louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04068779: Long-term Clinical Outcomes in Patients With FFR Guided-Deferred Coronary Lesions, Assessed by IVUS Analysis
Official title: Long-term Clinical Outcomes in Patients With FFR GuidEd-DeFERred CoRonAry Lesions, Assessed by IVUS Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 459
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: From January 2007 to August 2014, patients who meet the criteria for selection and exclusion from Keimyung University Dongsan Hospital, Seoul National University Hospital, Inje University Busan Paik Hospital, and Ulsan University Hospital are included.

Brief summary: This study was a multicenter retrospective study that included intravascular ultrasound (IVUS) in patients with delayed stent insertion based on fractional flow reserve (FFR) in moderately narrowed coronary lesions. We would like to see the effect of lesion characteristics on clinical course.

Detailed description: From January 2007 to August 2014, patients who meet the criteria for selection and exclusion from Keimyung University Dongsan Hospital, Seoul National University Hospital, Inje University Busan Paik Hospital, and Ulsan University Hospital are included.

1. Target patient screening The database will select patients who meet the selection and exclusion criteria.
2. target patient characteristics The age, sex, smoking status, medical history (hypertension, diabetes mellitus, hyperlipidemia), diagnosis, and left ventricular blood count measured by echocardiography should be checked through a computerized medical record.
3. coronary angiography Coronary angiography images of the subjects in the blinded state are analyzed to investigate the length of lesions, reference vessel diameter, and minimal vessel diameter.
4. intravascular ultrasound In the blinded state, the vessel's vessel area, plaque area, lumen area, etc. are measured by analyzing intravascular ultrasound images of the patient using EchoPlaque (Indec Systems, Mountain View, CA).

Eligibility criteria: Inclusion Criteria:

* Subject over 19 years old
* Patients with mild or moderate stenosis lesions on coronary angiography
* Patients with lesions with FFR values greater than 0.80
* Patients with analytical intravascular ultrasound images

Exclusion Criteria:

* Left main lesion
* History of coronary artery bypass grafting
* Patients with lower left ventricular ejection fraction (\<25%)

Primary outcomes:
measure: patient-oriented composite outcome
timeFrame: during 5-year
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: KeimyungUniversity
Study officials:
References:
Clinical trial NCT02138279: Comparative Study of Non-contact Tonometers for Intraocular Pressure and Corneal Cell Thickness Measurements
Official title: Comparative Study of the Topcon Tonometers - CT-800, CT-1, CT-1P and TRK-2P to Demonstrate Conformance to ANSI Z80.10-2009 Ophthalmic Instruments -Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification [510(k)] Submissions, and to the Applicable Supplemental Information Sheet and Comparison of Pachymetry Values for CT-1P and TRK-2P With the Konan CellChek Plus (Predicate)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraocular Pressure
Corneal Pachymetry
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2014-05-14
Enrollment: 65
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: Ophthalmology practice

Brief summary: The primary objective of this clinical study is to collect clinical data to support FDA 510(k) submissions for the Topcon CT-800, CT-1, CT-1P and TRK-2P non-contact tonometers. The secondary objective is to evaluate any adverse events found during the clinical study.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age of either sex and any race or ethnicity;
* Willing and able to provide written informed consent prior to any study procedures being performed;
* Willing and able to follow all instructions and attend all study visits;
* Best Spectacle Corrected Visual Acuity (BSCVA) of 0.3 logMAR (20/40 Snellen equivalent) or better in both eyes as measured using an ETDRS chart.

Exclusion Criteria:

* Only one functional eye;
* Poor or eccentric fixation;
* Corneal scarring or have had corneal surgery, including corneal laser surgery;
* Microphthalmos;
* Buphthalmos;
* Contact lens wearer, meaning having worn soft contact lenses within the past 3 months and/or rigid permeable gas lenses within the past 6 months;
* Dry eyes, meaning having been diagnoses by a physician with dry eyes and currently using a prescribed medication;
* Lid squeezer - blepharospasm;
* Nystagmus;
* Keratoconus;
* Any other corneal or conjunctival pathology or infection;
* Condition or a situation, which in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.

Primary outcomes:
measure: Agreement of intraocular pressure measurements from predicate vs. investigational device
timeFrame: Single timepoint - 1 day
measure: Agreement of central corneal thickness measurements from predicate vs. investigational device
timeFrame: Single time point - 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
References:
Clinical trial NCT01265979: WB-DWI for Early Prediction of Therapy Response in Patients With Advanced Metastatic GIST Treated With Regorafenib
Official title: Whole Body Diffusion-weighted MRI (WB-DWI) for Early Prediction and Evaluation of Therapy Response in Patients With Advanced Metastatic Gastrointestinal Stromal Tumors (GIST) Treated With Regorafenib.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Stromal Tumors
Keywords: advanced
metastatic
gastro-intestinal
stromal
GIST
regorafenib
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2010-12-23
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with advanced, metastatic gastro-intestinal stromal tumors treated with regorafenib or placebo

Brief summary: The purpose of this study is to evaluate WB DWI as early predictor of response to treatment with regorafenib or placebo in patients with advanced metastatic GIST.

Detailed description: Aim of the study

- To assess whole body diffusion-weighted magnetic resonance imaging (WB-DWI) for the assessment and early prediction of response of treatment with regorafenib or placebo in patients with advanced, metastatic gastro-intestinal stromal tumors (GIST)

1. Evaluation of pretreatment apparent diffusion coefficient (ADC) and b1000 signal intensity (SI) of GIST visualized on the WB-DWI as predictor of time to progression, determined by progression-free survival (PFS)
2. Evaluation of WB-DWI using changes of high b-value SI and ADC early during treatment (2weeks after start of therapy; allowed optimal window 10-14 days) as early predictor of time to progression or patient benefit according to RECIST (stable disease + partial response + complete response)
3. Evaluation of WB-DWI for treatment follow-up 3 months after initiation of treatment. Confirmation of prior published pilot study (Dunet V et al, J Nucl Med 2010)
4. Comparison of WB-DWI with conventional CT imaging for response assessment

Eligibility criteria: Inclusion Criteria:

* patients with advanced, metastatic gastro-intestinal stromal tumors treated with regorafenib or placebo

Exclusion Criteria:

* in case of a known contraindication for MRI (eg. pacemaker), the patient will not be admitted to the study

Primary outcomes:
measure: WB-DWI as early predictor for regorafenib treatment response
timeFrame: jan 2011-dec 2011
Secondary outcomes:
measure: Evaluation WB-DWI parameters in correlation with progression free survival (PFS)
timeFrame: jan 2011-dec 2011
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Radiology Department
Study officials:
affiliation: University Hospital Gasthuisberg, department of Radiology
name: Vincent Vandecaveye, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00914979: AngioSculpt Scoring Balloon Catheter For Bifurcation Coronary Lesions (ABC Study)
Official title: AngioSculpt Scoring Balloon Catheter For Bifurcation Coronary Lesions (ABC Study) Prospective, Multi-center, Non-randomized, Single-arm Registry
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Bifurcation Coronary Disease
Keywords: Angiosculpt
Bifurcation Lesion
Side branch
IVUS
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2009-06-05
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Assess the impact of lesion preparation using the AngioSculpt balloon in the treatment of bifurcation lesions in native coronary arteries.

Detailed description: The purpose of the AngioSculpt® Scoring Balloon Catheter For Bifurcation Coronary lesions (ABC registry) is to demonstrate the acute procedural success, device performance and long term outcome associated with use of the AngioSculpt Scoring Balloon Catheter (AngioScore, Inc., Fremont, CA) for lesion preparation in the treatment of bifurcation lesions in native coronary arteries

Eligibility criteria: Inclusion Criteria:

* Patients with significant (≥ 50% diameter stenosis) native coronary artery disease involving a bifurcation (Medina class (x,x,1)).

Exclusion Criteria:

* Concomitant use of Rotablator, Cutting Balloon, or investigational coronary devices.
* Additional planned coronary interventions for a non-target lesion within 30 days of the study procedure.

Primary outcomes:
measure: Procedural success ≤ 50% diameter stenosis of the main and the side branch at the conclusion of the procedure in the absence of in-hospital MACE
timeFrame: 9 Months
Secondary outcomes:
measure: Rate of side branch stenting
timeFrame: 9 Months
measure: Angiographic dissection rate and grade
timeFrame: 9 months
measure: MACE rate at 30 days post-procedure
timeFrame: 9 months
measure: Cumulative stent thrombosis and TLR rates at 9 months
timeFrame: 9 months
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Khalid Suleiman
city: Rehovot
country: Israel
facility: Oded Izenberg
city: Zefat
country: Israel
facility: Alexander Goldberg
city: Zrifin
country: Israel
facility: Ricardo Krakover
Study officials:
affiliation: Heart Institute; Ha'Emek Medical Center
name: Khalid Suleiman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03213379: Assessment of Actigraphy Procedures on the Initiation of an Apomorphine Treatment Delivered Through a Pump to Patients With Parkinson's Disease
Official title: Assessment of Actigraphy Procedures on the Initiation of an Apomorphine Treatment Delivered Through a Pump to Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: actimeter
apomorphin pump
Lead sponsor: Orkyn'
Sponsor class: INDUSTRY
First posted: 2017-07-11
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of the study is to compare the impact of different actigraphy procedures on the healthcare organization of Parkinson's disease (PK) patients using an apomorphine pump. To do so, the study design includes a patients' randomisation in two groups that will be followed during 6 months.

Detailed description: The two groups are:

Referent group with one actimetric report at baseline Actimetry group with one actimetric report at baseline and during the follow-up. Using these reports the investigator will be able to modify the prescription of the apomorphin pump without seeing the patient.

It is planned to follow the patients during 6 months of follow-up and 3 medical visits will be conducted as per the standard practice:

1 visit before the installation of the pump

1 visit after the pump installation straight after the patient comes out the hospital

1 visit at 6 months

Eligibility criteria: Inclusion Criteria:

Adult suffering from Parkinson's disease aged up to 75 years (included) Patient for whom a first set-up of an apomorphine pump has been decided under medical guidelines Patient who chose the OPTIPARK package (ORKYN nurses) Patient willing to wear the actigraphy bracelet as per the protocol Patient who read, understood and signed the consent form.

Exclusion Criteria:

Patient not willing to take part in the study Patient who had a previous set-up of an apomorphine pump Patient with dementia Dependant patients or patients living in institutional care Patient with a temporary pump of apomorphine compromising a six months follow-up Patient with non-major motor fluctuations Patient already enrolled in an interventional study.

Primary outcomes:
measure: Assessment of the impact of different actigraphy procedures on the healthcare organization of Parkinson's disease (PK) patients using an apomorphine pump
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00998179: Effect of Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) on Post-exercise Expiratory Flow Volume in Healthy Subjects
Official title: Effect of Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) on Post-exercise Expiratory Flow Volume in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: TENS
acupuncture
FEV1
Normal Healthy subjects
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2009-10-20
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to investigate the effect of Acu-TENS on forced expiratory volume in one second (FEV1), a test of pulmonary function used to assess airway resistance, during sub-maximal treadmill exercise in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* With normal health

Exclusion Criteria:

* Suffered from respiratory, cardiovascular, musculoskeletal, neurological or endocrine disorders
* No allergic to gel

Primary outcomes:
measure: Forced expiratory flow volume in one second (FEV1)and forced vital capacity (FVC)
timeFrame: before and immediate after the exercise test
measure: Forced expiratory flow volume in one second (FEV1) and forced vital capacity (FVC)
timeFrame: at 15min, 30 min and 45min after the exercise test
Secondary outcomes:
measure: Exercise duration
timeFrame: Immediately after the exercise test
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Cardiopulmonary and exercise physiology laboratory, The Hong Kong Polytechnic University
Study officials:
affiliation: Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
name: Alice Jones, PhD, FACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06467279: Comparing Inhalation and Total Intravenous Anesthesia Methods
Official title: Comparison of Patient Outcomes Between Anesthesia Administered Via Target-Controlled Infusion Method and Inhalation Anesthesia Method in Pediatric Patients Undergoing Inguinal Hernia Repair.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Children
Hernia, Inguinal
Keywords: BIS
TIVA
İNFUSİON
İNGUİNAL HERNİA
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged 3-12 with ASA I-II undergoing inguinal hernia repair.

Brief summary: comparison of Anesthesia by Target-Controlled Infusion and Inhalation Methods on Pediatric Patients Undergoing Inguinal Hernia Repair: Effects on Patient Outcomes

Detailed description: COMPARİSON OF THE EFFECT OF ANESTHESİA APPLİED BY TARGET CONTROLLED INFUSİON METHOD AND INHALATİON ANESTHESİA METHOD ON PATİENT OUTCOMES İN PEDİATRİC PATİENTS UNDERGOİNG INGUİNAL HERNİA REPAİR

Eligibility criteria: Inclusion Criteria:

* Children aged 3-12 years
* Patients weighing over 10 kilograms
* Patients who will undergo inguinal hernia surgery
* ASA (American Society of Anesthesiologists) classification I and II pediatric patients.

Exclusion Criteria:

* Absence of systemic illness.
* ASA (American Society of Anesthesiologists) classification III pediatric patients.

Primary outcomes:
measure: Modified Aldrete Scoring System
timeFrame: after surgery 1 hours
Secondary outcomes:
measure: blood pressure (mmHg)
timeFrame: after surgery 1 hours
measure: heart rate (Beats/minute)
timeFrame: after surgery 1 hours
Other outcomes:
Locations:
city: Kayseri̇
country: Turkey
facility: Özlem OZ GERGİN
Study officials:
affiliation: TC Erciyes University
name: Özlem OZ GERGİN, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02714179: Preemptive and Preventive Use of Paracetamol for Pain Relief After Cesarean Section
Official title: A Double Blind Randomised Controlled Trial of Preemptive and Preventive Use of Paracetamol for Pain Relief After Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cesarean Section; Dehiscence
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators designed a prospective randomized study to investigate the efficacy of intravenous (IV) preemptive versus preventive paracetamol on postoperative pain scores, patient satisfaction, total morphine consumption and the incidence of morphine-related side effects in patients undergoing cesarean section.


Eligibility criteria: Inclusion Criteria:

38 weeks pregnancy, elective cesarean section.

-

Exclusion Criteria:

morbid obesity, cardiac failure, depression.

Primary outcomes:
measure: Visual analog score (VAS) for pain
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01570179: Sugammadex-dosing in Bariatric Patients
Official title: Sugammadex in Patients Undergoing Bariatric Surgery: An Equivalence Trial Comparing Real and Ideal Body Weight-based Dosing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neuromuscular Blockade
Keywords: bariatric surgery
residual paralysis
surgical conditions
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2012-04-04
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Should the dose of sugammadex in morbid obese patients be calculated on the real body weight or the ideal body weight?

The main objective of the trial is to compare in patients undergoing bariatric surgery the efficacy of sugammadex to obtain a TOF-ratio of 100% within 3 min when dosing is based on real body weight (control intervention) with dosing based on ideal body weight (experimental intervention). The research hypothesis is that both dosing regimens are equivalent

The secondary objective of the trial is to compare the impact of the depth of neuromuscular blockade on the surgical conditions: deep block (TOF-count 1 - 3) will be compared with very deep block (TOF count = 0 and PTC \< 5)


Eligibility criteria: Inclusion Criteria:

adult patients undergoing bariatric surgery according to the respective criteria of the French Medical Authority (HAS) and having given their written informed consent after appropriate information

Exclusion Criteria:

not fulfilling the inclusion criteria, known or suspected allergy to any of the drugs used in that study, absence of written informed consent,doubt of pregnancy in women of childbearing age, pregnancy and breast feeding

Primary outcomes:
measure: 100% TOF-recovery 3 min after sugammadex
timeFrame: 3 min
Secondary outcomes:
measure: impact of depth of block on surgical conditions
timeFrame: every 15 min during surgery
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: CHU Strasbourg Hôpital Civil
state: Alsace
city: Vandoeuvre-Les-Nancy
country: France
facility: CHU Nancy
state: Lorraine
Study officials:
References:
Clinical trial NCT06987279: Lactobacillus Plantarum and Hormonal Regulation in Obese Women
Official title: Lactobacillus Plantarum Lp90 and Hormonal Regulation in Obese Women：A Randomized, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Women
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the regulatory effect of Lactobacillus plantans Lp90 formula on visceral fat metabolism and sex hormone balance in obese women.


Eligibility criteria: Inclusion Criteria:

1. Age: 18 to 40 years old, female, BMI ≥ 25 kg/m2.
2. Be willing to receive follow-up during the intervention period.
3. Be willing to provide two blood, urine and fecal samples during the intervention period.
4. Be willing to take the compound probiotics by oneself every day during the intervention period.
5. Have good hearing and be able to hear and understand all instructions during the intervention period.

   -

Exclusion Criteria:

1. Suffering from digestive system diseases, mainly gastrointestinal diseases (celiac disease, ulcerative colitis, Crohn's disease).
2. Suffering from severe neurological disorders (epilepsy, stroke, severe head trauma, meningitis within the past 10 years, brain surgery, brain tumor, long-term coma - excluding general anesthesia).
3. Have received/are currently receiving treatment for the following mental illnesses: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder.
4. Take medication for depression or low mood.
5. Suffering from internal organ failure (such as heart, liver or kidney failure, etc.).
6. Have received radiotherapy or chemotherapy in the past.
7. Have received general anesthesia surgery/procedures within the past three years, or plan to receive general anesthesia procedures/surgeries within the next three months during this trial.
8. Have suffered from hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past.

   -

Primary outcomes:
measure: The changes of estradiol before and after the intervention
timeFrame: 0, 1, 2, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Fuwai Central-China Cardiovascular Hospital
state: Henan
Study officials:
References: