louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02010554: Development of a Talk Therapy Protocol to Help Patients Make Treatment Decisions in MS
Official title: Development of a Talk Therapy Protocol to Help Patients Make Treatment Decisions in MS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Relapsing-remitting Multiple Sclerosis
Keywords: Multiple Sclerosis
Disease modifying medication
Relapsing-Remitting MS
Motivational Interviewing
Telephone Counseling
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
First posted: 2013-12-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Between 15-20% of MS patients decide not to initiate disease modifying therapies after being diagnosed with MS. For this study, we will develop a telephone-based talk therapy intervention and then conduct a randomized controlled trial. Patients will be assigned to either 5 weekly 20 minute telephone sessions of psychotherapy or a brief education control condition. We hypothesize that patients undergoing phone therapy will be more likely to indicate they are interested in initiating disease modifying medications than patients given brief education and treatment as usual.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of relapsing remitting MS based on established guidelines
* Not taking recommended therapy
* Provider recommendation for DMT use
* At least 18 years of age
* Access to a telephone
* English speaking

Exclusion Criteria:

-

Primary outcomes:
measure: Adherence Treatment Survey
timeFrame: 10 weeks after enrollment
Secondary outcomes:
measure: Adherence Treatment Survey
timeFrame: 10 weeks after enrollment
measure: Adherence Treatment Survey
timeFrame: 5 weeks after enrollment
measure: Adherence Treatment Survey
timeFrame: 5 weeks after enrollment
Other outcomes:
measure: Motivation/Readiness Questionnaire
timeFrame: 10 weeks after enrollment
measure: Motivation/Readiness Questionnaire
timeFrame: 5 weeks after enrollment
Locations:
city: Kansas City
country: United States
facility: University of Missouri-Kansas City
state: Missouri
city: West Orange
country: United States
facility: Kessler Rehabilitation Institute
state: New Jersey
Study officials:
References:
Clinical trial NCT04800354: Brief Nurse-led Mindfulness Based Intervention
Official title: Brief Nurse-led Mindfulness Based Intervention Among Patients Scheduled for Knee and Hip Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Osteoarthritis, Knee
Osteoarthritis, Hip
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The feasibility, acceptability, and clinical effects of the nurse-led, very brief, preoperative mindfulness based intervention for hip and knee replacement patients will be investigated relative to nurse-led preoperative pain psychoeducation.

A secondary sub-analysis will compare two different styles of mindfulness practice (mindfulness of breath vs. mindfulness of pain) relative to preoperative pain psychoeducation.


Eligibility criteria: Inclusion Criteria:

* 1) Age ≥18,
* 2) Scheduled to undergo unilateral total knee arthroplasty

Exclusion Criteria:

* 1) Cognitive impairment preventing completion of study procedures.
* 2) Current cancer diagnosis,
* 3) Contralateral knee replaced in the previous 3 months,
* 4) Intent to have contralateral knee replaced or other, additional surgical procedure during the study period,
* 5) Intent to add new pain treatments during the study period (except for what is part of the study),
* 6) Other unstable illness judged by medical staff to interfere with study treatment.

Primary outcomes:
measure: Change in Pain Intensity Numeric Rating Scale
timeFrame: baseline and after the 15 minute preoperative nurse visit
Secondary outcomes:
measure: Change in Pain Unpleasantness Numeric Rating Scale
timeFrame: baseline and after the 15 minute preoperative nurse visit
measure: Change in Pain Medication Desire Numeric Rating Scale
timeFrame: baseline and after the 15 minute preoperative nurse visit
measure: Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0
timeFrame: During the 6 weeks prior to surgery and at the 6-week outpatient follow-up appointment
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
Clinical trial NCT02552654: Cortisol and the Formation of Intrusive Memories
Official title: Cortisol and the Formation of Intrusive Memories: An Experimental Approach With a Trauma Film Paradigm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrusive Memories
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2015-09-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Intrusive memories of traumatic events are core features of posttraumatic stress disorder (PTSD) but little is known about the neurobiological formation of intrusions. The aim of this study was to determine whether cortisol levels during an intrusion-inducing stressor influence subsequent intrusive memories.

Detailed description: The investigators conducted an experimental, double-blind, placebo-controlled study in 60 healthy women. Prior to watching an established trauma film paradigm that induces short lasting intrusions, participants received a single dose of either 10 mg hydrocortisone or placebo. The number of consecutive intrusions of the trauma film, the mean vividness of the intrusions and the mean degree of distress evoked by the intrusions were assessed during the following seven days. Salivary cortisol and alpha-amylase were collected at seven time points prior to, and after the trauma film.

Eligibility criteria: Inclusion Criteria:

* healthy participants
* German on a native level

Exclusion Criteria:

* former or present DSM IV Axis I disorders
* physical illnesses
* any medication intake (except oral contraceptive)
* history of sexual abuse or rape
* pregnancy or lactation period

Primary outcomes:
measure: Number of intrusive memories
timeFrame: seven consecutive days
Secondary outcomes:
measure: Vividness of intrusive memories
timeFrame: seven consecutive days
measure: Degree of distress of intrusive memories
timeFrame: seven consecutive days
Other outcomes:
Locations:
Study officials:
affiliation: Charite University, Berlin, Germany
name: Stefan Roepke
role: STUDY_DIRECTOR
References:
Clinical trial NCT06985654: The Effect of Preoperative Intravenous Fluid Bolus on Post-induction Hypotension in Elective Cystoscopies.
Official title: The Effect of Preoperative Intravenous Fluid Bolus on Post-induction Hypotension in Elective Cystoscopies.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Postinduction Hypotension
Hypotension During Surgery
Keywords: postinduction hypotension
hypotension
cystoscopy
lactated ringers
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to determine whether a standardized, weight-based crystalloid fluid bolus administered preoperatively reduces the incidence of postinduction hypotension (PIH) in patients undergoing cystoscopy.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old.
2. Undergoing elective cystoscopy surgery as the primary procedure.
3. Able to provide informed consent.

Exclusion Criteria:

1. Emergency surgeries.
2. Past history of amputations of any body part.
3. Allergies or contraindications to any medications used in the protocol or lactated ringers.
4. Systolic heart failure with LVEF \< 30% within the last year.
5. Severely depressed RV function within the last year.
6. Restrictive diastolic dysfunction within the last year.
7. Currently pregnant.

Primary outcomes:
measure: Incidence of Postinduction Hypotension
timeFrame: From the time patient enters the operating room to the end of surgery, assessed up to 24 hours.
Secondary outcomes:
Other outcomes:
measure: Inferior Vena Cava Size
timeFrame: From the time of consent to the beginning of surgery, assessed up to 24 hours.
measure: Respiratory Variability
timeFrame: From the time of consent to the beginning of surgery, assessed up to 24 hours.
Locations:
city: Columbia
country: United States
facility: University Hospital
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Sagar Bansal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04992754: Oral Health and Pregnancy
Official title: Oral Health and Pregnancy : Relation Between Knowledge, Practices and Social Representation of Pregnant Women in the Gynecologie Department at the Montpellier's CHRU
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dental Caries
Pregnancy Related
Keywords: Oral hygiene
Public Health
Pregnancy
Prevention
Patients coming to the CHU ADV Montpellier for consultation
Pregnant patients
Knowledge
Literacy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women over 18 years old in the Montpellier's hospital

Brief summary: The aim of this study is to identify the knowledge, behavior and social representation on dental health among pregnant women. This study could improve, in the future, prevention, treatments and care for them.

Detailed description: Pregnant women will have to complete a questionnaire that brings together their knowledge, practices and social representations of oral health during their current pregnancy.

Eligibility criteria: Inclusion criteria:

* pregnant t women over 18 years old
* French language

Exclusion criteria:

- pregnant women under 18 years old

Primary outcomes:
measure: Evaluate the knowledge
timeFrame: 1 day
measure: Evaluate the practices
timeFrame: 1 day
Secondary outcomes:
measure: Evaluate the social representation
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Camille INQUIMBERT, PhD
role: STUDY_DIRECTOR
affiliation: UH MONTPELLIER
name: Camille AMMOR, GRANDATI, resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02386254: Adaptation of a Premorbid Function Scoring System as a Predictor for Intensive Care Unit Mortality
Official title: Adaptation of a Premorbid Function Scoring System as a Predictor for Intensive Care Unit Mortality
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: ICU Mortality
ICU Morbidity
Keywords: premorbid
scoring system
ECOG
ICU
morbidity
mortality
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2015-03-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the critical care units of Presbyterian Hospital under the care of the medical ICU service with any diagnosis will be assessed for enrollment.

Brief summary: To evaluate whether a premorbid functioning scoring system such as the ECOG system can be adapted to predict ICU morbidity and mortality.


Eligibility criteria: Inclusion Criteria:

* All patients aged 18 years and older admitted to the Presbyterian Hospital intensive care units under the medical ICU service.

Exclusion Criteria:

-

Primary outcomes:
measure: Mortality
timeFrame: 30-day
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: OU Medical Center
state: Oklahoma
Study officials:
affiliation: Faculty
name: Kellie Jones, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00449254: Phase 2a Randomized, Double-Blind Study of Oleoyl-Estrone in Male Morbidly Obese Adults
Official title: A Phase 2a Randomized, Double-Blind, Placebo Controlled, Parallel Group, Safety and Efficacy Study of Oleoyl-Estrone (MP-101) in Male Obese Adults.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Obesity
Lead sponsor: Manhattan Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-03-20
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multi-center, multiple-dose, randomized, double-blind, three-arm, placebo-controlled study of fixed-dose repeated oral dosing for 30 days of 10 mg and 30 mg MP-101 and placebo in obese subjects.


Eligibility criteria: Inclusion Criteria:

* Subject is willing and able to provide signed informed consent.
* Subject is a male and is between 18-60 years of age.
* Subject is obese as defined as a BMI of 40 - 55.
* Subject is reasonably healthy and have a reasonably acceptable medical history
* Subject has a stable weight for the past 30 days per subject report.
* Subject who has at least one factor of the metabolic
* Subject exhibits stable behavior patterns with regard to smoking and exercise
* Subject can read, speak and write the English language and agrees to follow study procedures.

Exclusion Criteria:

* Subjects who have received any investigational medication within 3 months prior to administration of study drug
* Subjects with confirmed positive results of UDS or Alcohol
* Subjects who are unwilling to return to the clinical research center on specified days during the treatment periods.
* Subjects who have taken exclusionary medication
* Subjects with any clinically significant laboratory abnormality or illness which, in the opinion of the Investigator, would contraindicate study participation
* Subjects who have a history of testing positive for Hepatitis B virus, Hepatitis C virus, or HIV.
* Subject has been involved in a formal or informal (self-imposed) diet regimen within the last 30 days.
* Subject has a confirmed diagnosis or history of cancer, with the exception of nonmelanoma skin cancer.
* Subject is otherwise unsuitable for the study, in the opinion of the investigator.

Primary outcomes:
measure: To evaluate the safety and tolerability
Secondary outcomes:
measure: To evaluate the preliminary efficacy
Other outcomes:
Locations:
city: New York
country: United States
facility: St. Luke's-Roosevelt Hospital
state: New York
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
References:
Clinical trial NCT03578354: 4-Aminopyridine, Atenolol, or Placebo in Patients With Vestibular Migraine
Official title: Prospective, Randomized, Placebo-controlled, Phase 2 Study of 4-aminopyridine, Atenolol, or Placebo in the Treatment of Patients With Vestibular Migraine
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Vestibular Migraine
Migraine Disorders
Vestibular Diseases
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This phase 2 randomized study will be used to test the efficacy of 4-aminopyridine (4AP) or atenolol to reduce severity and frequency of vestibular and headache symptoms of vestibular migriane sufferers. Blinded study drug will be taken by mouth twice a day for 14 weeks on study.


Eligibility criteria: Inclusion Criteria:

* Severe vestibular migraine (VM)

Exclusion Criteria:

* Neurologic or otologic disease other than VM
* Psychiatric illness requiring medication
* Medical illness including cancer, coronary artery or cerebrovascular disease
* Known allergy to one of the test medications
* Contraindication to use of one of the test medications - asthma, symptomatic hypotension, history of seizures
* Taking migraine prophylactic medication or vestibular suppressants.
* Pregnant or breast feeding women

Primary outcomes:
measure: Change in Dizziness Handicap Score
timeFrame: 14 weeks
Secondary outcomes:
measure: Change in number of dizziness episodes
timeFrame: 14 weeks
measure: Change in motion sickness susceptibility
timeFrame: 14 weeks
measure: Change in roll tilt perceptual threshold
timeFrame: 14 weeks
measure: Change in vestibulo-ocular reflex (VOR) time constant
timeFrame: 14 weeks
measure: Change in number of migraine episodes
timeFrame: 14 weeks
measure: Change in Headache Impact Test (HIT) score
timeFrame: 14 weeks
measure: Change in quality of life score
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
Study officials:
References:
Clinical trial NCT05416554: Long-term Cognitive, Neuropsychiatric and Functional Outcomes in Adults Who Have Received Chimeric Antigen-Receptor T-Cell (CAR-T) Therapy for Aggressive Lymphoma at Stanford
Official title: Long-term Cognitive, Neuropsychiatric and Functional Outcomes in Adults Who Have Received Chimeric Antigen-Receptor T-Cell (CAR-T) Therapy for Aggressive Lymphoma at Stanford - A Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Non Hodgkin Lymphoma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to assess the feasibility of performing neuropsychological testing to measure the cognitive performance of individuals following Axicabtagene ciloleucel CAR-T therapy at Stanford.


Eligibility criteria: Inclusion Criteria:

* \>/= 18 years-old
* Treated with Axicabtagene ciloleucel CAR-T therapy at Stanford Or
* Treated with standard commercial Axicabtagene ciloleucel CAR-T therapy elsewhere and followed primarily by SHC Blood and Bone Marrow transplant providers
* \>/= 6 months from the date of CAR-T infusion
* Fluent in English
* Able to attend and participate in in-person testing (Arm I)
* Able to participate in remote video testing with adequate workspace, computer and internet capabilities for a reliable telehealth video connection (Arm II)

Exclusion Criteria:

* Concurrent enrollment in a CAR-T therapeutics research study
* Unable to be present for the scheduled testing
* Unable to participate in testing due to severe cognitive or physical limitation
* Actively receiving chemotherapy
* Progressive cancer

Primary outcomes:
measure: Number of patients who complete neuropsychological testing in the post-CAR-T adult population
timeFrame: 6 months
measure: Number of patients who complete telehealth neuropsychological testing in the post-CAR-T adult
timeFrame: 6 months
Secondary outcomes:
measure: Wechsler Test of Adult Reading WTAR Neuropsychological testing
timeFrame: Baseline
measure: Hopkins Verbal Learning Test HVLT
timeFrame: Baseline
measure: Controlled Oral Work Association Test COWAT
timeFrame: Baseline
measure: Trails A and B (Oral Trails)
timeFrame: Baseline
measure: Digit Span
timeFrame: Baseline
measure: Clock Drawing Test
timeFrame: Baseline
measure: Short form of Quality of Life SF-36
timeFrame: Baseline
measure: General Anxiety Disorder Assessment GAD-7
timeFrame: Baseline
measure: Patient Health Questionnaire PHQ9
timeFrame: Baseline
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Stanford Cancer Center
state: California
Study officials:
affiliation: Stanford University
name: Brian Scott, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03244254: Intestinal Fatty Acid-binding Protein (I-FABP) Levels in Pediatric Celiac Patients
Official title: I-FABP Levels in Pediatric Celiac Patients in Transition From Active Disease to Remission
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Celiac Disease in Children
Keywords: Celiac Disease
Children
I-FABP
Lead sponsor: Schneider Children's Medical Center, Israel
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 70
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients undergoing endoscopy at the research hospital.

Brief summary: A prospective, longitudinal study meant to compare blood levels of I-FABP in pediatric celiac patients during diagnosis to levels under gluten free diet, it's correlation with traditional serology testing and questionnaire regarding patient responsiveness to the gluten free diet, and in comparison to a control group.

Detailed description: I-FABP is a reliable marker for intestinal damage and has been proved to respond more swiftly than traditional serology to enterocyte injury in celiac patients who do not a gluten free diet. In this study a pediatric population of celiac patients will be tested for I-FABP levels during initial endoscopic diagnosis and during one year of follow up. Their levels will be compared to a control group of pediatric patients undergoing endoscopy for reasons other than suspicion of celiac disease. During the period of follow up, the test group will undergo repeat testing for I-FABP levels, as well as the traditional follow up testing for serology in celiac patients and a questionnaire regarding. The results will be analyzed in the hope of finding a way to use I-FABP as a more direct, accurate marker of disease activity, and of correlations between it's level and the patient's Marsh score at diagnosis.

Eligibility criteria: Inclusion Criteria:

* Children undergoing endoscopy for diagnosis of celiac disease, with elevated serology (TTG more than 3 times the norm), and whose histological Marsh score is 2 or higher.

Exclusion Criteria:

* Diseases known to cause elevation in I-FABP levels: Bowel ischemia, inflammatory bowel disease, Primary Biliary Cholangitis, liver failure, biliary duct obstruction, liver malignancy.
* Bowel trauma or abdominal surgery or acute gastroenteritis in the last 3 months
* NSAID use in the last week.
* Intensive daily physical activity (over 1 hour) in the 2 days prior to endoscopy.
* Known genetic disorders (such as Down's syndrome).
* Patients whose TTG was elevated but lower than 3 times the normal range.

Primary outcomes:
measure: I-FABP levels at diagnosis
timeFrame: 1 day of enrollment
measure: I-FABP levels during remission
timeFrame: 6 months & 12 months after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Petaẖ Tiqwa
country: Israel
facility: Schneider Children's Medical Center of Israel
Study officials:
affiliation: Director
name: Raanan Shamir, Prof
role: STUDY_DIRECTOR
References: