanols/metabolites will help to further support a causal link between flavanol-intake and improved vascular function.


Eligibility Criteria:
Inclusion Criteria:

* CAD patients over 18 years of age
* Contact university for more details.

Exclusion Criteria:

* Contact university for more details.
A Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis

To explore the effective dose and safety of the effect of hydronidone and entecavir on hepatic fibrosis in chronic viral hepatitis B.

Primary observation indexes:

Hepatic fibrosis Ishak score after treatment decreases by the proportion not less than 1 compared with that before treatment.

Secondary observation indexes :

1. Negative conversion ratio of HBV DNA after treatment (HBV DNA\<1×103copies/mL) and falling range.
2. The falling proportion of Fibrocan Kpa value after treatment compared with that before treatment.
3. The falling proportion that decreases not less than 1 level and progression-free fibrosis after treatment compared with that before treatment.
4. The improvement of ALT of liver function.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-65, all genders.
2. History of chronic hepatitis B, HBsAg positive≧six months.
3. ALT\<eight-fold ULN (maximum).
4. Significant liver fibrosis confirmed by liver biopsy.
5. HBeAg positive patients, HBV DNA\>2.0×104 IU/mL (copies/mL); HBeAg negative patients，HBV DNA\>2.0×103 IU/mL (104copies/mL).
6. Having not accepted the antiviral therapy with interferon and/or nucleoside analog.
7. Having not taken anti-inflammatory drugs to protect liver within 1 month before selection.
8. Capable of understanding and signing the informed consent before the study.

Exclusion Criteria:

1. Failing to meet any one requirement of the inclusion criteria.
2. Having suffered massive hemorrhage of gastrointestinal tract within 3 months before selection
3. TBiL\>three-fold ULN.
4. AFP\>100 ug/L
5. PLT≦60×109/L
6. PTA\<50%
7. Having obvious space-occupying lesion in liver as shown by B ultrasound examination.
8. With a portal vein ≧1.2cm wide as shown by B ultrasound examination.
9. BMI index\>30.
10. The patient who suffered from liver function decompensation hepatic cirrhosis and liver neoplasms.
11. The patient with alcoholic, drug-induced, hereditary, immune and other viral and non- viral chronic hepatitis.
12. The patient with angiocarpy, lung, kidney, incretion, nerve and blood system disease and mental disease.
13. The patient with active peptic ulcer.
14. Gestational and breast feeding women.
15. The subject is the legal disabled person according to the Law of the People's Republic of China on the Protection of Disabled Persons of the April 2008 edition.
16. The subject who participated in other drug tests within recent 3 months.
17. The patient who is suspected with poor compliance or disagrees to participate in the test.
18. The patient who is considered by other investigators not to be suitable for participating in the study.
Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Type 2 Diabetes

This trial is conducted in Oceania and North America. The aim of this trial is to assess the long term safety and efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes who have completed the BIAsp-1234 trial.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have been correctly included in and completed BIAsp-1234

Exclusion Criteria:

* Persistent non-compliance with study medication, visit schedules or other trial specific procedures during the preceding trial
* Fulfilment of any withdrawal criteria prior to and including the final visit of the BIAsp-1234.
* Females only: breast feeding, intention of becoming pregnant, or judged to be using inadequate contraceptive measures (adequate contraceptive methods are sterilisation,IUD (Intra Uterine Device), oral contraceptives or barrier methods)
* Known or suspected allergy to trial product or related products
* Development since entry into the previous trial of late diabetic micro or macro vascular complications, which in the opinion of the Investigator indicates a progressed state of disease
Increasing Physical Contact Between Prenatally Anxious/Depressed Mothers and Their Infants to Improve Maternal Sensitivity.

The goal of this randomized controlled pilot trial is to evaluate the feasibility, acceptability, and clinical utility of a baby carrier intervention aimed at improving maternal sensitivity and mother-infant bonding in prenatally anxious/depressed mothers. The study has three main questions:

1. Is the intervention feasible (e.g., enrollment and recruitment rates) and acceptable to participants (e.g., compliance and perceived benefits)?
2. Does the intervention improve maternal sensitivity compared to a waitlist control group?
3. Does the intervention increase mother-infant neural synchrony compared to a waitlist control group, measured using functional near-infrared spectroscopy?

Participants will A. Choose between two soft ergonomic baby carriers and be expected to use the baby carrier for the prescribed amount of time (intervention group).

B. Have two home visits, one at the start (at postpartum week 8) and another one at the end of the study (at postpartum week 16).

C. Complete questionnaires about depression and anxiety symptoms, mother-infant bonding, and rate protocol burden.

D. Share their feelings and lived experiences about the frequent use of a baby carrier and increased physical contact with their baby through open-ended interview questions (intervention group).

The intervention involves mothers in the experimental group using a soft ergonomic baby carrier for a prescribed amount of time over a period of six weeks. Weekly adherence self-reports will be collected via REDCap. Participants will be recruited from the Perinatal Multisite Databank (PMD), an ongoing clinical cohort of individuals receiving psychiatric services during pregnancy and the first six months postpartum in the province of Quebec, Canada.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* be able to communicate in English or French
* diagnosed with a depressive or anxiety disorder (or both) during their intake visit within the Perinatal Multisite Databank (PMD)
* residing in the greater Montreal area
* have given birth to a healthy baby

Exclusion Criteria:

* having known alcohol or substance use issues,
* having been diagnosed with psychosis or schizophrenia during the PMD intake assessment, or have had thoughts of harming the self or the baby
* having physical restrictions that may prevent the regular use of a baby carrier
* taking any medications regularly that cause potential participants to feel drowsy or dizzy
* already using a baby carrier with their current baby for more than 5 hours a week