cyrilzakka/clinical-trials huggingface dataset:
Transpulmonary Thermodilution and Transesophageal Echocardiography in Early Septic Shock

The purpose of this study is to assess the concordance of therapeutic changes proposed after an early hemodynamic evaluation (hemodynamic profile) in septic shock patients using jointly the transpulmonary thermodilution technique and transesophageal echocardiography (TEE).

Each patient will be assessed by both the transpulmonary thermodilution technique and TEE (H0). The two assessments will be performed in random order (central randomization stratified by participating center), but within 30 minutes (no change of ongoing treatment during the assessment period). Two investigators not involved in patient care and blinded to the results of the alternative technique will performed independently the hemodynamic assessment using one of the two modalities for hemodynamic assessment tested in the study. They will interpret the results at bedside and propose a therapeutic change to the attending physician, according to the hemodynamic profile. The latter will finally: precisely identify the clinical problem to be solved (e.g., therapeutic target of the Surviving Sepsis Campaign not reached, tissue hypoperfusion), choose a therapy adapted while taking into account the clinical scenario and the results of both the transpulmonary thermodilution and TEE, evaluate the efficacy of this treatment (problem solved or not) and its tolerance (potential side-effect attributable to the treatment). In addition, the presence or resolution of signs of tissue hypoperfusion will systematically be assessed at H6, H12 and H24. Primary and secondary outcomes will be assessed by an independent committee of experts.

Eligibility Criteria:
Inclusion Criteria:

* ventilated patient in sinus rhythm with septic shock requiring a hemodynamic assessment

Exclusion Criteria:

* \< 18 yr-old
* pregnancy
* contra-indication for TEE, non sinus rhythm, aplasia, prior participation to the study, hemodynamic assessment using any other technique than those tested in the study.
Emergency Department (ED) Drug Interaction in Emergency Department Patients

This study examines how hepatic cytochrome CYP2D6 drug interactions affects the efficacy of oxycodone, hydrocodone, and ondansetron in Emergency Department (ED) patients.

Patients with pain and/or nausea are enrolled in the Emergency Department (ED). They are given either oxycodone, hydrocodone, or ondansetron at the discretion of the Emergency Department (ED) provider or the triage nurse by triage protocol. Detailed prescription, over the counter, herbal, supplement, and illicit drug ingestion histories are taken from the patient or their health care proxy. Serial visual analogue scales are captured prior to study drug administration then between 30 and 90 minutes following drug administration.

Eligibility Criteria:
Inclusion Criteria:

* self-reported pain or nausea identified by the initial nursing assessment

Exclusion Criteria:

* unable to speak English,
* \< 18 y.o.,
* previously diagnosed with chronic pain or cyclic vomiting
Fluorescence Imaging in Head and Neck Cancer

Fluorescent technology continues to advance in the detection of sentinel lymph nodes (SLNs). Currently, this requires switching from near-infrared light to white light to be able to identify the fluorescent tissue contrasting with normal surrounding tissue. Currently, no system has been studied specifically for head and neck sentinel lymph node biopsies using a hands free goggle system that can visualize white light (normal surgical visualization) and nearinfrared light (ICG fluorescence) simultaneously. This technology may have implications on the safety and accuracy of sentinel lymph node biopsy for head and neck mucosal and cutaneous tumors. Secondarily, this may reduce operative costs by decreasing the amount of time required to perform the SLNB procedure.

Regarding parathyroid identification, this technology has the potential to identify these very small glands during procedures they are at risk. These glands are not only at risk of inadvertent removal if not adequately identified, but may also be at risk if devascularized by manipulation during the surgical procedure. Therefore, early and accurate identification may decrease the rate of temporary and permanent hypoparathyroidism and hypocalcemia. This is not only an issue during thyroid and parathyroid surgery, but during laryngectomy surgery where the anatomic region these glands are located are often resected to remove at risk lymph nodes from cancer spread. Therefore, identifying these glands may help preserve parathyroid function in this patient population as well.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or older will be considered eligible.
* Patients with head and neck malignancies, such as melanoma, non-melanoma cutaneous malignancies, or oral cavity squamous cell carcinoma. Patients with central neck pathology including thyroid neoplasms, parathyroid neoplasms, and laryngeal neoplasms undergoing surgical resection.

  * Candidates for sentinel lymph node biopsy or central neck surgery
  * Newly diagnosed with clinically node negative head and neck cancer being staged with sentinel lymph node biopsy.
* Not pregnant or breast feeding.
* Able to understand and willing to sign an IRB-approved written informed consent document.
* Able to understand written or spoken English.

Exclusion Criteria:

* History of allergy to iodide drugs or shellfish (iodine allergy)
* Pregnant or breast feeding
* Do not fit age criteria
* Prisoners
* Unable to provide written consent
* Contraindications for surgery

  \*Presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection of the head and neck, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Receiving any other investigational agents
Mapping COVID-19 Spread in a Tertiary Hospital

One of the major problems in suppressing the spreading of an epidemic resides in understanding and monitoring its propagation patterns, and in evaluating how these are modified by enforced policies. The standard solution requires detailed information at the microscopic scales, e.g. how infected people have moved and whom they came in contact with, which is hardly ever available. The researchers propose a novel approach to the study of the propagation of COVID-19, in which a proxy of this information is derived at macroscopic scales. This will be based on two ingredients: the spatiotemporal study in shiny with mathematical models with aggregated or non aggregated data and the reconstruction of functional networks of spreading patterns, and the development of a supporting software.


Eligibility Criteria:
Inclusion Criteria:

* positive test (PCR or serology) for SARS-CoV-2
* outpatient follow-up

Exclusion Criteria:

* hospitalisation in ward or ICU
Mitral Valve Reconstruction in Chronic Heart Failure (CHF): Identification of Predictors for a Successful Therapy

The aim of the study is to evaluate hemodynamic and echocardiographic parameters in patients with secondary mitral insufficiency and CHF.

1. Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in CHF patients.
2. Collection of clinical factors for the assessment of the postoperative course after mitral valve reconstruction in CHF patient.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old
2. Dilatative Cardiomyopathy with LVEF \< 35%
3. NYHA III oder IV under maximal medical treatment
4. Angiographic and hemodynamic MI \> II° (LAP- mean pressure \> 15-20 mmHg; LA v-wave-oder PCWP v-wave \> 35 mmHg under exercise)
5. Echocardiographic MI \> II°
6. At least 1 hospitalization for heart failure before OP

Exclusion Criteria:

1. Secondary Cardiomyopathy by vitium cordis
2. Planned secondary procedure like CABG, aortic valve surgery, surgery of the tricuspid valve etc
3. Inclusion in another trial
4. Euro-Score \> 30%
5. Former valve operation or CABG
New Data Analysis Methods for Actigraphy in Sleep Medicine

The purpose of this study is to develop statistical and informatics tools for analyzing and visualizing Actical™ (actigraphy) data linked to fatigue in Sleep Medicine Center patients.

An Actical™ is a watch-like device attached to the wrist that uses an accelerometer to measure movement nearly continuously over several days. The American Academy of Sleep Medicine practice parameters report that actigraphy is a useful tool for detecting sleep in healthy individuals, assessing specific aspects in insomnia and restless legs syndrome, circadian-rhythm disorders, and excessive sleepiness. Concurrent with these recommendations is an increased interest in the use of actigraphy as a tool for objectively measuring fatigue. With improved high-end statistical methods for analyzing this data, actigraphy has the potential to become more important as an objective diagnostic tool for determining fatigue, sleep abnormalities and assessing response to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patient presenting to the Washington University Sleep Medicine Center for evaluation of obstructive sleep apnea syndrome, restless legs syndrome, or insomnia
* Older than 18 years of age
* Ability to consent to participation in the study
* Willingness to wear the Actical™ for two 7 day periods and to return the equipment promptly

Exclusion Criteria:

* Inability to provide valid consent
* Pregnancy
* Night or rotating shift workers
Beta-Cell Function After Near-Normalisation of Blood Glucose

The incretin effect is attenuated in patients with type 2 diabetes mellitus partly due to impaired potentiation of beta-cell responsiveness to glucose by glucose dependent insulinotropic polypeptide and glucagon-like peptide-1 respectively. The aim of the present study was to investigate whether 4 weeks of near-normalization of blood glucose could improve the insulin responses to GIP and GLP-1 in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years
* Type 2 diabetes diagnosed after 30 years of age
* BMI \> 25

Exclusion Criteria:

* Severe complications to diabetes
* Abnormal liver and kidney function
* Haemoglobin below the lower limit
* Macroalbuminuria
* Systemic disease
* Pregnancy
A Pilot Trial of Acupuncture for Knee Osteoarthritis With Differential Functional Status of Acupoints

The investigators plan to undertake a rigorous multicentre randomised controlled trial, comparing acupuncture on sensitized acupoints with low/non-sensitive points or no acupuncture (waiting-list), to test if acupuncture on sensitized acupoints may result in improved treatment outcomes in patients with Knee osteoarthritis (KOA).The current pilot study aimed to assess the feasibility of performing the definitive randomised controlled trial.

Patients in the intervention group received acupuncture treatment on the 5 most sensitized points/ acupoints.Patients in the control group received acupuncture treatment on the 5 least /non-sensitized points. All other treatment settings were the same as in the intervention group.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients are those aged 40 years or older who are diagnosed with KOA and have signed the informed consent.
* The diagnosis of KOA will follow the diagnostic criteria according to the Chinese Guidelines for the Medical Management of Osteoarthritis:
* refractory knee pain for most days in the last month;
* joint space narrowing, sclerosis or cystic change in subchondral bone (as indicated by X-ray);
* laboratory examinations of arthritis: clear and viscous synovial fluid (≥2 times) and white blood cell count \< 2000/mm3;
* age 40 years or older;
* morning stiffness continues less than 30 minutes;
* bone sound exists when joints was taking flexion and/or extension. A person is confirmed to be diagnosed with KOA if meeting the either of the three criteria set: (1 and 2), or (1,3 and 5), or (1,4,5 and 6).

Exclusion Criteria:

Patients will be excluded if they:

* Can not adhere to the study protocol in the future 6 months;
* Are diagnosed with conditions leading to skeletal disorders, such as tuberculosis, tumors or rheumatism of knee/bone joint, rheumatoid arthritis;
* Have sprain or other trauma;
* Are unable to walk properly due to foot deformity or pain;
* Are present with mental disorders;
* Have comorbidities including severe cardiovascular disease, liver or kidney impairment, immunodeficiency, diabetes mellitus or blood disorder;
* Females who are pregnant or lactating;
* Were using physiotherapy treatments for osteoarthritis knee pain;
* Had used intra-articular injection of glucocorticoid or viscosupplementation in the past 6 months;
* Received knee-replacement surgery;
* Were participating or had participated in the other clinical trials.
Middle School Matters Study

This study aims to evaluate the short-term and long-term efficacy of two preventative intervention approaches designed to support middle school youth.

This study involve two parts: Part 1 entailed screening 7th and 8th graders from 4 public middle schools to identify students who may be showing moderate signs of stress. Students who score at the designated cutoff on a depression symptoms measure received a brief check-in to determine eligibility for the follow up randomized trial (Part 2). An "indicated" sample of 120 adolescents in the 7th and 8th grade and their caregivers were randomly assigned to a brief, Individual Support Program (ISP) comparison group or a Skills Group Program. Research interviews were conducted at multiple timepoints with students and caregivers, and teacher questionnaires were used to examine changes in outcome measures. Following completion of the intervention, all participants were followed for 12-months.

Eligibility Criteria:
Inclusion Criteria:

* 7th and 8th grade students at 4 participating middle schools
* Score 14 or above on the Mood and Feelings Questionnaire at screening (approximately top 25%)
* No imminent plans to move or change to non-participating school
* At minimum 6th grade language skills
* Agree to participate in random assignment and research interviews
* One Parent/caregiver willing to complete research interviews

Exclusion Criteria:

* Student with past or current Major Depressive Disorder (MDD) or Probable MDD
* Students with parents who do not speak English or Spanish
* Students in concurrent treatment
* Students in self-contained classroom, or with cognitive delays, or emotional behavioral problems that would preclude them from benefiting from the group or being a good group member
* Parent not willing to complete research interviews
Relationship Between Topiramate Use and Ocular Angle Status

We test the hypothesis whether topiramate narrows the angles which may render Asians more likely to suffer from acute angle closure glaucoma.

Topiramate is approved for the treatment of epilepsy and prophylaxis of migraine attacks. There were case reports of acute angle closure glaucoma (AACG) associated with its use. AACG is particularly common in Asians because of a higher prevalence of narrow angle., we test the hypothesis whether topiramate narrows the angles which may render them more likely to suffer from AACG.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18-75 with an indication for starting topiramate.

Exclusion Criteria:

* Patients with known allergy or intolerance to topiramate.
* Recent exposure to topiramate (\<3 months).
* Moderate to severe renal failure.
* Known history of renal calculi or hepatic failure
* Inability to give informed consent.
* Pregnant women or women of child-bearing age who do not practise an acceptable means of contraception.
* Patients known to have angle-closure glaucoma.
Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD): the Development and Feasibility of an Education Package

The purpose of this study is to assess the feasibility and acceptability of the revised Living Well With COPD programme (LWWCOPD for Pulmonary Rehabilitation) when used to deliver the education component of pulmonary rehabilitation.

There is limited guidance on what should be included in the education component of pulmonary rehabilitation. International guidelines for COPD and pulmonary rehabilitation suggest numerous topics but do not provide specific information relating to the principal topics and how these should be delivered (BTS 2001, NICE 2004, ATS/ERS 2006). Recently this research team conducted focus groups of patients with COPD and established from their perspective the important education topics that should be covered in pulmonary rehabilitation, along with information on how these should be delivered (Wilson, O'Neill et al. 2008).

The Living Well with COPD (LWWCOPD) programme mostly includes these topics (Bourbeau, Julien et al. 2003). LWWCOPD, which is based on Bandura's self-efficacy theory, has been shown to significantly reduce healthcare utilisation and improve quality of life (Bourbeau, Julien et al. 2003, Bandura 1986). With modification and reformatting, the LWWCOPD programme could be delivered within the structure of pulmonary rehabilitation.

Although the LWWCOPD programme has been previously validated, it is important that the revised version is assessed for feasibility within the context of pulmonary rehabilitation. The practicality of delivering the programme and its acceptance by healthcare providers and patients should be assessed. Therefore, this study will involve a process evaluation to assess the feasibility and acceptability of using the revised LWWCOPD programme (LWWCOPD for Pulmonary Rehabilitation) to deliver the education component of pulmonary rehabilitation in Northern Ireland.

Eligibility Criteria:
Inclusion Criteria:

Participants

* Clinical diagnosis of COPD.
* Good understanding of written English in order to be able to provide accurate feedback on the patient information booklet and material used to facilitate the education sessions (as reported by the individual patient).
* Eligible for pulmonary rehabilitation Health Professionals
* Involved in the delivery of education sessions during pulmonary rehabilitation

Exclusion Criteria:

Participants

* Unable to safely partake in pulmonary rehabilitation (e.g. unstable angina, some musculoskeletal conditions).
* Unable to comprehend or follow instructions (e.g. dementia).
Deep Parasternal Intercostal Plane Block

Cardiac surgery is a source of severe post operative pain witch can cause major respiratory complications due to non optimal post operative rehabilitation.

Multimodal analgesia provides acceptable pain control , but does not seem sufficient during coughing or mobilization. The use of morphine also exposes patients to side effects (nausea, vomiting, pruritus, respiratory depression, chronic pain, ileus). Bleeding and hemodynamic risks of peridural and spinal aneshesia limits their use.

The postoperative efficacy of deep parasternal intercostal plane block has not yet been evaluated sufficiently. The aim of this study is to evaluate the efficacity of TTMPB on the quality of postoperative recovery after cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring cardiac surgery with sternotomy

Exclusion Criteria:

* Emergency procedure
* Procedures requiring lateral chest drainage
* Hemodynamic instability
* Severe kidney or liver failure
* BMI \> 40
* Chronic pain
* Allergy to local anesthesics
* Pregnant woman
* Long term opioïds use
Bacterial Gene Profiling to Predict Antibiotic Resistance During Cystic Fibrosis Pulmonary Exacerbations

Pulmonary exacerbations (PEx) are key events that lead to a decline in health status among CF patients, with many never recovering to baseline health. With the advancement of new CFTR modulators and other therapies increasing the lifespan of those living with CF, it will become increasingly important to have better strategies to manage PEx in order to have better outcomes following treatment. PEx treatment decisions will need to take into consideration the increasing frequency of antimicrobial resistance bacteria and the need to treat multiple types of bacteria at once. The purpose of this study is to analyze sputum samples from CF subjects at the time of PEx in order to identify markers of antimicrobial resistant bacteria and see how those relate to treatment responses. CF patients will be recruited from patients followed by the Adult CF Program at National Jewish Health. Within 48 hours of admission to the hospital for treatment of a PEx, subjects will be enrolled and sputum will be collected. The sputum will be processed and analyzed for the presence of antimicrobial resistant bacteria. These results will be compared to clinical data, such as spirometry and frequency of hospitalizations.


Eligibility Criteria:
Inclusion Criteria:

* CF patients 18 years or older who are hospitalized for IV treatment of an acute PEx
* Chronically infected with Pseudomonas aeruginosa and/or Staphylococcus aureus
* Can produce sputum
* Can provide written consent
* Willing to comply with study procedure

Exclusion Criteria:

* Subjects who are not colonized with Pseudomonas aeruginosa and/or Staphylococcus aureus
* The presence of a condition or abnormality that, in the opinion of the Principal Investigator, would compromise the safety of the patient or the quality of the data
The Expression of the Ionotropic Glutamate Receptors in Colon of IBS

The study aims to determine the expression of the ionotropic glutamate receptors in colon of irritable bowel syndrome (IBS) patients and evaluate the relationship between the ionotropic glutamate receptors and IBS symptoms.

Ionotropic glutamate receptors participate in pain in nervous system. In this study,participants will examine the expression of the ionotropic glutamate receptors in colon of irritable bowel syndrome (IBS) patients and evaluate the relationship between the ionotropic glutamate receptors and IBS symptoms.

Participants may futher study the mechanism using cell experiment.

Eligibility Criteria:
Inclusion Criteria:

Patients meeting IBS Rome III criteria. Asymptomatic individuals for health surveillance or patients for follow up after polypectomy.

Exclusion Criteria:

Patients with known cancers or abdominal surgery. Alarm symptoms such as anaemia, gastrointestinal bleeding or obstruction, marked weight loss, abdominal mass. Patients who are unwilling to sign or give the informed consent form. Patients with impaired cardiac, liver or renal function. Patients with coagulopathy. Patients with pregnancy or breastfeeding.