louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04250857: HeartStart FRx Defibrillator Event Registry
Official title: HeartStart FRx Defibrillator Event Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sudden Cardiac Arrest
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2020-01-31
Enrollment: 1400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Use of the HeartStart FRx AED is intended for the following populations in addition to adults: newborns, neonates, infant, children, and adolescents. It may also be used on pregnant women. Devices are located in public access spaces and with first responders around the world.

Brief summary: This post market clinical follow-up study is a multi-center, non-randomized, unblinded, observational registry of the performance of the FRx Automated external defibrillator (AED) used in conjunction with electrodes with or without use of the infant/child key. The registry is focused only on on post-event data collection and does not prescribe any device usage. This registry has several safeguards in place to prevent against selections bias, including enrollment of all participants who have pads placed. This registry will evaluate the safety and verify the clinical performance of the device in relation to its claims, when used in accordance with the Device Manual.


Eligibility criteria: Inclusion Criteria:

* Subjects accepted into the study must: have been suspected of a circulatory arrest for any cause
* Have had HeartStart FRx AED with electrodes: HeartStart SMART PADS II applied to their body and powered up, regardless of whether a defibrillation shock was delivered

Exclusion Criteria:

* AED or pad use other than the HeartStart FRx AED with electrodes : HeartStart SMART PADS II
* AED used for training purposes.

Primary outcomes:
measure: Algorithm accuracy
timeFrame: Up to 15 minutes after device placement
measure: Shock Delivery
timeFrame: 1 day
measure: Unexpected adverse events.
timeFrame: 1 day
measure: Unanticipated adverse device effects (UADE)
timeFrame: 1 day
Secondary outcomes:
measure: Time Intervals
timeFrame: 1 day
measure: Device Preparation
timeFrame: 1 day
measure: Shock Energy Delivered
timeFrame: 1 day
measure: Pad Replacement
timeFrame: 1 day
measure: User
timeFrame: 1 day
Other outcomes:
Locations:
city: Monroeville
country: United States
facility: Philips
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04846257: Specific Preoperative Dynamic Contrast-enhanced MRI Semi-quantitative Markers Can Correlate With Vascularity in Specific Areas of the Glioblastoma Tissue and Predict Recurrence
Official title: Specific Preoperative Dynamic Contrast-enhanced MRI Semi-quantitative Markers Can Correlate With Vascularity in Specific Areas of the Glioblastoma Tissue and Predict Recurrence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioblastoma
Lead sponsor: Egyptian Medical Syndicate
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 260
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed glioblastoma

Brief summary: Radiological Markers of vascularity as wash-in rate, washout rate, and capillary time to peak in different single tumour regions were extracted for all glioblastoma patients before being surgically resected from preoperative DCE-MRI. Tissue samples were obtained from different intratumoral regions and peritumoral oedema and evaluated for the vascular endothelial growth factor (VEGF)


Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed glioblastoma with a maximum diameter from 3-5 cm as a single lesion identified by MRI.
* The lesions should be surgically resected at the time of the presentation.

Exclusion Criteria: N/A

Primary outcomes:
measure: Recurrence of tumor
timeFrame: 2018-2021
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Neurosurgery, Cairo University Faculty of Medicine
Study officials:
References:
Clinical trial NCT00428857: Noninvasive Ventilatory Support After Lung Surgery in COPD Patients
Official title: Noninvasive Ventilatory Support After Lung Surgery to Prevent Pulmonary Complications in COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Post Pulmonary Resection
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2007-01-30
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Rationale: respiratory complications are the most frequent complications following lung resection and represent a noticeable cause of mortality. Benefits from non-invasive ventilation (NIV) in acute respiratory failure are now clearly demonstrated. The use of preventive NIV after lung resection, in the absence of acute respiratory failure and/or hypercarbia, could be justified by the physiological benefits expected. The goal of this study is to assess the efficacy of post-operative NIV in moderate-to-severe COPD, for prevention of respiratory complications.

Material and Methods: This is a prospective randomised multicenter trial with an open parallel design in moderate-t-o-severe COPD patients hospitalised in thoracic surgery for lung resection.

Expected results: This study will determine whether post-operative NIV decreases the incidence of acute respiratory events (acute respiratory failure) and whether some subgroups of patients benefit more from this strategy.

Conclusion: This study should help evaluating the utility of post-operative NIV after lung resection.


Eligibility criteria: Inclusion Criteria:

* Patients with COPD (FEV1 pre-operative \<80% and FEV1/CV\<70%)
* Patients undergoig pulmonary resection
* Informed consent

Exclusion Criteria:

* Apnea syndrom and chronic noninvasive support
* Post-operative extrarespiratory organ failure
* Inhability to follow study protocole
* Absence of medical coverage

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Hopital Du Bocage
city: Paris
country: France
facility: Hotel Dieu
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Paris
country: France
facility: HEGP
city: Pontoise
country: France
facility: hopital de Pontoise
city: Strasbourg
country: France
facility: CHU strasbourg
city: Toulouse
country: France
facility: CHU Larrey
Study officials:
affiliation: APHP
name: christine lorut, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: APHP
name: antoine rabbat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05726357: Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis
Official title: Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis: A Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulpitis - Irreversible
Keywords: vital pulp therapy
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 380
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: high-quality evidence is needed to add to current knowledge and also assess the long-term outcomes for full/complete pulpotomy after carious pulpal exposure in patients with signs and symptoms indicative of irreversible pulpitis


Eligibility criteria: Inclusion Criteria:

* a mature permanent tooth
* symptoms indicative of IRP
* responsive to cold and EPT sensibility testing
* restorable and can be adequately isolated during treatment
* One tooth (molar or premolar) per patient.

Exclusion Criteria:

* active periodontal disease
* complex medical histories
* unable to consent
* pregnant or breast-feeding
* excessive bleeding that cannot be controlled

Primary outcomes:
measure: pain score
timeFrame: day 3 post treatment
Secondary outcomes:
measure: pain score
timeFrame: 6 months post treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
affiliation: Professor of Endodontics
name: shehabeldin Saber
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05163457: Prevalence of Frailty Among People Aged 75 and Over Living at Home
Official title: Prevalence of Frailty Among People Aged 75 and Over Living at Home
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Keywords: Frailty - SEGAm - living at home
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 100
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients aged of 75 and more living at home

Brief summary: The aging of population lead to study ways to prevent dependence. Frailty is a precursor to dependence which can be reversible. In the literature, estimate of prevalence of frailty is highly variable depending on the frailty definition, the population studied and the screan tool used. In fact, many scales to measure frailty have emerged without gold standard.

The SEGAm showed its usefulness in aged patients living at home.

Detailed description: The aim of the study is to describe prevalence of frailty in patients aged of 75 and more living at home.

Eligibility criteria: Inclusion Criteria:

* male or female
* aged of 75 and more
* living at home
* agreeing to participate in the study

Exclusion Criteria:

- none

Primary outcomes:
measure: Frailty
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Bar-sur-Seine
country: France
facility: Maison de Santé Pluridisciplinaire de Bar sur Seine
state: Grand-Est
Study officials:
References:
Clinical trial NCT01665157: Efficacy and Acceptability of Low-Residue Diet Package (Enimaclin®) as Diet Control Before Colonoscopy
Official title: A Randomized, Single-blinded, Comparative Study to Evaluate the Efficacy and the Acceptability of Low-residue Diet Package (Enimaclin®) as Diet Control Before Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Keywords: Diet Control before Colonoscopy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-08-15
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate the efficacy and the acceptability of low-residue diet package (Enimaclin®) as diet control before colonoscopy.

Detailed description: In this study, we investigate a randomized, single-blinded, comparative study to evaluate the efficacy and the acceptability of low-residue diet package (Enimaclin®) as diet control before colonoscopy.

Eligibility criteria: Inclusion Criteria:

* Male or female
* Outpatient or healthy volunteer for health examination, 20\~75 years old
* Eligible for oral bowel preparation
* BMI (Body Mass Index) ≤ 30

Exclusion Criteria:

* Patients with severe constipation (as fewer than three stools per week)
* Patients with bowel obstruction
* Patients contraindicated with treatment drug
* Patients who need emergency medication
* Ineligible for bowel preparation
* Pregnant or breast-feeding
* Patients with known allergies to treatment drug or low-residue diet package
* Patients who are ineligible to enroll

Primary outcomes:
measure: Overall Cleansing Level at Colonoscopy by Ottawa Bowel Preparation Scale
timeFrame: 1 day
measure: Overall Cleansing Level at Colonoscopy by Aronchick Scale
timeFrame: 1 day
measure: Total Volume of Purgatives That Ingested
timeFrame: 1 day
measure: Segmental Cleansing Level at Colonoscopy (Right Segment Preparation Failure)
timeFrame: 1 day
Secondary outcomes:
measure: Willingness to Choose the Same Protocol After Different Low Residual Diet and PEG-ELS Protocol
timeFrame: 1 day
measure: Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol
timeFrame: 1 day
measure: Convenience of Different Low Residual Diet and Bowel Preparation Protocol
timeFrame: 1 day
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: E-Da Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital Bei-Hu Branch
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
affiliation: NTUH
name: Han-Mo Chiu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00099957: A Clinical Study to Assess the Effect of Vildagliptin on Postprandial Lipid Parameters in Patients With Type 2 Diabetes
Official title: A Clinical Study to Assess the Effect of Vildagliptin on Postprandial Lipid Parameters in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: type 2 diabetes
vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-12-22
Enrollment: 38
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was not conducted in the United States. Many people with type 2 diabetes also have high cholesterol levels. The purpose of this study was to evaluate the effects of vildagliptin, an unapproved drug, on blood lipid measures such as triglycerides and cholesterol in people with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Blood glucose criteria must be met
* Genetic markers associated with increased risk of cardiovascular disease
* Not currently on drug therapy for type 2 diabetes
* Body mass index (BMI) in the range 25-40

Exclusion Criteria:

* Pregnancy or lactation
* Type 1 diabetes
* High cholesterol as defined by the protocol
* Evidence of serious diabetic complications
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Postprandial serum total triglycerides at 4 weeks
Secondary outcomes:
measure: Postprandial total cholesterol at 4 weeks
measure: Postprandial total apo B at 4 weeks
measure: Postprandial triglycerides in the two lipoprotein fractions - chylomicrons and VLDL1+VLDL2+IDL (VLDL/IDL) at 4 weeks
measure: Postprandial cholesterol in the two lipoprotein fractions - chylomicrons and VLDL1+VLDL2+IDL (VLDL/IDL) at 4 weeks
measure: Postprandial apo B-48 and apo B-100 in the two lipoprotein fractions - chylomicrons and VLDL1+VLDL2+IDL (VLDL/IDL) at 4 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT04161157: Piloting Pathways With Lung Cancer Patients
Official title: Piloting Pathways, a Hope-enhancing Intervention to Address Activity and Role Function in Metastatic Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Lung Cancer
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-11-13
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research is to determine the feasibility of a new supportive intervention, called Pathways, for patients with advanced stage and metastatic lung cancer.

Detailed description: In this study, investigators will first test the Pathways procedures with 6 patients to identify any improvements that need to be made. Then, investigators will test the feasibility of the Pathways intervention with 20 patients who are undergoing cancer treatment for advanced stage or metastatic lung cancer. Pathways is designed to help patients set and pursue personal goals during lung cancer treatment. In this study, investigators want to see if they can recruit patients with lung cancer who are being treated at the University of Kentucky Markey Cancer Center to participate in the Pathways intervention.

Eligibility criteria: Inclusion Criteria:

* new or recurrent stage IIIB, stage IIIC or stage IV non-small cell lung cancer (NSCLC) or extensive stage SCLC
* 18 years of age or older
* ECOG PS 0-2/Karnofsky 60-100
* 3 to 12 weeks into active cancer treatment

Exclusion Criteria:

* unstable brain metastases
* cognitive or psychiatric condition for which participating would be inappropriate
* unable to speak and read English

Primary outcomes:
measure: Feasibility of Enrollment: Percentage of Eligible and Approached Patients Who Agree to Participate
timeFrame: 9 months
measure: Acceptability: Ratings
timeFrame: 9 months
Secondary outcomes:
measure: PROMIS Satisfaction With Participation in Social Roles - Short Form 8a
timeFrame: 9 months
measure: Hope - State Hope Scale (Snyder)
timeFrame: 9 months
measure: Purpose - PROMIS Meaning and Purpose 4a
timeFrame: 9 months
measure: Distress - PROMIS Depression Short Form 6a
timeFrame: 9 months
measure: Lung Cancer Stigma - Lung Cancer Stigma Inventory (Hamann)
timeFrame: 9 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Laurie McLouth, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01770457: Cytokine Response in Septic Shock
Official title: Cytokine Response in Septic Shock
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Septic Shock
Keywords: ICU population
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2013-01-17
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients with septic shock admitted to intensive care units who are receiving vasopressors for septic shock for \<24 hrs. No significant exclusions exist.

Brief summary: This study is designed to examine the early sequential cytokine responses during antibiotic therapy and resuscitation of septic shock in relation to clinical manifestations of disease.

The specific objective is to obtain sequential serum samples from patients with septic shock, examine a broad range of cytokine responses (TNF, IL-1, IL-6, MIF, LIF, HMGB1, etc) in a rigorous manner and correlate these responses to administration of antibiotics, resuscitative efforts and physiologic responses to illness (temp, HR, blood pressure, WBC, etc).

Detailed description: Patients must be on vasopressors Patients cannot be on pressors for \> 24 hrs prior to consent

Eligibility criteria: Inclusion Criteria:

* Adult ICU patients: . 18 years admitted with septic shock
* Receiving Vasopressors \< 24 hrs

Exclusion Criteria:

* Consent refused by patient or SDM
* Received Vasopressors \> 24hrs

Primary outcomes:
measure: Cytokine response in septic shock
timeFrame: Hours 0, 3, 6, 12, 18, 24, 36, 48, 96 and day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre, Winnipeg
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Anand Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00535457: The Effects of Pre-operative Magic Tricks Performance on Pre-operative Anxiety in Children
Official title: The Effects of Pre-operative Magic Tricks Performance on Pre-operative Anxiety in Children
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Anxiety
Keywords: anxiety
maladaptive behavior
anesthesia
Anxiety before anesthesia and maladaptive behavior after anesthesia.
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-09-26
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It is not uncommon for children to undergo surgery. Surgery is a threatening event that is composed of various stress-provoking stimuli. Pre-operative anxiety is a common emotional response among operated children and their parents. In the current study we are going to examine if tricks done by the anesthesiologist before anesthetic induction are equally as effective as oral midazolam premedication in the reduction of pre-operative anxiety in children before and after surgery. A successful anxiety reduction may be advantageous over pharmacological premedication by cost reduction, a possibly shorter post anesthesia care stay and by reducing postoperative maladaptive behavior rate.

Study hypothesis: 1. similar anxiety scores will be observed in children that will watch their anesthesiologist performing tricks and in those who will receive oral midazolam premedication but no tricks.

2. Similar rates of postoperative maladaptive behavior will be found in children that that will see tricks and in those that will receive midazolam premedication.


Eligibility criteria: Inclusion Criteria:

* age 3-12 years
* minor surgeries / diagnostic procedures such as endoscopy, biopsy

Exclusion Criteria:

* children that do not speak Hebrew
* American Society of Anesthesiologists (ASA) status above II
* a need for regional anesthesia only
* a need for an intravenous (IV) cannulation at the induction room or operating room before the induction of anesthesia.

Primary outcomes:
measure: anxiety scores
timeFrame: Technical problems with video-taping of the patients still avoid us from recruiting patients. Therefore, the time frame of the study is still unclear tome.
measure: postoperative maladaptive behavior rate
Secondary outcomes:
measure: preoperative anxiety scores and rate of postoperative maladaptive behavior
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Ze'ev Shenkman, MD
role: PRINCIPAL_INVESTIGATOR
References: