cyrilzakka/clinical-trials huggingface dataset:
Helm CPAP Versus Mask CPAP After Major Abdominal Surgery

Postoperative pulmonal complications (Abbreviation - PPC) after major abdominal surgery remains a significant clinical problem delaying rehabilitation after surgery. CPAP is one approach to minimize the frequency and severeness of PPC.

In the investigators' organization intermittent mask CPAP every 2 hour, 15min, is used routineously after major abdominal surgery.

Recently new devices has been designed, which give the opportunity tip deliver continuously CPAP with out interruptions because of presumed better comfort. Therefore better patient compliance.

No studies to date have investigated the possible benefit of using continuously helm CPAP versus the traditional intermittent mask CPAP after major abdominal surgery.

The investigators' study will investigate if there are any benefits with continuously Helm CPAP Versus intermittent Mask CPAP After Major Abdominal Surgery.


Eligibility Criteria:
Inclusion Criteria:

* Elective major abdominal surgery

Exclusion Criteria:

* Severe lung disease. Airway deformity. Need for CPAP at home. Ongoing oxygen therapy. Cannot give informed consent.
Common Engagement Strategies (Common Factors) for Childhood Anxiety

This trial examines the effectiveness of training pediatric primary care providers (nurse practitioners, doctors) to use of strategies that enhance family/youth empowerment and engagement during office visits for children with mild to moderate problems with anxiety. Children coming for routine care at one clinic are screened for anxiety symptoms and seen by either a specially trained provider or one of the clinic's other regular staff members.

Children who are thought to have mild to moderate anxiety will, via their parents, be offered the opportunity to receive treatment from their pediatric primary care provider. Providers will either use their existing anxiety approaches or will use those approaches combined with extra communication skills designed to promote patient and parent engagement in care. Children will be seen for up to 4 30-minute visits at 2 week intervals, with a follow-up telephone call 3 months later to asses the impact of treatment. Children with more severe anxiety (or those whose parents so desire) will be referred for specialized mental health care.

Eligibility Criteria:
Inclusion Criteria:

* Coming for well-child visit to designated clinical site;
* SCARED score 25 or greater

Exclusion Criteria:

* acute medical illness, SCARED 40 or greater
Effect of Reducing Phosphorus Absorption on Cardiac Biomarkers in Hemodialysis Patients

Hyperphosphatemia and elevated cardiac biomarkers are two key characteristics of patients in end stage renal diseases(ESRD),however the majority of whom are in the absence of acute coronary syndrome(ACS). And it is still unclear why cardiac biomarkers would increase in those patients. We hypothesized that excessive phosphorus is account for that phenomenon.To confirm that hypothesis,we used one phosphorus binder to reduce phosphorus absorption in hemodialysis patients for some time and observed the change of cardiac biomarkers of those patients.

Cardiovascular disease is one of the leading causes of morbidity and mortality in patient with chronic kidney disease(CKD), accounting for more than 50% of all deaths.When myocardial cells get injured, cardiac biomarkers will be released into the circulation. Elevated cardiac biomarkers have been observed in patients with various degrees of renal failure. However, the majority of those CKD patients are in the absence of acute coronary syndrome. So far, it is still unclear the mechanisms of the increased biomarkers in CKD patients. Meanwhile, hyperphosphatemia is one of the major features of CKD, particularly of end stage renal disease(ESRD). Lots of evidences have shown that high levels of serum phosphorus and an elevation of the serum calcium × phosphorus product can lead to cardiovascular calcifications and subsequent cardiovascular morbidity and mortality in patients with CKD.it is tempting to hypothesize that hyperphosphatemia may be responsible for the rise of cardiac biomarkers in CKD patients.So we use one phosphate binder to reduce phosphorus absorption in hemodialysis patients for one year and observe the change of cardiac biomarkers of those patients.

Eligibility Criteria:
Inclusion Criteria:

* Time of receiving hemodialysis is more than 1 year;
* Hyperphosphatemia before hemodialysis;
* Never use any phosphorus binder in the past 6 months.

Exclusion Criteria:

* Receiving coronary artery stent implantation before;
* Having any cardiovascular disease in the past 6 months;
* Cannot tolerate the side effects of phosphorus binder;
* Dose not take medicine according to the prescription;
* inadequate dialysis.
Population Pharmacokinetics of Paracetamol in Overweight and Obese Children

The main objective of the study is to define population pharmacokinetic parameters and variability factors for paracetamol and its metabolites in overweight and obese children compared to children with normal weight for age and sex.

This study will determine the pharmacokinetic parameters of paracetamol and its metabolites in overweight and obese children compared to children with normal weight for age and sex. The results will enable establishing dosage recommendations for paracetamol in overweight and/or obese children and adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Child aged 6 to 17 inclusive with normal weight for age and gender (body mass index \[BMI\]\<25kg/m2 adult equivalent at 18 years \[IOTF 25\]), overweight (body mass index \[BMI\]≥ 25kg/m2 adult equivalent at age 18 \[IOTF 25\] and obese (BMI ≥ 30kg/m2 adult equivalent at age 18 \[IOTF 30\]) for age and sex
* Surgical procedure requiring treatment with paracetamol intravenously as an analgesic
* No opposition by the holder(s) of parental authority

Exclusion Criteria:

* History of chronic anaemia (≤ 5g/100ml)
* History of hepatocellular insufficiency (ASAT, ALAT ≥ 3N)
* History of renal impairment (\<60mL/min\*1.73m2)
* History of Gilbert's disease
* History of Type 2 diabetes
* Major motor or neurological disability
* Intake of paracetamol within 24 hours before study inclusion (injection of paracetamol IV or oral intake)
* Patients treated with medicinal products known to affect CYP2E1 or UGT (UDP glucuronosyltransferase): isoniazid, antiepileptic drugs (carbamazepine, phenytoin or phenobarbital), antiretroviral and tyrosine kinase inhibitors
Perioperative Magnesium Sulphate as a Cerebral Protector in Neurosurgical Patients

The purpose of this study is to determine the relationship between magnesium sulphate administration and levels of S100B protein in serum of patients undergoing supratentorial brain parenchymal resection.


Eligibility Criteria:
Inclusion Criteria:

* Male and females older than 18 years.
* Undergoing supratentorial parenchyma resection surgery.
* Capable of collaborate on probes and explorations included in the study.
* Signature the written informed consent form.

Exclusion Criteria:

* Life expectancy less than 12 months due to the suspected histological type of tumour.
* Hypothalamic-pituitary axis illness.
* Presence of Melanoma previously.
* Glomerular filtration rate less than 60 mL/min.
* Thyroid or parathyroid glands pathology.
* Myasthenia gravis.
* Respiratory depression.
* Pregnancy or breastfeeding.
Sildenafil for DCI

Each year, approximately 30,000 people in the United States suffer an intra-cranial hemorrhage due to aneurysmal rupture. Of those surviving the initial event, up to 40% will go on to have further neurological injury secondary to stroke (delayed cerebral ischemia) caused by constriction of blood vessels (i.e. vasospasm). Previous studies have shown that the medication sildenafil, given intravenously, improves vasospasm, but has an associated degree of hypotension. The degree of hypotension was well within safety thresholds for these patients.

Sildenafil is a medication that strongly inhibits the protein phosphodiesterase-V (PDE-V). The hypothesis for this study is that oral sildenafil will also improve vasospasm, but does not result in as much hypotension. Specifically, the investigators look to show that comparable doses of oral sildenafil produces the same degree of PDE-V inhibition as an intravenous dose while the degree of hypotension is reduced. Additionally, using measurements of cerebral blood flow regulation acquired using transcranial Doppler ultrasound, the investigators look to show that oral sildenafil produces the same degree of improvement in vasospasm and blood flow regulation.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 21
2. Onset of symptoms within 72 hours from presentation
3. Subarachnoid hemorrhage from ruptured cerebral aneurysm
4. Cerebral vasospasm diagnosed on transcranial doppler, CT angiography, or digital subtraction angiography

Exclusion Criteria:

1. Pregnancy
2. Subarachnoid hemorrhage secondary to traumatic or mycotic aneurysm
3. Pre-ictal sildenafil therapy (last dose within 1 week of presentation)
4. Contraindications to sildenafil therapy (i.e. use of nitrates, left ventricular outflow obstruction, impaired autonomic blood pressure control)
Remodulin as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn

This study assessed the safety and treatment effect of intravenous (IV) Remodulin as an add-on therapy in neonates with persistent pulmonary hypertension of the newborn (PPHN).

This study was designed to investigate if the addition of Remodulin reduced the rate of clinical worsening (defined as the need for additional treatment targeting PPHN, need for extracorporeal mechanical oxygenation \[ECMO\], or death) in neonatal subjects with PPHN who did not show an adequate response to inhaled nitric oxide (iNO). This study was part of a pediatric investigation plan agreed upon by the EMA (EMEA 000207-PIP01-08-M08).

Eligibility Criteria:
Inclusion Criteria:

* Parent(s) or legal guardian provided consent for the subject to participate
* Weight at least 2 kg at Screening
* Gestational age of ≥34 weeks and ≤14 days old at Screening
* Diagnosis of PPHN, which was either idiopathic in nature or associated with the following: meconium aspiration syndrome, pneumonia, respiratory distress syndrome, sepsis, birth hypoxia, perinatal encephalopathy, or unilateral congenital diaphragmatic hernia
* Currently requiring ventilator support
* Two consecutive oxygenation index (OI) of 15 or greater separated by at least 30 minutes, after receiving iNO for at least 3 hours
* Echocardiographic (ECHO) evidence of pulmonary hypertension with elevated right ventricle pressure
* Dedicated venous access for the administration of study drug (central line or peripherally inserted central venous catheter)

Exclusion Criteria:

* Previous or concurrent use of a phosphodiesterase-5 inhibitor, endothelin receptor antagonist, or prostanoid
* Significant congenital heart disease as detected by ECHO, minor valvular abnormalities, or expected transitional findings such as a patent foramen ovale, or patent ductus arteriosus.
* Clinically significant, untreated active pneumothorax at Screening
* Evidence of clinically significant bleeding at Screening
* Necrotizing enterocolitis (≥Bells stage II at Screening)
* Uncontrolled hypotension (mean systemic pressures ≤35 mmHg at Screening)
* Uncontrolled coagulopathy and / or untreated thrombocytopenia (\<50,000 platelets/µL at Screening)
* History of severe (Grade 3 or 4) intracranial hemorrhage at Screening
* Currently receiving extracorporeal mechanical oxygenation (ECMO) or had immediate plans to initiate ECMO
* Expected duration on mechanical ventilation of \<48 hours
* Life expectancy was less than 2 months or had a lethal chromosomal anomaly
* Contraindication to ECMO
* Bilateral congenital diaphragmatic hernia
* Active seizures at Screening
* Currently participating in another clinical drug study
Circulatory Oscillations in Post Cardiac Surgery Patients

In this observational study investigators examine the presence of circulatory oscillations in blood pressure, heart rate, and doppler laser flow before and after planned cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for routine coronary artery bypass graft (CABG) surgery, single procedure only

Exclusion Criteria:

* no sinus or pacemaker rhythm
* ejection fraction below 0.5
* serious valvular disease
* right ventricular failure
* pulmonary hypertension
* serious postoperative bleeding
Molecular and Microbiota Signatures Underlying Colonic Diverticular Disease

The pathogenesis of diverticular disease is likely multifactorial in origin. This project aims to study the involvement of environmental factors in the pathophysiology of diverticular disease, the underlying molecular mechanisms, and alterations in the microbiota.

The pathogenesis of diverticular disease is likely multifactorial in origin. Some studies have demonstrated the role of genetic factors, while others have highlighted the role of environmental factors. The present project aims to study the involvement of environmental factors in the pathophysiology of diverticular disease, the underlying molecular mechanisms, and alterations in the microbiota.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years.
* Belonging to one of the following groups:

  1. Patients with diverticula of the colon without symptoms.
  2. Patients symptomatic for diverticular disease.
  3. Subjects undergoing colonoscopy for colorectal cancer prevention or follow-up of previous polypectomies, asymptomatic for digestive symptoms.
* Obtaining informed consent.

Exclusion Criteria:

* Acute complicated diverticulitis (bleeding, perforation)
* Previous colon surgery
* Antibiotics or laxatives within the past 90 days
* Pregnancy and/or lactation
* Systemic and psychiatric disorders
* Asthma, food allergies and other allergic-type disorders
* Possible diseases leading to intestinal bacterial contamination (diabetes, blind loop syndrome, rheumatologic diseases).
Circulating Tumor DNA: TBCRC-068

This is a single-arm, phase II study examining elacestrant in the adjuvant treatment of patients with ER+ breast cancer who test positive for circulating tumor DNA (ctDNA) during the screening period of the trial.

This is a single-arm, phase II study examining elacestrant in the adjuvant treatment of patients with ER+ breast cancer who test positive for circulating tumor DNA (ctDNA) during the screening period of the trial. Patients with ER+ breast cancer anatomic stage IIB or III at diagnosis who are at least five years from diagnosis and have completed intended course of adjuvant endocrine therapy and are currently off endocrine therapy will be screened with ctDNA testing. Patients who test positive for ctDNA during the screening phase will receive treatment with elacestrant for one year and continue ctDNA testing and imaging with CT scans every three months. During the follow-up period, patients in the study will continue to be ctDNA tested every six months and monitored for one year and will be allowed to continue on elacestrant for an additional year, resume standard endocrine therapy, or continue with standard of care surveillance during follow up.

Eligibility Criteria:
Inclusion Criteria:

1. Women or men aged 18 years and older.
2. Previous diagnosis of anatomic stage IIB or anatomic stage III histopathologically or cytologically confirmed ER+, HER2-, breast cancer per local laboratory as per ASCO/CAP guidelines. In the context of this trial, ER status will be considered positive if \>10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry, with or without progesterone receptor positivity. Patients who are PR positive but ER-negative are not eligible.
3. Participants must have been diagnosed with ER+HER2- breast cancer at least five years ago and no more than 15 years ago and must have completed adjuvant endocrine therapy.
4. Participants must be off endocrine therapy for at least six months prior to screening.

Exclusion Criteria:

1. Known current metastatic disease.
2. Known contraindication to receiving elacestrant as per FDA package insert.
3. Current treatment with endocrine therapy.
4. Prior treatment with elacestrant or other investigational SERDs.
5. Current or past invasive cancer other than breast cancer, except:

   1. Adequately treated basal or squamous cell carcinoma of the skin.
   2. Cancer survivors of previously diagnosed invasive cancer who were treated with curative intent and have no evidence of disease recurrence for five years or more and are considered low risk for future recurrence by the treating physician.
6. Patients in the screening phase, or in the randomized trial (treatment phase), cannot start receiving therapy on another therapeutic clinical trial.
Escalating and Cumulative-Dose Study of Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety of A006

The main objective is to evaluate the bronchodilatory efficacy, safety and pharmacokinetic profiles of A006 (Albuterol Dry Powder Inhaler (DPI)), in comparison with those of an active control, Proventil-HFA (Albuterol Metered Dose Inhaler (MDI)), and a Placebo DPI in escalating and cumulative-doses up to 1440 mcg, eight (8) times of the proposed clinical dose.


Eligibility Criteria:
Inclusion Criteria:

* Body weight ≥ 50 kg for men and ≥ 45 kg for women, and BMI within the range of 18.5 - 30.0 kg/m2 inclusive;
* Sitting blood pressure ≤ 135/90 mmHg;
* Demonstrating negative alcohol/drug screen tests;
* Demonstrating negative HIV, HBsAg and HCV-Ab screen tests;
* With mild-to-moderate persistent asthma for at least 6 months prior to Screening, and having used inhaled β-agonist(s) for asthma control;
* Demonstrating a Mean Screening Baseline FEV1 at 50.0 - 85.0 % of predicted normal;
* Demonstrating a ≥ 15.0% Airway Reversibility in FEV1 within 30(±5) min after inhaling 2 actuations of Proventil-HFA;
* Demonstrating Peak Inspiratory Flow Rate within 80-150 L/min;
* Demonstrating proficiency in the use of DPI and MDI after training;
* Females of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;
* Having properly consented to participate in the trial.

Exclusion Criteria:

* Smoking history of ≥ 10 pack-years, or having smoked within 6 months prior to Screening;
* Upper respiratory tract infections within 2 wk, or lower respiratory tract infection within 4 wk;
* Asthma exacerbations that required emergency care or hospitalized treatment, within 4 wk prior;
* Any current or recent respiratory conditions that might significantly affect pharmacodynamic response to the study drugs, besides asthma;
* Concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignancies, or other illnesses that could impact on the conduct, safety and evaluation of the study;
* Known intolerance or hypersensitivity to any of the ingredients of the A006 or Proventil-HFA;
* Use of prohibited drugs or failure to observe the drug washout restrictions;
* Having been on other clinical drug/device studies in the last 30 days;
* Having donated blood within the last 30 days prior to Screening.
Age-specific Prevalence and Comparisons of UDS and Bladder Diary Between OAB-wet and -Dry Women

The knowledge of the age-specific prevalence of overactive bladder syndrome (OAB)-wet and -dry women is important for understanding the impact of aging on OAB. Thus, our aim is to describe clinically differences between OAB-wet and -dry women.

Between July 2009 and January 2018, all women with OAB visiting a medical center for evaluation were reviewed. The classification of OAB-wet or OAB-dry is based on the record of the three-day bladder diary of each patient. The diagnosis of OAB in each patient was based on the presence of at least one episode of urgency in her three-day bladder diary and with the absence of stress urinary incontinence. The presence of at least one episode of urgency associated incontinence was defined to be OAB-wet, otherwise, OAB-dry.

Eligibility Criteria:
Inclusion Criteria:

1. More than 20-year-old
2. Female
3. Diagnosed with overactive bladder by bladder diary

Exclusion Criteria:

1. Younger than 20-year-old
2. Pregnant or planned to be pregnant
Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder

The objective is to investigate the safety of the AMPLATZER Muscular VSD Occluder for the treatment of muscular ventricular septal defects, which are hemodynamically significant and are either isolated or in conjunction with other congenital heart defects in infants and children.

The objective of this feasibility study is to investigate the safety of the AMPLATZER Muscular VSD Occluder for the treatment of muscular ventricular septal defects, which are hemodynamically significant and are either isolated or in conjunction with other congenital heart defects in infants and children.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hemodynamically significant muscular VSD's (demonstrated by echocardiography or angiography), either isolated or in conjunction with other congenital heart defects
* Age \< 18 years old

Exclusion Criteria:

* Less than 4 mm distance from the semilunar (aortic and pulmonary) and atrioventricular valves (mitral and tricuspid)
* Patients with severely increased pulmonary vascular resistance above 7 woods units and a right-to-left shunt and documented irreversible pulmonary vascular disease
* Patients with perimembranous (close to the aortic valve) VSD
* Patients \< 3 kg
* Patients with sepsis (local/generalized)
* Patients with gastritis, gastric ulcer, duodenal ulcer, bleeding disorders etc. and other contraindications to aspirin therapy unless other anti-platelet agents can be administered for 6 months
* Inability to obtain informed consent
Temporary Clipping of the Uterine Arteries During Laparoscopic Myomectomy

The aim is to verify, whether intraoperative temporary clipping of the uterine vessels with vascular clips can reduce blood loss significantly.


Eligibility Criteria:
Inclusion Criteria:

* Patients are eligible for the study when between 18 and 50 years of age,
* diagnosed with either symptomatic or asymptomatic leiomyomata, and with desire to keep the uterus, and whose leiomyomata had a minimal combined diameter of ≥ 4 cm.

Exclusion Criteria:

* patients with severe accompanying medical problems, or
* with psychiatric illnesses, which jeopardize the participation, or
* undergoing treatment affecting coagulation and/or hematopoiesis, and
* patients with suspected malignancy.