louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06121440: Musical-animated Toys and Audio Books in Pediatric Palliative Care.
Official title: The Effect of Musical-Animated Toys and Audio Books on Fear, and Pain in the Tracheostomy Care of Children in the Palliative Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheostomy Infection
Keywords: Palliative care
Children
Audiobook
Musical-moving toy
Pain
Fear
Anxiety
Lead sponsor: Artvin Coruh University
Sponsor class: OTHER
Collaborators: name: Ataturk University
First posted: 2023-11-08
Enrollment: 16
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to determine the effect of audio book and musical-moving toy on fear, anxiety and pain in tracheostomy care of children in palliative clinic.

Detailed description: In children with receiving palliative care will be randomly divided into two groups: audiobook group and musical-moving toy. Interventions will be applied for 2 days, 1 times a day (2 sessions). No intervention will be applied to both groups besides audiobook or musical-moving toy intervention. The children will be assessed before, during and after. Pain, fear and anxiety due to tracheostomy care procedure will be evaluated using the Wong Baker Facial Pain Scale, Child Anxiety Scale-Stateness and Children's Fear Scale . In addition, the heart rate, respiration, blood pressure and SPO2 values of the children will be measured with the help of a bedside monitor.

Eligibility criteria: Inclusion Criteria:

1. Between the ages of 6 months and 18 years
2. Receiving inpatient treatment in paediatric palliative care service
3. No visual and hearing abnormalities

Exclusion Criteria:

1. The family's desire to leave research.
2. Deterioration of the child's condition

Primary outcomes:
measure: Patient Identification Form
timeFrame: baseline
Secondary outcomes:
measure: Wong Baker Facial Pain Scale
timeFrame: baseline
Other outcomes:
measure: Child anxiety Scale-State
timeFrame: baseline
measure: Child Fear Scale
timeFrame: baseline
Locations:
city: Erzurum
country: Turkey
facility: Erzurum City Hospital
state: Central
Study officials:
affiliation: Ataturk University
name: Türkan KADİROĞLU, 3
role: STUDY_CHAIR
affiliation: Erzurum City Hospital
name: Aysun ÖNCER, 4
role: STUDY_CHAIR
affiliation: Erzurum City Hospital
name: Döne KILIÇ BULUT, 5
role: STUDY_CHAIR
References:
citation: Hoag JA, Karst J, Bingen K, Palou-Torres A, Yan K. Distracting Through Procedural Pain and Distress Using Virtual Reality and Guided Imagery in Pediatric, Adolescent, and Young Adult Patients: Randomized Controlled Trial. J Med Internet Res. 2022 Apr 18;24(4):e30260. doi: 10.2196/30260.
Clinical trial NCT03552640: Accuracy of Digital Three-Dimensional Root Position Prediction Via Digitized Models
Official title: Accuracy of Digital Three-Dimensional Root Position Prediction Via Digitized Models
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Orthodontic Appliance Complication
Keywords: Orthodontics
Digitized Models
Root Position
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having only permenant teeth and no decidous ones, requiring orthodontic treatment not involving extraction of teeth in their treatment plan

Brief summary: Measuring the accuracy of a new technique by which root positions can be predicted at the pre-finishing stage of the comprehensive orthoodntic treatment

Detailed description: A CBCT is taken Pre-Treatment

Segmentation of teeth is done from the CBCT exported as STL files and kept aside.

Routine comprehensive orthodontic treatment is done till pre-finishing stage.

Impression for teeth is taken at this timepoint.

A cast is poured and laser scanned.

Now the investigators have segmented teeth and a cast with new crown positions

The investigators will superimpose the teeth on the crowns of the digital cast to obtain the " Predicted Root Position" (PRP)

To check accuracy of this Prediction a CBCT is taken and compared to the prediction to check its accuracy.

Eligibility criteria: Inclusion Criteria:

* Patients requiring orthodontic treatment
* Adult set of permanent dentition
* Non-extraction cases

Exclusion Criteria:

* Syndromic patients

Primary outcomes:
measure: Accuracy of Root Position Prediction as assessed by Color Map Heat Analysis
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Orthodontic Department
Study officials:
References:
Clinical trial NCT01146340: Safety and Efficacy Study of Dose-escalated Hypofractionated Radiotherapy For Prostate Cancer
Official title: Phase I/II Study of Dose-Escalated Hypofractionated Radiotherapy for Low- and Intermediate-Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: Prostatic Neoplasms
Radiotherapy
Hypofractionation
Low and Intermediate Risk Prostate Cancer
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Canadian Association of Radiation Oncology
First posted: 2010-06-17
Enrollment: 30
Sex: MALE
Minimum age (years): 18
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 determine the safety and efficacy of a short course of radiotherapy (40 Gy / 5 fractions / 29 days) for the treatment of low- and intermediate-risk prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Men \>18 years
* Histologically confirmed prostate adenocarcinoma
* Low or low-intermediate risk prostate cancer, defined as Clinical stage T1-2b, Gleason Score \<=6, and PSA \<15 ng/mL, OR Clinical stage T1-2b, Gleason Score 7, and PSA \<=10 ng/mL

Exclusion Criteria:

* Prior pelvic radiotherapy
* Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
* Diagnosis of bleeding diathesis
* Presence of a hip prosthesis
* Pelvic girth \>40cm - Large prostate (\>90cm3) on imaging
* Severe lower urinary tract symptoms (International Prostate Symptom Score \>19 or nocturia \>3)

Primary outcomes:
measure: Incidence of grade 3+ rectal toxicity
timeFrame: Acute period (<3 months)
Secondary outcomes:
measure: Incidence of grade 3+ urinary toxicity
timeFrame: Acute (<3 months) and Late (>6 months)
measure: Quality of Life
timeFrame: 5 years
measure: Biochemical (ie. prostate specific antigen) disease free survival
timeFrame: 5 year
measure: Incidence of grade 3+ rectal toxicity
timeFrame: Late (>6 months)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Andrew Loblaw, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Harvey Quon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Quon HC, Musunuru HB, Cheung P, Pang G, Mamedov A, D'Alimonte L, Deabreu A, Zhang L, Loblaw A. Dose-Escalated Stereotactic Body Radiation Therapy for Prostate Cancer: Quality-of-Life Comparison of Two Prospective Trials. Front Oncol. 2016 Aug 29;6:185. doi: 10.3389/fonc.2016.00185. eCollection 2016.
Clinical trial NCT04415840: Lugol's Solution in Addition to Acetic Acid During Colposcopy
Official title: Benefits of Using Lugol's Solution in Addition to Acetic Acid During Colposcopy in Women With Cervical Dysplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Cervical Dysplasia
Keywords: cervical dysplasia
colposcopy
Lugol's solution
acetic acid
Lead sponsor: Zydolab - Institute of Cytology and Immune Cytochemistry
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 323
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-pregnant women referred for colposcopy due to cervical abnormalities

Brief summary: To assess the benefits of using Lugol's solution in addition to acetic acid during colposcopy in women with cervical dysplasia.


Eligibility criteria: Inclusion Criteria:

* women referred for colposcopy due to cervical abnormalities
* written informed consent

Exclusion Criteria:

* pregnant women
* presence of a language barrier
* history of conization or other treatments on the cervix uteri
* iodine allergy

Primary outcomes:
measure: additional identified dysplastic lesions on the cervix uteri due to the use of Lugol's Solution
timeFrame: 1 minute
Secondary outcomes:
measure: Sensitivity
timeFrame: 1 minute
measure: Specificity
timeFrame: 1 minute
measure: PPV
timeFrame: 1 minute
measure: NPV
timeFrame: 1 minute
Other outcomes:
Locations:
city: Dortmund
country: Germany
facility: Zydolab - Institute of Cytology and Immune Cytochemistry
state: NRW
city: Herne
country: Germany
facility: Department of Obstetrics and Gynecology of the Ruhr University Bochum
state: NRW
Study officials:
affiliation: Zydolab - Institute of Cytology and Immune Cytochemistry
name: Ziad Hilal, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00628940: PET Imaging of High-grade Glioma Using 18F-fluoromethylcholine: a Tool for the Early Detection of Tumour Recurrence After Combined Radiochemotherapy?
Official title: PET Imaging of High-grade Glioma Using 18F-fluoromethylcholine: a Tool for the Early Detection of Tumour Recurrence After Combined Radiochemotherapy?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: High-grade Glioma of the Brain
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
name: Special Research Fund, Belgium
First posted: 2008-03-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to define preferential sites of tumour recurrence by observing tracer uptake in the tumour in sequential PET images with 18F-fluoromethylcholine (and perfusion MR, see also below). Changes in the intensity of the tracer uptake in the tumour during and after the course of radiotherapy will be correlated with the site of tumour recurrence as will be assessed by conventional MRI. In due time, these results must enable clinicians to change their therapeutic approach of high-grade glioma.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* patients with high-grade glioma who will undergo adjuvant radiochemotherapy after surgery

Exclusion Criteria:

* low global performance state
* pregnancy
* lactation period
* presence of pacemaker, vascular clips in the brain ,epidural electrodes, implanted hearing device, set of false theeth attached by means of magnetes, wig attached by means of metal clips

Primary outcomes:
measure: time to local recurrence after neurosurgery and adjuvant radiochemotherapy
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Ingeborg Goethals, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06693440: The Immune Assessment of PD-1 Antibody Therapy in Tumor
Official title: The Immune Assessment of PD-1 Antibody Therapy in Tumor - A Case-Control Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Efficacy, Team
Adverse Event
Keywords: PD(L)-1 inhibitor
efficacy
adverse event
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2024-11-18
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with cancer

Brief summary: This retrospective study will leverage previous immune function monitoring results in conjunction with clinical case data at this medical center.

Detailed description: The primary aim of this study is to evaluate the efficacy and safety of PD(L)-1 antibody therapy for malignant tumors in real-world settings. Treatment outcomes will be assessed according to RECIST V1.1 and iRECIST criteria, with safety graded according to CTCAE V5.0 standards. The study aims to enroll 3000 adult cancer patients treated at this center and analyze their prognosis outcomes based on previous treatment.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years.
2. Pathologically confirmed malignant tumors.
3. Complete medical records.
4. Assessable immune function test data.

Exclusion Criteria:

1. Age \<18 years.
2. No confirmed tumor pathology.
3. Untraceable medical records.
4. Non-assessable immune function tests.

Primary outcomes:
measure: Objective response rate
timeFrame: 6 months
measure: Adverse events
timeFrame: 1 year
Secondary outcomes:
measure: Overall survival
timeFrame: 1 year
Other outcomes:
measure: Duration of response
timeFrame: 2 years
Locations:
city: Zhengzhou
country: China
facility: Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Quanli Gao
role: STUDY_DIRECTOR
References:
Clinical trial NCT02519140: Assessing How the Viscosity of Submucosal Gel Injections Helps With Endoscopic Mucosal Resections
Official title: Assessing How the Viscosity of Submucosal Gel Injections Helps With Endoscopic Mucosal Resections
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Gastric Cancer
Colon Cancer
Keywords: Gastric cancer
colon cancer
EMR
biopsy
bariatric surgery
Lead sponsor: Maimonides Medical Center
Sponsor class: OTHER
First posted: 2015-08-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to determine how the viscosity (thickness) of an FDA approved gel affects the ease in which endoscopic mucosal resections (EMR) can be performed.

Detailed description: This is a study to determine how the viscosity (thickness) of an FDA approved gel made by Cook medical affects the ease in which endoscopic mucosal resections (EMR) - a type of endoscopic surgery performed for localised cancer - can be performed when the gel is injected submucosally. The lifting characteristics of the gel will be assessed by height and diameter and ease with which the subsequent EMR dissection can be performed. These characteristics would be assessed on excised human stomachs and colon, which are harvested during routine sleeve gastrectomy surgeries or colectomies, in an ex-vivo manner.

Eligibility criteria: Inclusion Criteria:

* Pts undergoing sleeve gastrectomy
* Pts undergoing colectomy

Exclusion Criteria:

* Unable to give or understand consent
* All of the excised tissue will be needed for diagnostic purposes

Primary outcomes:
measure: Lift Efficacy
timeFrame: 1 hour
Secondary outcomes:
measure: Dissection Adequacy
timeFrame: 1 hour
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
Study officials:
affiliation: Maimonides Medical Center
name: Danny Sherwinter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chandrasekhara V, Sigmon JC Jr, Surti VC, Kochman ML. A novel gel provides durable submucosal cushion for endoscopic mucosal resection and endoscopic submucosal dissection. Surg Endosc. 2013 Aug;27(8):3039-42. doi: 10.1007/s00464-013-2813-y. Epub 2013 Feb 8.
Clinical trial NCT05541640: Intraoperative Lidocaine Infusion and Surgery-induced Release of Pro-inflammatory Cytokines After Abdominal Surgery
Official title: Effect of Intraoperative Lidocaine Infusion on Inducing Intestinal Motility and Surgery-induced Release of Pro-inflammatory Cytokines After Abdominal Surgery. A Prospective, Comparative, Randomized Double Blind Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Enhanced Recovery After Surgery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lidocaine is an amide local anaesthetic and an antiarrhythmic agent, first synthesized in 1942, and after approval for human use was launched in 1948 in Sweden The first observations of post operative analgesic effects of perioperative intravenous lidocaine (IVL) were initially proposed in 1951 subsequently many more enthusiastic reports followed. Postoperative formal clinical evaluations in the perioperative setting were conducted in the late 1950s where IV Lidocaine was demonstrated to have a postoperative analgesic effect without posing the risk of respiratory depression, reducing the occurrence of postoperative nausea and vomiting (PONV), and enhance post-surgical recovery. IV Lidocaine also potentiated the depth of anesthesia and led to a better tolerance of endotracheal intubation.Around 40% of patients experience a delay in resumption of normal bowel function after colorectal surgery. This delay leads to symptoms of nausea, vomiting, constipation, and abdominal distension, which then require unpleasant supportive interventions such as intravenous fluids and nasogastric tube insertion. There is no remedy to address this delay. ALLEGRO, "A placebo-controlled randomized trial of intravenous Lidocainein accelerating Gastrointestinal Recovery surgery," is the latest ongoing multicenter research study across the United Kingdom, investigating the use of intravenous lidocaine to improve recovery after colorectal surgery


Eligibility criteria: Inclusion Criteria:

* Age 18 years and older.
* Both sexes, males and females
* Patients scheduled for elective intestinal surgery.
* Body mass index (BMI) 18-30 kg•m-2.
* ASA I - II.

Exclusion Criteria:

* Patient refusal
* Patients with preoperative gastrointestinal dysfunction.
* Patients with a history of drug abuse, or long-term opioid use.
* ASA III and VI
* Patients with a history of previous gastrointestinal surgery

Primary outcomes:
measure: postoperative visual analogue score (VAS SCORE)
timeFrame: 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT01289340: Wound Healing and Pain Management in Partial Thickness Burns
Official title: Pain Management and Wound Healing in Partial Thickness Burn: Comparative, Post Marketing, Observational Trail Comparing Advanced Foam Dressings to Conventional Treatment.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pain
Keywords: wound healing
pain
burn
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2011-02-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients ages 18-40 with no co-morbidities nor pregnant.

Brief summary: the aim of the study is to compare between two advanced wound dressing and conventional dressing for the primary ER treatment of superficial partial thickness burns


Eligibility criteria: Inclusion Criteria:

patients with minor superficial partial thickness burns

Exclusion Criteria:

co-morbidities, pregnancy

Primary outcomes:
measure: complete wound healing
timeFrame: up to two to three weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Petah tikva
country: Israel
facility: Beilinson hospital, RMC
Study officials:
affiliation: Rabin medcial Center
name: Dean D Ad El, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03335540: An Adaptive Study to Match Patients With Solid Tumors to Various Immunotherapy Combinations Based Upon a Broad Biomarker Assessment
Official title: ADaptiVe Biomarker Trial That InformS Evolution of Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-11-07
Enrollment: 20
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 this study is to evaluate the treatment of solid tumors with various immunotherapy combinations. The treatment will be determined based upon a broad biomarker assessment.


Eligibility criteria: Inclusion Criteria:

* Participants must have an ECOG performance status of less than or equal to 1
* Participants must have had prior therapy;Participants who have received adjuvant or neoadjuvant anti-PD(L)1 therapy andprogressed within 6 months of completing therapy will be considered IO refractory.
* Participants must have at least 2 lesions with measurable disease as defined by RECIST Version 1.1

Exclusion Criteria:

* Participants with suspected, known, or progressive CNS metastases, have untreated CNS metastases, or have the CNS as the only site of disease
* Participants with carcinomatous meningitis
* Participants with other active malignancy requiring concurrent intervention

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Number of participants with qualified tumor biopsy specimen at baseline
timeFrame: Up to 28 days
Secondary outcomes:
measure: Percent of change from baseline in histopathologic features
timeFrame: Up to 4 years
measure: Percent of change from baseline in biomarker expression patterns
timeFrame: Up to 4 years
measure: Number of Adverse Events (AEs)
timeFrame: Up to 4 years
measure: Number of Serious Adverse Events (SAEs)
timeFrame: Up to 4 years
measure: Number of Laboratory Abnormalities
timeFrame: Up to 4 years
measure: Number of Adverse Events(AEs) leadind to discontinutaion
timeFrame: up to 4 years
measure: Number of Deaths
timeFrame: up to 4 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Local Institution - 0001
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Local Institution - 0002
state: Maryland
city: Pittsburgh
country: United States
facility: Local Institution - 0003
state: Pennsylvania
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: