louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06269757: Exercise Program for ITB Syndrome
Official title: Efficacy of an Individualized Exercise Program for Iliotibial Band Syndrome: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Iliotibial Band Syndrome
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with diagnosed iliotibial band (ITB) syndrome indicated for non-operative management will be randomized to individualized exercise program or standard physical therapy over the course of 3 months to determine any possible difference in clinical outcomes.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ITB syndrome
* Age 18-65
* Ability to comply with a standardized physical therapy protocol
* Willing and able to provide consent

Exclusion Criteria:

* Patients at any increased risk of falls or at increased risk from harm due to falling, including issues with vertigo, osteoporosis, or a history of past falls
* Patient otherwise deemed at increased risk from this investigational rehabilitation program by their referring surgeon or physical therapist
* Patients who are pregnant

Primary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score Physical Short-Form (KOOS-PS) Score
timeFrame: Month 6
measure: Visual Analogue Scale (VAS) Score
timeFrame: Month 6
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NYU Langone Health
name: Guillem Gonzalez-Lomas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01977248: Sensorimotor Affect Relationship-based Therapy (SMART) for Children With Autism Spectrum Disorders Ages 2-12
Official title: Sensorimotor Affect Relationship-based Therapy (SMART) for Children With Autism Spectrum Disorders Ages 2-12
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Autistic Disorder
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2013-11-06
Enrollment: 37
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The SMART Program at Nationwide Children's Hospital is an interdisciplinary social skills group that teaches children with autism spectrum disorders (ASD) ages 2-12 the fundamental social skills necessary to build and maintain relationships. The manualized curriculum addresses skills such as joint attention, eye contact, play, and peer engagement. Currently individual goals are set for each child who participates and this is documented in the daily treatment note. In order to research group outcomes, the investigators will use parent questionnaires (an addition to current clinical practices) to measure changes in behavior after each 12 week session for up to one year of treatment. The investigators hypothesize that maladaptive behaviors will decrease and adaptive behaviors will increase in children with ASD after participation in the SMART program.


Eligibility criteria: Inclusion Criteria:

* Ages 2 to 12.5
* Diagnosis of ASD OR who meet a minimum ASD cutoff score on a screening questionnaire (SCQ or ASQ:SE, depending on age)

Exclusion Criteria:

* Non-English speaking
* Uncorrected vision disorder
* Moderate to severe hearing loss
* Non-ambulatory
* Previous participation in a SMART group
* Accompaniment by aide
* Extreme behavioral disorder

Primary outcomes:
measure: Pervasive Developmental Disorder Behavior Inventory (PDDBI)
timeFrame: Upon enrollment in the study (baseline), day 1 of treatment, and end of treatment for each 12 week session (up to 4 sessions)
Secondary outcomes:
Other outcomes:
Locations:
city: Hilliard
country: United States
facility: Nationwide Children's Hospital Hilliard Close to Home
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Kelly J Tanner, MOT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02090257: Pediatric Heart Transplantation: Transitioning to Adult Care
Official title: Pediatric Heart Transplantation: Transitioning to Adult Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Transplantation
Keywords: Heart transplant recipients who are entering into adult care.
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-03-18
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this pilot trial, Transitioning to Adult Care (TRANSIT), is to develop and test an intervention (i.e., a standardized, tailored transition program focused on enhancing adherence) to improve outcomes for emerging adults who underwent heart transplantation as children and transfer to adult care.


Eligibility criteria: Inclusion Criteria:

* Have received a heart transplant at a children's hospital and are ready to transition, as determined by the pediatric heart transplant cardiologist, to the adult heart transplant center with whom a collaborative relationship has been established;
* 18 years or older;
* Able to speak, read at a fifth grade level or above, and write English;
* Physically able to participate.

Exclusion Criteria:

* History of psychiatric hospitalization within the last 3 months, assessed on a case-by-case basis with exclusion only if patients could not potentially benefit from the intervention.

Primary outcomes:
measure: To assess the feasibility of TRANSIT by measuring the transition program adherence for those randomized to the intervention and survey completion for all participants.
timeFrame: 6 months
Secondary outcomes:
measure: To determine the efficacy of TRANSIT on patient-level outcomes .
timeFrame: 6 months
measure: To determine the efficacy of TRANSIT on meso-level outcomes.
timeFrame: 6 Months
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Aurora
country: United States
facility: Universtiy of Colorado Denver/Children Colorado
state: Colorado
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: New York
country: United States
facility: Columbia University
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia/University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Ann and Robert Lurie Children's Hospital
name: Elfriede Pahl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Kathleen Grady, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03368157: PREG-MS: New England MS Pregnancy Registry
Official title: PREG-MS: New England MS Pregnancy Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Pregnancy Related
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who are pregnant or are actively trying to become pregnant.

Brief summary: The purpose of the study is to develop a detailed pregnancy registry of patients with Multiple Sclerosis in the New England states. Women with a diagnosis of MS that are either pregnant or actively planning to become pregnant are eligible to participate.

The study will solely take place through phone interviews. One of the study coordinator at the Partners MS Center will contact the participant for an intake phone interview where general information about the individual, their pregnancy and their MS will be collected. Thereafter the coordinator will contact the participant every 3 months for 20 minutes follow up interviews. After birth, the coordinator will collect information on the growth and development of the participant's baby. Pediatric interviews will be conducted at 2, 4, 6, 9, 12, 18, 24, 36 months. Information from the participant's neurologist and obstetrician, as well as information from the baby's pediatrician, will be made available to the study staff at regular intervals throughout the duration of the study.

Through this study, the investigators hope to learn more about the effects of MS on pregnancy and pediatric development, and about the effects of pregnancy on the course of MS.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Multiple Sclerosis;
* Pregnant or actively planning to become pregnant.

Exclusion Criteria:

-

Primary outcomes:
measure: The relationship between EDSS and pregnancy course
timeFrame: 9 months
Secondary outcomes:
measure: The relationship between MS treatments and pregnancy course
timeFrame: 9 months
Other outcomes:
measure: The weight (pounds) of infants born to MS affected mothers
timeFrame: 3 years
measure: The length (inches) of infants born to MS affected mothers
timeFrame: 3 years
measure: The head circumference (inches) of infants born to MS affected mothers
timeFrame: 3 years
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT03177057: SMART Project in Preventing Skin Cancer
Official title: Self-Monitoring and Readiness Texting Project (SMART)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Carcinoma
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-06-06
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This pilot clinical trial studies how well Self Monitoring And Readiness Texting (SMART) project works in sun exposure and protection behaviors. Measuring how behavior tracking and individually tailored messages affect risk behaviors in patients with skin cancer may help doctors plan the best prevention plan and decrease national melanoma incidence and mortality.

Detailed description: PRIMARY OBJECTIVES:

I. To test the effects of a behavior tracking and individually-tailored daily text message intervention on sun protection and exposure behaviors and to see if these techniques will be most effective in conjunction or separately.

SECONDARY OBJECTIVES:

I. To examine mediators in the effects of the intervention on safe sun behaviors, based on Fishbein?s Integrative Model.

OUTLINE: Patients are randomized to 1 of 4 study arms.

ARM I (SELF-MONITORING): Patients complete tanning and sun protection usage entries daily for 14 days.

ARM II (TEXT MESSAGES): Patients receive individualized text messages based on baseline assessment of tanning motives (appearance, enjoyment, social) daily for 14 days.

ARM III (COMBINED GROUP): Patients complete tanning and sun protection usage entries and also receive individualized text messages daily for 14 days.

ARM IV (CONTROL GROUP): Patients complete study assessments.

After completion of study, patients are followed up at 2 weeks.

Eligibility criteria: Inclusion Criteria:

* Women from the Philadelphia metropolitan area who own a mobile phone and who meet criteria for at least moderate risk of skin cancer based on a brief risk assessment tool

Primary outcomes:
measure: Change in ultraviolet radiation (UV) exposure and sun protection behaviors based on behavior tracking and individually tailored daily text messages
timeFrame: Baseline to up to 2 weeks
Secondary outcomes:
measure: Mediators and moderators of the intervention on behavior
timeFrame: At 2 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Carolyn Heckman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03408457: Influence of Perioperative Fluid Balance on Serum Concentrations of Antibiotics and Surgical Site Infections
Official title: Influence of Perioperative Fluid Balance on Serum Concentrations of Antibiotics and Surgical Site Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antibiotic
Anti-Bacterial Agents
Surgical Wound Infection
Keywords: Surgical wound infection
antibiotic concentration
blood level
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Surgical Patients of the University Medical Center Mainz

Brief summary: This study evaluates antibiotic serum concentrations in correlation with perioperative fluid balance. Patients will be recruited in rectum and esophageal surgery (representative for low blood loss and restrictive fluid management) and in liver surgery (representative for high blood loss and liberal fluid management). The hypothesis is that high blood loss and liberal fluid management dilute antibiotic serum concentrations thereby potentially increasing surgical site infections.


Eligibility criteria: Inclusion Criteria:

* elective surgery of rectom, esophagus or liver with indication for a central venous catheter
* informed consent

Exclusion Criteria:

* pregnancy
* medical emergency
* participation in another study

Primary outcomes:
measure: Serum concentration of antibiotic
timeFrame: 2 days
Secondary outcomes:
measure: Surgical wound infection
timeFrame: 30 days
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Medical Center of the Johannes Gutenberg-University Mainz
state: Rheinland-Pfalz
Study officials:
affiliation: University Medical Center of the Johannes Gutenberg-University Mainz
name: Serge C Thal, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05969457: Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach
Official title: Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach: Randomized, Double-blind Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Hysterotomy; Affecting Fetus
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: Groupe Hospitalier du Havre
First posted: 2023-08-01
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The research procedure is the injection of 20 mL of Ropivacaine solution (vs. saline) to create a paracervical block at the beginning of surgery, while the patient is already under general anesthesia.

This injection will take place 3 minutes before the vaginal incision, via 4 injection points. Injections are made 3 mm deep into the vaginal cul de sac.

Randomization takes place before surgery by vNOTES:

* Experienced group: Local anesthesia with injection of Ropivacaine (20mL of ropivacaine 7.5 mg/mL, i.e. 150mg) and general anesthesia
* Control group: Injection of 20mL of placebo (saline) and general anesthesia

In both groups, systematic intraoperative and postoperative analgesia will be identical.


Eligibility criteria: Inclusion Criteria:

* Adult patients aged 18 to 70 inclusive
* Patient scheduled for vNOTES surgery for total hysterectomy for benign pathology, whether or not associated with an adnexal procedure (unilateral or bilateral salpingectomy or adnexectomy (for cysts smaller than 6 cm)).
* Person having read and understood the information letter and signed the consent form
* Person affiliated to a social security scheme

Exclusion Criteria:

* Suspicion of malignant pathology
* History of rectal surgery
* History of pelvic inflammatory disease
* Suspicion of recto-vaginal endometriosis
* Virginity
* Contraindication to NAROPEINE 7.5 mg/mL, solution for injection in ampoule
* Contraindication to PROAMP SODIUM CHLORIDE 0.9%, solution for injection
* Patients on a low-salt diet
* History of more than 2 caesarean sections
* Estimated uterine size \> 700 g according to the following formula y = 0.35x + 107 (x = a × b × c), based on measurements taken on preoperative imaging (MRI or ultrasound). a=longitudinal diameter, b=sagital diameter, c=transverse diameter.3
* BMI \> 35
* Contraindication to analgesic molecules in intraoperative and postoperative protocols.

Primary outcomes:
measure: pain after surgery
timeFrame: 4hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04618848: Performance Evaluation Study
Official title: Performance Evaluation Protocol for Sight Diagnostics' OLO CBC Analyzer by Ichilov Oncology Daily Care Center
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hematology
Keywords: Hematology
Lead sponsor: Sight Diagnostics
Sponsor class: INDUSTRY
Collaborators: name: Tel Aviv Medical Center
First posted: 2020-11-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Oncologic patient

Brief summary: This study aims to establish OLO's performance accuracy of CBC results for finger prick samples across the OLO reportable range, and particularly around relevant medical decision points

Detailed description: This study aims to establish OLO's performance accuracy of CBC results for finger prick samples across the OLO reportable range, and particularly around relevant medical decision points.

The evaluation will include two studies:

1. A matrix study will compare a capillary sample collected via finger prick with a venous sample collected into a blood tube, both scanned on OLO.
2. A method comparison study will compare Sight OLO to the site reference analyzer using a venous sample collected into a blood tube.

Eligibility criteria: Inclusion Criteria:

* Blood samples will be collected from oncologic patients older than 18 years old arriving at the oncologic daily care center of Ichilov hospital, with predefined normal and abnormal blood counts

Exclusion Criteria:

* Patient younger than 18 years old
* Visibly hemolyzed specimens (sample plasma should be checked for hemolysis by technician while selection of specimen from tube racks).
* Visibly clotted specimens (Reasonable to assume that samples processed with clinical reported results are not clotted).
* A sample that is not successfully scanned on OLO within 3 attempts (e.g. rejected due to irregular cell morphology, or microscopically visible hemolysis).

Primary outcomes:
measure: CBC Comparison
timeFrame: Immediately after sample collection is completed
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sponsor GmbH
name: Yochay Eshel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01307748: Effects of Stress-reducing Aromatherapy
Official title: Physiologic and Expectancy Effects of Stress-reducing Aroma in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Stress-related Problems
Keywords: aromatherapy
stress
older adults
stress-related change
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2011-03-03
Enrollment: 92
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study purpose is to evaluate efficacy of stress-reducing aromatherapy and learn about how aromatherapy works.

Detailed description: The study purpose is to evaluate efficacy of stress-reducing aromatherapy and learn about how aromatherapy works by comparing participants' physiologic responses to laboratory challenge tasks with and without experiencing aromatherapy.

Eligibility criteria: Inclusion Criteria:

* in good physical and cognitive health
* reporting moderate level of stress
* able to perceive aromas
* able to understand and follow study instructions

Exclusion Criteria:

* taking medications affecting central nervous system (CNS) function or physiologic measures (e.g. steroids or neuroleptics)
* reporting smell sensitivities or allergies
* smoking presently or in the past less than one year prior to enrollment

Primary outcomes:
measure: Percent of Baseline Level of Salivary Cortisol
timeFrame: assessed at baseline (60 min prior to aroma exposure and stress), stress battery (30 min after aroma exposure and during stress), post-stress (60 min after completing stress battery)
Secondary outcomes:
measure: Electroencephalography (EEG) Frontal Asymmetry
timeFrame: assessed at baseline (60 min prior to aroma exposure and stress), at the onset of aromatherapy exposure, stress battery (30 min after aroma exposure and during stress), post-stress (60 min after completing stress battery)
measure: Cognitive Performance: Percent Change From Baseline in Digit Span Backward Task Score
timeFrame: Baseline (60 min prior to aroma exposure and stress), post-stress (60 min after completing stress battery)
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Barry S Oken, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chamine I, Oken BS. Aroma Effects on Physiologic and Cognitive Function Following Acute Stress: A Mechanism Investigation. J Altern Complement Med. 2016 Sep;22(9):713-21. doi: 10.1089/acm.2015.0349. Epub 2016 Jun 29.
citation: Chamine I, Oken BS. Expectancy of stress-reducing aromatherapy effect and performance on a stress-sensitive cognitive task. Evid Based Complement Alternat Med. 2015;2015:419812. doi: 10.1155/2015/419812. Epub 2015 Jan 31.