louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00599794: A Simple Clinical Tool to Help Assess Patient Volume (Fluid) Status
Official title: A Simple Clinical Tool to Help Assess Patient Volume (Fluid) Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: Sepsis
Intravascular volume
Ultrasound
Noninvasive measurement
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Allina Health System
First posted: 2008-01-24
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers, then critically ill patients already in the intensive care unit who are felt to have intravascular volume depletion.

Brief summary: Patients may have actual or relative intravascular volume depletion in a number of different disease states, particularly with sepsis syndrome. However, it is clinically difficult to determine volume status without invasive monitoring, which may cause unintended complications. Our hypothesis is that we can accurately estimate central venous pressure, which is a surrogate marker of volume status, with a noninvasive portable ultrasound device.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older.
* Healthy, euvolemic volunteers and critically ill patients who are already in an intensive care unit and who will have a central venous catheter placed as part of their planned medical treatment.

Exclusion Criteria:

* Inability to use ultrasound to measure jugular vein (neck brace or bandage), "code" situation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: A. S. Keller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06694194: Global, Regional, and National Burdens and Trends of Tracheal, Bronchial, and Lung Cancer in Individuals Aged 70 Years and Older from 1990 to 2021
Official title: Global, Regional, and National Burdens and Trends of Tracheal, Bronchial, and Lung Cancer in Individuals Aged 70 Years and Older from 1990 to 2021
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer Patients
Lead sponsor: Nanchang University
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 111627
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with lung cancer and aged 70 years and older

Brief summary: Despite the increasing health burden of tracheal, bronchial, and lung (TBL) cancer patients aged ≥ 70 years worldwide, data on its burden and trends are limited. This study aimed to analyze the global, regional, and national burdens and trends of TBL cancer from 1990 to 2021.

Detailed description: The latest cancer report indicates that tracheal, bronchial, and lung (TBL) cancer, the most widespread cancer globally, accounts for 12.4% of new diagnoses and 18.7% of cancer-related deaths, thereby presenting significant societal, public health, and economic challenges.Despite the increasing health burden of tracheal, bronchial, and lung (TBL) cancer patients aged ≥ 70 years worldwide, data on its burden and trends are limited. This study aimed to analyze the global, regional, and national burdens and trends of TBL cancer from 1990 to 2021.

Eligibility criteria: Inclusion Criteria:

Pathologic Diagnosis of lung cancer

Exclusion Criteria:

breast cancer Age less than 70 years

Primary outcomes:
measure: The incidence, mortality, and disability-adjusted life years (DALYs) data for TBL cancer patients aged ≥ 70 years, spanning 1990-2021.
timeFrame: 1990-2021
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06366594: First-line Nurse Manager Authentic Leadership Training Program
Official title: Effectiveness of First-line Nurse Manager Authentic Leadership Training Program on Nurses' Attitudes in Medical and Surgical Care Units
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intervention
Keywords: leadership
Training program
Nurse manager
Nurse
Self-efficacy
Trust
Lead sponsor: Matrouh University
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: A quasi-experimental research design
Primary purpose: OTHER

Brief summary: Authentic leadership behavior is considered a mandatory strategy for enhancing the nurse manager capabilities and practice as well as achieving positive nurses' attitudes.

Detailed description: Authentic leadership behavior is considered a mandatory strategy for enhancing the nurse manager's capabilities and practice as well as achieving positive nurses' attitudes. This study aimed to investigate the effectiveness of authentic leadership programs for first-line nurse managers on nurses' attitudes, including nursing care self-efficacy and trust.

Eligibility criteria: Inclusion Criteria:

First-line nurse managers

* willing to participate in the study
* work in medical and surgical wards
* Sign a consent

Exclusion Criteria:

* First-line nurse managers

  * work in outpatient units and other wards
  * Did not sign a consent
  * Absent from training

Primary outcomes:
measure: Questionnaire to measure first-line nurse managers' knowledge about authentic leadership
timeFrame: one month
measure: questionnaire to measure authentic leadership behavior among first-line nurse managers
timeFrame: one month
measure: Questionnaire to measure nursing care self-efficacy
timeFrame: one month
measure: Questionnaire to measure nurses' trust in their workplace
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Mersa Matruh
country: Egypt
facility: Faculty of Nursing, Matrouh University
Study officials:
affiliation: Faculty of Nursing, Matrouh University, Egypt
name: Nagah Abd El-Fattah Mohamed Aly, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Nursing, Matrouh University, Egypt
name: Wael M. Lotfy, Ph.D
role: STUDY_DIRECTOR
affiliation: Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Alexandria University, Egypt
name: Safaa M. El-Shanawany, Ph.D
role: STUDY_CHAIR
affiliation: Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Alexandria University, Egypt
name: Maha Ghanem, Ph.D
role: STUDY_CHAIR
affiliation: Faculty of Nursing, Matrouh University , Egypt
name: Hanaa Abbass, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00906594: Additive Intra-ocular Pressure Reduction Effect of Fixed Combination of Maleate Timolol 0.5%/Dorzolamide 2% on Monotherapy With Latanoprost in Patients With Elevated Intra-ocular Pressure
Official title: Additive Intra-ocular Pressure Reduction Effect of Fixed Combination of Maleate Timolol 0.5%/Dorzolamide 2% on Monotherapy With Latanoprost in Patients With Elevated Intra-ocular Pressure: a Prospective, Four-week, Open-label, Randomized, Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the additive effect of dorzolamide/timolol fixed combination in patients undergoing monotherapy with latanoprost.


Eligibility criteria: Inclusion Criteria:

All patients were at least 18 years old, with unilateral or bilateral open-angle glaucoma (defined as IOP \> 21 mmHg, mean of three consecutive measurements, at any time during the day, at the moment of glaucoma diagnosis) or ocular hypertension (IOP\> 25 mmHg, mean of three consecutive measurements, at anytime during the day, at the moment of diagnosis). Glaucoma was defined as a reproducible glaucomatous visual field defect based on GHT outside normal limits and/or PSD lower than 0,5% or glaucomatous changes of the optic disc associated to elevated IOP. A visual acuity (ETDRS) of 20/80 or better was required for randomization.

Exclusion Criteria:

Included woman of childbearing potential, pregnancy, systemic contra-indication to beta-blocker therapy, argon laser trabeculoplasty three months before screening visit, any history of filtering surgery, ocular surgery or uveitis three months before screening visit, hypersensitivity to any compound of the study drugs, concomitant use of any experimental drug, any condition in which treatment with beta-blocker is contraindicated or any other abnormal and/or ocular condition or symptom that would prevent study participation, according to the judgment of the investigator. The use of systemic beta-blocker, if needed, was allowed and not considered an exclusion criterion. Latanoprost non-responders defined as lower than 15% IOP reduction after run-in period with latanoprost monotherapy were excluded from the study.

Primary outcomes:
measure: additional IOP reduction obtained with cosopt in addition to xalatan
timeFrame: 4 week
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
state: SP
Study officials:
References:
Clinical trial NCT04868994: Magnetic Imaging for Diagnostic of Amyotrophic Lateral Sclerosis
Official title: Contribution of Whole Body Muscle MRI for Early Diagnosis of Amyotrophic Lateral Sclerosis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis With Dementia
Keywords: Amyotrophic
Sclerosis
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Nearly 60% of Amyotrophic Lateral Sclerosis (ALS) patients have a low level of diagnostic certainty (possible, probable) at the time of diagnosis. In the absence of biomarkers, this diagnosis is based, among other things, on the demonstration of the diffusion of signs of denervation by electroneuromyography (ENMG). The objective of this study is to improve the earliness and the level of diagnostic certainty by better demonstrating the diffusion of the denervation process by whole body muscular MRI.

Detailed description: The objective of this study is to show that the combination of ENMG and whole body muscle MRI (WB-MRI) can increase the diagnosis of definite ALS at the onset of the disease For 50 consecutive patients with suspected ALS, the present study will prospectively perform needle electromyography (EMG) and muscle analyses on whole body MRI. The diagnostic category will be determined by revised El Escorial criteria and Awaji criteria. On whole body MRI acquisition, for 83 muscles, will be explored fatty infiltration and atrophy on fat images (chronic denervation) and muscle edema on water images (acute denervation). EMG studies will be performed in at least 10 muscles (tongue, biceps brachii, first dorsalis interosseous, T10 paraspinalis, vastus lateralis, and tibialis anterior). Diagnostic classification according EMG and/ or MRI abnormalities in bulbar and the 3 spinal regions will be compared independently.

Eligibility criteria: Inclusion Criteria:

* Consent form signed by the patient
* Patients suspected ALS defined according Awaji Shima criteria (possible, probable, defined)
* Clinical assessment of upper motor neuron involvement
* Electrophysiologic assessment of lower motor neuron involvement

Exclusion Criteria:

* inability to give informed consent
* a contraindication to MRI
* respiratory failure impairing ability to lie flat in the scanner.
* Patient placed under judicial protection or under another protective regime,
* Females who are pregnant

Primary outcomes:
measure: Diagnostic certainty 1.ENMG according to El Escorial revised criteria using ENMG alone, MRI alone and ENMG+MRI to define denervation diffusion
timeFrame: 1 month
Secondary outcomes:
measure: Define precise topographic and characteristic of muscle involvement in ALS by MRI
timeFrame: 1 month
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Pascal CINTAS
Study officials:
affiliation: University Hospital, Toulouse
name: Pascal CINTAS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02196194: A Prescription-Event Monitoring (PEM) Study of Tiotropium
Official title: A Prescription-Event Monitoring (PEM) Study of Tiotropium Based on Prescription Data Collected by the Prescription Pricing Authority (PPA) in England for Tiotropium (Spiriva®)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-21
Enrollment: 13891
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: Patients treated with tiotropium

Brief summary: This prescription-event monitoring study was based upon 'event' monitoring and so capable of identifying signals of events that might be associated with the use of tiotropium, which none of the participating general practitioners (GPs) suspected to be an adverse drug reaction. The methodology of this study readily permits follow up of specific events and the obtaining of additional data as appropriate.


Eligibility criteria: Inclusion Criteria:

* patients who were prescribed tiotropium

Exclusion Criteria:

* not applicable

Primary outcomes:
measure: incidence density of events
timeFrame: up to sixth month of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02062294: An Observational Study of Valcyte (Valganciclovir) in D+/R- Liver Transplant Recipients
Official title: Retrospective Review of Valganciclovir Efficacy in Preventing CMV Disease in D+/R- Liver Transplant Recipients - A Non-Interventional Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cytomegalovirus Infections
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-02-13
Enrollment: 14
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Liver transplant recipients at high risk of developing Cytomegalovirus disease

Brief summary: This retrospective review will evaluate the efficacy of Valcyte (valganciclovir) in preventing Cytomegalovirus (CMV) disease in D+/R- liver transplant recipients. Data from eligible patients will be collected for the 6 months following transplantation.


Eligibility criteria: Inclusion Criteria:

* Liver transplant recipients, \>/= 16 years of age
* Transplantation between January 2004 and June 2009
* CMV seronegative recipient (R-) who received a liver transplant from a seropositive donor (D+)
* Valganciclovir therapy for at least 70 days beginning within 10 days post transplantation
* Assessment of CMV disease status within the first 6 months post transplantation

Exclusion Criteria:

* None

Primary outcomes:
measure: Proportion of Patients Developing Cytomegalovirus (CMV) Disease Within 6 Months of Liver Transplantation Under Valcyte Prophylaxis
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants With Any Serious Adverse Events (SAEs) or Adverse Events (AEs)
timeFrame: 6 months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital Bern; Viszerale Chirurgie und Medizin
city: Genève
country: Switzerland
facility: HUG; Transplantation
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich; Klinik für Gastroenterologie und Hepatologie
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01439594: Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation
Official title: Pilot Study to Evaluate Optical Frequency Domain Imaging as a Tool for Assessing the Tissue Response to Radiofrequency Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett's Esophagus
Keywords: Barrett's Esophagus
Esophagus
OCT
Imaging
Radiofrequency Ablation
BARRX
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2011-09-23
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The goal of this research is to conduct a pilot clinical study to evaluate the potential use of esophageal Optical Frequency Domain Imaging (OFDI) for assessing the success and degree of injury associated with therapeutic radiofrequency ablation techniques.

Detailed description: This is a single center pilot study conducted in 30 patients scheduled for therapeutic intervention. As the purpose of the study is to assess the response of the esophagus to radio frequency (RF) ablation, and the degree of residual Barrett's Esophagus (BE) remaining following treatment, OFDI imaging of study participants will occur prior to the scheduled BARRX RF treatment, and at the standard 3 and 6 month follow-up visits.

Following initial visual surveillance of the esophagus, the study experimental procedure will begin. Imaging will be performed with the OFDI system in 4 longitudinal (\~5cm) volumetric segments that are spaced equally circumferentially along the esophagus in a similar fashion to the standard 4-quadrant biopsy protocol.

Each of the 4 OFDI imaging segments will be acquired in less than 1 minute.

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of Barrett's esophagus
* Patients undergoing an Esophagogastroduodenoscopy (EGD)
* Patients scheduled for treatment with RF ablation or patients that have had previous BARRX RF ablation
* Patients must be over the age of 18
* Patient must be able to give informed consent
* Women with child bearing potential must have a negative pregnancy test prior to procedure

Exclusion Criteria:

* Patients on oral anticoagulation medications
* Patients with a history of hemostasis disorders
* Patients that are pregnant
* Patients with esophageal strictures

Primary outcomes:
measure: Feasibility of OFDI Imaging as Determined by Number of Successful Imaging Sessions
timeFrame: During the OFDI imaging session (about 5 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Guillermo Tearney, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Norman Nishioka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02058394: Retained Lens Fragments After Phacoemulsification
Official title: Postoperative Events in Patients With and Without Retained Nuclear Fragments in the Anterior Vitreous After Routine Phacoemulsification
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract
Keywords: Retained nuclear lens fragments
Phacoemulsification
Cataract Surgery
Lead sponsor: Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC
Sponsor class: OTHER
First posted: 2014-02-10
Enrollment: 500
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: Subjects will be recruited serially from eligible candidates on the basis of presentation for cataract evaluation and subsequent cataract surgery with phacoemulsification.

Brief summary: The purpose of this study is to investigate postoperative events in patients noted to have retained nuclear fragments in the anterior vitreous during routine phacoemulsification and in those who did not.

Detailed description: In this study, we investigate whether presence of retained nuclear fragments in the anterior vitreous noted during uncomplicated cataract surgery is associated with higher incidence of postoperative adverse events. We will be assessing events including cystoid macular edema, iritis, elevated intraocular pressure, and retinal detachment.

Eligibility criteria: Inclusion Criteria:

* Routine cataract surgery with phacoemulsification

Exclusion Criteria:

* Pre-existing macular edema
* Active uveitis
* Intraocular exclusion surgeries
* Significant ocular trauma
* Evidence of phacodonesis or zonular weakness .

Primary outcomes:
measure: Macular edema
timeFrame: 1 month postoperatively
Secondary outcomes:
measure: Intraocular inflammation
timeFrame: 1 month postoperativley
measure: Elevated intraocular pressure
timeFrame: 1 month postoperatively
measure: Macular Edema
timeFrame: 1 week postoperatively
measure: Intraocular Inflammation
timeFrame: 1 week postoperatively
measure: Elevated Intraocular Pressure
timeFrame: 1 week postoperatively
measure: Macular Edema
timeFrame: 3 months postoperatively
measure: Intraocular Inflammation
timeFrame: 3 months
Other outcomes:
measure: Surgical Complications
timeFrame: Intraoperatively
Locations:
city: New York
country: United States
facility: Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC
state: New York
Study officials:
affiliation: Ophthalmic Consultants, Cornea and Refractive Surgery Assoicates, PC
name: David Ritterband, MD
role: PRINCIPAL_INVESTIGATOR
References: