cyrilzakka/clinical-trials huggingface dataset:
Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia

A lung condition called bronchopulmonary dysplasia (BPD) is a major cause of poor outcomes and death for premature infants. Infants with BPD are also at high risk for pulmonary hypertension (PH)-an important contributor to their condition. Previous research has suggested that a protein in the blood, endothelin-1 (ET-1), is associated with pulmonary disease.

This study aims to investigate the incidence of PH and levels of ET-1 among premature babies with BPD. It will also potentially allow us to focus further research efforts and treatment towards these infants, some of our sickest patients at LPCH.

This study aims to 1) investigate the incidence of PH among premature infants with BPD versus those without BPD and 2) investigate ET-1 levels in infants with BPD-associated PH versus those without BPD-associated PH. This study will allow us to help define a high-risk population at LPCH-namely, premature infants with BPD-associated PH. It will also potentially allow us to focus further research efforts and treatment targets towards these infants who encompass some of our sickest patients at LPCH.

In 2009 the Division of Lung Diseases of the National Heart, Lung and Blood Institute (NHLBI) published seven priority areas for research in pediatric pulmonary diseases, one of which was pulmonary vascular disease. An emphasis was made on finding 'clinical strategies that anticipate the development of PH \[which\] may allow earlier recognition and more aggressive therapy, thereby slowing the development of PH in many chronic lung parenchymal and vascular diseases'. This study attempts to address this goal. Specifically we aim to evaluate ET-1 levels in premature infants diagnosed with BPD and with BPD-associated PH. If ET-1 levels are found to correlate with disease state the possibility of prediction and possible early treatment for PH in these infants is raised and merits investigation.

Eligibility Criteria:
Inclusion Criteria:

* Premature Infants (\<30 weeks EGA)

Exclusion Criteria:

* Major congenital malformations (cardiac, respiratory, gastrointestinal)
* congenital infection, and/or
* known genetic syndromes (i.e. trisomy 21)
Absorption of Corticosteroids in Children With Juvenile Dermatomyositis

Juvenile dermatomyositis (JDM) is a connective tissue disease that causes skin rash and weak muscles in children. The purpose of this study is to measure the absorption of oral prednisolone and intravenous (IV) methylprednisolone and to determine levels of disease activity indicators in the blood. These levels will be compared to see if there are patterns specific to active and less active JDM.

JDM is a connective tissue disease that is characterized by inflammation of the muscles and the skin. Corticosteroids, such as prednisolone and methylprednisolone, can be administered to help control symptoms of the disease, but absorption patterns of these medications in oral and IV forms are unknown. This study will assess absorption of oral prednisolone and IV methylprednisolone, measure levels of two disease activity indicators (von Willebrand factor and neopterin), and correlate these values in children with JDM.

Patients will participate in this study twice within a period of up to a year, once when the patient's disease is active, and again 6 to 12 months later when the disease is less active. Each of the two study periods will last two nights and two days. Patients will be admitted to the hospital the first night, and a small IV port will be inserted in the patient's arm the first morning to allow for multiple blood draws without additional needle sticks. Patients will receive oral prednisolone the first morning and IV methylprednisolone the second morning. Baseline blood draws will be performed prior to administration of drug, with 13 additional draws over a 6 hour period following drug administration. Following the final blood draw on the second day, the IV port will be removed from the patient's arm and the patient will be discharged from the hospital.

Blood drawn from patients will be assessed for absorption of the drugs and levels of von Willebrand factor and neopterin. Patients will undergo the same sequence of events sometime between 6 to 12 months after the first hospitalization, after their vasculitis is judged to be less active.

Eligibility Criteria:
Inclusion Criteria:

* Juvenile dermatomyositis with evidence of active vasculitis
* Elevated von Willebrand factor antigen prior to study entry
* Elevated neopterin level prior to study entry

Exclusion Criteria:

* Severe renal involvement
* Critically ill or clinically unstable
* Diseases other than dermatomyositis with vasculitis
Can Mass Media Campaigns Reduce Child Mortality

A cluster-randomised trial will be undertaken in Burkina Faso to investigate whether a comprehensive mass media campaign using local radio stations can change behaviours on a scale large enough to result in measurable and sustainable reductions in under-five child mortality.

It is hypothesised that as a result of the scale and multi-pronged nature of the campaign, reductions of between 10% and 20% in child mortality will be achieved.

The evaluation is conducted in 14 geographical locations throughout Burkina Faso. Seven of these 14 clusters have been randomly allocated to receive the mass media intervention while the remaining 7 clusters will serve as controls.

Data collection includes household surveys in all 14 clusters at three "key" times:

* At baseline: Before the implementation of the intervention, between December 2011 and February 2012 to measure the current level of child mortality and evaluate current knowledge and behaviours of relevance to child health.
* At midline: Fifteen months after implementation of the intervention to evaluate the coverage of the intervention (in the intervention clusters) and, in each cluster, knowledge and behaviours.
* At endline: Two and a half years after implementation of the intervention to evaluate intervention coverage (in the intervention clusters), knowledge and behaviours and child mortality.

Eligibility Criteria:
Inclusion Criteria:

* Residence in study clusters

Exclusion Criteria:

* None
Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)

This study is crossover study to evaluate safety and efficacy of lansoprazole in preterm infants with gastroesophageal reflux.


Eligibility Criteria:
Inclusion Criteria:

* preterm infant
* symptoms suspecting gastroesophageal reflux

Exclusion Criteria:

* unstable general conditions due infection or acute illness
* congenital anomaly in upper gastrointestinal tract including esophagus
* drug history of H2, proton pump inhibitor, blocker during last 1 week
* medication of warfarin, carbamazepine, phenytoin, rifampin
* inappropriate clinical conditions judged by researchers
Rapid On Site Evaluation of Pleural Touch Preparations in Diagnosing Malignant Pleural Effusion in Patients Undergoing Pleuroscopy

This trial studies how well rapid on site evaluation of pleural touch preparations works in diagnosing cancerous fluid in between the linings of the lungs (malignant pleural effusion) in patients undergoing a pleuroscopy. A type of laboratory testing called rapid on site evaluation of pleural touch preparations that uses pleural biopsy tissue samples collected during an already-scheduled pleuroscopy may be able to diagnose malignant pleural effusion.

PRIMARY OBJECTIVES:

I. To estimate the specificity of rapid on site evaluation (ROSE) of touch preparations (preps) for predicting malignancy on final pathology in pleuroscopy.

SECONDARY OBJECTIVES:

I. To estimate the sensitivity of rapid on site evaluation (ROSE) of touch preparations (preps) for predicting malignancy on final pathology in pleuroscopy.

II. To estimate the specificity and sensitivity of visual assessment of pleura for predicting malignancy on final pathology in pleuroscopy.

III. To compare the specificity and sensitivity of ROSE of touch preps between centers.

OUTLINE:

Patients undergo biopsy of the lining of the lung using pleuroscopy. Medical chart of patients is also reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo pleuroscopy with biopsy

Exclusion Criteria:

* Patients with known malignant pleural effusion
* Inability or unwillingness to give informed consent
Effectiveness of Sacral Neuromodulation in Low Anterior Resection Syndrome

Low anterior resection syndrome (LARS) is a complex disorder suffered by patients who undergo rectal resection mainly due to rectal cancer. It is characterized by fecal incontinence, fragmented defecation, constipation, defecatory urgency among others, which induce an impairment in quality of life.

LARS treatment armamentarium is scarce and with no long-term relief, being a difficult challenge for surgeons. There is evidence showing that sacral neuromodulation (SNM) improves patients' symptoms and quality of life. However, no prospective randomized studies have supported this improvement.

This is a prospective randomized cross-over study which evaluates the effectiveness of SNM in LARS, specifically analyzing intestinal, urinary, sexual symptoms as well as quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have had an anterior rectal resection with sphincter preservation by any approach, with or without preoperative radiotherapy.
* Patients with symptomatology of major anterior resection syndrome (\>29 points on LARS score) including fecal incontinence, defecatory urgency, fecal fragmentation.
* Period greater than one year since the last definitive surgery (rectal resection or ileostomy closure).
* Period longer than one year in cases in which any other type of therapy has been performed for the anterior resection syndrome (for example: biofeedback, posterior tibial stimulation, physiotherapy, etc).

Exclusion Criteria:

* Patients who refuse to sign informed consent or are unable to understand the study.
* Patients with progression of the oncological disease.
* Patients in initial stage IV (metastatic).
* Patients with inflammatory bowel disease.
* Patients with known irritable bowel prior to rectal surgery.
* Patients who have undergone resection of other intestinal segments.
* Patients with systemic neurological diseases with involvement of long pathways or spinal cord injury.
Can Nephrocheck™ Predict the Reversibility of Early, Acute Kidney Injury During Septic Shock?

Patients with septic shock in the intensive care unit have an elevated risk of developing acute kidney injury (AKI).

Patients with septic shock in the intensive care unit have an elevated risk of developing acute kidney injury (AKI). AKI is an independent factor for mortality. Interventions that limit the worsening of renal function might have an impact on the mortality rate in these patients. Given the absence of validated pharmacological treatments for limiting the progression of AKI or for accelerating recovery from AKI, early intervention and the restoration of the glomerular filtration rate (GFR) in this context of hemodynamic change during the initial phase of septic shock might improve the patients' prognosis. One major challenge is therefore how to determine whether or not the AKI is reversible. The best-studied biomarkers (NGAL and KIM 1) have little discriminant power in septic patients because of their poor specificity or unsuitable kinetics for very early diagnosis. The combination of urine assays for tissue inhibitor of metalloproteinase 2 (TIMP2) and insulin-like growth factor binding protein 7 (IGFBP7) has shown good diagnostic performance for the very early detection of the risk of developing AKI in the following 12 hrs. Urine levels of these two markers specifically reflect damage to kidney tubules. Moreover, the levels appear to be strongly correlated with the severity of tubule damage. Thus, one can reasonably hypothesize that measurement of these markers in the very early stages of septic shock might determine the presence and severity of kidney tubule damage. A threshold (yet to be defined) would help to differentiate between (i) transient, non-severe injury and (ii) injury that is already too severe to be reversible.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over
* Septic shock (according to Bone's criteria) within 4 hours of introduction of catecholamines
* AKI, characterized by a KDIGO score ≥ 1
* Social security coverage

Exclusion Criteria:

* AKI requiring emergency RRT (in the critical care physician's opinion).
* Anuria
* Stage 4-5 chronic kidney failure with a GFR below 30 ml/min.
* Rapidly progressing renal disorders (glomerulonephritis, HUS, blockage, etc.)
* Obstructive AKI
* Probable glomerular damage (nephritic syndrome, nephrotic syndrome, chronic glomerulonephritis)
* Pregnancy or breastfeeding
* Legal guardianship or lack of social security coverage.
* Cardiocirculatory arrest
* Life expectancy \<48 hours.
* Child C cirrhosis
* Prior occurrence of AKI during the current hospital stay
* Transplantation
* Subject participating in another study with an exclusion period ongoing at the time of the pre-inclusion
Study to Evaluate the Impact of Using Wearable Devices in Addition to Standard Clinical Practice on Parkinson´s Subject Symptoms Management

Evaluate the benefits of Kinesia-360™ wearable technology in addition to standard clinical practice on improving Parkinson´s disease motor symptoms, Neupro dosing regimen and adherence to Neupro compared with only standard clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Subject is newly prescribed Neupro and is expected to commence Neupro treatment. Historical Neupro treatment is permitted
* Informed Consent form (ICF) is signed and dated by the subject, before any study-related procedures
* Subject is considered reliable and capable of adhering to the protocol, visit schedule, completion of the diary, and using Kinesia devices according to the judgment of the Investigator
* Male or female subject, \>=18 years of age at the time of the Screening Visit
* Subject has Parkinson's disease, defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: tremor at rest, rigidity or impairment of postural reflexes, and without any other known or suspected cause of Secondary Parkinsonism
* Subject experiences motor symptoms associated with Parkinson's disease that are not sufficiently controlled by current therapy. The average of the triplicate resting tremor scores and triplicate finger tapping scores from Kinesia-ONE™ (6 scores in total) must be \>1.0

Exclusion Criteria:

* Subject is currently participating in any study with an investigational medicinal product or investigational device
* Subject has any medical, neurological or psychiatric condition which, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study
* Subject with Deep Brain Stimulation (DBS) device implant
Combining Donepezil With Perceptual Learning in Normal and Amblyopic Human The Effect of Donepezil on Perceptual Learning in Adult Amblyopia

The research deals with amblyopia or lazy eye, a condition that affects about 3% of the population, and results in a variety of visual deficits. Recent work suggests that there is limited neural plasticity in the visual system of adults with amblyopia. This study is aimed at understanding and increasing this plasticity. In this study, the investigators aim to understand how the amblyopic brain learns and how this process is affected by a drug called donepezil, which is sometimes given as a treatment for Alzheimer's disease. The investigators hope that this study will help to identify the chemical components that help the brain to learn, as well as the mechanism of amblyopia. The investigators also plan to test the normal periphery, as control.

The research deals with amblyopia or lazy eye, a condition that affects about 3% of the population, and results in a variety of visual deficits. Recent work suggests that there is limited neural plasticity in the visual system of adults with amblyopia. This study is aimed at understanding and increasing this plasticity. In this study, the investigators aim to understand how the amblyopic brain learns and how this process is affected by a drug called donepezil, which is sometimes given as a treatment for Alzheimer's disease. The investigators hope that this study will help to identify the chemical components that help the brain to learn, as well as the mechanism of amblyopia. The investigators also plan to test the normal periphery, as control.

In this study, donepezil will be administered while amblyopic subjects (or normally sighted subjects tested in the periphery) are trained on a low-contrast single-letter recognition task, or an uncrowd task (recognizing a letter closely embedded within two other letters). Subjects will be asked to identify the target letter (the low-contrast single letter, or the letter embedded within other letters). Training will take place for 10 consecutive days. Pre- and post-tests will be conducted immediately before and after training, and will consist of the measurements of visual acuity, crowding extent and contrast threshold for recognizing single letters.

Eligibility Criteria:
Subjects with amblyopia

Inclusion Criteria:

* corrected visual acuity being 20/30 or worse in the poorer eye (at least 20/20 in the better eye)
* reduced stereoacuity
* normal retina

Exclusion Criteria:

* with other diagnosed eye diseases

Subjects with normal vision

Inclusion Criteria:

* corrected visual acuity at least 20/20 in each eye
* normal stereoacuity
* normal retina

Exclusion Criteria:

* with other diagnosed eye diseases
Safety and Efficacy Study of the Effect of Etanercept in Hemodialysis Patients

Etanercept is a novel anti-inflammatory agent currently used in patients with rheumatoid arthritis. We are examining whether Etanercept is effective in improving the nutritional status of hemodialysis patients as a consequence of its ability to decrease inflammation.

Hemodialysis patients with end stage renal disease have a high mortality rate. In individual patients, mortality is associated with a low serum albumin concentration, a marker of poor nutritional status, and with elevated C-reactive protein, a marker of inflammation. Since efforts to improve nutrition through dietary intake have not been successful, inflammation is thought to play a key role in determining nutritional status. Recently, it has been shown that malnutrition, inflammation, and atherosclerosis are closely related in patients with chronic renal failure. It is our hypothesis that suppression of the cycle of inflammation, malnutrition, and vascular injury caused by atherosclerosis will improve survival in dialysis patients. This study is designed to examine whether suppression of the inflammatory response can be accomplished safely with Etanercept and to determine if this suppression will improve nutritional status and clinical outcome in hemodialysis patients with poor nutritional status and evidence of inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Presence of end stage renal disease

Exclusion Criteria:

* History of Tuberculosis History of Recurrent Infection Recent AMI, Cancer within previous 5 years Presence of Hepatitis B, Hepatitis C, HIV, systemic lupus erythematosis, presence of transcutaneous access (external catheter)
Surgery As Needed for Oesophageal Cancer - 2

A prospective cohort study on active surveillance after neoadjuvant chemoradiation for oesophageal cancer: SANO-2 study.

An active surveillance approach after completion of neoadjuvant chemoradiotherapy for locally advanced oesophageal cancer is being investigated in the SANO (Surgery As Needed for Oesophageal cancer) trial, that completed patient inclusion in December 2020. First long term results are expected end 2023. Based on current retrospective studies and short term results of the SANO, to date there is no evidence that active surveillance is unsafe. Within the follow-up of the SANO trial, the safety of active surveillance is continuously monitored. Based on a high participation rate (\>90%) in the SANO trial and on the view of the Dutch patient federation for cancer of the digestive tract (SPKS) to offer active surveillance as an alternative treatment option in a controlled setting, there is a demand for a tailored surgery approach after neoadjuvant chemoradiotherapy until results of the SANO trial are available. When patients request active surveillance outside the SANO trial, it is of the utmost importance to set up a prospective cohort study (extension study) in order to monitor safety, implementation and effectiveness of active surveillance outside the SANO trial before the final results of the SANO trail are available.

Eligibility Criteria:
Inclusion Criteria:

* Operable patients who are planned to undergo or who recently underwent neoadjuvant chemoradiotherapy according to CROSS followed by surgical resection for histologically proven oesophageal squamous cell carcinoma or adenocarcinoma of the oesophagus or oesophago-gastric junction
* Age ≥18
* Written, voluntary, informed consent.

Exclusion Criteria:

* Non-FDG-avid tumour at baseline PET-CT scan
* Initial treatment with endoscopic resection
* Patients who underwent of who are planned to undergo definitive chemoradiotherapy
* Language difficulty, dementia or altered mental status prohibiting the understanding and giving of informed consent.
High Dose Rate Interstitial Brachytherapy With Three Dimensional Printing Template for Recurrent Gynecologic Tumors

This is a single-center study.Eligible patients will have histologically proven pelvic recurrence of cervical cancer after radiotherapy .

The results of treatment, examination and follow-up of patients with recurrent cervical cancer after radiotherapy who recieved imaging guided three dimensional printing personalized template assisted with 192Ir high dose rate interorganizational braided therapy were statistically analyzed .

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed pelvic recurrence of cervical cancer.
* Age ≥ 18 years and ≤ 75 years.
* Previous accept pelvic radiotherapy;
* Karnofsky ≥60；
* Patients reject or cannot tolerate surgery;
* Received 192Ir high dose rate intertissue salvage therapy;
* Ultrasound guidance or computed tomography guidance;
* Regular review and follow-up.

Exclusion Criteria:

* Patients participated in clinical trials of other drugs within four weeks;
* The patient had a previous history of bleeding, and any bleeding event with severity rating of CTCAE5.0 or above occurred within 4 weeks prior to screening;
* There are any puncture taboos.
* Patients with severe cardiovascular and cerebrovascular diseases.
* Unable to treat as planned.
* Patients lack major indicators and cannot participate in post-treatment review and follow-up.