louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06232278: Long-term Results of Percutaneous Left Atrial Closure at Brest University Hospital (CLAPOT)
Official title: Long-term Results of Percutaneous Left Atrial Closure at Brest University Hospital.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation
Cardioembolic Stroke
Left Atrial Appendage Thrombosis
Anticoagulant-induced Bleeding
Keywords: Left atrial appendage occlusion · WATCHMAN · AMPLATZER Amulet · Atrial fbrillation · Stroke · Echocardiography · Cardiac computed tomography angiography
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with non-valvular atrial fibrillation and a definitive contraindication to anticoagulants who underwent left atrial appendage occlusion in the CHU of Brest between December 2014 and August 2023

Brief summary: Atrial Fibrillation represents an important risk of cardioembolic stroke. In more than 90% of cases, thrombus originate in the left atrial appendage. Therefore guidelines recommend the anticoagulation of patients with atrial fibrillation and a significant cardioembolic risk, predicted by the CHA2DS2VASc score.

However, serious bleeding complications may definitively contraindicate the use of anticoagulants.

For those patients, percutaneous Left Atrial Appendage Occlusion (LAAO) has became a recommended alternative to prevent the thrombus formation and reduce the risk of cardioembolic events.

In the CHU of Brest, more than 120 patients have been treated with LAAO for the last 8 years with two different occluder devices : WATCHMAN®, Boston Scientifc and AMPLATZER Amulet®, Abbott Laboratories.

This retrospective longitudinal observational study named CLAPOT (CHU of Brest' Left Atrial Appendage Percutaneous Occlusion Treatment) aims to evaluate the long term results of this procedure for effectiveness and safety and to compare the results between the two devices (Watchman and Amplatzer).


Eligibility criteria: Inclusion Criteria:

* Major
* Non opposition
* All patients with non-valvular atrial fibrillation and a definitive contraindication to anticoagulants who underwent left atrial appendage occlusion in the CHU of Brest between December 2014 and August 2023

Exclusion Criteria:

* Minor
* Patients under tutorship or curatorship
* Formulated opposition

Primary outcomes:
measure: Effectiveness of left atrial appendage occlusion with both devices WATCHMAN®, Boston Scientifc and AMPLATZER Amulet®, Abbott Laboratories
timeFrame: From 15 February 2024 to 15 April 2024
Secondary outcomes:
measure: Safety of left atrial appendage occlusion (LAAO) with both devices WATCHMAN®, Boston Scientifc and AMPLATZER Amulet®, Abbott Laboratoriesleft atrial.
timeFrame: At 8 weeks
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
References:
Clinical trial NCT01986478: OCT Reference Database
Official title: Topcon 3D OCT-1 Maestro and 3D OCT-2000 Optical Coherence Tomography Systems: Reference Database Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2013-11-18
Enrollment: 389
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: Subjects that are Normal

Brief summary: To collect data for a reference database.

Detailed description: Collection of multiple subjects to create a reference database.

Eligibility criteria: Inclusion Criteria:

1. Subjects 18 years of age or older on the date of informed consent
2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
3. Subjects presenting at the site with normal eyes (eyes without pathology)
4. IOP ≤ 21 mmHg bilaterally
5. BCVA 20/40 or better (each eye)
6. Both eyes must be free of eye disease

Exclusion Criteria:

1. Subjects unable to tolerate ophthalmic imaging
2. Subject with ocular media not sufficiently clear to obtain acceptable OCT images
3. HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD \< 5%
4. HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses \> 33% or false positives \> 25%, or false negatives \> 25%
5. Presence of any ocular pathology except for cataract
6. Previous ocular surgery or laser treatment, other than uncomplicated refractive procedure or cataract surgery, performed within six months prior to study scanning
7. Narrow angle
8. History of leukemia, dementia or multiple sclerosis
9. Concomitant use of hydroxychloroquine and chloroquine

Primary outcomes:
measure: Retinal Thickness
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Horizon Eye Specialist & Laser Center
state: Arizona
city: Livermore
country: United States
facility: Valley Eyecare Center
state: California
city: Los Angeles
country: United States
facility: Keck School of Medicine
state: California
city: Pomona
country: United States
facility: Western University of Health Sciences
state: California
city: New York
country: United States
facility: Stat University of New York College of Optometry
state: New York
Study officials:
affiliation: Senior Manager Product Planning Group
name: Michael Sinai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01826578: Single Port Myomectomy Versus Conventional Myomectomy
Official title: Prospective Randomized Controlled Trial to Analyze the Benefits of Single Port Laparoscopic Myomectomy in the View of Cosmetics and Patient Satisfaction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cosmetic Outcomes
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-04-08
Enrollment: 106
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is about the evaluation of which benefits single port laparoscopic myomectomy has in the perspective of cosmetics and patient satisfaction.

Detailed description: There were several studies about feasibility and cosmetic benefit of single port laparoscopic adnexal surgery and hysterectomy compared to conventional multiport laparoscopic surgery. Meanwhile, no study mentioned benefit of single port laparoscopic surgery in myomectomy because single port myomectomy needs more labor and operator's skill than other pelvic surgery. At this point, the investigators need to verify the effectiveness and benefit of single port laparoscopic myomectomy.

Eligibility criteria: Inclusion Criteria:

* premenopausal women
* image confirmed myoma
* scheduled to have laparoscopic myomectomy
* number of myoma =\<4 and largest size \<10cm

Exclusion Criteria:

* scheduled to have co-operation of other surgery
* clinically significant hematologic abnormality
* DM or malnutrition
* under the medication which can affect wound healing
* previous history of other pelvic surgery

Primary outcomes:
measure: Cosmetic benefits of single port laparoscopic myomectomy to conventional myomectomy in the view of scar evaluation
timeFrame: for 8 weeks
measure: Cosmetic benefits of single port laparoscopic myomectomy to conventional myomectomy in the view of patient satisfaction
timeFrame: for 8 weeks
Secondary outcomes:
measure: General composite characteristics of surgery procedure and outcome
timeFrame: 1 week
Other outcomes:
Locations:
city: Sungnam-si
country: Korea, Republic of
facility: Seoul University Bundang Hospital OB & GY
state: Kyeonggi-do
Study officials:
References:
Clinical trial NCT07007078: Efficacy of Dihydroartemisinin for Treating Acne Vulgaris
Official title: A Pilot Study to Evaluate the Therapeutic Effect of Dihydroartemisinin on Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Acne Vulgaris
Keywords: acne vulgaris
dihydroartemisinin
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if dihydroartemisinin (DHA) works to treat Acne Vulgaris in adults. The main question it aims to answer is:

• Does DHA improve the acne severity by at least one grade after treatment. Researchers will treat patients who are clinically diagnosed as Acne Vulgaris to see if DHA works to alleviate the symptoms of Acne Vulgaris.

Participants will:

* Take DHA every day for 3 months
* Visit the clinic once every month for checkups and tests


Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed with acne vulgaris;
* For female patients, no pregnancy plans within the next 6 months.

Exclusion Criteria:

* Patients who have used sex hormones or other systemic medications for acne treatment within the past 3 months;
* Patients who have used topical medications for acne within the past 2 weeks;
* Pregnant or breastfeeding women;
* Patients with known severe diseases of vital organs (e.g., heart, liver, kidney) or malignancies.

Primary outcomes:
measure: Improvement of acne severity by Investigator's Global Assessment (IGA)
timeFrame: Before and immediately after 90-day treatment
Secondary outcomes:
measure: Change of Global Acne Grading System (GAGS) score from baseline to the end of treatment
timeFrame: Before and immediately after 90-day treatment
measure: Change of inflammatory lesion count from baseline to the end of treatment
timeFrame: Before and immediately after 90-day treatment
measure: Change of non-inflammatory lesion count from baseline to the end of treatment
timeFrame: Before and immediately after 90-day treatment
measure: Number of participants who achieved an IGA score of 0 or 1 at the end of treatment
timeFrame: Before and immediately after 90-day treatment
measure: Change of serum total testosterone from baseline to the end of treatment
timeFrame: Before and immediately after 90-day treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jingjing JIANG, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04394078: Impact of COVID-19 Pandemic on Depression and Quality of Life
Official title: Impact of COVID-19 Pandemic on Depression and Quality of Life: Cross Sectional Study on Turkish Society and Suggestions on Potential Solution
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Quality of Life
Covid 19
Social Isolation
Keywords: Covid 19
Depression
Quality of Life
Turkish Society
Social Isolation
Lead sponsor: Okan University
Sponsor class: OTHER
Collaborators: name: Yuksek Ihtisas University
First posted: 2020-05-19
Enrollment: 543
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of the individuals between 15 - 65 ages in Turkey is 56.391.925 people. It is calculated that there are 42.463.119 individuals cover the criterion as universe of the study.

Brief summary: It is aimed to investigate the depression and quality of life of Turkish society caused by Covid-19 pandemic and reveal the relationship between them

Detailed description: Study hypothesis that people are tend to be depressed and the quality of life is affected negatively by Covid-19 pandemic. Although Turkey has affected moderately, the immediate change on depression and quality of life observable and measurable. It is aimed to investigate the depression and quality of life of Turkish society caused by Covid-19 pandemic and reveal the relationship between them. According to existing data and perspective of psychology and physiotherapy, potential solutions will be aligned.

Eligibility criteria: Inclusion Criteria:

* being Turkish
* understanding Turkish
* currently living in Turkey
* being between the age of 15 - 65
* being literate
* have internet access

Exclusion Criteria:

* being diagnosed with a psychological disorder before the pandemic
* having missing value on outcome measures
* giving incomprehensible answering

Primary outcomes:
measure: Sociodemographic information form
timeFrame: two months after Covid 19 recognised as pandemic
measure: Zung Depression Scale
timeFrame: two months after Covid 19 recognised as pandemic
measure: World Health Organization Quality of Life - Bref
timeFrame: two months after Covid 19 recognised as pandemic
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Okan University
Study officials:
References:
Clinical trial NCT05380778: Depth of Anesthesia and Proteomics
Official title: BIS Controlled Anesthesia Depth is Associated With Different Protein and Peptide Expression in the Cerebrospinal Fluid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia Complication
Immune Suppression
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of the study is to compare cellular activity of T-cells, NK-cells and monocytes after anesthesia. Phagocytosis and cellular lysis activity of neutrophils and monocytes are analyzed by flow cytometry. Secondly, we analyze anesthesia induced protein expresssion pattern in the blood. The proteome of monocytes is identified by 3D-gel-chromatography and mass spectrometry (MALDI-TOF).

Detailed description: Patients undergoing shoulder surgery in the orthopedic center are screened and consented to the randomized controlled, blinded study. Patients, surgeons, and the study personell involved in data interpretation and management are blinded towards the randomly assigned computerized group allocation (SAS, Cary, NC). The study director informs the anesthesiology staff about the group allocation. Patients are randomized to deep vs. light general anesthesia guided using a bispectral index monitor (BIS Vista, Aspect) with BIS \< 45 in group 1 (deep anesthesia) or BIS ≥ 55 in group 2 (light anesthesia). Anesthesia depth is recorded via USB port every minute.

Eligibility criteria: Inclusion Criteria:

enrolment for longer shoulder surgery consent for the standard anesthesia form in combination with the interscalene plexus block ASA Status 1-3

Exclusion Criteria:

sedative premedication severe immune deficiency (diabetes, steroid or antihistamine medication, cancer, chemotherapy, status post transplantation, drug and alcohol abuse), recent surgery (1 month) or blood transfusion

Primary outcomes:
measure: Proteome: depression of immune stimulative proteins
timeFrame: 70-90 min
Secondary outcomes:
measure: Proteome: overexpression of immune depressive proteins
timeFrame: 70-90 min
Other outcomes:
Locations:
Study officials:
affiliation: University of Heidelberg, Faculty Mannheim
name: Thomas Frietsch
role: STUDY_CHAIR
References:
Clinical trial NCT06752278: Efficacy of Pilocarpine As a Secretagogue Versus Artificial Tears for the Treatment of Dry Eye
Official title: Efficacy of Pilocarpine As a Secretagogue Versus Artificial Tears for the Treatment of Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Disease (DED)
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-12-30
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Management approaches for dry eye disease (DED) typically start with low-risk, easily accessible, patient-applied therapies like artificial tears for early-stage disease. As the condition worsens, treatment progresses to more advanced therapies for severe forms of DED. This study aims to compare the effectiveness and safety of pilocarpine as a secretagogue versus artificial tears in the treatment of dry eye disease. Our goal is to provide reliable, high-quality evidence regarding the efficacy of secretagogues, thereby contributing to the development of recommendations that aid clinicians in their decision-making process


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with DED

Exclusion Criteria:

* Previous Occular surgery.
* Refuse to particupate.
* Patients with sjogren syndrome

Primary outcomes:
measure: Ocular Surface Disease Index
timeFrame: At the baseline and after 6 weeks
measure: tear film break-up time
timeFrame: At the baseline and after 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Al-Azhar university
Study officials:
References:
Clinical trial NCT01010178: Can Airflow Limitation in Chronic Obstructive Pulmonary Disease (COPD) be Reversible by Drugs?
Official title: Combination of Approved Drug in COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Macrolid
reversibility
Theophylline
Corticosteroids
symptoms PFT
Lead sponsor: Baqiyatallah Medical Sciences University
Sponsor class: OTHER
First posted: 2009-11-09
Enrollment: 64
Sex: ALL
Minimum age (years): 22
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Critical combination of various approved drugs in management for patients suffering with COPD.


Eligibility criteria: Inclusion Criteria:

* current or past smoker COPD

Exclusion Criteria:

* history of significant occupational or other environmental exposures or a connective tissue disease

Primary outcomes:
measure: 15% increasing in forced expiratory volume in 1 second
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Research Center of Chemical Injuries, Baqiyatallah Medical Sciences University, Mollasadra St,
Study officials:
References:
Clinical trial NCT00962078: Pulmonary Rehabilitation in Patients Before Lung Transplantation (LTx)
Official title: Effects of a Complex Pulmonary Rehabilitation Program on Patients With End Stage Lung Diseases Undergoing Evaluation for Lung Transplantation (Pre-LTx)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Pre-Lung-Transplantation
Hypercapnia
Respiratory Insufficiency
Keywords: COPD
Pre-Lung-Transplantation
Intervall versus continuous training
6 MWD
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
First posted: 2009-08-19
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the effects of a complex pulmonary rehabilitation program on mobility measured by 6 minute walking distance (6MWD) and physical activity, measured via Dynaport and Actibelt Aktivitätsmonitor, dyspnoea (VAS), quality of life (HRQL (SF36, EuroQul)), anxiety and depression (HADS)and PaCO2-behavior under physical activity.


Eligibility criteria: Inclusion Criteria:

* pre-LTx (listed for lung-transplantation or currently undergoing evaluation)
* COPD Stadium IV GOLD
* α-1-Antitrypsin-deficiency-Emphysema
* respiratory Insufficiency
* oxygen therapy (LTOT)

Exclusion Criteria:

* serious Exacerbation (Symptoms longer than three days, change of therapy, e.i. antibiotics, steroids) during the last four weeks before rehabilitation
* clinical signs of manifest heart insufficiency
* acute coronar syndrome
* left heart insufficiency(EF \< 40%)
* missing Compliance

Primary outcomes:
measure: Effects of a Multimodal Pulmonary Rehabilitation Program on 6 Minute Walking Distance (6MWD)
timeFrame: value at day 21 minus value at day 1
Secondary outcomes:
measure: Dyspnoea During Exercise Measured on the Borg Scale
timeFrame: mean values from day 1 to day 21
Other outcomes:
Locations:
city: Schönau am Königssee
country: Germany
facility: Klinikum Berchtesgadener Land
Study officials:
affiliation: Klinikum Berchtesgadener Land, Schön-Kliniken
name: Klaus Kenn, Dr.med.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01632878: Omacor Plus Standard Therapies In Post Myocardial Infarction (MI) Subjects Evaluation: The OPTIMISE Observational Study
Official title: Omacor Plus Standard Therapies In Post MI Subjects Evaluation: The OPTIMISE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction (MI)
Keywords: Secondary prevention post MI
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: inVentiv Health Germany GmbH
name: EBC - Evidence Based Communication
First posted: 2012-07-03
Enrollment: 1531
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The OPTIMISE study is a prospective, multi-center, multi-national, structured data collection initiative, first compiling data on the current treatment of post myocardial infarction patients (screening-log) and then, prospectively evaluating only those patients being prescribed Omacor as part of their standard secondary prevention treatment. The aim is to observe the Omacor cohort of patients for a period of 12 months, collecting long term observational data as clinical and patient-reported outcomes, especially, but not exclusively, recurrent non fatal Myocardial Infarction (MI), sudden death, or new Congestive Heart Failure (CHF). No predefined additional visits, medical tests, labs, procedures or interventions will be mandated. Only results from routinely performed tests, labs, procedures and/or interventions will be collected if available.


Eligibility criteria: Inclusion Criteria

* Male and female patients, from the screening-log, having been prescribed prior to their inclusion in the study Omega-3-fatty-acid ethyl esters (Omacor) as adjuvant treatment in secondary prevention after their myocardial infarction, in addition to standard therapy \[e.g. statins, antiplatelet medicinal products, beta blockers, Angiotensine Converting Enzyme (ACE) inhibitors/Angiotensine II Receptor Blockers (ARBs), etc\].

Exclusion Criteria

* Omega-3-fatty-acid ethyl esters (Omacor) approved contra-indication as per the labeling information in participating countries

Primary outcomes:
measure: Number of Occurrences of Cardio-vascular Events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: Site Reference ID/Investigator# 81558
Study officials:
affiliation: Mylan
name: Katinka Giezeman
role: STUDY_DIRECTOR
References: