louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00645320: A Study of Ziprasidone for the Treatment of Psychosis in Patients Who Had Already Had Benefits From Ziprasidone Treatment in a Previous Study
Official title: An Open Label, Extension Study To Assess The Efficacy And Tolerability Of Oral Ziprasidone In Patients Successfully Completing A Previous Study With Ziprasidone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pyschotic Disorders
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and tolerability of ziprasidone in patients who successfully completed a study of ziprasidone treatment of psychosis (Protocol A1281074).


Eligibility criteria: Inclusion Criteria:

* Psychotic disorder
* Completion of previous study of intramuscular ziprasidone
* Ability to continue with oral ziprasidone

Exclusion Criteria:

* Concomitant treatment with other anti-psychotic agents within 12 hours prior to the enrollment; for depot agents, a period of two weeks or a cycle, whichever is longer, should occur between the last administration and the patient's enrollment.
* Treatment with antidepressants or mood stabilizers within seven days prior to the enrollment; for MAOIs (monoamine oxidase inhibitors) and moclobemide, this period should be of two weeks; for fluoxetine, five weeks.
* Resistance to conventional psychotic agents. (Resistance is defined as a failure to present a therapeutic response during the acute exacerbation after proper attempts of treatment with marketed antipsychotic agents in two or more occasions during the two years prior to the enrollment in the study.)

Primary outcomes:
measure: Change from baseline in Clinical Global Impression-Severity (CGI-S) score
timeFrame: Until Final Visit (within 3 months)
Secondary outcomes:
measure: Adverse events
timeFrame: Baseline and Months 1, 2, and 3
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Pfizer Investigational Site
state: Bahia
city: Fortaleza
country: Brazil
facility: Pfizer Investigational Site
state: Ceara
city: Belo Horizonte
country: Brazil
facility: Pfizer Investigational Site
state: MG
city: Curitiba
country: Brazil
facility: Pfizer Investigational Site
state: PR
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Jardim Santa Monica SN
country: Brazil
facility: Pfizer Investigational Site
state: Salvador - BA
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: RIO DE Janeiro RJ
country: Brazil
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00042120: Farming and Movement Evaluation Study (FAME)
Official title: Pesticides and Risk in the Agricultural Health Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Movement Disorders
Keywords: Parkinson's disease
Movement Disorders
Epidemiological Study
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2002-07-26
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE

Brief summary: The long term goal of this research is to elucidate the cause(s) of Parkinson's disease, with a focus on environmental determinants. We propose to investigate the relationship between Parkinson's disease and exposure to pesticides and other factors by conducting a nested case-control study in the Agricultural Health Study.

Detailed description: The long term goal of this research is to elucidate the cause(s) of Parkinson's disease, with a focus on environmental determinants. We propose to investigate the relationship between Parkinson's disease and exposure to pesticides and other factors by conducting a nested case-control study in the Agricultural Health Study.

The Agricultural Health Study is a cohort study of 52,000 licensed pesticide applicators and 32,000 of their spouses, conducted in North Carolina and Iowa. It is a joint effort of the National Cancer Institute, the National Institute of Environmental Health Sciences, and the US Environmental Protection Agency.

The studies proposed here take full advantage of the Agricultural Health Study. We believe that this work could provide a critical and dramatic next step in furthering our knowledge of environmental determinants of PD, and thereby take us closer to our goal of finding its cause(s)

Eligibility criteria: Inclusion Criteria:

* Subjects will be recruited from members of the Agricultural Health Study cohort.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sunnyvale
country: United States
facility: The Parkinson's Institute
state: California
Study officials:
affiliation: The Parkinson's Institute
name: Caroline M Tanner
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04754620: Distant Management of Crohn's Disease by Smartphones is Feasible and Effective Additionally it Reduces the Costs
Official title: Implementation and Evaluation of Smartphone-Based Videoconferance Telehealth for Patients With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn Disease
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 139
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: HEALTH_SERVICES_RESEARCH

Brief summary: Evaluation of the feasibility, acceptability, patient satisfaction and economic benefits of smartphone video-based telehealth in the management of Crohn's disease patients

Detailed description: Patients were examined by two gastroenterologists (HY, AED) either at a video conference based visit or face to face visit in outpatients clinics. We used the WhatsApp business application.The online visit notion was the same as traditional face-to-face visit except physical examination.

Eligibility criteria: Inclusion Criteria:

* The study group included patients with documented Crohn's disease, based on clinical, endoscopic, and histologic findings
* Patient between 18-80 years old
* Participants who have been receiving treatment for more than six months

Exclusion Criteria:

* Patients were excluded from the study if they had no internet connection
* Unable to use smartphones because of blindness, deafness, or mental disorders

Primary outcomes:
measure: Satisfaction score with the video visits
timeFrame: the day after the visit
Secondary outcomes:
Other outcomes:
Locations:
city: Izmit
country: Turkey
facility: Kocaeli University Medical Faculty Hospital
state: Kocaeli
Study officials:
affiliation: Kocaeli University
name: göktuğ şirin
role: STUDY_DIRECTOR
References:
Clinical trial NCT02799420: Role of Probe-based Confocal Laser Endomicroscopy Targeted Biopsy in the Molecular Study of Undifferentiated Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Undifferentiated Gastric Cancer
Keywords: confocal laser endomicroscopy
undifferentiated gastric cancer
target biopsy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 74
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to conduct a study on genetic pathology, obtaining of pure cancer tissues is mandatory. Although the endoscopy with biopsy has been a gold standard for diagnosing gastric cancer, percentage of cancer cells in biopsy samples is usually 30% or less. Recently, confocal laser endomicroscopy has been introduced for real-time histopathologic diagnosis in various cancers. In previous pilot study in our institution, pCLE-targeted biopsy provided superior results in terms of the proportion of cancer cells in biopsy samples compared to WLE-targeted biopsy, especially for gastric cancers with undifferentiated histology. However, there was a limitation because of small sample size. Therefore, the investigators aim to evaluate that biopsy using probe-based confocal laser endomicroscopy for undifferentiated gastric cancer will increase the percentage of cancer cells and expression ratio of tumor marker in biopsy samples.


Eligibility criteria: Inclusion Criteria:

A. Age, between 20 and 80 B. Patients with undifferentiated gastric cancer who will be underwent surgery

Exclusion Criteria:

A. Previous subtotal gastrectomy B. Previous EMR/ESD history C. Significant cardiopulmonary disease D. Active hepatitis or severe hepatic dysfunction E. Severe renal dysfunction F. Severe bone marrow dysfunction G. Severe neurologic or psychotic disorder H. Pregnancy or breast feeding

Primary outcomes:
measure: The percentage of cancer cells in biopsy samples
timeFrame: Day 3
Secondary outcomes:
measure: The expression ratio of tumor marker in biopsy samples
timeFrame: Day 3
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei university of medical center
Study officials:
References:
Clinical trial NCT03130920: Hepatoprotective Effect of Remote vs Local Preconditioning of Liver
Official title: Comparison of Hepatoprotective Effect From Ischemia-reperfusion Injury of Remote Ischemic Preconditioning of the Liver vs. Local Ischemic Preconditioning of the Liver During Human Liver Resections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Metastases
Keywords: preconditioning, resection
Lead sponsor: University Hospital Dubrava
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate hepatoprotective effect from ischemia-reperfusion injury of remote ischemic preconditioning of the liver against local ischemic preconditioning of the liver during human liver resections.

Detailed description: In this randomized control study, a total of 60 patients were randomized into 3 groups: remote ischemic precondition group - RIPC (3 intervals of 5 minute right upper limb ischemia with 3 intervals of 5 minute reperfusion), local ischemic precondition group - LIPC (15 minutes of inflow liver occlusion followed by 10 minutes of reperfusion before liver transection), control group - CG (group without ischemic preconditioning before liver transection). Patients were also stratified according to the extent of the hepatectomy. Hepatoprotective effect was evaluated by comparing serum transaminase levels, bilirubin levels, albumin, and protein levels, coagulograms and pathohistological exams. We also measured flow rate by Doppler ultrasound of hepatic artery and portal vein before and after preconditioning.

Eligibility criteria: Inclusion Criteria:

* patients with colorectal cancer liver metastasis all of which signed an informed consent

Exclusion Criteria:

* having any other underlying liver disease, or preoperative increased liver transaminase, bilirubin
* patients with chronic cardiac, pulmonary or renal disease

Primary outcomes:
measure: Change in synthetic liver function
timeFrame: Preoperatively, first, third and seventh postoperative day
Secondary outcomes:
measure: Flow through the hepatic artery and portal vein
timeFrame: Before and after preconditioning
measure: Liver histology evaluation
timeFrame: Up to 10 days after operation
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Dubrava
Study officials:
affiliation: Clinical Hospital Dubrava
name: Leonardo Patrlj
role: STUDY_CHAIR
References:
Clinical trial NCT01590420: Cost-utility Study of Continuous Positive Airway Pressure Treatment in Obstructive Sleep Apnea Syndrome Patients
Official title: Cost-utility Study of CPAP Treatment in Obstructive Sleep Apnea Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: OSA
Sleep
CPAP
Cost
Lead sponsor: Associação Fundo de Incentivo à Pesquisa
Sponsor class: OTHER
First posted: 2012-05-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to estimate the cost-utility of continuous positive airway pressure (CPAP) therapy in obstructive sleep apnea (OSA) patients in Sao Paulo city, Brazil, after 3 years of treatment and to estimate the cost-effectiveness of CPAP on the number of medical visits, hospitalizations, medical examinations, used medications, new case incidence and cost of traffic accidents and absence from work. It is also designed to estimate quality-adjusted extended years of life, and to assess cost-effects of the therapy (device, masks, supplies, maintenance/year for membership of professional consulting, electric power) on the cost-effectiveness

Detailed description: OSA is highly prevalent in Sao Paulo city, Brazil. It is associated with significant comorbidities. The cost-utility study is important to (1) support decision-making on health policies, (2) to incorporate new technologies, (3) implementation of preventive programs and policy development assistance in the medical field.

Probably CPAP treatment in the long-term, will improve health, physical and mental state, and especially, reduces spending on public health, demonstrating cost-utility.

Eligibility criteria: Inclusion Criteria:

* Both genders
* Aged 30 to 70 years old
* AHI \> 30 events/hour

Exclusion Criteria:

* Patients residing in other cities and states other than São Paulo / SP / Brazil
* Patients with no fixed residence
* Previous CPAP contact

Primary outcomes:
measure: costs of medical events post CPAP treatment
timeFrame: 3 years
measure: Number of hospitalizations
timeFrame: 3 years
measure: Changes in medications
timeFrame: 3 years
Secondary outcomes:
measure: Costs relative to CPAP treatment
timeFrame: 3 years
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Associação Fundo de Incentivo à Pesquisa
Study officials:
affiliation: Federal University of São Paulo
name: Camila F Rizzi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Dalva Poyares, PhD
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Sergio Tufik, PhD
role: STUDY_DIRECTOR
affiliation: Federal University of São Paulo
name: Marcos F Bosi, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05864820: Photogrammetric Scan System for Body Composition Analysis
Official title: The Use of Photogrammetric Technology for the Evaluation of Anthropometric Measurements and Body Composition
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anthropometry
Musculoskeletal System
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects of the general population

Brief summary: This observational study evaluates the goodness of the IGOODI photogrammetric scan system in measuring anthropometry and estimating the body composition of 75 healthy subjects, comparing the results with the measurements taken using methods used in clinical practice, including body circumferences and bioimpedance analysis.


Eligibility criteria: Inclusion Criteria:

* Male or female gender
* Between the ages of 18 and 85
* Caucasian race
* Cognitively intact
* Acceptance and signing of informed consent
* Height between 120 and 200 cm (included)

Exclusion Criteria:

* Congenital or acquired musculoskeletal deformities of the limbs or trunk
* Implants resulting from cosmetic surgery
* Articular prostheses and/or means of synthesis
* Current oncological or metabolic pathologies
* Photosensitivity
* Epilepsy
* Claustrophobia
* Subjects unable to independently maintain an upright position
* Wearers of pacemakers

Primary outcomes:
measure: Correlation between anthropometric circumferences
timeFrame: Baseline and after 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
Study officials:
affiliation: IRCCS Istituto Ortopedico Galeazzi
name: Matteo Briguglio
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04522973: The Impact of Oral Ethanol and Vaped Ethanol on the Evaluation of Impairment
Official title: The Impact of Oral Ethanol and Vaped Ethanol on the Evaluation of Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electronic Cigarette Use
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: U.S. Department of Justice
First posted: 2020-08-21
Enrollment: 7
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research study is to find out about ethanol-containing e-cigarettes impact ethanol breath tests, field sobriety tests, or other tests of sobriety. Ethanol is a common part of e-cigarette liquids.


Eligibility criteria: Inclusion Criteria:

* e-cigarette users
* willing to provide informed consent
* able to attend the lab sessions as needed
* agree to use designated products according to study protocol.

Exclusion Criteria:

* Women who are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
* Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the stud

Primary outcomes:
measure: Change in preliminary ethanol breath level
timeFrame: Conducted before and after the e-cigarette is used by the participant, at multiple time points (change from baseline reading at 45, 55, 125, 155, 200, 250, 280 minutes after e-cigarette use)
measure: Standard Field Sobriety Test
timeFrame: Conducted before and after the e-cigarette is used by the participant, at multiple time points (change from baseline at 55, 90, and 250 minutes after e-cigarette use)
Secondary outcomes:
Other outcomes:
measure: Direct Effects of Vaping Questionnaire
timeFrame: Administered after e-cigarette use (at 90 and 250 minutes after e-cigarette use)
measure: Biphasic Alcohol Effects Scale
timeFrame: Conducted before and after the e-cigarette is used by the participant (change from baseline at 90 and 250 minutes after e-cigarette use)
measure: General Labeled Magnitude Scale
timeFrame: Administered after e-cigarette use (at 90 and 250 minutes after e-cigarette use)
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Alison Breland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03248973: Successful Treatment of Maternal Listeria Monocytogenes Bacteremia in the First Trimester
Official title: Successful Treatment of Maternal Listeria Monocytogenes Bacteremia in the First Trimester of Pregnancy: a Case Report and Review of Literatures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Listeria Monocytogenes
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 1
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One pregnant woman with listeria monocytogenes bacteremia in the first trimester

Brief summary: Successful Treatment of Maternal Listeria Monocytogenes Bacteremia in the First Trimester of Pregnancy

Detailed description: A 34-year-old nulliparous woman with 11 gestational weeks with flu-like illness was proved to be infection by Listeria monocytogenes, and then treated by intravenous ampicillin 2 g every 4 hours for 3 weeks. A healthy unaffected male baby was delivered at 41 weeks' gestation.

Eligibility criteria: Inclusion Criteria:

* One pregnant woman with listeria monocytogenes bacteremia in the first trimester

Primary outcomes:
measure: Successful treatment
timeFrame: 1 month after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
References:
Clinical trial NCT04036773: Food Pharmacy at Oregon Health & Science University (OHSU) Knight Cardiovascular Institute (KCVI)
Official title: The Impact of a Fruit and Vegetable Provision Program on Cardiovascular Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemias
Keywords: diet
nutrition
hyperlipidemia
produce
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Participants in the intervention group of this study will receive weekly home deliveries of fruit \& vegetables for 3 months. The primary objective of this study is to determine if increased access to fruits and vegetables leads to sustained dietary changes, measured through changes in the Healthy Eating Index (HEI). Secondary objectives are to determine whether increased fruit and vegetable access (increased HEI) ultimately leads to improved cardiovascular (CV) health indicators (e.g., body mass index, waist circumference, blood pressure, and levels of blood lipids and hemoglobin A1c).


Eligibility criteria: Inclusion Criteria:

* Age 19 years and older
* Established patient at OHSU Center for Preventive Cardiology
* Not requiring changes to medication regimen for the 6-month study duration
* Must be eligible to register with produce delivery company (reside in Portland-metro area; have access to a computer with internet service; able to read English)

Exclusion Criteria:

* Triglycerides \> 500 mg/dL
* Heavy alcohol use (\> 3 drinks/day)
* Uncontrolled hypertension (BP \> 140/90)
* LDL-C \> 160 mg/dL
* Uncontrolled diabetes mellitus (HbA1c \> 8%)
* Failure to provide informed consent
* Current pregnancy
* Healthy Eating Index (HEI) score of ≥ 80

Primary outcomes:
measure: Intake of fruits and vegetables measured by changes in Healthy Eating Index (HEI)
timeFrame: 6 months
Secondary outcomes:
measure: Changes in weight measured by body mass index
timeFrame: 6 months
measure: Changes in waist circumference
timeFrame: 6 months
measure: Changes in total cholesterol
timeFrame: 6 months
measure: Changes in HDL-cholesterol
timeFrame: 6 months
measure: Changes in LDL-cholesterol
timeFrame: 6 months
measure: Changes in triglycerides
timeFrame: 6 months
measure: Changes in blood pressure
timeFrame: 6 months
measure: Changes in blood glucose
timeFrame: 6 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Tracy Severson, RDN
role: PRINCIPAL_INVESTIGATOR
References: