cyrilzakka/clinical-trials huggingface dataset:
Establishing Optimal PEEP Setting for Obese Patients in the Steep Trendelenburg Position

The purpose of this study is to determine whether the Enlight 2100 electrical impedance tomography (EIT) belt can optimize positive end-expiratory pressure (PEEP) during surgery better than standard anesthesia machines.

Positive end-expiratory pressure (PEEP) is a measure taken intraoperatively to manage breathing during surgery. The Enlight 2100 is a device that uses electrical impedance tomography (EIT) to measure PEEP and provide a live image of the lungs while a patient is mechanically ventilated. In this study, the investigators will use the Enlight 2100 EIT belt to measure PEEP intraoperatively in order to better optimize PEEP settings for difficult cases.

Eligibility Criteria:
Inclusion Criteria:

1. BMI ≥ 40 kg/m2
2. Age \> 18 years
3. Scheduled for elective laparoscopic abdominal surgery in the steep Trendelenburg position.
4. Able to provide informed consent.

Exclusion Criteria:

1. Currently pregnant.
2. Presence of pacemaker, neurostimulator, spinal cord stimulator, or implantable cardioverter-defibrillator.
3. Skin ulcerations on upper torso near the belt placement.
4. Presence of phrenic nerve palsy or other diaphragm conditions.
5. Thoracic circumference \> 134 cm.
6. Tracheomalacia.
7. Inability to speak and understand English.
Zyprexa® Relprevv™ Patient Care Program

The goal of the Zyprexa Relprevv Patient Care Program is to mitigate the risk of negative outcomes associated with Zyprexa Relprevv post-injection delirium/sedation syndrome (PDSS).

The goal of the Zyprexa Relprevv Patient Care Program is to mitigate the risk of negative outcomes associated with Zyprexa Relprevv post-injection delirium/sedation syndrome (PDSS) by:

1. Ensuring Zyprexa Relprevv is prescribed only by certified prescribers, dispensed only by certified dispensers, and dispensed for use only in certified healthcare facilities with ready access to emergency response services, and dispensed for use only with documentation of safe use conditions;
2. Informing health care providers and patients about the risks and the need for continuous observation of patients for at least 3 hours in certified healthcare facilities; and
3. Establishing long-term safety and safe use of Zyprexa Relprevv through periodic monitoring for the risk of PDSS events and by enrolling all patients who receive Zyprexa Relprevv in the Zyprexa Relprevv Patient Care Program registry.

Eligibility Criteria:
Inclusion Criteria:

* Any patients receiving Zyprexa Relprevv enrolled in Zyprexa Relprevv Patient Care Program

Exclusion Criteria:

* Any patient not receiving Zyprexa Relprevv
Sodium-Lactate and Traumatic Brain Injury

The purpose of this study is to compare the effect of bolus of either sodium-lactate or mannitol on the evolution of intracranial pressure (ICP) during intracranial hypertensive episodes (IHE)

Osmotherapy with mannitol remains the first treatment currently recommended to treat intracranial hypertension in severe head injury.However, this treatment in not always efficient and is associated with side-effects and a transitory action. Hypertonic sodium-lactate, by its osmotic and energetic properties could be superior to mannitol to decrease ICP. Study objectives : to compare the effect of mannitol and sodium-lactate on ICP at the fourth hour after the start of infusion during IHE in severe traumatic brain injury (TBI) (main endpoint) ; to compare the percentage of successfully treated episodes between both treatments and to compare the neurological status after one year of evolution (glasgow outcome score)(secondary endpoints)

Patients inclusion : adult severe TBI (glasgow coma score \< 9) \< 66 yrs Exclusion criteria : polytrauma, bilateral fixed dilated pupils, motor score \< 4, neurosurgery, prolonged episode of hypoxia or arterial hypotension, 34 patients included from november 2003 to november 2004 and randomized into two groups : MAN group receiving mannitol 20% 100 ml in 15 min (17 patients, 36 episodes of IHE treated) and LAC group receiving semimolar sodium-lactate 100 ml in 15 min (17 patients, 37 episodes of IHE treated). For ethical reasons a rescue treatment in a crossover fashion was performed for each episode of IHE when the randomized treatment failed.

Follow-up : one year after the TBI. Study end : november 30, 2005

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 65 years
* severe traumatic brain injury
* prehospital glasgow coma scale \< 9
* rapid neurological worsening before admission

Exclusion Criteria:

* neurosurgical intervention
* polytrauma
* bilatéral fixed dilated pupils
* motorscore \< 4
* prolonged episode of hypoxia or arterial hypotension
* abundant rinorrhea
Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)

The primary objectives of this study are to evaluate the pharmacokinetics (PK), safety, and tolerability of bezlotoxumab (MK-6072) in children aged 1 to \<18 years of age with a confirmed diagnosis of Clostridium difficile infection (CDI) who are receiving antibacterial drug treatment. The primary hypothesis is that the area under the concentration-time curve from 0 to infinity (AUC0-inf) of bezlotoxumab after treatment of pediatric participants with bezlotoxumab is similar when compared to the AUC0-inf of bezlotoxumab after treatment of adults with bezlotoxumab.

Historical adult pharmacokinetic data is from NCT01241552 and NCT01513239.

Eligibility Criteria:
Inclusion Criteria:

* At screening has suspected or confirmed Clostridium difficile infection (CDI), and is receiving or is planning to receive a 10- to 21-day course of antibacterial drug treatment for CDI
* At study infusion has a diagnosis of CDI confirmed by a diagnostic assay which detects the presence of C. difficile toxin in stool, and is still receiving antibacterial drug treatment for CDI
* Female is not pregnant, and not breastfeeding; but if of childbearing potential agrees to follow contraceptive guidance during the treatment period and for at least 12 weeks after the last dose of study treatment
* Participant and/or parent or caregiver must be able to read, understand, and complete the daily diary

Exclusion Criteria:

* Has an uncontrolled chronic diarrheal illness
* Has a known hypersensitivity to bezlotoxumab, its active substance and/or any of its excipients
* At randomization, their planned course of antibacterial drug treatment for CDI is longer than 21 days
* At screening has received any listed prohibited prior and concomitant treatments and procedures
* Has previously participated in this study, has previously received bezlotoxumab, has received an experimental monoclonal antibody against C. difficile toxin B, or has received a vaccine directed against C. difficile or its toxins.
* Has received an investigational study agent within the previous 30 days, or is currently participating in or scheduled to participate in any other clinical study with an investigational agent during the 12-week study period
Monitoring of Tissue Transfer Flaps by Modulated Imaging

Tissue transfer flaps are a method of moving tissue from a donor location to a recipient location. In the case of a free tissue transfer flaps, the blood vessels to the transferred tissues are detached and then re-attached to different arteries and veins at the recipient site. The process of reconstructive surgery using tissue transfer flaps is not without complications. These complications may include acute arterial or venous occlusion, as well as the development of late complications such as fat necrosis and flap atrophy.

The researchers developed a safe, non-contact, intra-operative and post-operative device called Modulated Imaging, can detect changes in a flap's optical properties and can correlate with arterial or venous occlusion or with the development of fat necrosis or flap atrophy.

Eligibility Criteria:
Inclusion Criteria:

* Adult 18 years and older planned to undergo reconstructive surgery

Exclusion Criteria:

* All emergency reconstructive surgery
Fermented Plant-based Portfolio Diet 4 Metabolic Health

The primary objective of this study is to evaluate the metabolic effects of a high-fiber portfolio diet based on fermented plant-based foods compared to a corresponding non-fermented plant-based diet and a control diet (habitual diet). This will be assessed across gut microbiome profiles (high/low Prevotella), focusing on cardiometabolic risk factors, particularly inflammation.

A total of 100 men and women who meet all inclusion criteria and none of the exclusion criteria will be invited to participate. The study will employ a three-way randomized, controlled cross-over design, featuring six-week interventions separated by six-week washout periods. Participants will attend the clinic on 15 occasions, including screening visits.


Eligibility Criteria:
Inclusion Criteria:

* Sign of metabolic syndrome

Waist circumference \> 102 cm/88 cm M/W and at least one of the following:

* High density lipoprotein (HDL) ≤1.0 mmol/L men / HDL ≤1.3 mmol/L
* Triglycerides ≥ 1,7 mmol/L
* Blood pressure ≥130/85 mmHg
* Fasting glucose ≥5.6 mmol/L

Other inclusion criteria:

* Signed informed consent
* Willingness to consume the intervention foods
* Body mass index 25-35 kg/m2
* Hemoglobin 120-160 g/L
* Serum thyroid-stimulating hormone (S-TSH) \<4 mIU/L
* Serum C-reactive protein (S-CRP) \<5 mg/L
* Access to a -18⁰ C freezer
* Any medication stable for the last 14 days.

Exclusion Criteria:

* Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study.
* Following any weight reduction program or having followed one during the last 6 months
* Food allergies or intolerances
* History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery, Helicobacter infection, Peptic ulcer disease, untreated celiac disease, etc.)
* Previous major gastrointestinal surgery
* Pregnant or lactating or wish to become pregnant during the period of the study.
* Unable to understand written and spoken Swedish
* Lack of suitability for participation in the trial, for any reason, as judged by the medical doctor or PI.
* Pharmacological medication with drugs known to affect the microbiota, e.g., antibiotics, within 6 months prior to baseline.
* Intake of any probiotic pills or foods enriched in probiotics within 6 months prior to baseline.
* Type I diabetes
* Small bowel bacterial overgrowth
* Diarrheal disease
* Receiving pharmacological treatment for type II diabetes (treatments based on lifestyle interventions are acceptable, as long as it is compatible with the study protocol)
* Using nicotine products on a daily basis (including chewing gum, patches, snus etc.)
* History of heart failure or heart attack (TIA) within 1 year prior to screening
* Thyroid disorder
* Planned surgery within the next eight months
Intraneural Facilitation as a Treatment for Carpal Tunnel Syndrome

We hypothesize that a standard course of INF can result in significant improvement in CTS as measured by clinical, electrodiagnostic, or ultrasound measures.

INF is a novel non-invasive therapy based on the principle of restoring vascular function at the capillary level in peripheral nerve. his therapy has been shown to improve clinical function in patients with diabetic-associated polyneuropathy, a model for various forms of ischemic neuropathy. CTS is a common condition where regional compression at the wrist results in ischemic focal demyelination of the distal median nerve. This results in sensory dysfunction, pain, and eventually axon loss and weakness if the compression is sufficiently severe and prolonged. Standard therapy for CTS includes wrist splints, regional lidocaine injections, ergonomic adjustments, various forms of occupation therapy, and ultimately surgical release of the carpal tunnel ligament. However, all of these are either temporary in their effect or invasive. The diagnosis of CTS relies on clinical, electrodiagnostic or NCS, and ultrasound methods.

Eligibility Criteria:
Inclusion Criteria:

1. Patients referred to the LLUH Neurology Electrodiagnostic Laboratory with electrodiagnostic and clinical evidence of CTS (uni- or bilateral)
2. Ages \>18 and \< 75 (irrespective of gender)
3. Current use of splints as long as the frequency of treatment is unaltered and onset of use is \> 1 week in duration

Exclusion Criteria:

1. Prior carpal tunnel release \> 2 years ago
2. The presence of any condition that would prevent NCS from accurately diagnosing CTS (e.g., hereditary polyneuropathy or acquired demyelinating polyneuropathy)
3. Workman's Compensation cases
4. Pregnancy
5. Undergoing conservative or surgical/injection therapy (physical or occupational therapy, injections)
6. Clinically silent CTS in face of positive electrodiagnostic results
7. Sufficiently severe clinical symptoms that warrant more aggressive therapy i.e., carpal injections or release
8. Any confounding medical condition that the investigator deems may adversely affect subject participation or outcomes
TetraGraph in Rocuronium Infusions

This is a prospective, non-blinded study to evaluate rocuronium infusion requirements using the TetraGraph Neuromuscular Transmission Monitor during surgical procedures in patients less than 18 yrs. of age.


Eligibility Criteria:
Inclusion Criteria:

* Patients less than 18 years of age
* American Society of Anesthesiologists classification (ASA) 1-4
* Patients undergoing a surgical procedure with general anesthesia and requiring the continuous administration of rocuroniuim

Exclusion Criteria:

* Patients less than 28 days old
* Patients with history of a progressive or degenerative peripheral neurologic or neuropathic disorder
* Patients undergoing a surgical procedure in which neuromuscular blockade is not required
* Edematous patients
Effectiveness of Physiotherapy to Treat the Urinary Incontinence and Erectile Dysfunction Post Retropubic Prostatectomy

The prostate cancer is the most common parenchymal neoplasia in men over 45 years old. Radical prostatectomy is curative treatment is most used today. Urinary incontinence and erectile dysfunction are the main complications of radical prostatectomy. Physical therapy has been used as a form of conservative treatment of these complications. However, the role of physiotherapy in the treatment of these complications is not well defined in the literature. We will do a randomized controlled study with patients undergoing radical prostatectomy. After removal of the Foley catheter, patients will be randomized into 3 groups: control group, group of pelvic floor exercises and anal electrostimulation group. These patients will be evaluated preoperatively in an attempt to meet prognostic factors for urinary incontinence and erectile dysfunction. They will be followed by 2 years after surgery, to assess whether the therapy will alter the course of urinary continence and erectile function in these patients.

Randomization was performed by a team of external statistics to the research team, using the method of randomization in blocks of three, who were randomly selected. The group to which the patient was allocated to researchers only be informed at the time of randomization, if patients satisfied the criteria for inclusion and exclusion.

Will be evaluated preoperatively: urodynamic studies and clinical evaluation. The following clinical data were evaluated: Body Mass Index (BMI), comorbidities, disease staging and sociodemographic information.

The following parameters will be evaluated in the pre-operative and after one, three, six and twelve months after surgery: evaluating the strength of the pelvic floor through perineometry, the 1 hour pad test, electromyographic evaluation of pelvic floor, and the application of instruments validated for the Portuguese language. The follow instruments will be applied: International Index of Erectile Function - 5 questions (IIEF-5), International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), International Prostate Symptom Score (IPSS).

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years
* diagnosed with localized or locally advanced prostate cancer
* that are undergoing radical prostatectomy as treatment of the condition
* they are coming from Barretos or a nearby region or has logistics facilities to come to the Barretos Cancer Hospital to perform the followup

Exclusion Criteria:

* those with mental or physical problems that make it impossible to collect data or that may influence the recovery of continence postoperatively
* patients with metastatic prostate cancer
* patients not undergoing retropubic prostatectomy as treatment for prostate cancer
4D- Flow- MRI After Aortic Valve Surgery

This randomized controlled trial was designed to analyze flow patterns in the ascending aorta with MRI after either Trileaflet reconstruction of the aortic valve with autologous pericardium (TriRec) or surgical valve replacement with biological prosthesis. The hypothesis is that after TriRec procedure more physiological flow patterns will be observed, compared to biological valve prosthesis.

Trileaflet reconstruction of the aortic valve with autologous pericardium (TriRec) is a new treatment option for diseased aortic valves and offers benefits compared to conventional valve replacement. At the moment no prospective randomized trials evaluating the role of the TriRec procedure are available and factors contributing to long- term durability are unknown.

The investigators want to examine aortic flow patterns with 4D- Flow- Magnetic Resonance Imaging (MRI) in patients after the TriRec procedure or biological prosthetic valve replacement in a prospective randomized trial. Flow patterns in the ascending aorta, examined with 4D- Flow- MRI, show nearly laminar flow patterns and no outflow obstruction in healthy subjects with tricuspid aortic valves. In contrast, helical flow patterns, turbulences and increased flow velocities are observed in diseased valves and also after valve replacement with mechanical or biological prostheses. These helical flow patterns seem to influence aortic wall remodeling and may contribute to structural valve dysfunction of biological prosthesis.

The investigators hypothesize that after TriRec procedure more physiological flow patterns will be observed, compared to biological valve prosthesis. The results can contribute to understand mechanisms for long- term performance of this technique and determine the role of this novel technique for treatment of aortic valve disease.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 50 years
* Documented symptomatic moderate or greater aortic stenosis or severe aortic insufficiency
* Aortic annulus \> 19 mm
* Written informed consent of the patients.

Exclusion Criteria:

* Concomitant intervention of the aortic root, ascending aorta or aortic arch
* Concomitant valve surgery
* Emergency surgery for any reason
* Neurological events (i.e. stroke, TIA) within the previous 6 months
* Coagulation disorders (including thrombocytopenia \< 100.000/ml)
* Porcelain aorta/severe calcification of the ascending aorta
* Active endocarditis or other active systemic infections
* Participating in another trial that may influence the outcome of this trial
* Pregnancy
* Dual antiplatelet therapy
* Previous cardiac surgery (excluding percutaneous procedures)
* Contraindication for MRI- examinations
Daptomycin Pharmacokinetics in Continuous Veno-venous Hemodiafiltration

The purpose is to investigate daptomycin pharmacokinetics in critically ill patients with suspected or verified bacteremia with Gram-positive cocci undergoing combined continuous hemodiafiltration at a filtration rate of 35ml/kg/h and to establish a dose recommendation for continuous hemodiafiltration at a filtrate rate of 35ml/kg/h.


Eligibility Criteria:
Inclusion Criteria:

* male or female of 18 years or older
* females: negative pregnancy test
* Hospitalisation in the medical ICU
* High suspicion or evidence of Gram-positive infections requiring antibiotic therapy
* Subjects receiving standard antibiotic treatment for Gram-positive infection
* Evidence of renal failure
* Clinical necessity for continuous renal replacement therapy
* Written informed consent signed by the patient or a next of kin and an independent physician in case the patient is not able to sign.

Exclusion Criteria:

* Skeletal muscle disorders or CPK levels of \> 2 x ULN
* History of hypersensitivity to the drug
* Participation in another study
* Subjects with a history of muscle disease
* Patients with severe liver function impairment (Child C)
* Life expectancy of less than 5 days
Rifaximin Improves Gut Dysbiosis in Insulin Resistance and Type 2 Diabetes

Gut Dysbiosis had been involved in some way in the pathogenesis of some extra-intestinal disorders including metabolic syndrome, cardiovascular disease, and obesity.

Accumulating evidence had linked metabolic syndrome and diabetes to dysequilibrium in gut microbiota, which are a critical regulator of host metabolism and immune responses. gut microbiota interacts with host signaling pathways, leading to modulation of the endocrine system, immune responses. gut microbial metabolites, in particular, short-chain fatty acids, have been significantly associated with liability to diabetes. patients with positive fecal short-chain fatty acids will be given rifaximin

Eligibility Criteria:
Inclusion Criteria:

* diabetes with gut dysbiosis

Exclusion Criteria:

* recent antibiotic use
* pregnancy
* diabetogenic drugs
HYPOPhosphatemia in the Intensive Care: A One-day Point Prevalence Survey

The point prevalence survey aims at defining the until now unknown real prevalence of hypophosphatemia (defined as blood phosphate value \< 0.8 mmol/l) in international critical care settings

The survey will be conducted on one single day in each centre (D-day), within a week defined by the project coordinator (International PI). On D-Day, the local investigators will be asked

1. to complete questions aiming at describing their ICU (number of beds, number of patients present on D-Day, type medical/surgical/other, local phosphate reference value, presence of an hypophosphatemia treatment protocol in the ICU and route of phosphate delivery in case of hypophosphatemia)
2. to indicate how many patients had a blood phosphate \<0.08 mmol/l, for each patient with hypophosphatemia, to record the exact lowest value on D-Day, and to record age, number of days in ICU on D-Day, presence (or not) of artificial nutrition and continuous renal replacement therapy, if any phosphate administration is ongoing Data will be recorded in and electronic Case Report Form (e-CRF) in REDCap, and analysed with descriptive statistics No outcome data will be recorded (pure point-prevalence) There is no intervention

Eligibility Criteria:
Inclusion Criteria: blood phosphate value \< 0.8 mmol -

Exclusion Criteria: Blood phosphate value \>0.8 mmol/l

-