louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01608295: Vilazodone for Treatment of Geriatric Depression
Official title: A Pilot Study of Double-blind Comparison of Vilazodone to Paroxetine in Geriatric Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: depressed
geriatric
older adults
antidepressants
depression
anxious
major depressive disorder
MDD
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2012-05-31
Enrollment: 65
Sex: ALL
Minimum age (years): 60
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 effects of vilazodone for the treatment of depression in older adults.

Detailed description: This is a 12-week double-blind comparison of a novel antidepressant, vilazodone, to the gold-standard drug, paroxetine, for the treatment of geriatric depression. We are interested in assessing the difference in response to vilazodone (VLZ) compared to paroxetine (PAR). We hope to detect difference in response in primary outcomes (depressed mood) and secondary outcomes cognition. We are seeking to examine this directly in 80 older adults (60 years of age or older) with major depression with anticipated 60 completers. This proposed trial will serve as a pilot study to estimate the efficacy and tolerability of the drug in older depressed adults, and use this project for dose-finding in this population.

Eligibility criteria: Inclusion Criteria:

* 60 years of age or older
* The presence of a major depressive disorder diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
* A 24-item Hamilton Depression Rating Scale (HAMD) score of 17 or higher at baseline
* Mini-Mental State Exam (MMSE) score \> 24.

Exclusion Criteria:

* Subjects will be excluded if they had any current and/or lifetime history of other psychiatric disorders (except unipolar depression with or without comorbid generalized anxiety disorder), or recent unstable medical or neurological disorders; any disabilities preventing their participation in the study; diagnosis of mild cognitive impairment (MCI)/dementia; those with known allergic reactions to paroxetine or vilazodone.

Primary outcomes:
measure: Hamilton Depression Rating Scale (HDRS)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: UKU Side-effect Profile
timeFrame: Each visit for 12 weeks
measure: Neurocognitive Measure: The Rey-Osterrieth Complex Figure Test
timeFrame: Baseline and Final Visit
measure: Changes in Proinflammatory Gene Expression From Baseline to Final Visit (up to 12 Weeks)
timeFrame: Baseline and Final Visit
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Semel Institute
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Helen Lavretsky, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02172495: Spiriva® in Patients With Chronic Obstructive Pulmonary Disease (COPD) in Daily Practice
Official title: Tolerability and Efficacy of Spiriva® 18 Micrograms in Patients With COPD in Daily Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-24
Enrollment: 4700
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief summary: Post-marketing surveillance to gather information regarding the tolerance and efficacy of Spiriva® 18 micrograms in patients with COPD under conditions of daily practice.


Eligibility criteria: Inclusion Criteria:

* Men and women aged at least 40 years with the symptoms of Chronic Obstructive Pulmonary Disease

Exclusion Criteria:

* Patients with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information

Primary outcomes:
measure: Change from baseline in breathlessness when walking/climbing stairs
timeFrame: Baseline, after 4 weeks
measure: Change from baseline in breathlessness on physical exercise
timeFrame: Baseline, after 4 weeks
measure: Change from baseline in breathlessness during everyday activities
timeFrame: Baseline, after 4 weeks
measure: Change from baseline in breathlessness during housework
timeFrame: Baseline, after 4 weeks
measure: Change from baseline in overall severity of the clinical picture
timeFrame: Baseline, after 4 weeks
measure: Occurrence of Adverse Events
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02897895: Study to Evaluate the Value of the Follow-up of CALCIneurin Activity to MOdulate Calcineurin Inhibitors-induced Immunosuppression in Lung Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Diseases
Keywords: Lung transplantation in end-stage lung diseases
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 134
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: The study is an interventional, multicentre, prospective, randomized, controlled, single-blind, comparative trial of two processes for adjusting the inhibitor of calcineurin (CNI) dosage in lung transplant recipients. Recipients will be stratified by transplant center and according to the underlying lung disease (affected with cystic fibrosis or not) and will be randomized to either evaluation of calcineurin activity (CN-a) in combination with CNI blood levels versus CNI blood levels alone in a 1:1 ratio. The objective is to compare the proportion of acute rejection that has required a specific curative treatment at 6 months after transplantation between patients in the two groups.


Eligibility criteria: Inclusion Criteria:

* Patient placed on the national waiting list for lung transplantation
* First de novo lung transplantation (single or double LTx)
* Prevention of allograft rejection by a usual immunosuppressive regimen including CNI (cyclosporine or tacrolimus)

Exclusion Criteria:

* Previous lung transplantation or other solid organ transplantation
* Combined lung transplantation with either liver or renal transplantation

Primary outcomes:
measure: number of episodes of acute rejection after LTx
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle Desalbres
role: STUDY_DIRECTOR
References:
Clinical trial NCT01253395: Exercise for Fibromyalgia
Official title: Randomized Equivalency Trial of Strength Compared to Aerobic Exercise on Pain Severity in Adults With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Exercise
Pain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-12-03
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized equivalency trial of the effects of strength training compared to aerobic exercise on pain severity in adults with fibromyalgia.


Eligibility criteria: Inclusion Criteria:

- Established diagnosis of fibromyalgia, age \> 18 years. Exclusion Criteria: cardiac, pulmonary or orthopedic condition that would limit exercise.

-

Primary outcomes:
measure: Pain severity
timeFrame: Week 3
Secondary outcomes:
measure: Muscle strength
timeFrame: Week 3
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: William M Hooten, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hooten WM, Rosenberg CJ, Eldrige JS, Qu W. Knee extensor strength is associated with pressure pain thresholds in adults with fibromyalgia. PLoS One. 2013;8(4):e59930. doi: 10.1371/journal.pone.0059930. Epub 2013 Apr 2.
citation: Hooten MW, Qu W, Townsend CO, Judd JW. Effects of strength vs aerobic exercise on pain severity in adults with fibromyalgia: a randomized equivalence trial. Pain. 2012 Apr;153(4):915-923. doi: 10.1016/j.pain.2012.01.020. Epub 2012 Feb 15.
Clinical trial NCT05707195: Learning Excellence Program and Improvement of Quality Care
Official title: Improvement the Quality of Care Through the Implementation of a Learning From Excellence Program in a Pediatric Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Satisfaction, Patient
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Improving the quality of care is a daily goal in pediatric intensive care units. Measuring patient and family satisfaction is recognized as an indicator of quality of care. A validated questionnaire was specially developed to study parental satisfaction in pediatric intensive care units. A positive multi-professional analysis of clinical situations, using appreciative inquiry, within a health service can create new opportunities for learning and innovation. The establishment of such a Learning From Excellence (LfE) program tends to increase the well-being and self-confidence of caregivers and promotes dynamic learning educational programs, including simulation.

It therefore seems important to assess the improvement in the quality of care in pediatric intensive care following the implementation of a Learning From Excellence program allowing positive reflection on practices as well as innovations within the service.


Eligibility criteria: Inclusion Criteria:

* All parents of children aged 0 to 18 who have been hospitalized in the pediatric intensive care unit over a period of 24 months once the research has been authorized and started

Exclusion Criteria:

* Parents unable to answer the questionnaire because they do not speak French
* Parents of children who died during their stay in the pediatric intensive care unit

Primary outcomes:
measure: Evaluation of the quality of care.
timeFrame: Day 1, the day of discharge from hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: CHU Toulouse
name: Sophie Breinig, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00170495: Acute Viral Respiratory Infections in Elderly
Official title: Etiology and Impact of Acute Viral Respiratory Infections in Ambulatory Elderly Populations
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Respiratory Infections, Acute
Keywords: respiratory illness, influenza, bronchitis, pneumonia, cold
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2005-09-15
Enrollment: 3000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: male and female adults age 65 and older with acute respiratory illness (common colds, flu, bronchitis, pneumonia)

Brief summary: This study is designed to assess the causes and impact of acute respiratory illness (common colds, flu, bronchitis, pneumonia) in adults age 65 and older. One of the ways to determine the virus causing a particular illness is to get a blood specimen when a person is sick and again later and look for the body's specific responses that identify the virus. Approximately 3000 subjects will be evaluated and their medical records assessed for details of recent illness and general health to help in understanding the subjects' current illness.

Detailed description: The purpose of this study is to determine the role of respiratory viruses in the etiology of medically attended acute respiratory illness in elderly populations and to assess the impact of these illnesses. Ambulatory elders presenting for health care with an acute respiratory illness will be recruited. Nose and throat swab specimens will be collected to test for one of the respiratory viruses, and acute and convalescent blood specimens will be collected to test for increases in specific antibody. Specimens will be collected within seven days of the onset of illness and then 1 month later for comparison specimens. A brief questionnaire will accompany the specimens, and more complete data on the illness and consequences will be obtained from the medical record. The pattern of illnesses by virus and their severity and duration will be determined.

Eligibility criteria: Inclusion Criteria:

1. 65 years of age or older
2. Presentation to the geriatric clinic with an acute respiratory illness of less than 7 days' duration.

Exclusion Criteria:

1. Presentation to the geriatric clinic with a history of a respiratory illness of greater than 7 days' duration.
2. Physician/physician assistant judgment that the respiratory complaints do not represent an acute infection.
3. Patient declines to permit specimen collection.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
Clinical trial NCT01085695: Study of E3810 for Healthy Japanese Male (Under Fasting Condition)
Official title: A Pilot Cross-over Bioequivalence Study of E3810 for Healthy Japanese Male (Under Fasting Condition)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Rabeprazole
Japan
healthy Japanese male
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2010-03-12
Enrollment: 16
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the pharmacokinetics of rabeprazole under fasting condition.

Detailed description: The purpose of this study is to assess bioequivalence after single administration of the following 4 types of formulation: normal 10 mg rabeprazole tablet rabeprazole, and Type 1, Type 2, and Type 3 granule formulation containing rabeprazole 10 mg.

Eligibility criteria: Inclusion criteria:

Subjects with homozygous or heterozygous extensive metabolizers of cytochrome P4502C19.

Exclusion criteria:

Subjects with allergy

Primary outcomes:
measure: The following pharmacokinetic parameters are calculated: maximum drug concentration (Cmax) in plasma; area under the plasma concentration time curve (AUC)
timeFrame: One day
Secondary outcomes:
measure: Vital signs, clinical laboratory screens of blood and urine, adverse event monitoring, adverse drug reaction monitoring
timeFrame: 13 days
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Research Center, Eisai, Co., Ltd
name: Kai Shibata
role: STUDY_DIRECTOR
References:
Clinical trial NCT02116595: Urine pH and Diet Net Acid Load
Official title: Alterations in Urine pH With Differing Diet Net Acid Loads
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy
Keywords: volunteers
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: optimal wellness labs
First posted: 2014-04-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Presently, the gold standard for testing diet acid intake is a urine collection done for many hours, usually 24 hours, which must be analyzed in a research lab for "net acid excretion". So, getting information about diet acid intake is difficult. Many people have suggested doing a much simpler test, which is checking the pH of the urine when you wake up. But, no one has studied if this simpler method is a valid method for estimating the 24 hour net acid excretion. Diet acid load may be important in many diseases associated with aging, such as loss of bone and muscle, and the development of kidney disease.

Detailed description: the primary outcome variable is morning urine pH and 24 hour urine net acid excretion

Eligibility criteria: Inclusion Criteria:

* no medical or psychological problems
* able to come to UCSF for study

Exclusion Criteria:

* pregnant or trying to become pregnant
* Hg \< 10
* abnormal screening labs
* anyone unable to follow study directions

Primary outcomes:
measure: high acid diet
timeFrame: 6 months
measure: low acid diet
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: lynda frassetto, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05545995: Time Lapse Assisted Embryo Selection Versus Non Invasive PGT-A Assisted Embryo Selection
Official title: IVF Outcomes Based on Time Lapse Assisted Embryo Selection Versus Non Invasive PGT-A Assisted Embryo Selection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Aneuploidy
Chromosome Abnormality
Keywords: IVF
PGT-A
NON- INVASIVE PGT-A
TIME LAPSE
EMBRYO SELECTION
Lead sponsor: Assisting Nature
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women aged 18- 39, faced with infertility issues, meeting the above inclusion criteria.

Brief summary: This is a prospective randomised study of the evaluation of the clinical IVF results after time lapse assisted embryo selection versus Non-invasive PGT-A assisted embryo selection in subfertile women.

Detailed description: A randomized prospective study focusing on subfertile women undergoing IVF treatment followed by embryo transfer on the blastocyst stage.

Women assigned to group A proceed to embryo transfer, after time lapse assisted embryo selection, while women of group B after non-invasive PGT-A assisted embryo selection.

IVF outcomes, regarding the success rate of the trasnfer and the time required to achieve conception is studied in both groups.

Eligibility criteria: Inclusion Criteria:

* Women who followed IVF treatment
* 39 years old or younger
* Single embryo transfer
* blastocyst stage cultured embryos

Exclusion Criteria:

* women over the age of 39 years
* not blastocyst transfer (transfers performed at earlier embryo stage)
* double embryotransfer
* women who had invasive PGT-a test
* women whose embryos were not time-lapse monitored

Primary outcomes:
measure: Embryotransfers to conceive
timeFrame: Up to the embryotransfer of the last enrolled patient (Dec 2023)
measure: Time interval to conceive
timeFrame: Up to the pregnancy test after the last embryo transfer of an enrolled patient (Jan 2024)
measure: Cumulative Live Birth Rate
timeFrame: Up to 38 weeks after the embryo transfer
Secondary outcomes:
measure: Abortion rate
timeFrame: Up to 2nd trimester miscarriages
measure: DaC rate
timeFrame: Up to 24 weeks of pregnancy according to Greek Law
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Assisting Nature
Study officials:
affiliation: Assisting Nature
name: Evangelos Papanikolaou, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03541395: Testosterone-Dependent Effects on Protein Biomarkers From Healthy Males
Official title: Testosterone-Dependent Effects on Protein Biomarkers From Healthy Males Before and After Pharmacological Castration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypogonadism, Male
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study is designed to identify and validate new protein biomarkers in blood related to testosterone activity. Thirty healthy young males underwent pharmaceutical castration to lower testosterone levels. After three weeks the subjects received an intramuscular injection of testosterone undecanoate. Blood samples from just before pharmaceutical castration, three weeks after castration, and one week after injection of testosterone undecanoate were collected representing normal testosterone levels, low testosterone levels, and testosterone at eugonadal levels.


Eligibility criteria: Inclusion Criteria:

healthy males

Exclusion Criteria:

use of anabolic steroids, use of narcotics,

Primary outcomes:
measure: Protein biomarkers
timeFrame: 48 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Lund University
name: Johan Malm, MD
role: STUDY_CHAIR
affiliation: Lund University
name: Roger Appelqvist, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lund University
name: Gyorgy Marko-Varga, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lund University
name: Aleksander Giwercman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lund University
name: Barbara Sahlin, MSc
role: PRINCIPAL_INVESTIGATOR
References: