cyrilzakka/clinical-trials huggingface dataset:
Vancomycin Reduction Practices (VRP) in the NICU

This multi-center, cluster randomized study aimed at improving implementation of vancomycin reducing practices (VRP) in NICUs. Sites will be recruited and randomized to receive either external facilitation or no external facilitation to assess the effect on center-level fidelity to the core components of VRP implementation. Interventions available to both study arms are directed at hospital staff and includes identification of local champions, educational outreach, unit-level audit \& feedback, and use of a clinical decision support tool.


Eligibility Criteria:
Inclusion Criteria:

* Level III NICU
* Affiliated with Kaiser Permanente Northern California (KPNC) or Children's Hospital of Philadelphia Newborn Care Network (CNBCN)
* Recruited by study team

Exclusion Criteria:

* Site not recruited for the study
Effect of Ocrelizumab on Neuroinflammation in Multiple Sclerosis as Measured by 11C-PBR28 MR-PET Imaging of Microglia Activation

Using magnetic resonance-PET (MR-PET) imaging with \[11C\]PBR28, a second-generation 18kDa translocator protein (TSPO) radiotracer, we have previously demonstrated abnormally high TSPO expression, indicative of microglia activation, across different brain tissue compartments of multiple sclerosis (MS) patients1.

In this study, we propose to study the efficacy of ocrelizumab, a humanized monoclonal antibody that has been shown to decrease neuroinflammation in relapsing-remitting multiple sclerosis (RRMS) and progressive multiple sclerosis (MS) patients.

We will test these effects by studying a cohort of 24 MS patients (12 RRMS, 12 progressive MS). Participants will be studied before (within 3 months prior to initiating treatment) and after treatment with ocrelizumab (\~12 month follow up), a therapeutic drug that will be part of their standard medical care. We will use \[11C\]PBR28 to help determine changes in neuroinflammation.

The purpose of this study is to determine the effects of ocrelizumab treatment on neuroinflammation by analyzing the uptake and distribution of \[11C\]PBR28 in individuals with multiple sclerosis. The specific aims of the current study are:

1. To assess whether treatment with ocrelizumab in subjects with either relapsing-remitting MS or progressive MS is associated with decreased \[11C\]PBR28 binding in the cortex and white matter (lesions and normal appearing white matter), suggesting reduced neuroinflammation.
2. To assess whether changes in neuroinflammation under ocrelizumab treatment, as measured by \[11C\]PBR28 uptake at 12-month follow up relative to baseline, are associated with changes in structural MR metrics of brain tissue damage including white matter lesion load, cortical atrophy, and demyelination in the cortex and in the normal-appearing white matter as measured by magnetization transfer ratio (MTR).
3. To explore whether changes in functional and structural imaging metrics under ocrelizumab are associated with changes in clinical outcome measures.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. RRMS and/or PMS subtype
3. EDSS between 0 and 7.0
4. Express at least one high-affinity (Ala147) allele of the TSPO receptor for PBR28
5. Initiating Ocrelizumab treatment within the next 3 months

Exclusion Criteria:

1. Hypersensitivity to trial medications
2. History of life-threatening reaction to Ocrelizumab
3. Acute or uncontrolled chronic medical condition
4. Impaired hearing
5. Claustrophobia
6. 300 lbs of greater (weight limit of MRI table)
7. Pregnancy or breastfeeding
8. Sensitivity to imaging agents
9. Contraindications to MRI
10. Use of benzodiazepines, topiramate, doxycycline, mynocicline
The Role of Dietary Calcium for the Treatment of Osteopenia in Girls With Rett Syndrome

Randomized, placebo-controlled trial of oral calcium supplementation for osteopenia in girls and women with Rett syndrome

Objective: The investigators conducted a randomized, double-blind, placebo-controlled trial to determine the safety and efficacy of oral calcium supplementation for the treatment of bone mineral deficits in individuals with Rett syndrome (RTT).

Methods: The investigators measured total body bone mineral content (BMC) and bone mineral density (BMD) by dual-energy x-ray absorptiometry and biomarkers of bone turnover by clinical laboratory techniques before and one year after oral calcium or placebo supplementation in 32 pre- and post-pubertal girls and young women with RTT. The calcium supplement was calculated to provide a twofold increase in the recommended dietary allowance of calcium for age.

Eligibility Criteria:
Inclusion Criteria

* clinical diagnosis of Rett syndrome

Exclusion Criteria

* parathyroid disease
* renal disease
OxyPrem Validation Study

The precision of the novel diagnostic near-infrared spectroscopy (NIRS) device for the measurement of tissue oxygenation and hemoglobin concentration (OxyPrem) is assessed by repeated measurements. The accuracy of OxyPrem is assessed by comparing the measurement data to those acquired simultaneously by established NIRS devices and standard clinical monitoring devices. In substudy 1, healthy adult subjects are enrolled, in substudy 2, measurements are conducted on preterm neonates.


Eligibility Criteria:
Substudy 1 (healthy adult volunteers)

Inclusion Criteria:

* Healthy adult
* Signed informed consent

Exclusion Criteria:

* Dense black hair at the location of measurement
* Neurological diseases.

Substudy 2 (preterm infants)

Inclusion Criteria:

* Pre-term neonates (gestational age at birth less than 37 weeks)
* Signed informed consent by at least one parent

Exclusion Criteria:

* Clinically instability
* Malformations
Effect of Acetazolamide on Subclinical High-Altitude Pulmonary Edema Detected by Lung Ultrasonography

The overall goal of this study is to detect preclinical signs of HAPE by lung ultrasonography and evaluate the effectiveness of acetazolamide at decreasing pulmonary edema by using ultrasound.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age
2. Able to consent
3. English speaking
4. Trekking directly to Everest Base Camp

Exclusion Criteria:

1. Age less than 18 years
2. Non-English speaking
3. Pregnant
4. Already had a diagnosis of acute mountain sickness, high-altitude cerebral edema, or high-altitude pulmonary edema
5. Been on a high-altitude trek 2 weeks prior to this study
6. Has taken acetazolamide 1 week prior to start of trek
7. Has a sulfa allergy
8. Has any type of acute or chronic pulmonary conditions
Daratumumab in Combination With Lenalidomide and Dexamethasone in Relapsed and Relapsed-refractory Multiple Myeloma

The purpose of this study is to establish the safety profile of daratumumab when given in combination with Lenalidomide and dexamethasone in participants with relapsed or relapsed and refractory Multiple Myeloma (MM).

The study is conducted in two parts. The dose escalation portion of the trial (Part 1) participants are enrolled into cohorts at increasing dose levels of daratumumab in combination with Len/Dex in 28 day treatment cycles. Part 2, the cohort expansion part of the trial, will further explore the maximum tolerated dose (MTD) (or the maximum tested dose) of daratumumab as determined in Part 1.

Eligibility Criteria:
Inclusion Criteria:

* (Part 1) Have relapsed multiple myeloma after receiving a minimum of 2 and a maximum of 4 prior lines of therapy and be eligible for treatment with lenalidomide and dexamethasone (Len/Dex)
* (Part 2) Have received at least 1 prior line of therapy for multiple myeloma
* Be older than or be 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status (0-2)
* Provide signed informed consent after receipt of oral and written information about the study and before any study-related activity is performed

Exclusion Criteria:

* Have previously received an allogenic stem cell transplant
* Have received autologous stem cell transplant within 12 weeks before the first infusion
* Have received antimyeloma treatment, radiotherapy, or any experimental drug or therapy within 2 weeks before the first infusion
* Have discontinued lenalidomide due to any treatment-related adverse event or be refractory to any dose of lenalidomide. Refractory to lenalidomide is defined as either, participants whose disease progresses within 60 days of lenalidomide, or participants whose disease is nonresponsive while on any dose of lenalidomide. Nonresponsive disease is defined as either failure to achieve at least an minimal response (MR) or development of progressive disease (PD) while on lenalidomide
Self-Injury Treatment and Recovery in Veterans

Nonsuicidal self-injury (NSSI) refers to the intentional destruction of one's own body tissue without suicidal intent and for purposes that are not socially sanctioned. While NSSI has been understudied among Veterans, the lifetime prevalence rate of NSSI in Veterans is approximately three times higher than the general population. Moreover, NSSI is associated with increased risk for violence, psychiatric distress, and marked impairment in psychosocial functioning. Even though NSSI is distinct from suicidal behaviors in several important ways, NSSI remains a strong predictor of a future suicide attempt. The primary goal of this project is to evaluate the treatment and acceptability of a brief intervention for NSSI that aims to reduce psychosocial impairment and NSSI behaviors in Veterans.

Nonsuicidal self-injury (NSSI) refers to the intentional destruction of one's own body tissue without suicidal intent and for purposes that are not socially sanctioned. While NSSI has been understudied among Veterans, the lifetime prevalence rate of NSSI in Veterans is approximately three times higher than the general population. Moreover, NSSI is associated with increased risk for violence, psychiatric distress, and marked impairment in psychosocial functioning. Even though NSSI is distinct from suicidal behaviors in several important ways, NSSI remains a strong predictor of a future suicide attempt. The primary goal of this project is to evaluate the treatment and acceptability of a brief intervention for NSSI that aims to reduce psychosocial impairment and NSSI behaviors in Veterans. This treatment, known as the Treatment for Self-Injurious Behaviors (T-SIB) incorporates evidence-based approaches to replace NSSI with behaviors that improve psychoso ial functioning. A core component of T-SIB is functional assessment that identifies the antecedents and consequences of NSSI. This project will enhance T-SIB by using ecological momentary assessment (EMA) to conduct NSSI functional assessment in-vivo. EMA reduces retrospective recall bias and can increase engagement with therapeutic goals.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Past service in the United States military
* Nonsuicidal self-injury engagement on 2 occasions in past 30 days
* Fluent in English
* Able to provide voluntary informed consent

Exclusion Criteria:

* Lifetime history of psychosis, mania, or hypomania
* Imminent risk for suicide/homicide warranting immediate intervention
* Unable/unwilling to complete study procedures
Effect of Biomechanical Correction in Medial Tibiofemoral Joint Osteoarthritis

Effect of Biomechanical Correction of Tibia on Medial Joint space loading, Varus deformity and functional tasks in patients with medial tibiofemoral joint osteoarthritis in which participants will be taken. The outcome measures taken are Trauma CAD Software, NPRS, WOMAC and Goniometery will be measured at the baseline after 3rd week of the intervention.

Background: Knee osteoarthritis (KOA) are very prevalent chronic disease of the joint which causing the functional disability and pain specifically in older adults.

Objective: Purpose of the study is to see that the biomechanical correction on the tibia and varus deformity is effective in the conventional treatment of participants with the KOA.

Study Design: A Randomized single group Pretest-Post test Clinical Trial. Methodology: Total '5' subjects were included in the study with the age of 40 to 60 years based on exclusion and inclusion criteria. For the pain, the NPRS will be taken, goniometer taken for the measurement of range of motion, WOMAC will be taken for the physical activity measurement and CAD Software will be taken to see the alignment of the affected limb. Conventional treatment will also be given.

Conclusion: Biomechanical correction shows the significant improvement and improves the subject's physical activity and reduces the pain and stiffness.

Keywords: Obesity, Osteoarthritis, Pain and Physical therapy modalities

Eligibility Criteria:
Inclusion Criteria: • 40-60 years of age paients will be included in this study

* BMI (25.1±4.2) kg/m2
* Subjects with stiffness and knee pain
* Subjects with objection of pain in knee joint that was aggravated by performing 2 or more of the following functional activities: prolonged cross sitting, stair assents and descent, squatting and kneeling.
* Subjects who are willing to take participation
* Individuals who obeys the commands properly
* Individuals exhibiting the subsequent biomechanical changes on screening
* Q angle \>12 degree for male and \>15 degree for female, femoral anteversion, external tibial torsion \>15 degree, lack of ≥ 5 degree of knee extension in supine position.

Exclusion Criteria:

* • Knee meniscal injuries or ligament injuries

  * Lately history of lower limb trauma and surgery
  * In recent times fracture in lower extremity
  * In lower extremity metal plantation
  * Cardio vascular conditions
  * Patella Dislocation/subluxation
  * Abnormality in foot or deformity
Study of the Relationships Between Apolipoprotein B-48 Kinetics and Expression of Genes That Regulate Intestinal Lipid Metabolism in Men With the Metabolic Syndrome (SMB48)

Several lines of evidence indicate that a significant proportion of cardiovascular disease (CVD) events are attributable to the presence of a cluster of metabolic abnormalities and perturbations, defined as the metabolic syndrome. It has been estimated that approximately 25% of the North American adult population is living with the metabolic syndrome. Recent studies show that overaccumulation of atherogenic triglyceride-rich lipoproteins (TRL) seen in insulin-resistant patients is partly due to increased production rate of intestinally derived apolipoproteinB-48-containing lipoproteins. This is of interest because substantial evidence exists indicating that elevated levels of intestinal lipoproteins are associated with increased CVD risk. However, as indicated in the body of this grant proposal, the underlying mechanisms that lead to intestinal overproduction of lipoproteins in insulin-resistant states are poorly understood.

The general objective of the proposed research is to investigate the mechanisms by which the metabolic syndrome affects apolipoproteinB-48 secretion in human. The primary hypothesis is that insulin resistance will be associated with higher levels of intestinal lipoproteins because of an increased secretion of these particles.


Eligibility Criteria:
Inclusion Criteria:

Subjects with metabolic syndrome:

* Men aged between 18-60 years
* Waist circumference \>102
* HDL-cholesterol \< 1.1 mmol/L
* Triglycerides \> 1.7 mmol/L
* Fasting blood glucose \>6.1 mmol/L
* Normal blood pressure (\<130/85)

Controls:

* Men aged between 18-60 years
* Waist circumference \>102
* HDL-cholesterol \> 1.1 mmol/L
* Triglycerides \< 1.7 mmol/L
* Fasting blood glucose \<6.1 mmol/L
* Normal blood pressure (\<130/85)

Exclusion Criteria:

* Women
* Men \< 18 or \> 60 years
* Smokers (\> 1 cigarette/day)
* Body weight variation \> 10% during the last 6 months prior to the study baseline
* Subjects with a previous history of cardiovascular disease
* Subjects with Type 2 diabetes
* Subjects with a monogenic dyslipidemia
* Subjects on hypertension medications or medications known to affect lipoprotein metabolism or the integrity of gastrointestinal mucosa
* Subjects with endocrine or gastrointestinal disorders
* History of alcohol or drug abuse within the past 2 years
* Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study
Double-Blind, Placebo-Controlled Trial of Vitamin E as Add-on Therapy for Children With Epilepsy

This is a study to see if vitamin E helps children with epilepsy have fewer seizures. About 20-30% of children with epilepsy do not have adequate seizure control with established antiepileptic drugs (AEDs). Other options for patients with uncontrolled epilepsy are newer antiepileptic medications, ketogenic diet and surgery. However, a small percentage of patients are candidates for these options. Therefore, additional treatments are needed to improve seizure control in patients with uncontrolled epilepsy. Animal studies have shown an association between vitamin E supplementation and seizure reduction. A study in children also showed that vitamin E helped reduce seizures. However, a similar study in adults did not show a reduction in seizures with vitamin E supplementation. Therefore, this research study is being done to help define vitamin E's usefulness and safety as a treatment for epilepsy. Fifty patients will be recruited from the Children's Epilepsy Program at The Children's Hospital in Denver, Colorado. Qualifying patients will have a confirmed diagnosis of epilepsy that is currently uncontrolled with standard AEDs. The study period is 6 months and includes the following: Baseline period (1 month), Arm I (2 months), Wash-out period (1 month), and Arm II (2 months). Patients must have been on the same AEDs for 2 months before enrollment. All medications and complementary therapies must remain constant throughout the study. If at any point the physician feels it is not best for the patient to continue the study they will be discontinued. Before the study starts, study participants will be asked about seizure activity, what they eat and about any complementary and/or alternative medicine they may use. The study is two phases. Study participants will be given either vitamin E or placebo (fake pill/liquid) in each phase of the study. They will receive both vitamin E and placebo during the study. Which phase they receive vitamin E and placebo will be decided by chance (similar to rolling dice). Study participants will take liquid vitamin E or placebo two times per day. The study participants and study doctors will not know who is taking vitamin E and who is taking placebo. Study participants will come to the hospital for 3 outpatient and 2 inpatient visits. Health-related quality of life questionnaires will be filled out and blood will be drawn at three of the visits. Seizure diaries will be maintained throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of intractable epilepsy, defined as 1) at least 4 seizures per month; 2) failure of at least 3 standard AEDs EEG within the last 6 months
* Measurable seizure occurrence (parent/caregiver is able to count the number of seizures in any given time period)
* Stable AED regimen, with at least one standard AED for at least 2 months prior to enrollment
* No vitamin E supplementation (except as in standard multivitamin for age) for 6 months prior to study entry
Predictors of Individual Training Effectiveness in Preventive Exercise

Physical exercise elicits beneficial changes in the body. These concern physical performance but also improvements in virtually all known risk factors for cardiovascular disease. Yet, the extent of individual benefit differs considerably even within homogenous groups and the prediction of individual training effectiveness is not yet possible. This study aims to find predictors of individual training effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects
* age 35-60

Exclusion Criteria:

* Any medical condition requiring medication (except thyroid hormones)
* Other complaints that might interfere with exercise
EtCO2 for Monitoring and Predicting Severity of DKA in Pediatric Emergency, Doha, Qatar.

Metabolic acidosis is one of the important and life-threatening pathophysiological changes in DKA and its monitoring is essential. It is known that the level of carbon dioxide (CO2) in the blood is correlating with the degree of metabolic acidosis. The CO2 level can be measured via the exhaled air by nasal cannula capnography (EtCO2) which is currently utilized to monitor the patient ventilation in many situations. Our primary objective is to study the degree of correlation between continuous EtCO2 monitoring and the severity of metabolic acidosis in blood gas measurement in patients with diabetic keto-acidosis (DKA). Secondary objectives are: ability of EtCO2 in ruling in or out DKA; discriminating the different severity grades of DKA. It is a cross-sectional, observational, prospective cohort study in convenience sample of children presenting with clinical manifestations consistent with DKA. Will be conducted in pediatric Emergency Center, Hamad General Hospital. Will include all DKA patients and excluding any condition or medication that affect the acid-base status.

The study will be conducted in pediatric emergency center, Hamad General Hospital, a recognized academic institution, in Doha, Qatar.

The DKA was defined as: hyperglycemia (blood glucose \>11 mmol/L or 200 mg/dL), venous pH \<7.3 and/ or bicarbonate \<15 mmol/L, and the association with, ketonemia, and ketonuria. The severity of DKA is categorized as mild (venous pH \<7.3 or bicarbonate \<15 mmol/L), moderate (venous pH \<7.2 or bicarbonate \< 10 mmol/L) and severe (venous pH \< 7.1 or bicarbonate \<5 mmol/L).

Eligible patients are all children with already known or newly diagnosed diabetics, regardless weather has been enrolled in previous encounter or not.

The patients with the following criteria are excluded: older than 14 years of age, airway obstruction, chest infection, complex congenital heart disease, Congestive heart failure, central or peripheral neurological disorders, hyper/hypothermia, and sever pain.

Physicians and nurses, and research assistance staff will be trained in the use of nasal capnography including the proper size, connection and wave forms shapes and its interpretation.

Eligibility Criteria:
Inclusion Criteria:

All children with already known or newly diagnosed diabetics, regardless weather has been enrolled in previous encounter or not.

Exclusion Criteria:

1. Older than 14 years of age
2. Airway obstruction
3. Chest infection
4. Complex congenital heart disease
5. Congestive heart failure
6. Central or peripheral neurological disorders
7. Hyper/hypothermia
8. Severe pain