louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03039933: Intervention to Reduce Fear of Hypoglycemia and Optimize Type 1 Diabetes Outcomes
Official title: Intervention to Reduce Fear of Hypoglycemia and Optimize Type 1 Diabetes Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1diabetes
Fear of Hypoglycemia
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of Virginia
First posted: 2017-02-01
Enrollment: 43
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall objective and Primary Aim of this Limited Competition: Small Grant Program (R03) is to address the critical need of identifying and decreasing fear of hypoglycemia, which will be accomplished by conducting a pilot randomized clinical trial to evaluate the efficacy of Blood Glucose Awareness Training, which has been adapted for, but never evaluated in adolescents with Type 1 Diabetes (T1D) and their parents.


Eligibility criteria: Inclusion Criteria:

* adolescents aged 10-17 years and their parent(s) or legal guardian;
* T1D duration \>1 year;
* insulin pump use \>6 months;
* agreement of both parent and adolescent to participate in intervention sessions;
* elevated scores on the Parent Hypoglycemia Fear Survey - Behavior Subscale.

Exclusion Criteria:

* developmental disability or reading disorder that prevents understanding of the intervention materials; and
* non-English speaking adolescents and parents.

Primary outcomes:
measure: Decrease in scores on the Hypoglycemia Fear Survey
timeFrame: Baseline, 3 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado, Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Kimberly Driscoll, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02496533: Patient Anxiety During Radiological Examination
Official title: The Prevalence of Anxiety in Patients Undergoing Radiologic Exam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anxiety
Lead sponsor: Midwestern Regional Medical Center
Sponsor class: OTHER
First posted: 2015-07-14
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This clinical trial design evaluates whether hand massage reduces anxiety levels in cancer patients as they undergo radiological examination to evaluate tumor response. Anxiety levels will be investigated before massage, after massage, and following the completion of the radiological exam. The Visual Analog Scale (VAS), a validated anxiety assessment tool, will be used to measure anxiety.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Age ≥ 18 years
* Scheduled to undergo radiologic imaging evaluation of a tumor

Exclusion Criteria:

* Known hand injury within 30 days prior to study participation
* Known pregnancy
* Mental disability as determined by the treating physician
* Actively receiving radiation therapy
* Actively receiving chemotherapy

Primary outcomes:
measure: Change in Anxiety as Measured by Visual Analog Scale
timeFrame: Baseline and After Imaging
Secondary outcomes:
measure: Change in Blood Pressure in mmHg
timeFrame: Baseline and After Imaging
measure: Change in Respiration Rate in Breaths Per Minute
timeFrame: Baseline and After Imaging
measure: Change in Pulse Rate
timeFrame: Baseline and After Imaging
Other outcomes:
Locations:
Study officials:
affiliation: Midwestern Regional Medical Center
name: Jessica Kapustin, RN-C
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05186233: Use of Consumer Sleep Technology to Treat Shift Work Disorder
Official title: Innovations in Wearable Technology for Correcting Circadian Misalignment in Shift Work Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shift-work Disorder
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: American Academy of Sleep Medicine
First posted: 2022-01-11
Enrollment: 63
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: The purpose of this study is to examine the effectiveness of a personalized light exposure schedule for Shift Work Disorder (SWD) in night shift workers compared to a non-personalized light exposure schedule.

Detailed description: Participants will be randomized into each condition (n = 25) in a 1:1 ratio. Variables of interest, dim light melatonin onset (DLMO) and shift work disorder (SWD) symptoms, will be assessed before and after the intervention, which will last two weeks. All participants (N=50) will be asked to wear an Apple Watch for two weeks leading up to an in-lab visit. Activity data collection from the Apple Watch will be processed through a mathematical model of the human circadian pacemaker (previously validated in SWD) to generate estimates of DLMO. This two-week period is followed by a 27-hour laboratory visit for pre-treatment assessment of DLMO (hourly saliva melatonin samples over 24 hours). At the end of this visit, participants will receive an orientation to the SHIFT mobile application, where they will be able to assess their prescribed light exposure schedule.

Eligibility criteria: Inclusion Criteria:

* Participants must work at least 2 night shifts a week
* Participants must have night shifts starting between 18:00 and 02:00 and lasting 8 to 12 hours
* Participants must have maintained this night shift schedule for at least 6 months
* Participants must have Shift Work Disorder, diagnosed based on ICSD-3 criteria

Exclusion Criteria:

* Medical history of central nervous system disorders
* Medical history of other sleep disorders
* Diagnosis of an unstable major medical condition medical chart review
* Dependence on alcohol (≥ 4 beverages a day)
* Heavy tobacco use (≥ 10 cigarettes per day)
* Recreational drug use
* Use of medications impacting central nervous system functioning
* Caffeine use in excess of 5-6 servings (\~ 600mg) per day
* Pregnancy

Primary outcomes:
measure: Dim light melatonin onset
timeFrame: Within two days of treatment for a duration of 24 hours
Secondary outcomes:
measure: Insomnia
timeFrame: Within one week of post-treatment
measure: Daytime sleepiness
timeFrame: Within one week of post-treatment
Other outcomes:
Locations:
city: Novi
country: United States
facility: Henry Ford Columbus Medical Center
state: Michigan
Study officials:
References:
Clinical trial NCT01529333: Middle-Ear Implant With MET V Transducer (Aka MET V System)
Official title: Middle Ear Implant With MET V for Mixed Hearing Loss
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mixed Conductive and Sensorineural Hearing Loss, Bilateral
Lead sponsor: Otologics LLC
Sponsor class: INDUSTRY
First posted: 2012-02-08
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose and objective of this study is to evaluate the safety and efficacy of the MET V System for the treatment of individuals with mixed hearing loss.

Detailed description: The MET V System is an investigational, fully-implantable middle ear hearing prosthesis. A mixed hearing loss has both a sensorineural component and a conductive component that results when sound being delivered to an impaired cochlea is attenuated by a disordered outer or middle ear.

Eligibility criteria: Inclusion Criteria:

* Adult men or women, 18 years of age or older
* Moderate to severe mixed hearing loss, as a result of a combination of sensorineural hearing loss and chronic ear disease, prior failed tympanoplasties, severe otosclerosis, radical mastoidectomy, or congenital abnormality as evidenced by the following in the ear to be implanted:

  * Bone conduction thresholds are measurable at 0.5,1,2,3 and 4 kHz
  * Bone conduction thresholds are 20 dB or poorer at greater than 2 kHz
  * Air conduction thresholds are 35 dB or poorer at 0.5,1,2,3 and 4 kHz
* Air-bone gap in ear to be implanted is greater than 15 dB at three or more frequencies from 0.5 - 4 kHz
* Word recognition appropriate for sensorineural component of loss
* Non-fluctuating and stable hearing status

  a. as defined as by no significant change or progression in the bone conduction thresholds \>15dB at two consecutive octaves for at least 12 months.
* English Speaking (fluent)
* Realistic expectations for the device
* Willingness to sign the informed consent and participate in the study

Exclusion Criteria:

* Vestibular disorder, including Meniere's Syndrome
* Recurring otitis media over the past year (\>2/year)
* Non-organic hearing loss
* Retrocochlear hearing loss
* Central auditory nervous system disorder
* Medical contraindications to surgery or use of the device
* Women who are pregnant or at risk of becoming pregnant
* Developmentally delayed or manifesting organic brain dysfunction
* Persons with physical or geographic limitations that may render them incapable of completing scheduled study visits

Primary outcomes:
measure: CNC Word Recognition Scores
timeFrame: Occurs at 3, 6, and 12 month follow-up visits
Secondary outcomes:
measure: BKB-SIN and Subject Questionnaires
timeFrame: Will be monitored to 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05088733: Yang Yin Fu Zheng Jie Du Therapy in HBV Related Hepatocellular Carcinoma Induced Anemia (YYFZJDTIHBVRHCIA)
Official title: Yang Yin Fu Zheng Jie Du Therapy in HBV Related Hepatocellular Carcinoma Induced Anemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Hepatocellular Carcinoma
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical research of Yang Yin Fu Zheng Jie Du therapy in HBV related hepatocellular carcinoma induced anemia. The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng Jie Du therapy for patients belong to HBV-HCC induced anemia.


Eligibility criteria: Inclusion Criteria:

* Meet the criteria of hepatocellular carcinoma
* Patients who tested positive for hepatitis B surface antigen (HBsAg) for \>6 months
* Meet the criteria of anemia
* Ages Eligible for Study: ≤75 years old;
* Informed consent from the patient.

Exclusion Criteria:

* Patients with upper gastrointestinal bleeding within 3 months before enrollment;
* History of blood transfusion within 3 months before enrollment;
* Patient with other chronic hepatopathy, such as AIH, NAFLD, ALD;
* Serious problem of heart, lung, or kidney with severe dysfunction;
* Pregnant or child breast feeding women;
* Mental or cognitive disorders;
* Participating in other drug trials;
* Who are allergic to the study drug.

Primary outcomes:
measure: Survival rate
timeFrame: 1 year
Secondary outcomes:
measure: Objective response rate
timeFrame: 1 year
measure: quality of life (QOL) questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Zhiyun Yang
state: Beijing
Study officials:
References:
Clinical trial NCT03244787: Patient Navigation for Colorectal Cancer Screening for Patients With Mental Illness and/or Substance Use Disorder
Official title: Patient Navigation for Colorectal Cancer Screening for Patients With Mental Illness and/or Substance Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ColoRectal Cancer Screening
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-08-10
Enrollment: 380
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The investigators propose to develop, implement, and evaluate a novel Colorectal (CRC) screening patient navigator program for patients with Mental Health (MH) and /or Substance Use Disorder (SUD) receiving care at Massachusetts General Hospital Charlestown. The study will involve randomly assigning eligible patients to early intervention or usual care/delayed intervention groups. The investigators believe this random assignment is ethical because Patient Navigation (PN) is an extremely limited resource, and all patients identified as eligible could not be contacted by the navigators in a short period of time. Thus the investigators will randomly assign access to PN during the study period, and then allow all patients to be navigated and screened after the study period is over. As a result, all eligible patients will be referred for PN, but the timing of the referral will be randomly assigned.


Eligibility criteria: Inclusion Criteria:

* adult patients aged 50-75 years who are not up to date on CRC screening (did not have had CRCs colonoscopy in the last 10 years or sigmoidoscopy in the last 5 years or fecal occult blood within last 12 months)
* receive care at MGH Charlestown
* have documented history of MH or SUD in electronic medical record

Exclusion Criteria:

* subsequently identified as having died prior to study intervention
* patients with total colectomy

Primary outcomes:
measure: Percentage of patients in intervention and control groups who completed any colorectal cancer screening during the six-month study period
timeFrame: 6 months
measure: Percentage of patients in intervention and control groups who completed any colorectal cancer screening during the six-month study period
timeFrame: 6 months
Secondary outcomes:
measure: As-treated primary outcomes among intervention patients contacted by patient navigator.
timeFrame: 1 year
measure: Number of cancers (stage) found in the intervention and control group during the study period
timeFrame: 1 year
measure: Number of polys found in intervention polyps (histology)
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: MGH
name: Sanja Percac Lima, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00701987: Safety, Tolerability, and Preliminary Efficacy Study of ALS-357 in Patients With Cutaneous Metastatic Melanoma
Official title: Dose-escalating, Pilot Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ALS-357 Topically Administered to Patients With Cutaneous Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Melanoma
Keywords: Cutaneous Metastatic Melanoma
Lead sponsor: Advanced Life Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A phase I trial to evaluate the safety and tolerability of ALS-357 when administered for four weeks as a topical ointment, in escalating doses, to patients with cutaneous metastatic melanoma and to evaluate the effect of escalating doses of topically applied ALS-357 on histological remission of cutaneous metastatic melanoma and induction of apoptotic biomarkers.


Eligibility criteria: Inclusion Criteria:

* Study Participants must be 18 years or older.
* Study Participants must have 2 sites of cutaneous metastatic melanoma that can not be removed with surgery.
* Study Participants may have been previously treated with chemotherapy or immunotherapy but not with in 4 weeks of first dose of study treatment.

Primary outcomes:
measure: Evaluate the safety and tolerability of ALS-357 when administered for four weeks as a topical ointment, in escalating doses, to patients with cutaneous metastatic melanoma.
timeFrame: Day 8, 15, 22, 29 and 43
measure: Evaluate the effect of escalating doses of topically applied ALS-357 on histological remission of cutaneous metastatic melanoma and induction of apoptotic biomarkers.
timeFrame: Day 8, 15, 22, 29 and 43
Secondary outcomes:
measure: Evaluate differences in induction of apoptosis in treated versus control lesions via TUNEL assay.
timeFrame: Day 15, 29 and 43
measure: Nucleic Acid will be isolated from portions of the biopsies to be utilized for gene expression profiling by various analytical platforms and correlated with other apoptotic in situ and surface protein expression pathways.
timeFrame: Day 15, 29 and 43
measure: Evaluate the plasma concentration of ALS-357 at each scheduled study visit.
timeFrame: Day 1, 8, 15, 22, 29 and 43
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center, Northwestern University
state: Illinois
Study officials:
affiliation: Robert H. Lurie Cancer Center
name: Timothy Kuzel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01734187: Efficacy and Safety of Fermented Cinnamon Vine Powder on Decrement of Body Fat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Fermented Cinnamon Vine Powde on decrement of body fat. The investigators measured decrement of body fat parameters , including abdominal fat, Body Fat Mass, LDL-C, HDL-C, Total Cholesterol and triglyceride, and monitored their blood pressure.


Eligibility criteria: Inclusion Criteria:

* Males and females 19-55 years old
* BMI(body mass index) ≥ 25 kg/m\^2 or WC(Waist Circumference) ≥ 90(men), WC ≥ 85(women)
* Able to give informed consent

Exclusion Criteria:

* Significant variation in weight(more 10%) in the past 3 months
* Allergic or hypersensitive to any of the ingredients in the test products
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnant or lactating women etc.

Primary outcomes:
measure: Changes in abdominal Fat
timeFrame: 12 weeks
measure: Changes in Body Fat Mass
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol)
timeFrame: 12 weeks
measure: Changes in HDL-Cholesterol(High Density Lipoprotein - Cholesterol)
timeFrame: 12 weeks
measure: Changes in total cholesterol
timeFrame: 12 weeks
measure: Changes in Triglycerides
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References:
Clinical trial NCT06489587: Creatine Supplementation At Simulated Altitude
Official title: Creatine Supplementation At Simulated Altitude
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Exercise Performance
Lead sponsor: California Polytechnic State University-San Luis Obispo
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized study to two arms: 1) creatine supplementation, 2) glucose supplementation
Primary purpose: TREATMENT

Brief summary: Creatine supplementation has been shown to increase exercise performance at sea level. The goal of this study is to determine the effects of creatine supplementation on exercise performance at simulated altitude.

Detailed description: Military personnel often encounter harsh environments such as high altitudes and hypoxic conditions, leading to significant constraints on their exercise capacity and performance. At sea-level creatine supplementation increases exercise performance; however no experimental studies have examined the effect of creatine supplementation at simulated altitude. The overall objective of this study is to investigate the effects of creatine supplementation on exercise performance, via a repeated sprints test (Wingate Test) after a 2-day supplementation period, compared to a placebo group.

Eligibility criteria: Inclusion Criteria:

* 18-40 years old
* BMI 18.5 to 40 kg/m2
* Habitually active (\>150 minutes per week of moderate-vigorous physical activity)

Exclusion Criteria:

* Pregnant or trying to become pregnant
* Recent use of creatine supplementation
* Supplemental allergies

Primary outcomes:
measure: Peak power
timeFrame: Change from baseline to 3 days
Secondary outcomes:
measure: Body Weight
timeFrame: Change from baseline to 3 days
measure: Relative peak power
timeFrame: Change from baseline to 3 days
measure: Mean power
timeFrame: Change from baseline to 3 days
measure: Relative mean power
timeFrame: Change from baseline to 3 days
measure: Fatigue index
timeFrame: Change from baseline to 3 days
Other outcomes:
Locations:
city: San Luis Obispo
country: United States
facility: California Polytechnic State University
state: California
Study officials:
affiliation: California Polytechnic State University-San Luis Obispo
name: Todd Hagobian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00890487: Hyaluronic Acid and Vaginal Distress
Official title: Effects of Hyaluronic Acid Oral Supplementation on the Vaginal Epithelium: a Prospective, Randomized, Double-Blind, Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaginal Disease
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2009-04-29
Enrollment: 70
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to study the effects of the oral supplementation hyaluronic acid in menopause women with vaginal distress for treatment vaginal distress.


Eligibility criteria: Inclusion Criteria:

* menopause
* vaginal distress
* no other therapy

Exclusion Criteria:

* vaginal infection
* Sjogren Syndrome

Primary outcomes:
measure: effects of the oral somministration hyaluronic acid in menopause women with vaginal distress
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Menopause centre of the G. Martino University Policlinic
state: Sicily
Study officials:
affiliation: Centre Menopause
name: Tindara TL La Galia, PhD student
role: PRINCIPAL_INVESTIGATOR
References: