louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05790642: Comparison of Different Non-invasive Methods to Assess Pulse Wave Analysis
Official title: Vergleich Verschiedener Nicht-invasiver Verfahren Zur Pulswellenanalyse
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Pressure
Arterial Stiffness
Arrythmia
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: general population

Brief summary: The primary goal of the study is to compare different methods for pulse wave measurement and analysis which are cuffless and contactless. The novel measurement tools will be compared to cuff-based reference methods.


Eligibility criteria: Inclusion Criteria:

* older than 18 years
* male or female sex
* signed informed consent.

Exclusion Criteria:

* acute sickness which influences hemodynamic parameters
* arm circumference is below or above the limits for the blood pressure of the reference method (i.e. below 20 or above 40 cm)

Primary outcomes:
measure: Systolic and diastolic blood pressure
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Cardiovascular examination center of the University Medicine Greifswald
Study officials:
References:
Clinical trial NCT04481542: Aortic Dissection With 4-dimensional Phase-contrast Magnetic Resonance Imaging
Official title: Aortic Dissection With 4-dimensional Phase-contrast Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: MRI
Keywords: CVS MRI
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with aortic disease

Brief summary: We prospectively collected information on consecutive patients who had been evaluated using 4D PC-MRI for aortic pathology in a tertiary hospital between April 2018 and Feb 2020. Patients were eligible for inclusion in the study if they had a clinical indication for CTA of aortic dissections.

Detailed description: The exclusion criteria were non-MRI-compatible ferromagnetic devices and pregnancy. In addition, patients with poor compliance and with unstable status that prevented them from lying down for the MRI protocol were excluded. Initially, 26 patients evaluated. One patient was excluded due to fever at the scheduled time, and another was unable to lie down due to complicated spine disease. All patients underwent CTA scan on a 64-slice multidetector scanner (Somatom Sensation 64; Siemens Healthcare, Erlangen, Germany) with the intravenous administration of contrast media, followed by 4D PC-MRI to assess aortic pathology

Eligibility criteria: Patients were eligible for inclusion in the study if they had a clinical indication for CTA of aortic dissections. The exclusion criteria were non-MRI-compatible ferromagnetic devices and pregnancy. In addition, patients with poor compliance and with unstable status that prevented them from lying down for the MRI protocol were excluded.

Primary outcomes:
measure: stroke volume
timeFrame: 5 years
Secondary outcomes:
measure: adverse event
timeFrame: 5 years
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Yao-Kuang Huang
state: Chiayi County
Study officials:
References:
Clinical trial NCT04347642: Umbilical vs Paraumbilical Trocar Placement in Patients Undergoing Elective Laparoscopic Cholecystectomy
Official title: Umbilical vs Paraumbilical Trocar Placement in Patients Undergoing Elective Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Incisional Hernia
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 180
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: The aim of this study will be to assess the incisional hernia rate of umbilical or paraumbilical port 12 months after laparoscopic cholecystectomy.

Patients will be randomized into 2 groups:

* G1: 12mm Umbilical port will be inserted in the umbilical region, with open access and using a Hasson port
* G2: 12 mm paraumbilical port will be inserted laterally to the midline, with close access and using and optical port.

Incisional hernia at the level of this port insertion will be assessed by physical examination and, in case of doubst, by ultrasonography, 12 months after surgery.

Detailed description: The aim of this study will be to assess the incisional hernia rate of umbilical or paraumbilical port 12 months after laparoscopic cholecystectomy.

Patients will be randomized into 2 groups:

* G1: 12mm Umbilical port will be inserted in the umbilical region, with open access and using a Hasson port. Pneumoperitoneum will be done by this Hasson port.
* G2: 12 mm paraumbilical port will be inserted laterally to the midline, with close access and using and optical port, traversing the rectus abdominal muscle. Pneumoperitoneum will be previously done using a Veress needle.

Incisional hernia at the level of this port insertion will be assessed by physical examination and, in case of doubst, by ultrasonography, 12 months after surgery.

Eligibility criteria: Inclusion Criteria:

* Elective laparoscopic cholecystectomy
* Acceptance to participate in the study and sign of informed consent form

Exclusion Criteria:

* A gallstone larger than 10mm observed at preoperative ultrasonography
* Coexistence of umbilical hernia or previous umbilical hernioplasty
* Previous laparotomy involving the umbilical region
* Emergency surgery

Primary outcomes:
measure: Incisional hernia at the level of the trocar insertion
timeFrame: 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Gilberto Gonzalez
city: Madrid
country: Spain
facility: Jaime Ruiz-Tovar
state: Introducir Provincia O Estado
Study officials:
affiliation: Centro PDH
name: Gilberto Gonzalez
role: STUDY_CHAIR
References:
Clinical trial NCT01962142: Assessment of Activity Limitation in Asthma Patients
Official title: Subjective and Objective Assessment of Activity Limitation in Asthma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2013-10-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Exacerbated asthma patients coming to the outpatient clinic of pulmonology.

Brief summary: Limitation of activity is one of the main item used by composites scores designed to assess the level of asthma control. Since this item is systematically subjectively assessed by the patient, the investigators would like to know if these subjective data are correlated with objective data.

Aims of this study are: 1) To describe what means "limitation of activity" for asthma patients and how they deal with; 2) To describe the objective exercise capacity and characteristics of daily activity in two situations (on exacerbation, out of an exacerbation).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of asthma made by a pulmonologist.
* Age ≥ 18 yrs-old, \< 65 yrs-old.
* Moderate or severe exacerbation of asthma (as defined by Reddel et al in 2009) at the time of inclusion.

Exclusion Criteria:

* All other diseases than asthma that can affect the physical activity (e.g. orthopaedic or neuromuscular disease, cardiac or vascular disease).
* Pregnancy or suspicion of pregnancy at the time of inclusion. The women who become pregnant during the study period will be excluded.

Primary outcomes:
measure: Energy expenditure (expressed in MET's) measured during an ergospirometry, at the time of an exacerbation of asthma and 6 weeks later.
timeFrame: At the time of inclusion
Secondary outcomes:
measure: Walking distance in 6 min (expressed in meters) measured at the time of an exacerbation of asthma and 6 weeks later.
timeFrame: 6 weeks
measure: Quality of life (assessed with the Asthma Quality of Life Questionnaire) measured at the time of an exacerbation of asthma and 6 weeks later.
timeFrame: At the time of inclusion
measure: Self-assessment of activity limitation
timeFrame: 7 last days before inclusion
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU St Pierre; pulmonology department
Study officials:
References:
Clinical trial NCT01936142: The Use of Renal Guard System in Patients Undergoing CRT Implantation
Official title: The Effect of Forced Diuresis With Matched Hydration in Reducing Acute Kidney Injury During CRT Implantation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Kidney Injury
Keywords: Resynchroniztion therapy
Kidney
Contrast media
Prevention
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-09-05
Enrollment: 0
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: The purpose of this study is to determine whether the use of RenalGuard system which creates high urine output with fluid balancing may prevent contrast induced nephropathy in patient undergoing cardiac resynchronization therapy (CRT) implantation.


Eligibility criteria: Inclusion Criteria:

1. eligible for CRT implantation
2. estimated GFR \< 60ml/min/1.73m2

Exclusion Criteria:

1. On Dialysis
2. Sensitivity to Furosemide
3. Contraindication for urinary catheter
4. Pregnancy

Primary outcomes:
measure: Change in Renal function
timeFrame: 24 and 48 hours post implantation and 8-11 days post implantation, 6 month post implantaion
Secondary outcomes:
measure: Left ventricular lead implantation success
timeFrame: 1 day post implantation
Other outcomes:
measure: Mortality
timeFrame: 6 month
measure: Hospitalization due to infection
timeFrame: 6 month
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Souraky MC
Study officials:
affiliation: Tel Aviv Sourasky MC
name: Yoav Michowich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06054542: Turkish Version of Digital Eye Strain Questionnaire (DESQ)
Official title: Validity and Reliability of the Turkish Version of Digital Eye Strain Questionnaire (DESQ)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cultural Adaptation
Reliability
Validity
Adults
Eye Strain
Lead sponsor: Alanya Alaaddin Keykubat University
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults who spend two or more continuous hours a day on their digital devices (computer, tablet, smartphone) or use more than one device

Brief summary: The aims of this study were to perform cultural adaptation of the DESQ and provide information regarding the factor structure, reliability and validity of the instrument in Turkish speaking adults.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-65 years
* People who spend two or more continuous hours a day on their digital devices (computer, tablet, smartphone) or use more than one device

Exclusion Criteria:

* History of ophthalmic surgery or active ocular disease
* Participants who did not understand the instructions or did not sign a consent form were excluded

Primary outcomes:
measure: DESQ
timeFrame: Baseline and after 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Alanya Alaadin Keykubat University
Study officials:
References:
Clinical trial NCT02578342: Brain Activity in Adults With ADHD During Neuropsychological Tasks
Official title: Brain Activity and Functional Connectivity in Adults With Attention-Deficit Hyperactivity Disorder (ADHD) During Tasks of Motor Inhibition and Cognitive Switching
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Lead sponsor: Kantonsspital Aarau
Sponsor class: OTHER
First posted: 2015-10-16
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Three groups:

1. healthy volunteers
2. ADHD subjects receiving medications
3. medication-naive ADHD subjects

Brief summary: The aim of the study is to investigate the response on cognitive testing of healthy persons compared to adults with or without medication against ADHD.

Detailed description: Attention Deficit Hyperactivity Disorder (ADHD) is one of the most prevalent psychiatric disorders in children and adolescents. It is characterized by inattentive, hyperactive, impulsive behaviour and neuropsychological deficits. In 40-60% of cases emerge in childhood and persists into adulthood.

The aim of the study is to investigate the response on cognitive testing of healthy persons compared to adults with or without medication against ADHD. As a secondary endpoint a more robust diagnosing method combining advanced imaging methods with neuropsychological evaluation is tested.

Neuropsychological testing, functional MRI and spectroscopy will be performed. Statistical analysis will assess differences in the functional magnetic resonance imaging, spectroscopy and neuropsychological evaluation results between three groups: 1) group of healthy volunteers, 2) participants with ADHD with medication and 3) participants with ADHD without medication.

Eligibility criteria: Inclusion Criteria:

* Participant is between 20-55 years old
* Participant is not pregnant

Exclusion Criteria:

* Participant is not able to consent him/herself
* Suspected or proven pregnancy
* Nursing
* Neurological diseases that could interfere with a diagnosis of ADHD
* Psychiatric comorbidity under treatment
* Previous history of psychiatric medication
* Substance abuse
* Intelligence quotient\<75
* Claustrophobia
* Electrical simulator nerve or bone
* Implanted medication infusion pump
* Cerebral aneurysm clips
* Unstable medical condition

Primary outcomes:
measure: Changes in blood oxygenation level dependency (BOLD)
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
state: Aargau
Study officials:
References:
citation: Berberat J, Huggenberger R, Montali M, Gruber P, Pircher A, Lovblad KO, Killer HE, Remonda L. Brain activation patterns in medicated versus medication-naive adults with attention-deficit hyperactivity disorder during fMRI tasks of motor inhibition and cognitive switching. BMC Med Imaging. 2021 Mar 19;21(1):53. doi: 10.1186/s12880-021-00579-3.
Clinical trial NCT06051942: PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs
Official title: PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Localized Prostate Cancer
Keywords: AQUABEAM
AQUABEAM Robotic System
Aquablation
Aquablation therapy
Robotic Waterjet Treatment
RWT
Prostate cancer
Lower urinary tract symptoms
LUTS
BPH
Lead sponsor: PROCEPT BioRobotics
Sponsor class: INDUSTRY
First posted: 2023-09-25
Enrollment: 125
Sex: MALE
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to assess the performance and safety of the AQUABEAM Robotic System for the resection and removal of prostate tissue in patients experiencing lower urinary tract symptoms (LUTS) and are diagnosed with localized prostate cancer. Participants will go through baseline and follow up assessments up to 12 months.


Eligibility criteria: Inclusion Criteria:

* International Prostate Symptom Score (IPSS) ≥ 8
* Gleason Grade Group 1-3
* Prostate-specific Antigen (PSA) ≤20ng/mL
* Cancer stage less than or equal to T2c

Exclusion Criteria:

* Patients with previous surgical treatment of benign prostatic hyperplasia
* MRI evidence of extracapsular extension of cancer
* Any severe illness that would prevent complete study participation or confound study results

Primary outcomes:
measure: Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment
timeFrame: 3 months post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: La Mesa
country: United States
facility: San Diego Clinical Trials
state: California
city: Glenview
country: United States
facility: Endeavour Health (NorthShore University HealthSystem)
state: Illinois
city: Austin
country: United States
facility: Urology Austin, PLLC
state: Texas
city: Alexandria
country: United States
facility: Potomac Urology Center
state: Virginia
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
city: Beirut
country: Lebanon
facility: American University of Beirut
Study officials:
References:
Clinical trial NCT00825942: An Open-Label Study of the Effect of an Ophthalmic Solution on Asteroid Hyalosis
Official title: An Open-Label Study of the Effect of C-KAD Ophthalmic Solution on Asteroid Hyalosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Asteroid Hyalosis
Keywords: Asteroid hyalosis
Opthalmic Study
Lead sponsor: Chakshu Research, Inc.
Sponsor class: INDUSTRY
First posted: 2009-01-21
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the safety and initial efficacy of C-KAD ophthalmic solution in patients with asteroid hyalosis


Eligibility criteria: Inclusion Criteria:

* Presence of asteroid hyalosis

Exclusion Criteria:

* Active ocular infection
* Glaucoma
* Ocular hypertension
* Ocular inflammatory disorders

Primary outcomes:
measure: Reduction in the number of asteroid bodies
timeFrame: 180
Secondary outcomes:
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Mountain View Optometry and Contact Lens Clinic
state: California
Study officials:
affiliation: Chakshu Research, Inc.
name: Ira Wong, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04081142: Application of Indicator Based-electrical Impedance Tomography Method Assess Lung Regional Perfusion in ICU Patients
Official title: Application of Indicator Based-EIT Method Assess Lung Regional Perfusion for Critically Ill Patients in ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure
Hypoxemia
ARDS, Human
Keywords: EIT, pulmonary perfusion
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients within 7days, who were sequentially admitted to the Department of Critical Care Medicine and required central venous catheters for clinical requirment were eligible for the study.

Brief summary: This study is an observational study. Investigate the relationship of oxgenation and lung regional ventilation and perfusion assessed by the indicator based-EIT method in the critically ill patients in ICU

Detailed description: 1. Written informed consent was obtained from all patients or next of kin before data were included in the study.
2. When the research team was available, adult patients within 1w, who were sequentially admitted to the Department of Critical Care Medicine and required central venous catheters for resuscitation were eligible for the study.
3. Information collected at enrollment included demographic characteristics such as age, sex, Acute Physiology and Chronic Health Evaluation II score (APCHEII); . The global hemodynamic, respiration condition and PaO2 were measured. At the same time, the lung regional ventilation and perfusion assessed by the indicator based-EIT method(injection 10%NaCL).
4. The 10%NaCL was injected by the central venous catheter.

Eligibility criteria: Inclusion Criteria:

* Time of admission ICU \< 7days
* Age (\> 18 years old)
* Have been placed central venous catheter based on clinical requirement

Exclusion Criteria:

.Chest skin injured and cannot be monitored by EIT.

* Severe Hypernatremia
* Pregnancy

Primary outcomes:
measure: Lung regional perfusion
timeFrame: Hour 1
measure: oxygenation
timeFrame: Hour 1
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Science
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yun Long
role: STUDY_CHAIR
References:
citation: He H, Chi Y, Long Y, Yuan S, Zhang R, Yang Y, Frerichs I, Moller K, Fu F, Zhao Z. Three broad classifications of acute respiratory failure etiologies based on regional ventilation and perfusion by electrical impedance tomography: a hypothesis-generating study. Ann Intensive Care. 2021 Aug 28;11(1):134. doi: 10.1186/s13613-021-00921-6.