cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Health Outcomes of the Joslin Why WAIT? Program

Evaluating the health outcomes of patients that were enrolled in Joslin's Why WAIT Program. These outcomes include BMI, A1C, lipid profile.

This study is aimed to evaluate the health outcomes of patients enrolled in Joslin's Why WAIT Program. This program aims to control diabetes and help patients lose weight.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 diabetes with BMI over 35

Exclusion Criteria:

* Patients with type 1 diabetes
Airway Complications After LMA in Children

Background: The removal of Laryngeal Mask Airway (LMA) in children may be associated with respiratory adverse events. The incidence of these adverse events may be influenced by the type of anesthesia maintenance. It is not clear whether Total Intravenous Anesthesia (TIVA) with propofol is associated with a lower incidence of respiratory events upon removal of LMA as compared to maintenance with sevoflurane.

Specific Aim: The primary aim of this study is to compare the prevalence of respiratory adverse events following LMA removal in patient receiving TIVA versus sevoflurane inhalational anesthesia in a pediatric population aged between 6 month and 6 years old. Secondary outcomes include quality of induction, maintenance and emergence from anesthesia between the 2 groups as evidenced by ease of LMA insertion, absence of bucking or movement during the procedure, time to LMA removal, and absence of emergence agitation.

Methods: In this prospective randomized clinical trial, children will be enrolled in one of two groups: Group 1 will receive propofol for induction and maintenance of anesthesia, Group 2 will receive sevoflurane for induction and maintenance of anesthesia. In both groups patients will be mechanically ventilated. At the end of the procedure, LMAs will be removed when patients are fully awake as defined by the return of reflexes, eye opening, and purposeful movements.

Significance: Data comparing the influence of TIVA and sevoflurane on the occurrence of respiratory adverse events after LMA removal are limited. Both techniques are standard of care at our institution. However, as per our clinical observations, we hypothesize that TIVA is superior to sevoflurane. This study will identify the technique that provides optimal anesthetic conditions and improved patient's safety.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 6 months to 6 years old
2. Patients undergoing short duration procedure ( ˂ 2 hours) (such as polysite removal, closed reduction, eye examination, excluding thoracic and abdominal surgery)
3. American Society of Anesthesiologists (ASA): I-III
4. Patients undergoing LMA general anesthesia. (NPO, short procedures, patient without known airway abnormalities).
5. Parental consent

Exclusion Criteria:

1. Age: more than 6 years old and less than 6 months
2. Patients having: Asthma, hyper reactive airway (Acute exacerbation)
3. Patients having recent respiratory tract infection within 2 weeks.
4. Patients with congenital heart disease
5. Patients not eligible for LMA (full stomach, hiatal hernia, known or predicted difficult airway, syndromic patient with facial or airway malformation, patient undergoing major abdominal or thoracic surgery)
6. Patients at high risk of aspiration
7. Anticipated difficult airway
8. Patient with neurologic disorders (children with known neurologic disorders: seizure, mental retardation, cerebral palsy)
9. Difficult LMA insertion (\> 3 attempts)
The Role of Estrogen in the Neurobiology of Eating Disorders

This is a randomized, double blind, placebo-controlled study of the effects of transdermal estradiol versus placebo on cognitive flexibility, reward processing, and eating disorder pathology in hypoestrogenemic female adolescents and young adults (ages 14-35 years) with an eating disorder characterized by extreme dietary restriction and/or excessive exercise. Subjects will be randomized 1:1 to 12 weeks of transdermal estradiol with cyclic progesterone or placebo patches and cyclic placebo pills. Study visits include a screening visit to determine eligibility and visits at baseline, 8 weeks, and 12 weeks. Study procedures comprise behavioral, neuroimaging, and endocrine assessments.


Eligibility Criteria:
Inclusion criteria:

* Female
* 14-35 years
* Bone age ≥13.5 years (applicable only for participants \<16 years)
* Clinically significant eating disorder characterized by restriction and/or excessive exercise and high drive for thinness
* Hypoestrogenemia: Oligo-amenorrhea defined as lack of menses for ≥3 months within a 6-month period of oligomenorrhea (cycle length ≥5 weeks) or absence of menses at \>15 years if premenarchal or low estradiol levels evaluated by the study physician
* Low or normal weight defined by a body mass index that is \<85th percentile for 14-18 year olds and a body mass index \<25 kg/m2 for adults

Exclusion criteria:

* Suicidal ideation where outpatient treatment is determined unsafe by study clinician
* Other causes of oligo-amenorrhea, unless a study clinician determines that missed menstrual periods are more likely a consequence of restrictive eating
* Medications that contain estrogen ± progesterone within the past 3 months
* Levonorgestrel-releasing intrauterine device if subject is unable to provide two to three weekly blood samples for estradiol of if estradiol levels are determined to be too high by study doctor
* Neurological or psychiatric disorders that may impact neural circuitry of interest
* Lifetime history of seizure disorder or electroconvulsive therapy
* Pregnancy/breastfeeding
* Gastrointestinal tract surgery
* Contraindications to estrogen use
* Any other significant illness or condition that the investigator determines could interfere with study participation or safety or put the subject at any unnecessary risk
Social-Psychological Intervention to Improve Adherence to HAART

All eligible patients will be invited to use electronic monitoring of medication (MEMS) during the next six months. After two months with MEMS the enrolled patients will be randomized to intervention group or to control group. The intervention group will be submitted to four social-psycho sessions with a pre-trained health professional. The control group will receive the usual care of the health service.

The study will compare the rate of adherence to antiretroviral therapy between the intervention group and the control group. The duration of the study will be of six months. The analysis will be based on "intention-to-treat.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged more than 18 years old, with detectable viral load and more than six months under HAART

Exclusion Criteria:

* Pregnant women
* Patients participating in other trials
* Patients in treatment for hepatitis and for active opportunistic infection
* Patients with mental or physical condition which do not allow their attendance to the health service
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis

This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for sustaining clinical response achieved in study RA0055 Period 1 \[NCT01519791\]. Subjects entering this study RA0055 Period 2 achieved sustained Low Disease Activity at Week 52 in study RA0055 Period 1.


Eligibility Criteria:
Inclusion Criteria:

- Those subjects in previous study RA0055 Period 1 who are in sustained LDA (defined as DAS28\[ESR\] ≤ 3.2 at Weeks 40 and 52) at Week 52 in previous study RA0055 Period 1

Exclusion Criteria:

- Those subjects in previous study RA0055 Period 1 who are NOT in sustained LDA (defined as DAS28\[ESR\] ≤ 3.2 at Weeks 40 and 52) at Week 52 in previous study RA0055 Period 1
A Comparison of Epidural Analgesia: Continuous Infusion Versus Programmed Intermittent Boluses

The analgesic approach in labor can be done in different ways, among which the neuraxial approach has shown the best analgesic results and fetal outcomes. Currently, programmed epidural intermittent bolus has been included in the neuraxial approach for a better distribution of the solution into the epidural space as compared with the continuous infusion strategy. In this study, the investigators seek to compare both strategies in 132 laboring women.


Eligibility Criteria:
Inclusion Criteria:

* At term pregnancy
* Laboring patients requiring epidural analgesia

Exclusion Criteria:

* American Society of Anesthesiologists physical status \> or equal than 3
* allergy to local anesthesics
* Neuraxial contraindications
* Hemodynamic instability
* Systemic disease such as diabetes mellitus or hypertension
* Chronic usage of analgesics
* Disease associated to pregnancy such as gestational diabetes, preeclampsia, fetal malformations among others
PLASMA Mexico (PLASMA Mexico)

Collect data on Mexican patients diagnosed with Heart Failure with reduced ejection fraction, their treatments, and their progress in a real-world environment. Additional objectives will be analyzed, such as mortality, the use of resources associated with the follow-up of this group of patients and the barriers, if any, to receiving the indicated treatment.

* Identify the main epidemiological and clinical characteristics of patients with Heart Failure with reduced ejection fraction, as well as the medical treatment models used.
* Determine the prescription rate of a cardiovascular pharmacological treatment and the prescription and implant rate of a cardiac medical device in patients with Heart Failure with reduced ejection fraction.
* Determine the mortality rate and its classification in patients with Heart Failure with reduced ejection fraction.
* Identify the barriers, if any, to prescribing and implanting a cardiac medical device in those patients with a Class I recommendation according to the ACC/AHA/HRS 2017 guidelines.
* Determine the population with a profile of 1.5 primary prevention of sudden cardiac death (patients with Heart Failure in primary prevention who have one or more of the following risk factors: syncope or pre-syncope; left ventricular ejection fraction less than 25%; presence of non-sustained ventricular tachycardia; more than 10 ventricular extrasystoles per hour observed in a 24-hour Holter).
* Collect data on the use of resources associated with the follow-up of patients diagnosed with Heart Failure with reduced ejection fraction during a period of 12 months to perform a secondary economic analysis.

Eligibility Criteria:
Inclusion Criteria

* Men and women ≥18 years
* Patients with Heart Failure with LVEF ≤ 45% will be included
* Patients must be willing to comply with the study requirements and complete the Informed Consent Form (defined as the legally valid and documented confirmation of a patient's voluntary agreement to participate in the clinical study)

Exclusion Criteria

* Patients without Heart Failure or with Heart Failure with LVEF \> 45%
* Patients unable of comply with the Clinical Investigation Plan
* Patients who are already enrolled or plan to participate in a concurrent clinical study of any medication and/or device at any time during the course of this clinical study without prior documented approval of the Medtronic Study Manager
Pharmacological Cognitive Enhancement

There is growing debate on the use of drugs that can promote cognitive enhancement. Amphetamine-like drugs have been employed as cognitive enhancers, but all of them have important side effects and may induce addiction. In our study, we will investigate the use of modafinil which, in recent years, has been proposed as cognitive enhancer. Modafinil appears to have less side effects compared to amphetamine-like drugs and we will analyzed whether the drug can influence cognitive performances and the brain resting state network activity of healthy young subjects.

Subjects will be included in a double-blind, placebo-controlled study in which a single dose (100 mg) of modafinil will be administered. Both groups will be, before and three hours after administration of drug or placebo, tested for neuropsychological performances with the Raven's Advanced Progressive Matrices II set (APM).

Resting state functional magnetic resonance (rs-fMRI) will be also employed, before and after three hours, to study changes in the activity of resting state brain networks. Finally, with Diffusion Tensor Imaging (DTI) we will evaluate the structural connectivity of the two groups.

Eligibility Criteria:
Inclusion Criteria:

* subjects do not meet the criteria for exclusion

Exclusion Criteria:

* current signs of psychiatric, neurological or medical (hypertension, cardiac disorders, epilepsy) conditions as determined by the Millon test and by clinical examination;subjects showing visual or motor impairments. All subjects taking any psychoactive drug or having a history of alcohol abuse.
Development and Evaluation of Techniques for Computer Aided Detection and Diagnosis From Existing Radiologic Images

Background:

Radiologic images are getting more complex. They are also being used more often. Medical personnel are overwhelmed with data. Computer Aided Detection (CAD) and diagnosis may be able to improve medical care. Researchers want to create and test ways to use CAD. To do this, they want to use data from the Clinical Center s Department of Diagnostic Radiology.

Objective:

To create algorithms and software that accurately detect and characterize lesions, model anatomy, and monitor diseases on radiologic studies.

Eligibility:

People of all ages who have radiologic exams stored in the clinical PACS (picture archiving system) of the Clinical Center since July 6, 1953 with no end date. People with target lesions of any kind will be included.

Design:

This study will use existing data. Participants will include males and females of all ages. They will be chosen by keyword search on NIH databases.

The data that is used may include CT, MRI, ultrasound, and other images. It may include a participant s name, date of birth, and date of exam. It may include the name of the doctor, radiologist, and hospital. Data such as age, gender, race, disease, and treatment may be used. Other data from charts or studies may be used.

Imaging data of all organs of the body will be studied.

Data will be kept in computers and servers. The equipment will be password protected. Printouts will be stored in locked rooms.

This study will last 10 years.

Study Description:

This study uses artificial intelligence techniques to improve radiology diagnosis.

Objective:

Development of Computer Aided Detection techniques to improve radiology imaging.

Study Population:

Up to 1,000,000 NIH Clinical Center patients.

Description of Sites/Facilities conducting research:

NIH Clinical Center

Study Duration:

10 years

Eligibility Criteria:
* INCLUSION CRITERIA:
* All radiologic exams available in the clinical PACS (picture archiving system) of the Clinical Center taken from July, 6, 1953 with no end date.
* Males and Females of all ages.
* Patients with target lesions of any kind will be included
* Patients without the target lesion will be included to determine the specificity of the computer aided detection or diagnosis algorithm

EXCLUSION CRITERIA:

None
Comparison of Eccentric Training on Injury Prevention and Hamstring Strength in Football Players

To determine the effect of the eccentric exercise training on injury prevention and hamstring strength in football players.

Hamstrings injuries are common among footballers with a higher prevalence rate in male footballers. Despite the relatively high incidence of hamstring injuries in sports, no clear prevention methods have been identified. Most hamstring muscle injuries occur during an eccentric phase of any activity. Eccentric hamstring training has been used for injury prevention in recent years. The two distinguishing characteristics of eccentric muscle contractions have been well understood: 1) great force output; and 2) low energy cost to produce the force. Due to these distinguishing characteristics, eccentric exercise is widely used in injury prevention programs.

The aim of this study is to determine the effectiveness of eccentric training as compared to conventional training in hamstring muscle injury prevention and strengthing in football players.

Eligibility Criteria:
Inclusion Criteria:

* Football players with age 18 to 40
* Male
* Players playing football for \> 1 year

Exclusion Criteria:

* Having history of injury and surgery in past
* Those players having any kind of musculoskeletal, neurological, cardiovascular, or degenerative problems
* Those players who have any medical conditions
Effects of Glucagon Like Peptide-1 on No-reflow

The investigators planned to evaluate the effects of liraglutide on no-reflow in patients with acute ST-segment elevation myocardial infarction (STEMI).

Acute myocardial infarction (AMI) is a major cause of mortality and morbidity. Primary percutaneous coronary intervention (PCI) is currently the most effective treatment strategy for AMI. Brisk thrombolysis in myocardial infarction (TIMI) grade 3 flow immediately after PCI in patients with AMI is associated with improved clinical outcomes compared with lower flow grades. However, myocardial reperfusion is suboptimal in many patients, mostly because of the 'no-reflow' phenomenon. No-reflow is defined as suboptimal myocardial reperfusion in part of the coronary circulation without angiographic evidence of mechanical vessel obstruction. To date, however, very few drugs have been shown to reverse established no-reflow.

Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose, and GLP-1 analogues were recently introduced for the treatment of acute myocardial infarction. GLP-1 has antioxidant and anti-inflammatory properties, and may protect endothelial function. Experimental studies have also revealed that GLP-1 or its analogues protect against reperfusion injury in pigs. Exenatide, a GLP-1 analogue, was reported to reduce reperfusion injury in patients with ST-segment elevation myocardial infarction. Similarly, liraglutide was reported to reduce cardiac rupture and infarct size and improve cardiac output in normal and diabetic mice. To date, however, there is no clinical evidence for the effects of liraglutide on no-reflow in patients with AMI. Therefore, the aim of this study was to evaluate the effects of liraglutide pretreatment on myocardial no-reflow of prime PCI in patients with AMI.

Eligibility Criteria:
Inclusion Criteria:

Patients with ST-segment elevation myocardial infarction were eligible for the study.

Exclusion Criteria:

Patients were excluded for the following reasons: unconscious at presentation; had cardiogenic shock, hypoglycaemia, or diabetic ketoacidosis; had a history of myocardial infarction, stent thrombosis, or renal insufficiency; or had previously undergone coronary artery bypass surgery.
Study of Cetuximab With and Without Weekly Paclitaxel for Patients With Previously Treated Advanced Urothelial Cancer

The purpose of this research study is to determine whether the investigational drug cetuximab, (Erbitux) alone or with paclitaxel (Taxol) can stabilize the growth of urothelial cancer.

This research study is being done to find out if cetuximab, alone or with paclitaxel will slow the growth of urothelial cancers. Cetuximab is an antibody that blocks a protein called epidermal growth factor receptor (EGFR). EGFR sits on the outside of tumor cells and controls tumor cell growth. This agent has been looked at alone and with other chemotherapy drugs including paclitaxel. It has been found to be safe and can shrink other types of cancer.

This research study is also being done to find out if cetuximab, alone or with paclitaxel shrinks urothelial tumors. If it extends the time the tumors shrink. If it helps people live longer.

The purpose of this research study is to find out what effects (good and bad) these treatments have on you and your cancer. We do not know if you will benefit from this research study. It is possible that your condition will get better, but it is also possible that there will be no effect on your condition or that your condition will get worse. We can use what we learn from this research study to help other people with the same disease.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed carcinoma of the urothelium (bladder,renal pelvis, ureter)
* Measurable disease by RECIST
* Patients who received only one prior systemic non-taxane regimen for urothelial cancer. May have received this in the adjuvant or neoadjuvant setting or for advanced disease.
* Signed IRB approved consent
* Must have tissue available for EGFR assessment and additional correlative studies
* ECOG PS 0-2
* 18 years of age or older
* Not of child bearing potential or negative pregnancy test within 7 days of treatment
* ANC greater than or equal to 1,500/ul
* Platelets greater than or equal to 100,00/ul
* Creatinine less than or equal to 2x institutional ULN or create. clearance greater than or equal to 30, bilirubin less than or equal to 1.5x ULN, AST\&ALT less than or equal to 5x ULN

Exclusion Criteria:

* Received more than one prior regimen for advanced disease
* Prior radiation to more than 30% of marrow containing skeleton
* Prior therapy that specifically and directly targets the EGFR pathway
* Prior severe infusion reaction to a monoclonal antibody, pre-existing neuropathy greater than or equal to grade 2
* Prior reaction to Cremophor EL
* Known acute hepatitis B or C or known HIV
* Active or uncontrolled infection
* Significant history of uncontrolled cardiac disease
* Any concurrent chemotherapy not indicated in this study; or
* Any other investigational agents
A Salivary miRNA Diagnostic Test for Autism

The goal of this study is to validate a panel of miRNAs that distinguish children with autism spectrum disorder (ASD) from their non-ASD peers with a positive MCHAT-R. These biomarkers may allow earlier diagnosis of autism, allowing earlier service, and also help us to understand some of the changes in the brains of autistic children.

The central aim of this project is to validate a panel of expressed microRNA (miRNA) in the saliva of children identified at risk for developing ASD by the MCHAT-R. Further, this study aims to assess the value of the current panel as an adjunctive test that may increase specificity of MCHAT-R positive results, or affirm clinical diagnoses alongside the ADOS or other objective assessments.

The primary endpoints of this study are as follows:

1. Evaluate the diagnostic ability (sensitivity and specificity) of the current a salivary microtranscriptome panel for distinguishing children with ASD from their non-ASD peers.
2. Assess stability of the salivary microtranscriptome diagnosis over time, and interrogate longitudinal microtranscriptome levels relative to neuropsychological measures.

Secondary endpoints are the identification of microtranscriptome features whose concentrations correlate with ASD endophenotypes.

Eligibility Criteria:
Inclusion Criteria:

* Age at enrollment: 24 months to 48 months (inclusive)
* MCHAT-R score of 3 or greater
* Parent/guardian must be fluent in spoken English (required to complete study specific questionnaires etc)

Exclusion Criteria:

* confounding neurological (i.e. cerebral palsy, epilepsy), sensory (i.e. auditory or visual) impairments, and feeding tube dependence.
* history of extreme pre-term birth (\< 32 weeks gestation)
* wards of the state
* Autistic subjects with known syndromic autism (attributed to a known genetic mutation)