louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06076551: Sex Difference of Coronary Microvascular Dysfunction in Patients With Non-obstructive Coronary Artery Disease
Official title: Sex Difference of Coronary Microvascular Dysfunction Evaluated by Coronary Flow Reserve in Patients With Non-obstructive Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Microvascular Angina
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients who experienced chest pain but with no obstructed coronary arteries (\<50% stenosis)

Brief summary: Sex difference of coronary microvascular dysfunction evaluated by coronary flow reserve will be assessed in patients with non-obstructive coronary artery disease

Detailed description: The investigators will select consecutive patients who experienced chest pain but had no significant coronary artery stenosis (\<50% stenosis). Coronary microvascular function will be evaluated by adenosine stress echocardiography. Coronary blood flow velocities will be measured at 1, 2, and 3 min after adenosine infusion.

Sex difference of coronary microvascular dysfunction evaluated by coronary flow reserve will be assessed.

Eligibility criteria: Inclusion Criteria:

* Typical/atypical chest pain or ischemic symptoms including dyspnea
* No significant coronary artery stenosis (\<50% stenosis) in coronary angiography or computed tomography

Exclusion Criteria:

* ≥ Moderate valvular heart disease
* Congenital heart disease
* Chronic renal failure (estimated glomerular filtration rate \<30 ml/min/1.73m2) or end-stage renal failure undergoing hemodialysis or peritoneal dialysis
* Asthma, chronic obstructive pulmonary disease and primary pulmonary hypertension
* Receiving anticancer drugs
* Vasculitis associated with autoimmune diseases
* Atrioventricular block with more than second degrees, symptomatic bradycardia, cryo-node failure syndrome, Wolff-Parkinson-White (WPW) patients

Primary outcomes:
measure: A composite outcome including all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for heart failure
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Seong-Mi Park, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Anam Hospital
name: Mi-Na Kim, PhD
role: STUDY_CHAIR
affiliation: Korea University Anam Hospital
name: Dong-Hyuk Cho, PhD
role: STUDY_CHAIR
affiliation: Korea University Anam Hospital
name: So Ree Kim, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06812351: Clinical and Radiographic Outcome of Regeneration in Immature Permanent Human Teeth Using a New Scaffold
Official title: Clinical and Radiographic Outcome of Regenerative Endodontic Treatment in Immature Permanent Human Teeth Using a Collagen Hydroxyapatite Scaffold
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Randomized Clinical Trial
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 22
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate clinical and radiographic outcome of regeneration in immature permanent human teeth using two different types of scaffolds:

1. Collagen-hydroxyapatite scaffold (Osteon III collagen) after blood clot.
2. Conventional blood clot scaffold.


Eligibility criteria: Inclusion Criteria:

1. Single rooted immature permanent teeth.
2. Symptoms:

   1. Pulp necrosis either due to infection or trauma.
   2. Periapical condition; tooth should have periapical radiolucency.
3. Tooth should be restorable without the need for further post placement.
4. Age: from 6-15 years.
5. Sex: males or females.
6. Preoperative Cone beam Computed tomography is a must.

Exclusion Criteria:

* Teeth with complete root formation. 2. Teeth that are badly broken down with difficult isolation. 3. Medically compromised patients. 4. Periodontally affected teeth.

Primary outcomes:
measure: Root completion of immature teeth
timeFrame: 1 year follow up
Secondary outcomes:
measure: positive sensibility test
timeFrame: 1 year follow up
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShams university
Study officials:
affiliation: AinShams University
name: Abeer Abdelhakim El gendy, PhD
role: STUDY_DIRECTOR
affiliation: AinShams University
name: Maram Farouk Obeid, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00847951: Ultrasound for Perfusion in Neonates
Official title: 3D Ultrasound for Perfusion in Neonates
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Kidney Perfusion
Keywords: renal
neonates
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2009-02-19
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the effectiveness of renal ultrasound to check kidney perfusion in premature and/or very low birth weight babies.

Detailed description: The purpose of this study is to evaluate the effectiveness of 3D (3 dimensional)renal ultrasound to check kidney perfusion (to see if the kidney is receiving enough blood flow to function as it should) in premature and/or very low birth weight babies.

Eligibility criteria: Inclusion Criteria:

* Very low birth weight babies in ICU in stable condition and/or premature babies in ICU in stable condition

Exclusion Criteria:

* Unstable very low birth weight/premature babies

Primary outcomes:
measure: To determine if ultrasound imaging can accurately help physicians determine if the kidneys are being adequately perfused.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: Univeristy of Michigan Hospital
name: Jonathan Rubin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03367351: Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitoring
Official title: Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Continuous Glucose Monitor
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 8
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, un-blinded intervention/control design
Primary purpose: TREATMENT

Brief summary: The goal of this pilot study is to produce a high-quality, theory-driven, therapeutic, web-based intervention that provides extended training and peer support to adolescents and young adults with type 1 diabetes who are newly implementing CGM. Overall, this web-based intervention represents an efficient way to bring together professionally-supported CGM educational materials and social support to overcome known barriers and address factors associated with inconsistent CGM use.


Eligibility criteria: Inclusion Criteria:

1. Ability to read and speak English
2. Diagnosed with type 1 diabetes (T1D) for \> 3 months before consent is obtained
3. Aged \>15 years and \<24 years at time of enrollment
4. Must have access to a smartphone, tablet or laptop/desktop computer with high speed internet access and speaker
5. Must be using/initiating a Dexcom CGM

Exclusion Criteria:

1. Cognitive or learning disability (e.g., inability to read) that would preclude their ability to comply with the study protocol
2. Significant medical comorbidity in the adolescent or young adult that could, in the opinion of the PI, affect subject's capacity to follow study protocol
3. Previous use of a CGM within the last 3 months
4. Unwilling or unlikely to return to clinic for a follow-up HbA1c test
5. Unwillingness to accept randomization

Primary outcomes:
measure: Adherence to CGM
timeFrame: 3 months
Secondary outcomes:
measure: HbA1c
timeFrame: 1-week run in, 3-months post implementation
measure: CGM Satisfaction
timeFrame: 1-week run in, 7 weeks
measure: CGM Self-Efficacy
timeFrame: 1-week run in, 7 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Madison B Smith, BSN, PhD Candidate
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith MB, Albanese-O'Neill A, Yao Y, Wilkie DJ, Haller MJ, Keenan GM. Feasibility of the Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitor (IDEAL CGM) Training and Follow-Up Support Intervention: Randomized Controlled Pilot Study. JMIR Diabetes. 2021 Feb 9;6(1):e15410. doi: 10.2196/15410.
Clinical trial NCT05288751: Contingency Management for Opioid and Stimulant Use Disorders in Primary Care
Official title: Contingency Management as a Treatment for Opioid Use Disorder and Stimulant Use Disorder in a Primary Care Setting
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Stimulant Use Disorder
Keywords: opioid use disorder
stimulant use disorder
contingency management
primary care
addiction medicine
buprenorphine
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Contingency management (CM) is a behavioral intervention that involves incentivizing participants for target behaviors in a clinical setting. When applied to the treatment of substance use disorders, it has demonstrated efficacy in reducing the number of urine toxicology screens positive for illicit substances and increased engagement in treatment programs. However, there is a need to translate CM treatment to primary care settings. This study will implement and assess a CM program for patients with opioid use disorder, with or without comorbid stimulant use disorder, initiating outpatient addiction medicine services at a family medicine residency clinic. Eligible patients will earn monetary incentives for attending addiction medicine appointments and abstaining from substances during outpatient treatment. Data gathered from this pilot program will be used to improve patient outcomes, treatment, and retention for persons receiving medications for opioid use disorder (MOUDs) in a primary care setting.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Diagnosis of Opioid Use Disorder and/or Stimulant Use Disorder
* Recently initiated medications for opioid use disorder (MOUDs) at Broadway Family Medicine (BFM), within 2 weeks of recruitment
* Have an active prescription for buprenorphine-naloxone (Suboxone)

Exclusion Criteria:

* Prescription for an amphetamine would exclude patients from the abstinence-based CM, but they could participate in the attendance-only CM.
* Dementia, development disabilities, or cognitive functioning that is too low to participate in study measures, as determined by chart review and consultation with overseeing physician.

Primary outcomes:
measure: Preliminary efficacy of CM on clinical outcomes: Visit Frequency
timeFrame: 30 days post-intervention
measure: Preliminary efficacy of CM on clinical outcomes: Urine toxicology
timeFrame: 30 days post-intervention
measure: Feasibility of CM for OUD in primary care: Recruitment
timeFrame: 30 days post-intervention
measure: Feasibility of CM for OUD in primary care: Retention
timeFrame: 30 days post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Robert Levy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04910451: Investigating the Safety and Effect of Overnight Orthokeratology and Its Influencing Factors
Official title: Investigating the Safety and Effect of Overnight Orthokeratology and Its Influencing Factors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myopia
Keywords: orthokeratology
myopia control
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 400
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: myopia patients who were using orthokeratology for myopia control

Brief summary: To investigate the Safety and Effect of Overnight Orthokeratology and Its Influencing Factors in China

Detailed description: Patients who were successfully prescribed with orthokeratology lenses in Eye Center of the Second Affiliated Hospital of Zhejiang University School of Medicine were enrolled in the study. Our study used two different methods to collect data. For complications and effect of orthokeratology information, data were collected by a retrospective survey. A questionnaire was used to collect influencing factors of safety and effect of orthokeratology.

Eligibility criteria: Inclusion Criteria:

* Patients who were successfully prescribed with ortho-k lenses in Eye Center of the Second Affiliated Hospital of Zhejiang University School of Medicine

Exclusion Criteria:

* Patients who have ceased wearing orthokeratology or who were using other methods of myopia control

Primary outcomes:
measure: axial length
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Zhiwen Bian, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04897451: Quality of Life After Cervical Ripening
Official title: Quality of Life 3 Months After Cervical Ripening
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delivery
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 160
Sex: FEMALE
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: All Women who experienced at least one method of cervical ripening in our hospital.

Brief summary: Women's experience of childbirth differs with type of labor, mode of delivery and parity. Induction of labor (IOL) is associated with lower satisfaction of women than spontaneous labor.

A Nigerian study of 252 women with induced labor, irrespective of parity and device used for IOL and a French cohort study of 3042 women with IOL have been published. Theses latter identified several determinants of maternal dissatisfaction.

However, no published study has reported the assessment of quality of life of women at long term after cervical ripening according to the device required for cervical ripening.

The aim of this study is to characterize the quality of life of women after cervical ripening according to parity and device required, and to assess possible factors associated with this quality of life at long-term after delivery.


Eligibility criteria: Inclusion Criteria:

- Woman who experienced at least one method of cervical ripening in our hospital

Exclusion Criteria:

- Patient's refusal

Primary outcomes:
measure: EuroQol 5 Dimension Score
timeFrame: 3 months after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche Sur Yon
country: France
facility: CHD Vendée
Study officials:
affiliation: CHD Vendee
name: Guillaume DUCARME
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05551351: CT in Calcified Coronary Arteries With Photon Counting Detector
Official title: CT av förkalkade kranskärl Med fotonräknarteknik
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Stenosis
Calcific Coronary Arteriosclerosis
Keywords: Cardiac Computed Tomography
Photon Counting Detector
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 29
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population are at least 65 years old with an expected median age of \~80 years. This group of patients has generally a high coronary artery calcium burden which prevents conventional cardiac CT from evaluation of the coronary arteries.

Since cardiac CT and coronary artery angiography is performed as part of routine care in this patient cohort, no extra examinations are needed for the reference measure of the primary outcome.

Brief summary: Coronary CT angiography is challenging in patients with more than mildly calcified coronary vessels, because of calcium artefacts that prevents evaluation of the lumen. The purpose of the CCT-PCD-1-study is to evaluate the diagnostic accuracy and image quality in coronary CT angiography using a commercially available CT system equipped with a photon counting detector technology.

Patients referred for cardiac CT and conventional coronary angiography as part of routine preoperative evaluation before Transcatheter Aortic Valve Implantation (TAVI) will be asked for inclusion in the study. This group of patients has generally a coronary artery calcium burden and perform cardiac CT and coronary angiography as part of routine care.

The diagnostic accuracy concerning significant coronary artery stenosis on the preoperative CT will be evaluated with the conventional coronary angiography as reference. Also, CT examination image quality will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Patients referred for cardiac CT AND conventional coronary angiography as part of routine preoperative evaluation.

Exclusion Criteria:

* \<65 years old.
* Heart arrhythmia.
* Heart rate \>90/min with contraindication against beta blockers.
* Not capable of giving informed consent
* eGFR \<30 mL/min/1.73m2

Primary outcomes:
measure: Diagnostic accuracy of CT concerning coronary stenosis with conventional angiography as reference
timeFrame: 1 day. (Coronary angiography is usually performed the same day as cardiac CT.)
Secondary outcomes:
measure: Image quality
timeFrame: 1 day. (Image quality is assessed on the performed examination)
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Röntgenkliniken Universitetssjukhuset Örebro
Study officials:
affiliation: Örebro University, Sweden
name: Mats Lidén, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03249051: Optimization of Nutritional Therapy in Mechanically Ventilated, Critically Ill Patients.
Official title: Optimization of Nutritional Therapy by Variation of Methods to Determine Energy Needs in Mechanically Ventilated, Critically Ill Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critically Ill
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate whether an individualized determination of energy requirements using indirect calorimetry instead of a formula-based approach leads to an optimized nutritional support and as a consequence to an optimized nutritional status of the critically ill, mechanically ventilated patients measured by the phase angle.


Eligibility criteria: Inclusion Criteria:

* age over 18 years
* mechanical ventilation
* an hospital stay of at least three days at the intensive care unit of the University Hospital of Tübingen
* possibility to perform indirect calorimetry measurements (FiO2 ≤70, PCO2 ≤ 0,5)
* possibility to perform Bioelectrical Impedance Analysis (BIA)
* underlying indication for enteral or/and parenteral nutritional support
* written informed consent from the patient or a legal authorized person

Exclusion Criteria:

* cardiac pacemaker

Primary outcomes:
measure: Phase angle (PhA)
timeFrame: PhA was measured between one and 90 days (during ICU stay)
Secondary outcomes:
measure: Nitrogen Balance
timeFrame: Nitrogen Balance was measured between one and 90 days (during ICU stay)
measure: Extracellular to body cell mass ratio (ECM/BCM - Ratio)
timeFrame: ECM/BCM-Ratio was measured between one and 90 days (during ICU stay)
measure: Length of hospital stay in days
timeFrame: Length of hospital stay was measured between one and 180 days
measure: Length of stay in intensive care unit (ICU) in days
timeFrame: Length of ICU stay was measured between one and 90 days
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: University of Hohenheim
Study officials:
affiliation: University of Hohenheim, 70599 Stuttgart, Germany
name: Stephan C Bischoff
role: PRINCIPAL_INVESTIGATOR
References: