cyrilzakka/clinical-trials huggingface dataset:
Imatinib (QTI571) in Pulmonary Arterial Hypertension

A multinational, multicenter, double blind, placebo-controlled study evaluating the efficacy and safety of imatinib as an add-on therapy in the treatment of patients with severe pulmonary arterial hypertension (PAH).


Eligibility Criteria:
Key Inclusion criteria

* Male or female patients ≥18 years of age with a current diagnosis of pulmonary arterial hypertension (PAH) according to the Dana Point 2008 Meeting: World Health Organization (WHO) Diagnostic Group I, idiopathic or heritable (familial or sporadic) PAH, PAH associated with collagen vascular disease including systemic sclerosis, rheumatoid arthritis, mixed connective tissue diseases, and overlap syndrome. PAH following one year repair of congenital heart defect \[Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) or Posterior Descending Artery (PDA)\], or PAH associated with diet therapies or other drugs
* A Pulmonary Vascular Resistance (PVR) ≥ 800 dynes.sec.cm-5 (as assessed by Right Heart Catheterization (RHC) at screening or in the 3 months preceding the screening visit) despite treatment with two or more specific PAH therapies, including Endothelin Receptor Antagonists (ERAs), phosphodiesterase 5 inhibitors (PDE5), or subcutaneous, inhaled, intravenous or oral prostacyclin analogues for ≥ 3 months. Background therapy doses were to be stable for ≥ 30 days except for warfarin and prostacyclin analogues ( ≥ 30 days but doses could vary even within the month before enrollment).
* World Health Organization functional Class II-IV. For WHO Functional Class IV, one of the 2 or more specific PAH therapies were to be an inhaled, subcutaneous, intravenous or oral prostacyclin analogue, unless the subject showed intolerance of prostacyclin analogues.
* 6MWD ≥ 150 meters and ≤ 450 meters at screening. Distances of two consecutive 6MWTs were to be within 15% of one another.

Key Exclusion criteria

* With a pulmonary capillary wedge pressure \> 15 mm Hg to rule out PAH secondary to left ventricular dysfunction.
* With a diagnosis of pulmonary artery or vein stenosis
* Left ventricular ejection fraction (LVEF) \< 45%
* With Disseminated Intravascular Coagulation (DIC)
* With evidence of major bleeding or intracranial hemorrhage
* With a history of elevated intracranial pressure
* With a history of latent bleeding risk such as diabetic retinopathy, gastrointestinal bleeding due to gastric or duodenal ulcers, or colitis ulcerosa
* With a QTcF \> 450 msec for males and \> 470 msec for females at screening and baseline in the absence of right bundle branch block.
* With a history of ventricular tachycardia, ventricular fibrillation or ventricular flutter
* With a history of Torsades de Pointes
* With a history of long QT syndrome
* Having undergone atrial septostomy in the 3 months prior to the screening visit
China Alair System Registry Study-CARE Study

The objective of this Registry is to collect real-world outcome data for bronchial thermoplasty (BT) procedures in patients with severe persistent asthma who remain symptomatic despite taking standard of care maintenance medications.

Data will be used to confirm the impact of BT on safety, effectiveness, quality of life, and the anticipated reduction in healthcare utilization events and cost by way of a reduction in severe asthma exacerbations.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is an adult aged 18 years or older with severe persistent asthma who remains symptomatic despite taking standard of care maintenance medications.
2. Patient is able to read, understand, and sign a written Informed Consent to participate in the Registry and able to comply with the study requirements.
3. Patient is able to undergo bronchoscopy in the opinion of the Investigator or per hospital guidelines and as described in the Alair System Directions for Use (DFU).

Exclusion Criteria:

1. Patient has an implanted electrical stimulation device (e.g., a pacemaker, cardiac defibrillator, or deep nerve or deep brain stimulator).
2. Patient has any other medical condition that would make them inappropriate for study participation, in the Investigator's opinion.
Adrenomedullin in Context With Pulmonary Embolism

The pulmonary embolism (PE) causes a blockade of the pulmonary arteries typical due to a thrombus which is formed in the lower region of the body or pretty rare to other materials (tumor, air, fat). The working group plans to evaluate the pathology of the thromboembolism in the case of a partial, subtotal or even total pulmonary embolism. The acute PE is still often in the adult population and in many accompanied by death. Etiological the problem occurs through an acute right ventricular failure and leads into severe pulmonal perfusion disorder with shock and hypoxemia. The right diagnose is pretty hard in the clinical day because all symptoms are common and unspecific. To provide the best treatment in short time it is needed to sum up all the symptoms and evaluate the risk of an acute pulmonary embolism and it's morbidity.

The easiest and fastest way treating a PE is to apply a systemic intravenous thrombolysis but bleeding complications are the most common and most frequently side effects. The decision-making process in patients without shock is pretty hard because of having no clear diagnose. Lab parameters and imaging (CT angiography) is important for the best decision in critical ill PE patients but time is sometimes missing.

A possible new biomarker in identifying a PE is adrenomedullin.

Elevated adenomedullin levels in septic patients with left ventricular heart failure, severe dyspnoea and intubated patients are well known, but in the case of PE it wasn't analysed yet. Human adrenomedullin is a protein with 52 amino acid which is produced in the lung and first extracted in the adrenal gland. The sequence homology is pretty similar to the Calcitonin-Gene-Related-Peptide (CGRP)-protein superfamily (vasodilatation). Its precursor is named pro-adrenomedullin peptide and it shows a significant weaker vasodilatation activity compaired to adrenomedullin. Adrenomedullin causes severe hypotonia in scientific studies where it was applied as an intravenous bolus or infusion. This vasodilatation effect concern to the systemic and as well in the pulmonary circulation. Its vasodilatation mechanism is not clarified yet.

The trial is defined as an prospective study, where the investigators would like to measure/analyse the adrenomeulline level in PE patients in the intermediate high and high risk population. The diagnose and treatment of the patients is fixed to the European Society of Cardiology (ESC) recommendations of the cardiology society of 2019 Guidelines on Acute Pulmonary Embolism (Diagnosis and Management of Pulmonary Embolism).


Eligibility Criteria:
Inclusion Criteria:

* Patients with intermediate high and high risk of an acute pulmonary embolism with clinical symptoms.
* On image based procedures confirmed pulmonary embolism (TTE, contrast CT-angiography).
* Written agreement to the examination.

Exclusion Criteria:

* Age under 18.
* Missing written agreement or cancelled agreement on any time.
Special Turku Atherosclerosis Risk Factor Intervention Project for Children (STRIP)

1062 children at the age of 7 months and their families were randomized 1:1 in an intervention arm and a control arm. The intervention families has received child-oriented and individualized nutritional and life-style counseling that aims at decreasing child's exposure to the known environmental atherosclerosis risk factors. The controls children receive information as given at the well-baby clinics and in school health care of children and adolescents. The hypothesis is that the intervention children have healthier food habits and serum serum lipid and lipoprotein concentrations than the controls, fewer of them start smoking, and their physical activity level is higher than that of the controls.

1062 children at the age of 7 months and their families were randomized 1:1 in an intervention arm and a control arm. The intervention families has received child-oriented and individualized nutritional and life-style counseling that aims at decreasing child's exposure to the known environmental atherosclerosis risk factors. The controls children receive information as given at the well-baby clinics and in school health care of children and adolescents. The hypothesis is that the intervention children have healthier food habits and serum serum lipid and lipoprotein concentrations than the controls, fewer of them start smoking, and their physical activity level is higher than that of the controls. We further hypothesised that the life-style intervention had no adverse mental or somatic effects on the children. Intima-media thickness of the carotid and brachial arterias and aorta and vasodilatation of the brachial artery induced by endogenous NO production have been also been measures at 2-year intervals since the age of 11 years. Recruitment to the study began in 1990 and continued for 2 years. The children are now between 14 and 16 years of age. 550 children remain in the study, which will continue until the last children have reached the age of 20 years.

Eligibility Criteria:
Inclusion Criteria:

* children at the age of 7 months and their families, recruited from the general population

Exclusion Criteria:

* severe sickness
Labor Induction in Preeclampsia High-risk Women

Preeclampsia (PE) is one of the leading causes of maternal and perinatal morbidity and mortality. This pregnancy-specific disorder poses to both pregnant women and their offspring an increased risk of immediate and long-term health problems. The study team is conducting a study entitled "FORECAST" (Implementation of First-trimester Screening and preventiOn of pREeClAmpSia Trial) and established the infrastructure for the first-trimester "screen and prevent" program for preterm PE. However, there is no established evidence regarding the benefit of scheduled labor induction versus expectant management among women identified as high-risk for PE with uncomplicated pregnancy at term. The investigators postulate that induction of labor at 39 weeks' gestation may possibly be an effective intervention to reduce placental complications in women with uncomplicated pregnancy by 39 weeks at high-risk PE women.


Eligibility Criteria:
Inclusion Criteria:

* Age no less than 18 years
* Singleton pregnancy with cephalic presentation and no contraindication to vaginal delivery
* Live fetus
* Screened high-risk for PE
* Informed and written consent

Exclusion Criteria:

* Multiple pregnancy
* Pregnant women who plan to have Cesarean delivery
* Pregnancies complicated by the major fetal abnormality
* Women who are severely ill, those with learning difficulties, or serious mental illness
* Pregnant women with medical, obstetric, or fetal complications or any other indications for delivery before 39 weeks' gestation
Effect of Single Doses of 10 mg NRL001 Applied as a Suppository to the Anal Canal or Rectum

Study to assess the effects of 10mg NRL001 on mean anal resting pressure (MARP) when administered as a slow release suppository applied to the anal canal or rectum. In addition, the pharmacokinetics of NRL001 in plasma, adverse events, and any changes in heart rate or blood pressure were to be assessed.


Eligibility Criteria:
Inclusion Criteria:

* No previous history of ano-rectal conditions/ diseases
* No history of cardiovascular disease
* 18 to 75 years of age
* Males and females (pre-menopausal females of child-bearing potential must be using adequate contraceptive methods and have a negative pregnancy test before the start of the study)

Exclusion Criteria:

* Use of medication in the last 30 days with a vasodilatory activity
* Use of monoamine oxidase inhibitors (MAOI) presently or within the last two weeks before study participation
* Use of any medication in the last 30 days applied to the anus and/or via the rectum (exception: participation in NRL001-01/2006 (SUPP) for previous dosing into the anal canal)
* Application of any unlicensed medication within the previous 3 months (exception: participation in NRL001-01/2006 (SUPP))
* Regular intake of more than 21 units of alcohol per week
* History or any evidence of cardiovascular disease including ischaemic heart disease and hypertension (defined on examination: systolic blood pressure greater than 160mmHg or diastolic blood pressure greater than 90mmHg; based on at least two separate readings), peripheral vascular disease or Raynaud's syndrome
* Presence of diabetes mellitus
* History or symptoms of thyroid diseases, including hypo- or hyperthyroidism
* Pregnant females
* Breast feeding mothers
* Presence of concomitant gastrointestinal diseases or disorders, such as significant abdominal symptoms and haemorrhoids but also any significant organ (e.g. renal, hepatic or cardiac) dysfunction
* Volunteers whom the investigator feels would not be compliant with the requirements of the trial
EoE(Eosinophilic Esophagitis)

To evaluate quantitative magnetic resonance imaging(MRI) as a potential non-invasive, radiation-free diagnostic tool for evaluating esophageal wall remodeling (thickness and stiffness) and response to treatment in children and adolescents with newly diagnosed eosinophilic esophagitis (EoE) presenting with dysphagia (difficulty swallowing) and food impaction.

Eosinophilic esophagitis(EoE) is a form of chronic inflammation affecting the esophagus which often results in wall thickening and esophageal stiffening and is associated with complications, such as esophageal tears and strictures (narrowings). Chronic dysphagia and acute food impaction (swallowed food stuck in the esophagus) are common symptoms of EoE and are associated with esophageal wall thickening and stiffness.

Current diagnostic techniques such as endoscopy with biopsy give only limited information about changes in the esophageal wall in eosinophilic esophagitis(EoE). In routine clinical practice, repeat endoscopic evaluation with biopsy is commonly performed about 3-6 months after initial therapy for eosinophilic esophagitis(EoE). However, follow-up endoscopy with biopsy has drawbacks as it is invasive, costly and typically requires deep sedation or general anesthesia.

We propose to evaluate quantitative MRI as a potential non-invasive diagnostic option for evaluating esophageal wall remodeling in patients with eosinophilic esophagitis(EoE).

Eligibility Criteria:
Inclusion Criteria:

1. Pediatric patients ages 8 to 18 years of age.
2. Pediatric patients with dysphagia(difficulty swallowing) or an episode of food impaction.
3. Pediatric patients newly diagnosed with Eosinophilic Esophagitis -

Exclusion Criteria:

1. Are not able to undergo an MRI without needing sedation or general anesthesia
2. Are allergic to gadolinium-based contrast material
3. Have an ongoing acute kidney injury
4. Have chronic kidney disease with an estimated glomerular filtration rate(eGFR)of \<40 ml/min.
5. Have a presence of eosinophilia involving the stomach and/or esophagus.
6. Have a prior history of caustic ingestion
7. Have a prior history of esophageal surgery, including history of tracheoesophageal fistula.
8. Have known celiac disease
9. Have known Crohn's disease
10. Have known malignancy
11. Have hypereosinophilic syndrome
12. Have recent history of parasitic infection
13. Have known inflammatory bowel disease -
Study of CGC-11047 (PG-11047) in Subjects With Advanced Refractory Solid Tumors

This phase I study aims to assess the safety and tolerability of a new drug - PG-11047 - and to establish what happens to the drug once inside the body. An escalating dose of PG-11047 will be investigated in this study and the maximum tolerated dose of the drug will be established.

This is an open-label phase I, dose-escalation safety study in subjects with refractory solid tumors. The primary objectives of the study are to assess the safety, tolerability, and pharmacokinetics of PG-11047. PG-11047 will be administered as a 60-minute intravenous infusion on days 1, 8 and 15 of each 28 day cycle. The planned minimum treatment schedule is 2 cycles (8 weeks) of PG-11047 treatment. Subjects who tolerate treatment may be eligible to receive additional cycles as per investigator's medical judgment. Evaluation of anti-tumor response will be performed every 2 cycles.

Eligibility Criteria:
Inclusion Criteria:

* non-hematological malignancy where standard therapeutic measures do not exist or no longer effective.
* ECOG - 0-2.
* Life expectancy \> 3 months.

Exclusion Criteria:

* chemotherapy or radiotherapy within 4 weeks prior to entering the study.
* previous high-dose chemotherapy with autologous allogeneic hematopoietic stem cell transplantation.
* primary brain tumors or active brain metastases
* history of significant or symptomatic cardiac arrhythmia, prior myocardial infarction or evidence of a current significant ventricular conduction abnormality
A Single Bolus of Dexmedetomidine Versus Nalbuphine in Postoperative Agitation

The hypothesis of this study is to investigate and compare the efficacy between the administrations of single intravenous (IV) dose of dexmedetomidine versus nalbuphine in preventing immediate postoperative agitation in children undergoing cleft palate repair.

A written informed consent will be taken from the guardian of children.Patients will be assigned randomly to three groups (30 subjects each) to be anesthetized. The study drug will be delivered in opaque bags labeled "study drug" and 90 patients will be allocated in three groups (of 30 patients each) to receive the study drug at the end of surgery; a single dose of 0.5 µ/kg IV dexmedetomidine (Group D) or a single dose of 0.1 mg/kg IV nalbuphine (Group N) or same volume of saline placebo (Group C).

Eligibility Criteria:
Inclusion Criteria:

* Children (age 1-7 years) of American Society of Anaesthesiologists physical status (ASA) I-II
* Elective cleft palate repair ± cleft lip surgery under general anesthesia.

Exclusion Criteria:

* Ventriculo-peritoneal shunt
* Suspected meningitis
* Congenital hydrocephalus
* Clinical signs of suspected increased intracranial pressure
* On treatment for seizures or metabolic diseases
* Children with developmental delay
* Hypersensitivity to dexmedetomidine or nalbuphine
Fixed Dose Rate Gemcitabine and Cisplatin Followed by Chemoradiation for Locally Advanced Pancreatic Cancer

This is a phase Ⅱ trial of fixed dose rate gemcitabine and cisplatin chemotherapy followed by chemoradiation with capecitabine in patients with locally advanced pancreatic cancer.

The main purpose of this study is to evaluate the efficacy and safety of fixed dose rate gemcitabine and cisplatin chemotherapy followed by chemoradiation with capecitabine in patients with locally advanced pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

* unresectable locally advanced pancreatic cancer
* no distant metastasis
* histologically confirmed adenocarcinoma of pancreas
* 18-75 of age
* ECOG performance status 0-2
* normal marrow function :

  * WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3
  * Platelet count at least 100,000/mm3
* normal liver function :

  --Bilirubin no greater than 2.0 mg/dL AST less than 3 times upper limit of normal (ULN)
* normal renal function :

  --Creatinine no greater than 1.5 times ULN
* signed informed consent
SBRT in the Management of Solid Spinal Metastases

Documenting efficiency of SBRT in the management of epidural spinal metastases from solid tumors

The department of radiotherapy in UZLeuven recently included Stereotactic Body Radiotherapy (SBRT) in the standard of care for the management of patients with spinal metastases. The aim of this study is to prospectively document neurological outcome, performance and quality of life following surgery + SBRT for spinal metastases with imminent / actual spinal cord compression, and compare outcomes with the historical cohort of the UZLeuven patients included in the Global Spine Tumor Study Group database between 2011 and 2019 in whom prospective neurological, performance and quality of life outcomes were collected following surgery + conventional radiotherapy

Eligibility Criteria:
Inclusion Criteria:

* Radiological diagnosis of spinal metastasis from solid tumor with epidural imminent or actual spinal cord compression, with or without neurological deficits. Patients will be scheduled for surgery + SBRT. If contra-indications preclude surgery and only SBRT is performed, patients will still be included.
* Written informed consent to participate in the study must be obtained from the subject or proxy /legal representative
* Males and females \> 18 years

Exclusion Criteria:

* Any concomitant condition or disease which, in the opinion of the investigator, would affect the reliability of the collected data.
* Patients that had previous radiotherapy on the index spinal level without the possibility for additional SBRT at that particular level.
The Anabolic Effects of Estrogen on Skeletal Muscles

Purpose: to study the effect of estrogen replacement on muscle hypertrophy in response to 12 weeks resistance training in postmenopausal women Hypothesis: Transdermal administration of 17-β estradiol enhance the anabolic effect of resistance training on muscle mass, strength in postmenopausal women Primary outcome: Muscle hypertrophy (muscle CSA, muscle fiber type specific CSA) Secondary outcome: Messenger RiboNucleic Acid (mRNA)(real-time PCR), protein (western blotting), satellite cell proliferation and activation, Strength, functional test, muscle protein synthese.

Design: Two groups of healthy postmenopausal women (½-5 years after menopause) who have not performed regular resistance exercise (\<1 times per week) the last two years. Randomized, controlled intervention study +/- transdermal administration of estrogen (17-β estradiol). Both groups perform 12 weeks of supervised progressive resistance training (3/week) aiming to induce muscle hypertrophy in the legs.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women, more than 6 months, but less than 5 years since last menstruation.

Exclusion Criteria:

* Less than 2 hours exercise with moderate to high intensity per week the last year, no regular resistance exercise the last 2 years (less than 5 exercise bouts during the last year)
* No previous or present lower limb injuries which may hinder participation in strength training
* No use of medicine which may influence the adaptation to strength training such as regular use of nonsteroidal anti-inflammatory drugs and use of statins, no muscle
* Joint or metabolic diseases or other chronic diseases that would affect the results of the investigation, high blood pressure (\>140/90), smoking