louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00002251: A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir
Official title: A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cytomegalovirus Infections
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Ganciclovir
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Biological Availability
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: This study is designed to determine the influence of food on the absorption and relative bioavailability of oral ganciclovir by comparing the absorption of oral ganciclovir in a fed and fasting state at steady state plasma levels.


Eligibility criteria: Inclusion Criteria

Patients must have the following:

* Confirmation of HIV infection by HIV antibody testing, p24 antigen, or culture of HIV.
* Documented confirmation of present or past CMV infection.
* Must understand the nature of the study, agree to tests required in the protocol, and must understand and sign an informed Consent form approved by the appropriate Institutional Review Board and by Syntex.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Uncontrolled diarrhea or clinically significant gastrointestinal symptoms including persistent nausea or abdominal pain.

Concurrent Medication:

Excluded:

* Antimetabolites. Interferons. Other nucleoside analogs. Zidovudine (AZT). Any investigational drug.

Patients with the following are excluded:

* Any concomitant conditions listed in Exclusion Co-Existing Conditions.
* Karnofsky score \< 70.
* Hypersensitivity to acyclovir.
* Displaying signs of dementia or decreased mentation which would interfere with the ability of the subject to follow protocol schedule.

Prior Medication:

Excluded:

* Anti-cytomegalovirus therapy including ganciclovir therapy for treatment of CMV disease.
* Excluded within 4 days of study entry:
* Antimetabolites.
* Interferons.
* Other nucleoside analogs.
* Zidovudine (AZT).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Davies Med Ctr
state: California
city: Washington
country: United States
facility: Georgetown Univ Med Ctr
state: District of Columbia
Study officials:
References:
citation: Lavelle J, Follansbee S, Trapnell CB, Buhles WC, Griffy KG, Jung D, Dorr A, Connor J. Effect of food on the relative bioavailability of oral ganciclovir. J Clin Pharmacol. 1996 Mar;36(3):238-41. doi: 10.1002/j.1552-4604.1996.tb04193.x.
Clinical trial NCT05837351: The CARE (Collaborative Adolescent Running Experience) Project
Official title: The CARE Project: Collaborative Adolescent Running Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Major Depressive Disorder
Bipolar Disorder
Keywords: Running
Adolescents
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 4
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being completed to see if participants activity levels may have an impact as a treatment for depression, or depressive symptoms.

Eligible participants will be enrolled and have an 8-week running intervention three times each week.

The study hypothesizes that adolescents with Psychiatric disorders that are experiencing depressive symptoms will participate in a supported running intervention.


Eligibility criteria: Inclusion Criteria:

* Psychiatric disorders that are experiencing depressive symptoms (defined by the protocol)
* Must have a smart phone
* Parents/guardians will be advised to discuss their child's participation in the intervention with the participant's primary care physician

Exclusion Criteria:

* Adolescents with unstable cardiac, pulmonary, endocrine or renal disorders
* Adolescents with previous injuries or other conditions that may impact the safety of a running intervention

Primary outcomes:
measure: The number of completed running sessions
timeFrame: weeks 1-8 during treatment period
Secondary outcomes:
measure: Change in depression severity as reported by The Patient Health Questionnaire for Adolescents (PHQ-A)
timeFrame: Baseline (prior to treatment), 8 weeks (post intervention)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Richard Dopp, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05976451: Time Effect on the Predictability of Different Grafting for Gingival Recession RT 1
Official title: Time Effect on the Predictability of Different Grafting Materials in Treatment of Gingival Recession RT 1in the Esthetic Zone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession Types One(RT1)
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 22
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study was to evaluate time effect on the clinical predictability of collagen matrix Xenograft (CMX) with melatonin gel versus connective tissue graft (CTG) and determine whether it is proposed to be an alternative in multiple adjacent gingival recession (MAGR) in recession type one (RT1)

Detailed description: this study was conducted to evaluate time effect on the clinical predictability of collagen matrix Xenograft (CMX) with melatonin gel versus connective tissue graft (CTG) and determine whether it is proposed to be an alternative in multiple adjacent gingival recession

Eligibility criteria: Inclusion Criteria:

* Presence of RT1 GRs of the maxillary or mandibular arch in the esthetic zone with a GR depth ≥2 mm,
* patients \>18 years old,
* Full mouth plaque index score \<20%
* Systemically and periodontally healthy patients.

Exclusion Criteria:

* Smokers
* Patients with periodontitis stage III and IV were previous surgical treatment of GR,
* Pregnant or breastfeeding women; P
* Patients with para-functional habits or any source of occlusal trauma.

Primary outcomes:
measure: interproximal clinical attachment level
timeFrame: 6-9 months
measure: Probing pocket depth (PPD)
timeFrame: 6-9 months
measure: Recession depth
timeFrame: 6-9 months
Secondary outcomes:
measure: Keratinized tissue width
timeFrame: 6-9 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Al Qahirah
Study officials:
References:
Clinical trial NCT00714051: Fall Prevention Program for Older Adults
Official title: Fall Prevention Program for Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Accidental Falls
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Illinois at Chicago
First posted: 2008-07-14
Enrollment: 55
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the effectiveness of a fall prevention program for older adults. Participants assigned to the intervention group will train weekly on a special treadmill that will simulate tripping. Patients not assigned to the tripping program will walk on a standard treadmill.

Detailed description: The purpose of this study is to test the effectiveness of a fall prevention program for older adults. Participants assigned to the intervention group will train weekly on a special treadmill that will simulate tripping. Patients not assigned to the tripping program will walk on a standard treadmill. The training program will last for 4 weeks. Upon completion, participants will complete a test where a trip is simulated. Those assigned to the intervention group will test one additional time as well.

Eligibility criteria: Inclusion Criteria:

* 65-80 yr old,
* normal reflexes and muscle tone

Exclusion Criteria:

* lower extremity fracture or surgery last 5 yrs
* back surgery or disc herniation last 5 yrs
* noticeable gait impairment,
* low back pain,
* decreased disease-related vision,
* dizziness,
* history of heart problems,
* bone mineral density \<.65,
* mini-mental score \<24

Primary outcomes:
measure: Number of Participants Who Fell on a Tripping Test
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hines
country: United States
facility: Edward Hines, Jr. VA Hospital
state: Illinois
Study officials:
affiliation: Edward Hines Jr. VA Hospital
name: Eileen G. Collins, PhD RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05797051: Application of Hyperspectral Imaging in the Diagnosis of Glomerular Diseases
Official title: Application of Hyperspectral Imaging in the Diagnosis of Glomerular Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glomerulonephritis, IGA
Glomerulonephritis, Membranous
Diabetic Nephropathies
Nephrosis, Lipoid
Hyperspectral Imaging
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with massive proteinuria were diagnosed as IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy and minimal change nephropathy by renal biopsy.

Brief summary: Morning urine samples of patients with IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy, and minimal degenerative nephropathy confirmed by renal needle biopsy in our hospital from November 2020 to January 2022 were collected. By scanning the morning urine samples of corresponding patients with microhyperspectral imager, machine learning and deep learning were used to classify microhyperspectral images, and the classification accuracy was greater than 85%. Thus, hyperspectral imaging technology could be used as a non-invasive diagnostic means to assist the diagnosis of glomerular diseases.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old;
* Patients with IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy, minimal change nephropathy confirmed by renal biopsy;
* Had not received hormone and/or immunosuppressive therapy before renal biopsy;
* Complete clinical data, all signed the "Admission Certificate of Qianfoshan Hospital of Shandong Province", and agreed to use relevant medical information, biological specimen examination and examination results for scientific research.

Exclusion Criteria:

* There are factors causing secondary membranous nephropathy, such as immune diseases (systemic lupus erythematosus), tumors/infections (viral hepatitis), drugs or poisons, etc.;
* Severe infection: fever, cough and expectoration, sore throat, abdominal pain, diarrhea, carbuncle and furuncle and other clinical manifestations of skin and soft tissue infection, blood routine white blood cell count beyond the normal range (10×109/L);
* Severe cardiovascular disease: including chronic heart failure grade 3 or above and various arrhythmias;
* Infectious diseases: active hepatitis, AIDS, syphilis, etc. ;
* Tumor evidence: it has been found that there is a certain tumor or clinical manifestations, tumor markers, etc., suggesting the possibility of tumor.

Primary outcomes:
measure: Microhyperspectral image of urine specimen
timeFrame: 2023.4-2023.10
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04451551: Myocardial Perfusion Imaging by 15O-H2O PET/CT
Official title: Myocardial Perfusion Imaging by 15O-H2O PET/CT: Reference Values and Prognostic Value
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Heart Disease
Keywords: Myocardial Perfusion Imaging
Positron-Emission Tomography
Coronary Artery Disease
Coronary Flow Reserve
Myocardial Blood Flow
Prognosis
Reference Value
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 5000
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: Any patient with known or suspected ischemic heart disease referred for a clinical H2O-PET at Department of Nuclear Medicine and PET Centre, Aarhus University Hospital, not meeting any exclusion criteria will be enrolled in the study.

Brief summary: The trial will include 5000 patients with evident or suspected ischemic heart disease refered to Department of Nuclear Medicine \& PET Centre, Aarhus University Hospital, for perfusion imaging by 15O-H2O PET/CT scan of the heart during rest and stress. The patients will undergo the clinical scan as normal.

Data from the scans will be used to determine reference values of the examination.

Follow up will be done for up to 10 years in regards to major cardiovascular events in order to determine the prognostic value of the scan.


Eligibility criteria: Inclusion Criteria:

* Known or suspected ischemic heart disease referred for a clinical H2O-PET at Department of Nuclear Medicine and PET Centre, Aarhus University Hospital

Exclusion Criteria:

* Claustrophobia, severe asthma, younger than 18 years

Primary outcomes:
measure: Prognostic value within 10 years
timeFrame: 10 years
Secondary outcomes:
measure: Myocardial blood flow
timeFrame: 5 Years
measure: Coronary flow reserve
timeFrame: 5 Years
measure: Pulmonary transit time
timeFrame: 5 Years
measure: Left ventricular end-systolic volume
timeFrame: 5 Years
measure: Left ventricular end-diastolic volume
timeFrame: 5 Years
measure: Right ventricular end-systolic volume
timeFrame: 5 Years
measure: Right ventricular end-diastolic volume
timeFrame: 5 Years
measure: Immediate coronary angiography followup
timeFrame: 5 years
measure: Immediate percutaneous coronary intervention (PCI) followup
timeFrame: 5 years
measure: Immediate coronary artery bypass graft (CABG) followup
timeFrame: 5 years
measure: Prognostic value within 5 years
timeFrame: 5 years
measure: Prognostic value within 2 years
timeFrame: 2 years
measure: Prognostic value within 1 years
timeFrame: 1 years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Aarhus N
Study officials:
References:
Clinical trial NCT01126151: Parent Interventions to Prevent Student Drinking
Official title: Parent Interventions to Prevent Student Drinking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Consumption
Keywords: drinking
alcohol consequences
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2010-05-19
Enrollment: 1900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Examine the efficacy of parent interventions to prevent college student drinking in first year students.

Detailed description: The aims of the study are to:

1. efficacy of parent interventions to prevent college student drinking in first year students;
2. examine mediators of efficacy; and
3. examine moderators of efficacy.

Eligibility criteria: Inclusion Criteria:

* first year students

Exclusion Criteria:

* none

Primary outcomes:
measure: heavy episodic drinking
timeFrame: 12 months post baseline
Secondary outcomes:
measure: drinking related consequences
timeFrame: 12 months post baseline
Other outcomes:
Locations:
city: University Park
country: United States
facility: Penn State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Robert Turrisi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02238951: Cancer Care Coordination for Chemotherapy Patients
Official title: Use of mHealth to Support Nurse-directed Care Coordination for Chemotherapy Patients: Improving Health, Healthcare Delivery, and Healthcare Utilization.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: care coordination, mobile health, chemotherapy, technology
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: McKesson Foundation
name: Boston University
First posted: 2014-09-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to compare nurse-led care coordination for persons receiving cancer chemotherapy treatment incorporating mobile health technology to nurse-led care coordination without any mobile health enhancements.

Detailed description: This study will randomize sixty (60) participants receiving cancer chemotherapy treatment to receive nurse-led care coordination using a HIPAA-compliant mobile health platform compared to no technology-enhanced care coordination.

All participants receive nurse-led care coordination throughout chemotherapy treatment.

RESEARCH AIMS:

* Demonstration of a HIPAA-compliant social networking platform;
* Facilitate communication and collaboration among patients with cancer and their care team;
* Assess patient health outcomes (chemotherapy-related physical and psychological side effects; pain, quality of life and patient satisfaction)
* Assessment of healthcare utilization including emergency department visits, unplanned clinic visits and hospitalization;
* For patients assigned to the mobile health care coordination, understanding their experience of use of the technology

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Newly diagnosed cancer - any site or stage
* Initiating chemotherapy
* Ability to read and write English
* Manual dexterity sufficient to use a tablet technology
* Cognitive capacity to participate
* Preferential recruitment of publicly insured and/or living in rural communities

Exclusion Criteria:

* Oral chemotherapy

Primary outcomes:
measure: Change in Patient Health Outcome
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Demonstration of a HIPAA-compliant platform to coordinate care overtime
timeFrame: Baseline, 6 months
Other outcomes:
measure: Change in Patient Health Outcomes
timeFrame: Baseline, 3 months, 6 months
measure: Change in Healthcare Outcomes
timeFrame: Baseline, 6 months
measure: Change in Healthcare Utilization
timeFrame: Baseline, 3 months, 6 months
measure: Mobile health usability overtime
timeFrame: 2 weeks, 8 weeks
Locations:
city: Sacramento
country: United States
facility: UC Davis Comprehensive Cancer Care Center
state: California
Study officials:
affiliation: University of California, Davis Betty Irene Moore School of Nursing
name: Jill G Joseph, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02316951: Monitoring Postoperative Pain and Recovery Following Orthopedic Surgery
Official title: Monitoring Postoperative Pain and Recovery Following Orthopedic Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pain, Postoperative
Keywords: Postoperative
Pain
Symptoms
Video recording
Orthopedic surgery
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2014-12-15
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (age \>21) recovering from orthopedic surgery residing in an area hospital and under the care of the acute pain service.

Brief summary: This pilot study will seek to use emotion recognition technology from video to link patient facial expressions, heart rate and respiratory rate changes, and movement patterns to patient pain scores.

Detailed description: During hospitalization, beginning after orthopedic surgery, study participants will be asked to wear a small motion detector on their wrist. A computer vision system which analyzes both whole-body movement as well as facial expressions will be used at the bedside to compare common signs and symptoms of post op pain to patient pain scores.

Up to 30 study participants will be selected.

Study participants will be asked to complete a written pain diary during waking hours.This information will be compared to the pain scores found in the patient's medical record and/or the amount and frequency of pain medications they receive.

Eligibility criteria: Inclusion Criteria:

* Recovery following Orthopedic Surgery
* Non-vulnerable adult patient
* Residing on the 6th floor of the South Tower of UF Health Shands Hospital
* Under the care of the acute pain service

Exclusion Criteria:

* Inability to understand pain assessments
* Inability to wear a motion tracking device
* Amputation of limb
* Vulnerable subject status
* Anticipated discharge from hospital within 24 hours following enrollment
* \< 21 years of age

Primary outcomes:
measure: pain assessment (Correlate pain scores with motion measurements obtained through measurement of movement activity and video.)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Patrick Tighe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01206751: Multi-detector Computer Tomography Protocol Project: Chest Imaging Technique and Case Presentation
Official title: Multi-detector Computer Tomography Protocol Project: Chest Imaging Technique and Case Presentation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Dissection
Thrombosis in Left Atrium and Right Axillary Artery
Double IVC
May-Thurner Syndrome
Pulmonary Thromboembolism
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-09-22
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with complete clinical images

Brief summary: Multi-detector computer tomography protocol project: Chest imaging technique and case presentation.


Eligibility criteria: Inclusion Criteria:

* Patients with complete clinical images

Exclusion Criteria:

* Patients with incomplete clinical images

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University-Wan Fang Hospital
Study officials:
affiliation: Taipei Medical University-Wan Fang Hospital
name: Wing P. Chan
role: PRINCIPAL_INVESTIGATOR
References: