louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02390830: Falls Prevention and Balance Rehabilitation in Multiple Sclerosis
Official title: Falls Prevention and Balance Rehabilitation in Multiple Sclerosis: a Bi-centre Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2015-03-18
Enrollment: 119
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background. Balance disorders and falls are common in People with Multiple Sclerosis (PwMS) Objective: Our hypothesis was that PwMS treated for balance disorders would reduce balance disorders and frequency of falls.

Methods: A bi-centre randomised Rater-blinded controlled trial. Participants in both groups received 20 treatment sessions. Participants in the intervention group received treatment aimed at improving control of the position and movement of the centre of mass and body segments. Participants in the control group received treatments to reduce limitations at activity and body function level.

Group allocation was done by an independent clinician by a randomization list made before the beginning of the study. Group allocation was kept concealed throughout the study and participants were not aware of group assignment.

Data was analyzed according to a preplanned protocol by using an intention to treat approach.


Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of Multiple Sclerosis Must be able to walk (also with aid) for 6m Must be able to maintain standing position with open eyes for at least 30".

Exclusion Criteria:

Must not be able to maintain monopodalic-standing position for 10", Must not be able to to maintain tandem position for 30", cognitive disorders hampering the execution of the exercises/assessment.

Primary outcomes:
measure: Change from Baseline in Frequency of fallers at 2 and 4 months
timeFrame: baseline, then participants were followed for the duration the outpatient treatment protocol, an average of 8 weeks, and at follow up 2 months after the end of the treatment protocol
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06507930: The COMPASSION Study
Official title: The COMPASSION Study: Applying Telehealth to Innovate and Strengthen Connections for Patients With Metastatic Breast Cancer Receiving Hospice Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Metastatic Breast Cancer
Advanced Breast Cancer
Unresectable Breast Carcinoma
Keywords: Breast Cancer
Metastatic Breast Cancer
Advanced Breast Cancer
Unresectable Breast Cancer
Hospice Care
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this research study is to better understand the in-home hospice experience for participants, caregivers, hospice nurses, and oncology providers by conducting telehealth check-ins between participants and caregivers and oncology care teams.

Detailed description: The aim of this research study is to better understand the in-home hospice experience for participants, caregivers, hospice nurses, and oncology providers by conducting telehealth check-ins between participants and caregivers and oncology care teams.

Study procedures include giving verbal consent to participate and a one-time survey delivered by email or phone call.

About 200 people, which includes 50 participants, 50 caregivers, 50 hospice nurses, and about 50 oncology providers, are expected to participate in this research study.

Eligibility criteria: Inclusion Criteria:

* Patient of any gender with unresectable locally advanced or metastatic breast cancer
* Eligible for in-home hospice services and referred by DFCI clinical team to in-home hospice \</= 1 week before enrollment
* Ability to conduct video or phone check-ins, even if assistance required.
* Able to provide verbal consent with a willingness to take a survey at 4-6 weeks, if medically able
* Hospice setting is within Massachusetts
* Non-English language allowed but interpreter services must be present at each meeting and will be coordinated by scheduling team
* Willingness to provide a caregiver/loved one's contact information for survey contact at 4 weeks after enrollment

Exclusion Criteria:

* Unable to provide verbal consent
* Hospice care planned outside of a home setting (note: if participants start out in a home hospice setting but later transition their hospice care to an inpatient setting, enrollment is allowed as long as they started in a home setting)
* Hospice setting outside of Massachusetts
* Individuals who are under the age of 18, as this is not a project focused on pediatric patients.

Primary outcomes:
measure: Proportion of Participant Intervention Completion
timeFrame: Up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Claire Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00638430: The Effect of Myopic Optical Defocus on the Humphrey Matrix 30-2 Test
Official title: The Effect of Myopic Optical Defocus on the Humphrey Matrix 30-2 Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Keywords: myopia
Humphery Matrix 30-2 test
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2008-03-19
Enrollment: 40
Sex: ALL
Minimum age (years): 27
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: tertiary care clinic

Brief summary: The purpose of this study is to examine the effect of the myopic optical defocus on the Humphrey Matrix 30-2 test.

Detailed description: The Humphery Matrix (Zeiss, Dublin, California, USA; in cooperation with Welch Allyn, Skaneateles, New York, USA), which is a recently developed version of FDT perimetry, showed more improved technology to detect early glaucomatous damage. The user's guide for the Humphrey Matrix (Humphrey® matrix visual field instrument user's guide. Zeiss, Dublin, California, USA; in cooperation with Welch Allyn, Skaneateles, New York, USA; 2003) suggests that myopic refractive errors more than -3.0 D need to be corrected before the 30-2 test. However, the proper correction of the optical defocus is not always easy because of a lack of trial frame.

The purpose of the present study is twofold. At first, the influence of the low-grade myopia on the Humphery Matrix 30-2 test will be evaluated and compared to the effect of moderate-grade myopia. Secondly, the influence of myopic optical defocus and the glaucomatous visual field damage on the pattern deviation plot change according to the severity of glaucomatous visual field damage will be estimated.

Eligibility criteria: Inclusion Criteria:

* intra-ocular pressure 23 or higher
* suspicious glaucomatous optic disc change
* suspicious defect of retinal nerve fiber layer
* or eyes with various degrees of glaucoma

Exclusion Criteria:

* a high myopic eye (SE more than -6.0 D)
* moderate to severe cataract
* evidence of diabetic or hypertensive retinopathy
* macular disease
* intra-ocular inflammation
* history of intraocular surgery and any other ocular lesion that could have an influence on the perimetry result

Primary outcomes:
measure: mean defect
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Department of Ophthalmology, Samsung Medical Center,
name: Changwon Kee, M.D.
role: STUDY_CHAIR
References:
citation: Anderson AJ, Johnson CA. Frequency-doubling technology perimetry and optical defocus. Invest Ophthalmol Vis Sci. 2003 Sep;44(9):4147-52. doi: 10.1167/iovs.02-1076.
Clinical trial NCT05191030: Cortisol and Food Insecurity
Official title: Food Insecurity, Poor Diet, and Metabolic Syndrome: Cortisol's Amplifying Role
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Food Insecurity
Keywords: Food insecurity
Physiological Stress
Psychological Stress
Cortisol
Eating
Diet
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-01-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study is a within-subjects experiment. The order in which participants undergo the experimental or control conditions/arms will be counterbalanced. 50% of participants will undergo the experimental condition first and then the control condition, one month later. The rest of the sample will undergo the control condition first then the experimental condition, one month later.
Primary purpose: BASIC_SCIENCE

Brief summary: This study will use a within-subjects design in a sample of individuals with a range of food insecurity recruited from the Los Angeles community (N = 400; 50% men). These participants will then, in counterbalanced order, be exposed to a gold-standard laboratory stressor and a control condition, one month apart. Moderation analyses will test whether cortisol reactivity to the stressor acts as a modulator of the relationship between high levels of food insecurity and increased hyperpalatable food intake.


Eligibility criteria: Inclusion Criteria:

* Age 18+
* English-speaking

Exclusion Criteria:

* Recent (\<1 year) diagnosis of major psychiatric disorders including any mood disorder, schizophrenia, or PTSD
* Recent (\<1 year) diagnosis of eating disorder
* Recent (\<1 year) diagnosis of metabolic or endocrine disorder or steroid or hormonal contraceptive use
* Pregnancy
* Allergy to any of the foods in the food buffet
* Participation in strict dieting or caloric restriction

Primary outcomes:
measure: Hyperpalatable Food Intake Measured in Kilocalories
timeFrame: Hyperpalatable food intake will be measured immediately after the intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: A. Janet Tomiyama, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kirschbaum C, Pirke KM, Hellhammer DH. The 'Trier Social Stress Test'--a tool for investigating psychobiological stress responses in a laboratory setting. Neuropsychobiology. 1993;28(1-2):76-81. doi: 10.1159/000119004.
citation: American Diabetes Association. Diabetes care standards of medical care in Diabetes - 2019. J Clin Appl Res Educ 2019.
Clinical trial NCT01705925: Multicenter Evaluation of Children and Young Adults With Genotype Positive Long QT Syndrome
Official title: Multicenter Evaluation of Children and Young Adults With Genotype Positive Long QT Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Long QT Syndrome
Lead sponsor: Pediatrix
Sponsor class: OTHER
First posted: 2012-10-12
Enrollment: 92
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and Young Adults with Genotype Positive Long QT Syndrome

Brief summary: The purpose of the study is to provide comprehensive follow-up in patients with Long QT Syndrome (LQTS) and gain additional information regarding genotype-phenotype correlation and effective management and treatment options.


Eligibility criteria: Inclusion Criteria:

* Children and/or young adults diagnosed with heterogeneous repolarization disorder who have genotype positive Long QT, or
* Newly diagnosed mutation positive patients with a confirmed test

Exclusion Criteria:

* Children who are phenotypically positive with no molecular testing
* Children that are phenotypically positive but genotype negative

Primary outcomes:
measure: Adverse Cardiac Events on patients with genotype positive LQT1 who have a normal EKG and absence of symptoms, but a molecular confirmation of LQT1.
timeFrame: Enrollment is expected to take approximately 5 years. The patients will be followed until they are no longer cared for by a pediatric cardiology facility (typically post-college) or approximately 21 years of age.
Secondary outcomes:
measure: Adverse Cardiac Events on patients with both phenotype and genotype positive.
timeFrame: Enrollment is expected to take approximately 5 years. The patients will be followed until they are no longer cared for by a pediatric cardiology facility (typically post-college) or approximately 21 years of age.
Other outcomes:
Locations:
city: Austin
country: United States
facility: Children's Cardiology Associates
state: Texas
Study officials:
affiliation: Pediatrix
name: Mitchell Cohen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatrix
name: Arnold Fenrich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatrix
name: Reese Clark, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00144625: Long-term Treatment Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)
Official title: An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety, Efficacy and PK of MRA in Patients With pJIA Who Participated in Study MRA318JP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Polyarticular Juvenile Idiopathic Arthritis
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 19
Sex: ALL
Minimum age (years): 2
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, extension, Phase III study to evaluate the long-term safety, efficacy and PK of MRA in patients with pJIA who participated in Study MRA318JP.


Eligibility criteria: Inclusion criteria

* Of the patients who received three infusions with MRA in the previous study and for whom a last observation was conducted
* the patients who did not have problems with safety in the previous study"

Exclusion criteria

* Patients who were not enrolled by 3 months after completion of the previous study
* Patients who received any of the following since completion of the previous study until initiation of treatment in the present study

  1. DMARDs or immunosuppressants
  2. Intravenous and intramuscular injection of corticosteroids
  3. Plasma exchange therapy
  4. Other drugs and therapies that may affect evaluation of drug efficacy

Primary outcomes:
measure: Efficacy:Percentage of patients showing 30% improvement in the JIA core set every 3M, LOBS
timeFrame: every 3 months
measure: Safety:Incidence and severity of adverse events and adverse drug reactions
timeFrame: whole period
measure: Pharmacokinetics:The time course of the trough values for the serum MRA concentration
timeFrame: whole period
Secondary outcomes:
measure: Efficacy:The time course of the percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, each variable of the JIA core set, CRP, pain every 3M, LOBS
timeFrame: every 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Chugai Pharmaceutical
name: Takahiro Kakehi
role: STUDY_DIRECTOR
References:
Clinical trial NCT02030925: Ph2a Study to Evaluate IW-3718 in Patients With Gastroesophageal Reflux Not Completely Responsive to Proton Pump Inhibitors
Official title: A Phase 2a Study to Evaluate the Effect of IW-3718 Administered Orally for 4 Weeks in Patients With GERD Not Completely Responsive to Proton Pump Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastroesophageal Reflux
Lead sponsor: Ironwood Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-09
Enrollment: 93
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: This study is meant to assess the effect of IW-3718 as an added treatment to ongoing once-daily protocol pump inhibitor (PPI) treatment for patients who continue to experience symptoms of their gastroesophageal reflux disease (GERD).


Eligibility criteria: Inclusion Criteria:

* Patient is between 18 and 65 years of age at the Screening Visit; females must not be pregnant or must not be breastfeeding;
* Patient has a confirmed diagnosis of gastroesophageal reflux disease, must be currently taking a proton pump inhibitor (PPI), and must be experiencing GERD symptoms as specified by the protocol.

Exclusion Criteria:

* Patient may not meet any of the excluded conditions specified in the protocol;
* Patient is experiencing alarm symptoms such as GI bleeding, anemia, vomiting, dysphagia, or unexpected weight loss;
* Patient has a clinically significant hypersensitivity or allergies to any of the active ingredients or excipients in the study medication.

Primary outcomes:
measure: Exploratory Endpoints - GERD Symptoms
timeFrame: Change from baseline: Treatment Period (weeks 1-4) compared with 2-week (baseline) Pretreatment Period
Secondary outcomes:
Other outcomes:
Locations:
city: North Little Rock
country: United States
facility: Ironwood Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: Ironwood Investigational Site
state: California
city: Monroe
country: United States
facility: Ironwood Investigational Site
state: Louisiana
city: Chesterfield
country: United States
facility: Ironwood Investigational Site
state: Michigan
city: Raleigh
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Ironwood Investigational Site
state: Ohio
city: Chattanooga
country: United States
facility: Ironwood Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Ironwood Investigational Site
state: Tennessee
city: Logan
country: United States
facility: Ironwood Investigational Site
state: Utah
city: South Ogden
country: United States
facility: Ironwood Investigational Site
state: Utah
Study officials:
References:
Clinical trial NCT05336825: CO2 Laser vs Lidocaine for Vestibulodynia in Premenopausal Women
Official title: The Application of External Fractional CO2 Laser Energy Versus Topical Lidocaine for the Treatment of Vestibulodynia in Premenopausal Women on Hormonal Contraception: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvodynia
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
Collaborators: name: Foundation for Morristown Medical Center
First posted: 2022-04-20
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: CO2 laser energy is currently used widely for the treatment of postmenopausal women who have vaginal atrophy due to the lack of estrogen. However, its effect on premenopausal women with hormonally-mediated vulvar vestibulodynia is unknown. This study seeks to evaluate the effect of CO2 laser on young women and compare it to topical lidocaine.

Detailed description: The purpose of this study is to see if vaginal laser therapy with MonaLisa Touch® will be more effective in treating vestibulodynia than current treatment with a topical lidocaine ointment. Vestibulodynia is a common bothersome condition and is more likely to occur in women on hormonal contraceptive treatment. To date, there are no effective treatments that address the underlying causes of the disease. MonaLisa Touch® is a laser procedure that delivers CO2 laser energy to the vaginal wall tissue. This energy causes the patient's own body to regenerate collagen and blood vessels, changing the tissue to make it healthier. The MonaLisa Touch® technology may help vestibulodynia by potentially fixing the underlying cause. This may be more effective than using the topical lidocaine which makes the tissue numb.

Eligibility criteria: Inclusion Criteria:

* Age 18 years to 40 years
* Hormonal contraceptive therapy for at least one year consecutive duration
* Vestibulodynia diagnosis meeting the following criteria:

  * Localized vulvar pain to vaginal vestibule
  * At least 3 months duration
  * Without clear identifiable cause

Exclusion Criteria:

* Suspected primary cause to vestibular pain that warrants directed treatment
* History of chronic infection or autoimmune disease
* Prior pelvic surgery including mesh placement for incontinence or prolapse, vestibulectomy, vulvectomy, or labiaplasty
* Active vulvar or vaginal infection
* Allergy or contraindication to topical lidocaine treatment
* Prior diagnosis or treatment of vulvar intraepithelial neoplasia or vulvar malignancy

Primary outcomes:
measure: VAS
timeFrame: 3 months
Secondary outcomes:
measure: PFDI
timeFrame: 3 months
Other outcomes:
Locations:
city: Denville
country: United States
facility: Garden State Urology
state: New Jersey
Study officials:
References: