louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03421678: Ethnic/Racial Differences in Metabolism and DNA Adduct Formation
Official title: Ethnic/Racial Differences in Metabolism and DNA Adduct Formation by 1,3-butadiene
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lung Cancer
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2018-02-05
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 300 smokers will be recruited from the Multiethnic Cohort (MEC) study or the general population in Hawai'i

Brief summary: The study will investigate the role of 1,3-butadiene metabolic activation and deactivation in lung cancer risk among various ethnic/racial groups. This project will require urine samples from smokers and nonsmokers from the three ethnic/racial groups recruited by the Clinical and Biomarker Core for the analysis of 1,3-butadiene DNA adducts. Data on nicotine intake (urinary TNE) in these subjects as well as in 400 lung cancer cases and 400 controls from Project 1 will be also required for this project.


Eligibility criteria: Inclusion Criteria:

* One of the three targeted ethnic groups:

  * Japanese American - two parents of Japanese descent
  * Non-Hispanic Whites - two parents of non-Hispanic white descent
  * Native Hawaiians will include individuals with at least one parent of Hawaiian descent;
* Smoke 5 cigarettes per day over the past three months;
* \>21 years of age;
* Consumes 14 or fewer drinks of alcohol per week;
* Generally stable and good health (determined by review of medical history);
* Able to provide written voluntary consent before performance of any study related procedure.

Exclusion Criteria:

* Current use of other nicotine containing products for \> 4 times per month (and no use of any nicotine-containing products except cigarettes for 2 weeks prior to their study visits);
* Acute or uncontrolled medical or psychiatric conditions;
* Currently taking any medications that affect relevant metabolic enzymes or anti- inflammatory medications such as ibuprofen (this will be reviewed by study investigators on a case-by-case basis);
* Active infection (e.g., influenza, cold, respiratory infection, sinus infection) at the time of the visit;
* Pregnant or nursing or planning on becoming pregnant during the study;
* Unable to read and understand English.

Primary outcomes:
measure: Butadiene-DNA adducts in different ethnic groups
timeFrame: Day 1 & 2
measure: Butadiene-DNA adduct load in smokers with lung cancer
timeFrame: Day 1 & 2
measure: Polymorphisms of carnicogen metabolizing genes
timeFrame: Day 1 & 2
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Minnesota, Department of Psychiatry
name: Dorothy Hatsukami, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06073678: Photobiomodulation in Palate Wounds: Somatosensorial Evaluation
Official title: Photobiomodulation in Gingival Graft Donor Areas: Clinical, Somatosensory, and Quality of Life Evaluations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgical Wound
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the effects of photobiomodulation with red laser on gingival graft donor areas of the palate in comparison to only protection with wound dressing. The main questions it aims to answer are: Does photobiomodulation on the palate promote faster somatosensory recovery? Does photobiomodulation reduce pain in palate donor sites, improving the quality of life? Participants who need gingival graft surgeries will receive laser irradiation on the palate donor area or just protection with wound dressing. Data will be collected up to 60 days. Researchers will compare protection on the palate and protection plus laser irradiation to see if laser therapy may reduce pain and accelerate somatosensory normalization. Moreover, they will measure changes in the quality of life after treatment.


Eligibility criteria: Inclusion Criteria:

* Palate with normal and healthy mucosa
* Patient with indication of gingival graft surgery

Exclusion Criteria:

* Patients using prosthesis with palate coverage
* Former removal of gingival graft in the palate
* Smokers
* Pregnancy and breastfeeding mothers
* Use of anticonvulsants and immunosuppressors

Primary outcomes:
measure: Somatosensory recovery
timeFrame: 30 and 60 days postoperatively
Secondary outcomes:
measure: Assessment of Pain
timeFrame: 24 hours, 3 days, 7 days and 14 days
measure: Measurement of Quality of life
timeFrame: Baseline, 7 days and 14 days postoperatively
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: Bauru School of Dentistry
state: São Paulo
Study officials:
References:
citation: Zhao H, Hu J, Zhao L. The effect of low-level laser therapy as an adjunct to periodontal surgery in the management of postoperative pain and wound healing: a systematic review and meta-analysis. Lasers Med Sci. 2021 Feb;36(1):175-187. doi: 10.1007/s10103-020-03072-5. Epub 2020 Jul 1.
citation: Dias SB, Fonseca MV, Dos Santos NC, Mathias IF, Martinho FC, Junior MS, Jardini MA, Santamaria MP. Effect of GaAIAs low-level laser therapy on the healing of human palate mucosa after connective tissue graft harvesting: randomized clinical trial. Lasers Med Sci. 2015 Aug;30(6):1695-702. doi: 10.1007/s10103-014-1685-2. Epub 2014 Nov 6.
Clinical trial NCT04366778: Thrombosis and Covid-19
Official title: Evaluation of TEM-tPA (Thromboelastometry With tPA) to Detect Covid-19 Patients at High Risk of Thrombosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombosis
Covid-19
SARS-CoV 2
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 341
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 confirmed diagnosis of Covid-19 (PCR test positive or clinical signs associated with lung CR scan showing typical Covid-19 manifestation)

Brief summary: The coronavirus disease of 2019 (COVID-19) is a viral illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), now deemed a pandemic by the World Health Organization. Some COVID-19 patients may develop coagulopathy which is associated with poor prognosis and high risk of thrombosis. Some patients develop severe thrombotic complications, such as pulmonary embolism, despite anti-thrombotic prophylaxis by low molecular weight heparin. The aim of this project is to evaluate modified thromboelastometry for identifying patients at high risk of thrombosis. The hypothesize is that hypofibrinolysis with increased plasma PAI-1, TAFI (thrombin-activatable fibrinolysis inhibitor ) levels in association with high thrombin generation may explain high incidence of thrombosis in this population. A simple laboratory assay, widely available in hospitals, such as thromboelastometry, might be of great clinical interest to detect Covid-19 patients with high risk of thrombosis. In order to make ROTEM more sensitive to hypofibrinolysis, exogenous t-PA will be added in the assay. The preliminary results showed that patients with Covid-19 have significant hypercoagulability detectable with ROTEM and Covid-19 patients with thrombosis have both hypercoagulability and hypofibrinolysis.


Eligibility criteria: Inclusion Criteria:

* Patients with Covid-19
* non-opposition of the patient to participate

Exclusion Criteria:

* Non-Covid-19 acute respiratory distress syndrome
* Non-Covid septicemia
* Pregnant women
* Breastfeeding women
* Protected vulnerable adults

Primary outcomes:
measure: Coagulability
timeFrame: Day 0
measure: Coagulability
timeFrame: Day 3
measure: Coagulability
timeFrame: Day 6
measure: Coagulability
timeFrame: Day 9
measure: Coagulability
timeFrame: Day 12
measure: Coagulability
timeFrame: Day 15
measure: Venous thrombotic event (VTE) or arterial thrombosis
timeFrame: Day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Louis Pradel
Study officials:
References:
Clinical trial NCT04113278: Role of Fibirnogen Like Protein 2 as Aprognostic Factor in High Grade Glioma
Official title: Role of Fibirnogen Like Protein 2 as Aprognostic Factor in High Grade Glioma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Tumor Adult
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population was selected from high grade glioma pateints attending the Department of Clinical Oncology, Assiut University hospital during the period from December 2018 to September 2020, we analyzed human high grade gliomas paraffin block for FLG2 expression

Brief summary: The study population was selected from high grade glioma pateints attending the Department of Clinical Oncology, Assiut University hospital during the period from December 2018 to September 2020, we analyzed human high grade gliomas paraffin block for FLG2 expression

Detailed description: Glioblastoma is the most common malignant primary brain tumor in adults, and despite aggressive treatment, it is incurable Patient prognosis differs considerably within the different World Health Organization (WHO) grades, poorest prognosis for patients with the grade IV tumour- the glioblastoma multiform (GBM).

Fibrinogen-like protein 2 (FGL2),regulates both innate and adaptive immunity. FGL2 is a 439 amino acid secreted protein that is similar to the β- and γ-chains of fibrinogen.

Secreted FGL2 (sFGL2) is the key regulator in immunosuppression may play important role in malignant transformation of low to high by inhibiting the proliferation of T cell Study the role of fibrinogen-like protein2 on Immunosuppression and progression ，free survival and overall survival in high grade glioma

Eligibility criteria: Inclusion Criteria:

* Pateints\>18 years old
* Pathologically proven high grade glioma
* Total or subtotal resection of the tumor
* Patients received concurrent radiation therapy with temozolomide followed by adjuvant temozolamide for 6 months

Exclusion Criteria:

* Pregnancy
* Breast feeding
* Other comorbidity
* Previous malignancy or radiation therapy or chemotherapy

Primary outcomes:
measure: Rple of FGL2in high grade glioma as aprognostic factor
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Latha K, Yan J, Yang Y, Gressot LV, Kong LY, Manyam G, Ezhilarasan R, Wang Q, Sulman EP, Eric Davis R, Huang S, Fuller GN, Rao A, Heimberger AB, Li S, Rao G. The Role of Fibrinogen-Like Protein 2 on Immunosuppression and Malignant Progression in Glioma. J Natl Cancer Inst. 2019 Mar 1;111(3):292-300. doi: 10.1093/jnci/djy107.
citation: Yan J, Zhao Q, Gabrusiewicz K, Kong LY, Xia X, Wang J, Ott M, Xu J, Davis RE, Huo L, Rao G, Sun SC, Watowich SS, Heimberger AB, Li S. FGL2 promotes tumor progression in the CNS by suppressing CD103+ dendritic cell differentiation. Nat Commun. 2019 Jan 25;10(1):448. doi: 10.1038/s41467-018-08271-x.
Clinical trial NCT02795078: The Coexistence of Atherosclerotic Intracranial Arterial Stenosis With Intracranial Aneurysms
Official title: To Investigate the Coexistence of Atherosclerotic Intracranial Arterial Stenosis With Intracranial Aneurysms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atherosclerotic Intracranial Arterial Stenosis With Intracranial Aneurysms
Keywords: Atherosclerotic Intracranial Arterial Stenosis
Intracranial Aneurysms
Lead sponsor: Ministry of Science and Technology of the People´s Republic of China
Sponsor class: OTHER_GOV
Collaborators: name: National Clinical Research Center for Neurological Diseases
First posted: 2016-06-09
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient who had the coexistence of intracranial Arterial Stenosis With Intracranial Aneurysms were included in this study

Brief summary: Atherosclerotic intracranial arterial（ICA） stenosis and intracranial aneurysms are the common causes of ischemic stroke and hemorrhagic stroke, respectively. Investigators aimed to assess the prevalence of cerebral aneurysms in patients with atherosclerotic intracranial arterial stenosis.

Detailed description: Based on prospective data of patients with symptomatic or asymptomatic ICA stenosis admitted to Beijing Tiantan Hospital between Jan 2015 and July 2016, all patients underwent brain CTA / MRA/DSA. Investigators determined the number of the patients with intracranial aneurysms, calculated overall prevalence of the coexistence of atherosclerotic ICA stenosis with aneurysms and analyzed the clinical features.

Eligibility criteria: Inclusion Criteria:

1. DSA identified the coexistence of intracranial Arterial Stenosis With Intracranial Aneurysms
2. Stenosis caused by atherosclerosis

Exclusion Criteria:

1. patients do not agree
2. Stenosis caused by no atherosclerosis disease

Primary outcomes:
measure: new stroke events during perioperative period
timeFrame: perioperative period
Secondary outcomes:
measure: stroke events during follow up
timeFrame: 6 months after discharge
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT06739278: Individual Treatment of Ustekinumab in Perianal Fistulizing Crohn's Disease
Official title: Analysis for the Efficacy of Individual Treatment of Perianal Fistulizing Crohn's Disease With Ustekinumab
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Crohn Disease
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with perianal fistulizing Crohn's disease

Brief summary: This study intends to further explore the actual efficacy of ustekinumab in the individualized treatment of anal fistula Crohn's disease.

Detailed description: Participants in the study receive ustekinumab injections as part of routine medical care. The study just observes the efficacy retrospectively and does not interfere with treatment.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Perianal Fistulizing Crohn's Disease
* Receive ustekinumab therapy

Exclusion Criteria:

* Ustekinumab combined with hormones, immunosuppressants, other biologics or small molecule drugs
* Combined with other autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, Graves disease, etc.
* Combined with serious infectious diseases, such as active tuberculosis, EBV infection, cytomegalovirus infection, etc.
* Combined with malignant tumor
* Clinical data missing ≥30% or no follow-up

Primary outcomes:
measure: imaging remission rate of anal fistula
timeFrame: Treatment week 0 to 32
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References:
Clinical trial NCT06862778: Clinical Diagnosis of Diabetes Using Surface-enhanced Raman Spectroscopy Liquid Biopsy and Machine Learning
Official title: Clinical Diagnosis of Diabetes Using Surface-enhanced Raman Spectroscopy Liquid Biopsy and Machine Learning
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Sensing
SERS
Gold nanoparticles
Diagnositcs
Surface-enhanced Raman Spectroscopy
Lead sponsor: University Hospital, Aachen
Sponsor class: OTHER
Collaborators: name: University of Agriculture Faisalabad
name: Nishtar Medical University
First posted: 2025-03-06
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This project aims to adapt the gold nanoparticle-based surface-enhanced Raman spectroscopy (SERS) technology to clinical application. In this exploratory study, a measurement protocol will be established to investigate whether SERS (combined with multivariate data analysis or machine learning algorithms) allows the diagnosis of patients with diabetes.

Detailed description: This study on the clinical application of surface-enhanced Raman spectroscopy (SERS) comprises two parts. First, a SERS measurement protocol will be developed to enhance the interactions between gold nanoparticles and the components of the patient's samples, maximizing Raman spectroscopical signatures. Given the complex composition of human blood, which encompasses numerous biological constituents, the study focuses on serum, a component obtained through centrifugation after removing cells and clotting factors. Fifteen spectra will be recorded per sample. The raw spectra will be post-processed, including removal of the substrate signal, baseline correction, vector normalization, and smoothing steps.

The SERS measurement protocol established in the first section will subsequently be applied to samples of healthy and diabetes patients. Two different approaches will be followed. First, multivariate data analysis will be performed to identify distinctive feature characteristics in the samples that correlate to their group (healthy and diabetes patients), allowing patient diagnosis. Second, different machine learning algorithms and data augmentation strategies will be explored for better patient diagnosis.

Eligibility criteria: Inclusion Criteria:

* Patient at Nishtar Medical University
* Patient age from 18 to 70 years
* Confirmed disease (for diabetic group)

Exclusion Criteria:

* Patients with severe concurrent diseases

Primary outcomes:
measure: SERS measurements to differentiate between healthy and diabetic patients
timeFrame: Through study competition, up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: RWTH Aachen university hospital
Study officials:
References:
Clinical trial NCT00175578: Detection of Early Lung Cancer by Serum Protein Expression Profiling
Official title: Differences in SELDI Produced Serum Protein Profiles of Non-small Cell Lung Cancer Patients Compared to Healthy Heavy Smoking Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-small Cell Lung Cancer
Keywords: Early stage (0/I) non-small cell lung cancer
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 220
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with non-small cell lung cancer and healthy heavy smoking adults.

Brief summary: Promising new technology exists to examine small proteins that are shed by cancers into the blood stream. The purpose of this study is to see if there are differences in the proteins and protein levels in blood from individuals with early stage lung cancer compared to healthy adults.

Detailed description: A prospective longitudinal patient-based pilot study is proposed whereby surfaced enhanced laser desorption ionization time-of-flight mass spectroscopy (SELDI-TOF-MS) will be used to discover and validate serum proteomic expression profiles diagnostic of early lung cancer. A unique approach will be used to compare the serum proteomic expression profiles of patients with non-small cell lung cancer compared to healthy heavy smoking adults, as well as differences before and after anatomic pulmonary resection with curative intent. Discriminatory proteins will be selected by their differential expression before compared to after surgical removal of a tumor. The protein profile of blood obtained from the draining pulmonary vein at the time of resection will be used to identify materials potentially shed by the tumor that may serve as biomarkers in peripheral blood. The serum samples will be used to develop a training data set and then a test set for validation using a class prediction model. Candidate proteomic patterns will then serve as a basis for a larger prospective multi-centre clinical trial.

Eligibility criteria: Inclusion Criteria:

* Presence of early stage non-small cell lung cancer
* Elective surgical resection of lung lesion at Vancouver General Hospital (VGH)
* No preoperative chemoradiation therapy
* No previous cancer
* Ability to provide informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital BC Cancer Agency
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: John Yee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05816278: The Association Between Anemia and Cardiomegaly
Official title: The Association Between Anemia (Hemoglobin Level) and Cardiomegaly Based On Chest Radiograph and Echocardiography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anemia in Children
Cardiomegaly
Lead sponsor: Universitas Sumatera Utara
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 56
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All children diagnosed with anemia; whether from the pediatric ward and pediatric cardiology outpatient clinic

Brief summary: Anemia is one of the major global problems that continues to this day. According to World Health Organization (WHO) data, anemia is found in 1.62 billion people or equivalent to 24.8% of the world's population while, the prevalence of anemia in children under 6 years of age in Indonesia reached 38.4%. Anemia, if undiagnosed or untreated for a long period of time can lead to multiorgan failure. The cardiovascular system is the most commonly affected system in chronic anemia. Between one-third and two-thirds of patients with severe anemia have cardiomegaly and this will return to normal within a few weeks after the anemia is well managed. This abnormality can be evaluated on chest radiograph or echocardiography.


Eligibility criteria: Inclusion Criteria:

* Anemia patients aging maximum 18 years old
* Anemia patients who had undergone chest radiograph and echocardiography

Exclusion Criteria:

* Anemia patients who had undergone definitive surgery
* Anemia patients who had took iron supplementation in the last 3 months
* Anemia patients who had other anemic conditions such as chronic kidney disease or hemolytic anemia

Primary outcomes:
measure: Anemia
timeFrame: April 2023 - September 2023
measure: Cardiomegaly
timeFrame: April 2023 - September 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Medan
country: Indonesia
facility: Universitas Sumatera Utara
state: North Sumatera
Study officials:
References: