louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04351100: Efficacy of Diacerein on Ocular Surface Disease in Degenerative Arthritis Patients
Official title: Efficacy of Diacerein on Ocular Surface Disease in Degenerative Arthritis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ocular Surface Disease
Osteoarthritis
Diacerein
Keywords: Dry Eye Syndromes
Osteoarthritis
Ocular surface inflammation
Interleukin-1
Interleukin-1 receptor antagonist
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with osteoarthritis that prescribed Diacerein at out-patient clinic, Department of Orthopedic, King Chulalongkorn Memorial Hospital

Brief summary: Dry eyes is multi-factorial disease which inflammation play etiological role. Diacerein is drug which has anti-inflammatory effect by antagonist Interleukin-1, decrease Interleukin-1 receptor, increase Interleukin-1 Receptor antagonist. This observational study enrolled participants who going to take diacerein for osteoarthritis, measure corneal staining score, Ocular surface disease index score, Tear Osmolarity, Tear break up time, Schirmer 1 test, Interleukin-1 Receptor antagonist, Interleukin-1 alpha, Interleukin-1 beta level in tear at the time of enrollment and after 2 months.


Eligibility criteria: Inclusion Criteria:

1. Osteoarthritis with
2. Ocular surface index score ≥ 13 with
3. Corneal staining score ≥ 3

Exclusion Criteria:

1. Allergic to diacerein
2. Use Cyclosporin within 30 days
3. Eyelid problem
4. Change artificial tear while in the study
5. Pregnancy or breast feeding

Primary outcomes:
measure: Corneal staining score change from baseline at 2 months
timeFrame: At the time of enrollment and 2 months
Secondary outcomes:
measure: Ocular surface disease index score
timeFrame: At the time of enrollment and 2 months
measure: Tear Osmolarity
timeFrame: At the time of enrollment and 2 months
measure: Tear break up time
timeFrame: At the time of enrollment and 2 months
measure: Schirmer 1 test
timeFrame: At the time of enrollment and 2 months
measure: Interleukin-1 receptor antagonist, Interleukin-1 alpha, Interleukin-1 beta level in tear
timeFrame: At the time of enrollment and 2 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of medicine, Chulalongkorn university
Study officials:
affiliation: Department of Ophthalmology, Chulalongkorn University
name: Ngamjit Kasetsuwan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06917300: Virtual Reality as a Digital Premed to Alleviate Pain and Anxiety Preoperatively in Patients Undergoing Spine Surgery
Official title: Virtual Reality as a Digital Premed to Alleviate Pain and Anxiety Preoperatively in Patients Undergoing Spine Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety and Fear
Pain, Postoperative
Stress
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 150
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this research study is to evaluate the impact of immersive VR exposure on preoperative anxiety and pain. Additionally, to assess whether VR intervention would significantly alleviate pain and anxiety levels of patients undergoing complex spinal surgeries. Investigators hypothesize that the application of pre-operative VR-based intervention will alleviate anxiety and pain both pre- and post-operatively when it is used as treatment to complement standard care compared to standard routine care alone, and that it may lead to better outcomes and higher satisfaction in patients.


Eligibility criteria: Inclusion Criteria:

* Adult patients between 25-70 years old, undergoing an elective spinal surgery.
* Patient's admission prior to surgery day (at least 1 day).
* Expected hospital stay - 2 days.
* Capable of providing informed consent and participate in the study follow-up questionnaire.
* Patients speak Polish.

Exclusion Criteria:

* Congestive heart failure, hypertension and anti-hypertensive medications
* Adrenal insufficiency
* Alcohol addiction (evaluated by CAGE/AUDIT) and substance addiction (evaluated by DUDIT)
* Cognitive impairment (evaluated by MMSE, MoCA)
* Cerebrovascular diseases, ophthalmological diseases (strabismus, diplopia, retina degeneration, glaucoma), neurological conditions (epilepsy or seizure, dementia, vertigo, dizziness, motion sickness) - evaluated by: history taking, examination, vision test (Ishihara test), Simulator Sickness Questionnaire
* Auditory impairment
* Psychiatric illness (schizophrenia, bipolar disorder, psychotic depression) - (evaluated by MINI questionnaire)
* Patients with neuropathic pain
* Use of sedative drugs, anti-depressants, anxiolytics, and anti-epileptic drugs
* Intracranial functional lesions (patients after TBI (Traumatic Brain Injury), cognitive or executive dysfunction)
* Patient with high risk due to major and emergency operations
* Claustrophobia
* GCS \< 15

Primary outcomes:
measure: Stress (STAI-S) and Pain (VAS)
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Satisfaction (EVAN-G) and Postoperative Stress (PSS-10)
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Łódź
country: Poland
facility: Redwan Rahman Jabbar
state: Lodzkie
Study officials:
References:
Clinical trial NCT05476900: A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Autoimmune Hepatitis.
Official title: A Randomized, Open-label, Multicenter, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Autoimmune Hepatitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autoimmune Hepatitis
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-27
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, open-label, multicenter, parallel groups, Phase II clinical trial
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of HR19042 capsules for the treatment of autoimmune hepatitis. It will also explore the optimal frequency and dosage of HR19042 capsules administration for the treatment.


Eligibility criteria: Inclusion Criteria:

1. 18 years old≤Female or male patients≤70 years old；
2. Clinical-confirmed autoimmune hepatitis；
3. Biopsy-confirmed autoimmune hepatitis；
4. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥ 3 × upper limit of normal (ULN)；
5. Willing and able to give informed consent and follow the protocols during the trial.

Exclusion Criteria:

1. Patients with other chronic liver diseases；
2. Patients with liver cirrhosis；
3. Patients with hepatic encephalopathy；
4. Positive results in HIV-Ab/TP-Ab/hepatitis virus tests
5. Severe chronic or active infection requiring systemic anti-infective therapy within 14 days before screening；
6. Patients with severe cardiovascular diseases；
7. Patients with malignancy within the past 5 years；
8. Patients received organ transplantation；
9. Patients treated with any systemic corticosteroids within 3 months before screening；
10. Patients treated with any systemic immunosuppressive drugs within the 6 months before screening.

Primary outcomes:
measure: Percentage of biochemical response after 12 weeks of treatment.
timeFrame: 12 weeks
Secondary outcomes:
measure: Percentage of biochemical response with the absence of glucocorticoid-related adverse events after 12 weeks of treatment.
timeFrame: 12 weeks
measure: Percentage of partial response after 12 weeks of treatment
timeFrame: 12 weeks
measure: Percentage of biochemical response after 24 weeks of treatment.
timeFrame: 24 weeks
measure: Percentage of biochemical response with the absence of glucocorticoid-related adverse events after 24 weeks of treatment.
timeFrame: 24 weeks
measure: Percentage of partial response after 24 weeks of treatment.
timeFrame: 24 weeks
measure: Change from baseline in serum ALT levels.
timeFrame: 2, 4, 8, 12, 18, 24 weeks
measure: Change from baseline in serum AST levels.
timeFrame: 2, 4, 8, 12, 18, 24 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao Tong University School of Medicine, Renji Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT03452800: Addiction Among Mental Health Professionals
Official title: Work on the Social Representation of Addiction Among Mental Health Professionals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Addiction
Keywords: addiction
mental health
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health professional with more than 5 years of professional experience in the field of management of mental illnesses

Brief summary: Our goal is to determine the representations of addiction among caregivers working in the field of mental health. We hypothesize that caregivers, despite their investment in care, have a negative social representation of patients suffering from addictive disorders, which could be related to a lack of training on the pathology and its social repercussions.


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years
* Health professional with more than 5 years of professional experience in the field of management of mental illnesses
* Health professional having accepted to participate in the study

Exclusion Criteria:

- Refusal to participate in the stud

Primary outcomes:
measure: Number of addictions
timeFrame: Period from 5 years of professional experience will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Psychiatrie 1
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Laurence LALANNE-TONGIO, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01598870: Diagnosis of Spontaneous Bacterial Peritonitis
Official title: Redefinition of Diagnostic Criteria for Spontaneous Bacterial Peritonitis: Assessment of Accuracy of Available Tests and of Reference Standard
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spontaneous Bacterial Peritonitis
Keywords: Spontaneous bacterial peritonitis.
Lead sponsor: Azienda Ospedaliera di Lecco
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 100
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 with cirrhosis and ascites requiring paracentesis.

Brief summary: The study is aimed to revise the current criteria for the diagnosis of spontaneous bacterial peritonitis and the decisional thresholds to start treatment. The accuracy of current diagnostic tests will be compared with that of new tests, which could potentially become more accurate reference standards. This could lead to the definition of a more accurate and effective diagnostic algorithm.


Eligibility criteria: Inclusion Criteria:

* Patients with cirrhosis and ascites with clinical indication to carry out a diagnostic and/or therapeutic paracentesis.

Exclusion Criteria:

* Etiology of ascites other than cirrhosis

Primary outcomes:
measure: Comparing the accuracy of current reference standard for the diagnosis of spontaneous bacterial peritonitis, i.e. neutrophil count in ascitic fluid of >250/mm3 as determined by microscopy, with alternative diagnostic tests.
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Lecco
country: Italy
facility: Department of Medicine, A. Manzoni Hospital
Study officials:
affiliation: AO Provincia di Lecco, Department of Medicine, A. Manzoni Hospital, Lecco
name: Agostino Colli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05462470: Impact of Surgical Management for Relapse After Conversion Hepatectomy for Initially Unresectable Colorectal Liver Metastasis
Official title: Impact of Surgical Management for Relapse After Conversion Hepatectomy for Initially Unresectable Colorectal Liver Metastasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Liver Metastases
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with initially unresectable colorectal liver metastasis (IU-CRLM) underwent hepatectomy after conversion therapy

Brief summary: For patients with initially unresectable colorectal liver metastasis (IU-CRLM) receiving effective conversion therapy, disease relapse after conversion hepatectomy is common due to the extensive tumor load. Yet, few studies have focused on the assessment and management of relapse after conversion hepatectomy for IU-CRLM. This study aimed to investigate the impact of surgical management for relapse after conversion hepatectomy in IU-CRLM.


Eligibility criteria: Inclusion Criteria:

* initially unresectable colorectal liver metastasis (IU-CRLM)
* received conversion therapy
* underwent conversion hepatectomy

Exclusion Criteria:

* the histologic type of CRLM was not called adenocarcinoma
* uncontrollable extrahepatic metastases, such as peritoneal, bone, brain metastasis
* history of previous hepatectomy
* the primary tumor was not resected or palliative resection
* R1 or R2 liver resection

Primary outcomes:
measure: overall survival
timeFrame: 5 years
Secondary outcomes:
measure: first relapse free survival
timeFrame: 5 years
measure: second relapse free survival
timeFrame: 5 years
measure: Severe complication rate after resection of primary and metastatic lesions
timeFrame: 30 days after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Department of General Surgery, Zhongshan Hospital, Fudan University
name: Jianmin Xu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06237270: External Validation Study for Risk Prediction Model for Unsuccessful Elbow Flexion Recovery After Nerve Transfer Surgery in Patients With Brachial Plexus Injury
Official title: Multicenter External Validation for Risk Prediction Model for Unsuccessful Elbow Flexion Recovery After Nerve Transfer Surgery in Patients With Brachial Plexus Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brachial Plexus Injury
Keywords: nerve transfer
neurotization
brachial plexus injury
predictive factors
external validation
risk prediction model
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
Collaborators: name: Lerdsin General Hospital
First posted: 2024-02-01
Enrollment: 200
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Traumatic brachial plexus injury patients underwent nerve transfer operation

Brief summary: The goal of this observational study is to validate a risk prediction model developed for unsuccessful elbow flexion recovery after nerve transfer surgery in patients with brachial plexus injury. The main question it aims to answer is how well a risk prediction model perform in a different dataset, which are patients with brachial plexus injury who underwent surgery in a different time period or a different hospital.


Eligibility criteria: Inclusion Criteria:

* Traumatic brachial plexus injury patients underwent nerve transfer operation for re-innervation of elbow flexion at Siriraj Hospital between 2018 and 2020 and Lerdsin General Hospital between 2008 and 2022
* Patients had follow-up duration at least 24 months after surgery

Exclusion Criteria:

* Incomplete medical records
* Patients underwent free functioning muscle transfer as primary surgery for elbow flexion
* Obstetric brachial plexus injury
* Radiation-induced brachial plexopathy

Primary outcomes:
measure: Number of participants with failure of biceps recovery at 24 months
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
References:
Clinical trial NCT03357770: The Maximum Tolerated Dose of Mesenchymal Stem Cells From Umbilical Cord
Official title: Evaluating the Maximum Tolerated Dose of Mesenchymal Stem Cells From Umbilical
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Umbilical Cord Bleeding
Keywords: mesenchymal stem cells
Knee Osteoarthritis
Umbilical Cord
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the maximum tolerated dose of Mesenchymal Stem Cells (MSCs) from umbilical cord in the treatment of human knee OA

Detailed description: This is a single-centre, quadruple blined, randomized controlled trail with a total of 9 knee osteoarthrits patients as participants, who will be randomly assigned into high dose group, moderate dose group or low dose group. The participants in the high dose group will receive the treatment of high dose MSCs (1×10\^8cells/3mL) anticular injection.The dose of the MSCs in medium dose group is 5×10\^7cells/3mL, and the dose in the low dose group is 1×10\^7cells/3mL. Unexplained local and systemic symptoms will be assessed to determine the the maximum tolerated dose of mesenchymal stem cells in anticular injection.

Eligibility criteria: Inclusion Criteria:

① K / L score of 2-3; ② chronic knee pain; ③ no local or systemic infection; ④ without obvious contraindication of the joint puncture from hematology and biochemical tests; ⑤ informed consent. -

Exclusion Criteria:

① older than 75 years old or less than 18 years old, or without full capacity for civil conduct; ② HIV, hepatitis virus or syphilis virus infection or their serology is positive; ③ BMI index is greater than 30; ④ congenital or acquired knee deformity; ⑤ pregnant or lactating women; ⑥ tumor patients; ⑦ immunodeficiency patients; ⑧ intra-articular drug injection history within 3 months; ⑨ participating in other clinical trials; ⑩ other patients who researchers believe are not eligible for inclusion such as suffering from other concomitant diseases.-

Primary outcomes:
measure: Unexplained local and systemic symptoms or death
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: arthritis clinic and research center
name: Jianhao Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01760070: Comparison of O-type Hybrid Knife and IT Knife in ESD
Official title: Comparison of O-type Hybrid Knife and IT Knife in Endoscopic Submucosal Dissection for Upper Gastrointestinal Neoplasms: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Cancer
Esophageal Dysplasia
Stomach Cancer
Stomach Dysplasia
Keywords: cancer
endoscopy
endoscopic submucosal dissection
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2013-01-03
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: By combining injection and dissection capability together, O-type Hybrid knife could possibly shorten the endoscopic submucosal dissection procedure for upper gastrointestinal neoplasms.

Detailed description: Endoscopic submucosal dissection (ESD) has been accepted as an minimal invasive alternative to surgery for localized early upper gastrointestinal neoplasms recently. However, the procedure remains to be technically challenging and time consuming. Many modified methods or newly developed devices were developed to simplify the procedure. A new insulated tip dissecting knife (O-type Hybrid knife) has been recently developed with both injection and lateral cutting capability. The aim of this study was to investigate whether ESD procedure could be shortened with this new device.

Eligibility criteria: Inclusion Criteria:

* Gastric or esophageal adenoma or early cancer which is eligible for conventional ESD indications
* The patients who agreed informed consent

Exclusion Criteria:

* Recent drug history of anticoagulant or antiplatelet agent within 7 days
* Recurrent gastric or esophageal adenoma or early cancer
* Pregnant or breast feeding patients.

Primary outcomes:
measure: Procedure time for ESD
timeFrame: up to 1 day
Secondary outcomes:
measure: Submucosal dissection time
timeFrame: up to 1 day
measure: Perforation rate
timeFrame: up to 7 day
measure: Bleeding Rate
timeFrame: up to 7 days
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
affiliation: Xijing Hospital of Digestive Diseases
name: Zhiguo Liu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lingenfelder T, Fischer K, Sold MG, Post S, Enderle MD, Kaehler GF. Combination of water-jet dissection and needle-knife as a hybrid knife simplifies endoscopic submucosal dissection. Surg Endosc. 2009 Jul;23(7):1531-5. doi: 10.1007/s00464-009-0433-3. Epub 2009 Apr 3.
citation: Fukami N, Ryu CB, Said S, Weber Z, Chen YK. Prospective, randomized study of conventional versus HybridKnife endoscopic submucosal dissection methods for the esophagus: an animal study. Gastrointest Endosc. 2011 Jun;73(6):1246-53. doi: 10.1016/j.gie.2010.12.004. Epub 2011 Feb 12.