cyrilzakka/clinical-trials huggingface dataset:
Metabolic Mapping and Cardiac Resynchronization

The purpose of this study is to gather information on the safety and effectiveness of cardiac resynchronization therapy (CRT) in patients who have mild heart failure (HF) and left bundle branch block (LBBB).


Eligibility Criteria:
Inclusion Criteria:

* Left Ventricular Ejection Fraction (LVEF) 35%-50%
* New York Heart Association (NYHA) class I-II
* QRS duration of ≥120ms
* Left bundle branch block (LBBB)
* Patient is able to receive a transvenous pectoral CRT implant
* Patient is able to sign informed consent
* Two echocardiograms are required to confirm a stable reduced LVEF
* Patient is on optimal and stable medical therapy (ACE inhibitor or angiotensin II type 1 (AT1 )blocker, beta blocker, etc. over the last 6 months)

Exclusion Criteria:

* Advanced comorbid conditions with life expectancy \<1 year
* Patient is \<18 of years of age
* Patient has a CRT device
* Female patients who is pregnant or not on a reliable form of birth control. Women of childbearing potential are required to have negative pregnancy test within the 7 days prior to device implant
* Unwilling or unable to return for required follow-up visits
* Patient decides study participation is cost-prohibited
Single/Multiple Dose Bioavailability Trial

To determine the pharmacokinetic profile of an extended release tablet of naproxen sodium 660 mg relative to the established commercial Aleve 220 mg tablet following single dose administration and at steady-state following multiple dose administration for 4 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, ambulatory, male and female volunteers between 18 - 55 years of age with BMI of approximately 18 to 30 kg/m2, and total body weight \>50 kg (110Ibs)

Exclusion Criteria:

* History of hypersensitive to aspirin (ASA), naproxen sodium, or acetaminophen, and similar pharmacological agents or components of the products
* History of gastrointestinal bleeding or perforation related to previous Non-Steroidal Anti-Inflammatory Drug (NSAID) therapy Active, or history of current peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding)
* Have taken ASA, ASA-containing products, acetaminophen (acetyl-para-amino-phenol or APAP) or any other NSAID (OTC or prescription) 7 days prior to dosing or during the treatment period, other than study treatment
Expanded Access for AG-221

This is an expanded access program (EAP) for eligible participants designed to provide access to AG-221.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Effects of Aerobic Blood Flow Restriction

The aim is to evaluate the effects of aerobic blood flow restriction on academy football players. Randomized clinical trial, with two intervention groups: Experimental group I will carry out training based on running on the treadmill using blood flow restriction (BFR) on match days 4 and 3 pre-competition (MD-4, MD-3). On the other hand, the Experimental II group will perform the same training without the use of BFR for 6 weeks. The study will be carried out during the 2023-2024 season in the National and Youth Honor Divisions of Spanish soccer, with soccer teams from Mallorca Island. Before and after 6 weeks of intervention, the countermovement jump (CMJ), maximum aerobic speed (MAS), VO2max, and repeat sprint ability will be evaluated. The levels of muscle soreness (DOMS) will be evaluated at MD-4, MD-3, and MD-2. The same procedure will be carried out to evaluate muscle fatigue, sleep quality, and stress through a questionnaire. Sociodemographic and anthropometric data will be collected before starting the study. In addition, the rate of exertion perceived will be evaluated at MD-4, MD-3, and MD-2.

The warm-up will consist of federation Internationale football association (FIFA) 11+. In addition, the warm-up will contain a familiarization with the jump test.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* No injuries players
Penicillin Allergy Delabeling Project

A investigational study to establish:

1. A validated cllinical pathway for delabeling declared Penicillin allergiy outside allergologic departments.
2. A survey to examine anesthesiologists attitudes and knowledge about penicillin delabeling.
3. A qualitative focus group study investigating barriers and facilitators in penicillin delabeling among hospital nurses and physichians.

2. Implement the pathway for delabeling declared penicillin allergy outside allergologic clinics across the Western Norway health region.

Patients labeled penicillin allergic is a significant and growing public health problem. 10% of all patients report penicillin allergy. 9 out of 10 however tolerate penicillin on provocation, To be labeled as penicillin allergic has several well documented negative health outcomes for the individual, and on a public health scale.

One of the biggest obstacles in delabeling penicillin allergy is the lack of validated tools i Norwegian, the lack of in vitro tests for severe late /T cell mediated reactions and the accessibility of the gold standard procedure, drug provocation test.

In this study patients having a penicillin allergy label will after giving their written concent be screened used a risk stratification tool. The low risk patient will then directly undergo a single full dose amoxicillin challenge. High risk patients are refered to a allergologic clinic and undergoes full allergologic examination. The investigators seek to document that in low risk patients is a single dose Amoxicillin challenge safe and beneficial outside an allergologic clinic, and to validate the risk stratification tool in Norwegian.

To implement such pathways i qualitative data is needed to facilitate the right efforts and translate the method into every day clinical practice in a sustainable way. Here a anesthesiologist survey and focus group interviews with hospital nurses and physichians is planned.

Finally we will implement the method in an implementation study across the Western Norway Health region

Eligibility Criteria:
Inclusion Criteria:

* Penicillin allergy in the patient journal oder patient reported

Exclusion Criteria:

* Not able to give concent. Under 16 years of age.
Cardiac Amyloidosis : Diagnostic Using Red Flag Signals

Cardiac amyloidosis is an increasingly contributor of degenerative cardiac diseases. However, its frequency remains underestimated, and diagnosis is often realized at late stages of the disease. A larger use of clinical and echographic Red Flag signals during routine echocardiographic examination may enhance the identification of early stage of the disease.

The objective is to evaluate the clinical and epidemiological aspects of cardiac amyloidosis using a systematic screening of even moderate left ventricular hypertrophy, taking into account the presence of Red Flag signals. Red Flag Signals will include history or symptoms of carpal tunnel syndrome, hearing loss, chronic gastrointestinal disorders, heart failure, cervical or lumbar stenosis, or echographic abnormalities such as apical sparring, increased left ventricular filling pressure, atrio-ventricular block.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of left ventricular hypertrophy defined by a parietal thickness (interventricular septum or posterior wall) ≥ 12 mm on the echocardiogram
2. Age equal or greater than 45 years
3. Current residency in Martinique, Guadeloupe or French Guyana
4. Ability to receive and understand research information
5. Ability to freely deliver informed written consent

Exclusion Criteria:

1. Pregnant or breastfeeding woman
2. Severe uncontrolled hypertension
3. Chronic hemodialysis
4. Person under legal protection measures (guardianship, curatorship, safeguard of justice), and person deprived of liberty
Phase II Study of 2-weekly RAILIRI Versus FOLFIRI as Second-line Treatment in Advanced Colorectal Cancer Patients

This study is designed to compare the efficacy and safety of two-weekly RAILIRI regimen with FOLFIRI regimen in the treatment of advanced colorectal cancer patients in the second-line setting.


Eligibility Criteria:
Inclusion Criteria:

* aged 18-70 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma
* Eastern Cooperative Oncology Group performance status of 0 to 1
* life expectancy of ≥ 3 months
* patients who had failed first-line treatment with either XELOX (capecitabine combined with oxaliplatin) or FOLFOX (5-fluorouracil/leucovorin with oxaliplatin)
* at least one measurable disease lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria
* have adequate bone marrow, hepatic, and renal function

Exclusion Criteria:

* patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction
* patients with symptomatic brain metastases
* active clinical severe infection
* previously received irinotecan or raltitrexed
* dihydropyrimidine dehydrogenase (DPD) enzyme adequate
Pharmacogenetic of Salbutamol in Pediatric Asthma Crisis

this study is designed to identify the genetic factors which can be implicated in the salbutamol responsiveness for asthmatic children in pediatric emergency department

Patients from 6 to 16 years old consulting for an acute asthma exacerbation and receiving a treatment by salbutamol according to the usual care could be recruited.Saliva from patient were collected using Oragen®.DNA OG-500 kit or swabs.Based on literature review, four SNP were chosen:ADBR2 gene), ARG gene, and GSNOR gene.

Eligibility Criteria:
Inclusion Criteria:

* children
* 6-16 years old
* asthmatic patients
* consulting for an exacerbation in a pediatric emergency department
* parental informed consent

Exclusion Criteria:

* comorbidity
* peak flow no available
* pneumonia
Study of the Effect of a Fermented Dairy Product on Gastrointestinal Well Being in Adult Women

The purpose of this study is to evaluate the effect of a commercially available fermented dairy product containing probiotics (4 weeks, twice a day) on the improvement of gastrointestinal well being and digestive symptoms in adult women reporting minor digestive troubles among the general population.


Eligibility Criteria:
Inclusion Criteria:

* Female free-living subject aged from 18 to 60 years.
* Subject with a body mass index between 18 and 30.
* Subject with minor digestive symptoms as defined by screening questionnaire of frequency of digestive symptoms.
* Subject with normal stool frequency

Exclusion Criteria:

* Subject with a diagnosis of Irritable Bowel Syndrome (IBS) or other functional bowel disease (constipation, diarrhoea...)
* Subject with known organic disease, including an inflammatory bowel disease, a benign or malign tumour of intestine or colon and significant systemic disease
* Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs
* Subject having taken antibiotics in the last 4 weeks
* Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject.
* Subject with known lactose intolerance or immunodeficiency
* Subject with known allergy to product component (milk protein for example)
Study Evaluating Bosutinib-Letrozole Combination Versus Letrozole Alone In Post Menopausal Women With Breast Cancer

This is a phase 2 study of bosutinib administered in combination with letrozole versus letrozole alone in post-menopausal women with breast cancer. This is a 2-part study. Subjects in part 1 will receive bosutinib and letrozole daily, and will be closely monitored for 28 days. The second part will proceed with subjects receiving a dose that is determined to be safe based on the safety evaluation of the first part. Eligible subjects will be randomly assigned to receive either bosutinib daily combined with daily letrozole, or daily letrozole alone for a specified period of time. Subjects will be followed up for survival after study drug discontinuation.

This study was terminated on 19 April 2009 due to unfavorable risk benefit ratio of Bosutinib in combination with Letrozole including one confirmed Hy's law case. 37.5% of patients had treatment related liver events with the majority of severe events resulting in permanent study treatment discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* Surgically sterile or post-menopausal women.
* Confirmed pathologic diagnosis of breast cancer.
* Locally advanced or metastatic, or loco-regional recurrent breast cancer not amenable to curative treatment with surgery or radiotherapy.
* Documented ER+ and/or PgR+ and erbB2- tumor based on most recently analyzed biopsy, as documented by a local laboratory.
* At least 1 radiologically measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST).
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Exclusion Criteria:

* Prior letrozole (except in adjuvant setting), prior bosutinib, or any other prior Src inhibitor.
* Prior endocrine treatment for locally advanced or metastatic breast cancer (up to one prior adjuvant Aromatase Inhibitor (AI) agent/regimen is permitted).
* More than 1 prior chemotherapy regimen in locally advanced or metastatic breast cancer.
* Adjuvant endocrine therapy \<=12 months prior to day 1 of treatment.
* Disease refractory (ie, Progressive disease (PD) within 6 months from initiation of therapy) to previous adjuvant antiestrogen therapy.
* Bone or skin as the only site of disease.
* Extensive visceral disease or active Central Nervous System (CNS) disease.
* Any other cancer within 5 years of screening with the exception of ER+ contralateral breast carcinoma, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.
* Major surgery or radiotherapy within 14 days of treatment day.
* Inadequate hepatic/renal/bone marrow function.
* History of clinically significant or uncontrolled cardiac disease.
* Serious concurrent illness.
Clinical Impact of Fluoroquinolone Resistance in Bacteremia Caused by Gram-Negative Bacilli of Urinary Tract Origin

The information collected will optimize the management of patients with urinary tract infections with secondary bacteremia, primarily with gram negative bacteria especially Escherichia coli. The current IDSA guideline endorses the use of fluoroquinolones and trimethoprim-sulfamethoxazole as the first line agents. However, over use of this empiric regimen could result in in appropriate treatment of bacteremia.

The following information will be collected: age, sex, occupation, hospital location at the time of positive culture (ER, medical ward, ICU etc), prior hospitalization, receipt of outpatient dialysis, home care or other regular medical care (eg, outpatient chemotherapy), presence of invasive devices, receipt of antibiotics, including their type and whether they were adequate for the resistance profile of the organism, prior positive microbiologic cultures, time and location of positive cultures, underlying diseases and severity of illness, presence of urinary or intravascular devices, recent immunomodulative therapies or radiation therapy, physical exam findings, laboratory and radiographical data, antimicrobial usage within 30 days of onset of the infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome,gender, height, weight, ethnicity, and past medical history. We will collect information retrospectively.

Eligibility Criteria:
Inclusion Criteria:

* Clinical information is collected by chart review of "case" and "control" patients. A "case" patient is defined as follows:

  * One or more blood cultures are positive for Gram-negative bacteria.
  * The same organism is recovered in urine culture within a 48-hour period.
  * The organism is ciprofloxacin resistant.
* A "control" patient is defined as follows:

  * One or more blood cultures are positive for Gram-negative bacteria.
  * The same organism is recovered in urine culture within a 48-hour period.
  * The organism is ciprofloxacin susceptible.

Exclusion Criteria:

* negative culture
Efficacy of Ketamine in Post Anesthesia Recovery Room

Observational study to assess efficacy of IV ketamine bolus when used in the post anesthesia recovery unit for uncontrolled pain despite use of opioids.

In this observational study, the investigators will monitor all patients with significant pain after any non-cardiac surgical intervention at the University of Alberta Hospital.

After receiving an adequate dose of potent opioids (hydromorphone, morphine), the participants will receive up to 0,2-0,25 mg/kg IV ketamine bolus. In our center these boluses are given with 10-20mg increments.

The adequate dose of opioids will be determined by the attending anesthesiologist, depending on what patients received intraoperatively and on their comorbidities.

Pain scores will be assessed before and after administration of this drug. The incidence of any side effect after ketamine administration will be documented.

Eligibility Criteria:
Inclusion Criteria:

Adult patients undergoing non cardiac surgery at University of Alberta Hospital meeting the following criteria:

* age ≥ 18
* significant pain despite narcotics used in post-anesthesia care unit
* ketamine ordered by attending anesthesiologist

Exclusion Criteria:

* Patient refusal to receive ketamine
* Patients undergoing cardiac surgery
* Patients who received no narcotics
* Contra-indication to receiving ketamine (determined by attending anesthesiologist)
Corneal Transplantation Guided by OCT RESCAN

The investigators will evaluate 30 patients with surgical indication for corneal transplantation. Participants will be divided according to the following diseases diseases: keratoconus, bullous keratopathy, corneal dystrophies. Participants will be informed about the risks and benefits of the study and sign an informed consent form. In the preoperative evaluation will be submitted to a complete ophthalmologic examination with complementary tests, such as optical coherence tomography.

One group of participants will undergo corneal surgery using the OCT Lumera microscope RESCAN - ZEISS and another group with a conventional microscope. Everyone will have their filmed and documented surgery. The team of surgeons will answer the questionnaire on the surgical difficulty about the ease of assessing corneal transplantation. After surgery, participants will be assessed on days 1, 7,15, 30, 60, 90 and 180 after surgery.

Surgeries and study procedures will be performed by the same team of surgeons and performed by IPEPO - Paulista Institute of Studies and Research in Ophthalmology / Vision Institute.

Participants will be allocated in one of the following groups:

1. Control Group The control group will undergo corneal transplant with conventional microscope without coupled OCT. The team of surgeons will answer the questionnaire on the surgical difficulty regarding corneal transplantation (ANNEX 1).
2. Group OCT RESCAN In the group microscope coupled to OCT, patients will undergo retinal surgery using the Lumera Microscope WITH RESCAN OCT - ZEISS. The team of surgeons will answer the questionnaire on the surgical difficulty regarding corneal transplantation (ANNEX 1).

The investigators will evaluate intraoperative conditions, complications, operative time and postoperative results in both groups.

All patients will be monitored and evaluated with full ophthalmological examination in all postoperative visits (day 1, 7,15,30, 60, 90, 180) and will be subjected to the following tests:

* Measurement of visual acuity with best correction
* Previous Biomicroscopy
* Corneal Topography
* tonometry
* Optical coherence tomography (OCT)
* Microscopy speculate

Eligibility Criteria:
Inclusion Criteria:

* Visual acuity less than 20/60 in the affected eye
* 18 years at least
* Diagnostic of the following diseases:

  * keratoconus
  * Keratopathy Bullosa
  * Corneal dystrophy

Exclusion Criteria:

* Better visual acuity than or equal to 20/60
D3-GHR Polymorphism and Turner Syndrome

The protein polymorphism of the growth hormone receptor characterized by the genomic deletion of exon 3 has been linked to the magnitude of the first-year-growth response to growth hormone (GH) in girls with Turner syndrome.

Objective: to study the long-term effect of GH therapy in Turner syndrome in correlation to this GHR polymorphism in a mainly retrospective design (chart-review).


Eligibility Criteria:
Inclusion Criteria:

* Turner syndrome defined by a structural aberration or lack of the X chromosome.
* Growth velocity less than 2 cm/year at the time of final analysis (= final height).

Exclusion Criteria:

* Age \<3.5 or \>14 years at start of GH therapy,
* GH peak serum levels \< 8 ng/ml in two independent tests,
* Thelarche at start or during the first year of treatment,
* Oxandrolone therapy for any time and a duration of GH therapy less than 2 years.
HeadStART: Evaluating the Effectiveness of Community ART Delivery for People Newly Diagnosed With HIV

This is a cluster randomized controlled trial at 12 health centers in refugee settlements in Uganda aiming to evaluate effectiveness of expansion of community antiretroviral therapy (ART) delivery to people newly diagnosed with HIV in achieving HIV viral suppression.

Community antiretroviral therapy (ART) delivery is a differentiated care model that fosters social support and reduces time and transportation barriers yielding improved engagement in HIV care. In Uganda, to participate in community ART delivery, clients must be "stable" in care (\> 1 year on ART and viral load \< 1,000 copies/mL). Therefore, persons newly diagnosed with HIV are not eligible for community ART delivery. Community ART delivery may benefit persons newly diagnosed with HIV in refugee settlements by bolstering social support and by bringing ART closer to individuals living in these expansive rural settlements. The primary objective of this research is to evaluate the effectiveness of expanding community ART delivery to clients newly diagnosed with HIV.

Eligibility Criteria:
Inclusion Criteria:

1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Adult ≥18 years of age or mature minors or emancipated minor. Mature minors are defined as individuals 14-17 years of age who have drug or alcohol dependency or a sexually transmitted infection. Emancipated minors are defined as individuals below the age of majority (18 years) who are pregnant, married, have a child, or are self-sufficient.
4. Tested HIV positive in the past 6 months and not already known to be HIV positive.
5. Able to communicate in one of the following 5 study languages: Kiswahili, Runyankore, Kinyarwanda, Somali, or English.

Inclusion criteria for data abstraction only:

1. Adult ≥18 years of age or mature minors or emancipated minor.
2. Tested HIV positive in the past 6 months and not already known to be HIV positive.

Exclusion Criteria:

1. Pregnant and breastfeeding women.
2. Clients deemed by the clinician(s) unfit for community-based care secondary to medical need.
3. Concurrently enrolled in another biomedical clinical trial.