louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03096483: Clinical Evaluation of the OEC Elite Vascular Mobile Fluoroscopy System
Official title: Clinical Evaluation of the OEC Elite Vascular Mobile Fluoroscopy System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Interventional Vascular Conditions
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2017-03-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of the study is to collect survey data on the use of the OEC Elite Mobile Fluoroscopy System based on the routine clinical use of the device.

Detailed description: This prospective clinical study is being conducted to acquire image guidance adequacy data from physicians conducting clinically-indicated vascular, gastrointestinal (GI), urology and pain management procedures for engineering use, as deemed appropriate by the Sponsor, for the investigational OEC Elite Mobile Fluoroscopy System (OEC Elite) in the vascular configuration. Clinical procedures included in this study will involve three (3) anatomical regions of interest - extremities and neck, thorax, and abdomen and pelvis. These regions are being targeted because they represent the range of clinical applications and anatomical regions intended for OEC Elite in the vascular configuration.

Eligibility criteria: Inclusion Criteria:

1. Male or female between the ages of 18 and 75 years (≥18 and ≤75 years old);
2. Clinical indication for a vascular, gastrointestinal (GI), urology or pain management procedure for which mobile fluoroscopy has been prescribed;
3. Able and willing to comply with study procedures; and
4. Able and willing to provide written informed consent to participate.

Exclusion Criteria:

1. Pregnant or suspected to be pregnant based on the opinion of and as documented by a medically qualified physician investigator;
2. Expected to be at increased risk due to study participation (e.g. due to allergies, sensitivities), in the medical opinion of an investigator; or
3. Previously participated in this study, or enrolled in another active GEHC study or other research study that could be expected to interfere with participation in study procedures, in the opinion of the investigator.

Primary outcomes:
measure: Imaging Guidance Adequacy Assessed by Number of Questionnaires
timeFrame: 2 Months
Secondary outcomes:
measure: Number of Investigator Procedure Surveys Assessed by Survey Questionnaire
timeFrame: 2 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: Hamilton General Hospital
name: Theodore Rapanos
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03105583: A Cross-sectional Study Evaluating Pregnancy Related Use of Vitamins and Medication
Official title: A Cross-sectional Study Evaluating Pregnancy Related Use of Vitamins and Medication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medication and Supplement Use
Pregnant Women
Keywords: Medication beliefs
Information desire
Vitamin deficiencies
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
First posted: 2017-04-10
Enrollment: 381
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who visit the obstetrics department of the University Hospitals of Leuven (campus Gasthuisberg) will be invited to participate, independent of their pregnancy trimester.

Women can only participate once during their pregnancy.

Brief summary: This cross-sectional study will try to give answers to the following project aims:

* To provide an overview of the prevalence of health products' use among Belgian pregnant women (prescription and OTC medication, vitamin supplements, phyto-therapeutics, dermatologic products), including where pregnant women buy or get their health products (online web survey).
* To document women's beliefs about medication during pregnancy and their information desire (online web survey).
* To determine the current vitamin status among pregnant women and to reveal clinical targets for supplementing deficiencies in this population (blood sample analysis).

The study will be performed at the obstetrics department of the University Hospitals of Leuven (campus Gasthuisberg).

We aim to include 300 pregnant women (100 per trimester), of which 150 women will be asked to determine their vitamin status (50 per trimester).


Eligibility criteria: Inclusion Criteria:

* Pregnant women who visit the obstetrics department of the University Hospitals of Leuven
* ≥18 years
* Able to understand Dutch, French or English

Exclusion Criteria:

* \<18 years
* Don't able to understand Dutch, French or English

Primary outcomes:
measure: Medication and supplement use among Belgian pregnant women
timeFrame: Completion of a questionnaire during pregnancy: between 8-12weeks or 24-32weeks gestational age
Secondary outcomes:
measure: Vitamin deficiencies among Belgian pregnant women
timeFrame: One blood sample during pregnancy: between 8-12weeks or 24-32weeks gestational age
measure: Medication beliefs among Belgian pregnant women
timeFrame: Completion of a questionnaire during pregnancy: between 8-12weeks or 24-32weeks gestational age
Other outcomes:
Locations:
Study officials:
affiliation: KU Leuven
name: Veerle Foulon, PhD, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05650983: Effect of Exercise on Cognitive Function and Mental Health in Heroin Addicts
Official title: Effect of Exercise on Cognitive Function and Mental Health in Heroin Addicts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unspecified Symptoms and Signs Involving Cognitive Functions Following Unspecified Cerebrovascular Disease
Heroin Addicts
Executive Function
Negative Thinking/Affect
Lead sponsor: Guangzhou Sport University
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this \[type of study: exercise intervention study\] is to test in describe participant health conditions. The main questions it aims to answer are:

* \[Whether physical exercise improves executive function of male heroin addicts\]
* \[Whether physical exercise improves negative thinking/affect psychological experience of male heroin addicts\] Participants will be randomly selected for medium-intensity strength training (resistance exercise,n=30), 30 will be selected for 1-hour long balloon volleyball sessions (aerobic exercise) at 60-70% volume of oxygen uptake during peak exercise, weekly 5 times for 12 weeks; and 30 will be assigned to the no-exercise control group, Participants will perform Executive function tests and the Symptom Checklist-90 Revised questionnaire at pre and post intervention.

Researchers will compare resistance exercise group,aerobic exercise group and no-exercise control group to see if effects of exercise on executive function and negative thinking/affect psychological experience of male heroin addicts.


Eligibility criteria: Inclusion Criteria:

* were men who met the Manual of Mental Disorders (DSM)-IV criteria for current heroin dependence

Exclusion Criteria:

* any major mental illness other than heroin addiction
* any exercise taboo

Primary outcomes:
measure: using the Symptom Checklist-90-R (SCL-90-R) questionnaire to investigate the improvement of physical exercise on psychological symptoms in heroin addicts,
timeFrame: Month 3
measure: using the executive functioning tests to investigate the improvement of physical exercise on executive function in heroin addicts,
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Desk and Computer and Playground
state: Guangdongsheng
Study officials:
References:
Clinical trial NCT03390283: A Survey of Parent/Caregiver Practices on the Storage, Use, and Disposal of Opioids in a Comprehensive Cancer Center
Official title: A Survey of Parent/Caregiver Practices on the Storage, Use, and Disposal of Opioids
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Caregiver
Malignant Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-01-04
Enrollment: 115
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents/caregivers of a child (under 18) who has received an opioid prescription within the last 6 months

Brief summary: This trial uses a survey to study parent and caregiver practices on the storage, use, and disposal of opioids in a comprehensive cancer center. It is not known if parents and/or caregivers are aware of the guidelines and recommendations for proper and safe disposal of opioids. This survey will help health care providers assess the needs and improve the safety of patients and their families from the potential dangers of misuse and abuse of prescription opioid medications.

Detailed description: PRIMARY OBJECTIVES:

I. To determine the frequency of unsafe storage, use, and disposal of unused and currently used opioids by parents and/or caregivers of patients 18 years and younger at MD Anderson Cancer Center.

II. To explore potential association between other covariates with the unsafe storage, use, and disposal of opioids.

OUTLINE:

Participants complete online survey on an iPad over 20 minutes.

Eligibility criteria: Inclusion Criteria:

* PARENTS/CAREGIVERS: Must be at least 18 years old (a. The child of the parents/caregivers must be 18 years old or younger; b. The child of the parents/caregivers must have received an opioid prescription within the last six months.)
* PARENTS/CAREGIVERS: Must be able to understand, read, write, and speak English.
* PARENTS/CAREGIVERS: Parent/caregiver must sign an informed consent.

Primary outcomes:
measure: Reported frequencies of unsafe storage of opioids
timeFrame: Up to 2 years
measure: Reported frequencies of unsafe use of opioids
timeFrame: Up to 2 years
measure: Reported frequencies of unsafe disposal of opioids
timeFrame: Up to 2 years
Secondary outcomes:
measure: Other covariates
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Kevin Madden
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04564183: Advancing Prevention of Pulmonary Fibrosis
Official title: Advancing Prevention of Pulmonary Fibrosis - A Cohort Study of Preclinical Pulmonary Fibrosis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: IPF
Pulmonary Fibrosis
ILD
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: University of California, Los Angeles
name: University of Texas
name: University of Pennsylvania
First posted: 2020-09-25
Enrollment: 800
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will enroll up to 1,000 participants who are in families with two or more reported cases of pulmonary fibrosis.

Brief summary: This study plans to learn more about pulmonary fibrosis and how it develops. We want to determine if the disease can be detected early, before the lung is permanently scarred.

This study will enroll participants who are not currently diagnosed with pulmonary fibrosis, but who have family members with pulmonary fibrosis. Because there is an increased risk within affected families, this cohort will allow us to learn how pulmonary fibrosis develops, and how the lungs change over time.


Eligibility criteria: Inclusion Criteria:

* Unaffected first degree relative from Familial Interstitial Pneumonia families (two or more family members with IIP)
* Age at least 40 years old and younger than 75 years old

Exclusion Criteria:

* Diagnosed with known (physician-diagnosed) pulmonary fibrosis prior to informed consent
* Other genetic diseases associated with interstitial lung disease
* Pregnant women

Primary outcomes:
measure: Screen all subjects for early Idiopathic Pulmonary Fibrosis (IPF) with High Resolution CT Scan of the Chest
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado School of Medicine
name: David Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00925483: Decreasing Dialysis Cardiovascular Risk: Daily Versus Longer Treatments
Official title: Decreasing Dialysis Cardiovascular Risk: Daily Versus Longer Treatments
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Disease
Keywords: left ventricular mass
cardiac MRI
long dialysis
daily dialysis
Lead sponsor: Dallas VA Medical Center
Sponsor class: FED
First posted: 2009-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Given the known increased risk of heart disease in hemodialysis patients, this study aims to evaluate the change in both size and function of the heart by using cardiac magnetic resonance imaging (MRI) in patients undergoing either daily long (4 hours, 6 times weekly), daily short (2 hours 6 times weekly), or alternate day conventional (4 hours, 3 times weekly) and alternate day long (8 hours, 3 times weekly) dialysis for 6 months from randomization. The patients are randomly put in the groups based on predetermined randomization schedule and the cardiologist trained in cardiac MRI readings is blinded to the patient treatment schedule. Given that changes in heart function may be seen with cardiac imaging techniques within 6 months, the expectation is that groups on daily treatment may have better outcome for this parameter as changes in volume and blood pressure may also be affected in a positive way in patients on daily dialysis.


Eligibility criteria: Inclusion Criteria:

* End stage renal disease patients on hemodialysis

Exclusion Criteria:

* Weight \> 350 lbs
* Known poor dialysis and or treatment compliance
* Unable to come for daily treatments if randomization occurs in this group
* Prognosis less than 6 months
* Difficulty in tolerating dialysis and possibility of discontinuation of dialysis before 6 months

Primary outcomes:
measure: LVM change per Cardiac MRI
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
Study officials:
affiliation: VA North Texas Health Care System, Dallas VA Medical Center
name: Devasmita C. Dev, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06880783: Manual Diaphragmatic Release Technique on Exercise Capacity and Sleep Quality
Official title: Effect of Manual Diaphragmatic Release Technique on Exercise Capacity and Sleep Quality in Older Adults With Type II Diabetes: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 44
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate if there is a significant effect of manual diaphragmatic release technique on exercise capacity, sleep quality, chest expansion, ADL, fatigue and quality of life in older adults with type II diabetes.

Detailed description: Participants, including both genders, will have a history of Diabetes Type II for more than one year. They will be well controlled with HbA1c≤7. Patients will be aged from 55 years and above and had a body mass index less than 30 kg/m². Patients will follow up on the training program and instructions. They will be medically stable.

Eligibility criteria: Inclusion Criteria:

* History of Diabetes Type II for more than one year.
* They will be well controlled with HbA1c≤7.
* Patients will be aged from 55 years and above and had a body mass index less than 30 kg/m².
* Patients will follow up on the training program and instructions. They will be medically stable.

Exclusion Criteria:

* Chest diseases.
* Diaphragmatic hernia, clinical evidence of phrenic nerve injury, recent abdominal or thoracic surgery, or history of traumatic lesion possibly affecting diaphragm.
* History of Myocardial infarction and/or cardiothoracic surgery
* Unstable medical status.
* Cognitive disability hindering responding to the questionnaires.

Primary outcomes:
measure: 6-minute walk test
timeFrame: up to 6 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni suef hospital
Study officials:
References:
Clinical trial NCT02970383: Narcotic Use After Minor Hand Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Minor Surgical Procedures
Narcotics Use
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
First posted: 2016-11-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of larger or smaller opioid prescriptions following minor surgery on the amount of narcotic used, patient reported satisfaction, refill requests, and leftover narcotic.

Detailed description: Patients are randomized to receive prescriptions for either 10 or 30 tabs of 5 mg hydrocodone/325 mg acetaminophen following minor hand surgery. Patients are allowed to request additional medication as needed. Patients are contacted by phone 10-14 days after their surgery to answer a questionnaire regarding number of pills taken, number of refills requested, number of remaining pills, their satisfaction with their pain control and their surgery, and their opinion regarding the appropriateness of the prescription size.

Eligibility criteria: Inclusion Criteria:

* patients undergoing minor hand surgery by a participating surgeon within the study period

Exclusion Criteria:

* narcotic use within previous 3 months
* concurrent procedure
* acute trauma
* pregnancy
* allergy or other contraindication or intolerance to hydrocodone or acetaminophen
* post-operative complications
* inability to provide personal consent to the procedure or the research

Primary outcomes:
measure: Narcotic used
timeFrame: 10-14 days post-op
Secondary outcomes:
measure: Number of refills requested
timeFrame: 10-14 days post-op
measure: Number of left over tabs
timeFrame: 10-14 days post-op
measure: Patient reported efficacy of pain control
timeFrame: 10-14 days post-op
measure: Patient reported satisfaction with pain control
timeFrame: 10-14 days post-op
measure: Patient reported satisfaction with overall surgical experience
timeFrame: 10-14 days post-op
measure: Patient Opinion Regarding Appropriateness of Size of Initial Prescription
timeFrame: 10-14 days post-op
Other outcomes:
Locations:
Study officials:
affiliation: Carilion Clinic
name: Cassandra Mierisch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gaddis A, Dowlati E, Apel PJ, Bravo CJ, Dancea HC, Hagan HJ, Mierisch CM, Metzger TA, Mierisch C. Effect of Prescription Size on Opioid Use and Patient Satisfaction After Minor Hand Surgery: A Randomized Clinical Trial. Ann Surg. 2019 Dec;270(6):976-982. doi: 10.1097/SLA.0000000000003127.
Clinical trial NCT02072083: Intranasal Dexmedetomidine vs Midazolam-ketamine Combination for Premedication of Pediatric Patients
Official title: Intranasal Dexmedetomidine Versus Intranasal Midazolam-ketamine Combination for Premedication of Pediatric Patients Undergoing Strabismus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Premedication
Oculocardiac Reflex
Keywords: dexmedetomidine
intranasal
strabismus surgery
premedication
oculocardiac reflex
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2014-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is using intranasal dexmedetomidine versus intranasal midazolam-ketamine combination for premedication and preventing the oculocardiac reflex of pediatric patients undergoing strabismus surgery.

Detailed description: Preanesthetic medication in pediatrics is very helpful in relieving anxiety, fear and psychological trauma due to maternal deprivation. Midazolam and ketamine are commonly used for this purpose. Dexmedetomidine is an alpha 2 -agonist with a more selective action on the alpha 2 adrenoreceptor when administered via the nasal mucosa bioavailability of dexmedetomidine is too high. Intranasal route is an effective way to administer premedication and sedation to children. The oculocardiac reflex is a major complication of pediatric strabismus surgery.

Eligibility criteria: Inclusion Criteria:

* the pediatric patients undergoing strabismus surgery
* the pediatric patients between 2-11 years old
* ASA physical status I-II
* the patients whose parents give permission for this study

Exclusion Criteria:

* a known drud allergy or hypersensitive reaction to drugs used
* mental retardation
* cardiac arrhythmia or congenital cardiac disease
* organ disfunction (liver , kidney)
* nasal pathology
* psychotropic treatment

Primary outcomes:
measure: the efficacy of premedication on ramsey sedation score
timeFrame: 30 min after premedication
Secondary outcomes:
measure: the effects of premedication on oculocardiac reflex
timeFrame: during the surgery
measure: mask acceptance scale
timeFrame: 30 min after sedation
measure: the parenteral separation anxiety scale
timeFrame: 30 min after sedation
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes university hospital
Study officials:
affiliation: erciyes univercity
name: Müge Yüce Yıldırım, resident
role: PRINCIPAL_INVESTIGATOR
References: