louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02928471: Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis; Weight Loss
Official title: Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis Following a Significant Weight Loss, Investigating the Impact on Inflammation (A Substudy to "Effect of Liraglutide on Body Weight and Pain in Overweight or Obese Patients With Knee Osteoarthritis: A Randomised, Double Blind, Placebo-controlled, Parallel Group, Single-centre Trial" (NCT02905864)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Obesity
Keywords: Liraglutide
Liraglutide 3 mg
Osteoarthritis
Obesity
Magnetic resonance imaging
Computed tomography
Dynamic contrast enhanced MRI
Lead sponsor: Parker Research Institute
Sponsor class: OTHER
First posted: 2016-10-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants eligible for parent trial (NCT02905864), i.e. overweight/obese individuals with knee osteoarthritis

Brief summary: This is a substudy to a randomised trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counseling, after which. Patients will be randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle.

This substudy aims to investigate any changes in MRI associated with the initial 8-week weight loss intervention, and the value of CT scans in predicting the effect of weight loss.


Eligibility criteria: Inclusion Criteria:

* Same as parent trial (NCT02905864)

Further Exclusion Criteria

* Same as parent trial (NCT02905864)
* Usual exclusion criteria for MRI (i.e. pacemakers etc.)

Primary outcomes:
measure: Change in the degree of inflammation in the knee-joint (DCE-MRI)
timeFrame: Week -8 to 0
Secondary outcomes:
measure: Change in the degree of inflammation in the knee-joint (CE-MRI)
timeFrame: Week -8 to 0
measure: Change in the degree of inflammation in the knee-joint (MRI)
timeFrame: Week -8 to 0
measure: Change in cartilage composition
timeFrame: Week -8 to 0
measure: Change in bone marrow lesions (BML)
timeFrame: Week -8 to 0
measure: Prediction of clinical symptoms (KOOS pain) by the level of crystal deposition on dual-energy CT at week 0
timeFrame: Week 0
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: The Parker Institute and Department of Radiology at Bispebjerg and Frederiksberg Hospital
state: Capital Region
Study officials:
References:
Clinical trial NCT00405171: Efavirenz to Nevirapine Switch and Low-Density Lipoprotein (LDL)-Dyslipidemia
Official title: Efavirenz to Nevirapine Switch in HIV-1 Infected Patients With Severe Dyslipidemia: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Hypercholesterolemia
Antiretroviral Therapy
Keywords: Efavirenz
Nevirapine
Dyslipidemia
HIV
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2006-11-29
Enrollment: 40
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: Dyslipidemia and coronary heart disease (CHD) are increasingly recognized in persons with human immunodeficiency virus (HIV) infection. Many antiretrovirals, including efavirenz (EFV), are associated with increases in serum lipids. The investigators investigated whether stopping EFV and replace EFV by nevirapine can reduce significantly Low-Density Lipoprotein cholesterol, while keeping virologic control of HIV.


Eligibility criteria: Inclusion Criteria:

* HIV-1 infected adults, who were receiving antiretroviral therapy including efavirenz for at least 6 months
* plasma HIV RNA\<400 cp/ml during the previous 4 months on 2 occasions 14 days apart
* Severe dyslipidemia with Low-Density Lipoprotein cholesterol (LDL-c) \>3.4 mmol/L in the presence of at least one of the 3 following coronary heart disease (CHD) risk factors: age\>45 among males or age\>55 among females, hypertension, current smoking, family history of CHD
* Low-Density Lipoprotein cholesterol (LDL-c)\>4.1 mmol/L regardless of CHD risk factors.

Exclusion Criteria:

* Protease inhibitors use within the previous 6 months,
* Prior exposure to nevirapine
* Asparate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5N if hepatitis virus B or C were negative
* AST or ALT\>1.25N if hepatitis virus B or C were positive
* Fasting glycemia\>1.26g/L,
* Current CHD
* Triglycerides\>4.6 mmol/L
* Introduction of lipid lowering drugs, corticoïds, retinoïds and betablockers within the previous 3 months.

Primary outcomes:
measure: Decrease in LDL cholesterol between baseline and week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Côte de Nacre University hospital
Study officials:
affiliation: University Hospital, Caen
name: Jean-Jacques Parienti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Côte de Nacre
name: Renaud Verdon, MD, PhD
role: STUDY_CHAIR
References:
citation: Parienti JJ, Peytavin G, Reliquet V, Verdon R, Coquerel A. Pharmacokinetics of the treatment switch from efavirenz to nevirapine. Clin Infect Dis. 2010 Jun 1;50(11):1547-8. doi: 10.1086/652718. No abstract available.
citation: Parienti JJ, Massari V, Rey D, Poubeau P, Verdon R; SIROCCO study team. Efavirenz to nevirapine switch in HIV-1-infected patients with dyslipidemia: a randomized, controlled study. Clin Infect Dis. 2007 Jul 15;45(2):263-6. doi: 10.1086/518973. Epub 2007 Jun 6.
Clinical trial NCT01710371: Quantitative 18F-AV-133 PET Imaging in Subjects With Diabetes and Healthy Controls
Official title: Quantitative PET Imaging of Pancreatic Beta-Cell Mass in Healthy Overweight/Obese Subjects, Subjects With Prediabetes, and Type 2 Diabetes Patients With 18F-FP-DTBZ (18F-AV-133)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2012-10-19
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate 18F-AV-133 imaging of the pancreas in patients with early type 2 diabetes, late type 2 diabetes, subjects with pre-diabetes and in healthy overweight/obese control subjects. These subjects will also be evaluated for beta-cell function as measured by the insulin and C-peptide response to a challenge with intravenous arginine under basal and glucose enhanced conditions.


Eligibility criteria: Inclusion Criteria:

* Male and/or female subjects of non-childbearing potential between the ages of 30 and 65 years inclusive.
* Able to tolerate PET, PET/CT and MR imaging
* Estimated creatinine clearance \>= 60mL/min
* Informed consent documents signed and dated by subject
* Subjects must be willing and able to comply with all scheduled visits, treatments laboratory tests, scans and other study procedures.
* In addition, subjects must meet classification requirements for one of the following

  1. Healthy Overweight
  2. Pre-diabetes
  3. T2DM
* (T2DM only) Subjects with other chronic medical conditions (besides diabetes) that are well controlled and stable on medication are acceptable for inclusion in this study.

Exclusion Criteria:

* Subjects who are affiliated with or relatives of staff members of either the site or Pfizer directly involved in the conduct of the trial.
* Conditions which in the opinion of the study investigator may interfere with the subject's ability to participate in the study
* History of allergic reaction to drug/contrast agent or history of drug/alcohol abuse
* Subjects who have received investigational medications within the last 30 days or a radiopharmaceutical in the past 7 days.
* Pregnant or nursing females; females of childbearing potential.

Primary outcomes:
measure: Optimal PET-determined mean pancreatic Binding Potential of 18F-AV-133
timeFrame: PET visit 1
measure: Optimal PET-determined mean pancreatic Standardized Uptake Value (SUV) of 18F-AV-133
timeFrame: PET visit 1
measure: Optimal PET-determined mean pancreatic Volume of Distribution (VT) of 18F-AV-133
timeFrame: PET visit 1
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Research Site
state: Connecticut
Study officials:
affiliation: Avid Radiopharmaceuticals
name: Chief Medical Officer
role: STUDY_DIRECTOR
References:
Clinical trial NCT03020771: Phase I Study to Evaluate Basic Pharmacodynamic, Pharmacological and Toxicological Effects of the Newly Developed Crimean-Congo Hemorrhagic Fever Vaccine for Humans
Official title: Phase I Study to Evaluate Basic Pharmacodynamic, Pharmacological and Toxicological Effects of the Newly Developed Crimean-Congo Hemorrhagic Fever Vaccine for Humans, Prepared in Cell Culture and Inactivated With Formalin, and Administered Subcutaneously or Intramuscularly With Two Different Doses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Crimean-Congo Hemorrhagic Fever
Keywords: Crimean-congo hemorrhagic fever
vaccine
human
phase I
Lead sponsor: The Scientific and Technological Research Council of Turkey
Sponsor class: OTHER
Collaborators: name: MonitorCRO
First posted: 2017-01-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study covers the first trial of the Crimean-Congo Hemorrhagic fever virus (CKKA) vaccine on humans (healthy volunteers), which has been developed in Turkey and has completed preclinical toxicology studies to be performed on experimental animals. Also, this study is a Phase I, randomized, double-blind, national, single-center, placebo-controlled study that is designed to evaluate the safety and efficacy of the CKKA vaccine. A total of 60 (12 + 48) healthy male and/or female volunteers will be participating in this study, and the study is planned to last approximately one year.


Eligibility criteria: Inclusion Criteria:

* Healthy, white in the 18-55 age range, men and/or women who agree not to become pregnant until 2 months after the start of the last vaccination
* Body weights are at limits to exclude anorexia or obesity (The BMI limits accepted for this study are 18.5-30 kg /m2)
* According to clinical and standard laboratory tests, physical and spiritually healthy volunteers.

Exclusion Criteria:

* The 20 days before the study any vaccination applied volunteers
* Persons with clinically significant liver, kidney, gastrointestinal, cardiovascular, psychiatric, pulmonary, hematologic, endocrinological, or other significant acute or chronic abnormalities in the medical history of the volunteer or in the examination.
* Volunteers who have previously had any pulmonary infection or have previously used immunosuppressive drugs (including corticosteroids) for any reason

Primary outcomes:
measure: Safety of the IMP in terms of number and frequency of any adverse events, any abnormal findings in physical examinations, ECGs, and laboratory parameters occurred during the follow up period.
timeFrame: One year follow up
Secondary outcomes:
measure: Immunogenicity
timeFrame: One year follow up
Other outcomes:
Locations:
Study officials:
affiliation: TC Erciyes University
name: Aydın Erenmemisoglu, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04354571: Erector Spinae Plane Block in Pediatric Hip Surgery
Official title: Evaluation of Post Operative Analgesia of the Erector Spinae Plane Block in Pediatric Patients Undergoing Hip Surgery: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Analgesia
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Hip Surgery in pediatric patients is considered an extremely painful procedure. Managing pain in this surgery is challenging even with several available options, each with limitations. Erector spinae plane (ESP) block is a novel technique that has been used in different types of surgery, with promising results. Many case reports for use of ESPB are available in the literature but to our knowledge, no cohort studies or randomized controlled trials have been performed on ESPB for hip surgery in pediatrics age group against a traditional method as caudal block.1,2 AIM OF WORK

. The Primary outcome of this study is to compare the efficacy of analgesia resulting from the Erector spinae plane block versus the caudal block in pediatric patients undergoing hip surgery using the FLACC score and the duration of the analgesia of both methods till the first rescue analgesic.

The Secondary outcome is to compare the analgesic rescue frequency and total dose given in both groups as well as comparing the complications that might occur from each analgesic technique.


Eligibility criteria: Inclusion Criteria:

* ASA I II scheduled for hip surgery.

Exclusion Criteria:

* • Parent refusal

  * Coagulopathy
  * Patient with congenital heart disease
  * Infection at the site of puncture
  * Significant spinal anatomical anomaly
  * Patient with neuromuscular disorder
  * Any known allergy to the drug used

Primary outcomes:
measure: Pain assessment
timeFrame: 1 day .
Secondary outcomes:
measure: complications
timeFrame: through study completion, an average of 1 day
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria university
Study officials:
References:
Clinical trial NCT02231671: A Phase 1, Open-Label Study of the Absorption, Metabolism, Excretion and Absolute Bioavailability of ALS-008176
Official title: A Phase 1, Open-Label Study of the Absorption, Metabolism, Excretion and Absolute Bioavailability of 14C-ALS-008176 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Syncytial Virus Infections
Lead sponsor: Alios Biopharma Inc.
Sponsor class: INDUSTRY
First posted: 2014-09-04
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to see how ALS-008176 is taken up, broken down, and removed from the body.


Eligibility criteria: Inclusion Criteria:

* Body mass index 18.0 to 32.0 kg/m2 (inclusive) and a total body weight \>50 kg

Exclusion Criteria:

* Creatinine clearance as calculated by the Cockroft-Gault formula of less than 60 mL/min
* Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator or the sponsor medical monitor. Reticulocyte count, haemoglobin and platelet counts must not be less than the lower limit of normal for the subject.
* History of clinically significant cardiovascular, renal, hepatic, chronic respiratory, GI, haematological, neurological, endocrinological, immunological, musculoskeletal disease or any uncontrolled medical illness (eg active infection) or psychiatric disorder, as judged by the investigator or medical monitor.
* Clinically significant abnormal electrocardiogram (ECG) findings

Primary outcomes:
measure: Absolute Bioavailability
timeFrame: Days 1-8
measure: Mass Balance
timeFrame: Days 1 - 14
Secondary outcomes:
measure: Safety
timeFrame: Days 1-14
measure: To investigate the metabolic profile of [14C] - ALS-008176
timeFrame: Days 1-14
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Clinical
Study officials:
affiliation: Quotient Clinical
name: Pui Leung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03031171: Community Engaged Colon Cancer Screening Patient Navigator Program
Official title: Community Engaged Colon Cancer Screening Patient Navigator Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ColoRectal Cancer
Keywords: community engagement, navigation, cancer screening
Lead sponsor: University of Nevada, Reno
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: University of California, Davis
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2017-01-25
Enrollment: 415
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The goal of the project is to increase colorectal cancer screening within the priority population of female and male adults age 50 to 85 in Northern Nevada. A successful community-based cancer patient navigator program will be modified in partnership with the community into a multi-level screening intervention.

Detailed description: The goal of the project is to increase colorectal cancer screening within the priority population of female and male adults age 50 to 85 in Northern Nevada. A successful community-based cancer patient navigator program will be modified in partnership with the community into a multi-level screening intervention. A well-tested behavioral change theory (the health belief model; HBM) will guide the intervention and the relative efficacy of a) the theory's constructs and b) evidence-based intervention practices on increasing screening rates will be examined. Although increased screening rates are associated with program navigators, it is unclear which program components are related to the outcome. In addition, there is ambiguity surrounding a) the temporal impact of the HBM on cancer screening and b) the relationships among the model's constructs. A quasi-experimental time-series design will be used to evaluate the outcome objective of increased screening rates by comparing screening rates one year pre- and post-intervention and whether navigated patients are better prepared for screening than non-navigated patients. A minimum of 315 participants (to correspond with a power level of .80) in the navigator program will be surveyed on knowledge about colorectal cancer, and satisfaction with and usefulness of the program. The anticipated contribution of the project will be to increase community efficacy, colorectal cancer screening in the project area, and to reduce cancer morbidity and mortality.

Eligibility criteria: Inclusion Criteria:

* Insurance, no history of colon cancer,

Exclusion Criteria:

* No experience of relevant GI symptoms

Primary outcomes:
measure: Colonoscopy completion
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Reno
country: United States
facility: Univeristy of Nevada, Reno
state: Nevada
Study officials:
affiliation: University of Nevada, Reno
name: Paul Devereux, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06010771: The Effect of Listening to Stories and Watching Cartoon Film on Pain in the Aspiration Process in Children Receiving Palliative Care
Official title: The Effect of Listening to Stories and Watching Cartoon Film on Pain in the Aspiration Process in Playing Age Children Receiving Palliative Care: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aspiration; Syndrome
Keywords: Palliative care
Children
Listening to Stories
Watching Cartoon Film
Pain
Lead sponsor: Artvin Coruh University
Sponsor class: OTHER
Collaborators: name: Ataturk University
First posted: 2023-08-25
Enrollment: 15
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to determine the effect of listening to fairy tales and watching cartoons on pain in the aspiration process in play-age children receiving palliative care.

Detailed description: 15 voluntary children with receiving palliative care, aged between 1-3 years will be randomly divided into two groups: fairy tale group and cartoon group. Interventions will be applied for 3 weeks, 1 times a day (16 sessions). No intervention will be applied to both groups besides fairy tale or cartoon intervention. The children will be assessed before, during and after. PAIN DUE TO ASPIRATION PROCEDURE will be evaluated using the FLACC Pain Scale. In addition, the heart rate, respiration, blood pressure, tidal volume and fever values of the children will be measured with the help of a bedside monitor.

Eligibility criteria: Inclusion Criteria:

* Being in the 1-3 age group
* Being in the palliative care service for at least 3 months
* Receiving inpatient treatment in the pediatric palliative care service
* Absence of visual and hearing anomalies
* No other chronic disease
* Having a tracheostomy

Exclusion Criteria:

* The family's desire to leave research.
* Deterioration of the child's condition
* The child's diagnosis of an additional chronic disease

Primary outcomes:
measure: Patient Identification Form
timeFrame: baseline
measure: Physiological Parameter Record Form
timeFrame: baseline and up to 4 weeks
measure: FLACC Pain Scale
timeFrame: baseline and up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Erzurum City Hospital
state: Central
Study officials:
affiliation: Artvin Coruh University
name: Gamze AKAY, 1
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sarialioglu A, Kurudirek F, Oluc T. The effect of storybook reading on children's preoperative fear and anxiety levels: A randomized controlled study. Child Care Health Dev. 2023 Sep;49(5):906-913. doi: 10.1111/cch.13100. Epub 2023 Feb 8.