louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03786445: Analysis of In-hospital Emergency Team Calls in a German Tertiary Care University Hospital From 2013 to 2016
Official title: Analysis of In-hospital Emergency Team Calls in a German Tertiary Care University Hospital From 2013 to 2016
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergencies
Lead sponsor: Universitätsklinikum Köln
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 1664
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients in the hospital

Brief summary: A retrospective analysis of 1,664 emergency forms from MET activities, ranging from January 2013 to December 2016. Every MET activation call via the emergency telephone number ("5555") and following emergency treatment was recorded by a standardized documentation form.

Detailed description: Recent studies demonstrated that in-hospital emergencies are linked to a higher mortality in patients. In total, 1 out of 10 patients is suffering from an unexpected incident during the hospital stay. Therefore, establishing and developing medical emergency teams (MET) is getting more important in the future. Aim of the present study was an analysis of medical documentation, operational tactics and procedures taken by MET in a 4-year-period, ranging from 2013 to 2016. A retrospective analysis of 1,664 emergency forms from MET activities, ranging from January 2013 to December 2016. Every MET activation call via the emergency telephone number ("5555") and following emergency treatment was recorded by a standardized documentation form.

Eligibility criteria: Inclusion Criteria:

* all patients treated with emergencies

Exclusion Criteria:

* none

Primary outcomes:
measure: Death
timeFrame: 2013 to 2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Schmitz J, Kerkhoff S, Sander D, Schulz G, Warnecke T, Hinkelbein J. [Deployment of the in-hospital emergency team in a tertiary care university hospital : Data analysis for the time period 2013-2016 in North-Rhine/Westphalia]. Anaesthesist. 2019 Jun;68(6):361-367. doi: 10.1007/s00101-019-0586-y. Epub 2019 Apr 10. German.
Clinical trial NCT04691245: 3D US Guided Femoral Artery Access for TAVI
Official title: Three Dimensional Ultrasound Guided Femoral Access for Transcatheter Aortic Valve Implantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ultrasound Therapy; Complications
Femoral Artery Injury
Keywords: 3D Ultrasound
vascular access
Transcatheter aortic valve implantation
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
Collaborators: name: Eindhoven University of Technology
First posted: 2020-12-31
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized clinical trial with two arms
Primary purpose: OTHER

Brief summary: Rationale: Bleeding and vascular complications of the femoral artery still account for significant morbidity and mortality in transcatheter aortic valve implantation procedures. Although steadily declining over the past years through smaller diameter devices and use of ultrasound, major complications still occur in 3-4 % of patients. Femoral access is often obtained using 2D US guidance already. New 3D US probes can aid in increasing anatomical awareness. This can improve first pass success during procedures. Furthermore, for new closure devices, entering the artery at a straight angle at precisely 12 o'clock probably reduces complications. Therefore, the investigators hypothesize improved real time needle guidance using three dimensional ultrasound can decrease procedure related complications.


Eligibility criteria: Inclusion Criteria:

* Adult age (\>18 years)
* Scheduled to undergo elective transcatheter aortic valve implantation with percutaneous access through the femoral artery
* Written Informed consent

Exclusion Criteria:

* Unable to obtain informed consent
* Vascular access via alternative approach (radial/subclavian) or surgical cutdown

Primary outcomes:
measure: first pass success
timeFrame: during procedure/surgery
Secondary outcomes:
measure: imaging time
timeFrame: during procedure/surgery
measure: procedure time
timeFrame: during procedure/surgery
measure: total number of punctures
timeFrame: during procedure/surgery
measure: number of needle redirections
timeFrame: during procedure/surgery
measure: 12 o clock entry
timeFrame: during procedure/surgery
measure: needle visualization
timeFrame: during procedure/surgery
measure: operator satisfaction
timeFrame: during procedure/surgery
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis Eindhoven
state: Noord-Brabant
Study officials:
References:
Clinical trial NCT04721145: CGM Use in Poorly Controlled Youth With Type 1 Diabetes
Official title: IMPaCT: IMPlementing Continuous Glucose Monitoring in High-risk, Poorly Controlled Children With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Hypoglycemia
High Blood Sugar
Keywords: Continuous Glucose Monitoring
Time in range
Hemoglobin A1c
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2021-01-22
Enrollment: 26
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this prospective study is to determine if trial use of a Dexcom G6 CGM system for a 10 day wear period in high risk, poorly controlled pediatric Type 1 diabetes patients increases uptake of personal CGM use, and improves short-term time in range glucose control.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Type 1 diabetes for \>3 months

Exclusion Criteria:

* CGM use in the last 6 months

Primary outcomes:
measure: Change in Personal CGM Use
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change in the Percent Time in Range Glucose Control
timeFrame: 1-5 days and 6-10 days
measure: Change in Hemoglobin A1c
timeFrame: Baseline, 3-6 months
measure: Using Personal CGM
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Pediatric Diabetes Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Risa Wolf, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin T, Manfredo JA, Illesca N, Abiola K, Hwang N, Salsberg S, Akhtar Y, Mathioudakis N, Brown EA, Wolf RM. Improving Continuous Glucose Monitoring Uptake in Underserved Youth with Type 1 Diabetes: The IMPACT Study. Diabetes Technol Ther. 2023 Jan;25(1):13-19. doi: 10.1089/dia.2022.0347. Epub 2022 Nov 7.
Clinical trial NCT06517745: Effect of Prone Positionning in Non Intubated Patients
Official title: Prone Positionning in Non Intubated ICU Patients With SARS-COV2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV 2 Pneumonia
Acute Respiratory Distress Syndrome
Prone Positioning
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult (\> 18 years) patients admitted in the ICU:

* with acute respiratory failure due to COVID-19 pulmonary infection
* non intubated
* regardeless of the exygenation method: HFONC, face mask, non invasive ventilation

Brief summary: Retrospective single center study on the effect of awake prone positioning in ICU patients with severe hypoxemia related to SARS-COV2

Detailed description: Retrospective, observational study on the effects of awake prone positioning on oxygenation, invasive mechanical ventilation requirement and mortality in non intubation patients with severe hypoxemia related to SARS-COV2 and regardeless of the oxygen supplementation method.

Eligibility criteria: Inclusion Criteria:

* All adult (\> 18 years) patients, non intubated, with acute respiratory failure due to COVID-19 pulmonary infection

Exclusion Criteria:

* patients: hemodynamic instability and high doses of vasopressors
* patients with contraindications of prone positioning: pregnancy, recent abdominal surgery
* patients with pulmonay embolism
* patients requiring invasive mechanical ventilation for extra respiratory reasons: neurological failure, urgent surgery

Primary outcomes:
measure: Intubation
timeFrame: at day 7
measure: Intubation
timeFrame: at day 14
Secondary outcomes:
measure: ICU mortality
timeFrame: at Day 14
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Mongi Slim hospital
Study officials:
References:
Clinical trial NCT00701545: A Canadian Study to Assess the Safety of Humate-P® Ivr (Infusion Volume Reduced)
Official title: A Canadian, Multi-center, Prospective, Open-label, Observational, Pharmacovigilance Study to Assess the Safety of Humate-P® Ivr (Infusion Volume Reduced) in Patients Transitioning From Treatment With Currently Available Humate-P®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Von Willebrand Disease
Keywords: von Willebrand disease
VWD, Humate-P®
Infusion volume reduced
ivr
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2008-06-19
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with von Willebrand disease treated with Humate P® ivr in Canada

Brief summary: As part of CSL Behring Canada's continued commitment to ensuring the safety of the new low volume preparation of Humate-P®, CSL Behring Canada proposes to conduct a prospective, multi-center structured data collection of routine management of patients with von Willebrand disease treated with Humate P® ivr in Canada. The surveillance will be non-interventional and non-experimental. During the observation period, the routine medical care of the patient will be documented.

It is expected that there will be no difference in the safety and tolerability of Humate-P® ivr compared to Humate-P®


Eligibility criteria: Inclusion Criteria:

* Male or female patients of any age;
* Patients who are suffering with von Willebrand disease previously treated with Humate-P®;
* Patients who are able to communicate well with the Investigator and his/her representatives;
* Patients who are able and agreeing to comply with all study requirements;
* Patients who have provided written signed and dated informed consent prior to any study procedures being performed.

Exclusion Criteria:

* Patients who have received any investigational drug ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy.

Primary outcomes:
measure: To assess the safety and tolerability of Humate-P® (reported adverse events)
timeFrame: 6 months
Secondary outcomes:
measure: To capture efficacy data on Humate-P® ivr: • supporting clinical management of bleeding episode or surgery • incidence of relevant bleeding episodes
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
Study officials:
affiliation: CSL Behring Canada
name: David G. Barnes, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03777345: Comparison Between Injection Molded Polyetheretherketone (PEEK) Framework and Cobalt Chromium Framework Removable Partial Dentures Regarding Periodontal Health of Abutment Teeth
Official title: Evaluation of Periodontal Health of the Abutment Teeth in Partial Dentures Made of Injection Molded PEEK Framework Versus Cobalt Chromium Framework in Mandibular Kennedy Class I Edentulous Cases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mandibular Prosthesis User
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is aiming to evaluate the periodontal status of the abutment teeth in Polyetheretherketone ( PEEK ) framework partial dentures compared with cobalt-chromium ones in mandibular kennedy class I edentulous cases aiming to preserve the optimum periodontal health of the abutment teeth .


Eligibility criteria: Inclusion Criteria:

* Kennedy Class I partially edentulous subjects indicated for framework partial denture

Exclusion Criteria:

* 1- uncooperative patients . 2- bad oral hygiene patients .

Primary outcomes:
measure: Periodontal status
timeFrame: Change in periodontal status will be assessed at base line , after one month and after 3 months .
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and Dental Medicine Cairo University
Study officials:
References:
citation: Abdel-Bary SK, Rostom EM, Elboarey AN. Thermoplastic Removable Partial Dentures versus Metal Cobalt-Chromium. RESEARCH JOURNAL OF PHARMACEUTICAL BIOLOGICAL AND CHEMICAL SCIENCES. 2016 Jul 1;7(4):464-70.
Clinical trial NCT03365245: Partial Least Squares Regression Modelling for Glaucoma Detection
Official title: Partial Least Squares Regression Modelling for Glaucoma Detection Using Retinal Nerve Fiber Layer, Ganglion Cell Layer and Visual Field Data
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 19
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A partial least squares regression model for visual field testing among glaucoma patients will be developed.

In addition, microperimetry will be compared to conventional perimetry and reproducibility will be assessed.

Detailed description: Aim of this study is to develop a partial least squares regression model incorporating retinal nerve fiber layer (RNFL) and retinal ganglion cell layer (RGCL) measurements as well as visual field testing to represent a glaucoma expert opinion on the stage of glaucoma.

In addition, microperimetry will be compared to conventional perimetry and reproducibility will be assessed.

Eligibility criteria: Inclusion Criteria:

* Age 21 and older
* written informed consent prior to surgery
* any glaucoma-associated changes in one or both eyes (i.e. increased intraocular pressure, optic disc changes, known visual field defects) in the "glaucoma patients" and the absence of any glaucoma associated changes in the "healthy eyes group".

Exclusion Criteria:

* Secondary glaucoma
* In case of pregnancy (pregnancy test will be taken in women of reproductive age)

Primary outcomes:
measure: partial least square regression
timeFrame: one month
Secondary outcomes:
measure: reproducibility
timeFrame: one month
measure: Retinal nerve fiber thickness (RNFL) and the the retinal ganglion cell layer (RGCL)
timeFrame: one month
measure: Microperimetry versus visual field testing
timeFrame: one month
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: VIROS
Study officials:
affiliation: Vienna Institute for Research in Ocular Surgery
name: Oliver Findl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02126345: MASTER SL Clinical Study
Official title: A Prospective, Observational, Multi-centre, Cohort Study of the MASTER SL Femoral Stem and the DELTA TT Acetabular Cup in Patients With Degenerative Disease of the Hip
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Requiring Hip Replacement
Lead sponsor: Limacorporate S.p.a
Sponsor class: INDUSTRY
First posted: 2014-04-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients Requiring Hip Replacement

Brief summary: The purpose of this study is:

* to generate data to evaluate Orthopaedic Data Evaluation Panel (ODEP) rating to support existing short-term clinical results and CE documentation;
* to assess the clinical performance of the MASTER SL femoral stem and the DELTA TT acetabular cup under standard conditions of use;
* to determine any adverse events and assess whether they constitute risks when weighed against the intended performance of the device.


Eligibility criteria: Inclusion Criteria:

* Male and female ≥18 years;
* Radiologically confirmed diagnosis of primary osteoarthritis (OA) of the hip and suitable for primary total hip replacement;
* Life expectancy of \>10 years;
* Voluntary written Informed Consent obtained.

Exclusion Criteria:

* Prospect for recovery to independent mobility compromised by known coexistent, medical problems;
* Requiring revision hip replacement;
* Loss of abductor musculature, poor bone stock, or poor skin coverage around the hip joint;
* Previous organ transplant;
* Previous hip replacement (resurfacing or THR) on the contra-lateral side within the last 6 months;
* Previous hip replacement (resurfacing or THR) on the contralateral side and whose outcome is achieving an Oxford Hip score \<18 points;
* Body mass index (kg/m2) exceeds 40;
* Active or suspected infection;
* Known sensitivity to device materials;
* Women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period.

Primary outcomes:
measure: Rate of failure
timeFrame: 3 years
Secondary outcomes:
measure: Clinical progression measured with HHS score, OHS score, Non-Arthritic Hip Score, EQ-5D-5L
timeFrame: from baseline to all time-points
Other outcomes:
measure: Any undesirable side effects
timeFrame: 3 and 5 years
Locations:
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital NHS Foundation Trust
city: Cardiff
country: United Kingdom
facility: University Hospital Llandough Cardiff and Vale University Health Board
city: Oswestry
country: United Kingdom
facility: The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
Study officials:
affiliation: Royal Bournemouth Hospital NHS Foundation Trust
name: Robert Middleton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00410345: Cervical Rippening With Antiprogesterone in Midtrimester Abortions
Official title: Cervical Rippening With Antiprogesterone in Midtrimester Abortions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abortion, Missed
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-12-12
Enrollment: 145
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Induction of midtrimester abortion includes cervical ripening and then contraction to induce uterine evacuation. There are several protocols, but most of them include using prostaglandins (PG). The disadvantages of using PG include uncomfortable side effects and limits of using it for women after cesarean section. Mifepristone is an antiprogesterone drug and been used for induction of abortion in first and second trimesters abortions. The aim of this study is to explore the effectiveness of Mifepristone for cervical ripening before high dose Oxytocin drip.

Detailed description: The aim of this study is to explore the effectiveness of Mifepristone for cervical ripening before high dose Oxytocin drip in midtrimester abortions. After informed consent, all the women will be randomized for Mifepristone or placebo. 48 hours later, high dose oxytocin drip will be started and we will examine the success rate to induce abortion, the duration from starting oxytocin till evacuation of uterus and side effects.

Eligibility criteria: Inclusion Criteria:

* midtrimester late abortion
* midtrimester induced abortion

Exclusion Criteria:

* placenta previa
* infected abortion
* rupture of membranes
* s/p cesarean section \*2 or more

Primary outcomes:
measure: success of abortion induction
measure: abortion induction duration
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Assaf Ben-Meir, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00926445: Neonatal Pain- and Distress Experiences and Later Pain Behavior of Former Preterm and Critically Ill Newborn Infants
Official title: Effect of Neonatal Pain- and Distress Experiences on Later Pain Behaviour of Former Preterm and Critically Ill Newborn Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain
Keywords: Pain behavior
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2009-06-23
Enrollment: 120
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature, critically ill term infants are recruited from the NICU of the University hospital of Cologne. Healthy newborns are recruited from the nursery of the University hospital of Cologne.

Brief summary: Preterm and critically ill neonates experience many painful manipulations. The aim of the study is to evaluate the influence of these experiences and maternal deprivation on later pain behavior. Using Scoring systems, Prechtl general movements, skin conductance, testing flexor reflex levels with von Frey filaments and measuring salivary cortisol levels the investigators compare pain behavior of preterm (birth weight (BW) \< 1500 grams), term neonates with need of ventilation (\> 48 hours) with healthy neonates at the time of their first vaccination at the age of 3-4 months. The investigators are also testing flexor reflexes and skin conductance and general movements in regular intervals during the initial hospital stay. The investigators hypothesize that pain behavior is different at the age of 3-4 months in children with many early painful experiences.


Eligibility criteria: Inclusion Criteria:

* Preterm \< 1500 grams BW, critically ill term newborn on ventilation \> 48 hours

Exclusion Criteria:

* Asphyxia
* ICH grade 3 and higher

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Neonatologische Intensivstation
state: NRW
Study officials:
References: