cyrilzakka/clinical-trials huggingface dataset:
Choline-PET: Exploratory Study Assessing the Potential Role of F-choline PET Imaging in New and Emerging Indications

Choline is an important building block of phospholipids in cell membranes. Certain cancers and medical conditions are known to demonstrate increased absorption and incorporation of choline into their cell membranes. 18-F-fluorocholine (F-choline) and 11-C-choline (C-choline) are diagnostic positron emission tomography (PET) radiotracers that can be used to image, in vivo, the metabolism of choline. Both tracers have been extensively studied in prostate cancer and C-choline has obtained US FDA approval for the investigation of recurrent prostate cancer. F-choline is currently not approved for clinical use by the FDA or Health Canada, but it offers many advantages over C-choline due to its better physical characteristics (mainly due to its positron range, shorter and longer half-life). In recent years, reports have started to emerge on broader potential applications of choline PET imaging, particularly for imaging parathyroid adenomas, certain cervical cancers and certain liver cancers.

The main objective is to discover and explore potential new and emerging indications in which F-choline could play a role and provide clinically relevant information.

Secondary objectives are 1) To assess the safety of F-choline PET imaging using F-choline produced at the CRCHUM; 2) assess changes in patient/disease management following F-choline PET imaging.

Researchers hypothesize that F-choline will provide useful and incremental clinical information in a variety of conditions, and outperform the "standard" workup in numerous conditions.

F-Choline PET exams will be performed on hybrid PET/CT scanners according to standard procedures. These examinations could be repeated at the discretion of the treating physician (up to a maximum of 4 exams per year) if the treating physician and the research team deem this could provide additional clinically useful information (for example, by helping to assess response to newly started therapy).

The results will be provided to the attending physician and any new knowledge could lead to a change in treatment or an investigation of the condition that prompted enrollment in the study.


Eligibility Criteria:
Inclusion Criteria:

* Any patient with a known or suspected condition in which F-choline PET imaging might provide clinically useful information.

Exclusion Criteria:

* Pregnancy
* Breastfeeding woman, unwilling to discontinue breastfeeding for 48 hours
* Known allergy to F-choline or any excipients
* Pediatric patient (\< 18 years old)
Sensitivity of the Home Macular Perimeter (HMP)

estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD

The HMP device is intended to aid patients in identifying their visual abnormalities and in addition to their own symptoms or Amsler grid use and aid in their prompt referral to eye care professional examination so clinical diagnosis can be made. As such the goal of the clinical plan is to demonstrate that patients who have CNV do demonstrate visual field abnormalities when tested with the HMP

Eligibility Criteria:
Inclusion Criteria:

* Capable and willing to sign a consent form and participate in the study
* subjects with AMD related lesions: New onset (up to 60 days) non-treated CNV
* Age \>50 years
* VA with habitual correction \>20/200 in study eye
* Familiar with computer usage

Exclusion Criteria:

* Evidence of macular disease other than AMD or glaucoma in the study eye
* Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, CFP, or FA
* Any non-macular related ocular surgery performed within 3 months prior to study entry in the targeted eye
* Inability to tolerate intravenous FA
* Participation in another study with the exclusion of AREDS study
SonoVue®-Enhanced Ultrasound Versus Unenhanced US for Focal Liver Lesion Characterization

The purpose of this study is to demonstrate the superiority of SonoVue®-enhanced ultrasound versus unenhanced ultrasound for characterization of Focal Liver Lesions using final diagnosis based on histology or combined imaging/clinical data as truth standard.

Unit of analysis for the outcome measures was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.

Eligibility Criteria:
Inclusion Criteria:

* Male/female.
* Provides written Informed Consent and is willing to comply with protocol requirements.
* Is at least 18 years of age.
* Has at least 1 focal liver lesion (FLL) (target lesion) requiring work-up for characterization. Target lesions may include those:
* Incidentally detected,
* In subjects with chronic hepatitis or liver cirrhosis,
* In subjects with known history of malignancy.
* Is scheduled for surgical removal or biopsy of the target lesion from 24 hours to 30 days after the SonoVue® administration OR
* In case tissue biopsy is not indicated nor surgery planned, is scheduled for or has performed a contrast-enhanced (CE) CT and/or CE-MRI of the target lesion from 30 days to 48 hours prior to or from 24 hours to 30 days after the administration of SonoVue®.

Exclusion Criteria:

* Has an acoustic window insufficient for adequate ultrasound examination of the liver.
* Has a FLL that cannot be identified with unenhanced ultrasound.
* Has received or is scheduled for antineoplastic chemotherapy or an invasive procedure in the time period between test procedures and truth standard assessments which may have modified the target lesion.
* Is receiving any other contrast medium, within the 48 hours before and up to 24 hours following the administration of SonoVue®.
* Has previously been enrolled in and completed this study.
* Known right to left cardiac shunt, bidirectional or transient.
* Has any known allergy to 1 or more of the ingredients of the investigational product (sulfur hexafluoride or to any components of SonoVue®).
* Has any contraindication to 1 of the planned imaging procedures (ultrasound, CT or MRI), e.g., implants, claustrophobia, inadequate medical conditions etc.
* Has received an investigational compound within 30 days before admission into this study.
* Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.
* Is determined by the Investigator that the subject is clinically unsuitable for the study.
* Is a pregnant or lactating female. Exclude the possibility of pregnancy by:

  * testing on site at the institution serum beta-human chorionic gonadotropin (βHCG) within 24 hours prior to the start of SonoVue® administration,
  * surgical history (e.g., tubal ligation or hysterectomy),
  * post menopausal with a minimum 1 year without menses.
Determination of the Optimal Spontaneous Breathing Trial During Weaning of Mechanical Ventilation

Assessment and comparison of three spontaneous breathing trials in five specific profiles of intensive care unit and perioperative patients. A physiological cross over study

Mechanical ventilation is the most used organ replacement therapy in intensive care unit (ICU). After resolution of acute illness, separating the ventilator from the patient may be specially challenging. Before extubation, it is recommended to perform a spontaneous breathing trial (SBT) to evaluate the ability to sustain breathing with minimal or no support.

The way to carry out this step of the weaning process present important variation across regions of the world. Two techniques are preferentially used : the T-piece trial (oxygen supply without positive pressure) and low pressure support ventilation (PSV) from 6 to 10 cmH2O according to the airway humidification device.

The best strategy for successful weaning remains unknown, especially about specific subgroups of respiratory and neurological diseases.

Our aim is to assess which spontaneous breathing trial would best reproduce post-extubation inspiratory effort. We compare T-piece trial, PSV 7 cmH2O without positive end expiratory pressure (PEEP) and PSV 0 cmH2O without PEEP. Five specific profiles are evaluated : chronic obstructive pulmonary disease (COPD), severe brain injury, blunt thoracic trauma, post abdominal surgery and miscellaneous.

The hypothesis is that T-piece trial and PSV 0 CPAP 0 trial are the best for mimic inspiratory effort after extubation. However, we could highlight various results according to different subgroups of ICU patients. The final aim is to determine a personalized wean trial for each.

Eligibility Criteria:
Inclusion Criteria:

* ICU patient with invasive mechanical ventilation for at least 24 hours
* Physician decision to extubate and all criteria for ventilatory weaning must be present
* Resolution of disease acute phase for which the patient was intubated
* Conscious patient (Richmond Agitation-Sedation Scale (RASS) \> 0), no sedation
* Good coughing effort, good swallowing, positive leak test (\> 12% of tidal volume (VT))
* No important secretions
* No respiratory acidosis, adequate oxygenation (PaO2 / FiO2 \> 150 mmHg and CPAP ≤ 8)
* Adequate pulmonary function (respiratory rate (RR) ≤ 35, negative inspiratory force (NIF) \> 20 cmH2O, RR/VT \< 105)
* Stable cardiovascular status (heart rate (HR) \< 140 bpm, systolic blood pressure \> 90 mmHg, no or minimal vasopressors)
* If severe brain injury, the VISAGE score must be ≥ 3 (visual pursuit, good swallowing, GCS \> 10)

Exclusion Criteria:

* Obese patients with BMI ≥ 35 kg/m2
* Contraindication for nasogastric tube or esophageal manometric balloon placement
* Refusal of study participation or to pursue the study by the patient, no consent
* Pregnancy or breastfeeding
* Absence of coverage by the French statutory healthcare insurance system
Mask Leak With Nasal Cannula in Noninvasive Positive Pressure Ventilation

This is a prospective randomized cross over study of healthy volunteers undergoing continuous positive airway pressure ventilation via a noninvasive ventilation (NIV) mask with and without the addition of nasal cannulas. Mask leak will be measured by the ventilator after 60 seconds of spontaneous resting ventilation, with each subject serving as his or her own control.

This is a randomized cross over study. A convenience sample of staff and resident physicians and physician assistants from the San Antonio Military Medical Center (SAMMC) Department of Emergency Medicine will be used to assess NIPPV mask seal during CPAP administration with and without nasal cannula. Volunteers will be solicited via Grand Rounds and staff meetings at San Antonio Military Medical Center. Subjects will undergo permuted block randomization by random number generator to the order of intervention, mask alone or mask with nasal cannula at 15L/min of oxygen. An emergency medicine trained physician will place equipment and operate the ventilator. After placement of the NIPPV mask and prior to each study intervention period, appropriate adjustments to enhance mask seal will be made as would happen in a therapeutic setting and the volunteer will be allowed up to two minutes to acclimate to continuous noninvasive positive pressure ventilation. Mask leak will be measured by the ventilator unit and will be recorded after 60 seconds of spontaneous restful ventilation.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Volunteer for study

Exclusion Criteria:

* Known cardiac disease
* Known pulmonary disease (to include respiratory infections)
Genetic Study of Idiopathic Scoliosis in a Cohort of Families (SCOGEN)

This study will focus on a large cohort of multiplex families, to precisely identify candidate genes. The fact of have a large database (fifty families, collected by the principal investigator for more than two decades), will contribute to the discovery of genes of interest. It will also allow testing for the presence or absence of mutations found in other cohorts in previous studies. The main objective of this study is to identify genetic abnormalities associated with the presence and severity of idiopathic scoliosis, in families of scoliosis.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for "sick" patients:

* Presence of idiopathic scoliosis, diagnosed by a clinical examination by an orthopedic doctor and confirmed by the presence of a Cobb angle greater than 10 ° on radiographs of the spine
* Signed informed consent
* Affiliation to a social security scheme or beneficiary of such a scheme

Inclusion criteria for "healthy relatives":

* Be related to the first or second degree with at least 2 individuals suffering from idiopathic scoliosis, and whose family tree over 3 generations finds at least 3 cases of idiopathic scoliosis
* Do not present with scoliosis (clinical examination by an orthopedic doctor and x-rays of the spine).
* Affiliation to a social security scheme or beneficiary of such a scheme

Exclusion Criteria:

Non-inclusion criteria for "sick" patients:

* Be part of one of the following categories of vulnerable people: protected adults, adults unable to express their consent and not subject to a protection measure, pregnant women, parturients and nursing mothers, people deprived of their liberty, people hospitalized without consent, people admitted to a health or social establishment for purposes other than research
* Suspicion of scoliosis secondary to clinical examination

Non-inclusion criteria for "healthy relatives":

* Be part of one of the following categories of vulnerable people: protected adults, adults unable to express their consent and not subject to a protection measure, pregnant women, parturients and nursing mothers, people deprived of their liberty, people hospitalized without consent, people admitted to a health or social establishment for purposes other than research
* Discovery of scoliosis during research (if scoliosis of an idiopathic nature: patient included in the cohort of patients, if secondary scoliosis: exclusion from the family).

All patients :

Pregnancy in progress or desired with discontinuation of contraception (contraindication to the realization of x-rays).
Efficacy and Safety of Four Doses of Glycopyrronium Bromide (NVA237) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), in Comparison to an Active Comparator Tiotropium

This study will assess the efficacy and safety of glycopyrronium bromide (NVA237) in patients with stable COPD, in comparison to an active comparator.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
* Patients with moderate to severe COPD according to the Gold Guidelines (2006).
* Patients who have smoking history of at least 10 pack years. Ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.
* Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥30% and \< 80% of the predicted normal, and post-bronchodilator FEV1/forced vital capacity (FVC) \< 0.7 at Visit 2. For non-Japanese patients predicted FEV1 should be calculated according to Quanjer predictive equations \[Quanjer PH 1993\], for Japanese patients predicted FEV1 should be calculated according to Japanese Respiratory Society predictive tables \[Japan Respiratory Society 2001\].

Exclusion Criteria:

* Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test).
* Patients requiring oxygen therapy on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1 or between Visit 1 and Visit 3.
* Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1. Patients who develop a respiratory tract infection during the screening period (up to Visit 3) must discontinue from the trial, but will be permitted to re-enroll at a later date (at least 6 weeks after the resolution of the respiratory tract infection).
* Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) unstable ischemic heart disease, cancers, left ventricular failure, long term prednisone therapy, history of myocardial infarction, arrhythmia (all), narrow angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment.
* Patients with a history of asthma indicated by (but not limited to):

  1. Blood eosinophil count \> 400/mm3
  2. Onset of symptoms prior to age 40 years.

Other protocol-defined inclusion/exclusion criteria may apply
Trilogy Comparison Study - Pediatrics

The objective of this study (Part II) will be to compare the performance of the Trilogy device and a conventional ventilator (participant's current device). Both devices will be set to the participants' current mode and prescription settings.

A. Primary Hypothesis and end-point In patients with respiratory insufficiency, when compared to conventional ventilators, the Trilogy device achieves comparable level of gas exchange (measured as partial pressure of carbon dioxide (CO2) in arterial, venous or capillary blood)and peripheral capillary oxygen saturation, (SpO2) levels during various modes of ventilation.

B. Secondary Hypothesis and end-points In patients with respiratory insufficiency, when compared to conventional ventilators, the Trilogy device achieves comparable breathing pattern (tidal volume, respiratory rate, minute ventilation), hemodynamics (heart rate), and subjective measures of breathing comfort (measured by modified Borg dyspnea scale).

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 1years of age; \< 18 years of age
2. Greater than 5 kg
3. Considered clinically stable, with low flow oxygen requirements less than 15 LPM (or FIO2 less than 60 %) and PEEP no greater than 10 cm H2O
4. Requiring mechanical ventilation through nasal/facial mask, tracheostomy or endotracheal tube (ET Tube)

Exclusion Criteria:

1. Clinically unstable, i.e.,

   1. Acute Respiratory Failure
   2. Participants with refractory hypotension defined as systolic blood pressure less than 90 mm Hg despite inotropic agents)
   3. Uncontrolled cardiac ischemia or arrhythmias
   4. or as otherwise determined inappropriate for the study as determined by the investigator
2. Patients suffering from metastatic or terminal cancer and patients with do-not-resuscitate orders
3. Pregnancy
Prospective Long-Term Outcomes of a Standardized Ross Procedure

This standardized prospective long-term outcome analysis will help reaffirm these findings via a multicenter patient cohort and describe the best practices/techniques for stabilization of the autograft and right ventricular outflow tract reconstruction.

The optimal approach for aortic valve replacement in adults with an anticipated life expectancy greater than fifteen years remains unclear. Mechanical and bioprosthetic valves, while often used, have specific downfalls. Mechanical valves require lifelong anticoagulation usage and bioprosthetic tissue valves have a limited lifespan. The Ross procedure (pulmonary autograft replacement) is the only operation which replaces the diseased aortic valve with a living substitute. Concerns over increased surgical risk and potential long-term failure have shown decreased use of this procedure. However, recent publications from expert centers have shown, in the current era the Ross procedure can be reliably performed safely and reproducibly in selected patients. Furthermore, an increasing body of evidence suggests the Ross procedure is associated with better long-term outcomes compared with conventional aortic valve replacement (AVR) in young and middle-aged adults (jamc 2018,72:2761-77. This standardized prospective long-term outcome analysis will help reaffirm these findings via a multicenter patient cohort and describe the best practices/techniques for stabilization of the autograft and right ventricular outflow tract reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing Ross procedure at Baylor Scott and White The Heart Hospital, Plano, The University of Pennsylvania, The University of Washington, and Northwestern University.

Exclusion Criteria:

* Less than 18 years of age
* Presence of active malignancy
* Pregnant at the time of surgery
* Inability to provide informed consent
Comparison Between Hysterectomy and Conservative Management in Treatment of Placenta Accreta Regarding Maternal Complication

AIM OF THE WORK The aim of the study is to compare the maternal morbidity and mortality between obstetric hysterectomy and conservative surgery for pregnant ladies \> 28 weeks with placenta accreta during caesarean section at Ain Shams University Maternity Hospital in the last five years and prospective study in the next six months.

Hypothesis In women with placenta accrete undergoing hysterectomy may be similar to conservative surgery as regard maternal morbidity and mortality.

The study included all cases of placenta accreta that were diagnosed preoperative or intra-operative and treated by conservative surgery or by hysterectomy during caesarean section between January 2011 to December 2015 at Ain Shams University Maternity Hospital and from July 2016 to January 2017.

The collected data will be categorized according to the way of management and will be analyzed regarding:

Mortality rates.

Intraoperative morbidities:

Blood loss and it's amount and need for transfusion. Amount of blood and blood products transferred. Injury to adjacent organs eg: bladder or bowel injury.

Early postoperative morbidities:

Blood and blood product transfusion Length of maternal Hospital admission post operative Acquiring intensive care unit admission and identifying the cause and duration Wound sepsis Septic shock Peritonitis DVT Acute pulmonary embolism Hysterectomy after conservative management and its indication Wound dehiscence Burst abdomen

Late postoperative morbidities:

Anemia Recurrence of placenta accretes in next pregnancy. Hysterectomy after conservative management and its indication Uterine necrosis Fistula eg. urinary fistula

Eligibility Criteria:
Inclusion Criteria:

* Women admitted for elective caesarean section. Pregnant women more than 28weeks of gestation. Women with no associated medical diseases eg. DM, PET. Pre-operatively Hemodynamically stable women. Women diagnosed with placenta accrete either preoperative or accidentally discovered intraoperative.

Exclusion Criteria:

* Pregnant women less than 28weeks of gestation. Women with associated medical co-morbidity eg bleeding tendency eg: DM, PET.