louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07025811: A Study to Explore Signs, Symptoms, and Biomarkers in Dry Eye Disease Participants Following Anti-inflammatory Treatment
Official title: A Longitudinal, Open-label, Multi-center Study to Explore the Relationship Between Signs, Symptoms, Molecular and Imaging Biomarkers in Participants With Dry Eye Disease Following Anti-inflammatory Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Dry Eye Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2025-06-18
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the performance of biomarkers and their responsiveness to standard-of-care treatments (Vevye® or Xiidra®), in participants with dry eye disease (DED) compared to healthy volunteers (control participants).

Detailed description: This study aims to characterize longitudinal changes in signs, symptoms, molecular, and imaging markers of the ocular surface to investigate pathological mechanisms and biomarkers (BMs) of DED after treatment with either of two commercially approved therapeutics (Vevye® \[cyclosporine ophthalmic solution\], Xiidra® \[liftegrast ophthalmic solution\]).

Eligibility criteria: Inclusion Criteria:

A. Inclusion Criteria for Participants with DED:

* The participant reported dry eye-related ocular symptoms for at least 6 months before the screening visit
* The participant must have either used lubricant eye drops regularly OR had the desire to use lubricant eye drops in the past 3 months
* Participant must be classified as having moderate/severe DED
* The participant is deemed by the physician to require a prescription medication for DED (e.g., cyclosporin A or lifitegrast)

B. Inclusion Criteria for Healthy Volunteers:

- The participant does not have overt clinical signs of DED in either eye

Exclusion Criteria:

* Intraocular pressure (IOP) \>21.00 millimeters of mercury (mmHg) in either eye
* Acute allergic conjunctivitis in either eye within 3 months prior to screening
* Use of contact lenses within 30 days prior to screening
* Current punctal plugs or punctal cauterization or occlusion
* Use of ocular anti-inflammatory agents or ocular immunosuppressive agents within 3 months prior to screening
* Any intraocular injections (e.g., intravitreal \[IVT\] anti-vascular endothelial growth factor \[VEGF\]) within 3 months prior to screening, or such injections planned for within the study period
* Any intraocular immunosuppressive implants within 12 months prior to screening
* Any history of isotretinoin use within 12 months prior to screening
* Uncontrolled ocular or systemic disease

Primary outcomes:
measure: Change From Baseline in Corneal Staining as Measured by Sodium Fluorescein
timeFrame: Up to Week 12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01662011: Application of Neurally Adjusted Ventilatory Assist to Children After Congenital Cardiac Surgery
Official title: Application of Neurally Adjusted Ventilatory Assist to Children After Congenital Cardiac Surgery: the Effect of Patient-ventilator Interaction, Gas Exchange and Hemodynamics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Mechanical Ventilation Complication
Congenital Heart Disease
Keywords: patient-ventilator interaction
neurally adjusted ventilatory assist
diaphragm electrical activity
pressure support ventilation
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2012-08-10
Enrollment: 72
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Neurally adjusted ventilatory assist (NAVA) is a new mode of mechanical ventilation that delivers ventilatory assist in proportion to neural effort. It was a controlled randomized single-center prospective study in order to explore the efficacy of this new mode of mechanical ventilation after corrective open-heart surgery for congenital heart disease.

Detailed description: 1. To evaluate the effect of the patient-ventilator interaction in children underwent open-heart surgery when ventilated with NAVA, compared with conventional mechanical ventilation.
2. To verify the benefits of NAVA in improving the gas exchange and hemodynamics after biventricle repair for CHD.

Eligibility criteria: Inclusion Criteria:

* patients underwent cardiac surgery with biventricle repaired
* patients need mechanical ventilation more than 24hrs after cardiac surgery

Exclusion Criteria:

* age \>18 years
* inappositely of catheter insertion
* hemodynamic instability
* coagulation disorders or bleeding
* inclusion in other research protocol

Primary outcomes:
measure: Asynchrony index and Comfort Scale
timeFrame: 2 weeks
Secondary outcomes:
measure: Dosage of sedatives
timeFrame: 2 weeks
measure: hemodynamics
timeFrame: 2 weeks
measure: Duration of mechanical ventilation
timeFrame: 2 weeks
measure: Gas exchange
timeFrame: 2 weeks
measure: Length of ICU stay
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University
Study officials:
affiliation: Cardiac intensive care unit, Department of Thoracic and cardiovascular Surgery, Shanghai children's Medical Center
name: Limin Zhu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04343911: Postoperative Peripheral Neuropathy After Laparoscopic Colorectal Surgery
Official title: Position-related Postoperative Peripheral Neuropathy After Laparoscopic Colorectal Surgery - a Comparative Single-center Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Neuropathy
Postoperative Complications
Keywords: positioning
neuropathy
trendelenburg
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This prospective cohort study of patients undergoing colorectal surgery positioned conventionally with shoulder braces was performed. After initial results the implementation of the Pink Pad ® took place in order to compare the two groups. This study favours Pink Pad over conventional positioning concerning postoperative neuropathy.

Detailed description: Laparoscopic colorectal surgery requires perioperative positioning in the dorsal lithotomy position and intermittent Trendelenburg position, which is associated with postoperative peripheral neuropathy, which is a substantial cause of anesthesia-related claims. This study aims to primarily assess the incidence of postoperative peripheral neuropathy of patients positioned conventionally by shoulder braces and secondly to compare this group with patients positioned on the foam mattress Pink Pad ® 24-hours after surgery and secondarily at a 30-day postoperative follow-up.

This consecutive single-center prospective cohort study of 155 patients undergoing colorectal surgery was performed between November 2014 and June 2015. After initial results the implementation of the Pink Pad ® took place and a total of 52 patients were included between May 2016 and February 2017 in order to compare the two groups.

Position related postoperative peripheral neuropathy is an important complication after laparoscopic colorectal surgery. This study concludes that careful attention should be payed to positioning and favors Pink Pad ® over conventional positioning with shoulder braces.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Elective laparoscopic colorectal surgery
* Sufficient written and verbal Danish skills
* Awake, responsive and oriented in the post-surgical inclusion period

Exclusion Criteria:

* Pre-existing peripheral neuro- or musculopathy,
* Conversion to open operation
* Lack of consent were defined as exclusion criteria.

Primary outcomes:
measure: position related postoperative peripheral neuropathy
timeFrame: 24-hours after surgery
Secondary outcomes:
measure: Position related postoperative peripheral neuropathy
timeFrame: 30 day follow-up after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Copenhagen University Hospital, Hvidovre
name: Signe AW Laursen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04267211: Prenatal Consult With Illustrated Literature
Official title: Prenatal Consult With Illustrated Literature
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Prenatal Stress
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 82
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The overall purpose of this study is to determine whether implementing a 'Prenatal Consult Bundle' to the existing prenatal consult, including provision of sample questions, added discussion points and handouts, and a return visit, will decrease parental anxiety and improve information recall. Additionally, this study will determine if this effect is further increased with the use of illustrated literature.

Detailed description: This study will be a prospective randomized control trial. Seventy participants will be enrolled for the 'Standard' consult. These women will receive a questionnaire 6-24 hours after their consult. Then 140 participants will be randomized to either the 'Standard Upgrade' or 'Illustrated Upgrade' arm. Randomization will additionally be stratified based on estimated gestational age. These participants will receive an upgraded consult implementing the 'Prenatal Consult Bundle' which emphasizes the parents' role and follow up, with or without an illustrated handout. These participants will receive the same questionnaire 6-24 hours after their consult. Demographic information collected will include maternal age, gravidity, use of magnesium, social support and health literacy. All data will be collected to assess whether either arm of the consult 'upgrade' reduces anxiety or improves knowledge retention after the prenatal consult. Analyses will be completed using Statistical Analysis Software (SAS) using appropriate statistical testing.

Eligibility criteria: Inclusion Criteria:

* Pregnant women admitted to OB unit at the University of Virginia Medical Center
* Estimated gestational age of \>25 weeks and \<35 weeks

Exclusion Criteria:

* Non-English Speaking
* Pregnant women \<15 years of age
* Known critical conditions or congenital anomalies
* Women who have had any prior prenatal consultations regarding current pregnancy

Primary outcomes:
measure: Maternal Anxiety
timeFrame: Within 48 hours of consultation
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: UVA Health
state: Virginia
Study officials:
affiliation: University of Virginia
name: Namrita Odackal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Odackal NJ, Conaway M, Cha J, Swanson JR. Prenatal consults with illustrated literature (PnCIL): a RCT studying visual aids during prenatal consults. J Perinatol. 2020 Aug;40(8):1154-1162. doi: 10.1038/s41372-020-0709-y. Epub 2020 Jun 8.
Clinical trial NCT04756011: Health-related Quality of Life and Psychosocial Aspects of Diabetes Technology (Insulin Pumps)
Official title: Aspects of Diabetes Technology (Insulin Pumps) Children Perspective, a Cross - Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: T1DM
Health Related Quality of Life
Insulin Pump
Keywords: Insulin pump
T1DM
HRQL
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from Ain shams pediatric and adolescent diabetes unit(PADU)

Brief summary: This study will be prospective comparative trial comparing between insulin pumps vs Multiple daily injections (MDI) in treatment of type 1 diabetes mellitus (T1DM) in terms of health- related quality of life (HRQL) and efficacy of glycemic control (HbA1c level )

Hypothesis:

Type 1 diabetes is characterized by autoimmune destruction of insulin-secreting pancreatic b cells leading to disturbed glucose regulation and overt hyperglycemia which leads to variable consequences and complication. Consequently, individuals with type 1 diabetes have a lifelong dependency on insulin replacement therapy.

Aim of the Work:

To compare the psychosocial impact of insulin pumps versus multiple daily injections in treatment of type 1 diabetes mellitus (Via questionnaire) in terms of health-related quality of life and efficacy of glycemic control (HbA1c level).


Eligibility criteria: Inclusion Criteria:

* 1.Type 1 diabetes mellitus.
* 2.Patients who are on insulin pumps must be for at least 3 months on them

Exclusion Criteria:

* 1. Other types of DM e.g., T2DM, MODY.
* 2. Patients with other comorbidities; cardiac, renal, neurological, hepatic ....etc.

Primary outcomes:
measure: Confidence in diabetes self care questionnaire (CIDS)
timeFrame: 10 min
measure: socioeconomic level of the family scale
timeFrame: 5 minutes
measure: MINI-KID (Mini International Neuropsychiatric Interview )
timeFrame: 25 minutes
measure: Evaluation of health-related quality of life (HRQL)
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams University
state: Abbasia
Study officials:
References:
citation: El Samahy MH, Salah NY, Abdeen MS, Falastin BRK. Psychosocial aspects of continuous subcutaneous insulin infusion in children with type 1 diabetes in Egypt; a limited resources country perspective. Diabetol Metab Syndr. 2022 Jun 11;14(1):82. doi: 10.1186/s13098-022-00853-6.
Clinical trial NCT06228911: Increased Blood Glucose Levels After Steroid Injection
Official title: Increased Blood Glucose Levels After Steroid Injection Into Osteoarthritic Knee in Diabetic Patients' Type 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Diabete Type 2
Lead sponsor: Syrian Private University
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

Brief summary: a sample of 600 patients diagnosed as Knee osteoarthritis injected with 40 mg triamcinolone, recorded their morning fasting blood glucose levels for 7 days before injection used as the baseline blood glucose level, which was compared with FBS levels for 14 days after steroid injection. Our study compared the differences in blood glucose changes between HbA1c \>7% and HbA1c ≤7% groups and those between insulin and non-insulin treated groups.


Eligibility criteria: Inclusion Criteria:

Age \> 18 years, patients with knee osteoarthritis diagnosed according to American College of Rheumatology (ACR) Criteria (17), and grade1-3 in Kallgren-Laurence radiographic scale (18), whom failed to response to medical treatment including paracetamol and nonsteroidal anti-inflammatory medication, and to physical therapy, checking their blood glucose values daily.

Exclusion Criteria:

Patients who were unable to provide consent, patients had any contraindications to corticosteroids, patients who had received oral corticosteroid in the past 6 months or corticosteroid injection in the previous 3 months, patients who had no monitoring HbA1c level before injection or also whom had not monitor blood glucose levels before or after injection.

Primary outcomes:
measure: high blood glucose
timeFrame: 3 years
measure: low blood glucose
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Faculty of Medicine, Damascus University, Syria
Study officials:
References:
Clinical trial NCT06950411: Validation of AI Lumbar Spine Anatomy Measureing Function
Official title: Functionality Assessment of RadiSpine, an Artificial Intelligence Software as Medical Device for Lumbar Spine Quantification System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Compression
Keywords: Artificial Intelligence(AI) Algorithm Spinal anatomy
Lead sponsor: RadiRad Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Taipei Veterans General Hospital, Taiwan
First posted: 2025-04-30
Enrollment: 150
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects should be aged 20 or older and younger than 75, with an equal gender distribution of 50% male and 50% female. From this group, 150 subjects with reasonable datavalues will be selected, with a requirement that at least 30% of them are male and at least 30% are female.

Brief summary: Spinal degeneration and its associated clinical diseases are common ailments in aging societies. With the advent of a super-aging society, the importance of assistive technologies for spinal image interpretation is increasingly significant to enhance care efficiency and reduce medical personnel expenditure. Recently, due to the rapid development of artificial intelligence (AI) algorithm, AI-based computer-assisted detection (CADe) devices gradiually become a convenient method for spinal anatomy measurement. However, the accuracy of these devices has not been fully established. This study aims to validate the performance of RadiSpine (an application program) in spinal anatomy segmentation and measurement.


Eligibility criteria: Inclusion Criteria:

The subjects should be aged 20 or older and younger than 75, with an equal gender distribution of 50% male and 50% female. From this group, 150 subjects with reasonable datavalues will be selected, with a requirement that at least 30% of them are male and at least 30% are female.

Exclusion Criteria:

1. With history of spinal surgery
2. Spinal trauma
3. Spinal osteoporosis
4. Spinal metastasis or infection

Primary outcomes:
measure: Segmentation accuracy (Mean)
timeFrame: 30 mins per individual
Secondary outcomes:
measure: Measurement accuracy
timeFrame: 30 mins per individual
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References:
Clinical trial NCT05168111: The Correlation Between the Metabolism and the Functional Status of Multiple Organs in the Early Stage of Diquat Poisoning
Official title: The Correlation Between the Metabolism and the Functional Status of Multiple Organs in the Early Stage of Diquat Poisoning---A Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diquat Poisoning
Keywords: Diquat Metabolomics Toxicology Multicenter
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-12-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute poisoning of diquat are mainly selected.

Brief summary: Diquat (DQ), as a conductive biocidal herbicide, is classified as medium according to Chinese pesticide toxicity classification standards. Since the sale and use of paraquat are stopped in 2016, incidents of diquat poisoning have begun to increase. Diquat is very toxic to the human body. Mistake of Diquat can cause damage to multiple organs throughout the body. It has a high fatality rate and no specific treatment.The treatment method has become a research hotspot of modern poisoning treatment.

The degree of organ dysfunction caused by DQ poisoning is mainly related to the patient's intake and the distribution of the poison in the human body.So far, the distribution concentration of DQ under the influence of the time gradient in the body and the influence of DQ on the human environment，metabolimics,，immune regulation activity and the comprehensive mechanism of action of various inflammatory factors have not been fully elucidated. Therefore, this research mainly focuses on analyzing the internal environment metabolism research in patients with DQ poisoning, and to conduct exploratory research on the severity of the impact on their organ functions


Eligibility criteria: Inclusion Criteria:

1.Time from poisoning to hospital admission: within 6 hours, 2 The age is greater than 18 years old, less than 65 years old 3 There is at least one target organ dysfunction 4 Previous physical fitness 5 No bad habits (drug use, alcohol addiction)

Exclusion Criteria:

1. Refuse to join this study
2. Missing/incomplete information
3. Pregnant women, vulnerable groups such as those who have no capacity for civil conduct and cannot determine the consent of their attorneys
4. Chronic organ dysfunction (chronic heart insufficiency, chronic respiratory insufficiency, chronic renal insufficiency, chronic Liver insufficiency)
5. Tumors, blood system diseases, various systemic immune diseases
6. Various infectious diseases (various hepatitis, tuberculosis, AIDS)

Primary outcomes:
measure: The poison metabolomics of Diquat
timeFrame: 2022-06
Secondary outcomes:
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: SAHZU
state: Zhejiang
Study officials:
affiliation: SAHZU
name: Yongan Xu
role: STUDY_DIRECTOR
References: