cyrilzakka/clinical-trials huggingface dataset:
Exploratory Study of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW Canada)

The Exploratory study of the Edwards APTURE transcatheter shunt system (APTURE system) is a multi-center, prospective, exploratory study to evaluate initial clinical safety, device functionality, and effectiveness of the APTURE system.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic HF:

  * NYHA II w/ history of \> II; III; or ambulatory IV AND
  * ≥1 HF hospitalization OR treatment with IV or oral diuresis within 12 months OR Elevated NT-proBNP value \> 150 pg/ml in normal sinus rhythm, \>450 pg/ml in atrial fibrillation, OR a BNP value \> 50 pg/ml in normal sinus rhythm, \> 150 pg/ml in atrial fibrillation within the past 6 months prior to study entry
* On stable GDMT for HF
* Left Ventricular Ejection Fraction (LVEF) ≤ 40% as determined by site cardiologist
* Hemodynamic criteria

  o At rest: Elevated LAP (or PCWP) \> 15 mmHg AND LAP \> RAP + 5 mmHg AND/OR supine ergometer exercise: elevated LAP (or PCWP) \> 25 mmHg AND LAP \> RAP + 10 mmHg
* Pulmonary Vascular Resistance (PVR) \< 5.0 WU as determined by site cardiologist

Exclusion Criteria

* Severe HF:

  * NYHA IV, stage D, non-ambulatory, transplant list
  * Cardiac index ≤ 1.5 L/min/m2
  * Left Ventricular End-Diastolic Diameter (LVEDD) \> 8 cm
  * LVEF \<20%
* Valve disease

  * MR \>3+ or \> moderate MS, TR \>3+ (severe on 5-point scale), AR \>2+,
  * OR \> moderate AS
* MI or therapeutic invasive cardiac procedure \< 3 months
* TIA, stroke, CRT implanted \< 6 months
* RV dysfunction \> mild by TTE OR TAPSE \<1.2 OR RV size ≥ LV size by TTE, OR Right Ventricular Fractional Area Change (RVFAC) ≤ 25%
* Dialysis OR renal dysfunction (S-Cr \> 220 micromol/L OR e-GFR \< 25ml/min/1.73 m2)
* 6MWT \<50m OR \>400m
* Active endocarditis or infection \< 3 months
* Mean Right Atrial Pressure (mRAP) \> 15 mmHg as determined by site cardiologist
* Body Mass Index (BMI) ≥ 45 kg/m2
Gene Therapy for X-linked Chronic Granulomatous Disease (X-CGD)

X-linked chronic granulomatous disease (X-CGD) is a rare genetic disorder, which affects boys. It is caused by an error in a gene that makes part of the immune system. The basic defect lies in specialised white blood cells called phagocytic cells (or phagocytes), which are responsible for protection against infection by destroying invading bacteria and fungi. They do this by pouring large amounts of substances similar to bleach onto these organisms. In CGD, there is a defect in the system that makes the bleach, called the NADPH-oxidase. In X-CGD (which accounts for two thirds of patients), the defect lies in a gene which makes up a critical part of the NADPH-oxidase (known as gp91-phox), and the cells cannot make bleach-like substances. Therefore they kill bacteria and fungi poorly, and the patients suffer from severe and recurrent infections. This also results in inflammation which can damage parts of the body such as the lung and gut.

In many cases, patients can be adequately protected from infection by constant intake of antibiotics. However, in others, severe life-threatening infections break through. In some cases, inflammation in the bowel or urinary systems results in blockages which cannot be treated with antibiotics, and which may require the use of other drugs such as steroids. Development of curative treatments for CGD is therefore of great importance.


Eligibility Criteria:
Inclusion Criteria:

* Male X-CGD patients
* Molecular diagnosis confirmed by DNA sequencing
* At least one prior ongoing or resistant severe infection and/or inflammatory complications requiring hospitalisation despite conventional therapy
* No HLA-matched donor available after 3 months search unless the risk of waiting for a potential match or for performing an allogeneic transplant is considered unacceptable by the investigator

Exclusion Criteria:

* Contraindication for leukapheresis
* Contraindication for administration of conditioning medication
* Administration of gammainterferon within 30 days before the infusion of transduced autologous CD34+ cells
Comparing Two Types of Needle for Oocytes Retrieval

In the early stages of assisted reproductive technologies (ART), oocyte retrieval was performed via laparoscopy, a cumbersome and expensive process requiring general anesthesia. Today, transvaginal oocyte retrieval for ART is a routine procedure performed under ultrasound guidance. Double-lumen retrieval needles, which are capable of flushing ovarian follicles, were developed to overcome the possibility of oocyte retention within the ovarian follicles and retrieval collection system. Single lumen needles have been introduced and are routinely used by most groups due to their supposed ability to retrieve the same number of oocytes in a shorter operation time.

After a long period in which Humanitas department used double lumen needles for oocytes retrieval in the last four years the choice of the needle is an operator choice, usually influenced by the number of follicles present at human Chorionic Gonadotropin (hCG) trigger.

This prospective randomized controlled clinical trial is designed to highlight differences between Double Lumen Aspiration Needle and Single Lumen Needle commonly used in Humanitas' clinical practice primarly in terms of number of retrived oocytes per procedure (A). Secondary outcomes are the number of punctured follicles (B), the retrieval rate (%) (A/B), the number of follicles at the last ultrasound performed prior to the ovulation trigger (C), the number of retrieved oocytes / number of follicles at trigger-day (A/C), retrieval procedure time (D), single oocyte retrieval time (D/A), the number of mature oocytes (and MII) and complications rate. Number of transferred embryos, number of frozen embryos and oocytes, clinical pregnancy rate per retrieval and per transfer (considering the number of pregnancies diagnosed by US visualization of one or more gestational sacs or definitive clinical signs of pregnancy per 100 cycles) and total number of clinical pregnancies with fetal heart beat (confirmed by visualization of one or more embryos with heartbeat at early dating ultrasound), are also evaluated. Standard protocols will be used for controlled ovarian hyper stimulation. Trans vaginal ultrasound-guided oocyte retrieval will be performed 36 hours ± 2 after hCG injection with the patient under deep sedation.

One hundred patients per each needle will be enrolled in this trial.

Eligibility Criteria:
Inclusion Criteria:

* IVF/ intracytoplasmatic sperm injection (ICSI) cycles;

Exclusion Criteria:

* Ovarian Endometriomas;
* Severe previous pelvic inflammatory disease with frozen pelvis
A 12 Week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.

This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to severe airflow limitation.

NOTE: Detailed Description: data not entered

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients that have signed informed consent and are \>/= 40 years of age.
* Patients with stable COPD according to GOLD 2011.
* Patients with a post-bronchodilator FEV1 of \>/= 30% and \< 80% predicted and a post-bronchodilator FEV1/FVC \<0.70.
* Current or ex-smokers who have a smoking history of at least 10 pack years.
* Patients with an mMRC grade 2 or greater.

Exclusion Criteria:

* Patients with Type I or uncontrolled Type II diabetes - Patients with a history of long QT syndrome or whose QTc measured at Visit 101 (Fridericia method) is prolonged (\>450 ms for males and females) and confirmed by a central assessor. (These patients should not be re-screened.)
* Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 102. (These patients should not be re-screened.)
* Patients with a history of malignancy of any organ system, treated or untreated, within the last five years.
* Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or moderate-severe renal impairment or urinary retention.
* Patients who had a COPD exacerbation within 6 weeks prior to screening.
* Patients who have a respiratory tract infection within 4 weeks prior to screening.
* Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.
* Patients with a history of asthma. 8. Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to age 40 years.
* Patients with a blood eosinophil count of greater than 600 mm/3 during run-in.
* Patients with concomitant pulmonary disease.
* Patients with a diagnosis of alpha-1 anti-trypsin deficiency.
* Patients with active pulmonary tuberculosis.
* Patients in the active phase of a pulmonary rehabilitation programme.
* Other protocol-defined inclusion/exclusion criteria may apply
Expressive Language and Cognitive Early Development in Very Low Birth-Weight Preterm Toddlers

The aim of the present study is to describe the performance of very low birth-weight preterm toddlers regarding expressive language and cognitive development during sensorimotor and beginning of pre-operational periods, as well as to compare the performance presented by these children to that presented by their full-term peers, according to Genetic Epistemology theoretical principles.

The hypothesis of this study is that very-low birth weight preterms would present a poorer performance, concerning expressive language and cognition development,than their full-term peers.

Very low birth weight preterm infants are known to have risks of cognitive and behavioral problems, including learning difficulties, attention deficits and hyperactivity, as well as neuromotor deficits. Moreover, they are reported to have a high risk of speech and language impairments up to school age, even in cases where major neurological abnormalities are excluded. Impairments have been reported both in receptive and expressive language and, more specifically, in morphosyntax and naming.

Eligibility Criteria:
Study Group:

Inclusion Criteria:

* gestational age lower than 34 weeks (according to the date of last menstrual period - DLMP);
* birth weight equal or lower than 1500g;
* exposed only to Brazilian Portuguese

Exclusion Criteria:

* presence of major malformations, genetic syndromes, severe neonatal asphyxia, hearing impairment or visual impairment.

Control Group:

Inclusion Criteria:

* gestational age higher than 38 weeks;
* adequate for gestational age;
* birth weight higher than 2500g up to 3999g
* exposed only to Brazilian Portuguese

Exclusion Criteria:

* pre, peri or post natal intercurrence
Study to Evaluate the Non-inferiority of Cavir in HBeAg(+)Chronic Hepatitis B Patients Treated With Baraclude

Open-labeled, Prospective, Randomized, Multi-center, Interventional, Phase IV study.

The purpose of this study is to evaluate the non-inferiority and safety in terms of HBV DNA undetectability comparing Baraclude Tab. in HBeAg(+) chronic hepatitis B patients treated with long-term Baraclude Tab.

Eligibility Criteria:
Inclusion Criteria:

* Patients (over the19 years of age) currently taking Baraclude® monotherapy for chronic HBV infection for at least 24 month with \< HBV DNA 60 IU/mL level, HBeAg positive and HBeAb negative status at screening.

Exclusion Criteria:

* Patients are diagnosed Hepatitis cancer and hepatocellular carcinoma (HCC)
* Patient has concomitant other chronic viral infection (HAV/Hepatitis C Virus (HCV)/Hepatitis D Virus(HDV)/HIV)
* Patient had documented resistance mutations at any time before or at screening
* Patient has clinically confirmed alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency and Wilson's Disease.
* Patient has received antiviral agent including interferon other than Baraclude within 24 months before screening for this study.
* Patient has received immunosuppressive agent within 24 weeks before screening or corticosteroids for 4 weeks.
* Clinical signs as indicated by any one of the following: Ccr(Cockroft-Gault) \< 50ml/min, Total bilirubin \> 3.0 mg/dl, Albumin \< 2.7 g/dl, Prothrombin time \> INR 2.3
* Patient is pregnant or breastfeeding or willing to be pregnant
* Patient has malignancy except for thyroid cancer and Borderline malignancy.a history of treated malignancy is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding five years
Impact of the Development of Pediatric Palliative Care

Despite medical advances, cancer remains the leading cause of death by disease in children.

Brain tumors are the second most common cause of cancer in children after leukemia, representing 25% of pediatric cancers.

The overall survival rate is about 50% with extremes ranging from less than 5% to more than 90% depending on the histological type of brain tumor.

The end of life of children with a brain tumor is marked by the possibility of discomfort symptoms, painful or not, and by a progressive neurological deterioration, which makes the management of these children complex for both families and health professionals.

Over the last decade, the concept of palliative care has been increasingly integrated into pediatric onco-hematology services with the primary objective of better symptom control in a global approach to the child and his or her family in order to aim at a better quality of life.

The main objective of the study is to compare the occurrence and management of end-of-life symptoms in children who died of a primary brain tumor over 2 periods, in 2009 - 2010 and in 2019 - 2020, followed in the Pediatric Oncology departments of Strasbourg, Besançon, Dijon, Nancy and Reims.

Eligibility Criteria:
Inclusion criteria:

* Patient less than 17 years of age
* Suffering from a primary brain tumor
* Died during the period 2009-2010 or during the period 2019-2020
* Follow-up in one of the Pediatric Oncology departments participating in the study (Strasbourg, Besançon, Dijon, Nancy and Reims)
* Absence of refusal expressed in the medical file by the parents or the holder(s) of parental authority concerning the reuse of the child's personal data for research purposes.

Exclusion criteria:

* Refusal expressed in the medical file by the parents or the holder(s) of parental authority concerning the reuse of the child's personal data for research purposes
* Patient with a brain tumor secondary to another cancer
Pressure and Diabetic Foot

Diabetic foot ulcer (DFU) is a worldwide burden in the management of patients with diabetes. Peripheral neuropathy has a key role in the physiopathology of DFU. Others factors as skin vulnerability to plantar pressure, glycation of skin protein, articular rigidity, vascular component and abnormal foot plantar pressure are also important to take into account. The aim of the study is to assess prospectively different factors involved in DFU pathogenesis notably the neurovascular response to non noxious pressure.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Type 2 diabetic subject
* Absence of active diabetic foot ulcer
* Patients "Grade 0", "Grade 1", "Grade 2" or "Grade 3" of the International Working Group on Diabetic Foot Risk Classification defined by:
* absence of alteration of perception of Monofilament 10g at the level of the plantar arch for the "grade 0"
* alteration of perception of Monofilament 10g at the level of the plantar arch for the "grade 1"
* alteration of perception of Monofilament 10g at the level of the plantar arch associated with foot deformity and / or an arteriopathy defined by the absence of perception of one of the two peripheral pulses for the "grade 2"
* History of diabetic foot ulcer for the "grade 3"
* Signature of consent to participate in the study

Exclusion Criteria:

* Chronic alcoholism with usual consumption of at least 5 alcoholic drinks per day
* Pregnancy
* Congenital methemoglobinemia.
* Porphyria
* Skin injured on the tibia, whatever the lesion
* Recent major cardiovascular history (less than 3 months)
* Severe renal disease (serum creatinine\> 300 μmol.l-1)
Pregnancy Cohort in Multiple Sclerosis (MS)

Multiple sclerosis (MS) is a common inflammatory demyelinating disorder of the central nervous system frequently affecting females in their reproductive phase of life. In this prospective observational study, we obtain data on the outcome of pregnancies in MS patients and the influence of pregnancy on clinical, laboratory and MRI parameters in MS.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* signed informed consent
* diagnosis of multiple sclerosis or clinically isolated syndrome

Exclusion Criteria:

* clinically relevant comorbidities
* contraindications for MRI, e.g. pacemaker, metal implants, allergy against gadolinium
* alcohol or drug abuse
Natural History of Apparent Mineralocorticoid Excess Syndrome

Apparent mineralocorticoid excess (AME) is a rare inherited disease that can cause severe high blood pressure and low blood potassium in children and adults. It is caused by abnormal hormone metabolism and can be fatal. This study will focus on the genetic basis, natural history, disease progression, and survival of people with AME.

AME is a rare genetic disorder that is caused by a mutated HSD11B2 gene, which encodes the metabolic enzyme 11BHSD2. The altered gene interferes with the ability of 11BHSD2 to inactivate the hormone cortisol. Above-normal cortisol activity then leads to a rise in blood pressure and a reduction of potassium in the blood. It also leads to low levels of the enzyme renin and the hormone aldosterone, both of which are involved in the regulation of long-term blood pressure. Long-term high blood pressure and metabolic defects start at an early age in children with severe AME. In others, AME may start later in life and cause less serious side effects. Symptoms can include poor growth in childhood, delayed puberty, muscle weakness, heart rate irregularity, frequent urination, and thirst. If left untreated, AME can cause serious damage to the eyes, kidneys, heart, and other organs.

Current treatment with the synthetic steroid spironolactone usually improves symptoms; however, despite treatment, some individuals with AME still experience disease progression and even death within years of being diagnosed with AME. Understanding more about AME, how it progresses, and how it affects people differently may help to improve treatment options. The purpose of this study is to examine the genetic basis, natural history, disease progression, and outcome of children and adults with AME. The study will also examine the family members of study participants with AME for any genetic abnormalities and possible mild forms of AME.

This study will last 2 to 7 years. Participants and their family members will attend yearly study visits that will include interviews about medical history, symptoms, and hospital stays; a physical exam; blood pressure testing; and blood and urine collection. Interim reviews of medical records will occur as necessary. Children will undergo an x-ray of the left hand. During the initial study visit, participants will be asked questions about family members and birth size.

Eligibility Criteria:
Inclusion Criteria for Participants with AME:

* High blood pressure characterized by low plasma renin and serum aldosterone levels
* Elevated urinary cortisol/cortisone metabolite ratio (\[THF + 5aTHF\]/THE)
* Molecular genetic diagnosis of AME with two mutations of the HSD11B2 gene

Inclusion Criteria for Family Members without Genetic Diagnosis of AME:

* Carrier of the HSD11B2 mutation that the AME participant has

Exclusion Criteria for All Participants:

* Any other illness or condition that might interfere with study participation
Neural Integrity Monitor Electromyogram (NIM-EMG) Endotracheal Tube Intubation With Video Laryngoscope

Laryngeal nerve monitoring is performed to prevent intraoperative nerve damage in thyroidectomy operations. NIM-EMG intubation tube is used while monitoring the recurrent laryngeal nerve. Care should be taken when placing this tube. Ensure that the electrodes on the tube are in contact with the vocal cords. Both the macintosh laryngoscope and the videolaryngoscope can be used when inserting the NIM-EMG tube. The aim of our study is to compare these two intubation methods.

Anesthesiologists play a key role for the medications used for anesthesia and placement of the endotracheal tube in operations with intraoperative monitoring. While placing the NIM-EMG tube, the size of the endotracheal tube is very important so that the tube can contact the vocal cords.

The placement of the tube may change due to reasons such as movement of the neck during the operation. In addition, endotracheal tube placement may be problematic due to poor vision during direct laryngoscopy. Incorrect placement of the tube may result in equipment inoperability and increase the likelihood of injury to the recurrent laryngeal nerve.

Laryngoscopy is a term for tracheal intubation that provides visualization and evaluation of the larynx with its upper airway structures.

Until recently, direct laryngoscopy was considered the standard technique for endotracheal intubation. Recently, a wide variety of methods have been developed for endotracheal intubation. Video laryngoscopes are similar to direct laryngoscopes but provide laryngeal imaging with a small video chip on their blade. This imaging is superior compared to direct laryngoscopy. The aim of the study was to compare the use of direct laryngoscopy and video laryngoscopy in intubation with the NIM-EMG tube, which is routinely used in operations where the recurrent laryngeal nerve (RLN) may be damaged, in terms of intubation success, intubation time, tracheal intubation comfort, hemodynamic responses, surgical satisfaction, and complications that may develop after anesthesia or surgery.

Eligibility Criteria:
Inclusion Criteria:

* The American Society of Anesthesiologists (ASA) physical status classification system 1-2
* Age 18-65
* Undergoing Elective Thyroid and Parathyroidectomy surgery
* undergoing Intraoperative Recurrent Laryngeal Nerve Monitoring

Exclusion Criteria:

* History of head and neck surgery
* Body mass index less than 19 or greater than 30
* Muscle relaxant allergy
* Lidocaine allergy
* IDS score \>5
* Uncontrolled hypertension, bronchial asthma, tracheal pathology
* undergoing emergency surgery
* Cases that cannot give informed consent