cyrilzakka/clinical-trials huggingface dataset:
Canadian Avonex PEN Productivity Study

This study is primarily designed to evaluate the impact of AVONEX PEN autoinjector on work capacity of participants with multiple sclerosis (MS) starting on this device. This study will also evaluate as secondary endpoints various patient-reported outcomes over the short-term (1 month), including adherence, treatment satisfaction and convenience, and the long-term (12 and 24 months), including adherence, persistence, quality of life (QOL), treatment satisfaction and convenience. It will also assess health resource utilization by MS participants starting on AVONEX PEN autoinjector, as well as overall safety/tolerability, and will correlate all secondary outcomes with the primary (i.e., work capacity).


Eligibility Criteria:
Key Inclusion Criteria:

* Must be prescribed AVONEX PEN as per local labeling (Product Monograph) and enrolled in MS Alliance (MSA) program
* If being switched from another DMT, must be on this DMT for at least 6 months
* Last DMT the subject is switched from must be injectable
* Must be able to physically demonstrate use of the AVONEX PEN autoinjector device and be able to self-administer the injections
* Must give written informed consent. If required by local law, candidates must also authorize the release and use of protected health information (PHI)
* Must be able to understand and comply with the protocol

Key Exclusion Criteria:

* Female subjects considering becoming pregnant while in the study or who are currently pregnant or breast-feeding
* Current enrollment in any investigational study involving drug, biologic or non-drug therapy
* Participation in other clinical studies within the past 6 months
* Treatment with immunosuppressive regimens (e.g. cyclophosphamide, azathioprine, methotrexate or mitoxantrone) or with intravenous immunoglobulin (IVIg) in the last 6 months
* The most recent DMT the subject is switched from is non-injectable (i.e., oral)
* Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrollment

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
PS230005 Control-IQ 1.5 Post-Approval Study

This 522 post-market surveillance study is a single-arm, decentralized prospective observational cohort study designed to collect safety data on Control-IQ technology v1.5 in children with type 1 diabetes ages 2 to \<6 years old. Participants will use Control-IQ technology v1.5 for 12 months in the real-world setting.

The study will recruit participants age 2 to \<6 years old who begin Control-IQ technology v1.5 use in the real-world setting, with a goal of a minimum of 120 completers at 12 months. All enrolled participants will be monitored from baseline through 12 months following the initiation of therapy with the Control-IQ 1.5 system. The primary endpoint is the risk of diabetic ketoacidosis (DKA) and severe hypoglycemia (SH) events. Secondary outcomes include CGM time in range measurements, and patient reported outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported type 1 diabetes who have been prescribed the Control-IQ 1.5 system in the t:slim X2 or Mobi insulin pump
* Age 2 to \<6 years at time of screening
* Using an insulin approved for use in the pump
* Using an iCGM sensor approved for use with the pump
* Agreement to use Control-IQ technology 1.5, and to continue use for at least 12 consecutive months after study enrollment.
* Agree to provide HbA1c result, obtained within the 6-month period prior to enrollment.
* Ability for parent/guardian to respond to alerts and alarms, and to provide basic diabetes self-management.
* Reside full-time in the United States.
* Willingness to download the t:connect Mobile application to their smartphone and keep it active throughout the study if using a Tandem t:slim X2 pump. Participants who are unable to use the t:connect mobile application must be willing to manually upload their insulin pump data to Tandem Source every three months and at the completion of the study.
* Participant's parent/guardian has read, understood and agreed to participate in the study, and has electronically signed the Informed Consent Form (ICF).

Exclusion Criteria:

* Use of any glucose-lowering therapy other than insulin.
* A medical or other condition, or medications being taken that in the investigator's judgement would be a safety concern for participation in the study.
Comparison of Erector Spinae Plane Block vs Intravenous Lidocaine for Chronic Pain Post Mastectomy.

Patients undergoing breast surgery were divided into two groups: Intravenous Lidocaine (Lido-IV) vs Erector Spinae Block (ESP).

For Lido-IV group, patients received a loading dose of Lidocaine than a continuous infusion till the end of surgery.

For ESP group, an ultrasound guided ESP Block was perormed before anesthetic induction.

Persistant pain post mastectomy was assessed by SFM-PQ score at 1, 3 and 6 months post surgery.

Patients undergoing breast surgery with lymph node dissection were divided into two groups: Intravenous Lidocaine (Lido-IV) vs Erector Spinae Block (ESP).

For Lido-IV group, patients received a loading dose of 1.5 mg/kg of Lidocaine than a continuous infusion of 2 mg/kg/h till the end of surgery.

For ESP group, an ultrasound guided ESP Block was perormed before anesthetic induction with injection of 30 ml of Ropivacaine 3.75%.

For both group, persistant pain post mastectomy was assessed by Item 5 of BPI score at 1, 3 and 6 months post surgery.

Eligibility Criteria:
Inclusion Criteria:

* Female patients
* patients aged 18 and older
* American Society of anesthesiologists classification I or II
* patients proposed for planned mastectomy with axillary lymph node dissection.
* hemodynamic stability.

Exclusion Criteria:

* patient refusal
* male gender
* history of major surgery within the year.
* allergy to local anesthetics
* BMI\>40
* hemodynamic instability
* Patients on long-term analgesics
* Severe heart and/or kidney damage
* neurological/psychiatric impairment
Support Annual Strain Update, Safety and Immunogenicity of an Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008, When Administered to Subjects 18-64 Years Affected by Chronic Diseases.

This phase II, open label, is designed as a seasonal study to support annual strain update evaluating the safety, clinical tolerability and immunogenicity of the 2007-2008 formulation of Novartis Vaccines' adjuvanted, subunit influenza vaccine in adults with underlying chronic diseases


Eligibility Criteria:
Inclusion Criteria:

* 18 to 64 years of age adult volunteers, mentally competent, willing and able to give written informed consent prior to study entry, suffering from at least one of these chronic diseases: hypertension, heart disease, chronic obstructive pulmonary disease (COPD) or asthma, hepatic or renal insufficiency, arteriosclerotic disease or insulin dependent diabetes mellitus

Exclusion Criteria:

* Hypersensitivity to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate or any other component of the vaccine;
* History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;
* Known or suspected impairment/ alteration of immune function;
* Having received within the past 12 months more than one injection of influenza vaccine
* Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
EGFR_IUO 3.20 Clinical Study Protocol

An interventional, prospective clinical performance study protocol, for the testing of DNA extracted from FFPE Fine needle aspirate samples, using the Idylla EGFR_IUO/3.20, from patients with Non-Small Cell Lung Cancer screened in AstraZeneca's NeoADAURA clinical trial (Protocol No. D516AC00001)

This is a prospective, interventional diagnostic study using the For Investigational Use Only EGFR_IUO/3.20 for FFPE FNA sections. Screened patients with available FNA specimens, collected per SoC, who are found to have exon 19 deletions or L858R mutations in the EGFR gene based on the results of EGFR_IUO/3.20 and who meet all other study eligibility criteria will be randomized into one of three arms of the NeoADAURA study: neoadjuvant osimertinib as monotherapy or in combination with pemetrexed/platinum chemotherapy, versus pemetrexed/platinum chemotherapy plus placebo.

The use of the investigational IVD does not require invasive sampling that is not part of standard of care (SoC). Investigational testing for patient selection will be performed on FFPE FNA specimens, obtained as SoC for diagnosis and/or pathologic staging prior to definitive surgery. By using available specimens obtained as SoC, there is no risk to patients as a result of invasive sampling for EGFR testing.

Eligibility Criteria:
Inclusion Criteria:

• All patients who provided consent (by signing and dating the Consent Form for AstraZeneca NeoADAURA Protocol No. D516AC00001), may be included in the device study.

Exclusion Criteria:

* Patients whose FFPE FNA samples are not Clinical Trial Assay evaluable will be excluded from the study.
* Patients with samples identified for the study which have insufficient testing material will also be excluded.
An Open Label Study to Assess the Efficacy, Safety and Tolerability of COZAAR Plus (Losartan Potassium 50mg/Hydrochlorothiazide 12.5mg) Possibly Titrated up to COZAAR Plus-F (Losartan Potassium 100mg/Hydrochlorothiazide 25mg) in Patients With Essential Hypertension (0954A-325)

Evaluate blood pressure after 6 weeks of treatment with COZAAR plus.


Eligibility Criteria:
Inclusion Criteria:

* Patient treated with valsartan 80mg or irbesartan 150mg or vandesartan 8mg for at least 4 weeks prior to visit 1
* Patient with systolic blood pressure between 140 to 159 mmhg and diastolic pressure between 90 to 99mmhg taken at visit 1

Exclusion Criteria:

* History of angina pectoris that has not been stabilized in the past 6 weeks
* History of clinically significant abnormal lab results or diseases
* Myocardial infarction within the past 6 months
* Stroke in the past 6 months
Prospective Evaluation of the Resection Margins and the Ganglionic Status Using a Quality Standard Resection for Adenocarcinoma of the Head of the Pancreas

This multicentric prospective study evaluates the role of the margins resection and the ganglionic status when using a quality standard for the resection of adenocarcinoma of the head of the pancreas.

Primary objective:

* Evaluation of the prognosis role of the invasion of the margins on the overall survival after a standard resection of adenocarcinoma of the head of the pancreas.

Secondary objectives:

* Evaluation of the prognosis role of the invasion:

  * Of margins on the overall survival.
  * Of each margins (distal pancreatic margin, gastric, posterior, retro-venous, retro-arterial) on the overall survival.
  * Of the ganglionic group of the superior mesenteric artery and the other nodes.

Eligibility Criteria:
Inclusion Criteria:

* A head of the pancreas tumor compatible with adenocarcinoma diagnosis
* tumor apparently removable
* patient aged from 18 to older
* signed consent

Non inclusion criteria:

* pregnancy, breast feeding
* patient in an urgency situation or patient with legal protection

Exclusion Criteria after surgery:

* tumor other than adenocarcinoma of the head of the pancreas.
* analysis of the margins not done with the defined criteria
* nonadhesion to the surgical protocol
Factors Associated With Quality of Dreams During General Anesthesia

Patients frequently report having dreams during general anesthesia. The incidence of dreams during general anesthesia that have been reported by patients upon awakening has been reported to range from 10 to 36% \[1\] and to be higher in younger patients, female patients \[2\], and patients who received ketamine \[3\]. The quality of dreams during general anesthesia is often reported as pleasant, but some patients report unpleasant or not pleasant dreams \[4, 5\]. However, the factors associated with the quality of dreams have remained to be elucidated. Therefore, the aim of this study was to determine the relationships between the quality of dreams during general anesthesia and perioperative factors.


Eligibility Criteria:
Inclusion Criteria:

* We recruited patients who were more than 20 years of age
* Patients who were scheduled for elective surgery under general anesthesia regardless of the type of surgery

Exclusion Criteria:

* diagnosis of a psychological disorder,
* major afective disorder
* major drug dependence disorder,
* inability to understand the content of our study,
* planned postoperative ventilation,
* anticipation of unavailability for postoperative interviews
Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With Scleroderma

Clinical and experimental studies suggest that bosentan could delay the progression of interstitial lung disease (ILD) associated with systemic sclerosis (SSc), a condition for which no established efficacious treatment is available. The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) WHO Class III and IV, to a new category of patients suffering from ILD associated with SSc.


Eligibility Criteria:
Main inclusion criteria:

* Systemic Sclerosis diffuse or limited
* Significant Interstitial Lung Disease on HRCTscan
* DLco \< 80% predicted
* Dyspnea on exertion
* Walk not limited by musculoskeletal reasons

Main exclusion criteria:

* Interstitial Lung Disease due to other conditions than SSc
* End stage restrictive or obstructive lung disease
* Severe cardiac or renal diseases
* Significant pulmonary arterial hypertension
* Smoker (\> 5cig./day)
* Treatment with immunosuppressive, antifibrotic drugs, high dose corticosteroids (within 4 weeks of randomization)
Safety Study of Abatacept in Rheumatoid Arthritis Participants

A observational study to assess whether biologic disease-modifying (BDM) treatment initiation with abatacept for rheumatoid arthritis is associated with an increased risk of serious infection and cancer


Eligibility Criteria:
Inclusion Criteria:

* Patient initiates BDM treatment with at least one claim for the treatment. Patients will be presumed to be new users of a treatment if there is no claim for the drug or any other BDM in the 180 days prior to the cohort entry date
* Patient has at least two diagnoses for RA in the patient's history prior to and including the entry date or within the 180 days after the entry date
* Patient is aged 18 years or older on the entry date
* Patient was enrolled in the database for at least 180 days before the entry date

Exclusion Criteria:

* Patient is younger than 18 years on the entry date
* Patients who receive abatacept and another biologic simultaneously
* Patients who have an outcome diagnosis in the baseline period will be excluded from the cohort analyses for that outcome

Other protocol defined inclusion/exclusion criteria could apply
the Potential Immunomodulatory Effects of Spirulina on Thalassemic Children

The aim of this study is to evaluate the possible immunologic effects of spirulina in children with beta thalassemia.


Eligibility Criteria:
Inclusion Criteria:

* children with thalassemia major

Exclusion Criteria:

* children with other chronic hemolytic anemias
Cough Reflex and Obstructive Sleep Apnea Syndrome

Up to 70% of obese patients undergoing bariatric surgery have obstructive sleep apnea syndrome (OSAS). OSAS is responsible for laryngeal sensory impairment. As the afferent neural pathway involved in the initiation of cough is located in the laryngeal epithelium, cough reflex sensitivity may be decreased in obese OSAS patients. The researchers therefore conducted this study to determine the effect of OSAS associated with obesity on cough reflex sensitivity, assessed by cough reflex threshold to an inhaled irritant (citric acid).

Obese patients undergoing scheduled bariatric surgery underwent a cough challenge as part of their routine preoperative evaluation. Patients were classified as presenting OSAS if apnea-hypopnea index obtained from preoperative full-night polysomnography was greater than 5/hour. Cough threshold was measured with citric acid. Increasing concentrations of mouth- nebulized citric acid (2.5, 5, 10, 20, 40, 80, 160, 320 and 640 mg/mL) were delivered during inspiration until a cough was elicited. The citric acid concentration eliciting one cough (C1) was defined as the cough reflex threshold.

Eligibility Criteria:
Inclusion Criteria:

* Obese patient scheduled to undergo bariatric surgery

Exclusion Criteria:

* Age less than 18
* Active smoking
* Psychotropic medication
* Angiotensin-converting enzyme inhibitor or angiotensin II receptor antagonist medication
* Pregnancy
* Anesthesia or endotracheal intubation during the previous month
* Allergic rhinitis
* Upper airway or bronchopulmonary infection during the previous month
* Chronic cough
* Chronic respiratory disease
* Pharyngolaryngeal disease
* Neurological disease
Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration

The Phase 1 safety study of VOY-101 comprises of escalating dose Cohorts, followed by a Phase 2a.

This is a prospective, open-label, multi-center Phase 1/2a study to evaluate the safety of a single, unilateral intravitreal (IVT) injection of escalating dose levels of VOY-101 therapy in subjects with advanced non-neovascular age-related macular degeneration (AMD).

Eligibility Criteria:
Inclusion Criteria:

* Are ≥50 years of age at the time of consent.
* Are willing and able to understand and provide written informed consent.
* Are willing and able to return for scheduled treatment and follow-up examinations.
* Are able to undergo ETDRS BCDVA testing and ophthalmic imaging.
* Well-demarcated GA secondary to AMD in the absence of MNV and in the absence of history of MNV.
* Absence of signs of non-exudative MNV.
* Additional Ocular Inclusion Criteria for study eye.
* Meet certain genotype criteria for risk of AMD.

Exclusion Criteria:

* Are women of childbearing potential (WOCBP) and are pregnant or unwilling to use and document use of effective contraception for the duration of the study.
* Additional Systemic, Ocular, and Genetic Exclusion Criteria.
Nexus Evaluation Primary Trident II Uncemented Shell

This is a prospective cohort study assessing the survival of a new acetabula component which is based on the original Trident acetabular system (cementless shell) which is used for Total Hip Arthroplasty. The manufacturer recently introduced the evolution of this product, the Trident® II acetabular shell which was launched in 2017. This implant is CE marked and is now widely available for the UK market, however has minimal clinical outcomes data to support its use. As part of a stepwise introduction of devices to orthopaedic practice. This study will report the 10 year implant survival and patient functional outcomes of this new implant.

125 patients will be recruited at a single-centre as part of a, phase-4 post-market surveillance, prospective cohort study

This is a 10-year study of the Trident II acetabular component as part of total hip replacement at the Royal Infirmary of Edinburgh, NHS Lothian.

Patients will receive a Trident® II acetabular component as part of primary total hip arthroplasty at the study centre. This component is CE marked and widely available for use by UK surgeons. The Trident® II shells are HA coated, cementless, press-fit acetabular shells composed of a Titanium (Ti-6Al-4V) substrate featuring a CpTi roughened surface with PureFix™ HA. The cup is available in a range of sizes and is indicated for primary and revision procedures.

A standard operative technique will be employed by all study surgeons, using the posterior approach. The routine post-operative patient care protocol of the study centre will be employed.

10 year implant survival is the primary aim, but in addition functional and radiographical outcome will be assessed a 1, 2, 5, 7 and 10 years.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing planned primary total hip arthroplasty with standard implants, suitable for the use of the uncemented Trident® II acetabular component.
2. Patients aged 18-75
3. Patients willing and able to comply with the study protocol
4. Patients that provide informed consent

Exclusion Criteria:

1. Patients not meeting study inclusion criteria
2. Bone stock that is inadequate for support or fixation of the prosthesis
3. Patients with a body mass index (kg/m2) \>40
4. Procedures performed for pain relief in those with severely restricted mobility
Health Care Analysis on Myocardial Revascularization in Patients With Chronic Coronary Heart Disease (CHD)

Myocardial infarction and chronic coronary heart disease (cCHD) are the most frequent causes of death in Germany. Treatment options include widening of the narrowed / blocked coronary vessel via catheter and stent or bypass surgery in which the narrowed vessel sites are bridged. The "German National Disease Management Guideline on cCHD" helps doctors to decide which treatment is most appropriate for the severity of vascular damage and possible concomitant diseases of the patient. Nevertheless, there are other factors determining treatment decision. For example, the equipment or preferences of the hospital or department in which patients are admitted, play a role in the decision.

The aim of the REVASK project is to investigate whether and to what extent the collaboration of cardiology and heart surgery specialists in so-called "heart teams" influences the decision on therapy.

For this purpose, doctors and patients will be interviewed about how the treatment decision was made and how satisfied both sides are with the outcome of the treatment and the decision. In addition, claims data from several German health insurance companies (Techniker, BARMER, Betriebs- und Innungskrankenkassen) will be analyzed. Treatment data, which is documented as usual by the treating medical staff and passed on to the health insurance companies for accounting purposes, is used. Furthermore, treatment data recorded in the registers of the professional societies is analyzed.


Eligibility Criteria:
Inclusion Criteria:

* with chronic coronary heart disease
* and 2- or 3-vessel or main-vessel disease
* who are being treated at one of the recruitment sites
* with a promptly planned intervention for myocardial revascularization
* who are insured with pre-specified German health insurance companies (BARMER or TK)

Exclusion Criteria:

-