cyrilzakka/clinical-trials huggingface dataset:
Mobile Technology and Online Tools to Improve Asthma Control in Adolescents - Usability

This project will fully develop and preliminarily validate CampAir, an empirically-based dynamic e-health intervention (based on the evidence-based ASMA) to assist adolescents with uncontrolled asthma to learn how to manage their illness and improve their asthma control. In addition to developing a highly novel product for adolescents with asthma, the research proposed for this project will address unique scientific questions. Despite the high asthma prevalence among adolescents, few interventions have specifically targeted adolescents. This study is innovative in that it is among the few to focus on adolescents, who are often overlooked by the healthcare system. This research will assess factors associated with successful implementation of CampAir, thereby providing new information regarding how e-health interventions can be effectively developed and implemented for use with adolescents with asthma.

This project will fully develop and preliminarily validate CampAir, an empirically-based dynamic e-health intervention (based on the evidence-based ASMA) to assist adolescents with uncontrolled asthma to learn how to manage their illness and improve their asthma control. In addition to developing a highly novel product for adolescents with asthma, the research proposed for this project will address unique scientific questions. Despite the high asthma prevalence among adolescents, few interventions have specifically targeted adolescents. This study is innovative in that it is among the few to focus on adolescents, who are often overlooked by the healthcare system. This research will assess factors associated with successful implementation of CampAir, thereby providing new information regarding how e-health interventions can be effectively developed and implemented for use with adolescents with asthma. To ensure the software and website function as intended, investigators will systematically test each of the seven CampAir modules with target end users. Participants will review one module per week for seven weeks. As part of each module, participants will also complete a daily asthma checklist. Following the review of each module, participants will be prompted to complete measures assessing technology acceptability and usability and product quality. Results will be used to modify and finalize the user interface and navigation to maximize usability. Results are expected to support that all participants find the CampAir product to be of high quality and technical acceptability. Participants are expected to rate the usability and relevance of the CampAir product highly. All participants are expected to advocate use of the product and recommend continued development and testing.

Eligibility Criteria:
Inclusion Criteria:

* Between ages 13 - 18 years
* Prior Asthma diagnosis
* Use of a prescribed Asthma medication in the past 12 months
Light Protection of TPN and Oxidative Stress in Preterm Infants

Urinary peroxides and plasma glutathione/glutathione disulfide (GSH/GSSG) ratio will be measured in preterm infants less than 32 weeks gestation before and 7 days after receiving either Light-protected (Group 1) or Light-exposed (Group 2) Total Parenteral Nutrition (TPN) solutions.

This study will be a prospective single blinded randomized control trial.

Inborn preterm infant less than 32 wks gestational age, receiving TPN in neonatal intensive care unit (NICU) of Mansoura University Children's Hospital as a part of their care will be included.

Preterm infant will be randomly divided into 2group:- Group 1 includes preterm infant who will receive their TPN through bags and tubing system that are protected from light by aluminum foil.

Group 2 includes preterm infant who will receive their TPN through bags and tubing system that are exposed to light.

Randomization will be done using random table technique with opaque sealed envelopes containing the serial number and the group to which the subject will be enrolled.

These envelopes will be kept in the unit ready for use at any time; each one has a number which is the serial number of the baby and group of TPN to which the baby will be enrolled.

The urine sample will be sent to the laboratory with this serial number with no information about the group of study to which this sample follows for peroxide level as well as blood sample for GSH\\GSSG.

Two blood samples and two urine samples will be collected. The first one will be at 0 hour before starting TPN regimen as a base line and the second will be at 7 days of starting TPN regimen. Blood sample will be at least 1cc of blood for GSH/GSSG assay. Urine collection bag will be placed on the infant to obtain minimum of 1cc of urine for urinary peroxide level assay.

Other secondary outcomes will be assessed with duration of NICU admission including death and /or bronchopulmonary dysplasia in preterm infant at time of hospital discharge, necrotizing enterocolitis (NEC), sepsis with positive blood cultures, length of hospital stay, retinopathy of prematurity (ROP), time to full enteral feeding, duration of respiratory support, liver function, cholestasis defined as an elevated serum conjugated bilirubin \>2 mg/dL, and metabolic response.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infant less than 32 weeks gestational age

Exclusion Criteria:

* Infant with major congenital anomalies
* Infant of diabetic or hypertensive mother
Cohort of Patients With Systemic Granulomatosis and Associated Biological Collection

The GRAMI-BIO study is a prospective single-centre cohort study to recruit 150 patients followed up in the the Bordeaux University Hospital. The total duration of the GRAMI-BIO study is ten years (five years of inclusion with five years of follow-up): Consecutive inclusion of patients meeting the definition of systemic granulomatosis. The main objective of this cohort is to describe to clinical progression of systemic granulomatosis and to collect blood fraction samples (serum bank, plasma bank, urine bank, DNA bank) from subjects participating in the cohort.

Systemic granulomatosis is a group of diseases whose common feature is the anatomopathological existence of giganto-cellular granulomas composed of macrophages, epithelial cells and CD4+ T lymphocytes. The exact cause of the development of these granulomas remains unknown, although numerous studies suggest the hypothesis of environmental factors (infectious, exposure to particles) and genetic susceptibility factors. The persistence of granulomas is deleterious, ultimately leading to local destruction and tissue damage resulting in fibrosis of neighbouring tissues. Granulomatosis is a heterogeneous group in terms of aetiology: schematically, either an aetiology is identified: infection, environmental factors (berylliosis, pneumoconiosis), iatrogenesis (drugs), neoplasia, immune deficiency; or granulomatosis is said to be idiopathic, the most common case, falling within the definition of systemic sarcoidosis. Therefore, with a view to future research work, it seems imperative to set up a biological bank of patients being monitored for systemic granulomatosis within the division. It is particularly important to identify genetic variants, circulating biomarkers associated with the onset, severity and response to treatment of these diseases. The main aim of the "GRAMI-BIO" study is to describe the clinical evolution of patients with systemic granulomatosis (sarcoidosis and other granulomatoses) followed at the Bordeaux University Hospital, and to collect samples from blood fractionation (serum bank, plasma bank, urine bank, DNA, RNA bank) to constitute a biobank.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or over
* Patients with systemic granulomatosis (diagnosis proven by anatomopathological sampling) at diagnosis.
* Persons affiliated to or benefiting from a social security scheme.
* Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).

Exclusion Criteria:

* Patients infected with human immunodeficiency virus (HIV), Hepatitis B virus (HBV) and/or Hepatitis C virus (HCV)
* Pregnant or breast-feeding women
* Patients already receiving specific treatment for systemic granulomatosis
* Persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent.
Study of SGR-1505 in Mature B-Cell Neoplasms

The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or recommended dose (RD) of SGR-1505.

This is a study of SGR-1505, an oral inhibitor of MALT1, in subjects with relapsed/refractory (R/R) B-cell lymphomas to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or recommended dose (RD) of SGR-1505. Exploratory cohorts will evaluate additional PK, PD, preliminary anti-tumor activity, and safety to establish the SGR-1505 RD. A planned amendment will evaluate SGR-1505 in combination with other anti-cancer agents, such as BTK and BCL-2 inhibitors, in patients with specific B-cell malignancies.

Eligibility Criteria:
Inclusion Criteria:

* Subject must have a history of histologically or cytologically confirmed mature B-cell malignancy.
* Subject must have measurable or detectable disease according to the applicable disease-specific classification system and meet criteria for initiation of treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy ≥ 12 weeks.

Exclusion Criteria:

* The subject is in need of immediate cytoreductive therapy (unless the patient has no remaining treatment choice with potential benefit).
* Subject has previous invasive malignancy in the last 2 years.
* Subject has a known allergy to SGR-1505 or excipients of SGR-1505.
* Subject has symptomatic or active CNS involvement of disease.
* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would place the participant at increased risk to the use of an investigational drug.
Effects of Programming Parameters on Back Pain Relief in Subthreshold Spinal Cord Stimulation

The purpose of this study is to investigate the effects of varying programming parameters in subthreshold spinal cord stimulation therapy for pain relief.


Eligibility Criteria:
Inclusion Criteria:

* Chronic intractable pain of the trunk and/or limbs
* Documented history of trunk and/or limb pain of at least 180 days
* Average back pain intensity of 5 or greater on a 0-10 numerical rating scale during the 7-day period prior to the Screening Visit
* Pass study site's routine psychological/psychiatric evaluation within 180 days of the Trial Lead Insertion Visit
* If taking any medications for chronic pain, must be on a stable prescription during the 14-day period prior to the Trial Lead Insertion Visit and agree to continue on the same prescription throughout study participation
* Subject is willing and able to comply with all protocol-required procedures and assessments/evaluations
* Subject is able to independently read and complete all questionnaires and/or assessments provided in English
* 18 years of age or older when written informed consent is obtained
* Subject signs a valid, Ethics Committee-approved informed consent form (ICF) provided in English

Exclusion Criteria:

* Unable to operate the PrecisionPlus™ system
* Primary source of pain is cancer-related, pelvic, visceral, angina, or migraine
* Is a high surgical risk
* Is diabetic
* Is immunocompromised
* Currently on any anticoagulant medications that cannot be discontinued during perioperative period
* Untreated major depression or untreated generalized anxiety disorder
* Diagnosed with somatoform disorder, severe personality disorder, borderline personality disorder
* Diagnosed with any major psychiatric disorder not specifically listed in previous two exclusion criterion
* Currently diagnosed with cognitive impairment that would limit subject's ability to discern differences in pain severity, complete a pain diary, perform wound care
* Current abuse of alcohol or illicit drugs
* Subject requires Magnetic Resonance Imaging (MRI) while implanted with lead(s).
* Subject is participating (or intends to participate) in another investigational drug or device clinical trial that may influence the data that will be collected for this study
* Subject has previously undergone a spinal cord stimulation trial or is already implanted with an active implantable device(s) to treat their pain (IPGs, implantable drug pump, etc) or pacemaker or implantable cardiac defibrillator
* Patient is a woman who is not using adequate contraception, is pregnant or breastfeeding or intends to become pregnant during the course of the study (a urine pregnancy test must be performed within 28 days prior to the Trial Lead Insertion Visit in women of child-bearing potential and the test result document)
Quetiapine Augmentation for Treatment-resistant PTSD

The purpose of this study is to compare the response of veterans with PTSD without an optimal response to paroxetine to quetiapine augmentation versus placebo.

This is a two-site study designed to evaluate the efficacy and safety of quetiapine augmentation of paroxetine treatment in veterans with PTSD who have failed to respond to paroxetine treatment.

In Phase I, eligible patients will take open-label paroxetine (up to 60 mg daily) for 8 weeks. Patients who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for the second phase. In Phase II, patients will continue taking open-label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) or placebo for 8 weeks in a double-blind fashion.

Eligibility Criteria:
Inclusion Criteria:

* Veteran age 18 to 75.
* Competent to give informed consent.
* Meeting DSM-IV criteria for PTSD.
* Minimal CAPS score of 50 at baseline.
* If female of childbearing potential, patient must have a negative pregnancy test and, if sexually active, be using a medically approved contraceptive method.
* Patients who have not taken psychiatric medications within 1 week prior to study entry (except fluoxetine \[5 weeks\])

  * monoamine oxidase inhibitors (MAOIs \[4 weeks\])
  * depot neuroleptics \[4 weeks\])
  * or any investigational drug within 30 days prior to study enrollment.
* To be eligible for Phase II

  * patients must be refractory to paroxetine in Phase I, as defined by less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8
  * must have PTSD symptoms at least moderate severity on CGI-S
  * and must have been compliant with study medicine in Phase I, as defined by taking at least 80% of prescribed doses.

Exclusion Criteria:

* History of sensitivity to paroxetine or quetiapine.
* Failure to respond to a prior adequate therapeutic trial i.e. minimum of 8 weeks at maximum tolerated dose of paroxetine (up to 60 mg daily) or quetiapine (up to 800 mg daily).
* Women who are

  * breast-feeding
  * pregnant
  * expect to become pregnant during the course of the study
  * or are sexually active and are not using a medically acceptable method of birth control.
* Presence of clinically significant hepatic

  * cardiovascular
  * or other medical conditions that may prevent safe administration of paroxetine or quetiapine
  * or any other clinically significant unstable medical conditions.
Clinical Outcomes, Nutritional Status, Exercise and Psychosocial Factors in Pediatric Hematopoietic Cell Transplant

Children who receive hematopoietic cell transplants (HCT) are at high nutritional risk due to comorbidities and complications that are likely to develop before, during and after transplant. Prior to transplant, many children undergo multiple rounds of chemotherapy which affect appetite and cause gastrointestinal toxicities that limit food intake. During transplant, painful mucositis makes it difficult to consume adequate nutrients and often children will require nutrition support such as parenteral or enteral nutrition. Energy imbalance and physical deconditioning following transplant can result in loss of lean body mass and functional impairment; these nutritional side effects are exacerbated if the child develops graft-versus-host disease. After transplant, a substantial number of childhood cancer survivors become overweight and develop metabolic syndrome. However, little is known about the prevalence and distribution of pediatric malnutrition (under-nutrition as well as obesity), the psychosocial factors that affect dietary intake and how the quality of the child's food intake and physical activity level throughout the transplant process might affect body composition and clinical outcomes. In this exploratory study, we will monitor nutritional status in pediatric patients undergoing HCT. This study will test the feasibility of collecting patient-reported dietary intake data along with anthropometric, body composition, functional status and psychosocial measurements that may influence dietary intake in pediatric patients undergoing HCT. The data collected in this preliminary analysis will inform future interventional studies.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric hematopoietic cell transplant patients, aged 2-25 years.
* Participants and/or at least one caregiver must speak, read and understand English.

Exclusion Criteria:

* Children younger than 2 years old at the time of their transplant or any child who is still breastfeeding will not be eligible due to the nature of the questionnaires and measurements.
Early Feeding Following Percutaneous Gastrostomy Tube Placement

This study plans to learn more about the safety of early feeding following placement of a feeding tube. Doctors in other specialties feed patients 4 hours after patients receive a feeding tube. However, Interventional Radiologists typically wait to feed patients for 24 hours following feeding tube placement. The investigator would like to demonstrate that feeding after 4 hours does not increase complications and can actually reduce the burden to patients who receive a feeding tube.


Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18-80 years
* Outpatients receiving a gastrostomy tube at University of Colorado that do not require post-pyloric feeding
* Patients that have no contraindication for intragastric feeding immediately following tube placement
* INR (international normalized ratio) \<1.5
* Platelet count \> 50,000/µL
* WBC (white blood cell count) 4.0-11.1 x 109/L

Exclusion Criteria:

* Patients \< 18 years or \> 80 years of age
* Patients admitted to the hospital at the time of screening (i.e., inpatients)
* Women who are pregnant (confirmed by urine pregnancy screen)
* Patients requiring post-pyloric feeding
* Patients receiving venting gastrostomy tubes
* Patients receiving primary Gastro-Jejunal (GJ) Tube tube placement
* Patients with an interposed bowel on CT after stomach insufflation
* INR \> 1.5
* Platelet count \< 50,000/µL
* WBC \> 11.1 x 109/L
* Known active infection
* Need for post-gastric feeding
* History of gastric bypass surgery or Roux-En-Y
* Mechanical obstruction of the GI tract
* Active peritonitis
* Known hemodynamic instability as demonstrated by tachycardia, hypotension, labile blood pressure or altered mental status.
* Bowel ischemia
* Ascites
* Recent Gastro-Intestinal (GI) bleeding (within 2 weeks)
* Respiratory compromise as demonstrated by hypercarbia (CO2\>45mmHg) or hypoxia (O2\<90%)
* Unable to provide informed consent
Stapled Anopexy Versus Closed Haemorrhoidectomy for Haemorrhoids

The aim of this study is to determine the role of stapled anopexy in the treatment of haemorrhoids by comparing it to the current gold standard treatment, which is excisional haemorrhoidectomy.

The current gold standard treatment of haemorrhoids namely, excisional haemorrhoidectomy is associated with severe postoperative pain and prolonged recovery period. Methods aiming at improving the outcome of excisional surgery included mainly modifications of the existing technique. Alternative instruments other than scissors have been used for the actual excision of haemorrhoids with a view to reducing the postoperative pain. However, with the wound in the sensitive anoderm following excisional haemorrhoidectomy, pain continues to be a major problem irrespective of the method of excision or of the instrument employed.

The new technique of stapled anopexy introduced in 1998 uses a radically different approach to treat haemorrhoids. The prolapsed anal cushion is repositioned and fixed without actually excising the haemorrhoidal pedicle thereby avoiding an external wound. This should result in reduction of the postoperative pain and subsequently should improve the recovery time. Further potential advantages of the technique should include a more physiological approach to the treatment of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Adult human subjects (age \>=16 years) with symptomatic haemorrhoids (Primary or recurrent)
* symptomatic haemorrhoids (grades 2, 3, 4) needing surgical treatment

Exclusion Criteria:

* concurrent untreated or recurrent colorectal cancer
* Active inflammatory bowel disease
* Previous major anorectal surgery
* On anticoagulant medications
* Non-consenting patients
* Unwilling for randomisation
Hyperglycemia, Exercise, and Endothelial Function

The main purpose of this study is to determine if exercise preserves vascular function during hyperglycemia. All subjects will consume a sugary beverage three times daily for seven days. Subjects will be randomly assigned to either the glucose with (GLU+EX) or without (GLU) structured exercise group.

Acute (oral glucose tolerance test) and chronic (type 2 diabetes) hyperglycemia are associated with impaired endothelial function. Both a single bout of exercise and chronic exercise training are associated with improvements in vascular endothelial function. It remains unknown if exercise can preserve vascular endothelial function during hyperglycemia.

Eligibility Criteria:
Inclusion Criteria:

- Healthy young men 18-35 years of age.

Exclusion Criteria:

* Hypertension,
* Hyperlipidemia,
* Smoking,
* Heart disease,
* Chest pain upon exertion,
* Previous heart surgeries or history of arrhythmias,
* Diabetes,
* Obesity (body mass index ≥30kg/m2),
* Kidney disease,
* Pulmonary disease,
* Autonomic disorders,
* Individuals whom engage in structured exercise (≥30min, ≥2d/wk),
* Current use of medications which influence outcome measures