cyrilzakka/clinical-trials huggingface dataset:
Comparison of Blood Pressure Measurement With an Omron HEM-907 Device in a Clinical Setting and a Research Setting

Automated office blood pressure (AOBP) devices are recommended for high blood pressure diagnosis. One of those devices is the Omron HEM-907 (Omron Healthcare). It is currently not known if blood pressure measurements performed with this device in a clinical setting are equivalent to those made in a research setting. Therefore, this randomized-controlled trial was designed. It aims to compare the blood pressure measurements performed in a clinical and a research setting. Seventy patients will be included and randomized to a clinical/research or research/clinical sequence.

Hypertension is a common condition, with an estimated prevalence around 20 percent in Canada. It is a major risk factor for cardiovascular disease. Recently, Hypertension Canada has updated its guidelines and recommend we should consider a 120 mm Hg systolic blood pressure target in high-risk patients aged 50 years or older. This recommendation derives mainly from the SPRINT trial. In this trial, blood pressure was measured with an automated oscillometric blood pressure (AOBP) device, the Omron HEM-907 (Omron Healthcare). However, it is not known if measurements performed with this device in a clinical setting are equivalent to those made in a research setting. Therefore, this randomized-controlled trial was designed. It aims to compare the blood pressure measurements of 70 patients in a clinical and a research setting. Patients will be randomized to a clinical/research or a research/clinical sequence.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Hypertensive or presumed hypertensive
* Patients with a scheduled visit at the IRCM hypertension clinic.

Exclusion Criteria:

* Limitation preventing the measurement of blood pressure
* Introduction or withdrawal of any blood pressure-modifying medication starting 4 weeks before the first and until the last study visit.
* Recreative drug use (except cannabis)
* Alcohol use of more than 4 drinks during the day
* New symptoms during the research visit, that warrants a medical evaluation
* Mean systolic blood pressure \>180 mm Hg or mean diastolic blood pressure \>110 mm Hg (using AOBP)
Effect of Sprint Interval Training Frequency on Improvements in Fitness

The goal of this study is to learn how the number of weekly exercise sessions affects improvements in fitness in healthy university aged students. The main question it aims to answer is how training frequency affects improvements in fitness. Participants will complete a pre-testing sessions to assess fitness level and sprint performance. Following this participants are assigned to one of four groups. A group that exercises 2 days a week, a group that trains 3 days a week, a group that trains 4 days a week, or a no-exercise control group. Participants in this group will not complete any training and allow the researchers to compare the exercise groups to a group that didn't train. Each participant will train for 4 weeks. During each training session participants will complete 4-6 30 second all-out sprints with 4 minutes of rest between each. Participants will complete the same tests they did during the pre-testing session following the 4 weeks of training to see how frequency affects improvements.


Eligibility Criteria:
Inclusion Criteria:

* Recreationally active: exercising at least 2-3 days per week and not currently involved in, or had been involved in a systematic training program for at least 3 months prior to data collection.
* Safe to become physically active based on the Canadian Society for Exercise Physiology - Get Active Questionnaire.

Exclusion Criteria:

* Smoking
* Consuming supplements known to affect metabolism (e.g., creatine, carnitine, nitric oxide, brain chain amino acids).
* Failure to meet inclusion criteria
Effects of Daily Home Hemodialysis on Circulation, Mental Functions, and Quality of Life

This study was designed to discover mechanisms responsible for the decrease in (high) blood pressure after starting daily hemodialysis, as has been observed by various investigators. We hypothesized that better control of body water and sodium content and a decline in the autonomic (sympathetic) nervous system activity, increased in chronic renal failure patients, would contribute to improved blood pressure regulation.

Moreover, we studied the effects of daily hemodialysis on mental functions, like information processing and memory, in relation to the previously reported improvement in quality of life, and the effects on nutrition. We hypothesized that all would improve.

Although conventional hemodialysis has faced many technical improvements in recent years, a great deal of end-stage renal disease patients, treated with this modality, have suboptimal or high blood pressure, and suffer poor quality of life. Daily hemodialysis has been reported to improve both, but the pathophysiological background is poorly understood.

Patients were studied before and after 6 months of daily (i.e.6 times a week) home hemodialysis, and again after two months of conventional (i.e. thrice weekly) hemodialysis.

We measured the effects of daily dialysis (compared with conventional dialysis) on blood pressure, cardiac output, extracellular fluid volume, plasma renin activity, sympathetic nervous system activity (through MSNA), the electroencephalogram (EEG), neurocognitive functioning (speed of information processing, memory, executive functioning, and attention), quality of life, and nutritional status

Eligibility Criteria:
Inclusion Criteria:

* End-stage renal disease patients
* Fit and motivated for home hemodialysis

Exclusion Criteria:

* Patients, who were treated with frequent dialysis (5 or 6 times a week) before
* Diabetes mellitus
* Severe comorbidity (e.g. malignancies)
Efficacy and Safety Study of Beclometasone/Formoterol Single Inhaler in Patients With COPD

To evaluate the 1-year efficacy and safety of the fixed combination beclometasone/formoterol pMDI in a twice daily regimen in patients with stable severe COPD.

The purpose of this study is to evaluate the long-term efficacy and safety of the fixed combination beclometasone/formoterol pMDI in a twice daily regimen in patients with stable severe COPD. Patients are randomised to receive either beclometasone/formoterol or budesonide/formoterol DPI or formoterol DPI during 48 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of COPD (according to GOLD guidelines)
* FEV1 \> or equal 30% and \< 50% of predicted normal post-bronchodilator (and at least 0.7 L absolute value)
* COPD symptoms for at least 2 years
* At least 1 exacerbation requiring medical intervention (oral corticosteroid and/or antibiotic treatment and/or need for a visit to an emergency department and/or hospitalization) within 2-12 months before screening
* Current or previous smoker with a cumulative exposure to smoke of more than 20-pack year

Exclusion Criteria:

* Current or past diagnosis of asthma, or any evidence suggestive of asthma
* Positive FEV1 reversibility test
* Clinically significant or unstable concurrent diseases, including clinically significant laboratory abnormalities
* Acute COPD exacerbation or lower tract infection and/or treatment with oral or injectable corticosteroids and antibiotics in the 2 months before screening or during run-in
* Long term oxygen therapy
Dumping Syndrome After Operation of Esophageal Atresia Type III

The purpose of this study is to evaluate the prevalence at 3.5 months of age of dumping syndrome in children operated at birth for oesophageal atresia type III et IV.

Consecutive patients with type III and IV oesophageal atresia that are born in 8 different centers in France and Sydney (Australia) are included in the study, if willing. As soon as they weigh more than 4.150kg and if they are still younger than 3.5 months, an Oral Glucose Tolerance Test (OGTT) is performed. Glycemia and insulinemia are monitored every 30 minutes from intake to 240 minutes. Clinical signs that are presented are noted. If early hyperglycemia or late hypoglycemia are biologically or clinically observed, ascarbose treatment is initiated.

Eligibility Criteria:
Inclusion Criteria:

* New born less than 3.5 months or age corrected for premature new born
* Weight ≥ 4, 150 kg
* Esophageal atresia (EA) type III or IV
* EA Surgery between May 2013 and June 2016
* Stop of prokinetic treatment \> 72 h before OGTT
* Information and consent of parents
* Patients with health insurance

Exclusion Criteria:

* Age \> 3.5 months
* Weight \< 4.150 kg
* Other types of EA
* Dumping syndrom from other origin: microgastria, dysautonomia, small intestine surgery
* Other pathology that can modify glycemia: neonatal diabete, hyperinsulinism
* Treatment that can modify gastric motility: domperidone, erythromycin, baclofen that hasn't been stopped in the 72h before OGTT
* Absence of consent
* Patient judiciary protected
* Simultaneous participation to another clinical trial
* No health insurance
Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension.

The primary objective of this study is to evaluate the effect of selexipag on the physical activity of patients with pulmonary arterial hypertension (PAH) in their daily life, by using a wearable wrist device (actigraph). The actigraph will collect data on daily life physical activity in the patient's real environment. In addition, the PAH symptoms and their impacts will be assessed by using an electronic patient reported outcome measure in the patient's real environment. Patients will be assigned randomly to either selexipag or placebo.

This study is designed as exploratory with the purpose to generate hypotheses on new endpoints

Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 75 years old inclusive.
* Women of childbearing potential must have a negative serum pregnancy test at planned visits and use an acceptable method of birth control from screening up to 30 days after study treatment discontinuation.
* Symptomatic pulmonary arterial hypertension (PAH) belonging to one of the following subgroups only:

  * Idiopathic
  * Heritable
  * Drug or toxin induced
  * Associated with one of the following: connective tissue disease; HIV infection; corrected simple congenital heart disease.
* With the following hemodynamic characteristics assessed by right heart catheterization (RHC) prior to randomization:

  * Mean pulmonary artery pressure (mPAP) ≥ 25 mmHg
  * Pulmonary vascular resistance (PVR) ≥ 240 dyn•sec/cm5 (or 3 Wood Units)
  * Pulmonary artery wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) ≤ 15 mmHg.
* Treatment with an endothelin receptor antagonist (ERA) for at least 90 days and on a stable dose for 30 days prior to randomization.
* If an ERA is given in combination with a phosphodiesterase-5 (PDE-5) inhibitor or soluble guanylate cyclase (sGC) stimulator, these treatments must be ongoing for at least 90 days and on a stable dose for 30 days prior to randomization.
* WHO functional class (FC) II or III at randomization
* 6-minute walk distance (6MWD) ≥ 100 m at screening.
* Ability to walk without a walking aid.
* Valid baseline data for daily life physical activity (DLPA) and PAH-SYMPACT®.

Exclusion Criteria:

* Patients on a PAH-specific monotherapy targeting the nitric oxide pathway (i.e. PDE-5 inhibitor or sGC stimulator).
* Patients treated with prostacyclin, prostacyclin analog or selexipag within 3 months prior to screening.
* Any hospitalization during the last 30 days prior to screening.
* Severe coronary heart disease or unstable angina.
* Documented severe hepatic impairment or severe renal insufficiency at screening.
* Participation in a cardio-pulmonary rehabilitation program based on exercise training within 8 weeks prior to screening
* Any factor or condition likely to affect full participation in the study or compliance with the protocol (such as adherence to protocol mandated procedures), as judged by the investigator.
Hostile Interpretation Bias Training to Treat Irritability

Hostile interpretation bias may be a feature of severe, chronic irritability in children, one of the most common psychiatric symptoms of childhood. Interpretation bias training (IBT) is a computer-based training program that may reduce irritability in youths. This trial lays the groundwork for a test IBT on irritability.

This trial lays the foundation for a preliminary test of efficacy of IBT on irritability by establishing IBT's neurocognitive treatment targets: hostile interpretation bias and response in the neural threat-learning system.

The design is a single-blinded, randomized controlled trial of IBT on its targets. The study will have four arms, with 25 participants in each arm for all four conditions of training (active versus sham) and scanning (in MRI or out of MRI scanner). During IBT, participants judge as happy or angry facial expressions which are on a continuum between happy and angry. The point at which judgments shift from predominantly happy to angry on this continuum is the indifference point. During training feedback encourages no change in the indifference point or a change in the indifference point towards more happy judgments of ambiguous faces. A shift in indifference point towards more benign judgments is interpreted as a reduction in hostile interpretation.

The design will test whether active relative to sham IBT shifts the indifference point towards more benign judgments. Neural response to active versus sham IBT will be measured in half the sample.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents in mental health treatment, with at least:

  1. mild, clinically significant irritability, and
  2. typical intellectual functioning (IQ\>80)

Exclusion Criteria:

* Any of the following mental health diagnoses:

  1. current post-traumatic stress
  2. lifetime bipolar I or II disorder
  3. lifetime cyclothymic disorder
  4. lifetime psychotic disorder
  5. lifetime autism spectrum disorder
* Major medical problems, including head trauma.
* MRI-specific safety exclusions for the MRI arms.
* Clinical instability.
Playing-Related Factors and Occupational Balance

As the violin is the riskiest string instrument played by Turkish musicians, violinists were chosen for the sample in this study. The aim of this study was to investigate the relationship between posture, pain, functionality and occupational balance in violinists. The hypothesis was that good playing posture, lack of pain, and functionality affect occupational balance positively.

Occupational balance is the participation in and satisfaction derived from different elements of daily life, including work. Playing performance affects occupational balance of musicians so that complaints arising from the playing of their instruments may negatively affect occupational balance. Forty-five violinists at six different symphony orchestras and conservatories in Istanbul were included. The Personal Information Form, the Edinburgh Handedness Inventory, the Wong-Baker Faces Pain Rating Scale, the Disability of Arm, Shoulder and Hand - Sports/Musicians (DASH-SM), the Rapid Upper Limb Assessment, and the 11-item revised version of the Occupational Balance Questionnaire (OBQ11 - T) were used. Spearman correlation analysis was performed to examine the relationship between the variables.

Eligibility Criteria:
Inclusion Criteria:

* to play the violin in a conservatory or orchestra,
* to be at least 18 years old,
* to volunteer to participate in this study.

Exclusion Criteria:

* Those who played any other instrument professionally.
Epidemiology of Persistent Pulmonary Hypertension of the Newborn - SCOR in Lung Biology and Diseases in Infants and Children

To conduct an epidemiologic study of persistent pulmonary hypertension of the newborn ( PPHN) infant.

BACKGROUND:

The study on the epidemiology of persistent pulmonary hypertension of the newborn (PPHN) was a subproject within a Specialized Center of Research (SCOR) in Lung Biology and Diseases in Infants and Children. The SCOR and its subproject were awarded in December, 1991. Dollars were estimated at 20 percent of total center dollars.

DESIGN NARRATIVE:

Data from a previous study of PPHN were analyzed. The objectives were to: identify the effects of a variety of potentially adverse prenatal exposures from interview data; formulate multi-variate models of risk of PPHN to determine if smoking or use of prostaglandin inhibitors increased the risk of PPHN; explore associations of PPHN with history of illicit drug use and maternal hypoxia; examine the relationships of postnatal care and perinatal risk factors on the incidence and outcome of PPHN; test the relationships of PPHN to the biochemical presence of nicotine and drugs in neonatal urine.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Effect of Goal-directed Fluid Therapy Using Stroke Volume Variation in Patients Undergoing Free Flap Reconstruction After Head and Neck Cancer Resection

Investigators hypothesized that goal-directed fluid therapy using stroke volume variation will improve postoperative recovery in patients undergoing free flap reconstruction after head and neck cancer resection. Investigators will compare the effect of goal-directed fluid therapy using stroke volume variation on recovery in patients undergoing free flap reconstruction after head and neck cancer resection.


Eligibility Criteria:
Inclusion Criteria:

* adult patients of age over 20 years scheduled for free flap reconstruction after head and neck cancer resection

Exclusion Criteria:

* valvular heart disease
* congestive heart failure
* liver failure
* renal failure
* pregnant woman
* allergy to hydroxyethyl starch solutions
* coagulation abnormalities
Effect of Topical Application of Black Pepper Essential Oil and Peripheral Catheter Insertion

The investigators aimed to determine the effects of topical application of black pepper essential oil on peripheral intravenous catheter insertion success.This randomized controlled trial was carried out on 60 patients randomly assigned to either the experimental group (n=30) or the control group (n=30) reporting to the endoscopy unit of the clinic between May 2019 and October 2019. In the experimental group, black pepper essential oil was used to increase vein degree before the procedure, while in the control group, no extra interventions were applied. The time taken in determining an appropriate vein, time taken for successful catheter insertion, and the patient's and nurse's satisfaction after the process were recorded.

Introduction: The literature describes many techniques to increase vein visibility and palpability that facilitate peripheral intravenous catheter insertion. However, there is only one study examining the effect of topical essential black pepper oil on veins. The investigators aimed to determine the effects of topical application of black pepper essential oil on peripheral intravenous catheter insertion success.

Methods: This randomized controlled trial was carried out on 60 patients randomly assigned to either the experimental group (n=30) or the control group (n=30) reporting to the endoscopy unit of the clinic between May 2019 and October 2019. The study results were evaluated using an information form, a catheter insertion form, and a visual analog scale (VAS). In the experimental group, black pepper essential oil was used to increase vein degree before the procedure, while in the control group, no extra interventions were applied. The time taken in determining an appropriate vein, time taken for successful catheter insertion, and the patient's and nurse's satisfaction after the process were recorded via a chronometer.

Eligibility Criteria:
Inclusion Criteria:

Must be evaluable their veins as 1, 2 and 3 according to vein assessment scale Must be able to communicate

Exclusion Criteria:

Clinical diagnosis of peripheral vascular disease Clinical diagnosis of any other chronic illness (except cancer)
Effects of Underwater Ultrasound Therapy on Hand Function and Quality of Life in Patients With Rheumatoid Arthritis

In this randomized, double-blind, placebo-controlled study the effects of underwater ultrasound (US) therapy were investigated in 48 patients with moderately active rheumatoid arthritis (disease activity score in 28 joints (DAS28) ≥3.2 and ≤5.1).

Patients randomly assigned to the ultrasound group (N=25) received underwater ultrasound therapy to both wrists and hands for 7 minutes per session with an intensity of 0.7 W/cm2 during 10 sessions. The control group (N=23) received sham treatment under the same conditions. At baseline, at the end of treatment (Week 2) and at the follow-up visit (Week 14), the following parameters were evaluated: disease activity - erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), tender and swollen joint counts, pain on a visual analogue scale, and DAS28, hand function (fist making, wrist extension and flexion, hand grip strength), quality of life - Health Assessment Questionnaire (HAQ), and the patients rated their own condition.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age with mild-to-moderate (DAS28 \> 3.2 and \< 5.1) rheumatoid arthritis meeting the American College of Rheumatology (ACR) diagnostic criteria
* No distinction was made between seropositive and seronegative patients (regarding rheumatoid factor and anti-citrullinated peptide antibody)
* a stable-dose pharmacotherapy (DMARDs therapy), NSAIDs, steroid) given for at least 2 months
* no physiotherapy within 1 month before starting the study

Exclusion Criteria:

* included high disease activity (DAS28 \> 5.1) and remission (DAS28 \< 2.6)
* other concomitant autoimmune diseases
* stable-dose pharmacotherapy for less than 2 months
* conditions contraindicating US therapy (severe osteoporosis when T-score \< -3.5; infection; fever; osteomyelitis; pregnancy; untreated high blood pressure)
* physiotherapy within 1 month before starting the study
CAre of Patients With PArenteral Nutrition At Home

This research aims to give an overview of a number of aspects related to the quality of care for adult patients on home parenteral nutrition.

Concretely this study follows up different aspects on different moments in the care of the patient pathways:

* process indicators concerning indication, parenteral nutrition, training, team access roads and the succession of complications
* Outcome indicators
* the health-related quality of life
* discrepancies in medication use
* the role of the different health care providers

Adult patients on HPN will be contacted by phone at three different time moments after their discharge to ask them about indicators, quality of life and discrepancies in medication use. After the follow-up, medical dossiers will be consulted to know which indicators are followed in practice.

The role of the different health care providers will be investigated by face-to-face interviews with different healthcare professionals.

Eligibility Criteria:
Inclusion Criteria:

* Patients in Flanders who speak Dutch, are older then 18 years and are able to give an informed consent.

Exclusion Criteria:

* Patients who are younger then 18 years.