louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02893800: Validation and Optimization of the Individual Benefits of Locating Systems in Dementia Care
Official title: Assistive Technology for Dementia: Validation and Optimization of the Individual Benefits of Locating Systems in Dementia Care (VODINO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: assistive technology
dementia care
tracking technology
locating systems
user experience
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Alzheimer Society
First posted: 2016-09-09
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The project aims to make new technologies for locating people with dementia easier to use for the patients and those caring for them.

Objective: To systematically understand what improves the user experience of persons with dementia (PwD) and their primary caregivers (CG) with locating system watches to ultimately allow users to obtain more benefits from using these watches.

Aim: Improving the user experience of PwD and CG with locating system watches using a cross-over design and a theory-based educational session approach.

Detailed description: This entire research field (assistive technology in dementia care) is based on the need to address care solutions for a growing number of PwD and CG in the absence of a cure for (Alzheimer's) dementia.

Methods: A user study with two free available locating watches. In educational sessions PwD obtain a locating watch and their CG a smartphone with the application of the locating watch installed on it. By using a cross-over design each dyad (PwD and CG) obtaining both locating systems. The designed educational session hopefully ease subsequent use and make it more enjoyable. The dyads will use each system over four weeks in their real environment.

Eligibility criteria: Inclusion Criteria:

* diagnosis of all kinds of dementia or mild cognitive impairment

Exclusion Criteria:

* not able to move outside alone

Primary outcomes:
measure: Usability
timeFrame: 8 weeks
Secondary outcomes:
measure: Caregiver burden
timeFrame: 8 weeks
measure: Acceptance and Practicability
timeFrame: 8 weeks
measure: Subjective quality of life
timeFrame: 8 weeks
measure: Activities of Daily Living
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Medicine
Study officials:
affiliation: Charité CBF
name: Oliver Peters, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Megges H, Freiesleben SD, Rosch C, Knoll N, Wessel L, Peters O. User experience and clinical effectiveness with two wearable global positioning system devices in home dementia care. Alzheimers Dement (N Y). 2018 Nov 9;4:636-644. doi: 10.1016/j.trci.2018.10.002. eCollection 2018.
Clinical trial NCT04478500: Neuroinflammation in Hypertension Study
Official title: The Role of Neuroinflammation in Hypertension.Minocycline for Resistant Hypertension: a Randomized Double Blind Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Resistant Hypertension
Lead sponsor: Royal Perth Hospital
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate that in patients with resistant hypertension oral treatment with minocycline via inhibition of central immune cell activation and inflammation results in reduced central sympathetic outflow and concomitant lowering of BP.

Detailed description: This is a randomized, double-blind, placebo controlled, parallel group design study aiming to compare the effects of minocycline 100mg twice daily vs matched placebo for 12 weeks on ambulatory BP and the parameters of sympathetic and immune activation

Eligibility criteria: Inclusion Criteria:

* Aged: 45 -65 years
* Signed informed consent
* Clinical diagnosis of Resistant Hypertension
* Daytime systolic ambulatory BP \>135mmHg.

Exclusion Criteria:• eGFR of \<45 mL/min/1.73m2

* History of myocardial infarction (MI) or any cardiovascular event within 3 months of screening period, clinically significant AV conduction disturbances and/or arrhythmias,
* current of past history of heart failure (LVEF ≤40%)
* psychotropic agents, antidepressants and NSAIDS
* alcohol consumption of \>3 standard drinks.
* known hypersensitivity or contraindication to minocycline or other tetracyclines.

Primary outcomes:
measure: The difference in the daytime systolic blood pressure between groups after respective treatment.
timeFrame: 12 weeks
measure: Assessment of change in central and peripheral inflammation
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in muscle sympathetic nerve activity
timeFrame: 12 weeks
measure: Change in central Blood Pressure
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
Study officials:
affiliation: University of Western Australia and Royal Perth Hospital
name: Markus Schlaich, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carnagarin R, Matthews V, Zaldivia MTK, Peter K, Schlaich MP. The bidirectional interaction between the sympathetic nervous system and immune mechanisms in the pathogenesis of hypertension. Br J Pharmacol. 2019 Jun;176(12):1839-1852. doi: 10.1111/bph.14481. Epub 2018 Sep 25.
citation: Santisteban MM, Ahmari N, Carvajal JM, Zingler MB, Qi Y, Kim S, Joseph J, Garcia-Pereira F, Johnson RD, Shenoy V, Raizada MK, Zubcevic J. Involvement of bone marrow cells and neuroinflammation in hypertension. Circ Res. 2015 Jul 3;117(2):178-91. doi: 10.1161/CIRCRESAHA.117.305853. Epub 2015 May 11.
Clinical trial NCT00286000: High Dose Simplified Folfiri in Advanced Colorectal Cancer: a Multicentre Phase II Study
Official title: High Dose Simplified Folfiri in Advanced Colorectal Cancer: a Multicentre Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Colorectal Cancer
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-02-02
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A multicentre phase II study to evaluate the results of high dose simplified folfiri in advanced colorectal cancer


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically proven adenocarcinoma of the colon or rectum
* Documented progressive metastatic disease
* Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to response evaluation criteria in solid tumours (RECIST)
* WHO performance status of 0 or 1
* Adequate laboratory values of haematology, liverfunction and renal function
* No previous chemotherapy for metastatic colorectal cancer

Exclusion Criteria:

* Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except curatively treated cancer free of disease for more than 10 years.
* Bowel obstruction or sub-obstruction. Crohn's disease, or ulcerative colitis.
* Other severe illness or medical condition such as unstable cardiac disease under treatment, myocardial infarction within 6 months before inclusion.
* Active uncontrolled infection
* Other concomitant anticancer agent

Primary outcomes:
measure: Response rate
Secondary outcomes:
measure: Resectability
measure: Safety
measure: TTP
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Marc Peeters, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00292500: Efficacy of Automated Distal Vascular Anastomosis in Coronary Surgery: Phase II
Official title: Efficacy of Automated Distal Vascular Anastomosis in Coronary Surgery: Phase II
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: CABG, anastomotic device; myocardial revascularization
Lead sponsor: Cardica, Inc
Sponsor class: INDUSTRY
First posted: 2006-02-16
Enrollment: 170
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This evaluation is designed to evaluate the feasibility of using an automated distal coronary anastomotic to facilitate grafting of the left internal mammary artery to the left anterio descending coronary artery during myocardial revascularization in patients with coronary artery disease requiring surgical intervention. The study is designed to assess the ability to compare the patency of grafts created using an automated device versus hand-sewn grafts of the same vessels in the same patient population.

Detailed description: Evaluation of automated distal anastomotic device as a surrogate for hand-sewn grafts for completion of arterial conduit anastomosis between the Left Internal Mammary Artery and Left Anterior Descending Artery among patients with coronary artery disease requiring surgical revascularization.

Eligibility criteria: Inclusion Criteria:

* Age between 50 and 85 years (inclusive)
* Diagnostically confirmed coronary disease
* Ejection fraction \> 30%
* Tolerate contrast media
* Acceptable LIMA (conduit) and LAD (target)for grafting
* Life expectancy \> 1 year

Exclusion Criteria:

* Refusal to give informed consent
* Unable to meet study travel and general health requirements
* Pregnancy
* Previous cardiac surgery
* NYHA Class IV
* Preoperative need for IABP
* Acute or chronic dialysis (creatinine \> 200mmolor 2.3 mg/dL) within 30 days of surgery
* Acute or suspected systemic infection
* Need for ongoing immunosuppressive therapy
* Recent history (\<2 weeks) of CVA
* Aspirin allergy

Primary outcomes:
measure: Coronary patency of index graft at the sixth post-operative month
timeFrame: 6 months post-op
Secondary outcomes:
measure: Establish preliminary safety profile
timeFrame: 6 months post-op
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Klinik für Herzchirurgie
Study officials:
affiliation: Herzzentrum Leipzig Gmbh
name: Jan Gummert, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05668000: Mobile App for Heart Failure
Official title: Self-Monitoring Using Mobile App for Reduction of Rehospitalization and Mortality in Heart Failure (SMART-HF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: KT Corporation
First posted: 2022-12-29
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators developed a mobile health platform to self-management in HF. The aim of this study is to evaluate whether this smartphone app-based intervention can improve symptoms of HF when compared to usual care in HF patients.


Eligibility criteria: Inclusion Criteria:

* Patients aged 20 years or older hospitalized for acute heart failure.
* Patients who have obvious symptoms or sign of HF at admission
* N-terminal prohormone of brain natriuretic peptide (NT-proBNP) ≥400 pg/mL or brain natriuretic peptide (BNP) ≥100 pg/mL.
* participants should be able to use smartphone well.

Exclusion Criteria:

* Patients who have baseline systolic blood pressure \<90 mmHg or resting heart rate \<50 beats per minutes
* Patients who cannot use smartphone
* Patients who had cardiac implantable electronic device will be excluded

Primary outcomes:
measure: HF symptom by application scores.
timeFrame: 4 weeks
measure: HF symptom by questionnaire
timeFrame: 4 weeks
Secondary outcomes:
measure: Composite outcome
timeFrame: 4 weeks
measure: Application satisfaction score
timeFrame: 4 weeks
measure: change in body water composition f
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Catholic University college of medicine
city: Seoul
country: Korea, Republic of
facility: Korea Univ. Guro hospital
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Hospital
Study officials:
affiliation: Seoul National Univeristy Bundang Hospital
name: Dong-Ju Choi
role: STUDY_CHAIR
References:
Clinical trial NCT01060800: The Genetics of Chiari Type I Malformation
Official title: The Genetics of Chiari Type I Malformation (CMI) With or Without Syringomyelia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chiari Type I Malformation
Keywords: Chiari
Chiari Type I
Chiari Type I Malformation
Familial Chiari
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2010-02-02
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study is not currently enrolling new participants.

Brief summary: Duke University Medical Center is investigating the hereditary basis of Chiari type I malformations with or without syringomyelia (CM1/S). Our research is aimed at learning if CM1/S is indeed caused by factors inherited through the family and, if so, which genes are involved.


Eligibility criteria: The study is not currently enrolling new participants.

Primary outcomes:
measure: Genetic factors contributing to Chiari Type I malformation
timeFrame: end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Allison Ashley-Koch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06246500: Severe Head Trauma: Coagulation and CT-Scan Aggravation.
Official title: Severe Head Trauma: Coagulation and CT-Scan Aggravation.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Head Trauma
Lead sponsor: Centre Hospitalier Annecy Genevois
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient data will be selected retrospectively and consecutively according to in and exclusion criteria. All patient admitted in emergency room between January 2016 and December 2018 severe head injury defined

Brief summary: Retrospective, multicenter cohort study describing the biological, radiological and clinical criteria of patients managed for isolated severe head trauma between January 2016 and December 2018.

Detailed description: The objective of the study is to describe the evolution of CTscan lesions in patients with isolated Head Trauma between admission and re-evaluation after 24 hours.

Eligibility criteria: Inclusion Criteria:

* Adults
* Patients informed and did not object to the collection of their medical data for the study
* Patient admitted in Trauma center between January 2016 and December 2018 severe head injury defined by a Glasgow Coma Scale (GCS) \< 9 AND/OR Abnormalities on the first brain CT-scan with pathological transcranial Doppler (Vd \< 25 cm/s and IP \> 1.25)

Exclusion Criteria:

* Abbreviated Injury Score (AIS) head and neck ≤ 3 AND/OR AIS out of head and neck \> 3
* Taking drugs that interfere with hemostasis, such as anticoagulant or antiplatelet antiaggregants in preventive or curative doses;
* Patients under guardianship
* Patients still alive at the time of data collection AND opposed to the collection of their data

Primary outcomes:
measure: Describe the evolution of CT scan lesions between admission and reassessment CT scan
timeFrame: 24 hours
Secondary outcomes:
measure: Mortality
timeFrame: Day 28
measure: Causes of death
timeFrame: Day 28
measure: Describe the coagulation status on admission with severe head trauma trauma
timeFrame: 24 hours
measure: Describe the coagulation status on admission with severe head trauma trauma
timeFrame: 24 hours
measure: Describe the coagulation status on admission with severe head trauma trauma
timeFrame: 24 hours
measure: Describe the coagulation status on admission with severe head trauma trauma
timeFrame: 24 hours
Other outcomes:
Locations:
city: Pringy
country: France
facility: Centre Hospitalier Annecy Genevois
Study officials:
References:
Clinical trial NCT00568100: Effect of Pressure Support Ventilation and Neurally Adjusted Ventilatory Assist (NAVA) in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: Effect of Pressure Support Ventilation and Neurally Adjusted Ventilatory Assist (NAVA) in COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: gas exchange
pressure support ventilation
respiratory mechanics
COPD
NAVA
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2007-12-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators' aim is to study the effect of pressure support ventilation at two levels of PEEP and Pressure Support versus neurally adjusted ventilatory assist (NAVA) in COPD patients.

Detailed description: In this study, two levels of pressure support and PEEP during pressure support ventilation are compared with neurally adjusted ventilatory assist (NAVA) in COPD patients by measuring respiratory mechanics, intrinsic PEEP, work of breathing and patient's level of comfort.

Eligibility criteria: Inclusion Criteria:

* Stable COPD patients during non invasive mechanical ventilation

Exclusion Criteria:

* Haemodynamic instability
* Coma

Primary outcomes:
measure: Respiratory mechanics, gas exchange, work of breathing
timeFrame: 5 minutes
Secondary outcomes:
measure: Comfort of breathing
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Policlinico Hospital
Study officials:
affiliation: Policlinico Hospital
name: Davide Chiumello, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00755300: Total Knee Arthroplasty And Thromboembolism: A Comparison Between Two Surgical Techniques
Official title: Total Knee Arthroplasty And Thromboembolism: A Comparison Between Two Surgical Techniques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Knee Replacement
Venous Thromboembolism
Keywords: Total knee replacement
esophageal echocardiography
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2008-09-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for elective total knee replacement

Brief summary: In patients undergoing total knee arthroplasty, thromboembolism is a common occurrence, especially following tourniquet deflation. The resulting cardiopulmonary emboli can potentially lead to hypoxemia, hypotension, hemodynamic collapse and post operative cognitive dysfunction due to emboli. The standard surgical technique involves placing an intramedullary rod in the femur to determine the angle and degree of resection from the end of the femur. A new surgical technique utilizes computer navigation system to perform the desired cuts in the appropriate position. The investigators hypothesize that the avoidance of intramedullary instrumentation in computer assisted total knee replacement will result in fewer thromboembolic events compared with the standard technique using manual instrumentation in the femur. The present study will test this hypothesis by quantifying the extent of thromboembolism during both surgical techniques.

Detailed description: Currently, Transesophageal Echocardiography (TEE) is routinely used intraoperatively to monitor patients undergoing total knee arthroplasty for thromboembolic events. Video recording (without any patient identifiers) of the TEE loops before and after tourniquet release, offline analysis to quantify the extent of thromboembolism and the two surgical techniques will be compared. Patients are assigned to a particular technique according to some non-rigid criteria. This study has no impact on their selection into one group or the other. Participation in this study does not influence the choice/selection. We will simply record and analyze the echo loops in twenty patients already assigned to each surgical technique.

Eligibility criteria: Inclusion Criteria:

* Adult patients scheduled to undergo Total Knee Arthroplasty at UC Davis Medical Center
* 18 years and above

Exclusion Criteria:

* Any contraindication to perform TEE

Primary outcomes:
measure: Total venous embolic load
timeFrame: Acute, 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
Study officials:
affiliation: Associate Professor, Cardiovascular and Thoracic Anesthesiology, UC Davis, Department of Anesthesiology and Pain Medicine
name: Amrik Singh, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02709200: Effect of Dexmedetomidine on Pacemaker Function Following Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Congenital Heart Disease
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Congenital heart disease patients having open heart surgery.

Brief summary: This is a prospective study looking at the effects of dexmedetomidine on pacemaker function in patients who have surgery for congenital heart disease utilizing cardiopulmonary bypass (CBP). For the purpose of the study, no change in intraoperative care will be dictated. The use of dexmedetomidine will be left up to the discretion of the treating physicians. The study will involve only the collection of data regarding the amplitude required to capture and specific demographics and intraoperative features including cross clamp time, time on CPB, and vasoactive agents that were and are being administered. In addition to these data, it will be noted whether dexmedetomdine was used or not and whether it is being administered on arrival to the CTICU.


Eligibility criteria: Inclusion Criteria:

* Patients with temporary surface pacemaker leads following surgery for congenital heart disease.

Exclusion Criteria:

* Patients with single ventricle anatomy
* Patients receiving epinephrine
* Infants less than 6 months of age

Primary outcomes:
measure: Amplitude
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References: