cyrilzakka/clinical-trials huggingface dataset:
Sepsis Post Market Observational Study and Potential Reduction of Time to Antibiotics - Washington University

The purpose of this study is to demonstrate that addition of the Monocyte Width Distribution (MDW) parameter to current standard of care improves a clinician's ability to recognize sepsis in the Emergency Department, resulting in earlier decision to administer antibiotics from time of ED presentation for sepsis patients (simulated primary endpoint), with concomitant reductions in length of stay and in-hospital mortality for those patients (secondary endpoints).

The objective of this study is to develop a method for identifying sepsis patients from electronic health records (EHR) based on Sepsis-2 criteria. Sepsis patients will be identified using a Sepsis Definition which includes meeting SIRS score of ≥2 within 12 hours of ED presentation and any microbial testing ordered within 24 hours of ED presentation. The patient will be enrolled if it meets the Sepsis Definition and additional EMR data elements will be extracted to complete case report form. Furthermore, objectives include to confirm the clinical validity and performance of MDW in a control population of sepsis patients where MDW is measured but not reported to physicians. This study is an observational study which will simulate the decision impact of MDW on sepsis identification and patient management

Eligibility Criteria:
Inclusion Criteria:

* All race and ethnicities
* Presenting to the emergency department with suspicion of infection
* Whose assessment includes a CBC with differential
* Meets EMR Sepsis Definition

Exclusion Criteria:

* Pregnancy
* Prisoners
* Transfers from other ED
* Previously enrolled
TriBEL Registry: National Belgian Registry of Percutaneous Tricuspid Valve Repair Using a Transcatheter Edge-to-edge Repair Technique

In this study, patients who have undergone or will undergo a transcatheter edge-to-edge repair (TEER) for tricuspid valve regurgitation (TR) will be followed up for 5 years. The goal of this prospective and retrospective, observational, non-randomized, multicenter registry is to confirm that TEER is a feasible, safe and effective treatment option for TR and to evaluate the long-term efficacy and safety of TEER.

The main endpoints are:

* Change in tricuspid regurgitation grade: number of patients with a reduction in tricuspid regurgitation score by at least one grade
* Composite of major adverse event: number of patients with composite of major adverse event (cardiovascular mortality, acute kidney injury, myocardial infarction, stroke or TIA, coronary revascularization, new onset AF or ventricular arrhythmia)


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Eligible for TEER procedure
* Informed consent signed

Exclusion Criteria:

* Unwilling to provide informed consent
Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab

A one year study assessing the efficacy and safety of secukinumab compared with placebo in adult patients with moderate to severe palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks


Eligibility Criteria:
Inclusion Criteria:

* Palmoplantar pustular psoriasis for at least 6 months before Randomization
* Moderate to severe palmoplantar pustular psoriasis as defined at Baseline by:

  * ppPASI score of ≥ 12 and
  * DLQI ≥ 10
* Candidate for systemic therapy, defined as having palmoplantar pustular psoriasis inadequately controlled by:

  * Topical treatment, and/or
  * Phototherapy, and/or
  * Previous systemic therapy

Exclusion Criteria:

* Forms of psoriasis other than chronic plaque psoriasis and pustular palmoplantar psoriasis (e.g., erythrodermic, guttate, or generalized pustular psoriasis)
* Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors, or lithium) or history of proven contact dermatitis
* Patients not willing to limit UV light exposure (e.g. sunbathing and/or the use of tanning devices) during the course of the study
* Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy). Washout periods detailed in the protocol have to be adhered to
* Previous exposure to any biologic drug directly targeting IL-17 or IL-17 Receptor (e.g., secukinumab, ixekizumab, or brodalumab)
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment and for 16 weeks after stopping treatment
* Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy
* Use of any other investigational drugs within 4 weeks of study drug initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer

Other protocol-defined inclusion/exclusion criteria may apply.
Prospective Evaluation of the StatusFirst™ CHF NT-proBNP Device in Human Whole Blood and Plasma Samples

The primary objective of the study is to establish the correlation between NT-proBNP measurements in fresh human whole blood samples and those in plasma samples from the same study subjects, where said samples are collected in EDTA and Li-Hep anticoagulant tubes and measured by the StatusFirst™ CHF NT-proBNP device in conjunction with the DXpressTM Reader in a laboratory setting.


Eligibility Criteria:
Inclusion Criteria:

* Have clinically confirmed heart failure (NYHA class I-IV) or have presented to an emergency room or clinic with signs, symptoms and/or risk factors suggestive of heart failure, OR
* Be non-CHF controls greater than 45 years of age with no history of heart failure or cardiovascular disease.

Exclusion Criteria:

* Be 45 years of age or younger
Adapting the FACETS Program to Sickle Cell Disease

Adaptation of a fatigue management program combining the principles of cognitive-behavioral therapy and energy conservation strategies (FACETS program) for a population of adult patients with sickle cell disease (Drépa-FACETS program).


Eligibility Criteria:
Inclusion Criteria:

* Participant having freely given his oral agreement.
* Participant with a major sickle cell syndrome, regardless of genotype (e.g. SS, SC, Sbeta).
* Participant with a sufficient command of spoken and written French to take the assessments, complete the questionnaires, follow the program sessions and carry out the home exercises.

Exclusion Criteria:

* Participant with one or more severe psychiatric pathologies (e.g. severe depression, psychosis) that could interfere with the conduct of the study, in particular the primary and secondary endpoints.
* Participants with another chronic pathology causing fatigue.
* Participants in vaso-occlusive crisis (VOC) or hospitalization.
* Participant under legal protection (guardianship, curatorship, safeguard of justice, deprived of liberty).
Analgesic Efficacy of Continuous Infusion of Local Anaesthetic Versus Single-shot Injection Interscalene Block

The aim of this study is to study the analgesic efficacy of a continuous infusion of local anaesthetics for interscalene brachial plexus block after major shoulder surgery in the setting of multimodal analgesia, in order to determine whether the use of a catheter is still necessary in a contemporary practice.

The hypothesis of this study is that in contemporary practice, comprising the administration of multimodal analgesia, the continuous infusion of local anesthetic via a catheter remains superior in terms of analgesia at 24 h compared to a single-shot injection at the level of the interscalene brachial plexus after major shoulder surgery.

This prospective randomized monocentric superiority study will include two parallel groups: a SS (single-shot injection) group and a CI (continuous infusion) group.

All patients will have a preoperative ultrasound-guided interscalene brachial plexus block with 20 ml of lidocaïne 1% and epinephrine 1:100,000, followed by the insertion of a catheter. In the post-operative period, after clinical assessment of motor recovery in the operated limb (flexion of the forearm possible) in order to exclude any neurological damage of surgical origin, ropivacaine 0.5% 20 ml will be injected through the catheter. In the SS group, the catheter will be removed. In the CI group, a continuous infusion of ropivacaine 0.2% at a flow rate of 6 ml.h-1 will be running for 48h after the bolus administration of ropivacaine 0.5%.

In both groups, patients will receive during surgery multimodal analgesia inclusive of iv dexamethasone 8 mg, iv magnesium sulfate 40 mg.kg-1, iv ketorolac 30 mg, and iv acetaminophen 1000 mg, according to the current practice in our institution.

Assignment to one of these two groups will be done according to a computer-generated list of random numbers, and the sealed envelopes method will be used.

In the postoperative period, patients will be prescribed an iv pca of morphine.

Eligibility Criteria:
Inclusion Criteria:

* patient scheduled for a major shoulder surgery (total shoulder arthroplasty or rotator cuff repair);
* ASA class 1 to 3;
* age more than 18 years old.

Exclusion Criteria:

* patient refusal or inability to understand and/or sign the inform consent
* contraindication for perineural block (allergy to local anesthetics, infection of puncture site, major coagulopathy, sensitive or motor deficiency on the operative side arm);
* chronic alcool abuse;
* chronic pain under chronic opioid treatment
* opioid drug abuse or under substitution treatment
* patients known for allergies to paracetamol, non steroidal anti inflammatory drugs, dexamethasone, sulfate magnesium, ondansetron, droperidol, and omeprazole;
* patients under chronic corticotherapy
* patients known for malignant hyperthermia;
* patients with chronic kidney failure class 3 or more;
* patients with severe pulmonary disease;
* patients with history of neck surgery or radiotherapy on the operative side;
* pregnancy.
Ventilatory Parameters and Inflammatory Responses of Neonates Ventilated by Different Modes of Ventilation

The main purpose of this study is to investigate effects of SIMV+VG (synchronized intermittent mandatory ventilation+volume guarantee) or PSV+VG (pressure support ventilation+volume guarantee) ventilation on vital signs, patient - mechanical ventilation synchrony, ventilation parameters and inflammatory mediators in neonates.

Term or preterm neonates may need mechanical ventilation due to different etiologies. In all patients aim of mechanical ventilation is to promote pulmonary gas exchange, reduce the respiratory work of patient. Ideal mechanical ventilation must minimize pulmonary trauma with low inspiratory pressures that obtains adequate and constant tidal volumes. Ventilation associated pulmonary injury is an important subject that must be considered during mechanical ventilation. Atelectotrauma, volutrauma, barotrauma and biotrauma must be monitored. Volutrauma, barotrauma and oxygen toxicity cause cytokine increase that results in biotrauma. This parenchymal inflammation is a risk factor for chronic lung disease which is an important morbidity of ventilated neonates.

From past to present neonates were ventilated with different ventilation modes including IMV (Intermittent Mandatory Ventilation), SIMV, A/C (Assist Control Ventilation), PSV,HFV (High Frequency Ventilation). Both PSV and SIMV are patient trigger ventilation modes but SIMV is a time cycled and PSV is a flow cycled mode. In recent years hybrid techniques were developed to combine beneficial features of volume and pressure limited ventilation. In commercial ventilation devices these techniques have different names as volume guaranteed pressure limited ventilation (Drager Babylog 8000), pressure regulated volume controlled ventilation (Siemens servo 3000), volume guaranteed pressure support ventilation (VIP Bird Gold).

Since there is not a standard protocol for mechanical ventilation of neonates different countries and even different NICU's use different ventilation protocols.

Literature supports volume targetted ventilation to reduce barotrauma with low maximum inspiratory pressures and to reduce volutrauma with constant tidal volumes. When A/C+VG and SIMV+VG were compared in a crossover trial, more constant tidal volumes were obtained in A/C mode. Inflammatory cytokines have also been measured in different groups of patients with variable ventilatory management techniques. So far there has not been a randomized study published comparing VG+SIMV with VG+PSV in newborns with regards to tidal volume , peak inspiratory pressure variability,or inflammatory cytokines. Therefore in this study the investigators aimed to compare these two ventilation modes with regards to short term outcome.

Eligibility Criteria:
Inclusion Criteria:

* neonates with respiratory distress who need mechanical ventilation
* gestational age less than or equal to 37 weeks
* neonates who need mechanical ventilation within first 24 hours

Exclusion Criteria:

* neonates who need mechanical ventilation other than conventional ventilation
Is There is a Role of Prophylactic Therapy With Tamsulosin Before Extracorporeal Shock Wave Lithotripsy to Avoid Development of Steinstrasse ?

The purpose of this study is to determine if there is a role of prophylactic therapy with tamsulosin prior extracorporeal shock wave lithotripsy to avoid development of steinstrasse. 150 persons that will go to Extracorporeal shock wave lithotripsy will randomize to 2 groups.

Group 1 -of 75 persons will recieve tamsulosin 0.4 mg x 1/d 2 days before the lithotripsy .

Group 2 - of 75 persons will not recieve tamsulosin. 48 hour after the ESWL all 2 group will take abdominal radiograph to evaluate the presence of steinstrasse.


Eligibility Criteria:
Inclusion Criteria:

* size of stone 1-2 cm

Exclusion Criteria:

* ureteral stricture Presence of internal stent prior use of alfa bloker prior ESWL
Long Term Open Follow-up With H376/95 vs. Warfarin

The purpose of this study is to evaluate tolerability of long-term treatment with ximelagatran compared to standard treatment with warfarin.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Completion of the study SH-TPA-0002, history of chronic atrial fibrillation (i.e. rapidly beating heart), at least one risk factor for stroke (e.g. high blood pressure, age over 65, previous stroke or similar attack, diabetes or coronary heart disease)

Exclusion Criteria:

* Conditions associated with increased risk of bleeding, renal impairment, known active liver disease or liver insufficiency
Acupuncture Treatment for Chronic Sciatica: the Neuroimaging Pain-network Study

Sciatica is a common pain disorder in the neurological clinic that typically present as low back or gluteal pain and may radiate to one leg with motor or sensory complaint. Sciatica has drawn more attention worldwide as a public health issue for its pain disability, high prevalence and significant medical and economic burden. A meta-analysis of sciatica treatment revealed discectomy, epidural injections, non-opioid analgesics, and acupuncture might relieve pain. However, the central effect of acupuncture-induced analgesia and its functional connectivities in various brain region remain unclear. Besides, the number of acupoints selection and its correlation in functional connectivity also need to be discussed. This clinical trial would collect the sciatica subjects assign by intent to treat, divided to acupuncture and non-acupuncture herbal control group. The treatment of acupuncture assigns randomized as high dose and low dose acupuncture group. The acupuncture will perform two times a week for four weeks. The primary outcomes are visual analog scale for pain and sciatica bothersomeness index; the secondary outcomes are Roland's disability questionnaire for sciatica, WHOQOL, and traditional Chinese medical constitutional scale. The functional magnetic resonance imaging scan would apply at the baseline and after four weeks' treatment. This study aims to explore the model of DMN in sciatica patients; it's central effect in different stimulation modality and to investigate the mechanism of the long-lasting, sustained impact in different acupuncture dosage.


Eligibility Criteria:
Inclusion Criteria:

1. 35 - 70 y/o.
2. Low back or gluteal pain radiating into one leg.
3. Pain duration of at least two weeks.

Exclusion Criteria:

1. Known or suspected severe spinal pathology (for example, cauda equina syndrome, or spinal fracture).
2. Pregnant or breastfeeding women.
3. Scheduled or being considered for spinal surgery or interventional procedures for sciatica during the 8-week treatment period.
4. Administration of sedative or analgesics within 24 h before the fMRI scan.
5. Comorbidities include systemic malignancy, bleeding tendency, rheumatic arthritis and other known autoimmune diseases.
6. Focal neurologic deficits with progressive or disabling symptoms
7. History of received acupuncture treatment in the past one month.
8. Any contraindication related to acupuncture and MRI.
9. Visual analog scale \< 3.
10. Low back pain without sciatica.
ESP Block in MIS Lumbar Spine Surgery

This is a prospective, randomized controlled trial of patients undergoing minimally invasive transforaminal lumbar interbody fusion. This study will randomize patients into one of two groups: erector spinae plane (ESP) block and no ESP block.

Minimally invasive (MIS) spinal surgical procedures such as MIS transforaminal lumbar interbody fusion (TLIF) are being increasingly performed due to reduced morbidity. However, the mainstay for perioperative analgesia after these surgeries remains to be opioid pain medications, which have a number of associated adverse effects such as respiratory depression, hyperalgesia, and opioid habituation. Recently, the erector spinae plane (ESP) block has been introduced as an opioid-sparing regional anesthetic for lumbar spinal surgery with touted benefits including opioid use reduction and improved pain control. The proposed study aims to enroll patients in a double blind randomized controlled trial to undergo MIS TLIF with an ESP block or as conventional control group. Preoperative patient demographics, comorbidities, history of opioid use, and operative details will be obtained. Comprehensive assessment of opioid utilization, postoperative pain, non-opioid pain medication use, opioid-induced complications, time to opioid cessation, time to physical therapy clearance, length of stay, as well as other related outcomes will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* Patients scheduled for MIS TLIF (any level) with the principal investigator
* ASA 1, 2, 3

Exclusion Criteria:

* ASA 4 or higher
* BMI \>40
* Chronic opioid use (daily use for \> 3 months)
* Revision surgery, any history of previous lumbar spine surgery
* Allergy to any of the study medications
* Non-English speaking
* Chronic renal insufficiency or failure (creatinine \>2) or severe hepatic disease (cirrhosis, failure)
* Pregnancy
* Any concomitant surgery
Optimizing Maintenance Therapy in COPD Patients

Background: Effectiveness of maintenance therapy for COPD with Dry Powder Inhalers (DPIs) requires an optimal Peak Inspiratory Flow Rate (PIFR), a proper inhalation technique and adequate medication adherence from patients. Recent studies have suggested that patients with reduced peak inspiratory flow may have worse COPD-related symptom burden and increased risk of COPD-related hospitalizations. However, in primary care, little is known about how many COPD patients have suboptimal PIFR. Furthermore, there is a paucity of knowledge concerning the associations of PIFR, inhalation technique and medication adherence with the effectiveness of maintenance therapy.

Objective: To examine associations of PIFR, inhalation technique, and medication adherence with health status and disease, exacerbations, and healthcare resource utilization in patients with COPD receiving maintenance treatment with dry powder inhalers.

Study design: Cross-sectional observational study in five European countries\*.

Study population: COPD patients aged 40 years or older who have received COPD maintenance therapy through DPIs in the past 3 months or longer.

Main study parameters: Health status as measured with the Clinical COPD Questionnaire (CCQ), COPD Assessment Test (CAT), number of exacerbations, an assessment of PIFR, inhalation technique errors, medication adherence, healthcare resource utilization (HCRU), medication use and demographic and clinical covariates.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No significant burden from participating is expected. Risk of participating is deemed negligible. In addition, patients may benefit from participating. Specifically, patients who manifest inhalation errors, will receive a tailored inhalation instruction to remediate their inhalation errors. The impact of this instruction will not be evaluated in any way, therefore it should not be seen as an intervention.

\* If the preplanned number of patients cannot be included also because of national outbreaks of SARS-COV-2 resulting in travel restrictions, participation will be sought from researchers from three other European countries


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of COPD;
* Age ≥ 40;
* Use of maintenance therapy through a DPI in the last 3 months or longer
* Sufficient investigator-assessed decision-making capacity to provide informed consent (patients will not be invited if they have acute psychotic disorders, severe pervasive developmental disorders / severe intellectual disability or advanced neurodegenerative disease)

Exclusion Criteria:

* An exacerbation in the past 6 weeks (as this requires a patient to recover)
* Life threatening disease and life expectancy \< 6 months (as inclusion of these patients is unethical)
* Participation in a randomized clinical trial on COPD medication
Atrial FIbrillation Treatment With Cryoballoon in Heart failurE (AFICHE)

In this study 404 patients with heart failure and an ejection fraction of 0.40 or less, with paroxysmal atrial fibrillation, will be randomly assigned to standard treatment or standard treatment plus a session of cryoballoon ablation (left atrial balloon cryoablation for pulmonary vein isolation). All patients with either have an ICD or CRT-D/P device implanted or an implantable electrocardiographic monitoring device. The primary study endpoint will be the time to AF burden exceeding 1% over any 30-day period (calculated as the ratio of time spent in AF over total time).16 This AF burden corresponds to 7.2 hours per month.

A powered secondary endpoint will be the time to the composite of all-cause mortality and unplanned hospitalization for heart failure.


Eligibility Criteria:
Inclusion criteria:

* A minimum of at least two separate AF episodes recorded within the last 12 months, either on 12-lead rest ECG or on ambulatory ECG recordings (at least 5 minutes of AF on Holter recordings will be required),
* LVEF \<40% on sinus rhythm,
* symptoms consistent with heart failure (New York Heart Association II or higher) despite rate control treatment,
* age \>21 years old.

Exclusion criteria:

* previous left atrial ablation,
* left atrial diameter \>28 mm/m2 BSA on TTE (parasternal long axis view),
* strong clinical suspicion that reduced LVEF is primarily due to tachycardiomyopathy,
* pre-existing device (ICD or CRT) without AF detection algorithms and/or (for CRT devices) diagnostics of effective biventricular pacing,
* known primary electrical heart disease (e.g. Brugada syndrome),
* presence of thrombus in a heart chamber,
* presence of prosthetic valve at any position,
* moderate/severe valvular heart disease,
* active infectious disease or malignancy,
* moderate or severe hepatic impairment (Child-Pugh class B or C),
* severe renal failure (estimated glomerular filtration rate \<20 ml/min/1.73 m2),
* inability or unwillingness to adhere to standard treatment or to provide consent.