louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06282549: Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients with Essential Hypertension
Official title: A Prospective Long-term Cohort Study to Identify the Predictive Model of Cardiocerebrovascular Risk Factors in Elderly Patients with More Than Three Antihypertensive Agents in Patients with Essential Hypertension in Korea
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Essential Hypertension
Keywords: Telmisartan/Amlodipine/Chlorthalidone Fixed-Dose Combination (Truset)
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2024-02-28
Enrollment: 1219
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: Patients in General Hospital

Brief summary: This study is to develop a predictive model for cardiocerebrovascular risk factors in elderly patients with essential hypertension with Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination.

Detailed description: This is a phase IV, open-label, prospective, long-term cohort, observational study to identify the predictive model of cardiocerebrovascular risk factors in elderly patients with more than three antihypertensive agents in patients with essential hypertension in Korea.

Eligibility criteria: Inclusion Criteria:

1. A patient over 65-year-old with essential hypertension
2. A patient with essential hypertension who require treatment with 3 or more antihypertensive medication, as determined by investigator's decision
3. A patient with no MACCE within 6 months prior to the enrollment
4. A patient who voluntarily signed the informed consent form

Exclusion Criteria:

1. A patient who participates in clinical trial
2. A patient who are contraindicated for the Truset tablet according to the label.
3. A patient who is unable to complete the study judged by the investigator.

Primary outcomes:
measure: Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events)
timeFrame: 12, 24 and 36months
Secondary outcomes:
measure: Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) in patients with asymptomatic target organ damage
timeFrame: 12, 24 and 36months
measure: Mean Systolic Blood Pressure (MSBP)/ Diastolic Blood Pressure (MDBP)
timeFrame: 12, 24 and 36months
measure: Patients Achieving the treatment goal in Mean Systolic Blood Pressure (MSBP)
timeFrame: 36months
measure: Percentage of patients who terminated the treatment
timeFrame: 36months
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Busan Veterans Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Veterans Hospital
city: Gwangju
country: Korea, Republic of
facility: Gwangju Veterans Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Veterans Health Service Medical Center
Study officials:
affiliation: Veterans Health Service Medical Center
name: Changhoon Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03067649: Parents' Adherence to Treatment Recommendations
Official title: Parents' Adherence to Treatment Recommendations: Do It for the Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Help-Seeking Behavior
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2017-03-01
Enrollment: 194
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental intervention vs. an information only control
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study was to test whether conducting a brief motivational interview that focused on perceived barriers to treatment seeking would increase the likelihood that a parent with psychiatric problems would seek treatment for themselves.

Detailed description: The primary aim of this study was to test a method for increasing adherence to treatment recommendations for parents of children with emotional/behavior problems. Mental health problems in parents can be a serious risk factor for psychiatric and medical problems in children, yet most parents of children receiving services for mental health or medical problems do not get treatment for their own problems. The specific aim of this study was to increase parents' adherence to recommendations for treatment. Parents were randomly assigned to either the Enhanced Motivational Intervention (EMI) or an information only control group. The EMI involves motivational interviewing comprised of a brief intervention that elicits the parents' "story," provides education about their problem(s), describes the potential link between parents' and children's symptoms, assesses their prior treatment history, expectations, and concerns about treatment, identifies potential barriers to treatment seeking, and determines the next step. Evaluations at baseline and 8-weeks and 4-months post intervention will assess parents' symptoms, functioning, and service utilization. The investigators hypothesized that adherence to treatment recommendations would be significantly greater for parents in the EMI group compared to parents in the control group.

Eligibility criteria: Inclusion Criteria:

* Parent or guardian of a child who is receiving services for emotional or behavioral problems.
* Must have legal custody of the child

Exclusion Criteria:

* Current psychosis

Primary outcomes:
measure: Contact a treatment provider
timeFrame: by the 4-month post intervention evaluation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05407649: Abscopal Effect of Radiotherapy in Combination With rhGM-CSF for Advanced Thymic Epithelial Tumours
Official title: Abscopal Effect and Safety of Recurrent and Refractory Advanced Thymic Epithelial Tumours Treated With Combined Therapy of Local Radiotherapy and Granulocyte-macrophage Colony-stimulating Factor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Thymoma
Lead sponsor: Shanghai Cancer Hospital, China
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether radiotherapy (RT) combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) is safe, effective in the treatment of patients with advanced thymic epithelial tumours.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years;
2. Histologically proven thymic epithelial tumours；
3. Stage IV according to UICC stage system(version 8,2017), at least with two evaluable abscopal lesions (≥1cm)（excluding intestinal metastasis）;
4. Evaluated as effective or stable disease after first-line chemotherapy or progressed after second-line chemotherapy (progression sites were no more than three sites);
5. ECOG performance status: 0-1;
6. Life expectancy ≥ 3 months.
7. Adequate baseline organ and marrow function: absolute neutrophil count greater than 1500 cells per μL, platelet concentration of greater than 50 000 per μL, total bilirubin less than 1•5 times the upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase less than 2•5 times the ULN, and serum creatinine less than 1•5 times the ULN;
8. Female subjects have a negative urine or serum pregnancy test within 1 week prior to treatment if of childbearing potential;
9. Asymptomatic subjects with brain metastasis can be included, but the sites of brain cannot be considered as target sites;
10. Asymptomatic subjects with bone metastasis can be included, but the sites of bone cannot be considered as target sites.

Exclusion Criteria:

1. Having received immunotherapy within 4 weeks prior to inclusion;
2. Allergic to GM-CSF, INF-α2b or diagnosed with immune system disease, receiving immunosuppressant, such as prednisone, dexamethasone, methylprednisolone, methotrexate, hydroxychloroquine, cyclophosphamide, azathioprine and so one;
3. Receiving treatment of other trials;
4. Any unstable systemic disease, including active infection, symptomatic congestive heart failure,myocardial infarction onset six months before included into the group, unstable angina, and severe arrhythmia, uncontrolled chronic lung disease;
5. Unwilling to sign consent;
6. Women in pregnancy or lactation;

Primary outcomes:
measure: The abscopal effect rate
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT00739349: NOVA22007 0.05% and 0.1% Cyclosporine Versus Vehicle for the Treatment of Dry Eye
Official title: A Phase II, Multi-Center, Double-Masked, Randomized Study of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Cationic Emulsions Compared to Vehicle for the Treatment of the Signs and Symptoms of Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye
Keywords: Dry Eye
Cyclosporine
Lead sponsor: Santen SAS
Sponsor class: INDUSTRY
First posted: 2008-08-21
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study is to assess the safety and efficacy of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Cationic Emulsions QD compared to vehicle for the treatment of the signs and symptoms of dry eye after a 3 month treatment period.


Eligibility criteria: Inclusion Criteria:

* Male and female 18 years and older
* Diagnosis of dry eye in both eyes

Exclusion Criteria:

* Contraindications to the use of the study medications
* Known allergy or sensitivity to the study medications or their components
* Female currently pregnant, nursing, or planning a pregnancy; or woman who has a positive pregnancy test
* Have participated in an investigational drug or device study within 30 days of Visit 1

Primary outcomes:
measure: Assess the safety and efficacy of two doses of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Emulsions
timeFrame: Approximately 13 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lewiston
country: United States
facility: Central Maine Eye Care, PA
state: Maine
Study officials:
References:
Clinical trial NCT04505449: Invasive Left Heart Catheterization Registry
Official title: Role of Invasive Left Heart Catheterization for Patients Suspected Heart Failure With Preserved Ejection Fraction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure With Preserved Ejection Fraction
Left Ventricular Diastolic Dysfunction
Keywords: Heart failure with preserved ejection fraction
Left ventricular end diastolic pressure
Echocardiography
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 404
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospectively enrolled symptomatic patients who underwent left heart catheterization

Brief summary: Retrospectively enrolled suspicious of heart failure with preserved ejection fraction (HFpEF) patients who underwent left heart catheterization with the measurement of left ventricular end-diastolic pressure.

Detailed description: Heart failure (HF) with preserved ejection fraction (HFpEF) remains a poorly understood clinical syndrome without effective targeted therapies. The clinical syndrome of HFpEF develops from a complex interaction of several risk factors such as aging, obesity, hypertension, myocardial ischemia, and arterial stiffness that cause organ dysfunction and, ultimately, clinical symptoms. Although the H2FPEF and HFA-PEFF scores have recently been proposed to estimate the probability of HFpEF in patients suffering from unexplained dyspnea, diagnosing HFpEF remains still challenging. The aim of the current registry was to evaluate the role of invasive left heart catheterization with the measurement of left ventricular end-diastolic pressure (LVEDP) in suspicious of HFpEF patients.

Eligibility criteria: Inclusion Criteria:

* Left ventricular ejection fraction \> 50%
* Patients who had a symptom and/or signs of heart failure (dyspnea on exertion, chest discomfort, fatigue, dizziness, or ankle edema)
* Patients who underwent left heart catheterization with the measurement of left ventricular end-diastolic pressure

Exclusion Criteria:

* Left ventricular ejection fraction \<50%
* Acute coronary syndrome
* More than moderate valvular heart disease
* Primary cardiomyopathies such as dilated cardiomyopathy and hypertrophic cardiomyopathy, amyloidosis
* Pulmonary arterial hypertension
* Heart transplantation
* Constrictive pericarditis
* Stress-induced cardiomyopathy

Primary outcomes:
measure: Rates of Death or re-hospitalization due to heart failure
timeFrame: 10 Years
Secondary outcomes:
measure: Rates of All-cause death
timeFrame: 10 Years
measure: Rates of Re-hospitalization due to heart failure
timeFrame: 10 Years
measure: Rates of Myocardial infarction
timeFrame: 10 Years
measure: Rates of Stroke
timeFrame: 10 Years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jeong Hoon Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05247749: CONVIVO System to Discriminate Healthy Tissues vs Tumor Tissues During Brain Tumor Resection
Official title: Clinical Investigation to Evaluate the CONVIVO System for Discrimination of Normal Tissues From Abnormal Tissues During Brain Tumor Resection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Brain Tumor
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 0
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 the study is to do a direct comparison of the CONVIVO system (camera imaging device) with our normal Stanford pathology process. CONVIVO system is being tested to see if the device creates the images very quickly by touching a special camera to the surgical wound.

Detailed description: Primary Objective:

The primary objective of this study is to determine the feasibility of using the CONVIVO imaging system to identify tumor type.

Secondary Objective: The secondary objectives are to determine the average time needed for tissue visualization with the CONVIVO system as compared to standard cryosectioning, and to describe the ability of the CONVIVO imaging

-To describe the ability of the CONVIVO imaging system to generate readable images.

Eligibility criteria: Inclusion Criteria:

* The subject demonstrates the ability to understand and the willingness to sign a written informed consent document.
* The subject is suspected to be suffering from following brain tumor: low-grade glioma, high grade-glioma, metastases, or meningioma.
* The subject has been deemed eligible for surgical resection by a practicing Stanford physician.
* Macroscopic tumor visualization using IV infusion of 500mg sodium fluorescein is planned as part of the subject's standard of care treatment.
* The subject is older than 18 years.
* The subject is receiving their surgery at Stanford Hospital.

Exclusion Criteria:

\* Patients with any kind of contraindication to the use of fluorescein

Primary outcomes:
measure: Feasibility of using the CONVIVO imaging system to identify tumor tissue identified by the operating surgeon
timeFrame: 12 months
Secondary outcomes:
measure: Average time needed for tissue visualization with the CONVIVO system as compared to standard cryosectioning
timeFrame: 12 months
measure: Ability of the CONVIVO system capture a readable image
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Stanford Universiy
name: Gordon Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01152749: Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum
Official title: Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum. A Study in Healthy Smokers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Keywords: Smoking Cessation
Nicotine pharmacokinetics
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2010-06-29
Enrollment: 76
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study examines the bioequivalence between an oral nicotine replacement product and Nicorette® gum.

Detailed description: The study is a single-dose, randomized, crossover study with 76 subjects (all subjects will receive all treatments). The investigational products will be given as single doses at separate treatment visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Blood for pharmacokinetic analyses will be drawn before and at 5, 10, 15, 20, 30, 45, and 60 minutes, as well as at 1.5, 2, 4, 6, 8, and 10 hours after start of product administration. Used gums will be collected and analyzed to determine the amount of remaining nicotine. Subjects will also be monitored to capture any adverse events that may occur.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and body mass index (BMI) between 17.5 and 30.0 kg/m2.
* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Pregnancy, lactation or intended pregnancy.
* Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.

Primary outcomes:
measure: Pharmacokinetic measurements
timeFrame: Baseline and during 10 hours after product administration
Secondary outcomes:
measure: tmax
timeFrame: Baseline and during 10 hours after product administration
measure: Lamda z
timeFrame: Baseline and during 10 hours after product administration
measure: Released amount of nicotine
timeFrame: After 30 minutes of chewing
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: McNeil AB Clinical Pharmacology R&D
Study officials:
affiliation: McNeil AB
name: Elisabeth Kruse, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04043949: The Influences of Dry Eye Disease on Optical Quality
Official title: The Influences of Dry Eye Disease on Optical Quality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye
Vision; Disturbance, Hysterical
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Aged between 18-65 years old.

Brief summary: DED could result in visual disturbance and damage optical quality. We aimed to evaluate the influences of dry eye disease (DED) on optical quality and their correlations.

Detailed description: This study is aimed at evaluating changes of optical quality in dry eye patients with superficial punctate keratopathy after being treated by artificial lubricant and anti-inflammatory eye drops.

Eligibility criteria: Inclusion Criteria:

1. patients were diagnosed as dry eye according to the criteria provided by the Dry Eye Workshop (DEWS)
2. positive corneal fluorescein staining (CFS)
3. best-corrected distance visual acuity better than 20/20.

Exclusion Criteria:

History of ocular surgeries, contact lens wear, meibomian gland dysfunction, and any type of corneal scarring such as dystrophies or infections.

Primary outcomes:
measure: The severity of DED influenced the optical quality of dry eye patients
timeFrame: 2017.7-2019.7
measure: High order abberations
timeFrame: 2017.7-2019.7
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Hong Qi, MD,Phd
role: STUDY_CHAIR
References:
Clinical trial NCT03302949: Treating Tuberculosis Wasting With a High-protein Supplement
Official title: Nutritional Supplement Trial in Patients With Tuberculosis to Improve Anthropometry and Treatment Outcome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tuberculosis
Tuberculosis, Pulmonary
Undernutrition
Malnutrition
Keywords: Nutritional Supplement
Health-related Quality of Life
Dietary Intake
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Bandim Health Project
name: Arla Foods
First posted: 2017-10-05
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Undernutrition at the time of diagnosis of active tuberculosis is a risk factor for increased mortality, and lack of weight gain during anti-tuberculous treatment has been linked to an increased relapse risk. The purpose of this study is to test the effect of Lacprodan® DI-8090 whey protein concentrate on anthropometric measures, treatment outcome and health-related quality of life, against standard practice during anti-tuberculous treatment on patients with a BMI \<20 living in Guinea-Bissau.

Detailed description: It is hypothesized that patients with tuberculosis receiving whey protein concentrate as nutritional supplement will experience a greater gain in adverse anthropometric measures, and experience a decreased risk of relapse and death, compared with patients with tuberculosis, who do not receive nutritional supplement. 260 patients will be recruited from and included/randomized at 4 trial sites in Bissau, Guinea-Bissau (Bandim Health Center, Belem Health Center, Cuntum Health Center and Hospital Raoul Follereau). Patients randomized to the intervention arm will receive one package of whey protein concentrate (approx. 62.5g) per day for the duration of the 6-month long anti-tuberculous treatment. Patients will be followed bimonthly during the treatment period, with clinical examinations, blood sample analyses, and nutritional status and dietary intake assessments.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with TB
* Aged 18 years and above
* BMI\<20

Exclusion Criteria:

* Pregnancy
* Commencement of treatment ≥30 days prior to inclusion
* Decreased kidney function
* Missing informed consent
* Mentally ill/disabled patients unable to comply with the treatment/intervention regimen

Primary outcomes:
measure: Anthropometry
timeFrame: 6 months
Secondary outcomes:
measure: Treatment Outcome
timeFrame: 6 months
measure: Treatment outcome
timeFrame: 2 years
measure: Anthropometry
timeFrame: 2 years
measure: Diet
timeFrame: 6 months
measure: Health-related quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Bissau
country: Guinea-Bissau
facility: The Bandim Health Project
state: Denmark
Study officials:
affiliation: University of Aarhus
name: Cecilie B Patsche
role: PRINCIPAL_INVESTIGATOR
References: