louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00405106: The Effect of Final Exam Preparation on Anxiety Level, Self-Perception, Ocular Symptoms, Accommodation and Vergence in Myopia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Keywords: stress
anxiety
myopia progression
accommodation
vergence
Lead sponsor: Southern California College of Optometry at Marshall B. Ketchum University
Sponsor class: OTHER
First posted: 2006-11-29
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: To evaluate the effects of exam preparation on anxiety level, self perception, ocular symptoms and oculomotor responses in myopes

Detailed description: Twenty two first year optometry students were evaluated towards the end of their first academic year on a battery of Oculomotor and Survey tests. This occurred during two sessions, one Low Stress session and one High Stress session. Sessions were separated by one month.

Low Stress Session (LS), No Exams or Minor Exams High Stress Session (HS), Final Exam Preparation week

Battery of Surveys:

Adult Manifest Anxiety Scale for College Students (AMAS-C):

36 items which probe 4 types of anxiety

* Worry/Oversensitivity
* Test Anxiety
* Physiological Anxiety (Somatic responses to anxiety)
* Social Concerns

Self Perception Profile (SPP):

45 items which probe 9 domains

* Scholastic Competence
* Social Acceptance
* Athletic Competence
* Physical Appearance
* Job Competence
* Romantic Appeal
* Behavioral Conduct
* Close Friendship
* Global Self-worth

CI Symptom Survey (CISS-15):

15 items which probe ocular and aesthenopic signs and symptoms

Students also reported Hours of daily near work (NWhrs).

Battery of Oculomotor Tests:

(20/30 ETDRS target used for all) Vergence Tests

* Phorias Near and Far (Neutralized Alternate Cover Test)
* Vergence Ranges Near and Far (Prism Bar)
* Vergence Facility Near and Far (3BI/12BO)
* Near Point of Convergence

Objective Accommodative Tests (SRW-5000autorefractor)

Monocular Accommodative Responses to:

* Near Target (33cm)
* Minus Lens (-3D) while viewing distant (6m) target

Subjective Accommodative Tests:

Monocular Accommodative Responses to:

* Donder's Push Up Amplitude test
* Near Accommodative Facility (+/-2.00, five practice trials)
* Distant Accommodative Facility (plano/-2.00, five practice trials)

Eligibility criteria: Inclusion Criteria:

* Any first year optometry student

Exclusion Criteria:

* Previous Refractive surgery, amblyopia, strabismus, RGP wearer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: SCCO
state: California
Study officials:
affiliation: SCCO
name: Lynn Marran, OD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02145806: Validation of Korean Version of ICIQ-SF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Keywords: Urinary incontinence
Validation study
Pregnant women
Postpartum period
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
Collaborators: name: National Cancer Center, Korea
First posted: 2014-05-23
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 130

Brief summary: 1. Validation of the Korean version of the ICIQ-UI SF for pregnant and postpartum women
2. Evaluation the effect of urinary incontinence in pregnant and postpartum women.


Eligibility criteria: Inclusion Criteria:

* Being pregnant or postpartum ≤ 3 weeks
* Able to read and understand Korean
* At least 18 years of age

Exclusion Criteria:

* Refuse to participate in the study
* Pelvic inflammatory disease
* Psychiatric disease
* Needed to be treated in the 7 days

Primary outcomes:
measure: Urinary incontinence
timeFrame: 1-2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03595306: Human Gut Microbiota and Prebiotic Response
Official title: Human Gut Microbiota and Prebiotic Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Gut Microbiota
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 41
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to examine the shift in gut microbiota and their metabolism after consumption of a dietary supplement (prebiotic) by healthy participants. The investigators will provide participants with a panel of over the counter prebiotics and monitor their gut microbiome response in stool. All prebiotics will be commercially available, over-the-counter food, food additives, or dietary supplements, without any known market-use adverse effects beyond minimal discomfort.


Eligibility criteria: Inclusion Criteria:

* Provide Stool Samples at no risk to yourself

Exclusion Criteria:

* No oral antibiotic treatments within previous 1 month
* No known allergy to milk products or lactose intolerance
* no known allergy to wheat or gluten intolerance
* no history of irritable bowel syndrome
* no history of inflammatory bowel disease
* no history of type-2 diabetes
* no history of chronic kidney disease or reduced kidney function
* no current intestinal obstructions
* no current untreated colorectal cancer
* not currently pregnant or breastfeeding

Primary outcomes:
measure: change in levels of SCFAs in stool samples
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: change in levels of cytokines in stool samples
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Lawrence David
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06577506: Diabetes Education and Care for Deaf Populations
Official title: Improving Access to Diabetes Education and Care for Deaf Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will assess the feasibility and preliminary efficacy of a 10-week intervention called "Deaf Diabetes Can Together".


Eligibility criteria: Inclusion Criteria:

* Identify as Deaf/Hard of Hearing
* living with diabetes (any type)
* speak and understand English or American Sign Language
* have access to internet
* willing to participate in the intervention

Exclusion Criteria:

* participating in another diabetes study
* have significant cognitive impairment
* are pregnant or planning to become pregnant in the next year
* have life expectancy of \<6 months

Primary outcomes:
measure: A1C Level
timeFrame: 6 months: (Test at 0 weeks, 12 weeks, and 24 weeks)
Secondary outcomes:
measure: Diabetes Distress Level Using the Screening Scale Questionnaire
timeFrame: 6 months: (Test at 0 weeks, 12 weeks, and 24 weeks)
measure: Diabetes Self-Care Level using the Self-Care Inventory Revised Questionnaire
timeFrame: 6 months: (Test at 0 weeks, 12 weeks, and 24 weeks)
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
Clinical trial NCT00544206: Comparison of Enteral Products for Tube Fed Patients With Type 2 Diabetes
Official title: Comparison of Enteral Products for Tube Fed Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2007-10-16
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare the glucose response in tube fed subjects with type 2 diabetes of a standard enteral product to that of a diabetes-specific enteral product


Eligibility criteria: Inclusion Criteria:

* signed and dated informed consent
* diagnosis of type 2 diabetes
* HbA1c between 7.0 and 9.0%
* 18 - 75 years of age
* currently receiving a standard enteral product
* anticipated duration on tube feeding at least one month
* 100% of patient's nutrient and energy needs are anticipated to be met by enteral nutrition support
* anticipated life expectancy is more than or equal to 6 months
* free of infections
* no change in medications within 2 weeks prior to screening that could profoundly affect blood glucose

Exclusion Criteria:

* composition of either product is inappropriate for the patient due to allergies or intolerance to any ingredient found in the study products
* composition of either product is inappropriate for the patient due to protein, fluid or electrolyte restrictions for concomitant conditions
* significant cardiovascular event less than or equal to 2 weeks prior to study entry
* major surgery less than or equal to 2 weeks prior to study entry
* pre-planned surgery during the study period
* active malignancy, including melanoma and excluding cutaneous malignancies
* severe dementia
* known allergies to medical grade adhesives and/or skin disinfectants
* taking octreotide
* chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV
* participation in a concomitant trial

Primary outcomes:
measure: mean glucose level
timeFrame: 24 hours
Secondary outcomes:
measure: fasting capillary blood glucose level;percentage change from baseline in the dose and amount of antihyperglycemic medication(s), including insulin
timeFrame: 24 hours
Other outcomes:
Locations:
city: Miami
country: United States
facility: Segal Institute for Clinical Research
state: Florida
Study officials:
affiliation: University of Wisconsin, Madison
name: Gordon Sacks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alish CJ, Garvey WT, Maki KC, Sacks GS, Hustead DS, Hegazi RA, Mustad VA. A diabetes-specific enteral formula improves glycemic variability in patients with type 2 diabetes. Diabetes Technol Ther. 2010 Jun;12(6):419-25. doi: 10.1089/dia.2009.0185.
Clinical trial NCT03934606: Evaluating an Alternative Clinical Genetics Cancer Care Deliver Model
Official title: Evaluating an Alternative Clinical Genetics Cancer Care Deliver Model: A Pilot Study of Patient Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreas Cancer
Prostate Cancer
Hereditary Cancer
Genetic Predisposition to Disease
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2019-05-02
Enrollment: 1488
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: Patients seen at Penn Medicine with a pancreas cancer or metastatic prostate cancer.

Brief summary: To evaluate an alternative clinical genetics cancer care delivery model, using non-genetic providers to introduce and order genetic testing. 250 prostate and 250 pancreatic patients will be recruiting. They will undergo genetic testing and complete study questionnaires. Results from this pilot study will be used to inform the strategies used by the Clinical Risk Evaluation Program (CREP) Genetic Counelors (CGS) and GI/GU physicians to deliver genetic testing and return genetic risk information to patients with prostate or pancreatic cancer.


Eligibility criteria: Inclusion Criteria:

* • Penn patient age 18 years or older.

  * Diagnosed with prostate cancer or pancreas cancer.
  * Deemed to be clinically appropriate for multiplex genetic testing by their Urologic Cancer Program (GU) physician or Gastrointestinal Cancer Program (GI) physician at the Abramson Cancer
  * Agreed to receive clinical multiplex genetic testing from their physician.
  * English-fluent; the surveys were designed and validated in English and are not currently available in other languages.

Exclusion Criteria:

* • Patients who do not or will not receive their ongoing cancer care at Penn

  * Major psychiatric illness or cognitive impairment that in the judgment of the study investigators or study staff would preclude study participation.
  * Any patients who are unable to comply with the study procedures as determined by the study investigators or study staff.

Primary outcomes:
measure: baseline to post-results change in distress levels
timeFrame: 1-3months
measure: baseline to post-results change in distress levels
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine - University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00308906: Identification of Gene and Protein Markers of Kidney Injury in Aminoglycoside-treated Children
Official title: Assessment of Gene and Urinary Protein Expression in Aminoglycoside-treated and Untreated Infants, Children and Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Renal Dysfunction
Keywords: infection
renal dysfunction
aminoglycoside
protein
child
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: University of Louisville
First posted: 2006-03-30
Enrollment: 166
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Aminoglycoside treated and untreated newborns, infants and children.

Brief summary: The purposes of this study are to identify potential gene and protein markers of aminoglycoside-induced kidney injury in infants, children and adolescents treated with aminoglycoside antibiotics.


Eligibility criteria: Inclusion Criteria: (1) Hospitalized male and female newborns, infants, children and adolescents (ages birth to 18 years) with a diagnosis of suspected or proven bacterial sepsis, meningitis or other indication necessitating aminoglycoside therapy (2) hospitalized and outpatient newborns, infants, children and adolescents (ages birth to 18 years) who are not receiving aminoglycoside therapy.

Exclusion Criteria: (1) Current treatment with inhaled or ophthalmic aminoglycosides (2) Prior treatment with an aminoglycoside within the last 30 days

Primary outcomes:
measure: Indicators of renal injury
timeFrame: Pre and post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Lousiville
state: Kentucky
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Mary Jayne Kennedy, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05986006: Fusion Status After ACDF
Official title: Fusion Status of Machined Allograft Versus Iliac Crest Allograft in Anterior Cervical Discectomy and Fusion: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Spine Fusion
Spine Surgery
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pseudarthrosis, a failure of bony fusion, is one of the most common causes of revision surgery following anterior cervical discectomy and fusion (ACDF). The interbody spacer is an important component of bony fusion in ACDF, and we aim to compare machined allograft spacers versus iliac crest allograft in a randomized controlled trial.

Detailed description: Pseudarthrosis, a failure of bony fusion, is one of the most common causes of revision surgery following anterior cervical discectomy and fusion (ACDF). The interbody spacer is an important component of bony fusion in ACDF, and we aim to compare machined allograft spacers versus iliac crest allograft in a randomized controlled trial. We hypothesize that iliac crest allograft will improve anterior cervical discectomy and fusion arthrodesis rates and diminish the amount of intervertebral graft resorption when compared to off-the-shelf machined allografts

Eligibility criteria: Inclusion Criteria:

* patients 18 years of age or older
* preoperative diagnosis of cervical radiculopathy and/or cervical myelopathy.

Exclusion Criteria:

* patients undergoing a revision cervical procedure
* current smokers
* patient with surgical indications of tumor, infection, or trauma

Primary outcomes:
measure: Improved participant reported outcome measures (PROMs)-1
timeFrame: 2 years
measure: Improved participant reported outcome measures (PROMs)-2
timeFrame: 2 years
measure: Improved participant reported outcome measures (PROMs)-3
timeFrame: 2 years
measure: Fusion status after surgery
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03107806: Monitoring Glucose Levels in Patients With Myocardial Infarction
Official title: COMGAMI Continuous Monitoring of Glucose in Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Coronary Syndromes
Hyperglycemia
Hypoglycemia
Keywords: acute coronary syndromes
hyperglycemia
hypoglycemia
continuous glucose monitoring
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Swedish Heart Lung Foundation
First posted: 2017-04-11
Enrollment: 14
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: To evaluate the OptiScanner® for continuous glucose monitoring as a tool to optimize glucose levels in patients hospitalized for acute coronary syndromes

Detailed description: Methodology Part a) Explorative Part b) Randomised, parallel-group design

Eligibility criteria: Inclusion Criteria:

* Acute coronary syndrome according to the joint recommendations by the European Society of Cardiology (48, 49)
* Signed written informed consent consistent with Helsinki declaration and local legislations prior to participation in the trial.

Exclusion Criteria:

* \<18 years old.
* Congestive heart failure.
* Patients who, in the opinion of the investigator, will have difficulties to comply with the protocol (examples: alcohol or drug abuse, psychiatric disorder).

Primary outcomes:
measure: Accuracy of glucose values derived by the new equipment vs. standard lab recordings
timeFrame: During the first part of the study, up to 6 months
Secondary outcomes:
measure: Glucose variability
timeFrame: Hospitalization, through study completion, an average of 1 year
measure: Number of episodes of Hypoglycemia
timeFrame: Hospitalization, through study completion, an average of 1 year
measure: Number of episodes of Hyperglycemia
timeFrame: Hospitalization, through study completion, an average of 1 year
measure: Work load in nursing staff
timeFrame: Hospitalization, through study completion, an average of 1 year
measure: Time in targeted glucose values
timeFrame: Next step after the completion of the first and ongoing part. through study completion, an average of 1 year
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University hospital
Study officials:
affiliation: Karolinska Institutet
name: Camilla Hage, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03825406: Prevalence of Wildtype Amyloid After TAVR
Official title: Prevalence of Wildtype Amyloid Among TAVR Patients With Impaired Hemodynamics
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Amyloidosis
Lead sponsor: North Florida Foundation for Research and Education
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This research is interested in determining how prevalent wildtype amyloidosis is after transcatheter aortic valve replacement (TAVR) patients with impaired hemodynamics. Amyloidosis is a condition characterized by abnormal protein which can accumulate and impair various organs, including the heart. Research suggests that amyloidosis might be common among TAVR patients, but this condition is not routinely evaluated for. We suspect that wildtype amyloidosis may be especially common among patients with abnormal vital signs after their TAVR procedure.

Brief summary: Those with abnormal vital signs after TAVR need to be willing to obtain a bone scan to evaluate for wildtype amyloidosis. Positive bone scan findings will require evaluation for primary amyloidosis with blood and urine monoclonal immunoglobulin testing. Primary amyloidosis is a different type of disease which requires different treatment.

Detailed description: This research is interested in determining how common wildtype amyloidosis is after transcatheter aortic valve replacement (TAVR). Amyloidosis is a condition characterized by abnormal protein which can accumulate and impair various organs, including the heart. Research suggests that amyloidosis might be common among TAVR patients, but it is a condition that is not routinely evaluated for. We suspect that wildtype amyloidosis may be especially common among patients with abnormal vital signs after their TAVR procedure.

Eligibility criteria: Inclusion Criteria

* Patients that underwent a TAVR procedure at the Malcolm Randall VA Medical Center.
* Implant of current generation TAVR (i.e. Sapien S3, Evolut R, or Evolut Pro).
* Willingness to obtain bone scintigraphy if evidence of impaired hemodynamics after valve deployment.
* Willingness to have blood drawn
* Willingness to complete SF12 quality of life KCCQ

Exclusion Criteria:

--Patient that do not qualify for a TAVR procedure as normal clinical care

Primary outcomes:
measure: Number of participants who die or have poor quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 1 to 2 years post TAVR
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: ACC AHA
name: Anthony Bavry, MD
role: PRINCIPAL_INVESTIGATOR
References: