cyrilzakka/clinical-trials huggingface dataset:
Does Patent Foramen Ovale Size Matter in Men and Women

A patent foramen ovale (PFO) is present in \~30% of the general population. The PFO has historically been considered to be trivial. However, recent work by the investigator's group and others has identified that, compared to individuals without a PFO, those with a PFO have worse pulmonary gas exchange efficiency, have a higher core body temperature, blunted ventilatory responses to chronic hypoxia and acute carbon dioxide and increased susceptibility to altitude illnesses such as acute mountain sickness, and high altitude pulmonary edema (Lovering, Elliott \& Davis J Appl Physiol 2016). Specific to this application,subjects with a PFO may have worse pulmonary gas exchange efficiency because a PFO is a potential source of right-to-left shunt that will make pulmonary gas exchange efficiency worse. If true, then this may negatively impact exercise capacity and/or exercise tolerance. Further, in those with a PFO compared to those without, preliminary work from the investigator's lab indicates that there may be an effect of PFO size on pulmonary gas exchange efficiency. This is such that those with a large PFO (grade 3 or higher) display significantly worse gas exchange efficiency compared to those with a small (grade 2 or lower) or no PFO,even at low exercise workloads. Additionally, the investigators were curious as to whether there would be a sex effect, but due to logistical constraints, the investigators were unable to recruit an equal number of female and male subjects. Thus, in addition to the potential size effect on the investigators outcome measures, the investigators would like to build on this work by examining the potential effect of biological sex. Although a PFO has been traditionally considered to have a minimal impact of physiology and pathophysiology, emerging evidence suggests this may not be the case. The investigator's lab is focused on understanding how and why a relatively small hole in the heart (PFO) can have a relatively large impact on cardiopulmonary and respiratory physiology, and how these impacts may be based on the size of the PFO.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18-40
* Known to have/not have a PFO.

Exclusion Criteria:

* Previous history of coronary artery disease(ischemic heart disease such as angina, heart attack, myocardial infarction).
* Failure of Modified Allen's Test in both hands.
* Currently taking medications or herbal supplements for any heart or respiratory disease that they cannot stop taking for 48 hrsprior to testing (seasonal allergy medication not included in exclusion medications).
* Lidocaine, nitroglycerine or heparin allergy.
* Women who are pregnant or trying to become pregnant.
* Previous history of any condition that would prevent the subject from performing cycle ergometer exercise (for exercise study only).
SGLT-i Use in Diabetic Foot Ulcer Disease

Background: People with diabetes and either current or previous diabetic foot ulcer disease (DFUD) are at very high risk for adverse cardiovascular events including heart attacks and strokes. Sodium-glucose co-transporter 2 (SGLT2) inhibitors are a class of medications that have shown to be very effective in reducing heart disease and event risk. However, one recent study found that SGLT2i's may increase minor amputation risk in those with DFUD, though this finding has not been replicated in other similar studies. However, as a result, there has been limited further investigation into this issue and as such the use of SGLT2i's in those with DFUD remains a contentious issue, despite their potential for significantly reducing cardiovascular disease risk in this population.

In the absence of further randomised controlled trials investigating the use of SGLT2is in these populations, there is a need for clinical guidelines advising on their use based on expert clinical consensus, including specific criteria or scenarios in which they should or should not be used. The Delphi methodology is an iterative survey technique that uses expert opinion from various relevant backgrounds and experiences to generate a consensus based upon various statements and/or scenarios.

Aim: The aim of this study is to use the Delphi technique to generate expert consensus-based clinical guidelines on the use of SGLT2i's in those with diabetes and DFUD.

Methods: This is a Delphi technique-based study using a purposive sample of convenience. Consensus development methods will be used to generate clinical guidelines, endorsed by key clinical groups, on the use of SGLT2i's in patients with diabetic foot ulcer disease, including acknowledgement of specific scenarios or patient characteristics that may influence these guidelines.

The consensus group will consist of n=20 healthcare practitioners, including GPs, secondary care diabetologists, foot care specialists, cardiologists and pharmacists in order to ensure a breadth of expertise and input. Two rounds of the Delphi consensus process will take place, in order to iteratively develop the consensus-based clinical guidelines. This process is expected to take 4-6 months. The analysis will be on-going throughout the study and completed within 3 months of the last questionnaire round of the Delphi process.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are trained healthcare practitioners involved in the care of patients with current or previous diabetic foot ulcer disease

Exclusion Criteria:

* Potential participants who do not give informed consent. Potential participants who will not be able to participate in both rounds of the Delphi process.
Leflunomide + Methotrexate in Rheumatoid Arthritis

To determine the efficacy and safety of the combination of leflunomide and methotrexate for treating active rheumatoid arthritis (RA) in an open noncomparative multicenter trial.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between ages of 18 and 75 years old.
* Female subjects must be of nonchildbearing potential (i.e., surgically sterile or at least 2 years postmenopausal) OR their participation is contingent upon the following:
* They are practicing a medically accepted contraceptive regimen (acceptable methods must include one of the following: systemic contraceptive, oral or implanted estrogen/progestin; diaphragm with intravaginal spermicide; cervical cap; intrauterine device; or condom with intravaginal spermicide) AND
* they are demonstrated not to be pregnant (by serum pregnancy test) or breast-feeding at the time of study entry AND
* they intend to continue the contraceptive regimen and remain not pregnant throughout the study AND
* they are willing to undergo pregnancy testing (serum) at screening and (urine) monthly thereafter AND
* they are fully informed as to the risks of entering the trial and provide written consent to enter the trial; female patients not sexually active should also be adequately informed about appropriate methods of contraception AND
* they agree to not get pregnant for 24 months after discontinuation of treatment with study medication or they undergo a washout procedure with cholestyramine or charcoal.
* Male subjects must consent to practice contraception during the study. The subject needs to have clinically diagnosed rheumatoid arthritis including diagnosis of RA by ACR criteria greater than or = to 6 months prior to enrollment active disease by ACR criteria . Men wishing to father a child should consider discontinuing use of study drug and taking cholestyramine 8 gm 3 times daily for 11 days. In addition, males should consider discontinuation of methotrexate treatment and waiting an additional three months.
* Active disease by ACR criteria despite methotrexate therapy for three of the following four criteria:
* greater than or = to 9 tender joints
* greater than or = to 6 swollen joints
* greater than or = to 45 minutes of morning stiffness
* ESR greater than or = to 28mm/hr

  * Subject must remain on unchanged doses of NSAIDs for at least 4 weeks prior to study drug administration and throughout the timecourse of the study.
  * Concomitant therapy will be permitted with corticosteroids at a dose of less than or = to 10 mg prednisone daily (or the steroid equivalent administered orally), provided the dose has been stable for at least 4 weeks prior to the study drug administration; dose must remain constant throughout the timecourse of the study.
  * Subjects must not receive intramuscular, intra-articular or intravenous corticosteroids within 4 weeks prior to initiating study participation or during the study.
  * Subjects must be able and willing to comply with the terms of this protocol. Informed consent must be obtained for all subjects before enrollment in the study.
Development and Evaluation of a Hormone Replacement Therapy Decision-Aid

The decision regarding the use of post-menopausal estrogen hormone replacement therapy (HT) is complex because patients must balance the short and long-term risks and benefits. Information from new and important clinical trials must also be considered. The purpose of this research is to develop and evaluate the efficacy of a HT CD-ROM decision-aid in improving the decision making process for women considering the use of estrogen HT.

Background:

The decision regarding the use of post-menopausal estrogen hormone replacement therapy (HT) is complex because patients must balance the short and long-term risks and benefits. Information from new and important clinical trials must also be considered. The purpose of this research is to develop and evaluate the efficacy of a HT CD-ROM decision-aid in improving the decision making process for women considering the use of estrogen HT.

Objectives:

The objectives of the study are to: 1) develop a model of the decision-making process for postmenopausal women considering hormone (HT), based on Multi-Attribute Utility Theory (MAUT); 2) produce an interactive CD-ROM decision-aid for HT; 3) evaluate the effect of the interactive CD-ROM decision-aid on patient satisfaction with decision (SWD) and knowledge about menopause and HT; and 4) test the effect of the interactive CD-ROM decision-aid on women�s decisions regarding use of HT.

Methods:

Phase I (completed) used structured interviews and surveys in the development of a decision model for HT. In phase II, an interactive CD-ROM decision-aid was developed and a randomized controlled trial (RCT) of its effect on decision processes was conducted. Postmenopausal women, aged 45-74 were recruited from the primary care clinics of the four participating Veterans Affairs hospitals: Milwaukee, Madison, Chicago-Hines, and Chicago-Westside. The primary hypothesis was that women who use the CD-ROM decision-aid would demonstrate increased satisfaction with their decision regarding hormone replacement therapy use compared to women receiving the control intervention.

Status:

Enrollment and follow-up assessments have been completed. The study is in the analysis phase. The study was presented to the VA HSR\&D Combined Monitoring Board on February 5, 2003 and the committee voted unanimously to recommend continuation of the trial. The study has had one publication and several scientific abstract presentations.

Eligibility Criteria:
Inclusion Criteria:

- postmenopausal as defined by: Amenorrhea for 12 months or FSH greater than or equal to 25

Exclusion Criteria:

* unable to speak English
* are assessed not to have capacity for making medical decisions for their own care
* had alcohol or drug abuse issues in past 6 months before baseline visit
* personal history of breast cancer, active liver disease, active vascular thrombosis, and/or active unexplained vaginal bleeding
NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer

This study was designed to evaluate the effect of two dose levels of NUC-1031 (500 mg/m2 and 750mg/m2) in patients with ovarian cancer. The primary objective was to determine the anti-tumor activity of NUC-1031 at the selected dose level (500 mg/m2 or 750 mg/m2).

A total of 53 patients were randomized, of whom 51 patients were treated in Part I of the study, 24 patients in the 500 mg/m2 arm and 27 patients in the 750 mg/m2 arm. Eligible, consenting patients received NUC-1031 by IV infusion on Days 1, 8, and 15 of each 28-day cycle. Patients continued to receive NUC-1031 until the occurrence of disease progression and underwent imaging every 8 weeks. After disease progression, patients were followed for overall survival.

Part II of the study was designed to select one of the treatment dose levels for further evaluation based on clinical and laboratory assessments of patients recruited in Part I. Despite promising efficacy and a good tolerability profile in Part I, it was decided not to initiate Part II as the pre-specified boundary for efficacy was uncertain to be met in this heavily pre-treated population with significant co-morbidities.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed written informed consent.
2. Original diagnosis and/or histological confirmation of high-grade serous, high-grade endometrioid, undifferentiated/unclassifiable epithelial ovarian, fallopian tube or primary peritoneal cancer.
3. Time from the last line of platinum-based chemotherapy of less than 6 months.
4. Received at least 3 prior chemotherapy-containing regimens.
5. Age ≥18 years.
6. Ability to comply with protocol requirements.
7. Patients are not of childbearing potential or they must agree to use a physical method of contraception.

Exclusion Criteria:

1. Disease that progressed while receiving initial line of platinum-based chemotherapy.
2. Received fewer than 3 prior chemotherapy-containing regimens.
3. Prior therapy with single-agent gemcitabine.
4. Prior history of hypersensitivity to gemcitabine.
5. Prior chemotherapy, radiation (other than short cycle of radiation to reduce bone pain), treatment with a VEGF inhibitor, PARP inhibitor or immunotherapy within 21 days of first receipt of study drug. Hormone therapy within 14 days of first receipt of study drug.
6. Residual side effects from chemotherapy or radiation, which have not gotten better except for nerve pain or tingling or hair loss.
7. Patients who have a history of another type of cancer diagnosed within the past 5 years, with the exception of adequately treated non-melanoma skin cancer curatively treated cervical cancer or ductal carcinoma in situ (DCIS) of the breast.
8. Presence of an serious illness, uncontrolled illness, or active infection requiring IV antibiotics.
9. Presence of any serious illnesses, serious medical conditions, serious medical history, active bacterial or viral infections including hepatitis B or C, or known to be HIV positive.
10. Currently pregnant, lactating or breastfeeding.
11. History of blocked intestines because of ovarian cancer, unless fully resolved.
Randomised Trial Between LHM Alone Vs LHM With Anterior Fundoplication In Achalasia Cardia

Back ground: Achalasia Cardia (AC) manifests with major symptom dysphagia. Surgery as the treatment modality relieves dysphagia in most of the patients. Laparoscopic Heller's myotomy(LHM) is the surgery of choice but is associated with gastroesophageal reflux. Anterior fundoplication (Dor Fundoplication) is usually combined with LHM in patients with AC. It reduces gastroesophageal reflux following LHM. It has been observed that along with reduction of gastroesophageal reflux Dor Fundoplication also affects relief of dysphagia. But it has not been prospectively studied.

Hypothesis:The hypothesis of present study is that "Frequency of dysphagia following Laparoscopic Heller's myotomy with Dor fundoplication is more than that compared to Laparoscopic Heller's myotomy alone in patients with Achalasia Cardia".

Methods: From December2017 to November 2018 minimum of 20 patients with diagnosis of Achalasia cardia will be randomized to receive either Laparoscopic Heller's myotomy (LHM) alone or LHM with Dor fundoplication. Symptomatic outcomes would be assessed using frequency of dysphagia and Eckardt's score. .

Outcomes: Primary outcome is Frequency of dysphagia and secondary outcome is manometry pressure assessment. Statistical analysis would be done using Statistical Package for the Social Sciences (SPSS) soft ware. P value \< 0.05 is considered significant.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients (18 years or more) with Achalasia cardia

Exclusion Criteria:

* Patients of achalasia with axis deviation
* Patients with history of pneumatic dilatation
* Patient with other associated motility or non motility disorders
* Patients with pseudoachalasia Prior gastric or esophageal surgery
Effects of Pulsed-Dyed Laser on Scar Formation

The purpose of this study is to identify changes in color, thickness, and stiffness, of scars from skin grafting after burns when treated with a pulsed-dyed laser.

Pulsed-dyed lasers have been used in the past to treat scars from minor surgery as well as burns. The laser has been used at different times, close to injury or late after injury. Success or failure of the laser has been judged by subjective observer scales.

In this study we will treat the seams of 1/2 of a skin graft with a pulsed-dyed laser, beginning about one month after surgery. We will use objective measures of color (redness on digital pictures), scar volume(via laser scanning), and elasticity(measured by BTC-2000) as well as subjective assessment by an independent observer and the patient.

Eligibility Criteria:
Inclusion Criteria:

* \> 9 years old
* not pregnant
* new skin graft to extremity
* able to follow simple instructions

Exclusion Criteria:

* age less than 9 years
* pregnancy
* any behavior pattern that would lead to conclusion that patient may not reliably follow simple instructions
Af Ablation In Brady-Tachy Syndrome

The aim of the study is to evaluate the impact of atrial fibrillation ablation in patients presenting a brady-tachy syndrome on the AF burden.

The hypothesis of the study is that AF ablation prevents not only from AF episodes recurrence but also from bradycardic episodes.

The study is a randomized study 1:1 AF ablation vs non AF ablation. Patients are followed for 1 year. 38 patients will be required to show a significant reduction in AF burden.

Eligibility Criteria:
Inclusion Criteria:

* paroxystic AF
* symptomatic pauses (\>5s at night or 3s during daytime)

Exclusion Criteria:

* permanent AF
* age \> 80 y
* pregnant women
* minors
Impact of Perivascular Tissue on Endothelial Function in Coronary Artery Bypass Grafting

The success of coronary artery bypass grafting is reliant on the quality of the grafts used. A new technique for harvesting veins used as grafts has been introduced. The study hypothesis is that veins harvested with this technique have an improved endothelial function.


Eligibility Criteria:
Inclusion Criteria:

* Isolated elective, primary CABG requiring cardiopulmonary bypass
* Left ventricular ejection fraction \>35%
* at least one saphenous vein graft required as part of revascularization strategy

Exclusion Criteria:

* Acute or chronic inflammatory diseases
* Malignancies
* Pregnancy
* Previous cardiac surgery
* Serum creatinine \>120 μmol/L
* Coagulopathy
* Insulin dependent diabetes mellitus
* Smoking during last 6 months
* Leg not suitable for No-touch vein harvesting as judged by the operator.
* Need for nitrates on operation day
* not receiving statins
Early Mechanical Ventilation for Guillain Barré Syndrome

The purpose of this study is to determine whether early mechanical ventilation can prevent hospital acquired pneumonia in adults with Guillain Barré Syndrome.

Hospital acquired pneumonia is a common and severe complication of Guillain Barré Syndrome. Several factors have been recognized as predictors of respiratory failure in adults with Guillain Barré Syndrome. They include a time from disease onset and patient admission of less seven days, inability to lift head, impaired swallowing and a forced vital capacity of less than 60% of predictive value. We reasonned that early mechanical ventilation may prevent aspiration which is likely the main cause of pneumonia in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Guillain Barré Syndrome
* Age of 18 years old or more
* Inability to lift head
* Time from onset of motor deficit less than 7 days
* Written informed consent

Exclusion Criteria:

* Glasgow coma score of less than 8
* Unstable hemodynamic status
* Current pneumonia
* Pregnancy
Evaluation of Efficacy and Long-term Safety for the InFo - Instant Focus © Lens / PMCF

This is a monocentric, longitudinal, prospective, observational post-market follow-up study.

30 patients with a cataract will receive an InFo - Instant Focus © lens implant. After the cataract procedure, data collection will take place during visits planned by the physician as part of normal follow-up.

Patients with cataract will be recruited from the clinic by the investigator based on the inclusion and exclusion criteria.

The patient will be followed up after one day, one week, one month, six months, one year and three years post-op. An interim analysis will be performed with one-year clinical results.

The main objective of the study is to evaluate is to evaluate efficacy and long-term safety for the InFo - Instant Focus © lens.


Eligibility Criteria:
Inclusion criteria:

* Suffering from cataract
* Physician has made the decision to implant on InFo - Instant Focus © lens
* Age ≥ 18 years, of either sex
* Having given written informed consent, prior to any procedure

Non inclusion criteria:

* Presenting with an astigmatism of \>1.00D
* Presenting contraindications for the implantation of an intraocular lens
* Presenting an ophthalmic disorder liable to interfere with study endpoints
* History of previous intraocular surgery in the study eye in the previous 6 months
* Refusing or unable to comply with the follow-up schedule
* Participation in other interventional therapeutic trial at time of inclusion
* Pregnant, breastfeeding, or unable to understand the character and individual consequences of the investigation
Comparison of Cardiac Computed Tomographic Angiography (CTA) to Tc-99m Single Photon Emission Computed Tomography (SPECT)

Cardiovascular disease and ischemic heart disease is the #1 killer in Canada. Currently, Cardiac invasive catheterization angiography (CICA) is the gold standard for the assessment of the arteries in the heart. However, cardiac catheterization has risks which prohibit its use in all patients. These risks include: death, heart attack, stroke and bleeding. Cardiac computed tomography angiography (CTA) is a new non-invasive technology which may enable the evaluation of patients' coronary anatomy without exposing patients to the risks of invasive cardiac catheterization.

The purpose of this project is to compare CT angiography (CTA) to Tc-99m single photon emission computed tomography (Tc-99m SPECT)

We will enroll patients who are waiting for a CICA or who have been referred for a TC-99m SPECT or CTA scans at the University of Ottawa Heart Institute. Consenting patients who are waiting for a CICA will have both a CTA and a Tc-99m SPECT scan. Consenting patients referred for a CTA or Tc-99m SPECT will have both the CTA and Tc-99m SPECT in a random order but not CICA (unless ordered by your physician).


Eligibility Criteria:
Inclusion Criteria:

* Patients referred for Tc-99m SPECT or CTA; or
* Patients referred for CICA without preceding (\< 12 months) MPI or CTA

Exclusion Criteria:

* Previous revascularization (PCI or CABG)
* Age \< 18 years or lack of consent
* Renal Insufficiency (GFR \< 60 ml/min)
* Allergy or contraindication to contrast agent or dipyridamole
* Refractory angina requiring urgent/emergent coronary angiography
* Contraindication to radiation exposure (e.g. pregnancy)
* Uncontrolled HR
* Atrial fibrillation, frequent atrial or ventricular ectopy (\> 1/minute)
* Unable to perform 10 second breath-hold