louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06725654: Evaluation of Oral and Dental Health of Institutionalized Orphan Children Residing in Children's Homes in Turkey
Official title: Evaluation of Oral and Dental Health of Institutionalized Orphan Children Residing in Children's Homes in Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries
Orphaned Children
Periodontal Index
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Orphaned children aged from 6 to 18 years old residing in children's home who meet the inclusion criteria.

Brief summary: Both dental caries prevalence and periodontal status of children residing in children's homes in Sivas province of Turkey were evaluated.

Detailed description: This study was carried out in 16 state-protected children's homes in Sivas under the Directorate of Coordination of Children's Homes Centres of the Ministry of Family and Social Policies of Turkey. A total of institutionalized 90 orphan children between the ages of 6 and 18, who did not have any chronic diseases, were not taking medication, and were compliant and healthy, were included in the study. Since all participants of this study are under state protection, Sivas Children's Homes Center Coordination Directorate was contacted. The aim of the study and the procedures were explained in detail and official permission was obtained. The children's caregivers signed informed consent forms approved by the Ethics Committee. The examination procedures were performed by two trained dentists as recommended by the WHO. DMFT and deft, GI and PI indices were used to assess dental caries experience, gingival inflammation, and the amount of plaque on the tooth surface, respectively. Also, periodontal status and treatment need were evaluated using the CPITN index.

Eligibility criteria: Inclusion Criteria:

* Does not have any chronic disease.
* Not taking any medication.
* To be compatible and healthy.

Exclusion Criteria:

-

Primary outcomes:
measure: Caries Experience
timeFrame: Immediately after the orphans filled the survey forms at the first visit
measure: Gingival Index (GI, Löe and Sillness-1963) measurements
timeFrame: Immediately after the orphans filled the survey forms at the first visit
measure: Plaque Index (PI, Sillness and Löe-1964) measurements
timeFrame: Immediately after the orphans filled the survey forms at the first visit
measure: Community Periodontal Index of Treatment Needs (CPITN)
timeFrame: Immediately after the orphans filled the survey forms at the first visit
Secondary outcomes:
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Cumhuriyet University
Study officials:
affiliation: Cumhuriyet University
name: Arzu Koçkanat, Asst.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03986554: Swallowing Pressure Profiles in Healthy Adults
Official title: Swallowing Pressure Profiles in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Swallowing
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Participants will include healthy adults, between the ages of 18 and 45 years with no major medical history.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is designed to determine the impact of a pharyngeal High Resolution Manometry catheter on swallowing biomechanics

Detailed description: During pharyngeal High Resolution Manometry (pHRM) a small bore flexible catheter is introduced into the pharynx to detect intrabolus pressure and contact of pharyngeal structures during swallowing. The presence of the catheter through the upper esophageal sphincter (UES) leads to a violation of its natural closed state. It is not clear how this intrusion influences the swallowing biomechanics . Hence, this project's goal is to identify how hyoid movement is altered during swallowing with the presence of a pHRM catheter in place.

Eligibility criteria: Inclusion Criteria:

* healthy adults between the ages of 18-45 with no major medical conditions.
* no specific gender or race will be excluded or targeted for participation in this study.

Exclusion Criteria:

* adults who are pregnant
* adults with swallowing impairment, brain injury, deviated septum, G.I. strictures, obstructions, or Zenker's diverticulum, surgeries to nose, neck, or throat, or bleeding disorders will be excluded from this study

Primary outcomes:
measure: Change in peak anterior and superior hyoid movement
timeFrame: Baseline; Week 1
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health at the University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Emily K Plowman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01052454: Mindfulness-Based Stress Reduction for Hot Flashes
Official title: Pilot Study to Assess the Feasibility of MBSR for Hot Flashes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Vasomotor Symptoms
Keywords: hot flashes
mindfulness
stress
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2010-01-20
Enrollment: 110
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to determine if participation in a mindfulness-based stress reduction program is feasible for women experiencing five or more hot flashes/day, and whether it affects either the frequency and/or intensity of their hot flashes, or the degree of bother they experience from them


Eligibility criteria: Inclusion Criteria:

* Women experiencing 5 or more hot flashes/day

Primary outcomes:
measure: Hot Flash intensity/bother
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Medical School
state: Massachusetts
Study officials:
References:
Clinical trial NCT03358654: Evaluating Safety and Efficacy of Mesenchymal Stem Cells From Umbilical Cord
Official title: Evaluating the Safety and Efficacy of Mesenchymal Stem Cells From Umbilical Cord in the Treatment of Knee Joint Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Umbilical Cord Bleeding
Knee Osteoarthritis
Keywords: Umbilical Cord Bleeding
Knee Osteoarthritis
stem cells
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was to evaluate the safety and efficacy of Mesenchymal Stem Cells (MSCs) from umbilical cord in the treatment of 7 knee OA patients by assessing unexplained local and systemic symptoms or death before and at 1, 2, 3, 6 months after the injection.

Detailed description: This is a single group assignment study with a total of 9 knee osteoarthritis patients participants. All of the patients will receive the anticular injection with MSCs from umbilical cord and unexplained local and systemic symptoms or death before the end of following-up will be assessed to evaluate the safety and efficacy of mesenchymal stem cells from umbilical cord.

Eligibility criteria: Inclusion Criteria:

① K / L score of 2-3; ② chronic knee pain; ③ no local or systemic infection; ④ without obvious contraindication of the joint puncture from hematology and biochemical tests; ⑤ informed consent. -

Exclusion Criteria:

① older than 75 years old or less than 18 years old, or without full capacity for civil conduct; ② HIV, hepatitis virus or syphilis virus infection or their serology is positive; ③ BMI index is greater than 30; ④ congenital or acquired knee deformity; ⑤ pregnant or lactating women; ⑥ tumor patients; ⑦ immunodeficiency patients; ⑧ intra-articular drug injection history within 3 months; ⑨ participating in other clinical trials; ⑩ other patients who researchers believe are not eligible for inclusion such as suffering from other concomitant diseases. -

Primary outcomes:
measure: Unexplained local and systemic symptoms or death
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: arthritis clinic and research center
name: Jianhao Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06162754: What do Parents Know About Space Maintainers
Official title: What do Parents Know About Space Maintainers: Its Relationship With Parents' Oral Health Literacy and Children's Oral Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Health
Dental Caries in Children
Tooth Loss
Keywords: oral health literacy
space maintainer
dental caries
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: children who applied for the dental trearment to the Faculty of Dentistry in Rize

Brief summary: Space maintainers are frequently used to prevent malocclusion problems in early primary tooth loss. Oral health literacy is defined as the capacity of individuals to learn, understand and evaluate basic oral health information. It is considered that parents' awareness of space maintainers may be affected by various factors such as their demographic characteristics and oral health literacy. The aim was to evaluate the relationship between variables by determining parents' awareness of space maintainers and their oral health literacy.

Detailed description: This cross-sectional study included 600 children and their parents. The survey, which included questions about sociodemographic characteristics and space maintainer awareness, was administered to parents face to face. Then, parents' oral health literacy levels were measured with TREALD-30 and TREALD-30A scales.

Eligibility criteria: Inclusion Criteria:

* Patients who did not require urgent treatment,
* Who did not use medication for psychiatric reasons,
* Who did not have any mental illness were included.

Exclusion Criteria:

* Those who did not meet the inclusion criteria were excluded from the study.

Primary outcomes:
measure: the knowledge about space maintainers of the parents
timeFrame: for three months from the beginning of the study
measure: oral health literacy of the parents
timeFrame: for three months from the beginning of the study
measure: oral health literacy of the parents assessed by TREALD-30A scale
timeFrame: for three months from the beginning of the study
Secondary outcomes:
measure: the correlation between oral health literacy and knowledge about space maintainers of parents
timeFrame: for three months from the beginning of the study
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan University Training and Research Hospital
city: Rize
country: Turkey
facility: Sema AYDINOGLU
Study officials:
affiliation: Recep Tayyip Erdogan University Training and Research Hospital
name: Sema AYDINOGLU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00268554: Enhancement of Postocclusive Reactive Hyperaemia by Dipyridamole
Official title: Enhancement of Postocclusive Reactive Hyperaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperemia
Hypoxia
Keywords: adenosine
caffeine
dipyridamole
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2005-12-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether dipyridamole enhances postocclusive reactive hyperaemia by increasing extracellular adenosine concentrations during ischemia and reperfusion. Furthermore we hypothesize that dipyridamole augments postocclusive reactive hyperaemia by increasing adenosine receptor stimulation.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers between 18 and 50 years

Exclusion Criteria:

* none specified

Primary outcomes:
measure: forearm blood flow
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university Nijmegen Medical Centre
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Gerard Rongen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06134154: Safety and Efficacy of Carbon Dioxide Gas for Endoscopy
Official title: Safety and Efficacy of Carbon Dioxide Gas for Endoscopic Insufflation in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Abdominal Pain
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 350
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to compare the efficacy and safety of air versus carbon dioxide gas insufflation for endoscopy in children.

The main question\[s\] it aims to answer are:

•to determine safety of CO2 Assess patient comfort (abdominal pain, flatulence and bloating) with CO2 use when compared to air.

Detailed description: In this study, children (6 months -18 years) undergoing all endoscopic procedures that includes an upper endoscopy including but not limited to Esophagogastroduodenoscopy (EGD/ upper endoscopy), EGD/ Colonoscopy, Endoscopic Retrograde Cholangiopancreatography (ERCP), Endoscopic ultrasound (EUS) e.t.c after appropriate consent, will be randomized 1:1 to either Air or CO2 gas for endoscopic insufflation. We will record demographics (name, age, sex, MRN, race/ethnicity), anthropometrics including weight, height/length, weight for length (WFL), WFL z score, BMI, BMI z score, indication/ reason for scope, other co-morbidities (other medical problems), personnel involved (faculty only, vs faculty + trainee), minute by minute end tidal CO2 levels, minute by minute minute ventilation levels, baseline blood pCO2, and blood pCO2 after each procedure. Pre and post procedure patient reported abdominal pain, bloating and flatulence. Pre and post procedure nurse assessed pain. Pre and post procedure vital signs. Patients will be randomized using a sealed envelope method by the endoscopy technician. Both patients and providers will be blinded to arm of enrollment.

Eligibility criteria: Inclusion Criteria:

- Infants and children 6 months to 18 years undergoing any upper endoscopy related procedure including but not limited to EGD/Colonoscopy, ERCP, EGD only, EUS, EGD with foreign body removal, Enteroscopy.

Exclusion Criteria:

* Patients with American Society of Anesthesiology (ASA) Physical Status Classification System of 4 and above
* Children with chronic lung disease,
* Children who are wards of the state will be excluded.
* Children needing language interpreting services that is not Spanish.

Primary outcomes:
measure: Abdominal Pain
timeFrame: baseline/ pre-procedure to immediately after the procedure
Secondary outcomes:
measure: PCO2 level
timeFrame: baseline/ preprocedural to immediately after the procedure
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References:
Clinical trial NCT05735054: A Novel Technique for Endoscopic Transaxillary Thyroidectomy Comparison
Official title: A Novel Technique for Endoscopic Transaxillary Thyroidectomy: a Preliminary Report and Comparison With the Open Procedure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Diseases
Keywords: endoscopy
thyroidectomy
transaxillary
open
Lead sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 300
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the patient who required thyroidectomy

Brief summary: The clinical data from all except the first 20 cases who underwent our novel transaxillary thyroidectomy were collected retrospectively, while the data from patients who underwent conventional open thyroid lobectomy by same surgeon during the same period were used as a control.


Eligibility criteria: Inclusion Criteria:

1. The patients with benign or malignant thyroid disease require lobe thyroidectomy;
2. The patient had cosmetic requirements and agreed with transaxillary thyroidectomy;
3. Benign lesions with the largest diameter ≤5 cm;
4. Differentiated thyroid cancer(DTC) meets the following conditions at the same time: ①The maximum diameter of the primary lesion is \<2.5 cm; ②There is no extraglandular invasion or only minimal external invasion of the anterior thyroid capsule or minor invasion of the sternum thyroid muscle;

Exclusion Criteria:

1. the patients had poor compliance and could not be reexamined regularly;
2. There was a history of neck or thyroid surgery;
3. The patients require total thyroidectomy or lateral neck dissection.

Primary outcomes:
measure: operation time (OT)
timeFrame: during the operation
measure: bleeding
timeFrame: during the operation
measure: complications
timeFrame: 6 moths after oepration
Secondary outcomes:
measure: hospital stay
timeFrame: 1 week
measure: drainage days.
timeFrame: 1 week
measure: drainage volume
timeFrame: 1 week
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of General Surgery , Second Afﬁliated Hospita l, Xi'an Jiaotong Universi ty School of Medicine
Study officials:
affiliation: Xi'an Jiaotong University Second Affiliated Hospital
name: Yang Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01889654: Anti-nucleosome B Lymphocytes in Lupus
Official title: Analysis of Frequency and Phenotype of Anti-nucleosome B Lymphocyte in Systemic Lupus
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Systemic Lupus Erythematosus With or Without Clinical Activity
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2013-06-28
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: lupus patient and healthy volunteers

Brief summary: Lupus disease is characterized by the production of pathogenic autoantibodies, which participate in end-organ damages. The phenotype of B cells producing the pathogenic autoantibodies in lupus patients is today unknown. Antinucleosome antibodies are characteristic of lupus disease.This project proposes to detect antinucleosome B cells in lupus patients and to analyse their phenotype and their frequency.


Eligibility criteria: Inclusion criteria for SLE patients:

SLE patient : diagnostic based on ACR criteria

* SLE patient producing seric anti-nucleosome antibodies (ELISA)
* SLEDAI-2K activity score : inferior to 5 for quiescent patients, superior to 8 since at least 2 months for active patients

Exclusion criteria for SLE patients:

-- Other autoimmune diseases than SLE- Induced lupus

* Treatment with corticosteroids \>10mg/d (prednisone) for quiescent patients
* Treatment with corticosteroids \>20mg/d (prednisone) for active patients
* Oral immunosuppressive treatment during the last 6 months (methotrexate, azathioprine, ciclosporine, mycophénolate mofétil) for all patients, treatment during the last year with cyclophosphamide or monoclonal antibodies (rituximab, belimumab) for pour quiescent patients
* Disease which can modify B and T lymphocyte functions: primary immune deficiencies, evolutive infections, chronic viral infection (VIH in particular), chemotherapy or neoplasm antecedent

Primary outcomes:
measure: all cause mortality
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
state: Bas Rhin
Study officials:
References:
Clinical trial NCT03922854: Monitoring of Babies' Heart Rates During Labour Using Mobile Monitors
Official title: Determining the Predictive Utility of Short-term Variation (STV) of Fetal Heart Rate (FHR) for Fetal Acidaemia, and the Feasibility of Using This for Decision Making in High-risk Women During Labour
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Acidemia
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 200
Sex: FEMALE
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: Pregnant population

Brief summary: The study has been designed as a prospective, non-randomised, single centre study to determine the predictive utility of Short Term Variation (STV) of the Fetal Heart Rate (FHR)from the intrapartum FHR data collected using the portable fetal ECG monitor (Monica AN24) in women requiring continuous monitoring during labour due to antenatal or intrapartum risk factors.


Eligibility criteria: Inclusion Criteria:

* Singleton term pregnant labouring women during established labour (cervix \>3cm dilated, regular uterine contractions \>3:10 minutes)
* Written informed consent
* At least 18 years of age

Exclusion Criteria:

* Preterm labouring women
* Multiple pregnancy
* Involved in another study using a device or medicinal product

Primary outcomes:
measure: Sample Size
timeFrame: Recruitment period January 2018-April 2019
measure: Recruitment Rate
timeFrame: Recruitment period January 2018-April 2019
measure: Data Capture
timeFrame: Recruitment period January 2018-April 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Jessop Wing Hospital
state: South Yorkshire
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Habiba Kapaya
role: PRINCIPAL_INVESTIGATOR
References: