louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02332018: Measurements Of Lower Limbs And Spine Based On Biplanar Radiographs: Microdose Compared To Standard Dose Protocol
Official title: Two-dimensional And Three-dimensional Measurements Of Torsion And Length Of Lower Limbs And Spine Based On Biplanar Radiographs: Microdose Imaging Protocol Compared To Standard Dose Imaging Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Underdevelopment; Congenital Malformation, Lower Limb
Scoliosis
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients referred for assessment of spine or lower limb with biplanar x-ray-scanner

Brief summary: Evaluation of accuracy and reliability of 2D and 3D measurements of the spine and lower limbs in adults based on biplanar radiographs with MicroDose protocol compared to a standard dose protocol

Detailed description: Evaluation of accuracy and reliability of 2D and 3D measurements of the spine and lower limbs in adults based on biplanar radiographs with MicroDose protocol compared to a standard dose protocol

Part 1: retrospective evaluation of 50 patients: lower limb images with MicroDose protocol and lower limb images with standard dose protocol Part 2: prospective evaluation of 100 patients: lower limb images with MicroDose protocol and lower limb images with standard dose protocol Part 3: prospective evaluation of 150 patients: spine images with MicroDose protocol and spine limb images with standard dose protocol

Eligibility criteria: Inclusion Criteria:

* Inclusion: All patients referred for biplanar radiographs of spine and lower limb (from 18 to 99 years of age)

Exclusion Criteria:

* Exclusion criteria: no informed consent

Primary outcomes:
measure: 2D- and 3D- measurements (torsion angles, scoliotic and kyphotic angles, length etc.) on biplanar radiographs with and without "MicroDose"-protocol and comparison of image quality parameters
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Radiology Department, Balgrist University Clinic
state: ZH
Study officials:
affiliation: Balgrist University Hospital
name: Andrea Rosskopf
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01084018: Development and Evaluation of a Nursing Virtual Intervention Tailored for Pain After Cardiac Surgery
Official title: Development and Evaluation of a Nursing Virtual Intervention Tailored for Pain After Cardiac Surgery-SOULAGETAVIE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cardiac Surgery
Pain
Adult
Pain Management
Keywords: acute postoperative pain
nursing intervention
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: GRISIIQ
name: FIIC
name: Chaire de recherche sur les nouvelles pratiques de soins infirmiers
name: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
First posted: 2010-03-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this project is to develop and evaluate the effects of a computer-tailored intervention targeting pain barriers and catastrophizing in adults having cardiac surgery.

The hypotheses are that in the experimental group, in comparison to the control group, participants will show lower levels of pain, less pain interference in their activities, less attitudinal barriers, and less pain catastrophizing.

A pilot-RCT is privileged to assess the preliminary effects of the intervention on the following outcomes: pain intensity, analgesic consumption, pain interference, barriers and pain catastrophizing.


Eligibility criteria: Inclusion Criteria:

* first intention cardiac surgery
* 18 years old or more
* able to fill up questionnaires in french

Exclusion Criteria:

* participation to another psychosocial intervention
* cognitive or psychiatric disorder

Primary outcomes:
measure: pain intensity
timeFrame: 24, 48, 72 hrs, 7 days, 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Hotel-Dieu (CHUM)
state: Quebec
Study officials:
affiliation: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
name: José Côté, PhD
role: STUDY_DIRECTOR
affiliation: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
name: Manon Choinière, PhD
role: STUDY_DIRECTOR
affiliation: Université de Montréal
name: Géraldine Martorella, PhD (c)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martorella G, Cote J, Racine M, Choiniere M. Web-based nursing intervention for self-management of pain after cardiac surgery: pilot randomized controlled trial. J Med Internet Res. 2012 Dec 14;14(6):e177. doi: 10.2196/jmir.2070.
Clinical trial NCT02005718: Impact of Vitamin D on Endothelial Function and Blood Biomarkers Including CD28 Null Cells in CKD
Official title: Impact of Cholecalciferol on Endothelial Fucntion and Blood Biomarkers in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: CKd Patients With Stage 3 and 4
Lead sponsor: St George's, University of London
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Vitamin D deficiency is common in CKD and assciated with CV complications. Endothelial dysfucntion is common in CKD and is a harbinger of atherosclerosis. The study investigated the impact of Vitamin D on endothelial fucntion and blood biomarkers in CKD.


Eligibility criteria: Inclusion Criteria:

* CKD 3-4 Age 18-80

Exclusion Criteria:

* Recent MI, CVA, malignancy active infection active inflammation High calcium already on Viatmin D therapy

Primary outcomes:
measure: Flow mediated dilation
timeFrame: 16 weeks
Secondary outcomes:
measure: CD28 null cell frequency
timeFrame: 16 weeks
measure: Blood biomarkers of endothelial function and inflammation
timeFrame: 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: St Georges
name: Debasish Banerjee
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chitalia N, Ismail T, Tooth L, Boa F, Hampson G, Goldsmith D, Kaski JC, Banerjee D. Impact of vitamin D supplementation on arterial vasomotion, stiffness and endothelial biomarkers in chronic kidney disease patients. PLoS One. 2014 Mar 19;9(3):e91363. doi: 10.1371/journal.pone.0091363. eCollection 2014.
Clinical trial NCT03916718: Care EcoSystem: Ochsner Health System
Official title: The Dementia Care EcoSystem: The Feasibility of a Care Management Program Addressing Healthcare Quality, Access, and Cost for Patients With Dementia and Their Caregivers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 290
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population includes patients seen at Ochsner Clinic Foundation, \>=55 years old, diagnosed with dementia, and meeting other inclusion/exclusion criteria. this study will recruit subjects identified as high utilizers of the Ochsner System. This will be defined by \>= 2 ED visits, \>= 2 Hospitalizations, or some combination prior to baseline. We will co-variate by insurance plan.

Brief summary: 1. To determine the feasibility and acceptability of the Care Ecosystem program in the Ochsner clinical setting.
2. To assess the effect of the Care Ecosystem program on health care cost and quality care quality as measured by primary outcome variables.

   * Adapted from the Care Ecosystem, memory.ucsf.edu/Care-Ecosystem


Eligibility criteria: Inclusion Criteria:

* Male or female ≥55 years of age at baseline
* Probable dementia diagnosis as evidenced by one or more of the following criteria:

  * Dementia listed on medical record problem list as of January 1, 2015 or later, or, in the opinion of the referring provider has dementia
  * Prescribed with any of the following: donepezil, memantine, galantamine HBR, rivastigmine, or tartrate; or, in the opinion of the referring provider, could take such medication
* Lives in community

Exclusion Criteria:

* Documented history of Multiple Sclerosis, ALS, Traumatic Brain Injury, Huntington's Disease, Schizophrenia, Bipolar Disorder, or current Substance Abuse Disorder
* Lives in a nursing home or assisted living facility
* Unable to complete monthly telehealth or phone visits

Primary outcomes:
measure: Rate of ED and Hospital Admissions
timeFrame: through study completion, an average of 1 year
measure: Quick Dementia Rating Scale (QDRS)
timeFrame: through study completion, an average of 1 year
measure: Quality of Life in Dementia (QUALI-DEM)
timeFrame: through study completion, an average of 1 year
measure: Zarit Caregiver Burden Scale- Short Form
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Rate of Falls
timeFrame: through study completion, an average of 1 year
measure: Rate of UTIs
timeFrame: through study completion, an average of 1 year
measure: Rate of medication change
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Health System
state: Louisiana
Study officials:
affiliation: Ochsner Health System
name: R. John Sawyer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04536818: Outcomes After Laparotomy for Penetrating Abdominal Trauma
Official title: Outcomes After Laparotomy for Penetrating Abdominal Trauma: A Cohort Study From a Tertiary Trauma Hospital in South Africa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Penetrating Abdominal Trauma
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: University of Stellenbosch
First posted: 2020-09-03
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to Tygerberg Academic Hospital, Cape Town, South Africa.

Brief summary: The purpose of this study is to evaluate outcomes of adult patients hospitalised due to penetrating abdominal trauma at a tertiary trauma hospital in South Africa. Our primary objective is to study the association between waiting time to surgery and outcome (mortality, complications, and length of hospital stay) in normotensive patients treated with laparotomy for penetrating abdominal trauma.


Eligibility criteria: Inclusion Criteria:

* Patients that are admitted due to penetrating abdominal injuries, irrespective of injury mechanism, time from injury and prior treatment.
* Patients that are treated with laparotomy.

Exclusion Criteria:

* Patients that are admitted due to blunt trauma or combinations of blunt and penetrating trauma.
* Patients who are dead on arrival.
* Patients that are only re-admitted during the study period, i.e. patients that received primary treatment by TBH before study initiation.

Primary outcomes:
measure: Death
timeFrame: Through study completion, an average of 2 weeks
Secondary outcomes:
measure: Complications
timeFrame: Through study completion, an average of 2 weeks
measure: Length of stay
timeFrame: Through study completion, an average of 2 weeks
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Tygerberg Academic Hospital
state: Western Cape Province
Study officials:
References:
Clinical trial NCT03192618: The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.
Official title: The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-06-20
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy.


Eligibility criteria: Inclusion Criteria:

* older than 18 years old and younger than 75 years;
* ECOG PS\<3;
* proven hepatocellular carcinoma with MVI according pathological examination;
* not previous treated for tumor;
* tumor was removed in operation;
* no recurrence occurence at 4 to 7 weeks after surgery;
* the lab test could meet: neutrophil count≥1.5×109/L; hemoglobin≥80g/L; platelet count≥60×109/L; serum albumin≥28g/L; total bilirubin\<3-times upper limit of normal; ALT\<5-times upper limit of normal; AST\<5-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 6 seconds; INR≤2.3;
* sign up consent;
* unrolled by other clinical trials about hepatocellular carcinoma.

Exclusion Criteria:

* cannot tolerate TAI;
* CNS or bone metastasis exits;
* known history of other malignancy;
* be allergic to related drugs;
* underwent organ transplantation before;
* be treated before (interferon included);
* known history of HIV infection;
* known history of drug or alcohol abuse;
* have GI hemorreage or cardiac/brain vascular events within 30 days;
* pregnancy;

Primary outcomes:
measure: Disease-free survival (DFS)
timeFrame: From date of randomization until the date of recurrence, assessed up to 60 months
Secondary outcomes:
measure: recurrence rate
timeFrame: 1 year, 2 year, 3 year, 5 year after surgery
measure: Overall survival (OS)
timeFrame: From date of randomization until the date of death from any cause, assessed up to 60 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center of Sun Yat-Sen University
Study officials:
References:
citation: Li S, Mei J, Wang Q, Guo Z, Lu L, Ling Y, Xu L, Chen M, Zheng L, Lin W, Zou J, Wen Y, Wei W, Guo R. Postoperative Adjuvant Transarterial Infusion Chemotherapy with FOLFOX Could Improve Outcomes of Hepatocellular Carcinoma Patients with Microvascular Invasion: A Preliminary Report of a Phase III, Randomized Controlled Clinical Trial. Ann Surg Oncol. 2020 Dec;27(13):5183-5190. doi: 10.1245/s10434-020-08601-8. Epub 2020 May 16.
Clinical trial NCT02705118: Evaluation of Performance of Automatic Fusion for Radiofrequency Ablation of Hepatocellular Carcinoma
Official title: Evaluation of Performance of S-fusion for Radiofrequency Ablation of Hepatocellular Carcinoma: A Randomized, Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: radiofrequency ablation
image fusion
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 82
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fusion imaging of US and MRI is very helpful for interventional procedure such as radiofrequency ablation in liver. However, manual registration of US and magnetic resonance (MR) imaging is somewhat time-consuming and difficult for less-experienced physicians. Recently, automatic registration function was developed to help the fusion of US and CT/MRI imaging. The purpose of this trial is to compare the registration time and accuracy of manual registration system and automatic registration system.

Detailed description: 1. Patients will be randomized and assigned.
2. For automatic registration group, automatic image fusion will be done by RS80A US unit and RF ablation will be performed. Image fusion time will be measured.
3. For manual registration group, manual image fusion will be done by LOGIQ-E9 US unit and RF ablation will be performed. Image fusion time will be measured.

3) After radiofrequency (RF) ablation, immediate, contrast enhanced CT will be performed to evaluate technical success and complications 4) Accuracy of registration will be measured by home-made software using 3D techniques.

5) After one month, technical effectiveness will be evaluated by contrast enhanced CT 6) F/U of CT images will be obtained until one year after RF ablation with a interval of 1-3 months.

Eligibility criteria: Inclusion Criteria:

* More than 40-years old
* Patients with hepatic malignancy who will underwent radiofrequency ablation

Exclusion Criteria:

* Not using fusion imaging (CT guidance or fluoroscopic guidance)

Primary outcomes:
measure: Registration accuracy
timeFrame: Immediately after RF ablation
Secondary outcomes:
measure: Technical success
timeFrame: Within 48 hours after RF ablation
measure: Technical effectiveness
timeFrame: One month after RF ablation
measure: Registration time
timeFrame: Within 48 hours after RF ablation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's Hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Joon-Il Choi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05773313: A Study of Overcoming Social Determinants of Health
Official title: Social and Relational Capital to Overcome Social Determinants of Health.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Determinants of Health (SDOH)
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2023-03-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is being done to determine if assistance in accessing community resources can improve health outcomes. Social determinants of health are the conditions in which individuals are born, work and live that can impact health. These can include access to healthcare, healthy food, education, safe neighborhoods, transportation, political and social environments that are safe and fair.


Eligibility criteria: Inclusion Criteria:

- Identified social determinants of health (SDOH). need that impacts healthcare outcomes (identified by the healthcare team)

Exclusion Criteria:

- Non-english speaking patients

Primary outcomes:
measure: Change in participant CMS Accountable Health SDOH Screening Assessment
timeFrame: Baseline and 12 months
measure: Change in resilience
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Hospitalizations
timeFrame: 12 months
measure: Emergency room visits
timeFrame: 12 months
measure: Primary care visits
timeFrame: 12 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Nathan Delafield, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03172013: Platelet Indices Could Predict Spontaneous Bacterial Peritonitis in Cirrhotic Ascitic Patients
Official title: Platelet Indices Could Predict Spontaneous Bacterial Peritonitis in Cirrhotic Ascitic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cirrhosis, Liver
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cirrhotic ascites

Brief summary: Spontaneous bacterial peritonitis (SBP) is an ascitic fluid infection in cirrhotic patients

Detailed description: Platelet indices can be utilized as a non-invasive predictor of SBP.

Eligibility criteria: Inclusion Criteria:

* Cirrhotic patients and ascites

Exclusion Criteria:

* patients with ascites due to causes other than cirrhosis- immunocompromised patients,
* patients with abnormal thrombocytes due to non-hepatic causes.

Primary outcomes:
measure: Number of patients with SBP and abnormal platelet indices
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Tanta university hospital
Study officials:
affiliation: Consultant of Hepatology - Tanta University
name: Taher Eldemerdash, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00828113: Long-term Varenicline Treatment for Smoking Cessation
Official title: Long-term Varenicline Treatment for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking
Keywords: smoking
relapse
withdrawal
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2009-01-23
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy in conjunction with individual counseling for smoking cessation. Adult volunteers in generally good health, smoking 5 or more cigarettes per day, will receive 13 weeks of open-label varenicline therapy. At 12 weeks after their target quit date, they will be assigned in a random, double-blind manner to either 40 additional weeks of varenicline or placebo. It is hypothesized that biochemically-confirmed abstinence rates will be higher for the varenicline group at 52 weeks. Participants will be followed for an additional 26 weeks post-treatment.


Eligibility criteria: Inclusion Criteria:

* daily smoker
* 5+ cigarettes per day for at least one year
* expired carbon monoxide level of 5+ ppm

Exclusion Criteria:

* current use of smoking cessation pharmacotherapies
* current or history of psychotic disorder
* current major depressive disorder
* history of suicidal ideation in the previous 3 months
* unstable medical condition
* pregnant, nursing, or planning to become pregnant
* planning to move from study area within 18 months

Primary outcomes:
measure: Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52
timeFrame: 7-day point prevalence
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Center for Tobacco Research and Intervention
state: Wisconsin
city: Milwaukee
country: United States
facility: Center for Tobacco Research and Intervention
state: Wisconsin
Study officials:
References: