louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06823687: Virtual Reality Glasses on Applied During Thyroid Fine Needle Aspiration Biopsy
Official title: The Effect of Virtual Reality Glasses on Applied During Thyroid Fine Needle Aspiration Biopsy on Anxiety Level, Pain Intensity and Patient Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Nodule
Keywords: Thyroid Fine Needle Aspiration Biopsy
Lead sponsor: Istanbul Sabahattin Zaim University
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is an experimental study with pre-test and post-test control groups
Primary purpose: OTHER

Brief summary: The Effect of Virtual Reality Glasses on Applied During Thyroid Fine Needle Aspiration Biopsy on Anxiety Level, Pain Intensity and Patient Satisfaction

Detailed description: Beginning 1-2 minute before the start of the procedure, the patients will be watched (5-10 minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars Glasses.

Eligibility criteria: Inclusion Criteria:

* Being over 18 years old
* Ability to communicate adequately
* Volunteering to participate in the research

Exclusion Criteria:

* Those with psychiatric problems
* Being unconscious

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Baseline, pre-intervention (Before Thyroid Fine Needle Aspiration Biopsy)
measure: Visual Analog Scale
timeFrame: Immediately after the intervention (Thyroid Fine Needle Aspiration Biopsy)
measure: State-trait anxiety inventory (STAI FORM TX-1)
timeFrame: Baseline, pre-intervention (Before Thyroid Fine Needle Aspiration Biopsy)
measure: State-trait anxiety inventory (STAI FORM TX-1)
timeFrame: Immediately after the intervention (Thyroid Fine Needle Aspiration Biopsy)
Secondary outcomes:
measure: Physiological Symptoms of Anxiety Follow-up Form
timeFrame: Baseline, pre-intervention (Before Thyroid Fine Needle Aspiration Biopsy)
measure: Physiological Symptoms of Anxiety Follow-up Form
timeFrame: Immediately after the intervention (Thyroid Fine Needle Aspiration Biopsy)
measure: Virtual Reality Glasses Application Satisfaction Form
timeFrame: Immediately after the intervention (Thyroid Fine Needle Aspiration Biopsy)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Sabahattin Zaim University, Faculty of Health Sciences
state: Küçükçekmece
Study officials:
affiliation: İstanbul Sabahattin Zaim Üniversitesi
name: Zülfünaz Özer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Toraman RL, Eskici Ilgin V. Effect of Virtual Reality Glasses Application on Pain, Anxiety, and Patient Satisfaction During a Transrectal Prostate Biopsy: A Randomized Controlled Trial. Biol Res Nurs. 2024 Oct;26(4):485-497. doi: 10.1177/10998004241236154. Epub 2024 Feb 28.
Clinical trial NCT05907187: Research in Ethno-Medicine and Education (REMED)
Official title: Intervention to Promote Cervical Cancer Prevention and Early Detection, and Understand the Role of Plants in HPV. (Research in Ethno-Medicine and Education)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Human Papilloma Virus
HPV
Human Papillomavirus Infection
Keywords: Twalet Deba
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Cigna Foundation
First posted: 2023-06-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to gain information about intravaginal practices, like intravaginal "twalet deba", among Haitian women living in South Florida. Intravaginal "twalet deba" may include douching, cleaning inside the vagina with different kinds of products, or using steam/vapor that enter the vagina. The investigators want to help learn the best way to increase early detection and/or prevention for cervical cancer. The investigators would like to know what plants, herbs, commercial products and medicines are used in these practices, how these products are prepared, applied, why these products are used, and how these products affect the vagina and cervix.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Self-identifies as Haitian or Haitian-American
* Resident of Miami-Dade, Broward or Palm Beach County
* Currently engages in regular intravaginal cleansing practices that involve more than just water alone
* No history of hysterectomy
* Speaks Creole or English

Exclusion Criteria:

* Are adults unwilling or unable to provide consent
* Individuals less than 18 years of age
* Pregnant women
* Prisoners

Primary outcomes:
measure: Plant products used for intravaginal twalet deba.
timeFrame: Up to 30 days
measure: Methods of using plant products for intravaginal twalet deba.
timeFrame: Up to 30 days
measure: Cultural beliefs surrounding the practice of intravaginal twalet deba.
timeFrame: Up to 30 days
measure: Health access for cervical cancer screening as measured by REMED tool
timeFrame: Up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Martine Poitevien
state: Florida
Study officials:
affiliation: University of Miami
name: Erin Kobetz-Kerman, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01509287: Metabolic Screening in Patients With Donnai-Barrow Syndrome
Official title: Metabolic Screening in Patients With Donnai-Barrow Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Donnai-Barrow Syndrome
Keywords: Donnai-Barrow Syndrome (DBS)
metabolic testing
genes
genetic
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-01-12
Enrollment: 78
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children/infants affected with Donnai-Barrow Syndrome

Brief summary: This study focuses on the genetics and metabolism of Donnai-Barrow Syndrome (DBS).

Detailed description: The purpose of this study is to better understand the role of certain nutrients and vitamins in promoting the healthy development of individuals with Donnai-Barrow Syndrome. The investigators hope that the information gained by studying the metabolism of children with Donnai-Barrow Syndrome and their family members will lead to significant advances in the treatment of this disease.

Eligibility criteria: Inclusion Criteria:

All individuals affected with Donnai-Barrow Syndrome

Primary outcomes:
measure: measures of blood sugar, cholesterol, vitamins A and D, and other compounds
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Barbara Pober, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03420287: Evaluation of MPM Prepared From Allogenic Bone Graft in Alveolar Cleft Closure: A Prospective Randomized Clinical Trial
Official title: Evaluation of Mineralized Plasmatic Matrix Prepared From Allogenic Bone Graft in Alveolar Cleft Closure: A Prospective Randomized, Triple Blinded, Parallel Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Cleft; Alveolar Process
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 56
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to figure out the efficiency of Mineralized Plasmatic Matrix prepared from allogenic bone graft on cleft alveolus and oro-nasal fistula closure, adequate bone volume and acceptable density at the site of grafting.MPM might improve the physiological properties of allogenic bone graft and facilitate its handling and application during surgical grafting.This might decrease the need of the second surgical site for harvesting autogenous bone to be grafted with its all complications and hurdles.This trial will help the practitioners in taking the decision of using the MPM prepared from allogenic bone in alveolar cleft closure or not.

Detailed description: Alveolar bone grafting will be performed at 6 to 12 years of age as following :

Group (A):Will undergo grafting with anterior iliac crest bone,(Control group). Group (B):Will undergo grafting with Mineralized Plasmatic Matrix prepared from allogenic bone graft (study group).

In all patients, this will be the first bone graft to be placed in the alveolar cleft. All patients will be monitored clinically and radiographically (by cone beam C.T) for up to 6 months after surgery.

Eligibility criteria: Inclusion Criteria:

* Unilateral or bilateral alveolar cleft patients

Exclusion Criteria:

* patients with previous failed alveolar cleft grafting procedure.

Primary outcomes:
measure: Oro-nasal Fistula
timeFrame: 6 months
Secondary outcomes:
measure: C.T analysis of secondary bone grafts
timeFrame: 6 months
measure: Donor site long standing pain
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03468387: Primary Urethral Realignment vs. Suprapubic Cystostomy for Initial Management of Pediatric Pelvic Fracture Urethral Injury
Official title: Primary Urethral Realignment vs. Suprapubic Cystostomy for Initial Management of Pelvic Fracture Urethral Injury in Children: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urethral Injury
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 42
Sex: MALE
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is prospective randomized comparative clinical trial comparing primary urethral realignment vs. suprapubic cystostomy in initial management of pediatric pelvic fracture urethral injury regarding:

1. The success rate after initial intervention.
2. The need for urethroplasty in the failed realignment group and cystostomy group.
3. The success rate of urethroplasty in the failed realignment group and cystostomy group.


Eligibility criteria: Inclusion Criteria:

* Male children less than 18 years presenting with pelvic fracture urethral injury

Exclusion Criteria:

* Associated bladder neck injury.
* Associated rectal injury.
* Late presentation \>2weeks since trauma.
* History of previous urethral intervention.

Primary outcomes:
measure: The success rate after initial intervention (realignment or suprapubic cystostomy).
timeFrame: 3 months after initial intervention.
Secondary outcomes:
measure: The success rate of urethroplasty in both groups.
timeFrame: 3 months after urethroplasty.
measure: The need for urethroplasty in both groups.
timeFrame: 3 months after initial intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05500287: Virtual Care In Pediatric Asthma
Official title: Effect of Virtual Care Given To Child Patients With Asthma On Disease Management And Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Children
Keywords: Virtual Care
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 97
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to determine the impact of virtual care for children with asthma on the disease management and quality of life of children with asthma.

Detailed description: After children were randomized by protocol number, they completed the child information form, the quality of life scale of the child with asthma, and the asthma control test at the first interview. PEF meter and asthma diary were given at the first interview. Children in the virtual care group received online training in four modules within the first month.The virtual group provided counseling services by phone and video conference for six months. The control group received the standard care provided in the clinic. Asthma diary data were collected from both groups at the end of each month

Eligibility criteria: Inclusion Criteria:

* having a smartphone or tablet with internet connection, parents and patient willing to maintain a daily log of symptoms and medication use

Exclusion Criteria:

* Children who had mental problems, had not attended at least one of the training and did not send at least one month of their asthma diary were excluded from the study.

Primary outcomes:
measure: Change from baseline in symptom number
timeFrame: first, third and the sixth month
Secondary outcomes:
measure: Change from baseline in quality of life
timeFrame: Baseline and sixth month
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University
Study officials:
References:
Clinical trial NCT06176287: Assessment of Pain Associated With Insertion Torque and Correlation of Primary Implant Stability Measurement Methods
Official title: Assessment of Pain Associated With Insertion Torque and Correlation of Primary Implant Stability Measurement Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implantation
Keywords: dental implants
dental implantation
pain assessment
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: MIS Implant Technologies, Ltd
First posted: 2023-12-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: TREATMENT

Brief summary: The objective of this observational study is to evaluate the primary stability of dental implants and the relationship between insertion torque and patients' pain levels assessed with the visual analogue scale (VAS)

Detailed description: Primary implant stability plays a key role in providing osseointegration. Higher insertion torque indicates higher primary stability. However, the effect of increased insertion torque on patient pain levels has not been clearly demonstrated. Several methods for measuring primary stability have been defined so far. Insertion torque, periotest measurements, and resonance frequency analysis are mostly preferred due to their ease of use and non-invasiveness.

The aim of the present study is to evaluate the relationship between insertion torque and patients' pain levels assessed with the visual analogue scale (VAS) and to assess the relationship between insertion torque, periotest measurements, and resonance frequency analysis.

Eligibility criteria: Inclusion Criteria:

* No contraindications for implant surgery;
* Bilateral single-tooth loss in the posterior mandible;
* Sufficient bone amount for implant diameter and height at the implant site;
* At least 3 months after tooth extraction at the implant site;

Exclusion Criteria

* History of chronic infection or pain at the implant site;
* History of radiotherapy to the head and neck region for any reason;
* Local or systemic causes of persistent anti-inflammatory or analgesic medication;
* Patients with suspicion of pregnancy.

Primary outcomes:
measure: Pain levels assessed with the visual analogue scale (VAS)
timeFrame: 7 days
Secondary outcomes:
measure: Insertion torque values
timeFrame: 1 day
measure: Periotest measurements
timeFrame: 1 day
measure: Resonance frequency analysis values
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00556387: Efficacy of Ketamine in Children With Severe Brain Injury for Brain Cell Protection
Official title: Possible Neuroprotective Effects of Ketamine in Children With Severe Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Traumatic Brain Injury
Keywords: traumatic brain injury
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2007-11-12
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the possible effects of an anesthetic agent called Ketamine on the injured brain in children.

The researchers think that it will effect the outcomes of children with these injuries.


Eligibility criteria: Inclusion Criteria:

* are 1 month to 16 years of age; AND
* are admitted to the PICU following severe TBI (any GCS 3-8 inclusive) within 8 hours after the injury; AND
* are intubated and ventilated for the management of TBI; AND
* are anticipated to have an indwelling arterial or venous catheter for blood sampling during the first three days of study enrollment; AND
* have an intra-cranial pressure (ICP) monitoring device for management of TBI.

Exclusion Criteria:

* are less than 4 kilograms in weight upon admission
* are less than 1 month of age;
* are greater than 16 years of age;
* have a clinical diagnosis of non-accidental TBI;
* have suffered immersion injury or prolonged hypoxic injury (lasting greater than 10 minutes);
* have a known allergy to ketamine;
* have a planned removal of endotracheal tube or the removal of central venous catheter AND arterial catheter within 72 hours of study enrollment;
* have a current history of neuromuscular disease;
* have a current history of hepatic failure;
* have a current history of glaucoma
* require chronic treatment with anti-epileptic drugs (AEDs) or devices;
* more than 8 hours have elapsed from the time of injury to PICU admission;
* have documentation of a positive pregnancy test at the time of enrollment;
* if there is a lack of commitment to aggressive intensive care therapies (the subject is either on a DNR status due to pre-existing medical condition, or the family decides to withdraw support prior to participation in the study due to other multiple severe injuries and organ failures resulting from the trauma).

Primary outcomes:
measure: To compare clinical, radiological, and neurodevelopmental outcomes between children who receive ketamine vs placebo infusions following traumatic brain injury.
timeFrame: 1 year
Secondary outcomes:
measure: To compare the expression of biomarkers of CNS injury between cases and controls.
timeFrame: 96 hours
Other outcomes:
Locations:
Study officials:
affiliation: Arkansas Children's Hospital Research Institute
name: Muayyad Tailounie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00551187: A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED)
Official title: A Randomized, Double-Blinded, Tolerability and Immunogenicity Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered Concomitantly With GARDASIL to 16- to 26- Year-Old Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Cancer
Vulvar Cancer
Vaginal Cancer
Genital Warts
Human Papillomavirus Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-30
Enrollment: 620
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate vaccine immunogenicity and how well the body tolerates V504 when given with Gardasil.


Eligibility criteria: Inclusion Criteria:

* Females between 16- to 26-years-old
* Has never had Pap testing or has only had normal Pap test results.
* Lifetime history of 0 to 4 sexual partners

Exclusion Criteria:

* History of an abnormal cervical biopsy result
* History of a positive test for HPV; History of external genital/vaginal warts
* Currently a user of illegal drugs or an alcohol abuser
* History of severe allergic reaction that required medical attention
* Are pregnant
* Received a marketed HPV vaccine
* Currently enrolled in a clinical trial
* Currently has or has a history of certain medical conditions or is currently taking or has taken certain medications (details will be discussed at the time of consent)

Primary outcomes:
measure: Geometric mean titers (GMTs) to HPV types contained in the administered vaccines
timeFrame: 4 weeks post dose 3
Secondary outcomes:
measure: Seroconversion percentages to HPV types contained in the administered vaccines
timeFrame: 4 weeks post dose 3
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Luxembourg A, Brown D, Bouchard C, Giuliano AR, Iversen OE, Joura EA, Penny ME, Restrepo JA, Romaguera J, Maansson R, Moeller E, Ritter M, Chen J. Phase II studies to select the formulation of a multivalent HPV L1 virus-like particle (VLP) vaccine. Hum Vaccin Immunother. 2015;11(6):1313-22. doi: 10.1080/21645515.2015.1012010.
Clinical trial NCT00293787: A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
Official title: A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open-angle Glaucoma
Ocular Hypertension
Keywords: Open-angle
glaucoma
ocular
hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-02-20
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety and effectiveness of an investigational therapy for treating patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* 18 years or older.
* Diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension.
* Mean IOP in each eye less than 18 mmHg at the screening visit.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Pregnant.
* History of chronic or recurrent severe inflammatory eye disease.
* Ocular trauma within the past six months in either eye.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean intraocular pressure (IOP) change at 3 months from baseline
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: