louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05010395: Increasing Health Insurance Enrollment Among Uninsured Americans
Official title: Increasing Health Insurance Enrollment Among Uninsured Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: health insurance enrollment
Lead sponsor: Office of Evaluation Sciences
Sponsor class: FED
First posted: 2021-08-18
Enrollment: 811795
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This randomized evaluation used behaviorally-informed letters to increase health insurance take-up on the Affordable Care Act (ACA) Marketplaces.

Detailed description: During Open Enrollment Periods for the ACA Marketplaces, qualifying individuals can purchase health insurance plans through the Federal Health Insurance Marketplace (FHIM). As of early February 2015, many people had visited HealthCare.gov and started an online account, but not yet selected a plan. The Department of Health and Human Services (HHS), in collaboration with the Office of Evaluation Sciences (OES), developed and sent letters to assist these individuals with completing their enrollment before the deadline.

To evaluate the effect of the letters, the team used a randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* Those with an English language preference; those who had not enrolled in an ACA plan as of early February 2015

Exclusion Criteria:

* Those with a Spanish language preference

This intervention was a program evaluation and did not go through Human Subjects Protection Review.

Primary outcomes:
measure: Percent of individuals enrolling in an ACA plan by the end of the Open Enrollment period.
timeFrame: Two weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Brown University
name: David Yokum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yokum D, Hopkins DJ, Feher A, Safran E, Peck J. Effectiveness of Behaviorally Informed Letters on Health Insurance Marketplace Enrollment: A Randomized Clinical Trial. JAMA Health Forum. 2022 Mar 4;3(3):e220034. doi: 10.1001/jamahealthforum.2022.0034. eCollection 2022 Mar.
Clinical trial NCT02266914: Magnetic Resonance Elastography of Cardiac Transplant Rejection
Official title: Magnetic Resonance Elastography of Cardiac Transplant Rejection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Graft Rejection
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2014-10-17
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Magnetic Resonance Elastography (MRE) for cardiac transplant patients.

Detailed description: Patient will undergo MRE beginning 4-8 weeks post transplant, then with each scheduled cardiac biopsy through 7-8 months post transplant. Results of the MRE will be compared against results of the cardiac biopsy to determine if the non-invasive MRE can predict cardiac transplant rejection.

Eligibility criteria: Inclusion Criteria:

* Patients must have undergone cardiac transplantation at the Ohio State University Ross Heart Hospital.
* Patients must be able to lie flat on their back in the scanner for up to 60 minutes
* Patient must be able to hold their breath for up to 15 seconds at a time.

Exclusion Criteria:

* Patients who are claustrophobic
* Patients who are pregnant, due to potential risks to the fetus.
* Patients with any unapproved, non-MRI safe metal/devices in their bodies.

Primary outcomes:
measure: Cardiac Stiffness With Magnetic Resonance Elastography (MRE)
timeFrame: 24-48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: The Ohio State University Medical Center Dept. of Radiology
name: Richard White, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02884414: Gait Modifications and Cutaneous Stimulation
Official title: Analysis of Joint Mechanics in Response to Gait Modifications and Cutaneous Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Knee Pathology
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to quantify differences in joint mechanics between different types of walking in healthy individuals and individuals with knee pathology. The investigators will determine how modifying gait through feedback and/or cutaneous stimulation changes joint loading.


Eligibility criteria: Inclusion Criteria:

* BMI \< 35 kg/m\^2
* For knee pathology subjects: Diagnosis of knee pathology (e.g. knee osteoarthritis, ACL injury, etc) and/or knee pain
* Full weight-bearing status

Exclusion Criteria:

* Non-ambulatory
* Use of walking aid
* For healthy volunteers - history of surgical intervention at any joint of the lower extremity
* Inability to cooperate with study protocol due to medical or psychiatric reasons
* Inability to provide informed consent
* For healthy subjects: Any diagnosis of knee osteoarthritis or knee pain

Primary outcomes:
measure: Change in Peak Knee Flexion Moment (%Bw*Ht)
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Thomas Andriacchi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02628314: Reliability of Pupil Response to Acute Pain
Official title: Reliability of Pupil Response to Acute Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pain
Osteoarthritis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with athritis in the knee or hip with moderate average daily pain score

Brief summary: The purpose of this research study is to test whether researchers can reliably measure the response pupils have when an acute painful stimulus is experienced. Changes in the size of the pupil of the eye can be an indicator of brain activity in a region of the brain that is important for feeling pain.

Detailed description: There is strong rationale to support a role for locus coeruleus (LC) responsivity to acute painful stimuli in regulating speed of recovery after surgery and for LC responsivity as a mechanistic link explaining the risks for slow recovery from weak Conditioned Pain Modulation (CPM), catastrophizing cognitive style, and low enzyme activity catecholamine-O-methyltransferase (COMT) genotype. Preliminary data show feasibility to perform the proposed study.

Primary Hypothesis: An observational study of pupil responses to noxious stimuli shows strong intra-individual reliability over 8 weeks.

Key secondary hypotheses: Compared to individuals homozygous for val at the val158met site of the catecholamine-O-methyltransferase (COMT) gene, those homozygous for met will show smaller pupil responses to noxious stimuli and weaker CPM.

Eligibility criteria: Inclusion Criteria:

* Adult (18-70)
* Pain from hip or knee arthritis of moderate intensity
* American Society of Anesthesiologists physical status 1-3

Exclusion Criteria:

* Inability to complete study questionnaires
* Pregnancy
* Litigation or workers compensation related to hip or knee pain
* Taking \> 50 mg morphine equivalents/day
* History of Raynaud's disease of the feet
* Psychotic disorder or a recent psychiatric hospitalization
* History of eye surgery or topical eye medications that would would directly affect pupil diameter

Primary outcomes:
measure: Percentage of change in pupil diameter
timeFrame: 8 weeks
measure: Change from Baseline Verbal Pain Scores
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: James C Eisenach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05203614: Positive Activities for Asian American Cancer Patients and Caregivers
Official title: Positive Activities for Asian American Cancer Patients and Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2022-01-24
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Positive Activities for Asian American Cancer Patients and Caregivers

Detailed description: Primary Objectives:

The overall objective of this project is to design and test the feasibility of two positive activities, household contribution and outside contribution, to increase quality of life in AA cancer patients.

Secondary Objectives:

Aim 1: To assess the acceptability and feasibility of household and outside contribution positive activities for AAs through a mixed qualitative and exploratory quantitative investigation.

Aim 2: To use the qualitative and quantitative data from Aim 1, in collaboration with the mentorship team, AA community members, and clinicians, to develop one or both positive activity intervention(s) (i.e., household or outside contribution) specifically for AA cancer patients.

Eligibility criteria: Inclusion criteria for patients will be:

* self-identifies as AA,
* males or females ages 25-75 years
* within 1 year of any cancer diagnosis
* actively undergoing systemic therapy (e.g., chemotherapy, radiation)
* able to identify a caregiver (e.g., spouse) who lives in the same household and consents to participate in the study,
* able to read, write, and speak English (i.e., English proficient; EP),
* access to internet, computer/phone, and web browser.

Exclusion criteria for patients will be:

* life expectancy less than 6 months in the opinion of the primary physician,
* inability to stand or walk on their own or other physical limitations that preclude them from participating (3+ on ECOG performance status),
* major thought disorder (e.g., schizophrenia or bipolar \[patient records or

Inclusion criteria for caregivers will be:

* identifies as AA,
* patient considers them to be caregiver, -
* EP,
* access to computer/phone, internet, and web browser.

Exclusion criteria for caregivers will be:

* unwilling or unable to participate in the study for any reason,
* under the age of 18.

Primary outcomes:
measure: Quality of Life Questionnaires(HRQOL & interpersonal well-being )
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: LI Qian
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00216814: Antiangiogenic Effects of BCG on Urinary Concentration of Angiogenic Factors
Official title: Intravesically Administered BCG May Have Antiangiogenic Effects on Urinary Concentrations of Basic Fibroblast Growth Factor ( bFGF), Vascular Endothelial Growth Factor (VEGF) and Interleukin (IL-8)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bladder Cancer
Keywords: antiangiogenic effects of bcg treatment and prognosis
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 220
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with bladder cancer that are receiving treatment with BCG.

Brief summary: To determine if there is an association between basic fibroblast growth factor,vascular endothelial growth factor, and interleukin levels and a patients response to BCG treatment ( as standard treatment)in the urine of patients with superficial TCC. To determine if the levels of these angiogenic factors can predict response to BCG, disease recurrence, progression risk factors.

Detailed description: 200 patients that are candidates for intravesical BCG therapy and 20 control patients with no history of malignancy will be enrolled. The study group wol;; be asked to provide a urine sample just prior to receiving their first BCG treatment(week # 1) and just prior to receiving their last (week # 6) BCG treatment. The control patients will provide one urine sample only. Samples will be analysed by enzyme-linked immunosorbant assay(ELISA). clinical data will be reviewed on tumor stage and grade prior to BCG, timme to recurrence, tumor stage and grade of recurrence, time to disease progression and death, cause of death and total follow-up time.

Eligibility criteria: Inclusion Criteria:

200 study group 1. Must be a candidate for BCG therapy. 20 control group 1. No history of malignancy.

Exclusion Criteria:

* N/A

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: LHRI
name: Jonathan Izawa, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03888014: Intraoperative Fluorescence With Augmented Reality
Official title: Phase 4 Open Label Study Of Indocyanine Green Video Angiography (ICG-VA) And Comparative Utility Of Glow800 And FL800 Intraoperative ICG-VA Tools For Intracranial Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular; Lesion, Central Nervous System
Brain Tumor
Cerebral Aneurysm
Cerebral AVM
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 7
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: adult patients with a brain lesion requiring surgery and for whom ICG videoangiography would be used

Brief summary: This is a study looking at a new way to evaluate vascular problems or tumors in brain surgery patients using a standard \& approved intravenous dye and augmented reality.

Detailed description: This is a study investigating a new technique with an approved medication (ICG or indocyanine green) and using that and a near infrared mode on a standard operating room microscope to see the information provided for vascular or neoplastic (tumor related) neurosurgical problems. The technique uses the data from the microscope and using ICG with augmented reality overlaying the data into the microscope view (this is the new process). The technique is called GLOW800.

Eligibility criteria: Inclusion Criteria:

* adult patients with a brain lesion requiring surgery and for whom ICG videoangiography would be used

Exclusion Criteria:

* allergy to ICG (indocyanine green)

Primary outcomes:
measure: Usefulness of Glow800 Technique
timeFrame: 48 hours
Secondary outcomes:
measure: Utility in Identifying a lesion
timeFrame: 48 hours
measure: Surgical workflow
timeFrame: 48 hours
measure: Additional Cost
timeFrame: 48 hours
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
References:
Clinical trial NCT03738514: Comparison of Efficacy of 5% Fluorocalcium Phosphosilicate Dentifrice and Potassium Nitrate Dentifrice on Dentinal Hypersensitivity
Official title: Comparison Of Efficacy Of Dentifrice Containing 5% Fluorocalcium Phosphosilicate With Dentifrice Containing Potassium Nitrate And Placebo On Dentinal Hypersensitivity: A Triple Masked Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dentinal Hypersensitivity
Keywords: Dentinal Hypersensitivity
Visual Analogue Score
Lead sponsor: Government Dental College and Research Institute, Bangalore
Sponsor class: OTHER
Collaborators: name: Group Pharma
First posted: 2018-11-13
Enrollment: 120
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of this study was to assess and compare the efficacy of a dentifrice containing 5% fluoro calcium phosphosilicate and dentifrice containing potassium nitrate on Dentinal Hypersensitivity (DH) compared to a placebo over a period of 6 weeks.

Detailed description: A total of 120 subjects were divided into 3 groups randomly. Group 1 was given the dentifrice containing 5% fluoro calcium phosphosilicate ,Group 2 was given the dentifrice containing potassium nitrate and group 3 was given placebo. Sensitivity scores (VAS score) were recorded at baseline, 2 weeks, 6 weeks.

Eligibility criteria: Inclusion Criteria:

* The volunteers selected at baseline were in good general health and should have at least 20 natural permanent teeth and history of hypersensitivity to hot, cold, sour stimuli on at least two teeth with a VAS score of ≥4.

Exclusion Criteria:

* Patients with active cervical caries or deep abrasion requiring cervical filling, chipped teeth or fractured cusps, tender tooth in same quadrant as the hypersensitive teeth, Subjects using any type of desensitizing paste or desensitizing therapy for last 6 months, Pregnant/ lactating women or subjects with history of chronic use of anti-inflammatory and analgesic medications were excluded.

Primary outcomes:
measure: Visual Analogue Scale score for Dentinal Hypersensitivity
timeFrame: Change in VAS score from Baseline to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Department of Periodontics, GDCRI Bangalore
state: Karnataka
Study officials:
affiliation: GDCRI, Bangalore, INDIA
name: Avani R Pradeep, MDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03261414: HYSTERIA Evaluation of Clinical HYpnosis After Surgical Resection for Crohn Disease on Post-operative Analgesia
Official title: Prospective Randomized Study Evaluating the Effect of Pre-operative Hypnosis on Anesthesia, Analgesia and Perioperative Stress Laparoscopic Ileo-caecal Resections of Crohn's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Anesthesia
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study will be to show a decrease in postoperative morphine consumption by the practice of perioperative self-hypnosis in patients undergoing laparoscopic ileo-caecal resection for Crohn's disease


Eligibility criteria: Inclusion Criteria:

* Being affected by a crohn's disease, reaching the small intestine (ileal or ileo-colic) and requiring ileo-caecal resection by laparoscopy
* Never been operated for abdominal crohn's disease

Exclusion Criteria:

* Pregnant women
* A history of intestinal resection for crohn's disease
* Emergency surgery
* Corticotherapy in progress
* Deaf patients
* non-Francophone Patients
* Patients with knowledge of self-hypnosis

Primary outcomes:
measure: Total morphine consumption
timeFrame: During the first 24 postoperative hours
Secondary outcomes:
measure: Total morphine consumption
timeFrame: between the 24 and the 48 postoperative hours
measure: Total number of patients with complications
timeFrame: during first 7 postoperative days
measure: Intraoperative consumption of hypnotics and opioids
timeFrame: during first 7 postoperative days
measure: Antiemetics consumption
timeFrame: during first 7 postoperative days
measure: Postoperative nausea and vomiting (PONV) Score
timeFrame: first 24 postoperative hours
measure: Duration of hospital stay
timeFrame: during first 7 postoperative days
measure: Time physiological function recovery
timeFrame: during first 7 postoperative days
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Claude Huriez
Study officials:
affiliation: University Hospital of Lille
name: Philippe Zerbib, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00674895: Far Infrared Irradiation for Management and Treating of Parkinson's Disease (PD)
Official title: Phase 1 Study to Determine the Efficacy of Using Far Infrared Radiation for Control and Treatment of Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Parkinson's Disease
Keywords: Idiopathic Parkinson's Disease
Lewy Body Parkinson's Disease
Paralysis Agitans
Parkinson's Disease, Idiopathic
Parkinson's Disease, Lewy Body
Primary Parkinsonism
Lead sponsor: GAAD Medical Research Institute Inc.
Sponsor class: OTHER
First posted: 2008-05-08
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Parkinson's disease (PD) is a degenerative disorder of the central nervous system that often impairs the sufferer's motor skills and speech. This study will investigate the use of far infrared radiation to manage, control and treat PD.

Detailed description: Parkinson's disease belongs to a group of conditions called movement disorders. It is characterized by muscle rigidity, tremor, a slowing of physical movement and, in extreme cases, a loss of physical movement. The primary symptoms are the results of decreased stimulation of the motor cortex by the basal ganglia, normally caused by the insufficient formation and action of dopamine, which is produced in the dopaminergic neurons of the brain. PD is both chronic and progressive.

Observations from our research studies indicate that, far infrared rays provide energy to the body, improve the autonomic functions of the nervous system, restore the functions of the endocrine system, strengthen the immune system, improve blood circulation and increase the level of oxygen in the cells and promote the regeneration of muscle cells, nerves and brain cells.

It is hereby postulated that irradiation using far infrared, with wavelength between 5 to 20 microns, of the central nervous system, the endocrine system and the whole body could prevent, control, manage or possibly lead to complete rehabilitation of people who have PD.

Eligibility criteria: Inclusion Criteria:

* People with Parkinson's Disease

Exclusion Criteria:

* None

Primary outcomes:
measure: Cure for PD
timeFrame: 2 years
Secondary outcomes:
measure: Rehabilitation of PD Patients
timeFrame: 2 Years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Centre for Incurable Diseases
state: Ontario
Study officials:
affiliation: GAAD Medical Research Institute Inc.
name: Ken Nedd, M.D.
role: PRINCIPAL_INVESTIGATOR
References: