louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06793059: Evaluation of Flow Diverter Technology Device for Intracranial Aneurysm (SHIELD)
Official title: Evaluation of Flow Diverter Technology Device for Intracranial Aneurysm (SHIELD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Aneurysm
Lead sponsor: Jacobs institute
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 10
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Jacobs Institute is participating in a study designed to collect prospective clinical evidence to evaluate the approved use of the Pipeline™ Flex Embolization Device with Shield Technology™ for the endovascular treatment of adults (22 years of age or older) with wide-necked intracranial aneurysms

Detailed description: The Pipeline™ Flex Embolization Device with Shield Technology™ for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments. The Pipeline™ Flex Embolization Device with Shield Technology™ is also indicated for use in the internal carotid artery up to the terminus for the endovascular treatment of adults (22 years of age or older) with small and medium wide-necked (neck width ≥ 4 mm or dome-to-neck ratio \< 2) saccular or fusiform intracranial aneurysm (IAs) arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 5.0 mm.

Eligibility criteria: Inclusion Criteria:

* Adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments.

Exclusion Criteria:

Exclusion Criteria:

* Cannot provide consent or legally authorized representative not available to provide consent Criteria:

Primary outcomes:
measure: Occurrence of thromboembolic event(s)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Jacobs Institute
state: New York
Study officials:
References:
Clinical trial NCT02620059: A Lifestyle Program on Healthy Weight in Postpartum Period
Official title: Development and Evaluation of a Lifestyle Intervention Program for Women' Weight Reduction After Childbirth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Reduction
Keywords: Postpartum Period
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-12-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to examine the impact of lifestyle intervention on postpartum weight loss. So the investigators will have two groups in this study. In Experimental group women will receive the Healthy Lifestyle Intervention. This intervention will have been delivered during 12 weeks. In Control group women will receive general information via pamphlet about postpartum period and tips for stress management.

Detailed description: This study will be conducted in two phases. In the first phase , the investigators will conduct a cross-sectional study to assess factors related to the healthy lifestyle after childbirth based on the PRECEDE model. Regarding results of the study, the investigators will plan and implement a lifestyle promoting intervention and will evaluate the effect of the intervention on weight reduction among postpartum women.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* Lactating
* Non-smoking
* Full-term birth
* Lack of medical problems
* Lack of any pregnancy-related complications (eg, multiple pregnancy, fetal anomalies, fetal or maternal complications in current or previous pregnancy, and hypertension in pregnancy).
* Nonparticipation in other studies which may affect the results.
* 18.5≤ BMI≤29 before pregnancy
* Women who are sedentary according to the International Physical Activity Questionnaire.

Exclusion Criteria:

* Unwilling to continue participation in the study
* Pregnancy during the study
* Suffering physical problems during the study
* Smoking after birth

Primary outcomes:
measure: Body weight changes
timeFrame: Changes from baseline at 12 months postpartum
Secondary outcomes:
measure: Dietary intake changes
timeFrame: Changes from baseline at 12 months postpartum
measure: Physical activity changes
timeFrame: Changes from baseline at 12 months postpartum
Other outcomes:
measure: Postpartum weight retention changes
timeFrame: Changes from baseline at 12 months postpartum
measure: Stress management changes
timeFrame: Changes from baseline at 12 months postpartum
measure: Cognitive changes based on the selected behavior change model/s
timeFrame: Changes from baseline at 12 months postpartum
Locations:
Study officials:
References:
Clinical trial NCT01655459: Evaluation of the LMA Position Using Ultrasound in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infraumbilical Surgeries
Keywords: ultrasound, LMA, fiberoptic bronchoscopy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Following Internal Review Board approval(4-2011-0800) and written informed consent, total 100 patients(ASA I and II children aged 1 month to 6years) undergoing infra-umblicular urologic surgeries were included in the study. Children with upper respiratory tract infection, restricted mouth opening, congenital heart disease and those at risk for aspiration were excluded.

Brief summary: Introduction: Although the LMA insertion is not difficult and majority of the cases with LMA fare well in ventilation, the FOB assessment demonstrates a high incidence of LMA malpositioning. The LMA must be seated at the laryngeal inlet with the occlusion of esophageal inlet by the inflated tip. When we meet the signs of LMA malposition, we then reinsert the LMA. The laryngoscopic grading of Rowbottom et al. is commonly used for LMA position, but the rotated degree of LMA was not considered in that grading. We hypothesized that the LMA can affect the position of the arytenoids/thyroid cartilages and it may be detected on ultrasound. This study was designed to assess the predictability of the rotated LMA according to the position change of arytenoids/thyroid cartilages using ultrasound.

Methods: Children, aged 1 ms - 6 years, undergoing infraumbilical surgery were enrolled to this study. Ultrasound was performed on supraglottic and vocal cords area before and after LMA insertion. Transverse images were obtained on end-expiratory phase. LMA-position was evaluated with Bonfils fiberscopy. Position grading was made as usual. If grade \>3 was showed, LMA was repositioned while fiberscopic watching. If the face of LMA was rotated to one-side, the LMA was rotated to the opposite side a little. The ultrasound findings of pre- and post-LMA were compared. On fiberscopic images, conventional LMA grade and the degree of rotation were measured.


Eligibility criteria: Inclusion Criteria:

* Aged 1 ms - 6 years,
* undergoing infraumbilical surgery

Exclusion Criteria:

* coagulopathy
* pathologic lesions on neck or upper airway
* mallampati class III or IV
* difficult airway past history
* high risk group of aspiration pneumonitis

Primary outcomes:
measure: changes of Ultrasound image of upper airway after Fiberoptic bronchoscopic grade of LMA insertion.
timeFrame: After the induction of general anesthesia, ultasound image was gained before and after the LMA insertion. Fiberoptic bronchoscpy was done after the LMA insertion.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00831259: Risk of Stroke in Pulmonary Embolism With a Patent Foramen Ovale (PFO)
Official title: Silent Cerebral Infarcts in Patients With Pulmonary Embolism and a Patent Foramen Ovale: a Prospective Diffusion-weighted Magnetic Resonance Imaging Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Silent Stroke
Pulmonary Embolism
Patent Foramen Ovale
Keywords: stroke
PFO
embolism
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2009-01-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive series of patients with a pulmonary embolism

Brief summary: Pulmonary embolism is associated with a small but definite risk of paradoxical embolism in patients with a patent foramen ovale (PFO). While neurologic complications are unfrequent the incidence of clinically silent brain infarction is unknown. We will assess the rate of clinically apparent and silent cerebral embolism in patients with a pulmonary embolism (PE) in relation to the presence or not of a PFO.


Eligibility criteria: Inclusion Criteria:

* Pulmonary embolism, informed consent signed, no-contraindication to MRI

Exclusion Criteria:

* contra-indication to MRI, informed consent not obtained

Primary outcomes:
measure: Incidence of cerebral infarcts as detected by Diffusion-weighted MRI
timeFrame: during hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: USIC CHU de Caen
Study officials:
References:
Clinical trial NCT01544959: Postoperative Analgesia Impact of Narcotic Free Anesthesia
Official title: The Impact on Postoperative Pain of Substituting Opioids by Beta Blockers for Peroperative Hemodynamic Control in Patients Undergoing Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Breast Cancer
Postoperative Nausea and Vomiting
Keywords: Narcotic
Opioid
betablocking drug
postoperative pain
postoperative nausea and vomiting
breast cancer
hyperalgesia
cancer recurrence
anesthesia
mastectomy
chronic postsurgical pain syndrome
acute postoperative pain
postmastectomy pain syndrome
pain
ambulatory surgery
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2012-03-06
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The first hypothesis of the study is that substituting fentanyl by esmolol and metoprolol during general anesthesia for patients undergoing mastectomy will result in less pain and less narcotic consumption in the recovery room. The investigators will also verify the impact of that substitution on nausea and vomiting, on the time spent in the recovery room and on chronic postsurgical pain (3 and 6 months).

Finally, the investigators will see the impact on breast cancer recurrence 5 years after the surgery.


Eligibility criteria: Inclusion Criteria:

* Woman
* 18 to 65 years old
* ASA 1 or 2
* First breast surgery
* Unilateral breast cancer
* Partial mastectomy or radical modified mastectomy ± axillary dissection

Exclusion Criteria:

* Allergy or contrindication to any medication figuring in the protocol or to Aspirin
* Patient taking betablocking drug drug or lanoxin or calcic channels blocking drug
* Narcotic consumption in the past month of 10 mg/day of morphine equivalent
* Chronic pain
* Moderate to severe asthma
* BMI of more than 40
* Diabetes
* Chronic renal or hepatic faiure
* Heart failure
* Anticipated difficult airway
* High grade heart block or bifascicular block
* Mental retardation

Primary outcomes:
measure: Postoperative consumption of narcotic in recovery room
timeFrame: Immediately after surgery
Secondary outcomes:
measure: Pain level in recovery room
timeFrame: immediately after surgery
measure: Occurence of nausea and vomiting in the recovery room
timeFrame: immediately after surgery
measure: Time spent in recovery room
timeFrame: immediately after surgery
measure: Chronic post-surgical pain
timeFrame: 3 and 6 months
measure: Reccurence of breast cancer
timeFrame: 5 years
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Etienne de Medicis, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05946759: Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment
Official title: Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment in a Single-centric PMPF Study (SHIELD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer - Ductal Carcinoma in Situ (DCIS)
Breast-Conserving Surgery
Keywords: Reoperation Rate
Breast Conserving Surgery
Confocal laser scanning microscope
Confocal microscopy
Lead sponsor: SamanTree Medical SA
Sponsor class: INDUSTRY
Collaborators: name: St. Vincenz Krankenhaus GmbH, Paderborn
First posted: 2023-07-14
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This PMPF study is proposed to evaluate in real life the reoperation rates (ROR) of breast cancer and/or DCIS surgery when including the use of the HLS in the context of breast lumpectomy margin assessment.


Eligibility criteria: Inclusion Criteria:

* Adult female Subject ≥18 years old.
* Subject Scheduled for breast conserving surgery of invasive and/or in-situ ductal carcinoma.
* Subject is able to read, understand and sign the informed consent.

Exclusion Criteria:

* Subject previously treated for ipsilateral breast cancer and/or ductal carcinoma in situ surgery.
* Subject with previous radiotherapy of the ipsilateral breast.
* Subject with multicentric/multilateral breast cancer.
* Subject with planned mastectomy, tumor-adapted breast reduction.
* Subject with pre-surgical/ preoperative neo-adjuvant treatment.
* Subject is pregnant/ lactating.
* Participation in any other clinical study that would affect data acquisition.

Primary outcomes:
measure: Reoperation Rate
timeFrame: 2-30 days post Breast Surgery
Secondary outcomes:
measure: Margin status of intraoperative specimen vs. postoperative pathology assessment [Clinical Performance]
timeFrame: 0-30 days post Breast Surgery
measure: System Usability Scale (SUS) of the IVD device and accessories [Usability]
timeFrame: Only during the time of the breast surgery
measure: Change in hospital cost with or without IVD device and accessories [Economic Impact]
timeFrame: 30 days post surgery date
measure: Incidence of adverse device effects [Safety]
timeFrame: Only during the time of the breast surgery
Other outcomes:
Locations:
city: Paderborn
country: Germany
facility: St. Vincenz-Krankenhaus GmbH, Frauenklinik St. Louise
Study officials:
affiliation: St. Vincenz Krankenhaus GmbH, Paderborn
name: Michael P Lux, Prof. Dr MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00650559: Thorax Enlarging Surgery: a Novel Surgical Approach to Emphysema
Official title: Chest Wall Enlargement by Widening Sternotomy in Patients With Severe Emphysema: a Feasibility Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: COPD
Emphysema
Keywords: COPD
Emphysema
thorax enlargement
LVRS
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2008-04-01
Enrollment: 4
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There is a growing population of end-stage COPD patients for whom surgical treatments like lung transplantation and lung volume reduction surgery are not possible. In such patients, size mismatch between large emphysematous lungs and a restricted chest wall is a major cause for the reduction of dynamic lung volumes and consequent dyspnea. We hypothesized that enlargement of the thorax would be a potential alternative strategy to volume reduction surgery as it may improve lung mechanics by resizing the chest to the lung and does not further deprive patients from lung tissue which is already scarce.

Detailed description: Lung volume reduction surgery primarily increases vital capacity by reducing RV more than TLC. As the chest wall is the major TLC limiting factor, an alternative approach that could circumvent size mismatch would be a surgical enlargement of the thorax cavity. Any post-operative increase of TLC would allow greater dynamic operational lung volumes to occur with an equal amount of dead space. Moreover, resizing of the thorax would have a tremendous advantage over resizing of the lung, in that it would not require resection of the lung in patients in whom lung tissue is already scarce. Chest expansion will only be guaranteed if the sternal widening osteotomy will obtain a solid union. Small poly-ether-ether-keton (PEEK) cages were designed to match both sternal halves in a 'press fit' way, which were filled with lyophilised bone and fixed with extra wires as in a classical sternotomy. These bone-filled cages function as a perfect matrix for progressive in-growth of cancellous bone.

Eligibility criteria: Inclusion Criteria:

patients with end-stage emphysema and

* Disabling dyspnea
* GOLD III or IV
* Residual volume \> 200% predicted
* Total Lung capacity \> 120% predicted
* RV/TLC \> 0.6
* Resting CO2 \< 50 mmHg
* diffusion capacity \> 20% predicted
* age \< 70 years

Exclusion Criteria:

* previous sternotomy
* contraindication of general anesthesia
* chronic treatment with corticosteroids
* any tobacco use within 6 months
* candidates for lung volume reduction surgery or lung transplantation

Primary outcomes:
measure: Improvement of FEV1
timeFrame: 1 year
Secondary outcomes:
measure: Improvement of exercise capacity
timeFrame: 1 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University hospital Leuven
state: Flanders
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Marc Decramer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02475759: Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics
Official title: Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-06-19
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics. A randomized controlled trial.

Detailed description: Nutritional Prehabilitation Program and Cardiac Surgery in Pediatrics. A randomized controlled trial to compare the outcome of malnourished congenital heart surgery patients who randomly received nutritional rehabilitation program 2 weeks and 1 week before surgical intervention.

Eligibility criteria: The study included all infants with CHD, admitted to the cardiothoracic unit for either palliative or corrective surgery, and suffering from nutritional deficiencies with moderate or severe malnutrition .

Infants received long-term nutritional prehabiliatation. Those with congenital or acquired anomaly of the gastrointestinal tract; multiple congenital anomalies; chromosomal, metabolic,or endocrine diseases; any systemic illness; or fever or infection within 1 wk before the study entry were excluded

Primary outcomes:
measure: daily feeding characteristics
timeFrame: admission
measure: anthropometric and laboratory measure
timeFrame: admission
Secondary outcomes:
measure: length of ICU stay
timeFrame: 3weeks
measure: duration of mechanical ventilation and extubation timing
timeFrame: 3 weeks
measure: postoperative vital stability, surgical complication,nosocomial sepsis,inotropes withdrawal
timeFrame: admission
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: 38 abbasia, next to nour mosque, Ain Shams University Hospital, Pediatrics department
Study officials:
References:
Clinical trial NCT03985059: Impact of Verticalization on Intracranial Hemodynamics Assessed in Transcranial Doppler at the Acute Phase of Cerebral Infarction
Official title: Impact of Verticalization on Intracranial Hemodynamics Assessed in Transcranial Doppler at the Acute Phase of Cerebral Infarction (STAND : iSchemic sTroke evAluated at Bed Side With ultrasouND)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Stroke
Keywords: Verticalization
Doppler
Intracranial hemodynamic
Cerebral artery velocity
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2019-06-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited during their hospitalization in the USINV for the management of ischemic stroke.

Brief summary: The management of patients with ischemic stroke or transient ischemic attack is based on the preservation of a brain area by maintaining sufficient intracranial hemodynamics (IH) and with rapid recanalization.

The impact of the patient's position (supine or seated position) on the IH in the event of narrowing or occlusion of an artery is poorly assessed but may be of particular importance. Variations in blood flow according to the positioning of the patient's body are measurable using a transcranial Doppler.

The main objective is to verify whether intracerebral hemodynamic changes during early verticalization after ischemic stroke or transient ischemic attack are more frequent in patients with carotid stenosis or occlusion compared to those without stenosis or occlusion.


Eligibility criteria: Inclusion Criteria:

* Ischemic stroke (AIC) or transient ischemic attack (AIT) of the carotid artery
* Duration of symptoms less than 48 hours
* Absence of homolateral or downstream intracranial stenosis or occlusion M1
* Lifting authorized by the referent clinician.
* Rankin's score before AIC/AIT ≤ 2

  • For cases:
* Carotid stenosis of more than 50% NASCET (North American Symptomatic Carotid Endarterectomy Trial) or an occlusion

  • For controls:
* Absence of carotid stenosis greater than 50% NASCET (North American Symptomatic Carotid Endarterectomy Trial) or occlusion

Exclusion Criteria:

- Disrupted vigilance

Secondary exclusion criteria:

* Absence of a homolateral temporal acoustic window at the lesion
* Impossibility to verticalize the patient

Primary outcomes:
measure: Percentage of patients with a change in mean cerebral artery velocity (MCAVM) in transcranial Doppler
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmique Adolphe de Rothschild
Study officials:
References: