louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00682786: Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma
Official title: Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectal Carcinoma
Keywords: rectal
rectum
cancer
carcinoma
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2008-05-22
Enrollment: 135
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: Determine if genotype-directed neoadjuvant chemoradiation, using information from the thymidylate synthase promoter polymorphism, result in a greater degree of tumor downstaging in high risk patients compared to historical controls.


Eligibility criteria: Inclusion Criteria:

* Biopsy proven adenocarcinoma of the rectum
* Lesion evaluated by surgeon and found to be resectable
* Stage T3 or T4 disease on radiography or ultrasound
* Karnofsky Performance Status at \>60
* Laboratory criteria:

  * Absolute neutrophil count \>= 1.5 K
  * Platelets \>= 100 K
  * Total Bilirubin \<= 2.0;
  * SGOT and Alkaline Phosphatase \<= 2 x upper limit of normal
  * Creatinine \< 2.0
* Informed consent signed
* Patients with distant metastatic disease will be eligible if they satisfy all other conditions.

Exclusion Criteria:

* Pregnant women, children \< 18 years, or patients unable to give informed consent
* Patients with a past history of pelvic radiotherapy.
* Patients with prior malignancy in the past 5 years except: skin cancer or in-situ cervical cancer. However, patients with synchronous adenocarcinomas are eligible provided either (a) the synchronous adenocarcinoma was in a removed pedunculated polyp and did not invade the stalk or (b) the synchronous adenocarcinoma was in a removed polyp that lay within the surgical field (extent of resection would not be changed) or (c) the synchronous adenocarcinoma is smaller than the index rectal cancer and lies completely within the radiation field (clinically favorable second lesion and the extend of radiation and surgery would not be changed).
* Patients with known allergy to 5-fluorouracil or irinotecan

Primary outcomes:
measure: Rate of Tumor Downstaging Compared With Historical Controls.
timeFrame: 1 year after enrollment
Secondary outcomes:
measure: Complete Response Rates
timeFrame: 1 year after enrollment
measure: Define Patient Quality of Life Prior to and Following Neoadjuvant Chemoradiation.
timeFrame: Prior to start of study treatment and 3-6 weeks post completion of radiation therapy
measure: Determine Patient Fears and Expectations of Pharmacogenetics.
timeFrame: Prior to start of study treatment and 3-6 weeks post completion of radiation therapy
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Benjamin Tan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03758586: Spatial Skill Training for Robot-assisted Surgery
Official title: An Efficient Single-Session Spatial Skill Trainer for Robot-assisted Surgery: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spatial Learning
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Surgical residents from a single tertiary medical center were divided into 2 groups. All residents performed 2 tasks on a Da Vinci robotic simulator system after which they were either given a real training session in spatial skills (study group) or shown a short presentation regarding robotic surgery. After training/watching the presentation, they repeated the for mentioned tasks on the robotic simulator. Improvement in surgeon performance, especially regarding tissue damage was documented.

Detailed description: Importance: Robot-assisted surgery is becoming the mainstay of modern surgery. Efficient training techniques are essential for enhanced performance. Optimal performance during a surgical task is key to successful surgery and minimal adverse events.

Objective: To introduce and examine a single session of spatial skill training as an efficient means of improving surgical suturing performance in robot-assisted surgery.

Design: Forty-one surgical residents will be randomly assigned to training and control conditions. (1) participants will perform two da-Vinci skills simulator (dVSS) tasks to determine baseline performance. (2) the training group will undergo computer-based simulator training of spatial skills while the control group will engage in a neutral activity. (3) two dVSS tasks will be performed within 2 days of training completion to evaluate post-training performance. The experiment will be conducted until December 2018.

Participants: A convenience sample comprised of 41 surgical residents with non-robotic surgical suturing skills.

Eligibility criteria: Inclusion Criteria:

* Surgical Residents with no previous robotic surgery experience.

Exclusion Criteria:

* Non surgical residents.

Primary outcomes:
measure: Tissue piercing
timeFrame: up to 2 hours from enrollment
measure: Tissue tearing
timeFrame: up to 2 hours from enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam Health Care Campus
name: Roy Lauterbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05930886: Focus Groups in Ethnically and Racially Diverse Families
Official title: Focus Groups to Optimize Research Methodology in a Multinutrient Study of Racially and Ethnically Diverse Children With ADHD and Emotional Dysregulation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Attention Deficit/Hyperactivity Disorder
Emotional Dysfunction
Irritable Mood
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community samples of Portland, Oregon individuals who self-identify as Hispanic/Latino/a for one focus group and Black/African American for another.

Brief summary: Focus groups to identify treatment needs and barriers to participation in the planned multinutrient study among racially and ethnically diverse (Black and Hispanic) communities.

Detailed description: Focus group purpose is to understand parents' priorities regarding their child's mental health, and facilitators or barriers to research participation generally, with inquiry about CIH intervention use, and the multinutrient feasibility study specifically. Researchers will engage Black and Hispanic families in focus groups to discuss mental health priorities related to their children, and real or perceived barriers to engagement in research studies. The feedback will inform the final design and recruitment for the multinutrient feasibility study in Black and Hispanic populations. One group will comprise individuals who self-identify as Hispanic, another, as Black, in order to create space to hear perspectives that may differ between broadly defined groups.

Eligibility criteria: Inclusion Criteria:

* Adult parents/caregivers self-identified as Black or Hispanic/Latino
* With a family member 6-18 years old with suspected ADHD and/or emotional dysregulation, or provide care for, or teach someone who meets these criteria
* Who have sought or are interested in treatment
* Willing to discuss child's mental health care needs and provide feedback regarding feasibility study
* Able to attend focus groups in person
* Able to communicate in English or Spanish
* Agree to focus group session audio recording

Exclusion Criteria:

* Unwilling to be recorded

Primary outcomes:
measure: Input and Feedback on Proposed Feasibility Study
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Jeanette Johnstone, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02916186: Evaluation of Subepithelial Connective Tissue Graft Versus Acellular Dermal Matrix With Tunnel Technique in Treatment of Multiple Gingival Recessions
Official title: Evaluation of Subepithelial Connective Tissue Graft Versus Acellular Dermal Matrix With Tunnel Technique in Treatment of Multiple Gingival Recessions (Randomized Clinical Trial, Parallel Design)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Recession
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of the present study is to compare the amount of root coverage resulting from subepithelial connective tissue graft and acellular dermal matrix associated with tunnel technique among patients suffering from multiple gingival recession.

Detailed description: Acellular dermal matrix with Tunnel technique will offers great advantages for patients with multiple gingival recession as regards decrease surgical time, Post-Operative pain and root coverage, clinical attachment level, width of Keratinized gingiva, gingival biotype compared to subepithelial connective tissue graft with Tunnel technique.

Eligibility criteria: Inclusion Criteria:

* Subjects with facial multiple gingival recession defects classified as either class I or II defects according to Miller's classification (Miller 1985).
* Subjects aged between 18 - 60 years old.
* Patients should be free from any systemic disease that may affect normal healing of tissue, and predictable outcome.
* Patients with good oral hygiene.

Exclusion Criteria:

* Current and former smokers.
* Pregnant females.
* Subjects received any periodontal therapy for minimum of 6 months prior to the study.
* Subjects taking drugs known to interfere with wound healing.
* Subjects with unacceptable oral hygiene with plaque index \>2.
* Teeth with non-carious cervical lesions (NCCL), cervical caries and malalignment.

Primary outcomes:
measure: patient Satisfaction .
timeFrame: 1 year
Secondary outcomes:
measure: root coverage
timeFrame: 1 year
measure: Clinical Attachment Level
timeFrame: 1 year
measure: Width of Keratinized Tissue
timeFrame: 1 year
measure: Gingival Bio-type
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01755286: OTO-201 for Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
Official title: A Prospective, Randomized, Double-Blind, Placebo- and Sham-Controlled, Multicenter, Phase 1b Study of OTO-201 Given as a Single Intratympanic Injection for Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement
Lead sponsor: Otonomy, Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-24
Enrollment: 83
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to describe the safety and tolerability of two dose levels of OTO-201, placebo and sham when administered intra-operatively in pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.


Eligibility criteria: Inclusion Criteria includes, but is not limited to:

* Subject is a male or female aged 6 months to 12 years, inclusive
* Subject has a clinical diagnosis of bilateral middle ear effusion requiring tympanostomy tube placement
* Subject's caregiver is willing to comply with the protocol and attend all study visits

Exclusion Criteria includes, but is not limited to:

* Subject has a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with tympanostomy tube placement
* Subject has a history of sensorineural hearing loss
* Subject has a history of chronic or recurrent bacterial infections other than otitis media that likely will require treatment with antibiotics during the course of the study

Primary outcomes:
measure: Safety
timeFrame: Up to 1 month
Secondary outcomes:
measure: Clinical Activity
timeFrame: Up to 1 month
measure: Microbiological Eradication
timeFrame: Up to 1 month
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Call/Email Otonomy Central Contact for Trial Locations
state: California
Study officials:
affiliation: Otonomy, Inc.
name: Carl LeBel, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01976286: A Pilot Study Testing Salicylic Acid Peels Versus Glycolic Acid Peels for the Treatment of Melasma
Official title: A Pilot Study Comparing the Efficacy of Glycolic Acid Peels vs. Salicylic Acid Peels for the Treatment of Melasma: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Melanosis
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2013-11-05
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out the safety and effectiveness of Glycolic Acid Chemical Peels compared to Salicylic Acid Chemical Peels for the treatment of melasma.

Detailed description: Participants in this study will be patients who are clinically diagnosed with at least a 2 x 2 cm patch of melasma on each side of their face (forehead or cheek). One half of the subject's face will be randomly selected to receive 4 treatments of 30% glycolic acid peels and the other half of the face will receive 4 treatments of 30% salicylic acid peels/ weeks 0, 4, 8, and 12. Follow up visit will be at week 16. This study is a pilot study designed to determine feasibility of these procedures.

Eligibility criteria: Inclusion Criteria:

1. Subjects aged 18 years or older
2. Subjects with at least a 2 x 2 cm patch of melasma on each side of the face (forehead or cheek)
3. Subjects in general good health
4. Subjects must be willing and able to understand and provide informed consent for the use of their tissue and communicate with the investigator
5. Subjects must be willing to not apply other treatment options for melasma during the course of the study

Exclusion Criteria:

1. Subjects under 18 years of age
2. Subjects who are pregnant and/or lactating
3. Subjects who are unable to understand the protocol or to give informed consent
4. Subjects diagnosed with mental illness
5. Subjects who have concurrent active uncontrolled disease to facial area (i.e uncontrolled acne)
6. Subjects who have had a chemical peel in the past 3 months
7. Subjects who have used a prescribed retinoid in the past 3 months
8. Subjects with a bleeding disorder
9. Subjects with a history of abnormal wound healing
10. Subjects with a history of abnormal scarring

Primary outcomes:
measure: Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 16
timeFrame: 1 hour at baseline and week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04431986: ER2 Frailty Levels and Incident Adverse Health Events in Older Community Dwellers
Official title: Association Between Emergency Room Evaluation and Recommendations Tool (ER2) Frailty Levels and Incident Adverse Health Events in Older Community Dwellers: Results of the NuAge Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Frailty
Emergencies
Aging
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 1741
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals eligible for this study will be participants of the NuAge study who agreed to be part of the NuAge Database and Biobank for future research purposes

Brief summary: Older adults' health and functional status are heterogeneous because of the various cumulative effects of chronic diseases and physiologic decline, contributing to a vicious cycle of increased frailty 1-4. Thanks to advances in medicine and hygiene, a growing number of older adults spend more years with a greater range of chronic diseases causing disability but not mortality 5. Health systems need to face this new challenge 4,5. Quantification of frailty and its association with the occurrence of incident adverse health events (i.e., functional decline, unplanned hospitalizations) is crucial to understand how health systems may efficiently respond to this situation 6. This study aims to examine the association of the ER2 tool score and its stratification in three levels for incident adverse health events in older community dwellers and to compare this association with three validity frailty indexes which are the Cardiovascular Health Study (CHS) frailty index, Study of Osteoporotic Fracture (SOF) index and Rockwood frailty index.


Eligibility criteria: Inclusion Criteria:

* All enrolled participants of NuAge Study who agreed to be part of the NuAge Database and Biobank for future research purposes

Exclusion Criteria:

* Missing data
* Participants' refusal to use their data for a purpose not identified during their recruitment.

Primary outcomes:
measure: ER2
timeFrame: 4 years
measure: SOF index
timeFrame: 4 years
measure: CHS index
timeFrame: 4 years
measure: Rockwood index
timeFrame: 4 years
measure: Physical functional decline
timeFrame: 4 years
measure: Falls
timeFrame: 4 years
measure: Hospitalizations
timeFrame: 4 years
measure: Mortality
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Jewish General Hospital
name: Cyrille Launay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05079386: Clinical Feasibility of a New Voice Prosthesis
Official title: Early Clinical Feasibility Study of a New Voice Prosthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngectomy
Lead sponsor: Atos Medical AB
Sponsor class: INDUSTRY
Collaborators: name: The Netherlands Cancer Institute
First posted: 2021-10-15
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The objective of this clinical investigation is to evaluate the short-term clinical feasibility of a new voice prosthesis and explore its acceptability, limitations and advantages. As a result of the evaluations, design changes may be implemented and evaluated until the optimal design has been determined, or until it is decided not to pursue further development of the device. Main outcome will be the patient's acceptance of the voice prosthesis, secondary outcomes are stickiness of the valve mechanism and speech.


Eligibility criteria: Inclusion Criteria:

* Laryngectomized patients using either the Provox Vega 22.5 or the Provox ActiValve Light voice prosthesis, with a length of 4, 6, 8, or 10 mm
* 18 years and older

Exclusion Criteria:

* Current tracheoesophageal puncture problems such as enlarged puncture or infection
* Active recurrent or metastatic disease (medical deterioration)
* The use of ActiValve Strong/XtraStrong or XtraSeal
* Unable to understand the Patient Information and/or unable to give Informed Consent
* The previous 2 VPs had a device lifetime \> 12 months
* History of oral resections negatively affecting speech

Primary outcomes:
measure: Patient acceptability
timeFrame: 2 week
Secondary outcomes:
measure: Voice Assessment - Maximum phonation
timeFrame: Baseline and 2 weeks
measure: Voice Assessment - Highest volume
timeFrame: Baseline and 2 weeks
measure: Voice Assessment - Lowest Volume
timeFrame: Baseline and 2 weeks
measure: Voice Assessment - Softness
timeFrame: Baseline and 2 weeks
measure: Voice Assessment - Loudness
timeFrame: Baseline and 2 weeks
measure: Voice Assessment - Glide tones
timeFrame: Baseline and 2 weeks
measure: Quality of Life by EQ-5D-5L
timeFrame: Baseline and 2 weeks
measure: Voice Handicap Index - 10
timeFrame: Baseline and 2 weeks
measure: Device life
timeFrame: Baseline, and week 52
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute: NKI
Study officials:
affiliation: The Netherlands Cancer Institute
name: Michiel van den Brekel, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heirman AN, Tellman RS, van der Molen L, van Son R, van Sluis K, Halmos GB, Van den Brekel MWM, Dirven R. The acceptance and voice quality of a new voice prosthesis 'Vega High performance' - a feasibility study. Acta Otolaryngol. 2023 Aug;143(8):721-729. doi: 10.1080/00016489.2023.2241876. Epub 2023 Sep 1.
Clinical trial NCT01815086: Radioimmunoimaging of Light Chain (AL) Amyloidosis
Official title: Radioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody (mAb) Murine (Mu) 11-F4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: AL Amyloidosis
Keywords: Radioimmunoimaging
AL Amyloidosis
PET/CT
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2013-03-20
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive monoclonal antibody (mAb) to document the presence and distribution of amyloid deposits by PET/CT imaging in patients with AL amyloidosis.

Detailed description: To be eligible for this study, patients must have a confirmed diagnosis of AL amyloidosis without significant cardiac (New York Heart Association class IV) disease and not be on kidney dialysis. Additionally, after testing, their blood must not contain antibodies to mouse proteins. The study requires an intravenous infusion, given over 10 minutes, of the radiolabeled antibody, followed 48 hours later by a PET/CT scan. A repeat scan is done 5 days after infusion of the antibody. A 5-ml blood specimen needs to be furnished 4 and 8 weeks after the antibody infusion.

Eligibility criteria: Inclusion Criteria:

* Patients with a confirmed diagnosis of AL amyloidosis.

Exclusion Criteria:

* New York Heart Association class IV
* On renal dialysis
* Serum antibodies to mouse protein

Primary outcomes:
measure: Determination of the capability of a radiolabeled amyloid-reactive monoclonal antibody (mAb) to document the presence and distribution of amyloid deposits by PET/CT in up to 30 patients with AL amyloidosis.
timeFrame: Five days post PET/CT scan
Secondary outcomes:
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
Study officials:
References: