louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04694911: Development of the Oncology Opportunity Cost Assessment Tool
Official title: Development of the Oncology Opportunity Cost Assessment Tool (OOCAT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated for cancer at Jefferson Center City, Jefferson Methodist Hospital, or Jefferson Abington

Brief summary: This study develops and tests an instrument to measure opportunity costs called the Oncology Opportunity Cost Assessment Tool (OOCAT) in cancer patients. Patients experience significant costs, both direct financial as well as indirect costs, associated with seeking cancer treatment. While the direct financial impact of care on patients is receiving increased attention, other important consequences, such as opportunity cost, remain largely unmeasured. Opportunity cost is an economics term that refers to the loss of potential benefits from other options when one option is chosen - if resources are used for one purpose, they are no longer available for the next best option. The information and knowledge gained from this study may help researchers develop the OOCAT, which may allow them to understand the opportunity cost of treatment for each patient. The OOCAT may then be used to determine not just the best medications for patients, but also the best comprehensive treatment plan that will allow them to get the right treatment in the right place at the right time.


Eligibility criteria: Inclusion Criteria:

* Treated for cancer at one of the 3 participating sites (Jefferson Center City, Jefferson Methodist Hospital, Jefferson Abington)
* English speaking
* Able to attend and participate in a focus group

Exclusion Criteria:

* Treated at a Jefferson site other than the ones mentioned
* Non-English Speaking

Primary outcomes:
measure: Patient-level opportunity costs associated with oncology care
timeFrame: 1 Day of Interview
measure: Development of the Oncology Opportunity Cost Assessment Tool (OOCAT)
timeFrame: 1 Day of Interview
measure: Implementation of OOCAT
timeFrame: 1 Day of OOCAT administration
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03550911: Biological Collection From Samples From The Gut Microbiota In Patients Having A Bone Or Joint Infection Treated By A Suppressive Subcutaneous Antibiotherapy With Betalactamine (CARBAMICROBIOTA)
Official title: Constitution Of A Biological Collection From Samples From The Gut Microbiota In Patients Having A Bone Or Joint Infection Treated By A Suppressive Subcutaneous Antibiotherapy With Betalactamine (CARBAMICROBIOTA)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bone Infection
Joint Infection
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine.

Brief summary: Optimal surgical therapy (debridement in chronic osteomyelitis; device exchange in patients with chronic prosthetic joint infection (PJI)) could be sometimes non-feasible, especially in the elderly population. Therefore, a medical therapy with oral prolonged suppressive antibiotic therapy (PSAT) seems to be an option to prevent recurrence and prosthesis loosening. Unfortunately, some patients are infected with resistant pathogens for which oral antibiotics are not suitable. Subcutaneous (SC) administration of injectable intravenous antibiotics as prolonged suppressive antibiotic therapy could be a convenient way to limit catheter-related complications and facilitate ambulatory care.

However, there are few data concerning the development of resistance under subcutaneous prolonged treatment with betalactamine.

The aim of this study is just to constitute a biological collection from samples from the Gut microbiota in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. Later analysis will be led on those samples to detect the acquisition of resistance or not.


Eligibility criteria: Inclusion Criteria:

* Patients having a bone or joint infection
* Patients treated by a suppressive subcutaneous antibiotherapy with betalactamine

Exclusion Criteria:

* None

Primary outcomes:
measure: Biological Collection From Samples From The Gut Microbiota
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre de référence des infections ostéo-articulaires de Lyon - Hôpital de la Croix-Rousse
Study officials:
References:
Clinical trial NCT04995211: Validity and Reliability of Commercially Available Metabolic Carts
Official title: Validity and Reliability of Commercially Available Metabolic Carts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolism and Nutrition Disorder
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults

Brief summary: The validity (by alcohol burning and gas infusions) and reliability (day-to-day variability in healthy subjects) of six metabolic carts will be compared.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female.
* Age 18-65 y.
* BMI between 18.5 kg/m2 and 40 kg/m2 (inclusive).
* Are willing to fast and not consume non-caloric stimulant for 10h before the assessments, and during the stay in the center.
* Are willing to avoid moderate or vigorous physical activity during 24h before the visits.

Exclusion Criteria:

* Smoking or use of tobacco products within the last 3 months
* Diagnosed with diabetes.
* Previous bariatric surgery (or other surgeries) for obesity or weight loss.
* Use of medications affecting metabolism or sleep.
* History of neurological disease.
* History of cardiovascular disease, including hypertension, or other chronic diseases.
* Pregnant, planning to become pregnant, or breastfeeding
* Claustrophobia impeding to stay calm under a plastic canopy.

Primary outcomes:
measure: Resting metabolic rate
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References:
Clinical trial NCT06721611: A Comprehensive Optical Blood Pressure Assessment Tool to Identify Cases of Unscreened Hypertension Across an Active Population in the U.S.
Official title: A Comprehensive Optical Blood Pressure Assessment Tool to Identify Cases of Unscreened Hypertension Across an Active Population in the U.S.: a Prospective Single-center Observational Clinical Study.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hypertension
Keywords: hypertension
blood pressure
Lead sponsor: Nucor
Sponsor class: INDUSTRY
First posted: 2024-12-06
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 100 subjects aged 25 to 70 years old who do not have a known diagnosis of hypertension and are employed at the Nucor Corp facility.

Brief summary: To screen for and identify subjects with potential undiagnosed hypertension using an optical blood pressure monitoring device across an active workforce population in the US (Nucor employees).

Detailed description: 100 voluntary Nucor facility employees with no previous diagnosis of hypertension will be recruited and will receive an optical blood pressure monitoring device (Aktiia G1 Device) that is a miniature bracelet placed in the wrist and measure blood pressure continuously without inflating.

Each participant will wear the device continually during 28 days.

Eligibility criteria: Inclusion Criteria:

1. Adult subjects aged 25 to 70 years old.
2. People who self-report that they do not have a diagnosis of hypertension.
3. People employed as a Nucor team member.
4. People who can read and speak English.
5. People who use either an iOS or Android smart phone.
6. Subjects who agree to follow study procedures.
7. Subjects who have signed the informed consent form.

Exclusion Criteria:

1. Subjects with a known diagnosis of i. atrial fibrillation ii. congestive heart failure iii. heart valve disease iv. pheochromocytoma v. Raynaud's disease vi. arm lymphedema.
2. Subjects who take insulin.
3. Subjects who are on hemodialysis.
4. Women who are known to be pregnant.
5. Subjects whose arms shake uncontrollably or are paralyzed (cannot move).
6. Subjects who do not have two arms.
7. Subjects with upper arm circumference \< 22cm or \> 42cm.
8. Subjects with wrist circumference \> 23cm.

Primary outcomes:
measure: The percentage of subjects with undiagnosed hypertension
timeFrame: Each participant will wear the device continuously for 28 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Nucor
state: North Carolina
Study officials:
References:
Clinical trial NCT05861011: Bladder Neck Surgery in Children With Neurogenic Bladder
Official title: Surgical Outcomes of Bladder Neck Procedures in Children With Neurogenic Bladder: a Retrospective Monocentric Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incontinence, Urinary
Bladder Dysfunction
Spina Bifida
Neurogenic Bladder
Keywords: Bladder Neck Surgery
Children
Surgical Outcomes
Retrospective Study
Lead sponsor: University of Lorraine
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 48
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with neurogenic bladder

Brief summary: Surgical outcomes of bladder neck surgery in children with neurogenic bladder.

Consequences on bladder voiding.

Detailed description: Surgical outcomes of bladder neck surgery in children with neurogenic bladder:

Quality of voiding: spontaneous, need for catheterization, or incontinence.

Other surgical complications.

Eligibility criteria: Inclusion Criteria:

* Patients, with neurogenic bladder and younger than 18 years old ,who underwent a bladder neck procedure

Exclusion Criteria:

* Patients, with neurogenic bladder and older than 18 years old ,who underwent a bladder neck procedure

Primary outcomes:
measure: Number of participants with delayed or incomplete opening of the bladder neck during the voiding phase of micturition impeding urine flow
timeFrame: Baseline (Before surgery)
measure: Number of participants with muscular bladder
timeFrame: Baseline (Before surgery)
Secondary outcomes:
measure: Length of stay
timeFrame: From admission to discharge home, up to 20 days
measure: The time length between the surgery date and the postoperative consultation date
timeFrame: Through study completion, an average of 2 years
measure: Surgical complications after bladder neck procedure
timeFrame: Through study completion, an average of 2 years
measure: Operating time
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: ULorraine
state: Grand-Est
Study officials:
affiliation: University of Lorraine
name: Christelle Destinval, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stein R, Bogaert G, Dogan HS, Hoen L, Kocvara R, Nijman RJM, Quaedackers J, Rawashdeh YF, Silay MS, Tekgul S, Radmayr C. EAU/ESPU guidelines on the management of neurogenic bladder in children and adolescent part II operative management. Neurourol Urodyn. 2020 Feb;39(2):498-506. doi: 10.1002/nau.24248. Epub 2019 Dec 3.
Clinical trial NCT00583011: Local Anesthesia and Pain Perception During an Amniocentesis
Official title: Local Anesthesia and Pain Perception During Amniocentesis: A Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Amniocentesis
Genetic amniocentesis
Fetal lung maturity
Pain control
Pregnancy
High risk pregnancy
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2007-12-28
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study is been designed to answer the question of whether local anesthesia (1% lidocaine) decreases the perception of pain associated with amniocentesis in a randomized double blind placebo controlled manner. Our objective is to determine the effect of local anesthesia on the maternal pain perception from an amniocentesis.

Detailed description: Women meeting criteria for project and agreeing to treatment will be randomized into either the 1% Lidocaine or placebo(normal saline) group. The initial injection of either 1% lidocaine or placebo (normal saline) will be administered 2 minutes prior to the amniocentesis procedure. 2cc of 1% lidocaine or placebo (normal saline) will be initially administered as an intradermal "wheal", followed by a deeper infiltration of the 1% lidocaine or placebo (normal saline) to the depth of the peritoneum. All procedures will be performed by either the Maternal-Fetal medicine (MFM) or the reproductive geneticist utilizing continuous ultrasound guidance under sterile conditions. Each woman will be asked to rate their pain perception immediately after the procedure on two pain scales.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancies
* Signed consent to participate in the trial
* Women between the ages of 18 and 45 years
* Gestational ages 15 - 24 weeks

Exclusion Criteria:

* Multiple gestation
* Refusal to participate in the trial
* Known hypersensitivity to lidocaine
* Amniocentesis during this pregnancy
* Amnioinfusion/amnioreduction where the procedure is likely to be prolonged

Primary outcomes:
measure: Intensity of Perceived Maternal Pain as Measured by the Visual Analogue Scale (VAS)
timeFrame: Immediately following amniocentesis procedure
Secondary outcomes:
measure: Intensity of Perceived Maternal Pain as Measured by the 101 Point Numerical Rating Scale (NRS-101)
timeFrame: Immediately following amniocentesis procedure
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Andrew Elimian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03500211: Post-Op Lidocaine Patch
Official title: Lidocaine Patch for Adjunct Analgesia for Postoperative Cesarean Birth Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: Cesarean section
Postoperative pain
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized control trial evaluating use of lidocaine vs placebo patch for post-operative cesarean incision pain.

Detailed description: The purpose of this study is to determine if lidocaine patches decrease post-operative pain associated with cesarean births. While the Lidoderm lidocaine patch has been FDA approved for the treatment of skin pain, it has not been studied in women undergoing cesarean birth who experience postoperative pain. Even though this medication has been used in post-operative pain in published studies, the use of this medicine under these circumstances is still considered experimental. A lidocaine patch may provide added benefit for pain control in addition to standard medicines participants would receive after surgery, such as spinal, intravenous, and oral pain medications following cesarean delivery.

Eligibility criteria: Inclusion Criteria:

* Pregnant patients who require a scheduled or non-urgent cesarean birth
* Patient able to receive neuraxial analgesia
* Patient able to give verbal and written consent for both cesarean birth and study

Exclusion Criteria:

* Patients requiring emergent cesarean birth
* Patients allergic to lidocaine or adhesive
* Patients who have already received an epidural during this admission or requiring general anesthesia for cesarean birth
* Patients using chronic oral neuromodulators
* Patients with cardiac disease or using anti-arrhythmic agents
* Patients with fibromyalgia or chronic pain syndromes such as rheumatoid arthritis, osteoarthritis, or lupus.
* Daily narcotic or opiate use for greater than the 2 months prior to enrollment in the study.

Primary outcomes:
measure: 12-hour Postoperative Pain Scores
timeFrame: Postoperative (12 hours)
measure: 24-hour Postoperative Pain Scores
timeFrame: Postoperative (24 hours)
measure: 36-hour Postoperative Pain Scores
timeFrame: Postoperative (36 hours)
measure: 48-hour Postoperative Pain Scores
timeFrame: Postoperative (48 hours)
Secondary outcomes:
measure: 5-days Postoperative Narcotic Use
timeFrame: Postoperative (5 days)
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Catherine Leclair, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06115811: Radiation Treatment Plan Evaluation Learning Tool Pilot Project
Official title: Development and Assessment of a Novel, Systematic Radiation Treatment Plan Evaluation Learning Tool for Radiation Oncology Residents
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Radiation Oncology
Keywords: Radiation Oncology
Education
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study involves both the development of a novel learning tool, the Radiation Treatment Plan Evaluation Learning Module, as well as a pilot program to validate this tool as an effective resource to teach treatment plan review and optimization to radiation oncology residents.

Detailed description: This study involves both the development of a novel learning tool, the Radiation Treatment Plan Evaluation Learning Module, as well as a pilot program to validate this tool as an effective resource to teach treatment plan review and optimization to radiation oncology residents.

Stud procedures include screening for eligibility and completion of surveys and oncology examinations.

Participation is expected to last about 6-8 weeks.

It is expected about 20 radiation oncology resident physicians will participate in the study.

Eligibility criteria: Inclusion Criteria:

* The pilot program will be open to radiation oncology resident physicians that are in their PGY-2, PGY-3, or PGY-4 year.
* All residents must have completed a breast cancer-specific radiation oncology rotation at least 3 months prior to enrollment in the pilot program in order to be eligible.

Exclusion Criteria:

-The study will not include any special populations.

Primary outcomes:
measure: Objective Examination Score
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Oncology Resident Confidence Rate
timeFrame: Week 1 - 8
measure: Oncology Resident Perceived Competence Rate
timeFrame: Week 1 - 8
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Rachel Jimenez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01838811: Applying Speed of Processing Training to Individuals With Traumatic Brain Injury
Official title: Applying Speed of Processing Training (SPT) to Individuals With TBI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Processing Speed
Intervention
Traumatic Brain Injury
Cognition
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2013-04-24
Enrollment: 20
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 pilot study will document the efficacy of a behavioral intervention for Processing Speed (PS) in Traumatic Brain Injury (TBI), Speed of Processing Training (SPT), which has been successful used in the aging population in several studies. This study will (1) apply a treatment protocol for PS impairments, well-validated in aging, to persons with TBI with impaired PS, and document its efficacy on standard neuropsychological (NP) tests (2) assess the effectiveness of the intervention utilizing global measures of daily life, including an objective measure (TIADL) (3) examine the long term impact of SPT. This study is unique in that it will be the first to evaluate the efficacy of a highly-manualized structured behavioral treatment for processing speed deficits in persons with TBI utilizing the optimal methodology for carrying out such studies, a randomized clinical trial. Given the prevalence of PS deficits in the TBI population and the significant impact such deficits have on everyday functioning, public safety, and overall quality of life, the identification of an effective intervention for PS deficits in TBI could have a profound impact on the population and society as a whole.


Eligibility criteria: Inclusion Criteria:

* fluent in English
* processing speed impairment (based on evaluation).

Exclusion Criteria:

* currently taking steroids and /or benzodiazepines
* prior stroke or neurological disease
* history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II.
* significant alcohol or drug abuse history

Primary outcomes:
measure: Processing Speed Performance
timeFrame: week 6 and week 12
Secondary outcomes:
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Nancy Chiaravalloti, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: