cyrilzakka/clinical-trials huggingface dataset:
Strengthening Community Mental Health

The goal of this clinical trial is to examine the impact of the Communities Organizing for Power through Empathy (COPE) intervention in adults in communities having recently experienced or at risk of experiencing disaster. The main questions it aims to answer are:

* How does the COPE intervention affect individual mental health?
* How does the COPE intervention affect protective factors like coping and social support?
* How does the COPE intervention affect community resilience?
* How does delivery of the COPE intervention in partnership with a broad-based organization affect participant recruitment and retention, as well as outcomes?

Participants will participate in the three session COPE intervention. Researchers will compare individuals who participate in the COPE intervention to individuals who participate in house meetings to see if the COPE intervention improves mental health, coping, social support and community resilience. Researchers will also examine factors that affect implementation and intervention delivery.

This Community-Based Participatory Research (CBPR) study will follow a multiphase mixed-methods design to adapt, deliver, and assess the efficacy of the Communities Organizing for Power through Empathy (COPE) intervention model. We will partner with a broad-based community organization, Together Baton Rouge, to adapt the intervention model to fit the context of East Baton Rouge Parish (EBRP) and deliver it to members of religious and non-profit institutions.

The objectives of the multi-level COPE intervention model are twofold: (1) reduce psychological distress and amplify protective factors among individuals and communities at risk of experiencing disasters; and (2) build individual and community psychological support response capacity. The intervention will be delivered by trained Community Facilitators (CFs) at community institutions (i.e., churches) to their institutional members. We will conduct a stepped wedge cluster randomized controlled trial (SWCRCT) to examine the impact of the COPE intervention. Measures of mental health, coping, social support and community resilience will be assessed at four timepoints (see timeline for data collection timepoints). We will conduct interviews and group reflections with CFs and participants to gain insight into their experiences with the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Individuals 18 years of age or older who are staff or members of an organization that is part of Together Baton Rouge and who participate in the intervention or are/were involved in the adaptation or implementation of the brief intervention in any capacity

Exclusion Criteria:

* Persons who are not 18 years of age or older and persons who are not staff or members of an organization that is part of Together Baton Rouge and/or not involved with the intervention
Study of Single Dose Daptomycin in Pediatric Patients With Gram-positive Infection for Which They Are Receiving Standard Antibiotics

The purpose of this study is to evaluate the pharmacokinetics of a single dose of daptomycin in patients aged 2-17 years old who have a suspected or proven gram-positive infection for which they are receiving standard antibiotic therapy. The tolerability of a single dose of daptomycin in these patients will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* 2-17 years old
* Suspected or diagnosed gram-positive infection for which the patient is receiving standard antibiotic therapy
* Clinically stable with no evidence of hemodynamic instability in the 72 hour window prior to enrollment, and no history or evidence of renal or hepatic compromise, or clinically significant alterations in fluid/electrolyte homeostasis
* Creatinine clearance (CLcr) ≥ 80 ml/min/1.73 m2 as determined by the Schwartz equation
* Creatine phosphokinase (CPK) levels within normal limits

Exclusion Criteria:

* Known allergy to daptomycin
* History of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma is acceptable), gastrointestinal, endocrine, hematologic, or autoimmune disease
* Pneumonia as sole gram-positive infection
* Use of HMG-CoA reductase inhibitors or other systemic anti-hyperlipidemic agents within 7 days prior to study drug administration and expected use through 3 days post-dose
* Clinically significant abnormal laboratory test results (including electrocardiograms \[ECGs\]), as determined by Investigator
* Body mass index (BMI) that is outside of the 5th to 95th percentile for age
* History (personal or 1st degree relative) of clinically significant muscular disease, nervous system, seizure or psychiatric disorder
* Expected intramuscular (IM) injection within 3 days following dosing
* Expected surgical procedure(s) within 3 days following dosing
* Unexplained muscular weakness
* Rhabdomyolysis, myositis or septic shock
Treatment of Peri-implant Mucositis on Incongruous Dental Prostheses Versus Congruous

The aim of the present study was to test the hypothesis that non-surgical periodontal therapy on peri-implant mucositis resolution results in a greater clinical improvement in patients with congruous versus non-congruous single dental implant restoration.

The aim of the present study was to test the hypothesis that non-surgical periodontal therapy on peri-implant mucositis resolution results in a greater clinical improvement in patients with congruous versus non-congruous single dental implant restoration by comparing two groups of patients with peri-implant mucositis.

Eligibility Criteria:
Inclusion Criteria:

* peri-implant mucositis
* bleeding on probing and/or a gingival index \<1 at least at one site at baseline
* absence of peri-implant bone loss during the last 2 years before baseline

Exclusion Criteria:

* Periodontal disease
* Systemic diseases
Colchicine for the Stability of Coronary Plaque in Acute Coronary Syndrome (COLOCT)

Evidence from the COLCOT Trial has shown that anti-inflammatory effect of colchicine reduced the risk of cardiovascular events in patients with recent myocardial infarction. We hypothesized that this might be due to the improvement of the coronary plaque stability by colchicine. Optical coherence tomography (OCT) is the most precise method to detect plaque stability in clinical practice. Thus, the purpose of this study is to evaluate the efficacy and safety of colchicine on improving the stability of coronary plaque in patients with acute coronary syndrome.

This is a single-center, randomized, double-blind, placebo-controlled clinical trial. OCT coronary images analyzed at an independent imaging core laboratory (Department of Cardiology, Second Affiliated Hospital of Harbin Medical University, Harbin, China) by blinded expert readers.

Eligibility Criteria:
Inclusion Criteria:

1. Participants who understand and sign the informed consent form voluntarily.
2. Age ≥ 18 years old and ≤ 80 years old, regardless of sex.
3. hospitalized patients diagnosed with acute coronary syndrome within 1 month.
4. at least one non-culprit lesion with diameter stenosis percentage of 30% to 70% by visual estimation on coronary angiography (CAG) after completing any planned percutaneous revascularization.
5. the lesion shown by OCT was lipid-rich plaque (Lipid pool arc \> 90 °).

Exclusion Criteria:

1. Allergic to colchicine.
2. Colchicine was taken within 10 days before randomization.
3. Abnormal liver function (ALT \> 3 times the upper limit of normal value).
4. Abnormal renal function (creatinine clearance rate \< 45 ml/min).
5. Thrombocytopenia (PLT \< 100G/L).
6. Uncontrolled infectious diseases during the screening period.
7. Known immune diseases or immune-related diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, malignant tumor and so on.
8. Pre-existing or plan for the administration of systemic anti-inflammatory treatments such as non-steroidal anti-inflammatory drugs, hormones, immunomodulatory and chemotherapeutic drugs.
9. History of surgery or interventional therapy within 6 months prior to the screening period.
10. A history of coronary artery bypass grafting or a plan for coronary artery bypass grafting within 1 year.
11. Left main coronary disease (≥50% reduction in lumen diameter by angiographic visual estimation).
12. Significant coronary calcification or tortuosity deemed to preclude OCT evaluation.
13. Diagnosed with mental disorders such as anxiety or depression.
14. Pregnant women, lactating women or women of childbearing age who do not use effective contraceptive methods.
15. Participated in other clinical trials within 3 months before the screening period.
16. Do not receive standardized treatment after being diagnosed with coronary heart disease.
17. The life expectancy of the subjects is less than 1 year.
18. The researchers determined that other conditions in which the patient was not suitable to participate in the clinical trial.
Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis (OA)

This study will evaluate the efficacy and safety of using lumiracoxib in the treatment of patients with knee osteoarthritis (OA)


Eligibility Criteria:
Inclusion Criteria:

* Primary osteoarthritis of knee (confirmed by American College of Rheumatology \[ACR\] criteria).
* Requirement of regular non-steroidal anti-inflammatory drug (NSAID) therapy.

Exclusion Criteria:

* Evidence of active peptic ulceration within 12 months prior to the screening visit or history of active gastrointestinal bleeding within the previous 5 years.
* Known hypersensitivity to analgesics, antipyretics, or NSAIDS (including celecoxib).

Other protocol-defined inclusion/exclusion criteria may apply
Equivalence of New Breath AnalyzerCompared to Currently BreathID System in Assessment of Liver Function

The aim of the study is to confirm that the new generation state of the art breath analyzer gives equivalent results to the previous model of the Exalenz breath analyzer.

Healthy and chronic liver disease subjects of all grades will be tested to see that the two devices give equivalent results in both devices. Subjects will be connected to both devices at the same time and will be tested for one hour.

The breath test includes automatic baseline breath collection, 13C-Methacetin ingestion in solution and breath collection post ingestion.

Eligibility Criteria:
Inclusion Criteria:

1. Over 18 years of age
2. Ability and willingness to sign the Informed Consent Form

   For patient group:
3. a. Known chronic liver disease (based on medical history)

For healthy volunteers:

3.b. No known liver disease (based on medical history)

Exclusion Criteria:

1. Gastric bypass surgery or extensive small bowel resection
2. Total parenteral nutrition
3. Pregnant or breast feeding
4. Allergy to acetaminophen and/or other related medications.
5. Documented drug-related concurrent hepatotoxicity or drug-related silent steatosis or drug-related fibrosis (e.g. amiodarone, methotrexate and tamoxifen).
6. Uncontrolled malabsorption or diarrhea
7. Placement of a transjugular intrahepatic portosystemic shunt (TIPS)
8. Subject should not have taken any of the following for at least 48 hours prior to the breath test: Acyclovir, allopurinol, carbamazepine, cimetidine, ciprofloxacin, daidzein, (herbal) disulfiram, echinacea, enoxacin, famotidine, fluvoxamine, methoxsalen, mexiletine, montelukast, norfloxacin, phenylpropanolamine, phenytoin, propafenone, rifampin, terbinafine, ticlopidine, thiabendazole, verapamil, zileuton or oral contraceptives or any medication that might interfere with Methacetin metabolism or might affect CYP 1A2
9. Subject should not have taken amiodarone within the last 30 days prior to the breath test
Perioperative Analgesia in Neonates Who Underwent Primary Cleft Lip Repair Surgery

In retrospective data search the investigators will identified the cumulative consumption of opioid analgesics during surgery and 24 hours after surgery in neonate with cleft lips who underwent primary cleft lip repair surgery.

The cumulative consumption of opioids during surgery and 24 hours after surgery in neonates with cleft lips who underwent primary cleft lip repair surgery is not known. Patients were divided into two groups according to the time period when they underwent surgery. Group 1 were neonates who underwent primary cleft lip repair surgery under general anaesthesia without regional anaesthesia - the time period before regional anesthesia is introduced into the standard procedure. Group 2 are newborns who underwent primary cleft lip repair surgery under general anaesthesia with regional anaesthesia. Group 1 underwent surgery in time period before regional anesthesia was introduced into the standard procedure. In this retrospective study, the anesthesiology perioperative data from January 2018 till December 2021 in the tertiary center of Pediatric anaesthesia will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* neonates with unilateral or bilateral cleft lip (U/BCL), all neonates with unilateral or bilateral cleft lip and alveolus (U/BCLA) or with unilateral or bilateral cleft lip, alveolus and palate (total cleft; U/BCLAP) who underwent cleft lip repair surgery in the neonatal period
* the study period (1/2018-12/2021)

Exclusion Criteria:

* ● presence of coagulopathy

  * thrombocytopenia or thrombopathy
  * patients at risk of malignant hyperthermia
  * patients who were not neonates (older than 28 days)
  * patients who required postoperative mechanical ventilation
Optimal Coronary Sinus Lead Implantation Using Intracardiac Impedography and Magnetic Resonance Imaging

Despite the dramatic effect of cardiac resynchronization therapy (CRT) on survival and morbidity in people with congestive heart failure, 50-70% of eligible patients do not respond to this intervention. There is retrospective evidence that placement of the left ventricular (LV) lead at the region of latest mechanical delay markedly improves response to CRT. However, there is no feasible way to gauge dyssynchrony at LV lead sites during CRT implantation. Impedance recordings from pacing lead tips allow for real-time assessment of mechanical motion and may represent a useful intraoperative tool to guide optimum placement of the LV lead during CRT implantation. This pilot trial will assess the use of intraoperative impedograms in humans to measure regional dyssynchrony at potential LV lead locations during CRT implantation.

This is a clinical trial using intracardiac impedance signals (impedograms) to assess regional dyssynchrony at various sites of left ventricular (LV) lead placement in humans undergoing CRT device implantation. This study will test the following hypotheses during the funding period:

1. LV lead impedograms as an implant tool to place leads at sites of latest mechanical delay are feasible and correlate with other means of assessing dyssynchrony.
2. LV lead impedograms vary significantly depending on LV lead location.
3. There are several characteristics of LV lead impedograms that correlate with mechanical phenomena of the heart.

Eligibility Criteria:
Inclusion Criteria:

* Patients with NYHA class III or IV heart failure
* LVEF ≤ 30%
* QRS duration ≥ 120 ms

Exclusion Criteria:

* Not a candidate for CRT implantation
Safety and Efficacy of Sufentanil Combined With Midazolam in Bronchoscopy Under Conscious Sedation: Retrospective Study

The aim of this study was to determine the safety and efficacy of sufentanil combined with midazolam in bronchoscopy under conscious sedation. A retrospective analysis was conducted on all patients undergoing bronchoscopy applying sufentanil and midazolam under conscious sedation in the First Affiliated Hospital of Guangzhou Medical University from September 2013 to July 2017.


Eligibility Criteria:
Inclusion Criteria:

Patients who had undergone bronchoscopy applying topical lidocaine, sufentanil and midazolam under conscious sedation in the First Affiliated Hospital of Guangzhou Medical University from September 2013 to July 2017

Exclusion Criteria:

Patients who had undergone bronchoscopy not applying topical lidocaine, sufentanil and midazolam under conscious sedation
Arterial Thrombosis and Inflammatory Bowel Disease: a Series of 6 Cases and Literature Review

Vascular complications in patients with inflammatory bowel disease (IBD), comprising mainly Crohn's disease (CD) and ulcerative colitis (UC), representing 2% extra-intestinal complications. In over 60% of cases, these vascular complications of deep venous thrombosis (DVT) or pulmonary embolism (PE). Several studies have shown that patients with IBD have a risk of venous thromboembolic disease (VTE) increased from 1.5 to 3.5. This risk is closely related to disease activity.

Vascular complications in patients with inflammatory bowel disease (IBD), comprising mainly Crohn's disease (CD) and ulcerative colitis (UC), representing 2% extra-intestinal complications. In over 60% of cases, these vascular complications of deep venous thrombosis (DVT) or pulmonary embolism (PE). Several studies have shown that patients with IBD have a risk of venous thromboembolic disease (VTE) increased from 1.5 to 3.5. This risk is closely related to disease activity.

However, the association between IBD and arterial thromboembolic events such as cases of myocardial infarction, stroke, aortic thrombus, mesenteric ischemia, peripheral arterial disease and members senior, was described less and remains a subject of debate. These arterial complications occur in young subjects accountability of IBD remains debated, and no clear pathophysiology. Here the investigators describe a series of 6 cases of patients with IBD who developed severe arterial complications, and whose cause was retained digestive inflammatory underlying disease.

This study is report of six (6) cases that will be described

Eligibility Criteria:
Inclusion Criteria:

* Patients with arterial Thrombosis and Inflammatory Bowel Disease admitted in Paris Saint Joseph Hospital

Exclusion Criteria:

* No exclusion criteria
Treatment of PCNSL With R-IDARAM and Intrathecal Immunochemotherapy

This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high effective in primary central nervous system lymphoma (PCNSL) patients.

The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity in primary central nervous system lymphoma (PCNSL) after systemic and intrathecal immunochemotherapy with deferred radiotherapy.

Eligibility Criteria:
Inclusion criteria:

* Newly diagnosed histologically proven non-Hodgkin's lymphoma (NHL).

Exclusion criteria:

* Involved sites other than the brain, meninges, CSF, or the eyes.
* Age less than 18 years or greater than 75 years.
* Inadequate bone marrow capacity (defined as neutrophils\<1.5 ×10\^9/L, platelets \<100 ×10\^9/L, and hemoglobin level\< 8 g/dL).
* Known cause of immunosuppression (ie, HIV type I infection).
* Any previous malignancy.
* Creatinine clearance below 60 mL/min.
* Heart insufficiency (NYHA IIIB or IV).
* Uncontrolled infection.
* Noncompensated active pulmonary or liver disease.
* Previously treated for PCNSL, except by corticosteroids.
Pre-pregnancy Lifestyle Intervention to Prevent the Recurrence of Gestational Diabetes in Overweight and Obese Women

The overall purpose of this study is to determine the efficacy of a pre-pregnancy lifestyle intervention to reduce the recurrence of gestational diabetes mellitus in multiethnic women with overweight or obesity.


Eligibility Criteria:
Inclusion Criteria:

* Prior diagnosis of gestational diabetes.
* BMI \> 25 kg/m2
* Planning to have a baby in the next 1-3 years
* English or Spanish speaking

Exclusion Criteria:

* Age less than 18 years
* Women with Type 2 or Type 1 diabetes
* Current pregnancy
* Relocating in the next 2 years
* Medications that affect weight/diabetes
* Serious current physical disease
* History of eating disorders
* History of bariatric surgery
* Current problems with drug abuse
* Current treatment of a serious psychological disorder
Upper Airway Inflammation and Olfaction: Mechanisms of Loss and Recovery

The goal of this clinical trial is to understand the mechanisms leading to olfactory dysfunction (OD) in chronic rhinosinusitis (CRS). The main questions it aims to answer are:

* Is the type 2 inflammation impacting the olfactory epithelium regeneration, leading to OD?
* Does a treatment interfering with one of the major T2 inflammatory cytokines, have an impact on the mechanisms of OD in CRS?

Participants will undergo olfactory testing and nasal brushing before and after 3 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* At least two of the following symptoms: nasal obstruction, rhinorrhoea, smell loss, facial pain for 12 weeks.
* Endoscopic visualisation of bilateral sinonasal polyps
* SSI (TDI) \< 30.75 and decreased sense of smell subjectively
* Eosinophilia \> 300/μl of blood Ku/l
* On a stable nasal steroid treatment for at least 4 weeks

Exclusion Criteria:

* Active smoking
* Primary and secondary immune deficiencies
* Ciliary diseases (cystic fibrosis, primary ciliary diskinesia)
* History of or current nasal malignancies
* \< 18 years and \> 70 years
* Patients unable to express consent
* Use of systemic corticosteroids for \< 4 weeks before visit 1 • Use of systemic or local antibiotics for \< 4 weeks before visit 1
Prefrontal Transcranial Random Noise Stimulation in Patients With Depression

Transcranial random noise stimulation is used to stimulate the prefrontal cortices in patients with depression. It's a placebo-controlled two-arm study.

Transcranial random noise stimulation (tRNS) is a non-invasive electric stimulation technique of the brain which was shown to be superior effective in contrast to other electric stimulation such as transcranial direct current stimulation (tDCS). These studies investigated mainly healthy controls and specific tasks. Only one case report is available for depression. Here we stimulate patients with depression with tRNS in a placebo-controlled two-arm design. Stimulation will be done as add-on to standard therapy. Electrodes will be applied over both dorsolateral prefrontal cortices which are standard target points of tDCS and also transcranial magnetic stimulation in depression.

Eligibility Criteria:
Inclusion Criteria:

* episode of depression (unipolar or bipolar) ( ICD-10)
* female or male between 18 and 70 years old
* skills to participate in all study procedures
* 18 or more points in the Hamilton rating scale or depression
* written informed consent

Exclusion Criteria:

* clinically relevant unstable internal or neurological comorbidity
* evidence of significant brain malformations or neoplasm, head injury
* cerebral vascular events
* neurodegenerative disorders affecting the brain or prior brain surgery
* metal objects in and around body that can not be removed
* pregnancy
* alcohol or drug abuse
* eczema on the head
* heart pacemaker
* high dose tranquillizers
Agrylin Drug Use-Result Survey

The objective of this survey is to collect data to evaluate the safety and efficacy of anagrelide hydrochloride in the post-marketing phase in participants diagnosed with Essential Thrombocythemia (ET).

Anagrelide hydrochloride Drug Use-Result Survey

Eligibility Criteria:
Inclusion Criteria:

- All cases who received treatment with Agrylin.

Exclusion Criteria:

-