louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05325905: Analysis of Gingival Crevicular Fluid
Official title: Analysis of Gingival Crevicular Fluid IL-1β, IL-10, IL-36γ Cytokine Levels in Gingivitis and Periodontitis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Keywords: pathogenesis
Gingival crevicular fluid
cytokine
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
Collaborators: name: Selcuk University
First posted: 2022-04-13
Enrollment: 81
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were selected from among admitting to Dentistry Faculty of Selcuk University.

Brief summary: The purpose of this study was to investigate and compare GCF interleukin-1β (IL-1β), interleukin-10 (IL-10), interleukin-36γ (IL-36γ) levels in patients with healthy (H), gingivitis (G) and chronic periodontitis (CP) status.

Detailed description: Gingival crevicular fluid (GCF) is formed when fluid exudes from the vessels of the microcirculation into the inflamed periodontal tissue and into the sulcus or pocket. As the fluid traverses the inflamed tissue, it is thought to pick up enzymes and other molecules that participate in the destructive process, as well as products of cell and tissue degradation. Efforts to develop diagnostic tests based on host factors have been focused almost entirely on analysis of GCF.

The purpose of this study was to investigate and compare GCF interleukin-1β (IL-1β), interleukin-10 (IL-10), interleukin-36γ (IL-36γ) levels in patients with healthy (H), gingivitis (G) and chronic periodontitis (CP) status.

Systemically healthy and non-smokers 80 participants (30 males and 50 females) who were selected from among admitting to Dentistry Faculty of Selcuk University were included in this study. Clinical periodontal parameters were recorded and GCF samples were obtained. Samples were stored in -80 ˚C until analysis with Enzyme-Linked ImmunoSorbent Assay (ELISA).

Eligibility criteria: Inclusion Criteria:

* Systemically healthy
* non-smokers,
* presence of at least 20 teeth in the mouth

Exclusion Criteria:

* receiving periodontal therapy in the last 6 months;
* receiving antibiotics or anti-inflammatory drugs in the last 6 months;
* currently pregnant or breastfeeding
* using a removable partial denture and removable or fixed orthodontic appliances.

Primary outcomes:
measure: Interleukin-36γ (IL-36γ) levels in GCF
timeFrame: Baseline
Secondary outcomes:
measure: Probing depth (PD)
timeFrame: Baseline
measure: Clinical attachment level (CAL)
timeFrame: Baseline
measure: Bleeding on Probing (BoP)
timeFrame: Baseline
measure: IL-10 and IL-1β levels in GCF
timeFrame: Baseline
measure: Plaque Index (PI)
timeFrame: Baseline
measure: Gingival Index (GI)
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Bezmialem University
name: Mehtikar Gürsel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03100305: Amino Acids Profiles in Premature Infants Receiving Nutritional Support
Official title: A Prospective Study of Amino Acids Profiles in Premature Infants Receiving Nutritional Support
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Infant
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 124
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants who experience various nutritional stages including total parenteral nutrition, partial parenteral nutrition and enteral nutrition

Brief summary: The aim of this study is to investigate the changes of amino acid metabolic profiles in different nutritional stages of preterm infants and determine the effects of nutritional intervention on the amino acid metabolic status of preterm infants.


Eligibility criteria: Inclusion Criteria:

Premature infants, and admitted to hospital within 24 hours after birth; Documentation of informed consent; In need of receiving parenteral nutrition after birth;

Exclusion Criteria:

Premature infants with a parenteral nutrition period of less than 3 days; Inborn error of metabolism; Chromosomal abnormalities or multiple malformations;

Primary outcomes:
measure: Amino acid profiles in blood
timeFrame: through the transition to enteral nutrition, an average of 1 month
Secondary outcomes:
measure: Weight
timeFrame: Until the corrected gestational age is 37 weeks or discharged
measure: Height
timeFrame: Until the corrected gestational age is 37 weeks or discharged
measure: Head circumference
timeFrame: Until the corrected gestational age is 37 weeks or discharged
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Zhenjuan He, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02710305: Oral Hyoscine Butyl Bromide With Cervical Lidocaine Cream in Reducing Pain During Hysterosalpingography
Official title: Randomized Clinical Trial of Oral Hyoscine Butyl Bromide With Cervical Lidocaine Cream in Reducing Pain During Hysterosalpingography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain Relief
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-03-16
Enrollment: 140
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: hysterosalpingography is a diagnosis procedure in the evaluation of infertile women and considered to be the traditional and the gold standard in the assessment of the patency of the fallopian tubes. The major disadvantage of hysterosalpingography is pain. In a study reported the patients complained of moderate to severe pain during the procedure. It is reported that some patients undergoing hysterosalpingography was more stressful and anxiety and effect on pain scores.


Eligibility criteria: Inclusion Criteria:

• The infertile women who indicated for HSG

Exclusion Criteria:

* contraindications to Hyoscine or lidocaine
* known sensitivity to contrast media
* abnormal uterine bleeding
* genital tract infection
* suspected pregnancy

Primary outcomes:
measure: Mean pain score during HSG
timeFrame: intraoperative
Secondary outcomes:
measure: Mean pain score after HSG
timeFrame: 30 minutes
measure: rate of side effects
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT05819905: Radiomics for prEdiction of lunG cAncer biologY
Official title: Prediction of Lung Cancer Characteristics Using PET/CT Radiomics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Small Cell Lung Cancer
PET/CT
PD-L1
Gene Mutation-Related Cancer
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Histologically proven NSCLC with molecular biology analysis and initial staging PET/CT

Brief summary: Therapeutic progress for subgroups of Non Small Cell Lung Cancer can largely be attributed to the accumulation of molecular knowledge and the development of new drugs that specifically target molecular abnormalities. An understanding of the immune landscape of tumors, including immune-evasion strategies, has also led to breakthrough therapeutic advances.These new options require prior treatment tumoral sampling to identify patients who have neoplasms with specific genomic aberrations or favorable immune environment. Medical imaging and radiomic approach may provides surrogate markers non invasively.The objective of the present retrospective study is to build and validate a predictive model of common molecular alterations and PD-L1 expression in NSCLC using pre treatment PET/CT derived radiomics.


Eligibility criteria: Inclusion Criteria:

* Histologically proven NSCLCC
* pre treatment 18F FDG PET/CT
* available molecular biology and histology results

Exclusion Criteria:

* non available PET/CT images

Primary outcomes:
measure: prediction of PDL1 expression
timeFrame: 1 month
measure: prediction of EGFR genomic alteration
timeFrame: 1 month
Secondary outcomes:
measure: Prediction of KRAS alteration
timeFrame: 1 month
measure: Prediction of BRAF mutation
timeFrame: 1 month
measure: Prediction of ALK/ROS translocation
timeFrame: 1 month
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU Poitiers
Study officials:
References:
Clinical trial NCT03945305: Safety and Efficacy of Remote Ischemic Conditioning Treatment for Community-based Essential Hypertension
Official title: Safety and Efficacy of Remote Ischemic Conditioning Treatment for Community-based Essential Hypertension: a Randomized, Parallel-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Essential Hypertension
Keywords: Essential Hypertension, Remote Ischemic Conditioning
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the efficacy and safety of remote ischemic conditioning for essential hypertension in the community population.

Detailed description: At present, stroke has become the leading cause of death in China, with hypertension being the primary risk factor and one of the controllable risk factors. Current studies have shown that remote ischemic conditioning can improve vascular endothelial function, inhibit sympathetic nervous system activity and regulate immune and inflammatory reactions. Thus it may exert anti-hypertensive effects through multiple mechanisms. The purpose of this study is to investigate the efficacy and safety of remote ischemic conditioning for essential hypertension in the community population.

Eligibility criteria: Inclusion Criteria:

1. Age≥40 years, ≤ 75 years, regardless of sex;
2. Having the history of essential hypertension and the systolic blood pressure of at least 140 mm Hg on two consective days;
3. Signed and dated informed consent is obtained

Exclusion Criteria:

1. Blood pressure ≥ 180/110mmHg;
2. Planned adjustment of antihypertensive drugs in the next month;
3. Severe hematologic disorders or significant coagulation abnormalities;
4. Individuals who had contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury in the upper limb, acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc;
5. Pregnant or lactating women;
6. Severe hepatic and renal dysfunction, or ALT/AST \>3 times upper limit of normal, or serum creatinine \>265umol/l (\>3mg/dl);
7. Patients being enrolled or having been enrolled in another clinical trial within the 3 months prior to this clinical trial;
8. Patients unsuitable for enrollment in the clinical trial according to the investigator's discretion.

Primary outcomes:
measure: Changes of mean systolic blood pressure
timeFrame: 12-14 days
Secondary outcomes:
measure: Mean systolic blood pressure level
timeFrame: 12-14 days
measure: Changes of mean diastolic blood pressure
timeFrame: 12-14 days
measure: Mean diastolic blood pressure level
timeFrame: 12-14 days
measure: Blood pressure compliance rate
timeFrame: 15-28 days
Other outcomes:
Locations:
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
Study officials:
References:
Clinical trial NCT04287205: The Effect of Dydrogesterone on Sexual Function in Women With Endometriosis
Official title: The Effect of Dydrogesterone on Sexual Function in Women With Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Sexual Dysfunction
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 79
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aimed to assess the effects of dydrogesterone on sexual function in women with endometriosis using Female Function Sexual Index (FSFI).

Detailed description: Sexual dysfunction is an important outcome for patients with endometriosis. In this study, we compare the fsfi (female sexual function index) questions and the scores before and after dydrogesterone treatment in patients with endometriosis. We aim to measure the effect of dydrogesterone in patients with endometriosis.

Eligibility criteria: Inclusion Criteria:

* no history of malignancies,
* normal findings at gynecological examinations and transvaginal ultrasonography
* normal uterine size, normal cervical smear results,
* patients not use any contraception methods in the last 6 months

Exclusion Criteria:

* with a history of systemic and/or psychiatric diseases,
* gynecological pathologies (myoma uteri, endometriosis, uterine anomalies, existing genital infections)
* pelvic organ prolapse
* pelvic surgeries

Primary outcomes:
measure: The Effect of Dydrogesterone on Sexual Function
timeFrame: 6 months
Secondary outcomes:
measure: The Effect of Dydrogesterone on Sexual Function in women with endometrioma
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Pinar Yalcin Bahat
state: İ̇stanbul
Study officials:
References:
Clinical trial NCT03580005: A 6-week Study to Evaluate the Safety and Efficacy of Quillichew ERCT in 4-5 Year Old Children With ADHD.
Official title: A Phase 4, Double-blind, Randomized, Parallel Group, Placebo-controlled Study Of The Efficacy And Safety Of Quillichew (Methylphenidate Hydrochloride (Hcl)) Extended Release Chewable Tablets (Erct) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (Adhd)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Attention Deficit Hyperactivity Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-07-09
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A 6-week double-blind study to evaluate the safety and efficacy of Quillichew extended release chewable tablets in 4-5 year old children with attention deficit hyperactivity disorder.


Eligibility criteria: Inclusion Criteria:

1. Male or female child 4-5 years of age at baseline.
2. Signed and dated informed consent document.
3. Meets DSM-V criteria for ADHD based on the K-SADS-PL.
4. ADHD RS-IV Preschool Home Version score at Screening and Baseline \>/= 90th percentile for gender and age in \>/=1 of the following: hyperactive-impulsive subscale, inattentive subscale, or total score.
5. Peabody Picture Vocabulary Test 4 (PPVT4)Standard Score \>/=70.
6. Child Global Assessment Scale (CGAS) score \</= 55.

Exclusion Criteria:

1. Treated with atomoxetine within 30 days prior to the Baseline.
2. Received any investigational products or devices within 30 days prior to the Baseline visit.
3. History of stimulant nonresponse, intolerability or hypersensitivity to any dose of Quillichew ERCT or other stimulant.
4. An intelligence quotient (IQ) \<70.
5. History of acute or chronic medical or psychiatric condition or cardiac or laboratory abnormality.
6. Less than 5th percentile for height or weight at Screening.
7. History of recent clinically significant self-harming behaviors.

Primary outcomes:
measure: Safety-incidence of treatment emergent adverse events
timeFrame: 6 months
measure: Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version
timeFrame: 6 weeks
Secondary outcomes:
measure: incidence of adverse events
timeFrame: 6 weeks
measure: Clinical Global Impression of Improvement (CGI-I) Scale Score
timeFrame: weeks 1-6
measure: Intellectual Performance of Children Using Child Behavior Checklist 4-18 Years (CBCL 4-18)
timeFrame: Weeks 1-6
measure: Children's Global Assessment Scale (CGAS)
timeFrame: Week 6
measure: Mean Clinical Global Impression - Severity (CGI-S) score
timeFrame: Weeks 1-6
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01201005: B Vitamin Status in Premature and Small for Gestational Age(SGA) Infants
Official title: B VITAMIN STATUS IN PREMATURE AND SMALL FOR GESTATIONAL AGE INFANTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biochemical Cobalamin Status
Motor Neurodevelopment
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2010-09-14
Enrollment: 80
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Premature birth and low birth weight implies insufficient intrauterine growth and fetal malnutrition. During the first months of life where the infant is breastfed, the low stores aquired during fetal life, may cause specific B vitamin deficiencies. In this study infants with a birth weight below 3000 g will be studied at 6 weeks, 4 and 6 months. At 6 months infants with biochemical signs of impaired cobalamin status (i.e.: tHcy \> 97.5 percentile for cobalamin treated infants, i.e.: tHcy\>6.5 µM/L) will be randomised to cobalamin treatment or placebo. At 7 months the investigators will evaluate the effect of cobalamin or placebo treatment according to infant biochemical status and neurodevelopment.

Study hypothesis: Cobalamin treatment given to infants with biochemical cobalamin deficiency will normalize biochemical status and cause improved motor neurodevelopment.


Eligibility criteria: Inclusion Criteria:

* Birthweight \< 3000 grams
* Age 6 months (+/- 0.5 months)
* Plasma total homocysteine \> 6.5 umol/L

Exclusion Criteria:

* Plasma total homocysteine \< 6.5 umol/L

Primary outcomes:
measure: Changes in biochemical status and neurodevelopment
timeFrame: 4 weeks
Secondary outcomes:
measure: Maternal evaluation of changes in infant behaviour/development
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
References:
citation: Bjorke-Monsen AL, Torsvik I, Saetran H, Markestad T, Ueland PM. Common metabolic profile in infants indicating impaired cobalamin status responds to cobalamin supplementation. Pediatrics. 2008 Jul;122(1):83-91. doi: 10.1542/peds.2007-2716.
citation: Torsvik IK, Ueland PM, Markestad T, Midttun O, Bjorke Monsen AL. Motor development related to duration of exclusive breastfeeding, B vitamin status and B12 supplementation in infants with a birth weight between 2000-3000 g, results from a randomized intervention trial. BMC Pediatr. 2015 Dec 18;15:218. doi: 10.1186/s12887-015-0533-2.
citation: Torsvik IK, Markestad T, Ueland PM, Nilsen RM, Midttun O, Bjorke Monsen AL. Evaluating iron status and the risk of anemia in young infants using erythrocyte parameters. Pediatr Res. 2013 Feb;73(2):214-20. doi: 10.1038/pr.2012.162. Epub 2012 Nov 20.
Clinical trial NCT03153605: The Correlation and Relationship Between Chromaticity Parameters and Treatment Satisfaction Before and After Tooth Bleaching
Official title: The Correlation and Relationship Between Chromaticity Parameters and Treatment Satisfaction Before and After Tooth Bleaching
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bleaching; Satisfactory
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Explore the correlation and specific relationship between chromaticity parameters and treatment satisfaction before and after tooth bleaching, compare the curative effect of different tooth bleaching programs.


Eligibility criteria: Inclusion Criteria:

* age around 20\~28 years,
* at least six anterior teeth without restorations,
* good general and oral health (no dental caries and periodontal disease).

Exclusion Criteria:

* tooth sensitivity,
* any condition that could cause tooth sensitivity (non-carious cervical lesions, dentin exposure),
* participants under orthodontic treatment,
* smokers.

Primary outcomes:
measure: Changes of tooth color
timeFrame: baseline, 7 days after treatment, 14 days after treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: