louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06097377: Lymphatic Magnetic Resonance Imaging Abnormalities in Children With Tetralogy of Fallot: A Case-Control Study
Official title: Lymphatic Magnetic Resonance Imaging Abnormalities in Children With Tetralogy of Fallot: A Case-Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tetralogy of Fallot
Lymphatic
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: controls and ToF patients between 6 - 18 years of age.

Brief summary: This study examines subclinical lymphatic abnormalities in Tetralogy of Fallot patients, utilizing lymphatic magnetic resonance and near-infrared fluorescence imaging.


Eligibility criteria: Inclusion Criteria:

* ToF

Exclusion Criteria:

-

Primary outcomes:
measure: Lymphatic abnormalities
timeFrame: During scan
Secondary outcomes:
Other outcomes:
Locations:
city: København Ø
country: Denmark
facility: Rigshospitalet
Study officials:
References:
Clinical trial NCT01517477: One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects
Official title: A Prospective, Randomized, Controlled Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications, Implanted With One, Two, or Three Trabecular Micro-Bypass Stents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open Angle Glaucoma (POAG)
Keywords: Open angle
Glaucoma
surgery
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2012-01-25
Enrollment: 119
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: The purpose of this study is to evaluate the safety and efficacy of the intraocular pressure (IOP) lowering effect of one, two, or three iStent devices in eyes of subjects previously on two anti-glaucoma medications.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with primary open-angle glaucoma (POAG)
* Subject on two topical hypotensive medications

Exclusion Criteria:

* Traumatic, uveitic, neovascular, or angle closure glaucoma
* Fellow eye already enrolled

Primary outcomes:
measure: Mean diurnal intraocular pressure (IOP) reduction of greater than or equal to 20% at month 12 vs. baseline
timeFrame: 12 Months
Secondary outcomes:
measure: Mean diurnal IOP <18 mmHg at month 12
timeFrame: 12 months
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: S.V. Malayan's Ophthalmology Centre
Study officials:
References:
Clinical trial NCT06604377: Model of Predicting Biochemical Recurrence After Radical Prostate Cancer Based on Pre-treatment PSMA PET / MR Image Features
Official title: Model of Predicting Biochemical Recurrence After Radical Prostate Cancer Based on Pre-treatment PSMA PET / MR Image Features
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: PET/MR
Prostate cancer
Biochemical recurrence
Multicenter
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 203
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with prostate cancer undergoing PSMA PET/MR examination prior to surgery

Brief summary: The purpose of this study is to investigate the predictive value of preoperative 18F-PSMA-1007 PET/MR in the predictive effect of biological recurrence (BCR) after radical prostatectomy (RP) for localized prostate cancer (PCa).

Detailed description: Construct a predictive model for biochemical recurrence (BCR) in patients after radical prostatectomy using imaging parameters from preoperative 18F-PSMA-1007 PET/MRI, and compare the predictive performance of this model with existing clinical models. Data from three centers will be collected, with datasets from two centers used as the training set for the selection of predictive factors and model construction, while the dataset from the remaining center will serve as the validation set to assess the predictive performance of the model for BCR after prostatectomy.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Histologically confirmed prostate cancer without other types of malignancy -

Exclusion Criteria:

1.Surgery or endocrine therapy is performed prior to the examination

-

Primary outcomes:
measure: 18F-PSMA-1007 PET/MR image parameters
timeFrame: Before surgery
Secondary outcomes:
measure: Biochemical recurrence-free survival time
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
Study officials:
References:
Clinical trial NCT01790477: Auricular Acupuncture for The Treatment of Post-Tonsillectomy Pain
Official title: Auricular Acupuncture for The Treatment of Post-Tonsillectomy Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Tonsillitis
Peritonsillar Abscess
Obstructive Sleep Apnea
Keywords: Tonsillectomy
Acupuncture
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
First posted: 2013-02-13
Enrollment: 134
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: The goal of this study is to assess the role of battlefield acupuncture in the reduction of pain scores status post adult tonsillectomy. Secondary goals of this study include reduction in narcotic usage, decreased nausea and vomiting, and evaluating patient factors that lend an increased risk of worsening pain or improved response with acupuncture.


Eligibility criteria: Inclusion Criteria:

* Any adult patient who meets criteria and is scheduled for tonsillectomy

Exclusion Criteria:

* Any patient with prior use of acupuncture
* Individuals under age 18
* Tonsillectomy performed with other surgical procedures, i.e UPPP, adenoidectomy,
* Patients with a known personal or family history of a bleeding disorder will be excluded.
* Patients with a history of kidney or liver problems will also be excluded.
* Patients found to be pregnant will be excluded from participation.
* Patients unwilling to enroll in the study will have the tonsillectomy with or without adenoidectomy performed according to current practice standards.

Primary outcomes:
measure: Reduction in VAS scores between experimental and control group
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: NMCSD Balboa
state: California
Study officials:
affiliation: NMCSD
name: Anil Shah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00062777: The Framingham Study: Examining DNA Markers and Links to Diseases
Official title: A Genome-Wide Scan for Quantitative Trait Loci of Hematocrit - A Framingham Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Diseases
Keywords: Genetics
Populations
CVD Risk
Gene Mapping
Epidemiology
Framingham Study
Vascular Diseases
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2003-06-16
Enrollment: 330
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Since 1948, residents of Framingham, Massachusetts, have participated in a program that collects blood samples and clinical data to provide a rare and valuable database for scientific research.

The purpose of this study is to support this national resource by aiding in its research capacity. Specifically, researchers in this study will (1) investigate heart, lung, and blood diseases; stroke; memory loss; joint disease; bone loss; deafness; cancer; blood vessel diseases and other health conditions, and (2) examine DNA and its relationship to risk of developing these disease and health conditions.

Approximately 330 families have participated in the Framingham Study. Participants will be required to undergo a four-hour exam and to take that exam every two years thereafter. During the exam, the Framingham investigators will (1) interview participants about medical status, health issues, and lifestyles; (2) perform a regular physical exam; (3) obtain blood and urine samples and administer a glucose-tolerance test; (4) supervise a brisk six-minute treadmill walk; (5) administer an ultrasound procedure; and (6) review and obtain copies of medical and hospital records. Participants will also be asked to complete a questionnaire at home regarding dietary and health habits.

Detailed description: Many studies have shown that hematocrit (HCT) levels are associated with cerebrovascular disease, cardiovascular disease (CVD), peripheral vascular disease, as well as all-cause mortality. Twin studies have shown that HCT variation is largely determined by genetic factors with heritability estimated as 40% - 65%. So far, no linkage analysis in humans between HCT and DNA markers have been reported. The purpose of this protocol is to identify chromosome regions that contain quantitative trait loci (QTL) involved in controlling HCT levels. In the Framingham Study, a 10cM genome scan (about 400 markers) has been conducted in 330 families. HCT was measured in the original cohort and Framingham offspring. These data provide us the opportunity to undertake linkage analyses using variance component method to map quantitative trait loci (QTL) of HCT.

Eligibility criteria: * INCLUSION /EXCLUSION CRITERIA

The study population will include the members of the 330 Framingham Study families with genome scan.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
References:
Clinical trial NCT00000277: Mazindol for Cocaine Abuse - 2
Official title: Mazindol for Cocaine Abuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: Cocaine-Related Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: VA Connecticut Healthcare System
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate high and low dose mazindol for cocaine abuse.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Side effects
measure: Drug use
measure: Retention
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System
name: Thomas R Kosten, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Substance Abuse, 18(3):125-131, 1997.
Clinical trial NCT03207477: Premavision Cohort Follow-up
Official title: Visual Maturation in Prematurely Born Infants According to Factors Influencing Its Development. Premavision Follow-up at 18 Months Corrected Age, 4 and 7 Years of Age.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Visual Disorder
Keywords: Infant
Prematurely born
maturation
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Longitudinal cohort study with a control group
Primary purpose: SCREENING

Brief summary: This study aim at following a cohort of prematurely born infants at 18 months corrected age, 4 and 7 years of age. This cohort had an evaluation of visual maturation at term equivalent age (TEA) with factors associated with impaired visual maturation. (PREMAVISION-CLinicalTrials.gov ID: NCT02890251).

In this follow-up study, prematurely born infants vision will be compared to term born infants matched for postnatal age.


Eligibility criteria: Inclusion Criteria:

* Infants included in the Premavision cohort
* Term born healthy control infants at matched postnatal age

Exclusion Criteria:

* Ocular malformation
* Genetic abnormality
* Neurodevelopmental impairment

Primary outcomes:
measure: Visual acuity measurement
timeFrame: 18 months corrected age
measure: Visual acuity measurement
timeFrame: 4 years post-natal age
measure: Visual acuity measurement
timeFrame: 7 years post-natal age
Secondary outcomes:
measure: Measurement of cyclopegic refraction
timeFrame: 18 months corrected age
measure: Measurement of cyclopegic refraction
timeFrame: 4 years of age
measure: Measurement of cyclopegic refraction
timeFrame: 7 years of age
Other outcomes:
Locations:
city: Nancy
country: France
facility: Maternity Hospital CHRU
Study officials:
References:
Clinical trial NCT04404777: Local Recurrence Due to Rectal Cancer in Sweden
Official title: Local Recurrence Due to Rectal Cancer in Sweden - the Actual Incidence, Treatment and Outcome After Treatment
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rectal Neoplasms
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 12000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All patients treated in Sweden with a curative intent in 2007-2018 will be included. The number of recurrences, patterns of recurrence and outcome after treatment will be evaluated

Brief summary: The aim of this retrospective national registry study is to validate the reporting of local recurrence in the registry. Another aim is to identify preoperative risk factors for local recurrence. This can in turn indicate the need for a more intense follow-up. The treatment of local recurrence, including the impact of the multidisciplinary team conference (MDT) and the surgical procedure and the referral pathways of local recurrences will also be determined.

We aim to evaluate treatment outcome after local recurrence for patients operated or treated between 2007-2018.


Eligibility criteria: Inclusion Criteria:

* Rectal cancer with a curative intent

Exclusion Criteria:

* Rectal cancer without curative intent

Primary outcomes:
measure: Number of local recurrences
timeFrame: Between 2007-2018
measure: 3 year survival
timeFrame: 3 years
Secondary outcomes:
measure: Percentage R0 resection after local recurrence
timeFrame: 1-2 months after initiated treatment
measure: MDT effect on treatment of local recurrence
timeFrame: 1-3 months after diagnosis of recurrence
measure: Reported metastases
timeFrame: 5 years
measure: MRI features at primary diagnosis and relation to recurrence
timeFrame: 2 months
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Study officials:
References:
Clinical trial NCT01111877: Natural History Study of Incidence of Otorrhea Following Tympanostomy Tube Insertion in Children 6 Months to 12 Years
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Otorrhea
Keywords: ear tubes
ear drainage
ear infection
ear drops
tympanostomy tubes
Pediatric patients
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-04-28
Enrollment: 1389
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients between the ages of 6 months and 12 years who are undergoing unilateral or bilateral myringotomy with placement of tympanostomy tube.

Brief summary: This study was conducted to describe the time to first incidence of otorrhea post tympanostomy tube insertion.


Eligibility criteria: Inclusion Criteria:

* Participants must be at least 6 months old and no more than 13 years of age at the time of enrollment scheduled for unilateral or bilateral myringotomy and tympanostomy tube insertion. Patients and/or child must read/sign informed consent and comply with requirement of the study.

Exclusion Criteria:

* There are no exclusion criteria.

Primary outcomes:
measure: Incidence of, time to, and relationship of risk factors associated with otorrhea post tympanostomy tube insertion.
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT03321877: Down-titration of Steroids in Patients With Difficult Asthma With no Bronchial Hyperreactivity
Official title: Down-titration of Steroids in Patients With Difficult Asthma With no Bronchial Hyperreactivity: Severe Asthma or Simply Over-treatment?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: An 8 week 'real-life' inhaled corticosteroid (ICS) dose reduction study in patients with severe asthma without evidence of bronchial hyperactivity.

Detailed description: We aim to describe the proportion of patients with severe asthma, but without objective evidence of active disease, who can successfully be reduced in ICS dose for a period of 8 weeks. This is also intended as an exploration of the methodology and feasibility of step-down studies with this patient group, to act as a pilot for future projects.

This study enrolled patients from the SATS severe asthma study, in which they had undergone systematic investigation for comorbidities, triggers and barriers to good asthma control.

After baseline investigations, the patient's ICS dose is halved (or as close as possible to, but not below, 50%). Patients continued on the same inhaled steroid drug and device. Patients taking a combined ICS/LABA inhaler halve the dose of this, as per usual clinical practice. Other asthma medicaitons are continued unchanged.

Eligibility criteria: Inclusion Criteria:

* Physician-diagnosed asthma for at least 6 months
* Fulfill ERS/ATS giudelines for severe asthma
* Stable dose of ICS for at least 4 weeks
* Able to carry out study procedures
* Negative metacholine provocation test at screening
* Negative reversibility to beta agonist at screening
* FeNO under 50 ppb

Exclusion Criteria:

* Treatment with prednisolone, methotrexate, ciclosporin, omalizumab or nucala in the last 6 months
* FEV1 under 70% of predicted
* Acute upper or lower airway infection requiring antibiotics in the last 4 weeks
* Exacerbation of asthma requiring prednisolone in the last 6 months
* Current smoking
* Pregnancy or breastfeeding
* Other clinically significant lung disease
* Current participation in another interventional study

Primary outcomes:
measure: Responsiveness to metacholine bronchial challenge
timeFrame: 8 weeks
Secondary outcomes:
measure: ACQ score
timeFrame: 8 weeks
measure: miniAQLQ score
timeFrame: 8 weeks
measure: Pulmonary function tests
timeFrame: 8 weeks
measure: FeNO
timeFrame: 8 weeks
measure: Sputum cell differentials
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Lungemedicinsk Forskningsenhed
Study officials:
References:
Clinical trial NCT00437177: Relationship Between D2 Receptors SPECT and the Apomorphine Test in Patients With OH Dependence (ALC-DRD2-APO)
Official title: Relationship Between D2 Receptors SPECT and the Apomorphine Test in Patients With OH Dependence: Predictive Value for Relapse
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Alcoholism
Keywords: alcoholism
apomorphine
iodobenzamide
imaging
spect
relapse
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2007-02-19
Enrollment: 50
Sex: MALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: OH dependence is associated with DA receptor changes. Both, the apomorphine test and the D2Rec SPECt are usefull for monitoring DA receptor status. We aimed at studying whether DA receptor hypofunction, assessed by means of the apomorphine test and the D2Rec SPECT, is a marker of relapse in detoxified OH dependents patients.


Eligibility criteria: Inclusion Criteria:

* alcohol dependence
* alcohol dependence length at least 8 years.
* male
* age 25 - 60 years

Exclusion Criteria:

* other drug dependence (except nicotine dependence)
* another major axis I psychiatric diagnosis
* comorbid neurological disorder
* comorbid cardiovascular disorder
* comorbid metabolic disorder
* brain injury
* apomorphine allergy
* iode allergy
* diazepam allergy

Primary outcomes:
measure: To detertmine the agreement rate of the dopaminergic sensibility assessed by two different techiniques: the apomorphine test and and IBZM SPECT.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Psychiatry Service, Hospital Universitari Vall d'Hebron
state: Catalonia
Study officials:
affiliation: Psychiatry Service, Hospital Universitari Vall d'Hebron
name: Miquel Casas, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06371677: Polish Nationwide Register of Hospitalized Patients in Cardiac Intensive Care Units
Official title: Polish Nationwide Register of Hospitalized Patients in Cardiac Intensive Care Units
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Shock
Death
Cardiac Intensive Care Unit
Treatment Complication
Stroke
Multiple Organ Failure
Infections
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients hospitalized at Polish CICUs.

Brief summary: Cardiac Intensive Care Units (CICUs) provide care for a diverse patient population. Understanding the clinical characteristics, analysis of treatment modalities, and prognosis of patients hospitalized in the CICU are important to improve cardiovascular care. The purpose of this registry is to determine the demographics, clinical, treatment, and prognosis of patients hospitalized in the Polish CICUs. Data from this multicenter, prospective observational study will provide more robust data to facilitate quantitative characterization of cardiac care in contemporary Polish CICUs and enable the development of infrastructure for clinical trials in CICUs.


Eligibility criteria: All consecutive patients hospitalized at Polish CICUs.

Primary outcomes:
measure: All-cause death
timeFrame: 01.10.2024 - 31.03.2025
Secondary outcomes:
measure: Shock (cardiogenic/hypovolemic/anaphylactic/septic/neurogenic/obstructive)
timeFrame: 01.10.2024 - 31.03.2025
measure: Treatment-related complications (tamponade, dissection, stroke, embolism, etc.)
timeFrame: 01.10.2024 - 31.03.2025
Other outcomes:
Locations:
Study officials:
affiliation: 1st Department of Cardiology, Medical University of Warsaw
name: Robert Kowalik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: 1st Department of Cardiology, Medical University of Warsaw
name: Monika Gawałko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: