louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02235285: Asian Outcomes of Primary Breast Augmentation
Official title: Asian Outcomes of Primary Breast Augmentation in 162 Consecutive Cases Using Single Antibiotic Breast Irrigation by A Single Surgeon Under Sedative Anesthesia (Propofol Infusion)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Augmentation
Keywords: capsular contracture
reoperation
breast augmentation
Lead sponsor: Winners Clinic
Sponsor class: OTHER
First posted: 2014-09-09
Enrollment: 162
Sex: ALL
Minimum age (years): 22
Maximum age (years): 57
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In 162 Asian patients, primary breast augmentations were performed by a single surgeon during 5 years. The purpose of this study evaluates Asian outcomes in primary breast augmentation using single antibiotic breast irrigation by a single surgeon's practice and examines the comparison of Asian and Western outcomes in primary breast augmentation.

Detailed description: A retrospective chart review was performed to examine a total of 162 patients received the same brand of implants for primary breast augmentation under sedative anesthesia (propofol infusion) in a single surgeon's practice. Asian patients' demographics, preoperative and postoperative measurements, surgical technique (single antibiotic breast irrigation), implant type, size, texture, soft tissue coverage, implant placement, incision approach, complications, and incidence of reoperation were documented.

Eligibility criteria: Inclusion Criteria:

* primary case

Exclusion Criteria:

* secondary case
* breast reduction

Primary outcomes:
measure: Post Surgical Complications and Reoperation Rate During Breast Augmentation
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Department of Plastic Surgery, Winners Clinic
Study officials:
affiliation: Winners Clinic
name: CHEOLHWAN KIM, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spear SL, Murphy DK, Slicton A, Walker PS; Inamed Silicone Breast Implant U.S. Study Group. Inamed silicone breast implant core study results at 6 years. Plast Reconstr Surg. 2007 Dec;120(7 Suppl 1):8S-16S. doi: 10.1097/01.prs.0000286580.93214.df.
Clinical trial NCT01803685: Nationwide Treatment Survey of Intracranial Arteriovenous Malformation in China
Official title: A Nationwide Treatment Survey of Intracranial Arteriovenous Malformation: a Multicenter Retrospective and Prospective Register Study in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Arteriovenous Malformations
Keywords: Intracranial Arteriovenous Malformations
Surgical removal
Endovascular embolism
Stereotaxic radiosurgery
Outcomes
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2013-03-04
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients that diagnosed of intracranial AVM by DSA/CT/MRI

Brief summary: This register study will collect the treatment information of the intracranial arteriovenous malformation patients in China. We aim to understand the current treatment situation of the disease in China.

Detailed description: Intracranial arteriovenous malformations are congenital lesions that consist of multiple arteries and veins, connecting as a fistula without intervening normal capillary bed. The treatment strategy including surgical removal, endovascular embolism and stereotaxic radiosurgery and comprehensive treatment. China is a united multi-ethnic nation of 56 ethnic groups, and has the largest population in the world. We have most extensive and valuable clinical resources of intracranial arteriovenous malformation in the world. But we know little about the current treatment situation of the disease in China.

In order to realize the treatment situation of intracranial arteriovenous malformation in China, we designed a retrospective and prospective register study to collect the treatment and outcome information all over China.

Eligibility criteria: Inclusion Criteria:

* All the patients that diagnosed of intracranial AVM by DSA/CT/MRI
* All patients gave written informed consent

Exclusion Criteria:

* patients refuse to attend the survey

Primary outcomes:
measure: modified Ranking Scale
timeFrame: six months after operation
Secondary outcomes:
measure: Treatment complications
timeFrame: six months after treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Neurosurgery, Beijing Tiantan Hospital Affiliated to Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Shuo Wang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01282515: Treatment of Female Genital Erosive Lichen Planus(GELP) With Hexaminolevulinate PDT
Official title: A Study of Topical Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) and a Phase III Comparative Treatment Study of HAL PDT in Female Genital Erosive Lichen Planus (GELP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Genital Lichen Planus
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Photocure
First posted: 2011-01-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effect and side effects of photodynamic treatment and traditional topical steroid treatment in female genital erosive lichen planus

Detailed description: To assess the feasibility, efficacy and safety of hexyl 5-aminolevulinate-hydrocloride (HAL)-PDT in GELP in women.

Eligibility criteria: Inclusion Criteria:

Women with symptomatically genital ELP, clinically verified by at least one doctor attended to the Vulva clinic.

Untreated for ELP for at least 4 weeks. Written Informed Consent signed Age 18 or above

Exclusion Criteria:

Current pelvic inflammatory disease, genital malignancy, or gynecological infection.

Known or suspected porphyria

Known allergy to hexaminolevulinate or similar compounds (e.g. hexaminolevulinate or aminolevulinic acid) Pregnancy and lactation Participation in other clinical study either concurrently or within the last 30 days

Primary outcomes:
measure: Percentage change of GELP score and/or VAS score 6 weeks after start of treatment.
timeFrame: 6 weeks
Secondary outcomes:
measure: Percentage change of GELP score and/or VAS score 6 months after start of treatment.
timeFrame: 6 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet, OsloUniversity hospital
Study officials:
affiliation: research fellow
name: anne lise helgesen, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02680015: Understanding the Effects of Intervention on the Brain in Autism
Official title: Understanding the Effects of Intervention on the Brain in Autism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Asperger Disorder
PDD-NOS
Autism
Keywords: PEERS
friendships
brain
Lead sponsor: Marquette University
Sponsor class: OTHER
First posted: 2016-02-11
Enrollment: 400
Sex: ALL
Minimum age (years): 4
Maximum age (years): 28
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examines how the PEERS (Laugeson \& Frankel, 2010; Laugeson, 2016) social-behavioral intervention affects social relationships and brain development and function in autistic preschoolers, adolescents, and young adults.


Eligibility criteria: Inclusion Criteria:

* Verbal, speaking in full sentences
* Meets ASD criteria
* Meets IQ criteria \>70

Exclusion Criteria:

* schizophrenia or bipolar disorder

Primary outcomes:
measure: Social Responsiveness Scale (SRS: Constantino, 2005)
timeFrame: within two weeks of PEERS completion
measure: Test of Adolescent Social SKills (TASSK: Laugeson & Frankel, 2010)
timeFrame: within two weeks of PEERS completion
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Marquette University
state: Wisconsin
Study officials:
affiliation: Marquette University
name: Amy Van Hecke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02238015: Tear Film Evaluation After Phacoemulsification
Official title: To Investigate Tear Film Change After Phacoemulsification With SS-OCT
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cortical Senile Cataract
Keywords: cataract ,tear film,SS-OCT
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 eyes from 30 age-related cataract participants underwent cataract surgery with 3.0 mm clear corneal incision at 11 o'clock in one eye and the other eye without surgery history

Brief summary: To compare tear film differences between surgical eyes and nonsurgical eyes in patients who had cataract surgery by phacoemulsification in one eye.

Detailed description: All participants granted their written informed consent to participate in the research protocol.

Eligibility criteria: Inclusion Criteria:

age-related cataract without surgery history and dry eye symptoms history

Exclusion Criteria:

diseases influencing tear secretion (such as Sjögren syndrome, Steve-Johnson syndrome, diabetes, thyroid disease, etc.); history of ocular surgeries or nuclear hardness IV and V, which required the use of larger phacoemulsification energy; use of drugs that affect tear secretion and stability (such as glaucoma medications, artificial tears, corticosteroid drugs, etc.); or presence of ocular diseases (such as Pterygium, blepharitis, uveitis, glaucoma, lacrimal apparatus, etc.).

Primary outcomes:
measure: Phacoemulsification influence on the postoperative tear functions
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: WenZhou
country: China
facility: Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Wenzhou Medical University
name: Qian Zheng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03688815: Dipyridamole Induced Ischemia and Biomarkers
Official title: Relationship Between the L-arginine Pathway Metabolites and Dipyridamole Stress Induced Transient Myocardial Ischaemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Heart Disease
Ischemic Attack
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with IHD were enrolled.

Brief summary: Analysis of certain biomarkers and transient myocardial perfusion deficit revealed by myocardial perfusion scintigraphy.

Detailed description: The prospectively enrolled patients were followed up to 5 years. Adverse major events (MI, stroke, death) suffered during follow-up were retrospectively analysed.

Eligibility criteria: Inclusion Criteria: 1. written informed consent. 2. clinical diagnosis of ischemic heart disease (IHD) -

Exclusion Criteria: 1. refused written informed consent. 2. lost data during follow-up

-

Primary outcomes:
measure: Myocardial perfusion abnormality
timeFrame: 5 year follow-up after MPS
Secondary outcomes:
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: University of Pecs
state: Baranya
Study officials:
affiliation: University of Pecs
name: Tihamer Molnar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Molnar T, Horvath A, Szabo Z, Vamos Z, Doczi T, Illes Z. Detection of silent cerebral microcirculatory abnormalities in patients with manifest ischemic coronary disease: a perfusion brain MRI study combined with dipyridamole stress. Scand Cardiovasc J. 2021 Apr;55(2):97-101. doi: 10.1080/14017431.2020.1821911. Epub 2020 Sep 18.
Clinical trial NCT02737215: Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting in Patients With Obstructive Sleep Apnea
Official title: Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting in Patients With Obstructive Sleep Apnea: a Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Obstructive Sleep Apnea
Coronary Artery Bypass Grafting
Lead sponsor: University of Pernambuco
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 144
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background. Atrial fibrillation is one of the most common complications in the postoperative period of coronary artery bypass grafting (CABG) surgery and usually associated with increased length of hospital stay and higher hospital costs. Among the main mechanisms involved, excessive sympathetic activation, oxidative stress and inflammation are fundamental elements in the pathophysiology of obstructive sleep apnea. Objectives. To evaluate the effects of continuous positive airway pressure (CPAP) in reduction of atrial fibrillation after CABG in patients with obstructive sleep apnea. Methodological procedures: A multicenter randomized controlled study to compare the incidence of atrial fibrillation between the intervention group and the control group, both monitored seven days with Holter.


Eligibility criteria: Inclusion Criteria:

* apnea-hypopnea index \> 15 events/hour

Exclusion Criteria:

* ejection fraction \< 45%
* chronic atrial fibrillation
* periprocedural instability (haemodynamic, neurological)

Primary outcomes:
measure: atrial fibrillation
timeFrame: first 7 days after CABG
Secondary outcomes:
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Instituto de Medicina Integral Prof Fernando Figueira - Imip
state: Pernambuco
city: Recife
country: Brazil
facility: Pronto Socorro Cardiológico de Pernambuco - Procape
state: PE
city: Sao Paulo
country: Brazil
facility: INCOR - Instituto do Coração da Faculdade de Medicina da Universidade de São Paulo
state: SP
Study officials:
References:
citation: Chalegre ST, Barros MM, Silva BPG, Furlan SF, Giampa SQC, Marques JN, Albuquerque ALT, Monteiro VS, Drager LF, Pedrosa RP. Impact of Continuous Positive Airway Pressure on Postoperative Atrial Fibrillation in Patients with Obstructive Sleep Apnea Undergoing Coronary Artery Bypass Graft Surgery: An Exploratory Randomized Multicenter Study. Am J Respir Crit Care Med. 2022 Aug 1;206(3):358-360. doi: 10.1164/rccm.202112-2669LE. No abstract available.
Clinical trial NCT04448015: Perinatal Care and Medication Assisted Treatment: Carbon/Emery Counties
Official title: Perinatal Care and Medication Assisted Treatment: Carbon/Emery Counties
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Pregnancy Related
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to enhance perinatal opioid use disorder (OUD) treatment in a rural setting by developing an evaluated curriculum of perinatal OUD provider education.

Detailed description: The research team will establish and evaluate a perinatal model of care for OUD serving two counties, Carbon and Emery, which have high rates of OUD and overdose. This model of care will entail University of Utah medical clinicians providing education and webinars to healthcare providers in Carbon/Emery counties who care for pregnant women with OUD and their babies. This model of care will also help other social and behavioral health care providers in the area to understand how to treat and better coordinate care. No clinical services are being provided by University of Utah investigators or staff.

Eligibility criteria: Provider Inclusion Criteria:

* Must be employed as staff at one of our sub-contracted agencies or community partners
* Must directly provide care to pregnant women with OUD in Carbon and/or Emery Counties, UT

Provider Exclusion Criteria:

* Unwilling or unable to adopt treatment approaches presented from University of Utah clinicians to patient care
* Not directly working with pregnant patients with OUD

Primary outcomes:
measure: Self-report of linkage and adherence to treatment as assessed by the Treatment Service Review- 6 (TSR-6)
timeFrame: This data will be collected from each participant during a baseline assessment, a pre-delivery assessment occurring between 34 and 40 weeks of gestation, and a final assessment conducted within 30-days following delivery.
Secondary outcomes:
Other outcomes:
Locations:
city: Price
country: United States
facility: Eastern Utah Women's Health LLC
state: Utah
Study officials:
References:
citation: Bryan MA, Smid MC, Cheng M, Fortenberry KT, Kenney A, Muniyappa B, Pendergrass D, Gordon AJ, Cochran G. Addressing opioid use disorder among rural pregnant and postpartum women: a study protocol. Addict Sci Clin Pract. 2020 Oct 31;15(1):33. doi: 10.1186/s13722-020-00206-6.
Clinical trial NCT03157115: Validation of Kinocardiography, New Technology for Cardiac Linear and Torsional Contractility Measurement, to Assess Heart Failure Patient With Low Ejection Fraction
Official title: Validation of Kinocardiography, New Technology for Cardiac Linear and Torsional Contractility Measurement, to Assess Heart Failure Patient With Low Ejection Fraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impaired Left Ventricular Ejection Fraction
Keywords: Kinocardiography
Cardiac contractility
Heart kinetic energy
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 130
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Measuring cardiac contractility is commonly realized with gold standard echocardiography or MRI. Portable devices to measure this contractility are not available as for rhythm and electric function assessment. The new Kinocardiography technology could provide a non invasive and portable tool to measure contractility.

This device records the electric and mechanic function of the heart simultaneously. With electrodes and adequate electronics, ECG is recorded. 6 degrees of freedom accelerometers are also included in the device to measure the micro accelerations of the body at the body surface when the device is placed on the skin. Using physics principles and adequate calibration, those accelerations allow the investigators to calculate parameters such as kinetics energies related to cardiac contractility. Kinocardiography is a non invasive and portable technology.


Eligibility criteria: Inclusion Criteria:

* Control group: Left Ventricle Ejection Fraction ≥ 50 %
* Heart failure patients: Left Ventricle Ejection Fraction \< 50 %

Exclusion Criteria:

* Intracardiac devices and arrhythmia at the time of assessment
* Participates in other clinical study or trial.

Primary outcomes:
measure: Total heart kinetic energy
timeFrame: 1 hour
Secondary outcomes:
measure: Ratio of torsional kinetic energy over total kinetic energy
timeFrame: 1 hour
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Eva De Keyzer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04136015: Early Conversion of Dasatinib in CML-CP Patients
Official title: A Prospective Study on Early Conversion of Dasatinib in CML-CP Patients Who Have Not Early Molecular Response on Imatinib
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Validity and Safety
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: CML-CP patients treated with imatinib failed to achieve the best therapeutic effect（BCR/ABLIS\>10.00% in 3m or BCR/ABLIS\>1.00% in 6m）convert to dasatinib.

Brief summary: Chronic myeloid leukemia (CML) is a malignant disease of acquired hematopoietic stem cells. The BCR-ABL fusion gene is the pathogenic basis of CML. Tyrosine kinase inhibitors (TKIs) are targeted drugs for this fusion protein. With the wide clinical application of TKIs, the efficacy of CML patients has been greatly improved. However, there are still a significant number of patients who have poor response to the first generation of TKI drugs, imatinib, most of them have early molecular response failures (BCR-ABL（IS）\>10% at 3 or 6 months) ，which means lower rates of molecular response, increased risk of progression, and higher overall survival. For them, the early conversion of dasatinib might be a better choice.


Eligibility criteria: Inclusion Criteria:

1.18-65 years old； 2.CML-CP,and Imatinib treatment longest for 6 months ； 3.Q-pcr monitoring of BCR/ABLIS failed to achieve the best therapeutic effect（BCR/ABLIS\>10.00% in 3m or BCR/ABLIS\>1.00% in 6m）； 4.No previous history of malignant tumor; 5.Informed consent of the patient or his legal representative

Exclusion Criteria:

1. History of CML-CP or CML-AP;
2. Resistant to dasatinib,or treatment with imatinib more than 6 months;
3. Received allogeneic hematopoietic stem cell transplantation,or immunotherapy;
4. woman who is pregnant or nursing
5. Combined with other serious organic diseases, serious arrhythmia, pulmonary hypertension, cardiomyopathy, serious autoimmune diseases.

Primary outcomes:
measure: MMR in 1 year
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: NanfangH
state: Guangdong
Study officials:
References: