louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06220305: DNA Methylation Combined With Artificial Intelligence Imaging to Identify Lung Nodules
Official title: DNA Methylation Combined With Artificial Intelligence Imaging for Early Benign and Malignant Differentiation of Lung Nodules:an Observational,Single-center Clinical Trial(MAGIC Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer Diagnosis
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with single pulmonary nodule found by CT scan.

Brief summary: Lung cancer is the leading cause of cancer deaths,and the key to reducing mortality in lung cancer patients is early diagnosis and treatment.Currently,peripheral blood DNA methylation is a novel in vitro molecular marker for tumors.Meanwhile artificial intelligence diagnostic system can further improve the diagnostic ability.The purpose of this study is to apply the overall DNA methylation level (i.e.,methylation profile) and the altered methylation degree of specific genes as tumor diagnostic indexes,and combined with the artificial intelligence imaging technology for the early and accurate diagnosis of lung cancer,to achieve the early detection,diagnosis,and treatment of lung cancer,and to effectively reduce the mortality rate of lung cancer.


Eligibility criteria: Inclusion Criteria:

* (1) Patients with pulmonary nodules diagnosed by imaging;
* (2) No contraindications to blood collection;
* (3) Voluntary completed DNA methylation testing;
* (4) Signed informed consent and performed all the study mandated procedures.

Exclusion Criteria:

* (1) Pregnant or lactating(6 months) women;
* (2) History of malignancy or known malignancy or precancerous lesions or known tuberculosis within 3 years;
* (3) Autoimmune system disorders;
* (4) Undergoing any diagnostic puncture therapy, such as percutaneous lung biopsy, transbronchial, pre-enrollment biopsy, or surgical procedures (within 6 months); (5) Recipients of organ transplants or prior non-autologous (allogeneic) bone marrow transplants or stem cell transplants; (6) Received antibiotic therapy within 14 days or applied a drug that elevates white blood cells within 45 days prior to the blood draw.

Primary outcomes:
measure: Efficacy of early diagnosis of benign and malignant lung nodules by blood DNA methylation results combined with AI imaging
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT02985905: The Effect of Oral Zinc Supplementation on Thiol Oxido-reductive Index
Official title: The Effect of Oral Zinc Supplementation on Thiol Oxido-reductive Index and Thiol Related Enzymes in Spermatozoa of Iraqi Asthenospermic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthenozoospermia
Keywords: Zinc supplementation
Thiol
Glutathione peroxidase
Sulfhydryl oxidase
Lead sponsor: Babylon University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Iraq
First posted: 2016-12-07
Enrollment: 120
Sex: MALE
Minimum age (years): 26
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although several studies have considered the relationship between infertility and semen thiol compounds levels, no study on the effects of asthenospermia treatments such as oral zinc supplementation on thiol related enzymes activity which are important in fertility of the individual has been reported.

Detailed description: The present study was conducted to study the effect of zinc supplementation on the quantitative and qualitative characteristics of semen along with reduced thiol, oxidized thiol and thiol related enzymes in the seminal plasma of asthenospermic patients.

Eligibility criteria: Inclusion Criteria:

* The presence of asthenozoospermia in the semen sample.

Exclusion Criteria:

* The absence of endocrinopathy, varicocele, and female factor infertility. Smokers and alcoholic men were excluded from the study because of their recognized high seminal ROS levels and decreased antioxidant levels.

Primary outcomes:
measure: Thiol oxido-reductive index levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Thiol oxido-reductive index levels.
timeFrame: up to three months.
Secondary outcomes:
measure: Glutathione peroxidase activity levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Glutathione peroxidase activity levels.
timeFrame: up to three months.
measure: Sulfhydryl oxidase activity levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Sulfhydryl oxidase activity levels.
timeFrame: up to three months.
Other outcomes:
Locations:
city: Hilla
country: Iraq
facility: Mahmoud Hadwan
state: Babylon
Study officials:
affiliation: Babylon University
name: Mahmoud Hadwan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Babylon University
name: L Almashhedy, PhD
role: STUDY_DIRECTOR
affiliation: Babylon University
name: Alsalman Abdulrrazaq, PhD
role: STUDY_CHAIR
References:
citation: Alsalman ARS, Almashhedy LA, Hadwan MH. Effect of Oral Zinc Supplementation on the Thiol Oxido-Reductive Index and Thiol-Related Enzymes in Seminal Plasma and Spermatozoa of Iraqi Asthenospermic Patients. Biol Trace Elem Res. 2018 Aug;184(2):340-349. doi: 10.1007/s12011-017-1215-8. Epub 2017 Dec 8.
Clinical trial NCT03907605: Anti-Mullerian Hormone (AMH) is a Marker for Ovarian Reserve. There Are Many Studies About AMH Changes in Ovarian Surgery, But Little is Known for Other Surgeries. We Seek to Investigate the Hormone Variations Before and After Uterine Artey Ligation for Postpartum Hemorrage (PPH)
Official title: Comparison of Serum Anti-Mullerian Hormone Levels Following Uterine Artery Ligation for PPH.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anti-Mullerian Hormone Deficiency
Post Partum Hemorrhage
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who need artery ligation for PPH during C-section.

Brief summary: Anti-Mullerian hormone (AMH) is a marker for ovarian reserve. There are many studies about AMH changes in ovarian surgery, but little is known for other surgeries. We seek to investigate the hormone variations before and after uterine artey ligation for postpartum hemorrage (PPH)

Detailed description: All patients belong to the same group. The blood samples will be collected at the time of surgery and 3 months after surgery from the patients who need uterine artery ligation for PPH. The blood samples will be centrifuged within 2 hours after being obtained and assessed on the same day. AMH concentrations will be measured with an enzymatically amplified two-sided immunoassay

Eligibility criteria: Inclusion Criteria:

* age 18- 40 years
* no systemic or endocrine diseases
* patients who had uterine artery ligation due to PPH

Exclusion Criteria:

* Pregnancy with IVF or oosit donation
* Patients with endocrinopathy, diseases which require radiotherapy and chemotherapy etc.
* Patients with BMI \>40

Primary outcomes:
measure: 1- Anti-Mullerian Hormone levels variation
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Pinar Yalcin Bahat
state: İ̇stanbul
Study officials:
References:
Clinical trial NCT03482505: Rainbow Acoustic Monitoring (RAM) in Patients Weighing up to 10kg Comparison Study
Official title: Rainbow Acoustic Monitoring (RAM) in Patients Weighing up to 10kg Comparison Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiration Rate
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2018-03-29
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of this clinical investigational study is to compare the acoustic respiration rates (RRa) obtained using the INVSENSOR0004 sensor in the subjects up to 10 kg with the respiration rates determined by manual annotations (RRref), and when applicable with capnography respiration rate (RRcap).


Eligibility criteria: Inclusion Criteria:

* Subjects weighing up to 10kg
* Subjects will be inpatients and/or outpatients admitted to the NICU (Neonatal Intensive Care Unit) or PICU (Pediatric Intensive Care Unit) or PACU (Post-Anaesthesia Care Unit)
* The parent/legal guardian has given written informed consent/assent to participate in the study.

Exclusion Criteria:

* Subjects with underdeveloped skin
* Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, infections, abnormalities, etc.
* Subjects deemed not suitable for the study at the discretion of the investigator.

Primary outcomes:
measure: Accuracy of Acoustic Respiration Rate (RRa)
timeFrame: One study visit lasting up to 60 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Dallas
country: United States
facility: Children's Medical Center Dallas
state: Texas
Study officials:
References:
Clinical trial NCT01784705: Transcranial Bright Light Therapy in Seasonal Affective Disorder (SAD)
Official title: Transcranial Bright Light Therapy in Seasonal Affective Disorder (SAD)- a Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seasonal Affective Disorder (SAD)
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2013-02-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bright light therapy (BLT) has been found to be effective in treatment of seasonal affective disorder (SAD). The mechanism of action of conventional BLT in the treatment of SAD is under debate. Recently, transcranial bright light (TBL) via ear canals has been proved to modulate the neural networks of the human brain and improve cognitive performance in healthy subjects. Moreover, TBL has been found to alleviate symptoms of SAD in open trial. In this case the investigators will study the effect of transcranial bright light treatment via ear canals on depressive and anxiety symptoms in patients suffering from SAD in randomized controlled double-blind study design.


Eligibility criteria: Inclusion Criteria:

* patient has (according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision \[DSM-IV-TR\]) a Major depression, recurrent episode, seasonal pattern
* Structured Interview Guide for the Hamilton Depression Rating Scale - Seasonal Affective Disorder Version Self Rating Version (SIGH-SAD-SR) score ≥ 16
* patient is over 18 years and under 66 years
* patient can read and understand the subject information sheet
* patient has signed the informed consent form
* patient is not pregnant

Exclusion Criteria:

* patient has a lifetime psychotic disorder
* patient has a bipolar disorder
* patient has alcohol or some other substance use dependence or misuse
* patient has some unstable somatic disorder
* patient uses some psychotropic agencies
* patient is, in the opinion of the investigator, unsuitable for any reason
* patient is a member of the site personnel or their immediate families
* patient has administered bright light therapy via ear canals during the current episode

Primary outcomes:
measure: Structured Interview Guide for the Hamilton Depression Rating Scale - Seasonal Affective Disorder Version Self Rating Version, total score ≤9
timeFrame: At the end of the four week study period
Secondary outcomes:
measure: Beck Depression Inventory-II, total score <=10
timeFrame: At the end of the four week study period
measure: State Trait Anxiety Inventory -Y2, total score
timeFrame: At the end of the four week study period
measure: Trail- making test (TMT-A and TMT-B),total time
timeFrame: At the end of the four weeks study period
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University
Study officials:
References:
Clinical trial NCT04249505: Refractive Accuracy of "2WIN" and Portable Autorefractors
Official title: The Refractive Accuracy of Photoscreeners "2WIN" and "PlusoptiX" and the "Retinomax" Auto Refractor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractive Error - Myopia Axial
Astigmatism
Accomodation
Visual Impairment
Hyperopia of Both Eyes
Keywords: photoscreening
photo refraction
auto refraction
spectacle dispensing
Lead sponsor: Alaska Blind Child Discovery
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 708
Sex: ALL
Minimum age (years): 6
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children and adults attending pediatric ophthalmology and adult strabismus clinic

Brief summary: Youth and some adults have photoscreening refractions and hand-held auto refraction before cycloplegia refraction during new and follow up eye examinations. Vector math is applied to each refraction to determine how closely the hand-held "dry" devices match actual refraction.

Detailed description: A closeness-of-fit algorithm utilizing vector transformations of astigmatism is designed and applied to 50-years of clinical international refractive experience.

As a part of new and follow up comprehensive eye examinations, patients and parents consented to confirm the cycloplegic refraction to other portable refractive tools.

The ability of photoscreeners "2WIN" ("Adaptica," Padova italy), "PlusoptiX A12" (Nuremberg, Germany) and "Retinomax" (Righton, Tokyo, Japan) to match actual refraction is assessed utilizing the new algorithm.

This algorithm could then be applied to batches of donated spectacles distend by charitable organizations worldwide if portable auto refracting devices are employed.

Eligibility criteria: Inclusion Criteria:

* Patient undergoing new or follow examination at pediatric eye and adult strabismus clinic Willing to undergo screening refractive device developmental delays included

Exclusion Criteria:

* Intraocular lens in place

Primary outcomes:
measure: Refractive Accuracy
timeFrame: 1 day
measure: Refractive Accuracy
timeFrame: 1 day
measure: Refractive Accuracy
timeFrame: 1 day
Secondary outcomes:
measure: Impact of age
timeFrame: 1 day
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Children's EYE & Strabismus
state: Alaska
Study officials:
affiliation: Coordinator Alaska Blind Child Discovery
name: Bob Arnold, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arnold SL, Arnold AW, Sprano JH, Arnold RW. Performance of the 2WIN Photoscreener With "CR" Strabismus Estimation in High-Risk Patients. Am J Ophthalmol. 2019 Nov;207:195-203. doi: 10.1016/j.ajo.2019.04.016. Epub 2019 May 9.
Clinical trial NCT05149105: Efficiency of Using Argon Plasma Coagulation in Weight Regain in Patients Following Gastric Bypass
Official title: Efficiency of Using Argon Plasma Coagulation in Weight Regain in Patients Following Gastric Bypass. Monocentric, Comparative, Randomized, Open Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bariatric Surgery Candidate
Lead sponsor: Saint-Gregoire Private Hospital Center
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Among the techniques of bariatric surgery, the gastric Y bypass according to Roux (RYGB) allows greater weight loss and more lasting over time than sleeve gastrectomy and gastric banding. However, around 20% of patients will regain weight within 24 months after surgery. Among the many mechanisms that lead to weight regain, we can mention distension of the gastric pouch and gastro-jejunal anastomosis. A reoperation is then necessary. Argan plasma coagulation intervention (APC) by endoscopy allows to reduce the caliber of the gastro-jejunal anastomosis. The aim of the study is to show the efficacy of APC associated with multidisciplinary medical management and to compare it with multidisciplinary medical management alone in weight regain of patients.


Eligibility criteria: Inclusion Criteria:

* Be between 18 and 65 years old.
* Have had a gastric bypass in Y more than 2 years ago
* Have a weight regain of more than 10% of the lowest weight after the first intervention.
* Have benefited from a multidisciplinary medico-psychological reassessment.
* Understand the interest of the study and agree to long-term follow-up.
* Agree to be included in the study and have signed a consent form in a free and informed manner.
* Be affiliated with health insurance.
* For female patients of childbearing potential, have an effective method of contraception

Exclusion Criteria:

* Presence of a disease unrelated to obesity that is life-threatening.
* Pregnancy or wish to become pregnant within the year.
* "Breastfeeding" patients
* Female patients of childbearing age and unable or unwilling to use an effective method of contraception
* Presence of an unhealed gastric ulcer or stenosis of the gastrointestinal anastomosis
* Presence of a psychiatric pathology compromising the proper understanding of the study or patient under guardianship or guardianship.
* Patient not understanding French or unable to give consent.
* Patient already included in a study or in conflict of interest with this study.

Primary outcomes:
measure: Comparison of the percentage change (loss) in excess weight from Day 0 to Month 12 between the 2 arms
timeFrame: Day 0 (before the intervention) and Months 12 (one year after Day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-gregoire
country: France
facility: CHP Saint-Grégoire
Study officials:
References:
Clinical trial NCT06115005: Treatment of Challenging Macular Holes Using Plasma Rich in Growth Factors
Official title: Treatment of Challenging Macular Holes Using Plasma Rich in Growth Factors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Macular Holes
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim of the Study:To report the structural and visual outcomes of plasma rich in growth factors in closure of challenging macular holes

Detailed description: Challenging full thickness macular holes ( FTMH) include :

Recurrent FTMH Persistent (refractory) FTMH Macular holes in eyes with pathological myopia Large macular holes with an inner diameter of more than 650 µm. Plasma rich in growth factors (PRGF) is characterized by a moderate concentration of platelets, in the absence of leukocytes.

This absence of leukocytes is based on the fact that they synthesize matrix metalloproteinases, free radicals, and proinflammatory cytokines, which do not contribute and even impair the altered tissue regeneration Aim of the Study:To report the structural and visual outcomes of plasma rich in growth factors in closure of challenging macular holes

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years
2. Challenging FTMH which include Recurrent macular holes Persistent(refractory) macular holes Macular holes in eyes with pathological myopia Large macular holes with an inner diameter of more than 650 µm

Exclusion Criteria:

* 1-Corneal opacities 2-Glaucomatous patients 3-Co-existing macular pathology ( e.g. diabetic retinopathy, vein occlusion and age related macular degeneration ) 4-History of PPV for any reason other than FTMH

Primary outcomes:
measure: Number of participants that revealed closure of challenging macular holes
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University Hospital
Study officials:
References:
citation: Mahmoud TH, Thompson JT. The Treatment of Difficult Macular Holes. Ophthalmol Retina. 2021 Apr;5(4):315-316. doi: 10.1016/j.oret.2021.02.002. No abstract available.
citation: Arias JD, Hoyos AT, Alcantara B, Sanchez-Avila RM, Arango FJ, Galvis V. PLASMA RICH IN GROWTH FACTORS FOR PERSISTENT MACULAR HOLE: A PILOT STUDY. Retin Cases Brief Rep. 2022 Mar 1;16(2):155-160. doi: 10.1097/ICB.0000000000000957.
Clinical trial NCT00517205: Study on 'The Use of Non-contrast Helical Computerized Tomogram in Predicting Treatment Outcomes of Upper Ureteric Stone by Extracorporeal Shock Wave Lithotripsy Using the Sonolith 4000+ Lithotripter'
Official title: The Use of Non-contrast Helical Computerized Tomogram in Predicting Treatment Outcome of Upper Ureteric Stone by Extracorporeal Shock Wave Lithotripsy Using the Sonolith 4000+ Lithotripter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ureteral Calculi
Keywords: upper ureteric stone
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2007-08-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient suffered upper ureteric stone

Brief summary: The purpose of this research is to assess the role of non-contrast helical computerized tomogram in predicting the treatment outcome of upper ureteric stone by extracorporeal shock wave lithotripsy (ESWL).


Eligibility criteria: Inclusion Criteria:

* Adult patient (\> 18 years old)
* With solitary upper ureteric stone (defined as ureter above the sacroiliac joint as seen on plain radiography) diagnosed by NCHCT \*(\* can have stones at the other site but the indexed stone is a solitary stone)
* Size 5 to 15 mm in the maximal diameter as measured from plain radiography.
* Planned for primary in-situ ESWL

Exclusion Criteria:

* Patient contraindicated for ESWL - active urosepsis, coagulopathy, pregnant lady etc
* Presence of percutaneous nephrostomy or ureteric stent
* Suspected distal obstruction

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Prince of Wales Hospital
Study officials:
affiliation: Department of Surgery, Division of Urology, The Chinese University of Hong Kong
name: Chi Fai Ng, Dr
role: PRINCIPAL_INVESTIGATOR
References: