louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03148301: Spina Bifida in Daily Life: an Exploratory Study
Official title: Spina Bifida in Daily Life: an Exploratory Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spina Bifida
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 250
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Spina Bifidat patients that are seen on the consultation or day care unit of UZ Leuven

Brief summary: Spina Bifida can lead to physical neurocognitive and psychological symptoms. Still little is know about the daily impact of spina bifida on participation possibilities in social life. This exploratory research project want to investigate which lif choices patients with spina bifida has to make and in which way their daily life is organized. In a second part, quality of life will be measured and we hope to discover some dynamics in order to improve patient care.

Detailed description: This exploratory research project wants to investigate how patients with spina bifida live their daily life and which impact spina bifida has on their choices of life. This will be done by a survey that will ask questions about different domains in life: demographic variables, education, work, social functioning, spare time, housing, mobility, independency and quality of life. The survey is based on empirical findings in literature. The quality of life questioning is based on the SF36. The survey will be done once during a clinical consultation.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Spina Bifida

Exclusion Criteria:

* Not able to read or write Dutch

Primary outcomes:
measure: Descriptive statistics about life choices
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
Clinical trial NCT01818401: Medico-economic Interest of the Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During the Poses of Complete Prosthesis of Knee GMK ®. Multicentric, Prospective, Controlled, Opened, Randomised Study About a Medical Device. (My Knee)
Official title: Medico-economic Interest of the Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During the Poses of Complete Prosthesis of Knee GMK ®. Multicentric, Prospective, Controlled, Opened, Randomised Study About a Medical Device.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis
Keywords: Ancillary tailored
medico-economic study,
total knee replacement
primary or secondary osteoarthritis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2013-03-26
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Over 70.000 total knee arthroplasty (TKA) are performed in France every year, with a 10% yearly increase since the early 1990s. The clinical experience shows a strong rate of success on pain relief and on function. Longevity of the implants has been shown to be determined by the biomechanical design of the prosthesis, and by the implantation technique, especially the correct positioning of the bone cuts during the surgery. To improve the precision of these cuts, the patient matched cutting blocks developed by Medacta allow to adapt the bone cuts to the patient's anatomy, improving the reliability of this procedure. A reduction of the surgery time lengh and bleeding would be other benefits expected with this type of ancillary. The objective of this trial is to study the reliability of patient matched cutting blocks for total knee arthroplasty, by both clinical and radiological assessment, the effect on morbidity reduction during and after the procedure and also the benefit it could bring on an economic point of view.


Eligibility criteria: Inclusion Criteria:

all patients requiring a total knee arthroplasty line: primary or secondary osteoarthritis advanced beyond medical treatment.

Exclusion Criteria:

distorded axes or laxity requiring the establishment of constrained prosthesis

Primary outcomes:
measure: compare the functionality of the knee after installation of a total knee replacement between the 2 groups
timeFrame: 2 years after
Secondary outcomes:
measure: to assess knee function by autoquestionnaire KOOS, the KSS knee score, operative time, procedure bleeding, reliability of the ancillary
timeFrame: 2 years after
measure: medico-economic evaluation type "Cost minimization"
timeFrame: 2 years after
Other outcomes:
Locations:
city: Nantes
country: France
facility: University Hospital of Nantes
Study officials:
References:
Clinical trial NCT05627401: Customized Multiple Orbital Wall Decompression for Sight-threatening Graves's Ophthalmopathy
Official title: Customized Modified Multiple Orbital Wall Decompression With Fat Removal for Sight-threatening Graves's Ophthalmopathy : a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Eye Disease
Keywords: Orbital decompression
Graves' orbitopathy
Dysthyroid optic neuropathy
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2022-11-25
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This was a retrospective cohort study of patients with sight-threatening Graves orbitopathy (GO) who underwent customized/individual multiple orbital wall decompression plus fat removal at Sun Yat-Sen Memorial Hospital from Jan. 2017 to Dec. 2021.

Brief summary: Graves' orbitopathy (GO) is an disfiguring and disabling autoimmune condition. Sight-threatening GO is an most severe form and occurs in about 5% of patients with Graves' disease. It can cause blurred vision, color vision and vision function damage, and affects the quality of life. The goal of this retrospective cohort study is to propose a customized orbital decompression algorithm for patients with sight-threatening Graves'ophthalmopathy and to explore the therapeutic effect of customized orbital decompression in sight-threatening patients.


Eligibility criteria: Inclusion Criteria:

* Sight-threatening patients undergoing interdisciplinary discussion and orbital decompression operation.
* The sight-threatening GO refer to those with DON, exposure keratitis or corneal breakdown.
* DON was diagnosed according to the following clinical findings including optic nerve head edema, visual field defect, impaired color vision, afferent pupil defect, retinal folds, radiologic evidence of apical optic nerve compression or globe subluxation.
* Diagnosis of exposure keratitis or corneal breakdown was made based on physical exam signs, e.g. microepithelial defects, abrasion or ulcer. A minimum follow-up of 12 months was required for inclusion.

Exclusion Criteria:

* Patients were excluded if exophthalmos, rather than acute visual loss, was the indication for surgery.
* Cases with a history of previous ocular surgery, glaucoma, and visual defects from other ocular conditions were excluded from the study.

Primary outcomes:
measure: BCVA
timeFrame: 12 months
measure: CAS
timeFrame: 12 months
measure: proptosis
timeFrame: 12 months
measure: EVP
timeFrame: 12 months
Secondary outcomes:
measure: GO-QOL
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Peng Tian, PhD., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05838001: Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer After Neoadjuvant Therapy
Official title: Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer After Neo-adjuvant Therapy : a Prospective Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Breast-conserving Surgery
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The standard method for localizing non-palpable breast cancer is currently clip localization, its positive margin rate still remains around 20-50%. This study aims to compare the accuracy and efficacy of single vs. combined breast tissue markers in localizing non-palpable breast cancer.


Eligibility criteria: Inclusion Criteria:

1. female patients, age≥18 year
2. A score of ≥ 2 on the Eastern Cooperative Oncology Group scale
3. Patients pathologically diagnosed with breast cancer by core-needle biopsy, received neoadjuvant treatment and the lesion becomes non-palpable before enrollment.
4. Patients are willing to undergo breast conserving surgery and have no contraindications to breast conserving surgery

Exclusion Criteria:

1. Inflammatory breast cancer or Paget's disease
2. Breast deformities and other conditions that impact breast conservation success rate
3. Patients with contraindications to breast-conserving surgery, as well as those with systemic diseases, mental disorders, or other subjective reasons that may affect their ability to participate in the trial. Patients with severe bleeding disorders or coagulation disorders were also excluded.
4. Pregnancy or lactation
5. Patients with hook-wire, radioactive 125I seed or other localization techniques in the breast cancer lesions before enrollment
6. Patients with stage IV diseases or unresectable lesions in either breast
7. Patients combined with other diseases that may affect survival
8. Patients with multicentric breast cancer lesions or lesions \> 5 cm in diameter on imaging examinations
9. Patients who have previously undergone radical mastectomy for ipsilateral breast cancer or chest wall radiotherapy
10. Patients with history of ipsilateral breast cancer radical mastectomy or chest wall radiotherapy

Primary outcomes:
measure: Marginal positive rate
timeFrame: up to 3 months
Secondary outcomes:
measure: Re-operation rate.
timeFrame: up to 3 months
measure: The proportion of breast-conserving surgery.
timeFrame: up to 3 months
measure: IDFS
timeFrame: 2 years, 3 years, and 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Sun Yat-sen Memorial Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT06200701: Intervention Program of a Job Crafting
Official title: Intervention Program of a Job Crafting: Job Crafting Behavior, Work Meaningfulness, Change Attitude, Task and Adaptive Performance Among Nurses
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Educational Problems
Work-Related Condition
Nurse's Role
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The implementation of effective intervention programs is crucial in enhancing the overall well-being and performance of healthcare professionals, particularly in demanding environments such as nursing

Detailed description: The implementation of effective intervention programs is crucial in enhancing the overall well-being and performance of healthcare professionals, particularly in demanding environments such as nursing. This study focuses on the design and impact of an intervention program centered around job crafting among nurses. Job crafting involves employees proactively shaping their roles to align with personal strengths and preferences. In the context of nursing, this intervention aims to investigate the influence of job crafting behavior on various dimensions, including work meaningfulness, change attitude, task performance, and adaptive performance. Understanding the interplay between job crafting and these critical aspects is essential for developing targeted strategies to improve job satisfaction, performance, and adaptability among nurses, ultimately contributing to the enhancement of overall healthcare quality. This introduction sets the stage for exploring the multifaceted effects of a job crafting intervention within the nursing profession.

Eligibility criteria: Inclusion Criteria:

* willingness to participate
* less than 60 years old

Exclusion Criteria:

* enter training in any educational program at least 6 months

Primary outcomes:
measure: nurses' job crafting
timeFrame: three months
measure: nurses' Work And Meaning
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Masjid Al Khiḑr
country: Egypt
facility: Faculty of Nursing
state: Semoha
Study officials:
affiliation: Faculty of nursing, Alexandria university, Egypt
name: mohamed H atta
role: STUDY_DIRECTOR
References:
Clinical trial NCT04720001: Florbetaben PET Imaging in PPA
Official title: Florbetaben PET Imaging in Primary Progressive Aphasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Progressive Aphasia
Alzheimer Disease
Keywords: Alzheimer's Disease
Dementia
Primary Progressive Aphasia
Neurocognitive Disorders
Speech Disorders
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Northwestern University
First posted: 2021-01-22
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from other research projects at Northwestern's Mesulam Center. Some of these projects recruit participants from the local Chicagoland area and others recruit participants from across the United States. As Primary Progressive Aphasia is an uncommon syndrome, participant recruitment is not focused on a specific demographic area.

Brief summary: The purpose of this research is to better understand how dementia affects activity in different parts of the brain.

Detailed description: This study will examine Positron Emission Tomography (PET) imaging with Florbetaben F18. Florbetaben F18 is a radioactive tracer that binds to particles in your brain. This process displays activity in the brain. Florbetaben F18 is a PET amyloid imaging agent approved by the United States Food and Drug Administration (FDA) to estimate the amount of beta-amyloid plaque in adult patients who are being evaluated for Alzheimer's disease and other causes of cognitive decline. The purpose of this research is to better understand how dementia affects activity in different parts of the brain. Currently, the scientific community is limited by how well it can see inside the brain. The use of a PET scan better helps us understand what the brain looks like in a diseased state. Participation in the study will help to understand what brain activity looks like, especially around language regions.

Eligibility criteria: Inclusion Criteria:

* Participants must have a diagnosis of PPA or a related dementia syndrome

Exclusion Criteria:

* Pregnant
* Breastfeeding
* Receiving radiation clinically

Primary outcomes:
measure: Amyloid plaque levels in PPA participants
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago - American School Building
state: Illinois
Study officials:
affiliation: University of Chicago
name: Emily Rogalski, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00125801: The Pain Pen for Breakthrough Cancer Pain
Official title: Breakthrough Cancer Pain: A Randomized Trial Comparing Oral Morphine Immediate Release and Self-Administration of Subcutaneous Hydromorphone Using an Injection Pen
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Neoplasms
Pain
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2005-08-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see whether injection of hydromorphone through a subcutaneous injection device is more effective in treating breakthrough cancer pain than oral morphine.

Detailed description: Breakthrough pain is an exacerbation of severe pain that occurs on a background of otherwise controlled pain. Breakthrough pain is common in patients with advanced cancer. Current medications to treat breakthrough pain include oral immediate release opioid formulations and more recently oral transmucosal fentanyl citrate.

The pain pen study is a randomized controlled double blind cross-over study comparing the efficacy of oral immediate release morphine with that of subcutaneous hydromorphone, injected through a so called pain pen, on breakthrough pain in cancer patients. Preliminary experience with the pain pen suggests that it has a more rapid time of onset of pain relief than oral formulations.

Eligibility criteria: Inclusion Criteria:

* Stable cancer pain requiring the equivalent of 60-1000 mg oral morphine/day
* 1-4 breakthrough pain episodes/day
* Patients must be able, in the opinion of the investigator, to fully comply with trial requirements
* Patients who have given written informed consent

Exclusion Criteria:

* Uncontrolled pain
* Women who are pregnant, lactating or intend to become pregnant
* Cardiopulmonary disease that would increase the risk of opioids
* Neurologic or psychiatric disease that would compromise data collection
* Recently started chemotherapy or radiotherapy in as far as it would be effective in lowering breakthrough pain

Primary outcomes:
measure: Pain intensity difference (PID) at t=15 minutes
timeFrame: t=15 minutes
Secondary outcomes:
measure: PID 5'
timeFrame: 5 min
measure: PID 30'
timeFrame: 30 min
measure: PID 45'
timeFrame: 45 min
measure: PID 60'
timeFrame: 60 minutes
measure: time to onset of meaningful pain relief
timeFrame: time to onset
measure: global efficacy rating at 60'
timeFrame: 60 min
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Dept. Neurology, Erasmus MC
Study officials:
affiliation: Dept. Neurology, Erasmus MC
name: Joost L. Jongen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Enting RH, Mucchiano C, Oldenmenger WH, Fritzon M, Wallen A, Goslinga-van der Gaag S, Sillevis Smitt PA, Delhaas E. The "pain pen" for breakthrough cancer pain: a promising treatment. J Pain Symptom Manage. 2005 Feb;29(2):213-7. doi: 10.1016/j.jpainsymman.2004.05.010.
Clinical trial NCT03595501: Analytical and Clinical Performance Testing Plan
Official title: Analytical and Clinical Performance Testing Plan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematology
Hematologic Test
Lead sponsor: Sight Diagnostics
Sponsor class: INDUSTRY
First posted: 2018-07-23
Enrollment: 679
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult and pediatric patients with normal (healthy) or abnormal blood counts (known clinical condition)

Brief summary: Clinical and analytical tests will be performed based on risk assessment and system specifications to verify that the performance of the investigational device is in accordance with its specifications.

Detailed description: Comparison and precision studies will be conducted in up to 5 clinical sites in Israel and the US, and include:

* Precision
* Sample Matrix Comparison
* Method comparison study and flagging analysis
* Reference interval range

Eligibility criteria: Inclusion Criteria:

For Residual Samples:

* Specimen obtained by venipuncture or finger prick and collected into tubes normally used by the site
* Patient is at least 3 months of age
* Samples within 8 hours from phlebotomy

For Prospectively collected samples:

* Subject is at least 22 years of age
* Non-diseased individuals or, for specific studies, individuals with blood count ranges to cover indicated medical decision points and ranges
* Samples within 8 hours from phlebotomy

Exclusion Criteria:

Exclusion criteria post blood draw and pre sample scan - For whole blood samples:

* Visibly hemolyzed or clotted specimens
* Specimens with insufficient blood volume to complete the procedure
* Samples older than eight hours

Exclusion criteria post sample scan:

* Instrument failure or sample rejected by the instrument due to system error or sample mishandling
* The daily quality control sample measurements indicate that the assay run is outside the specifications for the instrument
* Operator related error documented in the study records
* Failure to adhere to study specifics or protocols

Primary outcomes:
measure: Reproducibility of CBC parameters provided by the OLO device
timeFrame: 3 months
measure: Repeatability of CBC parameters provided by the OLO device
timeFrame: 3 months
measure: Sample Matrix Comparison
timeFrame: 3 months
measure: Method Comparison
timeFrame: 3 months
measure: Reference Interval Range
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Colombia University
name: Dr. Eldad Hod, Dr
role: PRINCIPAL_INVESTIGATOR
References: