louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06179030: Systemic and Local Inflammatory Biomarkers in the Treatment of Refractory Diabetic Macular Edema
Official title: Systemic and Local Inflammatory Biomarkers in the Treatment of Refractory Diabetic Macular Edema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Macular Edema
Inflammation
Keywords: diabetic macular edema
biomarkers
inflammation
optical coherence tomography
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2023-12-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: treatment naive patients who were diagnosed with diabetic macular edema and had poor response to the 3 consecutive bevacizumab intravitreal injection loading phase.

Brief summary: The current study aims to investigate the relationship between systemic inflammatory biomarkers and local inflammatory biomarkers on OCT in patients with treatment resistant diabetic macular edema(DME) and further explore the associations with treatment outcomes.

Detailed description: This study was designed as a prospective open-label non rondomised observational study. The study was registered between April 18, 2022 and October 18, 2023. It is planned to include 80 volunteer patients over the age of 18 who are being followed up with the diagnosis of naive DME in the Retina Department of Prof Dr Cemil Tascioglu City Hospital and had poor response to the 3 consecutive initial monthly intravitreal bevacizumab loading dose. It was planned to evaluate systemic and local(OCT biomarker) inflammatory biomarker levels before swiching intravitreal agents, which may include intravitreal ranibizumab or intravitreal dexamethasone implant. The markers planned to be checked in blood samples are: IL-6, IL-8, TNF-a, ICAM-1, MCP-1, VEGF, HbA1c, CRP, ESR, haemogram, creatinine, AST, ALT, cholesterol. Patients were followed up monthly for 3 months after the switching. It was aimed to evaluate the level of systemic inflammatory biomarkers and the associations with treatment effectiveness. In addition, local OCT biomarkers (serous macular detachment and hyperreflective foci, etc.) and their relationship with treatment results were examined.

Eligibility criteria: Inclusion Criteria:

* who had refractory DME after 3 consecutive initial bevacizumab therapy
* treatment-naive

Exclusion Criteria:

* who had underwent anti-vegf treatment previously
* systemic inflammatory disease
* who had ocular surgery 6 months prior to enrollment
* uncontrolled hypertension
* \<18 years old

Primary outcomes:
measure: systemic inflammatory biomarkes correlates with OCT biomarkers and higher in poor responders
timeFrame: 6 months
Secondary outcomes:
measure: The anatomical and visual recovery will be compared to dexamethasone versus ranibizumab
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Prof. Dr. Cemil Tascioglu City Hospital
state: Sisli
Study officials:
References:
Clinical trial NCT00893230: A Study of a Probiotic in Atopic Dermatitis
Official title: A Double-Blind, Randomized, Placebo-Controlled Intervention Study of the Efficacy and Safety of "NFM proBio65" in the Atopic and Allergic Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
chemokines
probiotics
Lead sponsor: Chungbuk National University
Sponsor class: OTHER
Collaborators: name: Yeungnam University Hospital
name: Korea Research Institute of Bioscience & Biotechnology
name: Gachon University Gil Medical Center
First posted: 2009-05-05
Enrollment: 88
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to assess the clinical effect of Lactobacillus sakei supplementation in children with atopic dermatitis.

Detailed description: Probiotics were also shown to reduce severity of AEDS when administered to infants with early onset AEDS. In contrast, only a few studies have evaluated the therapeutic effectiveness of probiotics on the groups of older children with established AEDS. In these studies, administration of Lactobacillus strains to unselected children aged 1 year and over was associated with improvement in the clinical severity of eczema. The purpose of this study was to evaluate the clinical efficacy in AEDS of a newly identified probiotic strain, Lactobacillus sakei KCTC 10755BP, which showed the most potent inhibitory activity against S aureus growth among Lactobacillus species in our preliminary experiment. We administered L sakei to an unselected group of children aged 2 to 10 years with moderate and severe AEDS and evaluated the clinical outcome at the end of the intervention. In addition, we also measured levels of serum chemokines as activity markers for AEDS to provide a more objective evidence for the beneficial role of this probiotic.

Eligibility criteria: Inclusion Criteria:

* patients with atopic dermatitis present for at least 6 months before inclusion
* a total SCORAD score above 25
* a change in a total SCORAD score of not more than 10% within 2 weeks

Exclusion Criteria:

* patients who had been treated with cyclosporine, systemic steroid, topical calcineurin inhibitor, or Chinese herbal medicine during the preceding 3 months

Primary outcomes:
measure: SCORAD score
timeFrame: 12 weeks
Secondary outcomes:
measure: Chemokine levels
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
Study officials:
affiliation: Department of Pediatrics, College of Medicine and Medical Research Institute, Chungbuk National University, Cheongju, Korea,
name: Youn-Soo Hahn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00131430: An Eighteen Month Efficacy and Safety Study in Obese Patients (0364-020)(COMPLETED)
Official title: An 18-Month Study to Assess the Safety, Tolerability, and Efficacy of MK0364 in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Obesity and Obesity-related Medical Conditions
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-08-18
Enrollment: 500
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: A study to determine the safety and efficacy of an investigational drug in patients with obesity.


Eligibility criteria: Inclusion Criteria:

* Obese patients with a body mass index between 30kg/m2 and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43kg/m2, inclusive for those with obesity-related comorbidities including hypertension, dyslipidemia and sleep apnea).

Exclusion Criteria:

* Patients with serious or unstable current or past medical conditions.

Primary outcomes:
measure: After 24 weeks, body weight, safety, and tolerability
timeFrame: After 24 weeks
Secondary outcomes:
measure: After 80 weeks, body weight
timeFrame: After 80 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03256630: Evaluation of a Blood Biomarker to Try and Distinguish Between the Presence or Absence of Aggressive Prostate Cancer
Official title: A Laboratory Study To Evaluate A Blood Biomarker That Can Distinguish Between the Presence Or Absence of Aggressive Prostate Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Cancer
Keywords: Active Surveillance
Radical Prostatectomy
Lead sponsor: Genomic Health®, Inc.
Sponsor class: INDUSTRY
Collaborators: name: AdventHealth
First posted: 2017-08-22
Enrollment: 128
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prostate cancer patients who are planning to have a Radical Prostatectomy at the Global Robotics Institute and are informed and willing to participate in study.

Brief summary: A Laboratory Study to Evaluate Urine and Blood Biomarkers That Can Distinguish Between the Presence or Absence of Aggressive Prostate Cancer

Detailed description: The over-arching goal of this study is to evaluate if biomarkers within the blood or urine of men with localized prostate cancer can distinguish between those with indolent cancer, defined as Gleason Grade Groups 1 and 2 and those with more aggressive disease (Gleason Grade Groups 3, 4, and 5).

Eligibility criteria: Inclusion Criteria:

1. Patient has been diagnosed with Prostate Cancer and is planning on having a Radical Prostatectomy performed at the Global Robotics Institute.
2. Diagnostic PSA ≤ 20 ng/mL.
3. Pathology report from most recent positive biopsy, prior to Radical Prostatectomy, is available.
4. Ability to read and understand the informed consent form.
5. Patient must have signed informed consent form

Exclusion Criteria:

1. Any of the following active therapies received: radiation, chemotherapy, biologic agents, surgery, local therapies including cryotherapy or HIFU.
2. Diagnostic PSA \> 20 ng/mL or missing PSA.
3. Patients who are unable or unwilling to provide informed consent.

Primary outcomes:
measure: Characterize the distribution of clinical/pathological factors of the samples by the Gleason Grade Group and to characterize the distribution of the signal of each biomarker by the Gleason Grade Group or combination of groups.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Celebration
country: United States
facility: Florida Hospital Global Robotics Institute
state: Florida
Study officials:
References:
Clinical trial NCT05135130: Retrospective Record-review Study in Patients Who Had Diabetic Foot Ulcer
Official title: A Retrospective Record-review Study in Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Foot Ulcer
Lead sponsor: Oneness Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-11-26
Enrollment: 176
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The ON101CLCT02 trial enrolled 236 subjects and was conducted in Taiwan, China, and USA. The target population of this study consists of the Taiwanese DFU patients who had completed or early withdrawn from the ON101CLCT02 trial.

Brief summary: The purpose of the study is to evaluate the medical cost of illness for DFUs on the patients who had used ON101 or Aquacel® in the ON101CLCT02 trial.


Eligibility criteria: No additional inclusion or exclusion criteria will be applied.

Primary outcomes:
measure: Demographic characteristics
timeFrame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial
measure: Wound characteristics of DFUs (classification and proportion)
timeFrame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial
measure: Proportion of DFU recurrence after completing or withdrawing from the ON101CLCT02 trial
timeFrame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial
measure: Medical costs due to DFUs
timeFrame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial
measure: Proportion of wound infection, gangrene, and amputation
timeFrame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial
measure: Frequency of wound infection, gangrene, and amputation
timeFrame: Up to two years after the patient had completed or early withdrawn from the ON101CLCT02 trial
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: Oneness Biotech Co., Ltd.
name: Shyi-Gen Chen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01904630: Sequencing to Identify Gene Variants in Familial Colorectal Cancer
Official title: Exom-sekvensering for å Identifisere høyrisiko Genvarianter i en Familie Predisponert for Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: gene sequencing
familial
risk factors
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2013-07-22
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A specific family showing increased risk for CRC

Brief summary: The project will use exome sequencing to search for genetic predispositions for familial colorectal cancer (CRC). Except for certain syndromes there is today no good method for identifying individuals with a hereditary high risk for CRC (about 25% of the cases). There is currently no routine screening of the population in Norway for CRC today. Coloscopy, which is the most reliable method, is demanding with respect to resources, it can be painful, and may have complications. This project will attempt to find genetic determinants for identification of individuals with increased risk for familial CRC. Such methods will reduce unnecessary medical examination of unaffected family members, and will make it easier to focus health services on individuals with increased risk. This will represent a significant contribution towards improved health reduced death rate caused by CRC. The project includes research on the ethical aspects, in particular challenges related to how feedback to donors is handled.

Detailed description: Participants will be from a specific family, and will be selected by invitation to volunteer.

Eligibility criteria: Inclusion Criteria:

* Member of a specific family with increased risk of CRC, including individuals both with and without CRC

Exclusion Criteria:

* Young age

Primary outcomes:
measure: Data on association between sequence variants in exons and CRC risk
timeFrame: Data available within 18 months after recruitment completed
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Finn Drabløs, PhD/Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hansen MF, Johansen J, Bjornevoll I, Sylvander AE, Steinsbekk KS, Saetrom P, Sandvik AK, Drablos F, Sjursen W. A novel POLE mutation associated with cancers of colon, pancreas, ovaries and small intestine. Fam Cancer. 2015 Sep;14(3):437-48. doi: 10.1007/s10689-015-9803-2.
Clinical trial NCT05666830: One-step Application of Artificial Dermis
Official title: A Study to Observe the Effect of One-step Application of Artificial Dermis on Burn and Plastic Wounds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wounds and Injuries
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2022-12-28
Enrollment: 37
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-infectious wounds of deep burns, full-thickness traumatic skin defects or plastic surgery that require repair and reconstruction of dermal defects.

Brief summary: The goal of this observational study is to study the effectiveness of one-step application of Lando® artificial dermal regeneration matrix for burn and plastic wound repair.

The main question it aims to answer is: the effectiveness of one-step application of Lando® artificial dermal regeneration matrix, including the take rate of skin graft and the appearance recovery of the wound.

Participants will be treated with artificial dermis that perfomed with STSG simultaneously. According to the routine clinical practice, the take rate of split-thickness skin graft at about 2-3 weeks and the appearance recovery of the wound at 3 months and 6 months after the implantation were measured.


Eligibility criteria: Inclusion Criteria:

1. Age ≤ 70 years old.
2. Patients with non-infectious wounds of deep burns, full-thickness traumatic skin defects or plastic surgery that need to be repaired and reconstructed by artificial dermis.
3. Patients who voluntarily participate in this clinical trial and sign the informed consent form. When the subjects are under 18 years old or they have no capacity or limited capacity, they should have the consent and signature of the guardian or legal representative.

Exclusion Criteria:

1. Patients who need to participate in other clinical researchers within 30 days before or during the period of joining the group.
2. Patients with poor control of diabetes (those with fasting blood glucose ≥ 7.0mmol/L or glycosylated hemoglobin HbA1c ≥ 12% after drug control, transaminase \> 1.5 times and other diabetic complications).
3. Other cases that researchers believe not suitable for the participants of the trial.

Primary outcomes:
measure: Take rate of skin graft
timeFrame: 2~3 weeks
Secondary outcomes:
measure: Effective rate of skin grafting
timeFrame: 2~3 weeks
measure: Vancouver Scar Scale score of skin grafting site
timeFrame: 3 months
measure: Vancouver Scar Scale score of skin grafting site
timeFrame: 6 months
measure: Vancouver Scar Scale score of donor site
timeFrame: 3 months
measure: Vancouver Scar Scale score of donor site
timeFrame: 6 months
measure: Percentage of wound contraction
timeFrame: 3 months
measure: Percentage of wound contraction
timeFrame: 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT03241030: Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial
Official title: Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Herpangina
Gingivostomatitis
Hand, Foot and Mouth Disease
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2017-08-07
Enrollment: 102
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to see if sucralfate, a medication commonly used for patients with stomach ulcers, may help pediatric patients with mouth ulcers decrease their pain level and improve their ability to drink.


Eligibility criteria: Inclusion Criteria:

* Age ≥6 months and ≤5 years old
* Present with oral infectious ulcers such as gingivostomatitis, herpangina, or hand, foot and mouth disease
* History of decreased oral fluid intake by parent or guardian
* English or Spanish speaking parents or guardians

Exclusion Criteria:

* Severely dehydrated or toxic, requiring immediate resuscitation
* Exclusively breastfed
* Severe dental disease
* Significant mouth trauma
* Active Malignancy
* Preexisting upper airway obstruction or swallowing difficulties
* Received intravenous fluids within 24 hours
* Administration of BOTH acetaminophen AND ibuprofen prior to triage and within 4 hours of enrollment

Primary outcomes:
measure: Oral Intake in ml/kg
timeFrame: Approximately 60 minutes after medication administration.
Secondary outcomes:
measure: Number of Participants That Require Intravenous Fluid Administration
timeFrame: 6 hours from the time of enrollment
measure: Number of Participants That Require Admission
timeFrame: 6 hours from the time of enrollment
measure: Number of Participants With Unscheduled Visits
timeFrame: Approximately 72 hours from ED visit
Other outcomes:
Locations:
city: Austin
country: United States
facility: Dell Children's Medical Center
state: Texas
Study officials:
affiliation: UT Dell Medical School
name: Nina Vaidya, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singh NV, Gabriele GA, Wilkinson MH. Sucralfate as an Adjunct to Analgesia to Improve Oral Intake in Children With Infectious Oral Ulcers: A Randomized, Double-Blind, Placebo-Controlled Trial. Ann Emerg Med. 2021 Sep;78(3):331-339. doi: 10.1016/j.annemergmed.2021.01.019. Epub 2021 Apr 16.
Clinical trial NCT06982430: Early Recurrence of Renal Colic: Predictive Factors
Official title: Identification of Predictive Factors for Early Recurrence of Renal Colic Pain After Emergency Department Treatment: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Colic
Emergency Department Patient
Keywords: early recurrence, RC pain, emergency department
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 878
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: included patients over 18 years of age who were admitted to the ED for acute abdominopelvic pain and whose final diagnosis was RC

Brief summary: Renal colic (RC) is a common pathology in emergency medicine, with a high risk of recurrence. Early recurrence remains a major concern, affecting up to 30% of patients, with around 84% of these recurrences occurring within two days of the initial episode , despite preventive measures, both pharmacological and non-pharmacological . The recurrence of RC varies significantly between individuals, and systematic evaluation may facilitate personalized treatment . Recurrence is likely influenced by multiple factors, and identifying these could help clinicians develop better preventive strategies.The main aim of our study was to identify factors predictive of early recurrence of RC pain after emergency department (ED) management.


Eligibility criteria: Inclusion Criteria:

* patients over 18 years of age who were admitted to the ED for acute abdominopelvic pain and whose final diagnosis was RC

Exclusion Criteria:

* patients with documented or suspected pregnancy, and patients without a phone number

Primary outcomes:
measure: RC recurrence
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Nouira Semir
Study officials:
References: