louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03576196: Preoperative Pain Neuroscience Education in Patients With Carpal Tunnel Syndrome
Official title: Preoperative Pain Neuroscience Education Combined With Therapeutic Exercise Post-surgery in Patients With Carpal Tunnel Syndrome. A Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: physical therapy
Pain
disability
kinesiophobia.
Lead sponsor: Hospital Clínico La Florida
Sponsor class: OTHER
First posted: 2018-07-03
Enrollment: 2
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: Study Design: A double-blind randomized controlled study.

Background: Patients operated on for carpal tunnel release surgery may persist with pain after surgery, which could be modulated by psychosocial factors such as depression, catastrophic thinking and kinesiophobia.

Objectives: To evaluate the efficacy of a preoperative session in pain neuroscience education combined with postoperative therapeutic exercise in the perception of pain, functionality and psychosocial variables in patients following carpal tunnel release.

Methods: Thirty participants were randomly assigned to the pain neuroscience education group combined with postoperative therapeutic exercise (n = 15) or to the control group with preoperative usual care combined with postoperative therapeutic exercise (n = 15). Evaluations included the Visual Analogue Scale (VAS), Disability of Arm, Shoulder, and Hand Questionnaire (QuickDASH), pain Catastrophizing Scale (PCS), Tampa scale of kinesiophobia (TSK-11) and Hospital Anxiety and Depression Scale (HADS) . A basal, fourth and twelfth week measurement was made.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age
* Medical diagnosis of Carpal Tunnel Syndrome waiting for surgery
* Agree to participate in the study.

Exclusion Criteria:

* Inability to understand instructions,
* Illiteracy,
* Previous participation in educational programs regarding pain,
* Pathology of uncontrolled mental health,
* Cognitive problems,
* Previous surgeries in the operated extremity.

Primary outcomes:
measure: Change of Disability in upper-limb
timeFrame: Change from Baseline Disability at fourth and twelfth week
Secondary outcomes:
measure: Change of Pain Interference: Kinesiophobia
timeFrame: Change from Baseline Kinesiophobia at fourth and twelfth week
measure: Change of Emotional status: Hospital Anxiety and Depression Scale (HAD).
timeFrame: Change from Baseline emotional status at fourth and twelfth week
measure: Change of Pain evaluation:
timeFrame: Change from Baseline Pain at fourth and twelfth week
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clinico La Florida
state: RM
Study officials:
References:
Clinical trial NCT06637696: The Effect of Implementation of Bundle for Preventing Blood Culture Contamination in Neonatal Intensive Care Unit
Official title: The Effect of Implementation of Bundle for Preventing Blood Culture Contamination in Neonatal Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborn; Infection
Keywords: blood culture bundle
blood culture contamination
cost-effectiveness
neonatal intensive care unit
neonates
Lead sponsor: Dr. Behcet Uz Children's Hospital
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 320
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The study included a total of 320 (160 neonates in pre-bundle period, 160 neonates in post-bundle period) neonates.
Primary purpose: DIAGNOSTIC

Brief summary: In this study, investigators aimed to evaluate the impact of blood culture bundles on the incidence of contamination in the neonatal intensive care unit (NICU).

Detailed description: Infections are never as frequent and life-threatening as in the neonatal period. The lack of sepsis-specific findings in the neonatal period, the narrow repertoire of clinical findings in newborns, and the fact that non-infectious clinical conditions frequently encountered in this period have similar findings pose a serious problem for early diagnosis and treatment of neonatal sepsis. Another important problem is that early empirical antibiotic treatment without diagnostic confirmation has to be resorted to very frequently in order to avoid morbidity and more importantly mortality with early intervention. This leads to unnecessary and prolonged treatment of newborns with potentially dangerous broad-spectrum antibiotics as well as prolonged hospitalizations and significant costs.

The rate of contaminated blood culture in the neonatal period is 2.6-18%. In this study, investigators aimed to evaluate the impact of blood culture bundles on the incidence of contamination in the neonatal intensive care unit (NICU).

Eligibility criteria: Inclusion Criteria:

Newborns diagnosed with sepsis

Exclusion Criteria:

Newborns receiving antibiotic treatment

Primary outcomes:
measure: Blood Culture Contamination Rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dr. Behcet Uz Children's Hospital
Study officials:
affiliation: Dr. Behcet Uz Children's Hospital
name: Oğuz Han Kalkanlı
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04226196: Rotational Stability of a Hydrophobic Acrylic Plate Haptic Intraocular Lens Using a Capsular Tension Ring - An Intraindividual Comparative Study
Official title: Rotational Stability of a Hydrophobic Acrylic Plate Haptic Intraocular Lens Using a Capsular Tension Ring - An Intraindividual Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intraocular Lens Rotation
Capsular Tension Ring
Keywords: Intraocular lens rotation
capsular tension ring
postoperative tilt & decentration
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 65
Sex: ALL
Minimum age (years): 45
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study should investigate the influence of a capsular tension ring on postoperative rotational stability of a plate haptic hydrophilic acrylic intraocular lens. All patients will be operated on both eyes in one occasion. Both eyes receive a Zeiss 409MP plate haptic intraocular lens, while only on eye receives an additional capsular tension ring. Follow up visits take place 1 hour, 1 week, 1 month and 4 to 7 months after surgery. At the follow up visits, the actual IOL axis will be determined by retroillumination photography. IOL centration and tilt will be determined by anterior segment SS-OCT Casia II. IOLs will be implanted in 4 different axis 0 +/- 10 degrees, 45 +/- 10 degrees, 90 +/- 10 degrees, 135 +/- 10 degrees. IOL rotation, decentration and tilt then will be compared intraindividually.


Eligibility criteria: Inclusion Criteria:

* Bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation
* Need for spherical IOL correction between +0.00 and +32.00 D
* Pupil dilation of ≥ 7.0 mm
* Age 45 to 95

Exclusion Criteria:

* Corneal abnormality (Corneal scaring)
* Preceding ocular surgery or trauma
* Uncontrolled glaucoma
* Proliferative diabetic retinopathy
* Iris neovascularization
* History of uveitis/iritis
* Microphthalmus
* Recurrent intraocular inflammation of unknown etiology Uncontrolled systemic or ocular disease
* Pregnancy
* Lactation

Primary outcomes:
measure: Change of axial intraocular lens position
timeFrame: 7 months
Secondary outcomes:
measure: Decentration
timeFrame: 7 months
measure: Tilt
timeFrame: 7 months
measure: Anterior chamber depth
timeFrame: 7 months
measure: Best corrected visual acuity (BCVA)
timeFrame: 7 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna Allgemeines Krankenhaus
Study officials:
References:
Clinical trial NCT04890496: Analysis of Hospitalization Data From ZOC
Official title: Analysis of Hospitalization Data in Zhongshan Ophthalmology Center
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ophthalmology
Hospitalization
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 560000
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 have retrospective inpatient records of ZOC from 1998 to 2020.

Brief summary: The real-world electronic health records (EHR) were derived from the hospitalization of Zhongshan Ophthalmic Center (ZOC) of Sun Yat-sen University from 1998-2020 to investigate the ophthalmology diagnosis and treatment activities.


Eligibility criteria: Inclusion Criteria:

* have retrospective inpatient records of ZOC from 1998 to 2020

Exclusion Criteria:

* Demographic data missing
* Diagnosis data missing

Primary outcomes:
measure: The prevalence of primary diagnosis
timeFrame: baseline
Secondary outcomes:
measure: The prevalence of secondary diagnosis
timeFrame: baseline
measure: Demographics
timeFrame: baseline
measure: costs of inpatient visits
timeFrame: baseline
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
name: Haotian Lin, Ph.D, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05645796: Improved Chest CT Diagnostic and Contrast Medium Administration
Official title: Improved Chest CT Diagnostic and Contrast Medium Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2022-12-12
Enrollment: 360
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups receiving contrast medium based on different approaches are included and compared with each other
Primary purpose: DIAGNOSTIC

Brief summary: Investigation of impact of using different CM approaches on contrast enhancement in chest Ct examinations - A prospective study

Detailed description: Continuing advances in computed tomography (CT) in the past decades such as short scanning times with multi-detector CT (MDCT) requires contrast medium (CM) administration to be precisely planned to ensure a diagnostically accurate CT scans. To improve the chest CT diagnostic, the contrast enhancement in the thoracic vessels shoulde be increased.

The most important patient-related factors affecting the magnitude of vascular and parenchymal contrast enhancement are body weight. Historical practice has been to use a fixed volume of CM independent of body weight. Research has shown a clear relationship between vessel enhancement and patient weight, and that fixed CM volume technique is inappropriate, as smaller patients may receive excessive volume, and larger patients insufficient volume resulting in reduced image quality and poor diagnostic. In addition, excess CM can result in contrast induced adverse effects and nephropathy. To overcome these problems, it is essential to adjust the CM volume to the patient's total body weight and body composition. This adjustment can be done in different ways. The aim of this study is to identify which weight/body tailored CM administration is the best replacement for fixed CM administration in chest CT. The cost and procedure time will also be explored.

Eligibility criteria: Inclusion Criteria:

* patients undergoing chest CT examination between August 2019 and September 2021
* age \> 18 years

Exclusion Criteria:

* hemodynamic instability
* cardiac failure
* pacemaker
* renal insufficiency (estimated glomerular filtration rate \<30 mL/min/1.73 m2)
* contraindications to contrast enhanced CT
* age \< 18 years

Primary outcomes:
measure: Contrast medium protocols in routine chest CT - A survey study
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: OsloMet University
Study officials:
affiliation: Oslo Metropolitan University
name: Safora F Johansen, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00781196: Folic Acid Supplementation in Phenytoin Induced Gingival Overgrowth
Official title: Effect of Low Dose Oral Folic Acid Supplementation on Phenytoin Induced Gingival Overgrowth: A Randomized Double Blind Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gingival Overgrowth
Keywords: phenytoin
gum hyperplasia
phenytoin induced gingival overgrowth
plaque index
gingival overgrowth grade
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2008-10-28
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Phenytoin, a common anti-seizure drug, leads to cosmetically unacceptable side effect of gingival overgrowth in a significant number of patients. There is some evidence of therapeutic effect of folic acid in cases of established phenytoin induced gingival overgrowth. In this study, the aim is to study the prospective preventive effect of low dose oral folic acid supplementation on phenytoin induced gingival overgrowth in epileptic children.


Eligibility criteria: Inclusion Criteria:

* Age: 6-15 yr
* Started on phenytoin within 1 mo of enrollment

Exclusion Criteria:

* Not willing to participate
* On other folic acid antagonists e.g. anti-neoplastic drugs for \>/= 2 wks during last 3 months
* Pre-existing gingival over-growth due to other cause

Primary outcomes:
measure: Occurrence of any grade of overgrowth in 2 groups after 6 mo of phenytoin therapy
timeFrame: 6 months
Secondary outcomes:
measure: Occurrence of grade > 2 hyperplasia at the end of 6 mo
timeFrame: 6 months
measure: Time to occurrence of grade > 2 overgrowth
timeFrame: open
measure: Correlation between following and occurrence of grade > 2 overgrowth *phenytoin dose (in mg/kg/d) *serum phenytoin levels *plaque index
timeFrame: 6 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
Study officials:
References:
citation: Arya R, Gulati S, Kabra M, Sahu JK, Kalra V. Folic acid supplementation prevents phenytoin-induced gingival overgrowth in children. Neurology. 2011 Apr 12;76(15):1338-43. doi: 10.1212/WNL.0b013e3182152844.
Clinical trial NCT02371096: Comparative Pharmacokinetic Trial of RGB-03 and MabThera
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Gedeon Richter Plc.
Sponsor class: INDUSTRY
First posted: 2015-02-25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT

Brief summary: Pharmacokinetic properties, efficacy, safety and tolerability of RGB-03 and MabThera will be compared in patients suffering from Rheumatoid Arthritis.


Eligibility criteria: Inclusion Criteria:

* Active Rheumatoid Arthritis
* Inadequate response or intolerance to other DMARDs and anti-TNFs
* Treatment with Methotrexate

Exclusion Criteria:

* Previous treatment with rituximab
* Patients with systemic manifestations of rheumatoid arthritis
* Patients seropositive for HIV, HCV, HBV
* Female patients nursing

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Area under the serum concentration versus time curve (AUC)
timeFrame: 0-24 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05301296: Trivandrum Breast Cancer Screening Trial
Official title: Evaluating of Clinical Early Detection of Breast Cancer in Trivandrum District, India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: International Agency for Research on Cancer
Sponsor class: OTHER
Collaborators: name: Regional Cancer Centre, Trivandrum, India
First posted: 2022-03-29
Enrollment: 115290
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The control group received standard of care while the intervention group received 3 rounds of screening with clinical breast examination, each 3 years apart. After the 3 rounds of screening, the participants were followed up for an additional 4 years to accrue information on breast cancer incidence and mortality, and the vital status.
Primary purpose: SCREENING

Brief summary: Cluster-randomized controlled trial in Trivandrum district, Kerala, India to evaluate the effect of triennial screening for breast cancer using clinical breast examination on breast cancer mortality.

Detailed description: The study population consisted of 274 administrative regions (clusters) in Trivandrum district, Kerala, southern Indian. 133 clusters were randomly assigned to the intervention arm (3 rounds of clinical breast examination conducted 3 years apart) and were compared to the remaining 141 clusters assigned to a control arm that received standard of care. The eligibility criteria were all healthy subjects aged 30 to 69, without a personal history of breast cancer. Informed consent was signed by each participant. The intervention arm consisted of 55,843 participants and the control group consisted of 59,447 participants.

Eligibility criteria: Inclusion Criteria:

* Residing in 274 study clusters in Trivandrum City, Kerala

Exclusion Criteria:

* Diagnosis with breast cancer prior to study
* Bedridden subjects
* Subjects suffering from open tuberculosis or other debilitating diseases

Primary outcomes:
measure: Breast Cancer Death Rate
timeFrame: 14 years
measure: Breast Cancer Incidence
timeFrame: 14 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Regional Cancer Centre, Trivandrum, India
name: Kunnambath Ramadas, MD. DNB. FAMS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Agency for Research on Cancer
name: Rengaswamy Sankaranarayanan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sankaranarayanan R, Ramadas K, Thara S, Muwonge R, Prabhakar J, Augustine P, Venugopal M, Anju G, Mathew BS. Clinical breast examination: preliminary results from a cluster randomized controlled trial in India. J Natl Cancer Inst. 2011 Oct 5;103(19):1476-80. doi: 10.1093/jnci/djr304. Epub 2011 Aug 23.
Clinical trial NCT06286696: Optic Nerve Sheath Diameter in Hypertensive Emergency
Official title: Point-of-care Ultrasound of Optic Nerve Sheath Diameter in Suspected Hypertensive Emergency
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hypertensive Emergency
Papilledema
Hypertension
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the emergency department with suspected hypertensive emergency.

Brief summary: This prospective observational study investigates the potential of point-of-care ultrasonography of the optic nerve sheath diameter (ONSD) to rule out papilledema in patients with suspected hypertensive emergency. The primary focus is on assessing ONSD sensitivity in identifying papilledema (hypertensive retinopathy grade 4), while secondary endpoints include hypertensive retinopathy grade 3, hypertensive encephalopathy, and the need for intravenous rapid-acting medications to lower elevated blood pressure. This study aims to determine the diagnostic characteristics of this procedure for the diagnosis of hypertensive retinopathy, thus assessing its potential as a screening tool to rule out hypertensive retinopathy by the acute internal medicine doctor.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* Any patient presenting to the emergency department (ED) with suspected hypertensive emergency i.e.: blood pressure of \> 200 millimetres of mercury (mmHg) systolic and/or \> 120 mmHg diastolic

Exclusion Criteria:

* Patients with preexisting optic nerve head changes such as glaucoma, pre-existing retinal artery/vein occlusions or any other condition that makes assessment of the fundi impossible.
* Primary neurological cause of hypertension: ischemic cerebrovascular incident

Primary outcomes:
measure: Papilledema
timeFrame: 2 years
Secondary outcomes:
measure: Hypertensive retinopathy grade 3 & 4 combined
timeFrame: 2 years
measure: Hypertensive encephalopathy
timeFrame: 2 years
measure: Rapid acting medications administered intravenously to lower the elevated blood pressure
timeFrame: 2 years
measure: Presence of a bulging optic nerve disc and/or crescent sign found by ultrasonography of the optic nerve
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Leiden University Medical Center
name: Tessa Mulder, MD
role: PRINCIPAL_INVESTIGATOR
References: