cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Anti-IL-5/IL5R Inhibitors

The goal of this observational study is to assess the response to treatment, in patients 18 years and older diagnosed with severe asthma in whom an IL5/IL5R antagonists was initiated between 2012 and 2020.

The main question\[s\] it aims to answer are:

* What is the response rate after one year of treatment with IL5/IL5R antagonists.
* What is the response and remission rate after one year of treatment with IL5/IL5R antagonists in subjects who fullfilled the original randomized control trials (RCTs) inclusion criteria compared with those who did not.

IL5/IL5-receptor (IL5R) antagonists are effective in reducing asthma exacerbations and have a corticosteroid sparing effect in selected severe eosinophilic asthmatics. The original randomized clinical trials that assessed the efficacy of IL5/IL5-R antagonists included highly selected patients who are not necessarily representative of the asthmatic population treated with IL5/IL5R antagonists in clinical practice.

The aims of this study are:

1. To assess the response to treatment, in patients 18 years and older diagnosed with severe asthma in whom an IL5/IL5R antagonists was initiated between 2012 and 2020.
2. To compare the response and remission rate after one year of treatment with IL5/IL5-R antagonists in asthmatics who would and would have not met the inclusion criteria of the original randomized clinical trials.

We will perform a retrospective cohort study using data from the hospital charts of severe asthmatics treated with mepolizumab, reslizumab or benralizumab between November 2012 and December 2020 at the outpatient asthma clinic of a tertiary center (Sacre-Coeur Hospital) in Montreal. Cohort entry (CE) will be defined as the first prescription filled of IL5/IL5R antagonists. Authorization from the research ethics committee of the CIUSSS du Nord-de-l'île-de-Montréal and from the director of Professional Services was obtained.

Statistical analysis Descriptive statistics will be used to summarize clinical, functional, and demographic characteristics of the patients of the whole cohort, as well as of the RCT in group and RCT out group. Baseline data will be recorded on the date closest to cohort entry. Results will be expressed as mean and standard deviation, except for data with a non-normal distribution, which were expressed as median and interquartile ranges and proportions for categorical variables. Chi-squared test and Student's t test will be used to compare patients' characteristics between RCT in group and RCT out group. All tests will be two-tailed, and the statistical significance level will be set at 0.05.

Logistic regression analyses will be performed to identify factors associated with a positive response to treatment as well as the achievement of remission on treatment.

Eligibility Criteria:
Inclusion Criteria:

All patients 18 years and older diagnosed with severe asthma in whom an IL5/IL5R antagonist was initiated at the outpatient asthma clinic of a tertiary center (Sacre-Coeur Hospital) in Montreal.c between 2012 and 2020.

Exclusion Criteria:

None
Repetitive Transcranial Magnetic Stimulation Therapy in Essential Tremor

The purpose of this study is to evaluate the efficacy and electrophysiology of repetitive transcranial magnetic stimulation in the treatment of essential tremor.

This is a randomized controlled study.The purpose is to evaluate the efficacy of repetitive transcranial magnetic stimulation(rTMS) in the treatment of essential tremor,and explore the possible mechanism by detecting the changes of clinical scale and TMS-electroencephalogram(TMS-EEG), so as to seek an effective therapy for essential tremor.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as essential tremor conforming to the diagnostic criteria for essential tremor in the tremor group of the International Parkinson's and Movement Disorders Society (IPMDS).
2. Signed informed consent form.

Exclusion Criteria:

1. Complicated with brain organic diseases, epilepsy, other mental diseases, family history of dementia, metal devices implanted in the body and any contraindications to TMS;
2. History of craniocerebral surgery;
3. TMS cannot cooperate;
4. TMS-EEG examination artifacts are obvious, or cannot be analyzed due to other technical reasons.
Molecular Diagnosis of Allergic Contact Dermatitis (SMECA).

Allergic contact dermatitis (ACD) is a common inflammatory skin disease, which represents a major public health issue in industrialized countries. ACD is induced by repeated contact of individuals with environmental chemicals and is characterized by a delayed type IV hypersensitivity response with skin inflammation mediated by allergen-specific T cells in sensitized individuals.

The current diagnosis is based on clinical examination, assessment of environmental exposures and patch testing. Although the robustness of patch tests has long been established, this method can sometimes give inconclusive results, leading to problems in disease management.

Preliminary results indicate that the molecular analysis of Patch-Tests (PT) reactions could allow a more reliable diagnosis. Importantly, this gene profiling approach may help to identify patients with false positive PT reactions, i.e. patients whose PT reactions did not show any "allergy signature".

However, it remains to be demonstrated that the presence or absence of allergy biomarkers in PT lesions are indeed predictive of ACD response in patients.

The main objective is to describe the correlation between these molecular signatures and the reactivity of individuals when they are exposed to allergenic compounds under conditions of use (using ROAT test).


Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, over 18 years of age.
* Patient with at least one positive/doubtful patch test reaction for nickel, limonene hydroperoxide and/or linalool hydroperoxide
* Patient agreeing to undergo skin biopsies and blood sampling
* Patient agreeing to non-identifying pictures being taken of lesions
* Patient available to carry out skin tests and their interpretation
* Patient affiliated to or benefiting from a social security regime
* Patient having been informed and having signed a written, free and informed consent.

Exclusion Criteria:

* Patient with active dermatitis lesions on the forearm
* Patient with a history of allergic reaction to a local anesthetic product
* Patient with wound healing disorders (hypertrophic or keloids scars)
* Patient with hematological disorders
* Patient having topical treatments with corticosteroids or immunomodulators on the forearms during the 21 days prior to the start of the study
* Patient having had excessive exposure to ultraviolet during the 21 days prior to the start of the study.
* Patient on systemic corticosteroid therapy, immunosuppressants or biological therapy.
* Patient whose follow-up is impossible for reasons psychological or geographical.
* Patient taking part in another clinical study
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant, breast-feeding or parturient woman
Cardiometabolic Disease and Pulmonary Hypertension

This study will investigate if metformin can help people with obesity and high pressures inside their lung blood vessels. Metformin is approved by the U.S. Food and Drug Administration (FDA) to treat diabetes, but metformin is not approved by the FDA to treat pulmonary hypertension.

This study will examine whether Metformin will improve the high pressure inside lung blood vessels in people who are obese. The study will help understand the effect of metformin on pressures inside lung blood vessels.

Obesity can predispose people to develop high pressures inside their lung blood vessels, a condition called pulmonary hypertension, Pulmonary hypertension in turn, can lead to shortness of breath and other health complications such as heart failure. In this study, we seek to identify individuals at risk for the development of high pressures inside lung vessels based on BMI and dyspnea grade 1.

Participants will be screened by echocardiography to estimate pulmonary pressures. Potential participants will undergo invasive cardiopulmonary exercise testing with hemodynamic monitoring, in order to identify individuals with abnormal pulmonary vascular function either at rest or during exercise. Patients who have undergone clinically-indicated cardiopulmonary exercise testing and meet inclusion/exclusion criteria will also be recruited. Those with abnormal pulmonary vascular function will be randomized to receive Metformin or placebo for a total of 3 months under an IND exemption. The primary outcomes include the effect on pulmonary vascular function at rest and during exercise. Secondary outcomes include change in pulmonary artery endothelial cell phenotypes.

Eligibility Criteria:
Inclusion Criteria:

* Age 30-80 years
* History of obesity and current BMI ≥ 25 kg/ m2 for study volunteers or BMI ≥ 25 kg/ m2 for those with clinically indicated CPET or known HFpEF
* History of Dyspnea (Grade 1 or more)
* Able to provide informed consent and willing to comply with study

Exclusion Criteria:

* History of diabetes mellitus
* History of primary pulmonary arterial hypertension
* History of moderate to severe COPD
* History of severe Obstructive Sleep apnea
* History of renal disease (eGFR\< 45 mL/min/1.732)
* History of severe liver disease
* History of cardiovascular disease (recent heart attack or stroke) except known HFpEF
* History of blood clot in lung
* History of Splenectomy
* History of Active Cancer
* Platelets count of \< 75,000
* International normalized ration (INR) of \> 1.5
* History of recent anemia (HB \< 9g/dL)
* Current use of Metformin
* Prior LVEF \< 50% on echocardiogram
* Indication of severe valvular disease on echo
* Pregnant or planning to become pregnant in next 4 months
* History of HIV infection
Aequalis Resurfacing Head Study

Aequalis® Resurfacing Head implant is a range of shoulder arthroplasty device available for the treatment of various shoulder pathologies. It received CE Mark in June 2007.

The aim of this study is to collect immediate medium and long term data on performance and safety of the implant, retrospectively as well as prospectively, from a consecutive series of patients to assess the patients' outcomes and functional status.

Resurfacing head implants allow restoring of the normal joint mechanics and stability of the shoulder with minimal bone resection and low peripheral fracture risk, while preserving humeral bone stock. Non cemented head implants also allow for an easy re-intervention if needed. The success of resurfacing implants largely depends on the etiology, with the best results in primary shoulder arthrosis, and the worst in post-traumatic and cuff-tear arthropathy.

The Aequalis® Resurfacing Humeral Head is designed to restore the humeral head. It shares the same indications as shoulder arthroplasty in general, including the various types of arthritis and conditions resulting in loss of joint cartilage, joint incongruity, pain, and stiffness. Resurfacing humeral head implants allow minimal bone resection while preserving humeral bone stock as compared to standard anatomic humeral implants.

However, few data are available on mid-term effects of the resurfacing head implant developed by Tornier. This Post-Marketing study is implemented for the Aequalis® Resurfacing Head in shoulder arthroplasty to collect medium and long-term clinical data on performance and safety. It is designed to collect data from consecutive series in European patients for at least 12 months of follow-up and up to 10 years. If possible, the study duration and collection of information will be prolonged. Further follow-up can be implemented, by amendments.

Eligibility Criteria:
Inclusion Criteria:

* Patient has received an Aequalis® Resurfacing Head implant as per the manufacturer's instructions (including the recommended indication): degenerative indication such as primary osteoarthritis, secondary osteoarthritis (post-traumatic post instability), avascular osteonecrosis of the humeral head ;
* with a functional rotator cuff ;
* has clinical and radiographic follow-up data available ;
* is informed about the study and has provided Informed Consent as applicable.

Exclusion Criteria:

* Patient with proximal humeral fracture,
* previous history of infection,
* rotator cuff tear, cuff tear arthropathy,
* significant bone loss of the glenoid (more than 25% of the articular surface),
* nerve palsy,
* revision arthroplasty.
Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine

Comparison of Bilateral Transversus Abdominis Plane Block with Exparel versus Continuous Epidural Analgesia With Bupivacaine

The investigator goal is to compare the analgesic efficacy of TAP blocks with liposomal bupivacaine (Exparel) and continuous epidural blocks in patients who are scheduled for major lower abdominal surgery. To assess whether TAP block with Exparel is noninferior to continuous epidural analgesia on pain management, defined as noninferior for both pain control and total opioid consumption for 72 hours, in patients who had major lower abdominal surgery.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* 18-85 years old
* ASA Physical Status 1-3
* Scheduled for elective open or laparoscopic abdominal surgery, including colorectal and hysterectomy surgeries
* Anticipated hospitalization of three nights
* Expected requirement for parenteral opioids for at least 72 hours for postoperative pain
* Able to use IV PCA systems.

Exclusion Criteria:

* Hepatic disease, e.g. twice the normal levels of liver enzymes
* Kidney disease, e.g. twice the normal level of serum creatinine
* Bupivacaine sensitivity or known allergy
* Women who are pregnant or breastfeeding
* Anticoagulants considered to be a contraindication for epidural or TAP blocks.
* Surgeries with high port sites will be excluded
Promotion of Ambulation Before Non-cardiac Surgery

Primary Determine the impact of prescribing a routine pre-surgical walk scheduled compared to conventional intervention (not recommended exercise) in reducing the length of hospital stay and the time of onset of ambulation during postoperative hospitalization, in patients with ability to move, ≥30 years who will undergo non-cardiac surgery.

Secondary

1. Evaluate ischemic cardiovascular events (AMI), stroke (CVA) and cardiac mortality during hospitalization.
2. Evaluate the incidence of falls during hospitalization.

Methodology The PAMP project phase II, as a component of CARDIECOL program will be implemented by designing a pilot study, a randomized controlled trial. Adult-patients with greater than or equal to 30 years old entering elective non-cardiac surgery, prior informed consent will be randomized to an intervention prescribed of walking in the period of 2-3 weeks before surgery or will be assigned to a Control group/conventional care. The study was not blinded to patients, but evaluation and analysis of the data will be blinded for researchers and statisticians. Patients will be evaluated on their previous level of physical activity and will be evaluated by a physiatrist doctor for prescribing the walk (exercise). This study will include a sample of 500 patients, with capacity to mobilize, ability to walk at least 30 min/by day (150 min by week) for at least 1 week before surgery. Patients have to be hospitalized for at least 24 hours after the surgical procedure. Outcomes are length of stay, and time to first walk. Other results are evaluation falls during hospitalization and the presence of falls, report of cardiovascular events, and death by group.

Expected results

Randomization was planned to be performed one to five weeks before non-cardiac surgery for all eligible patients, once they have decided to participate in the study. It was performed on a random computed to an intervention group (Walk prescription); or conventional care group (no exercise) in a 2:1 relation respectively. Intervention and Management Processes The pre surgical intervention walk routine is defined of at least 150-300 minutes of walk before going into surgery.

Analysis will be following the principle of intention to treat. A description of categorical and quantitative demographic data will be performed. Evaluation will also include the mean difference in the length of hospital stay for each of the groups and standard deviation, given a confidence interval of 95%. An analysis of the time of occurrence of the first walk using the Kaplan-Meier estimator will be performed.

Eligibility Criteria:
Inclusion Criteria:

* undergoing non-cardiac surgery
* general anesthesia or epidural or spinal anesthesia
* age ≥ 30 years
* able to walk and communicate

Exclusion Criteria:

* having any alteration of their state of consciousness
* altered mental status and communication
Study of Bimatoprost Gel on Eyelash Growth

A internally controlled, single-blinded, randomized controlled trial to investigate the use of Bimatoprost eyelash gel on eyelash growth and appearance in breast cancer patients who suffer from madarosis (loss of eyelashes) due to the side effects of chemotherapy. IND and IRB approval have been obtained.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 YO females
* madarosis or hypotrichosis (loss of eyelashes) due to chemotherapy used to treat breast cancer
* only breast cancer patients

Exclusion Criteria:

* inability to follow up, apply gel
* active eye/eyelid infection or inflammatory process
* cancer not related to breast cancer, healthy patients
* males
Mammography Screening With Artificial Intelligence (MASAI)

The purpose of this randomized controlled trial is to assess whether AI can improve the efficacy of mammography screening, by adapting single and double reading based on AI derived cancer-risk scores and to use AI as a decision support in the screen reading, compared with conventional mammography screening (double reading without AI).

European guidelines recommend that mammography exams in breast cancer screening are read by two breast radiologists to ensure a high sensitivity. Double reading is, however, resource demanding and still results in missed cancers. Computer-aided detection based on AI has been shown to have similar accuracy as an average breast radiologist. AI can be used as decision support by highlighting suspicious findings in the image as well as a means to triage screen exams according to risk of malignancy.

Eligible women will be randomized (1:1) to the intervention (AI-integrated mammography screening) or control arm (conventional mammography screening). In the intervention arm, exams will be analysed with AI and triaged into two groups based on risk of malignancy. Low risk exams will be single read and high risk exams will be double read. The high risk group will contain appx. 10% of the screening population. Within the high-risk group, exams with the highest 1% risk will by default be recalled by the readers with the exception of obvious false positives. AI risk scores and Computer-Aided Detection (CAD)-marks of suspicious calcifications and masses are provided to the reader(s). In the control arm, screen exams are double read without AI (standard of care). Considering the interplay of number of interval cancers and workload, the study will be considered successful if the interval-cancer rate in the intervention arm is not more than 20% larger than in the control arm. If the interval-cancer rate is statistically and clinically significantly lower in the intervention arm than in the control arm, AI-integrated mammography screening will be considered superior to conventional mammography screening.

Eligibility Criteria:
Inclusion Criteria:

Women eligible for population-based mammography screening.

Exclusion Criteria:

None.
Long-term Performance of SLActive Implants After Immediate or Early Loading

This is a follow-up study with patients, who participated in the Straumann clinical study CR06/03. The objective is the assessment of long-term data (8 and 10 years after implantation) on the performance of immediate and early (28-34 days post implantation) non-occlusal loaded Straumann Tissue Level Implants with SLActive surface when used to support single crowns or 2-4 unit fixed dental prostheses in the posterior maxilla and mandible.

The primary objective is of the study is to analyse the change in crestal bone levels 8 and 10 years post-surgery compared to 6 months, 1 year, 2 years and 3 years post-surgery in the immediate and early loading group.

This is a prospective, post-market, open label, follow-up multicenter study with patients who participated in the Straumann clinical study CR06/03. The total study duration for each patient should be 2 years.

In total 2 visits are scheduled in this study. Bone level changes, implant success and survival, performance of the restorative components, and adverse events (AEs) will be assessed.

The study device is a CE-marked product and FDA approved.

Three centres, one in Portugal and two in Germany, will participate.

Eligibility Criteria:
Inclusion Criteria:

* Signed Written Informed Consent
* Patients with Straumann SLActive tissue level implants, who participated in the Straumann CR06/03 clinical study.
* Patients must be committed to the study for its full duration.
* Patient's Radiographic stent must be available from study CR06/03

Exclusion Criteria:

* Use of any investigational drug or device within 30 days before start of the study.
* Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with the analysis of the study results, such as history of non-compliance