louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05468086: VR Solace for Pain and Anxiety Using Survey and Biodata
Official title: Effects of Virtual Reality on Pain and Anxiety Using Validated Surveys and Biodata Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 35
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: TREATMENT

Brief summary: The purpose of this study is to assess the therapeutic response to VR Solace in patients with chronic pain and anxiety using real-time clinical and survey data. Regression analysis of demographic characteristics, lab and survey data will be conducted to better understand the efficacy of VR Solace in treating chronic pain and anxiety. The investigator also aims to explore the possible association between the patient-reported changes in pain or anxiety levels with real-time physiological changes observed during VR Solace use.


Eligibility criteria: Inclusion Criteria:

* Age 18+
* Endorsing pain/anxiety with objective measurement of 3 or greater on 10-point scale on validated survey
* Diagnosis with chronic pain/anxiety

Exclusion Criteria:

* Exclusion of patients that are followed by CL Psychiatry team at Cedars-Sinai Medical Center to avoid overlap with another ongoing VR study
* No active diagnosis of medical conditions that may cause physiological variations in vital signs (i.e. sepsis, cardiogenic shock/arrhythmia)
* No active diagnosis of seizures, migraines, severe nausea, severe propensity for motion sickness, or facial/head deformities that would allow for comfortable placement of headset
* Exclusions of patient currently taking beta blockers
* Unable to communicate/read English for survey items
* Unable to use VR independently - patients will be expected to maneuver through questions/steps of the VR system during the session

Primary outcomes:
measure: Patient-reported Pain Level Pre Versus Post-VR Session
timeFrame: Just prior to session to 15-minutes post session
measure: Patient-reported Anxiety Level Pre Versus Post-VR Session
timeFrame: Just prior to VR session and 15 minutes after the VR session
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Omer Liran, MD, MSHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01794286: Improving Childhood Immunization
Official title: Improving Childhood Immunization Compliance Using Electronic Health Records
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Improve Childhood Immunization Rates
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2013-02-18
Enrollment: 107
Sex: ALL
Minimum age (years): 28
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Specific Aim: To improve childhood immunization rates by utilizing automated Electronic Health Record-derived provider-specific performance feedback reports, coupled with automated Electronic Health Record-derived trigger alerts.

Hypothesis: The automated Electronic Health Record-derived provider-specific performance feedback reports will result in a 50% decrease in unimmunized children ages 0-13 years of age, when coupled with automated Electronic Health Record-derived trigger alerts, compared with trigger alerts alone.


Eligibility criteria: Inclusion Criteria:

* all pediatric resident providers in Harriet Lane Clinic at Johns Hopkins University

Exclusion Criteria:

* none

Primary outcomes:
measure: Receipt of missing immunization
timeFrame: Time to event analyses, with events measured across 7 quarters (21 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Harriet Lane Clinic
state: Maryland
Study officials:
References:
Clinical trial NCT03329586: High-intensity Training Safely Improves Exercise Capacity in Heart, Lung, Kidney, and Liver Transplant Recipients: a Comparative Study
Official title: High-intensity Training Safely Improves Exercise Capacity in Heart, Lung, Kidney, and Liver Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity After Organ Transplantation
Keywords: maximum oxygen consumption
organ transplantation
physical fitness
rehabilitation
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators will investigate whether high-intensity exercise training can safely improve physical performance in long-term stable heart, kidney, lung, and liver transplant recipients. Adult transplant recipients will participate in Transplantoux, a 6-month individualized home- and group-based training program, with the goal to cycle the Mont Ventoux in France. The investigators will do cardiopulmonary exercise testing : maximal oxygen consumption, maximal power and BMI.


Eligibility criteria: Inclusion Criteria:

* minimum post-transplant period of 6 months
* no acute rejection during the immediately preceding 6 months

Exclusion Criteria:

* patients with cardiovascular or orthopedic contra-indications for intensive physical exercise

Primary outcomes:
measure: VO2max
timeFrame: 6 months after start training
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
Study officials:
References:
Clinical trial NCT02379286: Impact of Media Images, Alcohol and Tobacco to Youth
Official title: Impact of Media Images, Alcohol and Tobacco to youthImpact Study and Development of a Prevention Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Institut de Cancérologie de la Loire
Sponsor class: OTHER
First posted: 2015-03-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tennagers aged between 14 and 17 years

Brief summary: The main objective is to assess the relationships between French teenagers' attitudes and beliefs towards alcohol and tobacco products and the degree to which they watch and relate to television series and music videos.

Detailed description: The research extends existing research conducted by Cristel A. Russell to assess the relationships between French teenagers' attitudes and beliefs towards alcohol and tobacco products and the degree to which they watch and relate to television series and music videos. We test whether the consumption of media (TV series and music video) are related to French youth's perceptions of the consequences related to the use of alcohol and/or tobacco and ultimately their intentions and behaviors. To do so, an online questionnaire will be passed. Teenagers will be recruited through a private research firm, Cint. Because the study focuses on teenagers (14-17 y.o), parental consent to participate to the study will be obtained prior to the teenager's one.

Eligibility criteria: Inclusion Criteria:

* Ages between14 to 17 years inclusive;
* Have access to television

Exclusion Criteria:

* Refusal to participate

Primary outcomes:
measure: Connectedness scale to media and intention of drinking and/or smoking
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: ICLN
name: Franck Chauvin, PhDMD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03325686: Vitamin D Supplementation in Physical Performance
Official title: Efficacy of Vitamin D Supplementation in Physical Performance of Iranian Elite Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Athletes
Keywords: vitamin D
atletes
physical performance
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was performed to evaluate the efficacy of weekly vitamin D supplementation on athletic performance in Iranian athletes

Detailed description: Seventy subjects were enrolled in the study. The athletes were randomly divided into two groups: vitamin D supplement (D; received 50,000 IU of vitamin D supplement weekly) and control (P, received a placebo weekly). Duration of the study was eight weeks. Anthropometric, dietary, athletic performance and biochemical evaluations were performed for all subjects in the beginning and in the end of the intervention period.

Eligibility criteria: Inclusion Criteria:

* healthy
* professional athletes

Exclusion Criteria:

* receiving vitamin D supplement in past 3 months

Primary outcomes:
measure: Changes from baseline serum 25-hydroxy vitamin D at eight weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes from baseline Truncal Fat at eight weeks
timeFrame: 8 weeks
measure: Changes from baseline visceral fat at eight weeks
timeFrame: 8 weeks
measure: Changes from Strength leg press at 8 weeks
timeFrame: 8 weeks
measure: Changes from Ergojump at 8 weeks
timeFrame: 8 weeks
measure: Changes from baseline Vertical jump at 8 weeks
timeFrame: 8 weeks
measure: Change from baseline Agility at 8 weeks
timeFrame: 8 weeks
measure: changes from Speed at 8 weeks
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tehrān
country: Iran, Islamic Republic of
facility: National Nutrition and Food Technology Research Institute
state: Tehran
Study officials:
affiliation: Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute (NNFTRI) and Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
name: Tirang R. Neyestani, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02904486: Effectiveness of Modified Health Belief Model Based Intervention to Reduce Body Mass Index
Official title: Effectiveness of Modified Health Belief Model Based Intervention to Reduce Body Mass
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 232
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to Effectiveness of Modified Health Belief Model Based Intervention to Reduce Body Mass Index for Age in Overweight Junior High School Students.

Detailed description: The purpose of this study is to Effectiveness of Modified Health Belief Model Based Intervention to change behavior to Reduce Body Mass Index for Age in Overweight Junior High School Students.

Eligibility criteria: Inclusion Criteria:

* junior High School Students
* age 12 - 15 years
* bmi for age ≥ median +1 SD
* Read and write Thai Language
* Agree to participate voluntarily .

Exclusion Criteria:

* students with medical conditions diagnosed by a physician and a barrier to participation .

Primary outcomes:
measure: Body Mass Index
timeFrame: 6 month
Secondary outcomes:
measure: Heath literacy for obesity in Junior High School Students.
timeFrame: 6 month
Other outcomes:
Locations:
Study officials:
affiliation: Chulalongkorn University
name: waraporn khumros, Ph.D study
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00946686: To Demonstrate the Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions
Official title: A Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-07-27
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability, parallel study Of Leflunomide 20 mg tablets under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 11 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novum Pharmaceutical Research Services
name: So Ran Hong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02279186: Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section
Official title: Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section ,A Randomized Clinical Trial .
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bleeding
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2014-10-30
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, the efficacy and safety of tranexamic acid in the reducing the blood loss during and after elective LSCS will be investigated.

Detailed description: To state the effectiveness clinically and laboratory and safety of tranexamic acid in reducing blood loss during and after the elective lower segment cesarean section.

Eligibility criteria: Inclusion Criteria:

* - Women undergoing caesarean delivery for various elective indications.
* Full term primiparas / multiparas.
* Singleton pregnancy being delivered by LSCS.

Exclusion Criteria:

* - Medical problems involving the heart, liver, kidney and brain .
* Blood disorders.
* Allergy to tranexamic acid.
* History of thromboembolic disorders, abnormal placentation, severe pre-eclampsia, uterine anomalies and pathology.
* Multiple pregnancy, macrosomia.
* Polyhydromnios .
* Patients requiring blood transfusion due to anemia

Primary outcomes:
measure: Amount of blood loss during cesarean section after placental delivery till end of the operation.
timeFrame: during and 2hours post cesarean section
Secondary outcomes:
measure: 1.Vital signs eg:blood pressure ,heart rate ,respiratory rate during first two post operative hours .
timeFrame: up to 24hours postoperative
measure: Adverse affect of tranexamic acid on mother and neonate .
timeFrame: first 24 hours
measure: 24 hours post operative haemoglobin and haematocrit .
timeFrame: after 24 hours.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity Hospital
Study officials:
affiliation: Ain Shams Maternity Hospital
name: Amr Abdelaziz, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06283186: Comparative Exercise-Induced Hypoalgesia in Upper and Lower Limbs: A Randomized Controlled Trial in Healthy Individuals
Official title: Differences in Exercise-Induced Hypoalgesia at Local and Distal Levels Using Lower and Upper Limb Cycle Ergometer Protocols: A Randomized Controlled Trial in Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Local Hypoalgesia
Distal Hypoalgesia
Aerobic Exercise
Pressure Pain Thresholds
Lead sponsor: Centro Universitario La Salle
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial with healthy subjects aims to compare exercise-induced hypoalgesia among three groups: one utilizing a lower limb cycle ergometer, another using an upper limb cycle ergometer, and a control group. The exercise protocol involves 30 minutes of aerobic activity at 70-80% of the heart rate reserve. Exercise-induced hypoalgesia will be assessed by measuring pressure pain thresholds in the thigh and elbow. Additionally, a secondary objective is to compare the lower limb and upper limb cycle ergometer groups in terms of their effects on pressure pain thresholds in the thigh and elbow. Thus, the study anticipates observing differences in local and distal hypoalgesia based on the trained region.


Eligibility criteria: Inclusion Criteria:

* Asymptomatic subjects aged between 18 and 64 years.

Exclusion Criteria:

* Cardiovascular, respiratory, metabolic, neurological, or osteomuscular signs or pathologies.
* History of epilepsy.
* Pregnant
* Pharmacological treatment.
* Participants who present any type of pain on the day of the measurements or who have frequently suffered pain during the previous 12 weeks.

Primary outcomes:
measure: Pressure pain threshold (PPT) on dominant quadriceps and dominant lateral epicondyle
timeFrame: Three measurementes: before, immediately after intervention, and 30 minutes after intervention
Secondary outcomes:
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Before intervention (up 5 minutes)
measure: Fatigue Assessment Scale (FAS)
timeFrame: Before intervention (up 5 minutes)
measure: Heart rate
timeFrame: During intervention (up 30 minutes)
measure: Rate of perceived exertion (RPE)
timeFrame: Immediately after intervention (up 10 seconds)
measure: Physical Activity Readiness Questionnaire (PAR-Q)
timeFrame: Before intervention (up 5 minutes)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CSEU LaSalle
Study officials:
References:
Clinical trial NCT05416086: iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
Official title: iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Atrial Flutter
Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Lead sponsor: Adagio Medical
Sponsor class: INDUSTRY
First posted: 2022-06-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective, single-arm, multi-center study designed to collect real world safety and performance data of the Adagio Medical iCLAS Cryoablation System in the treatment of drug refractory, recurrent, symptomatic, Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation (PsAF), and Atrial Flutter (AFL).

Detailed description: This Post-Market Clinical Follow-up (PMCF) study continues collecting additional information about the Adagio Medical iCLAS™ Cryoablation System in real world clinical settings.

Eligibility criteria: Inclusion Criteria:

* Subject is ≥ 18 years of age
* Planned ablation procedure according to the indication for use of the commercially available Adagio iCLAS™ Cryoablation System
* Subject willing to comply with study requirements and give informed consent.

Exclusion Criteria:

* In the opinion of the Investigator, any known contraindication to an atrial ablation procedure with the Adagio iCLAS™ Cryoablation System as indicated in the device Instructions For Use (IFU).
* Subject is enrolled in a study that has not been approved for concurrent enrollment by the sponsor.
* Any other condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than one year, extensive travel away from the research center)

Primary outcomes:
measure: Primary outcome - freedom from AF
timeFrame: 12 months
measure: Primary outcome - freedom from AF/AT/AFL
timeFrame: 12 months
measure: Primary outcome - freedom from Device/Procedure Related Adverse Events
timeFrame: during procedure and up to 12-month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouw Hospital Aalst (OLV)
city: Erlangen
country: Germany
facility: Universitatsklinikum Erlangen
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
References:
Clinical trial NCT06602986: Measuring the Density of Iodine in Lipiodol Depositions: Detecting an Invisible Residual Tumor After Conventional Transarterial Chemoembolization for Hepatocellular Carcinoma
Official title: Measuring the Density of Iodine in Lipiodol Depositions: Detecting an Invisible Residual Tumor After Conventional Transarterial Chemoembolization for Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HCC - Hepatocellular Carcinoma
Lead sponsor: Pak Emirates Military Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 96
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: ABSTRACT Objective: To detect presence of a residual tumor in patients of hepatocellular carcinoma (HCC) treated with Lipiodol based conventional trans arterial chemoembolization (cTACE) using density measurements on follow-up computed tomography (CT) scans Study Design: Prospective observational interventional study Place and Duration of Study: Interventional Radiology department of Armed Forces Institute of Radiology and Imaging (AFIRI) from April 2023-March 2024 Methodology: 96 patients undergoing conventional TACE were included in the study and followed up for residual tumor or tumor free status assessment using density measurement for iodine depositions using CT scan analysis and compared with gold standard digital subtraction angiography (DSA). Primary variables measured were comparison of enhancement scores between those with a residual tumor versus tumor free as well as the volume of iodine depositions in the arterial and venous phase between both groups. Sensitivity and specificity of the CT scan in assessing tumor diagnosis was compared with the gold standard digital subtraction angiography.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of HCC disease
* Must be able to swallow tablets

Exclusion Criteria:

* Insulin dependent diabetes
* Thyroid disease

Primary outcomes:
measure: Measuring the density of Iodine in Lipiodol depositions: Detecting an Invisible Residual Tumor after Conventional Transarterial Chemoembolization for Hepatocellular carcinoma
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: PakEmiratesMH
state: Punjab
Study officials:
References: