louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06964451: Assessing the Effect of Virtual Reality Gamification on Anxiety and Pain Management During Extraction of MIH-affected Lower First Permanent Molars in Pediatric Patients
Official title: Assessing the Effect of Virtual Reality Gamification on Anxiety and Pain Management During Extraction of MIH-affected Lower First Permanent Molars in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Distraction
Gamification
Tooth Extraction
Keywords: virtual reality
distraction
gamification
tooth extraction
MIH
Lead sponsor: University of Kragujevac
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 56
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The aim of this study was to evaluate the effectiveness of gamified virtual reality in reducing anxiety and pain during the extraction of lower first molars with MIH under local anaesthesia.

Detailed description: Dental anxiety can be tiggered by previous negative experiences, fear of pain, or loss of control, leading to avoidance of dental treatments and worsening oral health. To alleviate anxiety, various pharmacological and non-pharmacological measures are applied, including distraction as a cognitive-behavioral approach. One innovative method of distraction is gamification, which involves the use of Virtual Reality (VR) to redirect patients' focus to something relaxing instead of the treatment itself. The aim of this research was to evaluate the effectiveness of gamified virtual reality in reducing anxiety and pain during the extraction of molar-incisal hypomineralization (MIH) affected lower first molars under local anaesthesia. In prospective study, gamified virtual reality was applied during the extraction of lower first molars in 56 subjects using the split-mouth method. Through VR goggles, patients were immersed in a virtual video game world to distract them from the dental procedure.

Eligibility criteria: Inclusion Criteria:

* Indication for the extraction of both lower first molars due MIH grade 4.

Exclusion Criteria:

* Exclusion criteria for the study encompassed individuals with systemic disease, special needs, patients with a history of epileptic seizures or episodes of dizziness, as well as patients suffering from claustrophobia.

Primary outcomes:
measure: Face Scale
timeFrame: 1 day
measure: Heart rate
timeFrame: 1 day
Secondary outcomes:
measure: Satisfaction questionnaire
timeFrame: 1 day
Other outcomes:
Locations:
city: Kragujevac
country: Serbia
facility: Faculty od Medical Sciences University of Kragujevac
Study officials:
References:
Clinical trial NCT04330651: Post-Surgery Extracorporeal Life Support
Official title: Outcomes' Predictors in Post-Surgery Extracorporeal Life Support
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiogenic Shock
Extracorporeal Life Support
Extracorporeal Membrane Oxygenation Complication
Post Cardiac Arrest Syndrome
Post-cardiac Surgery
Keywords: extracorporeal life support
ecls
ecmo
outocome
prognostic factors
extracorporeal membrane oxygenation
Lead sponsor: University of Florence
Sponsor class: OTHER
Collaborators: name: Sandro Gelsomino
name: Edvin Prifti
name: Francesco Cabrucci
name: Marco Bugetti
name: Orlando Parise
name: Aleksander Dokollari
First posted: 2020-04-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients underwent cardiac surgery

Brief summary: Extracorporeal Life Support (ECLS) may provide pulmonary and circulatory support for patients with acute heart failure refractory to conventional medical therapy. However, indications and effectiveness of ECLS engagement post-surgery remains a concern. The investigators sought to analyze indications, modality and outcomes of PS-ECLS, to identify predictors of early and midterm survival after PS-ECLS. The investigators have recorded prospectively, and analysed data of 209 consecutive PS-ECLS patients between January 2004 and December 2018. Demographic and clinical data before, during and after PS-ECLS were collected and their influence on hospital mortality and outcomes (early and midterm) will analyse. Multivariate analysis of pre PS-ECLS implantation factors (as age, female sex , insulin-dependent diabetes, pulmonary hypertension, STS, type of surgical procedure data, pre-ECLS blood lactate level) will be made for identify prognostic risk factors of in-hospital mortality. Overall survival will be analysed, at 6 months,1-year and 5-years, respectively and the factors influencing mild/term outcome will be investigated.


Eligibility criteria: Inclusion Criteria:

* Patients underwent cardiac surgery

Exclusion Criteria:

* Age \< 18 years

Primary outcomes:
measure: Survival
timeFrame: 1 month after surgery
measure: Survival
timeFrame: At 1 Year after surgery
measure: Survival
timeFrame: At 5 years after surgery
Secondary outcomes:
measure: Prognostic factors
timeFrame: Early: 1 month after surgery
measure: Prognostic Factors
timeFrame: Late: 5 years after surgery
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Massimo Bonacchi
Study officials:
References:
Clinical trial NCT00191451: A Study of Gemcitabine and Carboplatin (Plus Herceptin in Human Epidermal Growth Factor Receptor 2 Positive [HER2+] Patients) With Metastatic Breast Cancer
Official title: Phase II Trial of Gemzar Plus Paraplatin (Plus Herceptin in HER2+ Patients) in Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purposes of this study are to determine the safety of gemcitabine and paraplatin either with or without trastuzumab Any side effects that might be associated with these compounds. Whether the two or three drugs listed above when given in combination can help patients with metastatic breast cancer. How long the treatment will stop the growth of the cancer.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of metastatic breast cancer
2. Able to visit the doctor's office at least every 14 days during the actual treatment
3. Able to care for yourself, even if you cannot work or participate in other normal activities
4. Your blood results must be adequate for therapy.
5. If you are a female of childbearing potential and test negative for pregnancy, use a reliable method of birth control during and for three months following the last dose of study drug.

Exclusion Criteria:

1. Have received gemcitabine, paraplatin, or trastuzumab for your cancer.
2. Be pregnant or breastfeeding
3. Have cancer to the brain and has not been treated
4. Have another active cancer besides breast cancer
5. Have received stem cell or bone marrow transplant for hematologic (blood type) cancer

Primary outcomes:
measure: Overall Tumor Response
timeFrame: baseline to disease progression/recurrence (up to 3.5 years)
Secondary outcomes:
measure: Duration of Response
timeFrame: date of response (CR or PR) until the first date of documented progression or death from any cause (up to 3.5 years)
measure: Number of Patients Who Experienced Alopecia
timeFrame: Baseline to 3.5 years
measure: Time to Disease Progression (TTP)
timeFrame: randomization date to the earliest date of the first documented disease progression date or the date of death if the patient dies due to study disease (up to 3.5 years)
measure: Percentage of Patients With Overall Survival at 1 Year and 2 Years
timeFrame: 1 Year, 2 Years
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Indiana
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01599351: Radiation Exposure During Endoscopic Retrograde Cholangiopancreatography Between Prone and Left Lateral Decubitus
Official title: Different Radiation Exposures to Patient and Endoscopists Between Performing ERCP in Patients Lying Prone and Left Lateral Decubitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Exposure to Ionizing Radiation
Keywords: Radiation exposure
ERCP
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2012-05-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to evaluate the radiation dose to patient at two positions (prone and left lateral) and to medical staff during Endoscopic retrograde cholangiopancreatography (ERCP) procedure using dose area product (DAP) meter and thermoluminescent dosimeter (TLD). Data were recorded on 20 patients at prone position and 20 patients at left lateral position.

Detailed description: The radiographic-fluoroscopic system manufactured by Siemens Model POLYSTAR was used for ERCP procedure at King Chulalongkorn Memorial Hospital. Dose Area Product (DAP) manufactured by PTW Model DIAMENTOR E, a transmission ionization chamber was attached to X-ray collimator to record the dose-area (cGy.cm2) in order to determine the entrance surface air kerma (ESAK, mGy) of the patients at two positions (prone and left lateral) while the Kodak Portal Pack for localization imaging was placed on the patient's couch to determine the exposed area (cm2) on the surface of the patient. TLD was attached at five positions, left eye, thyroid, left forearm, lower abdomen and left leg of the medical staff during ERCP procedure.

Eligibility criteria: Inclusion Criteria:

* Patients with common bile duct (CBD) stone and underwent ERCP
* age over 18 years
* ASA class I-II

Exclusion Criteria:

* Pregnant
* Abnormal coagulation
* ASA class III-IV
* Emergency/urgency conditions
* Unstable vital signs
* Denied to participate the study

Primary outcomes:
measure: Patients' entrance surface dose
timeFrame: within 12 hours after procedure
Secondary outcomes:
measure: Endoscopists' radiation dose
timeFrame: Within 12 hours after procedure
Other outcomes:
Locations:
city: Patumwan
country: Thailand
facility: King Chulalongkorn Memorial Hospital
state: Bangkok
Study officials:
affiliation: Chulalongkorn University
name: Phonthep Angsuwatcharakon, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01791751: Impact of Clomiphene Citrate Administration During the Early Luteal Phase on Endocrine Profile in IVF Cycles
Official title: Impact of Clomiphene Citrate Administration During the Early Luteal Phase on Endocrine Profile in Agonist Triggered GnRH Antagonist in Vitro Fertilization Cycles. Phase IV, Single-centre, Open-label, Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Female Infertility
Lead sponsor: Fundació Privada Eugin
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate the effect on LH levels of the 5-day CC administration during luteal phase in oocyte donors, to investigate whether the CC corrects the suppressed LH levels in the luteal phase and whether it prolongs the luteal phase in the agonist triggered antagonist cycles.


Eligibility criteria: Inclusion Criteria:

* Oocyte donors
* 18-35 years old
* BMI 18-29 Kg/m2
* Normal basal hormonal levels
* No contraceptive pill

Exclusion Criteria:

* Polycystic ovarian syndrome (PCOS)
* Previous participation in the study

Primary outcomes:
measure: LH Levels (IU)
timeFrame: Luteal phase (up to 2 weeks)
Secondary outcomes:
measure: Endometrial development (Noyes criteria)
timeFrame: Luteal phase (1 day)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Clínica EUGIN
Study officials:
affiliation: Clinica EUGIN
name: Marta Colodron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02924051: Interventions in Nutrition Education and Skills
Official title: Interventions in Nutrition Education and Skills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 188
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control/Intervention Groups (3 sites in each group)
Primary purpose: PREVENTION

Brief summary: Healthy eating can be difficult for people who live in poor, geographically isolated regions of the United States. In particular, people who live in Appalachia often experience food insecurity (i.e., their access to adequate food is limited by a lack of money and other resources at times during the year) and lack of access to healthy foods. This pilot study evaluates the effectiveness of motivational interviewing in helping individuals who live in these austere regions improve their diets in the context of limited resources and healthy food availability

Detailed description: Participants in three of the counties will receive an education/skills intervention paired with a form of coaching called motivational interviewing (MI) conducted by a trained registered nurse. Three similar counties that do not border any of the intervention counties are serving as controls (these counties receive the same nutrition education/skills intervention without motivational interviewing). All participants will receive cookbooks, cooking classes, food preparation tools, and prepared food dishes to take home to their families. The investigators will measure the impact of motivational interviewing on fresh fruit and vegetable consumption, saturated fat consumption and number of meals cooked at home.

Eligibility criteria: Inclusion Criteria:

• People who live in one of six rural Kentucky food desert counties

Exclusion Criteria:

* \<16 years old
* Unable to read/write English
* Any GI malabsorption disorder that prevents high fiber consumption

Primary outcomes:
measure: Change in BLOCK Fruit/Vegetable/Fiber Screener From Baseline at 12 Months
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Average Saturated Fatty Acid Intake/Day
timeFrame: Baseline, 12 months
measure: Frequency of Fast Food Consumption
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00226551: Vascular Response to Isoproterenol and β2 Adrenergic Receptor Polymorphisms
Official title: ß2 Adrenergic Receptor Polymorphisms and Vasodilation of Internal Mammary Artery Induced by Isoproterenol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-09-27
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Single nucleotide polymorphisms at codon 46 and 79 of the gene encoding for the ß2 adrenergic receptor (ß2AR) modify its pharmacological properties and may alter the response to ß2AR agonists. The goal of the present study was to evaluate the role played by the Arg16Gly and Gln27Glu polymorphisms on isoproterenol induced relaxation of internal mammary arteries segments ex-vivo.

Internal mammary leftover segments were collected from 96 patients undergoing coronary artery bypass graft operation. Four rings that were prepared from each specimen were allowed to reach equilibrium with physiological Krebs solution prior to precontraction with U46619. Using the organ bath technique, cumulative dose response curve of isoproterenol was constructed and mean EC50 calculated for each patient.


Eligibility criteria: Inclusion Criteria:

* patients scheduled to undergo coronary artery bypass graft operation

Exclusion Criteria:

* Chronic treatment with corticosteroids

Primary outcomes:
measure: Mean Ec50% in response to rising concentration of isoproterenol
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Yoseph Caraco, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khalaila JM, Elami A, Caraco Y. Interaction between beta2 adrenergic receptor polymorphisms determines the extent of isoproterenol-induced vasodilatation ex vivo. Pharmacogenet Genomics. 2007 Oct;17(10):803-11. doi: 10.1097/FPC.0b013e3281eb8f07.
Clinical trial NCT00922077: Individualized Neurodevelopmental Treatment
Official title: Individualized Neurodevelopmental Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cerebral Palsy
Lead sponsor: Hellenic Society for Disabled Children
Sponsor class: OTHER
First posted: 2009-06-17
Enrollment: 1
Sex: FEMALE
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to evaluate this therapeutic intervention by expressing functional level with valid quantitative data.

Detailed description: The intervention lasted 6 weeks. There were 3 sessions per week. At each session there was a part of standard physical therapy program and there was also a part with emphasis on dynamic balance exercises.

Eligibility criteria: Inclusion Criteria:

* spastic tetraplegia

Exclusion Criteria:

* vision problems

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Hellenic Society for Disabled Children
Study officials:
References:
Clinical trial NCT01014377: Effect of VascuActive Device on Foot Perfusion, Hemodynamics and Exercise Capacity in Patients With PVD & Limb Ischemia
Official title: Assessment of the Safety of the VascuActive™ Device and Its Preliminary Efficacy on Foot Perfusion, Hemodynamics and Exercise Capacity in Patients With Peripheral Vascular Disease and Limb Ischemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vascular Diseases
Lead sponsor: VascuActive LTD
Sponsor class: INDUSTRY
First posted: 2009-11-17
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and the immediate effect of the VascuActive device on patients with peripheral vascular disease and limb ischemia.


Eligibility criteria: Inclusion Criteria:

* Leg Ischemia, Fontaine grade IIa and IIb, i.e.: pain free walking distance in the range of 50 - 100 meters.
* Absent pulses in the two foot arteries (Anterior Tibial a., Posterior Tibial a.)
* ABI \< 0.7 by Doppler, in at least one of the two foot arteries

Exclusion Criteria:

* Absent femoral pulses
* Venous insufficiency by Duplex
* Pregnancy
* Infectious disease
* Malignant disease
* Severe cardiac disease, e.g., CHF grade 3 or higher
* Acute MI within last 3 months
* CABG within last 3 months
* Other severe systemic disease

Primary outcomes:
measure: Pain-free and Maximal walking distance
timeFrame: 1 hour
Secondary outcomes:
measure: Skin temperature
timeFrame: 1 hour
measure: Skin blood flow
timeFrame: 1 hour
measure: Transcutaneous partial pressure of O2 and CO2
timeFrame: 1 hour
Other outcomes:
Locations:
city: Zrifin
country: Israel
facility: Asaf Harofe Medical Center
Study officials:
References:
Clinical trial NCT03983577: Efficacy of Point Of Service Testing in MBC
Official title: Efficacy of Point Of Service Testing in Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Cancer
Breast Cancer
Keywords: genetic counseling
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will assess the efficacy of an innovative point of service cancer genetics counseling delivery model for metastatic breast cancer (MBC) patients whom have received a referral for hereditary cancer genetic counseling and testing.


Eligibility criteria: Inclusion Criteria:

* Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent.
* Able to speak and read in the English language.
* Have a diagnosis of human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer.
* Participants must be enrolled in the parent registry study.

Exclusion Criteria:

* Genetic testing for a breast cancer gene (BRCA) BRCA1 and BRCA2 mutation completed after 2013 or any BRCA 1 and BRCA2 testing with large rearrangement testing. Prior genetic counseling is allowed.
* Psychiatric illness/social situations that would limit compliance with study requirements.

Primary outcomes:
measure: Proportion of patients/participants that undergo hereditary cancer genetic testing after the telehealth intervention.
timeFrame: 24 months
Secondary outcomes:
measure: Overall participant satisfaction
timeFrame: 24 months
measure: Clinical decisional conflict score
timeFrame: 24 months
measure: Overall participant anxiety
timeFrame: 24 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The University of Kansas Cancer Center, Westwood Campus
state: Kansas
Study officials:
affiliation: University of Kansas
name: Lauren Nye, MD
role: PRINCIPAL_INVESTIGATOR
References: