louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06029634: Effects of T-bet B Cells in Persistent Virus Control After Discontinuance of NAs in CHB Patients
Official title: Effects of T-bet B Cells in Persistent Virus Control After Discontinuance of NAs in CHB Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic HBV Infection
Drug Withdrawal
Keywords: transcription factor bet
chronic hepatitis B
nucleotide analogs
function cure
B cell
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: CHB patients on NAs therapy

Brief summary: The immune mechanism of the nucleos(t)ide analogs (NAs) in inhibiting HBV replication effectively while having a low sustained virus control rate after drug withdrawal is unclear. B cell immunity and antibody response are the keys to prevent HBV reinfection and keep the virus under control. T-bet+ B, which can be regulated by IL-21, is a newly discovered major effector B cell in protection of pathogens and it is a main subtype of HBsAg-specific B cells. Thus, we suspect that T-bet+ B may play a role in ongoing controlling of the virus after withdraw of NAs in CHB patient. Based on our previous studies on CHB immunity, we use the RNAseq analyse, flow cytometry, and Elispot assay to analyze the frequency, function, and phenotype of B cells in CHB patients with different profiles after withdraw of NAs.


Eligibility criteria: Inclusion Criteria:

18 to 70 years old, no gender restriction, serum HBsAg positive than 6 months, can understand and sign informed consent, good compliance.

Exclusion Criteria:

coinfected with other hepatotropic virus such as hepatitis C virus,hepatitis D -virus,hepatitis E and hepatitis A etc; coinfected with HIV, markers such as ceruloplasmin, anti-nuclear antibodies and anti-mitochondrial antibodies for co-existent autoimmune and metabolic liver diseases were positive, with hepatocellular carcinoma(HCC) with uncontrollable extrehepatic disease, received glucocorticoid or other immune inhibitor therapy, pregnancy

Primary outcomes:
measure: phenotype of B cells
timeFrame: PBMC were collected 0、4、12、24 week after withdraw the NAs
measure: B cell ELISPOT assay
timeFrame: Cells were stimulated with R-848 (1 μg/ml) and IL-2 (10 ng/ml) for 5 days at 37 °C to aid memory B cell differentiation
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai hospital
Study officials:
affiliation: Chaihai hospital
name: Xuesong Liang, DR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03060434: Pentoxifylline and Lumbar Radiculopathy
Official title: Prospective Controlled Crossover Study of the Role of Pentoxifylline in the Management of Lumbar Radiculopathy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Lumbar Radiculopathy
Lumbar Disc Herniation
Lumbar Disc Disease
Keywords: pentoxifylline
Disc hernia
sciatica
lumbar radiculopathy
Lead sponsor: St Joseph University, Beirut, Lebanon
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each patient will receive for 1 month: Ibuprofen 600 mg bid; Paracetamol 1g tid if needed; pregabalin 75 mg bid pentoxifylline 400 mg bid will be added for either the first or second 15 days (randomization)
Primary purpose: TREATMENT

Brief summary: The objective of this prospective controlled crossover study is to evaluate the efficacy and safety of pentoxifylline per os (800 mg daily) in the management of lumbar radiculopathy

Detailed description: Patients with lumbar radiculopathy, are recruited from senior author clinic. After verification of inclusion and exclusion criteria, patients consenting to enter the study are given 2 sequences (order randomly assigned) of treatment: Ibuprofen 600 mg bid, with paracetamol 1000 mg tid, pregabalin 75 mg bid for 15 days with pentoxifylline and 15 days without it. Basic clinical and demographical data are noted. Lumbar MRI results are also noted. Clinical evaluation of the patient is performed and included: clinical examination (including motor exam of lower limbs); pain is assessed according to Numerical rating Scale (NRS), and relative percentage of global improvement.

Eligibility criteria: Inclusion Criteria:

* Unilateral lumbar radiculopathy
* Disc hernia confirming the diagnosis with radio-clinical concordance

Exclusion Criteria:

* Radicular deficit needing surgery
* Cauda equine syndrome
* Absence of radio-clinical concordance on MRI
* Contraindication for anti-inflammatory (Hypertension, renal insufficiency, gastric ulcer ...)
* Previous intolerance to pentoxifylline, and/or to pregabalin and/or paracetamol
* Pregnancy
* Follow-up not possible
* Hepatic dysfunction
* History of drug abuse
* Current use of tramadol, codeine and/or morphine and its derivative
* Antidepressant use

Primary outcomes:
measure: Numerical rating scale (NRS)
timeFrame: At day 15 (and Day 30)
Secondary outcomes:
measure: Patient global impression of improvement scale
timeFrame: day 15 and 30
measure: Side effects
timeFrame: Day 15 and 30
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Hotel Dieu de France Hospital
Study officials:
affiliation: Hotel Dieu de France Hospital - Beirut, Lebanon, 16 6830
name: Joseph Maarrawi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06651034: Efficacy of Intralesional Platelet Rich Plasma in Patients of De Quervain's Tenosynovitis
Official title: Efficacy of Intralesional Platelet Rich Plasma in Patients of De Quervain's Tenosynovitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: De Quervain Tenosynovitis
Lead sponsor: RESnTEC, Institute of Research
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Quasi-experimental study
Primary purpose: TREATMENT

Brief summary: De Quervain's tenosynovitis (DQT) was originally identified by Swiss surgeon Fritz de Quervain in 1895. It is a condition involving the entrapment of tendons within the first dorsal compartment of the wrist. In DQT, the sheaths surrounding the abductor pollicis longus (APL) and extensor pollicis brevis tendons thicken as they pass through a fibro-osseous tunnel near the radial styloid of the distal wrist. This thickening leads to pain, which worsens with thumb movements and radial or ulnar deviation of the wrist. Traditional treatment methods, such as corticosteroid injections and physical therapy, often provide only temporary relief and may not address the underlying inflammation effectively. Intralesional platelet rich plasma (PRP) therapy has emerged as a promising alternative, utilizing the patient's own growth factors and cytokines to promote healing and reduce inflammation. By investigating the efficacy of intralesional PRP in patients with DQT, this research aims to provide evidence for a minimally invasive treatment option that could enhance recovery times, reduce pain, and improve functional outcomes.


Eligibility criteria: Inclusion Criteria:

* Either gender,
* Aged between 18 and 60 years
* Presenting with de quervain's tenosynovitis

Exclusion Criteria:

* Previous surgery or intervention forde quervain's tenosynovitis
* Local skin infection or osteomyelitis
* Pregnant or lactating mothers

Primary outcomes:
measure: VAS Pain Score
timeFrame: 3-week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Department of Orthopedic surgery, KEMU/ Affiliated hospital
Study officials:
affiliation: Department of Orthopedic Surgery, Mayo Hospital, Lahore, Pakistan
name: Muhammad Zarak Awais, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01740934: A Study to Evaluate the Safety, Tolerability, and Effects of Anatabloc® Crème in Rosacea
Official title: An Eight-Week, Multi-Site, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Trial to Evaluate the Safety, Tolerability, and Effects of Anatabloc® Crème in Subjects With Rosacea Followed by an Open-Label Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rosacea
Keywords: rosacea
anatabine
Anatabloc
dermatology
Lead sponsor: Rock Creek Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-04
Enrollment: 117
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-site, four-visit, eight-week, double-blind, randomized, vehicle-controlled, parallel-group study followed by an eight-week open-label extension to evaluate the safety, tolerability, and potential effects of Anatabloc Facial Cream. The secondary aim is to evaluate if Anatabloc Facial Cream improves the appearance of the skin in subjects with mild to moderate rosacea.


Eligibility criteria: Inclusion Criteria:

* age between 25-70 years
* diagnosed with mild to moderate rosacea

Exclusion Criteria:

* allergy or sensitivity to the study products or their components
* severe rosacea
* current use of glucocorticoids, anti-acne products, antibiotics, topical retinoids, or vasoactive drugs
* recent oral isotretinoin use
* current use of anatabine-containing supplements (ie. Anatabloc, Anatabloc Unflavored, CigRx)

Primary outcomes:
measure: Adverse Effects
timeFrame: 8 to 16 weeks
Secondary outcomes:
measure: Change in the appearance of the facial skin
timeFrame: 8 to 16 weeks
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Susan H. Weinkle, MD
state: Florida
city: New Orleans
country: United States
facility: Lupo Center for Aesthetic & General Dermatology
state: Louisiana
city: New York
country: United States
facility: Diane Berson, MD
state: New York
Study officials:
affiliation: Star Scientific
name: M Varga, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06155734: Fluorescence Guided Minimally-Invasive Resection Of Abdominal Paragangliomas Using Indocyanine Green
Official title: Fluorescence Guided Minimally-Invasive Resection Of Abdominal Paragangliomas Using Indocyanine Green
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Paraganglioma
Keywords: Fluorescence Guided Surgery
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients \>18yo diagnosed with abdominal paragangliomas which underwent surgical resection

Brief summary: This study is exploring whether it's possible to detect paragangliomas (a rare type of tumor) during minimally invasive surgery by using a technique called near-infrared fluorescence imaging, guided by a substance called indocyanine green (ICG). The goal is to see if this method can help surgeons identify and treat paragangliomas more accurately and during minimally invasive procedures.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with abdominal paraganglioma and underwent minimally-invasive surgical resection

Exclusion Criteria:

* Open surgical procedures

Primary outcomes:
measure: Feasibility of real-time in-vivo identification of suspected paraganglioma's using Near-Infrared-fluorescence ICG imaging
timeFrame: perioperatively/periprocedurally, within 30 minutes after intravenous administration of the fluorescent dye, up until a maximum of 120 minutes after start of surgery.
Secondary outcomes:
measure: Accuracy of the detection of suspected lesions using Near-Infrared-fluorescence ICG imaging
timeFrame: Postoperatively, at the moment the definitive pathology result is known, approximately five days after surgery
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
Study officials:
References:
Clinical trial NCT02799134: Neural Mechanism of Cortisol Awakening Response Suppression Effect on Human High-order and Social Cognitions
Official title: Neural Mechanism of Cortisol Awakening Response Suppression Effect on Human High-order and Social Cognitions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Cortisol Awakening Response suppression
Dexamethasone Suppression Test
high-order cognition
social cognition
Lead sponsor: Beijing Normal University
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Sciences
name: Xuanwu Hospital, Beijing
First posted: 2016-06-14
Enrollment: 67
Sex: MALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: CAR is short for cortisol awakening response. The neural mechanism of CAR effect on high-order cognition and social cognition is less known...


Eligibility criteria: Inclusion Criteria:

* Healthy college students.

Exclusion Criteria:

* Current or history of psychiatric or neurological illness.
* Current use of any medications.

Primary outcomes:
measure: Cortisol Awakening Response Level(nmol/L) after Taking Dexamethasone
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Normal University
state: Beijing
Study officials:
affiliation: Beijing Normal University
name: Shaozheng Qin, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT04567134: Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea
Official title: Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Clostridium Difficile Infection
Keywords: clostridium difficile
incidence
Lead sponsor: Hanyang University Seoul Hospital
Sponsor class: OTHER
Collaborators: name: Korean Center for Disease Control and Prevention
name: Pfizer
First posted: 2020-09-28
Enrollment: 500
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who admitted at the tertiary hospitals in Korea and and diagnosed as Clostridioides difficile infection will be selected.

The tertiary hospitals located in Seoul-si, Gyeonggi-do, Pusan-si, Daegu-si, Jeollanam-do, Jeollabuk-do, and Chungcheongbuk-do. These hospitals distributes all over the country.

Brief summary: Our objective of this study is to derive a real incidence of CDI in tertiary hospitals located through Korean peninsula. In order to get a close value to the truth, the study is planned to co-perform with a national study which was proposed in evaluation process to include more hospitals. Along with the incidence of CDI, clinical characteristics and outcome of CDI will be examined and microbiologic characteristics of C. difficile isolates from CDI patients are studied.


Eligibility criteria: Inclusion Criteria:

* aged older than 19 years
* more than 3 times of unformed stools passage per day
* positive results of toxin gene test: GDH (+) + PCR (+), GDH (+) + toxin (+), or PCR (+) + toxin (+)
* agree with informed consent

Exclusion Criteria:

* less than 3 times of unformed stool passage per day
* use of oral metronidazole or vancomycin more than 24 hours before enrollment
* use of laxative before enrollment
* recurrent episode of CDI
* disagree with study protocol

Primary outcomes:
measure: incidence of CDI
timeFrame: through Oct 2020 to Dec 2021
Secondary outcomes:
measure: mortality rate
timeFrame: through Oct 2020 to May 2022
measure: recurrence rate
timeFrame: through Oct 2020 to May 2022
Other outcomes:
Locations:
Study officials:
affiliation: Hanyang University College of Medicine
name: Hyunjoo Pai, M.D., Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT06918834: Efficacy of Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Bridging Therapy Followed by Transplantation in Higher-Risk Myelodysplastic Syndrome Patients
Official title: Efficacy of Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Bridging Therapy Followed by Transplantation in Higher-Risk Myelodysplastic Syndrome Patients: A Multicenter, Randomized Controlled, Open-Label, Phase 2 Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Myelodysplastic Syndromes
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 236
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: This study aims to evaluate whether immediate allogeneic hematopoietic stem cell transplantation (HSCT) is non-inferior to HSCT following bridging therapy in patients with higher-risk myelodysplastic syndrome (HR-MDS).

Detailed description: This study aims to evaluate whether immediate allogeneic hematopoietic stem cell transplantation (HSCT) is non-inferior to HSCT following bridging therapy in patients with higher-risk myelodysplastic syndrome (HR-MDS).A total of 236 patients will be randomized in a 1:1 ratio into the immediate transplantation group (n=118) and the disease control group (n=118). The study will continue until at least 124 events occur.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years
2. High relapse risk MDS, defined by:

   * IPSS-R score ≥3.5.
   * IPSS-M stratification as intermediate-high, high, or very high risk.
3. Eligible for allogeneic HSCT (including matched or mismatched related/unrelated donor transplantations).
4. Karnofsky Performance Status (KPS) ≥60.
5. Signed informed consent.

Exclusion Criteria:

1. Severe organ dysfunction:

   * Left ventricular ejection fraction \<50%.
   * Oxygen supplementation requirement.
   * Serum bilirubin \>1.5x upper limit of normal (unless due to Gilbert syndrome) or AST/ALT \>5x upper limit of normal.
   * Estimated glomerular filtration rate (eGFR) \<50 mL/min.
2. History of prior allogeneic HSCT.
3. Any condition deemed unsuitable by the investigator.

Primary outcomes:
measure: 2-year Disease-Free Survival (DFS) post-HSCT
timeFrame: 2-year
Secondary outcomes:
measure: Cumulative Incidence of Allogeneic HSCT
timeFrame: The proportion of patients who undergo HSCT at 4, 8, 16, and 24 weeks post-randomization.
measure: Complete Remission (CR) or CR Equivalent Rate from Randomization
timeFrame: 2-year
measure: 2-year Overall Survival (OS) post-HSCT
timeFrame: 2-year
measure: 2-year Leukemia-Free Survival (LFS) from Randomization
timeFrame: 2-year
measure: 2-year Quality of Life (QoL) Assessment: 2-year Quality of Life (QoL) Assessment from Randomization
timeFrame: 2-year
measure: Molecular Clearance Rate
timeFrame: 2-year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01535534: Mediators of Inflammation, Prognostic Markers and Genetic Polymorphisms in Patients With Sepsis
Official title: Evaluation of Mediators of Inflammation, Prognostic Markers and Genetic Polymorphisms in Patients With Sepsis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Keywords: sepsis
inflammation
diagnosis
prognosis
survival
mortality
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2012-02-17
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from sepsis

Brief summary: During the past years many investigators have focused on the immunological changes in sepsis disease, and great attention has been paid to the development of practicable means of immunomonitoring. Little is known about diagnostic and prognostic vascular biomarkers during the time course of patients with sepsis.

Detailed description: Primary Outcome Measures:

New diagnostic and prognostic markers for septic patients

Estimated Enrollment: 300 patients Study Start Date: January 2012 Estimated Study Completion Date: open Estimated Primary Completion Date: open

Intervention Details:

Procedure: vein puncture comparison of different inflammatory markers in the blood of septic patients

Eligibility criteria: Inclusion Criteria:

* SIRS-Criteria
* Proven Infection
* One sepsis-induced organ-failure
* Adults \< 18 years old

Exclusion Criteria:

* Anemia
* Pregnancy
* Blood donor in the last 3 month

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: University Medical Centre Mannheim
state: Baden-Württemberg
Study officials:
affiliation: Universitätsmedizin Mannheim
name: Ursula Hoffmann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsmedizin Mannheim
name: Michael Behnes, MD
role: STUDY_DIRECTOR
References:
citation: Hamed S, Behnes M, Pauly D, Lepiorz D, Barre M, Becher T, Lang S, Akin I, Borggrefe M, Bertsch T, Hoffmann U. Diagnostic value of Pentraxin-3 in patients with sepsis and septic shock in accordance with latest sepsis-3 definitions. BMC Infect Dis. 2017 Aug 9;17(1):554. doi: 10.1186/s12879-017-2606-3.
citation: Behnes M, Bertsch T, Lepiorz D, Lang S, Trinkmann F, Brueckmann M, Borggrefe M, Hoffmann U. Diagnostic and prognostic utility of soluble CD 14 subtype (presepsin) for severe sepsis and septic shock during the first week of intensive care treatment. Crit Care. 2014 Sep 5;18(5):507. doi: 10.1186/s13054-014-0507-z.