cyrilzakka/clinical-trials huggingface dataset:
Building Resiliency and Vital Equity (BRAVE) Project: Understanding Native Americans' Perceptions/Beliefs About COVID-19 Testing and Vaccination Study

The Building Resilience and Vital Equity (BRAVE) project seeks to partner with American Indian tribal communities in North Carolina to establish COVID-19 services and resources for American Indian communities. The goal of this study is to 1) understand the barriers and social implications of COVID19 testing and vaccination among American Indians by designing and implementing culturally sensitive survey tools and intervention materials; 2) Implement BRAVE outreach and testing interventions to increase testing in American Indian communities; 3) analyze data and share back with tribal communities to improve perceptions of COVID-19 testing in the AI community and decrease in vaccine hesitancy.


Eligibility Criteria:
Inclusion Criteria:

- Self reports as Native American or American Indian

Exclusion Criteria:

* Does not self-report as Native American or American Indian
Observational Study of Drug Naive Diabetes Receiving Insulin Therapy

A multi-centre, open-label trial to investigate the efficacy and possible mechanism of Continuous Subcutaneous Insulin Infusion treatment in patients with drug naive type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

for type 2 diabetes:

1. Male or female age ≧ 25 years and ≦75 years old
2. HbA1c ≧8.0%
3. durg naive

for normal controls：

1. Male or female age ≧ 25 years and ≦75 years old
2. Normal glucose tolerance confirmed by oral glucose tolerance test

Exclusion Criteria:

1. Islet antibody positive
2. Athletes, has a history of skeletal muscle injury ( trauma or surgery ), skeletal muscle wasting diseases ( such as mitochondrial myopathy, muscular atrophy, etc )
3. Acute infection(such as cute upper respiratory infection, acute pneumonia)
4. long-term use of non-steroidal anti-inflammatory drugs, corticosteroids and immunosuppressive drugs
5. consists with other endocrine diseases
6. pregnancy
7. cancer
8. use of antibiotics in 3 months
9. chronic digestive inflammations
10. magnetic resonance imaging contraindications
Evaluation of the BRADA and ABILHAND Questionnaires

This protocol is designed to evaluate the BRADA and ABILHAND questionnaires in rheumatoid arthritis (RA) patients that will be treated with an effective therapy. Patients with moderate to severe RA treated with tocilizumab will be asked to complete the BRADA and ABILHAND questionnaires at screening, baseline, after 12 weeks and after 24 weeks of treatment. All other assessments and questionnaires from daily clinical practice (such as the global assessment of disease activity by the patient, the Health Assessment Questionnaire (HAQ), the SF36 questionnaire, measurement of ESR and CRP and the DAS 28 calculation), will also be used to evaluate these questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* patients with moderate to severe RA.
* Inadequate response on earlier optimal use of a minimum of two DMARDs (disease modifying anti-rheumatic drugs such as goldsalts, salazopyrine, leflunomide, methotrexate (MTX)) as far as one of the two used DMARDs is MTX that at the exception of a documented intolerance despite the association with folic acid, should have been administered IM or oral during a minimum of 3 months and at a minimal dose of 15mg/week.
* DAS 28 score ≥ 5.1
* For whom a drug that is registered for the treatment of moderate to severe RA is commercially available but does not constitute a satisfactory treatment for this patient.
IV Antibiotics With Lavage for Severe PD Peritonitis

This is a randomized controlled trial to evaluate whether a switch to intravenous antibiotics with adjunctive lavage can improve the outcome of severe peritoneal dialysis related peritonitis.

The standard treatment of peritoneal dialysis (PD) related peritonitis is intraperitoneal (IP) antibiotics. In severe cases not responding to the IP antibiotics treatment, timely Tenckhoff catheter removal is needed. There is no known adjunctive measure that can improve the clinical outcome of the patients suffering from severe PD peritonitis.

Based on the past experience in the investigators' center, switching IP to intravenous route of antibiotics administration, together with adjunctive lavage was proposed to improve the clinical outcome of severe PD peritonitis, in particular a possible improved catheter salvage rate. This method will be evaluated in the present clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Prevalent PD patients with age \>= 18 years old suffering from PD peritonitis
* PD effluent white cell count \>1090/mm2 on peritonitis day 3
* Lack of clinical response
* Informed consent available

Exclusion Criteria:

* PD peritonitis in association with exit site or tunnel infection
* Relapsing peritonitis (i.e. peritonitis caused by same organism within 4 weeks after completion of antibiotics therapy)
* Fungal peritonitis
* Mycobacterial peritonitis (both tuberculosis and non-tuberculosis species)
* Clinical suspicion of surgical peritonitis
* Penicillin- or cephalosporin allergy, that cefazolin and ceftazidime could not be used
Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Bayesian Basket Trial

PALETTE is a perpetual adaptive platform to efficiently study sepsis interventions within 'treatable traits' in all-ages patients enabling prompt evaluation of pandemic treatments. Treatable traits, therapeutic targets identified by phenotypes or endotypes (defined by biological mechanism or by treatment response) through validated biomarkers (measurable characteristic reflecting normal or pathogenic processes, or treatment responses), may include multi-omics, cellular, immune, metabolic, endocrine features, or intelligent algorithms. PALETTE Bayesian adaptive design enables parallel investigations of multiple interventions for sepsis, and quick inclusion of pandemic pathogens. PALETTE's new conceptual model will respond to the challenges of standard approaches, i.e. series of sepsis trials, each investigating one or two interventions, expensive, time consuming, and inappropriate in pandemic context.


Eligibility Criteria:
Inclusion Criteria:

* All genders patients aged \>37 weeks corrected gestational age with sepsis as per Sepsis-3 definition for adults, and as per the PHOENIX sepsis for children
* documented or suspected infection
* a Sequential Organ Failure Assessment (SOFA) score ≥2 for adults, and PHOENIX sepsis score of ≥2 for children.

Domain specific additional inclusion criteria :

1. Hyper or hypo inflammation based

   * For adults on, respectively: beta, delta and gamma sub-phenotypes, and/or circulating levels of IL-6 \> 100pg/mL, and lymphocytes counts \< 1.0 × 109/L and/or HLA-DR \<5,000 HLA-DR receptors/monocytes
   * For children on: the PODIUM (+specific criteria for children)
2. Corticosteroids domain Corticosteroids responses based on the combination of Glucocorticoid-induced 1 GLCCI1) AA and nuclear factor (NF)-KB1 DI genotypes.
3. Coagulation domain

   * Hypercoagulation state defined as a SIC score ≥4 points and neutrophils side fluorescence light (NEUT-SFL) \>66 Arbitrary Units (patients with disseminated intravascular coagulopathy, DIC) or NEUT-SFL ≤66 AU (septic coagulopathy)
   * Hypofibrinolytic state defined as SIC score ≥4 points and decreased plasminogen level \<1.2 nM.

Exclusion Criteria:

* refused to consent participating in the study
* pregnancy
* any condition for which patient's primary physician will consider inappropriate enrolling patient in the study
* previous enrollment in the study.
* additional domain specific exclusion criteria relevant to specific interventions, i.e. tocilizumab, baricitinib, anakinra, hydrocortisone, fludrocortisone, unfractioned heparin, tinzaparin, human recombinant thrombomodulin, sivelestat, fresh frozen plasma, according to the "base de données publiques des medicaments"

Patients can be included in multiple domains.
The Acute Effects of Food Structure on Post Prandial Glucose and Subsequent Metabolic Responses

Aims: To investigate the effects of different food structures on glucose concentrations and subsequent metabolic responses including insulin,GIP, GLP-1 DESIGN: A randomised, controlled, clinical trial.

Rationale:

There is very little evidence at the present time in the role of food structure in glucose homeostasis. There is circumstantial evidence that foods consumed intact have great effects on suppressing appetite.

To test the effect of three structurally different meals with the same nutritional content and volume on appetite regulation. Each participant will receive the following meals:

Solid meal group. Milled (intact-cell) meal group. Milled (destroyed-cell) meal group.

All of which will contain the same macro and micro nutrients from the same food sources

Eligibility Criteria:
Inclusion Criteria:

* Gender: male and female
* Age ≥ 18 years ≤ 65 years
* Normal weight as classified by BMI 20-29.9 kg/m2
* Healthy, not diagnosed with any chronic diseases assessed as appropriate for inclusion, based on the pre-study screening.
* Willingness and ability to understand, participate and to comply with the study requirements
* Willingness and ability to give written informed consent

Exclusion Criteria:

* Has thyroid defects
* Under hormone or steroids therapy
* Is pregnant or lactating (female)
* Had given birth within the past year (female)
* Is taking drugs that could affect appetite or plasma glucose levels.
* Is taking natural remedies that modulate appetite or plasma glucose levels.
* Has excessive alcohol intake
* Had blood donation within 12wks prior to start date
* Psychiatric illness
* Smokers
* History of any disease with unknown outcome
* Has diabetes
* Has nut allergy
Peritoneal Damage in Laparoscopic Surgery

The investigators hypothesized that applying a low intraperitoneal pressure pneumoperitoneum (≤ 8mmHg) during laparoscopic cholecystectomy, the adverse impact on the surgical peritoneal environment (measured as gene expression of extracellular matrix, adhesion and inflammatory cytokine as well as oxidative stress response and apoptotic index), can be minimized and probably clinical outcomes might be better.

Cholelithiasis is one of the most frequent abdominal diseases requiring surgical treatment. Laparoscopic cholecystectomy is currently the procedure of choice to remove the gallbladder. There is growing evidence that increased intra-abdominal pressure pneumoperitoneum, even for short periods of time, is associated with both transient and sometimes persistent adverse effects that might negatively affect the surgical peritoneal environment .There are some studies that have demonstrated that using low intraperitoneal pressure pneumoperitoneum, undesired effects like adverse impact on peritoneal tissue and negative clinical outcomes could be reduced.Therefore intraperitoneal pressure target during laparoscopy should be the lowest to allow surgery be securely performed. Many strategies have been tested in order to improve the volume of gas can be insufflated inside the abdominal cavity while maintaining low pneumoperitoneum pressure during laparoscopy.So far the most studied strategy has been deep neuromuscular blockade.However the effect of the depth of neuromuscular blockade in the intraabdominal volume is still controversial as sometimes in humans its benefits are marginal.There is scarce information in the medical literature regarding the adverse impact on peritoneal tissue of high pneumoperitoneum pressure during laparoscopy in humans. In addition available data are provided by non-prospective, non-randomized and small sample studies, so randomized controlled trials are required to ascertain this issues.To our knowledge our study is the first prospective and randomized controlled trial in humans aiming to study the adverse impact of high pressure pneumoperitoneum on peritoneal tissue as well as to associate it with clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years, signed informed consent, undergoing laparoscopic cholecystectomy for symptomatic cholelithiasis or gallbladder polyps.

Exclusion Criteria:

* Emergency surgery.
* Previous surgery at supramesocolic compartment.
* Previous peritoneal inflammatory process.
* Pregnancy or breastfeeding.
* Patient refusal to participate in the study
Role of Parasympathetic Activity in Mild to Severe Asthma With Fixed Airway Obstruction (PARASMA Study)

In asthma, the significant role of pathogenesis is chronic airway inflammation, bronchial hyperresponsiveness, and variable airflow obstruction. Asthma with irreversible or fixed airflow obstruction (FAO) is a clinical phenotype resulting from chronic airway inflammation with having longer disease duration, suggesting that airway remodeling contributes to the decline in lung function seen in individuals with asthma. Although this condition frequently occurs in patients with severe asthma, there are pieces of evidence occurring in those with mild to moderate asthma. According to previous research, low lung function, FEV1 less than 60% predicted, is a robust independent predictor of subsequent asthma attacks and other asthma outcomes, including asthma control and SABA use. In a recent study, the patients with mild to moderate asthma who received mild to medium dosed inhaled corticosteroid plus long-acting beta-2 agonist with or without asthma control showed evidence of FAO with or without bronchodilator reversibility. Therefore parasympathetic activity may be affected by FAO in those patients. The autonomic nervous system plays an essential role in asthma, especially from the parasympathetic, promoting bronchoconstriction and regulating airway inflammation and remodeling. This study hypothesizes that a cholinergic mechanism may play a significant role in FAO across patients with mild, moderate, and severe asthma. This might increase the fundamental evidence leading to early-step treatment with anti-cholinergic medication in early asthma severity driven by FAO.


Eligibility Criteria:
Inclusion Criteria:

* Asthmatic patients classified by severity Mild (achieved control with using low-dose ICS or as-needed ICS-formoterol) or Moderate (achieved controlled with using low-dose ICS/LABA or Severe ((achieved controlled with using medium to high dose ICS/LABA)
* Post-bronchodilator (Salbutamol) FEV1/FVC ratio less than 0.75 or below the Lower Limit of Normal (LLN) and Post-bronchodilator (Salbutamol) FEV1 predicted \< 80% with or without bronchodilator response
* History of smoking less than 10 pack-years or current smoking
* Patients who able to do spirometry without contraindication
* asthma control was defined by ACQ6 \< 1.5

Exclusion Criteria:

* Contraindication for spirometry
* Chest x-ray suggested any chronic lung diseased
* Contraindication for anticholinergic drug
* History of asthma exacerbation within 12 weeks before visit 1
* History of taking LAMA within 6 months before visit 1
Impact of Social Distancing on Bariatric Versus Non-Surgical Obese Patients During COVID-19 Pandemic

In response to the COVID-19 pandemic, weight management programs and metabolic surgery have been deferred to contain the virus. Quarantine and social distancing negatively impact dietary, exercise and psychological health of obese individuals. The study aims to evaluate the impact of social distancing measures on post-metabolic surgery patients compare to non-surgical obese patients and discuss potential strategies for management post COVID-19.

In Singapore, a nationwide partial lockdown, termed the "circuit breaker" was imposed from 7th April until 1st June 2020 in response to the COVID-19 pandemic (Appendix A). Our study aims to evaluate the impact of social distancing and lockdowns during this circuit breaker period on our patients with obesity, either post-metabolic surgery (MS) or undergoing active medical management (MM), during the COVID-19 pandemic in Singapore. Results will help inform and address the challenges in patient care that this pandemic has brought to light, its long-term implications on the management of the bariatric patient and discuss potential strategies for the management of a bariatric patient in a post COVID-19 society. To the knowledge of this paper, this is the first study to compare the impact of COVID on MS and MM patients which will allow understanding of unique stressors faced by MS patients

This study adopted a cross-sectional survey design to evaluate the impact of lockdown social distancing measures on obese patients in Singapore. The study conducted either face-to-face questionnaires in the clinic after lockdown for those who were not suitable for video consultation or questionnaires administered via telecommunication channels such as WhatsApp

Eligibility Criteria:
Inclusion Criteria:

* Obesity (BMI 30 kg/m2 and above)
* English literate
* Mental capacity to make their own decisions

Exclusion Criteria:

* Undergone bariatric surgery ≤ 6 months ago
* Have active eating disorders
* Pregnant or had given birth ≤ 6 months ago
* Admitted to hospital or tested positive for COVID-19
* Exhibit symptoms of active severe psychological and psychiatric conditions like psychosis, self-harm, suicide, hallucinations that may hinder them from providing accurate responses.
A Randomized Study of Temperature-controlled and Bipolar Radiofrequency for Inferior Turbinate Reduction

Currently, there are several alternative treatments for patients with chronic rhinitis (CR) who failed medication. Although, most of the researches have been focusing on temperature-controlled RF (TCRF), the cost is a major limitation for applying it worldwide. The investigators objective of this study is to compare the subjective and objective outcomes of Bipolar RF (BRF) with the more popular TCRF for CR treatment. The investigators hypothesized that both have equivalent outcomes but with less operative time and potentially at lower cost.


Eligibility Criteria:
Inclusion Criteria:

* Adults with snoring and chronic nasal obstruction.
* Respond to topical decongestant but not respond to nasal steroids, oral anti-histamine and oral decongestant
* Consent to the protocol.

Exclusion Criteria:

* Chronic active sinusitis, severe Deviated nasal septum (DNS), nasal polyps, sinonasal tumor, previous sinonasal surgery or head neck irradiation.
* Uncontrolled bleeding disorders, hypertension, or cardiovascular diseases
* Not complete the protocol
Brain Imaging to Understand the Role of Inflammation in N-Acetyl Cysteine (NAC) Treatment of Bipolar Depression

We are trying to understand what causes bipolar disorder and how medications treat bipolar depression. Particularly, we are looking at the importance of inflammation in the process. If you participate, you will have two different brain scans (MRI and PET scan). You will also have an experimental treatment for your depression named N-acetyl cysteine (NAC). The study is funded by the Columbia University Irving Institute to improve the treatment of bipolar disorder. Please contact us if you are interested in participating. Up to $600 in compensation if you are eligible and choose to participate. Up to 6 months of treatment for depression at no cost to you.


Eligibility Criteria:
Inclusion Criteria:

* Bipolar 2 disorder and meets criteria for a major depressive episode
* Age 18-60
* Females of child-bearing potential must be willing to use an acceptable method of birth control throughout the study
* Not currently taking psychotropic medications besides those allowed in the clinical trial

Exclusion Criteria:

* Failed trial or intolerable side effects of NAC
* Diagnosis of other major psychiatric disorders such as lifetime schizophrenia, schizoaffective disorder, psychotic features of bipolar disorder, current drug or alcohol abuse or recent drug or alcohol dependence
* Significant active physical illness, including blood dyscrasias, lymphomas, hypersplenism, endocrinopathies, renal failure, chronic obstructive lung disease, autonomic neuropathies, peripheral vascular disease. Any disorders with inflammation, malignancy, autoimmune or infectious etiology. Systolic blood pressure \>140 or diastolic blood pressure \> 100 Hemoglobin \<11 in females or \<13 in males
* Metal implants, pacemaker, metal prostheses, metal orthodontic appliances or shrapnel in the body
* Current, past or anticipated exposure to radiation
Investigation Into the Role of GTN & RIPC in Cardiac Surgery

The purpose of this study is to determine whether Glyceryl Trinitrate (GTN) reduces injury to the heart during heart-lung bypass surgery in combination with the newer technique of remote ischaemic preconditioning (RIPC).

Ischaemic heart disease is a leading cause of mortality in the western world. A number of patients undergo coronary artery bypass graft (CABG) surgery as treatment for ischaemic heart disease. With the rise of interventional procedures, patients who are coming to have CABG surgery are higher risk1. Remote ischaemic preconditioning (RIPC) has been shown to reduce perioperative myocardial injury (PMI) in patients having CABG even when cold blood cardioplegia or intermittent cross clamp fibrillation is used as cardioprotective measures. These patients have a general anaesthetic with multiple infusions including Glyceryl Trinitrate (GTN). The use of GTN in these patients is based on theoretical assumptions of coronary vasodilation pre operatively along with maintaining graft potency postoperatively. We intend to investigate the effect of GTN in patients undergoing cardiac surgery being subjected to RIPC in its role as a Nitric Oxide (NO) donor. Exogenous NO has been shown to be cardioprotective in animal models.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years all patients admitted for on- pump CABG and/or valve surgery
* Able to give consent

Exclusion Criteria:

* Allergies to excipients of IMP and placebo
* Chronic Renal failure (eGFR\<30 ml/min/kg)
* Severe liver disease
* Peripheral arterial disease
* Pregnant or lactating women
PSMA PET Imaging of Recurrent Prostate Cancer

The purpose of this study is to see if a new diagnostic research agent named 68Ga-HBED-CC-PSMA can show prostate cancer on a PET/CT scan that cannot be seen on other standard imaging even when the PSA levels are very low.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven adenocarcinoma of the prostate
* Initially treated with definitive local therapy (surgery and radiation therapy are the most common treatments, but other treatments are also eligible)
* For patients initially treated with surgery, radiation therapy, brachytherapy, or cryotherapy:

  * PSA ≥ 0.2 ng/mL in at least two consecutive tests within 6 months of date of consent for patients
  * Note: The most recent PSA value must be within 6 weeks of consent
* For patients who have received additional treatment in the recurrent or metastatic setting:

  ° PSA ≥ 2 ng/ml above the most recent therapy nadir
* Age ≥ 18 years
* Patient must be able to tolerate PET/CT or PET/MR imaging

Exclusion Criteria:

* Patient with claustrophobia that would preclude PET/CT or PET/MR imaging or other contraindications to CT imaging.