louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00767871: Changes of Cerebral Glucose Metabolism and After 12 Weeks of Escitalpram Treatment in Panic Disorder
Official title: Changes of Cerebral Glucose Metabolism Associated With the Fear Network Activity Before and After 12 Weeks of Escitalpram Treatment in Panic Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Panic Disorder
Keywords: Panic disorder
PET
Escitaopram
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: H. Lundbeck A/S
First posted: 2008-10-07
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Panic disorder is one of the most prevalent psychiatric disorders and recently abnormal fear network is known to be implicated in the pathophysiology of panic disorder. The fear network involves many brain regions such as amygdala, hippocampus, periaqueductal gray (PAG), locus coeruleus, parahippocampal gyrus, frontal cortex, and thalamus. Escitalopram, a highly selective serotonin reuptake inhibitor, is usually effective for panic dis order, but there is little information on how escitalopram affects the fear network.

The specific aim of this study is to test the following hypotheses using 18F-FDG positron emission tomography (PET)

1. Patients with panic disorder will show abnormal activity of the fear network compared to healthy comparison subjects.
2. Patients with panic disorder will show normalized activity of the fear network after 12-weeks of treatment with escitalopram.
3. The changes of fear work after the treatment will be associated with psychological variables and neurohormones.


Eligibility criteria: Inclusion Criteria:

* panic disorder
* 20-60 years

Exclusion Criteria:

* history of major psychosis (schizophrenia or bipolar disorder), social phobia, obsessive-compulsive disorder, and generalized anxiety disorder, and posttraumatic stress disorder. The acceptable score on the 17-item Hamilton Depression Rating Scale at entry into the study will be less than 17.
* patients and volunteers with alcohol dependence and current regular use of benzodiazepines will be excluded. Subjects with current or previous regular use of benzodiazepines will be excluded.

Primary outcomes:
measure: 18FDG-PET, PDSS & HAM-A
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Bum-Hee Yu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01278771: Coronary Anomalies in Congenital Heart Disease
Official title: Coronary Anomalies in Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Heart Disease
Keywords: CHD
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 1200
Sex: ALL
Maximum age (years): 86
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1200 patients with Congenital Heart Disease who underwent Cardiac catheterization with angiography.

Brief summary: This is a retrospective study. The investigators shall review the angiography data of 1200 consecutive cardiac catheterizations of children and babies with CHD (Congenital Heart Disease) since 1998 till now.

Coronary artery origin and course will be evaluated in relation to the morphologic cardiac anomalies.

Coronary artery anomalies will be described and statistical analysis will be performed.


Eligibility criteria: Inclusion Criteria:

* cradiac catheterization with angiography with congenital heart disease.

Exclusion Criteria:

* no congenital heart disease.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Medical Health Care Campus
name: Avraham Lorber, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05042271: PK of Meropenem in Patients on Plasma Exchange
Official title: Pharmacokinetics of Meropenem in Patients on Plasma Exchange
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autoimmune Diseases
Keywords: therapeutic plasma exchange
meropenem
pharmacokinetic
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: autoimmune diseases

Brief summary: Therapeutic plasma exchange (TPE) has been shown to be an important procedure for treatment of a variety of refractory immune complex disorders, such as Guillain-Barré syndrome and neuromyelitis optica. The intervention removes plasma, albumin, or some other substance. Meropenem is a broad-spectrum beta-lactam antimicrobial agent that is used for the treatment of serious nosocomial infections. Pathophysiological changes in patients on TPE can alter the pharmacokinetic (PK) patterns of coadministered antibiotics. This effect has an impact on the antimicrobial agents when paticipants are administered during the intervention. The aim of this study was to investigate the impact of TPE on meropenem PK.


Eligibility criteria: Inclusion Criteria:

* age≥ 18 years
* no shock
* hemoglobin ≥ 7 g/dl

Exclusion Criteria:

* pregnancy or breast-feeding female
* history of hypersensitivity to carbapenems
* renal replacement therapy

Primary outcomes:
measure: The plasma concentrations were measured at the following times: 0, 0.25, 0.5, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6 and 8 hour after the start of drug administration
timeFrame: 0-8 hours after the drug administration
Secondary outcomes:
measure: Maximum plasma concentration [Cmax]
timeFrame: 0-8 hours after the drug administration
measure: Minimum plasma concentration [Cmin]
timeFrame: 0-8 hours after the drug administration
measure: Area under the plasma concentration versus time curve [AUC]
timeFrame: 0-8 hours after the drug administration
measure: half-life [t1/2]
timeFrame: 0-8 hours after the drug administration
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Faculty of Medicine, Prince of Songkla University, Thailand
state: Songkla
Study officials:
affiliation: Faculty of Medicine, Prince of Songkla University, Thailand
name: Sutep Jaruratanasirikul, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02895971: Incidence of Venous Thromboembolism and Professional Practices in Brest Area
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Keywords: Venous Thromboembolism
professional Practices
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 1416
Sex: ALL
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: Patient with venous thromboembolism

Brief summary: The aim of this study estimate VTE incidence. Investigators prospectively record all cases of symptomatic pulmonary embolism (PE) and deep vein thrombosis (DVT) of the lower limbs diagnosed between March 1, 2013 and February 28, 2014 in hospitals and in the community.


Eligibility criteria: Inclusion Criteria:

* symptomatic pulmonary embolism (PE) and deep vein thrombosis (DVT) diagnosis confirmed
* Patient living in Brest area from time of diagnosis

Exclusion Criteria:

* invalid diagnosis
* asymptomatic event
* Main residence patient out of Brest area.

Primary outcomes:
measure: Gathering information about potential factors predisposing Thromboembolic disease and treatments undertaken.
timeFrame: two years after VTE
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT03044171: Evaluation of the Effect of Fluoride and Laser Application on the Prevention of Sensitivity in Bleached Teeth
Official title: Effect of Sodium Fluoride at 1.1%, Associated or Not With the Low-level Light Therapy in the Prevention of Post-bleaching Sensitivity: a Randomized, Double-blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dentin Sensitivity
Lead sponsor: Universidade Federal do Para
Sponsor class: OTHER
First posted: 2017-02-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: To investigate the effects of desensitizing agents on the dental bleaching process, testing the hypothesis that they may prevent dental sensitivity.

Detailed description: The objective of this double blind, randomized and controlled clinical study, was to evaluate the efficacy of 1.1% sodium fluoride associated with LLLT (Low Level Laser Therapy) on teeth that were exposed to 35% hydrogen peroxide during 4 weeks of bleaching treatment. Methods: 25 volunteers were evaluated through the split-mouth model, where the hemiarcates were ranzomized and later allocated in one of the experimental groups: G-FLUOR+LASER - constitutes the group treated with LLLT + 1.1% sodium fluoride; and G-FLUOR - constitutes the group treated with placebo + 1.1% sodium fluoride .

Eligibility criteria: Inclusion Criteria:

* Absence of active carious lesions;
* Good oral hygiene;
* Do not present hypersensitivity;
* Do not smoke;
* Not being pregnant.

Exclusion Criteria:

* Presence of periodontal disease;
* Presence of cracks or fractures;
* Presence of restorations and prostheses;
* Presence of gastroesophageal dysfunction;
* Patients with severe internal dental dimming.

Primary outcomes:
measure: Stimulated pain intensity measure (P5)
timeFrame: 4 weeks
Secondary outcomes:
measure: Non-stimulated pain intensity measure, (P28)
timeFrame: 28 days
measure: Recurrence of stimulated pain
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
References:
citation: Reis A, Dalanhol AP, Cunha TS, Kossatz S, Loguercio AD. Assessment of tooth sensitivity using a desensitizer before light-activated bleaching. Oper Dent. 2011 Jan-Feb;36(1):12-7. doi: 10.2341/10-148-CR. Epub 2011 Mar 24.
citation: Moosavi H, Arjmand N, Ahrari F, Zakeri M, Maleknejad F. Effect of low-level laser therapy on tooth sensitivity induced by in-office bleaching. Lasers Med Sci. 2016 May;31(4):713-9. doi: 10.1007/s10103-016-1913-z. Epub 2016 Mar 10.
Clinical trial NCT06794671: A Basket Trial of Vunakizumab in Inflammatory Skin Diseases
Official title: A Multicenter, Large-sample Case Registry Study to Evaluate Patient-reported Outcome and Medication Patterns With Vunakizumab for Inflammatory Skin Diseases
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Inflammatory Skin Diseases
Psoriasis
Keywords: inflammatory skin diseases
Psoriasis
vunakizumab
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients woh had adiagnosis of inflammatory skin disease are receiving or plans to receive vunakizumab for treatment.

Brief summary: This is a national multi-center, large sample size case registration clinical study. The registry population was patients with inflammatory skin diseases who were receiving treatment with vunakizumab. All outpatient and inpatient patients with inflammatory skin diseases who were receiving vunakizumab were eligible for enrollment. Patients' usual care was not affected by participation in the study. We only collected data in routine clinical practice.

The study had an enrollment period of 5 years or 10,000 patients were recruited early, whichever occurred first. All patients must provide written informed consent form before data collection, and each patient will be followed for 1 year to observe clinical progression.


Eligibility criteria: Inclusion Criteria:

* aged ≥ years；
* had adiagnosis of inflammatory skin disease；
* Is receiving or plans to receive vunakizumab for treatment;
* Patients provided written informed consent form.

Exclusion Criteria:

* no.

Primary outcomes:
measure: Change from baseline in DLQI scores over 52 weeks
timeFrame: Weeks 0 to 52
Secondary outcomes:
measure: Change from baseline in BSA over 52 weeks
timeFrame: Weeks 0 to 52
measure: Change from baseline in IGA over 52 weeks
timeFrame: Weeks 0 to 52
measure: Patterns of administration of vunakizumab for the treatment of different inflammatory skin diseases
timeFrame: Weeks 0 to 52
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02131571: Prevalence of Vertebral Fractures in HIV Infected Patients Older Than 50 Years
Official title: Prevalence of Vertebral Fractures in HIV Infected Patients Older Than 50 Years: Importance of Bone Mineral Density and Bone Biomarkers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vertebral Fractures
Keywords: HIV
bone
fractures
vitamin D
biomarkers
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2014-05-06
Enrollment: 130
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV infected patients older than 50 years

Brief summary: Prospective cohort study to determine the prevalence of vertebral fractures in HIV infected patients older than 50 years.

Detailed description: To determine the prevalence of asymptomatic vertebral fractures in HIV patients older than 50 years, and the risk of fracture during a follow up of 2 years, according to bone mineral density at inclusion, the level of serum bone biomarkers, and the presence of secondary factors such as hypovitaminosis D or/and secondary hyperparathyroidism.

Eligibility criteria: Inclusion Criteria:

* Age above 50 years
* HIV infection

Exclusion Criteria:

* Pregnancy
* Receiving corticosteroids or antiresorptive therapy

Primary outcomes:
measure: Prevalence of vertebral fractures in HIV patients older than 50 years
timeFrame: 2 years
Secondary outcomes:
measure: Risk of vertebral alteration according to bone mineral density and serum biomarkers
timeFrame: 2 years
measure: Vertebral alterations during follow up
timeFrame: 2 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Ramon y Cajal Hospital
Study officials:
affiliation: Ramon y Cajal Hospital
name: Jose L Casado, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04208971: Batch Enrollment for AI-Guided Intervention to Lower Neurologic Events in Unrecognized AF
Official title: Batch Enrollment for an Artificial Intelligence-Guided Intervention to Lower Neurologic Events in Patients With Unrecognized Atrial Fibrillation (BEAGLE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 1225
Sex: ALL
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: This study aims to enroll adult patients who have not been previously diagnosed with AF, are eligible for anticoagulation and have AI-predicted risks based on a normal sinus rhythm ECG.

Brief summary: This is a prospective study to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis of unrecognized atrial fibrillation (AF) and stroke prevention.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Had a 10-second 12-lead ECG done at Mayo Clinic
* Men with CHA2DS2-VASc ≥2 or women with CHA2DS2-VASc ≥3

Exclusion Criteria:

* Diagnosed atrial fibrillation or atrial flutter
* Missing date of birth or sex in the electronic health record (EHR)
* A history of intracranial bleeding
* A history of end-stage kidney disease
* Have an implantable cardiac monitoring device, including a pacemaker, a defibrillator, or implanted loop recorder
* Deemed by research personnel to have limitations that would prevent them from being able to provide informed consent, use the patch, or complete interviews will not be included.

Primary outcomes:
measure: Diagnosis of Atrial Fibrillation as Detected by Patch Application
timeFrame: Three Months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Xiaoxi Yao, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Peter Noseworthy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Noseworthy PA, Attia ZI, Behnken EM, Giblon RE, Bews KA, Liu S, Gosse TA, Linn ZD, Deng Y, Yin J, Gersh BJ, Graff-Radford J, Rabinstein AA, Siontis KC, Friedman PA, Yao X. Artificial intelligence-guided screening for atrial fibrillation using electrocardiogram during sinus rhythm: a prospective non-randomised interventional trial. Lancet. 2022 Oct 8;400(10359):1206-1212. doi: 10.1016/S0140-6736(22)01637-3. Epub 2022 Sep 27.
citation: Yao X, Attia ZI, Behnken EM, Walvatne K, Giblon RE, Liu S, Siontis KC, Gersh BJ, Graff-Radford J, Rabinstein AA, Friedman PA, Noseworthy PA. Batch enrollment for an artificial intelligence-guided intervention to lower neurologic events in patients with undiagnosed atrial fibrillation: rationale and design of a digital clinical trial. Am Heart J. 2021 Sep;239:73-79. doi: 10.1016/j.ahj.2021.05.006. Epub 2021 May 24.
Clinical trial NCT05697471: Comparisons of the Therapeutic Effects of Dienogest and Danazol on Endometriosis
Official title: Far Eastern Memorial Hospital
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Endometriosis
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the efficacy between dienogest and danazol.

Detailed description: Objective: Women with adenomyosis or endometripsis are often suffered from dysmenorrhea or menorrhagia. Dienogest and danazol are frequently used for the treatment of endometriosis. However, there was no literature mentioned about which medication is better for the treatment of endometriosis. Thus, the aim of this study is to evaluate the efficacy between dienogest and danazol.

Methods: All consecutive women, who have endometriosis, will be randomized to receive dienogest or danazol treatment, and will assess symptoms severity, receive CA125 examination, sonographic examination at baseline, 4 weeks and 16 weeks after treatment.

Eligibility criteria: Inclusion Criteria:

* \> 20 years old
* Have an endometriosis-related condition (including adenomyosis, adenomyoma, ovarian endometrioma, or pelvic endometriosis).

Exclusion Criteria:

* Minors.
* Have a history of breast cancer or other cancers.
* Patients with vascular obstruction such as stroke.

Primary outcomes:
measure: The change of severity in dysmenorrhea
timeFrame: 16 weeks
Secondary outcomes:
measure: The change of severity in urinary symptoms
timeFrame: 16 weeks
measure: The change of severity in quality of life related to urinary symptoms
timeFrame: 16 weeks
measure: The change of severity in menstrual amount
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT02550171: BioGene Bank Cohort Study for Approved Research Requests
Official title: The BioGene Bank Cohort Study is a Collection of Human Blood Samples (DNA and Plasma) Along With De-identified (Coded) Health Information, Questionnaire Responses on Environment and History of Family Disease to be Used for Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Chronic Disease
Keywords: Biobank
Genetics
DNA
Cohort
normal control
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2015-09-15
Enrollment: 7056
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anyone receiving care at the NS LIJ Health System and family members.

Brief summary: The BioGene bank: Is a centralized collection of human blood samples along with de-identified (coded) health information, environmental factors, family disease histories and information from DNA. Limited to the NSLIJHS catchment area.

Detailed description: The purpose of the BioGene Bank Cohort is to collect blood and store DNA from blood, along with health information to study how genetic variation in the population is associated with particular diseases, treatments and medical outcomes. Investigators may study the entire range of diseases and medical problems that exist within the NSLIJHS, including medical, surgical, psychiatric, pediatric and obstetric conditions. The specimens and medical information will be kept at a central Biorepository. This research study does not involve any treatment and individual research results are not provided.

Eligibility criteria: Inclusion Criteria:

* Anyone receiving care at the NS LIJ Health System would be eligible to join the BioGene Bank Cohort.
* Participants' family members who may or may not have medical records at NSLIJHS.

Exclusion Criteria:

* Patients unable to give consent because they are decisionally impaired or have a language barrier that cannot be overcome.
* Patients unable to provide a blood sample because it would adversely affect their health or who refuse to provide blood sample or share future discarded biological samples.
* Patients \<10kg in weight

Primary outcomes:
measure: Time from symptoms to diagnosis of autoimmune diseases
timeFrame: 10 years
Secondary outcomes:
measure: Chart Review of Participants who are diagnosed with autoimmune disease
timeFrame: average of 10 years
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: The Feinstein Institute for Medical Research
state: New York
Study officials:
affiliation: Northwell Health
name: Peter K Gregersen, MD
role: PRINCIPAL_INVESTIGATOR
References: