cyrilzakka/clinical-trials huggingface dataset:
A Study to Examine the Implantation Characteristics of Two Drug-Eluting Stents

Despite recent advances in stent technology and clot reducing drug therapy, acute stent occlusion or thrombosis (ST), still occurs and can be life threatening. It has been shown that certain features of how the stent relates to the artery wall may predict ST. One such feature, so-called stent strut malapposition (SSM), can be assessed after implantation but current imaging techniques are relatively unreliable. Optical Coherence Tomography (OCT) is a newer technology that can be performed safely and easily after angioplasty and may allow the stent struts to be assessed more accurately and reliably.

This study will use OCT to examine how two different types of commonly used drug-eluting stents relate to the artery wall. The Xience V (Abbott Vascular, USA) stent has thinner struts and a more open frame than the Cypher (Cordis, USA) stent. We hypothesise therefore that the potentially more pliable structure of the Xience V stent will be associated with greater contact with the vessel wall. This may have a bearing on the relative rate of SSM, although large studies have shown the rate to be low in both the Cypher and the Xience V stent. We believe that OCT imaging of SSM and symmetry of the stent immediately after angioplasty will compliment conventional visual assessment and may identify those patients in whom further improvement of stent with a balloon is necessary.

This study will involve the random allocation of forty patients requiring coronary angioplasty to one of the Cypher or Xience V stent. The procedure will be performed in the usual manner as indicated clinically and will include imaging of the stented artery segment with OCT once the operator is satisfied with the visual result by angiography.


Eligibility Criteria:
Inclusion Criteria:

* Presence of a coronary artery stenosis undergoing percutaneous coronary intervention and stenting (PCI).
* Eligibility for drug eluting stent (DES) deployment.
* Stable or unstable coronary syndrome presentation, including ST elevation myocardial infarction (STEMI).
* Aged 18-90

Exclusion Criteria:

* Contraindication to the use of a DES.
* Target lesion located within previous stent (in stent restenosis).
* Sustained haemodynamic instability following stent deployment (Systolic BP 90≤ mmHg or sustained ventricular arrhythmia).
Study of the Safety and Efficacy of Desvenlafaxine Succinate for Vasomotor Symptoms in Postmenopausal Women

The purpose of this study is to evaluate the efficacy and safety of 100 mg and 150 mg of DVS SR, an extended release form of desvenlafaxine succinate, in comparison to placebo for the treatment of Vasomotor Symptoms (VMS) associated with menopause in a population of postmenopausal women.

To assess the efficacy and safety of 100 mg and 150 mg of DVS SR in comparison to placebo for the treatment of moderate to severe VMS associated with menopause, as well as additional outcome indicators such as sleep disruptions, overall climacteric symptoms, mood changes, somatic symptoms, and overall satisfaction with DVS SR in postmenopausal women.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy, postmenopausal women who seek treatment for hot flushes
* Body Mass Index (BMI) less than or equal to 40 kg/m2

Other inclusions apply.

Exclusion Criteria:

* Hypersensitivity to Venlafaxine
* Myocardial infarction and/or unstable angina within 6 months of screening
* History of seizure disorder

Other exclusions apply.
Effect of Dual-wave Insulin Bolus on Postprandial Glycaemia

A study was conducted in adolescents with type 1 diabetes (T1D) examining the effect of different bolus types on 6-h postprandial glucose levels after the consumption of 3 standard meals with varying composition. Participants were asked to consume 10 different combinations of meal and bolus type.

The nutritional recommendations of children and adolescents with T1D should be similar to those of healthy people in order to achieve the desirable growth. Not only the carbohydrates' intake is underlined according to special guidelines by Canadian diabetes association, American diabetes association and International Society for Paediatric and Adolescent Diabetes but also proteins and fats are suggested to be taken into consideration in the management of T1D. In order to reach the desirable euglycemic control, children and adolescents can use multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). By using the CSII the insulin can be administrated in three different patterns; as a normal bolus, as a dual wave bolus and as a square wave bolus. Dual wave insulin bolus (D/WB) is suggested as the most suitable option based on the effects that is having after meals with different content of carbohydrates, fats and proteins. The aim of this study was to evaluate the impact of different types of D/WB on PPG after 3 given meals, in adolescents with T1D on CSII. In order to achieve that, 3 different meals were designed and combined with alternative types of boluses, D/WB and square wave insulin bolus (S/WB).

Eligibility Criteria:
Inclusion Criteria:

* duration of T1D \>3 years, CSII therapy for at least 1 year, good to moderate glycaemic control, as evidenced by HbA1c levels \<8.5% (69 mmol/mol).

Exclusion Criteria:

* Subjects with eating disorders, food allergy, celiac disease and known diabetic complications
Oral Complications After Haematopoietic Stem Cell Transplantation: a Retrospective Study

Haematopoietic stem cell transplantation (HSCT) is a potentially lifesaving treatment option for various diseases. It involves infusion of stem cells after a conditioning regimen of chemotherapy with or without total body irradiation. There is a concern that HSCT and accompanying treatments may increase the risk for oral complications. Nevertheless, longitudinal studies measuring oral health before and after HSCT are scarce. Hence, we formulated the following research question:

In adult HSCT recipients, do oral health parameters change from baseline (pre-HSCT) to 3 - 24 months post-HSCT, and is the type of conditioning regimen associated with this change in oral health parameters?

To answer this research question, we will use data from the electronic health records of the Radboudumc (Epic and Dentium). We will include at least seventy-five adult patients who are examined both before and after HSCT at the department of Dentistry (Radboudumc) as part of an oral care program. The following oral health parameters were assessed: status praesens, pocket probing depth, bleeding on probing, periodontal epithelial surface area, periodontal inflamed surface area, xerostomia, unstimulated and stimulated salivary flow rate and pH, cariesactivity, oral chronic Graft-versus-Host Disease and dental treatments.

Patients were subjected to different regimens in preparation for HSCT, namely myeloablative, reduced intensity or non-myeloablative conditioning. To estimate the association between conditioning regimen and the change in oral health parameters, we will use mixed effects models with random effects, adjusted for potential confounders. Results will be reported as regression coefficients with corresponding 95% confidence intervals.


Eligibility Criteria:
Inclusion Criteria:

* Allogeneic HSCT between 2013 and 2021 at Radboudumc
* Oral focal screening before HSCT, and at least one oral examination after HSCT performed at Department of Dentistry, Radboudumc
* Informed consent

Exclusion Criteria:

* Not meeting the inclusion criteria
Targeted Biopsies in Determining Response in Patients With Prostate Cancer Undergoing High-Dose-Rate Brachytherapy

This pilot clinical trial studies targeted biopsies in determining response in patients with prostate cancer undergoing high-dose-rate brachytherapy (a type of radiation therapy in which radioactive material sealed in needles, seeds, wires, or catheters is placed directly into or near a tumor). Studying tumor tissue obtained before and after treatment may help doctors understand changes in a pathway that looks at how deoxyribonucleic acid (DNA) is repaired after it is damaged and to see if there are differences in the prostate tissue prior to and after starting androgen deprivation therapy.

PRIMARY OBJECTIVES:

I. Demonstrate feasibility of obtaining adequate tumor tissue from an intra-prostatic index lesion prior to the start of androgen deprivation therapy (ADT) and again at the time of high-dose-rate (HDR) brachytherapy.

SECONDARY OBJECTIVES:

I. Use immunohistochemistry to stain cells pre-ADT and post 2 months of ADT for markers of non-homologous end joining and DNA double strand breaks using the following markers: Ku70, Ku80, DNA-dependent protein kinase catalytic subunits (PKCs), gamma-histone family, member X (H2AX).

OUTLINE:

Patients undergo biopsy at baseline before start of ADT and during brachytherapy.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary adenocarcinoma of the prostate
* National Comprehensive Cancer Network (NCCN) high risk disease (cT3 or Gleason score 8-10 or prostate specific antigen \[PSA\] \> 20)
* Not currently on ADT
* Magnetic resonance imaging (MRI) or transrectal doppler ultrasound demonstrating at least one target lesion
* Karnofsky performance status (KPS) \>= 70 or Eastern Cooperative Oncology Group (ECOG) = 2
* Understands the trial and procedure and is willing and able to sign the informed consent form

Exclusion Criteria:

* Patient is unable to receive high dose rate prostate brachytherapy
* Patient is unable to have a MRI or transrectal ultrasound
* Refusal to sign the informed consent
* Patients who are participating in a concurrent treatment protocol
Impact of a Community Health Worker Strategy on Produce Prescription Program Uptake Among People With Diabetes

Produce prescription programs (PRx) are promising interventions for improving health outcomes for patients with both type 2 diabetes (T2D) and food insecurity, but uptake has been suboptimal. There is a critical need for scalable, evidence-based implementation strategies for improving PRx uptake and optimizing the effectiveness and cost-effectiveness of these interventions. This study will co-design and pilot a community health worker (CHW) strategy and test the effectiveness of the strategy compared to PRx participants without a CHW. The overall objective of this study is to test and evaluate a theory-informed, user-centered community health worker (CHW) implementation strategy to improve uptake of a PRx, among Hispanic Medicaid-eligible patients with T2D in Connecticut (CT). CHWs will offer participants personalized support by overcoming barriers and leveraging facilitators to PRx uptake.

This study will have a small pilot followed by a randomized controlled trial. The focus of this registration is the randomized controlled trial.

First, following community co-design of the CHW strategy, investigators will conduct a two-month pilot study with an anticipated 10 participants to test the CHW strategy, the produce prescription program Rx, and overall study procedures. All participants will receive the PRx program with CHW strategy for two months.

Second, a randomized controlled trial to evaluate the effectiveness of the CHW strategy on barriers to PRx uptake, level of PRx engagement, and short-term program, behavioral, and health outcomes will be conducted.

Investigators hypothesize that participants who receive added CHW support during their enrollment in the PRx program will have reduced barriers to PRx uptake, higher PRx uptake, and greater improvements in the defined short-term program outcomes compared with participants who do not receive the CHW support during their enrollment in the PRx.

Eligibility Criteria:
Inclusion Criteria:

* Be a current primary or specialty care patient at Hartford Hospital
* Live in Hartford County
* Identify as Hispanic
* Have a current diagnosis of Type II Diabetes
* Be eligible for Medicaid based on household income and size.

Exclusion Criteria:

* Does not speak English or Spanish
* Has a diagnosis of gestational diabetes
* Individuals who are members of vulnerable populations, such as individuals who are incarcerated and individuals who are not able to consent.

Participants who are pregnant will be eligible for the study if they meet all of the inclusion criteria and do not have any of the exclusion criteria, as the study activities (additional funds to purchase fruits and vegetables, nutrition education, and support from a Community Health Worker) does not pose any additional risk to this group.
Patient-ventilator Asynchrony During Mechanical Invasive Assisted-ventilation in Pediatric Patients

The purpose of this study is to document the prevalence and type of asynchronies incidence during invasive mechanical ventilation in pediatric patients breathing under pressure support.

And to observe the impact of adjusting the expiratory trigger setting on asynchronies, and compare these incidences with asynchronies measured in pediatric patient breathing under NAVA system (Neurally Adjusted Ventilatory Assist).

Two sessions will be recorded, one in PSV, one with NAVA, delivered in a random order after being sure the infant is calm and comfortable, according to his parents and/or the nurse in charge.

Criteria for initiating invasive ventilation and to start PSV will follow the usual practice guidelines of the unit.

Ventilation parameters in PS will be adjusted by the clinician in charge of the patient, as usual based on clinical observation. Investigators will not interfere with ventilator settings. Ventilation will be applied via an endotracheal tube, uncuffed for the majority (if infant \< 5 years), according to commonly applied guidelines in this unit.

One 15 minutes session will be recorded, after being sure the infant is calm and comfortable according to the parents and/or the nurse in charge. Then the clinician in charge of the patient will modify the ETS, first decreasing it of 10% below the initial set value, and will be recorded the following 5 minutes after stabilization and secondly increasing it of 10% above the initial set value, and will be recorded the following 5 minutes after stabilization.

NAVA will be set to deliver initially the same peak pressure (comparable level of assist) than during the initial PS period. Same PEEP will be delivered in both modes. This is possible with a pre-visualization window, allowing adjustments before switching to the NAVA mode. Nava ventilation will be recorded during 20 minutes.

The 2 sessions, Pressure support and Nava, will be recorded consecutively.

Eligibility Criteria:
Inclusion Criteria:

* all consecutive patients from 4 weeks to 12 years (post natal interm infants) admitted to the pediatric intensive care unit (PICU) and receiving mechanical ventilation in pressure support ventilation

Exclusion Criteria:

* Non treated pneumothorax
* Hemodynamic instability
* At least 2 hours following the admission in the PICU in post cardiac surgery
* FiO2 \> 0.6
* Poor short term prognosis (defined as a high risk of death in the next seven days)
* contraindication for gastric tube or obtention of a reliable EMGdi signal
* Known esophageal problem (hiatal hernia, esophageal varicosities)
* Active upper gastro-intestinal bleeding or any other contraindication to the insertion of a naso-gastric tube
* Neuromuscular disease
* Patients with a pacemaker
Evaluation of Fluid Output Threshold for Safe Chest Tube Removal - A Potential Way to Decrease Length of Stay in Hospital and to Improve Postoperative Care After Lung Surgery?

Previous studies have shown that the removal of the chest tube after lung surgery significantly improves pain symptoms and lung function. The criteria for chest tube removal still remain vague in modern thoracic surgery and rely on personal experience instead of evidence-based criteria. Every hospital has its own traditional standard fluid threshold and believes in that without adapting and comparing it not even after introduction of newer and more minimal-invasive operation technique. According to literature the traditional fluid threshold is varying from 100 to 500 or even more millilitre in 24 hours. Since pleural fluid resorption is proportional to body weight the investigators believe that a body weight related approach of chest tube management would improve safety and would allow an earlier chest tube removal without a higher rate of complication. In this way the investigators believe in improving pain management and in achieving earlier discharge of the patient.


Eligibility Criteria:
Inclusion criteria:

* Lobectomy/ Bilobectomy
* Segmentectomy
* Signed consent
* Age of majority

Exclusion criteria:

* Pneumonectomy
* Atypical resections
* Empyema
* Pleural effusion (not related to surgery)
* Pleurodesis
* Pregnancy
A Study to Evaluate RO7204239 in Participants With Facioscapulohumeral Muscular Dystrophy

The purpose of this study is to evaluate the pharmacodynamics, safety, tolerability, pharmacokinetics, and efficacy of RO7204239, a humanized monoclonal antibody that binds to human latent myostatin, in ambulant adult participants with facioscapulohumeral muscular dystrophy (FSHD).


Eligibility Criteria:
Inclusion Criteria:

* Genetic confirmation of FSHD1 or FSHD2
* Clinical findings consistent with FSHD
* Ability to walk unassisted
* Ricci Clinical Severity Scale score ≥ 2.5 and ≤ 4
* Agreement to maintain the same frequency and intensity of physiotherapy, occupational therapy, and other forms of exercise during the clinical study

Exclusion Criteria:

* Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 17 months after the final dose of RO7204239
* Current or previous treatment (or receipt) of anti-myostatin therapies
* Treatment with any investigational therapy within 90 days prior to screening, or 5 drug-elimination half-lives of the drug, whichever is longer
* Contraindications to MRI scans
* Presence of clinically significant ECG abnormalities
* Presence of clinically significant cardiovascular disease
* Presence of clinically significant abnormal findings in echocardiography at screening, with the exception of mitral valve prolapse, which does not exclude participants from the study
* Any major illness within 1 month before screening
* Ascertained or presumptive hypersensitivity (e.g., anaphylactic reaction) to RO7204239, or to the constituents of its formulation
* History of malignancy (except in situ basal cell carcinoma of the skin and in situ carcinoma of the cervix of the uterus that have been excised and resolved with documented clean margins on pathology)
* Any clinically relevant history of anaphylactic reaction requiring inotropic support
* Any abnormal skin conditions, pigmentation, or lesions in the area intended for SC injection (abdomen) and that would prevent visualization of potential injection-site reactions to RO7204239
* Immobilization, surgical procedures, fracture, or trauma to the upper or lower limbs within 90 days prior to screening or longer, if judged by the investigator that it may affect motor function assessment
* Any planned surgery that may affect a participant's motor function assessment, including participants who have had surgery of scapular fixation within the 12 months preceding screening or that are planned during the study
* Use of the following medications within 90 days prior to enrollment: salbutamol or another β2-adrenergic agonist taken orally; creatine; recombinant human growth hormone; recombinant human insulin growth factor-1; testosterone, oxandrolone, or other anabolic steroid; chronic oral or parenteral use of corticosteroids (inhaled corticosteroid use is allowed) unless required to manage injection reactions;agents anticipated to increase or decrease muscle volume or strength
An Evaluation of a Developmentally-Based Parent Training Program for Children With Autism

The purpose of this study is to assess the efficacy of a parent training program in the treatment of social and communication deficits in children with autism. Specifically, this study will evaluate a developmentally based parent delivered intervention in the community developed by Pacific Autism Center for Education (PACE).

There are many treatments that claim to be effective for children with autism; however many of these treatments have not been investigated using scientifically rigorous methodology. A variety of developmentally based parent delivered interventions are gaining popularity as a type of treatment parents utilize to improve symptoms related to their child's diagnosis of autism. Pacific Autism Center for Education (PACE)is a agency that provides a developmentally based parent delivered intervention in the community. Currently, this parent training program has not been evaluated using scientific methodology. Investigation into this community delivered treatment and its effectiveness to improve social and communication deficits will aid clinicians in providing better care for children with autism.

Eligibility Criteria:
Inclusion Criteria:

* meets DSM-IV-TR criteria for an autism spectrum disorder (pervasive developmental disorder) on the basis of clinical evaluation and the research diagnostic methods
* age range between 18 months and 6.11 years
* male or female in good medical health
* will be starting PACE parent training program
* intends on continuing PACE program for a minimum of 12 weeks

Exclusion Criteria:

* medically unstable (e.g., more than one seizure a month)
* a medical diagnosis that causes autism like symptomology (e.g., Fragile X, Down syndrome, Angelman's syndrome, tuberous sclerosis, Rett's disorder)