cyrilzakka/clinical-trials huggingface dataset:
Empagliflozin in Acute Heart Failure

The objective is to study in a prospective, interventional, single arm, cohort study the potential synergistic diuretic effect of empagliflozin, in addition to furosemide, in hypervolemic patients admitted with acutely decompensated heart failure and diuretic resistance at the McGill University Health Centre (MUHC).

The investigators hypothesize that the sodium-glucose cotransporter-2 (SGLT-2) inhibitor empagliflozin will enhance the diuretic effect of furosemide in patients with acutely decompensated heart failure, moderate to advanced chronic kidney disease, and underlying diuretic resistance, as identified by the three-hour urine output post diuretic administration on the first day of the study, compared with furosemide alone.


Eligibility Criteria:
Inclusion Criteria (all have to apply) :

* moderate to advanced CKD, defined as an eGFR \<45 ml/min/1.73m2; The average creatinine values over the last 12 months will be used to calculate baseline eGFR.
* acutely decompensated heart failure, defined as dyspnea at rest or with minimal physical activity, associated with at least one clinical sign of congestion and at least one objective measure of heart failure (pulmonary-capillary wedge pressure \>20 mm Hg or evidence of pulmonary congestion on chest radiography or brain natriuretic peptide (BNP) level ≥400 pg/ml or N-terminal pro-BNP level ≥1000 pg/ml);
* evidence of inadequate response to loop diuretics, defined as a urine output \< 1000 ml/24h or a weight loss \< 1kg /24h. For patients who have not received loop diuretics, a furosemide stress test can be conducted.
* stable hemodynamics, defined as systolic blood pressure \>90 mmHg and/or mean arterial pressure \>65 mmHg in the absence of intravenous norepinephrine or epinephrine in the last 24 hours.

Exclusion Criteria:

* new use of a non-loop diuretic other than an MRA
* history of type 1 diabetes mellitus
* euglycemic diabetic ketoacidosis
* liver disease defined by serum levels of transaminases or alkaline phosphatase more than three times the upper limit of normal at screening
* known hypersensitivity to SGLT-2 inhibitors
* use within the last 48 h of an SGLT-2 inhibitor or a combined SGLT-1 and SGLT-2 inhibitor
* maintenance dialysis or need for emergent renal replacement therapy
* gastrointestinal surgery or gastrointestinal disorder that could interfere with trial medication absorption
* recurrent severe genital or urinary tract infection
* pregnancy or breastfeeding
* any other clinical condition that would jeopardize patient safety while participating in this trial
* Patients with an acute rise in creatinine levels (acute cardiorenal syndrome) upon presentation will not be excluded.
Assessment of Low-dose ASA Discontinuation Risk Associated With Concomitant PPI Use During the First Year of ASA Therapy

This study is conducted in a cohort of low dose aspirin (ASA) users previously ascertained .The aims of the post hoc analyses are:

To estimate the one year risk of discontinuation of use of low-dose ASA associated to PPI concomitant use versus non-use, crude and adjusted by confounding.

To estimate the one year risk of discontinuation of use of low-dose ASA associated to PPI concomitant use stratified by age and sex.

To evaluate other predictors of discontinuation of low-dose ASA during the first year of ASA therapy.

Assessment of low-dose ASA discontinuation risk associated with concomitant PPI use during the first year of ASA therapy for secondary prevention

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 50-84 years in 2000-2007.
* Patients with first prescription of low dose ASA ( see study population description).
* Patients were required to have been enrolled with their primary care practitioner (PCP) for at least 2 years and to have a computerized prescription history of at least 1 year before the start of the study.

Exclusion Criteria:

* Patients aged below age 50 and 85 years and above ( see study population description).
* Patients with a diagnosis of cancer, alcohol abuse or alcohol-related disease.
* Incomplete data recording in THIN.
Endoscopic Frontal Sinus Surgery Draf III in Moderate to Severe Eosinophilic Chronic Rhinosinusitis With Polyps

The aim of this study is to evaluate the effect of the primary endoscopic frontal sinus surgery on the clinical outcome in patients having moderate to severe eosinophilic chronic rhinosinusitis with polyps with primary outcome measures in form of recurrence of polyp using endoscopic polyp score and Secondary outcome measures include Lund MacKay score, SNOT-22 and need for corticosteroid to control polyp postoperatively.

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a common inflammatory disorder, affecting about 4% of the population worldwide and strongly impacts the quality of life of affected patient.

Eosinophilic chronic rhinosinusitis (ECRS) is a subtype of recalcitrant Chronic rhinosinusitis . Patients with ECRS and generally having a tissue eosinophil \>10 cells per high power field (HPF), have worse disease severity and poorer treatment outcomes compared to non-Eosinophilic chronic rhinosinusitis.

Eligibility Criteria:
Inclusion Criteria:

• Patients with moderate or severe eosinophilic chronic rhinosinusitis with polyps who failed appropriate medical treatment in the form of antibiotic, systemic and local corticosteroid for 3 months .

Exclusion Criteria:

* Narrow anteroposterior diameter of frontal sinus ostium(1cm or less)
* Patients showing less or highest degree of radiological complexity of surgery on studying the Computed Tomography.
* Any contraindication for general anesthesia.
* Patients below age of 18 years.
* Incomplete follow up
* previous sinus surgery
Evaluation of Infrared Cameras and Non-contact Infrared Thermometers for Measuring Body Temperatures

Fever is one of the key symptoms exhibited by contagious patients infected with the Ebola and other viruses. Thermographs and non-contact infrared thermometers (NCITs) are commonly used as early detection tools for screening and isolating sick individuals in healthcare settings and transit centers such as airports. The objective of this clinical study is to evaluate the temperature measurement accuracy of thermographs and NCITs. The study will be accomplished by establishing a protocol based on best practices for screening published in the IEC 80601-2-59:2008 Medical electrical equipment -- Part 2-59: Particular requirements for basic safety and essential performance of screening thermographs for human febrile temperature screening standard, performing initial measurements in patients to optimize clinical procedures, then performing quantitative clinical measurements in febrile and afebrile human subjects to compare thermographs - used in accordance with recognized best practices for measurement - with NCITs for fever screening. Since thermographs and NCITs represent the only currently viable mass screening approaches for infectious disease pandemics, like the recent Ebola virus disease (EVD) outbreak in West Africa, the study will evaluate these thermal modalities as medical countermeasures for fever-related pandemics and therefore improve response to these diseases.


Eligibility Criteria:
Inclusion Criteria:

* Any human subject above the age of 18 that can sit for about 40 minutes with permitted breaks as needed and follow the study instructions can be included.

Exclusion Criteria:

* Human subjects should be free of recent (1 week prior) or current disease affecting the ICR and forehead skin. They should not use topical cosmetics, creams or medications on the face on the day of participation.
Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis

This study is a phase II, multicenter, randomized, double-blind, placebo-controlled, seamless adaptive design clinical study, aiming to evaluate the safety and effectiveness of three doses of ASC42 matched placebo in subjects with primary biliary cholangitis.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤75 years old at screening.
* Definite or probable PBC diagnosis, as demonstrated by the presence of ≥ 2 of the following 3 diagnostic factors:

  1. Biochemical evidence of cholestasis based on ALP elevation.
  2. Presence of AMA, or other PBC-specific autoantibodies, including sp100 or gp210, if AMA is negative.
  3. Liver biopsy consistent with PBC.
* Screening ALP ≥ 1.67× ULN
* Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0, or unable to tolerate UDCA (no UDCA for ≥ 3 months) prior to Day 0.

Exclusion Criteria:

* ALT or AST \> 5× ULN; ALP \>10× ULN
* History or presence of other concomitant liver diseases
* Child-Pugh grade B or C
Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)

The primary purpose of the study was to test the efficacy of 2 tablets (twice daily) of ABT-712, compared to placebo, administered over a 4-week period in participants with moderate to severe mechanical chronic low back pain (CLBP).

The study used a randomized withdrawal design with an open label (OL) period prior to a double-blind (DB) period. Participants who were receiving benefit and were tolerating ABT-712 during the OL period were randomized into the DB period. Study drug was given for a total of 8 weeks, which included up to 3 weeks in OL, up to 4 weeks in DB, and a 1-week DB taper. During the OL period, all participants took increasing doses of ABT-712 until they were taking 2 tablets, twice daily. During the DB period, participants in the ABT-712 group took 2 ABT-712 tablets, twice daily throughout the 4 weeks, while participants in the placebo group took 2 placebo tablets twice daily.

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female subjects who voluntarily sign the informed consent
* Diagnosis of CLBP of 6 months duration

Exclusion Criteria:

* Incapacitated or bedridden subjects
* Subjects with history of surgical or invasive intervention
An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)

Evaluate safety and efficacy of intravenous (IV) iron isomaltoside/ferric derisomaltose re-dosing, in subjects who were previously treated with iron isomaltoside/ferric derisomaltose.

Among the various formulations of parenteral iron that are currently available, iron isomaltoside/ferric derisomaltose may allow flexibility in terms of high and rapid dosing. Up to now, most clinical trials with intravenous (IV) iron treatment were of 4-12 weeks in duration; longer trials are warranted to follow-up on long-term safety.

The aim of the trial was to evaluate the safety and efficacy of IV iron isomaltoside/ferric derisomaltose re-dosing in subjects who were previously treated with iron isomaltoside/ferric derisomaltose in lead-in trials.

This was a 6-months extension trial lasting 26 weeks. Eligible subjects attended 5 visits: screening, baseline (subjects treated with a single IV dose of 1000 mg iron isomaltoside/ferric derisomaltose), and follow-up visits at week 2, 13, and 26 weeks after the IV dose, for safety and efficacy assessments.

Eligibility Criteria:
Inclusion Criteria:

1. Completed one of the lead-in trials
2. Randomised and dosed with iron isomaltoside/ferric derisomaltose in one of the lead-in trials.
3. Haemoglobin (Hb) of ≤ 11 g/dL
4. Screening serum ferritin (s-ferritin) ≤ 100 ng/mL, or ≤ 300 ng/mL if transferrin saturation (TSAT) ≤ 30 %
5. Willingness to participate and signing the informed consent form (ICF)

Exclusion Criteria:

1. Intravenous (IV) iron treatment between the lead-in trial and screening
2. During 30-day period prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy
3. Received an investigational drug within 30 days of screening
4. Decompensated liver cirrhosis or active hepatitis
5. Pregnant or nursing women.
6. Any other laboratory abnormality, medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the subject's disease management at risk or may result in the subject being unable to comply with the trial requirements
Study to Compare Differing Dosing Regimens of ISV-303 (Bromfenac in DuraSite) to Xibrom and Vehicle in Post Cataract Surgery Volunteers

The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy in topical administration of differing dosing regimens of ISV-303 compared to vehicle and Xibrom™ when dosed for 2 weeks in post-cataract-surgery volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation on the day prior to study enrollment
* Meet the best corrected visual acuity score requirement
* Meet the IOP requirement
* Additional inclusion criteria also apply

Exclusion Criteria:

* Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the study medications or any of the procedural medications
* Use of any ocular topical, or systemic medication that could interfere with normal lacrimation, wound healing, the test agent, or the interpretation of study results, within 1 week prior to Day of Surgery
* Additional exclusion criteria also apply
Reduced Length of ADT and ARTA With XRT in High-Risk Prostate Cancer (RELAX): A Randomised Trial

Aim of the study to improve the treatment of high-risk non-metastatic prostate cancer by comparing reduced duration of hormone therapy to the standard duration of two years, when combined with curative intent standard of care radiotherapy to prostate and pelvic nodes. The reduced duration will be intensified with addition of newer hormonal agents such as abiraterone or enzalutamide tablets, which have been shown to improve disease control in locally advanced prostate cancer. This is hoped to reduce the side effects of prolonged hormone therapy, while maintaining similar rates of disease control and survival.

The effectiveness of both treatment approaches will be assessed in terms of cancer control, survival, and overall quality of life of patients. Additionally, the study will examine the side effects associated with each treatment regimen, which could provide valuable insights into impact of treatment duration on patients. If a person decides not to participate, they will still receive the standard two years of hormonal therapy and radiation therapy outside the study. This ensures that all patients receive appropriate care regardless of their involvement in the research. Participation is voluntary, and will not affect patient care.


Eligibility Criteria:
Inclusion Criteria:-

* Patients with biopsy proven prostate adenocarcinoma, deemed suitable for curative- intent radiotherapy
* Clinicoradiological stage T1-T4N0M0 using PSMA-PETCT and MRI
* High risk or very high risk (as per NCCN 2023): stage T3a + OR Gleason Score 4+4 or 4+5 OR PSA 20 +
* Patient fit and able to receive ADT for 2 years
* Patient fit and able to receive ARTA for 6 months
* ECOG performance status 0-2
* Patient able and willing for informed consent and reliable for follow-up

Exclusion Criteria:-

* Primary Gleason pattern 5 (Gleason score 5+4 or 5+5)
* Life expectancy deemed to be less than 2 years
* Uncontrolled comorbidities such as diabetes or hypertension causing ineligibility to receive ARTA
* Bulky primary disease with extensive infiltration into bladder/rectum/pelvic muscle
* Prior ADT more than 3 months before screening or prior orchiectomy
* Prior prostatectomy
* Unsuitable for curative dose of radiotherapy (severe urinary obstructive symptoms, inflammatory bowel disease, prior pelvic radiotherapy etc.)
* Presence of adverse pathological variants (such as small cell histology)
* Unable or unwilling to consent and follow up
Cardio-Respiratory Response of a Training Session Versus an Adapted Physical Activity Session

the aim of this study is to show that training session with nintendo WII requires the same cardiorespiratory demand than training session on ergocycle or treadmill, traditionally used in pulmonary rehabilitation program.


Eligibility Criteria:
Inclusion Criteria:

* patients with pulmonary disease

Exclusion Criteria:

* exacerbation of the pulmonary disease
* Weight \>150Kg
* Refusal to participate
* People in pre and post surgical rehabilitation
Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma

This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately 900 patients will be randomized.

Part 1:

Patients will be randomized in a 1:1:1 ratio to one of 3 treatment arms:

1. LGX818 450 mg QD plus MEK162 45 mg BID (denoted as Combo 450 arm)
2. LGX818 300 mg QD monotherapy (denoted as LGX818 arm) or
3. vemurafenib 960 mg BID (denoted as vemurafenib arm)

Part 2:

Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms:

1. LGX818 300 mg QD plus MEK162 45 mg BID (denoted as Combo 300 arm) or
2. LGX818 300 mg QD monotherapy (denoted as LGX818 arm)


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of locally advanced, unresectable or metastatic cutaneous melanoma or unknown primary melanoma (AJCC Stage IIIB, IIIC, or IV)
* Presence of BRAF V600E or V600K mutation in tumor tissue prior to randomization
* Naïve untreated patients or patients who have progressed on or after prior first line immunotherapy for resectable locally advanced or metastatic melanoma; prior adjuvant therapy is permitted (e.g. IFN, IL-2 therapy, any other immunotherapy, radiotherapy or chemotherapy), except the administration of BRAF or MEK inhibitors
* Evidence of at least one measurable lesion as detected by radiological or photographic methods
* ECOG performance status of 0 or 1
* Adequate bone marrow, organ function, cardiac and laboratory parameters
* Normal functioning of daily living activities

Exclusion Criteria:

* Any untreated central nervous system (CNS) lesion
* Uveal and mucosal melanoma
* History of leptomeningeal metastases
* History of or current evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or history of retinal degenerative disease
* Any previous systemic chemotherapy treatment, extensive radiotherapy or investigational agent other than immunotherapy, or patients who have received more than one line of immunotherapy for locally advanced unresectable or metastatic melanoma; Ipilimumab (adjuvant) or other immunotherapy treatment must have ended at least 6 weeks prior to randomization
* History of Gilbert's syndrome
* Prior therapy with a BRAF inhibitor and/or a MEK- inhibitor
* Impaired cardiovascular function or clinically significant cardiovascular diseases
* Uncontrolled arterial hypertension despite medical treatment
* HIV positive or active Hepatitis B, and/or active Hepatitis C
* Impairment of gastrointestinal function
* Patients with neuromuscular disorders that are associated with elevated CK
* Pregnant or nursing (lactating) women
* Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study

Other protocol-defined inclusion/exclusion criteria may apply
Bemiparin as a Thromboprophylaxis After Gynaecological Surgeries

The use of prophylaxis for venous thromboembolism (VTE) remains grossly underused for women who undergo gynecologic surgery for benign conditions world wide and especially in developing countries including our region. Having a research in our locality for the first time might raise awareness of the importance of VTE prophylaxis.

Deep vein thrombosis (DVT) and pulmonary embolism (PE), also referred to as venous thromboembolic events (VTE), are two major complications after gynaecological surgeries that can result in significant morbidity and mortality. The incidence of VTE after gynaecologic surgery varies depending on the method used for diagnosis. The rate of clinical DVT is estimated to be 3% after gynaecological surgery if no thromboprophylaxis was used. The rate of VTE assumed to decrease to 0.4% if Low molecular weight heparin was used as a thromboprophylaxis.

According to our knowledge there are no published researches on the effect of the new second generation Low molecular Weight Heparin Bemiparin as a thromboprophylaxis after benign gynaecological surgery in comparison to a control group.

Eligibility Criteria:
Inclusion Criteria:

* female undergoing Benign gynecological surgeries.
* Having moderate,high and very high risk factors for venous thromboembolism.
* No contraindications for the use of Heparin.

Exclusion Criteria:

* Having mild risk factors for thromboembolism.
* Active vaginal bleeding.
* Thrombocytopaenia.
* any patient who is already on anticoagulant.
* Sever renal or Liver diseases.
Belgian Prospective Multicentre Registry to Evaluate Safety and Performance of the Optimed Stent in the Superficial Femoral Artery

This is a Belgian prospective multicentre registry to evaluate safety and performance of the Sinus-Superflex-Visual stent (Optimed) in Superficial Femoral Artery (SFA) atherosclerotic lesions. Target number is 500 patients in approximately 11 centres. Patients will be followed for a period of 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Stenosis (\> 75%) or occlusion of the superficial femoral artery (lesion up to 3 cm distal to Hunter's canal and 4 cm proximal to the patella)
* TASC II (2007)type A, B or C lesions
* Target vessel diameter between 4.5 and 7 mm
* Debilitating claudication or critical limb ischemia (Rutherford 2 to 5)
* At least 1 outflow vessel down to the ankle
* Patient is at least 18 years old
* Life expectancy \> 2 years
* Patient is compliant with the requested follow-up visits

Exclusion Criteria:

* No informed consent
* Rutherford 6
* TASC II type D lesions
* Patient is not 18 years old
* Patient is pregnant
* Acute ischemia
* Patient is not compliant with the requested follow-up visits
* Unable to cross target lesion with guidewire
* Patient is allergic to nickel-titanium
* Presence of an aneurysm in the SFA