louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00763724: Antidepressant Drug Exposure and Risk of Suicide Attempt Resulting in Medical Intervention in US Adults
Official title: A Propensity-Matched Retrospective Cohort Study of Antidepressant Drug Exposure and Risk of Suicide Attempt in Adults From a Large U.S. Managed Care Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Suicide
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2008-10-01
Enrollment: 254432
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be based on data from the PharMetrics Patient-Centric Database, a commercially available claims database provided by PharMetrics, Inc., a Unit of IMS.

Brief summary: The primary objective of the study is to estimate the incidence of suicide attempts resulting in a medical encounter or hospitalization in seven propensity matched cohorts of subjects: patients treated with duloxetine for depression, patients treated with one of three other antidepressants or antidepressant classes (venlafaxine, SSRIs, or TCAs) for depression, patients treated with multiple antidepressants for depression (either concurrently or consecutively), depressed patients with no pharmacologic treatment, and a non-depressed general population sample.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older at index date
* Have at least 6 months of continuous enrollment data prior to index date.
* Have complete medical, facility, and pharmacy records (the latter of which will include complete quantity and days supplied information).

Exclusion Criteria:

* None

Primary outcomes:
measure: Incidence of suicide attempt resulting in medical encounter or hospitalization.
timeFrame: Endpoint
Secondary outcomes:
measure: Relative risk of suicide attempt resulting in medical encounters or hospitalization
timeFrame: Endpoint
Other outcomes:
Locations:
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon-Fri 9am - 5pm Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00343824: Bacterial Control in Partial Thickness Burns Using Silver-containing Wound Dressings
Official title: Bacterial Control in Partial Thickness Burns Using Silver-containing Wound Dressings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burn Wounds - Partial Thickness (2nd Degree)
Keywords: Burn wounds - Silver Dressings - Bacterial Control
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-06-23
Enrollment: 100
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to compare the treatment with two different silver-containing wound dressings: aquacel AG hydrofiber versus acticoat burn dressing.


Eligibility criteria: Inclusion Criteria:

* Burn wounds with flux values, measured by Laser Doppler Imaging, corresponding with expected healing time between 7 and 21 days, flux values between 200 and 1000 (red-pink or pink-yellow-green colour)
* Wounds treated with a hydrocolloid paste prior to LDI
* Possibility to follow the complete treatment schedule until wound healing and participation on complete follow-up schedule
* Informed consent
* Partial thickness burns with TBSE \< 40%

Exclusion Criteria:

* Mean flux values \< 200 or \> 1000
* TBSA \> 40%
* Impossibility to debride necrotic skin prior to LDI measurement
* Wounds treated with any topical ointments or dressings other than hydrocolloid prior to LDI
* Not following the complete treatment schedule or missing some evaluations during the follow-up period
* Patient has any condition that seriously compromises the patient's ability to complete the study
* Patient has participated in another study using an investigational drug within the previous 30 days
* Patient has one or more medical condition(s)that in the opinion of the investigator would make the patient an inappropriate candidate for this study
* The plastic surgeon decides that surgery is necessary due to unusual circumstances
* Patient wish to decline from the study
* No informed consent
* Full thickness burns

Primary outcomes:
measure: Evaluation of the efficacy of both wound dressings in controlling wound bioburden over a period of 21 days
timeFrame: Over a period of 21 days
Secondary outcomes:
measure: Comparison of blood silver levels
timeFrame: Every week until woundhealing. In folluw-up: at 3, 6 and 12 months
measure: Percentage of genetically-acquired resistance to silver
timeFrame: Once after wound closure.
measure: Healing time comparison
timeFrame: Every 3 days until healing
measure: Scar quality assessment
timeFrame: At 1, 3, 6 and 12 months after wound closure
measure: Cost-effectiveness
timeFrame: Once after wound closure.
measure: Health related quality of life
timeFrame: At 1, 3, 6 and 12 months after wound closure
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Stan Monstrey, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03170024: Health Literacy in Adults With Congenital Heart Disease
Official title: Assessment of Health Literacy in Adults With Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will be conducted solely in the the Adult Congenital Heart Clinic at Stanford, and patients with congenital heart disease (CHD) will be recruited for the study.

Brief summary: Currently, both oral and written health education make certain assumptions about the health literacy of patients and their parents. The prevalence of health literacy issues is unknown in the adult congenital heart disease (CHD) population. Having a better understanding of a patient's and/or their parents' health literacy will help us develop appropriate education and teaching tools to meet the patient's and their parents' needs.

Detailed description: When providers speak with patients regarding their congenital heart disease, they currently have no assessment of the patient's basic health literacy. If providers are aware of the level of their patients' health literacy, they will be better equipped to provide care on the level the patient best understands.

Eligibility criteria: Inclusion Criteria:

* Males or females 18 years of age and older with congenital heart disease.

Exclusion Criteria:

* Developmentally delayed subjects.
* Any subject not meeting inclusion criteria.

Primary outcomes:
measure: Assess Literacy
timeFrame: The final 3 months will be used for data analysis and the presentation/manuscript preparation.
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Hospital Adult Congenital Heart Clinic
state: California
Study officials:
affiliation: Stanford University
name: Susan Fernandes, LP.D.P.A.C
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05611424: Gene Therapy for Wet AMD
Official title: An Open-label, Single-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FT-003 in Subjects With Neovascular Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Neovascular Age-related Macular Degeneration
Lead sponsor: Frontera Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: The First Affiliated Hospital of Soochow University
name: Tianjin Medical University Eye Hospital
name: Peking Union Medical College Hospital
name: The First Affiliated Hospital of Zhengzhou University
First posted: 2022-11-10
Enrollment: 18
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Neovascular Age-related Macular Degeneration
Primary purpose: TREATMENT

Brief summary: FT-003 is a gene therapy product developed for the treatment of neovascular age-related macular degeneration (nAMD). Neovascular AMD is the main cause of blindness among elderly individuals. The available therapies for treating nAMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. Administration of FT-003 has the potential to treat nAMD by providing durable expression of therapeutic levels of intraocular protein and maintaining the vision of patients. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Subjects that are willing and able to follow study procedures;
* Female or male patients ≥45 years old at the time of signing the ICF;
* Clinically diagnosed with nAMD;
* Presence of active CNV
* The best corrected visual acuity (BCVA) of the studied eye is ≤ 53 letters;

Exclusion Criteria:

• Presence of any other intraocular diseases other than nAMD in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator.

Primary outcomes:
measure: Safety and tolerability after FT-003 injection
timeFrame: At Week 52
Secondary outcomes:
measure: Changes in best-corrected visual acuity (BCVA) of the studied eye from baseline
timeFrame: At Week 52
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of Soochou University
name: Peirong Lu, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Medical University Eye Hospital
name: Xiaorong Li, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking Union Medical College Hospital
name: Hanyi Min
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Guangming Wan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02748824: Five-year Incidence of Age-related Macular Degeneration in the Central Region of Portugal
Official title: Five-year Incidence of Age-related Macular Degeneration in the Central Region of Portugal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-Related Macular Degeneration
Keywords: Age- Related Macular Degeneration; Diabetic Retinopathy; Glaucoma; Cataract
Lead sponsor: Association for Innovation and Biomedical Research on Light and Image
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 5996
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of male and female subjects who have participated and phenotyped in the Epidemiologic Coimbra Eye Study (NTC01298674).

It is expected to recruit up to a total of 5.996 subjects, that is up to 2.975 subjects from the Mira Healthcare Unit and up to 3.021 subjects from the Lousã Healthcare Unit.

Brief summary: To assess the five-year incidence of AMD in a population from the central region of Portugal, previously phenotypically characterized.

Detailed description: Subjects who participated in the Epidemiologic Coimbra Eye Study (NCT01298674) between 2009 and 2013 will attend a single visit, after giving informed consent.

Eligibility criteria: Inclusion Criteria:

* Subjects who participated in the Epidemiologic Coimbra Eye Study (NCT01298674) and that were phenotyped;
* Subjects capable of understanding the information about the study and to give their informed consent to enter the study;
* Subjects willing and able to comply with the study procedures.

Exclusion Criteria:

- Not applicable

Primary outcomes:
measure: Phenotypic classification of AMD in the five-year clinical visit. Comparison of this classification with the grading of 5 years ago.
timeFrame: 5 years
Secondary outcomes:
measure: Risk factors: Demographic, Medical history, Ophthalmologic history, Family history of AMD, Systemic comorbidities and medication, Nutritional and Lifestyle habits. Signs of AMD on the multimodal evaluation.
timeFrame: 5 years
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: AIBILI/CEC - Centro Ensaios Clínicos
Study officials:
affiliation: Association for Innovation and Biomedical Research on Light and Image
name: Rufino Silva, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00326924: Age of Red Blood Cells in Premature Infants Study (ARIPI)
Official title: Age of Red Blood Cells in Premature Infants Study (ARIPI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Keywords: Transfusion
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2006-05-17
Enrollment: 377
Sex: ALL
Minimum age (years): 1
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if the age of blood transfused to new borns in the NICU setting has an impact on their outcome.


Eligibility criteria: Inclusion Criteria:

* birthweight of less than 1250g
* admitted to participating NICU
* consent acquired from proxy for the patient

Exclusion Criteria:

* already received one or more transfusions
* requirement for an exchange transfusion
* will be receiving directed donations
* have rare blood types/difficult cross-match
* proxy has refused consent
* moribund on admission to NICU/expected to die
* mitigating child protection issues

Primary outcomes:
measure: 1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality
timeFrame: 2 weeks, 4 weeks, 12 weeks, 90 days
Secondary outcomes:
measure: Clinically Suspected Infection and Culturally Confirmed Infections
timeFrame: 90 days
measure: Length of Stay
timeFrame: until last participants left neonatal intensive care unit
measure: Number of Participants Using Mechanical Ventilation.
timeFrame: whether a mechanical ventilation was used at any time point during 90 days
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
Study officials:
affiliation: OHRI
name: Dean Fergusson, PhD
role: STUDY_DIRECTOR
References:
citation: Kekre N, Mallick R, Allan D, Tinmouth A, Tay J. The impact of prolonged storage of red blood cells on cancer survival. PLoS One. 2013 Jul 16;8(7):e68820. doi: 10.1371/journal.pone.0068820. Print 2013.
citation: Fergusson DA, Hebert P, Hogan DL, LeBel L, Rouvinez-Bouali N, Smyth JA, Sankaran K, Tinmouth A, Blajchman MA, Kovacs L, Lachance C, Lee S, Walker CR, Hutton B, Ducharme R, Balchin K, Ramsay T, Ford JC, Kakadekar A, Ramesh K, Shapiro S. Effect of fresh red blood cell transfusions on clinical outcomes in premature, very low-birth-weight infants: the ARIPI randomized trial. JAMA. 2012 Oct 10;308(14):1443-51. doi: 10.1001/2012.jama.11953.
citation: Fergusson D, Hutton B, Hogan DL, LeBel L, Blajchman MA, Ford JC, Hebert P, Kakadekar A, Kovacs L, Lee S, Sankaran K, Shapiro S, Smyth JA, Ramesh K, Bouali NR, Tinmouth A, Walker R. The age of red blood cells in premature infants (ARIPI) randomized controlled trial: study design. Transfus Med Rev. 2009 Jan;23(1):55-61. doi: 10.1016/j.tmrv.2008.09.005.
Clinical trial NCT00005424: Prospective Analysis of the Effect of Widowhood on CVD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To determine the effect of widowhood on cardiovascular disease.

Detailed description: BACKGROUND:

Widowed persons have been found to have higher mortality rates than married persons in both cross-sectional and longitudinal studies. In many of these studies, excess mortality has been attributed to deaths from cardiovascular disease. Despite these consistent findings, the lack of detailed data collected prior to widowhood has hampered our ability to understand the mechanisms to explain this effect. Furthermore, an understanding of the mechanisms underlying this effect might help elucidate the apparent gender differences in mortality following widowhood.

DESIGN NARRATIVE:

The study took advantage of the data collected as part of the Framingham Study to investigate the effect of widowhood on cardiovascular disease. The Framingham dataset has extensive clinical data related to cardiovascular disease, as well as to health behaviors. These longitudinal data provided the opportunity to prospectively characterize the health of widows prior to and following the loss of a spouse in much greater detail than previously possible. The analyses used a prospective design in which those men and women who had a spouse die during the course of the study (N=626) were compared to men and women who remained married (N=2044). These analyses also provided the opportunity to examine reasons for the beneficial effect found of remarriage. The study addressed the following questions: 1. Can the increased risk of mortality from cardiovascular disease often found following widowhood be explained by pre-widowhood health status? 2. Can increased mortality following widowhood be explained by changes in health behaviors related to cardiovascular disease risk. 3. What pre-widowhood risk factors place the widowed at greater risk for cardiovascular disease morbidity and/or mortality following the death of a spouse? 4. Can pre-widowhood risk factors or post-widowhood behavior change account for gender differences in mortality following widowhood?

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00362024: MK0952 in Patients With Mild-to-Moderate Alzheimer's Disease (0952-004)(COMPLETED)
Official title: MK0952 in Patients With Mild-to-Moderate Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-08-09
Enrollment: 24
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: MK0952 is a phosphodiesterase type IV (PDE4) inhibitor in development for improvement of cognitive impairment in mild-to-moderate Alzheimer's disease.


Eligibility criteria: Inclusion Criteria:

* Male or females
* Age \>/= 55 years, With mild-to-moderate AD, with MMSE between 18 and 26, inclusive, MHIS score \</= 4, Global CDR score of 1 or 2
* Who have a reliable informant/caregiver to accompany patient to all clinic visits
* If using a symptomatic AD treatments, patients must be on stable dose for \>/= 6 months

Exclusion Criteria:

* Patients must not be living in nursing home or skilled nursing facility
* Patients must not have current evidence and/or history of Crohn's disease, ulcerative colitis, proctitis, GI bleeding, mesenteric arteritis
* Patients must not have current evidence and/or history of poorly-controlled hypertension, clinically significant cardiac arrhythmia, angina, or CHF
* Patients must not have current evidence and/or history of a psychotic disorder or major untreated depressive disorder
* Patients must not have current evidence and/or history of stroke or multiple lacunar infarcts, or neurological or neurodegenerative disorder (other than AD)
* Various concomitant therapy restrictions

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06218524: The Effectiveness of HP and TMZ Synergism on Adult Recurrence GBM
Official title: Clinical Study for Evaluating the Effectiveness of Haloperidol and Temozolomide Synergism on Adult Recurrence Glioblastoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Glioblastoma Multiforme
Keywords: Chemoresistance
Autophagy
Ferropotosis
DRD2
Haloperidol
Lead sponsor: Southern Medical University, China
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study of investigators indicated that TMZ can up-regulate dopamine D2 receptor (DRD2) expression, and mediates Ferroptosis inhibition and chemoresistance of GBM. The clinical data also proved that the DRD2 expression in recurrent GBM is significantly higher than that in primary GBM. Moreover, the DRD2 antagonist haloperidol can attenuate the above function of DRD2, and increase the sensitivity of GBM to the TMZ by inducing fatal autophagy and ferroptosis. In xenograft mice, the combined usage of haloperidol and Temozolomide (TMZ) can significantly inhibit tumor growth and increase overall survival. The investigators' findings have been published in Clinical cancer research. Haloperidol known as a butylbenzene antipsychotic drug, has been widely used in several kinds of mental illnesses, such as depression, schizophrenia, and Bipolar disorder. And the safe dosage of the haloperidol is clear so far. So in this study, the investigators will recruit the patients who suffered from recurrent GBM, and evaluate the effectiveness of single TMZ chemotherapy or combined with haloperidol.


Eligibility criteria: Inclusion Criteria:

* Adult patients
* Primary GBM underwent surgery and TMZ chemoradiotherapy, and MRI confirmed the tumor recurrence
* Without severe cardiac diseases

Exclusion Criteria:

* Child patients (\<18 years)
* Recurrence tumors grow fast, which needs surgery removal
* H3K27M midline glioblastoma
* Suffered with severe cardiac diseases

Primary outcomes:
measure: Percentage of partial relief and complete relief
timeFrame: 3 months
Secondary outcomes:
measure: Overall survival
timeFrame: One year
measure: DRD2 expression
timeFrame: One year
Other outcomes:
measure: Adverse drug reaction of haloperidol
timeFrame: One year
Locations:
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Yuntao Lu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shi L, Chen H, Chen K, Zhong C, Song C, Huang Y, Wang T, Chen L, Li C, Huang A, Qi S, Li H, Lu Y. The DRD2 Antagonist Haloperidol Mediates Autophagy-Induced Ferroptosis to Increase Temozolomide Sensitivity by Promoting Endoplasmic Reticulum Stress in Glioblastoma. Clin Cancer Res. 2023 Aug 15;29(16):3172-3188. doi: 10.1158/1078-0432.CCR-22-3971.