louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04547322: Effect of Virtual Reality on Preoperative Anxiety
Official title: The Effect of Virtual Reality on Preoperative Anxiety in Patients Undergoing Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preoperative Anxiety
Keywords: colorectal surgery
virtual reality
nurse
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, parallel, two arm, randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to determine the effect of virtual reality (VR) on the preoperative anxietyof patients undergoing colorectal surgery.

Detailed description: The sample of this study consisted of 86 patients in experimental and control groups. The experimental group received VR application in the preoperative period for 10 minutes. Anxiety level was assessed with the Anxiety Specific to Surgery Questionnaire (ASSQ) and measured with physiological responses of anxiety such as systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), respiratory rate (RR) and peripheral oxygen saturation (SpO2) before and after VR application.

Eligibility criteria: Inclusion Criteria:The study included

* conscious,
* orientated and cooperated patients who could speak and understand Turkish,
* who had no psychiatric diseases,
* who were 18 years old and older,
* who were scheduled for elective colorectal surgery for the first time,
* who did not take any sedative drugs before surgery, and
* who gave written and oral permission to participate in the study

Exclusion Criteria:n The study excluded

* had language problems,
* underwent emergency surgery,
* were over 65 years of age and
* refused to participate in the study.

Primary outcomes:
measure: Change Anxiety Specific to Surgery Questionnaire score
timeFrame: 10 minute
Secondary outcomes:
measure: Change systolic blood pressure
timeFrame: 10 minute
measure: Change diastolic blood pressure
timeFrame: 10 minute
measure: Change heart rate
timeFrame: 10 minute
measure: Change respiratory rate
timeFrame: 10 minute
measure: Change peripheral oxygen saturation
timeFrame: 10 minute
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University Hospital
state: Yenisehir
Study officials:
affiliation: Mersin University, Nursing Faculty
name: Gulay Altun Ugras, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06360822: Increasing Equity in Lung Cancer Screening
Official title: Increasing Equity in Lung Cancer Screening
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Eskenazi Health
First posted: 2024-04-11
Enrollment: 144
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall objective of this mixed methods study is to: 1) Refine the Emergency Department Lung Cancer Screening (ED-LCS) intervention using qualitative interviews among key stakeholders; 2) pilot test the ED-LCS intervention evaluating the intervention efficacy, acceptability, and feasibility; and 3) provide an in-depth description of stakeholders' experiences with the ED-LCS intervention for future refinement.


Eligibility criteria: Inclusion Criteria:

* • Eligible for LCS (50-80 years old, smoked in past 15 years, and smoked at least 20 pack years)

Exclusion Criteria:

* • Non-English/Spanish speaking

  * Decompensated psychiatric illness (suicidal, homicidal, psychosis). Will confirm with attending physicians at time of enrollment
  * Intoxicated with alcohol or drugs
  * Cannot provide reliable follow up contact information (cell phone)
  * Presenting to the ED with a life-threatening condition
  * Have received chest CT scan in past 12 months
  * Already enrolled in LCS
  * Hospice enrolled

Primary outcomes:
measure: Rate of patients receive Lung Cancer Screening
timeFrame: 6-12 months
Secondary outcomes:
measure: Patients ratings of intervention
timeFrame: At delivery
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Health
state: Indiana
Study officials:
References:
Clinical trial NCT02902822: Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo
Official title: Tele-dermatology of Skin Cancer: a Randomized Trial Comparing Remote Assessment With Conventional Visits in a Cohort of Local Health Authority Employees in the Province of Bergamo (the Shoot the Mole Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erysipelas
Impetigo
Herpes Zoster
Molluscum Contagiosum
Warts
Tinea
Melanoma
Actinic Keratosis
Basal Cell Carcinoma
Squamous Cell Carcinoma
Keywords: melanoma
non-melanoma skin cancer
mole
app
cliccailneo
Lead sponsor: Centro Studi Gised
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 461
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to demonstrate the validity and utility of a tele-dermatology system in the midterm periodic screening of non-widespread skin lesions of recent onset or for which a specialized early classification is deemed to change the prognosis - including precancerous skin lesions as well as melanoma and non-melanoma skin cancers - compared to control visits at fixed follow-up.


Eligibility criteria: Inclusion Criteria:

* Subjects currently working at the Local Health Authority of the province of Bergamo

Exclusion Criteria:

* Subjects who are not able to use the tele-dermatology system or who have no access to the website or the specific app.

Primary outcomes:
measure: Cumulative incidence of at least one non-widespread skin lesion identified and clinically confirmed as suspected / highly suspected
timeFrame: Two years
Secondary outcomes:
measure: Agreement between the tele-dermatology system and the direct dermatological visit as assessed by Cohen's kappa (within the experimental arm).
timeFrame: Within the two years study period
measure: Cumulative incidence of at least one non-widespread skin lesion identified as suspected / highly suspected among subjects who did not use the tele-dermatology system (within the experimental arm).
timeFrame: Within the two years study period
measure: Proportion of subjects who have at least one anticipated follow-up visit (within the comparator arm).
timeFrame: Within the two years study period
measure: Proportion of subjects with at least one missed scheduled visit at follow-up(within the comparator arm).
timeFrame: Within the two years study period
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Local Health Authority (ATS)
Study officials:
affiliation: Centro Studi Gised
name: Luigi Naldi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04156139: HFNC vs NPPV After Early Extubation for Patients With COPD
Official title: High-flow Nasal Cannula Versus Noninvasive Positive Pressure Ventilation Therapy After Early Extubation for Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Hypercapnic Respiratory Failure
Keywords: NPPV
HFNC
Weaning
COPD
PIC
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Health Science Center
First posted: 2019-11-07
Enrollment: 502
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: High-flow nasal cannula oxygen therapy(HFNC) has proved no significant difference compared with noninvasive positive pressure ventilation (NPPV) in preventing postextubation respiratory failure and reintubation in patients with acute hypoxemic respiratory failure.However, the efficacy of early postextubation sequential HFNC in COPD patients with hypercapnic respiratory failure is inconclusive.

Detailed description: The investigators conducted this prospective randomized controlled trial to explore the efficacy, safety of HFNC versus NPPV after early extubation in COPD patients with hypercapnic respiratory failure.The investigators hypothesized that the efficacy of HFNC after early extubation is non-inferior to that of NPPV.

Eligibility criteria: Inclusion Criteria:

* 1. COPD patients with bronchopulmonary infection 2. Patients with hypercapnia respiratory failure treated with invasive mechanical 3.14 days ≥ invasive mechanical ventilation ≥ 48 hours; 4.Reached the pulmonary infection control (PIC) window; 5.Have self-care ability with oxygen supply during stable phrase

Exclusion Criteria:

* Severe organ dysfunction;Myopathy or myasthenia gravis;Upper airway obstruction;A large amount of secretions and inability to drain;

Primary outcomes:
measure: reintubation
timeFrame: within the 7 days after extubation.
Secondary outcomes:
measure: Weaning failure
timeFrame: within the7 days after extubation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: XIE Lixin, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02730039: Meaning-Centered Psychotherapy Training for Cancer Care Providers
Official title: Meaning-Centered Psychotherapy Training for Cancer Care Providers
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer Care Providers
Keywords: Cancer Care Providers
Psychotherapy
15-321
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Northwestern University
name: MJHS Institute for Innovation in Palliative Care
name: Massachusetts General Hospital
name: City of Hope Medical Center
name: Dana-Farber Cancer Institute
name: New York Presbyterian Hospital
name: Odette Cancer Center - Sunnybrook Hospital
name: VA New York Harbor Healthcare System
name: University of Pennsylvania
name: Smilow Cancer Hospital - Yale New Haven Health
name: Department of Veterans Affairs, New Jersey
name: Vidant Cancer Care
First posted: 2016-04-06
Enrollment: 350
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: clinicians (20% MSKCC providers \& 80% outside providers)

Brief summary: The purpose of this project, entitled "Meaning-Centered Psychotherapy Training for Cancer Care Providers," is to develop a multi-modal training program in Meaning-Centered Psychotherapy (MCP) for multidisciplinary cancer care clinicians who provide psycho-oncology and psychosocial palliative care services for cancer patients.


Eligibility criteria: Inclusion Criteria:

* Clinicians who provide psycho-oncology and/or psychosocial palliative care services for to patients with cancer and/or severe medical illness/disease at MSKCC, other institutions, or in the community, as per self-report.
* Completed online MCPT application form and commits to attend the two-day intensive MCPT program, complete training follow-up assessments, and participate in required follow-up training activities.
* Able to speak, read, and understand English proficiently to participate in MCPT training sessions and complete assessments.

Exclusion Criteria:

* Does not meet the criteria of an appropriate candidate for training program, as determined by review of the MCPT Application Evaluation Checklist in the opinion of the investigator.

  * Materials for the training and the training will be conducted in English only.

Primary outcomes:
measure: participant's skills uptake at the end of the MCPT session score range 0-10
timeFrame: change from Baseline to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: William Breitbart, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00260039: Broad Spectrum HPV Vaccine Dose Ranging Study (V502-001)
Official title: A Randomized, International, Double-Blinded (With In-House Blinding), GARDASIL-Controlled, Dose-Ranging Study of Octavalent Human Papillomavirus (HPV) L1 Virus-like Particle (VLP) Vaccine Administered to 16- to 23- Year-Old Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HPV
Cervical Cancer
Premalignancy Anogenital Warts
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-12-01
Enrollment: 680
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This dose-ranging study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate that the vaccine is well-tolerated in women (2) To evaluate immune responses in women who are between 16 and 23 years of age at enrollment.


Eligibility criteria: Inclusion Criteria:

* Lifetime history of 0-4 sexual partners

Exclusion Criteria:

* History of abnormal PAP test or abnormal cervical biopsy result; history of external genital/vaginal warts; history of positive HPV test

Primary outcomes:
measure: The octavalent HPV VLP vaccine, when administered in a 3-dose regimen, induces acceptable responses for specific HPV types at 4 weeks Post dose 3. Immune responses measured by an HPV competitive Luminex immunoassay.
timeFrame: 4 weeks post dose 3 injection
Secondary outcomes:
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 NCT03725839: The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)
Official title: The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disordered Breathing
Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2018-10-31
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This investigation is designed to evaluate the performance as well as the patients overall acceptance of the interface.

Detailed description: A minimum of 40 OSA participants who currently use CPAP will be recruited for the trial. Participant will be in the trial for three weeks- first week will be a collection of Positive Airway Pressure baseline data on participant's usual interface. The participant will then use the trial interface in-home for 2 weeks. There is also an option of a six month extension if the participant wish to continue on the trial interface.

Eligibility criteria: Inclusion Criteria:

* Adult (18+ years of age)
* Able to give written consent
* AHI ≥ 5 on diagnostic night
* Either prescribed APAP, CPAP or Bi-level PAP for OSA

Exclusion Criteria:

* Inability to give written consent
* Anatomical or physiological conditions making PAP therapy inappropriate
* Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
* Current diagnosis of respiratory disease or CO2 retention
* Pregnant or may think they are pregnant.

Primary outcomes:
measure: Trial Mask usability
timeFrame: 14 ± 4 days in home
measure: Trial mask Performance
timeFrame: 14 ± 4 days in home
Secondary outcomes:
measure: Trial mask Reliability
timeFrame: 5 months and 2 weeks in home
measure: Trial mask performance measured in L/min
timeFrame: 14 ± 4 days in home
Other outcomes:
Locations:
city: Hastings
country: New Zealand
facility: Hawkes Bay Fallen Soldiers' Memorial Hospital
state: Hawkes Bay
city: Auckland
country: New Zealand
facility: Fisher & Paykel Healthcare
city: Wellington
country: New Zealand
facility: Well Sleep
Study officials:
affiliation: Clinical Manager
name: Bhavi Ogra
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06176339: Assessing the Clinical Utility of Adding Pentoxifylline to Neoadjuvant Chemotherapy Protocols in Breast Cancer Patients"
Official title: "Assessing the Clinical Utility of Adding Pentoxifylline to Neoadjuvant Chemotherapy Protocols in Breast Cancer Patients"
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Breast Cancer Female
Keywords: neoadjuvant chemotherapy
doxorubicin
cyclophosphamide
paclitaxel
efficacy
toxicity
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-12-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Breast cancer, a leading cause of cancer-related mortality in women worldwide, has spurred the investigation of novel therapeutic approaches. Pentoxifylline (PTX), a synthetic methylxanthine derivative, has shown promise in preclinical studies when combined with conventional anticancer drugs. This study aims to assess PTX's impact when added to neoadjuvant chemotherapy protocols in breast cancer patients, with the goal of improving treatment outcomes and reducing associated toxicities.


Eligibility criteria: Inclusion Criteria:

* Adult female patients \>18 years old with histologic confirmation of invasive breast cancer
* Planned to administer neoadjuvant chemotherapy protocol comprised of doxorubicin/ cyclophosphamide followed by paclitaxel (AC/T)
* Adequate hepatic, renal, and bone marrow functions

Exclusion Criteria:

* Patients on treatment regimen of phosphodiesterase inhibitors
* Patients who are taking antiplatelet or anticoagulant treatment
* Patients who are allergic to phosphodiesterase inhibitors
* History of recent hemorrhagic events
* Active peptic ulcer

Primary outcomes:
measure: Relative reduction in tumor size after neoadjuvant chemotherapy treatment
timeFrame: 6 months
Secondary outcomes:
measure: The number of patients achieving a pathological complete response
timeFrame: 6 months
measure: The relative change of left ventricular ejection fraction (LVEF)
timeFrame: 3 months
measure: The incidence of grade 2 or more of neurotoxicity according to common terminology criteria for adverse event (NCI-CTCAE) version 5
timeFrame: 2 months
measure: The relative change of liver function tests
timeFrame: 6 months
measure: The change in Serum Creatinine concentration
timeFrame: 6 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Oncology center of Mansoura University
Study officials:
affiliation: Oncology Center, Faculty of medicine, Mansoura University
name: Omar Hamdy Abdelaleem, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06999239: Evaluation of the Effect of Laser Therapy on Lateral Pterygoid Muscle in Patients With Wilke's Stage I and II Temporomandibular Disorders (TMD): Case Series Study
Official title: Evaluation of the Effect of Laser Therapy on Lateral Pterygoid Muscle in Patients With Wilke's Stage I and II Temporomandibular Disorders (TMD): Case Series Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Laser
Temporomandibular Joint Disorders
Lateral Pterygoid Muscle
Keywords: laser therapy, lateral pterygoid muscle, Wilke's, stage I and II, TMD.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 25
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study will be to evaluate the effect of laser therapy on lateral pterygoid muscle in patients with Wilke's stage I and II temporomandibular disorders (TMD).


Eligibility criteria: Inclusion criteria:

1. Patients age between 16-50 years with no sex predilection.
2. Patients who will be free from any systemic diseases that affect temporomandibular joint.
3. Patients who will be diagnosed with wilk's stage I and II temporomandibular disorders (TMD).
4. Patients who will be ready to give informed consent.

Exclusion Criteria:

1. Patients with previous temporo-mandibular surgeries.
2. Patients with previous facial fracture.
3. Patients who will be under another type of treatment for TMD (e.g., occlusal splints, pharmacological drugs, or head and neck surgery).
4. Patients who will not attend the proposed treatment sessions or follow-up visits.

Primary outcomes:
measure: Pain: will be obtained by Visual analogue scale (VAS).
timeFrame: pain will be measured : 1.day1 before the start of laser therapy, 2.week 1 3. week2 4.week 3 5. week 4 6.one month later 7. 3 months later.
Secondary outcomes:
measure: Mouth opening, lateral protrusive movement: will be obtained by a caliper.
timeFrame: Mouth opening, lateral protrusive movement will be measured : 1.day1 before the start of laser therapy, 2.week 1 3. week2 4.week 3 5. week 4 6.one month later 7. 3 months later.
Other outcomes:
measure: Clicking: will be obtained by Yes or No.
timeFrame: Clicking will be measured : 1.day1 before the start of laser therapy, 2.week 1 3. week2 4.week 3 5. week 4 6.one month later 7.after 3 months.
measure: Clicking: will be obtained by Yes or No.
timeFrame: Clicking will be measured : 1.day1 before the start of laser therapy, 2.week 1 3. week2 4.week 3 5. week 4 6.one month later 7. 3 months later.
Locations:
Study officials:
References: