cyrilzakka/clinical-trials huggingface dataset:
Physiological Control for Mechanical Circulatory Devices

Aim of this clinical study is to compare our newly developed control algorithms for mechanical circulatory support devices based on physiological demand with the standard manual LVAD speed operation. Specifically it shall be demonstrated that:

* Suction is properly detected by the pre-trained pump flow estimation algorithm
* Suction events (due to changes in physiological demand) can be reduced by control algorithms compared to continuous speed
* If suction is encountered, it can be detected and cleared
* The pump reacts adequately to changes in patient demand due to physical activity
* Physicians pump setpoints (of requested speed for a certain heartrate) can be achieved safely.

Patients complete a set of tests in constant speed setting and repeat the same tests with physiological control algorithms turned on. Order is randomized.

Eligibility Criteria:
Inclusion Criteria:

All patients with a Medtronic HVAD system implanted at the Medical University of Vienna, Division of Cardiac Surgery, which are able and willing to understand and sign the informed consent form, and which do not meet any exclusion criteria will be included.

Exclusion Criteria:

* Inability to provide informed consent
* Patients with known intraventricular or aortic root thrombus formation confirmed by transthoracic ultrasound diagnostic
* Known pathology of the coagulatory system
* Supra or sub-therapeutic anticoagulation (aPTT or INR)
* Suspected or confirmed pump thrombus (based on lab parameters, abnormal high pump power consumption or acoustic spectral analysis)
* History of ischemic or hemorrhagic stroke (\<2 months)
* Hypertension at rest (mean arterial pressure \> 120mmHg)
* Cerebrovascular or musculoskeletal disease preventing the performance of daily life activities or exercise training
* Severe arrhythmia (e.g. long QT syndrome), ventricular fibrillation or required defibrillation - excluding the LVAD implantation - in the previous 2 months
* All contraindications applicable to the HVAS are applicable to this study.

The System is contraindicated:

* In patients with a body surface area (BSA) less than 1.2 m²
* In patients who cannot tolerate anticoagulation therapy
* During pregnancy
Renin and Aldosterone Levels in the Preterm Neonate At Risk for Hypertension

The purpose of this study is to find out if mothers with high blood pressure (Hypertension) and/or diabetes have babies with high levels of different substances (that help to regulate blood pressure, called Renin and Aldosterone) in their blood. The investigators are also trying to determine if these babies have higher blood pressure than those babies born to mothers without high blood pressure or diabetes, during the first year of life.

The investigators will measure your baby's blood pressure once a day for the first 4 days, at 1 week of age, and then once per week until your baby is discharged. The investigators will also measure the blood pressure after discharge at 4 and 10 months of age, either on the day of your baby's follow-up appointment in the Neonatal Follow-up Clinic or at a visit to our Outpatient Nephrology Clinic, both at CHEO.

We will compare two groups of babies born between 26+0 and 34+0 weeks gestation.Group 1 is the babies born to mothers with diabetes and/or high blood pressure, and babies that are small for dates. Group 2 are babies that are 26 to 34 weeks of age, that are born to mothers without these problems.

In the study we will measure the baby's blood pressure once a day for the first 4 days, at 1 week of age, and then once per week until the baby is discharged. We will also measure the blood pressure after discharge at 4 and 10 months of age, either on the day of your baby's follow-up appointment in the Neonatal Follow-up Clinic or at a visit to our Outpatient Nephrology Clinic, both at CHEO.

As blood tests will be done. A small amount of extra blood, 0.75ml - 1.5 ml (about 1/6 -1/3 of a teaspoon, or approximately 1 ml) will be collected for measurement of the blood substances we are studying will be collected when the baby has their regular non-study blood work.

This will be done within six hours of birth and then again at 2-3 weeks of life.

Eligibility Criteria:
Inclusion Criteria:

1. Infants \< 6 hours of age who require NICU admission
2. Infants 26+0 to 34+0 weeks gestation.

Exclusion Criteria:

* Immediate Exclusion from Enrollment

  1. Maternal treatment with drugs known to be teratogenic and cause nephrotoxicity in the fetus (i.e. ACE-Inhibitor).
  2. Infants with known congenital anomalies and/or renal anomalies.
  3. Infants with known chromosomal anomalies.
  4. Infants with severe asphyxia defined as cord pH \< 7.0, 5 min Apgar \< 3, and urine positive for blood.
  5. Infants with a known or suspected blood loss at birth (ie: uterine rupture, placental abruption, bleeding placenta previa, or post-natal blood loss in the delivery room).
  6. Infants who will not receive follow-up care in Ottawa upon discharge from the NICU (ie: live out of town).
Xenon Against Postoperative Oxygen Impairment

Acute lung injury (ALI) is the vital complication of Stanford type A aortic dissection. It is confirmed that Xenon has the significant protective effect on important organs and has no suppression on the cardiovascular system. Furthermore, our earlier trial has already clarified that static inflation with 50% Xenon during cardiopulmonary bypass could attenuate ALI for Standford A acute aortic dissection. However the protection effect was restricted for the limited time. Aimed to enhance the protection effect of Xenon, we designed this randomized trial that anesthesia with 50% xenon one hour before and after CPB and pulmonary static Inflation with 50%,75% and 100% Xenon during CPB respectively.


Eligibility Criteria:
Inclusion Criteria

Consultant's clinical diagnosis of Stanford type A AAD using local pathways of diagnosis, which may include clinical history, chest radiography (X-rays), transthoracic ultrasound, and contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI)

Patients aged 18 to 65 years

Eligible for AAD surgery

Exclusion Criteria

Have coronary heart disease, heart failure, severe cardiac tamponade, unstable hemodynamics, severe nervous system abnormalities, clinically apparent malperfusion\[9\] including lower limb, cerebral, coronary and renal malperfusion, and visceral ischemia, sever hepatic and renal abnormalities

Have undergone any of the cardiac and thoracic surgeries

Are unlikely to be able to perform the required clinical assessment tasks

Have significant cognitive impairment or language issues

Are unable to provide consent with regard to their participation in the study

Prescribed with non-steroidal anti-inflammatory drugs or corticosteroids before or after admission
Early Treatment Versus Expectant Management of PDA in Preterm Infants

Patent ductus arteriosus (PDA) in very preterm newborns is associated with severe neonatal mor-bidity: intraventricular hemorrhage (IVH), bronchopulmonary dysplasia (BPD), necrotizing en-terocolitis (NEC), retinopathy of prematurity (ROP). Existing methods of management PDA do not reduce the incidence of these diseases. The efficacy of cyclooxygenase inhibitors (COX) which are currently the standard of treatment in extreme preterm infants is about 70-80%. COX inhibitors have significant side effects. On the other hand, surgical ligation of the ductus arteriosus is associated with deterioration due to cardio-pulmonary problems and long-term complications. Paracetamol has been proposed for treatment of hemodynamically significant PDA because it has a different mecha-nism of action compared with COX inhibitors and a better safety profile.

Recently, expectant approach has becoming more popular, although there is not enough evidence to support it.

The objective of this study is to investigate whether in preterm infants, born at a GA less than 32 weeks, with a PDA (diameter \> 1.5 mm) at a postnatal age of \< 72 h, an expectant management is non-inferior to early treatment with regard to the composite of mortality and/or severe morbidity.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age \< 32 weeks
* Birthweight \<1500 g
* Age less than 72 hours
* PDA diameter \> 1.5 mm
* Signed informed consent obtained from both parents

Exclusion Criteria:

* Birthweight ≥ 1500 g and/or gestation age ≥ 32 weeks
* Lack of informed consent of the parents
* Congenital heart defect, other than PDA and/or patent foramen ovale (PFO)
* The presence of a clinically apparent hemorrhagic syndrome
* Any intraventricular hemorrhage (IVH) in the first 48 hours or IVH grade 3-4
* A platelet count of \< 50,000/mm3
* A serum creatinine concentration of \> 110 μmol/L
* Oliguria \<1 ml/kg/h
* Suspected/apparent NEC
* Suspected/apparent lung hypoplasia
Measuring Head Control Change With 2D Video Analysis After Utilization of Headpod in Children With Poor Head Control

Inclusion Criteria: children ages 2 to 14 years with poor head control and non progressive diagnoses. Exclusion criteria: significant change of status i.e. prolonged hospitalization, surgery; inability to tolerate using Headpod. Requires use of Headpod 3x per day for minimum of 15 minutes each time over a 6 month period. Log must be kept documenting usage of the Headpod. Video will be taken to document changes.

Requires usage of the Headpod 3x per day for a minimum of 15 minutes each time. Usage required for 6 month period. Log must be kept documenting usage of the Headpod. Video will be taken on initial trial use, 1 week post trial use, at 3 months post utilization of the Headpod and at 6 months post utilization of the Headpod.

Eligibility Criteria:
Inclusion Criteria:

* non progressive diagnoses with poor head control

Exclusion Criteria:

* recent prolonged hospitalization; surgery, inability to tolerate wearing the Headpod
Acute Hospital Care at Home for People Living With Dementia

The investigators will perform a parallel-group multicenter randomized controlled trial of a 1-year pre-enrolled acute hospital care at home intervention vs usual care for people living with dementia. Patients will be randomized only after eligibility determination and after the family caregiver agrees to enroll; people living with dementia will assent when able. Patients will be allocated in a concealed fashion to the control and intervention groups in randomly selected block sizes of 4 or 6 in 4 strata reflecting their functional status (activities of daily living: 0, 1, 2-3, 4-6). Although family and clinicians cannot be blinded, the investigators will blind the data collectors and assessors.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate or severe dementia (as ascertained by the Quick Dementia Rating System; QDRS)
* Resides in a private or assisted living residence with or nearby (\<15min travel time) to a family caregiver
* Resides within the MGB home hospital catchment area
* Has had at least 1 hospitalization in the last 12 months.

Exclusion Criteria:

* No functioning utilities, such as no working heat (October-April), no running water, or no electricity.
* Resides in skilled nursing facility
* Resides in group home
* Domestic violence screen positive
* In police custody
* Family caregiver unable to initiate or maintain communication with care team
* End-stage renal disease on hemodialysis
* On methadone requiring daily pickup of medication
* Active substance use disorder, without functioning treatment plan
* Psychiatric diagnosis that would prohibit successful home hospital care
* Acute delirium without explanation or without the ability to manage at home
* Patients with cancer requiring consistent hospital-based treatments
* Cannot ambulate to bedside commode with assistance present in the home (if different from baseline), unless home-based aides are available
Analgesic Effect of Intrathecal Morphine Combined With Low Dose Local Anesthetics on Postoperative Analgesia After Liver Resection

Efficient postoperative pain control plays a vital part in the management of patients after surgery. In particular, major surgeries including hepatectomy cause intense postoperative pain that may result in cardiovascular or respiratory complications post-surgery. One of the current methods of postoperative pain control after hepatectomy involves a multimodal approach including intrathecal morphine injection immediately prior to surgery. Because morphine alone is inadequate for immediate postoperative pain control due to a late peak effect time of 6 hours, current literature advocates a combination injection including bupivacaine. However, higher doses of bupivacaine may inadvertently cause motor block or hemodynamic side effects. The aim of this study was to compare the effectiveness and side effects of intrathecal morphine combined with low dose bupivacaine against intrathecal morphine alone and no intrathecal injection.

All patients enrolled in the current study will receive intrathecal injections immediately prior to general anesthesia. The patient will be on his or her side in the fetal position and after palpating the back to secure the space between the 3rd and 4th lumbar spine, the area will be properly disinfected and draped with a sterile towel. Using a 25G needle, a small volume of 1% lidocaine will be injected at the proposed puncture site. For the control group, 2ml of 1% lidocaine will be injected subcutaneously with the 25G needle used during local anesthetic injection. For the morphine group and the morphine + bupivacaine group, a 25G pencil point spinal needle will be used to advance into the intrathecal space. After confirming intrathecal position of the needle by CSF regurgitation, morphine 400mg or morphine 400mcg+ bupivacaine 5mg each to a total volume of 2ml will be injected. Afterwards, all patients will undergo general anesthesia by the same method.

Eligibility Criteria:
Inclusion Criteria:

1. Age 19 years to no upper limit
2. Patients receiving liver resection under general anesthesia (Including open surgery and laparoscopic surgery)
3. American Society of Anesthesiologists (ASA) physical status 1,2

Exclusion Criteria:

1. Patients presenting with coagulopathy prior to surgery
2. Patients with neurological deficits
3. Patients with spinal anomaly or disorders
4. Patients with allergies to opioids or local anesthetics
5. Patients with severe respiratory, cardiovascular, renal, or hepatic disorders
6. Severe systemic infection or infections involving proposed intrathecal injection site
7. Patients with severe psychological disorders severe that may interfere with pain evaluation
8. Patients with chronic diseases that require opioids
Prevalence of Amyloidosis in Trauma Patients

This study aims to determine the frequency of amyloidosis among patients undergoing trauma surgery.


Eligibility Criteria:
Inclusion Criteria:

* Men and women included in the waiting list for scheduled trauma surgery with at least one of the following criteria defined as red flags: Over 65 years old; Possible family history of amyloidosis, Cardiac pathology: aortic stenosis, presence of left ventricular hypertrophy defined as interventricular septal thickness \> 12mm measured by echocardiography, history of previous brady- or tachyarrhythmias including cardiac conduction blocks, history of syncope or presyncope, pro BNP \> 300 in previous blood tests; History of sensory peripheral neuropathy; History of nephropathy without etiological diagnosis; History of liver disease without a clear cause.
* Ability to cooperate in the necessary evaluations.
* Signed informed consent for inclusion in the study, either by the participant or their legal representative.

Exclusion Criteria:

- Participants previously diagnosed with amyloidosis cannot be included in the study.
Evaluation of the Rectal Reflex Using Anal Acoustic Reflectometry

Anal Acoustic Reflectometry (AAR) is a reliable and reproducible technique that has been studied in our department over the last 6 years. Sound waves pass into a balloon placed in the anal canal and are used to measure the cross-sectional area. By gradually increasing and decreasing the pressure in the balloon the investigators can measure the pressure at which the cross-sectional area starts to increase and decrease, and the anal canal starts to open and close. This assessment mimics the natural opening and closing of the anal canal and the effect of squeezing the muscles.

The gold standard investigation of the anal sphincter muscles has been manometry which measures anal canal pressure at rest and during squeeze. However, it has limitations. In previous studies AAR has shown promise in the assessment of faecal incontinence and, that unlike manometry, it has been able to distinguish between different types of incontinence.

The Recto-anal Inhibitory Reflex (RAIR) is a normal response when the rectum fills with faeces, fluid or air, whereby there is a change in the pressures within the anal canal to determine the type of contents. This can be absent or altered in patients who have difficulty in opening their bowels. The RAIR is currently measured by anal manometry using a 4.9mm catheter, resulting in an anal canal which is already partially opened prior to the measurement, and potentially distorted.

AAR is considered a catheter free technique as the balloon has a cross-sectional area of only 0.4mm2 when collapsed. The investigators propose to measure the RAIR using a 1.7mm diameter catheter alongside the AAR balloon to determine the effect that its placement has on the recorded parameters of AAR. This aims to improve our understanding of the opening and closing of the anal canal in response to distension of the rectum.


Eligibility Criteria:
Inclusion Criteria:

1. Adults over 18 years old
2. Have capacity to consent to the study
3. Patients with pelvic floor dysfunction.

Exclusion Criteria:

1. Minors under the age of 18 years old
2. Patients who lack capacity to consent
3. Patients with known rectal tumours and proctitis
4. Asymptomatic patients
Neurogenic Inflammation in Diabetes

Polyneuropathy is a complication of diabetes mellitus which leads to decreased sensation in arms and legs. This in turn can lead to the development of (infected) foot ulcers. Charcot's disease can also be a consequence of polyneuropathy. Patients with Charcot's disease suddenly develop a red, warm and swollen foot, like an infection. Charcot's disease leads to foot fractures. After these fractures have healed, the shape of the foot can be dramatically altered. This altered shape of the foot increases the risk of developing foot ulcers. Nerves are important in regulating the inflammatory response. This study aims to investigate whether the inflammatory response is different in patients with polyneuropathy with and without a history of Charcot's disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes with and without polyneuropathy.
* Patients with type 2 diabetes with a history of Charcot's disease.
* Healthy controls.
* Signed informed consent.

Exclusion Criteria:

* Peripheral arterial disease: toe pressure \< 70 mm Hg and/or transcutaneous oxygen tension \< 40 mm Hg and/or claudication.
* Renal insufficiency: MDRD creatinin clearance \< 30 ml/min.
* Systemic disease such as vasculitis or rheumatoid arthritis.
* Malignancy.
* (Diabetic) foot ulcer.
* Gout.
* Bacterial infection of an extremity.
* Skin condition of the dorsal aspect of the foot or the medial side of the upper arm.
* Bleeding disorder such as hemophilia.
* Use of medication for asthma.
* Impaired immunity such as in HIV/AIDS.
* Capillary blood glucose \< 3 mmol/l or \> 20 mmol/l at the time of the study.
* Peripheral oedema.
* Vaccination in the two months prior to study inclusion.
* Chemotherapy or radiation therapy in the twelve months prior to study inclusion.
* Surgery in the two months prior to study inclusion.
* Previous adverse reaction to Candida albicans antigen.
* Acute infection at the time of the study or in the month prior to study inclusion.
* Transfusion in the two months prior to study inclusion.
* Use of immunosuppressants in the two months prior to study inclusion.
* Pregnancy or breastfeeding.
A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C

Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules. Subjects will be confined on either days 1-3 and/or days 8-10. Follow-up visits are also required periodically through day 43. Study procedures involve taking blood samples for pharmacokinetic, pharmacodynamic, virologic, and safety assessments.


Eligibility Criteria:
Inclusion Criteria:

* Males and Females 18-65 years old
* Chronic HCV infection for at least 6 months, treatment naive
* HCV Viral load \> 100,000 IU/mL at Screening
* Monoinfection with HCV 1 genotype
* Hepatitis B surface antigen negative
* Screening ECG without clinically significant abnormalities
* BMI 18-33 kg/m\^2
* Creatinine clearing \> 70 mL/min
* Negative pregnancy test at screening

Exclusion Criteria:

* Pregnant or lactating subjects
* Co-infection with hepatitis B virus (HBV) or HIV
* History of Gilberts disease
* Particular abnormal laboratory parameters
* Diagnosis of autoimmune disease, poorly controlled diabetes, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), malignancy, hemoglobinopathy, retinal disease, and those who are immunosuppressed
* Evidence of hepatocellular carcinoma
* On-going alcohol abuse
* Positive uring drug screen
High Septal Pacing for Cardiac Resynchronization Therapy

The purpose of this acute study is to perform a preliminary investigation of high septal right ventricular pacing in the vicinity of the His bundle region as an alternate or adjunctive means for cardiac resynchronization in patients with heart failure and wide QRS.

The HISTORY Study is an acute, cross-sectional, multi-center, feasibility study with a randomized within patient test sequence designed to characterize the effects of high septal right ventricular pacing in the vicinity of the His bundle region compared to conventional biventricular pacing for cardiac resynchronization therapy.

Eligibility Criteria:
Inclusion Criteria:

* 50 years of age or older
* Patients willing and capable of providing informed consent, participating in all testing associated with this clinical investigation
* Patients undergoing a CRT implant procedure (pacemaker or defibrillator) for one of the following reasons

  * Indicated for a new device
  * Device upgrade
  * Device replacement
  * Lead revision
* Note: recognized indications for CRT-P and CRT-D as of October 2009 are valid for inclusion in this study. Should new indications become approved during the study conduct; those will also be applied within the inclusion criteria.

Exclusion Criteria:

* Patients unwilling or incapable of signing the informed consent, or patients having previously withdrawn their consent
* Patients in AF that cannot be cardioverted for the study
* RBBB pattern
* Sustained, uncontrolled ventricular tachycardia
* Sinus rhythm \< 30 bpm or \>100 bpm
* Complete AV node block
* Second degree AV block
* Women who are pregnant or plan to become pregnant during the study (method of assessment upon physician's discretion);
* History of (hemorrhagic) cerebro-vascular accident or TIA