cyrilzakka/clinical-trials huggingface dataset:
Endoscopic Gastric Reduction for Weight Management

The proposed study is a prospective, pilot study to assess the feasibility of a novel endoscopic suturing system to reduce gastric volume by changing the shape of the stomach for the primary treatment of obesity. The investigators aim to recruit ten subjects with a body mass index between 30-40 for this study. Vertical sutures will be performed using the endoscopic suturing system to deploy 10-17 interrupted full thickness sutures. Botulinum toxin(approximately 30 units) will be injected around the sutures insertion sites in half of the subjects randomly to slow down muscular grinding of the stomach to see if it improves durability of the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 30 and 40
* Age \>18 and ≤50
* Stable weight for 3 months (within 5% of BMI)
* Normal basic labs (CBC, chemistry profile, creatinine)
* Negative pregnancy test for females \>18 or ≤ 50

Exclusion Criteria:

* Diabetes
* Unstable coronary artery disease
* Heart failure
* Cardiac arrhythmia
* Cardiac valvular disease
* Obstructive of interstitial lung disease
* Females of child-bearing age \>18 or ≤ 50 who are pregnant or lactating
* Mallampati score of 4
* ASA 3 or above
* Previous gastric surgery
* Ulcer disease
* Gastroparesis,
* \> 5 cm Hiatal hernia
* Congenital anomalies of the GI tract
* Currently on or prescribed a medication known to affect weight within 3 months of study entry.
American Breast Laser Ablation Therapy Evaluation

The purpose of this patient tracking program is to monitor long term safety and effectiveness of the Novilase™ device and method in real world application.

ABLATE is a prospective, observational multi-center tracking database which will evaluate clinical outcomes from patients undergoing Novilase for benign breast conditions (i.e. fibroadenomas, papillomas, etc). Data captured will assess the potential advantages and disadvantages of the procedure as compared with lumpectomy. Tumor characteristics, equipment used, complications, patient satisfaction and cosmesis ratings will also be tracked.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis confirmed by needle core biopsy
* Tumors detected either by physical exam or imaging
* Tumors do not exceed 2 cm in diameter and measure at least 0.5 cm away from the skin and chest wall
* Single, multiple and/or bilateral tumors
* Patient has given consent prior to being treated with Novilase™

Exclusion Criteria:

* Patient is pregnant or lactating
* Hypercellularity suggestive of phyllodes
* Atypia
* Equivocal pathology report (e.g., discordance between radiographic and microscopic results)
* Fibroadenomas with stromal solidarity
Insulin Sensitivity and Substrate Metabolism in Patients With Cushing's Syndrome

The purpose of this study is to investigate the effect og chronic elevated levels of cortisol on metabolism and insulin sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Written consent
* Age between 18 and 70
* Diagnosed with Cushing's syndrome

Exclusion Criteria:

* Suspected malignancy
SCORE! ACTIVE Trial

Hamilton is a city with a growing newcomer population. Families who are new to Canada do not always have the same resources to access healthy active living (HAL) activities as compared to Canadian-born families. The SCORE! ACTIVE trial will recruit newcomer families with young children in Hamilton and help provide them with access to HAL activities. Through this, the investigators want to see if newcomer children's perspectives of physical activity will change over time. They will also see if increasing newcomer children's access to these resources will promote an increase in HAL behaviours.

The investigators will conduct a pragmatic, stepped-wedge cluster randomized trial in 14 neighbourhoods to determine the impact of SCORE! ACTIVE trial on the primary outcome of PA self-efficacy among 5-11-year-old children. The SW-CRT involves the sequential transition of clusters, in this case neighbourhoods, from control to intervention conditions in a randomized order. In this case, the method is pragmatic because recruitment and initial baseline measures in each community will occur just before the initiation of the intervention. There have been methodological challenges noted with SW-CRT including identification and recruitment bias, within cluster bias, and secular trends. However, this design is ideal for the implementation of the SCORE! ACTIVE trial because for practical reasons, it is not possible to deliver the intervention to many clusters at the same time. The trial will be reported using CONSORT guidelines and extension of SW-CRT.

Eligibility Criteria:
Inclusion Criteria:

* Newcomer families (those who have been in Canada for 10 years or less) with at least 1 child aged 5 up to 11 (11.99 years) living in a Hamilton, Ontario.
* At least one parent/guardian born outside of Canada and residing in Canada ≤ 10 years.
* Families must be living in one of the designated neighbourhood clusters

Exclusion Criteria:

* Children participating in organized physical activity programs for 3 or more times per week
* Families with involvement with child protection services and/or foster care
Von Willebrand Factor Point-of-care Testing to Improve Minimally Invasive TAVI Outcomes

Paravalvular regurgitation (PVR) is an important complication of Transcatheter Aortic Valve Implantation (TAVI) that is associated with a 2.5-fold increase risk of mortality. Transesophageal echocardiographic (TEE) is considered as the gold standard to assess the severity of PVR and guide the physician to perform corrective procedures during TAVI, but it requires general anesthesia (GA). With such approach (TEE+GA), the PARTNERII trial has demonstrated that very low rate of PVR (3,5%) can be achieved with current devices. Registries have demonstrated a strong trend for using a mini-invasive approach in which the procedure is performed under conscious sedation (CS) without TEE. However, several studies raised concerns on the safety of this mini-invasive approach concerning the PVR rate. Thus, the accurate and real-time assessment of the presence and severity of PVR is an unmet clinical need to optimize TAVI without TEE guidance. A recent study reported that a blood biomarker reflecting the Von Willebrand factor (VWF) activity, i.e. the closure time with adenosine diphosphate (CT-ADP), is a valuable non-invasive, highly reproducible, and easy to perform alternative to TEE for PVR evaluation.

The hypothesis is that the measurement of CT-ADP during TAVI performed without TEE guidance can improve both the detection of significant PVR and thus the procedural and clinical outcomes (primary objective).


Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled to undergo mini-invasive TAVI at any of the participating centers and fulfilling the inclusion criteria will be eligible for entry in the study. The decision to undertake TAVI will be made by the local heart team.
* Symptomatic aortic stenosis scheduled to undergo TAVI
* TAVI performed via mini-invasive approach defined as: transfemoral access route; local anesthesia/conscious sedation; no TEE guidance.
* All types of prosthetic valves (balloon-expandable, self-expandable, others) are accepted

Exclusion Criteria:

* TAVI through non-transfemoral approach
* TAVI with concomitant percutaneous coronary intervention
* TAVI performed under general anesthesia
* TAVI performed under TEE guidance
* Valve-in-valve procedure
* Inability to provide informed consent
* Associated ≥ moderate mitral regurgitation
* Peri-procedural treatment with ticagrelor or prasugrel treatment / direct oral anticoagulant
Study to Assess the Effect of Formoterol and Beclomethasone Dipropionate in Asthmatic Patients

The objective of this study is to evaluate the effect of the combination of formoterol and beclometasone dipropionate on central and peripheral airway dimensions in asthmatic patients using Computational Fluid Dynamics (CFD). Further more, the effect of this combination therapy on exhaled NO, lung function (spirometry, body plethysmography, diffusion and resistance) and subjective asthma control score as well as the safety of this combination will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Patients with asthma as defined by the current Global INitiative for Asthma (GINA) guidelines:
* Male or female patients aged ≥18 years
* Patients with a documented positive response to the reversibility test within the 12 months preceding the screening visit or performed at screening visit after a wash-out of 2 days for long acting β2 agonists or a documented positive response to the methacholine challenge test
* Patients with a co-operative attitude and ability to be trained to correctly use the pressurized Metered Dose Inhaler (pMDI)
* Written informed consent obtained

Exclusion Criteria:

* Pregnant or lactating females or females at risk of pregnancy
* Inability to carry out pulmonary function testing
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) as defined by the current Global initiative for chronic Obstructive Lung Disease (GOLD) guidelines
* History of near fatal asthma
* Hospitalization due to asthma or symptomatic infection of the airways in the previous 8 weeks
* Current smokers or recent (less than one year) ex-smokers, defined as smoking at least 10 cigarettes/day
* Patients with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study
* Patients with a QTc interval (Bazett's formula) at the screening visit Electrocardiogram (ECG) test \>450 msec
* Cancer or any other chronic disease with poor prognosis and /or affecting patient status
* History of alcohol or drug abuse
* Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients
* Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
* Patients who received any investigational new drug within the last 8 weeks prior to the screening visit
* Patients treated with any non-permitted concomitant medication
Pasteurization of Mother's Own Milk for Preterm Infants

We hypothesize that short term infection-related benefits of human milk feeding are decreased by the process of pasteurization. Primary objective of the study is to compare the incidence of late-onset sepsis in very low birth weight infants assigned randomly to receive either pasteurized or raw expressed mothers'own milk.

In this prospective, randomized, controlled trial, all patients born before 32 weeks of gestational age and/or with birth weight below 1500 g admitted to the tertiary neonatal intensive care unit(NICU) of the University Hospitals Leuven within 24 hours of birth, are eligible for inclusion in the study except for infants who died within the first 24 hours. Infants whose mothers intend to breastfeed will be randomly assigned, using a digital system, to receive either raw or pasteurized mother's own milk. The duration of the study is from birth to eight weeks of age or to discharge from the NICU, whichever occurs first. The need to ensure proper handling of the milk precludes true blinding of the caregivers. The institutional review board approved the study and written informed parental consent iss obtained before enrolment.

Eligibility Criteria:
Inclusion Criteria:

* all patients born before 32 weeks of gestational age and/or with BW below 1500 g admitted to the tertiary NICU of the University Hospitals Leuven within 24 hours of birth

Exclusion Criteria:

* died within 24 hours after birth
* no consent
* admitted after 24 hours of birth
Glycaemic Control and Quality of Care in Type 2 Diabetes on NovoMix® 30 Previously Treated With Mixtard® Insulins

This observational study is conducted in Europe. The objective of this retrospective observational cohort analysis is to assess the changes of glycaemic control and quality of care in those Type 2 diabetic patients who were previously treated with Mixtard® insulins after 6 months of their switch to analog premix insulin NovoMix® 30 therapy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with type 2 diabetes previously treated with BHI for at least 12 months
* Analogue premix administration for the last 6 months

Exclusion Criteria:

* Known or suspected allergy to insulin aspart
* Newly diagnosed diabetes
Study of LJP 394 in Lupus Patients With History of Renal Disease

The primary purpose of this study is to determine whether abetimus sodium is more effective than placebo in delaying time to renal flare in SLE patients with a history of renal disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Systemic Lupus Erythematosus (SLE)
* Active SLE renal disease within past 4 years.
* Males or females between 12 and 70 years old.
* Females must be non-pregnant and non-lactating. Females and males must use adequate birth control methods during course of study.
* Ability to have weekly intravenous (IV) administration of study treatment.

Exclusion Criteria:

* Active SLE renal disease within past 3 months prior to entering study.
* Use of the following therapies within 3 months prior to entering the study: alkylating agents, e.g., cyclophosphamide, TNF inhibitors, cyclosporine.
* Use of mycophenolate mofetil that exceeds 1000 mg/day, azathioprine that exceeds 100 mg/day, methotrexate that exceeds 10 mg/week, leflunomide that exceeds 10 mg/day within 2 months prior to entering study.
* Use of rituximab within 6 months prior to entering study.
* Current abuse of drugs or alcohol.
A Natural History Study of Biomarkers and Clinical Outcomes in Mucopolysaccharidosis Type IIIA (MPS IIIA; Sanfilippo Syndrome)

This protocol is a decentralized, single cohort, natural history and biomarker study enrolling up to 20 participants with MPS IIIA (Sanfilippo syndrome). At least 10 participants (\~50%) must be less than four years old at the time of the Parent/LAR consent. The study will have a screening process and 7 study visits, e.g. home visits, that will consist of serum collection and completion of a remote assessment of the Vineland Adaptive Behavior Scales 3rd Edition (Vineland-3)

MPS IIIA remains a devastating disease with a high unmet medical need. There is currently a limited number of available data to adequately characterize the progression of the disease. Analysis of blood biospecimens and adaptive behavior in this study will help researchers better understand the clinical progression of MPS IIIA. A better understanding of disease progression may assist in developing novel therapies for rare genetic disorders.


Eligibility Criteria:
Inclusion Criteria:

* Age of enrollment is as follows:

  1. All participants must be between 4 months and \< 14 years at time of consent
  2. At least 10 participants (ie, approx. 50% of expected total population) must be between 4 months old and \< 4 years old at the time of consent
* The participant has a confirmed diagnosis of Mucopolysaccharidosis Type IIIA (MPS IIIA) (i.e., Sanfilippo syndrome) based on at least 2 out of the 3 following criteria:

  1. Documented reduced N-sulphoglucosamine sulphohydrolase (SGSH) activity in plasma, white blood cells, and/or skin fibroblasts consistent with MPS IIIA (10% or less of the lower limit of the normal range based on the testing laboratory)
  2. Documented likely pathogenic variant of the SGSH gene
  3. Documented elevated heparan sulfate levels in urine and/or blood Participants and their families are willing to complete 7 blood draws and 7 Vineland-3 collections

Exclusion Criteria:

* Known history of HIV, hepatitis, or other infectious diseases
* Taken an investigational product in the last 30 days
* Experienced excess blood loss, including blood donation, defined as 80 mL in the last month or 160 mL in the previous two months
* Undergone an MPS IIIA gene therapy at any time unless prior Sponsor or designee's approval has been received
* Documented loss of activity of sulfatases other than N-sulphoglucosamine sulphohydrolase (SGSH), indicating multiple sulfatase deficiency
* Known genetic or acquired disorder associated with developmental delay, seizures or other significant CNS dysfunction that would be expected to confound the clinical or biomarker assessments
HIV/AIDS Orphaned and Vulnerable Children Public Health Evaluation

The PHE study is a two-year longitudinal study evaluating two interventions for reducing depression and HIV risk behaviors among highly vulnerable adolescents in the Eastern Cape of South Africa. Research suggests that children affected by AIDS are at heightened risk of HIV infection relative to their peers; however, evidence on how best to address HIV prevention and psychological health among this population is lacking. This study examines the efficacy of both a psychological and behavioral intervention, alone and in combination, on related outcomes among vulnerable youth age 14-17. A mixed methods approach is applied, including a community-randomized controlled trial with a factorial design, a cost-effectiveness analysis, and a qualitative component. At baseline data collection in January 2012, more than 1000 adolescents and their caregivers were interviewed; these participants were invited to take part in two more survey rounds designed to examine both the immediate and long term effects of the interventions. Support for this research was provided by USAID under Grant No. GHH-I-00-007-00069-00.

The study will apply a mixed-methods approach involving two primary components: 1) an impact evaluation using a community-randomized controlled trial (CRCT); and 2) a detailed analysis of intervention costs, linked to the impact evaluation to determine the cost-effectiveness of these interventions.

For the CRCT, sixty World Vision drop-in centers which deliver standard care were randomly assigned to one of four study conditions: IPTG, Vhutshilo, IPTG+Vhutshilo, and control. Approximately 1600 adolescent OVC aged 14-17 years (current beneficiaries at the drop-in centers) and their caregivers were eligible to participate in the study at baseline.

Participants were visited three times including the baseline survey. Follow-up data collection was conducted in two rounds. The first round took place 8 months after the baseline survey and immediately following intervention exposure. A second follow-up round took place a year later, allowing assessment of both the immediate and longer-term impact of the interventions.

Participants were interviewed at home in Xhosa or Sesotho. Caregivers in the sample completed face-to-face interviews with trained interviewers, while adolescents complete surveys used a mix of face-to-face interviewing and audio computer-assisted self-interview technology (ACASI).

Eligibility Criteria:
Inclusion Criteria:

* Aged 14-17 years old as of January 1, 2012;
* Enrolled in a selected World Vision site;
* Willing and able to assent to study participation; and
* Consent given by the parent or guardian for the adolescent to participate in the study.

Exclusion Criteria:

* Are not able to give informed assent due to known or recognizable cognitive or psychiatric impairment.
Myocardial Protection of Exenatide in AMI

Experimental evidence suggests exenatide, a glucagon-like peptide 1 receptor analogue, has significant cardiovascular protective effects in various conditions. The investigators examined whether conventional use of exenatide at the time of primary percutaneous coronary intervention would reduce the infarct size in patients with ST-segment elevation myocardial infarction (STEMI).

In this proof-of-concept trial, we assessed the effects of acute-phase adjunctive exenatide therapy in patients with STEMI.

Infarct size after STEMI was evaluated by both cardiac magnetic resonance image and cardiac biomarkers compared with standard treatment.

LV function was assessed by conventional and speckle tracking echocardiography. During 6-month follow up, the safety/tolerability of exenatide and clinical outcomes were also assessed.

Eligibility Criteria:
Inclusion Criteria:

* age between 20 and 79 years
* patients presenting with first ST-segment elevation myocardial infarction
* Thrombolysis in Myocardial Infarction \[TIMI\] flow grade 0)

Exclusion Criteria:

* cardiac arrest
* ventricular fibrillation
* cardiogenic shock
* hemodynamic instability
* suspicious stent thrombosis
* left bundle branch block
* previous acute myocardial infarction
* previous coronary artery bypass operation
* significant valvular heart disease
* primary myocardial disease
* atrial fibrillation
* significant hepatic or renal dysfunction, hypoglycaemia,
* diabetic ketoacidosis
* active infection or chronic inflammatory disease
* malignancy
* women who were pregnant or who were of childbearing age
Modeling of Regional Citrate Anticoagulation With a Dialysate Containing Calcium in Intermittent Hemodialysis (MARC)

The primary purpose of this study is to validate a mathematical modeling of treatment by intermittent hemodialysis using regional citrate anticoagulation with a dialysate containing calcium

The only visit to the study will be carried out during a usual dialysis session in the intensive care unit of Clermont-Ferrand University Hospital. In addition to the usual care, 2 blood samples will be taken from the blood circuit 1 hour after the start of the hemodialysis session by the nurse in charge of the patient.

Eligibility Criteria:
Inclusion Criteria:

* Major patient;
* Man or woman ;
* Treated with intermittent hemodialysis for chronic renal failure;
* In whom intermittent hemodialysis with citrate solution for regional anticoagulation is indicated;
* Affiliated with a social security scheme;
* Having given a signed agreement after detailed explanation of the protocol on the basis of the information sheet and likely to comply with it

Exclusion Criteria:

* Severe hepato-cellular insufficiency (PT \<50%, INR\> 1.5 without anticoagulant);
* Hemoglobin level \<7 g / dL
* Presenting a psychiatric pathology or cognitive impairment rendering him unable to give informed consent;
* Persons under guardianship, curatorship, deprived of liberty or safeguard of justice
* Pregnant or breastfeeding women
* Patient's refusal to participate in the study.