louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03804502: Pilot Study of TearCare System - Long-Term Extension
Official title: Pilot Study of TearCare System - Long-Term Extension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye Syndromes
Lead sponsor: Sight Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2019-01-15
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate the long-term clinical utility, safety, and effectiveness of re-treatment with the TearCare™ System in adult patients with dry eye syndrome who had previously been treated with the TearCare System.


Eligibility criteria: Inclusion Criteria:

* Previously enrolled in the TearCare arm of the TearCare Pilot Study
* Reports dry eye symptoms within 3 months of the baseline examination with a Standard Patient Evaluation for Dryness (SPEED) score ≥ 6
* TBUT of \<10 seconds in at least one eye
* Willing to comply with the study, procedures, and follow-up
* Willing and able to provide consent

Exclusion Criteria:

* Any active ocular or peri-ocular infection or inflammation
* Recurrent eye inflammation within the past 3 months
* Ocular surgery, oculoplastic surgery, ocular injury, Ocular Herpes Simplex, or Herpes Zoster
* Ocular surface abnormalities that may affect tear film distribution or treatment
* Abnormal eyelid function in either eye
* Diminished or abnormal facial, periocular, ocular or corneal sensation
* Ocular surface abnormalities such as corneal epithelial defects, ulcers, corneal dystrophies
* Systemic diseases resulting in dry eye (e.g. Sjogren's syndrome)
* Allergies to silicone tissue adhesives
* An absence or fibrosis of the Meibomian glands (e.g. ectodermal dysplasia).
* Unwillingness to abstain for the duration of the study from systemic medication known to cause ocular dryness (e.g. Accutane, antihistamines, etc.)
* Anyone who requires chronic use (i.e. for any portion of the study) of topical ophthalmic antibiotics, steroids, non-steroidal anti-inflammatory medications or who has been on any of these medications within the past 30 days.
* Unwillingness to washout and remain off certain dry eye medications for the duration of the study.
* Participation in another ophthalmic clinical trial within the past 30 days
* Co-existing conditions that could interfere with the assessment of safety or efficacy of treatment (e.g. macular disease, pregnancy, nursing, etc.)

Primary outcomes:
measure: Tear Break-Up Time
timeFrame: 1 month
Secondary outcomes:
measure: Meibomian Gland Secretion Score
timeFrame: 1 month
measure: SPEED II Questionnaire
timeFrame: 1 month
measure: OSDI Questionnaire
timeFrame: 1 month
measure: Corneal staining
timeFrame: 1 month
measure: Conjunctival staining
timeFrame: 1 month
measure: Adverse Events
timeFrame: 1 month
Other outcomes:
Locations:
city: Arlington Heights
country: United States
facility: Central Eye Care
state: Illinois
Study officials:
References:
Clinical trial NCT03184402: Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia (PART 2)
Official title: Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-blind, Active-controlled Study (PART 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Functional Dyspepsia
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2017-06-12
Enrollment: 124
Sex: ALL
Minimum age (years): 19
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 evaluate the Efficacy and Safety of DWJ1252 in treatment of Functional Dyspepsia.


Eligibility criteria: Inclusion Criteria:

* Male and female of at least 19 years old
* Patient with functional dyspepsia met the ROME III criteria

Exclusion Criteria:

* Patients with previous gastrointestinal surgery
* Patients with history of gastrointestinal bleeding, mechanical obstruction, perforation
* Patients with history of gastrointestinal cancer

Primary outcomes:
measure: The change from baseline in GIS (Gastrointestinal Symptom Score)
timeFrame: At 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Smg-Snu Boramae Medical Center
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: SMG-SNU BORAMAE MEDICAL CENTER
role: STUDY_CHAIR
References:
Clinical trial NCT02365402: Efficacies of Entecavir Add on HBeAg Negative Patients With HBV DNA Positive During Peginterferon Alpha 2a Treatment
Official title: Efficacies of Entecavir Add on HBeAg Negative Chronic Hepatitis B Patients With HBV DNA Load ≥1000 Copies/ml After 3 Months of Peginterferon Alpha 2a Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Hepatitis B
Keywords: chronic hepatitis B
peginterferon
sustained viral response
entecavir
HBeAg
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2015-02-18
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of interferon therapy in HBeAg negative chronic hepatitis B was to make patients obtain immune control to hepatitis B virus defined as sustained viral response after treatment. However this target could not be get if patients keep HBV DNA positive during interferon treatment and offend relapse after treatment withdraw. In this trail, entecavir will add on patients with HBV DNA load ≥1000copies/ml after 3 months of peginterferon alpha 2a treatment, and the efficacies of the combine treatment will be evaluated by the rate of sustained viral response after 48 weeks of treatment and 24 week follow up.

Detailed description: HBeAg negative patients with HBV DNA load ≥1000copies/ml after 3 months of peginterferon alpha 2a treatment would be randomize enrolled into two groups, in Interventional group, patients will receive entecavir combine with peginterferon alpha 2a treatment for 48 weeks and followed 24 weeks. Patients in control group will be continue treated only by peginterferon alpha 2a for 48 weeks and followed 24 weeks after treatment. Serum HBV DNA load, HBsAg/anti-HBs level, HBeAg/anti-HBe will be tested at enrollment and every 3 months during the treatment course. Parameters of Liver and kidney function, and liver ultrasound examination will be tested with intervals 1-3 months. The efficacies of combined therapy were evaluated by the rate of sustained viral response after 48 weeks treatment and 24 weeks follow up compared with control group.

Eligibility criteria: Inclusion Criteria:

* HBeAg negative patients with HBV DNA load ≥1000copies/ml after 3 months of peginterferon a-2a treatment

Exclusion Criteria:

* Active consumption of alcohol and/or drugs
* Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
* History of autoimmune hepatitis
* Psychiatric disease
* Evidence of neoplastic diseases of the liver

Primary outcomes:
measure: rate of sustained virual response
timeFrame: 72 weeks
Secondary outcomes:
measure: rates of HBsAg loss during treatment course and at the end of follow-up
timeFrame: 72 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan hospital,Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT01884402: Observational,Prospective Study to Develop and Validate a Prognostic Tool to Optimize Therapy in Patients With HCV G1/4
Official title: Observational,Post-authorization Prospective Study to Develop and Validate a Prognostic Tool for Optimizing Therapy in Patients With Hepatitis C Virus (HCV) Genotype 1 and 4.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2013-06-24
Enrollment: 770
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic hepatitis C genotype 1 and 4 mono-or co-infected with HIV who meet the selection criteria described.

Brief summary: Primary objective:

• Develop and validate a tool towards patients with chronic hepatitis C genotype 1 and 4 to allow optimize treatment.

Detailed description: This Tool:

1. Predicting the overall impact of prognostic factors (including the new factor of genetic polymorphism of the IL28B) on Sustained Viral Response (SVR).
2. Identify those patients most likely to respond.
3. Therapy and therefore optimize resources

The validation tool will check into clinical practice its predictive power (it will consider its ability to calibrate and discriminate) and make correct inferences and interpretations of the scores obtained when applying.

Eligibility criteria: Inclusion Criteria:

* Patients with \> 18 years old.
* Patients diagnosed with chronic hepatitis C in the presence of HCV RNA in plasma that meet criteria for initiating antiviral therapy in routine clinical practice conditions.
* Patients Genotype 1 and 4.
* Patients with the results of all the factors evaluable at the time of inclusion.
* Patients who have accepted their participation in the study through informed consent.

Exclusion Criteria:

* Patients previously treated with interferon (IFN) and ribavirin (RBV).
* Patients with genotype 2, 3, 5 and 6.
* Patients with co-infection with hepatitis B.
* Patients with other liver diseases.
* Patients with any contraindications to the drugs used in the treatment of hepatitis C.

Primary outcomes:
measure: Sustained Viral Response (RVS)
timeFrame: 1 ½ years (72 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Fundación Pública Andaluza para la Gestión de la investigación en salud de Sevilla (FISEVI)
Study officials:
affiliation: Hospital de Valme & ciberEHD
name: Manuel Romero-Gómez, Medicine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05924802: Physiological Effects Ketone Ester in Heart
Official title: Physiological Effects of Dietary Supplement Ketone Ester on the Heart
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo vs intervention group. Ketone ester is NOT a drug and only used to see the physiological effects on the heart.
Primary purpose: OTHER

Brief summary: The study is aimed to phenotype with cardiac MRI the physiological effects of ketone esters on the heart. Patients with heart failure will be recruited and given ketone esters or placebo in a randomized fashion. Cardiac MRI will be performed at baseline and after 12weeks follow up.


Eligibility criteria: Inclusion Criteria:

* heart failure EF \< 40%

Exclusion Criteria:

* Claustrophobia
* Contraindicated implanted device

Primary outcomes:
measure: Change in Left Ventricular Ejection Fraction
timeFrame: Pre-intervention and up to 12 weeks after intervention
Secondary outcomes:
measure: Change in Creatine concentration
timeFrame: Pre-intervention and up to 12 weeks after intervention
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cardiovascular Innovation Research Center
state: Ohio
Study officials:
References:
citation: Yurista SR, Matsuura TR, Sillje HHW, Nijholt KT, McDaid KS, Shewale SV, Leone TC, Newman JC, Verdin E, van Veldhuisen DJ, de Boer RA, Kelly DP, Westenbrink BD. Ketone Ester Treatment Improves Cardiac Function and Reduces Pathologic Remodeling in Preclinical Models of Heart Failure. Circ Heart Fail. 2021 Jan;14(1):e007684. doi: 10.1161/CIRCHEARTFAILURE.120.007684. Epub 2020 Dec 28.
citation: Yurista SR, Eder RA, Welsh A, Jiang W, Chen S, Foster AN, Mauskapf A, Tang WHW, Hucker WJ, Coll-Font J, Rosenzweig A, Nguyen CT. Ketone ester supplementation suppresses cardiac inflammation and improves cardiac energetics in a swine model of acute myocardial infarction. Metabolism. 2023 Aug;145:155608. doi: 10.1016/j.metabol.2023.155608. Epub 2023 Jun 1.
Clinical trial NCT00145002: A Study for Aggressive Adult T-cell Leukemia-lymphoma (ATLL)
Official title: Phase III Study of VCAP-AMP-VECP vs. Biweekly CHOP in Aggressive Adult T-cell Leukemia-lymphoma (ATLL): Japan Clinical Oncology Group Study, JCOG9801.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Adult T-cell Leukemia
Lymphoma
Keywords: ATLL
chemotherapy
phase III study
VCAP-AMP-VECP
biweekly-CHOP
Lead sponsor: Japan Clinical Oncology Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2005-09-05
Enrollment: 130
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test the superiority of VCAP-AMP-VECP regimen over biweekly-CHOP in aggressive ATLL in terms of survival benefit.

Detailed description: Nothing to describe.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of ATL was made based on seropositivity for HTLV-I by either enzyme-linked immunosorbent assay or particle agglutination assay, and histologically- and/or cytologically-proven peripheral T-cell malignancy
2. Aggressive ATL, i.e., acute-, lymphoma- or unfavorable chronic-type ATL
3. Aged 15-69 years
4. No prior chemotherapy or radiotherapy
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3 or 4 as a result of hypercalcemia
6. Preserved organ (bone marrow, liver, kidney, heart and lung) functions
7. All patients were required to provide written informed consent

Exclusion Criteria:

1. Diabetes mellitus necessitating treatment with insulin
2. Active systemic infection
3. Cardiac disorders expected to become worse as a result of the DOX-containing regimen
4. Acute hepatitis, chronic hepatitis or liver cirrhosis
5. Positive for HBs Ag or anti-HCV Ab
6. Active concurrent malignancy
7. Other serious medical or psychiatric conditions
8. Pregnancy or breast feeding
9. Central nervous system involvement by ATL cells

Primary outcomes:
measure: Overall survival
Secondary outcomes:
measure: Toxicity
measure: CR rate
measure: Progression free survival
Other outcomes:
Locations:
city: Nagasaki
country: Japan
facility: Nagasaki University Graduate School of Biomedical Science
Study officials:
affiliation: Nagasaki University Graduate School of Biomedical Science
name: Masao Tomonaga, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03341702: Predictive Factors of Violence in Prison
Official title: Predictive Factors of Violence in Prison, Retrospective Study in an French Incarcerated Male Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prisoner
Keywords: jail
violence
predictive factors
prevention
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2017-11-14
Enrollment: 1200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: male incarcerated in a french prison

Brief summary: Prison concentrates people with violent behavior and patients suffering from psychiatric disorders. Aggression are daily, the suicide rate is 5 to 10 times higher than the ordinary environment and current prevention devices have shown their limits.

That's why, in order to improve the violence's prevention in prison, the investigator propose to identify the predictive factors of violence by studying retrospectively the link between the psychiatric profile and commission of violence after being jailed.

Detailed description: From the 1st January to the 31 December 2012, every man incarcerated was screened thanks to the Mini International Neuropsychiatric Interview (MINI) to establish the presence of a current and/or past psychiatric diagnoses. In addition, collection of violent incidents based on penitentiary's reports (aggression, suicide, self-mutilation, intoxication, murder...) was conducted .

Then statistic analysis compared psychiatric characteristics of prisoners according to whether they commit violence or not within 12 months after being jailed, distinguish the authors of self and hetero aggressive violence. Those tests are completed with a cluster analysis to precise psychiatric from criminological profiles of dangerousness.

Eligibility criteria: Inclusion criteria:

- being jailed from 1st january 2012 to 31 dec 2012 in the Villeneuve Lès Maguelonne prison (Hérault, France)

Exclusion criteria:

- opposition form, unable to understand french, age under 18

Primary outcomes:
measure: violent event
timeFrame: within the 12 month after incarceration
measure: violent event
timeFrame: within the 12 month after incarceration
measure: violent event
timeFrame: within the 12 month after incarceration
measure: violent event
timeFrame: within the 12 month after incarceration
measure: violent event
timeFrame: within the 12 month after incarceration
measure: violent event
timeFrame: within the 12 month after incarceration
Secondary outcomes:
measure: suicide attempt
timeFrame: within the 12 month after incarceration
measure: physical assault
timeFrame: within the 12 month after incarceration
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Mathieu LACAMBRE, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01500902: Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome
Official title: The Assessment of Novel Functional Risk Factors for the Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: Acute Coronary Syndrome (ACS)
Percutaneous Intervention (PCI)
Coronary Stent (CStent)
Percutaneous Transluminal Coronary Angioplasty (PTCA)
stent placement
balloon angioplasty
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Qatar National Research Fund
First posted: 2011-12-29
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if testing patients for endothelial dysfunction will help identify which patients are more likely at risk to have another heart attack in the future. Study participants will undergo mental stress testing while at the same time being connected to a device that measures endothelial function via the Endopat device. These same participants will also undergo a sleep study via the Watchpat device.


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing revascularization by percutaneous intervention (PCI) for Acute Coronary Syndrome (ACS) at Mayo (STEMI and NonSTEMI patients)
2. Age greater than 18

Exclusion Criteria:

1. Patients likely not to complete the study due to co-morbid conditions (end stage renal disease; liver failure; malignancies)
2. Inability to sign a consent form or availability for follow up
3. Patients unable to tolerate the blood pressure cuff inflation on both arms
4. patients with tremors
5. sustained non-sinus cardiac arrhythmias
6. acrylic finger nails
7. permanent pacemaker
8. color blindness
9. use of alpha blockers and short acting nitrates \< 3 hours before study
10. Federal Medical Center inmates

Primary outcomes:
measure: Unstable Angina, Myocardial Infarction, Repeat Revascularization, Cardiac Death, Stroke
timeFrame: Will determine with statistical analysis after all patients have had 2 year follow-up
Secondary outcomes:
measure: Quality of Life
timeFrame: 6 months post revascularization.
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Amir Lerman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03709602: SDH of HPV Vaccine Completion
Official title: Social Determinants of HPV Vaccine Completion Among Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papilloma Virus
Keywords: HPV
adolescents
HPV Vaccine
social determinants
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 3076
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents ages 11 to 14 years and their parent from Duke University Primary Care Pediatrics at Roxboro Road.

Brief summary: The purpose of this research study is to find out which factors influence parents' ability to complete the human papillomavirus (HPV) vaccine series for their child. The information learned from this study may help the investigators develop programs to improve HPV vaccine completion rates among adolescents and reduce barriers to receiving the second shot of the vaccine series.


Eligibility criteria: Inclusion Criteria:

* For adolescents, participants need to be between the ages 11 to 14 years.
* Received 1 dose of the HPV vaccine series between January 2017 and December 2017.
* For parents, there is no age limit required.
* Parents as defined as the adolescent's biological mother or father, step-parents, or legal guardian.
* Parents or legal guardians who self-identified as the primary caregiver of the adolescent child and most likely to make medical decisions for the adolescent.

Exclusion Criteria:

* Parents with cognitive impairment.
* Adolescents with cognitive impairment.
* Adolescents emancipated from their parents or legal guardian
* Pregnant adolescent girls.

Primary outcomes:
measure: Overall HPV Vaccine Completion Rates
timeFrame: up to 14 months
Secondary outcomes:
measure: HPV Vaccine Completion Within 14-Months
timeFrame: within 14 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Primary Care Pediatrics at Roxboro Road
state: North Carolina
Study officials:
affiliation: Duke University
name: Rosa Gonzalez-Guarda, PhD
role: PRINCIPAL_INVESTIGATOR
References: