louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05137470: Emotion and Cognitive Function and Brain Imaging Change in HD Patients
Official title: Study on the Changes of Emotion and Cognitive Function and Brain Imaging in Uremic Patients Before and After Entering Dialysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Failure, Chronic
Cognitive Dysfunction
Magnetic Resonance Imaging
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2021-11-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Uremia patients undergoing hemodialysis treatment in the hemodialysis room of Beijing Friendship Hospital

Brief summary: 1. Observe the influence of entering hemodialysis treatment on the emotional and cognitive functions of ESRD patients.
2. Observe the influence of entering hemodialysis treatment on the brain structure imaging of ESRD patients.
3. Analyze and study the relevant clinical risk factors of the above-mentioned effects, and find targets for therapeutic intervention.

Detailed description: Select uremic patients and maintenance hemodialysis patients admitted to the Central Dialysis Room of Beijing Friendship Hospital, Capital Medical University from 2021, to collect and sort out the demographic characteristics of the patients: gender, age, clinical characteristics: primary disease, complications and Complications, body mass index (BMI), residual renal function, etc., clinical examination indicators: hemoglobin, blood calcium, blood phosphorus, blood PTH, blood albumin, URR, etc., hemodialysis treatment parameters: dialysis mode, dialyzer model, vascular access , Blood flow, etc., record the patient's emotional and cognitive function status, various clinical indicators and changes in the patient's quality of life before and after the start of treatment, and use multimodal magnetic resonance neuroimaging research sequences to analyze the changes in the patient's brain structure and function.

Eligibility criteria: Inclusion Criteria:

* Patients who are new to hemodialysis treatment, and those who are on regular hemodialysis treatment for ≥6 months.
* Age ≥ 18 years old.

Exclusion Criteria:

* There was already a severe central nervous system disease before dialysis.
* Hearing and visual impairment cannot communicate or cooperate.
* Mental illness and incapacity.
* The magnetic resonance examination could not be completed for various reasons.
* Life expectancy with serious diseases is less than 6 months.

Primary outcomes:
measure: Appears obvious emotional and cognitive decline, or abnormal head MRI
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: WENHU LIU, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00749970: Validity of the Spanish Version of Subjective Well-being Under Neuroleptics Scale (SWN-K) in Patients With Schizophrenia
Official title: Validity of the Spanish Version of Subjective Well-being Under Neuroleptics Scale (SWN-K) in Patients With Schizophrenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
Keywords: schizophrenia
subjective well-being
psychometric validation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-09-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient aged 18-year old or older with a diagnosis of schizophrenia, schizoaffective disorder, or shizophreniform disorder

Brief summary: Observational, short-term prospective, multicenter study to assess psychometric properties of the Spanish version of SWN-K scale in patients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder (DSM-IV TR criteria)
* Stabilized out-patients
* Under treatment with an oral antipsychotic drug

Exclusion Criteria:

* Administration of a depot antipsychotic drug
* Participation in another clinical trial within 4 weeks prior to enrolment into this study

Primary outcomes:
measure: SWN-K
timeFrame: 7 days
measure: PANSS
timeFrame: 7 days
Secondary outcomes:
measure: CGI-I
timeFrame: 7 days
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research site
city: Burgos
country: Spain
facility: Research site
city: Cordoba
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research site
city: Mallorca
country: Spain
facility: Research Site
city: Salamanca
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Tarragona
country: Spain
facility: Research site
city: Valencia
country: Spain
facility: Research Site
city: Valladolid
country: Spain
facility: Research Site
city: Vitoria
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
Study officials:
References:
Clinical trial NCT02991170: Effect of Radiofrequency Ablation in Patients With Ventricular Arrhythmia Undergoing CABG
Official title: Impact of Radiofrequency Ablation Therapy in Coronary Artery Bypass Grafts Surgery on Outcomes in Patients With Myocardial Infarction Related Ventricular Arrhythmia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: MI Related Malignant Ventricular Arrhythmia
Keywords: myocardial infarction
ventricular arrhythmia
radiofrequency ablation
Coronary Artery Bypass Grafts
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
Collaborators: name: Xuanwu Hospital, Beijing
name: Beijing Chao Yang Hospital
First posted: 2016-12-13
Enrollment: 180
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with myocardial infarction related potential malignant ventricular arrhythmia have high risk of sudden death. The aim of this clinical trial is evaluating therapeutic efficacy of unipolar or bipolar radiofrequency ablation in Coronary Artery Bypass Grafts (CABG) Surgery, which can reduce myocardial ischemia and block reentry circuits of ventricular arrhythmia at the same time. The observation indexes include the morbidity of potential malignant ventricular arrhythmia and major adverse cardiovascular events in mid-long-term after CABG surgery.


Eligibility criteria: Inclusion Criteria:

* The patients have been receiving coronary artery bypass grafts from 2015.1-2017.12
* The patients had old myocardial infarction related potential malignant ventricular arrhythmia
* Anti-arrhythmic drug treatment is invalid
* All enrolled patients must being signed the informed consent

Exclusion Criteria:

* Severe heart failure( ejection fraction under 35%)
* Patients with acute myocardial infarction
* Patients with ICD implanted

Primary outcomes:
measure: Morbidity of potential malignant ventricular arrhythmia
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Morbidity of major adverse cardiovascular events
timeFrame: 1 year after surgery
Other outcomes:
measure: Cardiac function
timeFrame: Change from Baseline Cardiac Function at 3 month, 6 month, 1 year, 2 year after surgery
measure: Cardiac electrophysiology index
timeFrame: Change from Baseline Cardiac Electrophysiology Index at 1 year and 2 year after surgery
measure: Seattle Angina Questionnaire
timeFrame: Change from Baseline Seattle Angina Questionnaire at 3 month, 6 month, 1 year, 2 year after surgery
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01394770: Aliskiren or Amlodipine in Hypertensive Hemodialysed Patients
Official title: Cardiovascular Events in Hypertensive Hemodialysed Patients: Aliskiren Versus Amlodipine. A Randomized, Double-blind Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Dialysis
Keywords: hypertension
dialysis
aliskiren
amlodipine
outcome
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
Collaborators: name: IRCCS San Raffaele
First posted: 2011-07-14
Enrollment: 350
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: Hypertensive haemodialysis patients are at high risk for cardiovascular events. This study was undertaken to ascertain whether aliskiren, a direct renin inhibitor, compared with amlodipine, a calcium channel blocker, reduces mortality and cardiovascular events in these high-risk patients.


Eligibility criteria: Inclusion Criteria:

* hemodialysed patients
* predialytic blood pressure greater or equal to 140/90 mmHg

Exclusion Criteria:

* history of heart failure
* history of ischemic heart disease
* severe aortic stenosis
* known allergy to aliskiren or amlodipine
* severe disorders of liver function

Primary outcomes:
measure: composite end-point of: all-cause mortality; cardiac event including myocardial infarction, need for coronary angioplasty or coronary bypass surgery, ischaemic stroke
timeFrame: 30 months
Secondary outcomes:
measure: composite end-point of: all-cause hospitalization, new-onset heart failure,new-onset atrial fibrillation
timeFrame: 30 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Second Univesity of Naples
Study officials:
References:
citation: Mugendi GA, Mutua FM, Natale P, Esterhuizen TM, Strippoli GF. Calcium channel blockers for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 Oct 1;10(10):CD011064. doi: 10.1002/14651858.CD011064.pub2.
Clinical trial NCT00768170: MK0633 Single Dose Study in Japanese Asthmatic Children Aged 12 to Less Than 16 Years (0633-028)
Official title: A Open-Label, Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK0633 in Japanese Asthmatic Children Aged 12 to Less Than 16 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-10-07
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the safety, tolerability and pharmacokinetics (PK) of MK0633 in adolescent mild-to-moderate Japanese asthma patients to permit further clinical investigation


Eligibility criteria: Inclusion Criteria:

* Patient Is Judged To Be In Good Health, Other Than Having Mild To Moderate Asthma, Based On Medical History, Physical Examination, Vital Signs, And Laboratory Safety Tests
* Patient Has No Clinically Significant Abnormality On Electrocardiogram (Ecg) Performed At The Prestudy (Screening) Visit And/Or Prior To Administration Of The Initial Dose Of Study Drug
* Patient Has At Least 1 Year Of Mild-To-Moderate Asthma
* Patient Has Been A Nonsmoker For At Least 6 Months
* Patients Of Childbearing Potential Must Agree To Use A Medically Acceptable Method Of Contraception During The Study
* Patients Must Be Able To Swallow Tablets

Exclusion Criteria:

* Patient Has A History Of Clinically Significant Endocrine, Gastrointestinal, Cardiovascular, Hematological, Hepatic, Immunological, Renal, Respiratory, Other Than Asthma, Or Genitourinary Abnormalities Or Diseases
* Patient Has Required A Visit To A Hospital Or Emergency Room Due To An Asthma Exacerbation Within 3 Months Of The Prestudy Visit
* Patient Has Unresolved Signs And Symptoms Of An Upper Respiratory Tract Infection (Uri) Or Has Had Had An Upper Respiratory Tract Infection Within 3 Weeks Prior To The Prestudy Visit
* Patient Has A History Of Stroke, Chronic Seizures, Or Major Neurological Disorder
* Patient Has A History Of Neoplastic Disease
* Use Of Theophylline, Anti-Allergic Compounds (Except For Nasal Drop And Eye-Drop Omalizumab, Zileuton, Oral Corticosteroid, And Oral Beta Agonists (Including Patch) Are Excluded \~ 2 Weeks Prior To Administration Of Study Drug And Throughout The Study 7)Patient Consumes Alcoholic Beverages

Primary outcomes:
measure: To evaluate the safety and tolerability of MK0633 in adolescent asthma patients based on any clinical or laboratory adverse experiences
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04120870: Comparison of Ketamine and Etomidate During Rapid Sequence Intubation in Trauma Patients
Official title: Comparison of Effects on Hemodynamics Between Ketamine and Etomidate During Rapid Sequence Intubation in Trauma Patients With High Shock Index
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Trauma
Shock, Traumatic
Keywords: etomidate
ketamine
rapid sequence intubation
trauma
hemodynamics
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
Collaborators: name: Unimedics (http://unimedics.co.kr)
First posted: 2019-10-09
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: ketamine group: ketamine 2 mg/kg iv as induction agent etomidate group: etomidate 0.2 mg/kg iv as induction agent
Primary purpose: OTHER

Brief summary: In trauma patients with high shock index, the investigators compare the effects on hemodynamics between ketamine and etomidate.

Detailed description: In trauma patients, rapid sequence intubation is recommended. The drug of choice, however, has been debated. One cohort comparative study showed ketamine had benefit in hemodynamics compared to etomidate in trauma patients. One observational study showed in high shock index patients, ketamine showed maintain systolic blood pressure. And other retrospective showed less clinical hypotension was less in ketamine. However there is no randomized controlled study comparing ketamine and etomidate in trauma patients. The purpose of this study is comparing the effects of hemodynamics between ketamine and etomidate in high shock index trauma patients.

Eligibility criteria: Inclusion Criteria:

* age 19\~70
* Shock index ≥ 0.9
* Patients who need intubation regarding to Ajou trauma center protocol

Exclusion Criteria:

* during CPR
* CPR before hospital arrival
* Severe head trauma
* Steroid intake history

Primary outcomes:
measure: Systolic blood pressure difference compared with baseline after 10 minutes
timeFrame: 13 minutes
Secondary outcomes:
measure: Intubating condition
timeFrame: 5 minutes
measure: Incidence of hypotension
timeFrame: 25 minutes
measure: Incidence of hypertension
timeFrame: 25 miinutes
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou university school of medicine
state: Gyeonggi-do
Study officials:
affiliation: Ajou University School of Medicine
name: In Kyong Yi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05543070: Low-dose Radiotherapy in iNHL
Official title: Low-dose Radiotherapy in Indolent Lymphoma：A Multi-center Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Indolent Lymphoma
Low-dose Radiotherapy
Keywords: indolent lymphoma
low-dose radiotherapy
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Shanxi Province Cancer Hospital
name: Beijing Tongren Hospital
name: Fujian Medical University Union Hospital
First posted: 2022-09-16
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of low-dose radiotherapy (3 Gy\*4f) in indolent lymphoma.


Eligibility criteria: Inclusion Criteria:

* Pathology proved iNHL
* ECOG PS ≤3
* Signed Informed consent

Exclusion Criteria:

* History of radiotherapy at the same site
* Primary malignant lymphoma of the gastrointestinal tract
* CTV (Clinical Target Volume)\>500ml
* Others that researchers consider inappropriate

Primary outcomes:
measure: Rate of clinical complete response after radiotherapy
timeFrame: 6-month after radiotherapy
Secondary outcomes:
measure: Overall response rate after radiotherapy
timeFrame: 6-month after radiotherapy
measure: Progression-free survival rate at year 2 after enrollment, 2y-PFS
timeFrame: 2-year
measure: Local control rate at year 2 after enrollment, 2y-LCR
timeFrame: 2-year
measure: Rate of acute toxicity (any and above grade 3)
timeFrame: From enrollment to 3 months after treatment
measure: Rate of late toxicity (any and above grade 3)
timeFrame: After 3 months of enrollment
measure: Quality of Life change, QoL
timeFrame: 1/3/6/12/24 months after radiotherapy
Other outcomes:
measure: Biomarkers to predict radiotherapy efficacy
timeFrame: baseline/through study completion, an average of 1 year
measure: Conjunctival microbiota
timeFrame: baseline/4 fractions/1/3/6/12/24 months after radiotherapy
Locations:
city: Beijing
country: China
facility: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
References:
Clinical trial NCT01366170: Biomarker Expression in Samples From Young Patients With Anaplastic Large Cell Lymphoma
Official title: Expression of T Immunoregulatory Proteins in ALK+ Anaplastic Large Cell Lymphoma (ALCL)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Keywords: childhood anaplastic large cell lymphoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-06-03
Enrollment: 7
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of anaplastic large cell lymphoma.

Brief summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment.

PURPOSE: This research trial studies biomarker expression in tissue samples from young patients with anaplastic large cell lymphoma.

Detailed description: OBJECTIVES:

* To determine the expression of immunoregulatory proteins including CD4, FOXP3 and CD276 in anaplastic large cell lymphoma (ALCL).
* To correlate the expression of these proteins with the levels of anaplastic lymphoma kinase (ALK) autoantibodies in patient of ANHL0131.

OUTLINE: Archived tissue microarray samples are analyzed by mass spectrometry and validated by Western blotting, flow cytometry, and IHC.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of anaplastic large cell lymphoma
* Tissue microarray samples available from the Cooperative Human Tissue Network (CHTN)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Expression of immunoregulatory proteins including CD4, FOXP3 and CD276 in ALCL
measure: Correlation of CD4, FOXP3, and CD276 with ALK autoantibody response in patients enrolled in ANHL0131
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: C.S. Mott Children's Hospital at University of Michigan Medical Center
name: Megan S. Lim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04340375: Anti-pollution Effects of AP Green Tea Extracts
Official title: A Clinical Study to Evaluate the Anti-pollution Effects of AP Green Tea Extracts in Subjects With Discomforts Related to the Respiratory System by Prolonged Exposure to Particulate Matter in Air Pollution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Conditions Due to Unspecified External Agent
Keywords: Anti-pollution
green tea extracts
Lead sponsor: Amorepacific Corporation
Sponsor class: INDUSTRY
First posted: 2020-04-09
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of this clinical trial is to evaluate the anti-pollution effects of AP green tea extracts in subjects with discomforts related to the respiratory system by prolonged exposure to particulate matter in air pollution


Eligibility criteria: Inclusion Criteria:

* Subjects aged 19 years or over
* Subjects with discomforts related to the respiratory system by prolonged exposure to particulate matter in air pollution
* Subjects who voluntarily decide to participate in this clinical study and sign the informed consent form on their own or through their representatives

Exclusion Criteria:

* At the screening visit, subjects who were diagnosed with acute or chronic respiratory disease and undergoing medication.
* Subjects who were diagnosed with ventricular associated disease, unstable and uncontrolled chronic medical disease, or active malignant tumor and undergoing medication within 4 weeks prior to the first administration of the investigational product
* Subjects who show a level of ALT/AST of 2 times or more the upper limit of normal as a result of a screening test and have acute or chronic hepatitis or known liver cirrhosis
* In addition to the above, subjects who are determined to be ineligible to participate in the clinical study according to the investigator's medical opinion

Primary outcomes:
measure: Pulmonary function test
timeFrame: 4 weeks
measure: Pulmonary function test
timeFrame: 8 weeks
measure: Respiratory health survey
timeFrame: 4 weeks
measure: Respiratory health survey
timeFrame: 8 weeks
measure: Biomarkers
timeFrame: 4 weeks
measure: Biomarkers
timeFrame: 8 weeks
measure: Heavy metals
timeFrame: 4 weeks
measure: Heavy metals
timeFrame: 8 weeks
Secondary outcomes:
measure: Bronchial assessment
timeFrame: 4 weeks
measure: Bronchial assessment
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
Study officials:
References: