cyrilzakka/clinical-trials huggingface dataset:
CRT Pilot Study for Children With Heart Failure

To collect information on pediatric patients receiving Cardiac Resynchronization Therapy (CRT) with permanent biventricular pacing (BVP) as a method of treating chronic heart failure.


Eligibility Criteria:
Inclusion Criteria:

1. Chronic and severe heart failure, NYHA class III or IV
2. Patients optimized and stable on diuretics and afterload reducing agents (with or without inotropes) for at least 1 week prior to enrollment
3. Chronic systemic ventricular dysfunction as defined in the protocol.
4. Intra ventricular conduction delay defined by spontaneous QRS duration \> ULN for age.
5. All children from 1 to 18 years of age, both male and female, and all ethnic backgrounds.
6. Signed and dated informed consent.
7. Able to receive pectoral or abdominal implant.

Exclusion criteria:

1. Suspected acute myocarditis.
2. Significant ventricular dysfunction, secondary to acquired or congenital heart defects amenable to surgical correction.
3. Acute coronary syndrome.
4. Adolescents who are pregnant.
5. Patient with BVP device implanted previously.
6. Patient has had prior/past heart transplantation.
Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI

The purpose of this study is to determine whether a left ventricular rapid pacing using the valve delivery guide-wire in transcatheter aortic valve implantation (TAVI) reduces the overall procedure duration in comparison with the conventional method.

Use of temporary pacing via a right ventricular lead in TAVI is still mandatory to ensure transient cardiac standstill while predilatation is performed and the valve is being positioned and deployed. This requires an additional venous vascular access and a pacing catheter which are both likely to generate complications.

This study compares the standard right ventricular rapid pacing to a new and simplified technique : a left ventricular rapid pacing is provided via the back-up 0.035 " guidewire. The cathode of an external pacemaker is placed on the tip of the 0.035" wire and the anode on a needle inserted into the groin. Insulation is ensured by the balloon or TAVI catheter.

Eligibility Criteria:
Inclusion Criteria:

* Subject is eligible for a TAVI
* Access considered for aortic valve bioprothesis delivery is transfemoral
* Aortic valve bioprothesis considered is Edwards Sapien 3® et/ou XT®
* Subject is ≥ 18 years of age
* Subject has signed informed consent form

Exclusion Criteria:

* Pregnancy
* Subject already included in this study
* Subject included in another study and whose inclusion in EASY TAVI implies a deviation in either study
Impact of Whole Grain Rye Bread on Health

This randomized controlled trial aims to study how a high intake of a fibre-rich bread affects the composition and functioning of the gut microbiota in healthy subjects, and how this, in turn, impacts on the release of gut peptides, intestinal permeability, stress and cognitive performance.

Healthy subjects will be recruited for a 3-week, randomized, parallel-controlled study. Subjects that are eligible to take part in the study will be blinded and randomly allocated to consume a fibre-rich bread or a control bread daily for 3 weeks. Measurements of biomarkers related to the gut-brain axis, microbiota composition and functioning, intestinal permeability, stress and cognitive functioning will be conducted on two separate test days, at baseline and after the 3 weeks intervention. On both test days (day 0 and day 21) subjects will come to the study centre after a 10 hours overnight fast and will deliver faecal samples collected at home. At the study centre, blood samples will be collected and a device for continuous assessment of autonomic nervous system response (Biopac) will be placed. Subjects will drink a multisugar solution and urine samples will be collected for gut permeability analysis. Sugar solution intake will be followed by a baseline period during which participants will rest for 30 minutes to adapt to the laboratory setting. After the baseline period, subjects will conduct a stress test and cognitive tests. Visual analogue scales (VAS) to assess momentary perceived stress levels and saliva samples will be collected before and after the stress test. The study subjects will also complete questionnaires at both visits (food frequency questionnaire, food diary, physical activity, gastrointestinal symptom rating scale, Euro Quality of Life).

Eligibility Criteria:
Inclusion Criteria:

* Age 18-44 years
* Body mass index (BMI) 18,5-30 kg/m2 (normal weight or overweight)

Exclusion Criteria:

* Significant acute or chronic illness, including an inflammatory or a functional disease of gastrointestinal track and psychiatric and psychological disorders
* Anxiety or depression (according to Hospital Anxiety and Depression Scale (HADS score) and Depression Anxiety Stress Scale (DASS-21 score))
* Use of a medication that may interfere with the study (e.g. cannabis, antipsychotics, anxiolytics, antidepressants, proton-pump inhibitors)
* Abuse of alcohol or drugs (according to AUDIT score)
* Use of antibiotic medication within the past 3 months before the study
* Use of laxative or anti-diarrhoea medication within the past 3 months before the study
* Regular consumption of probiotic or prebiotic product for the past 6 weeks before the study
* A diet that may interfere with the study (such as gluten free or low-carb diet)
* Smoking
* Pregnancy or breastfeeding
* Premenopausal female with irregular or short menstruation cycle and not using hormonal contraception
* Colour blindness, dyslexia or dyscalculia
* Unable to absent from caffeine, alcohol or intense exercise for 12 hours prior measurements.
Office-based Percutaneous Ultrasound-guided Renal Biopsy

The purpose of this research study is to create a prospectively maintained, multicenter database of patients undergoing renal biopsy for renal masses performed percutaneously (through skin), via an 18 gauge biopsy needle (.048 inches). In this database, the investigators will collect and maintain the data from the biopsy procedure. This will allow us to evaluate our experience with this procedure as well as to participate in multi-institutional collaborative studies in the future. At University of California Irvine, the investigators routinely biopsy patients with renal masses under real-time ultrasound control. Percutaneous renal biopsy under ultrasound guidance is a routine procedure performed to diagnose renal mass histopathology. The safety and efficacy of this procedure has been well documented in the literature. The indications for percutaneous renal biopsy have expanded as there has been a substantial increase in the number of renal masses that are being diagnosed, and the acceptance of percutaneous biopsy continues to expand in parallel. The biopsy procedure is part of your normal standard of care and if not being done for this research project.


Eligibility Criteria:
Inclusion Criteria:

* Must be undergoing standard percutaneous renal biopsy
* Patients must be ≥18 years of age
* Must be able to understand and render voluntary, written informed consent

Exclusion Criteria:

* Patients \<18 years of age
* Pregnant women
* Coagulopathy
* Active urinary tract infection
AeriSeal® System for Lung Volume Reduction in Patients With Advanced Emphysema

The purpose of this study is to assess the procedural and post-procedural safety and efficacy of AeriSeal therapy at up to 4 subsegments during a single treatment session in patients with GOLD Stage III/IV homogeneous or heterogeneous emphysema.

Emphysema is a progressive, debilitating disease characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. The most common cause of this condition is cigarette smoking, although genetic, occupational, and environmental causes account for up to 10% of cases. Despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death worldwide. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality for years to come.

The AeriSeal System is a novel device system being developed for the treatment of advanced emphysema. The AeriSeal System is administered bronchoscopically, and designed to provide the physiological benefits of lung volume reduction without the risks and cost of major surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of advanced emphysema as defined by FEV1/FVC\<70% predicted, FEV1 of \<50% predicted, TLC \> 100% predicted, and RV \> 135% predicted.
* Patients must have persistent symptoms despite medical therapy and either not be candidates for Lung Volume Reduction Surgery (LVRS) or have elected not to undergo LVRS.
* Patients must be \> 40 years of age, have symptoms despite medical therapy, and have none of the prespecified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.

Exclusion Criteria:

-
Optimal Brain Oxygenation in Neurologic Intensive Care Unit : The NeurO2 Study

The NeurO2 study is a multicenter observational study looking at NIRS monitoring in neurocrocritically ill patients during the acute phase of care following an acute brain injury. The study is nested within the HEMOTION Trial and the SAHaRA Trial

The NeurO2 study is a multicenter prospective study nested within two large-scale pragmatic randomized open blinded endpoint (PROBE) trials in neurocritically ill patients, the HEMOTION and the SAHaRa trials. These two trials are designed to compare a restrictive and a liberal transfusion strategies in critically ill patients with traumatic brain injury or subarachnoid hemorrhage. The NeurO2 will report on prospectively gathered regional cerebral oxygenation data (rSO2) from enrolled patients randomized to either the liberal or restrictive RBC transfusion strategy of their parent trials. The primary outcome will be 6-month neurologic function based on the GOSe. The established infrastructure of the trials will be used, including part of the data collection instruments and the outcome assessment team.

The NeurO2 study will achieve three separate but interconnected primary objectives: i) Evaluate if the cerebral hypoxemic burden as measured by NIRS during NICU stay, is associated with functional neurologic outcome (Glasgow Outcome Scale extended - GOSe) at 6 months, ii) Determine if the cerebral hypoxemic burden is impacted by red blood cell transfusion, iii) Determine if the level of response in cerebral hypoxemic burden after RBC transfusion is associated with the 6-month functional neurologic outcome (GOSe)

The secondary objectives are to evaluate whether the cerebral hypoxemic burden measured by NIRS is associated with other clinically relevant outcomes including ICU, hospital and 6-month mortality and hospital, ICU length of stay and quality of life.

Eligibility Criteria:
Inclusion criteria:

* Enrolment in one of the parent trials (HEMOTION or SAHaRA trials)
* HEMOTION trial (acute moderate of severe blunt traumatic brain injury (Glasgow Coma Score18 \[GCS\] ≤ 12))
* SAHaRA trial (acute subarachnoid hemorrhage as confirmed by treating neurosurgeon or neuro-interventionist and supported by blood in subarachnoid space resulting from a ruptured aneurysm)
* Adult patients (age ≥18 years old)
* Patients suffering from anemia (Hb ≤100 g/L)

Exclusion criteria:

* Contraindications or known objections to blood transfusions
* Active bleeding with hemodynamic instability at the time of enrollment
* Decision to withdraw or withhold life-sustaining therapies made
* NIRS monitoring not reliable
Cognitive, Emotional and Behavioural Impairments in Patients After Sars-Cov2 Infection

Recent studies suggest cognitive, emotional and behavioural impairments occur in patients after SARS-CoV-2 infection. Problems with memory, attention, information processing and executive functions are particularly prevalent in these patients, probably due to hypothesised sensitivity of the hippocampus to the virus. Cognitive impairment is also present in patients with no neurological, neuropsychological and neuropsychiatric history. Therefore, the aim of the present study is to describe neuropsychological and neuropsychiatric features in patients recovered from moderate to severe forms of Covid-19 some weeks after hospital dismission.


Eligibility Criteria:
Inclusion Criteria:

* Positive PCR from nasopharyngeal swab
* No ICU admission

Exclusion Criteria:

* Diagnosis of neurologic or psychiatric disorders;
* Previous cognitive impairment;
* Other medical conditions negatively affecting the cognitive status.
A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis

This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by alcohol) and liver cirrhosis (liver damage characterized by normal liver tissue being replaced by scar tissue).


Eligibility Criteria:
Inclusion Criteria:

* Liver biopsy performed within 6 months (26 weeks) prior to the screening period. If historical biopsy is not available, a liver biopsy will be performed during the screening period. Biopsy must be consistent with NASH and cirrhosis according to the NASH CRN classification, as assessed by the central reader
* Must be taking anti-diabetic, anti-obesity, or anti-dyslipidemic medications must have been on stable regimens for at least 3 months (12 weeks) (6 weeks for statins) prior to and during the screening period
* Participants taking vitamin E at doses greater than or equal to (\>=) 800 IU/day must have been on stable doses for at least 6 months (26 weeks) prior to and during the screening period. Vitamin E treatment (\>=800 IU/day) must not have been initiated after the qualifying liver biopsy was performed

Exclusion Criteria:

* Other causes of liver disease (e.g., alcoholic liver disease, hepatitis B virus infection, chronic hepatitis C virus infection \[HCV\], autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, α-1-antitrypsin deficiency, iron overload, and hemochromatosis); participants with HCV sustained viral response (undetectable HCV RNA) for at least 2 years prior to biopsy confirming study eligibility may be eligible
* Current or past history of hepatocellular carcinoma (HCC)
* Past or current evidence of hepatic decompensation (e.g., ascites, variceal bleeding, hepatic encephalopathy and/or spontaneous bacterial peritonitis) or liver transplantation
* Medical history of gastroesophageal varices, except if esophagogastroduodenoscopy \[EGD\] performed within 12 months prior to the Screening Period has shown \<= Grade 1 varices

Other protocol-defined inclusion/exclusion criteria apply
Dialogical Family Guidance for Neurodevelopmental Disorders

Previous studies have highlighted the need to offer targeted effective interventions to strengthen the wellbeing of all family members in families with children with neurodevelopmental disorders (NDD). Interventions for this target group requires development and research. A new family intervention, Dialogical Family Guidance (DFG) was tested in this study. All families received DFG intervention ( 6 meetings ).

Previous studies have highlighted the need to offer targeted effective interventions to strengthen the wellbeing of all family members in families with children with neurodevelopmental disorders (NDD). Interventions for this target group requires development and research. A new family intervention, Dialogical Family Guidance (DFG) was tested in this study.

Fifty families of children with NDD were randomized into two intervention groups. Intervention group I were delivered DFG immediately, and Intervention group II were delivered DFG after three months. Family functionality, health and support (FAFHES), SDQ and the 5-15-questionnaire and DFG parent questionnaires were used to collect data at baseline, after three and six months. Fifty families were invited to the study. Thirty-four families completed the study. A comparison were made between Intervention group I and II.

Eligibility Criteria:
Inclusion Criteria:

* clinical neurodevelopmental disorder diagnosis (eg ADHD, ASD, tics, language disorders)
* the child is aged between 4-16 years
* parent have adequate Finnish language skills
* parents are biological parents or step-parents of the child

Exclusion Criteria:

* the child is under 4 or over 16 years old
* parents do not have adequate Finnish language skills
Evaluating the Risk of Cognitive Impairment After Surgical and Transcatheter Aortic Valve Replacement

The investigators are conducting a pilot study to compare cognitive outcomes among Veterans with severe aortic valve stenosis who are scheduled to undergo either aortic valve replacement.

The investigators are conducting a pilot study to compare cognitive outcomes in up to 60 Veterans with severe aortic valve stenosis who are scheduled to undergo either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) at the Minneapolis VA Health Care System. Participants will be administered a short battery of cognitive tests before and three months after TAVR or SAVR over/up to a two year study period.

Eligibility Criteria:
Inclusion Criteria:

* Severe aortic stenosis (AVA: 1 cm2 and/or mean gradient =or \> 40 mmHg and/or peak velocity \> 4 m/s)
* Scheduled to undergo either surgical or transcatheter aortic valve replacement at the Minneapolis VA Health Care System

Exclusion Criteria:

* Severe cognitive impairment at baseline (i.e. unable to understand or follow-up study procedures)
* Unable or unwilling to provide informed consent
Phase II BGG492 Capsule Extension for Partial Epilepsy

This long-term extension study will assess the safety, tolerability and efficacy of BGG492 as adjunctive treatment in patients with partial onset seizures.


Eligibility Criteria:
Inclusion Criteria:

* Completed study CBGG492A2207, cooperated with the study procedures and did not experience persistent tolerability issues
* Outpatients ≥ 45 kg (99 lb) of weight
* Patient would like to continue BGG492 treatment and the investigator believes a reasonable benefit from the long-term administration of BGG492 may be expected
* Treated with a stable dose of one or a maximum of three licensed Antiepileptic drugs (AEDs)and are known to take their medication(s) as directed
* Will make themselves available for the study period and are able to record seizures and report adverse events themselves or have a caregiver who can record and report the events
* Provided written informed consent before any extension assessment is performed

Exclusion Criteria:

* Status epilepticus or seizure clusters occurring during study CBGG492A2207 or in the period between the end of study the double blind study and the start of study CBGG492A2212 for patients experiencing a treatment gap
* Have been treated with:
* Felbamate, unless treatment has been continuous for ≥ 2 years
* Vigabatrin during the 26 weeks prior to the first dose of open-label medication in the extension study
* Monoamine oxidase (MAO) inhibitors, tricyclic-antidepressants and narcotic analgesics
* L-Dopa formulations
* Use of concomitant medication that are potential inhibitors of Organic anion-transporting polypeptide (OATP) transporters
* No physical examination changes suggestive of progressive neurological changes during Study CBGG492A2207
* Used another investigational drug (other than BGG492) either at the time of enrollment in this extension study or within 5 half-lives prior to enrollment in this extension study
* History of hypersensitivity to the study drug or to drugs of similar chemical classes (e.g. sulfonamides) or had multiple drug allergies or one or more severe drug reactions to an Antiepileptic drugs (AEDs), including dermatological reactions
* Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply
eVent in the Human Patient Simulator

In this study, the investigators are testing the expert system called eVENT. eVENT provides expert advice about the patient's breathing. The investigators have developed and tested a prototype of eVENT and now want to test how it works in practice. To do this the investigators plan to use computer based simulations and test it when used by anesthesiologists in a full size human simulator. If these tests are successful the investigators will then be ready to evaluate eVENT on real patients.

The development of new sensors or the intelligent synthesis of existing signals (smart sensors) cannot reliably prevent adverse events unless the investigators assimilate the data produced from these devices and provide it to the clinician in a format that is easy to comprehend. The expert system that the investigators are developing will provide intelligent synthesis of data. The clinician focus can then be directed toward the patient rather than continual observation of the monitors.

Clinicians need an expert system to augment vigilance and situation awareness, and to aid in decision making to prevent patient harm.

The development of an expert system to assist the everyday anesthesiologist in the operating room is a significant challenge that is in urgent need of being addressed. Assistance is required in interpreting the overwhelming stream of physiological data, intelligently extracting key features from these data, and bringing them to the attention of the clinician.

Eligibility Criteria:
Inclusion Criteria:

* Staff anesthesiologist, fellows and 3rd - 5th year residents will be able to participate in this study.
* Subjects willing to provide informed consent.

Exclusion Criteria:

* Inability/failure to provide informed consent.
* Presence of any of the following conditions oPrevious participation in similar experiment oTaken sedative medication within last 24 hours
* Inability/failure to obtain 75% or above in the post-training quiz on the correct use of the eVent.
* Evaluation will be immediately discontinued at request of subject at any point during the study.