cyrilzakka/clinical-trials huggingface dataset:
Improving Prematurity-Related Respiratory Outcomes at Vanderbilt

The goal of IMPROV is to identify molecular mechanisms that contribute to lung injury and long-term breathing problems in preterm infants by investigating two interrelated biochemical pathways: the urea cycle-nitric oxide pathway and the glutathione pathway. The investigators hypothesize that prematurity-related limitations in the function of these important biochemical pathways contribute to respiratory disease risk over the first year of life.

The primary goal of the IMPROV/PROP study is to identify biomarkers (biochemical, physiological and genetic) and clinical variables that are associated with and thus potentially predictive of pulmonary status in preterm infants at 1 year corrected age. IMPROV will test the hypothesis that biochemical immaturity and functional genetic variation in the urea cycle-nitric oxide (UC-NO) and glutathione (GSH) pathways influence the development and severity of bronchopulmonary dysplasia (BPD), a form of chronic lung disease that affects more than 10,000 premature infants each year in the US. IMPROV will also test the hypothesis that the duration and degree of NO insufficiency and free radical excess predicts BPD severity and correlates with persistence of lung problems after NICU discharge. Our hypothesis implicates (a) an immature liver and gastrointestinal ability to make citrulline and GSH, (b) inadequacy of nutritional amino acid substrate and (c) common genetic variations in the UC-NO and the GSH pathways in the pathogenesis of BPD. These factors limit the ability of the anatomically and functionally immature lung to respond to the physiologic and environmental stress of preterm birth. As part of the PROP multi-center study, novel approaches to characterizing lung status with non-invasive respiratory measures prior to NICU discharge will be employed. A composite primary outcome of morbidity that is based on serial parental reports of respiratory symptoms, medications, hospitalizations and dependence on technology during the first year of life has been developed.

Eligibility Criteria:
Inclusion Criteria:

* Infants who are less than or equal to 7 days old;
* Gestational Age (GA) between 23 weeks and 0/7 days and 28 weeks and 6/7 days

Exclusion Criteria:

* The infant is not considered to be viable (decision made not to provide life-saving therapies);
* Congenital heart disease (not including PDA and hemodynamically insignificant VSD or ASD);
* Structural abnormalities of the upper airway, lungs or chest wall;
* Other congenital malformations or syndromes that adversely affect life expectancy or cardio-pulmonary development;
* Family is unlikely to be available for long-term follow-up.
Behavioral CVD Prevention Using Informatics

Overweight/obesity is strongly linked to mortality from multiple chronic diseases, including cardiovascular disease, diabetes, and obesity-related cancers.The successful management of overweight/obesity requires management of nutrition and physical activity over time. For racial/ethnic minority and low-income populations, who face both higher prevalence of obesity and chronic diseases compared to others, interventions promoting behavioral change are a national health priority. From the available range of behavioral change intervention strategies, there is a growing knowledge base that documents the efficacy of peer support interventions for improving self-care, quality of life, and behavioral change. In this study, the investigators will examine the following research question: What is the preliminary efficacy and degree of implementation and acceptability of an intervention approach in which peer counselors provide evidenced-based counseling about nutrition and physical activity behaviors for weight management to public housing residents using a computer-assisted program called CuesWeight?


Eligibility Criteria:
Inclusion Criteria:

* Willing to wear an accelerometer
* 18-65 years old
* Public housing resident with no plans to move in next 6 months
* Body mass index ≥25
* Open to making changes to diet \& physical activity habits

Exclusion Criteria:

* Currently enrolled in a comprehensive weight loss program or a research study whose primary outcome is weight loss
* Primary language spoken is a language other than Spanish or English
* Not willing to participate in study protocols, including wearing the accelerometer, not willing to have study staff send text messages
The Impact of Telelactation Services on Breastfeeding Outcomes

This project will assess the impact of a novel breastfeeding support intervention ("telelactation"), delivered via video calls on personal devices including mobile phones and tablets. The goal of this intervention is to increase access to International Board Certified Lactation Consultants to improve, and reduce disparities in, breastfeeding rates. By implementing a digital randomized controlled trial that recruits participants through a popular pregnancy tracker mobile phone application, this mixed methods study will recruit a national sample of 1800-2400 individuals (depending on rate of attrition) during their third trimester of pregnancy to 1) provide evidence on the effectiveness of a widely available, yet understudied, service and 2) leverage technology to promote one of the most widely recommended health behaviors to improve children's health and to reduce disparities in key maternal and child health outcomes.

This study is a pragmatic, parallel design randomized controlled trial that will generate evidence on the impact of telelactation on breastfeeding duration and exclusivity and explore differences in effectiveness by race/ethnicity. The study is mixed methods, and uses a sequential explanatory design in which qualitative interviews are used to explain and contextualize findings from the quantitative outcomes analysis. We will recruit primiparous, pregnant individuals age \> 18 who intend to breastfeed and live in states most underserved by IBCLCs. Recruitment will occur via Ovia, a pregnancy tracker mobile phone application (app) used by one million pregnant individuals in the U.S. annually. Participants will be randomized to: 1) on-demand telelactation video calls on personal devices or 2) ebook on infant care/usual care. Breastfeeding outcomes will be captured via surveys and interviews and compared across racial and ethnic groups. This study will track participants for eight months (including six months postpartum), generating 1) quantitative data on the impact of telelactation and differences in effectiveness across racial and ethnic minority groups; and 2) rich qualitative data on the experiences of different subgroups of parents with the intervention, including barriers to use, satisfaction, and strengths and limitations of this delivery model.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* pregnant with first child
* intend to attempt breastfeeding
* residing in a state underserved by IBCLCs

Exclusion Criteria:

* non-singleton pregnancy
* advised by healthcare provider not to breastfeed for a medical reason (e.g., HIV+ status, chemotherapy planned)
* in police custody or incarcerated
* infant to be separated from birthing parent (e.g., given up for adoption, military deployment)
Atelectasis Formation: Role of Positive Pressure Breathing, Hyperoxia, and Hypobaria

The primary aim of this project is to get further knowledge of the physiology of flight atelectasis and its prevention. We seek to: 1) assess whether low levels of positive pressure breathing can prevent atelectasis formation in humans during exposure to hyperoxia and +Gz-accelerations. 2) get further knowledge on the effects of hypobaria on regional ventilation and perfusion.

A secondary aim is to evaluate the effect of anti G-trouser inflation on ventilation and regional perfusion.

The effect of positive pressure breathing on lung function is being studied, when applied during exposure to hyperoxia and +Gz-accelerations. Focus is on lung tissue compression, ventilation and regional perfusion. In addition, the influence of hypobaria on these parameters is assessed.

This study is conducted in accordance with the amended Declaration of Helsinki. The Ethics Committee Ile-de-France III (ref. 3274) and the French National Agency for Drug Safety ANSM have approved the protocol (ref. ID RCB 2015-A00485-44 and ANSM 151046B-32).

Primary aim, item 1: Experiments are conducted in a human centrifuge. The protocol mimics a routine peacetime flight in combat aircraft, and includes 1hr05 min at +1Gz followed by 10-min exposure to +1.4 to +3.5Gz . Subjects are exposed three times to this sequence, breathing at positive pressure levels of 0, 5 or 10 hPa. Two groups of sixteen healthy male non-smoking volunteers, wearing anti-G trousers, are studied and compared: group 1 breathes air, group 2 100% O2.

Primary aim, item 2: Experiments are conducted in a hypobaric chamber. Sixteen healthy male non-smoking volunteers are exposed to four conditions: 0 or 15,000 ft altitude, breathing air or 100%O2. Protocol duration is 1h15min. Positive breathing pressure can be applied depending on the results of the experiments of item 1.

Secondary aim: Experiments are conducted in a human centrifuge. Sixteen healthy male non-smoking volunteers are exposed to four conditions: uninflated or inflated anti-G trousers (175 hPa), +1 or +3.5 Gz for 3 min.

Eligibility Criteria:
Inclusion Criteria:

* normal lung function checked by pulmonary function tests.
* normal ECG
* normal clinical examination

Aim 1 exclusion criteria:

* smoking
* myopia
* past medical history of heart or lung disease
* current medical treatment for heart or lung disease
* past medical history of back pain or spine trauma or disease
* otitis
* bad tolerance to +Gz accelerations (G-induced loss of consciousness, motion sickness)
* claustrophobia in the centrifuge gondola

Aim 2 exclusion criteria:

* smoking
* past medical history of heart or lung disease
* current medical treatment for heart or lung disease
* otitis
* bad tolerance to the altitude chamber (15,000 ft): ear pain, claustrophobia
The Role of Quadriceps Contraction in Patellar Repositioning - a Computed Tomography Study

Background Previous studies have a great discrepancy concerning the effects of quadriceps contraction on patellar lateral displacement and tilt in patients with patellofemoral pain syndrome. This discrepancy may be caused by lack of information regarding to classifications of patellofemoral alignment under quadriceps relaxed. We hypothesized quadriceps contraction has different effects on each type of patellofemoral malalignment.

Methods The investigators expect to recruit 150 subjects with patellofemoral pain syndrome to participate in this study. All patients underwent computed tomography imaging of symptomatic knees, with and without quadriceps muscle contraction in 0°, 15° and 30° of knee flexion. Patellar lateral condyle index and patellar tilt angles of Sasaki and modified Fulkerson were measured to investigate the effect of quadriceps contraction on patellar repositioning.

Background Previous studies have a great discrepancy concerning the effects of quadriceps contraction on patellar lateral displacement and tilt in patients with patellofemoral pain syndrome. This discrepancy may be caused by lack of information regarding to classifications of patellofemoral alignment under quadriceps relaxed. We hypothesized quadriceps contraction has different effects on each type of patellofemoral malalignment.

We expect to recruit 150 subjects with patellofemoral pain syndrome to participate in this study. All patients underwent computed tomography imaging of symptomatic knees, with and without quadriceps muscle contraction in 0°, 15° and 30° of knee flexion. Patellar lateral condyle index and patellar tilt angles of Sasaki and modified Fulkerson were measured to investigate the effect of quadriceps contraction on patellar repositioning.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria for patients with PFPS were suffering from pain with at least two kinds of knee-flexing activities such as:

  * sitting
  * getting up from sitting
  * walking upstairs or downstairs
  * squatting
  * getting up from squatting
  * running
  * kneeling
  * jumping

Exclusion Criteria:

The exclusion criteria included:

* The presence of any major medical disease
* Rheumatoid arthritis, gouty arthritis
* Recent history (within 3 months) of knee surgery
* Image findings of osteoarthritis
* Any deformity of lower limbs
Effect of Inulin on Iron Absorption in Humans

Prebiotics are non-digestible food ingredients that beneficially affect the host by selectively stimulating the growth or activity of species in the colon that can improve host health.

Inulin-type fructans (inulin and oligofructose) are natural food ingredients with prebiotic activity. Fermentation of inulin and oligofructose by lactic acid producing bacteria results in an increase in bacterial biomass and the production of SCFA (acetate, propionate and butyrate), lactic acid and the gases CO2 and H2. They are naturally present in significant amounts in several vegetables such as garlic, artichoke, onion, asparagus, leek and wheat (1-4%). Based on consumption data, the daily intake of inulin in Europe varies between 3.2 and 11.3g mainly from wheat (2-7.8g/d). However, this might have changed recently since inulin and oligofructose are used by the food industry either as sucrose and fat replacements or due to their health benefits for the human host.

Several human absorption studies evaluated the effect of inulin/oligofructose on mineral absorption. It was shown that calcium and magnesium absorption was positively influenced. Until now, the positive effect on iron absorption was only shown in animals. The influence on human iron absorption was investigated twice. Both studies reported no effect of inulin/oligofructose on iron absorption, but this was most likely due to poorly conceived study designs.

The aim of the present study is to demonstrate that inulin consumption over several weeks can lead to enhanced iron absorption in humans under optimized conditions.


Eligibility Criteria:
Inclusion Criteria:

* non-pregnant, non-lactating women
* between 18 and 40 years
* below 65kg

Exclusion Criteria:

* metabolic, chronic and gastro-intestinal disease
* long-term medication
* blood donation within 6 month before the study-
Congenital Heart Adolescents: Program of Transition Evaluation Research

The objective of this study is to evaluate the potential role of a cardiology clinic-based educational intervention for 15 to 17 year olds with congenital heart disease (CHD) and their parents, and to determine whether this intervention results in improved self-management skills (e.g., renewing medication prescriptions), teens having greater knowledge of their heart condition, and more teen and parent satisfaction with services. The results of this study will form the basis for a website that in turn may serve as an additional means of providing transition interventions. The results of this study may also be applicable to youth with other special health care needs.


Eligibility Criteria:
Inclusion Criteria:

* Age 15-17
* Followed in the Stollery Pediatric Cardiology Clinic or the Northern Alberta Adult Congenital (NAACH) clinic
* Moderate or Complex Congenital Heart Disease (as defined by the 2001 Bethesda guidelines) or Acquired Heart Disease (cardiomyopathy (dilated, hypertrophic, or restrictive forms), Marfan's syndrome or rheumatic heart disease with cardiac involvement)

Exclusion Criteria:

* Developmental Delay, reading level below grade 6 based on patient or parent report
Long-term Neurocognitive and Psychiatric Consequences in Severe COVID-19 Survivors.

Long-term neurocognitive and psychiatric consequences of COVID-19 remain mostly unknown to date. It has been reported that coronaviruses cause direct central nervous system infection (Needham et al. 2020). Besides that, new or worsening cognitive impairment commonly occurs and persists in survivors of intensive care unit (ICU) stay (Hosey \& Needham. 2020). The purpose of our study is to search and describe the cognitive and psychiatric long-term consequences of COVID-19 on patients who have been discharged from critical care units. This is an ambidirectional cohort study, that attempts to follow adults discharged from critical Care Units Adults due to COVID-19 up to 12 months after discharge, to evaluate the presence of cognitive impairment, linguistic and phonation function, depression, fatigue, functional gastroenterological symptoms, anxiety, or post traumatic disorder, and performance in activities of daily living and physical response to exercise as well.


Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years of age who have been hospitalized at critical care units, who were admitted for a diagnosis of COVID-19 and who present a score on the MOCA® cognitive test of less than 26 points at the time of hospital discharge .

Exclusion Criteria:

* History of underlying cognitive disorder. History of underlying primary psychotic disorder. MOCA® cognitive test score greater than or equal to 26 points at the time of hospital discharge.
Temporal Relationship Between Motor Fluctuations and Nonmotor Fluctuations

The purpose of this study is to determine the temporal relationship between motor fluctuations and non-motor fluctuations in persons with Parkinson's disease.

Observational study case-only

Objectives

1. how many patients will experience motor or nonmotor fluctuation during follow-up period?
2. in how many patients, does motor fluctuation precede nonmotor fluctuation?
3. in how many patients, does nonmotor fluctuation precede motor fluctuation?

Participants: persons with Parkinson disease in early stage who does not have motor or nonmotor fluctuation

Recruitment period: 3 years from the commencement of the study Follow-up period: 3 years for each participants

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of Parkinson disease by United Kingdom Parkinson's Disease Society Brain Bank criteria
* early stage

Exclusion Criteria:

* dementia (MMSE\<26)
* persons who refuse participating
Effect of Entecavir Treatment on Regression and Disease Outcome in HBV-induced Liver Fibrosis and Cirrhosis Patients

Patients who have completed 2 years follow-up of the past National 12th Five-Year Major Project on Infectious Diseases will receive another 8 years treatment with entecavir (10 years in total). Collect serology, imaging, and other clinical data to evaluate the incidence and mortality of decompensated cirrhosis and hepatocellular carcinoma. Understand the effects of long-term antiviral therapy on HBV-induced liver fibrosis/cirrhosis.

Patients who have completed 2-years entecavir-based treatment in Regress Study will receive another 8 years of entecavir extension therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBV-DNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan; A third liver biopsy will be performed at the 5th year of treatment in patients who have significant fibrosis at second biopsy. CT /MRI and endoscopy will be performed at baseline and the 5th and 10th year of treatment.

Eligibility Criteria:
Inclusion Criteria:

- Subjects who completed the 2 years of entecavir-based therapy in Regress study; Subjects who are willing to participate the extension study.

Exclusion Criteria:

- Any complication of severe heart, lung, kidney, brain, blood diseases or other important systematic diseases; Pregnant women; Subjects who could not compliance with the protocol judged by investigators; Subjects who are not suitable for the study judged by investigators.
A Study of Safety and Pharmacokinetics of Repeated Dose of Micafungin as Antifungal Prophylaxis in Children and Adolescents Who Undergo Hematopoietic Stem Cell Transplant

The study will evaluate PK and safety of two dose levels of Micafungin (FK463) as Antifungal prophylaxis in children and adolescents undergoing HSCT

This is a prospective, multi-center, open-label, repeat-dose pharmacokinetic study that contains two treatment (micafungin 1.0mg/kg and 1.5mg/kg) dose groups. Subjects will be enrolled according to age and stratified by weight to receive either 1.0mg/kg (weight \> 25kg) or 1.5mg/kg ( weight \< 25kg) micafungin.

Children (4 months to \< 2years, 2 to 5 years and 6 to 11 years) and adolescents (12 to 16 years) undergoing HSCT who require antifungal prophylaxis will be enrolled

Eligibility Criteria:
Inclusion Criteria:

* Institutional Review Board (IRB)-approved written informed Consent / Assent (as applicable) and HIPAA Authorization must be obtained from the subject (as able) and /or subject's parent/legally authorized representative prior to any study-related procedures
* Subject has sufficient venous access to permit administration of study drug, collect pharmacokinetic samples and monitor laboratory safety variables
* Female subject of childbearing potential must have a negative pregnancy test within 72 hours prior to the first dose of study drug, and if sexually active agree method of birth control per Investigator judgment for the duration of the study
* Subject (when able) and /or subjects parent/legally authorized representative agree to comply with the study requirements and with the concomitant medication restrictions
* Subject plans to undergo a HSCT

Exclusion Criteria:

* Subject has evidence of significant liver disease as defined by aspartate transamine (AST/SGOT), alanine transaminases (ALT/SGPT) 10 times the upper limit of normal (ULN) and total bilirubin or alkaline phosphatase \> 5 times the ULN
* Subject has concomitant medical condition that in the opinion of the Investigator and /or medical monitor precludes enrollment into the study
* Subject with evidence of an active systemic or disseminated fungal infection prior to enrollment
* Subject has a history of anaphylaxis, hypersensitivity, or any serious reactions to the echinocandin class of antifungals
* Subject had received treatment with an echinocandin within one week prior to first dose of study drug
* Subject status is unstable and subject is unlikely to complete required study procedures
* Female subject is pregnant or nursing. Females of childbearing potential must avoid becoming pregnant while receiving study drug
Ghrelin and Insulin Resistance

Ghrelin, a hormone produced in the stomach that stimulates hunger and food intake, declines immediately after weight loss surgery. Some studies suggest that ghrelin may worsen an individual's ability to respond to insulin. The purpose of this study is to determine if the decline in ghrelin levels after weight loss surgery contributes to the improvement of insulin sensitivity.


Eligibility Criteria:
Inclusion Criteria for RYGB group:

* Age 18-65
* BMI \> 35 kg/m2
* Scheduled for bariatric surgery at Vanderbilt University Medical Center

Inclusion Criteria for Lean group:

* Age 18-65
* BMI \< 30kg/m2

Exclusion Criteria:

* Prior bariatric surgery
* Serum creatinine \> 1.5 mg/dl
* Hepatic enzyme elevations \> 2x upper limits of normal
* Current use of warfarin or clopidogrel
* Intercurrent infections
* Females with positive pregnancy test
* Abnormal ECG