louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06892470: Visual Quality of Cataract Patients with High Myopia After Implantation of Different Intraocular Lenses
Official title: Assessment of Postoperative Visual Outcomes in Highly Myopic Patients Implanted with Different Intraocular Lenses
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cataract
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 62
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who undergo micro-incision cataract surgery and implantation of targeted intraocular lenses at the Hangzhou Branch of Wenzhou Medical University Eye Hospital.

Brief summary: This prospective study aims to compare the visual outcomes following the implantation of two different types of multifocal intraocular lenses (IOLs) in highly myopic patients. The study will evaluate visual quality, refractive outcomes, and patient satisfaction using various visual assessment techniques and subjective satisfaction surveys.


Eligibility criteria: Inclusion Criteria:

* 1: Patients are older than 18 years

  2: The axial length (AL) measured by IOLMaster 700 is ≥26 mm

  3: No anterior or posterior segment pathology that could potentially compromise visual potential (such as glaucoma, myopic traction maculopathy, corneal leukoma, etc.).

  4: Able to understand, cooperate, and complete all follow - ups

Exclusion Criteria:

* 1: History of amblyopia

  2: Retinal detachment in the same eye or the fellow eye

  3: Presence of multiple peripheral retinal degenerative changes

  4: History of previous ocular surgery

Primary outcomes:
measure: Defocus Curve
timeFrame: Three months after operation
measure: Visual Questionnaire
timeFrame: Three months after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: Ophthalmology and Optometry Hos
state: zhejian
Study officials:
References:
Clinical trial NCT02764970: Heart Rate Reducing Therapy in Cardiac CT Using Ivabradine and Bisoprolol
Official title: Heart Rate Reducing Therapy With Ivabradine and Bisoprolol Before Coronary Computer Tomographic Angiography in Ambulant Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradycardia
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting at the radiology center for a planned coronary computer tomographic angiography

Brief summary: Out-patients scheduled for coronary computer tomographic angiography (CCTA) were screened regarding their baseline heart rate. If heart rate was \> 75, patients were pretreated with 10mg bisoprolol (group 1) or 10mg bisoprolol plus 7.5mg ivabradine (group 2) to reduce heart rate one our before CCTA was performed.

Heart rate, additional use of i.v. bradycardic agents, motion artefacts, radiation dose and drug tolerance was monitored.

Detailed description: Aim of the study is to evaluate if ivabradine, an inhibitor of the funny channel (If), in addition to bisoprolol is effective in lowering heart rate before coronary computer tomographic angiography (CCTA) if administered orally one hour before the scan.

Out-patients of a single radiology center are included in this retrospective analysis. All patients are referred to an ambulant CCTA. All scans are performed with a Siemens Somatom Sensation Cardiac 64 Computer Tomograph and analyzed with Siemens Syngo Plaza software. Patients with an initial heart rate of ≥ 75 bpm are either pretreated with bisoprolol 10mg p.o. alone (group 1) or a combination of bisoprolol 10mg and ivabradine 7.5mg p.o. (group 2) one hour before the CT scan.

The change in treatment from bisoprolol only to the combination of bisoprolol and ivabradine was introduced as a change in standard treatment independent of the study. The study was only plannend and performed as a retrospective analysis after the last patient included into the analysis was already treated.

Additional betablocker is administered intravenously right before the scan if heart rate remains elevated.

The hypothesis is that the addition of ivabradine to bisoprolol results in a pronounced heart rate reduction. This heart rate reduction will lead to a reduced need of i.v. bradicardic drug use, a reduction in motion artifacts and a reduced radiation dose to to a higher rate of flash sequences.

Eligibility criteria: Inclusion Criteria:

* all comer study

Exclusion Criteria:

* none

Primary outcomes:
measure: Heart Rate
timeFrame: intraoperative
Secondary outcomes:
measure: Number of Participants With Use of i.v. Betablocker
timeFrame: time from first ECG in the CT-room to start of CT scan (average of 10 minutes)
measure: Radiation Dose
timeFrame: intraoperative
measure: Motion Artifacts
timeFrame: intraoperative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01312675: S.A.F.E.BT System Extracorporeal Treatment With DIAPACT CRRT
Official title: Randomized, Multi-Centre, Controlled Clinical Study on Effect of the Selective Adsorption System for Removal of Bacterial Toxins (S.A.F.E.BT) Therapy on Disease Severity and Inflammation in Mechanically-Ventilated Subjects Due to Severe Sepsis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Severe Sepsis
Keywords: severe sepsis
mechanical ventilation
Lead sponsor: B. Braun Medical Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-11
Enrollment: 16
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: The purpose of this study is to determine if Selective Adsorption System for Removal of Bacterial Toxins (S.A.F.E.BT) therapy is effective in the treatment of severe sepsis.

Detailed description: Is extracorporeal treatment effective in the treatment of sepsis

Eligibility criteria: Inclusion Criteria

* Clinical diagnosis of Sepsis
* Mechanical ventilation due to acute pulmonary dysfunction
* One additional (second) acute sepsis-related organ dysfunction

Exclusion Criteria

* Pregnant women and nursing mothers
* Conditions or medications associated with an increased risk of bleeding/complications from anticoagulation
* Previous episode of sepsis during this hospitalization
* PaO2/FiO2 ratio \< 300
* Severe granulocytopenia (leukocytes \<500 / μl)
* Acute hepatic diseases or severe liver failure or cirrhosis
* Chronic cardiovascular disease precluding extracorporeal treatment
* Human immunodeficiency virus complicated by AIDS defining illness
* Evidence of active bleeding - uncontrolled hemorrhage

Primary outcomes:
measure: Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment)
timeFrame: Baseline through Day 8
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
affiliation: BBraun Inc
name: Robert Wilkins, MBChB FRCA
role: STUDY_DIRECTOR
References:
Clinical trial NCT05883475: Effects of Hemiplegic Shoulder Pain
Official title: Investigation of Upper Extremity Function, Sleep Quality, and Functional Independence in Patients With Hemiplegic Shoulder Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Shoulder Pain
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Stroke patients

Brief summary: The purposes of this study is to investigate the differences in upper extremity function, sleep quality, and functional independence between patients with and without hemiplegic shoulder pain (HSP).

HSP is defined as musculoskeletal pain in the affected shoulders of individuals after stroke.Numerous studies have found an association between post-stroke shoulder pain and range of motion, sensory impairment, subluxation, spasticity, and complex regional pain syndrome. HSP is a problem that, starting from mild discomfort, leads to gradual functional impairment, ultimately resulting in increasing disability and decreased independence.In the literature, the relationship between HSP and upper extremity function, functional independence, and sleep quality has not been clarified.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Have had a stroke at least three months ago
* Volunteers who can understand or communicate test instructions

Exclusion Criteria:

* Having a history of shoulder surgery
* Having serious shoulder problems before stroke
* Having other neurological conditions

Primary outcomes:
measure: DASH
timeFrame: one hour
measure: AMAT
timeFrame: one hour
measure: Nine Hole Peg Test
timeFrame: one hour
Secondary outcomes:
measure: Sleep Qaulity
timeFrame: one hour
measure: Functional Independence
timeFrame: one hour
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation
state: Esenboğa
Study officials:
References:
Clinical trial NCT02972775: 15-year Mortality After Hospitalization for Exacerbation of Chronic Obstructive Pulmonary Disease
Official title: 15-year Mortality After Hospitalization for Exacerbation of Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Exacerbation Copd
Mortality
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
First posted: 2016-11-23
Enrollment: 845
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: Patients admitted with an exacerbation of Chronic obstructive pulmonary disease in the Zuyderland medical Centre from 1996 - 1999

Brief summary: The investigators examine the 15-year mortality after an admission for an exacerbation of Chronic Obstructive Pulmonary disease (COPD).

Detailed description: Several prognostic factors will be examined. Cause of death will be examined. Data will be recruited from medical records and calling general practitioners to find out if a patient is still alive. Statistical analysis will be done with Kaplan Meier, Cox proportional hazards and Chi square

Eligibility criteria: Inclusion Criteria:

* admission with exacerbation of COPD

Exclusion Criteria:

* none

Primary outcomes:
measure: Percentage of patients that died after 15 years
timeFrame: 15 years
Secondary outcomes:
measure: Prognostic factors for mortality
timeFrame: 15 years
measure: Cause of death
timeFrame: 15 years
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Zuyderland Medical Center
state: Limburg
Study officials:
affiliation: Zuyderland Medical Center
name: Martijn de Kruif, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9.
citation: Traver GA, Cline MG, Burrows B. Predictors of mortality in chronic obstructive pulmonary disease. A 15-year follow-up study. Am Rev Respir Dis. 1979 Jun;119(6):895-902. doi: 10.1164/arrd.1979.119.6.895.
Clinical trial NCT04485975: Therapeutic Plasma Exchange in Thyrotoxicosis
Official title: Preoperative Therapeutic Plasma Exchange and Surgical Treatment in Thyrotoxicosis Patients: a Single-centre Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyrotoxicosis
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 27
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: Therapeutic plasma exchange was performed in 27 thyrotoxic patients at the Adult Therapeutic Apheresis Center between January 1999 and February 2019. The patients were previously on treatment and follow-up in the Department of Endocrinology and Metabolism Diseases at our hospital.

Brief summary: Therapeutic plasma exchange (TPE) is indicated in cases where antithyroid medications cannot be used due to the side effects or attain no adequate hormonal suppression response at the highest dosage and in cases of rapid onset of clinical symptoms. This study presents the treatment results of patients who underwent TPE and subsequently operated for thyrotoxicosis.

Detailed description: Background: Therapeutic plasma exchange (TPE) is indicated in cases where antithyroid medications cannot be used due to the side effects or attain no adequate hormonal suppression response at the highest dosage and in cases of rapid onset of clinical symptoms. This study presents the treatment results of patients who underwent TPE and subsequently operated for thyrotoxicosis.

Methods: The files of 27 patients who underwent preoperative TPE for thyrotoxicosis between January 1999 and February 2019 were retrospectively analyzed. The demographic and clinical features of the patients were included.

Eligibility criteria: Inclusion Criteria:

* thyrotoxicosis unresponsive to medication
* adverse reaction to the medications
* need for rapid treatment in patients that need urgent surgery

Exclusion Criteria:

* The patients who did not undergo surgery post-therapeutic plasma exchange
* Preoperative hypocalcemia,
* hemodynamically unstable patients
* patients not suitable for central catheter placement

Primary outcomes:
measure: Thyroid hormone levels of patients after therapeutic plasma exchange
timeFrame: 1 week before the operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02346175: Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of SHR3824 in Type 2 Diabetes Mellitus Patients
Official title: Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of SHR3824 in Type 2 Diabetes Mellitus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: SHR3824 Type 2 diabetes mellitus SGLT2
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-01-26
Enrollment: 30
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 evaluate the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability following single and multiple oral doses of 5mg to 20 mg SHR3824 in Type 2 diabetes mellitus patients.


Eligibility criteria: Inclusion Criteria:

* BMI:20-35kg/m2;
* Medically stable based on physical examination, medical history, laboratory results, vital sign measurements, and 12-lead electrocardiogram (ECG) at screening;
* On a stable regimen of antihyperglycemic therapy for at least 8 weeks prior to screening and had fasting plasma glucose (FPG) concentration lower than 13.9 mmol/L at baseline;
* Stable antihyperglycemic regimens could include a single oral agent (eg, metformin, a sulfonylurea, a thiazolidinediones ketone, a benzoic acid derivatives, a dipeptidyl peptidase-4 inhibitor, or an α-glucosidase inhibitor) with glycated hemoglobin (HbA1c) between 7.0% and 10.0%.

Exclusion Criteria:

* History of clinically significant diabetic complications, type 1 diabetes mellitus, or repeated severe hypoglycemic episodes.
* Pregnancy or breastfeeding;
* Significant acute or chronic medical illness, including renal impairment, or recent surgery;
* Donation of blood or plasma within the 4 weeks prior to the start of the study;

Primary outcomes:
measure: Plasma pharmacokinetic parameters of SHR3824
timeFrame: up to Day 13
measure: Urine glucose concentration of SHR3824
timeFrame: up to Day 11
measure: Plasma glucose concentration of SHR3824
timeFrame: up to Day 11
Secondary outcomes:
measure: The number and type of adverse events reported
timeFrame: Up to Day 13
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03036475: Sienna and Sentimag in Sentinel Lymph Node Biopsy
Official title: Sentinel Lymph Node Biopsy Using a Magnetic Tracer Versus Standard Radio-isotope Technique in Early Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Kwong Wah Hospital
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate a new method for the localization of breast cancer sentinel lymph node using Sienna+® and Sentimag® detection in comparison to our standard techniques with radio-isotopes.

Detailed description: The use of radioisotope with or without blue dye has long become the gold standard for sentinel lymph node localization in the management of breast cancer. The latest evidence from a number of European trials has proven that a new tracer agent, superparamagnetic iron oxide particles (SPIOs, Sienna+®), is non-inferior to the standard method of lymphatic mapping. Its application and feasibility has yet been tried in most Asian countries.

This is a prospective paired comparison trial involving both the new magnetic technique and the standard method. Patients with preoperative diagnosis of invasive carcinoma or ductal carcinoma in-situ of the breast undergoing SNOLL (Sentinel node and occult lesion localization) will be recruited from the Breast Centre of Kwong Wah Hospital. Informed consent will be obtained. All patients recruited will receive subcutaneous injection of 2 ml of Sienna+® diluted with saline to 5 ml at Breast Centre in the morning of operation, followed by five minutes of massage to the injection site. Before incision, on-table transcutaneous detection with the handheld magnetometer are carried out after at least 20 minutes from injection. Intraoperative counts of sentinel lymph nodes identified as well as the ex-vivo counts of excised nodes are also measured. All procedures are supplemented with localization by radioisotope. All lymph nodes excised will be sent for histopathological examination.

Eligibility criteria: Inclusion Criteria:

* Women diagnosed with early-stage breast cancer (including ductal carcinoma in-situ) who are clinically or radiologically node-negative and consenting for sentinel lymph node biopsy
* Patients undergoing SNOLL (Sentinel node and occult lesion localization) with the use of radio-isotope in our Breast Centre

Exclusion Criteria:

* Patients with clinically T3 or T4 breast cancer and any contraindication to sentinel lymph node biopsy
* Patients with pacemaker or other implantable device in the chest wall

Primary outcomes:
measure: Proportion of successful procedures for sentinel lymph node identification (identification rate per patient) by the magnetic method compared with the standard method
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kwong Wah Hospital
name: Yolanda Chan, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00166075: Mental Health Symptoms and Intimate Partner Violence
Official title: Mental Health Symptoms and Intimate Partner Violence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Domestic Violence
Post-Traumatic Stress Disorder
Depression
Keywords: Suicidality
PTSD
depression
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Centers for Disease Control and Prevention
First posted: 2005-09-14
Enrollment: 569
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible African American female patients were approached in the ED waiting room during study periods. Patients participated in the screening process via a computer kiosk. Questions regarding IPV and mental health symptoms were asked using validated tools.

Brief summary: Using a touch screen computer, the researchers are screening emergency department patients for intimate partner violence and mental health issues.

Detailed description: Using a touch screen computer, the researchers are screening emergency department patients for intimate partner violence and mental health issues. The researchers are looking to see if those who participate in a computer screen and are given referral lists as well as having the computer printout placed on the physician clipboard, will increase physician awareness and recognition as well as patient use of resources compared to usual care.

Eligibility criteria: Inclusion Criteria:

* Female patients between the ages of 18-55 who present to the waiting room of the emergency department during study time periods

Exclusion Criteria:

* Psychotic
* Acutely intoxicated
* Too ill to participate
* Unable to read
* Not English speaking

Primary outcomes:
measure: Increased levels of PTSD
measure: Increased levels of suicidality
measure: Increased levels of depression
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Debra Houry
role: PRINCIPAL_INVESTIGATOR
References:
citation: Houry D, Kemball R, Rhodes KV, Kaslow NJ. Intimate partner violence and mental health symptoms in African American female ED patients. Am J Emerg Med. 2006 Jul;24(4):444-50. doi: 10.1016/j.ajem.2005.12.026.