cyrilzakka/clinical-trials huggingface dataset:
HBP Device EGM Data Collection

This is a single-arm, non-randomized, non-blinded study designed to collect device data in patients with permanent His bundle (HB) pacing lead and an existing Abbott permanent pacemaker, defibrillator, or cardiac resynchronization device. Prospective data collection includes surface electrocardiograms, intracardiac electrograms, and pacing parameters, recorded during a patient visit. Additional retrospective data collection includes procedural data during the HB pacing lead and device implant.

Up to 200 subjects will participate in this clinical investigation. The clinical investigation will be conducted at up to 8 centers worldwide.

The total duration of the clinical investigation is expected to be 1 year, including enrollment and data collection from all subjects.


Eligibility Criteria:
Inclusion Criteria:

* Has previously implanted with Abbott device and any pacing lead at HB
* Age ≥ 18 years
* Ability to provide informed consent for study participation
* Willing to comply with study evaluation requirements

Exclusion Criteria:

* Suspected pacing system failure
* Lead impedance out of range
* Ventricular sensing amplitude lower than 0.5 mV
Power Doppler in Hand Joints of Early RA Patients

It is a prospective case-control study with women diagnosed early rheumatoid arthritis. Three therapeutic failures were considered: failure 1 - to the first Disease-modifying antirheumatic drugs (DMARDs) (methotrexate); failure 2 - to the second DMARDs (leflunomide) and failure 3 - to the first immunobiological drugs (adalimumab). Ultrasound was performed bilaterally on the 2nd and 3rd metacarpophalangeal joints (MCFs), proximal interphalangeal joints (IFPs), and wrists (US10). Ultrasound measurements (qualitative and semi-quantitative) evaluated: 1 - inflammatory: synovial and tenosynovial proliferation in gray scale and power Doppler (0-3); 2 - joint damage: bone erosion (qualitative and semi-quantitative) and cartilage damage (qualitative and semi-quantitative). Clinical and laboratory variables were also assessed blindly at baseline and after 12, 24 e 48 weeks.


Eligibility Criteria:
Inclusion Criteria:

* early rheumatoid arthritis fulfilment of the 2010 ACR/EULAR RA classification criteria;
* age between 18-65 years;
* female gender,
* naive for treatment.

Exclusion Criteria:

* use of oral \> 10 mg/d glucocorticoid in the previous three weeks;
* serum aspartate aminotransferase or alanine aminotransferase level \> 3 times the upper limit of normal;
* bone marrow, auto-imune, lymphoproliferative or infectious diseases;
* pregnancy.
Antimicrobial Stewardship in Pediatric Surgery

Acute appendicitis is a common surgical emergency in children. Non-perforated appendicitis patients do not require antibiotics after appendectomy. Although guidelines and recommendations exist to decrease post-operative antibiotic mis-use after appendectomy, surgeons continue to prescribe unwarranted antibiotics.

The aim of this study is to determine if an Antimicrobial Stewardship Program in Pediatric Surgery will decrease the use of un-warranted antibiotics.

Many surgeons continue to treat non-perforated or "borderline perforated" appendicitis with postoperative antibiotics despite an evidence-based definition of perforation (in the pediatric surgical literature) and many guidelines and recommendations that specify that no postoperative antibiotics are required. Children with perforated appendicitis are also often treated with longer-than-necessary courses of antibiotics. Although surgeons may feel that they only prescribe additional doses on occasion, evidence suggests that this behavior occurs in over 50% of children with non-perforated appendicitis.

These additional doses contribute to a longer length of stay, excess costs to the health care system, and disrupt patient flow. Additionally, the patients are exposed to more antibiotics and their potential for adverse effects (such as incorrect dose, incorrect medication, allergic reaction, antimicrobial resistance or c difficile infection).

Antimicrobial stewardship programs have been successful in pediatrics and adult general surgery in curbing unwarranted antibiotic use, but have never been evaluated in pediatric general surgery.

Eligibility Criteria:
Inclusion Criteria:

* Participant (surgeon) is a pediatric surgeon at McMaster Children's Hospital and takes care of patients under the age of 18 who undergo appendectomy.
* Participant (surgeon) is able to read, write and understand English.
* Participant (surgeon) is able to provide informed consent.

Exclusion Criteria:

* Participant (surgeon) only has patients who undergo drain insertion, PICC line insertion or a secondary operation during the same admission
* Participant (surgeon) only has patients who do not undergo operation (i.e. "conservative management with interval appendectomy)
* Participant (surgeon) does not provide informed consent
* Participant (surgeon) does not understand written and spoken English diagnosis other than appendicitis at time of operation
Mapping of Metabolic Liver Functions in Patients With Non-alcoholic Fatty Liver Disease

Background: Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the western world and an important cause of morbidity and mortality including risk of cardiovascular disease. A ruling dogma is that a fatty liver is well-functioning. Recent studies imply the contrary but quantitative measurements of metabolic liver function have not been systematically investigated in NAFLD.

Objectives: To study and quantify specific metabolic liver functions in varying degrees of NAFLD. Furthermore to map the coagulation system of patients with NAFLD.

Methods: A human clinical study. Metabolic liver functions are studied by a series of functional tests (Galactose elimination capacity (GEC), Aminopyrine breath test (ABT), Indocyanine green plasma disappearance rate (ICG-PDR), Functional hepatic nitrogen clearance (FHNC)). Regional liver function evaluated by 2-\[18F\]fluoro-2-deoxy-D-galactose (FDGal) PET/CT is compared to fat infiltration assessed by Magnetic resonance imaging (MRI). Primary and secondary hemostasis, natural anti-coagulants and fibrinolysis are evaluated.

Perspectives: To challenge the dogma, that hepatic metabolic function is not affected in NAFLD, improving the understanding of the relationship between the clinical degree of NAFLD, histology, metabolic functions, and imaging. Furthermore to disclose a proposed procoagulant imbalance in NAFLD.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Hepatic steatosis found on ultrasound
* Clinical indication for liver biopsy (typically persistently elevated alanine transaminase (ALT) levels)

Exclusion Criteria:

* Other liver pathology
* Alcohol consumption \> 20g/day
* Chronic inflammatory disease, current infection or cancer
* Diabetes mellitus type I, II or HbA1c ≥ 48 mmol/mol (6.5 %)
* Prednisolone treatment within last 8 weeks
* Pregnancy within last 12 months
* Contraindication for MRI
Control of Emergence Blood Pressure During Craniotomy for Tumor Surgery Between Labetolol and Diltiazem

The purpose of this study is to determine the effectiveness of the antihypertensive drugs in the control of emergence blood pressure after tumor resection craniotomy; compared between labetalol (Avexa) and diltiazem (Herbessor).

Also the investigators seek to determine the effective dose of the antihypertensive drugs and their side effects in Thai population.

The study was randomized equivalence trial

Eligibility Criteria:
Inclusion Criteria:

* patients who scheduled for craniotomy for tomor removal

Exclusion Criteria:

* allergic to labetalol or diltiazem
* Bradycardia \< 60 beat/min
* Second or third degree heart block
* Severe asthma or severe COPD
* Brain stem tumor
Attention Capacity and Before-school Physical Activity Intervention Program

Despite the evidence and the potential of physical activity related to cognition and academic performance in children, the effects of a before-school physical activity program on these parameters remains unknown.

Despite public health concerns and the extensively documented health benefits of physical activity, a large proportion of Chilean children do not meet the physical activity recommendations (Aguilar-Farias et al., 2018). Since most children spend a majority of their waking hours at school, this environment is appropriate for the implementation of preventive interventions, particularly those that include activities promoting physical activity (Naylor \& McKay, 2009). With the absence of opportunities for physical activity during the school day, before-school programs have become a popular option to help children increasing their physical activity levels (Stylianou, van der Mars, et al., 2016). Although several recent studies support a positive effect of before school-based physical activity on health (Westcott, Puhala, Colligan, Loud, \& Cobbett, 2015), less literature has evaluate the cognitive outcomes (Stylianou, Kulinna, et al., 2016) such as attention capacity.

Eligibility Criteria:
Inclusion Criteria:

* All students in fourth grade (aged 8-10 years)
* Children's parents/caregivers will give their written consent to the children's participation.
* Collaboration in the family to respond to questionnaires

Exclusion Criteria:

* Children with some physical pathology or medical contraindication to perform physical exercise
* Diagnosed with learning disabilities or mental disorders
Cellular and Molecular Biomarkers in Patients With Lichen Planus

Lichen planus (LP) is a chronic inflammatory disease of unknown aetiology, affecting the skin and mucous membranes, characterised by a CD8+ cytotoxic T-cell infiltrate, associated with epithelial cell death and disruption of the basement membrane zone. In previous work, T cell antigen receptor (TCR) repertoire studies were performed. In all patients tested, whether with erosive or non-erosive LP, unique nucleotide sequences, called clonotypes, have been identified. They appear during the process of TCR gene rearrangement. These clonotypes are specific for human papillomavirus (HPV) in blood and lesions, suggesting antigenic stimulation of these clonotypes by a viral epitope of HPV, which crosses with an epitope on keratinocytes. The diagnosis of LP is made on the basis of clinical and histological criteria, but in some patients and in some anatomical locations, the diagnosis is difficult to make and LP may be confused with other skin conditions.

Lichen planus (LP) is a chronic inflammatory disease of unknown aetiology, affecting the skin and mucous membranes, characterised by a CD8+ cytotoxic T-cell infiltrate, associated with epithelial cell death and disruption of the basement membrane zone. Several triggers have been proposed for LP, including viral antigens. In previous work, T cell antigen receptor (TCR) repertoire studies were performed, i.e. investigating the diversity of TCRs expressed on the surface of an individual's lymphocyte population. In all patients tested, whether with erosive or non-erosive LP, unique nucleotide sequences, called clonotypes, have been identified. They appear during the process of TCR gene rearrangement. These clonotypes are specific for human papillomavirus (HPV) in blood and lesions, suggesting antigenic stimulation of these clonotypes by a viral epitope of HPV, which crosses with an epitope on keratinocytes. The diagnosis of LP is made on the basis of clinical and histological criteria, but in some patients and in some anatomical locations, the diagnosis is difficult to make and LP may be confused with other skin conditions.

Eligibility Criteria:
Inclusion Criteria:

* Subject coming at the time of diagnosis of the disease before any systemic treatment, or at the time of a progressive episode of the disease, without systemic treatment or after cessation of immunomodulatory or immunosuppressive treatment
* Ability to give their consent in writing
* Must understand spoken and written French
* Affiliated to the French social security or assimilated regimes

Exclusion Criteria:

* Dermatosis exclusively localised in the skin folds or on the face (risk of scarring from biopsies)
Impact of Umbilical Cord Milking in Preterm Neonates With Placental Insufficiency

To investigate the effect of umbilical cord milking (UCM) on peripheral hematologic parameters including hematopoietic progenitor cells in premature infants ≤ 34 weeks gestational age with placental insufficiency. We hypothesize that UCM would enhance peripheral CD34 concentration, hemoglobin and reduce prematurity complications like NEC and IVH in preterm infant ≤ 34 week gestational age with placental insufficiency.

A pilot prospective randomized controlled study will be conducted among 3 groups, all of them are preterm less than 34 weeks gestational age, in the first group umbilical cord milking will be done for preterm infant with placental insufficiency. Two control groups are present, in the first one umbilical cord milking will be done for preterm infants without placental insufficiency (Insufficiency vs. no insufficiency), another group of immediate cord clamping for preterm infants with placental insufficiency will be added (milking vs. no milking), 30 cases will be recruited in each group.

Umbilical cord milking (UCM) is typically performed by placing the infant below the level of the placenta. The cord is held at 20-25 cm distance from the baby and milked vigorously towards the umbilicus for 3 times at a speed of 10 cm/sec. After completion, the cord is clamped, and the neonate is handed to the resuscitation team.

One milliliter of fetal blood will be taken from peripheral venous blood in the first 30 min of life and CD34 will be assessed by flow cytometry. Secondary outcomes will be documented during NICU stay that include admission CBC, peak bilirubin concentrations, CBC after 2 months, neonatal morbidity such as sepsis, bronchopulmonary dysplasia, necrotizing enterocolitis, retinopathy of prematurity and polycythemia, therapeutic interventions such as need for inotropes, nasal CPAP, mechanical ventilation and phototherapy.

Eligibility Criteria:
Inclusion Criteria:

* preterm neonates \< 34 weeks gestational age

Exclusion Criteria:

* Vaginal bleeding due to placental abruption or tears
* Multiple pregnancies
* Suspected major fetal anomalies
* Suspected chromosomal aberration
* Maternal drug abuse
* Hydrops fetalis
* preterm who needed major resuscitative measures
A Study of the Safety and Efficacy of Bimatoprost in Patients With Glaucoma or Ocular Hypertension

A one month study which will determine the safety and efficacy of bimatoprost eye drops in patients with glaucoma or ocular hypertension


Eligibility Criteria:
Inclusion Criteria:

* Chronic glaucoma or ocular hypertension
* IOP controlled on Xalatan

Exclusion Criteria:

* Uncontrolled medical conditions
* Known hypersensitivity to study medications
Open Label Phase 1 Pharmacokinetics and Tolerability Study of Single TAB08 Administration in Healthy Volunteers

The purpose of this study is to assess safety and tolerability of ascending dosed of TAB08 after single i.v. infusion to the adult healthy volunteers. Additionally were assessed infusion speed tolerability, pharmacokinetics and pharmacodynamics of TAB08 after single i.v. infusion and to explore TAB mechanism-of-action biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Adult man aged from 18 to 40 years, who agreed to use adequate contraception.
* Body mass is at least 60 kg and BMI is within 20-27
* Volunteer is in good physical and mental health, as per his medical history and assessment results
* Volunteer's laboratory values are normal (or not clinically significant as per Investigator discretion) at screening, including baseline cytokines levels as per RESTORE test results
* Volunteer has signed the informed concent.

Exclusion Criteria:

* Any chronic or relapsing illness in the medical history
* Any abnormal assessment or laboratory result at screening, which is clinically significant as per Investigator discretion
* Active tuberculosis at the time of screening
* Any acute illness at the time of study enrollment
* Any blood donation within 4 weeks before Study Day 1
* Positive result for HBsAG, Hepatitis C, HIV
* Continuous use af any medications
* Use of any medications within 72 hours before study drug infusion
* Use of an investigational treatment within 4 weeks before screening, or within a period of 5 half-lives of the investigational treatment, whichever is longer
* High inflammatory cytokines levels as per RESTORE test results after ex vivo PBMC testing
High Blood Pressure Strategy (HBPS)

This program developed by the HSFO aims at helping people of Ontario and their primary healthcare providers better diagnose, manage and control high blood pressure. The High Blood Pressure Strategy brings together healthcare providers and patients to improve the way in which family doctors, nurse practitioners and pharmacists work together and with patients towards improved control of high blood pressure through the use of evidence-informed tools combined with local systems change.

Approximately 5,000 patients will participate in the study at 11 family practice sites throughout Ontario. Each of the 11 clinic sites will be randomised to either intervention or delayed intervention 9 months later. The intervention is a systems change involving interprofessional education and management tools to bring together physicians, nurses and pharmacists with the patient. Patients will be monitored by their family doctor or nurse practitioner at scheduled follow-up visits during a period of 36 months for an effect of the intervention over time on the patient's blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or older
* History of elevated BP reading or primary hypertension diagnosis

Exclusion Criteria:

* Major mental health illness of cognitive impairment
* Language barrier (unable to speak or read English)
* Lives in a long-term care home
* Secondary hypertension
PRognOstiC valuE of rEd Density in Ulcerative Colitis

Observational prospective multicenter study: baseline assessement of the disease activity by an automated endoscopic tool and follow up of 52 weeks to evaluate sustained clinical remission.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of UC for at least 3 months
* Clinical remission with SCCAI \<3 at baseline and stable remission for the last 3 months
* Ability to give informed consent by the patient or legal representative in case of minority.

Exclusion Criteria:

* Any contraindication for sigmoidoscopy or undergoing biopsies of the rectosigmoid.
* Uncontrolled coagulopathy.
* Any planned change in UC related treatment (both escalation and de-escalation) after the baseline endoscopy
* Planned UC related surgery
* Previous subtotal or total colectomy
* Short bowel, ileostomy or colostomy
* Pregnancy at baseline
* Age younger than 16 years
The Benefits of the Use of a Support Bra in Women Undergoing Coronary Artery By-Pass Graft Surgery

That study have the primary purpose identify if exist difference to the healing and quality of life between women that use of a surgical support bra, common support bra and without support bra after coronary artery bypass graft surgery.

To do this, will be assessed pain, healing of the wound (dehiscence, infection) and quality of life life through specific instruments.

The patients will be randomized and share into three groups: women after coronary artery bypass surgery use surgical support bra, women after coronary artery bypass surgery use common support bra and those who will not use any support bra.

They will be can tracked and invited to participate in the study few days before the surgery or during the post operatory (2 - 6 days after surgery). The assessement and the intervention must be start in the inpatient unit from the 2nd to 6th post operatory until their discharge.

Initially, it will be apply a questionnaire of quality of life (SF36) to assess the quality of life before the surgical procedure. In this moment, will be measured for breast size and also wil be identify the risk factors through a brief historical.

During the stay in the hospital, the patients will be assessed on a daily basis with respect to the following: pain (verbal numerical scale) and wound appearance.

The questionnaire of quality of life(SF36) will be applied again for more three times, about one month, two months and six months after the discharge together with the assessement to the pain and wound healing.

Eligibility Criteria:
Inclusion Criteria:

* Women who undergoing coronary artery bypass graft surgery
* Women who signed the term consent and informed

Exclusion Criteria:

* Women who have had any breast surgery
* Women who undergoing radiotherapy to the thorax.
* Women with cognitive impairments.
Norepinephrine Transporter Blockade as a Pathological Biomarker in Neurogenic Orthostatic Hypotension

The autonomic or automatic nervous system helps control blood pressure. Diseases of the autonomic nervous system may result in a drop in blood pressure on standing in many cases leading to fainting. Diseases that affect the autonomic nervous system include pure autonomic failure, multiple system atrophy and Parkinson's disease, and can present with very similar symptoms and it is sometimes difficult to determine an exact diagnosis. The purpose of the study is to find out if the blood pressure response from taking a single dose of the medication atomoxetine can help in the diagnosis of these diseases.

This is an observational, prospective three-year longitudinal study. The investigators will enroll participants with primary neurogenic orthostatic hypotension. All participants will undergo an extensive neurological and cardiovascular evaluation, including detailed autonomic testing and quality of life assessment. The investigators will then determine the magnitude of the pressor effect produced by 18 mg atomoxetine given orally, measured 1 hour after drug administration. Participants will be followed annually or more often if there is a significant change in their clinical condition. During follow up at year 3, the investigators will repeat the initial neurological, cardiovascular and autonomic evaluation. The primary endpoint would be the final diagnosis made at year 3 after the initial evaluation (at the end of the follow-up period) or if they develop significant worsening of symptoms during follow-up phone assessments, based on specific clinical criteria.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years old with Neurogenic orthostatic hypotension, ≥30 mmHg drop in SBP within 5 minutes of standing
* Associated with impaired autonomic reflexes, as determined by absence of blood pressure overshoot during phase IV of the Valsalva maneuver
* Absence of other identifiable causes of autonomic neuropathy
* Able and willing to provide informed consent

Exclusion Criteria:

* Pregnancy
* Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathy of unknown significance, and autoimmune neuropathies
* Known intolerance to atomoxetine, Pre-existing sustained severe hypertension (BP at least 180/110 mmHg in the sitting position)
* Clinically unstable coronary artery disease, or major cardiovascular or neurological event in the past 6 months
* Any other significant systemic, hepatic, cardiac or renal illness
* Use of MAO-I within 14 days
* Known closed-angle glaucoma or Life-threatening arrhythmias