louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05306665: PREventing Pain After Surgery
Official title: PREventing Pain After Surgery: a Feasibility and Acceptability Study of Acceptance and Commitment Therapy for the Prevention of Chronic Post-surgical Pain (PREPS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Back
Spinal Stenosis
Disc Herniation
Spondylosis
Spondylolisthesis
Back Injuries
Keywords: Chronic pain
Surgery
opioid
acceptance and commitment therapy
Prevention
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 140
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study aims to adapt and modify a brief presurgical Acceptance and Commitment Therapy (ACT) intervention aimed at preventing the transition to Chronic Post-Surgical Pain (CPSP) and reducing long-term opioid use. Investigators will then assess the acceptability, feasibility, and preliminary efficacy of the finalized intervention to prevent the transition to CPSP and reduce post-surgical opioid use six months following lumbar spine surgery. Finally, investigators will identify psychosocial and psychophysical phenotypes associated with response to this intervention.


Eligibility criteria: Inclusion Criteria:

* scheduled to undergo fusion, discectomy, vertebroplasty, kyphoplasty, or foraminotomy
* age 22 and older
* able to communicate fluently in English

Exclusion Criteria:

* inability to complete study procedures due to delirium, dementia, psychosis, or other cognitive impairment
* have a history of severe neurologic movement disorder
* are pregnant or intent to become pregnant during study
* have undergone previous spinal surgery
* have spinal deformity, pseudarthrosis, trauma, infection, or tumor as primary indication for surgery
* have undergone Acceptance and Commitment Therapy in last 2 years

Primary outcomes:
measure: Treatment Helpfulness
timeFrame: Immediately following the ACT workshop
Secondary outcomes:
measure: Pain Interference
timeFrame: 1 month post-op
measure: Pain Interference
timeFrame: 3 months post-op
measure: Pain Interference
timeFrame: 6 month post-op
measure: Treatment Helpfulness
timeFrame: 1 month post-op
measure: Opioid dose
timeFrame: 1 month post-op
measure: Opioid dose
timeFrame: 3 months post-op
measure: Opioid dose
timeFrame: 6 months post-op
measure: Pain Intensity
timeFrame: 1 month post-op
measure: Pain Intensity
timeFrame: 3 months post-op
measure: Pain Intensity
timeFrame: 6 months post-op
measure: Treatment Credibility
timeFrame: Immediately following ACT workshop
measure: Treatment Expectancy
timeFrame: Immediately following ACT workshop
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT00803465: Randomized Study to Compare the Bioequivalence of Two Fluticasone Propionate 0.05% Topical Creams
Official title: Bioequivalence of Two Fluticasone Propionate 0.05% Topical Creams
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Bioequivalence
Fluticasone Propionate
Lead sponsor: Padagis LLC
Sponsor class: INDUSTRY
First posted: 2008-12-05
Enrollment: 115
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Community Volunteers

Brief summary: The purpose of this study was to compare the relative vasoconstrictive effects of test and reference topical Fluticasone Propionate 0.05% Cream in healthy, female subjects.


Eligibility criteria: Inclusion Criteria:

* Non-tobacco using female subjects, 18 to 50 years of age
* Demonstrated blanching response to Reference Drug
* Weight within +/- 20% from normal for height and weight for body frame
* Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator
* Signed and dated informed consent form which meets all criteria of current FDA regulations

Exclusion Criteria:

* History of allergy to systemic or topical corticosteroids
* Presence of any skin condition or coloration that would interfere with the placement of test sites or the response or assessment of skin blanching
* Presence of medical condition requiring regular treatment with prescription drugs
* Drug or alcohol addiction requiring treatment in the past 12 months prior to dosing
* Use of any tobacco products in the 30 days prior to study dosing
* Use of any dermatological drug therapy on the flexor surface of the forearms within 30 days of dosing
* Receipt of any drugs as part of a research study within 30 days prior to study dosing
* Pregnant or lactating

Primary outcomes:
measure: Vasoconstriction will be measured by the degree of skin blanching observed after treatment removal using a ChromaMeter
timeFrame: Over the course of two days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05332665: AS-OCT Evaluation of Iridocorneal Angle of Patients of Angle Closure Glaucoma After Phacoemulsification
Official title: Anterior Segment Optical Coherence Tomography Evaluation of Iridocorneal Angle of Patients of Angle Closure Glaucoma After Phacoemulsification and YAG Laser Iridotomy, Comparative Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma, Angle-Closure
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 15
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute attack of ACG with phacoemulsification in this eye with YAG laser PI in the other eye

Brief summary: Evaluation of the effect of phacoemulsification and YAG Laser peripheral iridotomy on the anterior chamber angle anatomic parameters in PACG eyes, using anterior segment optical coherence tomography (SS ASOCT) device

Detailed description: The recent treatment of ACG is phacoemulsification in patients of acute attack with YAG laser iridotomy in the other eye.

The AS-OCT will be used for evaluation of the angle of the anterior chamber parameters in both eyes after phacoemulsification and YAG laser peripheral iridotomy.

Follow up of AS-OCT will be done 1,3,6 months after surgery and we will compare results in each eye and between both eyes.

.

Eligibility criteria: Inclusion Criteria:

* patients with acute attack of angle closure glaucoma in one eye.
* Patients fit for phacoemulsification

Exclusion Criteria:

* 1- Patients with history of any intraocular surgery. 2- Patients with history of refractive surgery. 3- Patients with diabetic retinal vasculopathy or retinal detachment. 4- Patients with chronic angle closure glaucoma, open angle glaucoma or 2ry glaucoma

Primary outcomes:
measure: IOP
timeFrame: up to 6 months
Secondary outcomes:
measure: Corneal endothelial count
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Minia
country: Egypt
facility: mohamed Mahmoud
state: El Minia
Study officials:
affiliation: Minia faculty of medicine
name: mohamed Salah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00072865: Pemetrexed and Carboplatin in Locally Advanced or Metastatic Breast Cancer
Official title: A Phase II Study of Alimta and Carboplatin in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Neoplasm Metastasis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2003-11-13
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a nonrandomized study of pemetrexed plus carboplatin, with the primary objective of determining the efficacy of the combination in tumor reduction, in patients with locally advanced or metastatic breast cancer.


Eligibility criteria: Inclusion Criteria:

* Histologic or cytologic diagnosis of locally advanced or metastatic breast cancer
* No prior chemotherapy for locally advanced or metastatic breast disease.
* Patient may have received prior adjuvant therapy finished greater than 1 year prior to enrollment.
* Adequate bone marrow, liver and kidney function
* RECIST criteria for disease status

Exclusion Criteria:

* Prior treatment with pemetrexed
* Pregnant or breast feeding
* Brain Metastasis
* unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.

Primary outcomes:
measure: antitumor activity
Secondary outcomes:
measure: duration of response;time to progressive disease;time to treatment failure
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
state: Russia
city: Saint Petersburg
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
state: Russia
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 NCT05896865: Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer
Official title: Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer: Non-randomized Phase II, Prospective Single Arm Study Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Stage III
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 120
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate treatment outcomes of breast cancer with internal mammary or supraclavicular lymph node metastasis according to total radiation dose of postoperative radiation therapy differentiated by tumor response to neoadjuvant chemotherapy.

The main questions it aims to answer are:

* 5-year disease-free survival
* 5-year overall survival
* 5-year locoregional recurrence
* Adverse events after radiation therapy
* Quality of life

Participants will be assessed by multi-dimensional methods before and after radiotherapy:

* Disease status evaluation including physical and radiological examination
* Quality of life assessment with questionnaires (BREAST-Q)
* Adverse event assessment according to CTCAE version 5.0


Eligibility criteria: Inclusion Criteria:

* Female with age 19 or older
* Metastasis to internal mammary and/or supraclavicular lymph nodes, assessed by radiological exams and/or biopsy
* Underwent neoadjuvant chemotherapy
* Pathologic confirmation of invasive breast cancer treated with breast conserving surgery or mastectomy
* Eastern Cooperative Oncology Group performance status 0-2
* Informed consent

Exclusion Criteria:

* Previous history of radiation therapy to the chest
* Distant metastasis

Primary outcomes:
measure: 5-year disease-free survival
timeFrame: 5 years from the initiation of the radiation therapy
Secondary outcomes:
measure: 5-year overall survival
timeFrame: 5 years from the initiation of the radiation therapy
measure: 5-year locoregional recurrence
timeFrame: 5 years from the initiation of the radiation therapy
measure: Adverse events
timeFrame: 5 years from the initiation of the radiation therapy
measure: Quality of life (BREAST-Q™)
timeFrame: 5 years from the initiation of the radiation therapy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Haeyoung Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01402765: Interface Pressure Measures for Matresses: Nimbus 3 Versus Summit
Official title: Interface Pressure Measures for Matresses: a Randomized, Cross-over, Non-inferiority Study Comparing the Nimbus 3 Versus Summit Matresses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Immobile Patients
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2011-07-26
Enrollment: 31
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to compare the distribution of pressure among pressure interfaces between two anti-bedsore mattresses.


Eligibility criteria: Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* Bedridden patients that still have some measure of mobility, or that can change beds with assistance.
* Patients with symmetrical buttox support
* Body mass index between 16 and 35

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* Strict decubitus dorsal position is contra-indicated
* State of agigation or non-cooperation
* Asymetrical deformation of the spine or hips in the frontal plane
* Bed sores present
* Evolving cardiac pathology
* Recent scar at a pressure interface
* Deep vein thrombosis
* Expected life span \< 24 weeks

Primary outcomes:
measure: Percentage of data capture time at < 30 mmHg (%)
timeFrame: Day 1
Secondary outcomes:
measure: Mean interface pressure (mmHg)
timeFrame: Day 1
measure: Minimum interface pression (mmHg)
timeFrame: Day 1
measure: Maximum interface pressure (mmHg)
timeFrame: Day 1
measure: Percentage of data capture time where the pressures are changing (%)
timeFrame: Day 1
measure: Matress tolerance: yes/no
timeFrame: Day 1
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: Centre Hospitalier Universitaire de Nîmes
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Emilie Viollet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00416065: PET/CT to Identify "Vulnerable" Arterial Plaque
Official title: PET/CT to Identify "Vulnerable" Arterial Plaque
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2006-12-27
Enrollment: 800
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this research is to evaluate the presence, location and intensity of FDG uptake in the large arteries using the new technology of fused PET/CT imaging and to compare FDG uptake with the presence of arterial calcifications as seen on the simultaneously acquired CT, in order to determine if FDG was increases incalcified plaque or in a different location in the arterial wall. we will also evaluate the relationship between FDG localization and future cardiovascular events in out patient population


Eligibility criteria: Inclusion Criteria:

* Patients referred for clinical FDG-PET/CT studies
* Patients 50 yr or older
* Patients signed informed consent

Exclusion Criteria:

* Patients unable or unwilling to tolerate the scan until its completion

Primary outcomes:
measure: the impact of the imaging modality on patient management
Secondary outcomes:
measure: the impact of the imaging modality on patient management
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Ora Israel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06311565: Effects of Education After Colorectal Cancer Screening
Official title: The Effect of Education Given to Individuals Undergoing Colorectal Cancer Screening on Attitudes, Beliefs and Healthy Lifestyle Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Lifestyle
Education
Keywords: colorectal cancer
cancer screening
healthy lifestyle
education
Lead sponsor: Istanbul Saglik Bilimleri University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 70
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled ( experimental and control group)
Primary purpose: PREVENTION

Brief summary: The aim of this study is to examine the effect of the education given to individuals undergoing colorectal cancer screening on their attitudes, beliefs and healthy lifestyle behaviors.

This study was planned to be conducted as a prospective randomized controlled study in a family health center in Istanbul. The universe of the research; The sample of individuals registered to the family health center will consist of a total of 70 individuals who meet the inclusion criteria for the study.

Patient Diagnosis Form, Colorectal Cancer Screening Attitude Belief Scale, Healthy Lifestyle Behavior Scale II will be used to collect data. Data will be collected at the first encounter, 1 month later, 3 months later, pre-test and post-test. In the research, individuals will be divided into two groups: intervention (n = 35) and control (n = 35). Training will be provided to the intervention group.


Eligibility criteria: Inclusion Criteria:

* Between 50-70 years old,
* Registered at the Family Health Center,
* Able to speak Turkish,
* No diagnosis of psychiatric disease and no history of anxiolytic drug use,
* They will have a Fecal Occult Blood test for the first time,
* Positive result of fecal occult blood test,
* Faecal occult blood test was positive and had a colonoscopy,
* Those who have not been diagnosed with colorectal cancer as a result of colonoscopy,
* Individuals who volunteer to participate in the research

Exclusion Criteria:

* Having had previous colon surgery,
* Individuals with a history of colorectal cancer will not be included in the study.

Primary outcomes:
measure: Colorectal cancer screening attitude belief scale
timeFrame: Baseline, after one month and after three months
measure: Healthy lifestyle behaviors scale II
timeFrame: Baseline, after one month and after three months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Hilal KARTAL
state: Beylikdüzü
Study officials:
References:
Clinical trial NCT04630665: Buccal Bone Resorption in Immediate Implants in Thin and Thick Buccal Plates of Bone in Esthetic Zone
Official title: Clinical Assessment of Buccal Bone Resorption in Immediate Implants in Thin and Thick Buccal Plates of Bone and Its Implication on Esthetics. A Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Buccal Bone Thickness
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To achieve esthetic immediate implants a minimum of adequate buccal bone thickness must be present. It was postulated that 2 mm of buccal bone thickness was needed to prevent recession of the buccal plate. However, this was reduced to 1 mm with more ongoing research. In a recent study postulated that a buccal bone thickness less than 1 mm could be sufficient.

Scarce literature was found that monitored the ridge alterations following implant placement.

In regards to the controversies regarding the minimal initial buccal bone thickness required to perform immediate implant placement, our study aims to monitor the buccal bone thickness and soft tissue changes over a year from implant and prosthetic placement.


Eligibility criteria: Inclusion Criteria:

* Subjects who have at least one unrestorable tooth in the esthetic zone that needs to be extracted.
* Subjects with healthy systemic condition.
* Availability of bone apical and palatal to the socket to provide primary stability.

Exclusion Criteria:

* Patients with signs of acute infection related to the area of interest.
* Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits.
* Smokers

Primary outcomes:
measure: buccal bone thickness
timeFrame: 1 year
Secondary outcomes:
measure: pink esthetic score (PES)
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Greater Cairo
Study officials:
References:
citation: Merheb J, Vercruyssen M, Coucke W, Beckers L, Teughels W, Quirynen M. The fate of buccal bone around dental implants. A 12-month postloading follow-up study. Clin Oral Implants Res. 2017 Jan;28(1):103-108. doi: 10.1111/clr.12767. Epub 2016 Jan 8.
citation: El Nahass H, N Naiem S. Analysis of the dimensions of the labial bone wall in the anterior maxilla: a cone-beam computed tomography study. Clin Oral Implants Res. 2015 Apr;26(4):e57-e61. doi: 10.1111/clr.12332. Epub 2014 Jan 23.