louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04827511: Refractive Disorders and Seric Vitamin D Level in Children With Disabilities
Official title: Refractive Disorders and Seric Vitamin D Level in Children With Disabilities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child, Only
Keywords: disability, healthy
Lead sponsor: Elisantes Teola SRL
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 161
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 80 children with disabilities like ADHD, autism, Down syndrome, deafness, phocomelia and 81 clinically healthy children

Brief summary: The investigator want to determine the refractive status of 80 children with disabilities and of 81 healthy children from a witness group. The vitamin D level of the children will be dosed for making different correlations with visual acuity status.

Detailed description: Refraction measurement will be done by the investigator in all 161 children. Visual acuity is checked, initial and after correction with proper correction. Vitamin D level is dosed from all the children in order to make correlations with the visual acuity, refractive status and risk for visual impairment.

Eligibility criteria: Inclusion Criteria:

* children with disabilities and healthy children

Exclusion Criteria:

* children diagnosed with another chronic diseases

Primary outcomes:
measure: Refractive disorders in children with disabilities
timeFrame: 1 January 2019-31 August 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Marghita
country: Romania
facility: Holhoș Larisa Bianca
state: Bihor
Study officials:
affiliation: Faculty of Medicine and Pharmacy Oradea
name: Holhoș L Bianca, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02696811: The Effects of Foods on Cell Damage Study
Official title: Randomised 6-week, Parallel Group, Placebo Controlled Intervention Trial to Investigate the Effects of White Carrots on Inflammatory Markers and Lymphocyte DNA Damage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: DNA Damage
Inflammation
Keywords: cancer
inflammation
dietary intervention trial
Lead sponsor: Newcastle University
Sponsor class: OTHER
First posted: 2016-03-02
Enrollment: 38
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Studies have shown that certain compounds inside vegetables can reduce the risk of cancer. Carrots in particular have an association with reduced incidence of colorectal, bladder and breast cancer. Compounds in carrots, called polyacetylenes, have been studied in isolated cells that have shown a reduction in cancer cells as well as inflammatory markers which have been associated with an increased risk of cancer. These polyacetylenes have not been well studied in the human body and it is unclear whether they are able to affect the biomarkers of health (disease) including DNA damage and inflammatory markers. The aim of this research project is to determine whether eating a portion of white carrots every day for 6 weeks can lead to a reduction in DNA damage and inflammatory markers compared to a control period of 6 weeks consuming a polyacetylene-free diet and a control food of a high fibre oat biscuit.


Eligibility criteria: Inclusion Criteria:

* Non -smokers
* BMI between 18.5 and 30

Exclusion Criteria:

* smoking
* taking anti-inflammatories
* taking aspirin or aspirin-like drugs
* antibiotic use in the last 3 months
* metabolic conditions or conditions affecting the metabolism or digestion

Primary outcomes:
measure: Change in lymphocyte DNA damage from baseline after 6 weeks of carrot or oat supplementation in the diet, and after 6 weeks wash out (no carrots or oats).
timeFrame: Baseline measures then 2 periods of 6 weeks (baseline, intervention and wash out)
measure: Change in inflammation from baseline after 6 weeks of carrot or oat supplementation in the diet, and after 6 weeks wash out.
timeFrame: Baseline measures then 2 periods of 6 weeks (baseline, intervention and wash out)
Secondary outcomes:
measure: Analysis of faecal water from baseline after 6 weeks of carrot or oat supplementation in the diet, and after 6 weeks wash out to determine toxicity to colon epithelial cells.
timeFrame: Baseline measures then 2 periods of 6 weeks (baseline, intervention and wash out)
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Agriculture Building, Newcastle University
state: Tyne and Wear
Study officials:
affiliation: Newcastle University
name: Kirsten Brandt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04224311: Immunogenicity of Quadrivalent Meningococcal Conjugate Vaccine in Frequent Platelets Donors
Official title: Immunogenicity of Quadrivalent Meningococcal Conjugate Vaccine in Frequent Platelets Donors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Preventive Immunization; Meningitis
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study, the investigators will evaluate the immunogenicity of a quadrivalent conjugate meningococcal vaccine in healthy, plateletpheresis donors.

Detailed description: This will be an open-label prospective vaccine response study evaluating one dose of MenACWY-D in plateletpheresis donors at the Brigham and Women's Hospital (BWH). Potential participants will be divided into three groups according to the number of plateletpheresis within 365 days of enrollment (including the day of enrollment): 1-2 sessions group (considered as the control group), 3-19 sessions group, 20-24 sessions group and randomly sampled from in allocation proportions of 0.45, 0.10, and 0.45, respectively; justification for this approach is provided in the Statistical Analysis section. MenACWY-D vaccine will be administered to each patient. Pre- and post-vaccination blood will be collected to assess immunogenicity, likely using serum bactericidal antibody (SBA) against Neisseria meningitidis for each serogroup. Immunogenicity will be primarily evaluated by seroresponse such as a fourfold increase of SBA titers between pre- and post-vaccination.

Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 years old or older
* Meet the standard requirements to donate platelets
* Have had at least one plateletpheresis in the prior 365 days (including the day of enrollment)

Exclusion Criteria:

* Participants who donated platelets in any other medical center in the previous 365 days
* Severe allergic reaction to a previous meningococcal vaccine or to any component of MenACYW-D
* History of Guillain-Barré syndrome

Primary outcomes:
measure: Seroresponse of vaccine
timeFrame: Months 1 and 6.
Secondary outcomes:
measure: Seroprotection
timeFrame: Months 1 and 6.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Lindsey Baden, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06039111: Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma
Official title: Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma: The IGNITE-V Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Vulvar Cancer
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
Collaborators: name: Juravinski Cancer Centre Foundation
First posted: 2023-09-15
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to confirm prospectively if the use of near infrared-indocyanine green (NIR-ICG) alone offers similar accuracy and sensitivity to the gold standard dual technique for sentinel lymph node detection in early stage vulvar cancer.


Eligibility criteria: Inclusion Criteria:

Adult women (18 years of age) with FIGO Stage IB (\> 1 mm depth of invasion) and small Stage II (4 cm) vulvar squamous cell carcinoma or cutaneous melanoma who are candidates for the Sentinel lymph node technique will be included (Negative clinical groin examination and/or imaging and primary unifocal vulvar tumor size of \< 4 cm).

Exclusion Criteria:

Women with a prior history of pelvic, vulvovaginal or inguinal radiation, with allergy or hypersensitivity to Technetium or ICG, or Bartholin gland cancer will be excluded.

Primary outcomes:
measure: false-negative rate of the detection technique using ICG alone compared to ICG and Technetium (Dual method) per groin
timeFrame: 2 years
Secondary outcomes:
measure: 1. The proportion of positive SLN detected by ICG for each groin divided by the total number of positive SLN detected using ICG and Technetium.
timeFrame: 2 years
Other outcomes:
measure: 2. The proportion of groins for which all SLN extracted were identified by ICG.
timeFrame: 2 years
measure: 3. The proportion of SLN extracted by ICG for each groin divided by the total number of SLN extracted using ICG and Technetium.
timeFrame: 2 years
measure: 4. Rate of successful mapping of at least 1 SLN (per groin)
timeFrame: 2 years
measure: 5. The specificity of positive SLN detected and number of SLN extracted by ICG will also be calculated, looking at the number of SLN which were detected by ICG alone.
timeFrame: 2 years
Locations:
Study officials:
References:
Clinical trial NCT06967311: Human and Microbial Determinants of the Onset of IBD Flares
Official title: Microbial and Human Determinants of the Onset of IBD Flares
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: IBD (Inflammatory Bowel Disease)
Keywords: observational
IBD
microbiome
Lead sponsor: Viome
Sponsor class: INDUSTRY
Collaborators: name: Universidade Federal de Santa Catarina
First posted: 2025-05-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults diagnosed with Crohn's Disease or Ulcerative Colitis that are patients at Universidade Federal de Santa Catarina (UFSC) Hospital and under care of Dr. Vivian Menegassi

Brief summary: This study will collect longitudinal biological samples and survey data to identify the triggers of IBD flares.

Detailed description: This is a longitudinal observational study whose goals are to identify:

Microbial and human molecular triggers of IBD relapses, Microbial and human molecular pathways strongly associated with flares that could be targeted with nutrition with a therapeutic potential, Biomarkers of IBD for Dx purposes, Identify microbial functions associated with release of BH4.

Eligibility criteria: Inclusion Criteria:

* Patient at Universidade Federal de Santa Catarina (UFSC) Hospital, under care of Dr. Vivian Menegassi

Exclusion Criteria:

* Cancer Diagnosis/Treatment
* Under 18 years old

Primary outcomes:
measure: Stool microbial KEGG orthologs (KOs) associated with IBD
timeFrame: For 12 months from enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Florianópolis
country: Brazil
facility: LABOX, Department of Biochemistry, Universidade Federal de Santa Catarina
state: Santa Catarina
Study officials:
References:
Clinical trial NCT05779111: A Retrospective Analysis: Whether Five Factors Affect PFS in Patients With Locally Advanced Cervical Cancer
Official title: A Retrospective Analysis: Whether Five Factors Affect PFS in Patients With Locally Advanced Cervical Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Locally Advanced Cervical Cancer
Radiotherapy
Lead sponsor: Chongqing University Cancer Hospital
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 183
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From May 2016 to July 2021, 183 patients with locally advanced cervical cancer received radiotherapy in our hospital ,with or without chemotherapy.Patients were scored according to 5 factors. PFS were compared between patients with scores greater than or equal to 3 points and those with scores less than 3 points. PFS is defined as the time from the end of treatment to disease progression or the time of the last follow-up 2022-10-01.

Brief summary: In previous studies, the investigators found that five factors were effective in predicting the probability of locally advanced cervical cancer with para-aortic lymph node metastasis.A retrospective study was conducted to explore the influence of 5 factors on PFS in patients with locally advanced cervical cancer receiving radiotherapy and chemotherapy.

Detailed description: In previous studies, the investigators found that five factors were effective in predicting the probability of locally advanced cervical cancer with para-aortic lymph node metastasis.5 factors included positive iliac lymph nodes, histological type, tumor size, positive pelvic lymph nodes on both sides, and maximum lymph node diameter greater than 1cm. Different factors give different scores.If the score is higher than 3, the probability of retroperitoneal lymph node metastasis in patients with locally advanced cervical cancer is significantly increased, and the prognosis of patients is affected. Patients with locally advanced cervix receiving radical radiotherapy were scored based on 5 factors.Patients with scores greater than or equal to 3 points were compared with patients with scores less than 3 points.

Eligibility criteria: Locally advanced cervical cancer patients receiving radiotherapy

Primary outcomes:
measure: Progression Free Survival（PFS）
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
state: Chongqing
Study officials:
affiliation: Chongqing University Cancer Hospital Chongqing, Chongqing, China,
name: Zou Dongling, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06829511: BARRIERS TOWARDS PHYSICAL ACTIVITY
Official title: BARRIERS TOWARDS PHYSICAL ACTIVITY IN CARDIAC PATIENTS
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiac Patients
Lead sponsor: Bahria University
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 323
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cardiac patients

Brief summary: A cross-sectional study of 323 cardiac patients aged 40 to 60 will be carried out at PNS Shifa and the National Institute of Cardiovascular Diseases. Data will be gathered using surveys and evaluated with SPSS software. The results are likely to show considerable differences in barrier frequency across demographic groups, offering insights into targeted treatments.

Understanding these limitations is critical for establishing successful physical activity regimens, improving heart health, and, eventually, lowering rehospitalization rates. The findings will help to develop specific approaches to overcome these challenges and encourage regular physical exercise among cardiac patients.

Objectives:

1. To identify and categorize the specific barriers to physical activity faced by cardiac patients.
2. To analyze how these barriers differ among various demographic groups (e.g., age, gender).
3. To examine how barriers to physical activity vary according to clinical characteristics.

Methodology:

Using a cross sectional study design, data data was collected from NICVD hospital and PNS shifa hospital by providing questionnaires to patient having cardiac disease. The questionnaires comprises of close ended questions.


Eligibility criteria: Inclusion Criteria:

* 1. Heart patients who have been diagnosed with a cardiovascular condition for more than six months.

  2. People between the ages of forty and sixty. 3. It was acceptable to have both male and female participants. 4. Patients either already participating in a cardiac rehabilitation program or those who had yet to engage in one were included.

Exclusion Criteria:

1. Existence of musculoskeletal disorders that might affect their physical activity levels.
2. Neurological conditions that could hinder exercise participation or influence responses to surveys.
3. Chronic illnesses such as diabetes or irritable bowel syndrome that could interfere with the barriers evaluated in the study.

Primary outcomes:
measure: risk factors
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Sutherland S, Penfold R, Doherty A, Milne Z, Dawes H, Pugh C, Boulton M, Newton JL. A cross-sectional study exploring levels of physical activity and motivators and barriers towards physical activity in haemodialysis patients to inform intervention development. Disabil Rehabil. 2021 Jun;43(12):1675-1681. doi: 10.1080/09638288.2019.1672214. Epub 2019 Oct 24.
Clinical trial NCT02976311: Comparison of Inflammatory Responses Subsequent to Different Cesarean Section Techniques
Official title: Comparison of Inflammatory Reactions Following Two Different Cesarean Surgery Techniques; The Modified Misgav-Ladach Versus the Pfannenstiel-Kerr Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delivery
Cesarean Delivery
Inflammation
Keywords: inflammatory reaction
IL-6
TNF
Misgav Ladach technique
Pfannenstiel-Kerr technique
cesarean delivery
cesarean technique
Lead sponsor: Kayseri Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2016-11-29
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In this study, the investigators aimed to find out whether there are any differences in inflammatory reactions occured subsequent to two different cesarean delivery techniques; modified Misgav-Ladach vs Pfannenstiel-Kerr techniques.

Detailed description: Cesarean section is one of the most undertaken operations in women of childbearing age. However, there is not a unique cesarean surgery technique. Pfannenstiel , reported his own technique in 1897. Because of the applicability of the technique, it went down well among obstetricians. After three decades, Kerr evolved this technique, and Pfannenstiel-Kerr technique became the method of choice until late 70's. In 1972, Stark et al defined the Misgav Ladach technique and in the following years this technique became popular among obstetricians. In late 80's Misgav Ladach technique was modified and started to be more popular. But, still Pfannenstiel-Kerr technique continued to be used frequently and studies comparing clinical outcomes of these two techniques were conducted for several times. However, the inflammatory responses which occured subsequent to application of these techniques were not investigated. This is the first study investigating the inflammatory response emerged after different cesarean surgery techniques.

Eligibility criteria: Inclusion Criteria:

* Cesarean section for the first time
* Term,singleton pregnancy

Exclusion Criteria:

* Any inflammatory disease
* Any pregnancy complication; IUGR,preeclampsia,preterm labor,preterm premature rupture of membranes
* Pregnancies \<37weeks gestational age

Primary outcomes:
measure: IL-6
timeFrame: 24 hours
measure: TNF-alpha
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02690311: A Study on the Changes of the Biological Rhythm by Display Image Modulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Circadian Rhythm Phase Shift
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-02-24
Enrollment: 22
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: Effects of Smartphone Use at Night with Light Emitting Diode Display With and Without Blue Light in Healthy Adults: A Randomized, Double-blind, Cross-over, Placebo-controlled Comparison


Eligibility criteria: Inclusion Criteria:

(1) Healthy males 20-40 years of age who understood the study procedure and agreed to participate after being fully informed about the study were included.

Exclusion Criteria:

1. psychiatric diseases according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria;15
2. cognitive or neurological disorders;
3. alcohol or substance abuse;
4. unstable or serious medical illness;
5. current use of psychoactive mediations including antidepressants, anxiolytics, neuroleptics, anticonvulsants, hypnotics, or stimulant medications;
6. primary sleep disorder;
7. habitual sleep onset earlier than 21:00 or later than 24:00;
8. shift worker;
9. travel across more than two time zones within 90 days of the study; and
10. ophthalmologic disease during the study period.

Primary outcomes:
measure: Changes of serum melatonin
timeFrame: serum melatonin levels were measured every 60 min from 7:00 PM on day 1 to 8:00 AM on day 2, from 7:00 PM on day 2 to 8:00 AM on day 3, and from 7:00 PM to 11:00 PM on day 3 for 3 days.
measure: Changes of serum cortisol
timeFrame: cortisol levels were measured every 120 min from 7:00 PM on day 1 to 8:00 AM on day 2, from 7:00 PM on day 2 to 8:00 AM on day 3, and from 7:00 PM to 11:00 PM on day 3 for 3 days.
measure: Changes of body temperature
timeFrame: body temperature was measured every 120 min from 7:00 PM on day 1 to 8:00 AM on day 2, from 7:00 PM on day 2 to 8:00 AM on day 3, and from 7:00 PM to 11:00 PM on day 3 for 3days.
Secondary outcomes:
measure: profile of mood states(POMS)
timeFrame: day 1,3
measure: Epworth Sleepiness Scale(ESS)
timeFrame: day 1,3
measure: Fatigue severity scale(FSS)
timeFrame: day 1,3
measure: continuous performance test(CPT)
timeFrame: day1,3
Other outcomes:
Locations:
Study officials:
References: